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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Suspension for intramuscular and subcutaneous administration 0.5 ml/1 dose: syringe 1 pc.
Marketing Authorization Holder
Sanofi Pasteur, S.A. (France)
Dosage Form
| 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).
Suspension for intramuscular and subcutaneous administration 0.25 ml/1 dose: syringe 1 pc.
Marketing Authorization Holder
Sanofi Pasteur, S.A. (France)
Dosage Form
| 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.
Suspension for intramuscular and subcutaneous administration 5 ml: fl. 1 pc.
Marketing Authorization Holder
Sanofi Pasteur, S.A. (France)
Dosage Form
| 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.
