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:

Physicians Total Care, 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. (9) 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

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: 10-test vial, 1 mL. package of 1 vial, NDC No. 54868-2972-1 50-test vial, 5 mL. The stopper of the vial for this product does not contain natural latex rubber. Store at 2° to 8°C (35° to 46°F). (21) 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 The product should be stored in the dark except when doses are actually being withdrawn from the vial. (22) A vial of TUBERSOL which has been entered and in use for 30 days should be discarded. (23) Do not use after expiration date.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

TUBERSOL - TUBERCULIN PURIFIED PROTEIN DERIVATIVE INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
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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 the US Standard
Tuberculin PPD-S. (3)
Independent studies conducted by the US Public Health Service in
humans have determined the amount
of CT68 in stabilized solution necessary (4) (5) (6) 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. (7) Subsequent restimulation of these sensitized
lymphocytes with the same or a
similar antigen, such as the int