TUBERSOL- tuberculin purified protein derivative injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Tuberculin Purified Protein Derivative (UNII: I7L8FKN87J) (Tuberculin Purified Protein Derivative - UNII:I7L8FKN87J)

Available from:

Sanofi Pasteur Inc.

INN (International Name):

Tuberculin Purified Protein Derivative

Composition:

Tuberculin Purified Protein Derivative 5 [iU] in 0.1 mL

Administration route:

INTRADERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TUBERSOL Tuberculin Purified Protein Derivative (Mantoux), is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease. The Centers for Disease Control and Prevention (CDC) have published guidelines regarding populations that would benefit from tuberculin skin testing (TST). Current recommendations can be accessed at: http://www.cdc.gov/tb/publications/factsheets/testing.htm. Previous BCG vaccination is not a contraindication to tuberculin testing. The skin-test results of BCG vaccinated persons can be used to support or exclude the diagnosis of TB infection. However, an FDA-approved interferon gamma release assay is preferred over tuberculin skin test for persons 5 years of age and older who were previously vaccinated with BCG. (8) Allergy to any component of TUBERSOL or an anaphylactic or other allergic reaction to a previous test of tuberculin PPD is a contraindication to the use of TUBERSOL. (See DESCRIPTION and HOW SUPPLIED.) TUBERSOL should not be administered to: - Persons who have had a severe reaction (e.g., necrosis, blistering, anaphylactic shock, or ulcerations) to a previous TST, - Persons with documented active tuberculosis or a clear history of treatment for TB infection or disease, (9) - Persons with extensive burns or eczema.

Product summary:

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. 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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

TUBERSOL- TUBERCULIN PURIFIED PROTEIN DERIVATIVE INJECTION, SOLUTION
SANOFI PASTEUR INC.
----------
TUBERCULIN PURIFIED PROTEIN DERIVATIVE
(MANTOUX)
TUBERSOL
AHFS Category: 36:84
_RX ONLY_
DIAGNOSTIC ANTIGEN
(Aid in the detection of infection with _Mycobacterium tuberculosis_)
FOR INTRADERMAL USE
POLYSORBATE 80 STABILIZED SOLUTION OF TUBERCULIN PURIFIED PROTEIN
DERIVATIVE
FOR TUBERCULIN TESTING IN HUMANS
DESCRIPTION
TUBERSOL
Tuberculin Purified Protein Derivative (Mantoux) (PPD) (1) for
intradermal
tuberculin testing is prepared from a large Master Batch Connaught
Tuberculin (CT68)
(2) and is a cell-free purified protein fraction obtained from a human
strain of
_Mycobacterium tuberculosis_ grown on a protein-free synthetic medium
and inactivated.
(2) The use of a standard preparation derived from a single batch
(CT68) has been
adopted in order to eliminate batch to batch variation by the same
manufacturer. (2)
TUBERSOL is a clear, colorless liquid.
TUBERSOL contains:
Purified protein derivative of _M._
_tuberculosis_
5 TU per 0.1 mL
Polysorbate 80
0.0006%
Phenol
0.22% to 0.35% w/v
in sterile isotonic phosphate buffered saline.
Before release, each successive lot is tested for potency in
comparison with a reference
standard.
Independent studies conducted by the US Public Health Service in
humans have
determined the amount of CT68 in stabilized solution necessary
(3)(4)(5) to produce bio-
equivalency with Tuberculin PPD-S (in phosphate buffer without
polysorbate 80) using 5
US units (TU) Tuberculin PPD-S as the standard.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
®
®
The sensitization following infection with mycobacteria occurs
primarily in the regional
lymph nodes. Small lymphocytes (T lymphocytes) proliferate in response
to the antigenic
stimulus to give rise to specifically sensitized lymphocytes. After
3-8 weeks, these
lymphocytes enter the blood stream and circulate for years. (6)
Subsequent
restimulation of these sensitized lymphocytes with the same or a
similar antigen, such
as the intradermal injection of