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Dosage form: & nbspintradermal solution
Composition:

Composition per 1 dose (0.1 ml):

Active ingredient: tuberculoprotein (allergen tuberculoprotein) - 2 TE;

Excipients: polysorbate-80 - 5 mcg, phenol - 275 mcg, sodium dodecahydragraphate - 783 mkg, potassium dihydrogen phosphate - 63 mcg, sodium chloride - 457 mcg, water for injections - up to 0.1 ml.

Description:Colorless, clear liquid.
Pharmacotherapeutic group:MIBP is an allergen
ATX: & nbsp
  • Other allergens
  • Pharmacodynamics:

    The preparation is a mixture of filtrates of heat-killed cultures of mycobacterium tuberculosis of human and bovine species, purified by ultrafiltration, precipitated with trichloroacetic acid, treated with ethyl alcohol and ether for anesthesia and dissolved in a stabilizing solution (0.85% solution of sodium chloride with phosphate buffer, with Tween-80 ).

    Immunological properties

    The active substance of the drug, allergen-tuberculoprotein, causes a specific hypersensitivity reaction of the delayed type in the form of local reaction - hyperemia and infiltrate (papules) in infected or vaccinated BCG / BCG-M patients during the implementation of the intradermal tuberculin test.

    Indications:

    The drug is intended for tuberculin diagnostics (exercise Intradermal tuberculin test Mantoux) with the aim:

    a) selection of contingents for BCG vaccination;

    b) diagnosis of tuberculosis;

    c) determining the infection of the population with mycobacteria tuberculosis (or a state of hypersensitivity to tuberculin, if the post-vaccination allergy does not give grounds for talking about infection).

    Contraindications:

    Common skin diseases, epilepsy, acute, chronic infectious and somatic diseases in the period of exacerbation; allergic conditions (rheumatism in acute and subacute phases, bronchial asthma, idiosyncrasy with severe cutaneous manifestations during exacerbation). The Mantoux test is made 1 month after all clinical symptoms have disappeared or immediately after quarantining.

    It is not allowed to conduct a Mantoux test in those children's groups where there is a quarantine for children's infections.

    Preventive vaccinations can affect the sensitivity to tuberculin. Proceeding from this, tuberculin diagnostics should be planned up to carrying out preventive vaccinations against various infections.In the event that a prophylactic vaccination was performed, tuberculin diagnostics should be carried out no earlier than 1 month after vaccination.

    In order to identify contraindications, the doctor (nurse) on the day of tuberculin testing is interviewing the persons subjected to the trial.

    Dosing and Administration:

    The drug is used for setting the intradermal Mantoux test. Enter strictly intracutaneously.

    The Mantoux sample is put to patients only in the sitting position, as in emotionally labile individuals the injection may cause fainting.

    One-gram tuberculin syringes of one-time use with short thin needles are used to conduct the intradermal test.

    It is prohibited to use insulin syringes, as well as syringes and needles with expired use for Mantoux test.

    The Mantoux test is prescribed by a specially trained nurse who has a document - admission to tuberculin diagnostics.

    In case of production of the drug in PJSC "PHARMSTANDART-BIOLEC", Ukraine, in case of drug packaging at OJSC "Pharmstandard-UfaVITA", Russia indicate:

    The ampoule with the preparation is carefully wiped off with gauze moistened with 70 ° ethyl alcohol, then the ampoule neck is filed with a knife ampoule and broken off.The required amount of the drug (0.2 ml, i.e. 2 doses of tuberculin) is taken with a one-gram disposable syringe, which is performed with a Mantoux test, with a sterile extraction needle (long). Then a thin sterile needle for intradermal administration (short) is put on the syringe and a superfluous amount of the drug is discharged into a sterile cotton swab together with air bubbles to a mark of 0.1 ml. The ampoule after opening is allowed to be stored under aseptic conditions for no more than 2 hours.

    The skin of the middle third of the inner surface of the forearm is treated with 70° ethyl alcohol and dried with sterile cotton wool. A thin needle is cut upward into the upper layers of the skin parallel to its surface - intradermally. After insertion of the needle into the skin from the syringe, strictly enter the scale division of 0.1 ml (2 TE) of the drug, i.e. 1 dose. With the correct technique of administration, a white papule is formed in the skin in the form of a "lemon crust", measuring 7-10 mm in diameter.

    Or in the case of production of the drug at CJSC "LEKKO", Russia indicate:

    From the bottle remove the upper protective cover, opening access to the rubber stopper. Then the stopper, cap and bottle with the preparation are carefully wiped with gauze soaked in 70° ethyl alcohol.A rubber stopper is pierced with a one-gram disposable syringe, which Mantoux test is performed with a sterile extraction needle (long) and the required amount of the drug is taken (0.2 ml, ie 2 doses of tuberculin). Then a thin sterile needle for intradermal administration (short) is put on the syringe and a superfluous amount of the drug is discharged into a sterile cotton swab together with air bubbles to a mark of 0.1 ml.

