CONTENTS

Inactivated hepatitis A vaccine, adsorbed.

PRESENTATION

Prefilled syringe 0.5 mL (susp for inj) x 1's.

DESCRIPTION

Each 0.5-mL dose contains hepatitis A virus (GBM strain*), inactivated**, 80 U***.
*Cultured on MRC-5 human diploid cells.
**Absorbed on aluminium hydroxide (quantity corresponding to 0.15 mg of aluminium).
***Antigen units measured using an in-house reference.
It also contains the following excipients: Phenoxyethanol, formaldehyde, Hanks Medium 199 (a complex mixture of amino acids, mineral salts and vitamins, hydrochloric acid or sodium hydroxide for pH adjustment and water for injection).

INDICATIONS

Prevention of infection caused by hepatitis A virus in children 12 months to 15 years.

DOSAGE & ADMINISTRATION

Recommended Dosage: 0.5 mL for each injection.
The vaccination schedule includes 1 primary vaccination dose. A booster dose is recommended 6-18 months after the initial dose.

Administration

The vaccine must be injected by IM route in the deltoid region (upper arm muscle).

CONTRAINDICATIONS

Hypersensitivity to hepatitis A vaccine, to any of the excipients of Avaxim 80 U Pediatric, neomycin, polysorbate or following a previous injection of Avaxim 80 U Pediatric.
Vaccination should be postponed in case of a febrile illness, acute infection or progressive chronic disease.

PRECAUTIONS

Inform the doctor if the patient suffers from immunodeppression.
Avaxim 80 U should never be administered by the intravascular or intradermal route.
Effects on the Ability to Drive or Operate Machinery: Avaxim 80 U is unlikely to produce an effect on the ability to drive and use machines.
Use in pregnancy & lactation: Avaxim 80 U Pediatric should be used during pregnancy on medical advice only.
Avaxim 80 U Pediatric may be used during lactation.

ADVERSE REACTIONS

The most common reactions are local reactions at the injection site eg, pain, redness, edema or induration; systemic reactions eg, headaches, GIT disorders (abdominal pain, diarrhoea, nausea, vomiting), muscular or joint pain, transitory behavior changes (decreased appetite, insomnia, irritability), fever, asthenia.
Cutaneous manifestations (rash, urticaria) have been observed on rare occasions.
All adverse reactions were moderate and confined to the first few days following vaccination with spontaneous recovery.

INTERACTIONS

The immunological response may be diminished in case of immunosuppressive treatment.
Avaxim 80 U Pediatric may be administered simultaneously, at 2 different injection sites, with the routine booster vaccines given to children during the 2nd year of life ie, the various vaccines containing 1 of the following valences: Diphtheria, tetanus, pertussis (acellular or whole cell), Haemophilus influenzae type b and inactivated or oral poliomyelitis.
Inform the doctor or pharmacist if any ongoing treatment or if any other medicinal products, even if non-prescription, have been taken recently.

CAUTIONS FOR USAGE

Instructions for Use and Handling: Shake before injection, until a homogenous suspension is obtained.

STORAGE

Store between 2-8°C (in a refrigerator). Protect from light. Do not freeze.
Shelf-Life: 3 years.