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Instructions

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Instruction for use: Rudivax

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Dosage form: Lyophilizate for the preparation of solution

Active substance: Vaccinum ad prophylaxim rubeollae vivum

ATX

J07BJ01 Rubella live weakened virus

Pharmacological group

Vaccines, serums, phages and toxoids

Nosological classification (ICD-10)

B06 Rubella [German measles]: German measles; Rubella; Epidemic rubella

Composition and release form

1 dose (0.5 ml) of the vaccine after dissolving the lyophilizate contains at least 1000 CTPD50 of a live attenuated rubella virus (strain Wistar RA 27 / 3M), traces of neomycin. Powder lyophilized for injection in vials of 1 dose complete with a solvent (water for injection) in syringes or ampoules of 0.5 ml; In the box 1 or 10 sets and in bottles of 10 doses complete with a solvent in 5 ml vials; In the box are 10 sets.

Characteristic

Vaccine for the prevention of rubella. A lyophilized live attenuated vaccine from a culture of the Wistar RA 27 / 3M rubella virus grown on human diploid cells.

Pharmachologic effect

Mode of action - Immunostimulating.

Forms a specific resistance to the rubella virus.

Clinical Pharmacology

Specific immunity against the rubella virus develops within 15 days after vaccination and lasts for at least 20 years. Seroconversion is observed in 95-100% of vaccinated patients. The vaccine can be administered to children under 1 year of age, but may not be effective (due to the possible retention of the mother's antibodies in the child), which requires a revaccination. In case of serological examination, the result of the analysis is considered positive - at a dilution of at least 1/20 (in RTGA): in this case the patient is regarded as having specific immunity, and vaccination is not required for it. When diluted less than 1/20 - the result is considered negative.

Indications of the Rudivax

Rubella prophylaxis: in children older than 1 year, in prepubertal girls, in women of childbearing age.

Contraindications

Hypersensitivity (including neomycin), acute infectious diseases, congenital or acquired immunodeficiencies (the possibility of immunization of children with HIV solves the consultation of pediatricians), acute and chronic progressive diseases, the introduction of immunoglobulins (before vaccination).

Application of pregnancy and breastfeeding

Contraindicated in pregnancy.

Side effects

Rarely, fever, erythema, lymphadenopathy, skin rash (in the form of small roseol or purple spots of various sizes). Patients in post-pubertal age may experience a slight enlargement of the lymph nodes (mostly the posterior ones), a mild rubella rash, inflammation and joint pain in the knee and wrist bands; These reactions occur between 10 and 15 days after immunization in 10% of patients.

Interaction

Compatible with other vaccines.

Dosing and Administration

SC or IM once with 0.5 ml (dissolved vaccine); In girls at prepubertal age (11-13 years) it is recommended to conduct a booster dose (without a preliminary serological examination).

Precautionary measures

To avoid possible inactivation of the vaccine strain, serum antibodies should not be administered immunoglobulins within 2 weeks after vaccination, and vaccination should be given within 6 weeks (if possible - 3 months) after the administration of immunoglobulins and blood products. All diluted vaccine should be immediately used. It is recommended to abstain from pregnancy within the next 2 months after vaccination (contraceptives are prescribed).

Special instructions

After vaccination, a false-negative tuberculin test may be temporarily indicated.

Storage conditions of the drug Rudivax

At a temperature of 2-8 C. (do not freeze).

Keep out of the reach of children.

The shelf life of the drug Rudivax

2 years.

Do not use beyond the expiration date printed on the package.

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