APLISOL- tuberculin purified protein derivative injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

TUBERCULIN PURIFIED PROTEIN DERIVATIVE (UNII: I7L8FKN87J) (TUBERCULIN PURIFIED PROTEIN DERIVATIVE - UNII:I7L8FKN87J)

Disponibil de la:

Par Pharmaceutical, Inc.

INN (nume internaţional):

TUBERCULIN PURIFIED PROTEIN DERIVATIVE

Compoziție:

TUBERCULIN PURIFIED PROTEIN DERIVATIVE 5 [iU] in 0.1 mL

Calea de administrare:

INTRADERMAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis . The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections.4 HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.3 Aplisol is contraindicated in patients with known hypersensitivity or allergy to Aplisol or any of its components. Aplisol should not be administered to persons who have previously experienced a severe reaction (e.g., vesiculation, ulceration, or necrosis) because of the sev

Rezumat produs:

Tuberculin PPD-Aplisol bioequivalent to 5 US units (TU) PPD-S per test dose (0.1 mL) is available in the following presentations:   NDC 42023-104-01 (Bio. 1525)   1 mL (10 tests) – multiple dose vial   NDC 42023-104-05 (Bio.1607)   5 mL (50 tests) – multiple dose vial This product is ready for use without further dilution. DO NOT FREEZE This product should be stored between 2° and 8°C (36° and 46°F) and protected from light. Vials in use more than 30 days should be discarded due to possible oxidation and degradation which may affect potency.

Statutul autorizaţiei:

Biologic Licensing Application

Caracteristicilor produsului

APLISOL- TUBERCULIN PURIFIED PROTEIN DERIVATIVE INJECTION
PAR PHARMACEUTICAL, INC.
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APLISOL
(TUBERCULIN PURIFIED PROTEIN DERIVATIVE, DILUTED [STABILIZED
SOLUTION])
DIAGNOSTIC ANTIGEN FOR INTRADERMAL INJECTION ONLY
DESCRIPTION
Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a
purified protein fraction for
intradermal administration as an aid in the diagnosis of tuberculosis.
The solution is stabilized with
polysorbate (Tween) 80, buffered with potassium and sodium phosphates
and contains approximately
0.25% phenol as a preservative.
This product is ready for immediate use without further dilution.
The purified protein fraction is isolated from culture media filtrates
of a human strain of _Mycobacterium_
_tuberculosis _by the method of F.B. Seibert.
Tuberculin PPD, diluted, is prepared from Tuberculin
PPD which is clinically bioequivalent in potency to the standard PPD-S
(5 TU per 0.1mL) of the U.S.
Public Health Service, National Centers for Disease Control.
The potency of each lot of tuberculin PPD, diluted is determined in
sensitized guinea pigs.
1
2
CLINICAL PHARMACOLOGY
In the United States, the prevalence of _Mycobacterium tuberculosis
_infection and active disease varies for
different segments of the population; however, the risk for _M.
tuberculosis _infection in the overall
population is low. Tuberculosis (TB) case rates declined steadily for
decades in the United States.
However, in 1985 the TB case rate stabilized and subsequently
increased through 1992, accompanied
by a 14% increase in the TB mortality rate in 1988. This has been
attributed to several complex social
and medical factors, including the human immunodeficiency virus (HIV)
epidemic, the occurrence of
TB in foreign-born persons from countries that have a high prevalence
of TB, the emergence of drug-
resistant strains of TB, and the transmission of _M. tuberculosis _in
congregate settings (e.g., health-care
facilities, correctional facilities, drug-treatment centers, and
homeless shelters). Because the overall
risk