Instruction for use: Influvac

Dosage form: Suspension for intramuscular and subcutaneous administration

Active substance: Vaccinum ad prophylaxim grippi inactivatum

ATX

J07BB02 Influenza virus inactivated cleavage or surface antigen

Pharmacological group

MIBP vaccines [Vaccines, sera, phages and toxoids]

The nosological classification (ICD-10)

J10 Influenza caused by an identified influenza virus: Influenza A; Influenza B; Influenza A type; Influenza A of type B

Composition and release form

Suspension for intramuscular and subcutaneous administration 1 dose (0.5 ml)

In one dose of the vaccine (0.5 ml), haemagglutinin (HA) and neuraminidase (HA) of the following viral strains are present:

A (H3N2) 15 μg HA

A (H1N1) 15 μg HA

B 15 μg HA

Auxiliary substances: potassium chloride; Potassium dihydrogen phosphate; Sodium phosphate dihydrate; sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; water for injections

In disposable syringes complete with injection needles of 0.5 ml; In a pack of cardboard 1 or 10 sets.

Description of dosage form

Transparent colorless liquid.

Characteristic

Vaccine influenza, subunit, inactivated. Influvac® is a trivalent inactivated influenza vaccine consisting of surface antigens (HA, HA) of influenza A and B viruses grown in chick embryos. Antigenic composition of influenza vaccine is updated annually according to WHO recommendations.

Pharmachologic effect

Mode of action - Forming the development of specific immunity.

Pharmacodynamics

Forms specific immunity to influenza viruses of types A and B, which occurs, usually after 14 days after vaccination and persists up to 1 year.

Indications for the Influvak® (Vaccine for the prevention of diphtheria, tetanus, pertussis (acellular), three-component adsorbed liquid)

Prevention of influenza in adults and children from 6 months.

Vaccination is recommended for all individuals and, above all, for the following categories of the population at increased risk in the event of a combination of influenza with already existing diseases / conditions:

Persons over the age of 65 regardless of their state of health;

Patients with respiratory diseases;

Patients with cardiovascular diseases of any etiology;

Patients with chronic renal insufficiency;

Patients with diabetes mellitus;

Patients with immunodeficient diseases (HIV infection, malignant blood diseases, etc.) and patients receiving immunosuppressants, cytotoxic drugs, radiation therapy or high doses of corticosteroids;

Children and adolescents (6 months to 18 years of age) receiving long-term preparations containing acetylsalicylic acid and, consequently, at increased risk of developing Ray's syndrome due to influenza infection;

Pregnant women (II-III trimester). Pregnant women belonging to the categories at increased risk should be vaccinated regardless of the stage of pregnancy.

Contraindications

Hypersensitivity to the chicken protein or to any other component of the vaccine;

Severe temperature or allergic reactions after previous vaccination with subunit influenza vaccines.

Vaccination is delayed until the end of acute manifestations of the disease and exacerbation of chronic diseases. With mild ARVI, acute intestinal and other diseases, vaccination is carried out immediately after the temperature is normalized.

Application of pregnancy and breastfeeding

Experience shows that Influvac® does not have a teratogenic or toxic effect on the fetus. Influvac® can be used during lactation.

Side effects

From the blood and lymphatic system: rarely - thrombocytopenia.

From the immune system: rarely - allergic reactions are possible; Very rarely anaphylactic shock.

From the nervous system: often - headache; Rarely - paresthesia, convulsions, encephalomyelitis, neuritis, Guillain-Barre syndrome.

However, there is no convincing evidence of a relationship between these reactions and vaccination.

From the side of the vascular system: very rarely - vasculitis with transient renal dysfunction.

General disorders: often - fatigue and neuralgia that do not require treatment and take place after 1-2 days.

Local reactions: redness, swelling, soreness, tightness, ecchymosis.

Systemic reactions: fever, malaise, trembling, sweating, tenderness in muscles and joints.

In the room where the vaccination is carried out, it is necessary to have drugs for the treatment of anaphylactic shock (adrenaline, glucocorticoids, etc.).

Interaction

Influvac ® can be used concomitantly with other vaccines (vaccines should be injected into different parts of the body with different syringes). There may be an increase in side effects.

If the patient receives immunosuppressive therapy, the immune response can be reduced.

After the vaccination, it is possible to obtain false-positive results of serological tests (when performing an enzyme-linked immunoassay (ELISA)), which are caused by the production of IgM after vaccination.

Incompatibility: incompatibilities are unknown.

Dosing and Administration

IM or SC (deeply). It is strictly forbidden to administer the drug IV. Immunization is carried out annually in the autumn period. Adults and adolescents (from age 14) - 0.5 ml once, for children: from 6 months to 3 years - 0.25 ml, from 3 to 14 years - 0.5 ml once; Children who had not previously had the flu and not vaccinated, as well as patients with immunodeficiency - twice with an interval of 4 weeks.

Precautionary measures

The drug may contain an undetectable residual amount of gentamicin, therefore caution should be exercised when vaccinating individuals with hypersensitivity to aminoglycosides.

Special instructions

The vaccine retains its properties for 12 months. The expiry date is June 30 of the year following the year of issue. Do not use after the expiration date indicated on the package.

Guidelines for handling disposable syringes

Before administration, the vaccine should be warmed to room temperature. Immediately prior to injection, the syringe must be shaken, the protective cap removed from the needle and the air removed from the syringe by holding it upright with a needle and slowly pressing the piston. When a dose of 0.25 ml is injected, the movement of the syringe piston is stopped at a time when its inner surface reaches the lower edge of the needle retainer.

Manufacturer

Solvay Pharmaceuticals BV, The Netherlands.

Storage conditions of the drug Influvac

In the dark place at a temperature of 2-8 ° C (do not freeze).

Keep out of the reach of children.

The shelf life of the drug Influvac

1 year.

Do not use beyond the expiration date printed on the package.