Rubella vaccine culture live attenuated (Vaccine rubella cultural 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 drug contains:

active substance: Rubella virus - not less than 1000 TCDs50 (tissue cytopathogenic doses);

Excipients: sorbitol 12.5 mg, gelatin 6.25 mg, L-arginine hydrochloride 4 mg, maltose 2.5 mg, sodium chloride 1.4 mg, lactalbumin hydrolyzate 1.12 mg, L-alanine 0.5 mg; Neomycin sulfate - no more than 25 mcg.

Description:

Lyophilizate - homogeneous porous mass from yellowish to pinkish color, 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:

Rubella rubella live, attenuated, lyophilizate for the preparation of a solution for subcutaneous administration, made of "Vaccine against rubella live attenuated, substance - frozen solution" (strain RA 27/3) produced by the "Institute of Immunology, Inc.", Republic of Croatia, ("INSTITUT OF IMMUNOLOGY, INC", CROATIA).

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 also provides for the vaccination of children aged 1 up to 18 years old, who were not ill, not vaccinated or vaccinated against rubella once, as well as girls aged 18 to 25 who were not ill, not vaccinated earlier.

Vaccinations can also be given to other population groups to prevent rubella outbreaks in limited populations or according to epidemiological evidence.

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 with the previous dose.

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:

Following the introduction of the vaccine, the following adverse reactions of varying severity can be observed.

Not infrequently (in the case of 1/100 - 1/1000):

at the injection site, short-term hyperemia, swelling and denseness accompanied by pain can develop.

Rarely (in the case of 1 / 1000-1 / 10000):

- skin rash (in the form of small roseol or purple spots of different sizes);

- short-term temperature increase to subfebrile values; higher temperature for individual grafted;

- lymphadenopathy (enlargement of mainly occipital and posterior lymph nodes);

- cough, runny nose, malaise, headache;

- nausea;

- arthralgia (in the knee and wrist joints); these reactions occur between 10 and 15 days after immunization;

- Transient arthritis with effusion into the joint cavity and without it.

Very rarely (in the case of <1/10000):

- transient polyneuropathy;

- thrombocytopenic purpura.

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

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.

Immunoglobulins and blood products:

After the administration of blood products (immunoglobulin, plasma, etc.), the vaccine is recommended to be 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.

When a vaccine is administered to persons receiving glucocorticoids or other immunosuppressive drugs or undergoing radiotherapy, an optimal immune response may not be obtained.After the appointment of immunosuppressants and radiotherapy, vaccination is carried out 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.
Packaging:

1 dose per ampoule.

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 out of the reach of children.

Transportation conditions

AT According to JV 3.3.2.1248-03 at a temperature from 2 before 8 ° C.

Shelf life:

2 years.

The drug is not eligible for use with expired use.

Terms of leave from pharmacies:For hospitals
Registration number:LS-002230
Date of registration:12.12.2011 / 18.08.2014
Expiration Date:Unlimited
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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