Rudivax (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.

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

Dosage Regimen

Administer the vaccine as a single dose once. Reconstitute the lyophilisate strictly according to the manufacturer’s instructions using the supplied solvent.

Inject the entire contents of the vial subcutaneously or intramuscularly. The preferred site for subcutaneous administration is the upper arm’s outer aspect (deltoid region).

For children, the recommended age for initial vaccination is 12 months and older. A single dose is sufficient to induce immunity.

For unvaccinated or non-immune adolescent girls and women of childbearing age, administer a single dose regardless of prior history of rubella. Serological testing prior to vaccination is not required but can be considered.

Do not administer the vaccine intravenously. Ensure effective contraception is used for at least two months following vaccination in women of childbearing potential.

Postpone vaccination for at least six weeks, and preferably three months, following the administration of immunoglobulins or other blood products.

This vaccine can be administered simultaneously with other inactivated or live viral vaccines, such as the combined measles, mumps, and rubella (MMR) vaccine. Use separate injection sites and different syringes if given concurrently.

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 decision on vaccination requires the conclusion of a medical council. 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 decision on vaccination requires the conclusion of a medical council. 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 falsely negative for some time.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.