Mastodon

Vaccinum morbilorum culturarum vivum (Lyophilisate) Instructions for Use

ATC Code

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

Active Substance

Measles vaccine (live)

Measles vaccine (live) (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Vaccine for the prevention of measles

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The attenuated measles virus strains Leningrad-16 and Moscow-5 are obtained by cultivation in a primary culture of Japanese quail embryo cells, followed by purification and lyophilization.

The vaccine stimulates the production of measles antibodies in 95% of seronegative individuals by days 21-28 after vaccination, and immunity lasts for at least 18 years.

The hyperattenuated measles virus Schwarz strain is cultured on chicken embryos. Specific immunity develops within 15 years and, according to available data, persists for at least 20 years.

Indications

  • Active prevention of measles in children from 12 months of age who have not had the disease.
  • Vaccination of older individuals who have not been previously vaccinated and have not had measles, for epidemiological indications.
  • Revaccination of previously vaccinated children in whose serum no antibodies to the measles virus were detected.

ICD codes

ICD-10 code Indication
Z24.4 Need for immunization against measles alone
ICD-11 code Indication
QC01.4 Need for immunization against measles 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.

Reconstitute the lyophilisate immediately before use with 0.5 ml of the supplied solvent per one vaccination dose.

Administer the entire reconstituted volume as a single dose.

The route of administration, either subcutaneous or intramuscular, is determined by the specific approved dosage form used; adhere strictly to the instructions for that product.

Adverse Reactions

Between days 5 and 18 post-vaccination, some patients may experience transient fever, pharyngeal hyperemia, rhinitis, mild cough, or conjunctivitis; a measles-like rash occurs rarely.

Very rare complications from the central nervous system include encephalitis and convulsions, typically occurring 6-10 days after vaccination, often against a background of high fever.

Monitor for allergic reactions in individuals with known intolerance to foreign proteins (e.g., albumin). Local reactions, such as injection site hyperemia and edema, may persist for 1-3 days.

Drug Interactions

Do not administer this live vaccine concurrently with other live viral vaccines; maintain an interval of at least 2 months between vaccinations.

Defer vaccination for at least 3 months following the administration of immunoglobulins or blood products.

Avoid administering immunoglobulins for at least 3 weeks after vaccination, as this may interfere with the immune response.

Contraindications

  • Hypersensitivity to any component of the vaccine, including trace residues from the manufacturing process (e.g., aminoglycosides, quail or chicken proteins).
  • Congenital or acquired immunodeficiency states, including HIV infection, and patients receiving immunosuppressive therapy.
  • Pregnancy is a contraindication for vaccines derived from the Leningrad-16 or Moscow-5 strains; live vaccines are contraindicated in pregnancy due to the theoretical risk of fetal infection.
  • History of severe allergic reaction to a previous dose of any measles-containing vaccine.

Overdose

Overdose is unlikely due to the single-dose presentation and administration by a healthcare professional.

No specific antidote exists; manage suspected overdose with symptomatic and supportive care.

Monitor for an exaggerated immune response or a potential increase in the frequency and/or severity of the described adverse reactions.

Use in Pregnancy and Lactation

Pregnancy is a contraindication for the use of the vaccine derived from the Leningrad-16 or Moscow-5 measles virus strain (live vaccines cannot be used in pregnant women, as the development of a disease caused by the vaccine strain is possible).

Pediatric Use

Used in children in accordance with the National Immunization Schedule and for epidemiological indications.

Geriatric Use

Used for epidemiological indications.

Special Precautions

A specific dosage form of the vaccine should be used strictly according to the indications and in accordance with the instructions for use.

The measles vaccination can be carried out no earlier than 2 months after vaccination against other infections, and also no earlier than 3 months after or 3 weeks before the administration of immunoglobulins.

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.

Medical Disclaimer

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

Marketing Authorization Holder

Vector VB State Research Center Federal State Institution of Rospotrebnadzor (Russia)

Dosage Form

Bottle Rx Icon Vaccinum morbilorum culturarum vivum Lyophilizate for preparation of solution for subcutaneous administration 1 dose: amp. or fl. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for subcutaneous administration 1 dose
Measles virus Not less than 1,000 TCID50

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

Marketing Authorization Holder

Vector VB State Research Center Federal State Institution of Rospotrebnadzor (Russia)

Dosage Form

Bottle Rx Icon Vaccinum morbilorum culturarum vivum Lyophilizate for preparation of solution for subcutaneous administration 2 doses: amp. or fl. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for subcutaneous administration 1 dose
Measles virus Not less than 1,000 TCID50

2 doses – ampoules (10) – cardboard packs.
2 doses – vials (10) – cardboard packs.

Marketing Authorization Holder

Vector VB State Research Center Federal State Institution of Rospotrebnadzor (Russia)

Dosage Form

Bottle Rx Icon Vaccinum morbilorum culturarum vivum Lyophilizate for preparation of solution for subcutaneous administration 5 doses: amp. or fl. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for subcutaneous administration 1 dose
Measles virus 1000 TCID50
Not less than 1,000 TCID50

5 doses – ampoules (10) – cardboard packs.
5 doses – vials (10) – cardboard packs.

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Dosage Form

Bottle Rx Icon Vaccinum morbilorum culturarum vivum Lyophilizate for preparation of solution for subcutaneous administration 1 dose: amp. 10 pcs. in a set with solvent or without it

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for subcutaneous administration in the form of a homogeneous porous mass of light pink color, hygroscopic; reconstituted preparation is a clear pink liquid.

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

Excipients : stabilizer – a mixture of 0.04 ml of aqueous solution LS-18* and 0.01 ml of 10% gelatin solution; gentamicin sulfate residual (technological) impurity – not more than 0.5 mcg.

Solvent water for injection – 1 ml (ampoules).

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

* 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 injection – up to 1 ml.

** for healthcare facilities

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Dosage Form

Bottle Rx Icon Vaccinum morbilorum culturarum vivum Lyophilizate for preparation of solution for subcutaneous administration 2 doses: amp. 10 pcs. in a set with solvent or without it

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for subcutaneous administration in the form of a homogeneous porous mass of light pink color, hygroscopic; reconstituted preparation is a clear pink liquid.

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

Excipients : stabilizer – a mixture of 0.04 ml of aqueous solution LS-18* and 0.01 ml of 10% gelatin solution; gentamicin sulfate residual (technological) impurity – not more than 0.5 mcg.

Solvent water for injection – 1 ml (ampoules).

2 doses – ampoules (10) – cardboard packs**.
2 doses – ampoules (10) in a set with solvent (amp. 1 ml 10 pcs.) – cardboard packs**.

* 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 injection – up to 1 ml.

** for healthcare facilities

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Group

VEKTOR-MEDIKA, JSC (Russia)

Dosage Form

Bottle Rx Icon Vaccinum morbilorum culturarum vivum Lyophilisate for preparation of solution for subcutaneous administration 5 doses: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for subcutaneous administration 1 dose
Measles virus Not less than 1,000 TCID50

5 doses – ampoules (10) – cardboard packs.

Table of Contents

→ TABLE OF CONTENTS