Rubella rubella culture vaccine (Vaccine rubella live)

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 inoculation dose (0.5 ml) contains:

active substance: attenuated strain RA 27/3 rubella virus not less than 1000 tissue cytopathogenic doses (TCDs50);

Excipients: stabilizer - a mixture of 0.100 ml of an aqueous solution of LS-18 (sucrose 250 mg, lactose 50 mg, sodium glutamic acid 37.5 mg, glycine 25 mg, L-proline 25 mg, Hanks dry mixture with phenolic red 7.15 mg, water for injection - up to 1 ml) and 0.025 ml of 10% gelatin solution.

Description:

Lyophilizate - homogeneous porous mass of light yellow color, pinkish tint is allowed. It is hygroscopic.

Reconstituted drug - transparent liquid of pink color.

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 preparation is prepared by culturing an attenuated strain of the rubella virus RA 27/3 on human diploid cells MRC-5.

Indications:

Prevention of rubella.

In accordance with the National Calendar of preventive vaccinations, vaccination is carried out at the age of 12 months, revaccination - in 6 years.

The national calendar of preventive vaccinations provides for the vaccination of children aged 1 to 18 years, women aged 18 to 25 (inclusive), not ill, not vaccinated, vaccinated once against rubella, who do not have information about vaccinations against rubella.

Contraindications:

- Allergic reactions to vaccine components;

- acute infectious and non-infectious diseases, exacerbation of chronic diseases;

- immunodeficiency states; Malignant blood diseases and neoplasms;

- pregnancy and the period of breastfeeding;

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

Note.

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

Carefully:
Pregnancy and lactation:

Vaccination is contraindicated.

Dosing and Administration:

Immediately before use, the vaccine is diluted with a solvent (water for injections) at the rate of 0.5 ml of solvent per vaccination dose of the vaccine. To avoid foaming, the vaccine is dissolved by gently rocking the ampoule. The vaccine should completely dissolve within 3 minutes. The dissolved vaccine is a clear liquid of pink color. Vaccine and solvent in ampoules with broken integrity, marking, and also when their physical properties (color, transparency, etc.), incorrectly stored, are not suitable for use.

Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules. Ampoule at the point of incision is treated with 70 ° alcohol and breaks, not allowing the alcohol to enter the ampoule. To dilute the vaccine, take all the necessary volume of the solvent and transfer it to an ampoule with a dry vaccine.After mixing, the vaccine is taken up by another needle in a sterile syringe and used for vaccination.

The vaccine is administered only subcutaneously in a dose of 0.5 ml in the shoulder region (at the border between the lower and middle third of the shoulder from the outside), after preliminary treatment of the skin at the injection site of the 70 ° ethyl alcohol.

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

The vaccination is recorded in the prescribed registration forms with the name of the preparation, the date of vaccination, the dose, the manufacturer, the serial number, the expiration date, the response to the vaccination.

Precautions for use

Given the possibility of developing allergic reactions of immediate type (anaphylactic shock, Quincke's edema, urticaria) in particularly sensitive individuals, vaccinated should ensure medical supervision for 30 minutes. Vaccination sites should be provided with anti-shock therapy.

Side effects:

After the introduction of the vaccine, the following adverse reactions of varying severity can be observed, the frequency of development of which is indicated in accordance with the recommendations of the World Health Organization and includes the following categories:

Often (1 / 10-1 / 100):

- Unnecessary skin rash, lymphadenopathy (enlargement of mainly occipital and posterior lymph nodes) is possible in 1-2% of vaccinated.

Infrequently (1 / 100-1 / 1000):

- Within 24 hours at the site of administration, short-term hyperemia, swelling and condensation accompanied by soreness may develop.

Rarely (1 / 1000-1 / 10000):

- Some vaccinated on day 6-14 may develop a short-term rise in temperature to subfebrile values, accompanied by catarrhal phenomena and the possibility of developing conjunctivitis.

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

Very rarely (<1/10000):

- thrombocytopenic purpura (develops more often from 5 to 21 days after vaccination);

- allergic reactions of immediate type, including anaphylactic.

Arthralgia, arthritis; these reactions occur 1-3 weeks after immunization, their frequency varies depending on age and sex.

Adult women:

Very often (≥1 / 10), the frequency can reach up to 25%;

Teenagers (girls):

Often (1 / 10-1 / 100), the frequency does not exceed 5%;

Children of early age, adult men:

Very rarely (<1/10000).

Overdose. Cases of overdose are not established.

Overdose:

Cases of overdose are not established.

Interaction:

Vaccination against rubella can be carried out simultaneously (on the same day) with other calendar vaccinations (against pertussis, diphtheria, tetanus, mumps, measles, poliomyelitis, hepatitis B) or not earlier than 1 month after the previous vaccination. With simultaneous vaccination drugs are injected into different places, mixing of vaccines in one syringe is prohibited.

After the administration of human blood products (immunoglobulin, plasma, etc.), the vaccine is administered no earlier than 3 months. After the introduction of the rubella vaccine, blood products can be administered no earlier than 2 weeks; If immunoglobulin is required before this time, rubella vaccination should be repeated after 3 months. In the presence of antibodies to the rubella virus in the serum, repeated vaccination is not performed.

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

After the appointment of immunosuppressants and radiotherapy, vaccination is given no earlier than 12 months after the end of treatment.

Special instructions:

Vaccination of women of childbearing age is carried out under the condition that women at the time of vaccination are not pregnant and will take precautions to avoid conception within 2 months after vaccination. Accidental vaccination of a pregnant woman is not an indication for abortion.

After acute infectious and non-infectious diseases, exacerbations of chronic diseases, vaccination is carried out not earlier than 1 month after recovery.

Effect on the ability to drive transp. cf. and fur:

No information.

Form release / dosage:Lyophilizate for the preparation of a solution for subcutaneous administration, 0.5 ml / dose.
Packaging:

1 dose of vaccine in an ampoule with a capacity of 2 ml.

In a pack of 10 ampoules with instructions for use and a liner with a number of stacker.

Storage conditions:

At a temperature of 2 to 8 ° C.

Keep at inaccessible to children.

Transportation conditions

In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C.

Shelf life:

2 years.

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

Terms of leave from pharmacies:For hospitals
Registration number:PL-000463
Date of registration:01.03.2011 / 21.03.2016
Expiration Date:Unlimited
Date of cancellation:2016-03-01
The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Manufacturer: & nbsp
Information update date: & nbsp13.01.2017
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