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Dosage form: & nbspintradermal solution
Composition:

Purified tuberculin in standard dilution is a filtrate of a mixture 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, dissolved in a stabilizing solvent.

1 dose (0.1 ml) of the preparation contains:

Name of components

amount

Active substance:

Allergen tuberculoprotein

2 tuberculin units (TE)

Excipients:

Sodium hydrophosphate dodecahydrate (sodium

phosphoric acid di-substituted 12-water)

0.783 mg

Sodium chloride (sodium chloride)

0.457 mg

Potassium dihydrogen phosphate (potassium)

phosphate monosubstituted)

0.063 mg

Polysorbate-80 (tween-80) (stabilizer)

0.005 mg

Phenol (preservative)

0.25 mg

Purified water

up to 0.1 ml

Description:

Colorless, clear liquid.

Pharmacotherapeutic group:MIBP is an allergen
ATX: & nbsp
  • Other allergens
  • Form release / dosage:A solution for intradermal administration, 2 TE / 0.1 mL.
    Packaging:

    In ampoules of 3 ml (30 doses), 2 ml (20 doses), 1 ml (10 doses), 0.6 ml (6 doses). 1 dose of the drug is 2 TE in 0.1 ml.

    1, 3, 5 or 10 ampoules in a contour acheive box in a cardboard box or a pack of cardboard with instructions for use and a scapegrator ampoule;

    10 ampoules in a cardboard box or a pack of cardboard with instructions for use and a scarifier ampoule;

    or kit: 1 ampoule per 0.6 ml (6 doses) or 1 ml (10 doses), 3 or 5 tuberculin syringes, respectively, instructions for use, the scapegrator ampoule in frame boxes or in a planar cell box in a cardboard box.

    As part of the contour cell package, a syringe box is allowed.

    When packing ampoules with notches, rings and fracture points, ampoule scalers do not invest.

    In a group container containing boxes or packs of 1 contour pack of 1.3 or 5 ampoules, syringes are allowed in the amount, corresponding to the number of production doses, that is, half the total number of doses in a group package.

    In a group container containing syringes with a device, preventing their repeated use, it is allowed to put instructions on the use of self-destructing syringes in an amount corresponding to the number of secondary (consumer) packages in a group container.

    Storage conditions:At a temperature of 2-8 ° C.
    Shelf life:2 years.
    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-002841/07
    Date of registration:21.09.2007 / 03.02.2015
    The owner of the registration certificate:St. Petersburg Research Institute of Vaccines and Serums and the enterprise for the production of bacterial preparations FSUE FMBASt. Petersburg Research Institute of Vaccines and Serums and the enterprise for the production of bacterial preparations FSUE FMBA
    Manufacturer: & nbsp
    Information update date: & nbsp30.03.2016
    Illustrated instructions
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