Allergen bacteria tuberkulezn y recombinant | Diaskintest solution for p / leather. enter 0.1 ml / dose 30 doses 3 ml bottle 1 pc. pack

Release form

Intradermal solution

Packing

Bottle 3 ml (30 doses)

Pharmacological action

Recombinant tuberculous allergen in standard dilution. It is a recombinant protein produced by a genetically modified culture of Escherichia coli BL21 (DE3) / pCFP-ESAT. Contains 2 antigens present in virulent strains of Mycobacterium tuberculosis and absent in the BCG vaccine strain.

The action of Diaskintest is based on the detection of a cellular immune response to antigens specific to Mycobacterium tuberculosis. With intradermal administration, Diaskintest causes a specific skin reaction in people with tuberculosis infection, which is a manifestation of delayed-type hypersensitivity.

Indications

Diaskintest is intended for intracutaneous testing in all age groups with the aim of:

diagnosis of tuberculosis, assessing the activity of the process and identifying individuals at high risk of developing active tuberculosis

differential diagnosis of tuberculosis

differential diagnosis of post-vaccination and infectious allergies (delayed-type hypersensitivity)

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

and other diseases during the exacerbation of

common skin diseases

allergic conditions

epilepsy.

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

Special instructions

For healthy individuals with a negative test result, preventive vaccinations (except BCG) can be given immediately after evaluating and recording the test result.

Composition

one dose (0.1 ml) of the preparation contains:

recombinant protein CFP10-ESAT6 - 0.2 Ојg,

sodium phosphate disubstituted 2-water - 0.3876 mg,

sodium chloride - 0.46 mg,

monosubstituted potassium phosphate - 0.063 mg,

polysorbate 80 - 0.005 mg,

phenol - 0.25 mg,

water for injection - up to 0.1 ml.

Dosage and administration of

The test is performed as prescribed by a doctor for children, adolescents and adults by a specially trained nurse who is approved for intradermal tests. The drug is administered strictly intradermally. For the test, tuberculin syringes and thin short needles with an oblique cut are used. Before use, it is necessary to check the date of their release and expiration date.

The bottle with the drug after opening can be stored for no more than 2 hours. Using a syringe, 0.2 ml (two doses) of Diaskintest is drawn and the solution is released to the 0.1 ml mark in a sterile cotton swab.

The test is performed by the subject in a 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 introduced into the upper layers of the stretched skin parallel to its surface.

When staging a sample, as a rule, a papule is formed in the skin in the form of a Ԭemon peelԠmeasuring 7ֱ0 mm in diameter with a whitish color.

For individuals who have a history of nonspecific allergies, it is recommended that the test be taken with desensitizing drugs for 7 days (5 days before the test and 2 days after it).

Recording of results

The result of the sample is evaluated by a doctor or trained nurse after 72 hours from the moment of its measurement by measuring the transverse (with respect to the axis of the forearm) size of hyperemia and infiltrate (papule) in millimeters with a transparent ruler. Hyperemia is considered only in the absence of infiltrate.

The response to the sample is considered:

negative - in the complete absence of infiltrate and hyperemia or in the presence of an ԩnjection reactionԠup to 2 mm

dubious - in the presence of hyperemia without infiltrate

positive - in the presence of an infiltrate (papule) of any size.

Positive reactions to DIASKINTEST conditionally vary in severity:

mild reaction - in the presence of an infiltrate of up to 5 mm

moderate reaction - with an infiltrate of 5ֹ mm

pronounced reaction - with an infiltrate of 10ֱ4 mm

hyperergic reaction - with an infiltrate size of 15 mm or more, with vesicle-necrotic changes and (or) lymphangitis, lymphadenitis, regardless of the size of the infiltrate.

Persons with doubtful and by

The response to the sample is considered:

negative - in the complete absence of infiltrate and hyperemia or in the presence of an ԩnjection reactionԠup to 2 mm

dubious - in the presence of hyperemia without infiltrate

positive - in the presence of an infiltrate (papule) of any size.

Positive reactions to DIASKINTEST conditionally vary in severity:

mild reaction - in the presence of an infiltrate of up to 5 mm

moderate reaction - with an infiltrate of 5ֹ mm

pronounced reaction - with an infiltrate of 10ֱ4 mm

hyperergic reaction - with an infiltrate size of 15 mm or more, with vesicle-necrotic changes and (or) lymphangitis, lymphadenitis, regardless of the size of the infiltrate.

