Trade name: Flu-M Tetra Quadrivalent Inactivated Split Influenza Vaccine.
Generic name: Influenza vaccine [inactivated].
Pharmaceutical form: solution for intramuscular injection.
Composition.
1 dose (0.5 mL) contains
Active ingredients:
inactivated split influenza viruses cultivated on chick embryos, which are represented by strains equal to the following strains:
А/ (H1N1) – 15 µg of hemagglutinin*;
А/ (H3N2) – 15 µg of hemagglutinin*;
В/ (Yamagata lineage) – 15 µg of hemagglutinin*;
В/ (Victoria lineage) – 15 µg of hemagglutinin*.
* The vaccine strain is updated in accordance with WHO recommendations for the current epidemic season.
Excipients:
stabilizer – Triton X-100, not more than 100 μg; preservative – thiomersal (merthiolate) 50 μg or no preservative, phosphate-buffered saline (sodium chloride; disodium phosphate dodecahydrate; potassium dihydrogen phosphate; water for injection) up to 0.5 mL.
Description.
Colorless slightly opalescent liquid.
Immunobiological properties.
Mode of Action
It is recommended to carry out vaccination every year, considering that influenza incidence is seasonal, and circulating virus strains may change every year and post-vaccination immunity weakens during the year.
Built-up immunity to a certain type or subtype of influenza virus offers limited or no protection from any other types of influenza virus. Post-vaccination antibodies to a certain antigen of influenza virus may offer no protective effect in respect of a modified antigen of the virus of the same type or subtype. Frequent change of antigens causes annual change in the strain composition of vaccine for influenza prevention. Thus, vaccines for influenza prevention are standardized in terms of hemagglutinin composition of influenza virus strains which are likely to circulate during the upcoming epidemic season.
Immunogenicity
The vaccine promotes generation of serum antibodies against influenza virus hemagglutinins and development of specific immunity against relevant A and B type influenza strains. Duration of post-vaccinal immunity against homologous strains or strains closely related to the same may vary, but in most cases it is 6-12 months.
Pharmacotherapeutic group.
MIBP – vaccine.
АТС code: J07BB02.
Indications for use.
Active annual preventive immunization against seasonal influenza in people aged from 18 to 60 years.
Contraindications.
Allergic reactions to chicken protein and vaccine components.
Allergic reactions to previously administered influenza vaccines.
A strong reaction (temperature above 40 °С, edema and hyperemia over 8 cm in diameters at the injection site) or complications caused by previous administration of the drug.
Acute infectious or non-infectious diseases, exacerbation of chronic diseases (the vaccination should be carried out 2–4 weeks after recovery or in the period of remission).
In case of non-severe acute upper respiratory infections or acute intestinal illnesses, vaccination is performed after the body temperature has returned to normal.
Age under 18 years
Use during pregnancy and lactation.
Global experience obtained in the course of use of inactivated influenza vaccines shows that the vaccination of women during breast feeding has no toxic impact on the baby.
The final decision on the vaccination of pregnant and breastfeeding women should be made on a case-by-case basis with due regard for the risk of influenza infection and possible complications caused by the development of a disease. The safest period of vaccination of pregnant women is the second and third trimesters of pregnancy.
