Clostridium tetani, are detoxified and purified.

The acellular pertussis components pertussis toxoid,

PEDIACEL™

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filamentous haemagglutinin, pertactin and fimbrial agglutinogens 2+3 are manufactured by culturing
Bordetella pertussis, from which the component are extracted and purified. The pertussis toxoid
Component Pertussis Vaccine and and filamentous haemagglutinin component are detoxified.
The diphtheria and tetanus toxoids as well as the acellular pertussis components are adsorbed to
Diphtheria and Tetanus Toxoids aluminium phosphate. No substance of human origin is used in the manufacture of the vaccine.
Adsorbed Combined with Injection of bacterial proteins such as diphtheria and tetanus toxoids results in the production of
protective antibodies. A primary series consisting of two or more injections is required to prime
Inactivated Poliomyelitis the immune system and produce a satisfactory protective antibody level. After completion of a
Vaccine and Haemophilus b Conjugate primary series, circulating antibodies to tetanus and diphtheria toxoids gradually decline but are
thought to persist at protective levels for up to 10 years. Tetanus and diphtheria toxoid boosters
Vaccine (Tetanus Protein – Conjugate) are recommended every 10 years. Protective antibody levels have not been established for
pertussis, but good protective efficacy has been shown in a clinical study.
The inactivated poliomyelitis vaccine is a highly purified, inactivated poliovirus vaccine produced by
PHARMACEUTICAL FORM microcarrier culture. A primary series induces protective antibody levels in more than 99% of
Solution for injection (suspension). For administration by intramuscular route recipients.

