AVAXIM PEDIATRIC READY-TO-USE INJECTOR 80 U WITH SUSPENSION FOR IM INJECTION 0.5 mL

Active ingredient: Each 0.5 mL dose contains:

Hepatitis A virus (GBM strain)* (inactivated)** 80U***

* MRC-5 was cultured in human diploid cells.** Adsorbed on aluminum hydroxide. (amount corresponds to 0.15 mg aluminum)*** antigen units expressed using in-house reference

Excipients: 2-Phenoxyethanol, formaldehyde, 199 Hanks medium, which is a complex mixture of amino acids, mineral salts, vitamins, hydrochloric acid or sodium hydroxide to adjust pH, and water for injection.

AVAXIM 80U PEDIATRIC is an injection suspension containing 0.5 mL of inactivated hepatitis A virus in a ready-to-use needle syringe.

This vaccine is used to prevent infection caused by the hepatitis A virus in children ages 12 months to 15 years inclusive.

Instructions for proper use and dosage/frequency of administration

The recommended vaccination schedule is a single dose of primary vaccination followed by a single booster dose injection 6 to 18 months later.

It is applied intramuscularly to the muscle in the upper arm.

Before injection, shake until you obtain a homogeneous suspension.

AVAXIM 80U PEDIATRIC is recommended for the prevention of infection caused by hepatitis A virus in children aged 12 months to 15 years old (15 years included).

Like all medicines, side effects may occur in people who are sensitive to the ingredients contained in AVAXIM 80U PEDIATRIC.

During clinical development, this vaccine has been administered to more than 3000 children (around 5900 administered doses) aged 12 months to 15 years.

Side effects are listed as shown in the categories below.

Very common: may occur in at least 1 in 10 patients.

Common: It may occur in less than 1 in 10 patients, but may occur in 1 or more of 100 patients.

⚠️ Disclaimer: The information provided on this website is for informational purposes only and does not substitute professional medical advice. Always consult a healthcare provider before using any medication.