Vaccinum parotitidi-morbillorum culturarum vivum (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07BD51 (Measles virus in combination with mumps virus, live attenuated)

Active Substance

Measles and mumps virus vaccine (live) (Grouping name)

Dosage Form

Vaccinum parotitidi-morbillorum culturarum vivum

Lyophilisate for preparation of solution for subcutaneous administration 1 dose: amp. 10 pcs.

Dosage Form, Packaging, and Composition

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

Excipients: stabilizer – a mixture of 0.08 ml of an aqueous solution of LS-18* and 0.02 ml of a 10% gelatin solution; gentamicin sulfate residual (technological) impurity – not more than 0.5 mcg.

1 dose – ampoules (10) – cardboard packs**.

* Composition of the aqueous solution LS-18: 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 injections – up to 1 ml.

** for healthcare facilities

Clinical-Pharmacological Group

Vaccine for the prevention of measles and mumps

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

It is a lyophilized mixture of liquid semi-finished products of measles and mumps vaccines, prepared by culturing attenuated strains of measles virus L-16 and mumps virus L-3 on a primary culture of quail embryo cells.

It stimulates the production of antibodies to measles and mumps viruses in seronegative vaccinees, reaching maximum levels at 3-4 weeks and 6-7 weeks after vaccination, respectively.

Indications

Prevention of measles and mumps, starting from the age of 12 months.

In accordance with the National Immunization Schedule, vaccination is carried out twice at the age of 12 months and 6 years for children who have not had measles and mumps.

ICD codes

Dosage Regimen

Administer the vaccine subcutaneously in a single dose of 0.5 ml.

Use the outer side of the upper arm (at the border of the lower and middle third) or the subscapular region as the injection site.

Reconstitute the lyophilisate immediately before use with the supplied solvent. Ensure the lyophilisate is fully dissolved into a clear, pink liquid.

Inspect the reconstituted vaccine visually for any foreign particulate matter or discoloration prior to administration; do not use if either is present.

Follow the National Immunization Schedule: administer the first dose at 12 months of age and the second dose at 6 years of age.

Vaccinate individuals who have not previously had measles or mumps.

For individuals who have received human immunoglobulin, defer vaccination for at least 2 months.

After vaccination with this vaccine, defer administration of immunoglobulin preparations for at least 2 weeks.

In case of acute illness with fever, postpone vaccination until after recovery.

Adverse Reactions

Frequently from day 5 to 15 – short-term slight increase in body temperature, catarrhal manifestations from the nasopharynx (mild pharyngeal hyperemia, rhinitis). With mass use of the vaccine, an increase in body temperature above 38.5°C (101.3°F) should not occur in more than 2% of vaccinees. An increase in body temperature above 38.5°C (101.3°F) in the post-vaccination period is an indication for the prescription of antipyretics.

Infrequently from day 5 to 18 – slight cough, conjunctivitis, measles-like rash, lasting 1-3 days.

Rarely: in the first 48 hours after vaccination, local reactions, expressed as skin hyperemia and mild swelling at the injection site, which resolve without treatment; from day 5 to 42 – short-term slight enlargement of the parotid salivary glands, lasting 2-3 days; anxiety, lethargy, sleep disturbance.

Very rarely in the first 24-48 hours – allergic reactions occurring in individuals with altered reactivity; after 6-10 days – convulsive reactions occurring after vaccination against a background of high fever; after 2-4 weeks – benign serous meningitis, each case of which requires differential diagnosis; development of encephalitis, each case of which requires differential diagnosis; abdominal pain, abdominal syndrome; painful short-term swelling of the testicles.

Contraindications

Anaphylactic reactions or severe forms of allergic reactions to aminoglycosides (because the preparation may contain gentamicin), chicken and/or quail eggs; primary immunodeficiency, malignant blood diseases and neoplasms; severe reaction (hyperthermia above 40°C (104°F), hyperemia or swelling more than 8 cm in diameter at the injection site) or complication to the previous administration of mumps or measles vaccines; acute diseases or exacerbation of chronic diseases; pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Vaccination with this vaccine is contraindicated during pregnancy and breastfeeding.

Special Precautions

To identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of the vaccinee with mandatory thermometry.

Vaccination with the mumps-measles vaccine is not recommended during the period of increased incidence of serous meningitis.

HIV infection is not a contraindication for vaccination.

Considering the possibility of developing immediate-type allergic reactions (anaphylactic shock, Quincke’s edema, urticaria) in particularly sensitive individuals, medical supervision must be ensured for the vaccinated for 30 minutes.

Vaccination sites must be equipped with anti-shock therapy means.

Vaccination is carried out after acute infectious and non-infectious diseases, after exacerbation of chronic diseases – after the acute manifestations of the disease have ended; for non-severe acute respiratory viral infections, acute intestinal diseases and other conditions – immediately after temperature normalization; after immunosuppressive therapy, vaccination is carried out 3-6 months after the end of treatment.

Persons temporarily exempted from vaccination should be placed under observation and vaccinated after the contraindications are lifted.

The vaccination performed is recorded in the established accounting forms indicating the name of the drug, date of vaccination, dose, manufacturer, batch number, manufacture date, expiration date, and reaction to the vaccination.

Drug Interactions

Vaccination can be carried out simultaneously (on the same day) with DTP and ADS vaccines, live and inactivated polio vaccine, hepatitis B vaccine, rubella vaccine, influenza vaccine, Haemophilus influenzae vaccine, provided they are administered into different parts of the body. Other live viral vaccines are administered at an interval of at least 1 month.

If it is necessary to perform a tuberculin test, it should be performed either simultaneously with vaccination or 6 weeks after it, since the measles (and possibly mumps) vaccine process can cause a temporary decrease in skin sensitivity to tuberculin, which will cause a false negative result.

After the administration of human immunoglobulin preparations, vaccinations should be carried out no earlier than 2 months later. After the administration of the mumps-measles vaccine, immunoglobulin preparations can be administered no earlier than 2 weeks later; if it is necessary to use immunoglobulin earlier than this period, vaccination against mumps and measles should be repeated.

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.