Vaktrivir combined vaccine against measles, rubella and mumps culture (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07BD52 (Measles virus in combination with mumps and rubella viruses, live attenuated)

Active Substance

Measles, mumps and rubella virus vaccine live (Ph.Eur.)

Dosage Form

Vaktrivir combined vaccine against measles, rubella and mumps culture

Lyophilizate for preparation of solution for subcutaneous administration 1 dose: amp. 0.5 ml 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for subcutaneous administration in the form of a homogeneous porous mass from yellowish to pinkish in color, hygroscopic.

Excipients: LS-18 aqueous solution* – 0.12 ml, 10% gelatin solution – 0.03 ml, gentamicin sulfate** – not more than 0.5 mcg.

*Composition of LS-18 aqueous solution: sucrose – 250 mg, lactose – 50 mg, sodium glutamate – 37.5 mg, glycine – 25 mg, L-proline – 25 mg, Hank’s dry mixture with phenol red – 7.15 mg, water for injection up to 1 ml.
**process-related impurity

1 dose – ampoules (10) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of measles

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

It induces the formation of immunity against measles, mumps, and rubella viruses.

After a single administration of the vaccine, the corresponding antibodies are produced in the body.

In children under 15 months of age, the response to the measles component of the vaccine may be absent due to the presence of circulating residual measles antibodies received from the mother.

The younger the child, the lower the likelihood of seroconversion.

After vaccination, the antibody level in the blood persists for more than 11 years.

Indications

Routine immunization of children against measles, mumps, and rubella; revaccination of children against measles, mumps, and rubella; immunization of persons planning trips abroad who lack immunity to measles, mumps, and rubella; immunization of women of childbearing age who do not have immunity against rubella; immunization of women susceptible to rubella in the postpartum period; immunization of children not immunized against rubella whose pregnant mothers are susceptible to rubella.

ICD codes

Dosage Regimen

Administer the vaccine subcutaneously into the outer surface of the upper arm.

Reconstitute the lyophilizate immediately before use with the supplied solvent to a volume of 0.5 ml.

Use a single dose of 0.5 ml for all patients, regardless of age.

For routine primary immunization, administer one dose to children at 12 months of age.

Perform revaccination with a single dose at 6 years of age.

Adhere strictly to the National Immunization Schedule for timing.

For unvaccinated individuals over one year of age, administer a single dose as soon as possible.

For women of childbearing age without rubella immunity, administer a single dose.

Ensure a minimum interval of one month between this and other live viral vaccines if not administered simultaneously.

Do not administer this vaccine for at least three months following a blood or plasma transfusion, or administration of human immunoglobulin.

Discard any unused reconstituted vaccine; do not store it.

Adverse Reactions

The following are possible transient burning or pain at the injection site; fever, rash, mumps, nausea, vomiting, diarrhea, thrombocytopenia, purpura, regional lymphadenopathy, skin reaction with hyperemia and blisters at the injection site, erythema, skin induration and tenderness, erythema multiforme; anaphylactic and anaphylactoid reactions, urticaria, myalgia, arthralgia and/or arthritis, polyneuritis, convulsions, headache, dizziness, paresthesia, polyneuritis, Guillain-Barré syndrome, ataxia, optic neuritis, paralysis of the eye nerves, otitis media, deafness associated with nerve damage, conjunctivitis; orchitis.

Contraindications

Anaphylactic, anaphylactoid and other immediate hypersensitivity reactions to chicken egg protein, to neomycin; respiratory diseases; infectious disease accompanied by fever; untreated active tuberculosis; immunosuppressive therapy; malignant diseases of the blood and lymphatic system; primary and acquired immunodeficiency (including AIDS or other clinical manifestations of HIV infection); disorders of cellular immunity; hypogammaglobulinemia or dysgammaglobulinemia; presence of congenital or hereditary immunodeficiency in family history until the immune status of the patient is determined; pregnancy.

Use in Pregnancy and Lactation

Studies on the effect of the vaccine on reproductive function, as well as on the fetus in case of vaccination during pregnancy, have not been conducted.

The vaccine should be used with caution in nursing mothers during lactation.

Women of childbearing age should use reliable contraceptive methods for 3 months after vaccination.

Pediatric Use

In children and young adults infected with HIV but without obvious clinical manifestations of immunosuppression, vaccination is allowed, but it may be less effective than in uninfected individuals.

Special Precautions

The vaccine should not be administered intravenously.

Given the possibility of developing anaphylactic and anaphylactoid reactions, the vaccine should be administered in conditions that allow for emergency therapy.

Use with particular caution in patients with a history of seizures (including family history), brain tissue damage, and any other conditions where an increase in body temperature should be avoided.

According to some data, if reactions associated with the consumption of chicken eggs were not anaphylactic or anaphylactoid, then the likelihood of complications upon vaccine administration is not increased.

In children and young adults infected with HIV but without obvious clinical manifestations of immunosuppression, vaccination is allowed, but it may be less effective than in uninfected individuals.

Vaccinated individuals should avoid contact with patients with measles, mumps, and rubella.

To assess the immune status and ensure adequate protective measures in case of its significant decrease, circulating antibody levels can be determined if necessary.

Vaccination should not be carried out for at least 3 months after blood or plasma transfusion, or administration of human immunoglobulin.

In most patients, within 7-28 days after vaccination, small amounts of live attenuated rubella virus were isolated from the nose and throat.

The possibility of virus transmission by this route from a vaccinated person to others has not been proven.

There are reports that live attenuated measles, mumps, and rubella vaccines in some cases cause temporary suppression of skin sensitivity to tuberculin.

Therefore, if necessary, tuberculin tests should be performed before or simultaneously with the administration of this vaccine.

This vaccine, like any other, does not cause 100% seroconversion in individuals susceptible to viral infections.

Drug Interactions

When administered simultaneously with immunoglobulins, a decrease in the expected immune response is possible.

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.