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TUBERSOL is a brand name for Purified Protein Derivative Of Tuberculin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
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…
Verbatim from this product's HC label. Tap a section to expand.
1 mL of TUBERSOL®, comprising 5 tuberculin units (TU). 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. 4 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. 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.
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. , 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.
1 Adverse Reaction Overview Induration at the TUBERSOL® injection site is the expected reaction for a positive skin test. 4 Administration, Interpretation of Test Results, section). 5 Post-Market Adverse Reactions The information pertaining to Adverse Events has been compiled from historical clinical studies and post-marketing experience with TUBERSOL®.
General disorders and administration site conditions Injection site pain, injection site pruritus, injection site discomfort Injection site erythema or injection site rash (without induration) occurring within 12 hours of testing. These reactions do not indicate TB infection.
Injection site haemorrhage and injection site haematoma up to three days after the administration of the test have been seen. Injection site vesicles, injection site ulcer or injection site necrosis may appear at test site in highly sensitive persons.
Injection site scar as a result of strongly positive reactions. (See PATIENT MEDICATION INFORMATION , Reporting Side Effects for Vaccines).
General Do not inject intravenously or intramuscularly. Do not inject subcutaneously. If this occurs, the test cannot be interpreted. (See 4 DOSAGE AND ADMINISTRATION section). Proper use of the tuberculin skin test requires knowledge of the antigen used (tuberculin), the immunological basis for 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. Hypersensitivity 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. For instructions on the recognition and treatment of anaphylactic reactions, see current edition of the Canadian Immunization Guide or visit the Health Canada website.
Monitoring and Laboratory Tests Limitations in Predictive Value False Positive Tests In any population, the likelihood that a positive test represents a true infection is influenced by the prevalence of infection with M. tuberculosis.
TUBERSOL® should not be administered to: persons with known hypersensitivity to TUBERSOL® or to any components of the formulation or container. , 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Presence and size of necrosis and edema (if present) should also be recorded, although it is not used in the interpretation of the test. The significance of induration measurements in diagnosing latent TB infection must be considered in terms of the patient’s history and his risk of developing active TB disease as indicated in Table 1 : Sanofi Pasteur Product Monograph 299 – TUBERSOL TUBERSOL Tuberculin Purified Protein Derivative (Mantoux) Page 5 of 17 Table 1: Interpretation of Test Results, Size of Induration.
TST Reaction Size (mm induration) Setting in which reaction is considered significant (meaning probable TB infection). , patient is from a population with a high prevalence of TB infection, is a close contact of an active contagious case, or has an abnormal X- ray).
This reaction size is not normally considered significant, but in the presence of immune suppression may be important. 5-9 HIV infection Contact of active contagious case Children suspected of having tuberculosis disease Abnormal chest X-ray with fibronodular disease Other immune suppression: TNF-alpha inhibitors, chemotherapy ≥10 All others The possibility should be considered that skin test sensitivity may also be due to previous contact with atypical mycobacteria or previous BCG vaccination.
The Booster Effect and Two-step Testing If tuberculin testing will be conducted at regular intervals, for instance among healthcare or prison workers, two-step testing should be performed as a baseline to avoid interpreting a booster effect as a tuberculin conversion.
If the first test showed either no reaction or a small reaction, the second test should be performed one to four weeks later. Both tests should be read and recorded at 48 to 72 hours. Patients with a second tuberculin test (booster) response of 10 mm or more should be considered to have experienced past or old infection.
Persons who do not boost when given repeat tests at one week, but whose tuberculin reactions change to positive after one year, should be considered to have newly acquired M. tuberculosis infection and managed accordingly. Give the patient a permanent personal record.
In addition, it is essential that the health professional record the testing history in the permanent medical record of each patient. This permanent office record should contain the name of the product, date given, dose, manufacturer and lot number, as well as the test result in millimetres of duration (including 0 mm, if appropriate).
Reporting results only as negative or positive is not satisfactory. Sanofi Pasteur Product Monograph 299 – TUBERSOL® TUBERSOL (Tuberculin Purified Protein Derivative (Mantoux)) Page 6 of 17
False positive tuberculin reaction tests occur in individuals who have been infected with other mycobacteria, including vaccination with BCG. However, a diagnosis of M. tuberculosis infection and the use of preventative therapy should be considered for any BCG- vaccinated person who has a positive tuberculin skin-test reaction, especially if the person has been, or is at, increased risk of acquiring TB infection.
4 Administration, Interpretation of Test Results, section). Since tuberculin reactivity may not necessarily indicate the presence of active tuberculosis disease, persons showing a tuberculin reaction should be further evaluated with other diagnostic procedures.
Sanofi Pasteur Product Monograph 299 – TUBERSOL® TUBERSOL (Tuberculin Purified Protein Derivative (Mantoux)) Page 8 of 17 False Negative Tests Not all persons infected with M. tuberculosis will have a delayed hypersensitivity reaction to TUBERSOL®.
There is no age contraindication to tuberculin skin testing of infants. Many infants <6 months of age who are infected with M. tuberculosis do not react to tuberculin tests because their immune systems are immature. In the elderly and individuals who are being tested for the first time, reactions may develop slowly and may not peak until after 72 hours.
4 Administration, Interpretation of Test Results, section). Since tuberculin sensitivity may take up to 8 weeks to develop following exposure to M. 1 Mechanism of Action section), persons who have a negative tuberculin test immediately following possible exposure should be retested ≥8 weeks following the initial test.
Altered Immune Status Impaired or attenuated cell mediated immunity (CMI) may cause a false negative tuberculin reaction. , mumps, rubella, varicella and yellow fever vaccines), overwhelming tuberculosis, other bacterial infections, fungal infections, metabolic derangements, low protein states, diseases affecting lymphoid organs, immunosuppressive drugs, malignancy and stress.
Tuberculin skin testing should be deferred for patients with major viral infections or patients who have received attenuated live-virus vaccines in the past month. Persons with the common cold may be tuberculin tested. 1 Pregnant Women Animal reproduction studies have not been conducted with TUBERSOL®.
However, the Canadian Tuberculosis Standard indicates that women who are pregnant can receive a tuberculin skin test. No teratogenic effects of testing during pregnancy have been documented. The risk of unrecognized tuberculosis and close postpartum contact between a mother with active disease and an infant leaves the infant in grave danger of tuberculosis and complications such as tuberculosis meningitis.
Therefore, the prescribing physician should consider if the potential benefits outweigh the possible risks for performing the tuberculin test on a pregnant woman or a woman of childbearing age, particularly in certain “high risk populations” (see 13 PHARMACEUTICAL INFORMATION, Additional Relevant Information).
2 Breast-feeding It is not known whether TUBERSOL® is excreted in human milk. Caution must be exercised when TUBERSOL® is administered to a nursing mother. TUBERSOL® should be administered to nursing mothers only if clearly needed following an assessment of the risks and benefit.
3 Pediatrics Due to immature immune systems, […]