Persons with doubtful and by

The response to the sample is considered:

negative - in the complete absence of infiltrate and hyperemia or in the presence of an ԩnjection reactionԠup to 2 mm

dubious - in the presence of hyperemia without infiltrate

positive - in the presence of an infiltrate (papule) of any size.

Positive reactions to DIASKINTEST conditionally vary in severity:

mild reaction - in the presence of an infiltrate of up to 5 mm

moderate reaction - with an infiltrate of 5ֹ mm

pronounced reaction - with an infiltrate of 10ֱ4 mm

hyperergic reaction - with an infiltrate size of 15 mm or more, with vesicle-necrotic changes and (or) lymphangitis, lymphadenitis, regardless of the size of the infiltrate.

Persons with doubtful and by

negative - in the complete absence of infiltrate and hyperemia or in the presence of an ԩnjection reactionԠup to 2 mm

dubious - in the presence of hyperemia without infiltrate

positive - in the presence of an infiltrate (papule) of any size.

Positive reactions to DIASKINTEST conditionally vary in severity:

mild reaction - in the presence of an infiltrate of up to 5 mm

moderate reaction - with an infiltrate of 5ֹ mm

pronounced reaction - with an infiltrate of 10ֱ4 mm

hyperergic reaction - with an infiltrate size of 15 mm or more, with vesicle-necrotic changes and (or) lymphangitis, lymphadenitis, regardless of the size of the infiltrate.

Persons with doubtful and by

negative - in the complete absence of infiltrate and hyperemia or in the presence of an ԩnjection reactionԠup to 2 mm

dubious - in the presence of hyperemia without infiltrate

positive - in the presence of an infiltrate (papule) of any size.

Positive reactions to DIASKINTEST conditionally vary in severity:

mild reaction - in the presence of an infiltrate of up to 5 mm

moderate reaction - with an infiltrate of 5ֹ mm

pronounced reaction - with an infiltrate of 10ֱ4 mm

hyperergic reaction - with an infiltrate size of 15 mm or more, with vesicle-necrotic changes and (or) lymphangitis, lymphadenitis, regardless of the size of the infiltrate.

Persons with doubtful and by

mild reaction - with an infiltrate of up to 5 mm in size

moderate reaction - with an infiltrate of 5ֹ mm

pronounced reaction - with an infiltrate of 10-14 mm

hyperergic reaction - with an infiltrate of 15 mm or more, with vesicle necrotic changes and (or) lymphangitis, lymphadenitis, regardless of the size of the infiltrate.

Persons with doubtful and by

mild reaction - with an infiltrate of up to 5 mm in size

moderate reaction - with an infiltrate of 5ֹ mm

pronounced reaction - with an infiltrate of 10-14 mm

hyperergic reaction - with an infiltrate of 15 mm or more, with vesicle necrotic changes and (or) lymphangitis, lymphadenitis, regardless of the size of the infiltrate.

Persons with doubtful and bya positive reaction to DIASKINTEST are examined for tuberculosis.

In contrast to the delayed-type hypersensitivity reaction, skin manifestations of a nonspecific allergy (mainly hyperemia) to the drug, as a rule, are observed immediately after the sample is placed and usually disappear after 48ַ2 hours.

Diaskintest does not cause delayed-type hypersensitivity reactions associated with BCG vaccination.

There is usually no response to Diaskintest:

in individuals not infected with Mycobacterium tuberculosis

in individuals previously infected with Mycobacterium tuberculosis with inactive tuberculosis

infection in patients with tuberculosis during the completion of the involution of tuberculous changes with no clinical, radiographic, activity of the

process in individuals cured of tuberculosis.

Side effects

Short-term signs of a general reaction may occur in individuals: malaise, headache, fever.

Drug interaction

For healthy individuals with a negative test result, preventive vaccinations (except for BCG) can be performed immediately after evaluating and taking into account the result of the sample.

A sample test with Diaskintest should be planned before prophylactic vaccinations. If preventive vaccinations are carried out, then the test with Diaskintest is carried out no earlier than 1 month after vaccination.

Storage conditions

The drug is transported and stored in accordance with SP 3.3.2.1248-03 at a temperature of 2 РC to 8 РC.

Do not freeze. Keep out of the reach of children.

Expiration

2 years.

Deystvuyuschee substances

Allergen bacteria tuberkulezn y recombinant

Conditions of supply of pharmacies

Prescription

Form of Treatment

simply entails dlya inaektsiy

Generium, Russia