Meals, mumps and rubella virus vaccine live attenuated (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Pharm Aid Ltd, LLC (Russia)

Manufactured By

Serum Institute Of India, Pvt. Ltd. (India)

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. European Pharmacopoeia)

Dosage Form

Meals, mumps and rubella virus vaccine live attenuated

Lyophilisate for preparation of solution for subcutaneous administration 1 dose: fl. 1 or 10 doses incl. with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for subcutaneous administration in the form of a homogeneous porous mass of a yellowish-white color, hygroscopic; the prepared solution is a clear liquid of a yellowish (1-dose vaccine) or pale yellow (10-dose vaccine) color.

* TCID₅₀ – tissue culture infectious dose.

Excipients: sorbitol 5%, gelatin 2.5%, neomycin B sulfate ≤2.5 µg.

Solvent: water for injections.

1 dose – dark glass vials (10) in a kit with a solvent (amp. 0.5 ml 10 pcs.) – cardboard packs.
1 dose – dark glass vials (50) in a kit with a solvent (amp. 0.5 ml 50 pcs.) – cardboard packs.
10 doses – dark glass vials (10) in a kit with a solvent (amp. 5 ml 10 pcs.) – cardboard packs.
10 doses – dark glass vials (50) in a kit with a solvent (amp. 5 ml 50 pcs.) – cardboard packs.

The vaccine meets WHO requirements.

Clinical-Pharmacological Group

Vaccine for the prevention of measles, mumps and rubella

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

It induces the formation of immunity against the 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 have no immunity to 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.

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

Reconstitute the lyophilisate immediately before use only with the supplied solvent.

Use a sterile syringe and needle for both reconstitution and administration.

Discard any reconstituted vaccine not used within six hours.

For primary immunization, administer one dose.

For revaccination, administer one additional dose according to the national immunization schedule.

Adhere strictly to the official vaccination calendar for timing of initial and subsequent doses.

Do not administer this vaccine intravenously under any circumstances.

Postpone vaccination in the presence of any acute febrile illness.

Defer vaccination for at least three months following administration of immunoglobulins or blood products.

Adverse Reactions

Possible transient burning or pain at the injection site; fever, rash, parotitis, nausea, vomiting, diarrhea, thrombocytopenia, purpura, regional lymphadenopathy, skin reaction with redness 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 the 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 methods of contraception for 3 months after vaccination.

Pediatric Use

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

Special Precautions

The vaccine should not be administered intravenously.

Given the possibility of 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.

Vaccination is allowed in children and young adults infected with HIV but without obvious clinical manifestations of immunosuppression; however, 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 when it is significantly reduced, 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 transmission of the virus in this way from a vaccinated person to other people 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 reduction 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.