The vaccine is clumsy cultural live

General characteristics. Structure:

Active ingredient: not less than 1 000 (3,0 lg) fabric cytopathic doses (TTsD50) of a virus of measles.

Excipients: the stabilizer - mix of aqueous solution LS-18 *, 10% of solution of gelatin, Gentamycini sulfas. Note. * Structure of aqueous solution of LS-18: sucrose, lactose sodium glutaminovokisly, glycine, L-proline, Hanks dry mix with phenolic red, water for injections.

The vaccine is clumsy cultural live, lyophilisate for preparation of solution for hypodermic introduction, Leningrad-16 (L-16) on primary culture of cells of embryos of quails prepares by method of cultivation of a vaccinal virus strain of measles.

Indications to use:

Planned and emergency prevention of measles. Planned inoculations carry out at the age of 12 months and 6 years to the children who did not have measles twice. Children, mothers, been born from seronegative to a virus of measles, vaccinate at the age of 8 months and further – in 14-15 months and 6 years. The interval between vaccination and revaccination has to be not less than 6 months.

Children aged from 1 year up to 18 years inclusive and the adults aged up to 35 years (inclusive) who are not imparted earlier, not having data on inoculations against measles not having measles earlier are vaccinated according to the application instruction with an interval not less than 3 months between inoculations twice.

The faces imparted earlier once are subject to carrying out single immunization with an interval not less than 3 months between inoculations.

The emergency prevention is carried out to the contact persons without restriction of age from the disease centers who were earlier not ill, are not imparted and not having data on preventive inoculations against measles or once vaccinated. In the absence of contraindications the vaccine is entered no later than in 72 h after contact with the patient.

Route of administration and doses:

Just before use the vaccine is parted with solvent for clumsy, parotitis and parotitis коревой vaccines cultural live (solvent is called further) at the rate of 0,5 ml of solvent on one inoculative dose of a vaccine.

The vaccine has to be dissolved completely within 3 min. with formation of transparent solution 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.), expired, 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 70% alcohol and break off, without allowing at the same time hit of alcohol in an ampoule.

For cultivation of a vaccine the sterile syringe select all necessary volume of solvent and transfer it to an ampoule with a dry vaccine. After hashing change a needle, gather a vaccine in the sterile syringe and do an injection.

The vaccine is entered subcutaneously of 0,5 ml under a shovel or to 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 an injection site of a vaccine of 70% alcohol.

The dissolved vaccine is used immediately and is not subject to storage. The carried-out vaccination 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, date of production, a 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. Use at pregnancy is contraindicated. Performing vaccination of women during breastfeeding according to the decision of the doctor taking into account assessment of a ratio of possible risk of infection and advantage of vaccination is allowed.

Side effects:

At the majority imparted vaccinal process proceeds asymptomatically. After introduction of a vaccine the following reactions of various degree of manifestation can be observed:

Often (1/10 – 1/100):

• with 6 on 18 days temperature reactions, an easy hyperemia of a pharynx, rhinitis can be observed. At mass use of a vaccine fervescence higher than 38,5 ºС should not be more, than at 2% vaccinated.

Seldom (1/1000 – 1/10000):

• the tussiculation and conjunctivitis proceeding during 1-3 days;
• an insignificant dermahemia and poorly expressed hypostasis which pass through 1-3 days without treatment.

Very seldom (<1/10000):

• easy indisposition and korepodobny rash; - the convulsive reactions arising, most often, later 6-10 days after an inoculation usually against the background of high temperature;
• the allergic reactions arising in the first 24-48 h at children with allergic the changed reactivity.

Note: Febrile spasms in the anamnesis, and also temperature increase higher than 38,5 ºС in the postvaccinal period are the indication to purpose of antipyretics.

Interaction with other medicines:

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

After administration of drugs of immunoglobulin of the person of an inoculation against measles carry out not earlier than in 3 months. After introduction of a clumsy vaccine the drugs of immunoglobulin can be administered not earlier than in 2 weeks; in case of need uses of immunoglobulin before this term vaccination against measles should be repeated.

After performing immunosuppressive therapy vaccination against measles can be carried out in 3-6 months after the end of treatment.

Contraindications:

1. Severe forms of allergic reactions to aminoglycosides (Gentamycini sulfas, etc.), chicken and/or quail eggs.
2. Primary immunodeficiency, malignant diseases of blood and new growth.
3. Strong reaction (rise in temperature is higher 40 With, hypostasis, a hyperemia more than 8 cm in the diameter in an injection site) or a complication to the previous introduction clumsy or parotitis коревой vaccines.
4. Pregnancy.

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 - 1 year.

Transport according to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C. Transportation is allowed short-term (no more than 24 h) at a temperature from 9 to 20 °C. Freezing is not allowed.

Issue conditions:

According to the recipe

Packaging:

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