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.
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, […]