Vaccine parotitic-measles culture live dry - instructions for use, dose, side effects, contraindications

Active substanceVaccine for the prevention of measles and mumpsVaccine for the prevention of measles and mumps

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Vaccine parotitic-measles alive live

lyophilizate PC

MICROGEN FGUP Scientific and Production Association Russia

Dosage form: & nbsplyophilizate for the preparation of a solution for subcutaneous administration

Composition:

One vaccine dose of the drug contains:

Active substances:

- measles virus - at least 1 000 (3.0 lg) tissue cytopathogenic doses (TCDs)₅₀);

- virus of mumps - not less than 20 000 (4,3 lg) TCDs₅₀.

Excipients:

- Stabilizer - a mixture of 0.08 ml of an aqueous solution of LS-18 * and 0.02 ml of a 10% gelatin solution;

- gentamycin sulfate - no more than 20 mcg.

Note. * The composition of the aqueous solution of LS-18: sucrose - 250 mg, lactose - 50 mg, sodium glutamic acid - 37.5 mg, glycine - 25 mg, L- proline - 25 mg, Hanks dry mixture with phenolic red - 7.15 mg, water for injection - up to 1 ml.

Description:

Homogeneous porous mass from yellowish to pinkish color, hygroscopic.

Pharmacotherapeutic group:MIBP vaccine

ATX: & nbsp

J.07.B.D Vaccine for measles prevention

J.07.B.D.51 The measles virus in combination with the mumps virus is a live attenuated

Pharmacodynamics:

Vaccine parotitic-measles live, lyophilizate for the preparation of a solution for subcutaneous administration,is a lyophilized mixture of liquid semifinished products of measles and mumps vaccines prepared by culturing attenuated strains of measles virus L-16 and the mumps virus L-3 on the primary culture of embryo cells of quails.

The vaccine stimulates seronegative vaccine production of antibodies to measles and mumps viruses that reach maximum values 3-4 weeks and 6-7 weeks after vaccination, respectively.

The drug meets WHO requirements.

Indications:

Preventing measles and mumps from the age of 12 months.

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

Contraindications:

- Anaphylactic reactions or severe forms of allergic reactions to aminoglycosides (gentamycin sulfate), chicken and / or quail eggs;

- primary immunodeficiency states, malignant blood diseases and neoplasms;

- a strong reaction (temperature rise above 40 ° C, hyperemia and / or swelling more than 8 cm in diameter at the site of administration of the vaccine) or complication of previous administration of mumps or measles vaccines;

- pregnancy and the period of breastfeeding;

- acute diseases or exacerbation of chronic diseases.

Note. HIV infection is not a contraindication to vaccination.

Pregnancy and lactation:

Vaccination is contraindicated.

Dosing and Administration:

Immediately prior to use, the vaccine is diluted with diluent for measles, mumps and mumps in live culture vaccines (hereinafter referred to as the solvent) at a rate of 0.5 ml of solvent per vaccination dose of the vaccine.

The vaccine should completely dissolve within 3 minutes. The dissolved vaccine looks like a transparent liquid of pink color.

Vaccine or solvent in ampoules with broken integrity, marking, as well as changing their physical properties (color and transparency, etc.), expired or incorrectly stored, are not suitable for use.

Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules.

Ampoules with a vaccine and a solvent at the incision site are treated with 70° ethyl alcohol and break off, while not allowing the ingress of alcohol into the ampoule.

To dilute the vaccine, take all the necessary volume of the solvent and transfer it to an ampoule with a dry vaccine.After mixing, the vaccine is taken up by another needle in a sterile syringe, which is then vaccinated.

The vaccine is administered subcutaneously in a volume of 0.5 ml under the scapula or in the shoulder region (on the border between the lower and middle third of the shoulder from the outside), pre-treating the skin at the site of administration of the vaccine 70° ethyl alcohol.

The dissolved vaccine is used immediately and is not subject to storage.

Vaccination is recorded in the prescribed registration forms with the name of the drug, the date of vaccination, dose, manufacturer, serial number, expiration date, response to vaccination.

