Vaccine against rubella live attenuated (Vaccine rubella live attenuated)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for the prevention of rubellaVaccine for the prevention of rubella
Dosage form: & nbsplyophilizate for the preparation of a solution for subcutaneous administration
Composition:

One vaccine dose of the vaccine (0.5 ml) contains:

- not less than 1000 tissue cytopathogenic doses (TCDs50) of the vaccine strain of the Wistar rubella virus RA 27/3;

- stabilizer: sorbitol 25 mg, gelatase 12.5 mg.

Antibiotics and preservatives do not.

Description:

Homogeneous porous mass of light yellow color, hygroscopic. The vaccine complies with WHO requirements.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07.B.J   Vaccine for the prevention of rubella

J.07.B.J.01   Rubella virus - a living weakened

Pharmacodynamics:

The vaccine for rubella prevention is made from an attenuated strain of the Wistar rubella virus RA 27/3 on human diploid cells MRC-5.

Indications:

Specific prevention of rubella.

In accordance with the National Calendar of preventive vaccinations, vaccination is carried out twice: upon reaching 12-months and in 6 years.

Showing also:

- vaccination of girls at the age of thirteen, previously not vaccinated and not sick with rubella, or who received only one inoculation at this age;

- single vaccination of girls and non-pregnant women of childbearing age who were not vaccinated and did not suffer from rubella, for the prevention of congenital rubella of the fetus;

- single vaccination of boys and men on epidemiological indications in limited collectives.
Contraindications:

1. Pregnancy.

2. Acute infectious and non-infectious diseases, exacerbation of chronic diseases.

3. Immunodeficiency states, malignant blood diseases and neoplasms.

4. Strong reaction (temperature rise above 40 ° C, hyperemia and / or edema more than 8 cm in diameter at the site of administration of the vaccine) or a complication of the previous administration of the vaccine.

Note

HIV infection is not a contraindication to vaccination.

Carefully:
Pregnancy and lactation:It is forbidden to administer the vaccine during pregnancy.Women of childbearing age should be warned about the need to take contraceptive measures within 28 days after vaccination. Accidental vaccination of a pregnant woman is not an unconditional indication to the termination of pregnancy.
Dosing and Administration:

The vaccine must be dissolved only with the applied solvent at a rate of 0.5 ml per 1 dose with a sterile syringe and needle.

The dissolved preparation is a clear liquid of light yellow color.

Dissolved vaccine in a 10-dose packing can be stored in a dark place at a temperature of 2 to 8 ° C for no more than 6 hours.

The vaccine dose of the drug (0.5 ml) must be injected deep into the shoulder region.

ATTENTION!

The vaccine should only be administered subcutaneously.

As with all vaccines in connection with the possibility of developing allergic reactions of immediate type, the vaccine should be monitored for at least 30 minutes.

Places of vaccination should be provided with anti-shock therapy

Side effects:

Most vaccines have a vaccine process that is asymptomatic.

Within 24 hours after vaccination, a short-term hyperemia, swelling and condensation accompanied by pain may occur at the site of administration of the vaccine.

1-3 weeks after vaccination, systemic reactions, predominantly arthralgia or arthritis, can develop in teenage girls of prepubescent age (not more than 5%) and in adult women (up to 25%), which last from several days to two weeks. Arthralgias and arthritis are very rare in infants and men who received a rubella vaccine (0% -3%).

The vaccine may cause a slight increase in temperature, lymphadenopathy (enlargement of the predominantly occipital and posterior lymph nodes), myalgia, paresthesia in some vaccines.

1-2% of those vaccinated on days 6-14 after vaccination may have a short-term (on average 2 days) uneventful rash.

Seldom there is a thrombocytopenia (less than 1 case on 30 000 grafted).

Anaphylactic reactions are also rare.

These reactions are characterized by a short-term course and pass without treatment.

Interaction:

The vaccine can be administered simultaneously (on the same day) with other vaccines of the National calendar of preventive vaccinations (against mumps, measles, pertussis, diphtheria, tetanus, poliomyelitis, hepatitis B) by individual syringes in different parts of the body or 1 month after the previous vaccination.

After the introduction of human blood products (immunoglobulins, plasma, etc.), the rubella vaccine should be administered no earlier than 3 months. After immunization with rubella vaccine, blood preparations should be administered no earlier than 2 weeks later. If it is necessary to use them earlier than this period, rubella vaccination should be repeated after 3 months.

Tuberculin tests are recommended to be performed before or 4-6 weeks after the introduction of the rubella vaccine.

Special instructions: Warnings:

- PAfter acute infectious and non-infectious diseases, after exacerbation of chronic diseases, vaccination can be carried out not earlier than 1 month after recovery;

- PIn non-severe forms of acute respiratory viral infection, acute intestinal diseases, etc., vaccination is carried out immediately after the temperature is normalized;

- PAfter immunosuppressive and radiotherapy, vaccination can be given no earlier than 12 months after the end of treatment. When administering a vaccine to people receiving corticosteroids, other immunosuppressive drugs or undergoing radiotherapy, an optimal immune response may not be obtained;

- atActin can be prescribed for children with an established or suspected HIV infection.Although the available data are limited, there is no evidence of a greater incidence of adverse reactions when a rubella vaccine is administered to children with clinical or asymptomatic HIV infection.

Form release / dosage:Lyophilizate for the preparation of a solution for subcutaneous administration (complete with a solvent).
Packaging:

Vaccine - 1 or 10 doses in glass bottles of brown color (type 1). For 10 vials with 1 dose of vaccine, 50 vials with 1 dose of vaccine (for LPU), 50 vials with 10 doses of vaccine (for health facilities) with Instructions for use in a cardboard pack.

Solvent - water for injections of 0.5 ml (per dose of vaccine) or 5.0 ml (per 10 doses of vaccine) in an ampoule of colorless transparent glass 1 of the hydrolytic class. For 10 ampoules of 0.5 ml or 10 ampoules of 5 ml in a blister of PVC / aluminum foil.

For 1 or 5 blisters with 0.5 ml in a cardboard box. For 5 blisters with 5.0 ml in a cardboard box.

Storage conditions:

Vaccine transported and stored at a temperature of 2 to 8 ° C.

Solvent transported and stored at a temperature of 5 to 30 ° C.

Freezing is not allowed.

Shelf life:

Vaccines - 2 years; solvent - 5 years.

The drug with expired shelf life is not subject to application.

Terms of leave from pharmacies:On prescription
Registration number:П N015218 / 01
Date of registration:25.11.2009 / 07.06.2013
Expiration Date:Unlimited
The owner of the registration certificate: Serum Institute of India, Ltd. Serum Institute of India, Ltd. India
Manufacturer: & nbsp
Representation: & nbspSerum Institute of India, Ltd.Serum Institute of India, Ltd.India
Information update date: & nbsp13.01.2017
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