Preparation Biolik Tuberculin PPD-L filtrate is heat killed mycobacterium tuberculosis culture of human and bovine type, purified by ultrafiltration or other techniques, precipitated with trichloroacetic acid, and treated with ethanol and ether anesthetic dissolved in a stabilizing solvent. The current drug substance – allergen tuberkuloprotein – causes the implementation intradermal skin test in infected or vaccinated organism specific delayed-type allergic reaction in the form of local reactions – redness and infiltration (papule).
0.1 ml of solution contains
active substance – allergen-tuberkuloprotein 2 TE,
excipients: Disodium phosphate dodecahydrate, potassium dihydrogen phosphate, sodium chloride, polysorbate 80, phenol, water for injections.
The preparation is intended for intradermal Mantoux tuberculin test:
contingent selection for revaccination with BCG
identification of tuberculosis infection (or a state of heightened sensitivity to tuberculin, which occurs if the post-vaccination allergy does not give grounds to speak about the infection) – diagnosis of tuberculosis
acute and chronic infectious diseases in exacerbation, including – convalescence (at least 2 months after the disappearance of clinical symptoms)
allergic conditions (rheumatism acute and subacute phase, bronchial asthma, idiosyncrasy with pronounced skin manifestations)
the presence of quarantine of infectious diseases in the children’s group
In some cases, patients with a high degree of allergy to tuberculin, local reactions, along with a large papules and erythema, may be accompanied by lymphangitis and lymphadenitis. In addition, sometimes observing the overall reaction: malaise, headache, fever
Often (> 1/100)
– pain, sensitivity to pain or discomfort at the injection site immediately after injection
Infrequently (< 1/100)
– headache, malaise
– Increase temperature
Rare (< 1/1000)
– anaphylactic reaction
– blistering and skin necrosis at the injection site due to hypersensitivity to tuberculin
How to accept, acceptance rate and dosage
The route of administration – intradermally (by Mantoux). Prior to the Mantoux test mandatory medical examination and conducting thermometry. Mantoux test is carried out strictly aseptically as follows: skin middle third of the inner surface of the forearm was treated with 70 ° ethanol and dried with sterile cotton. The vial with the drug carefully wiped with gauze soaked with ethyl alcohol 70 °, then the ampoule neck rasp lancet and break off. The required amount of tuberculin (0.2 ml) gaining a disposable 1 ml syringe with the scale division value of 0.1 ml with a sterile needle № 08h40. Then put on sterile syringe needle for intradermal application № 04h13, produce excess amounts of tuberculin and injected intradermally with 0.1 ml of the preparation. With proper injection technique infiltrate in the skin formed white diameter of approximately 8 mm – “lemon peel”. For each sample using a separate syringe and needle. After opening the ampoule is stored in aseptic conditions is not more than 2 hours. The size of the dose – 2 tuberculin units (TU) contained in 0.1 ml of the stabilizing solvent. Mantoux tuberculin skin test is performed by a doctor. Formulation and evaluation of Mantoux test performed by a doctor or specially trained nurse under the supervision of a physician.
Mantoux test results were evaluated after 72 hours. papules size measured using transparent millimeter ruler. Record the transverse (with respect to the hand axis) diameter papules. congestion zone is not taken into account. When the amount of papules from 0 to 1 mm in diameter is considered to be a negative reaction from 2 to 4 mm – questionable, and 5 mm and more – positive. Hyperergic considered reaction during the formation of papules 17 mm or more in children and adolescents, 21 mm or more in adults, as well as regardless of the size of the vesicles-papules presence of necrotic reaction, lymphangitis and regional lymphadenitis.
The sample is held in a sitting position. After the sample patient must be supervised by a doctor (nurse) for at least 30 minutes.
Store in a dark place at a temperature of from 2 ° C to 8 ° C. Freezing and heating above 18 ° C is not allowed.
Keep out of the reach of children!
Do not mix with other drugs in the same syringe.
Conducting diagnostic Mantoux test no earlier than 1 month after the disappearance of clinical symptoms of the diseases mentioned in the “Contra” quarantine or closure of an infectious disease in a group of children.
The interval between vaccination and prophylactic biological diagnostic Mantoux test should be not less than 1 month.
Vaccinations can be carried out after accounting Mantoux test – 72 hours.
In order to determine contraindications doctor (nurse) daily perform tuberculin tests carries out the survey and inspection of persons subject tuberkulindiagnostike. It is imperative to inform individuals undergoing diagnostic Mantoux test, their parents and guardians.
Pregnancy and lactation
Mantoux test can be performed during pregnancy and lactation.
Features of the drug effect on the ability to drive a vehicle or potentially dangerous machinery
Effect of the drug was not investigated for the ability to drive vehicles.
Do not use after the expiration date printed on the package.