Инфлювак®

General characteristics. Structure:

Инфлювак® represents the trivalent inactivated influenza vaccine consisting of surface antigens (hemagglutinin (HECTARE), a neuraminidase (ON)) **.

One dose of a vaccine (0,5 ml) contain hemagglutinin and a neuraminidase of the following virus strains:

 

A(H3N2) *  15 mkg of HECTARE

A(H1N1) *   15 mkg of HECTARE

In *             15 mkg of HECTARE

* after the name of type the name of the strain recommended to WHO for the current epidemic season of flu is taken out.

** are cultivated on chicken embryos of healthy hens.

The antigenic structure of an influenza vaccine is annually updated according to recommendations of World Health Organization.

Excipients: potassium chloride, potassium dihydrophosphate, phosphate sodium a dihydrate, sodium chloride, Calcii chloridum a dihydrate, chloride magnesium hexahydrate, water for injections, sodium citrate, HAVING BECOME, sucrose, formaldehyde, polysorbate-80.

Description

Transparent colourless liquid.

Pharmacological properties:

The vaccine creates development of specific immunity to influenza viruses of types A and B which comes, as a rule, in 14 days after an inoculation and lasts till 1 year.

Indications to use:

Prevention of flu at adults and children since 6 months.

Vaccination is recommended to all persons and, first of all, the following categories of the population which are put the increased risk in case of a flu combination to already available diseases:
persons are more senior than 65 years regardless of a condition of their health.
patients with diseases of a respiratory organs, including bronchial asthma;
patients with cardiovascular diseases of any etiology;
patients with a chronic renal failure;
patients with chronic disturbances of metabolism, including a diabetes mellitus;
patients with immunodeficient diseases and the patients receiving immunodepressants, cytostatics, radiation therapy or high doses of corticosteroids;
the children and teenagers (from 6 months to 18 years) for a long time receiving the drugs containing acetylsalicylic acid, and, therefore, subject to the increased risk of development of a syndrome of Ray owing to an influenzal infection.

Route of administration and doses:

• A dose for adults and teenagers (since 14 years): 0,5 ml. The vaccine is entered once.

• A dose for children from 3 to 14 years: 0,5 ml; a dose for children from the 6th monthly age and up to 3 years: 0,25 ml. The vaccine is entered once. The children who are earlier not vaccinated are recommended to enter a vaccine at an interval of 4 weeks twice.

Route of administration. Immunization is carried out annually to the autumn period. The vaccine is entered intramusculary or deeply subcutaneously.

It is strictly forbidden to administer the drug intravenously.

Before introduction the vaccine has to heat up to room temperature. To stir up the syringe just before an injection. To remove a protective cap from a needle and to remove air from the syringe, holding it in vertical position a needle up and slowly pressing the piston. At introduction of a dose of 0,25 ml the movement of the piston of the syringe is stopped while its internal surface reaches bottom edge of the fixer of a needle.

Features of use:

Indoors, where vaccination is carried out, it is necessary to have medicines for treatment of an acute anaphylaxis (adrenaline, glucocorticoids, etc.)

The injection should be made with care in order to avoid hit of drug in an intravascular bed.

The immune response at patients with endogenous or exogenous immunosuppression can be insufficient.

1 dose of a vaccine should not contain more than 0,1 mkg of ovalbumin.

Influence on ability to driving of the car or to control of cars and mechanisms

Инфлювак® does not exert impact on ability to driving or use of cars and mechanisms.

Incompatibility

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

Side effects:

At conduct of clinical trials were noted:

From a nervous system:

Often: headache *

From skin and hypodermic cellulose

Often: perspiration *

From a musculoskeletal system:

Often: mialgiya, arthralgia *

General frustration:

Often: temperature increase, indisposition, fever, fatigue

Local reactions:

Reddening, swelling, morbidity, consolidation *, ecchymomas

* - reactions usually take place during 1 −2 days and do not demand treatment.

During post-marketing observation separate cases of the following undesirable reactions were noted:

From circulatory and lymphatic system:

Tranzitorny thrombocytopenia, tranzitorny lymphadenopathy

From immune system:

Allergic reactions, in rare instances — an acute anaphylaxis, a Quincke's disease

From a nervous system:

Neuralgia, paresthesias, spasms, encephalomyelitis, neuritis, Giyen's syndrome — Barret.

From vascular system:

The vasculitis seldom or never associated with a passing renal failure

From skin and hypodermic cellulose:

Generalized skin reactions, including an itch, urticaria or nonspecific rash.

Interaction with other medicines:

Инфлювак® it is possible to apply along with other vaccines. At the same time vaccines should be entered into different body parts different syringes. Strengthening of side effects is possible.

At the patients receiving immunosuppressive therapy, the immune response on vaccination can be lowered.

After vaccination emergence of false positive results of the serological tests based on the ELISA method when determining antibodies against HIV (HIV1), hepatitis C, the T-cellular lymphotropic virus of the person (HTLV1) is possible. Laboratory diagnosis by method of Western blotting allows to exclude false positive results of the tests based on the ELISA method.

Passing false positive results can be caused by development of IgM after vaccination.

Use during pregnancy and in the period of a lactation

Experience of use of a vaccine for pregnant women is limited. Nevertheless, the available experience shows that Inflyuvak® has no teratogenic or toxic effect on a fruit. Pregnant women can use the vaccine Inflyuvak®, since the 2nd trimester of pregnancy. The pregnant women belonging to risk group should be vaccinated irrespective of duration of gestation. The vaccine Inflyuvak® can be used in the period of a lactation.

Contraindications:

Hypersensitivity to chicken protein or any other component of a vaccine.

Emergence of reactions of hypersensitivity to substances which can contain in residual quantities — to formaldehyde is possible, HAVING BECOME, to polysorbate-80 and gentamycin.

Vaccination is postponed until the end of acute displays of a disease and an exacerbation of chronic diseases. At not heavy SARS, acute intestinal diseases, etc. vaccination is carried out at once after normalization of temperature.

Storage conditions:

1 year. At the same time expiry date is considered on June 30 the year following after a year of release. Not to apply after a period of validity.

Storage conditions and transportations

To store and transport in the place protected from light at a temperature from 2 °C to 8 °C, not to freeze. Transportation is allowed at a temperature of 25 °C, but no more than 24 hours. To store in the places unavailable to children.

Issue conditions

The packaging containing 1 syringe is released from drugstores according to the recipe of the doctor. The packaging containing 10 syringes is released to treatment and prevention facilities.

Issue conditions:

According to the recipe

Packaging:

On 0,5 ml in the one-time syringe with a capacity of 1,0 ml with the needle closed by a plastic cap. On 1 or 10 syringes in the cardboard holder. The cardboard holder place in a cardboard pack with control of the first opening. Put the Application instruction in a cardboard pack.