SUMMARY OF PRODUCT CHARACTERISTICS,

LABELLING AND PACKAGE LEAFLET

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT

Human Albumin CSL Behring 25%, 250 g/l, solution for infusion

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Human Albumin CSL Behring 25% 250 g/l is a solution containing 250 g/l of total protein of which at least
96% is human albumin.

One vial of 50 ml contains 12.5 g of human albumin.

One vial of 100 ml contains 25 g of human albumin.

Human Albumin CSL Behring 25% is hyperoncotic to normal plasma.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for infusion.

A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated
and use of a colloid is appropriate.

The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual
patient, based on official recommendations.

4.2 Posology and method of administration

The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s
individual requirements.

Posology
The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid
and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be
used to determine the dose required.

If human albumin is to be administered, haemodynamic performance should be monitored regularly; this

may include:
• arterial blood pressure and pulse rate
• central venous pressure
• pulmonary artery wedge pressure
• urine output
• electrolyte
• haematocrit / haemoglobin
Paediatric population
The posology in children and adolescents (0-18 years) should be adjusted to the patient’s individual
requirements.

Method of administration
Human albumin can be directly administered by the intravenous route, or it can also be diluted in an isotonic
solution (e.g. 5% glucose or 0.9 % sodium chloride).
The infusion rate should be adjusted according to the individual circumstances and the indication.
In plasma exchange the infusion rate should be adjusted to the rate of removal.

4.3 Contraindications

Hypersensitivity to albumin preparations or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the infusion. In
case of shock, standard medical treatment for shock should be implemented.

Albumin should be used with caution in conditions where hypervolaemia and its consequences or
haemodilution could represent a special risk for the patient. Examples of such conditions are:
• decompensated cardiac insufficiency
• hypertension
• oesophageal varices
• pulmonary oedema
• haemorrhagic diathesis
• severe anaemia
• renal and post-renal anuria

The colloid-osmotic effect of human albumin 250 g/l is approximately four times that of blood plasma.
Therefore, when concentrated albumin is administered, care must be taken to assure adequate hydration of
the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration.

200–250 g/l human albumin solutions are relatively low in electrolytes compared to the 40–50 g/l human
albumin solutions. When albumin is given, the electrolyte status of the patient should be monitored (see
section 4.2) and appropriate steps taken to restore or maintain the electrolyte balance.

Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.

If comparatively large volumes are to be replaced, controls of coagulation and haematocrit are necessary.
Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors,
electrolytes, platelets and erythrocytes).

Hypervolaemia may occur if the dosage and infusion rate are not adjusted to the patient’s circulatory
situation. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion),
or increased blood pressure, raised venous pressure and pulmonary oedema, the infusion is to be stopped
immediately.

Transmissible agents
Standard measures to prevent infections resulting from the use of medicinal products prepared from human
blood or plasma include selection of donors, screening of individual donations and plasma pools for specific
markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of
viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the
possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or
emerging viruses and other pathogens.
There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia
specifications by established processes.
It is strongly recommended that every time that Human Albumin CSL Behring 25% is administered to a
patient, the name and batch number of the product are recorded in order to maintain a link between the
patient and the batch of the product.

4.5 Interaction with other medicinal products and other forms of interaction

No specific interactions of human albumin with other medicinal products are known.

4.6 Fertility, pregnancy and lactation

Pregnancy
No animal reproduction studies have been conducted with Human Albumin CSL Behring 25%. Its safety for
use in human pregnancy has not been established in controlled clinical trials and therefore it should only be
given with caution to pregnant women. However, clinical experience with albumin suggests that no harmful
effects on the course of pregnancy, or on the fetus and the neonate are to be expected.

Breast-feeding
It is unknown whether Human Albumin CSL Behring 25% is excreted in human milk. Since human albumin
is a normal constituent of human blood, treatment of the nursing mother with Human Albumin CSL Behring
25% is not expected to present a risk to the breastfed newborn/infant.

Fertility
No animal reproduction studies have been conducted with Human Albumin CSL Behring 25%. However,
human albumin is a normal constituent of human blood and harmful effects on fertility are not expected.

4.7 Effects on ability to drive and use machines

No effects on the ability to drive and use machines have been observed.