Precautions for use

Given the possibility of developing allergic reactions of immediate type (anaphylactic shock, Quincke's edema, urticaria) in particularly sensitive individuals, vaccinated should ensure medical supervision for 30 minutes.

Vaccination sites should be provided with anti-shock therapy.

Side effects:

Most vaccines have a vaccine process that is asymptomatic. After the introduction of the vaccine, the following adverse reactions of varying severity can be observed:

Often (1/10-1/100):

- from 5 to 15 days - a brief slight increase in body temperature, catarrhal phenomena from the nasopharynx (mild hyperemia of the throat, rhinitis).

In case of mass application of the vaccine, the increase in body temperature above 38.5 ° C should not be more than 2% of vaccinated. A rise in body temperature above 38.5 ° C in the post-vaccination period is an indication for the administration of antipyretics.

Infrequently (1/100 - 1/1000):

- from 5 to 18 days - cough, conjunctivitis, korepobodnaya rash, lasting 1-3 days.

Rarely (1/1000 - 1/10000):

- in the first 48 hours after vaccination, local reactions, manifested in skin hyperemia and mild edema at the site of administration of the vaccine, which go untreated;

- from 5 to 42 days - a short-term insignificant increase in parotid salivary glands lasting 2-3 days.

- anxiety, lethargy, sleep disturbance.

Very rarely (<1/10000):

- in the first 24-48 hours - allergic reactions that occur in persons with altered reactivity;

- after 6-10 days - convulsive reactions that occur after vaccination against a background of high temperature;

- after 2-4 weeks - benign serotonous meningitis, each case of which requires differential diagnosis;

- the development of encephalitis, each case of which requires differential diagnosis;

- abdominal pain, abdominal syndrome;

- painful short-term swelling of the testicles.

If side effects occur that are not described in the instructions, the patient should be informed of them by the doctor.

Overdose:

Cases of overdose are not established.

Interaction:

Vaccination can be carried out simultaneously (on the same day) with DTP and ADS vaccines, live and inactivated polio vaccine, hepatitis B vaccine, rubella, influenza, hemophilia, provided that it is injected into different parts of the body. Other live viral vaccines are administered at intervals of at least 1 month.

If necessary setting TST it should be carried out or simultaneously with the vaccination or 6 weeks after her as measles (and possibly mumps) vaccine process may cause a temporary decrease in skin sensitivity to tuberculin that will cause a false negative result.

After the administration of human immunoglobulin preparations, vaccinations should be given no earlier than 2 months. After the introduction of mumps-measles vaccine, immunoglobulin preparations can be administered no earlier than 2 weeks; atIf immunoglobulin is needed before this time, vaccination against mumps and measles should be repeated.

Special instructions:Vaccination is carried out:

- after acute infectious and non-infectious diseases, after exacerbation of chronic diseases - after the end of acute manifestations of the disease;

- with non-severe acute respiratory viral infections, acute intestinal diseases, etc. - immediately after the normalization of temperature;

- after immunosuppressive therapy, the vaccine is given 3-6 months after the end of treatment.

Vaccination with parotitic measles vaccine is not recommended during the period of rising incidence of serous meningitis.

Persons temporarily released from vaccination should be monitored and vaccinated after withdrawal of contraindications.

In order to identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of the vaccine with mandatory thermometry.

Effect on the ability to drive transp. cf. and fur:

No information.

Form release / dosage:Lyophilizate for the preparation of a solution for subcutaneous administration.

Packaging:

1 dose per ampoule.

In a pack of 10 ampoules with instructions for use and a liner with a number of stacker.

Storage conditions:

AT According to SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C.

Keep out of the reach of children.

Transportation conditions

AT According to JV 3.3.2.1248-03 at a temperature from 2 before 8 ° C.

Shelf life:

1 year.

The drug is not eligible for use with expired use.

Terms of leave from pharmacies:For hospitals

Registration number:P N000544 / 01

Date of registration:14.03.2008 / 05.02.2014

Expiration Date:Unlimited

The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Manufacturer: & nbsp

MICROGEN FGUP NGO Russia

Information update date: & nbsp12.01.2017

Illustrated instructions

Instructions

Vaccine parotitic-measles alive live (Vaccinum parotitidi-morbillorum culturarum vivum siccum)