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The product is the suspension of hepatitis A virions (LBA-86 strain), which were cultured on the passaged 4647 cell line, purified, concentrated, inactivated and adsorbed on aluminium hydroxide. One milliliter of the vaccine contains 50 ИФА (IEA) units (25 ng) of hepatitis A viral antigen: vaccine is free of antibiotics and preservative. Colourless transparent or slightly opalescent liquid with white precipitate; shaking results in homogenous and quickly sedimenting white suspension without flakes and extraneous inclusions.

 

Complete vaccination course provides long specific immunity in 90-95% of vaccinated persons.

 

Prevention of Hepatitis A in children from 3 years of age, adolescents and adults.

1. Acute infectious and non-infectious diseases; exacerbations of chronic diseases; the vaccination is carried out no earlier than 1 month after recovery (remission).

2. Serious reaction (temperature above 40 ⁰C; hyperemia and edema at the site of inoculation more than 8 mm in diameter) to the previous vaccination with “HEP-A-in-VAC”.

3. Malignant tumors and malignant blood diseases.

4. Pregnancy

 

In order to reveal contraindications to vaccination all persons to be vaccinated should be examined by the physician (or its assistant) with obligatory thermometry on the day of vaccination. Appropriate laboratory examination is carried out if necessary.

 

 

Vaccine is administered into deltoid muscle.

Single dose for children and adolescents under 17 years of age inclusively is 0.5 ml; single dose for adults is 1.0 ml. Complete course of vaccination consists of two vaccination procedures carried out 6 to 12 months apart and provides long protection against hepatitis A infection. In some cases (for epidemiological indications) single administration of the vaccine is admissible, which provides protection against infection for up to 12 months.

Intravenous administration of the vaccine is strictly prohibited!

 

Strict observance of antiseptics and asepsis is mandatory during the ampoule opening and vaccination procedure. The vaccine should be thoroughly mixed by shaking before drawing up into the syringe. Vaccine from open ampoule may be used within 30 minutes.

 

Never use the product if the ampoule or label are not intact; the product has changed its physical properties (colour, transparency), after the expiration date or improperly stored product.

 

Vaccinations are registered in approved Record forms. The information in forms should include date of vaccination; dose; manufacturer: batch number; vaccinal reaction.

 

Side effects associated with this preparation do not exceed corresponding side effects of other vaccines, which contain purified antigens adsorbed on aluminum hydroxide. Vaccinated persons may experience ailment, headache, and transient subfebrile temperature. In rare cases insignificant skin hyperemia and slight edema develop at the site of injection, which disappear within 1 to 2 days.

Ampoules containing 0.5 ml; 1.0 ml; and 2.0 ml of vaccine. 10 ampoules in each cardboard.

 

Vaccine should be stored according to “Sanitary rules 3.3.2.028-095” at 2 to6 ⁰C.

Never use vaccine if it was frozen. Please report on vaccinal complications and send claims for specific and physical properties of the product to State Agency for Control of medical immunobiological products (L.A. Tarasevich State Research Institute for Standardization and Control Over Medical Biological Products (GISK) (41 Sivtsev Vrazhek str., Moscow 121002, tel./fax 241-3922) and to the manufacturer.

 

Shelf-life of the vaccine is 1.5 years. Never use the product after expiration date.