Notice Restylane Angl PDF

Clinical Guide
to Restylane
Chapter X
Chapter X
Table of contents
Chapter 1
Introduction to Esthetic treatment ........................................................................................................................................... 4
Chapter 2
NASHA technology ..................................................................................................................................................................... 6
Chapter 3
Restylane range of products overview ................................................................................................................................ 10
Chapter 4
Treatment session ............................................................................................................................................................................ 12
Chapter 5
Injection techniques ........................................................................................................................................................................ 13
Chapter 6
Skin rejuvenation using the Restylane Injector ............................................................................................................. 16
Chapter 7
Pain management ............................................................................................................................................................................. 18
Chapter 8
Instructions for use and Needle assembly ......................................................................................................................... 19
Chapter 9
Treatment results ............................................................................................................................................................................. 28
Chapter 10
Questions and answers ................................................................................................................................................................ 30
References
Chapter X
Introduction to esthetic treatment

Esthetic treatment
Esthetics is a branch of philosophy concerned with beauty and
taste, while treatment can be defined as the treatment of a disease
or disability, or a healing power or quality. The term esthetic
treatment can therefore be interpreted to mean a treatment for the
restoration of beauty. In this short overview the focus will be on
the use of esthetic treatment as a means of restoring or improving
facial beauty.
Since ancient times, women and men have used various means
to improve or restore their facial beauty or mask the signs of skin
aging. At certain ages or under certain conditions more effective
methods have been sought to achieve the desired effect. Esthetic
treatments have therefore been developed to provide more effective
alternatives for those wishing to improve their facial appearance.
Structure and function of the skin

Successful esthetic treatment requires a thorough understanding
of the structure and function of the skin. The total surface of the
skin measures approximately 2 m2 and weighs about 2 kg. The skin
has a multitude of functions acting as a physical barrier against
ultraviolet (UV) radiation, water, chemicals, bacteria, fungi and
trauma. It also has an immunological function and regulates body
temperature. Sensory nerve endings in the skin detect pain, touch,
cold and heat, while vitamin D critical for the mineralization
of bones is synthesized in the skin through the action of UV
radiation. The skin may also play a role in reproductive function
as sexual attractiveness is influenced by both the visual appearance
and smell of the skin.
The skin comprises three layers: the epidermis, dermis and subcutis
(Figure 1).
The epidermis is subdivided into the basal cell layer, squamous cell
layer, granular layer, clear layer and outer cornified layer (stratum
corneum). The thickness of the epidermis varies across the body;
for example, the epidermis of the eyelid is about 0.05 mm thick,
Figure 1.
while on the soles of the feet it is about 2 mm thick. The cellular

population of the epidermis consists largely of keratinocytes,
with smaller populations of melanocytes (responsible for skin
pigmentation) and Langerhans cells (immunologically active
cells). The keratinocytes of the basal cell layer undergo cell
division and differentiate as they migrate upwards through the
strata, becoming flattened, losing their nuclei and filling with
keratin. At the stratum corneum flakes of dead cells are found
surrounded by lipids. These are called corneocytes and form the
principal skin barrier against water loss. Cell turnover from the
basal layer to the stratum corneum takes approximately 4 weeks in
a healthy individual. Due to the lack of vascularization within the
epidermis, nutrients and water must passively diffuse or be actively
transported from the dermal layer located beneath.
The upper part of dermis is denoted papillar dermis, comprising
fine elastic fibers, and below it the thicker reticular dermis. The
dermis varies in thickness from 0.5 mm on the eyelids to 3 mm
on the back. The cell population in this layer consists mainly of
fibroblasts which synthesize and maintain components of the
extracellular matrix. These components bind water to produce a
viscoelastic gel that allows nutrients, hormones and waste products
to pass through. The extracellular matrix also gives strength and
flexibility to the skin, and acts as a shock absorber. Some of the
important components of the extracellular matrix include collagen,
which prevents the skin from tearing when stretched, elastin that
gives the skin its elasticity, and hyaluronic acid, which binds water
and creates volume in the skin. Other components of the dermis
include mast cells, lymphocytes, lymph vessels, sebaceous glands,
free sensory nerve endings, hair shafts and bulbs, and sweat glands.
The dermis is vascularized by a network of capillaries within its
deeper layers.
The third layer of the skin is the subcutis, which consists of
subcutaneous fat. In addition to acting as a reservoir for energy,
this layer has a mechanical protective role.
Cross section through the skin.
Epidermis
(0.15-0.50mm)
Dermis
(1-3mm)
Restylane Vital
Restylane Touch
Restylane
Subcutaneous tissue
Restylane Perlane
Muscle tissue
Bone tissue
Chapter 1
Restylane SubQ
Mechanisms of skin aging

Skin aging is a complex process involving many different
mechanisms. These can be divided into intrinsic mechanisms (e.g.
the biological clock), which affect all three layers of the skin, and
extrinsic mechanisms related to environmental and lifestyle factors.
The visual signs of skin aging are mostly related to extrinsic factors
with photoaging of the skin by UV radiation from over-exposure to
the sun being a major cause. Other important factors are smoking
(which damages the vasculature of the skin), alcohol, food intake
and sleeping habits. The most effective methods to counteract skin
aging are avoiding overexposure to the sun, and not smoking.
Photoaging mainly affects the epidermis and dermis, as UV radiation
seldom reaches the subcutis. Epidermal changes from UV exposure
include roughening of the skins surface texture, increased scaling and
changes to skin pigmentation. In the dermis, collagen and elastin are
degraded, affecting the function of endogenous hyaluronic acid. The
net result is that skin elasticity and water-binding capacity decrease,
and subcutaneous fat undergoes partial atrophy and redistribution.
Thus, the visual signs of aging, such as alterations in skin texture and
pigmentation, wrinkles and sagging of the skin, directly correspond
to the effects of UV radiation on different layers of the skin.
Approaches to esthetic treatment

Given the diverse nature of the processes which contribute to
skin aging, successful esthetic treatment for facial rejuvenation
requires the choice of treatment to be tailored to the underlying
damage. This highlights the importance of understanding the
mechanisms of skin aging when choosing the right procedure or
combination of procedures for esthetic treatment. For example, a
face-lift procedure might tighten up the texture of aging skin, but
will not counteract any three-dimensional changes that have taken
place in the surrounding tissues such as bone resorption and fat
atrophy/redistribution. Additionally, changes in skin pigmentation
occurring over time will not be addressed by a face-lift. A number
of non-invasive treatments are available for facial rejuvenation.
Lasers have been used to correct pigmentation changes, activate
components in the dermis and remove small superficial vessels and
wrinkles. Under certain circumstances lasers can also be used for
lipolysis and dermabrasive therapy of the skin. Lasers are also used
in photodynamic therapy to activate a photosensitizer that destroys
diseased cells. This approach was originally used for the treatment
of pre-malignant skin conditions and basalioma, but has also proved
effective in cosmetic applications. Intensive pulsed light has been
used for hair removal and for the treatment of small superficial
vessels and pigmentation changes in the skin.
Skin peeling is a procedure aimed at removing old skin components
and stimulating the function of newly formed skin components in
order to achieve facial rejuvenation. This procedure is also useful
to treat superficial changes in skin pigmentation. Usually several
treatments sessions are required and some procedures (e.g. chemical
peeling) require extended pre-treatment periods and significant
downtime can be expected following treatment.
Other non-invasive techniques include monopolar radio frequencies
to deliver energy for the removal of wrinkles and folds, an effect
that has been attributed to the tightening of collagen in the dermis.
Botulinum toxin has also proved effective for the treatment of
dynamic wrinkles as well as modulating facial expression, by causing
relaxation of the facial muscles. However, a major disadvantage of
these non-invasive techniques is that they do not directly address
the loss of skin volume or hydration, or fat atrophy that may have
occurred as a result of aging. In these circumstances it is necessary to

augment the skin with a filler material.
The first products developed for facial tissue augmentation were
permanent dermal fillers and contained substances such as silicone,
followed in the early 1980s by bovine collagen implants. More
recently, animal-derived hyaluronic acid products and a diverse
range of semi-permanent and permanent dermal fillers have become
available. Some of these products are associated with a relatively
high frequency of complications while those of animal origin require
pre-testing to avoid hypersensitivy reactions. Permanent and semipermanent fillers should be used with great caution since the risk
of eliciting a foreign body response persists as long as the filler is
present within the tissue. Furthermore, aging-related changes in the
tissue surrounding the dermal filler may lead to the development of
local facial asymmetries.
Restylane: a new approach to facial tissue

augmentation
The introduction in the mid-1990s of stabilized hyaluronic acidbased gels of non-animal origin founded on the patented NASHA
technology of Q-Med AB, Uppsala, Sweden, set a new gold standard
in facial tissue augmentation. Various injectable NASHA based
gels including Restylane, Restylane Perlane, Restylane Lipp,
Restylane SubQ and Restylane Touch, have been developed as
instant esthetic treatments for facial soft-tissue augmentation. The
Restylane range of products are characterized by a non-permanent,
but long-lasting duration of action, and have demonstrated good
efficacy and safety profiles during extensive clinical testing. Since
NASHA based gels are stabilized to result in minimal modification
of the hyaluronic acid, these dermal fillers have a high degree of
biocompatibility. Many biodegradable dermal fillers shrink gradually
upon degradation, but NASHA based gels have the unique
property of maintaining their volume throughout this process.
Due to isovolemic degradation, the gel molecules are able to take
up more water as it is broken down. Variations in particle size and
cohesive properties of different Restylane dermal fillers allows for
true tissue tailoring, with the type of filler matched to the tissue layer
into which it will be placed. This results in superior lifting capacity
and minimal matrix disturbance.
The diverse collection of products in the Restylane range provides
numerous options for facial tissue augmentation (i.e. increase of
the skin/tissue volume), including the correction of lines and folds,
contouring of three-dimensional topography and enhancement of
individual facial esthetics. In addition to facial tissue augmentation,
the NASHA-based product range Restylane Vital rejuvenates
the skin by improving skin structure. The treatments restore skin
hydrobalance and improve elasticity to create a fresh and natural
look.
A thorough understanding of the structure and function of the
skin and the mechanisms involved in skin aging has allowed for the
development of highly effective esthetic treatment. The ability to
determine the type and extent of skin damage in a particular patient
enables tailoring of treatments specifically to the individual. The
Restylane range of NASHA based products offers effective and
biocompatible solutions for tissue augmentation and rejuvenation,
and as clinical experience with these products increases, further
beneficial effects of hyaluronic acid placement in the skin will
continue to emerge.
Chapter 1
NASHA technology
In 1998, Q-Med AB patented the NASHA technology, a science-based technological platform that
makes it possible to design products with special properties to address different intended uses and
patient needs.
The cornerstones of the

