The vaccine is brucellous live

General characteristics. Structure:

Active ingredient: ^{3.4×108-4.6×108} in 0.5 ml of solvent of the lyophilized culture of live microbes of a vaccinal strain of Brucella abortus 19 BA for hypodermic introduction and ^{4×109-1.6×1010} in 0.1 ml of solvent of the lyophilized culture of live microbes of a vaccinal strain of Brucella abortus 19 BA for cutaneous scarifying drawing.

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

Pharmacological properties:

Pharmacodynamics. The vaccine in 20-30 days after an inoculation provides development of immunity lasting 10-12 months, the maximum tension of immunity remains 5-6 months.

Indications to use:

Prevention of a brucellosis of goat-sheep type at adults. The persons performing the following works are subject to inoculations:

— on preparation, storage, processing of raw materials and the livestock products received from farms where cattle diseases of a brucellosis are registered;

— on slaughter of the cattle sick with a brucellosis, on preparation and processing of the meat and meat products received from it.

Cattle breeders, veterinary workers, livestock specialists in farms enzootichny on a brucellosis.

The persons working with live cultures of the causative agent of a brucellosis.

Route of administration and doses:

Vaccination is carried out once nakozhno or subcutaneously. One dose at cutaneous introduction makes 2 drops (0,1 ml) and contains 1х1010 m to., at hypodermic introduction makes 0,5 ml and contains 4x108 m to. The revaccination is carried out according to indications in 10-12 months nakozhno, using a half dose which makes 1 drop (0,05 ml) and contains 5 x 109 m to.

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 necessary laboratory examination.

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

Inoculations should be carried out not later than 3-4 weeks prior to the work connected with risk of infection.

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

Vaccination in the cutaneous way. Drug is dissolved chloride sodium solution for injections of 0,9% which is brought in an ampoule the sterile syringe with a needle at the rate of 0,1 ml on one inoculative dose. The ampoule is stirred up before formation of uniform suspension. Time of dissolution of a vaccine should not exceed 1 min. Soluble drug should not contain rainfall or flakes. The place of an inoculation - the outside surface of an average third of a shoulder - is processed alcohol or mix of alcohol with ether; use of other disinfectants is not allowed. After evaporation of alcohol and ether, without touching skin, put two drops of a vaccine at distance of 30-40 mm from each other, pull skin and carry out by the sterile scarificator through each put drop of a vaccine of 6 notches (3 longitudinal and 3 cross) 10 mm long everyone with distance between notches of 3 mm. Notches should not bleed, blood has to act only as dewdrops.

The flat party of the scarificator rub a vaccine in notches during 30 sec. and 5 min. allow to dry up.

At a revaccination apply a half dose, i.e. 1 drop of a vaccine through which do 6 notches.

Vaccination in the hypodermic way. The inoculative dose of drug at this way is 25 times less, than at cutaneous vaccination; cultivation of a vaccine produce at the rate of 12,5 ml of sodium of chloride of solution for injections 0,9% for one dose of a vaccine for cutaneous scarifying drawing (a hypodermic dose - 0,5 ml x 25 = 12,5 ml).

Drug is dissolved the same as for cutaneous vaccination then the received suspension is transferred to a sterile bottle for an injektor in which bring the necessary volume of solvent (for example if the ampoule contains 7 cutaneous doses of a vaccine, then contents have to be suspended in 12,5 ml x 7, i.e. in 87,5 ml).

The vaccine is entered an injektor, counted on hypodermic introduction (BI-ZM or an anti-infectious protector of PPI-2), according to the Application instruction of an injektor of 0,5 ml.

Inoculations carry out to the area of an outside surface of a shoulder on border between an upper and average third. The injection site is processed as well as at a cutaneous inoculation.

Features of use:

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

Special instructions. Precautionary measures at use. It is strictly forbidden to enter the vaccine divorced for cutaneous scarifying use subcutaneously.

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.

Data on possible influence on ability to driving of motor transport and to control of mechanisms. No.

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 and general reaction to vaccination are insignificant. Local reaction at a cutaneous inoculation can appear in 24-48 h in the form of a hyperemia, infiltrate of skin or in the form of rose-red small knots on the course of the notches which sometimes are merging in the roller or which are formed a small swelling. At a needleless method of introduction in 12-24 h on site injections can appear a hyperemia, infiltrate with a diameter up to 25 mm, weak morbidity. The general reaction arises in the first days at 1-2% vaccinated and is expressed by an indisposition, a headache, fervescence to 37,5 - 38 °C.

Interaction with other medicines:

Brucellosis inoculations carry out not earlier than in 1 month after other preventive inoculations or in 1 month prior to them.

Simultaneous cutaneous vaccination by live vaccines against a brucellosis with inoculations against one of the following infections is allowed: ku-rickettsiosis, tularemia and plague.

Contraindications:

— the postponed brucellosis in the anamnesis. Positive serological or kozhnoallergichesky test on a brucellosis;

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

— 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:

It is not established.

Storage conditions:

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 - 3 years.

Issue conditions:

According to the recipe

Packaging:

4-10 cutaneous doses - ampoules (5) - packs cardboard.