Instruction for use: Fluarix

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

Vaccines, serums, phages and toxoids

The nosological classification (ICD-10)

J11 Influenza, virus not identified: Influenza; Influenza in the early stages of the disease; Influenza in children; cold in the chest; Begins flu-like condition; Acute disease parainfluenza; parainfluenza; parainfluenza state; influenza epidemics; The pains of the influenza

Composition and release form

Suspension for injection 0.5 ml (1 dose)

Haemagglutinin of each of the recommended strains (antigenic composition and strains of the virus for the upcoming influenza epidemic season are determined annually by WHO) 15 μg

Auxiliary substances: sodium chloride; Sodium phosphate dodecahydrate; Polysorbate 80 (Tween 80); Octoxynol 9 (Triton X-100); Potassium dihydrogen phosphate; Alpha-tocopherol hydrosuccinate; Potassium chloride; Magnesium chloride hexahydrate; water for injections

In single-dose syringes of 0.5 ml each; In a box of 1 or 10 syringes; Or in single-dose ampoules of 0.5 ml each; In a box 10, 50 or 100 ampoules; Or in 0.5 ml single-dose vials; In a box of 1, 10, 50 or 100 bottles.

Description of dosage form

Colorless slightly opalescent liquid.

Characteristic

Vaccine for the prevention of influenza.

Pharmachologic effect

Mode of action - Immunostimulating.

The seroprotective level of antibodies is usually achieved within 2-3 weeks after the administration of the vaccine. The duration of postvaccinal immunity to homologous or related strains varies from 6 to 12 months.

Clinical Pharmacology

Vaccination is especially recommended for people older than 60 years and patients suffering from chronic physical illnesses, incl. Diseases of the cardiovascular system, diabetes mellitus, cystic fibrosis, chronic respiratory diseases, chronic renal failure, with congenital or acquired immunodeficiencies. Vaccination can also be recommended for preschool children, school children, people at increased risk of infection due to the nature of their work, for example, medical personnel, service workers, transport, educational institutions.

Indications of the Fluarix

Prevention of influenza in adults and children older than 6 months.

Contraindications

Hypersensitivity (including gentamycin sulfate, formaldehyde, merthiolate, sodium deoxycholate, egg whites protein used in the technological process), acute infectious diseases or exacerbation of chronic diseases. With mild ARVI, acute intestinal diseases, etc. Inoculations are performed immediately after the normalization of body temperature.

Application of pregnancy and breastfeeding

In pregnancy, Fluarix should be administered only if there is indisputable evidence (there is insufficient evidence of embryotoxicity and teratogenicity of the vaccine). There are no contraindications to the use of Fluarix during lactation.

Side effects

Soreness, redness and swelling at the injection site, a slight and short-term increase in body temperature, febrile conditions, malaise (all of these symptoms pass independently for 1-2 days).

In persons with known sensitivity to individual components of the vaccine, allergic reactions developed in the form of skin itching, hives and rashes. Such severe allergic reactions, as anaphylactic shock, were extremely rare.

Very rarely: neuralgia, paresthesia, seizures, transient thrombocytopenia, neurological disorders, vasculitis.

Interaction

The effectiveness of immunization may decrease with immunosuppressive therapy or immunodeficiency.

Fluarix can be used concomitantly with other vaccines (in this case, vaccines should be injected into different parts of the body with separate syringes).

Dosing and Administration

IM or SC (deeply). Adults and children older than 36 months - 0.5 ml once; Children from 6 months to 35 months - 0.25 ml once. Children who had not previously been vaccinated and not sick with the flu should re-enter the vaccine in the appropriate dose with an interval of at least 4 weeks. For immunization of children who are shown to administer a half dose (0.25 ml), it is necessary to take half of the contents of the ampule or vial using a graduated syringe, which allows measuring this volume. The remainder of the vaccine in the ampoule or vial should be destroyed.

Patients with thrombocytopenia and other diseases of the blood coagulation system are only administered SC.

Precautionary measures

As with other injectable vaccines, funds must always be available for use in the event of extremely rare anaphylactic reactions that may develop after the administration of the vaccine. For this reason, the vaccinee should be under the supervision of a doctor within 30 minutes after immunization.

After the vaccination against influenza, false positive serological tests are performed using the ELISA method to determine antibodies against HIV-1, hepatitis C and in particular HTLV-1, which may be the result of an immune response (IgM formation) for vaccination.

This vaccine does not prevent infections of the upper respiratory tract caused by other pathogens.

Special instructions

Vaccination is performed annually before the beginning of the epidemic season or depending on the epidemic situation.

Vaccination should be carried out at an age-appropriate dosage using a drug that has the antigenic composition recommended for this epidemic season.

Under no circumstances should the vaccine be administered IV.

Before use, the syringe, vial or ampoule with the vaccine should be vigorously shaken until a uniformly opalescent liquid forms.

The drug with altered physical properties (discoloration, presence of foreign inclusions) is not subject to application.

Manufacturer

SmithKlein Beecham, Germany.

Storage conditions of the drug Fluarix

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 Fluarix

1 year.

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