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Dosage form: & nbspRA mortar for intradermal administration.
Composition:

One dose (0.1 ml) of the preparation contains: recombinant protein CFP10-ESAT6 - 0,2 mkg, sodium phosphate disubstituted 2-water, sodium chloride, potassium phosphate monosubstituted, polysorbate 80, phenol, water for injection - up to 0.1 ml.

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

    Diaskintest® The allergen tuberculous recombinant in standard dilution is a recombinant protein produced by a genetically modified culture Escherichia coli BL21 (DE3)/pCFP-ESAT, diluted in a sterile isotonic phosphate buffer solution, with a preservative (phenol). Contains two antigens present in virulent strains of mycobacterium tuberculosis and absent in the vaccine strain BCG.

    Immunological properties

    The action of Diaskintest® is based on the identification of the cellular immune response to specific Mycobacterium tuberculosis antigens. When administered intradermally, Diaskintest® causes a specific skin reaction in persons with tuberculosis infection, which is a manifestation of delayed-type hypersensitivity.

    Indications:

    Diaskintest® is intended for setting an intradermal test in all age groups for the purpose of individual and mass diagnosis of tuberculosis infection, which includes:

    - diagnosis of tuberculosis in persons belonging to high-risk groups for tuberculosis, in combination with other methods;

    - identification of persons with a high risk of developing active tuberculosis (latent tuberculosis infection) *;

    - differential diagnosis of postvaccinal (BCG) and infectious allergies (delayed-type hypersensitivity);

    - evaluation of the effectiveness of anti-tuberculosis treatment in combination with other methods.

    Due to the fact that the preparation does not cause delayed-type hypersensitivity reaction associated with BCG vaccination, the sample with Diaskintest® preparation can not be used to select persons for vaccination and revaccination of BCG (BCG-M), but its the results must be taken into account when deciding whether to conduct immunization against tuberculosis.

    For differential diagnosis of tuberculosis, the sample with the Diaskintest® preparation is performed in conjunction with a clinical laboratory and radiographic examination. To monitor patients registered with a phthisiatrician with various manifestations of tuberculosis infection, in an anti-tuberculosis setting, an intradermal sample with Diaskintest® is carried out during a follow-up examination in all groups of dispensary records at intervals of 3-6 months.

    *) Latent tuberculosis infection - a state of persistent immune response to antigens of mycobacterium tuberculosis (Mycobacterium tuberculosis), in the absence of clinical manifestations of the active form of tuberculosis.

    Contraindications:

    - Acute and chronic (during an exacerbation) infectious diseases except for cases of suspicion of tuberculosis;

    - somatic and other diseases in the period of exacerbation;

    - common skin diseases;

    - allergic conditions;

    - epilepsy.

    In children's groups, where there is a quarantine for childhood infections, the sample is conducted only after the removal of quarantine.

    Pregnancy and lactation:

    The effect of the drug on women during pregnancy and lactation has not been studied, and the effect on the fetus and reproductive function is also unknown. The skin test of Diaskintest® in the comprehensive diagnosis of tuberculosis in pregnant women can only be used if the intended benefit to the mother exceeds the potential risk to the fetus.

    Data on the drug in the milk of women with lactation are absent.

    Dosing and Administration:

    The sample is performed according to the prescription of the doctor to children, adolescents and adults by a specially trained nurse who has the admission to conduct intradermal tests. The drug is administered strictly intracutaneously.To carry out the test, use tuberculin syringes and thin short needles with an oblique cut. Before use it is necessary to check the date of their release and the expiration date.

    The bottle can not be stored for more than 2 hours after opening. A syringe is collected 0.2 ml (two doses) of Diaskintest ® and the solution is discharged to a label of 0.1 ml in a sterile cotton swab.

    The sample is carried out by the subject in the sitting position. After treating the skin area on the inner surface of the middle third of the forearm with 70% ethyl alcohol, 0.1 ml of Diaskintest® is injected into the upper layers of the stretched skin parallel to its surface. When setting the sample, as a rule, a papule is formed in the skin in the form of a "lemon crust" 7-10 mm in diameter, whitish in color.

