Composition, form of production and packaging
The solution for intradermal administration is colorless, transparent.
1 dose (0.1 ml)
protein recombinant CFP10-ESAT6 * 0.2 Ојg
Excipients: sodium phosphate-disubstituted two-aqueous - 387.6 Ојg, sodium chloride - 460 Ојg, potassium phosphate monosubstituted - 63 Ојg, polysorbate 80 - 5 Ојg, phenol - 250 Ојg, water d / u - up to 0.1 ml.
3 ml (30 doses) - glass bottles (1) - packings of cellular contour (1) - packs of cardboard.
3 ml (30 doses) - bottles of glass (5) - packings of cellular contour (1) - packs of cardboard.
3 ml (30 doses) - glass bottles (5) - packings of cellular outline (2) - packs cardboard.
* Produced by genetically modified Escherichia coli BL21 (DE3) / pCFP-ESAT diluted in sterile isotonic phosphate buffer solution with a preservative (phenol) containing two CFP10 and ESAT6 antigens.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Allergen tuberculosis recombinant in standard dilution. It is a recombinant protein produced by the genetically modified Escherichia coli BL21 (DE3) / pCFP-ESAT culture. Contains 2 antigens present in virulent strains of mycobacterium tuberculosis and absent in the vaccine strain BCG.
The effect of Diaskintest В® is based on the detection of a cellular immune response to Mycobacterium tuberculosis specific antigens. When administered intradermally, Diaskintest В® causes a specific skin reaction in persons with tuberculosis infection, which is a manifestation of delayed type hypersensitivity.
It is intended for setting an intradermal test in all age groups with the aim:
- diagnosis of tuberculosis, evaluation of the activity of the process and identification of persons at high risk of developing active tuberculosis;
- differential diagnosis of tuberculosis;
- differential diagnosis of postvaccinal and infectious allergies (delayed-type hypersensitivity);
- evaluation of the effectiveness of anti-tuberculosis treatment in conjunction with other methods.
For individual and screening diagnosis of tuberculosis infection, the intradermal sample with Diaskintest В® is used by the doctor of the phthisiatrician or with its methodological support.
To identify (diagnose) a tuberculosis infection, the sample with the Diaskintest В® preparation is carried out:
- Persons sent to an anti-TB facility for additional examination for the presence of a tuberculosis process;
- Persons belonging to high-risk groups for tuberculosis, taking into account epidemiological, medical and social risk factors;
- to persons directed to the phthisiatrician by the results of mass tuberculin diagnostics.
For differential diagnosis of tuberculosis and other diseases, the sample with the Diaskintest В® preparation is performed in conjunction with a clinical laboratory and radiographic examination in an anti-tuberculosis setting.
To monitor patients registered with a phthisiatrician with various manifestations of tuberculosis infection in an anti-tuberculosis institution, an intradermal sample with Diaskintest В® is carried out during a follow-up examination in all groups of dispensary records at intervals of 3-6 months.
Due to the fact that the drug does not cause delayed-type hypersensitivity reaction associated with BCG vaccination, the sample with Diaskintest В® can not be used in place of the tuberculin test to select individuals for primary vaccination and BCG revaccination.
The sample is carried out 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. A syringe is collected 0.2 ml (two doses) of the Diaskintest В® preparation 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 processing the skin area on the inner surface of the middle third of the forearm with 70% ethyl alcohol, 0.1 ml of Diaskintest В® 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).
The result of the test is assessed by a doctor or a trained nurse after 72 hours from the moment of its measurement by measuring the transverse (in relation to the axis of the forearm) of the hyperemia and infiltrate (papule) in millimeters with a transparent ruler. Hyperemia is only considered if there is no infiltrate.
The response to the sample is considered:
negative - in the complete absence of infiltration and hyperemia or in the presence of "knock-off reaction" up to 2 mm;
doubtful - in the presence of hyperemia without infiltration;
positive - in the presence of infiltrate (papules) of any size.
Positive reactions to Diaskintest В® are conditionally different in degree of severity:
mild reaction - in the presence of an infiltrate up to 5 mm in size;
moderately expressed reaction - at a size of an infiltrate of 5-9 mm;
pronounced reaction - with infiltrate size 10-14 mm;
hyperergic reaction - with a size of infiltrate of 15 mm and more, with vesicle-necrotic changes and (or) lymphangitis, lymphadenitis, regardless of the size of the infiltrate.
Persons with a dubious and positive reaction to Diaskintest В® are examined for tuberculosis.
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 В® does not induce a delayed-type hypersensitivity reaction associated with vaccination with BCG.
The reaction to Diaskintest В® , as a rule, is absent:
- in persons not infected with Mycobacterium tuberculosis;
- in persons previously infected with Mycobacterium tuberculosis with inactive tuberculosis infection;
- in patients with tuberculosis during the completion of the involution of tuberculosis changes in the absence of clinical, X-ray tomographic, instrumental and laboratory signs of the activity of the process;
- in persons cured of tuberculosis.
At the same time, the sample with Diaskintest В® can be negative in patients with tuberculosis with severe immunopathological disorders due to severe tuberculosis, in people in the early stages of infection with Mycobacterium tuberculosis, in the early stages of the tuberculosis process in people with concomitant diseases accompanied by immunodeficiency.
In the registration documents note: a) the name of the drug; b) manufacturer, serial number, expiry date; c) the date of the sample; d) administration of the drug to the left or right forearm; e) the result of the sample.
The bottle with the drug after opening is allowed to store no more than 2 hours.
General reactions: in some cases, for a short time - malaise, headache, fever.
- acute and chronic (during an exacerbation) infectious diseases, except for cases of suspicion of tuberculosis;
- somatic and other diseases during the period of exacerbation;
- common skin diseases;
- Allergic conditions.
In children's groups, where there is a quarantine for childhood infections, the sample is conducted only after quarantining.
PREGNANCY AND LACTATION
Data on the use of Diaskintest В® during pregnancy and lactation (breastfeeding) are not provided.
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.
Data on the overdose of Diaskintest В® are not available.
The sample preparation with the Diaskintest В® preparation should be planned before carrying out preventive vaccinations. If preventive vaccinations are carried out, then the sample with Diaskintest В® is administered not earlier than 1 month after vaccination.
TERMS OF RELEASE FROM PHARMACY
For treatment and preventive and sanitary facilities.
TERMS AND CONDITIONS OF STORAGE
The preparation is transported and stored in accordance with JV 3.3.2. 1248-03 at a temperature of 2 В° to 8 В° C. Do not freeze. Shelf life - 2 years. The drug with expired shelf life is not subject to application.
The drug should be stored out of the reach of children.