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General characteristics. Structure:

Active agents: one immunizing dose (0,5 ml) contains not less, than on 5 mkg of hemagglutinin epidemic of urgent influenza strains of subtypes A (H1N1 and H3N2) and type B, production Abbott Biolodzhikalz B. V., the Netherlands, 500 mkg of Polioksidoniy® immunoadjuvant in the phosphatic and salt buffer; does not contain preservative.

Pharmacological properties:

The vaccine causes formation of high level of specific immunity against flu. The protective effect after vaccination, as a rule, occurs in 8-12 days and remains up to 12 months including at elderly persons. Protective antiserum capacities to influenza viruses after vaccination of persons of different age are defined at 75-95% vaccinated.

Inclusion in vaccinal drug of an immunomodulator Polioksidoniy® possessing a wide range of immunopharmacological action provides increase in an immunogenicity and stability of antigens, allows to increase immunological memory, it is essential to lower an inoculative dose of antigens, to increase resistance of an organism to other infections due to correction of the immune status.

Indications to use:

Specific prevention of flu at children, since the 6th monthly age, teenagers and adults without restriction of age.

The contingents which are subject to inoculations. The vaccine is especially shown:
1. To persons with high risk of emergence of complications in a case of flu:

60 years are more senior; to children of preschool age, school students
to the adults and children who are often ill ORZ suffering from chronic somatopathies including: diseases and malformations central nervous, cardiovascular and bronchopulmonary systems, bronchial asthma, chronic diseases of kidneys, a diabetes mellitus, metabolism diseases, autoimmune diseases, allergic diseases (except an allergy to chicken proteins); chronic anemia, the inborn or acquired immunodeficiency, HIV-positive
2. To the persons by the nature of a profession having high risk of a disease of flu or infections with it of other persons:

to medics, employees of educational institutions, spheres of social service, transport, trade, police, to the military personnel, etc.

Route of administration and doses:

Vaccination is carried out annually to the autumn and winter period. Vaccination at the beginning of epidemic rise in incidence of flu is possible.

To children is more senior than 3 years, to teenagers and adults the vaccine is entered intramusculary or deeply subcutaneously into an upper third of an outside surface of a shoulder (in a deltoid muscle), to children of younger age – in the perednebokovy surface of a hip intramusculary.
Children are from 6 to 35 months old inclusive on 0,25 ml with an interval of 3-4 weeks twice.
To children 36 months are more senior and the adult enter a vaccine once in a dose of 0,5 ml.

Earlier not hurting flu and to not vaccinated children perhaps double introduction of a vaccine with an interval of 3-4 weeks.
To patients with an immunodeficiency and receiving immunosuppressive therapy introduction of a vaccine twice on 0,5 ml with an interval of 3-4 weeks is possible.
Before use the vaccine should be sustained to room temperature and it is good to stir up. To remove a protective cover from a needle and to remove air from the syringe, holding it in vertical position a needle up and slowly pressing the piston.

For immunization of children to whom introduction of 0,25 ml (1/2 doses) of a vaccine is shown it is necessary to remove a half of contents of the syringe, having pressed on the piston to special risks, noted on the syringe case, or to the tag of red color applied on edge of the label and to enter the remained 0,25 ml.

Features of use:

In day of an inoculation vaccinated have to be examined by the doctor (paramedic) with obligatory thermometry. At a temperature above 37,0 °C vaccination is not carried out.

Drug in ampoules, bottles, the syringe doses with the broken integrity or marking is not suitable for use, at change of physical properties (color, transparency), at the expired period of validity, disturbance of requirements to storage conditions.

Not to enter intravenously. In offices where vaccination is carried out, it is necessary to have means of antishock therapy. Vaccinated has to be under observation of the medic within 30 min. after immunization.

Side effects:

The vaccine is high cleaning drug, is well transferred by children and adults. Local and general reactions to introduction of a vaccine, as a rule, are absent. Seldom in an injection site reactions in the form of morbidity, hypostasis and erubescence can develop. Very seldom at individuals the general reactions in the form of an indisposition, a headache, temperature increase, slight cold, a pharyngalgia are possible. The specified reactions usually disappear independently in 1-3 days. Extremely seldom, as well as at any other vaccination, allergic reactions, a mialgiya, neuralgia, paresthesia, neurologic frustration can be observed.

Interaction with other medicines:

The vaccine Grippol® plus can be applied along with the inactivated and live vaccines of the National calendar of preventive inoculations (except for BTsZh and BTsZh-M) and the inactivated vaccines of a calendar of preventive inoculations according to epidemic indications (except for antirabic). At the same time contraindications to each of applied vaccines have to be considered; the drugs should be administered in different body parts different syringes.

The vaccine can be entered against the background of basic therapy of a basic disease. Vaccination of the patients receiving immunosuppressive therapy (corticosteroids, cytotoxic drugs, radiotheraphy) can be less effective.

Contraindications:

Allergic reactions to chicken protein and components of a vaccine
Acute feverish states or exacerbation of a chronic disease. (Vaccination will be out after recovery or during remission)
To the persons which earlier had allergic reactions to introduction of influenza vaccines
At not heavy SARS, acute intestinal diseases vaccination is carried out after normalization of temperature
Pregnancy and lactation
Preclinical trials showed that the influenza vaccine inactivated polymer - subunit does not possess embriotoksichesky and teratogenic action. The decision on vaccination of pregnant women has to be made by the doctor individually taking into account risk of infection with flu and possible complications of an influenzal infection. Vaccination in the second and third trimesters is safest.

Feeding by a breast is not a contraindication for vaccination.

Overdose:

It is not described.

Storage conditions:

To store in the place protected from light at a temperature from 2 °C to 8 °C.
To protect from children!
Not to freeze! The drug which underwent freezing is not subject to use.

Transportation by all types of the covered transport in lightproof containers at a temperature from 2 °C to 8 °C, in the conditions excluding freezing. Transportation is allowed at a temperature up to 25 °C within 6 hours.

Issue conditions:

According to the recipe

Packaging:

On 0,5 ml (1 dose) in disposable syringes or in the ampoules or bottles which are hermetically corked by rubber bungs and pressed out by aluminum caps.

On 1, 5 or 10 syringes in a blister strip packaging from a film the polyvinyl chloride, covered aluminum foil with a polymeric covering, or the paper laminated with a polymeric covering. On 1 (containing 1 or 5 or 10 syringes) or 2 (the containing 5 syringes) planimetric packagings in a pack from a cardboard together with the application instruction.
On 5 ampoules or bottles in a blister strip packaging from a film polyvinyl chloride. On 1 or 2 blister strip packagings in a pack from a cardboard together with the application instruction.
Or 5 or 10 ampoules or bottles without blister strip packaging place in a pack from a cardboard together with the application instruction.