NASHA technology are to:
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The hyaluronic acid (HA) is manufactured
biotechnologically by using cultured bacteria
to obtain a very pure and consistent material.
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to the hyaluronic acid molecule to obtain the
desired physical form and to increase its
residence time in the body.
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superior tissue biocompatibility. Both properties are distinctive
advantages for medical and esthetic applications.
Hyaluronic acid
HA exists naturally in living organisms and is identical between
species and tissues. HA was first isolated in 1934 from the vitreous
of bovine eyes. In the last two decades its applications have
extended to many biomedical areas, including the treatment of
joint pain, fertility and medical esthetic applications.
HA is a polysaccharide made up of repeating disaccharide units,
comprising D-glucuronic acid and N-acetylglucosamine.
Independent of its origin hyaluronic acid contains only these two
sugar units. The identical structure of the HA molecule within and
between species, is of significance from a biological perspective
HA is thus an ideal material for medical use, due to its inherent
biocompatibility.
Approximately 56% of the bodys HA is found in the skin. The
dermis comprises a matrix of collagen and elastin fibers, suspended
in an HA-rich extracellular matrix. The environment created by
HA offers resistance to compression and protects the structures
underlying the skin from physical damage. HA also performs a
lubricating function, and enables the skin to accommodate changes
in shape and volume that occur when bones and joints move.
Chapter 2
The distribution of endogenous HA in the skin and throughout

the body changes over time. Less accessible HA and thereby
a diminished capacity for water-binding of the HA molecule
leads to loss of volume of the skin, wrinkle formation and the
characteristic signs of aging.
Biocompatibility
Figure 2.
Q-Med uses biotechnologically obtained HA as raw material in

the manufacturing process of esthetic and medical gel implants.
The HA used in the manufacturing process of Q-Med gel implants
is produced by bacterial cells. By using bacteria as a source for HA
the risk of having products contaminated with, for example, viruses
or proteins from animal sources has been abrogated. In addition,
the carefully controlled fermentation process, by which the HA
is produced, will minimize the presence of potentially harmful
components, such as proteins, endotoxins and other impurities.
The HA thus obtained is characterized by a high degree of purity.
The biocompatibility of Q-Med esthetic and medical implants has
been tested in accordance with the guidelines of the ISO 10993
standard on Biological Evaluation of Medical Devices. These tests
have shown that the gel implants have a very good safety profile.
They do not cause any local or systemic toxic effects, they are not
genotoxic, and they are not sensitizing or irritating.
Half-life in the skin, stabilization and isovolemic

degradation
The half-life of HA is <24 hours in the skin. This is why the bodys
own HA is not effective as implant material. Stabilization of the
HA molecule is thus essential to achieve the desired effectiveness
of a medical esthetic implant.
Q-Meds esthetic and medical gel implants, such as Restylane
contain stabilized HA - manufactured with Q-Meds patented
NASHA technology. Using this technology, HA molecules are
modified to a very minor degree (<1%). Stabilization results in
a 3-dimensional hyaluronic acid gel matrix through a minimum
degree of binding between neighboring HA molecules. Gel particles
of different sizes are thereafter produced for different esthetic and
medical applications. Q-Meds NASHA technology thus allows
the manufacture of products with physical characteristics that
match the intended uses. (Figure 2)
Figure 3.
Restylane gel injected in tissues as esthetic implant, results in

tangible, long-lasting (up to 1 year) volume enhancement effects,
as a consequence of the unique stabilization process and the
structural characteristics of the resulting gel particles. The removal
of the gel implant in time occurs through the degradation of the
three-dimensional gel matrix. HA chains are slowly released from
the gel and biodegraded by the same mechanisms as those that
degrade the bodys own HA. This occurs very slowly, by a process
called isovolemic degradation, which preserves implant volume
over time (Figure 3).
The NASHA gel is isovolemically degraded
Chapter 2
.H\EHQHWV1$6+$ technology
Non-permanent products
NASHA products consist of a crystal clear gel of stabilized
hyaluronic acid. The gel is biocompatible and readily becomes
integrated into the tissue. It is non-permanent, i.e. it is biodegraded
by the bodys own mechanism and will thus disappear naturally
over time.
Superior lifting capacity
NASHA gels are characterized by a superior skin lifting capacity,
i.e. the ability to lift the skin under a wrinkle or a fold to achieve
the desired esthetic effect.
This is achieved by the structure and properties of NASHA gels.
The treatment will result in increased dermal volume and plump
tissue which characterize young skin.
Skin rejuvenation
Kerscher et al studied the rejuvenating influence of Restylane
Vital on aged facial skin and found that the treatment generated
a significant increase in cutaneous elasticity and also a significant
decrease in skin surface roughness.
Tissue-tailored for maximum esthetic effect
The gel particle size in Restylane products, is carefully designed for
injection into different dermal layers, to support different esthetic
applications. This so-called tissue-tailoring concept enables the gel
to match the density of the target tissue for which it is intended,
resulting in a long-lasting esthetic enhancement. The versatility of
the Restylane gel product range allows you to optimize the esthetic
enhancement effect for each individual patient. (Figure 4)
6FLHQWLFDOO\GRFXPHQWHGHIFDF\
Q-Med has through several scientifically documented clinical
studies obtained an extensive amount of data demonstrating the
efficacy and the duration of the NASHA gels3. Clinical trials show
that the duration of the esthetic enhancement lasts considerably
longer than several other non-permanent esthetic treatments4. The
response is individual and depends on the injected NASHA gel
and the desired esthetic effect.
Chapter 2
Compliance with international safety standards

t NASHA gels contain stabilized hyaluronic acid of non-animal
origin. Therefore there is essentially no risk of inflammatory
reactions due to the presence of potentially harmful contaminants
such as viruses, proteins and endotoxins, as is the case when
using products containing hyaluronic acid from animal sources.
t All Q-Meds esthetic and medical implants are moist heat
sterilized for maximum safety and comply with international EU
safety standards. The manufacturing process for the Restylane
product range complies with the internationally recognized
ISO 13485:2003 standard, and the local requirements of
markets where the products are registered. Restylane was
the first HA-based dermal filler approved by the FDA.
t NASHA gels are associated with a minimal rate of transient
adverse events (0.04 -0.15 %), after > 10 million reported
treatments worldwide5. The most commonly observed adverse
events are injection-related reactions such as swelling, erythema,
tenderness and pain, which resolved spontaneously within 1-2
weeks6. There have been no reported implant rejection problems.
t The clinical documentation obtained through investigator
initiated studies (IIS) and Investigator Sponsored Studies
(ISS) on the safety of NASHA gels is readily available to all
customers.
Product development through science

t Q-Med has a well developed Research and Development
(R&D) department constantly working on product
innovation and optimization of treatment techniques.
t All NASHA gels are specially designed in order to meet the
patients needs and the anatomy and physiology of the skin. Gel
particle size, structure and characteristics are carefully adjusted
to match the different layers of the skin and the various intended
uses, in order to achieve maximum esthetic results.
Figure 4.
Tissue-tailoring concept
Chapter 2
Restylane range of products overview
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FUHDWLQJVRIWQHVVDQGUHYLWDOL]LQJWKHRYHUDOOORRNDQGIHHO,WLVRQHRIWKHZRUOGVPRVWZLGHO\
used products based on hyaluronic acid for esthetic enhancement. Restylane has an extensive and
JURZLQJERG\RISXEOLVKHGFOLQLFDOHYLGHQFHZKLFKXQGHUOLQHWKHHIFDF\DQGVDIHW\WKXVPDNLQJ
Restylane the obvious choice from an evidence-based medical perspective.
The Restylane product portfolio comprises a range of products for facial beauty treatment,
VSHFLDOO\GHVLJQHGWRUHMXYHQDWHOORXWIROGVDQGZULQNOHVFRQWRXUDQGFUHDWHYROXPH(DFK
product is specially designed to a particular tissue level in order to meet the different anatomy and
SK\VLRORJ\RIWKHVNLQ*HOSDUWLFOHVL]HVWUXFWXUHDQGFKDUDFWHULVWLFVDUHFDUHIXOO\DGMXVWHGWRPDWFK
the different layers of the skin and the various intended uses, in order to achieve maximum esthetic
results and duration.
Restylane
Restylane was the first hyaluronic acid product to be approved by the
FDA for esthetic use. It is specifically designed to reduce the appearance
of moderate facial wrinkles and folds, such as frown and glabellar lines.
It may also be used to treat smile lines and marionette lines at the corners
of the mouth.
Restylane Perlane
Restylane Perlane is used for the correction of deeper wrinkles and
folds such as nasolabial folds. It is also a powerful tool for shaping facial
contours, and provide minor to moderate contouring of the cheek or
eyebrow area, accentuating the existing features.
Restylane Touch
Restylane Touch is designed to reduce the appearance of fine, superficial
lines such as the periorbital and periorial lines. It can also be used to
reduce scars.
Restylane Lipp
Restylane Lipp is designed to meet the specific, highly dynamic
demands of the anatomy of the lip. It is structured to withstand the
strains associated with the full range of mouth movements. Restylane
Lipp is designed to provide lip enhancement over time.
10
Chapter 3
Restylane SubQ
Restylane SubQ is designed for volumetric contouring of facial features.
It is injected deeply to add volume, which supports the overlaying tissue
to provide facial fullness and restore symmetry. This treatment is ideal
for patients with flattened facial features, or those with an unbalanced
or asymmetrical face. It is also suitable for patients reluctant to undergo
facelift surgery or the insertion of permanent implants.
Restylane Vital
Restylane Vital is a smooth NASHA gel designed to restore and
maintain skin hydrobalance. It improves the elasticity and smoothness
of the skin. Restylane Vital is ideal for rejuvenation of mature and
photodamaged skin.
Restylane Vital should be given in a treatment cycle of 3 sessions 4
weeks apart, to be repeated after 6 months.
Restylane Vital Light
Restylane Vital Light is designed for younger, thinner skin which
requires a lighter rejuvenating effect. Restylane Vital Light is a smoother
and more fluid gel which adjusts well to delicate skin. Restylane
Vital Light is therefore suitable for areas with thin skin such as neck,
dcolletage and the back of hands.
Restylane Vital Light should given in a treatment cycle of 3 sessions
2-4 weeks apart, to be repeated after 4-6 months. Individual treatment
programs can be designed according to the quality of the skin area
treated.
Product
Recommended indications
Where to inject
Restylane
Moderate facial wrinkles
Mid dermis
Restylane Perlane
Deep wrinkles and folds, facial contouring
Deep dermis/ upper subcutaneous layer
Restylane Touch
Fine superficial lines
Upper dermis
Restylane Lipp
Lip enhancement
Deep dermis/ upper subcutaneous layer
Restylane SubQ
Facial contouring/chin
and cheek augmentation
Deep subcutaneous layer

or supraperiosteal
Restylane Vital
Rejuvenation of mature and

photodamaged skin
Dermis, preferably deeper
Rejuvenation of thin skin areas

and younger skin
Mid-dermis
Indications that can be

treated with Restylane
Upper face
t
t
t
t
Worry lines
Glabellar lines
Eye brow
Forehead
Middle face
t
t
t
t
t
t
Tear trough
Periorbital lines
Cheek augmentation
Nose
Nasal bridges
Ear lobes
Lower face
t
t
t
t
t
Nasolabial folds
Perioral lines
Smile lines & oral commisures
Lip enhancement
Chin augmentation
Skin rejuvenation
t
t
t
t
Face
Neck
Dcolletage
Hands
Chapter 3
11
The treatment session

