Description
Dosage form
Solution for intradermal administration
Pharmacological action
BIOLEC Tuberculin PPD-L is a filtrate of a heat-killed human and bovine tuberculosis tuberculosis culture, purified by ultrafiltration or other methods, precipitated with trichloroacetic acid, treated with ethyl alcohol and an anesthetic solvent. The active substance of the drug – an allergen-tuberculoprotein – causes, during an intradermal tuberculin test in an infected or vaccinated organism, a specific delayed allergic reaction in the form of a local reaction – hyperemia and infiltrate (papules).
Indications
The drug is intended for intracutaneous tuberculin test Mantoux:
selection of contingent for BCG revaccination
determination of infection of the population with tuberculosis (or a state of hypersensitivity to tuberculin, if the post-vaccination allergy does not warrant infection) – diagnosis of tuberculosis
Special instructions
Conducting a Mantoux diagnostic test no earlier than 1 month after the disappearance of the clinical symptoms of the diseases indicated in the ² ÑContraindications ² Ñ section or the end of the infectious disease quarantine in the children ² ¢s team.
The interval between preventive vaccination and biological diagnostic Mantoux test should be at least 1 month.
Routine vaccinations can be done after taking the Mantoux test – after 72 hours.
In order to determine contraindications, the doctor (nurse) on the day of performing tuberculin tests carries out a survey and examination of persons subject to tuberculin diagnostics. Mandatory information is required for persons who undergo a diagnostic test of Mantoux, their parents and guardians.
Pregnancy and lactation
Mantoux test can be performed during pregnancy and lactation.
Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms
The effect of the drug on the ability to drive vehicles has not been investigated.
Composition of
0.1 ml of the solution contains
active substance – allergen-tuberculoprotein 2 TE,
excipients: disodium phosphate dodecahydrate, potassium dihydrogen phosphate, sodium chloride, polysorbate 80, phenol, water for injection.
Dosage and Administration
Dosage and Administration – intradermal (Mantoux). Before conducting a Mantoux test, a mandatory medical examination and thermometry. The Mantoux test is carried out strictly aseptically in this way: the skin of the middle third of the inner surface of the forearm is treated with 70 ° ethanol and dried with sterile cotton wool. The ampoule with the preparation is thoroughly wiped with gauze moistened with 70 ° ethanol, then the neck of the ampoule is filed with a scarifier and broken off. The required amount of tuberculin (0.2 ml) is taken up with a 1 ml disposable syringe with a graduation scale of 0.1 ml with a sterile needle No. 08×40. Then put on a syringe a sterile needle for intradermal application No. 04×13, excess tuberculin is released and 0.1 ml of the drug is injected intradermally. With the correct technique of administration, an infiltrate is formed in the skinwhite with a diameter of approximately 8 mm – “lemon peel”. A separate syringe and needle are used for each subject. After opening, the ampoule is kept under aseptic conditions for no longer than 2 hours. Dose size – 2 tuberculin units (TE) contained in 0.1 ml of stabilizing solvent. Mantoux tuberculin test is carried out as prescribed by the doctor. The formulation and evaluation of the Mantoux test is carried out by a doctor or specially trained nurse under the supervision of a doctor.
Mantoux test results are evaluated after 72 hours. The size of the papule is measured using a transparent millimeter ruler. The transverse (relative to the axis of the arm) diameter of the papule is recorded. The hyperemia zone is not taken into account. If the papule size is from 0 to 1 mm in diameter, the reaction is considered negative, from 2 to 4 mm – doubtful, and from 5 mm or more – positive. A reaction is considered hyperergic with the formation of a papule of 17 mm or more in children and adolescents, 21 mm or more in adults, and regardless of the size of the papule, the presence of a vesicle-necrotic reaction, lymphangitis and regional lymphadenitis.
The test is carried out in a sitting position. After the test, the patient should be under the supervision of a doctor (nurse) for at least 30 minutes.
Side effects of
In some cases, in individuals with a high degree of tuberculin allergy, local reactions, along with large papule and hyperemia, may be accompanied by lymphangitis and lymphadenitis. In addition, sometimes a general reaction is observed: malaise, headaches, fever.
Often (> 1/100)
– pain, pain sensitivity or discomfort at the injection site immediately after
injection Infrequently (<1/100) – headache, malaise fever Rarely (<1/1000) anaphylactic reaction – the formation of vesicles and skin necrosis at the injection site due to hypersensitivity to tuberculin Drug Interactions Do not mix with other medicines in the same syringe. Overdose of Not described Storage conditions Store in a dark place at a temperature of 2 ° C to 8 ° C. Freezing and heating above 18 ° C is not allowed. Keep out of the reach of children! Expiration 1 year Do not use after the expiry date stated on the packaging. Deystvuyuschee substances Allerhen bacteria pharmacy terms for prescription Le drug form solution for injection
