Instruction for use: Priorix

Dosage form: Lyophilizate for the preparation of solution for intramuscular and subcutaneous administration

Active substance: Vaccinum ad prophylaxim morbillorum, rubeolae, parotitidis

ATX

J07BD52 Measles virus in combination with mumps and rubella viruses, live attenuated

Pharmacological group

Vaccines, serums, phages and toxoids

Nosological classification (ICD-10)

B05 Measles: Koplik Spots; Koryvyaya rash on the mucous cheek

B06 Rubella [German measles]: German measles; Rubella; Epidemic rubella

B26 Epidemic parotitis: Parotitis; Infectious parotitis (mumps)

Composition and release form

Powder lyophilized for solution for injection 1 Inoculation dose

Strain Schwartz, not less than 103TCID50

Strain RIT 43/85, not less than 103,7TCID50

Strain Wistar RA 27/3, not less than 103TCID50

Neomycin B sulfate, no more than 25 mcg

Auxiliary substances: lactose; Sorbitol; Mannitol; Amino acids

In vials of 1 dose; Complete with a solvent (water for injection) in an ampoule (0.5 ml), or in a syringe (0.5 ml) with 1 or 2 needles; In a carton box 1 set, or in a carton box 100 bottles, in a separate box - 100 ampoules with a solvent.

Description of dosage form

Lyophilizate for solution for injection: homogeneous porous mass from white to slightly pink. Solvent (water for injection): clear, colorless liquid, odorless, free from impurities.

Characteristic

It is a combined preparation of attenuated live vaccine strains of the measles virus (Schwarz) of mumps (RIT 43/85, a derivative of Jeryl Lynn) and rubella (Wistar RA 27/3) cultivated separately in chicken embryo cells (measles and mumps) and diploid Human cells (rubella virus). The vaccine complies with WHO requirements for the production of biological products, requirements for vaccines against measles, mumps, rubella and live combination vaccines.

Pharmachologic effect

Mode of action - Immunostimulating.

Forms immunity against measles, rubella and mumps. Clinical trials of the Priori vaccine showed high efficacy of the drug. Antibodies to measles virus were detected in 98% of the vaccinated, to the mumps virus in 96.1% of the vaccinated and to the rubella virus in 99.3% of the vaccinated. One year after vaccination, all seropositive persons retained a protective titer of antibodies to measles virus and rubella virus, and 88.4% had a mumps virus.

A certain degree of protection against measles disease can be achieved by administering the vaccine to nonimmune individuals within 72 hours of their contact with the measles.

Indications of the Priorix

Prevention of measles, mumps and rubella from 12 months of age.

Contraindications

Hypersensitivity, incl. To a squirrel of a chicken egg, neomycin; Allergic reactions to the previous administration of the drug; Primary and secondary immunodeficiency; Acute respiratory and exacerbation of chronic diseases accompanied by fever, pregnancy.

Side effects

Most often - hyperemia at the injection site, pain and swelling; Slight increase in body temperature, rash; Rarely - febrile convulsions, swelling of the parotid salivary glands; Very seldom did individual symptoms after vaccination have symptoms typical of upper respiratory tract infection (rhinitis, cough, bronchitis, etc.); Extremely rare - diarrhea, vomiting, anorexia, drowsiness, increased excitability, insomnia, acute otitis media, lymphadenopathy.

Interaction

The prioryx can be administered simultaneously (in one day) with DTP and ADP vaccines, live and inactivated poliovirus vaccine, Haemophilus influenzae type b vaccine, hepatitis B vaccine, provided injections are given with separate syringes in different parts of the body. Other live viral vaccines are administered with an interval of at least 1 month. Priority should not be confused with other vaccines in one syringe.

The Priority vaccine can be used to re-vaccinate individuals previously vaccinated with another combination vaccine against measles, mumps and rubella or with appropriate mono preparations.

Children who received immunoglobulins or other blood products from humans should not be vaccinated before 3 months after the possible ineffectiveness of the vaccine as a result of the effect of passively administered antibodies on vaccine viruses of measles, mumps and rubella. In the event that the immunoglobulin (blood product) was introduced earlier than 2 weeks after vaccination, the latter should be repeated.

If a tuberculin test is required, it should be performed either concomitantly with vaccination or 6 weeks after it, as a measles (and possibly mumps) vaccination process can cause a temporary decrease in the sensitivity of the skin to tuberculin, which will cause a false negative result.

Dosing and Administration

SC 0.5 ml each. Allowed IM introduction. Before injection, the powder is dissolved in the attached solvent - water for injection.

In accordance with the national calendar, Priorix vaccinations are administered to children aged 12 months with subsequent booster vaccination at the age of 6 years. In addition, vaccination of girls aged 13 years is indicated.

Precautionary measures

The presence of contact dermatitis caused by neomycin, in the anamnesis and allergic reaction to hen's eggs not anaphylactic in nature is not a contraindication to the vaccination.

The drug can be administered to people with asymptomatic HIV infection, as well as people with AIDS.

With mild ARVI, acute intestinal and other diseases, vaccinations can be carried out immediately after the normalization of body temperature.

Special instructions

Immediately before use, the contents of the supplied syringe or ampoule with a solvent at the rate of 0.5 ml per dose are added to the vial of the preparation. The bottle is shaken thoroughly until completely dissolved. The dissolution time of the preparation should not exceed 1 min. The dissolved preparation is a clear liquid from light orange to light red color. If it looks different, and also in the presence of extraneous particles, the vaccine is not used.

A new sterile needle should be used to administer the drug. When using the vaccine in multi-dose packs, a new syringe and needle should be used each time to take the drug. Dissolved drug in multi-dose packages should be used during the working day (for no more than 8 hours) if stored in a refrigerator (at a temperature of 2 to 8 ° C). The drug should be removed from the bottle with strict adherence to aseptic rules.

Before administering the vaccine, make sure that alcohol or other disinfectant has evaporated from the surface of the skin and vial plug, These substances can inactivate attenuated viruses in the vaccine.

Storage conditions of the drug Priorix

At a temperature of 2-8 ° C. Solvent at t 2-25 ° C.

Keep out of the reach of children.

The shelf life of the drug Priorix

2 years. 5 years solvent

Do not use beyond the expiration date printed on the package.