Grippol® Influenza Trivalent Polymer-Subunit Liquid Vaccine (Grippol)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for the prevention of influenza [inactivated] + Azoxime bromideVaccine for the prevention of influenza [inactivated] + Azoxime bromide
Dosage form: & nbsp
solution for intramuscular and subcutaneous administration
Composition:One dose (0.5 ml) contains 5 μg hemagglutinin of the influenza virus subtypes A (H1N1) and A (H3N2), 11 μg type B and 500 μg azoxime bromide.

The antigenic composition of the vaccine changes every year in accordance with the epidemic situation, the recommendations of the WHO and the Commission on influenza vaccine and diagnostic strains of the Ministry of Health and Social Development of Russia.

Description:

Colorless or slightly yellowish transparent liquid.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07.B.B.02   Influenza virus - purified antigen

J.07.B   Vaccines for the prevention of viral infections

Pharmacodynamics:

The vaccine is a surface glycoproteins (hemagglutinin and neuraminidase) isolated from purified influenza virus type A and V virions derived from the virus-containing allantoic fluid from chicken embryos from clinically healthy hens and diluted in phosphate buffer solution in combination with azoxime bromide (Polyoxidonium). The drug does not contain a preservative or contains a preservative thiomersal (merthiolate).

The antigenic composition of the strains changes annually in accordance with the epidemic situation, the recommendations of the WHO and the Commission on influenza vaccine and diagnostic strains of the Ministry of Health of Russia.

Immunobiological properties.

The vaccine causes the formation of high specific immunity against influenza. The protective effect after vaccination, as a rule, comes in 8-12 days and lasts up to 12 months, including in the elderly. Protective titers of antibodies to influenza viruses after vaccination of persons of different ages are determined in 75-92% of vaccinated.

The inclusion in the vaccine formulation azoximer bromide provides increased immunogenicity and stability antigens allows to increase the immunological memory, significantly reduce the dose of graft antigens to raise resistance to other infections due to the correction of immune status.

Indications:

Specific prevention of influenza in children from 6 months of age, adolescents and adults without age restriction.

The vaccine is especially shown:

1. Persons with a high risk of complications in the case of influenza:

- people over 60; children of preschool age, schoolchildren;

- adults and children with frequent episodes of acute respiratory disease, with chronic somatic diseases, including diseases and malformations of the central nervous, cardiovascular and broncho-pulmonary systems, including asthma, chronic kidney disease, diabetes, metabolic diseases, autoimmune diseases, allergic diseases (except allergy to chicken proteins); chronic anemia, congenital or acquired immunodeficiency, HIV infection.

2. Persons who have a high risk of influenza contamination of other persons:

- medical workers, employees of educational institutions, social services, transport, trade, police, servicemen.

Contraindications:
1. Allergic reactions to chicken proteins and vaccine components.
2. Acute febrile conditions or exacerbation of chronic
diseases (vaccination is carried out after recovery or during remission). For non-severe acute respiratory viral infections, acute intestinal diseases, vaccination is carried out after normalizing the temperature.
3. Post-vaccination complications for prior vaccination: increased temperature above 39.5 ° C, edema and hyperemia at the site of administration more than 8 cm in diameter.
Pregnancy and lactation:Preclinical studies have shown that the vaccine does not have embryotoxic and teratogenic effects. The decision on vaccination of pregnant and lactating women should be taken by a 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 injected intramuscularly (deltoid muscle) or deep subcutaneous injection in the upper third of the outer surface of the shoulder, in younger children perednenaruzhnuyu thigh intramuscularly.

Children from 6 months to 3 years:

- for 0.25 ml (1/2 dose) twice at intervals 4 weeks (previously not vaccinated);

- by 0,5 ml once, if a child in the previous season was vaccinated against the flu.

Children over 3 years old, adolescents and adults without age limit:

- by 0,5 ml once.

Patients with secondary immunodeficiency, including those receiving immunosuppressive therapy, are recommended to administer the vaccine twice by 0,5 ml with an interval of 4 weeks.

Ampoule opening and vaccination procedure performed under strict aseptic and antiseptic regulations: before opening the ampoule knife ampoule neck rubbed with cotton wool soaked in 70% ethanol, the ampoule is opened, gaining vaccine of disposable syringe and the syringe is removed from the excess air. Alcohol rubs the skin at the injection site. The drug in the opened ampoule is not subject to storage.

On the day of vaccination, the vaccinated should be examined by a physician (paramedic) with obligatory thermometry.At a temperature above 37 ° C vaccination is not carried out.

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.

Precautions for use. Do not administer intravenously. In the offices where the vaccination is carried out, it is necessary to have medicines for emergency and anti-shock therapy. The vaccinated should be under medical supervision for 30 minutes after immunization.

Side effects:

The vaccine is a highly purified preparation and well tolerated by the vaccinated. Local and general reactions to vaccine administration are generally not available, but the following adverse events may develop:

Rarely (1/1000 -1/10000):

- local reactions: edema and flushing of the skin at the injection site, the appearance of soreness at the injection site;

Very rarely (<1 / 10,000):

- general reactions: low-grade fever, malaise, weakness, headache, sore throat, rhinitis, myalgia, arthralgia.

These reactions, as a rule, do not require the appointment of therapy and disappear independently after 1 -2 days.

At high individual sensitivity, allergic reactions (anaphylactic shock, urticaria, rash, etc.) can be observed, therefore, the vaccinated should be under medical supervision within 30 minutes after vaccination; It is absolutely necessary to have emergency and anti-shock therapy in places of immunization.

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 patients receiving immunosuppressive therapy may be less effective. The vaccine can be used concomitantly with other inactivated vaccines, as well as combined with the vaccines of the national calendar of preventive vaccinations, with the exception of BCG. 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 and subcutaneous injection of 0.5 ml (1 dose).
Packaging:

In single-use ampoules or syringes with needle and protective cap.

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

5 ampoules in the outline of the cell. 2 contour uncoated package packs in a pack of cardboard together with instructions for use and a scarifier ampoule.

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

1 syringe with a vaccine in a contour pack. 1 contour pack in a pack of cardboard along with instructions for use.

Storage conditions:

Store in a dark place at a temperature of 2 to 8 ° C. Keep out of the reach of children.

Freezing is not allowed.

The drug, which has been frozen, is not subject to application.

Transportation at a temperature of 2 to 8 ° C. Freezing is not allowed. Transportation is allowed at temperatures up to 25 ° C for 6 hours.

Shelf life:

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

Terms of leave from pharmacies:On prescription
Registration number:P N003865 / 01
Date of registration:21.05.2010 / 17.05.2013
Expiration Date:Unlimited
The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Manufacturer: & nbsp
Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Information update date: & nbsp10.05.2017
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