Initial consultation
Pain management
t Inform the patient about the procedure and the possible outcome
as well as of the possibility of side effects. Answer any questions
or address any concerns they may have. A brief medical history
should be taken with special reference to any bleeding disorders
or previous skin therapies, e.g. tissue augmenting or laser and
peeling procedures.
t Discuss the appropriate indications, risks, benefits and expected
responses to the treatment.
t Advise the patient that the treatment takes approximately 30
minutes and that the final result may take a few days to see as
there may be some initial redness or swelling.
t Advise the patient of the necessary precautions before
commencing the procedure.
t A patient brochure is available from Q-Med for additional
information to read.
t Assess the patients need for pain management. Offer a variety

of choices such as using ice, EMLA or anesthesia and discuss
the risks and benefits with each patient. For lip enhancement a
dental block may be advisable.
Inform the patient about Restylane

t Emphasize that the Restylane range of products consist of
stabilized non animal hyaluronic acid gel which is almost
identical to the bodys own hyaluronic acid.
t The Restylane range of products cover many areas of interest
when considering facial treatment such as restoring hydrobalance
and increasing elasticity of large skin areas, correction of lines
and folds, contouring of the three dimensional topography and
enhancement of facial esthetics as requested on an individual
basis.
Treatment with the Restylane range of products

t It is strongly recommended that a signed informed consent
form is obtained from the patient prior to a treatment. These
can be obtained from Q-Med in several languages.
t Remove any make up and clean the treatment site with an
antiseptic solution.
t Remove the patient record label (removable label on the syringe)
and attach it in the patient record form, this ensures traceability
in case of any adverse events or other issues that may come up.
Record forms are available from Q-Med in several languages.
t There is a variety of injection techniques available to choose
from. Which technique to use will depend on a variety of
factors such as indication to be treated, individual patient
needs, and personal preference on the practitioner part. The
various injection techniques available are discussed further on
this clinical guide for Restylane.
Combination treatments
t For combination treatments such as with botulinum toxin, laser
or chemical peeling, a treatment plan needs to be set up to avoid
suboptimal results of the Restylane treatment.
Managing patient expectations

t It is recommended that the reason for the patient seeking
treatment and the suitability of the treatment modality for the
site and indication be discussed.
t Pre- and post-treatment photos are recommended.
t Inform the patient that touch ups may be necessary within 2-4
weeks to achieve optimal results.
t Recommend a maintenance plan similar to other beauty regimes.
Timing depends on indication treated, the patients intrinsic
and extrinsic factors and the degree of perfection expected by
the patient.
12
Chapter 4
Post treatment
t Provide the patient with a post treatment checklist. These can be
obtained from Q-Med.
t Provide the patient with contact details in case of questions or
concerns that may arise after leaving the clinic.
Injection techniques
There are various techniques available. The following techniques recommended for use with
the Restylane range of products have been selected based on usage during clinical trials with
the Restylane range of products or as recommended in peer reviewed journals. A number of
important factors must be considered when selecting the technique to be used, including the area
to be treated, depth of the injection, volume of the product injected, and technical features related
to the needle. Certain techniques may require the use of several needles in order to maintain
patient comfort throughout the treatment. As with all injection procedures/ techniques, before
injecting, the air should be removed from the syringe up to the point where a droplet is visible at
the tip of the cannula/needle.
Basic techniques
Figure A
Serial puncture technique
Serial puncture technique

Multiple injections are closely spaced punctures along fine lines,
wrinkles and folds. The serial placements of the product within
the skin should join together into a smooth continuous line. There
should be no spaces between the injected material. (Figure A)
Figure B
Linear/ serial threading technique
Linear/ serial threading technique

The full length of the needle is inserted in the middle of the
wrinkle. Restylane is injected while pulling the needle slowly
backwards (retrograde). The threads, each approximately
10 mm long, are injected along the length of a facial defect or
area of desired enhancement. Together the threads will form one
single string, lifting the wrinkle to the desired level of correction.
Serial threading combines the serial puncture and linear threading
techniques. (Figure B)
Chapter 5
13
Advanced techniques
For large areas and facial shaping
Figure C
Fanning technique
Fanning technique
Insert the needle at the periphery of the area intended to be
augmented as when using the linear threading technique. After
injecting one line do not withdraw the needle from the skin.
Instead, change the direction of the needle and inject as before
along a new line and repeat this in a fan shaped pattern. In this
way a relatively large area can be covered while minimizing the
number of puncture sites through the skin. (Figure C)
14
Chapter 5
Figure D
Cross-hatching technique
Cross-hatching technique
Insert the needle at the periphery of the area intended to be
augmented and inject as when using the linear threading
technique. Withdraw the needle from the skin and insert it 5-10
mm adjacent to the first puncture site and inject in the same way.
This procedure can then be repeated from different sites around
the area to be treated and at slightly different levels. (Figure D)
Advanced techniques
For volumetric contouring
Figure E
Transdermal injection technique using a blunt cannula / sharp needle
Transdermal injection technique using a blunt cannula

Create a transdermal aperture using an 18G needle or a number 11
blade scalpel to facilitate entry of the cannula. Insert the cannula
trough the aperture. Determine the position of the cannula tip
prior to injecting the product. Tent the overlying tissue with the
tip of the cannula to ensure the correct depth for injection. Inject
small aliquots in a retrograde fashion while withdrawing the
cannula creating tunnels along the way, with the cannula facing
downwards. Do not apply extensive pressure to the syringe at
any time. If resistance is encountered the cannula/needle should
be partially withdrawn and repositioned or fully withdrawn and
checked for function. Do not inject superficially. Avoid injecting
when removing the cannula. Leave a clear/ empty zone from the
point of incision. (Figure E)
Transdermal injection technique using a sharp needle
Inject using a perpendicular technique, i.e. vertically insert the
needle down to the bone/ periosteum. Aspirate before injecting to
make sure not injecting intravasculary. Inject a small bolus slowly
and while retracting the needle, taking care not to inject to close
to the skin (to superficially) Stop injecting the product, withdraw
the needle and move to an adjacent site. Repeat the process.
(Figure E)
For skin rejuvenation

Figure F
Micropuncture technique
Micropuncture technique
Inject very small amounts intradermally (mid to deeper part of
dermis) of micro deposits about 1 cm apart. Repeat the procedure
over the selected skin area. (Figure F)
Figure G
Short linear threading technique
Short linear threading technique

Insert approximately two thirds of the needle in mid-dermis.
While retracting the needle in a retrograde direction, gently press
the plunger for three separate depositions of product. Avoid
depositing product to close to each other. Adjust plunger pressure
to the needed extrusion force for each product used (the force to
extrude Restylane Vital Light is lower than for Restylane Vital).
(Figure G)
Chapter 5
15
Skin rejuvenation using

the Restylane Injector
The Restylane Injector assist in the delivery of Restylane Vital Light and gives predictable treatment results. This unique injection device
enables an even volume ditribution over large skin areas giving a controlled dosage of 10 l of gel per injection site. As the Restylane
Injector is preloaded with 2 ml of Restylane Vital Light, one injector can deliver approximately 200 doses.
1. Wind knob
2. Volume guide
3. Product reservoir
4. Dose activator
5. Luer lock adaptor
6. Protective cap
1a.
1. Apply needle
a. Hold the Restylane Injector at the product reservoir and unscrew the
protective cap.
1b.
1
b. Attach the needle firmly to the Restylane Injector, by pushing and
screwing the needle hub into the luer-lock connection until stop.
2
2.
2. Wind the Restylane Injector

Hold the Restylane Injector with one hand around the body and twist
the knob clockwise until it stops (approximately 20 full turns).
16
Chapter 6
3.
3. Prime the Restylane Injector
Remove the needle cap, hold the Restylane Injector upright and
press the dose activator until you hear a click. Repeat this procedure
(normally 15-25 times) until a droplet is visible on tip of needle.
4.
4. Rotate needle
If you prefer the needle tip in a specific position, this can be achieved
by twisting the product reservoir.
5.
5. Injection
a. Prepare the skin for treatment.
b. Hold the Restylane Injector comfortably, for example as if holding a
pen, with the index finger on the dose activator.
c. Insert the needle at the desired depth in the dermis.
d. Press the dose activator (you will now hear a click).
e. Wait until you hear a second click indicating that the full dose is
delivered, which typically takes up to 3 seconds.
f. Promptly move to the next site and immediately insert the needle to
minimize any product waste.
6. Rewinding
After approximately 50 injections the Restylane Injector needs to be
rewound. The need for rewinding will be indicated when delivery of
dose takes more than 3 seconds or when the dose activator no longer
responds when pressed. Normally, the Restylane Injector needs to be
rewound 2-4 times during a treatment session.
6.
7. Disposal
After approximately 200 deposits the product reservoir is empty and
the injector can be disposed. Remove the needle and place it in a
container for sharp objects.
Chapter 6
17
Pain management
(DFKSDWLHQWVQHHGIRUSDLQUHOLHIVKRXOGEHDVVHVVHGSULRUWRWUHDWPHQW,QVRPHFDVHVSDLQUHOLHILV
not necessary when injecting into the skin for the correction of wrinkles and folds. However, each
individual experiences pain differently and should be able to choose what suits them best.
3DWLHQWFRPIRUWWHFKQLTXHVLQFOXGHDQHVWKHVLDWRSLFDOLQOWUDWLYHDQGQHUYHEORFNLQJGLVWUDFWLRQ
techniques including carrying on a dialogue with the patient or using ice to numb the area of injection.
For certain indications Q-Med strongly recommends anesthesia such as lidocaine when injecting
the lips, for volumetric contouring or rejuvenation of large skin areas.
Zygomatic facial nerve block
Figure A
,PDJHRI]\JRPDWLFIDFLDOQHUYHEORFNEHLQJDGPLQLVWHUHG
Figure B
Image of infraorbital nerve block
Figure C
Image of topical anesthesia
Figure D
Image of ice pack being used
To anesthetize the outer cheek and orbital area locate the

zygomatic facial nerve(s,) which usually exit below the lateral
orbital retaining ligaments, and inject 1-2 ml of lidocaine with
epinephrine 10-20 mg/ml. (Figure A)
Infra orbital and/or mental nerve block

To anesthetize the central cheek and upper lip feel the gingival
of the upper teeth to locate the canine eminence (corresponding
to the socket of the canine tooth). Just lateral to it or between
the 3rd and 4th tooth at the mucosal fold you inject 0.5-1.0
ml of lidocaine with epinephrine 10-20 mg/ml. For the lower
lip and/ or chin locate the mucosal fold between the premolars
(4th and 5th tooth) and inject as above. (Figure B)
Topical anesthesia
The application of an anesthetic cream to the area to be treated
can reduce discomfort. It is usually not sufficient to use only
topical anesthesia when giving full lip treatment, but it can be
used when treating only the lip line. For sufficient numbing of
the area, the patient needs to sit with the anesthetic cream for at
least 30 minutes prior to injection. (Figure C)
Ice
Ice is often used in combination with pain relief such as
anesthesia or distraction techniques to further numb the area
as well as cause increased vasoconstriction of the injection
site. Recommend the patient to invest in an ice pack for post
treatment care for at home comfort once the anesthesia wears
off. (Figure D)
18
Chapter 7
Instruction for use and Needle assembly

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RESTYLANE TOUCH INSTRUCTIONS FOR USE

