Composition, form of production and packaging
Lyophilizate for the preparation of a solution for p / c injection in the form of a porous mass in the form of a tablet of light pink color.
1 dose
a yellow fever virus of at least 1,000 LD 50 or 1,600 pfu
Excipients: lactose monohydrate 20 mg, sorbitol 10 mg, L-histidine 1.2 mg, L-alanine 0.7 mg.
Solvent: water d / and.
1 ml (2 doses) - ampoules (10) complete with a solvent 1.25 ml - ampoules (10) in a separate carton pack - packs of cardboard.
2.5 ml (5 doses) - ampoules (10) complete with a solvent 3 ml - ampoules (10) in a separate carton pack - packs cardboard.
5 ml (10 doses) - ampoules (10) complete with a solvent 6 ml - ampoules (10) in a separate carton pack - packs of cardboard.
1 ml (2 doses) - ampoules (5) complete with a solvent 1.25 ml - ampoules (5) - packs of cardboard.
2.5 ml (5 doses) - ampoules (5) complete with a solvent 3 ml - ampoules (5) - packs of cardboard.
5 ml (10 doses) - ampoules (5) complete with a solvent 6 ml - ampoules (5) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
The vaccine stimulates the development of immunity to the virus of yellow fever lasting 10-15 years.
INDICATIONS
- prevention of yellow fever in children from 9 months of age and adults traveling abroad to yellow fever enzootic in regions, as well as in individuals working with live cultures of yellow fever.
DOSING MODE
Vaccination is performed once subcutaneously, with a syringe under the outer angle of the scapula or in the deltoid muscle region of the shoulder in a dose of 0.5 ml for all age groups no later than 10 days before leaving for the enzootic region. Revaccination, if necessary, is carried out 10 years after vaccination with the same dose.
The preparation is not suitable for use in ampoules with broken integrity and marking, with a change in physical properties (deformation of the "tablet" - a porous mass of light pink color changes shape and sharply decreases in volume, inhomogeneity of the dissolved drug, etc.), with expired shelf life, when the temperature regime of storage and transportation is disturbed.
Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules.
The entire contents of the ampoule with the solvent is used to dissolve the vaccine. The vaccine should be completely dissolved within 5 minutes. Dissolved, the vaccine is an opalescent liquid of a yellowish pink color. Dissolved vaccine is kept for 10-15 minutes, then the ampoule is shaken and one 0.5 ml injection is injected into the syringe. It is allowed to store the dissolved vaccine, closed with a sterile cloth, for no more than 1 hour at a temperature of 2 to 8 В° C.
The vaccination is recorded in the prescribed registration forms, indicating the name of the preparation, the date of vaccination, the dose, the number of the series, the response to the vaccination.
SIDE EFFECT
After the introduction of the vaccine in some cases, local and general reactions may develop.
Local reaction manifests itself in the form of hyperemia and edema (diameter not more than 2.5 cm), which can appear after 12-24 hours and disappears after 2-3 days after injection. In extremely rare cases, consolidation of subcutaneous tissue develops, accompanied by itching, pain, and regional lymph nodes.
The general reaction can develop in the interval between 4 and 10 days after inoculation in the form of a fever to 38.5 В° C, malaise, dizziness, headache, chills. The duration of the overall reaction does not exceed 3 days.
In rare cases, complications of an allergic nature are possible. In connection with this vaccination points should be equipped with anti-shock therapy, and the vaccine must be under medical supervision within 30 minutes after vaccination.
Persons susceptible to allergic reactions are prescribed antihistamines for 2-4 days before and after vaccination.
CONTRAINDICATIONS
- acute infectious and non-infectious diseases, chronic diseases in the stage of exacerbation or decompensation - vaccinations are carried out not earlier than one month after recovery (remission);
- an allergic reaction to a hen's egg protein in an anamnesis;
- primary (congenital) immunodeficiency;
- Secondary (acquired) immunodeficiency: treatment with immunosuppressants, antimetabolites, X-ray therapy - vaccinations are given no earlier than 12 months after recovery (end of treatment);
- Pregnancy.
In order to identify contraindications, the doctor on the day of inoculation is conducting a survey and examination of vaccinated patients with obligatory thermometry.A specific decision on the need to vaccinate certain groups of people (pregnant women, patients with chronic diseases, malignant blood diseases and neoplasms, etc.), living in the enzootic areas for yellow fever, depends on the degree of risk of the disease.
PREGNANCY AND LACTATION
Contraindicated in pregnancy.
APPLICATION FOR CHILDREN
Applied to children from 9 months old
DRUG INTERACTION
For persons over 15 years, it is allowed to vaccinate against yellow fever at the same time (on the same day) with other vaccinations of the national calendar of preventive vaccinations, provided that the drugs are administered to different parts of the body. For children under 15, the interval between the previous vaccination against another infection and vaccination against yellow fever should be at least 2 months.
Contraindicated in the use of yellow fever vaccine at the same time as vaccines designed to prevent cholera and paratyphoid A and B. In this case, the interval of 3 months should be observed between both vaccinations.
TERMS OF RELEASE FROM PHARMACY
For treatment and preventive and sanitary facilities.
TERMS AND CONDITIONS OF STORAGE
Transportation in accordance with SP 3.3.2.2329-08 at a temperature of 2 to 8 В° C in thermal containers. The vaccine is stored at a temperature of 2 to 8 В° C. The solvent is stored at a temperature of 2 to 8 В° C when combined with a vaccine and from 2 to 25 В° C - in a separate package with the vaccine. Freezing of the solvent is not allowed. Keep out of the reach of children. Shelf life - 2 years.
