Совигрипп Vaccine influenza inactivated subunit - instructions for use, dose, side effects, contraindications

hemagglutinin of influenza virus subtype A (H3N2) - 5 μg; hemagglutinin of influenza type B - 11 μg; adjuvant SOVIDON1 m - 500 mcg; preservative - thiomersal (merthiolate) - (50.0 ± 7.5) μg; phosphate-buffered saline solution up to 0.5 ml.

Vaccine without preservative haemagglutinin of influenza virus subtype A (H] Ni) - 5 μg hemagglutinin of influenza virus subtype A (H3N2) - 5 μg; hemagglutinin of influenza type B - 11 μg; adjuvant SOVIDON ™ - 500 mcg;

phosphate-buffered saline solution up to 0.5 ml.

Note. Composition (phosphate-buffered saline No. 1 (for the preparation without preservative): 9 g of sodium chloride, 1.5 g of sodium hydrophosphate, 0.12-0.14 g of potassium dihydrogen phosphate, water for injection up to 1 liter.

The composition of phosphate-buffered saline No. 2 (for the preparation with a preservative): 9 g of sodium chloride, 1.5 g of sodium hydrophosphate, 0.12-0.14 g of potassium dihydrogen phosphate, 0.85 ml of thiomersal (merthiolate) solution of 1% water for injection up to 1 liter.

Description:

Colorless or slightly yellowish transparent liquid.

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:

Immunobiological properties.

The vaccine forms a high specific immunity against seasonal influenza.

Indications:

Active annual prophylactic immunization against seasonal

influenza in people aged 18 years.

The vaccine is especially indicated

1. Persons at high risk of disease and complications

in case of influenza:

- persons over 60 years of age;

- Persons who are often ill with acute respiratory viral infections;

- Persons suffering from chronic physical diseases, including diseases and malformations of the cardiovascular, respiratory and central nervous systems, chronic kidney diseases, metabolic diseases, diabetes mellitus, chronic anemia, allergic diseases (except allergy to chicken proteins); congenital or acquired immunodeficiency, including the infected human immunodeficiency virus.

2. Persons who have a high risk of influenza or other persons who are infected by a kind of educational or professional activity:

- students over 18 years of age;

- medical workers;

- social workers,

spheres of management, education, service, public catering,

transport, trade;

- servicemen, police.

Contraindications:

1. Allergic reactions to chicken protein or other components of the vaccine.

2. Strong post-vaccination reactions (temperature above 40 ° C, the appearance of edema at the site of administration, hyperemia over 8 cm in diameter) or postvaccinal complications (collapse, nefembrilnye convulsions, anaphylaxis) for the previous introduction of the influenza vaccine.

Temporary contraindications.

1. Acute feverish conditions, acute infectious and non-infectious diseases, including the period of convalescence. Vaccination is usually done 2-4 weeks after recovery.

2. Chronic diseases in the acute stage. Vaccination is performed during remission. The possibility of vaccination of persons suffering from chronic diseases is determined by the attending physician, based on the patient's condition.

3. With mild forms of acute respiratory viral and intestinal infections, vaccination is performed after the temperature normalization and / or disappearance of acute symptoms of the disease.

Pregnancy and lactation:

Experience with the use of influenza inactivated vaccines shows that vaccination does not have teratogenic or toxic effects on the fetus or the baby and can be used in pregnancy and during breastfeeding.The final decision on vaccination of pregnant and breastfeeding should be taken by the doctor individually, taking into account the risk of infection with influenza and possible complications of influenza infection. The vaccination is most safe in the second and third trimesters.

Dosing and Administration:

Vaccination is carried out annually in the autumn-winter period. It is possible to vaccinate at the beginning of an epidemic rise in the incidence of influenza.

The vaccine is administered once intramuscularly in the upper third of the outer surface of the shoulder (in the deltoid muscle region) in a vaccine dose of 0.5 ml.

Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules. The drug in the opened ampoule is not subject to storage.

NOT FITNESSED to use the drug in ampoules with altered physical properties (color, transparency), broken integrity and marking, expired shelf life, violations of storage and / or transportation regimes.

Precautions for use. Do not administer intravenously! On the day of vaccination, the vaccinated should be examined by a therapist / paramedic with mandatory thermometry. At a temperature above 37 ° C vaccination is not carried out.

Vaccination sites should be equipped with anti-shock therapy. The vaccinated should be under medical supervision within 30 minutes after the administration of the drug.

Side effects:

The vaccine is a highly purified drug and good

is carried by the vaccinated. The development of the following reactions is possible:

Very often (> 1/10):

- local reactions: soreness in palpation, compaction, swelling and hyperemia of the skin at the site of injection;

- Systemic reactions: low-grade fever, malaise, headache, perspiration and sore throat, a slight runny nose.

These local and systemic reactions are transient in nature and disappear after 1-2 days without the appointment of specific therapy.

Very rarely (<1 / 10,000):

- with high individual sensitivity, allergic reactions can occur: anaphylactic shock, angioedema, hives, rash (erythematous, papular), etc.

Overdose:

Cases of overdose are not established.

Interaction:

The vaccine can be administered against the background of basic therapy of the underlying disease. Vaccination of people receiving immunosuppressive therapy may be less effective.

The vaccine can be used concomitantly with other inactivated vaccines (with the exception of anti-rabies vaccines). This should take into account contraindications to each of the vaccines used, the drugs must be injected into different parts of the body with different syringes.

Effect on the ability to drive transp. cf. and fur:Not installed.

Form release / dosage:Solution for intramuscular injection of 0.5 ml (1 dose).

Packaging:

Solution for intramuscular injection of 0.5 ml (1 dose) in ampoules or in single-use syringes with a needle and protective cap.

10 ampoules with instructions for use and a scapegrator ampoule in a cardboard box.

5 ampoules in the outline of the cell. 2 contour packs with instruction for use and ampoule ampoule in a pack of cardboard.

When packaging ampoules that have a break ring or a point for dissection, the ampoule scapegrator is not inserted.

1 syringe in a planar cell package. 1 contour pack with instructions for use in a pack of cardboard.

Storage conditions:

Conditions of transportation. Transport at a temperature of 2 to 8 ° C. Freezing is not allowed.

Storage conditions.Store at temperatures between 2 and 8 ° C out of the reach of children. Freezing is not allowed.

Shelf life:

1 year. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001836

Date of registration:13.09.2012

The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Manufacturer: & nbsp

MICROGEN FGUP NGO Russia

Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Information update date: & nbsp21.01.2014

Illustrated instructions

Instructions

Совигрипп Vaccine influenza inactivated subunit (Совигрипп Vaccine influenza inactivated subunit)