Inflyuvak

Inflyuvak – the trivalent subunit inactivated vaccine for prevention of flu.

Form of release and structure

Dosage form – suspension for intramuscular and hypodermic introduction: transparent colourless liquid (on 0,5 ml in one-time syringes (with a needle) with a capacity of 1 ml, on 1 syringe in holders the cardboard, 1 holder in a pack cardboard).

In 1 dose of a vaccine (0,5 ml) on 15 mkg of HECTARE (hemagglutinin) of the following virus strains:

• AND _(H3N2) *;
• AND _(H1N1) *;
• B*.

* after the name of type the name of the strain recommended by World Health Organization for the current epidemic season of flu is specified.

Additional components: phosphate sodium a dihydrate, potassium dihydrophosphate, sodium chloride, chloride magnesium hexahydrate, Calcii chloridum a dihydrate, sodium citrate, potassium chloride, formaldehyde, sucrose, polysorbate 80, STAV, water for injections.

Indications to use

Inflyuvak is applied to prevention of flu at adults and children 6 months are more senior. Especially, vaccination is recommended to the following categories of the population belonging to risk group of incidence of flu:

• Elderly people are aged more senior than 65 years;
• Children and teenagers aged from 6 months up to 18 years who receive acetylsalicylic acid for a long time owing to what they under the influence of an influenzal infection are subject to risk of development of a syndrome Reja;
• Patients with a chronic renal failure;
• Patients with cardiovascular diseases of any etiology;
• People with diseases of a respiratory organs, including with bronchial asthma;
• Patients with chronic disturbances of metabolism, including patients with a diabetes mellitus;
• Patients with immunodeficient diseases and the patients receiving radiation therapy, cytostatics, corticosteroids or immunodepressants in high doses.

Contraindications

• Hypersensitivity to components of a vaccine or chicken protein;
• To hypersensitivity reaction to substances which can contain in residual quantities – to gentamycin, HAVING BECOME, to formaldehyde, polysorbate-80.

At acute diseases and an exacerbation of chronic diseases vaccination should be postponed until improvement of a state.

At not heavy acute respiratory viral infections and acute intestinal diseases immunization can be carried out at once after normalization of body temperature.

Route of administration and dosage

Inflyuvak enter intramusculary or deeply subcutaneously. The injection should be carried out carefully to avoid hit of drug in an intravascular bed. It is strictly forbidden to enter a vaccine intravenously!

Immunization is carried out annually to the autumn period.

The recommended doses:

• Adults and children are more senior than 3 years – 0,5 ml once;
• Children from 6 months to 3 years – 0,25 ml once.

The children who are not vaccinated earlier are recommended to enter a vaccine with a 4 weeks interval twice.

Rules of introduction of a vaccine:

• To heat a vaccine to room temperature;
• Just before an injection to stir up the syringe;
• To remove a protective cap from a needle;
• To remove air from the syringe, holding it in vertical position a needle up and slowly pressing the piston;
• To enter a vaccine intramusculary or deeply subcutaneously. At introduction children of a dose of 0,25 ml should stop the movement of the piston of the syringe while its internal surface reaches bottom edge of the fixer of a needle.

Side effects

The side reactions revealed during clinical trials:

• Central nervous system: often – a headache *;
• Musculoskeletal system: often – an arthralgia *, a mialgiya;
• Local reactions: consolidation, morbidity, swelling and reddening *, ecchymomas;
• Others: the strengthened sweating *, fervescence, a fever, an indisposition, fatigue.

* these reactions usually take place independently within 1-2 days and do not demand special treatment.

The side effects revealed during post-marketing observations:

• Central and peripheral nervous system: paresthesias, neuralgia, neuritis, encephalomyelitis, spasms, syndrome to Giyena-Barra;
• System of a hemopoiesis: tranzitorny lymphadenopathy, tranzitorny thrombocytopenia;
• Cardiovascular system: a vasculitis (seldom or never can be followed by a tranzitorny renal failure);
• Dermatological and allergic reactions: generalized skin reactions, including itch, urticaria or nonspecific rash, manifestations of allergic reactions; in rare instances – an acute anaphylaxis, a Quincke's disease.

Special instructions

All means necessary for carrying out emergency treatment of an acute anaphylaxis, including glucocorticosteroids, adrenaline or Epinephrinum have to be provided in an inoculative office.

1 dose of a vaccine should not contain more than 1 mkg of ovalbumin.

Patients can have an insufficient response to vaccination with immunosuppression (both exogenous, and endogenous).

At the patients who underwent vaccination by Inflyuvak obtaining false positive results of the serological tests which are carried out by the ELISA method (immunoenzyme method) such as definition of antibodies against hepatitis C, HIV (HIV1), the T-cellular lymphotropic virus of the person (HTLV1) is possible. Laboratory diagnosis by the Western blotting method allows to exclude false positive results of these tests.

Inflyuvak does not exert a negative impact on the speed of reactions and ability to concentration of attention.

It is necessary to inform the attending physician of all cases of postvaccinal reactions.

Medicinal interaction

Inflyuvak it is possible to apply along with other vaccines, but it is necessary to enter them different syringes into various body parts. However in this case it is impossible to exclude probability of strengthening of side effects.

The immune response on vaccination can be lowered at the patients receiving immunodepressive therapy.

It is not necessary to take a vaccine from the syringe and to apply it in mix with other medicines.

Terms and storage conditions

To store and transport at a temperature of 2-8 ºС in the place protected from light. To protect from children. Not to freeze. If necessary it is possible to transport drug at a temperature of 25 ºС, but no more than 24 hours.

Period of validity – 1 year. The termination of a period of validity of a vaccine is always considered on June 30 the year following after a year of release.