Tuberculin PPD-L Bioloc solution for subcutaneous injection 2TU/dose (2TU/0.1ml) 1ml (10 doses) ampoules, 10pcs

Composition

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of 0.1 ml of the solution contains

the Active ingredient-allergen-tuberculoprotein 2 TE,

excipients:

disodium phosphate dodecahydrate,

potassium dihydrogen phosphate,

sodium chloride,

polysorbate 80,

phenol,

water for injection.

Pharmacological action

The preparation BIOLEK Tuberculin PPD-L is a filtrate of a culture of human and bovine tuberculosis mycobacteria killed by heating, purified by ultrafiltration or other methods, precipitated with trichloroacetic acid, treated with ethyl alcohol and anesthesia ether and dissolved in a stabilizing solvent. The Active ingredient of the drug – allergen-tuberculoprotein-causes a specific allergic reaction of a delayed type in the form of a local reaction – hyperemia and infiltration (papules) when performing an intradermal tuberculin test in an infected or vaccinated organism.

Indications

The drug is intended for intradermal tuberculin Mantoux test:

• selection of a contingent for BCG revaccination

• determination of the population’s infection with tuberculosis (or a state of hypersensitivity to tuberculin, if the existing post-vaccination allergy does not give grounds to talk about infection) – diagnosis of tuberculosis

Contraindications

• Skin diseases

• acute and chronic infectious diseases in the period of exacerbation, including convalescence (at least 2 months after the disappearance of clinical symptoms)

• allergic conditions (rheumatism in acute and subacute phases, bronchial asthma, idiosyncrasies with pronounced skin manifestations)

• epilepsy

• the presence of quarantine for an infectious disease in a children’s group

Side effects

In some cases, people with a high degree of allergy to tuberculin, local reactions, along with a large papule and hyperemia, can be accompanied by lymphangoitis and lymphadenitis. In addition, sometimes there is a general reaction: malaise, headaches, fever. Often (>1/100) – pain, pain sensitivity, or discomfort at the injection site immediately after injectionhaste (><1/100) – Headache, malaise – fever Occasionally (<1/1000)- anaphylactic reaction-blistering and skin necrosis at the injection site due to hypersensitivity to tuberculin

Interaction

Do not mix with other medications in the same syringe.

How to take, course of use and dosage

The method of use is intradermal (according to Mantoux). Before conducting a Mantoux test, a doctor’s examination and thermometry are required. 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° ethyl alcohol and dried with sterile cotton wool. The ampoule with the drug is thoroughly wiped with gauze moistened with 70° ethyl alcohol, then the neck of the ampoule is filed with a scarifier and broken off.

The required amount of tuberculin (0.2 ml) is collected with a disposable syringe with a capacity 1 ml with a scale division price of 0.1 ml with a sterile needle No. 08 x 40. Then a sterile needle for intradermal application No. 04 x 13 is put on the syringe, an excess amount of tuberculin is released and 0.1 ml of the drug is injected intradermally. With the correct injection technique, a white infiltrate with a diameter of approximately 8 mm is formed in the skin – a “lemon crust”. A separate syringe and needle are used for each subject. The ampoule after opening is kept in aseptic conditions for no longer than 2 hours. The dose size is 2 tuberculin units (TE) contained in 0.1 ml of a stabilizing solvent. The Mantoux tuberculin test is performed as prescribed by a doctor. The Mantoux test is performed and evaluated by a doctor or a specially trained nurse under the supervision of a doctor.

The results of the Mantoux test are evaluated after 72 hours. The size of the papule is measured using a transparent millimeter ruler. The transverse (relative to the arm axis) diameter of the papule is recorded. The area of hyperemia is not taken into account. When the size of the papule 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. Hyperergic reaction is considered to be a reaction with the formation of a papule of 17 mm or more in children and adolescents,21 mm or more in adults, as well as the presence of a vesiculonecrotic reaction, lymphangitis and regional lymphadenitis, regardless of the size of the papule.

The test is performed in a sitting position. After the test, the patient should be under the supervision of a doctor (nurse) for at least 30 minutes.

Overdose

Not described

Special instructions

Conducting a diagnostic Mantoux test no earlier than 1 month after the disappearance of clinical symptoms of diseases indicated in the section “Contraindications” or the end of quarantine for an infectious disease in a children’s group.

The interval between preventive vaccination and biological diagnostic Mantoux test should be at least 1 month.

Routine vaccinations can be carried out after taking into account the Mantoux test-in 72 hours.

In order to determine contraindications, the doctor (nurse) on the day of performing tuberculin tests conducts a survey and examination of persons subject to tuberculin diagnostics. It is mandatory to inform the persons who are undergoing a diagnostic Mantoux test, their parents and guardians.

Pregnancy and lactation

The Mantoux test can be performed during pregnancy and lactation.

Features of the drug’s effect 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 studied.

Form of production

Solution for intradermal use

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 reach of children!

Shelf life

1 year

Do not use after the expiration date indicated on the package.

Active ingredient

Allergens of bacteria

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection