Vaccinum parotitidi culturarum vivum (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07BE01 (Mumps virus live attenuated)

Active Substance

Mumps vaccine (live) (Ph.Eur.)

Dosage Forms

	Vaccinum parotitidi culturarum vivum	Lyophilisate for preparation of solution for subcutaneous administration 1 dose: amp. 10 pcs. in a kit with solvent or without it
		Lyophilisate for preparation of solution for subcutaneous administration 2 doses: amp. 10 pcs. in a kit with solvent or without it

Dosage Form, Packaging, and Composition

1 dose – ampoules (10) – carton packs.

2 doses – ampoules (10) – carton packs.

5 doses – ampoules (10) – carton packs.

Clinical-Pharmacological Group

Vaccine for the prevention of measles and mumps

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine stimulates the production of antibodies to the mumps virus in seronegative children, reaching a maximum level 6-7 weeks after vaccination. The drug meets WHO requirements.

Indications

• Prevention of mumps.

Scheduled vaccinations are carried out twice at the age of 12 months and 6 years for children who have not had mumps.

Emergency prophylaxis is carried out for children from 12 months, adolescents and adults who have been in contact with a mumps patient, who have not had mumps or have not been previously vaccinated against this infection.

In the absence of contraindications, the vaccine is administered no later than 72 hours after contact with the patient.

ICD codes

Dosage Regimen

Immediately before use, the vaccine is diluted with the solvent for measles, mumps and mumps-measles cultural live vaccines (hereinafter referred to as solvent) at the rate of 0.5 ml of solvent per one vaccination dose of vaccine.

The vaccine should dissolve completely within 3 minutes. The dissolved vaccine is a clear pink liquid.

The vaccine and solvent in ampoules with damaged integrity, labeling, as well as with changed physical properties (color, transparency, etc.), with an expired shelf life or improperly stored are not suitable for use.

The opening of ampoules and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antisepsis.

Ampoules with the vaccine and solvent are treated with 70% alcohol at the incision site and broken, preventing alcohol from entering the ampoule.

To dilute the vaccine, the entire required volume of solvent is collected and transferred to the ampoule with the dry vaccine. After mixing, the vaccine is drawn with another needle into a sterile syringe and used for vaccination.

The vaccine is administered s/c in a volume of 0.5 ml under the scapula or in the shoulder area (at the border between the lower and middle third of the shoulder on the outer side), having previously treated the skin at the injection site with 70% alcohol.

The dissolved vaccine is used immediately and must not be stored.

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

Adverse Reactions

In most children, the vaccination process is asymptomatic. Some children may experience

• From day 5 to 15 – temperature reactions, catarrhal phenomena from the nasopharynx (pharyngeal hyperemia, rhinitis);
• From day 5 to 42 – a slight enlargement of the parotid salivary glands lasting 2-3 days;
• In rare cases, in the first 48 hours after vaccination, local reactions, expressed in skin hyperemia and mild swelling at the injection site, which resolve without treatment.

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 vaccinated children.

Complications that develop extremely rarely include allergic reactions that occur in the first 24-48 hours in children with altered reactivity. In extremely rare cases, vaccinated individuals may develop benign serous meningitis after 2-4 weeks. Each case of serous meningitis requires differential diagnosis.

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.

Contraindications

• Severe forms of allergic reactions to aminoglycosides (gentamicin sulfate) and chicken eggs;
• Primary immunodeficiency states, malignant blood diseases and neoplasms;
• Severe reaction (temperature rise above 40°C (104°F), hyperemia and/or edema more than 8 cm in diameter at the injection site) or complication on previous administration of mumps or mumps-measles vaccines;
• Pregnancy.

To identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of the vaccinee with mandatory thermometry. If necessary, an appropriate laboratory examination is carried out.

HIV infection is not a contraindication to vaccination.

Persons temporarily exempted from vaccinations should be taken under observation and registered and vaccinated after the contraindications are lifted.

Use in Pregnancy and Lactation

Contraindicated in pregnancy.

Pediatric Use

Used as indicated.

Special Precautions

Vaccinations are carried out

• After acute infectious and non-infectious diseases, after exacerbation of chronic diseases – after the acute manifestations of the disease have ended;
• In non-severe ARVI, acute intestinal diseases, etc. – immediately after temperature normalization;
• After immunosuppressive therapy, vaccination is carried out 3-6 months after the end of treatment;
• Vaccination against mumps is not recommended during the period of increased incidence of serous meningitis.

Drug Interactions

Vaccination against mumps can be carried out simultaneously (on the same day) with other calendar vaccinations (against measles, rubella, poliomyelitis, hepatitis B, pertussis, diphtheria, tetanus) or no earlier than 1 month after the previous vaccination.

After the administration of human immunoglobulin preparations, vaccinations against mumps are carried out no earlier than 2 months later. After the administration of the mumps 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 should be repeated.

Storage Conditions

The vaccine is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature from 0 to 8°C (46.4°F) in a place inaccessible to children.

Shelf Life

The shelf life of the vaccine is 15 months. The drug with an expired shelf life must not be used.

Dispensing Status

For medical and preventive institutions.

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.