    The skin of the middle third of the inner surface of the forearm is treated with 70° ethyl alcohol and dried with sterile cotton wool. A thin needle is cut upward into the upper layers of the skin parallel to its surface - intradermally. After insertion of the needle into the skin from the syringe, strictly enter the scale division of 0.1 ml (2 TE) of the drug, i.e. 1 dose. With the correct technique of administration, a white papule is formed in the skin in the form of a "lemon crust", measuring 7-10 mm in diameter.

    Form release / dosage:

    Solution for intradermal administration, 2 TE / dose.

    Packaging:

    In the case of production of the drug at PJSC "PHARMSTANDART-BIOLEC", Ukraine indicate:

    3 ml (30 doses, 2 TE in 0.1 ml) or 1 ml (10 doses, 2 TE in 0.1 ml), or 0.6 ml (6 doses, 2 TE per 0, 1 ml) in ampoules.

    10 ampoules of 3 ml or 1 ml each, or 0.6 ml are placed in a pack of cardboard.

    1 ampoule of 1 ml is placed in an individual intermediate pack.Five sterile packs, each containing a tuberculin syringe with a needle for extraction (long) and a thin needle for intradermal administration (short), are placed in a cardboard box. One individual intermediate pack with an ampoule of 1 ml and one pencil with syringes and needles is placed in a pack of cardboard.

    1 ampoule of 0.6 ml is placed in an individual intermediate pack of cardboard. For 3 sterile packs, each containing a tuberculin syringe with a needle for extraction (long) and a thin needle for intradermal administration (short), is placed in a cardboard box. One individual intermediate pack with an ampoule of 0.6 ml and one pencil with syringes and needles is placed in a pack of cardboard.

    In each pack is invested: instructions for use and a knife ampoule.

    When using ampoules with a colored break ring or a colored fracture point, the ampoule opener is not inserted.

    In the case of packaging of the drug on OA O "Pharmstandard-Ufa VITA", Russia indicate:

    3 ml (30 doses, 2 TE in 0.1 ml) or 1 ml (10 doses, 2 TE in 0.1 ml), or 0.6 ml (6 doses, 2 TE per 0, 1 ml) in ampoules.

    10 ampoules of 3 ml or 1 ml each, or 0.6 ml are placed in a pack of cardboard.

    5 ampoules of 3 ml or 1 ml each are placed in a contoured cell pack of a film coated with aluminum foil or without foil.

    2 contour squares are placed in a pack of cardboard.

    1 ampoule of 1 ml is placed in an individual intermediate pack. Five sterile packs, each containing a tuberculin syringe with a needle for extraction (long) and a thin needle for intradermal administration (short), are placed in a cardboard box. One individual intermediate pack with an ampoule of 1 ml and one pencil with syringes and needles is placed in a pack of cardboard.

    1 ampoule of 0.6 ml is placed in an individual intermediate pack of cardboard. For 3 sterile packs, each containing a tuberculin syringe with a needle for extraction (long) and a thin needle for intradermal administration (short), is placed in a cardboard box. One individual intermediate pack with an ampoule of 0.6 ml and one pencil with syringes and needles is placed in a pack of cardboard.

    In each pack is invested: instructions for use and a knife ampoule.

    When using ampoules with a colored break ring or a colored fracture point, the ampoule opener is not inserted.

    In the case of production of the drug at ZAO "JIEKKO", Russia indicates:

    1 ml (10 doses of 2 TE in 0.1 ml) in bottles of glass 1 of hydrolytic class, sealed with rubber stoppers,Caps with aluminum-plastic caps with the control of the first opening.

    Five vials are placed in a contour mesh package made of a film. 2 contour squares with bottles along with the instructions for use are placed in a pack of cardboard.

    1 bottle is placed in the contour mesh from the film. Five sterile packs, each containing a tuberculin syringe with a needle for extraction (long) and a thin needle for intradermal administration (short), are placed in a cardboard box. One contour mesh package with a bottle and one pencil case with syringes and needles are placed in a pack of cardboard.

    In each pack insert instruction for use.

    Storage conditions:

    Storage - in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Do not freeze. Keep out of the reach of children.

    Transportation - 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 18 ° C for 15 days. Do not freeze.

    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-007558/09
    Date of registration:28.09.2009 / 24.01.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:FARM STANDART, OJSC FARM STANDART, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspPHARMSTANDART JSC PHARMSTANDART JSC Russia
    Information update date: & nbsp05.04.2017
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