Vaccine parotitic culture alive dry (Vaccinum parotitidis culturarum vivum siccum)

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

One vaccine dose of the drug contains:

Active substance:

- virus of mumps - not less than 20 000 (4,3 lg) of tissue cytopathogenic doses (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, Henks dry mix 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.E.01   Mumps virus - live attenuated

J.07.B.E.   Vaccine for prevention of mumps

Pharmacodynamics:

The moth culture live vaccine, lyophilizate for the preparation of a solution for subcutaneous administration, is prepared by culturing an attenuated strain of mumps virus Leningrad-3 on a primary culture of cells of quail embryos.

The vaccine stimulates seronegative vaccines for production of antibodies to the mumps virus, reaching a maximum level 6-7 weeks after vaccination.

The drug meets WHO requirements.

Indications:

Prevention of mumps from the age of 12 months.

In accordance with the National Calendar of Prophylactic Vaccinations, vaccination is carried out twice at the age of 12 months and 6 years for children who do not have mumps epidemic parotitis.

Emergency prevention conducted for children from 12 months, adolescents and adults who had contact with sick mumps, without a history of mumps, or previously not vaccinated against the infection. In the absence of contraindications, the vaccine is administered no later than 72 hours after the contact with the patient.

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;

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

- 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 before 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 is a transparent liquid of pink color.

Vaccine and solvent in ampoules with broken integrity, marking, as well as changing their physical properties (color, 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 in place of the incision are treated with 70 ° ethyl alcohol and break off, not allowing the alcohol to enter 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), pretreating the skin at the injection site of the 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).

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

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 slight 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 2-4 weeks - benign serous meningitis. Every case of serous meningitis requires differential diagnosis;

- 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 against mumps can be carried out simultaneously (on the same day) with other calendar vaccinations (against measles, rubella, poliomyelitis, hepatitis B, pertussis, diphtheria, tetanus, influenza, hemophilia) provided that it is injected into different parts of the body or not earlier than 1 month after the previous vaccination.

After the introduction of human immunoglobulin preparations, inoculations against mumps are carried out not earlier than 2 months after the injection. After the introduction of mumps vaccine, immunoglobulin preparations can be administered no earlier than 2 weeks; If immunoglobulin is required before this time, vaccination against mumps should be repeated.

Special instructions:

Vaccination is carried out:

- after acute infectious and non-infectious diseases, after exacerbation of chronic diseases - at 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 against mumps is not recommended during the period of rising incidence of serous meningitis.

Persons temporarily released from vaccinations should be monitored and recorded 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 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:

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:

2 years.

The drug is not eligible for use with expired use.

Terms of leave from pharmacies:For hospitals
Registration number:P N000262 / 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
Information update date: & nbsp12.01.2017
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