TRICHOPHYTON FOR INTRADERMAL SKIN TESTING- trichophyton mentagrophytes and trichophyton rubrum injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Trichophyton mentagrophytes (UNII: 199I7J3JIV) (Trichophyton mentagrophytes - UNII:199I7J3JIV), Trichophyton rubrum (UNII: 2ZAU32517N) (Trichophyton rubrum - UNII:2ZAU32517N)

Available from:

Allermed Laboratories, Inc.

INN (International Name):

Trichophyton mentagrophytes

Composition:

Trichophyton mentagrophytes 1 g in 1000 mL

Administration route:

CUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Intradermal skin tests with Trichophyton extract are indicated for use in persons who are suspected of having Type I hypersensitivity (i.e. allergy) to the fungus. Conditions under which the administration of allergenic extract may be contraindicated, depending upon individual circumstances, include: EXTREME SENSITIVITY TO AN ALLERGEN - Determined from the allergic history, or from previous anaphylaxis following skin testing or subcutaneous injection; MYOCARDIAL INFARCTION - Patients who have experienced a recent myocardial infarction may be less able to tolerate the life-threatening effects of a serious adverse reaction. ASTHMA - Patients with highly unstable asthma are at greater risk of fatal reactions from skin tests than are patients without asthma, especially during seasonal exacerbations of the disease. Also, the combination of unstable asthma and treatment with B-adrenergic blockers appears to increase this risk5 . Allergenic extract should be temporarily withheld from patients if any of the followin

Product summary:

One mL of extract for intradermal skin testing is supplied in 2 mL sealed multidose vials. Each vial contains enough extract for 10 tests.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

TRICHOPHYTON FOR INTRADERMAL SKIN TESTING- TRICHOPHYTON MENTAGROPHYTES
AND
TRICHOPHYTON RUBRUM INJECTION
ALLERMED LABORATORIES, INC.
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ALLERGENIC EXTRACT _TRICHOPHYTON_ FOR INTRADERMAL SKIN TESTING
WARNINGS
This product is intended for use by physicians who are experienced in
the administration of
allergenic extracts or for use under the guidance of an allergy
specialist. Skin tests should be
performed after the patient's physical well being and allergic history
have been evaluated. Patients
should be instructed to recognize adverse reaction symptoms and
cautioned to contact the
physician if symptoms occur. As with all allergenic extracts, severe
systemic reactions may
occur, and in certain individuals these reactions may cause death.
Patients should be observed for
at least 20 minutes after skin tests have been completed. Emergency
measures as well as personnel
trained in their use should be immediately available in the event of a
life threatening reaction.
This product should never be injected intravenously (see DOSAGE AND
ADMINISTRATION).
Also, see WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and OVERDOSE
Sections
below.
DESCRIPTION
_Trichophyton_ extract for diagnostic skin testing is a sterile
solution that is prepared by extracting
allergenic source material of equal parts of _Trichophyton
mentagrophytes_ and _Trichophyton rubrum_ with
an aqueous solution of 0.25% sodium chloride, 0.125% sodium
bicarbonate and 50% glycerol v/v.
Phenol is added at 0.4% w/v as a preservative. Extract for intradermal
administration is diluted with the
above solution without glycerol.
WEIGHT BY VOLUME (W/V) Weight by volume refers to the weight of raw
product added to a
measured volume of extraction solution. A 1:500 w/v extract contains 1
gram of source material in 500
mL of solution. The w/v designation refers to concentration rather
than potency. Extract labeled w/v has
no U.S. Standard of Potency.
CLINICAL PHARMACOLOGY
In sensitive persons, allergenic extract elicits immediate-type skin
reactions consisting of erythema