COMPOSITION The Haemophilus b Conjugate Vaccine (Tetanus Protein – Conjugate) is purified polyribose ribitol
1 dose = 0.5 mL. phosphate capsular polysaccharide (PRP) of Haemophilus influenzae type b, covalently bound to
tetanus protein. The Haemophilus b Conjugate Vaccine (Tetanus Prorein – Conjugate) induces
Active ingredients: immunologic memory. By covalently bonding the capsular polysaccharide of Haemophilus
Each dose (0.5 mL) contains: influenzae type b (PRP) to tetanus protein, a carrier-hapten is produced which converts a T-
Adsorbed purified pertussis toxoid (PT) 20 μg independent antigen into a T-dependent antigen. The advantages of a T-dependent antigen over a
Adsorbed purified filamentous haemagglutinin (FHA) 20 μg T-independent antigen include a quantitatively enhanced anticapsular polysaccharide antibody
Adsorbed purified fimbrial Agglutinogens 2 + 3 (FIM) 5 μg
Adsorbed purified PRN 3 μg response in young infants, predominantly of IgG isotype and the induction of immunologic memory
Adsorbed purified diphtheria toxoid allowing for a long lasting immunity. Priming of the immune system allows for an anamnestic
15 Lf response which is expected in cases of natural exposure to Hib. Bactericidal activity against Hib is
Adsorbed purified tetanus toxoid
5 Lf demonstrated in serum after immunization and statistically correlates with the anti-PRP antibody
Inactivated poliomyelitis type 1 40 DU units* response induced by Haemophilus b Conjugate Vaccine (Tetanus Protein – Conjugate)
Inactivated poliomyelitis type 2 8 DU units*
Inactivated poliomyelitis type 3 32 DU units* WARNINGS
purified polyribose ribitol phosphate capsular Intramuscular injections should be given with care in persons suffering from coagulation disorders
polysaccharide (PRP) of Haemophilus influenzae type b because of the risk of hemorrhage.
covalently bound to 20 μg of tetanus protein 10 µg PEDIACEL™ should not be administrered into the buttocks due to the varying amount of fatty
Other ingredients: tissue in this region, nor by the intradermal route, since these methods of administration may
aluminium phosphate 1.5 mg induce a weaker immune response.
2-phenoxyethanol 0.6 % v/v
Water for injection containing 20 ppm Tween qs ≤0.02 % Tween 80 As with any vaccine, immunization with PEDIACEL™ may not protect 100% of susceptible
individuals.
* The nominal quantities of D-antigen per virus serotype
The use of fractional doses in an attempt to reduce the severity of adverse reactions cannot be
In production stage porcine origin trypsin was used. In the stage of purification this vaccine is free
from trypsin. recommended because there is insufficient evidence on the safety or efficacy of such smaller doses.
Deferral
PHARMACEUTICAL CLASSIFICATION Deferral of the pertussis component of PEDIACEL™ should be considered in children with a
Vaccine, for administration by intramuscular route. progressive, evolving, or unstable neurologic condition (including seizures) because administration
of the pertussis component may coincide with the onset of overt manifestations of such disorders
INDICATIONS and result in confusion about causation. It is prudent to delay initiation of immunization with
pertussis vaccine until further observation and study have clarified the child’s neurologic status. In
For immunization of children from 2 months of age up to their 7th birthday against diphtheria, addition, the effect of treatment, if any, can be assessed. Immunization with PEDIACEL™ should
tetanus and whooping cough, poliomyelitis and invasive Haemophilus influenzae type b disease. be reinstituted when the condition has resolved, been corrected or controlled. Elective
immunization of persons over 6 months of age should be deferred during an outbreak of
CONTRAINDICATIONS poliomyelitis because of the risk of provocation paralysis.
General PRECAUTIONS
Immunization should be deferred in the presence of any acute illness, including febrile illness to The possibility of allergic reactions in persons sensitive to components of the vaccine should be
avoid superimposing adverse effects from the vaccine on the underlying illness or mistakenly evaluated. Although anaphylaxis is rare, facilities for its management must always be available
attributing to the vaccine a manifestation of the underlying illness. A minor a febrile illness such as during vaccination. Epinephrine Hydrochloride Solution (1:1,000) airway management and other
mild upper respiratory infection is not usually reason to defer immunization. appropriate agents should be available for immediate use in case an anaphylactic or acute
Absolute Contraindications hypersensitivity reactions occurs. Health-care providres should be familiar with current
recommendations for the initial management of anaphylaxis in non-hospital settings, including
Allergy to any component of PEDIACEL™ or an anaphylactic or other allergic reaction to a proper airway management.
previous dose of DPT Polio Adsorbed, TRIPACEL™, QUADRACEL™, IPV, or Act-HIB are Some authorities consider a hypotonic/hyporesponsive episode (HHE) following a dose of
contraindications to vaccination. pertussis-containing vaccine to be a precaution to further administration of pertussis containing
PEDIACEL™ should not be administered to children after their 7th birthday or to adults because of vaccines. No long-term sequelae have been associated with HHE; however, because there are no
the quantity of diphtheria toxoid and pertussis antigens may provoke enhanced local reactions, fever data on administration of component pertussis vaccine to infants and children who have
and malaise experienced HHE it may be prudent in areas of low pertussis incidence to without the pertussis
component and continue immunization with DT Polio Adsorbed and Act-HIB in children who have
PHARMACOLOGICAL PROPERTIES experienced a HHE following a previous dose of pertussis-containing vaccine. Children can
WHO ATC Code: J07CA, Diphtheria and Tetanus Toxoids, Pertussis and Poliomyelitis. continue immunization with PEDIACEL™ if the incidence of disease is high in their area.
Keep out of reach of children.
WHO ATC Code: J07AG, Haemophilus b conjugate Vaccine (Tetanus Protein-Conjugate). Intramuscular injections should be given with care in patients suffering from coagulation disorders
