Tubersol, 5 TU/0.1 mL — 1 mL Multi-Dose Vial, 10 Tests

TUBERSOL (Tuberculin Purified Protein Derivative, Mantoux), 5 TU/0.1 mL

PRODUCT OVERVIEW

TUBERSOL is a diagnostic antigen used for intradermal tuberculin skin testing. It is indicated to aid in the diagnosis of tuberculosis infection in persons at increased risk of developing active disease. TUBERSOL is not a vaccine and does not treat tuberculosis.

PRESENTATION

This product is supplied as one 1 mL multidose vial containing 10 test doses. Each standard 0.1 mL intradermal test dose provides 5 tuberculin units (TU) of purified protein derivative from Mycobacterium tuberculosis. The solution is polysorbate 80 stabilized, clear, and colorless. The vial stopper does not contain natural latex rubber.

ADMINISTRATION AND TEST READING

For intradermal use only by a healthcare professional. The labeled test dose is 0.1 mL (5 TU). Do not inject intravenously, intramuscularly, or subcutaneously. A trained healthcare professional should read the test 48 to 72 hours after administration by measuring induration, not redness, and recording the result in millimeters. Refer to the current full prescribing information and applicable public-health guidance for administration and interpretation.

IMPORTANT SAFETY INFORMATION

TUBERSOL is contraindicated in persons allergic to any component or with an anaphylactic or other allergic reaction to a previous tuberculin PPD test. It should not be administered to persons with a severe previous tuberculin skin-test reaction, documented active tuberculosis or a clear history of treatment for TB infection or disease, or extensive burns or eczema. Allergic reactions, including anaphylaxis, and syncope may occur. False-positive and false-negative reactions are possible; clinical history and risk factors must be considered.

STORAGE AND HANDLING

Store refrigerated at 35°F to 46°F (2°C to 8°C). Do not freeze; discard if exposed to freezing. Protect from light and keep the product in the dark except when doses are withdrawn. Discard an entered vial after 30 days. Do not use after the expiration date.

PRODUCT DETAILS

• Brand: TUBERSOL

• Generic name: Tuberculin purified protein derivative (PPD), Mantoux

• Manufacturer/labeler: Sanofi Vaccines US Inc.

• NDC: 49281-752-21 (49281075221)

• Form: Multidose vial

• Strength: 5 TU/0.1 mL

• Vial volume: 1 mL

• Package size: One vial; 10 tests

• Route: Intradermal

This summary does not replace the full prescribing information. Current label: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd