Tuberculosis allergen (tuberculin) solution for i / c injecting 2TE / 0.1ml ampoule 1ml + 5 syringes (Allerhen bacteria)

Release form

Intradermal solution

Packing

10 ampoules of 1 ml.

Pharmacological action

The active substance of the drug - an allergen-tuberculoprotein - causes an intradermal tuberculin test in infected or vaccinated BCG / BCG-M individuals with a specific delayed-type hypersensitivity reaction in the form of a local reaction - hyperemia and infiltrate (papule).

Contraindications

Common skin diseases, epilepsy, acute, chronic infectious and somatic diseases during the exacerbation of allergic conditions (rheumatism in the acute and subacute phases, bronchial asthma, idiosyncrasy with severe skin manifestations during the exacerbation). The Mantoux test is placed 1 month after the disappearance of all clinical symptoms or immediately after removal of the quarantine. Mantoux test is not allowed in those children's groups where there is a quarantine for childhood infections. Prophylactic vaccines can affect tuberculin sensitivity. Based on this, tuberculin diagnostics should be planned before carrying out preventive vaccinations against various infections. In the event that a preventive vaccination has been carried out, tuberculin diagnostics should be carried out no earlier than 1 month after vaccination.

In order to identify contraindications, the doctor (nurse) conducts a survey of exposed individuals on the day tuberculin samples are placed.

Composition

One dose (0.1 ml) of the preparation contains:

active substance - tuberculoprotein allergen - 2 TE (tuberculin units)

excipients - polysorbate - 80 (stabilizer) - 5 mcg, phenol (preservative) - 275 mcg, sodium hydrogen phosphate dodecahydrate - 783 μg, potassium dihydrogen phosphate - 63 μg, sodium chloride - 457 μg, water for injection - up to 0.1 ml.

Dosage and administration

The drug is used to produce the Mantoux intracutaneous test. Enter strictly intradermally. The Mantoux test is given to patients only in a sitting position, since in emotionally labile individuals, an injection can cause fainting. For intradermal tests, one-shot single-use tuberculin syringes with short thin needles are used.

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

The ampoule with the preparation is thoroughly wiped with gauze moistened with 70 В° ethanol, then the neck of the ampoule is filed with a knife to open the ampoules and broken off. The required amount of tuberculin (0.2 ml, ie 2 doses of tuberculin) is filled with a one-shot disposable syringe, which is used for the Mantoux test, with a sterile needle No. 845. Then a thin sterile needle is put on the syringe and an excess amount of tuberculin is released into a sterile cotton swab together with air bubbles to the mark of 0.1 ml. After opening, the ampoule can be stored under aseptic conditions for no more than 2 hours.

The skin area of ​​the middle third of the inner surface of the forearm is treated with 70 ° ethanol and dried with sterile cotton. A thin needle with a cut up is introduced into the upper layers of the skin parallel to its surface - intradermally. After the needle is inserted into the skin from the syringe, 0.1 ml (2 TE) of the drug is injected strictly according to the scale division, i.e. 1 dose. With the correct introduction technique, a whitish papule is formed in the skin in the form of a “lemon peel”, measuring 7-10 mm in diameter.

A Mantoux test is prescribed by the doctor’s appointment by a specially trained nurse who has a document - admission to tuberculin diagnostics.

Profitability Analysis.

The results of a tuberculin test are evaluated by a doctor or specially trained nurse. The Mantoux test result is evaluated after 72 hours by measuring the size of the infiltrate (papule) in mm. A transparent ruler with millimeter divisions measures and records the transverse (with respect to the axis of the forearm) infiltrate size. Hyperemia is considered only in the absence of infiltrate.

When making Mantoux tests, the reaction is considered:

negative - in the complete absence of infiltrate (papules) and hyperemia or in the presence of an injection prick (0-1 mm)

dubious - in case of an infiltrate of 2 - 4 mm or only hyperemia of any size without positive

infiltrate - if there is an infiltrate with a diameter of 5 mm or more

hyperergic - in children and adolescents a reaction with an infiltrate diameter of 17 mm or more is considered, in adults - 21 mm or more, and also in the presence of visiculonecrotic reactions, regardless of the size of the infiltrate with mfangoitom or without him.

The reaction to the administration of tuberculin is dependent on the level of specific reactivity of the body.

In individuals with a high degree of hypersensitivity. of a delayed type to tuberculin, local reactions may be accompanied by lymphangitis and lymphadenitis. In addition, sometimes a general reaction is observed: malaise, headache, fever.

For healthy individuals with a dubious or positive Mantoux test and children who are negative for tuberculin but not eligible for BCG vaccination, all preventive vaccinations can be given immediately after evaluating the Mantoux test.

Storage conditions for

at a temperature of 2 ° C to 8 ° C. Do not freeze. Keep out of the reach of children.

active substance

Allergens bacteria

Terms of delivery from

pharmacies Prescription

Formulation

injection solution

St. Peterʙurgskij epidemiological mikroʙiolo AIMS, Russia



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