Grippol Plus, 0.5 ml suspension

The vaccine induces a high level of specific immunity against influenza. Protective effect after vaccination usually comes after 8-12 days and lasts up to 12 months, including elderly people. The protective titers of antibodies to influenza viruses after vaccination of people of different ages are determined in 75-95% of the vaccinated.

The inclusion in the vaccine preparation of Polioxidonium® immunomodulator with a broad spectrum of immunopharmacological action increases immunogenicity and stability of antigens, enhances immunological memory, significantly reduces the inoculation dose of antigens, increases resistance of the body to other infections due to the correction of immune status.

Indications

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

Contents to be vaccinated. The vaccine is especially indicated:

1. People at high risk for complications from influenza:
   • over 60 years of age; preschool children, schoolchildren
   • adults and children with frequent acute respiratory infections, suffering from chronic somatic diseases, including: diseases and malformations of the central nervous, cardiovascular and bronchopulmonary systems, bronchial asthma, chronic kidney disease, diabetes mellitus, metabolic diseases, autoimmune diseases, allergic diseases (except allergies to chicken proteins); Chronic anemia, congenital or acquired immunodeficiency, HIV-infected
2. People with a high risk of influenza or infection of others by their profession:
   • medical workers, employees of educational institutions, social services, transport, trade, police, military personnel, etc.

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Composition

One dose (0.5 ml) contains:

Active components:

Antigen of influenza virus type

A (N1H1)* with hemagglutinin content – 5 µg <.

Antigen of influenza virus type

A (N3N2)* with gemaglutinin content – 5 µg

Antigen of influenza virus type B*

with hemagglutinin content – 5 µg

Polyxidonium® (Azoximer bromide) – 500 µg

Auxiliary components:

Phosphate-salt buffer solution – up to 0.5 ml.

Does not contain a preservative.

* Influenza virus antigen strains – according to WHO recommendations for the current epidemic season.

How to take, the dosage

Vaccination is carried out annually in the fall and winter period. Vaccination is possible at the beginning of the epidemic rise of influenza.

In children over 3 years of age, adolescents and adults the vaccine is given intramuscularly or deep subcutaneously in the upper third of the outer surface of the upper arm (deltoid muscle), younger children – intramuscularly to the anterolateral surface of the thigh.

In children from 6 to 35 months inclusive 0.25 ml twice with an interval of 3-4 weeks.

In children over 36 months and adults the vaccine is administered once in a dose of 0.5 ml.

Influenza-negative and unvaccinated children can get the vaccine twice at intervals of 3 to 4 weeks.

Patients who are immunodeficient and receiving immunosuppressive therapy can get the vaccine twice in 0.5 ml doses at intervals of 3 to 4 weeks.

The vaccine should be kept to room temperature and well shaken before use. Remove the protective cap from the needle and deflate the syringe by holding it upright with the needle up and slowly pushing down the plunger.

In order to immunize children who need 0.25 ml (1/2 dose) of the vaccine, remove half of the syringe by pushing down on the plunger to the special mark on the syringe barrel, or to the red mark on the edge of the label, and inject the remaining 0.25 ml.

The opening of ampoules and vials and the vaccination procedure shall be performed in strict adherence to aseptic and antiseptic rules: before opening the ampoule knife, the neck of the ampoule, or the cork of the vial is wiped with absorbent cotton moistened with 70% ethyl alcohol, the ampoule is opened, or the needle is pierced with the rubber cork of the vial, the vaccine is drawn into the syringe of single use and excess air is removed from the syringe. Alcohol is wiped off the skin at the injection site. The drug in the opened ampoule or vial must not be stored.

Interaction

The Grippol® plus vaccine can be used simultaneously with inactivated and live vaccines of the National calendar of preventive vaccinations (except BCG and BCG-M) and inactivated vaccines of the calendar of preventive vaccinations for epidemic indications (except for anti-rabies).

The contraindications for each of the vaccines used shall be taken into account; the drugs should be injected into different areas of the body with different syringes.

The vaccine may be given as part of the baseline therapy for the underlying disease. Vaccination of patients receiving immunosuppressive therapy (corticosteroids, cytotoxic drugs, radiotherapy) may be less effective.

Special Instructions

On the day of vaccination the vaccinated must be examined by a doctor (paramedic) with mandatory thermometry. At a temperature above 37.0 ° C the vaccination is not carried out.

The drug is not suitable for use in ampoules, vials, syringe doses with damaged integrity or labeling, with changes in physical properties (color, transparency), with expired shelf life, violations of the requirements for storage conditions.

The vaccine must not be administered intravenously

Impact on the ability to drive or operate machinery

Grippol® has no effect on the ability to drive or operate machinery.

Contraindications

• Allergic reactions to chicken protein and vaccine components
• Allergic reactions to previous flu vaccines
• Acute fevers or exacerbation of chronic disease. (Vaccination after recovery or remission period)
• Serious acute respiratory infections, acute intestinal diseases (vaccination after normalization of temperature)

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Side effects

The vaccine is a highly purified preparation and is well tolerated by children and adults.

Frequent (>1/100 <1/10). Local reactions in the form of soreness, hyperemia, thickening and swelling at the injection site. General reactions: malaise, weakness, subfebrile fever

Infrequent (>1/1000 <1/100)General reactions as a mild runny nose, sore throat, headache and fever above subfebrile

These reactions usually go away on their own within 1-2 days.

Rare (>1/10000 <1/1000)Allergic reactions, including immediate type

Very rare (>1/10000)

• Nervous system side: neuralgia, paresthesia, neurological disorders;
• movement system side: Myalgia

The patient should be informed to inform the physician of any severe, or not specified in these instructions, adverse reactions