Composition, form of production and packaging
Suspension for intradermal administration is homogeneous, grayish-white, during storage a precipitate forms, which easily breaks when shaken.
strains of Brucella melitensis Nos. 21 and 145 and Brucella abortus No. 544, inactivated by heating, a 1: 1: 1 mixture of 2 Г— 10 9 microbial cells
Excipients: sodium chloride 0.018 g, phenol 5 mg.
2 ml - ampoules (10) complete with a knife ampullum - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
The brucellosis inactivated therapeutic vaccine stimulates the reaction of specific immunity and promotes a more rapid release of the organism from the causative agent of brucellosis.
- treatment of patients with acute, subacute and chronic course of brucellosis.
The vaccine is administered to the patient intradermally in increasing doses in the region of the joints, shoulders or hips at points 40-60 mm apart; the minimum dose is 2 Г— 10 5 microbial cells, the maximum is 3 Г— 10 8 microbial cells.
Before use, every ampoule with the vaccine is carefully examined. The vaccine is not to be used: if the packaging is damaged, the appearance changes (foreign particles), the label is not damaged or broken, and after the expiration date.
The ampoule with the vaccine is carefully shaken until a homogeneous suspension is obtained, rubbed with alcohol, the neck of the ampoule is cut, covered with a sterile swab, and the sawn end is broken off. The vaccine from the opened ampoule is subject to immediate use.
The technique of breeding the vaccine. The vaccine is diluted immediately before consumption of 0.9% solution of sodium chloride for injection, which for 9 ml is poured into three sterile bottles. In the first vial, 1 ml of the vaccine is added using a syringe and mixed well, then 1 ml of the vaccine is transferred to the second vial from the first vial, from the second vial, 1 ml of the vaccine is transferred to the third vial. In a nerve bottle, a 1:10 dilution of a 1:10 vaccine containing 1 Г— 10 8microbial cells per ml, a 1: 100 vial containing 1 Г— 10 7 microbial cells per ml, and a third vial 1: 1000 with a 1 ? 10 6 microbial cells in 1 ml.
Using the data presented in the table, it is determined how much diluted vaccine contains the required amount of microbial cells.
Volume of preparation, ml Quantity of microbial cells at dilution of a vaccine
1:10 1: 100 1: 1000
0.1 1? 10 7 1? 10 6 1? 10 5
0.2 2? 10 7 2? 10 6 2? 10 5
0.3 3? 10 7 3? 10 6 3? 10 5
0.4 4 10 7 4 10 6 4 10 5
0.5 5? 10 7 5? 10 6 5? 10 5
0.6 6? 10 7 6? 10 6 6? 10 5
0.7 7? 10 7 ? 10 6 7? 10 5
0.8 8? 10 7 8? 10 6 8? 10 5
0.9 9? 10 7 9? 10 6 9? 10 5
1.0 1? 10 8 1? 10 7 1? 10 6
1.5 1.5? 10 8 - -
2.0 2? 10 8 - -
2.5 2.5? 10 8 - -
Method of treatment with vaccine.
Treatment with intradermal administration of the vaccine can be carried out in clinical and outpatient settings.
Dosage and duration of treatment is established by the attending physician depending on the form of the disease with brucellosis and the individual sensitivity of the patient. I determine the allergic reaction of the body! on the indicators of the Birne test before the beginning of treatment and the response of the body to the first introduction of a minimal dose of the vaccine.
The Burne test is performed using the brucellosis liquid allergen for intradermal application in accordance with the instructions for use of the preparation.
Reactivity (allergic reaction) is: 1) inadequate (areakivnost, hyporeactivity) - the lack of reaction or the appearance of mild edema (no more than 2 cm in diameter) at the site of the allergen and without a response to the introduction of the vaccine; 2) medium intensity (normoreakivnost) - a positive Burne test (edema size of 2 to 6 cm in diameter), the emergence of a general reaction of the body to the introduction of the vaccine in the form of an increase in body temperature to 37.5 В° C, cognition; 3) strong (hyper-reactivity) - a sharply positive Burne test (swelling more than 6 cm, sometimes accompanied by lymphadenitis and general reaction of the body), the appearance of a general reaction of the body to the introduction of the vaccine in the form of an increase in body temperature above 37.5 В° РЎ, chills, pain in the lesion.
When determining the dosage of a vaccine, the individual sensitivity of the patient should be taken into account each time.
An approximate treatment regimen for patients with brucellosis with normoreactivity when the vaccine is injected intravenously with an interval between injections of 2-3 days is as follows:
1 administration - 2 Г— 10 6 microbial cells in 0.2 ml dilution of the vaccine 1: 100 at 2 points;
2 administration - 4 Г— 10 6 microbial cells in 0.4 ml dilution of the vaccine 1: 100 at 4 points;
3 administration - 1 Г— 10 7 microbial cells per 1.0 ml dilution of the vaccine 1: 100 at 10 points;
4 administration - 2 Г— 10 7 microbial cells in 0.2 ml dilution of the vaccine 1:10 at 4 points;
5 administration - 1 Г— 10 8 microbial cells per 1.0 ml dilution of the vaccine 1:10 at 10 points;
6 administration - 2 Г— 10 8 microbial cells in 2.0 ml dilution of the vaccine 1:10 at 10 points;
7 administration - 3 Г— 10 8 microbial cells in 0.3 ml of undiluted vaccine at 6 points.
With giierreactivity, treatment starts with a dose of 2 Г— 10 5 microbial cells, with a pronounced local reaction, the dose of the vaccine should not be increased with subsequent injections.
With hyporeactivity, treatment starts with a dose of 1 Г— 10 7 microbial cells.
Repeated courses of vaccine therapy, if necessary, can be carried out not earlier than in 2-3 months.
Elevated temperatures above 38.5 В° C, chills, malaise, increased pain in the lesions.
Reaction to administration
It is manifested by an increase in body temperature to 37.5 В° C, by curettage. In places where the vaccine is administered after 24 hours, hyperemia and swelling should appear, the duration of which is determined by the individual sensitivity of the organism.
Decompensated diseases of the cardiovascular system;
- pronounced hemorrhagic diathesis;
- organic lesions of the central nervous system;
- neuritis of the auditory and optic nerves;
- inflammatory changes in the liver and kidneys;
active pulmonary tuberculosis;
- age up to 3 years and more than 60 years.
PREGNANCY AND LACTATION
Contraindicated in pregnancy.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in inflammatory changes in the kidneys.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in inflammatory changes in the liver.
APPLICATION FOR CHILDREN
Contraindicated at the age of 3 years.
APPLICATION IN ELDERLY PATIENTS
Contraindicated at the age of more than 60 years.
It is acceptable to use the vaccine concurrently with the course of antibiotic therapy.
TERMS OF RELEASE FROM PHARMACY
For treatment and prevention institutions.
TERMS AND CONDITIONS OF STORAGE
The drug with expired shelf life is not subject to application. Store in accordance with SP 126.96.36.1998-03 at a temperature of 2 to 8 В° C in a place inaccessible to children. Transportation is allowed at a temperature of no higher than 25 В° C for 10 days. Shelf life - 1,5 years.