Vaccine against a rubella cultural live

General characteristics. Structure:

Active ingredient: not less than 1000 fabric cytopathic doses (TTsD50) attenuirovanny strain of RA 27/3 of a virus of a rubella.

Excipients: the stabilizer - mix of aqueous solution LS-18 (sucrose, lactose, sodium glutaminovokisly, glycine, L-proline, Hanks dry mix with phenolic red, water for injections) and 0,025 ml of 10% of solution of gelatin.

Drug is prepared by method of cultivation of an attenuirovanny virus strain of a rubella of RA 27/3 on diploid cells of the person of MRC-5.

Indications to use:

Prevention of a rubella. According to the National calendar of preventive inoculations vaccination is carried out at the age of 12 months, a revaccination – in 6 years.

The national calendar of preventive inoculations provides vaccination of children aged from 1 year up to 18 years, women from 18 to 25 years (inclusive) which were not hurting, not vaccinated, vaccinated once against a rubella, not having data on inoculations against a rubella.

Route of administration and doses:

Just before use the vaccine is parted with solvent (water for injections) at the rate of 0,5 ml of solvent on one inoculative dose of a vaccine. In order to avoid foaming the vaccine is dissolved, slightly shaking an ampoule. The vaccine has to be dissolved completely within 3 min.

The dissolved vaccine represents transparent liquid of pink color.

The vaccine and solvent in ampoules with the broken integrity, marking are not suitable for use, and also at change of their physical properties (color, transparency, etc.), incorrectly stored.

Opening of ampoules and the procedure of vaccination are carried out at strict observance of rules of an asepsis and antiseptics.

Ampoules in the place of a cut process 70º alcohol and break off, without allowing at the same time hit of alcohol in an ampoule.

For cultivation of a vaccine select all necessary volume of solvent and transfer it to an ampoule with a dry vaccine.

After hashing the vaccine is gathered other needle in the sterile syringe and used for vaccination.

The vaccine is entered only subcutaneously in a dose of 0,5 ml into the area of a shoulder (on border between the lower and average third of a shoulder from the outer side), previously having processed leather in a vaccine 70º injection site alcohol.

The dissolved vaccine is used immediately and is not subject to storage.

The carried-out inoculation is registered in the established registration forms with the indication of the name of drug, date of vaccination, a dose, manufacturer, number of a series, period of validity, reaction to an inoculation.

Features of use:

Considering a possibility of development of allergic reactions of immediate type (an acute anaphylaxis, a Quincke's edema, a small tortoiseshell) at especially sensitive persons, for vaccinated it is necessary to provide medical observation within 30 min. Venues of inoculations have to be provided with means of antishock therapy.

Use at pregnancy and during breastfeeding. Performing vaccination is contraindicated. 

Side effects:

After introduction of a vaccine the following side reactions of various degree of manifestation can be observed.

Infrequently (1/100-1/1000):

• during 24 h in an injection site the short-term hyperemia, hypostasis and consolidation which are followed by morbidity can develop.

Seldom (1/1000-1/10000):

• at some imparted for 6-14 day the short-term temperature increase up to the subfebrile sizes which is followed by the catarral phenomena can develop;
• not plentiful skin rash, a limfoadenopatiya (increase in preferential occipital and zadnesheyny lymph nodes) is possible at 1-2% vaccinated. The specified reactions are characterized by a short-term current and take place without treatment.

Very seldom (<1/10000):

• Werlhof's disease; - allergic reactions of immediate type, including anaphylactic;
• arthralgia, arthritis; these reactions arise in 1-3 weeks after immunization. Their frequency at teenage girls does not exceed 5%, at adult women can reach 25%.

This form of complications very seldom occurs at children of early age and men imparted against a rubella.

Interaction with other medicines:

Vaccination against a rubella can be carried out at the same time (in one day) with other calendar inoculations (against whooping cough, diphtheria, tetanus, epidemic parotitis, measles, poliomyelitis, hepatitis B) or not earlier than in 1 month after the previous inoculation.

At simultaneous vaccination drugs enter into different places, mixing of vaccines in one syringe is forbidden. After introduction of blood preparations of the person (immunoglobulin, plasma, etc.) the vaccine is entered not earlier than in 3 months. After introduction of a vaccine against a rubella blood preparations can be administered not earlier than in 2 weeks; in case of need uses of immunoglobulin before this term vaccination against a rubella should be repeated in 3 months.

In the presence of antibodies to a rubella virus in blood serum repeated vaccination is not carried out. Tuberkulinovy tests are recommended to be carried out to or in 4-6 weeks after introduction of a vaccine against a rubella. After purpose of immunodepressants and radiation therapy vaccination is carried out not earlier than in 12 months after the end of treatment.

Contraindications:

Allergic reactions to vaccine components.

Acute infectious and noninfectious diseases, exacerbation of chronic diseases.

Immunodeficiency; malignant diseases of blood and new growth. Pregnancy and period of breastfeeding.

Strong reaction (rise in temperature is higher 40 With, hypostasis, a hyperemia more than 8 cm in the diameter in a vaccine injection site) or complication to the previous dose of a vaccine.

Note: In the presence of HIV infection vaccination of persons with 1 and 2 immune categories (absence or a moderate immunodeficiency) is allowed.

Storage conditions:

According to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C. To store in the place, unavailable to children. Freezing is not allowed. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

Lyophilisate for preparation of solution for hypodermic introduction. On 1 dose of a vaccine in an ampoule with a capacity of 2 ml. In a pack of 10 ampoules with the application instruction and an insert with number of the stacker.