Revision Year: 2013 Publisher: BB-NCIPD Ltd., 1504 Sofia, 26 Yanko Sakazov Blvd., Tel.: **359 2 9446 191, Fax: 359-2-9433455, e-mail: bulbio@bulbio.com
Known hypersensitivity to the active substance or to any of the excipients.
Effective use of tuberculin testing requires an understanding of the characteristics inherent to the test and extrinsic factors relating that have influence on interpretation of the results. The utility of the tuberculin test depends:
A separate, sterile syringe and needle, or a sterile disposable unit, must be used for each patient to prevent the transmission of infectious agents from one person to another.
Needless should be recapped and should be disposed of according to applicable biohazard waste guidelines.
Special care should be taken to ensure the product is given intradermally and on the dorsal or volar aspect of the forearm.
Needles should not be recapped and should be disposed of according to applicable biohazard waste guidelines.
Do not inject intravenously or intramuscularly.
Do not inject subcutaneously. If this occurs, the test cannot be interpreted.
Tuberculin PPD has not been evaluated for its carcinogenic or mutagenic potentials or impairment of fertility (26; 31).
The product should not be used for extended treatment over a long period of time.
Because in HIV-infected individuals, tuberculin skin-test results are less reliable as CD4 counts decline, screening should be completed as early as possible after HIVinfection occurs. Those HIV-infected patients at high risk for continuing exposure to patients who have TB should be screened periodically for TB infection. If they have TB symptoms or if they are exposed to a patient who has pulmonary TB, HIVinfected persons should be evaluated promptly for TB. Because active disease can develop rapidly in HIV-infected persons, the highest priority for contact investigation should be given to persons potentially co infected with HIV and TB (3; 8; 24; 30; 32).
The health-care provider should instruct patients to report to the health-care provider adverse events such as vesiculation, ulceration or necrosis which may appear at the test site in highly sensitive patients.
The health-care provider should also inform the patient that pain, pruritus and discomfort at the site may also occur. The health-care provider should inform the patient of the need to return for the reading of the test. Self reading of the test has been shown to be unreliable.
The health-care provider should inform the patient of the need to maintain a personal immunization record.
Tuberculin reactivity may indicate prior infection and/or disease with M. tuberculosis and does not necessarily indicate the presence of active tuberculous disease. Individuals showing tuberculin reactions considered positive by current public health guidelines should be evaluated by other diagnostic procedures, such as x-ray examination of the chest and microbiological examination of the sputum and other modern laboratory tests.
Reactivity to the test may be depressed or suppressed for up to 6 weeks in individuals who have had viral infections (rubella, influenza, mumps and probably others) or in those who are receiving corticosteroids or immunosuppressive agents. Reactivity to PPD may be temporarily depressed by certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella (5; 22). Therefore, if a tuberculin test is to be performed it should be administered either before, or simultaneously at separate sites with the injection of measles, mumps and rubella vaccines, in combined form or as separate antigens, or testing should be postponed for 4-6 weeks.
In those who are elderly or being tested for the first time, reactions may develop slowly and may not peak until after 72 hours.
There is no age contraindication to tuberculin skin testing of infants.
Because their immune systems are immature, many infants <6 weeks of age who are infected with M. tuberculosis do not react to tuberculin tests. Older infants and children develop tuberculin sensitivity 6 weeks or more after initial infection.
Pregnancy Category C (Tuberculin).
Well-conducted epidemiological studies indicate no adverse effects of PPD Tuberculin on pregnancy or on the health of the foetus/new-born child. (11; 20; 31) PPD Tuberculin can be used during pregnancy.
No studies on the effects on the ability to drive and use machines have been performed.
Common (>1/100): Local: Pain, irritation or discomfort at the injection site immediately after the injection.
Uncommon (<1/100): Systematic: Headache, fever. Local: Enlargement of regional lymph node.
Rare (<1/1.000): Local: Hypersensitivity to tuberculin can cause vesiculation and skin necrosis. Systematic: Anaphylactic reactions.
This medical product must not be mixed with other medical products.
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