Composition
Hyaluronic acid, stabilized
Phosphate buffered saline, pH 7
20 mg/ml
q.s.
Description
RESTYLANE* Touch is a clear, transparent and viscous gel supplied in
a glass syringe together with a 30 G needle. The product is for single
use only. RESTYLANE Touch is a unique form of stabilized non-animal,
hyaluronic acid. Hyaluronic acid is a natural polysaccharide which occurs
as an important structural element in the skin and in subcutaneous and
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acid belongs to a group of very few substances which are identical in all
living organisms.
Mode of action
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thereby supporting the overlying (dermal) tissue to restore the skin
contours to the desired level of correction.The hyaluronic acid molecules
hydrophilic nature combined with its three-dimensional structure allows
the molecules to bind water many times its own weight. The addition
of water helps to maintain the overall volume of the product resulting
in a longer duration. RESTYLANE Touch is naturally integrated into the
tissue and will in time undergo isovolemic degradation. The isovolemic
pattern of degradation increases the water binding capacity of the gel,
thus allowing RESTYLANE Touch to maintain the overall volume during
the degradation process.
Indication and usage
RESTYLANE Touch is intended to be used for facial tissue augmentation.
It is recommended to use the product for the correction of thin
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lines and smile lines.
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cutaneous contour deformities the best results are obtained if the defect
can be manually stretched to the point where it is eliminated. The degree
and duration of the correction depend on the character of the defect
treated, the tissue stress at the implant site, the depth of the implant in
the tissue and the injection technique. Markedly indurated defects may be
can be used dependant on individual patient need and severity of defect.
RESTYLANE range products.
RESTYLANE Touch has not been tested in pregnant or breastfeeding

women or in children.
Anticipated side effects

After the injection of RESTYLANE Touch, some common injection-related
reactions might occur. These reactions include erythema, swelling, pain,
itching, bruising or tenderness at the implant site. Typically resolution is
spontaneous within a few days after injection into the skin. Additionally,
temporary palpable lumpiness has been noted after the use of RESTYLANE
Touch in some patients.
Adverse events
have consisted of redness, swelling, tenderness and induration at the
implant site.These reactions may commence either shortly after injection
or after a delay of 2-4 weeks and have generally been described as mild
to moderate and self-limiting, with an average duration of 2 weeks. In
pronounced cases a short course of oral corticosteroids may prove
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be retreated with RESTYLANE Touch or any other product within the
RESTYLANE range of products.
The following very rare cases have been reported with RESTYLANE
products:
- biopsy proven granuloma formation
- necrosis, possibly due to suboptimal injection technique requiring medical
and/or surgical intervention
- persistent discolouration, possibly due to deposit of hemosiderin as
a consequence of injection site bleeding. These reactions have mostly
occurred after repeated injections.
into the upper half of the face has been reported.
Do not use if package is damaged.
Adverse events must be reported to the local Q-Med representative or

RESTYLANE distributor.
Precautions
Normal precautions associated with intradermal injections must be
observed. Like any such procedure, the implantation of RESTYLANE Touch
is associated with an inherent risk of infection. RESTYLANE Touch should
not be used in or near anatomic sites where there is active skin disease,
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Patients who are using substances that may affect platelet function, such as
Do not use RESTYLANE Touch together with any other injectable implant,
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RESTYLANE Touch should not be injected into an area where a permanent
implant has been placed. RESTYLANE Touch should not be used for patients
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at least until the initial swelling and redness have resolved.
If laser treatment, chemical peeling or any other procedure based on active
dermal response is considered after treatment with RESTYLANE Touch
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site.This also applies if RESTYLANE Touch is administered before the skin
has healed completely after such a procedure.
1. Grasp the narrow part of the needle shield loosely. Turn the needle
shield clockwise until you feel counter pressure.
Assembly of needle to syringe

For safe use of RESTYLANE Touch it is important that the needle is properly
assembled to the syringe. Improper assembly may result in separation of
the needle and syringe during injection.
See pictures 1 and 2.
*UDVSWKHZLGHUSDUWRIWKHQHHGOHVKLHOGUPO\Press and turn the

needle shield 90 (a quarter turn). The quarter turn is necessary
to lock the needle onto the syringe.
Dosage and administration

Before the treatment, the patients suitability for the treatment and the
need for pain relief should be assessed. For optimal patient comfort, topical
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contraindications, precautions, warnings and potential adverse events.
The treatment site should be cleaned with a suitable antiseptic solution.
RESTYLANE Touch is administered using a thin-gauge needle (30 G) by
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press the rod carefully until a small droplet is visible at the tip of the
needle. If RESTYLANE Touch is injected too deeply or intramuscularly,
the duration of the implant will be shorter because of a higher hyaluronic
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and bumps on the treatment site. If blanching is observed, i.e. the overlying
skin turns a whitish colour, the injection should be stopped at once and
the area massaged until it returns to a normal colour.
RESTYLANE TOUCH NVOD K POUIT
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Chapter 8
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The syringe, the needle and any unused material must be

discarded immediately after the treatment session.
Isolated cases of facial oedema and urticaria have also been reported but
it is uncertain whether these cases are related to treatment or caused by
underlying disease or concomitant medication.
Interactions
Treatment with RESTYLANE Touch in combination with drugs and other
devices or concomitant dermal therapies has not been evaluated in
controlled clinical studies.
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the treatment. RESTYLANE Touch is only intended to be administered by
authorized personnel in accordance with local legislation. Please consult
your local Q-Med representative or RESTYLANE distributor for more
details about techniques and training opportunities.
How supplied
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each syringe. A patient record label is a part of the syringe label. Remove
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attached to patient records to ensure traceability of the product. The
contents of the syringe have been sterilized using moist heat.The number
of units per package and the volume contained in each syringe is as stated
on the outer package.
been observed in clinical studies in people with dark skin (Fitzpatrick
Type IV-VI).
Warning
RESTYLANE Touch is only intended for use as an intradermal implant. Do
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Do not inject intravascularly. There is a potential risk with the procedure
that the material could be inadvertently injected into blood vessels. This
may rarely lead to vascular occlusion with transient impairment of vision,
transient ischemia or even necrosis.
Do not use in patients with bleeding disorders or patients who have
undergone therapy with thrombolytics, anticoagulants, or inhibitors of
platelet aggregation in the preceding 2 weeks.
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The injection technique with regard to the depth of injection and the
administered quantity may vary. The linear threading technique can be
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prefer a series of punctual injections or a combination of the two. Inject
RESTYLANE Touch while pulling the needle slowly backwards. Injection
should stop just before the needle is pulled out from the skin to prevent
material from leaking out from the injection site. Defects should be fully
corrected, but not overcorrected, at each treatment session.The correction
site should be massaged to conform to the contour of the surrounding
tissues. If the skin of the patient is very loose, it is recommended that
RESTYLANE Touch be injected on two or more separate occasions. For
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treated area is swollen directly after the injection, melting ice can be applied
on the site for a short period.
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may be necessary to achieve the desired level of correction. Periodic
follow-up injections help sustain the desired degree of correction.
A follow-up treatment before the full esthetic correction is completely
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STERILE NEEDLE
Follow national, local or institutional guidelines for use and disposal
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occurs.
To help avoid needle breakage, do not attempt to straighten a bent needle.
Discard it and complete the procedure with a replacement needle.
Do not reshield used needles. Recapping by hand is a hazardous
practice and should be avoided.
Discard unshielded needles in approved sharps collectors.
Shelf life and storage

As indicated on package. Store up to 25 C. Protect from freezing and
sunlight.
Manufactured by
Q-Med AB, Seminariegatan 21, SE-752 28 Uppsala, Sweden
3KRQH)D[
www.q-med.com, e-mail: info@q-med.com
Symbols
CE-marked according to MDD 93/42/EEC; 0344 is
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CE-marked according to MDD 93/42/EEC;
References
Product documentation is available at your local Q-Med representative or
RESTYLANE distributor, or on www.restylane.com.
* RESTYLANE is a trademark owned by Q-Med AB.
90-28386-03, Oct 2007

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Chapter 8
23
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Restylane VitalTM Light Injector Instructions for Use

Composition
12 mg/ml
q.s.
Description
Restylane Vital Light is a clear, transparent and viscous gel supplied
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for single use only. Restylane Vital Light is a unique form of stabilized
non-animal hyaluronic acid. Hyaluronic acid is a natural polysaccharide
which occurs as an important structural element in the skin and in
subcutaneous and connective tissues as well as in the synovial tissue
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which are identical in all living organisms.
Mode of action
Restylane Vital Light is naturally integrated into the skin where it helps
to restore skin hydrobalance, improve skin structure and the elasticity of the skin. This is accomplished by the water associated with the
stabilized hyaluronic acid in the gel. The unique characteristics of the
gel help maintain the effect for a long period of time.
Restylane Vital Light is intended to restore skin hydrobalance, improve
skin structure and the elasticity of the skin. It should be injected in the
dermal layer of the skin. The duration of the result depends on the
character of the area treated, the tissue stress at the injection site, the
depth of the injection in the tissue and the injection technique.
Other Restylane products are recommended for the correction of
folds and lines for facial contouring and to create volume.
Performance
In a clinical study with Restylane Vital, patients experienced
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6 months after initial treatment.
Warning
Restylane Vital Light is only intended for intradermal injections. Do
not resterilize Restylane Vital Light. Do not mix with other products.
Do not inject intravascularly. There is a potential risk with the procedure that the material could be inadvertently injected into blood
vessels. This may rarely lead to vascular occlusion with transient impairment of vision, transient ischemia or even necrosis.
Do not use in patients with bleeding disorders or patients who have
undergone therapy with thrombolytics, anticoagulants, or inhibitors of
platelet aggregation in the preceding 2 weeks.
Precautions
Normal precautions associated with intradermal injections must be
observed. Like any such procedure, the injection of Restylane Vital
Light is associated with an inherent risk of infection.
Restylane Vital Light should not be used in or near anatomic sites
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Patients who are using substances that may affect platelet function,
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any injection, experience increased bruising or bleeding at injection
sites.
Do not inject Restylane Vital Light into an area where another
injectable implant is present, except for other products from the
Restylane range of products.
Restylane Vital Light should not be injected into an area where a noninjectable implant has been placed. Restylane Vital Light should not be
used for patients with unattainable expectations.
The patient should be informed that he or she should not expose the
treated area to intense heat (e.g. solarium and sunbathing) or extreme

cold at least until the initial swelling and redness have resolved.
If laser treatment, chemical peeling or any other procedure based on
active dermal response is considered after treatment with Restylane
9LWDO/LJKWWKHUHLVDWKHRUHWLFDOULVNRIHOLFLWLQJDQLQDPPDWRU\UHaction at the injection site. This also applies if Restylane Vital Light
is administered before the skin has healed completely after such a
procedure.
Restylane Vital Light has not been tested in pregnant or breastfeeding
women or in children.

