Гриппол®

General characteristics. Structure:

Active ingredients: a vaccine without preservative: 5 mkg of hemagglutinin of an influenza virus of a subtype A (H1N1), 5 mkg of hemagglutinin of an influenza virus of a subtype A (H3N2), 11 mkg of hemagglutinin of an influenza virus of type B.

Vspomogatelne of substance: azoxymeasure bromide (Polyoxydoñas).

- a vaccine with preservative: 5 mkg of hemagglutinin of an influenza virus of a subtype A (H1N1), 5 mkg of hemagglutinin of an influenza virus of a subtype A (H3N2), 11 mkg of hemagglutinin of an influenza virus of type B – 11 mkg.

Excipients: an azoxymeasure - tiomersat bromide (Polyoxydoñas), preservative (mertiolit).

Note.

1. At stages of production of drug as solvent and the stabilizer рН the phosphatic buffered solution (PBS) is used: for drug without preservative - FBI No. 1, drug with preservative – FBI No. 2. Structure of FBI No. 1: 9 g of sodium of chloride, 1,5 g of sodium of hydrophosphate, 0,12-0,14 of potassium of dihydrophosphate, water for injections to 1 l. Structure of FBI No. 2: 9 g of sodium of chloride, 1,5 g of sodium of hydrophosphate, 0,12-0,14 of potassium of dihydrophosphate, 0,85 ml were tiomersat (mertiolyat) of solution of 1%, by water for injections to 1 l.
2. Polyoxydoñas are represented by mix of active agent a polioksidoniya (a bromide azoxymeasure) and excipients: Mannitolum, povidone and beta каротена aqueous solution, received as a result of a continuous production cycle.

The vaccine represents superficial glycoproteins (hemagglutinin and neuraminidases) allocated from the purified virions of an influenza virus of type A and B received from virussoderzhashchy allantoisny liquid of chicken embryos from clinically healthy hens, and divorced in phosphatic buffered solution, in a complex with an azoxymeasure bromide (Polyoxydoñas). Drug does not contain preservative or contains preservative tiomersat (mertiolit).

Indications to use:

The vaccine without preservative at children from 6-month age, teenagers and adults without restriction of age is applied to specific prevention of flu; a vaccine with preservative - at adults since 18 years.

The vaccine is especially shown:

1. To persons with high risk of emergence of complications in a case of flu: - to persons 60 years are more senior; to children of preschool age, school students; - to the persons who are often ill ORZ suffering from chronic somatopathies including: diseases and malformations central nervous, cardiovascular and bronchopulmonary systems, including bronchial asthma, chronic diseases of kidneys, a diabetes mellitus, metabolism diseases, autoimmune diseases, allergic diseases (except an allergy to chicken proteins and components of a vaccine); chronic anemia, the inborn or acquired immunodeficiency, HIV - an infection.
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.

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.

The vaccine is entered intramusculary (into a deltoid muscle) or deeply subcutaneously into an upper third of an outside surface of a shoulder, to children of younger age in the anteroexternal surface of a hip intramusculary.

To children from 6 months to 3 years:

• on 0,25 ml (1/2 doses, contained in an ampoule and selected by the sterile syringe having the corresponding graduation) twice with an interval of 4 weeks (earlier not vaccinated);
• on 0,5 ml once if the child during the previous season was vaccinated against flu.

To children 3 years, to teenagers and adults without restriction of age are more senior:

• on 0,5 ml once. Patients with the secondary immunodeficience including receiving immunosuppressive therapy are recommended to enter a vaccine on 0,5 ml with an interval of 4 weeks twice.

Opening of ampoules and the procedure of vaccination are carried out at strict observance of rules of an asepsis and antiseptics: before opening the ampoule knife, a neck of an ampoule are wiped with the cotton wool moistened 70% with alcohol, open an ampoule, gather a vaccine in a disposable syringe and delete excess of air from the syringe.

Wipe with alcohol skin in the place of an injection. Drug in the opened ampoule is not subject to storage.

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

Drug in ampoules 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.

Features of use:

Not to enter intravenously!

In offices where vaccination is carried out, it is necessary to have medicines for emergency and antishock treatment.

Vaccinated has to be under medical observation within 30 min. after immunization.

Use at pregnancy and during breastfeeding. When performing vaccination against flu of pregnant women the vaccines which are not containing preservatives are used. Preclinical trials showed that the vaccine does not possess embriotoksichesky and teratogenic action. The decision on vaccination of pregnant women and the nursing women has to be accepted 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.

Side effects:

The vaccine is high cleaning drug and is well transferred vaccinated. In response to introduction of a vaccine development of the following reactions is possible:

Very often (> 1/10):

• local reactions: morbidity at a palpation, consolidation, hypostasis and a dermahemia in an injection site;
• system reactions: subfebrile temperature, indisposition, weakness, headache, irritation and pharyngalgia, rhinitis, mialgiya, arthralgia.
The specified reactions have tranzitorny character and usually take place independently within 1-2 days without purpose of specific therapy.

Very seldom (<1/10 000):

• at high individual sensitivity allergic reactions can be observed: acute anaphylaxis, Quincke's disease, small tortoiseshell, rash (erythematic, papular), etc.

Interaction with other medicines:

The vaccine can be entered against the background of basic therapy of a basic disease. Vaccination of the patients receiving immunosuppressive therapy can be less effective.

The vaccine can be applied along with other inactivated vaccines, and also is combined with vaccines of a national calendar of preventive inoculations, except for BTsZh. At the same time contraindications to each of the applied vaccines have to be considered, the drugs have to be administered in different body parts by different syringes.

Contraindications:

1. Allergic reactions to chicken proteins and components of a vaccine.
2. Acute feverish states or an exacerbation of a chronic disease (vaccination will be out after recovery or during remission). At not heavy SARS, acute intestinal diseases vaccination is carried out after normalization of temperature.
3. Postvaccinal complications on the previous vaccination: temperature increase higher than 39,5 ºС, hypostasis and a hyperemia in an injection site over 8 cm in the diameter.
4. Age up to 6 months (at use of a vaccine without preservative).
5. Age up to 18 years (at use of a vaccine with preservative). 6. Pregnancy (at use of a vaccine with preservative).

Storage conditions:

Drug should be stored and transported at a temperature from 2 to 8 °C. Transportation is possible at a temperature up to 25 °C during 6 h. The drug which underwent freezing is not subject to use.

Issue conditions:

According to the recipe

Packaging:

Solution for intramuscular and hypodermic introduction on 0,5 ml (1 dose) in ampoules or syringes of single use with a needle and a protective cap. On 10 ampoules in a box from a cardboard together with the application instruction and the scarificator ampoule. On 5 ampoules in a blister strip packaging. On the 2nd blister strip packagings without covering in a pack from a cardboard together with the application instruction and the scarificator ampoule. When packaging the ampoules having a ring of a break or a point for opening the scarificator ampoule is not put. On 1 syringe with a vaccine in planimetric a cell to packaging. On 1 blister strip packaging in a pack from a cardboard together with the application instruction.