Mastodon

Vaxigrip® (Suspension) Instructions for Use

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)

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.

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

ICD-10 code Indication
Z25.1 Need for immunization against influenza
ICD-11 code Indication
QC01.8 Need for immunization against influenza

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Suspension

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 coagulation disorders should receive the vaccine subcutaneously. The vaccine must never be administered intravenously under any circumstances.

Adverse Reactions

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

Allergic reactions in patients with known sensitivity to individual vaccine components – skin itching, urticaria, rash; extremely rarely – 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 white used in the manufacturing process.

Use in Pregnancy and Lactation

Currently, there is insufficient data on the embryotoxicity and teratogenicity of this vaccine.

The need for vaccine use 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 detecting 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 (IgM formation) to vaccination.

Drug Interactions

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

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Sanofi Pasteur, S.A. (France)

Dosage Form

Bottle Rx Icon Vaxigrip® Suspension for intramuscular and subcutaneous administration 0.5 ml/1 dose: syringe 1 pc.

Dosage Form, Packaging, and Composition

Suspension for intramuscular and subcutaneous administration slightly whitish, weakly opalescent.

1 dose (0.5 ml)
Influenza viruses inactivated split, represented by strains equivalent to the following
   A/(H1N1)* 15 mcg HA**
   A/(H3N2)* 15 mcg HA**
   B/* 15 mcg HA**

* the field lists the names of strains recommended by WHO for the current influenza epidemic season.
** hemagglutinin.

Excipients : buffer solution (sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, water for injections) – up to 0.5 ml.
Process impurities (in trace amounts) formaldehyde, octoxinol-9, neomycin, ovalbumin.
Does not contain adjuvants and preservatives.

0.5 ml – syringes (1) – closed cell packaging (1) – cardboard packs.

The strain composition of the vaccine and the quantitative content of active substances comply with WHO recommendations for the Northern Hemisphere on the composition of influenza vaccines for the season and WHO recommendations for the production and control of influenza vaccines (inactivated).

Marketing Authorization Holder

Sanofi Pasteur, S.A. (France)

Dosage Form

Bottle Rx Icon Vaxigrip® Suspension for intramuscular and subcutaneous administration 0.25 ml/1 dose: syringe 1 pc.

Dosage Form, Packaging, and Composition

Suspension for intramuscular and subcutaneous administration slightly whitish, weakly opalescent.

1 dose (0.25 ml)
Influenza virus inactivated split, represented by strains
   A/(H3N2)* 7.5 mcg HA**
   A/(H1N1)* 7.5 mcg HA**
   B/* 7.5 mcg HA**

* the field lists the names of strains recommended by WHO for the current influenza epidemic season.
** hemagglutinin.

Excipients : buffer solution (sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, water for injections) – up to 0.25 ml.

Does not contain adjuvants and preservatives.
Process impurities (content per 1 dose) formaldehyde – not more than 15 mcg, octoxinol-9 – not more than 100 mcg, neomycin – not more than 10 ng, ovalbumin – not more than 0.025 mcg.

0.25 ml – syringes (1) – closed cell packaging (1) – cardboard packs.

The strain composition of the vaccine complies with WHO recommendations for the Northern Hemisphere and the EU decision on the composition of vaccines for the current influenza epidemic season.

Marketing Authorization Holder

Sanofi Pasteur, S.A. (France)

Dosage Form

Bottle Rx Icon Vaxigrip® Suspension for intramuscular and subcutaneous administration 5 ml: fl. 1 pc.

Dosage Form, Packaging, and Composition

Suspension for intramuscular and subcutaneous administration 0.5 ml (1 dose)
Hemagglutinin and neuraminidase of the following viral strains
A(H3 N2)* 15 mcg HA**
A(H1 N1)* 15 mcg HA**
B* 15 mcg HA**

* – after the strain name, the type name is listed; the strain composition is brought into line with WHO recommendations for the current influenza epidemic season.

** – hemagglutinin.

5 ml – bottles (1) – cardboard packs.

TABLE OF CONTENTS