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

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

Active substance:

- measles virus - at least 1 000 (3.0 lg) tissue cytopathogenic doses (TCD50).

Excipients:

- Stabilizer - a mixture of 0.04 ml of an aqueous solution of LS-18 * and 0.01 ml of a 10% gelatin solution;

- gentamycin sulfate - no more than 10 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:

Lyophilizate is a homogeneous, porous mass of light pink color, is hygroscopic.

Reconstituted drug - transparent liquid of pink color.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp
  • Measles virus - live attenuated
  • Pharmacodynamics:

    The live measles live vaccine, lyophilizate for the preparation of a solution for subcutaneous administration, is prepared by culturing a vaccine strain of measles virus Leningrad-16 (L-16) on the primary culture of cells of quail embryos.

    Immunological properties. The vaccine stimulates the production of antibodies to the measles virus, which reach a maximum level 3-4 weeks after vaccination, not less than 95% of the vaccinated. The drug meets WHO requirements.

    Indications:

    Scheduled and emergency measles prevention.

    Routine vaccinations are carried out twice at the age of 12 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.

    Children aged 1 to 18 years and adults under 35 years old (inclusive) who were not vaccinated before, who do not have information about measles vaccinations, who have not had measles before, are vaccinated in accordance with the instructions for use twice with an interval of at least 3 months between vaccinations. Persons vaccinated earlier once, are subject to a single immunization with an interval of at least 3 months between vaccinations.

    Emergency prophylaxis is carried out by contact persons without age limitation from foci of the disease, previously not infected, not vaccinated and not having information about preventive measles vaccinations or once vaccinated. In the absence of contraindications, the vaccine is administered no later than 72 hours after contact with the patient.

    Contraindications:

    1. Severe forms of allergic reactions to aminoglycosides (gentamycin sulfate, etc.), chicken and / or quail eggs.

    2. Primary immunodeficiency states, malignant blood diseases and neoplasms.

    3. A strong reaction (temperature rise above 40 ° C, swelling, hyperemia more than 8 cm in diameter at the injection site) or complication of previous administration of measles or mumps-measles vaccines.

    4. Pregnancy.

    Note

    In the presence of HIV infection, vaccination of persons with 1 and 2 immune categories is allowed (absence or moderate immunodeficiency).

    Pregnancy and lactation:

    Use during pregnancy is contraindicated.

    Vaccination is allowed women in the period of breastfeeding by a doctor's decision, taking into account the assessment of the ratio of the possible risk of infection and the benefits of vaccination.

    Dosing and Administration:

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

    The vaccine should completely dissolve within 3 minutes to form a transparent solution of pink color. Vaccine and solvent in 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 ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules. Ampoules in the place of incision are treated with 70% alcohol and break off, not allowing the alcohol to fall into the ampoule.

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

    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% 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, date of manufacture, 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,for those vaccinated, medical supervision must be provided within 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 reactions of varying severity can be observed:

    Often (1/10 - 1/100):

    - from 6 to 18 days can be observed temperature reactions, mild hyperemia of throat, rhinitis.

    In case of mass application of the vaccine, an increase in body temperature above 38.5 ° C should not be more than 2% of vaccinated.

    Rarely (1 / 1000- 1/10000):

    - cough and conjunctivitis, continuing for 1-3 days;

    - insignificant hyperemia of the skin and mild edema, which pass through 1-3 days without treatment.

    Very rarely (<1/10000):

    - mild ailment and korepobodnaya rash;

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

    - allergic reactions that occur in the first 24-48 hours in children with allergic changes in reactivity.

    Note

    Febrile convulsions in the anamnesis, as well as an increase in temperature above 38.5 ° C in the post-vaccination period, are an indication for the appointment of antipyretics.

    Overdose:

    Cases of overdose are not established.

    Interaction:

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

    After the administration of human immunoglobulin preparations, measles vaccines are given no earlier than 3 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 carrying out immunosuppressive therapy, measles vaccination can be carried out 3-6 months after the end of treatment.
    Special instructions:

    Vaccination conduct:

    - 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.

    Persons temporarily released from vaccinations 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:

    Not installed.

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

    1 or 2 doses per ampoule.

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

    Storage conditions:In accordance with SP 3.3.2.3332-16 at a temperature of 2 to 8 ° C. Keep out of the reach of children.

    Transportation conditions

    In accordance with SP 3.3.2.3332-16 at a temperature of 2 to 8 ° C.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:For hospitals
    Registration number:LS-002140
    Date of registration:21.02.2011 / 14.11.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Information update date: & nbsp12.01.2017
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