Influvac^® (Suspension) Instructions for Use

Marketing Authorization Holder

Abbott Biologicals, B.V. (Netherlands)

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 Form

Influvac®

Suspension for intramuscular and subcutaneous administration 0.5 ml/dose: syringes 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for intramuscular and subcutaneous administration in the form of a transparent colorless liquid.

Excipients: potassium chloride – 0.1 mg, potassium dihydrogen phosphate – 0.1 mg, sodium phosphate dibasic dihydrate – 0.67 mg, sodium chloride – 4 mg, calcium chloride dihydrate – 0.067 mg, magnesium chloride hexahydrate – 0.05 mg, water for injection – up to 0.5 ml, sodium citrate ≤1 mg, CTAB ≤15 mcg, sucrose ≤0.2 mg, formaldehyde ≤0.01 mg, polysorbate 80 – traces.

0.5 ml – disposable syringes with a capacity of 1 ml with a needle (1) – cardboard packs with first opening control.
0.5 ml – disposable syringes with a capacity of 1 ml with a needle (10) – cardboard packs with first opening control.

* after the type name, the name of the strain recommended by WHO for the current influenza epidemic season is given.

Influvac^® is a trivalent inactivated influenza vaccine consisting of surface antigens (hemagglutinin and neuraminidase) cultured on chicken embryos from healthy chickens.
The antigenic composition of the influenza vaccine is updated annually according to WHO recommendations.

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

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 disappear 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 vaccine injection site.

Contraindications

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

Use in Pregnancy and Lactation

Currently, there is 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.