Microflu [Vaccine influenza inactivated whole-virion] - instructions for use, dose, side effects, contraindications

Composition:The preparation contains 1 dose (0.5 ml): hemagglutinin active substances of influenza virus subtypes A (H1N1) and A (H3N2) of 9-11 μg, hemagglutinin of influenza type B 12-14 μg; auxiliary substances - human albumin (stabilizer) - 0,75-1,05 mg.

Description:

The vaccine is a virus of influenza A and B, obtained from the virus-containing allantoic fluid of a chicken embryo, purified, concentrated and inactivated.

Opalescent colorless liquid without foreign impurities and inclusions.

Pharmacotherapeutic group: MIBP vaccine

ATX: & nbsp

J.07.B.01.01 Influenza virus - inactivated whole virus

J.07.B.B Vaccine for the prevention of influenza

Pharmacodynamics:

The vaccine causes the formation of specific immunity against the influenza virus types A and B.

The protective effect of the vaccine, as a rule, comes in 3 weeks after vaccination and lasts 10-12 months.

Indications:Specific prevention of influenza in children aged 7 years and older with nasal administration of the vaccine, in adults over 18 years of age - with nasal or parenteral administration.

Contraindications:

For parenteral administration:

1. Acute infectious and non-infectious diseases, chronic diseases at the stage of exacerbation - vaccinations are carried out not earlier than a month after recovery (remission).

2.Allergy to egg white squirrel, allergic diseases and bronchial asthma in the acute stage.

3. Systemic diseases of connective tissue.

4. Diseases of the adrenal glands.

5. Hereditary, degenerative and progredient diseases of the nervous system.

The possibility of vaccination of persons suffering from chronic diseases not listed in the list of contraindications is determined by the attending physician based on the patient's condition.

With nasal administration:

1. Allergy to egg white squirrel.

2. Chronic rhinitis.

3. Acute infectious and non-infectious diseases, exacerbation of chronic diseases - vaccinations are given no earlier than 2 weeks after recovery (remission).

All persons subject to inoculations should be examined by a doctor taking into account anamnestic data. On the day of vaccination, the vaccinated should be examined by a physician with mandatory thermometry. At a temperature above 37 ° C vaccinations are not carried out.

The doctor is responsible for the correct administration of the vaccine.

Dosing and Administration:

Vaccinations are carried out in the autumn-winter period.

Every year, vaccination is recommended:

1. Individuals with a high risk of complications in the event of an influenza:

- people over 50;

- adults and children suffering from chronic physical illnesses: diseases and malformations of the central nervous system, cardiovascular and broncho-pulmonary systems, chronic kidney diseases, diabetes, metabolic diseases, autoimmune diseases, chronic anemia, congenital or acquired immunodeficiency, in including those infected with HIV;

- adults and children living in boarding schools, houses for disabled people, etc.

2. People of a profession with a high risk of influenza or other people: health workers, employees of education, social services, transport, trade, police, military personnel, etc.

The vaccine is administered subcutaneously, once in a volume of 0.5 ml with a syringe to the area of the outer surface of the shoulder a few centimeters below the shoulder joint, or intranasally in a dose of 0.5 ml (0.25 ml in each nasal passage) twice with an interval of 21- 28 days (the lengthening of the interval is permissible for 1-2 weeks). Introduction is carried out with a dispenser-dispenser of liquid of the type RJ-M4 in accordance with the instruction for its use. The nosepiece is wiped with 70% alcohol and injected at a depth of 0.5 cm into the nasal passages,previously cleaned of mucus. The graft is in a sitting position with a slightly upturned head for one minute.

Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules.

Disinfection of the nebulizer and tips is carried out in accordance with the instructions for use.

The drug in the opened ampoule is not subject to storage.

NOT suitable for use in ampoules with broken integrity or marking, with a change in physical properties (color, transparency), expired shelf life, violation of the requirements for storage conditions.

The Inoculation is recorded in the prescribed registration forms with an indication of the date of administration of the drug, dose, serial number and manufacturer.

Side effects:

With parenteral administration, a part of the vaccinated can see general reactions in the form of malaise, headache, fever. Not more than 3% of reactions over 37.5 ° С (including no more than 0.5% over 38.5 ° С), registered in the first two days after immunization, duration not more than three days are allowed. Local reactions with subcutaneous injection (hyperemia and puffiness) occur in the majority of vaccinated; a limited number of infiltrates can form in a part of the vaccinated.The development of an infiltrate up to 25 mm is allowed in no more than 3%. The duration of local reactions does not exceed 5 days.

With nasal administration, a small part of the vaccinated can develop common reactions in the form of malaise, headache, fever. Not more than 2% of the temperature increase reactions over 37.5 ° C, registered in the first two days after immunization, lasting no more than three days are allowed.

Interaction:

Not found.

Special instructions:Do not administer intravenously. In the offices where the vaccination is carried out, it is necessary to have medicines for anti-shock measures and relief of anaphylactic reaction. The vaccinated should be monitored by a health worker within 30 minutes after immunization.

Form release / dosage:Suspension for subcutaneous and nasal administration, 0.5 ml / dose.

Packaging:In ampoules of 0.5 ml (1 dose) or 1.0 ml (2 doses). 10 ampoules in a pack or box of cardboard or in a contour acheive box in a pack or box of cardboard along with instructions for use and a scarifier.

Storage conditions:

The drug is stored at a temperature of 4 to 8 ° C in a place inaccessible to children.

Transportation is carried out at a temperature of 4 to 8 ° C. Do not freeze.

Shelf life:

1 year. The drug with expired shelf life is not subject to application.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002842/07

Date of registration:21.09.2007 / 19.06.2014

Expiration Date:Unlimited

The owner of the registration certificate:St. Petersburg Research Institute of Vaccines and Serums and the enterprise for the production of bacterial preparations FSUE FMBASt. Petersburg Research Institute of Vaccines and Serums and the enterprise for the production of bacterial preparations FSUE FMBA

Manufacturer: & nbsp

St. Petersburg Research Institute of Vaccines and Serums and the enterprise for the production of bacterial preparations FSUE FMBA

Representation: & nbspSt. Petersburg Research Institute of Vaccines and Serums and the enterprise for the production of bacterial preparations FSUE FMBASt. Petersburg Research Institute of Vaccines and Serums and the enterprise for the production of bacterial preparations FSUE FMBA

Information update date: & nbsp08.06.2018

Illustrated instructions

Instructions

Microflu [Vaccine influenza inactivated whole-virion] (MicroFlu)