Influenza trivalent polymer subunit vaccine

Описание

The vaccine is surface glycoproteins (hemagglutinin and neuraminidase) isolated from purified virions of influenza virus type A and B obtained from the virus-containing allantoic fluid of chicken embryos of clinically healthy chickens and diluted in phosphate buffered saline in combination with azoximer bromide (Polyoxidonium). The product does not contain a preservative or contains the preservative thiomersal (merthiolate).

Presentation

РасSolution for intramuscular and subcutaneous injection, 0.5 ml (1 dose) per ampule or disposable syringes with needles and protective caps. 10 ampoules in each cardboard box with a package insert and an ampoule cutter. 5 ampoules in each dose tray. 2 dose trays in each cardboard package with a package insert and an ampoule cutter. If the ampoule has a score line, a ring or a dot, an ampoule cutter is not inserted. 1 syringe with the vaccine in each dose tray. 1 dose tray in each cardboard package with a package insert.

Ingredients

1 dose (0.5 ml) contains:

Vaccine without preservative:

• hemagglutinin of influenza virus subtype A(H1N1) - 5 µg;
• hemagglutinin of influenza virus subtype А(H3N2) - 5 µg;
• hemagglutinin of influenza virus type B - 11 µg;
• azoximer bromide (Polyoxidonium) – 500 µg.

Vaccine with preservative:

• hemagglutinin of influenza virus subtype A(H1N1) - 5 µg;
• hemagglutinin of influenza virus subtype А(H3N2) - 5 µg;
• hemagglutinin of influenza virus type B - 11 µg;
• azoximer bromide (Polyoxidonium) – 500 µg;
• preservative – thiomersal (merthiolate) - (50.0 ± 7.5) µg.

Note.

1. During production of the drug phosphate buffered saline (PBS) is used as a solvent and pH stabilizer: for formulation without preservative - PBS #1, for formulation with preservative - PBS #2. Composition of PBS #1: 9 g of sodium chloride, 1.5 g of sodium hydrogen phosphate, 0,12-0,14 g of potassium dihydrogen, water for injection up to 1 liter. Composition of PBS #2: 9 g of sodium chloride, 1.5 g of sodium hydrogen phosphate, 0,12-0,14 g of potassium dihydrogen, 0.85 ml of 1% thiomersal (merthiolate) solution, water for injection up to 1 liter.
2. Polyoxidonium is a mixture of the active substance polyoxidonium (azoximer bromide) and excipients: mannitol, povidone and beta-carotene aqueous solution, resulting from the continuous technological cycle.

Indications

For specific prevention of influenza the vaccine without preservation is used for children from the age of 6 months old, adolescents and adults without age limitation; the vaccine with preservation is used for adults from the age of 18 years old.

The vaccine is particularly indicated to:

1. Persons with high risk of complications if infected with influenza: – persons over 60 years old; preschool children; school children; - persons often suffering from ARD, chronic medical conditions, including diseases and malformations of the central nervous, cardiovascular and broncho-pulmonary systems, including asthma, chronic kidney disease, diabetes, metabolic diseases, autoimmune diseases, allergic diseases (except allergy for chicken proteins and vaccine components); chronic anemia, congenital or acquired immunodeficiency, HIV.
2. People who due to their educational or professional activities have a high risk of catching influenza or infecting other people: - healthcare, education, social service, transport, sales workers, military men or policemen.