The vaccine is tulyaremiyny live

General characteristics. Structure:

Active ingredient: ^{(2.0±0.5)•108} of living microbic cells in 0,1 ml for cutaneous scarifying drawing or ^{(1.0±0.1)•107} of living microbic cells in 0,1 ml for intradermal introduction.

Excipients: sucrose, glutamate sodium monohydrate, thiourea, gelatin.

Composition of solvent: water for injections.

Pharmacological properties:

Pharmacodynamics. The vaccine in 20-30 days after an inoculation provides immunity development by duration up to 5 years.

Indications to use:

Prevention of a tularemia from the 7th summer age (since 14 years - in the centers of field type). The population living in territories, enzootichny on a tularemia, and also arrived to these territories of the person performing the following works is subject to inoculations:

— agricultural;
— hydromeliorative;
— construction;
— other works on dredging and movement of soil;
— procuring;
— trade;
— geological;
— surveying;
— forwarding;
— deratization and disinsection;
— on logging, clearing and improvement of the wood, zones of improvement and rest of the population.

Route of administration and doses:

Vaccination is carried out once nakozhno or vnutrikozhno. The revaccination is carried out according to indications in 5 years by the same dose.

For the purpose of identification of contraindications the doctor (paramedic) in day of an inoculation conducts survey and survey imparted with obligatory thermometry. At a temperature above 37 °C the inoculation is postponed. In case of need conduct laboratory examination.

Before each inoculation at vaccinated without fail define existence of specific immunity by one of serological or skin and allergic reactions. Persons with negative reaction are subject to inoculations.

The carried-out inoculation is registered in the established registration forms with the instruction by the name of drug, date of an inoculation, dose, the name of the manufacturing enterprise of drug, number of a series, reaction to an inoculation.

Vaccination in the cutaneous way: the dry vaccine is parted with the water for injections which is complete with drug at the rate of 0,1 ml on a dose. The ampoule is stirred up within 3 min. before formation of a homogeneous suspension.

The inoculation is carried out on an outside surface of an average third of a shoulder. Leather before an inoculation is processed alcohol or mix of alcohol with ether, use of other disinfectants is not allowed. After evaporation of alcohol with ether, a sterile eyedropper apply on the processed site of skin on one drop of a divorced vaccine in two places at distance 30-40 mm from each other. Shoulder skin is slightly pulled and by the sterile scarificator (an ospoprivivalny feather) through each put drop of a vaccine do 2 parallel notches 10 mm long.

Notches should not bleed, blood has to act only in the form of small dewdrops. The flat party of an ospoprivivalny feather the vaccine is rubbed in notches during 30 sec. and 5-10 min. allow to dry up.

Vaccination in the intradermal way: for intradermal needleless introduction the vaccine is parted the same as for cutaneous scarifying drawing. Then to the sterile syringes of 1 ml transfer to a sterile bottle for an injektor where add 19 ml of sodium of chloride of solution for injections of 0,9%. 20 ml of the received suspension contain 200 doses of a vaccine for intradermal introduction. The place of an injection of a vaccine is previously processed alcohol or mix of alcohol with ether. The vaccine is entered vnutrikozhno of 0,1 ml into an outside surface of an average third of a shoulder according to the application instruction of an injektor of BI-ZM with an anti-infectious protector of PPI-2 at the mode counted on intradermal introduction.

Precautionary measures at use. It is vnutrikozhno strictly forbidden to enter the vaccine divorced for cutaneous scarifying drawing!

The vaccine which integrity of packaging is damaged, with the changed physical properties (foreign impurity, not dissolved flakes), expired is not subject to use, at disturbance of the mode of storage.

Opening of ampoules and the procedure of administration of drug are carried out at strict observance of rules of an asepsis and antiseptics. The divorced vaccine kept with observance of rules of an asepsis can be used during 2 h.

Considering a possibility of development of an acute anaphylaxis in certain highly sensitive persons, vaccinated has to be under medical observation not less than 30 min. Venues of inoculations have to be provided with means of antishock therapy.

Features of use:

Use at pregnancy and feeding by a breast. Use of drug is contraindicated.

Use for children. Vaccination are exposed children from 7 years.

Special instructions. Influence on ability to driving of motor transport and to control of mechanisms. Data are absent.

Special precautionary measures at destruction of unused medicine. Ampoules with an unused vaccine inactivate boiling within 30 min. then utilize according to the SanPiN 2.1.7.728-99 of "The rule of collecting, storage and waste disposal of treatment and prevention facilities".

Side effects:

Local reaction at a cutaneous inoculation has to develop at all vaccinated. On site notches from 4-5 in the afternoon, and at some vaccinated - the hyperemia and hypostasis with a diameter up to 15 mm develops in later terms (till 10 in the afternoon)-. On the course of notches vesicles of the size of prosyany grain can appear. From 10-15 in the afternoon on site inoculations the crust is formed, the local phenomena abate, after department of a crust on skin there is a scar. Small short-term increase and morbidity of regional lymph nodes can sometimes be observed. At a negative take along notches only the small redness within 1 - 2 days is noted.

At an intradermal way of introduction local reaction lasting up to 9 days is characterized by moderately expressed hyperemia and infiltrate of skin with a diameter up to 40 mm, is rare increase in regional lymph nodes. The general reaction arises in isolated cases about 3-4 days and is expressed by an indisposition, a headache, is more rare - short-term temperature increase to 38 °C. These phenomena disappear in 2-3 days. Extremely seldom at imparted on the third or fourth week after vaccination the general and local reactions of allergic character appear.

At the persons who were earlier ill a tularemia or revaktsinirovanny the general and local reactions to an inoculation develops more violently. Fading of inoculative reactions at the same time goes quicker, than at initially vaccinated.

The vaccine Privivayemost at cutaneous scarifying drawing is checked in 5-7 days, and in case of lack of skin reaction - repeatedly for 12-15 day. Assessment of results of intradermal vaccination is carried out in 4-5 days after an inoculation. Positive reaction consider existence of a hyperemia and infiltrate with a diameter not less than 5 mm. Persons with lack of a positive take of an inoculation are subject to repeated vaccination in 30 days after definition of existence of specific immunity.

Interaction with other medicines:

Simultaneous cutaneous vaccination of adult persons by live vaccines against a tularemia, a brucellosis and plague is allowed (on different body parts).

Contraindications:

— the postponed tularemia in the anamnesis;

— positive serological or kozhnoallergichesky test on a tularemia;

— acute infectious and noninfectious diseases, chronic diseases - inoculations carry out to aggravation stages not earlier than in 1 month after remission recovery);

— primary and secondary immunodeficiences. At treatment by steroids, antimetabolites, himio-and roentgenotherapies of an inoculation carry out not earlier than in 6 months after the end of treatment;

— general diseases of connecting fabric;

— malignant new growths and malignant diseases of blood;

— widespread recurrent diseases of skin;

— allergic diseases (bronchial asthma, an acute anaphylaxis, a Quincke's edema in the anamnesis);

— pregnancy and period of a lactation.

Overdose:

Symptoms of overdose, measure for assistance at overdose are not established.

Storage conditions:

To store according to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C in the place, unavailable to children. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

15 - 50 cutaneous doses - ampoules (5) complete with solvent of 5 ml of amp. 5 pieces - packs cardboard.