After the injection of Restylane Vital Light, some common injectionrelated reactions might occur. These reactions include erythema,
swelling, pain, itching, bruising or tenderness at the injection site.
Typically resolution is spontaneous within a few days after injection.
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cause intradermal lumps.
Adverse events
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products within the Restylane range of products.These reactions have
consisted of redness, swelling, tenderness and induration at the injection site. These reactions may commence either shortly after injection or after a delay of 2-4 weeks and have generally been described
as mild to moderate and self-limiting, with an average duration of
2 weeks. Infections should be excluded or treated if necessary. In
HIIHFWLYH)RUSDWLHQWVZKRKDYHH[SHULHQFHGFOLQLFDOO\VLJQLFDQWUHactions, a decision for retreatment with Restylane Vital Light or any
other product within the Restylane range of products should take
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For example, retreatment is not recommended following rare cases
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Before the treatment, the patients suitability for the treatment and
the need for pain relief should be assessed. The patient should be
informed about the indication, expected result, contraindications, precautions, warnings and potential adverse events.
Basic hygienic approach should be applied during the injection procedure. The treatment site should be cleaned with a suitable antiseptic solution. Restylane Vital Light is administered using a thin-gauge
needle (30 G) by injecting the material into mid dermis of the skin.
If Restylane Vital Light is injected too deeply or intramuscularly, the
duration of the effect might be shorter because of a higher hyaluronic
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may give bumps on the treatment site. If blanching is observed, i.e. the
overlying skin turns a whitish colour, the injection should be stopped
at once and the area massaged until it returns to a normal colour.
The injection technique and the administered quantity may vary. A
serial injection technique may be preferred in order to distribute the
small volume increments over a large skin area.The needle is inserted
into the desired depth in dermis for each volume application. After
deposit of the volume increment the needle is promptly moved to the
next injection site in order to minimize waste of the product. Treated
areas can be gently massaged immediately after the injection if any irregularities are noted. A treatment plan for Restylane Vital Light with
three treatments 2-4 weeks apart is recommended. Generally the
treatment plan is repeated every 4-6 months, but results and patient
preferences may vary.
Note! The correct injection technique is important for the esthetic
effect of the treatment. Restylane Vital Light is only intended to be
administered by trained authorized personnel in accordance with
local legislation. Please consult your local Q-Med representative or
Restylane distributor for more details about techniques and training
opportunities.
In rare cases intradermal lumps have been reported to remain for

several months or periods over one year after the use of Restylane Vital.
Preparation of the injector

1. 'HVFULSWLRQRILQMHFWRUSDUWV)LJXUH
The following very rare cases have been reported with Restylane
products:
- biopsy proven granuloma formation
- necrosis, possibly due to suboptimal injection technique requiring
medical and/or surgical intervention
- persistent discolouration, possibly due to deposit of hemosiderin
as a consequence of injection site bleeding. These reactions have
mostly occurred after repeated injections.
2. $VVHPEO\RIWKHQHHGOH)LJXUHDDQGE
a) Hold the product reservoir and remove the grey protective cap.
b) Hold the product reservoir. Press and turn the needle hub clockwise on the product reservoir until it is tight.
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reservoir.
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have been observed in clinical studies in people with dark skin
(Fitzpatrick Type IV-VI).
Isolated cases of facial oedema and urticaria have also been reported
but it is uncertain whether these cases are related to treatment or
caused by underlying disease or concomitant medication.
One case of transient visual disturbance following intra-arterial injection into the upper half of the face has been reported.
Adverse events must be reported to the local Q-Med representative
or Restylane distributor.
Interactions
Treatment with Restylane Vital Light in combination with drugs and
other devices or concomitant dermal therapies has not been evaluated in controlled clinical studies.
3. :LQGLQJWKHLQMHFWRU)LJXUH
Wind the load knob in a clockwise direction until it comes to a
stop (about 20 full turns). Do not overtighten after fully loading.
Priming the injector - load the system with product
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a) Remove the protective cap.
b) Hold the injector in an upright position and press the dose activator repeatedly, about 10-20 times, until a few drops of the
product emerge from the needle.
Once primed, the injector may again be wound up a few turns in
order to start with a fully loaded injector (optional).
The system should be primed before use and whenever
the needle is changed.
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To position the needle eye, turn the product reservoir until you
reach the desired direction.
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a) Prepare the skin for treatment.
b) Hold the injector comfortably, for example as if holding a pen,
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c) Insert the needle at the desired depth in the dermis.
d) Press the dose activator (you will now hear a click).
e) Wait until the full dose is delivered, which typically takes up to
3 seconds. The time may vary due to skin conditions as well as
number of injections since the injector was fully rewound.
f) Promptly move to the next site and immediately insert the needle
to minimize any product waste.
7. Rewinding
Normally, the injector needs to be rewound 2-4 times during a
treatment session. This will be indicated by the injector no longer
responding when the dose activator is pressed or when the dose
delivery takes over 3 seconds.
See section 3, 4 and 5 for rewinding
If desired, the injector may be rewound before it stops, i.e. more
frequently than described above.
8. Changing the needle
Change the needle if it is blunt or clogged.
Twist off the needle and discard in a sharps container.
Repeat steps 2-5.
The injector, the needle and any unused material must be
How supplied
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together with each injector. A sheet with patient record labels is copacked.This label is to be attached to patient records to ensure traceability of the product.The contents of the syringe have been sterilized
using moist heat. The number of units per package and the volume
contained in each syringe is as stated on the outer package.

As indicated on the package. Store up to 25 C. Protect from freezing and sunlight.
Manufactured by
Phone +46(0)18 474 90 00, Fax +46(0)18 474 90 01
Symbols
CE-marked according to MDD 93/42/EEC; 0344 is
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CE-marked according to MDD 93/42/EEC;
References
Product documentation is available at your local Q-Med representative or Restylane distributor.
Restylane and Restylane Vital are trademarks owned by Q-Med AB.
Restylane VitalTM/LJKW,QMHNWRUQiYRGNSRXLWt
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Restylane SubQ INSTRUCTIONS FOR USE

Composition
20 mg/ml
q.s.
Description
Restylane SubQ is a clear, transparent and viscous gel supplied in a glass syringe.
The product is for single use only. Restylane SubQ is a unique form of stabilized
non-animal hyaluronic acid. Hyaluronic acid is a natural polysaccharide that occurs
as an important structural element in the skin and in subcutaneous and connective
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of very few substances that are identical in all living organisms.
Mode of action
Restylane SubQ acts by adding volume to the tissue, thereby supporting the
overlying (dermal) tissue to shape the contours of the face, to the desired level
of correction.The hyaluronic acid molecules' hydrophilic nature combined with
its three-dimensional structure allows the molecules to bind water many times
its own weight.The addition of water helps to maintain the overall volume of the
product resulting in a longer duration. Restylane SubQ is naturally integrated
into the tissue and will in time undergo isovolemic degradation.
The isovolemic pattern of degradation increases the water binding capacity of
the gel, thus allowing Restylane SubQ to maintain the overall volume during
the degradation process.
Restylane SubQ is intended to be used for facial tissue augmentation. It is
recommended that the product be used for shaping the contours of the face,
e.g. more pronounced cheeks or chin.
The depth of injection may vary from injection into the subcutaneous fatty tissue
to supraperiostal administration depending on the treatment site. Restylane
SubQ shall only be injected by practitioners with expertise in the correction
of volume defects in the facial area. The degree and duration of the correction
depend on the tissue stress at the implant site, the depth of the implant in the
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to correct. For the correction of cutaneous contour deformities other products
from the Restylane range of products are recommended.
Warning
Restylane SubQ is only intended for subcutaneous and/or supraperiostal
administration.
Do not resterilize Restylane SubQ.
Do not mix Restylane SubQ with other products prior to injection of the
device.
Do not inject intravascularly. There is a potential risk with the procedure that
the material could be inadvertently injected into blood vessels. This may rarely
lead to vascular occlusion with transient impairment of vision, transient ischemia
or even necrosis. To ensure that the needle is not in a blood vessel, aspirate
with the syringe before injection.
Do not use in patients with bleeding disorders or patients who have undergone
therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation
in the preceding 2 weeks.
Precautions
Normal precautions associated with subcutaneous and/or supraperiostal injections must be observed. Like any such procedure, the implantation of Restylane
SubQ is associated with an inherent risk of infection. Contact your local Q-Med
representative or Restylane distributor for more information about injection
techniques and training opportunities.
A thorough anatomical knowledge of the treatment site is important. If a sharp
needle is used this is of particular importance in order to avoid the risk of
perforation of deeper, subdermally located structures such as vessels.
Based on clinical experience, adequate soft-tissue cover and soft-tissue support
are important parameters to minimize the risk of local mobility and lumpiness.
Patients who are using substances that may affect platelet function, such as
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experience increased bruising or bleeding at injection sites.
Restylane SubQ should not be used in or near anatomic sites where there is
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SubQ into an area where another injectable implant is present, except for other
products from the Restylane range of products. Restylane SubQ should not be
injected into an area where a non-injectable implant has been placed.
Restylane SubQ should not be used for patients with unattainable expectations.
The patient should be informed that he or she should not expose the treated
area to intense heat (e.g. solarium and sunbathing) or extreme cold at least
until the initial swelling and redness have resolved.
Restylane SubQ has not been tested in pregnant or breastfeeding women
or in children.
After the injection of Restylane SubQ, some common injection-related reactions might occur. These reactions include erythema, swelling, tenderness,
pain, bruising or itching at the implant site. Typically resolution is spontaneous
within one to two weeks.
Adverse events
In a clinical study, local mobility and lumpiness of Restylane SubQ was observed
in a few patients. The most likely explanation to local mobility is the use of too
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placement of Restylane SubQ. Based on clinical experience, adequate soft-tissue
cover and soft-tissue support are important parameters to minimize the risk of
local mobility and lumpiness. If any disturbing mobility or lumpiness should occur,
correction can be attempted by aspiration of some of the implanted gel.
The incidence of adverse events from post marketing surveillance is less than
1%. These adverse events include erythema, pain, swelling, induration, infection,
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occur more than one month after implantation and may recur at the implant sites.
Infections should be excluded or treated if necessary. In pronounced cases a short
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reactions. For example, retreatment is not recommended following rare cases
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Adverse events must be reported to the local Q-Med representative or
Restylane distributor.
Interactions
Treatment with Restylane SubQ in combination with drugs and other devices
has not been evaluated in controlled clinical studies.
Cannula/Needle
For the safe use of Restylane SubQ it is important to use an appropriate cannula/
needle. It is recommended to use a blunt cannula (with bullet tip) with a side
exit, within the range of 16-19 G. Sharp needles can be used by experienced
physicians with thorough anatomical knowledge of the treatment site. The
recommended sharp needle size is 21 G.
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/needle must be sterile. Both disposable and re-usable cannulae/needles are
available and can be used.
Assembly to syringe
For the safe use of Restylane SubQ it is important to use an appropriate cannula/needle and that the cannula/needle is properly assembled to the syringe.
Improper assembly may result in separation of the cannula/needle and syringe
during injection. 6HHJXUHV
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in order to tighten the hub to the bottom of the luer-lock of the syringe.
)LJD illustrates hub of re-usable cannula/needle and )LJE illustrates
hub of disposable cannula/needle.
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26
Chapter 8
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4. Local anesthesia can be accomplished by injecting e.g. 0.5% lidocaine with

epinephrine at the planned incision sites and at the site of planned implantation. Further anesthesia can be provided by regional nerve blocks.The use of
anaesthetic containing a vasoconstrictive agent lowers the risk of accidental
perforation of blood vessels.
5. Restylane SubQ should be administered by injecting the material into the
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give rise to lumpiness.
6. Before injecting, the air is removed from the syringe up to the point where
a droplet is visible at the tip of the cannula/needle.
7. If sharp needle is used, aspiration prior to injection is recommended.
8. Do not apply extensive pressure to the syringe at any time. If such resistance is encountered the cannula/needle should be partially withdrawn and
repositioned or fully withdrawn and checked for function.
9. Inject Restylane SubQ while pulling the cannula/needle slowly backwards.
Injection should stop well before the cannula/needle is pulled out from the
skin to prevent material from leaking out from the injection site. The correction site should be gently massaged to conform to the contour of the
surrounding tissues.
10. Only correct to 100% of the desired volume effect. Do not overcorrect.
11. If the treated area is swollen directly after the injection, melting ice can be
applied on the site for a short period.
12. At each treatment session a maximum volume of 2 ml per treatment site is
recommended.
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be necessary to achieve the desired level of correction. Periodic follow-up
injections help sustain the desired degree of correction.
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your local Q-Med representative or Restylane distributor for more information about injection techniques and training opportunities. Restylane SubQ
is only intended to be administered by authorized personnel in accordance
with local legislation.
The syringe and any unused material must be discarded immediately
after the treatment session.
How supplied
Restylane SubQ is supplied in a glass syringe with a luer-lock. Each syringe is terminally moist heat sterilized in its packaging and packed in a paper carton.A patient
record label is a part of the syringe label (see Fig 4)5HPRYHLWE\SXOOLQJWKHDS
marked with three small arrows. This label is to be attached to patient records
to ensure traceability of the product. The number of units per package and the
volume contained in each syringe is as stated on the outer package.
As indicated on package. Store up to 25 C. Protect from freezing and sunlight.
)LJGrasp the hub. Press and turn it clockwise on the syringe until it is tight.
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Different hubs may tighten at different levels. )LJ D illustrates the
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Manufactured by
Phone +46(0)18 474 90 00, Fax +46(0)18 474 90 01
Symbols on packaging

