Description
Packing
10 ampoules
Indications
Prevention of mumps starting at the age of 12 months.
In accordance with the National Preventive Vaccination Calendar, vaccination is carried out twice at the age of 12 months and 6 years for children who did not suffer from mumps.
Emergency prophylaxis is given to children from 12 months of age, adolescents and adults who have had contact with mumps, have not had mumps, or have not previously been vaccinated against this infection. In the absence of contraindications, the vaccine is administered no later than 72 hours after contact with the patient.
Contraindications
Anaphylactic reactions or severe allergic reactions to aminoglycosides (gentamicin sulfate), chicken and / or quail eggs
primary immunodeficiencies, malignant blood diseases and neoplasms
strong reaction (temperature rise above 40 ° C, more than 8 cm in diameter at the injection site) or a complication from the previous administration of mumps or mumps measles vaccines
pregnancy and lactation
acute diseases or obos renie chronic diseases.
note. HIV infection is not a contraindication to vaccination.
Use during pregnancy and lactation
Vaccination is contraindicated.
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 mild acute respiratory viral infections, acute intestinal diseases, etc. – immediately after the normalization of the temperature,
is administered after immunotherapy 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 exempted from vaccinations, should be taken under supervision and accounting and vaccinated after removal of contraindications.
In order to identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of the vaccinated with mandatory thermometry.
Impact on the ability to drive transp. Wed and fur.: No information.
Composition
One vaccination dose of the preparation contains: Active ingredient: – mumps virus – at least 20,000 (4.3 lg) tissue cytopathogenic doses (TCD50).
Excipients: – stabilizer – a mixture of 0.08 ml of an aqueous solution of LS-18 * and 0, 02 ml of a 10% solution of
gelatin – gentamicin sulfate – not more than 20 mcg.
note. * Composition of an 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 mix with phenol red 7.15 mg, water for injection up to 1 ml .
Dosage and administration
Immediately before use, the vaccine is diluted with measles solvent, mumps and mumps-measles culture live vaccines (hereinafter referred to as solvent) at the 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 clear pink liquid.
The vaccine and the solvent are not suitable for use in ampoules with impaired integrity, labeling, as well as when their physical properties (color, transparency, etc.) are changed, expired or improperly stored.
Opening of ampoules and the vaccination procedure is carried out with strict observance of the rules of asepsis and antiseptics.
Ampoules with vaccine and solvent at the incision site are treated with 70 ° ethanol and break off, avoiding the ingress of alcohol into the ampoule.
To dilute the vaccine, the entire required volume of solvent is taken and transferred to an ampoule with a dry vaccine. After mixing, the vaccine is filled with another needle into a sterile syringe, which is then vaccinated.
The vaccine is injected subcutaneously in a volume of 0.5 ml under the scapula or in the shoulder area (on the border between the lower and middle third of the shoulder from the outside), having previously treated the skin at the injection site with 70 ° ethanol.
The diluted vaccine is used immediately and cannot be stored.
The vaccination carried out is recorded in the established registration forms with the name of the drug, the date of vaccination, dose, manufacturer, serial number, expiration date, response to vaccination.
Precautions for using
Considering the possibility of developing immediate allergic reactions (anaphylactic shock, Quincke’s edema, urticaria) in particularly sensitive individuals, vaccinated patients must be monitored for 30 minutes.
Vaccination sites should be provided with anti-shock therapy.
Side effects of
In most vaccinees, the vaccination process is asymptomatic. After administration of the vaccine, the following adverse reactions of varying severity can be observed: Often (1 / 10-1 / 100): – from 5 to 15 days – a short-term slight increase in body temperature, catarrhal phenomena from the nasopharynx (mild hyperemia of the throat, rhinitis).
With the mass use of the vaccine, an increase in body temperature above 38.5 ° C should not be more than 2% of those vaccinated. An increase in body temperature above 38.5 ° C in the post-vaccination period is an indication for the appointment 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 injection site, which pass without
treatment – from 5 to 42 days – a slight increase in parotid salivary glands lasting 2-3 days
– restlessness, lethargy, sleep disturbance.
Very rarely (<1/10000): - in the first 24-48 hours - allergic reactions that occur in individuals with altered reactivity – after 2-4 weeks – benign serous meningitis. Each case of serous meningitis requires differential diagnosis of – a painful short-term testicular edema. If side effects occur that are not described in the instructions, the patient should inform the doctor about them. Drug interaction Mumps vaccination can be carried out simultaneously (on the same day) with other calendar vaccinations (against measles, rubella, poliomyelitis, hepatitis B, pertussis, diphtheria, tetanus, flu, hemophilic infection), provided that they are introduced into different parts of the body or not earlier than 1 month after the previous vaccination. After administration of human immunoglobulin preparations, vaccinations against mumps are carried out no earlier than 2 months later. After the introduction 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 time, the mumps vaccination should be repeated. Overdose Cases of overdose have not been established. Storage Conditions According to SP 3.3.2.1248-03 at 2 to 8 ° C. Keep out of the reach and sight of children. Transport conditions In accordance with SP 3.3.2.1248-03 at 2 to 8 ° C. Expiration 2 years. Dosage form solution for injection Microgen NPO, Russia