4.8 Undesirable effects

Summary of the safety profile

Mild reactions with human albumin solutions such as flush, urticaria, fever and nausea occur rarely. These
reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. Very
rarely, severe reactions such as shock may occur. In these cases, the infusion should be stopped immediately
and an appropriate treatment should be initiated.

Tabulated list of adverse reactions

The summary table below presents the adverse reactions which have been observed with Human Albumin
CSL Behring 25% during the postmarketing phase, according to the MedDRA system organ classification
(SOC and Preferred Term Level).
As the post marketing reporting of adverse reactions is voluntary and from a population of uncertain size, it
is not possible to reliably estimate the frequency of these reactions. Hence the frequency category “not
known (cannot be estimated from the available data)” is used.

System Organ Class (SOC, Adverse Reaction Frequency of ADR (MedDRA

MedDRA) Preferred Term, PT)
Immune system disorders Shock Not known
Gastrointestinal disorders Nausea Not known
Skin and subcutaneous tissue Flush, urticaria Not known
disorders
General disorders and Fever Not known
administration site conditions
For safety information with respect to transmissible agents, see section 4.4.

4.9 Overdose

Hypervolaemia may occur if the dosage and infusion rate are too high. At the first clinical signs of
cardiovascular overload (headache, dyspnoea, jugular vein congestion) or increased blood pressure, raised
central venous pressure and pulmonary oedema, the infusion should be stopped immediately and the patient's
haemodynamic parameters carefully monitored.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: plasma substitutes and plasma protein fractions, ATC code: B05AA01.
Human albumin accounts quantitatively for more than half of the total protein in the plasma and represents
about 10% of the protein synthesis activity of the liver.

Physico-chemical data: human albumin 250 g/l has a corresponding hyperoncotic effect.
The most important physiological functions of albumin results from its contribution to oncotic pressure of
the blood and transport function. Albumin stabilises circulating blood volume and is a carrier of hormones,
enzymes, medicinal products and toxins.

5.2 Pharmacokinetic properties

Distribution
Under normal conditions, the total exchangeable albumin pool is 4–5 g/kg body weight, of which 40–45% is
present intravascularly and 55–60% in the extravascular space. Increased capillary permeability will alter
albumin kinetics and abnormal distribution may occur in conditions such as severe burns or septic shock.

Elimination
Under normal conditions, the average half-life of albumin is about 19 days. The balance between synthesis
and breakdown is normally achieved by feedback regulation. Elimination is predominantly intracellular and
due to lysosome proteases.

In healthy subjects, less than 10% of infused albumin leaves the intravascular compartment during the first
2 hours following infusion. There is considerable individual variation in the effect on plasma volume. In
some patients the plasma volume can remain increased for some hours. However, in critically ill patients,
albumin can leak out of the vascular space in substantial amounts at an unpredictable rate.

5.3 Preclinical safety data

Human albumin is a normal constituent of human plasma and acts like physiological albumin.

In animals, single dose toxicity testing is of little relevance and does not permit the evaluation of toxic or
lethal doses or of a dose-effect relationship. Repeated dose toxicity testing is impracticable due to the
development of antibodies to heterologous protein in animal models.

To date, human albumin has not been reported to be associated with embryo-fetal toxicity, oncogenic or
mutagenic potential. No signs of acute toxicity have been described in animal models.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium N-acetyltryptophanate
Sodium caprylate
Sodium chloride
Water for injections

6.2 Incompatibilities

Human albumin must not be mixed with other medicinal products (except those mentioned in 6.6), whole
blood and packed red cells.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above +25 °C. Do not freeze. Keep the vial in the outer carton in order to protect from light.

6.5 Nature and contents of container

50 ml of solution in a single vial (glass type II) with a stopper (halogenated synthetic elastomer).
100 ml of solution in a single vial (glass type II) with a stopper (halogenated synthetic elastomer).

1 vial per pack (12.5 g/50 ml, 25 g/100 ml).

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

The solution can be directly administered by the intravenous route, or it can also be diluted in an isotonic
solution (e.g. 5% glucose or 0.9 % sodium chloride).
Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.
If large volumes are administered, the product should be warmed to room or body temperature before use.
Do not use solutions which are cloudy or have deposits. This may indicate that the protein is unstable or that
the solution has become contaminated.
Once the vial has been opened, the contents should be used immediately.

Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.

7. MARKETING AUTHORISATION HOLDER

<[To be completed nationally]>

8. MARKETING AUTHORISATION NUMBER(S)

<[To be completed nationally]>

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: {DD month YYYY}

Date of latest renewal: {DD month YYYY}
<[To be completed nationally]>

10. DATE OF REVISION OF THE TEXT

<{MM/YYYY}>

<[To be completed nationally]>

LABELLING
PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX

1. NAME OF THE MEDICINAL PRODUCT

Human Albumin CSL Behring 25%, 250 g/l, solution for infusion
Human albumin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Human Albumin CSL Behring 25% is a solution containing 250 g/l of total protein of which at least 96% is
human albumin.

One vial of 50 ml contains 12.5 g of human albumin.

One vial of 100 ml contains 25 g of human albumin.

3. LIST OF EXCIPIENTS
Sodium N-acetyltryptophanate, sodium caprylate, sodium chloride, water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion

12.5g/50 ml
25g/100 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous administration only.

Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE
SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP {MM.YYYY}
Once the vial has been opened, the contents should be used immediately.

9. SPECIAL STORAGE CONDITIONS

Do not store above +25 °C. Do not freeze.

Keep the vial in the outer carton in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

<[To be completed nationally]>

12. MARKETING AUTHORISATION NUMBER(S)

<[To be completed nationally]>

13. BATCH NUMBER

LOT {0000000000} ((10 digits))

14. GENERAL CLASSIFICATION FOR SUPPLY

<[To be completed nationally]>

15. INSTRUCTIONS ON USE

Do not use solutions which are cloudy or have deposits.

16. INFORMATION IN BRAILLE

<[To be completed nationally]>
MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

LABEL

1. NAME OF THE MEDICINAL PRODUCT

Human Albumin CSL Behring 25%, 250 g/l, solution for infusion
Human albumin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Human Albumin CSL Behring 25% is a solution containing 250 g/l of total protein of which at least 96% is
human albumin.

One vial of 50 ml contains 12.5 g of human albumin.

One vial of 100 ml contains 25 g of human albumin.

3. LIST OF EXCIPIENTS

Sodium N-acetyltryptophanate, sodium caprylate, sodium chloride, water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion

12.5g/50 ml
25g/100 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous administration only.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE
SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP {MM.YYYY}
Once the vial has been opened, the contents should be used immediately.

9. SPECIAL STORAGE CONDITIONS

Do not store above +25 °C. Do not freeze.

Keep the vial in the outer carton in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

<[To be completed nationally]>

12. MARKETING AUTHORISATION NUMBER(S)

<[To be completed nationally]>

13. BATCH NUMBER

LOT {0000000000} ((10 digits))

14. GENERAL CLASSIFICATION FOR SUPPLY

<[To be completed nationally]>

15. INSTRUCTIONS ON USE

Do not use solutions which are cloudy or have deposits.

PACKAGE LEAFLET
 Package Leaflet: Information for the User

Human Albumin CSL Behring 25%, 250 g/l, solution for infusion
Human albumin

Read all of this leaflet carefully before you are given this medicine because it contains important
information for you.

– Keep this leaflet. You may need to read it again.

– If you have any further questions, ask your doctor or healthcare professional.
– If you get any side effects, talk to your doctor or healthcare professional. This includes any possible
side effects not listed in this leaflet.

What is in this leaflet:

1. What Human Albumin CSL Behring 25% is and what it is used for
2. What you need to know before you are given Human Albumin CSL Behring 25%
3. How to use Human Albumin CSL Behring 25%
4. Possible side effects
5. How to store Human Albumin CSL Behring 25%
6. Contents of the pack and other information

1. What Human Albumin CSL Behring 25% is and what it is used for

What is Human Albumin CSL Behring 25%

Human Albumin CSL Behring 25% is a plasma substitute.

How Human Albumin CSL Behring 25% works

Albumin stabilises the circulating blood volume. It is a carrier of hormones, enzymes, medicines and toxins.
The albumin protein in Human Albumin CSL Behring 25% is isolated from human blood plasma. Therefore
the albumin works exactly as if it was your own protein.