1. Before the treatment, the patients suitability for the treatment and the need
for pain relief should be assessed.The patient should be informed about the
indications, expected result, contraindications, precautions, warnings and
potential adverse events. To avoid a possible risk of product mobility the
patient should be advised to avoid massaging the treatment site or applying
pressure to the area for a few days following the injection.
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References
Product documentation is available at your local Q-Med representative or
Restylane distributor or on www.restylane.com.
Restylane and Restylane SubQ are trademarks of Q-Med AB.
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draped in an appropriate manner.
Fig 2. Unscrew the tip cap of the syringe carefully.
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2. Different injection and administration techniques can be used. Contact your

local Q-Med representative or Restylane distributor for more information
about injection techniques and training opportunities. Restylane SubQ should
only be injected by practitioners with expertise in the correction of volume
defects in the facial area.
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3RNXGSRXtYiWHRVWURXMHKOXGRSRUXXMHPHSHGLQMHNFtSURYpVWNRQWUROQt
+\DOXURQLKDSSRPROHN\\OLH
1DVWtNDNXQLNG\StOLQHWODWH8FtWtWHOLRGSRUNDQ\OXLMHKOXiVWHQ
SRY\WiKQWHD]PWHSRORKXStSDGQML]FHODY\MPWHD]NRQWUROXMWHMHMt
5HVW\ODQH 6XE4 DSOLNXMWH ]D SRPDOpKR Y\WDKRYiQt NDQ\O\ L MHKO\ ]SW
9VWLNRYiQtXNRQHWHYGRVWDWHQpPSHGVWLKXSHGY\WDHQtPMHKO\] NH
DE\VH]DEUiQLORY\WpNiQtPDWHULiOX]PtVWDLQMHNFH0tVWRSODVWLN\LKQHGSR
LQMHNFLMHPQSURPDVtUXMWHDE\VHDGDSWRYDORQDREU\V\RNROQtWNiQ
,QGLNDDWLRWMDNl\WW|WDU
'HIHNW\NRULJXMWHQDSRDGRYDQpKRVWXSQNRUHNFHDOHQHYtFH
-HOL RHWRYDQi REODVW EH]SURVWHGQ SR DSOLNDFL RWHNOi O]H QD NUiWNRX
GREXQDWRWRPtVWRSLORLWOHG
-DNRPD[LPiOQtGiYNDSLNDGpPRHWHQtVHGRSRUXXMHPOGRMHGQRKR
DSOLNDQtKRPtVWD
3R SUYQtP ]iNURNX PH EW N GRVDHQt SRDGRYDQp ~URYQ NRUHNFH
QH]E\WQiGRGDWHQiDSOLNDFHStSUDYNX5HVW\ODQH6XE41iVOHGQpLQMHNFHY
SUDYLGHOQFKLQWHUYDOHFKSRPiKDMt]DFKRYDWSRDGRYDQVWXSHNRUHNFH
3URNRQHQYVOHGHN]iNURNXMHNOtRYiVSUiYQiLQMHNQtWHFKQLND
'RSRUXXMHPHDE\OpNDSHGSUYQtP]iNURNHPNRQWDNWRYDOPtVWQtKR]iVWXSFH
UP\40HGQHERGLVWULEXWRUDYUREN5HVW\ODQHDLQIRUPRYDOVHRPHWRGiFK
KRLGRLVWD .XGRNVHHQ LPS
Needle assembly
For safe use of any Restylane product it is important that the
needle is properly assembled.
1.
Grasp the narrow part of the needle shield loosely.

Turn the needle shield clockwise until you feel counter
pressure.
2.
Grasp the wider part of the needle shield firmly.

Press and turn the needle shield 90 (a quarter turn).
The quarter turn is necessary to lock the needle onto the
syringe.
Figure 1
Figure 2
Chapter 8
27
Treatment results
Skin rejuvenation
BEFORE
AFTER
Indication: Face
Product used: Restylane Vital and
BEFORE
AFTER
Indication: Neck
Product used: Restylane Vital
BEFORE
AFTER
Indication: Dcolletage
Product used: Restylane Vital
BEFORE
AFTER
Indication: Hands
Product used: Restylane Vital Light
AFTER
Indication: Lip enhancement,
nasolabial folds, worry lines,
periorbital lines
Product used: Restylane Perlane,
Restylane and Restylane Touch
BEFORE
AFTER
Indication: Nose-eyebrow
augmentation, tear trough
deformity, forehead lines, nasolabial
folds, upper lip contour
Product used: Restylane Touch,
Restylane, Restylane Perlane
Tissue augmentation, men
BEFORE
28
Chapter 9
Tissue augmentation, women
BEFORE
AFTER
Indication: Nasolabial folds, mouth
corners, lip line
Product used: Restylane,
Restylane Perlane
BEFORE
AFTER
Indication: Nasolabial folds, lip lines,
mouth corners, eyebrow, glabella, scar
Product used: Restylane
BEFORE
AFTER
Indication: Glabella, cheek fold, oral
commisures, nasolabial folds, chin
Restylane Perlane
BEFORE
AFTER
Indication: : Lips, nasolabial folds,
KRUL]RQWDOU\WKLGDWWKHURRWRIWKH
nose, glabella, oral commisures
Product used: Restylane, Restylane
Lipp and Restylane Perlane
BEFORE
AFTER
Indication: Cheek augmentation,
tear trough deformity, lip
augmentation, cupids bow
Restylane Lipp, Restylane SubQ
BEFORE
AFTER
Indication: Cheek augmentation,
tear trough deformity, lip
augmentation, philtrum, nasolabial
folds, glabella
Restylane Perlane, Restylane SubQ
Chapter 9
29
Questions and answers

What is Restylane?
Restylane is a gel that is injected into the skin in order to add
volume to lips and lift up wrinkles and folds. Restylane consists
of stabilized non animal hyaluronic acid (HA), which mimics
natural HA already present in the human body. Restylane works
by creating volume in the skin. Some dermal fillers are derived
from animal substances. The hyaluronic acid in Restylane is of
non-animal origin.
How was Restylane developed?
After many years of research, Dr Bengt gerup, the founder of
Q-Med AB in Uppsala, Sweden, succeeded in developing the
NASHA technology to produce minimally stabilized non animal
hyaluronic acid (HA) gels, to replace the loss of volume in the
skin. The first product, Restylane, was launched in 1996. Before
this, only collagen made from cow hide and hyaluronic acid made
from rooster combs had been available.
How is a treatment performed?

During treatment, Restylane gel is injected into the skin in tiny
amounts with a very fine needle. The gel produces volume under
the wrinkle, which is lifted up and smoothed out. When enhancing
lips or facial contours, Restylane adds volume and shape to the
treated area.
How long will the treatment session take?
Treatment with Restylane is a very quick and easy process. As no
pre-test is needed, the treatment can be carried out immediately. A
treatment generally takes 30 minutes. The time differs somewhat,
depending on the correction you wish to achieve.
How are Restylane products produced?

The hyaluronic acid in Restylane, is produced biotechnologically
by bacterial fermentation. A specific type of bacteria is used
because of its ability to produce a high yield of hyaluronic acid.
The hyaluronic acid is extracted and purified and is then subjected
to slight chemical modification (stabilization) to increase its
longevity in the tissue and to form a gel. The gel is put into syringes
and sterilized by moist heat. The syringes are put in blister packs
together with a needle. The blister packs are subsequently put in a
carton in which the instructions for use are packed.
Which areas of the face can be treated with Restylane?

Restylane can be used for smoothing out folds and wrinkles, lip
enhancements and shaping facial contours. The most common
areas are the glabellar lines (between the eyebrows), the nasolabial
folds (from the root of the nose to the angle of the mouth) and the
lips, although other sites can also be treated.
Is there a difference in structure between the products?

All the products are gels and have the same structure, however the
properties of the gel differ depending on which specific Restylane
product is in question.
What is the molecular weight of the Restylane products?
From a scientific point of view, it is not common practice to calculate
the molecular weight of a gel. Nevertheless, it may be appropriate
to do this in order to demonstrate the very large difference between
non-stabilized hyaluronic acid products and stabilized hyaluronic
acid in Restylane. In the NASHA gel particles, the hyaluronic
acid molecules are connected to each other in a network, i.e. every
individual gel particle can be regarded as a single molecule. The
molecular weight of a NASHA gel particle can then be estimated
to be about 1017 which is much larger than the molecular weight
of non-stabilized hyaluronic acid in various products, which varies
from one to ten million (106 107).
Chapter 10
Restylane is biodegradable. What does this mean?

Restylane is biodegraded in the body by free radical processes and
the action of enzymes.
What do Restylane products contain?

All Restylane products consist of stabilized hyaluronic acid
20 mg/ml and phosphate buffered saline, pH 7 q.s. They are clear,
transparent, viscous gels supplied in glass syringes. The hyaluronic
acid is produced biotechnologically by bacterial fermentation.
What is the difference between the Restylane products?

The difference between the Restylane products is the size of the gel
particles as well as intended use and recommended technique to
achieve optimal results.
30
Why are Restylane products moist heat-sterilized?

Restylane products are moist heat-sterilized for maximum safety.
Restylane has a sterility assurance level (SAL) of 10-6. This method
is superior to aseptic manufacturing and results in a product where
the probability of finding a syringe containing a micro-organism is
less than one in one million units.
Does the treatment cause pain?

