Composition, form of production and packaging
Liofilizate for the preparation of a slurry for s / w administration and naked scarification application in the form of a porous mass of white or white with a yellowish hue.
lyophilized culture of living microbes of the vaccine strain Brucella abortus 19 BA
for c / c is entered. 3.4 Г— 10 8 - 4.6 Г— 10 8 in 0.5 ml of solvent
for cutaneous scarification application of 4 Г— 10 9 - 1.6 Г— 10 10 in 0.1 ml of solvent
Excipients: sucrose 0.015 g, sodium glutamate monohydrate 0.00225 g, thiourea 0.00075 g, gelatin 0.00225 g.
4-10 dermal doses - ampoules (5) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
The vaccine after 20-30 days after vaccination ensures the development of immunity lasting 10-12 months, the maximum intensity of immunity persists for 5-6 months.
Prevention of goat-sheep brucellosis in adults.
Vaccinations are subject to persons performing the following works:
- for the procurement, storage, processing of raw materials and livestock products obtained from farms where brucellosis diseases are recorded;
- slaughter of livestock, brucellosis patient, for harvesting and processing of meat and meat products obtained from it.
Livestock breeders, veterinary workers, zootechnicians in farms enzootic for brucellosis.
Persons working with live cultures of the causative agent of brucellosis.
Vaccination is carried out once dermally or subcutaneously. One dose for skin administration is 2 drops (0.1 ml) and contains 1x10 10 m.k., with a subcutaneous injection of 0.5 ml and contains 4x10 8 m.k. Revaccination is carried out according to the indications after 10-12 months, using a half dose, which is 1 drop (0.05 ml) and contains 5 x 10 9 m.k.
In order to identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of the vaccine with mandatory thermometry. At a temperature above 37 В° C, the graft is delayed. If necessary, conduct the necessary laboratory examination.
Before each vaccination, the vaccinee is required to determine the presence of specific immunity with the help of one of the serological or skin-allergic reactions.Inoculations are subject to negative reaction.
Vaccinations should be carried out no later than 3-4 weeks before the start of work associated with the risk of infection.
The vaccination is recorded in the prescribed registration forms with the name of the drug, the date of vaccination, the dose, the name of the manufacturer of the drug, the serial number, the reaction to the vaccination.
Vaccination by the cutaneous method.
The drug is dissolved with sodium chloride solution for injection 0.9%, which is introduced into the ampoule with a sterile syringe with a needle at a rate of 0.1 ml per one inoculation dose. The ampoule is shaken until a uniform suspension is formed. The dissolution time of the vaccine should not exceed 1 min. The soluble drug should not contain precipitation or flakes. The place of inoculation - the outer surface of the middle third of the shoulder - is treated with alcohol or a mixture of alcohol and ether; use of other disinfectants is not allowed. After evaporation of alcohol and ether, without touching the skin, two drops of vaccine are applied at a distance of 30-40 mm from each other, the skin is stretched and a 6-incision (3 longitudinal and 3 transverse) 10 mm long with each scriber the distance between the notches is 3 mm. The serrations should not bleed, the blood should only act as a dewdrop.
The flat side of the scriber rubs the vaccine into the incisions for 30 seconds and allowed to dry for 5 minutes.
When revaccination, use a half dose, i.e. 1 drop of vaccine, through which 6 incisions are made.
The vaccine dose of the drug with this method is 25 times less than with the cutaneous vaccination; dilution of the vaccine is made at the rate of 12.5 ml of sodium chloride solution for injection 0.9% per dose of vaccine for cutaneous scarification (subcutaneous dose - 0.5 ml x 25 = 12.5 ml).
The preparation is dissolved in the same way as for the dermal vaccination, after which the resulting suspension is transferred to a sterile injector bottle in which the required volume of the solvent is introduced (for example, if the ampoule contains 7 doses of the vaccine, the contents should be suspended in 12.5 ml x 7, i.e. in 87.5 ml).
The vaccine is injected with an injector designed for subcutaneous administration (BI-3M or anti-infective protector PPI-2), according to the Instructions for the use of an injector in a volume of 0.5 ml.
Vaccinations are carried out in the area of вЂ‹вЂ‹the outer surface of the shoulder at the boundary between the upper and middle third. The injection site is treated in the same way as for the cutaneous inoculation.
Local and general response to vaccination is negligible. Local reaction with skin grafting can appear in 24-48 hours in the form of hyperemia, infiltration of the skin or in the form of pink-red nodules along the incisions, sometimes merging into the cushion or forming a small swelling. If the needle-free method of injection through 12-24 hours at the injection site may appear hyperemia, infiltration up to a diameter of 25 mm, a weak soreness. The general reaction occurs on the first day in 1-2% of the vaccinated and is expressed by malaise, headache, fever to 37.5 - 38 В° C.
- the transferred brucellosis in the anamnesis. Positive serological or skin-allergic reaction to brucellosis;
- acute infectious and non-infectious diseases, chronic diseases at the stage of exacerbation - vaccinations are given no earlier than 1 month after recovery (remission);
- Primary and secondary immunodeficiencies. In the treatment of steroids, antimetabolites, chemo- and X-ray therapy, vaccinations are given no earlier than 6 months after the end of treatment;
- systemic connective tissue diseases;
- malignant neoplasms and malignant diseases of the blood;
- common relapsing skin diseases;
- allergic diseases (bronchial asthma, anaphylactic shock, Quincke's edema in the anamnesis);
- pregnancy and lactation.
PREGNANCY AND LACTATION
The use of the drug is contraindicated.
Precautions for use
It is strictly forbidden to inject the vaccine diluted for the cutaneous scarification application subcutaneously.
It is not possible to use a vaccine whose package integrity is damaged, with changed physical properties (foreign impurities, insoluble flakes), expired, if storage conditions are violated.
Opening of ampoules and the procedure for administering the drug are carried out with strict adherence to aseptic and antiseptic rules. A diluted vaccine, preserved with aseptic rules, can be used for 2 hours.
Given the possibility of developing an anaphylactic shock in certain highly sensitive individuals, the vaccinated should be under medical supervision for at least 30 minutes. Vaccination sites should be provided with anti-shock therapy.
Information on the possible impact on the ability to drive vehicles and manage mechanisms
Special precautions for the destruction of unused medicinal product.
Ampoules with unused vaccine are inactivated by boiling for 30 minutes, after which they are disposed of in accordance with
SanPiN 22.214.171.1248-99 "Rules for Collection, Storage and Disposal of Waste of Treatment and Prevention Facilities"
Inoculations against brucellosis are carried out not earlier than 1 month after other preventive vaccinations or 1 month before them.
Simultaneous dermal vaccination with live vaccines against brucellosis and vaccination against one of the following infections is allowed: ku rikkettsioza, tularemia and plague.
TERMS OF RELEASE FROM PHARMACY
For treatment and prevention institutions.
TERMS AND CONDITIONS OF STORAGE
In accordance with SP 126.96.36.1998-03 at a temperature of 2 to 8 В° C in a place inaccessible to children. Shelf life - 3 years.