What Human Albumin CSL Behring 25% is used for

Human Albumin CSL Behring 25% is used to restore and stabilize the circulating blood volume. It is
normally used under intensive care situations, when your blood volume has decreased critically. This may be
the case e.g.:
• due to severe loss of blood after an injury or
• due to a large surface burn
The choice of using Human Albumin CSL Behring 25% will be made by your doctor. It will depend on your
individual clinical situation.

2. What you need to know before you are given Human Albumin CSL Behring 25%

 Read this section carefully. The information given should be taken into consideration by you and your
doctor before you are given Human Albumin CSL Behring 25%.

Do NOT use Human Albumin CSL Behring 25%

• if you are allergic (hypersensitive) to human albumin or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions

 Talk to your doctor or healthcare professional before you are given Human Albumin CSL Behring
25%
Which circumstances increase the risk of having side effects?
Your doctor or healthcare professional will take special care if an abnormal increase in blood volume
(hypervolaemia) or blood dilution (haemodilution) could be dangerous for you. Examples of such conditions
are:
• heart insufficiency which needs to be treated with medicines (decompensated cardiac insufficiency)
• high blood pressure (hypertension)
• expansion of the gullet vein (oesophageal varices)
• abnormal accumulation of liquid in the lung (pulmonary oedema)
• predisposition for bleeding (haemorrhagic diathesis)
• severe decrease of red blood cells (severe anaemia)
• severe decrease of urine excretion because of renal impairment or outflow impairment (renal and post-
renal anuria)
 Tell your doctor or healthcare professional before treatment if at least one of these conditions
applies to you.

When stopping the infusion may be required?

• Allergic reactions (hypersensitivity reactions) may occur and may very rarely be severe enough to
cause shock (see also section 4 “Possible side effects”).
 Tell your doctor or healthcare professional immediately if you notice such reactions during the
infusion of Albumin. He or she will decide to stop the infusion completely and start the
appropriate treatment.
• An abnormal increase in blood volume (hypervolaemia) may occur if the dosage and infusion rate are
not adequately adjusted to your condition. This may lead to an overload of the heart and circulatory
system (cardiovascular overload). First signs of such an overload are headache, breathing difficulty or
swelling of your neck veins (jugular vein congestion).
 Tell your doctor or healthcare professional immediately if you notice such signs. He or she will
stop the infusion and monitor your circulation as necessary.

Information on safety with respect to infections

When medicines are made from human blood or plasma, certain measures are put in place to prevent
infections being passed on to patients. These include
• careful selection of blood and plasma donors to make sure those at risk of carrying infections are
excluded,
• the testing of each donation and pools of plasma for signs of virus/infections
• the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
Despite these measures, when medicines prepared from human blood or plasma are administered, the
possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging
viruses and other types of infections.
There are no reports of virus infections with albumin manufactured to European Pharmacopoeia
requirements by established processes.

It is strongly recommended that every time you are given a dose of Human Albumin CSL Behring 25% the
name and batch number of the product are recorded in order to maintain a record of the batches used.

Other medicines and Human Albumin CSL Behring 25%

No specific interactions of Human Albumin CSL Behring 25% with other medicines are known.
 However, always tell your doctor or healthcare professional before treatment if you are taking, have
recently taken or might take any other medicines.

Pregnancy,breast-feeding and fertility

 Tell your doctor or healthcare professional if you are pregnant, plan to become pregnant or are breast-
feeding. Your doctor will decide whether you can receive Human Albumin CSL Behring 25% during
your pregnancy or while you are breast-feeding.

The use of Human Albumin CSL Behring 25% in pregnant or breast-feeding women has not been studied
separately. Nevertheless, medicines containing human albumin have been used in pregnant or breast-feeding
women. The experience showed that no harmful effects on the course of pregnancy, or on the fetus and the
newborn are to be expected.

Driving and using machines

No effects of Human Albumin CSL Behring 25% on the ability to drive and use machines have been
observed.