Most people find the injections relatively painless. If needed, a
topical anesthetic, ice, subcutaneous anesthesia or a nerve block
can be applied to the area being treated prior to the procedure.
When enhancing the lips, a local anesthetic injection is often
given. When contouring the cheeks or chin, a nerve block is
recommended.
Do Restylane products expand after injection?
Because the tissue pressure is sometimes disturbed and takes on
a higher value, e.g. in connection with oedema, or a lower value,
during low water intake, a small, yet significant, change (swelling
or shrinkage) may occur.
Is there a need for overcorrection?
No.
How soon will I see the results?
The results can be seen immediately. Except for with Restylane
Vital, this requires a treatment program and the best results will
appear after the third treatment.
How will I look like after the treatment?
Immediately after the treatment you can expect slight redness,
swelling, tenderness, bruising or an itching sensation in the treated
area. This is a normal result of the injection. The discomfort is
temporary and generally disappears in a few days. After a lip
treatment, the lips may become swollen and look somewhat
uneven. This can persist for a few days (up to a week). If the
discomfort continues, please contact your physician.
What should a patient bear in mind after a treatment with

Restylane?
During the first 48 hours after a treatment, there should be no
massage or rubbing of the treated area unless you as the treating
physician instruct otherwise. If you have had a lip enhancement,
avoid puckering your lips for the first two days after the treatment.
Until the initial swelling and redness have resolved, do not expose
the treated area to intense heat (e.g. in a solarium or by sunbathing)
or extreme cold.
Can Restylane be removed?
No. However, Restylane biodegrades naturally with time. If you
feel uncertain about the desired result, you can choose to have the
treatment done in steps on different occasions. In extreme cases
hyaluronidase has been described in the literature as a method
to make the Restylane product dissipate. Also, palpable bolus
injections of Restylane can be aspirated using an empty syringe.
Too superficial deposits can also be aspirated or evacuated using as
small incision in the skin and then applying subsequent pressure.
Can Restylane replace surgical procedures?
Restylane can in certain cases be used in conjunction with surgery
to fill out wrinkles that cannot be removed by surgery.
How long does the effect of a Restylane treatment last?
The length of time the effect of a Restylane treatment lasts is very
individual and depends on many factors, such as the structure of
the skin, lifestyle, age, the degree of perfection demanded and
the injection technique of the practitioner. Experience indicates
that touch-up and follow-up treatments will add to the duration.
Most people choose to have a new treatment within a year after
the treatment of wrinkles and folds and within 6 months after a
lip enhancement.
Does Restylane get stiffer in cold weather? What happens in
the sun?
You should not expose the treated area to intense heat (e.g. in a
solarium or by sunbathing) or extreme cold for the first few days
after the treatment in order to avoid the risk of inflammation as
the area has been disturbed. After the initial few days, you can
recommend the patient to return to their normal lifestyle.
What is the shelf life of Restylane products?
The shelf life is set at 36 months after the production date for most
of the Restylane products. Restylane SubQ and Restylane Lipp
have a shelf life of 18 months.
If the product is about to expire, will the durability be shorter
once injected?
No, degradation of the product does not start until it is injected.
At which temperature should Restylane be stored?
Restylane products should be stored at up to 25 degree C. Prevent
from freezing and keep out of sunlight.
What is the CE number of the Restylane range of products?
What does this actually mean?
The CE number is the same for all Restylane products, CE 0344.
This is the number of the Notified Body. A Notified Body is an
institution that issues the CE certificate. The CE certificate means
that the product complies with the requirements in the EU
directive and can be sold within the EU.
At what depth in the tissue should Restylane products be

injected?
It is recommended that: Restylane Touch should be injected in the
superficial dermal layer, Restylane should be injected in the mid
part of the dermis. Restylane Perlane should be injected in the
deep layer of the dermis and/or the surface layer of the subcutis.
Restylane Vital should be injected in the dermal layer, preferably
deeper, while Restylane Vital Light should be injected in middermis. Restylane Lipp should be injected into the deep layer of the
dermis and/or into the superficial layer of the subcutis. Regarding
Restylane SubQ the depth of injection may vary from injection
into the subcutaneous fatty tissue to supraperiostal administration
depending on the treatment site.
What happens if a Restylane product is not injected at the
recommended tissue depth?
Each Restylane product is tailored to match the tissue matrix
density at the different dermal layers. To ensure satisfactory results,
it is important that each product is injected at the right tissue
depth. For example, if a Restylane product intended to be only
injected in dermis (eg Restylane) is injected too deeply, the gel can
move in the tissue because the gel particles are too small.
Why do the lips sometimes become swollen immediately after
treatment and how long does the swelling normally last?
The cause of this is not yet understood. However, the swelling is
usually gone within a week after injection.
Which Restylane products are recommended for the treatment
of the lips?
Restylane Lipp is recommended for the enhancement of lips.
However, both Restylane and Restylane Perlane have also been
used to produce fuller lips and a pouting look.
How long does the effect of a Restylane treatment of lips last?
It has been shown in clinical trials that Restylane is effective for
up to six months. Clinical experience indicates that touch-up and
follow-up treatments add to the duration.
Can Restylane products be combined with other types of
implant?
Restylane products should not be used together with any other
injectable implant. The Restylane products should not be injected
into or nearby an area where a permanent implant has been
placed.
Can Restylane products be injected in a so-called sandwich
procedure?
Yes, a combination of our products can be used in this procedure.
For example, in a deep fold, Restylane Perlane can be injected first
and Restylane or Restylane Touch can then be added at a more
superficial level.
What needle size should I use?
For each Restylane product the appropriate needle size is
recommended in the corresponding IFU. Each needle size is
matched to facilitate the injection of that specific product. Too
small a needle can disrupt the gel.
Is different extrusion force needed to inject the different
Restylane products?
Yes, but in practice this difference is only of clinical importance
Chapter 10
31
when working with Restylane Vital and Restylane Vital Light.

Restylane Vital Light has a lower extrusion force, so care must be
taken not to over-inject.
Is there any risk for migration and/or displacement of Restylane
products from the site of injection?
There are no specific scientific studies related to migration of
Restylane products. However, when larger volumes of Restylane
products than those recommended in the instructions for use are
used the risk of displacement may no longer be negligible.
Are there any side effects or adverse reactions?
After the injection of Restylane, some common injection-related
reactions might occur. These reactions include erythema, swelling,
pain, itching, bruising or tenderness at the implant site. Typically
resolution is spontaneous within a few days after injection into the
skin and within a week after injection into the lips. Additionally,
temporary palpable lumpiness has been noted after the use of
Restylane in some patients. Inflammatory reactions have been
reported in rare cases. These reactions have consisted of redness,
swelling, tenderness and induration at the implant site. These
reactions may commence either shortly after injection or after a
delay of 2-4 weeks and have generally been described as mild to
moderate and self-limiting, with an average duration of 2 weeks. In
effective. The infection should be excluded or treated if necessary.
Patients who have experienced this type of reaction should not be
retreated with a Restylane product.
The following very rare cases have been reported with Restylane
products:
t biopsy proven granuloma formation
t necrosis, possibly due to suboptimal injection technique
requiring medical and/or surgical intervention
t persistent discoloration, possibly due to deposit of hemosiderin
as a consequence of injection site bleeding. These reactions have
mostly occurred after repeated injections.
t post inflammatory pigmentation changes due to deposit of
melanin have been observed in clinical studies in people with
dark skin (Fitzpatrick Type IV-VI).
t isolated cases of facial oedema and urticaria have also been
reported but it is uncertain whether these cases are related to
treatment or caused by underlying disease or concomitant
medication.
t one case of transient visual disturbance following intra-arterial
injection into the upper half of the face has been reported.
Can the products be used for patients who have undergone
laser treatment or chemical peeling?
Yes, although we recommend that these patients should wait until
the treated area has totally healed and the skin has normalized
(normally four to six weeks).
What happens if you use laser or chemical peeling on top of an
area treated with a Restylane product?
If laser treatment, chemical peeling or any other procedure based
on active dermal response is considered after treatment with
Restylane, there is a theoretical risk of eliciting an inflammatory
reaction at the implant site. This also applies if a Restylane product
is administered before the skin has healed completely after a
procedure of this kind.
32
Chapter 10
Can Restylane products be used for patients during pregnancy

or breast-feeding?
Treatment with Restylane products during pregnancy or breastfeeding has not been tested. During pregnancy there are multiple
significant metabolic, hormonal and immunologic changes
that produce cutaneous manifestations. Any therapy should be
reconsidered in the light of the pregnancy.
Are there any known interactions with antibiotics?
Treatment with Restylane products in combination with other
drugs and devices has not been tested. Theoretically, there is no
basis for any interaction with commonly used antibiotics.
Can patients with different kinds of allergy be more sensitive
to Restylane products?
So far, we have seen no connection between patients with allergies
and patients who report a reaction to Restylane products.
If a patient has had problems with recurrent facial herpes
simplex, can Restylane treatment contribute to another herpes
simplex eruption?
There is a risk that the injection process itself, i.e. the insertion of
a needle into the skin, could contribute to another herpes simplex
eruption.
Should you consider any prophylactic treatment for patients
with a medical history of recurring facial herpes?
You should take a decision about the need for prophylactic antiviral
treatment in consultation with your patient.
Can a person suffering from an autoimmune disease be treated
with Restylane products?
Autoimmune diseases are in general no contraindication for
treatment. However, it is Q-Meds policy to recommend patients
with an underlying disease to discuss and ask the treating physician
of the disease if he or she think its OK to inject Restylane. Thus,
a doctor performing the injection should not primarily make such
a decision.
Are there any articles about injections with Restylane and
patients with autoimmune diseases?
Until February 2008 no article is found when performing a
MEDLINE search combining search words autoimmune diseases
and Restylane.
Can a patient on Roaccutan (Isotretionin) treatment be injected
with Restylane?
Roaccutan (Isotretionin) treatment may cause dryness and even
irritation of the skin. Therefore it is recommend that the patient
discuss and ask the doctor who has prescribed Roaccutan if he or
she think its OK to inject Restylane. Thus, the doctor performing
the injection should not make such a decision, unless he or she is
the prescriber of the patients Roaccutan. In general, it is advisable
to wait some time after the Roaccutan treatment is finished before
Restylane treatment is started.
Will a vaccination for hepatitis A and B cause any interaction/
elicitate any reaction to Restylane?
There is no known interaction between vaccines and Restylane.
However, it is advisable to discuss this matter during consultation.
What is the minimum age that a patient has to be before they

can be treated with Restylane?
The studies that were performed to gain approval from the
European and US authorities were conducted on adults, so there
is no documented data on treatment of non-adults. Therefore, we
recommend that the minimum age should be in accordance with
the local legislation in each country concerning lawful adult age.
Is there a top age for Restylane to have effect?
The oldest patient receiving Restylane treatment in the study
performed to gain approval from the US authority was 78 years
old. Anecdotal reports and clinical experience indicates that there
are no upper age limit for treatment effect.
A patient has received 4 treatments with Restylane and after
the 4th treatment she developed a blue-grey discoloration in the
treated area. Is there any explanation for this?
The etiology of discoloration developing over time includes 1)
hemosiderin deposition after some bleeding in the tissue and
2) postinflammatory hypo- or hyper-pigmentation because of
repeated tissue trauma. An immediate blue discoloration (e.g.
Tyndall effect due to light is reflected differently) is presumably
caused by superficial deposition. However, in order to understand
each individual case, detailed information and photographs is
needed. Also, a punch biopsy would give the answer.
A patient has been treated 3 times (once every year for 3 years)
with Restylane in the lips. But the 4th time, she felt the product
has not had a long-lasting effect and both patient and doctor
are very surprised. What is the explanation of this?
This happens but fortunately its a rare thing. Also very experienced
physicians will report from time to time that the effect of a lip
treatment will disappear within days. The explanation for this
is unknown. Its hard to believe it is technique related and its
absolutely not due to the product which is always very carefully
checked before leaving the production unit in Uppsala.
A patient was treated with Restylane and Restylane Perlane,
but no visual difference was seen after treatment. Do we
recommend to inject the patient again or is it not worth it?
This is something that many physicians can give witness to,
sometimes you just dont get any effect after injecting Restylane.
We know that this can sometimes happen, however there is no
clear explanation as to why it happens at this time. If the patient
so wishes its perfectly OK to give a new treatment and maybe
sometimes it should even be recommended to offer this, otherwise
the patient will go away with a negative impression of Restylane.
What is the difference between Restylane Vital and Restylane