The diphtheria and tetanus components, which are obtained from cultures of Corynebacterium because of the risk of haemorrhage.
diphtheria and It is possible that children with immune deficiency may not achieve full immunity.
As with any vaccine, immunization with PEDIACEL™ may not protect 100% of Common Gastrointestinal Decreased feeding, vomiting.
susceptible individuals. ( ≥1/100) General disorder Fever, irritability, crying, drowsiness.
Do not inject into a blood vessel. Administration site Redness, tenderness, swelling at the
Use a separate sterile needle and syringe, or a sterile disposable unit, for each individual patient to conditions vaccination site
prevent disease transmission.
Rare Nervous system Febrile convulsions.
Before administration, take all appropriate precaution to prevent adverse reactions. This includes a ( ≥ 1/10,000) General disorders Hypotonic-hyporesponsive episodes*, high
review of the patient’s history concerning possible hypersensitivity to the vaccine or similar fever (> 40.5°C), unusual high pitched or
vaccine, previous immunization history, the presence of any contraindications to immunization and inconsolable crying.
current health status.
Before administration of PEDIACEL™, health-care providers should inform the patient, parent or * Hypotonic-hyporesponsive episodes [infant appears pale, hypotonic (limp) and unresponsive
guardian of the benefits and risks of immunization, inquire about the recent health status of the to parents] have not to date been associated with any permanent sequelae.
patient and comply with any local requirements regarding.
Information to be provided to the patient before immunization and the importance of completing Very Rare The following have been reported following administration of tetanus and/or
the immunization series. (<1/10,000) diphtheria toxoid and/or pertussis and/or Act-HIB® containing vaccines:
It is extremely important when a child returns for the next dose in the series that the patient,
Nervous system Neurologic (peripheral neuropathies,
parent or guardian should be questioned concerning any symptoms and/or signs of an adverse
demyelinating disease; encephalopathy with
reaction after the previous dose of vaccine.
and without permanent intellectual and/or
Use in Pregnancy motor impairment, polyradiculopathies)
Not relevant. Vascular disorders Edema of the lower extremities with cyanosis
or transient purpura.
Overdose
There are no report of overdosage. General disorders Anaphylactic reaction.
Frequent booster doses of tetanus or diphtheria toxoids in the presence of adequate or excessive
Administration site Transient painless circumferential limb
serum levels of tetanus or diphtheria antitoxins have been associated with increased incidence and
conditions swelling following booster doses. Granuloma
severity of reactions and should be avoided.
or sterile abscess at the vaccination site.
Interactions with Other Drugs
If PEDIACEL™ is used in persons with malignancies, persons receiving immunosuppressive PRECAUTIONS FOR USE
therapies, including irradiation, antimetabolities, alkylating agents, cytotoxic drugs, or persons who KEEP OUT OF REACH OF CHILDREN
are otherwise immunocompromised (including HIV-infected individuals, transplant recipients,
persons suffering from autoimmune disorders), the expected immune response may not be STORAGE AND SHELF LIFE
obtained. Store at +2°C - +8°C. DO NOT FREEZE. Discard product if exposed to freezing.
Because simultaneous administration of common childhood vaccines is not known to affect the Do not use after expiration date.
efficacy or safety of any of the routine recommended childhood vaccines, if return of a vaccine
recipient for further immunization is doubtful, simultaneous administration of all vaccines SHELF LIFE
appropriate for age and previous vaccination status (including MMR, and hepatitis B vaccine) at 30 months for syringe
separate sites with separate syringe is indicated. 12 months for vial
INSTRUCTIONS FOR USE
Inspect for extraneous particulate matter and/or discolouration before use.
PRESENTATION
1 Box, 1 syringe 0.5 ml 1 dose, Reg. No.DKI0555500243A1
SHAKE THE PRE-FILLED SYRINGE OR VIAL WELL to distribute uniformly the suspension before 1 Box, 1 vial 0.5 ml 1 dose, Reg. No.DKI0555500243A2
withdrawing each dose. When administering a dose from a stoppered vial, do not remove either
the stopper or the metal seal holding it in place. Aseptic technique must be used for withdrawal of
each dose.
Needles should not be recapped and should be disposed of properly. MANUFACTURED BY: Harus dengan resep dokter
Sanofi Pasteur Limited
POSOLOGY Toronto, Ontario, Canada
1 dose = 0.5 mL
As a guide, primary immunization is recommended: one 0.5 mL dose administered intramuscularly IMPORTED BY: PT Aventis Pharma, Jakarta, Indonesia
at 2, 4, 6 and 18 months of age. Where more rapid protection is preferred, the first three doses
may be administered at intervals of four weeks.
Administer the vaccine intramuscularly. The preferred site is into the anterolateral aspect of the
mid-thigh (vastus lateralis muscle) or into the deltoid muscle. In children >1 year of age, the
deltoid is the preferred site since use of the anterolateral thigh results in frequent reports of
limping due to muscle pain.
Children who have had tetanus or diphtheria should still be immunized since these clinical
infections do not always confer immunity. Children who have had natural pertussis can continue to
receive pertussis-containing vaccines. Children in whom invasive Hib disease develops before 24
months of age should still receive Hib-containing vaccine as recommended, since natural disease
may not induce protection.
HIV-infected individuals, both asymptomatic and symptomatic, should be immunized with
PEDIACEL™ vaccine according to standard schedules.
Do not inject by the intravascular, subcutaneous or intradermal route.

ADVERSE EFFECTS
The most frequent reactions include redness and tenderness at the injection site, irritability and
slight fever. These symptoms usually occur within the first 24 hours after vaccination and may
continue for 24-48 hours. There was a trend towards increasing local reaction rates at the booster
doses, but these were still significantly lower than with whole-cell pertussis combination vaccines.

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