    Persons who have had a history of nonspecific allergy should be tested against desensitizing drugs within 7 days (5 days before and 2 days after the test).

    Profitability Analysis

    The result of the test is assessed by a doctor or a trained nurse after 72 hours from her setting, by measuring the transverse (relative to the forearm axis) transverse (in relation to the forearm axis) hypermia and infiltrate (papules), in mm. Hyperemia is only considered if there is no infiltrate.

    The criteria for evaluating the response to the Diaskintest® sample are as follows:

    Reaction Category

    Criteria for evaluation

    Negative

    Complete absence of infiltration and hyperemia or presence of a "knock-off reaction" up to 2 mm.

    Doubtful

    Presence of hyperemia without infiltration.

    Positive

    The presence of infiltrate (papules) of any size.

    Slightly expressed

    Infiltrate size is up to 5 mm.

    Moderately

    expressed

    The size of the infiltration is from 5 to 9 mm.

    Expressive

    The size of the infiltration is from 10 to 14 mm.

    Hyperergic

    The size of the infiltrate is 15 mm or more; vesiculonecal changes; and (or) lymphangitis, lymphadenitis, regardless of the size of the infiltrate.

    In contrast to the delayed-type hypersensitivity reaction, skin manifestations of nonspecific allergy (mainly hyperemia) to the drug are usually observed immediately after the sample is placed and usually disappear after 48-72 h. Diaskintest® does not cause delayed-type hypersensitivity reactions associated with BCG vaccination.

    Persons with a dubious and positive reaction to Diaskintest® are subject to a comprehensive examination for tuberculosis.

    Not all infected individuals develop delayed-type hypersensitivity for the Diaskintest® trial.There are factors that reduce this reaction, such as: HIV, active tuberculosis with severe immunopathological disorders caused by the severe course of the process; concomitant diseases accompanied by immunodeficiency.

    In the registration documents for the registration of the results of the sample indicate: a) the name of the drug; b) manufacturer, serial number, expiry date; c) date of sampling; d) place of injection (left or right forearm); e) the result of the sample.

    Side effects:

    Individuals may have short-term signs of a general reaction: malaise, headache, fever.

    Interaction:

    Healthy individuals with a negative sample result preventive vaccinations (except BCG) can be carried out immediately after evaluation and taking into account the result of the sample. The sample preparation with the Diaskintest® preparation should be planned before carrying out preventive vaccinations. If prophylactic vaccinations are carried out, the sample with Diaskintest ® is carried out not earlier than 1 month after vaccination.

    Special instructions:

    The drug is used intracutaneously in a minimal dose and practically does not enter the systemic bloodstream.Therefore, the features of use in patients with violations of the liver and kidneys are absent.

    There are no age limits for the use of Diaskintest®.

    Effect on the ability to drive transp. cf. and fur:

    There are no data on the adverse effect of the drug on the ability to drive vehicles and work with mechanisms.

    Form release / dosage:

    RA mortar for intradermal administration, 0.1 ml / dose.

    Packaging:

    1.2 ml (12 doses) or 3 ml (30 doses) in glass bottles, corked with rubber stoppers with aluminum-plastic caps with the control of the first opening.

    1 bottle in a contour acrylic packing from a film of polyvinylchloride or polyethylene terephthalate.

    1 a contoured cell pack together with a medical instruction is put in a pack of cardboard.

    Storage conditions:

    Transportation and storage conditions

    In the "cold chain" conditions in accordance with the requirements of SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Do not freeze. Transportation is allowed at a temperature of no higher than 15 ° C - no more than 7 days.

    Allowed once storage at a temperature of no higher than 15 ° C - no more than 15 days or no more than 25 ° C - no more than 7 days.Keep out of the reach of children.

    Shelf life:

    2 of the year.

    Do not use after the expiry date printed on the package!

    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-006435/08
    Date of registration:11.08.2008 / 29.04.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:GENERIUM, CJSC GENERIUM, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp03.11.2016
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