Vital Light?
Restylane Vital and Restylane Vital Light are 2 different products
for rejuvenation of the skin. Both products are based on stabilized
hyaluronic acid, ensuring a long-term effect.
Restylane Vital efficiently rejuvenates mature and photodamaged
skin where it gives a profound, long-lasting effect. The product
contains 20 mg/ml stabilized hyaluronic acid and should be
administered in a treatment cycle of three sessions 4 weeks apart,
to be repeated after 6 months.
Restylane Vital Light is a smoother, softer and more fluid gel
designed to rejuvenate thin and delicate skin, such as neck,
dcolletage and back of hands. Restylane Vital Light is also ideal
when treating younger skin which requires a lighter treatment
with a refreshing effect.
The product contains 12 mg/ml stabilized hyaluronic acid and
should be administered in a treatment cycle of three sessions 2-4
weeks apart, to be repeated after 4-6 months.
Why is Restylane Vital Light of a lower concentration than the
rest of the Restylane range?
The lower gel concentration of Restylane Vital Light makes the
product more fluid and easier to inject in areas with thin skin
such as the neck. Restylane Vital Light distributes evenly upon
injection, and does not cause bumps if injected correctly.
Is Restylane Vital Light a mesotherapy treatment?
No, neither Restylane Vital nor Restylane Vital Light are
mesotherapy treatments. Correct injection technique is essential
when using the Restylane Vital products, too superficial injection
will cause bumps. Use the multipuncture or short linear threading
technique to inject small deposits of gel about 1 cm apart. For safe
and easy injection of Restylane Vital Light the Restylane Injector
can be used.
Can I combine Restylane Vital and Restylane Vital Light on
the same patient?
Yes, use the product suitable for the skin area that is treated. For
photodamaged facial skin Restylane Vital is ideal, but for neck and
dcolletage Restylane Vital Light should be used.
Is the duration of Restylane used for lip enhancement different

in smokers compared to non-smokers?
We have no data on how smokers are responding to Restylane.
What is known is that the skin is damaged by smoking. One
hypothesis might be that if someone is smoking the lips will be
more active and maybe the duration will be shorter because of
this.
Chapter10
33
References
1.
Olenius M. The first clinical study using a new biodegradeable implant for the treatment of lips, wrinkles and folds.
Aesth Plast Surg 1998; 22:97-101.
2.
Duranti F, Salti G, Bovani B, Calandra M, Rosati ML. Injectable hyaluronic acid gel for soft tissue augmentation. A clinical and histological
study.
Dermatol Surg 1998;24 (12): 1317-1325.
3.
Narins RS, Brandt F, Leyden J et al. A randomized, evaluator-blind, multicenter comparison of the efficacy and tolerability of Restylane versus
Zyplast for the correction of nasolabial folds.
Dermatol Surg 2003; 29 (6): 588-595.
4.
Lindqvist C, Tveten S, Bondevik Eriksen, B et al. A randomized, evaluator-blind, multicenter comparison of the efficacy and tolerability of
Perlane versus Zyplast in the correction of nasolabial folds.
Plast Reconstr Surg 2005; 115 (1):282-289.
5.
Friedman PM, Mafong EA, Kauvar ANB et al. Safety data of injectable nonanimal stabilized hyaluronic acid gel for soft tissue augmentation.
Dermatol Surg 2002; 28 (6): 491-494.
6.
Carruthers J, Carruthers A. A prospective, randomized, parallel-group study analyzing the effect of BTX-A (Botox) and nonanimal sourced
hyaluronic acid (NASHA, Restylane) in combination compared with NASHA (Restylane) alone in severe glabellar rhytides in adult female
subjects: Treatment of severe glabellar rhytides with a hyaluronic acid derivative compared with the derivative and BTX-A.
Dermatol Surg 2003; 29: 802-809.
7.
Carruthers A et al. Randomized, double-blind comparison of the efficacy of two hyaluronic acid derivatives, Restylane Perlane and Hylaform, in
the treatment of nasolabial folds.
Dermatol Surg 2005; 31 (11) Part 2: 1591-1598.
8.
Coleman S, et al. Restylane SubQ in aesthetic facial contouring.

Aesthetic Surg J 2006; 26 (Suppl).
9.
Lowe NJ, Grover R. Injectable hyaluronic acid implant for malar and mental enhancement.
Dermatol Surg. 2006 ; 32 (7):881-5; discussion p. 885.
10. Matarasso S, Carruthers J, Jewell M and the Restylane consensus group. Consensus recommendations for soft-tissue augmentation with
nonanimal stabilized hyaluronic acid (Restylane) (NASHA).
Plast Reconstr Surg 2006; 117: 11 (3S).
11. Kerscher M. Rejuvenating influence of a stabilized hyaluronic acid-based gel of non-animal origin on facial skin aging.
Derm Surg. 2008; 34:1-7.
12. For additional reading please see Restylane publications booklet 6th edition, 2007.
34
Chapter X
Chapter X
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E-mail:
Phone:
+61 2 9281 7727

+61 2 9281 4434
info.australia@q-med.com
+86 10 8532 1642

+86 10 6532 7310
info.shanghai@q-med.com
Belgium
Q-Med Benelux BV
PO Box 7241
1043W, Amsterdam, The Netherlands
Denmark
Q-Med
Seminarieg. 21
6(8SSVDOD6ZHGHQ
Phone:
Phone:
E-mail:
Fax:
E-mail:
Vlaanderen: +31 (0)610891648

Wallonia & Luxembourg: +32 473 44 38 13
Vlaanderen: +31 (0)205 722650
Wallonia & Luxembourg:+32 19 655 999
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d.marmann@q-med.com
Brazil
Administration
Q-Med Brasil
Comrcio e Importao de Produtos Mdicos Ltda
R. Alexandre Dumas, 2100 conj 22
Chcara Santo Antnio
&(36mR3DXOR%UD]LO
Phone:
+55 11 5185 5589
Warehouse and Call Center
Q-Med Brasil Comrcio e Importao de Produtos
Mdicos Ltda
Avenida das Americas
No. 500 Bloco 9 Sala 123, Barra da Tijuca
5LRGH-DQHLUR%UD]LO
Phone:
Fax:
(0DLO
+55 21 3139 9968

+55 21 3153 7615
LQIREUD]LO#TPHGFRP
Canada
Q-Med Inc.
703 Evans Avenue, Suite 504
M9C 5E9, Toronto, Ontario, Canada
Phone:
Fax:
E-mail:
+1 416 513 1323

+1 416 513 1325
info.canada@q-med.com
+45 20 37 73 23
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Finland,
Q-Med
Seminarieg. 21
6(8SSVDOD6ZHGHQ
Phone:
E-mail:
+358 40 777 1907

j.herrala@q-med.com
France
Q-Med S.a.r.l.
49 rue de Lisbonne
75008, Paris, France
Phone:
Fax:
E-mail:
+33 1 56 43 43 00
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info.france@q-med.com
Germany
Q-Med GmbH
Berliner Ring 89
64625, Bensheim, Germany
Phone:
Fax:
E-mail:
+49 6251 770 790

+49 6251 770 7911
info.germany@q-med.com
Italy
Q-Med ICT S.r.l.
Via M.Borsa, 11
26845, Codogno (LO), Italy
Phone:
Fax:
E-mail:
+39 0377 436091

+39 0377 436087
info.italy@q-med.com
Fax:
E-mail:
Phone:
E-mail:
+47 91 66 33 81
k.storasli@q-med.com
Poland
40HG3ROVND6S]RR
Nowy Swiat 47
:DUV]DZD3RODQG
Phone:
Fax:
E-mail:
+48 22 892 9120

+48 22 892 9129
info.poland@q-med.com
Spain
Q-Med S.L.
Parque Empresarial Alvia
(GLFLR3ODQWD%DMD0yGXOR
C/ Jose Echegaray 8
/DV5R]DV0DGULG6SDLQ
Phone:
+34 91 636 9205
Fax:
+34 91 630 1402
E-mail:
info.spain@q-med.com
Sweden
Q-Med Nordic Countries
Seminarieg. 21
8SSVDOD6ZHGHQ
Phone:
Fax:
E-mail:
+46 18 474 9000

+46 18 474 9001
info@q-medesthetics.com
UK
Q-Med Ltd
'HDQ)DUUDU6WUHHWWKRRU
6:+';/RQGRQ8.
)RUPRUHLQIRUPDWLRQSOHDVHFRQWDFW\RXUORFDO40HGRU5(67</$1(UHSUHVHQWDWLYH
&RQWDFWGHWDLOVFDQEHIRXQGRQWKH5(67</$1(ZHEVLWHZZZUHVW\ODQHFRP
Chapter X
+31 (0)610891648 (South);

+31 (0)610830209 (North)
+31 (0)205 722650
l.jansen@q-med.com (South)
t.vancapelle@q-med.com (North)
1RUZD\
Q-Med
Seminarieg. 21
6(8SSVDOD6ZHGHQ
Phone:
Fax:
E-mail:
36
+52 55 5616 8292

+52 55 5616 8306
info.mexico@q-med.com
+44 20 7976 3290

+44 20 7976 3299
info.uk@q-med.com
5HVW\ODQHDQGDOORWKHUSURGXFWQDPHVLQWKH5HVW\ODQHIDPLO\DVZHOODV1$6+$DUHWUDGHPDUNVRI40HG$%
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Q-Med AB (publ)
Seminarieg. 21
8SSVDOD6ZHGHQ

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Notice Restylane Angl PDF

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Clinical Guide

Introduction to esthetic treatment

Structure and function of the skin

while on the soles of the feet it is about 2 mm thick. The cellular

Cross section through the skin.

Mechanisms of skin aging

Approaches to esthetic treatment

occurred as a result of aging. In these circumstances it is necessary to

Restylane: a new approach to facial tissue

The cornerstones of the

The distribution of endogenous HA in the skin and throughout

Q-Med uses biotechnologically obtained HA as raw material in

Half-life in the skin, stabilization and isovolemic

Restylane gel injected in tissues as esthetic implant, results in

The NASHA gel is isovolemically degraded

Compliance with international safety standards

Product development through science

Restylane range of products overview

Moderate facial wrinkles

Deep wrinkles and folds, facial contouring

Deep dermis/ upper subcutaneous layer

Fine superficial lines

Deep dermis/ upper subcutaneous layer

Deep subcutaneous layer

Rejuvenation of mature and

Dermis, preferably deeper

Restylane Vital Light

Rejuvenation of thin skin areas

Indications that can be

The treatment session

t Assess the patients need for pain management. Offer a variety

Inform the patient about Restylane

Treatment with the Restylane range of products

Managing patient expectations

Serial puncture technique

Serial puncture technique

Linear/ serial threading technique

Linear/ serial threading technique

Transdermal injection technique using a blunt cannula / sharp needle

Transdermal injection technique using a blunt cannula

For skin rejuvenation

Short linear threading technique

Short linear threading technique

Skin rejuvenation using

2. Wind the Restylane Injector

Image of infraorbital nerve block

Image of topical anesthesia

Image of ice pack being used

To anesthetize the outer cheek and orbital area locate the

Infra orbital and/or mental nerve block

Instruction for use and Needle assembly

90-69914-02, Oct 2007

$ 5(67</$1( IHOW|OW DQ\DJ ~J

$ 5(67</$1( D] DUF V]|YHWHLQ

RESTYLANE TOUCH INSTRUCTIONS FOR USE

RESTYLANE Touch has not been tested in pregnant or breastfeeding

Anticipated side effects

Do not use if package is damaged.

Adverse events must be reported to the local Q-Med representative or

Assembly of needle to syringe

 *UDVSWKHZLGHUSDUWRIWKHQHHGOHVKLHOGUPO\Press and turn the

Dosage and administration

RESTYLANE TOUCH NVOD K POUIT

*UDVSWKHZLGHUSDUWRIWKHQHHGOHVKLHOGUPO\Press and turn the

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