TUBERSOL (Page 3 of 3)
Altered Immune Status
Impaired or attenuated cell mediated immunity (CMI) can potentially cause a false negative tuberculin reaction. Many factors have been reported to cause a decreased ability to respond to the tuberculin test in the presence of tuberculous infection including viral infections (e.g., measles, mumps, chickenpox and HIV), live virus vaccinations (e.g., measles, mumps, rubella, oral polio and yellow fever), overwhelming tuberculosis, other bacterial infections, leukemia, sarcoidosis, fungal infections, metabolic derangements, low protein states, diseases affecting lymphoid organs, drugs (corticosteroids and many other immunosuppressive agents), and malignancy or stress. (7)(16)(17) A TST should be deferred for patients with major viral infections or live-virus vaccination in the past month. Persons with the common cold may be tuberculin tested.
Because TST results in HIV-infected individuals are less reliable as CD4 counts decline, screening should be completed as early as possible after HIV-infection occurs. (17)
Booster Effect and Two-Step Testing
If tuberculin testing will be conducted at regular intervals, for instance among healthcare workers 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 should be considered to have experienced past TB infection. (13)(18)
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 tuberculosis infection and managed accordingly. (6)
HOW SUPPLIED
TUBERSOL Tuberculin Purified Protein Derivative (Mantoux), bioequivalent to 5 US units (TU) PPD-S per test dose (0.1 mL) is supplied in:
1 mL multi-dose vial (10 tests). NDC No. 49281-752-78; package of 1 vial, NDC No. 49281-752-21
5 mL multi-dose vial (50 tests). NDC No. 49281-752-98; package of 1 vial, NDC No. 49281-752-22
The stopper of the vial for this product does not contain natural latex rubber.
STORAGE
Store at 2° to 8°C (35° to 46°F). (19) Do not freeze. Discard product if exposed to freezing.
Protect from light. Tuberculin PPD solutions can be adversely affected by exposure to light. The product should be stored in the dark except when doses are actually being withdrawn from the vial. (20)
A vial of TUBERSOL which has been entered and in use for 30 days should be discarded. (21)
Do not use after expiration date.
REFERENCES
- 1
- Landi S. Preparation, purification, and stability of tuberculin. Appl Microbiol 1963;11:408-412.
- 2
- Landi S, et al. Preparation and characterization of a large batch of tuberculin purified protein derivative (PPD-CT68). Ann Scalvo.1980;22:889-907.
- 3
- Landi S, et al. Adsorption of tuberculin PPD to glass and plastic surfaces. Bull. WHO 1966;35:593-602.
- 4
- Landi S, et al. Disparity of potency between stabilized and nonstabilized dilute tuberculin solutions. Am Rev Respir Dis 1971;104:385-393.
- 5
- Landi S, et al. Stability of dilute solutions of tuberculin purified protein derivative. Tubercle 1978;59:121-133.
- 6
- Menzies D. Interpretation of repeated tuberculin tests. Am J Respir Crit Care Med 1999;159:15-21.
- 7
- American Thoracic Society: Diagnostic standards and classification of tuberculosis in adults and children. Am J Respir Crit Care Med 2000;161:1376-1395.
- 8
- CDC. Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection — United States, 2010. MMWR 2010; 59 (RR-5):1-25.
- 9
- CDC. Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR 2000;49(RR-6):23-5.
- 10
- Froeschle JE, et al. Immediate hypersensitivity reactions after use of tuberculin skin testing. Clin Infect Dis 2002;34:e12-13.
- 11
- Brickman HF, et al. The timing of tuberculin tests in relation to immunization with live viral vaccines. Pediatrics: 1975;55:392-396.
- 12
- CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-36.
- 13
- CDC. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR 2005;54(RR-17):1-141.
- 14
- CDC. The role of BCG vaccine in the prevention and control of tuberculosis in the United States. A joint statement by the Advisory Council for the Elimination of Tuberculosis and the Advisory Committee on Immunization Practices. MMWR 1996; 45(RR-4):1-18.
- 15
- CDC. Guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis: Recommendations from the National Tuberculosis Controllers Association and CDC. MMWR 2005;54(RR-15):1-37.
- 16
- Mori and Shiozawa. Suppression of tuberculin hypersensitivity caused by rubella infection. Am Rev Respir Dis 1985;886-888.
- 17
- CDC. Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents. Recommendations from the CDC, the National Institutes of Health, and the HIV Medicine Association of Infectious Diseases Society of America. MMWR 2009;58(RR-4):1-207.
- 18
- CDC. Prevention and control of tuberculosis in correctional and detention facilities: Recommendations from the CDC. MMWR 2006;55(RR-9):1-44.
- 19
- Landi S, et al. Stability of dilute solution of tuberculin purified protein derivative at extreme temperatures. J Biol Stand 1981;9:195-199.
- 20
- Landi S, et al. Effect of light on tuberculin purified protein derivative solutions. Am Rev Respir Dis 1975;111:52-61.
- 21
- Landi S, et al. Effect of oxidation on the stability of tuberculin purified protein derivative (PPD) In: International Symposium on Tuberculins and BCG Vaccine. Basel: International Association of Biological Standardization, 1983. Dev Biol Stand 1986;58:545-552.
Manufactured by:
Sanofi Pasteur Limited
Toronto Ontario Canada
Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
Product Information as of
October 2021
TUBERSOL is a registered trademark of Sanofi Pasteur. ©, 2021 TUBERSOL® , Sanofi Pasteur Limited — All rights reserved
PRINCIPAL DISPLAY PANEL — 1 mL Vial Label
Tuberculin Purified
Protein Derivative
(Mantoux)
TUBERSOL®
Multi-dose vial
1 mL (10 Tests)
Test dose: 5 TU/0.1 mL ID.
Protect from light.
Discard opened product after 30 days.
Rx only
Sanofi Pasteur Limited
PRINCIPAL DISPLAY PANEL — 1 mL Vial Carton
NDC 49281-752-21
PPD
Tuberculin Purified Protein
Derivative (Mantoux)
TUBERSOL®
Tween Stabilized Solution
Test dose: 5 TU/0.1 mL intradermally.
Multi-dose vial (10 Tests)5 Tuberculin units per test
Rx only
sanofi
PRINCIPAL DISPLAY PANEL — 5 mL Vial Label
Tuberculin Purified Protein
Derivative (Mantoux)
TUBERSOL®
Multi-dose vial 5 mL (50 Tests)
Test dose: 5 TU/0.1 mL ID.
Protect from light.
Discard opened product after 30 days.
Rx only
Sanofi Pasteur Limited
PRINCIPAL DISPLAY PANEL — 5 mL Vial Carton
NDC 49281-752-22
PPD
Tuberculin Purified Protein
Derivative (Mantoux)
TUBERSOL®
Tween Stabilized Solution
Rx only
Test dose: 5 TU/0.1 mL intradermally.
Multi-dose vial (50 Tests)5 Tuberculin units per test
sanofi
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Labeler — Sanofi Pasteur Inc. (086723285) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Sanofi Pasteur Limited | 208206623 | MANUFACTURE (49281-752) |
Revised: 01/2024 Sanofi Pasteur Inc.
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