Marketing Authorization Holder

St. Petersburg Research Institute of Vaccines and Sera of the FMBA, FSUE (Russia)

ATC Code

J07BB02 (Influenza virus inactivated split or surface antigen)

Active Substance

Influenza vaccine (split virion), inactivated

Influenza vaccine (split virion), inactivated (BP British Pharmacopoeia)

Dosage Forms

	Flu-M [inactivated split influenza vaccine]	Solution for intramuscular administration (with preservative): amp. 0.5 ml 10 pcs., fl. 5 ml 5 or 10 pcs.
		Solution for intramuscular administration (without preservative): amp. 0.5 ml 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular administration as a colorless, slightly opalescent liquid.

* The strain composition is brought into line with WHO recommendations for the current influenza epidemic season.
** hemagglutinin.

Excipients: stabilizer – Triton X-100 – not more than 100 mcg, preservative – thiomersal (merthiolate) – 50 mcg, phosphate-saline buffer solution (sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, water for injections – up to 0.5 ml).

0.5 ml (1 dose) – glass ampoules (10) – contour cell packs (1) – cardboard boxes.
5 ml (10 doses) – glass bottles (5) – contour cell packs (1) – cardboard boxes.
5 ml (10 doses) – glass bottles (5) – contour cell packs (2) – cardboard boxes.

Solution for intramuscular administration as a colorless, slightly opalescent liquid.

* The strain composition is brought into line with WHO recommendations for the current influenza epidemic season.
** hemagglutinin.

Excipients: stabilizer – Triton X-100 – not more than 100 mcg, phosphate-saline buffer solution (sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, water for injections – up to 0.5 ml).

0.5 ml (1 dose) – glass ampoules (10) – contour cell packs (1) – cardboard boxes.

Clinical-Pharmacological Group

Influenza vaccine for prophylaxis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Inactivated purified split influenza vaccine. Prevents diseases caused by influenza virus type A and B.

It induces the formation of humoral antibodies to hemagglutinins that neutralize influenza viruses. The seroprotective antibody level is usually achieved within 7-10 days after vaccine administration. The duration of post-vaccination immunity to homologous or related strains varies from 6 to 12 months.

Indications

Influenza prophylaxis.

ICD codes

Dosage Regimen

For different age categories, appropriate vaccine preparations should be used, taking into account contraindications.

Vaccination should be carried out before the start of the influenza epidemic season or taking into account the epidemic situation.

The vaccine is administered intramuscularly or deep subcutaneously. Patients with thrombocytopenia and other diseases of the coagulation system should be given the vaccine subcutaneously. The vaccine must never be administered intravenously under any circumstances.

Adverse Reactions

Systemic reactions possible – slight short-term increase in body temperature, febrile conditions, general malaise (these phenomena resolve on their own within 1-2 days); extremely rare – neuralgia, paresthesia, convulsions, transient thrombocytopenia, neurological disorders, vasculitis.

Allergic reactions in patients with known sensitivity to individual components of the vaccine – skin itching, urticaria, rash; extremely rare – severe allergic reactions, such as anaphylactic shock.

Local reactions pain, redness and swelling at the injection site.

Contraindications

Acute infectious diseases, exacerbations of chronic diseases, hypersensitivity to active or auxiliary components of the vaccine; hypersensitivity to gentamicin sulfate, formaldehyde, merthiolate, sodium deoxycholate, chicken egg protein used in the technological process.

Use in Pregnancy and Lactation

There is currently insufficient data on the embryotoxicity and teratogenicity of this vaccine.

The need to use the vaccine during lactation is decided by the doctor individually.

Special Precautions

This vaccine prevents diseases caused by the influenza virus and does not prevent the development of upper respiratory tract infections caused by other pathogens.

For non-severe acute respiratory viral infections, acute intestinal diseases, vaccination is carried out immediately after the temperature normalizes.

When using the vaccine, it is always necessary to have available means that may be required in case of rare anaphylactic reactions after administration. For this reason, the vaccinated person should be under medical supervision for 30 minutes after immunization.

After influenza vaccination, false-positive results of serological tests using the ELISA method for the determination of antibodies against HIV 1, hepatitis C and especially human T-lymphotropic virus 1 (HTLV 1) have been noted, which may be a consequence of the immune response (formation of IgM) to vaccination.

Drug Interactions

The effectiveness of immunization may be reduced due to immunosuppressive therapy carried out simultaneously with it, as well as in the presence of immunodeficiency.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.