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Rubella vaccine live cultural attenuated (Lyophilisate) Instructions for Use

ATC Code

J07BJ01 (Rubella virus live attenuated)

Active Substance

Rubella vaccine (live)

Rubella vaccine (live) (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Vaccine for the prevention of rubella

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

A live attenuated vaccine for the prevention of rubella. The attenuated vaccine virus (Wistar RA 27/3M strain) is cultured on human diploid cells.

A specific immunity develops within 15 days after vaccination and, according to available data, persists for at least 20 years.

Indications

Prevention of rubella in children, regardless of gender, starting from the age of 12 months; prevention of rubella in unvaccinated or non-immune pre- and post-pubertal girls and women of childbearing age.

ICD codes

ICD-10 code Indication
Z24.5 Need for immunization against rubella alone
ICD-11 code Indication
QC01.5 Need for immunization against rubella alone

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer a single dose of the reconstituted vaccine once.

Inject the dose subcutaneously or intramuscularly.

Initiate vaccination in children from the age of 12 months.

Vaccinate unvaccinated or non-immune pre- and post-pubertal girls and women of childbearing age.

For women of childbearing age, ensure the use of effective contraception for at least two months following vaccination.

Do not administer this vaccine during pregnancy.

Postpone vaccination of a child born to an HIV-infected mother until 9-10 months of age for immune status determination.

If the child is confirmed HIV-infected, require a medical council conclusion prior to vaccination.

Do not vaccinate within 6 weeks (preferably 3 months) after administration of immunoglobulins or other blood products.

Avoid using immunoglobulins for two weeks after vaccine administration.

Administer this vaccine simultaneously with other vaccines, such as the combined measles, mumps, and rubella (MMR) vaccine.

Adverse Reactions

More likely in adults. Slight enlargement of lymph nodes, rarely – rash and increased body temperature starting from the 5th day after vaccination.

Contraindications

Congenital and acquired immunodeficiencies (including those caused by HIV infection); administration of immunoglobulins at least within 6 weeks before vaccination; pregnancy.

Use in Pregnancy and Lactation

Rubella vaccine (live) is contraindicated for use during pregnancy.

It is recommended not to plan pregnancy for the next 2 months after vaccination. The use of this vaccine in women in the early stages of an as yet undiagnosed pregnancy is not an indication for termination of this pregnancy.

Pediatric Use

The decision on vaccination of a child born to an HIV-infected mother and the determination of his/her immune status is postponed until the age of 9-10 months, because maternal IgG, which crossed the placenta, can persist in the child’s blood up to the age of 14 months.

If after this period the child is recognized as HIV-infected, then a conclusion of a medical council is required to decide on vaccination. If the child is recognized as uninfected, routine vaccination is carried out.

Geriatric Use

Not applicable.

Special Precautions

For at least 2 months after vaccination, women of childbearing age should use effective methods of contraception.

The use of this vaccine in women in the early stages of an as yet undiagnosed pregnancy is not an indication for termination of this pregnancy.

The decision on vaccination of a child born to an HIV-infected mother and the determination of his/her immune status is postponed until the age of 9-10 months, because maternal IgG, which crossed the placenta, can persist in the child’s blood up to the age of 14 months. If after this period the child is recognized as HIV-infected, then a conclusion of a medical council is required to decide on vaccination. If the child is recognized as uninfected, routine vaccination is carried out.

Rubella vaccine (live) can be administered together with other vaccines. The most widely used is the combined vaccine for the prevention of measles, mumps and rubella.

Due to the possible inactivation of the vaccine strain by serum antibodies, vaccination is not carried out within 6 weeks (if possible, within 3 months) after the administration of immunoglobulins or other blood products, and also immunoglobulins are not used within 2 weeks after vaccine administration.

After vaccination, the tuberculin test may be false-negative for some time.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Dosage Form

Bottle Rx Icon Rubella vaccine live cultural attenuated Lyophilisate for preparation of solution for subcutaneous administration 0.5 ml/1 dose: amp. 10 pcs. in set with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for subcutaneous administration 1 dose
Rubella vaccine live 0.5 ml

Solvent water for injections.

1 dose – ampoules (10) in a set with solvent (amp. 10 pcs.) – cardboard packs.

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Dosage Form

Bottle Rx Icon Rubella vaccine live cultural attenuated Lyophilisate for preparation of solution for subcutaneous administration 1 dose: amp. 10 pcs. incl. with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for subcutaneous administration in the form of a homogeneous, porous mass from yellowish to pinkish color, hygroscopic: reconstituted preparation – a clear pink liquid.

1 dose
Rubella virus Not less than 1000 TCID50

Excipients : sorbitol – 12.5 mg, gelatin – 6.25 mg, L-arginine hydrochloride – 4 mg, maltose – 2.5 mg, sodium chloride – 1.4 mg, lactalbumin hydrolysate – 1.12 mg, L-alanine – 0.5 mg, neomycin sulfate – not more than 25 mcg.

1 dose – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Dosage Form

Bottle Rx Icon Rubella vaccine cultured live Lyophilisate for preparation of solution for subcutaneous administration 0.5 ml/dose: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for subcutaneous administration porous mass of light yellow color, a pinkish tint is allowed; hygroscopic; reconstituted preparation – a clear pink liquid.

1 dose
Rubella virus 0.5 ml
Not less than 1000 (3.0 lg) tissue cytopathogenic doses TCID50

Excipients : aqueous solution LS-181) – 0.100 ml, 10% gelatin solution – 0.025 ml.

1) Composition of aqueous solution LS-18: sucrose – 250 mg, lactose – 50 mg, sodium glutamate – 37.5 mg, glycine – 25 mg, L-proline – 25 mg, Hanks’ dry mixture with phenol red – 7.15 mg, water for injections – up to 1 ml.

1 dose – ampoules with a capacity of 2 ml (10) – cardboard packs with an insert.
1 dose – ampoules with a capacity of 2 ml (10) in a set with solvent (water for injections) of 1 ml – cardboard packs with an insert.

Marketing Authorization Holder

Institute of Immunology, Inc. (Croatia)

Dosage Form

Bottle Rx Icon Rubella vaccine live Lyophilisate for preparation of solution for subcutaneous administration 0.5 ml/1 dose: vial 50 pcs. in set with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for subcutaneous administration in the form of a homogeneous porous mass of white or slightly pink color.

1 dose (0.5 ml)
Rubella vaccine live (vaccine strain RA 27/3) 1000 TCID50

Excipients : sorbitol, gelatin, L-arginine hydrochloride, maltose, lactalbumin hydrolysate, L-alanine, sodium chloride, neomycin sulfate not more than 25 mcg.

Solvent water for injections – 5 ml.

1 dose (0.5 ml) – vials (50) in a set with solvent (0.5 ml amp. 50 pcs.) – cardboard boxes.

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