3. How to use Human Albumin CSL Behring 25%

Human Albumin CSL Behring 25% is given to you by your doctor or healthcare professional.It is intended
only for infusion into your veins (intravenous infusion).
Your doctor decides how much Human Albumin CSL Behring 25% you will be given. The amount and
infusion rate depends on your individual requirements.
Your doctor or health care professional will regularly monitor important blood flow values like:
• your blood pressure,
• your pulse rate,
• your urine output,
• your blood tests.
These values are monitored to determine the right dose and infusion rate.

If you are given more Human Albumin CSL Behring 25% than you should
Human Albumin CSL Behring 25% is administered under medical supervision only. An overdosage is
therefore very unlikely to occur. An abnormal increase in blood volume (hypervolaemia) may occur if the
dosage and infusion rate are too high. This may lead to an overload of the heart and circulatory system
(cardiovascular overload). First signs of such an overload include:
• headache,
• breathing difficulty,
• swelling of your neck veins (jugular vein congestion).
 Tell your doctor or healthcare professional immediately if you notice such symptoms.

Your doctor or healthcare professional may also detect signs like

• an increased blood pressure,
• a raised central venous pressure,
• an abnormal accumulation of liquid in the lung (pulmonary oedema).
In all these cases, he or she will stop the infusion and monitor your circulation as necessary.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Such side effects
may occur even when you have previously received Human Albumin CSL Behring 25% and had tolerated it
well.

General experience with human albumin solutions showed that the following side effects may be observed.

Allergic reactions (hypersensitivity reactions) may occur and may very rarely be severe enough to cause
shock.
Symptoms of an allergic reaction may include any, some or many of the following:
• skin reactions, e.g. redness, itching, swelling, blistering, rash or hives (itchy bumps)
• difficulty breathing, e.g. wheezing, chest tightness, shortness of breath or cough
• swelling of the face, eyelids, lips, tongue or throat
• cold-like symptoms, e.g. stuffy or runny nose, sneezing, red, itchy, swollen or watery eyes
• headache, stomachache, nausea, vomiting or diarrhoea.
  Tell your doctor or healthcare professional immediately if you notice such reactions during the
infusion of Human Albumin CSL Behring 25%.. In this case, he or she will stop the infusion
and start the appropriate treatment.

The following mild side effect may occur rarely (between 1 in 1,000 and 1 in 10,000 persons treated):
• flushing
• itchy rash (urticaria)
• fever
• nausea
They will normally disappear rapidly when the infusion is slowed down or the infusion is stopped.

The following severe side effects may occur very rarely (less than 1 in 10,000 persons treated):
• shock

The same side effects have been observed with Human Albumin CSL Behring 25% since the product is on
the market. However, the exact frequency of these side effects is not known.

 Talk to your doctor or healthcare professional if you get any side effects. This includes any
possible side effects not listed in this leaflet.

5. How to store Human Albumin CSL Behring 25%

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the outer carton and the vial label
after the abbreviation «EXP». The expiry date refers to the last day of that month.
• Do not store above +25 °C.
• Do not freeze.
• Keep the vial in the outer carton in order to protect from light.
• Do not use this medicine if you notice that the solution is cloudy or has particles.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Human Albumin CSL Behring 25% contains

• The active substance is human albumin.
Human Albumin CSL Behring 25% is a solution containing 250 g/l of total protein of which at least
96% is human albumin.

One vial of 50 ml contains 12.5 g of human albumin.

One vial of 100 ml contains 25 g of human albumin.

• The other ingredients are sodium N-acetyltryptophanate, sodium caprylate, sodium chloride, and
water for injections.

What Human Albumin CSL Behring 25% looks like and contents of the pack
Human Albumin CSL Behring 25% is a solution for infusion.
The solution is clear and slightly viscous. It may be almost colourless or yellow, amber or green.

Pack sizes:
1 vial per pack (12.5 g/50 ml, 25 g/100 ml).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

CSL Behring GmbH
Emil-von-Behringstrasse 76
D-35041 Marburg
Germany

This medicinal product is authorized in the Member States of the EEA under the following names:

Denmark: Human Albumin CSL Behring 25%

Italy: Alburex 25%, 250 g/l, soluzione per infusione

This leaflet was last revised in <{month YYYY}>.

<[To be completed nationally]>