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Dosage form: & nbspintradermal suspension
Composition:
The brucellosis inactivated therapeutic vaccine, a suspension for intradermal administration, is a mixture of heat-inactivated virulent microbial strains of Brucella melitensis Nos. 21, 145 and Brucella abortus No. 544 in a ratio of 1: 1: 1 (2 billion microbial cells in the ampoule), diluent: sodium chloride (0.018 g in ampoule), preservative: phenol (5 mg in ampoule).
Description:The homogeneous suspension is grayish-white, a precipitate forms during storage, which easily breaks when shaken.
Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp
  • Brucellosis antigen
  • Pharmacodynamics:
    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.
    Indications:Treatment of patients with acute, subacute and chronic course of brucellosis.
    Contraindications:
    Decompensated diseases of the cardiovascular system, severe hemorrhagic diathesis, organic lesions of the central nervous system, neuritis of the auditory and optic nerves, inflammatory changes in the liver, kidneys, active pulmonary tuberculosis, pregnancy, age of up to 3 years and over 60 years.
    Dosing and Administration:

    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 2·105 microbial cells, maximum - 3·108 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 the first vial, a dilution of 1:10 vaccine containing 1·108 microbial cells in 1 ml, in the second vial - 1: 100 with a content of 1·107 microbial cells in 1 ml, in the third vial - 1: 1000 with a content of 1·106 microbial cells in 1 ml.

    Using the data presented in the table, determine how muchThe vaccine contains the necessary amount of microbial cells.

    Volume of the preparation, ml

    The number of microbial cells in the dilution of the vaccine

    1:10

    1:100

    1:1000

    0,1

    1·107

    1·106

    1·105

    0,2

    2·107

    2·106

    2·105

    0,3

    3·107

    3·106

    3·105

    0,4

    4·107

    4·106

    4·105

    0,5

    5·107

    5·106

    5·105

    0,6

    6·107

    6·106

    6·105

    0,7

    7·107

    7·106

    7·105

    0,8

    8·107

    8·106

    8·105

    0,9

    9·107

    9·106

    9·105

    1,0

    1-108

    1·107

    1·106

    1,5

    1,5·108

    -

    -

    2,0

    2·108

    -

    -

    2,5

    2,5·108

    -

    -

    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. Allergic reaction of the body is determined by the indicators of the Birne test before the treatment and the response of the body to the first administration of the 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.

    Reactivity (allergic reaction) is: 1) inadequate (areactivity, hyporeactivity) - no reaction or appearance of mild edema (no more than 2 cm in diameter) at the site of administrationallergen and without a response to the introduction of the vaccine; 2) medium intensity (normoreactivity) is a positive Burne test (edema of 2 to 6 cm in diameter), the appearance 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 ° C, cognition; 3) strong (hyperreactivity) - a sharply positive test of Byrne (edema over 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 ° C, chills, lesions.

    When determining the dosage of a vaccine, the individual sensitivity of the patient should be taken into account each time.

    The approximate scheme of treatment of patients with brucellosis with normoreactivity for intradermal administration of the vaccine with an interval between injections of 2-3 days is as follows:

    1 introduction - 2·106 microbial cells in 0.2 ml dilution of the vaccine 1: 100 in 2 points;

    2 introduction - 4·106 microbial cells in 0.4 ml dilution of the vaccine 1: 100 at 4 points;

    3 introduction - 1·107 microbial cells in 1.0 ml dilution of the vaccine 1: 100 at 10 points;

    4 introduction - 2·107 microbial cells in 0.2 ml dilution of the vaccine 1:10 into 4 points;

    5 introduction - 1·108 microbial cells in 1.0 ml dilution of the vaccine 1:10 at 10 points;

    6 introduction - 2·108 microbial cells in a 2.0 ml dilution of the vaccine 1:10 at 10 points;

    7 introduction - 3·108 microbial cells in 0.3 ml of undiluted vaccine at 6 points.

    With hyperreactivity, treatment starts with a dose of 2·105 microbial cells, with a pronounced local reaction dose of the vaccine with subsequent injections should not be increased.

    When hyporeactivity, treatment starts with a dose of 1·107 microbial cells.

    Repeated courses of vaccine therapy, if necessary, can be carried out not earlier than in 2-3 months.

    REACTION FOR INTRODUCTION. It is manifested by increasing the temperature of the Tesch to 37.5 ° C, by curing. In places where the vaccine is administered, after 24 hours, hyperemia should appear and swelling, the duration of which is determined by the individual sensitivity of the organism.

    Side effects:
    Elevated temperatures above 38.5 ° C, chills, malaise, increased pain in the lesions.
    Interaction:It is acceptable to use the vaccine concurrently with the course of antibiotic therapy.
    Form release / dosage:
    Suspension for intradermal administration.
    Packaging:
    In ampoules of 2 ml. The package contains 10 ampoules of vaccine, instructions for use and an ampoule knife.
    Storage conditions:
    Store in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C in a place inaccessible to children. Transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Transportation is allowed at a temperature of no higher than 25 ° C for 10 days.
    Shelf life:Shelf life 1,5 years. The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-002483/10
    Date of registration:26.03.2010 / 05.11.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:48 CSRI MINISTRY OF THE RUSSIAN FEDERATION 48 CSRI MINISTRY OF THE RUSSIAN FEDERATION Russia
    Manufacturer: & nbsp
    Information update date: & nbsp12.01.2017
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