Measles vaccine, live attenuated (Meals vaccine live attenuated)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for measles preventionVaccine for measles prevention
Dosage form: & nbsplyophilizate for the preparation of a solution for subcutaneous administration
Composition:

One inoculation dose of the drug (0.5 ml) contains:

- not less than 1000 TCDs50 (tissue cytopathogenic doses) of the measles virus;

- stabilizer - sorbitol -25 mg, gelatin -12.5 mg.

Description:The preparation is a homogeneous, porous, loose mass of white or white-yellow color, hygroscopic.
Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07.B.D.01   Measles virus - live attenuated

J.07.B.D   Vaccine for measles prevention

Pharmacodynamics:

Measles vaccine live attenuated, lyophilizate for the preparation of a solution for subcutaneous administration, is made from a strain of measles virus Edmonston-Zagreb on human diploid cells MRC-5.

The vaccine stimulates the production of antibodies to the measles virus, which reach a maximum level 3-4 weeks after vaccination.

The drug meets WHO requirements.

Indications:

The vaccine is designed for routine measles prevention.

Routine vaccinations are carried out twice at the age of 12-15 months and 6 years for children who do not have measles.

Children born from seronegative measles virus to the virus are vaccinated at the age of 8 months and further - at 14-15 months and 6 years.

The interval between vaccination and re-vaccination should be at least 6 months.

Contraindications:

- Primary immunodeficiency states, malignant blood diseases and neoplasms;

- a strong reaction (temperature rise above 40 ° C, edema, hyperemia more than 8 cm in diameter at the injection site) or complication of previous administration of the vaccine;

- severe renal dysfunction;

- heart disease in decompensation;

- Pregnancy.
Dosing and Administration:

Immediately before use, the vaccine is diluted only with the applied solvent (water for injections) using a sterile syringe at a rate of 0.5 ml of solvent per vaccination dose of the vaccine.

The vaccine should completely dissolve within 3 minutes to form a clear, colorless or pale yellow solution.

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

Opening of vials, ampoules and vaccination procedure is carried out with strict adherence to aseptic and antiseptic rules. Ampoules in the incision site are treated with 70° alcohol and break, while not allowing the ingress of alcohol into the ampoule.

To dilute the vaccine with a sterile syringe, take out all the necessary volume of the solvent and transfer it to a bottle with a dry vaccine. After mixing, the needle is changed, the vaccine is taken into the syringe and injected.

The vaccine is administered deep 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° alcohol.

The diluted vaccine is not subject to storage.

The accompanying solvent is specially formulated for this vaccine.

DO NOT use solvents for other vaccines and measles vaccines from other manufacturers. The use of inappropriate solvents can lead to a change in the properties of the vaccine and severe reactions in recipients.
Side effects:

Reaction to administration

In the next 24 hours after the introduction of the measles vaccine, moderate pain may occur at the injection site.In most cases, the pain passes for 2-3 days without treatment. 5-15% of those vaccinated on the 7-12th day after vaccination may have a mild temperature increase of 1-2 days. In 2% of those vaccinated on the 7-10th day after the vaccination, a rash of up to 2 days may develop. Moderate adverse reactions occur less frequently after the second dose of the vaccine. In the post-vaccination period, encephalitis was registered at a frequency of 1: 1,000,000 doses administered, with no causal relationship with vaccination proven.

Complications that develop extremely rarely include convulsive reactions that occur, usually 6-10 days after vaccination, usually against a high temperature, and allergic reactions that occur in the first 24-48 hours in children with allergic reactivity.

Note. A rise in temperature above 38.5 ° C in the post-vaccination period is an indication for the administration of antipyretics.

Interaction:

After the administration of human immunoglobulin preparations, measles vaccines are given no earlier than 2 months.

After the introduction of measles vaccine, immunoglobulin preparations can be administered no earlier than 2 weeks; If immunoglobulin is required before this time, measles vaccination should be repeated.

After vaccination, there may be a transient inversion of the tuberculin-positive reaction to the tuberculin-negative reaction.

Vaccination against measles can be done simultaneously (on the same day) with other vaccinations of the National Calendar (against mumps, rubella, poliomyelitis, hepatitis B, pertussis, diphtheria, tetanus) or not earlier than 1 month after the previous vaccination.

Special instructions:

Edit Warnings

Vaccinations are conducted:

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

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

- after immunosuppressive therapy - 3-6 months after the end of treatment.

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

When a vaccine is administered to patients receiving corticosteroids, immunosuppressive drugs or undergoing radiotherapy, an adequate immune response may not be obtained.

A vaccine can be given to children with an established or suspected HIV infection.Although the available data are insufficient and additional studies are required, to date, there is no evidence of a greater incidence of adverse reactions when this vaccine or other measles vaccines are administered to children with clinical or asymptomatic HIV infection. The vaccine should not be administered in other immunodeficient conditions with a violation of cellular immunity.

ATTENTION! The vaccine should only be administered subcutaneously. Vaccinated should be under medical supervision for at least 30 minutes after immunization. Places of vaccination should be equipped with anti-shock therapy. To stop anaphylactic reactions that may occur in children with allergic reactivity to the introduction of not only the measles vaccine, but also other vaccines, you should have a 1: 1000 adrenaline solution ready. Injection of adrenaline should be made at the first suspicion of the onset of development of a shock reaction.

Form release / dosage:Lyophilizate for the preparation of a solution for subcutaneous administration, 0.5 ml / dose (complete with a solvent).
Packaging:

Vaccine - 1 or 10 doses in a vial of dark glass,10 vials with 1 dose of vaccine with instructions for use in a cardboard pack or 50 vials with 1 or 10 doses of a vaccine with 5 copies of instructions for use in a cardboard pack.

Solvent - 0.5 ml (per dose of vaccine) or 5.0 ml (per 10 doses of vaccine) in an ampoule of colorless clear glass. 10 ampoules of 0.5 ml each in a PVC / aluminum foil blister, 1 or 5 blisters in a cardboard bundle. 10 ampoules of 5.0 ml each in a PVC / aluminum foil blister, 5 blisters each in a cardboard bundle.

On bottles with a vaccine and on cardboard packs with bottles horizontal orange strips are put (Pantone 151C Orange).

Storage conditions:

Vaccines - at a temperature of 2 ° C to 8 ° C in a dark place out of the reach of children.

Thinner - at a temperature of 5 ° C to 30 ° C. Do not freeze.

Transportation of vaccine and solvent: at a temperature of 2 ° C to 8 ° C.

Shelf life:

Vaccines - 2 years; solvent - 5 years.

The drug with expired shelf life is not subject to application.

Terms of leave from pharmacies:For hospitals
Registration number:LSR-005239/09
Date of registration:30.06.2009 / 20.12.2012
Expiration Date:Unlimited
The owner of the registration certificate: Serum Institute of India, Ltd. Serum Institute of India, Ltd. India
Manufacturer: & nbsp
Representation: & nbspSerum Institute of India, Ltd.Serum Institute of India, Ltd.India
Information update date: & nbsp12.01.2017
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