TUBERSOL 5 TUB / 0.1 ML — DIN 00317268

What is TUBERSOL?

TUBERSOL 5 TUB / 0.1 ML contains PURIFIED PROTEIN DERIVATIVE OF TUBERCULIN : 5 TUB / 0.1 ML. It is listed in the Health Canada Drug Product Database under DIN 00317268, held by SANOFI PASTEUR LIMITED, supplied as SOLUTION for INTRADERMAL administration. Health Canada currently lists it as marketed, status dated 10-Nov-2006. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is TUBERSOL used for?

TUBERSOL [Tuberculin Purified Protein Derivative (Mantoux)] is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease. There are three general situations where risk of disease is increased: • Recent infection – most commonly contacts of a recently diagnosed patient with active contagious pulmonary TB, or immigrants within five years of their arrival in Canada from countries where TB is still common. • Increased risk of reactivation due to impaired immunity. This includes Human Immunodeficiency Virus (HIV) infection, diabetes, renal failure, corticosteroids or other immuno-suppressant medication and pulmonary silicosis. • Radiographic evidence of old healed inactive TB but no prior treatment. Previous BCG vaccination is not a contraindication to tuberculin testing. TUBERSOL may be used as an aid in the diagnosis of tuberculosis infection in persons with a history of BCG vaccination.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

The recommended dosage per test is 0.1 mL of TUBERSOL, comprising 5 tuberculin units (TU). The Mantoux test is performed by injecting 0.1 mL (5 Tuberculin units per test dose) of TUBERSOL® intradermally, in the volar aspect of the forearm. TUBERSOL® is a clear colourless liquid. Inspect for extraneous particulate matter and/or discolouration before use. If these conditions exist, the product should not be administered. Administration: 1. The preferred site of the test is the volar aspect of the forearm. Avoid areas on the skin that are red or swollen. Avoid visible veins. 2. The skin site is first cleansed with a suitable germicide and should be dry prior to injection of the antigen. 3. The test dose (0.1 mL) of TUBERSOL® is administered with a 1 mL syringe calibrated in tenths and fitted with a short, one quarter to one half inch, 26 or 27 gauge needle. 4. The stopper of the vial should be wiped with a suitable germicide and should be dry before needle insertion. The needle is then inserted gently through the stopper and 0.1 mL of TUBERSOL® is drawn into the syringe. Care should be taken to avoid injection of excess air with removal of each dose so as not to over pressurize the vial thus causing possible seepage at the puncture site. 5. The point of the needle is inserted into the most superficial layers of the skin with the needle bevel pointing upward and the dose administered by slow intradermal injection. If the intradermal injection is performed properly, a definite pale bleb will rise at the needle point, about 10 mm (3/8") in diameter. This bleb will disperse within minutes. No dressing is required. 6. A drop of blood may appear at the administration site following injection. Blot the site lightly to remove the blood but avoid squeezing out the tuberculin. In the event of an improperly performed injection (i.e., no bleb formed), the test should be repeated immediately at another site, at least 5 cm (2 inches) from the first site and the second injection site circled as an indication of the site to be read. Inform the patient of the need to return for the reading of the test by a trained health professional. Self-reading is inaccurate and strongly discouraged. Interpretation of the Test: The skin test should be read by a trained health professional 48 to 72 hours after administration of TUBERSOL. Skin test sensitivity is indicated by induration only; redness should not be measured. The diameter of the induration should be measured transversely to the long axis of the forearm and recorded in millimetres (including 0 mm). The tip of a ballpoint pen pushed at a 45° angle toward the site of injection will stop at the edge of induration. Presence and size of necrosis and edema (if present) should also be recorded, although it is not used in the interpretation of the test.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

TUBERSOL should not be administered to: • persons with known hypersensitivity to TUBERSOL® or to any components of the formulation or container. • persons who have had a severe reaction (e.g., necrosis, blistering, anaphylactic shock or ulcerations) to a previous tuberculin skin test, • persons with documented active tuberculosis or a clear history of treatment for TB infection or disease, and • persons with extensive burns or eczema because of greater likelihood of adverse reactions or severe reactions.

Warnings and precautions

Do not inject intravenously or intramuscularly. Do not inject subcutaneously. If this occurs, the test cannot be interpreted. Proper use of the tuberculin skin test requires knowledge of the antigen used (tuberculin), the immunological basis of the reaction to this antigen, the technique(s) of administering and reading the test, and the results of epidemiologic and clinical experience with the test. Before administration, take all appropriate precautions to prevent adverse reactions. This includes a review of the patient's history concerning possible hypersensitivity to the product or similar products, previous testing history with TUBERSOL, the presence of any contraindications to the use of TUBERSOL, and the patient's current health status. Use a separate, sterile needle and syringe, or a sterile disposable unit, for each individual recipient, to prevent disease transmission. Acute allergic reactions, including anaphylaxis, angioedema, urticaria and/or dyspnea, have been very rarely reported following skin testing with TUBERSOL®. Allergic reactions may occur following the use of TUBERSOL® even in persons with no prior history of hypersensitivity to the product components. As with all other products, Epinephrine Hydrochloride Solution (1:1,000) and other appropriate agents should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Healthcare providers should be familiar with current recommendations for the initial management of anaphylaxis in non-hospital settings, including proper airway management.