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Dosage form: & nbspintradermal solution
Composition:

1 intradermal dose (0.1 ml) contains:

A polysaccharide-protein complex obtained from a vaccine strain Brucella abortus 19-VA in the process of chemical treatment in a 0.9% solution of sodium chloride isotonic for injection, from 3.8 to 5.4 μg protein.

Description:Transparent, colorless or light yellow liquid.
Pharmacotherapeutic group:MIBP is an allergen
ATX: & nbsp
  • Other allergens
  • Pharmacodynamics:Immunological properties
    Intradermal injection of an allergen in a patient with brucellosis causes the development of a local reaction (edema, hyperemia, soreness). In healthy individuals, a local reaction to the administration of an allergen within 24-48 hours should be absent.
    Indications:

    Specific diagnosis of hypersensitivity to brucella.

    Contraindications:

    - Hypersensitivity to brucellosis antigen;

    - Presence of contraindications to the introduction of the drug Brucellosis live vaccine;

    - Hyperthermia.

    In order to identify contraindications, the doctor (or paramedic) on the day of sampling conducts an examination and a questioning of the patient with obligatory thermometry.

    Carefully:There is no information.
    Pregnancy and lactation:

    Contraindicated in pregnancy and during breastfeeding.

    Dosing and Administration:

    Intradermal (0.1 ml).

    An allergic test is placed on the inner surface of the middle third of the forearm. The skin at the injection site of the allergen is pretreated with 70% ethyl alcohol.

    Opening of ampoules and the procedure for administering the drug are carried out with strict adherence to aseptic and antiseptic rules. An opened ampoule with an allergen, preserved in accordance with the rules of asepsis, can be used within 2 hours.

    0.1 ml of the drug (1 dose) is syringed with a capacity of 1 ml with a thin needle and injected strictly intradermally, so that a small papule with a diameter of 3-5 mm is formed at the site of administration.

    Incorporation of reaction results

    It is carried out 24-48 hours after the injection of the allergen by examination and palpation of the skin. In some cases, the allergic reaction becomes positive to 72 hours.

    With a positive reaction A reddish or pale, painful swelling of an elongated or oval form appears on the site of the allergen injection. Edema can be well contoured with a clear elevation above normal skin.

    With a mild reaction Edema is only recognized by palpation (compare with a similar area of ​​skin on the other hand).

    Hyperemia of the skin in the absence of edema is taken as negative result.

    When taking into account the reaction, the size of the edema in centimeters (length and width), the degree of soreness after 24 and 48 hours are noted. If the result is negative, the reaction should also be taken into account after 72 hours.

    The presence of pronounced skin edema at the site of the allergen is considered a positive allergic reaction. Absence of pain and hyperemia in the presence of edema does not exclude a positive evaluation of the sample.

    The reaction, which appeared and disappeared earlier than six hours after the administration of the allergen, is considered nonspecific.

    Evaluation of reaction results:

    - Slightly positive - mild edema less than 2 cm in diameter;

    - positive - edema of 2 to 6 cm in diameter;

    - sharply positive - edema over 6 cm, sometimes accompanied by lymphadenitis and a general reaction of the body.

    The introduction of the brucellosis allergen is recorded in the prescribed registration forms with the name of the preparation, the date of formulation, the dose, the name of the manufacturer, the serial number, the reaction to the administration.

    Precautions for use

    Given the possibility of developing an anaphylactic shock in certain highly sensitive individuals, the subject should be under medical supervision for at least 30 minutes.Locations of the intradermal test should be provided with anti-shock therapy.

    Side effects:

    After setting the allergic test in 20-30 minutes at the site of the allergen injection, allergic reactions of the immediate type can occur in the form of an edema (infiltration), hyperemia and soreness of the skin. In persons highly sensitized to the brucellosis antigen, it is possible to develop a general reaction (fever, headache, chills, malaise), sometimes lymphadenitis, joint pain, tenderness at the site of the allergen, temperature rise (up to 38 ° C).

    The patient should be warned about the possibility of developing side effects not listed in the instructions.

    Overdose:

    Not installed.

    Interaction:

    CATEGORALLY IS PROHIBITED to conduct an allergy test simultaneously with the introduction of vaccines.

    Special instructions:

    Do not allow the injection of an allergen and the reception of patients in the same room.

    The allergen is not to be used, the integrity of the package is damaged, with changed physical properties (foreign impurities, insoluble flakes), with expired shelf life, if storage conditions are violated.

    Effect on the ability to drive transp. cf. and fur:No information.
    Form release / dosage:Solution for intradermal administration, 10 doses / ml.
    Packaging:

    1 ml (10 intradermal doses) in the ampoule.

    For 10 ampoules in a cardboard pack, along with instructions for use and a knife ampoule.

    Storage conditions:
    In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C in a place inaccessible to children.
    Transportation conditions
    In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C.
    Shelf life:

    2 years.

    The drug with expired shelf life is not subject to application.

    Terms of leave from pharmacies:For hospitals
    Registration number:LS-002624
    Date of registration:30.12.2011 / 29.01.2014
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Information update date: & nbsp12.02.2016
    Illustrated instructions
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