TREATMENT SET TS344592 injection, solution TREATMENT SET TS344801 injection, solution TREATMENT SET TS345048 injection, soluti

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K), CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR)

Available from:

Antigen Laboratories, Inc.

INN (International Name):

DERMATOPHAGOIDES PTERONYSSINUS

Composition:

DERMATOPHAGOIDES PTERONYSSINUS 2000 [AU] in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11 THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING. There are no absolute contraindications; however, extreme caution is necessary when using diagnostic ski

Product summary:

Individual treatment sets as prescribed by the physician. The allergenic extract contains a variable number of individual doses depending on the patient's sensitivity and maximum tolerated maintenance treatment dose.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

TREATMENT SET TS344592 - TREATMENT SET TS344592 INJECTION, SOLUTION
TREATMENT SET TS344801 - TREATMENT SET TS344801 INJECTION, SOLUTION
TREATMENT SET TS345048 - TREATMENT SET TS345048 INJECTION, SOLUTION
TREATMENT SET TS345049 - TREATMENT SET TS345049 INJECTION, SOLUTION
TREATMENT SET TS345050 - TREATMENT SET TS345050 INJECTION, SOLUTION
TREATMENT SET TS345268 - TREATMENT SET TS345268 INJECTION, SOLUTION
TREATMENT SET TS345302 - TREATMENT SET TS345302 INJECTION, SOLUTION
TREATMENT SET TS345303 - TREATMENT SET TS345303 INJECTION, SOLUTION
TREATMENT SET TS345380 - TREATMENT SET TS345380 INJECTION, SOLUTION
TREATMENT SET TS345381 - TREATMENT SET TS345381 INJECTION, SOLUTION
ANTIGEN LABORATORIES, INC.
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ALLERGENIC EXTRACTS
INDIVIDUAL TREATMENT VIAL
WARNINGS
INDIVIDUAL ALLERGENIC EXTRACT TREATMENT VIAL IS INTENDED FOR USE BY
PHYSICIANS WHO ARE
EXPERIENCED IN THE ADMINISTRATION OF ALLERGENIC EXTRACTS FOR
IMMUNOTHERAPY AND THE
EMERGENCY CARE OF ANAPHYLAXIS, OR FOR USE UNDER THE GUIDANCE OF AN
ALLERGY SPECIALIST.
INDIVIDUAL ALLERGENIC EXTRACT TREATMENT VIALS ARE NOT DIRECTLY
INTERCHANGEABLE WITH OTHER
ALLERGENIC EXTRACTS. THE INITIAL DOSE MUST BE BASED ON SKIN TESTING AS
DESCRIBED IN THE
DOSAGE AND ADMINISTRATION SECTION OF THIS INSERT. PATIENTS BEING
SWITCHED FROM OTHER TYPES
OF EXTRACT TO INDIVIDUAL TREATMENT VIALS SHOULD BE STARTED AS THOUGH
THEY WERE COMING UNDER
TREATMENT FOR THE FIRST TIME. PATIENTS SHOULD BE INSTRUCTED TO
RECOGNIZE ADVERSE REACTION
SYMPTOMS AND CAUTIONED TO CONTACT THE PHYSICIAN'S OFFICE IF REACTION
SYMPTOMS OCCUR. AS
WITH ALL ALLERGENIC EXTRACTS, SEVERE SYSTEMIC REACTIONS MAY OCCUR. IN
CERTAIN INDIVIDUALS,
THESE REACTIONS MAY BE LIFE-THREATENING. PATIENT SHOULD BE OBSERVED
FOR AT LEAST 20 MINUTES
FOLLOWING TREATMENT AND 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 NOT BE INJECTED INTRAVENOUSLY. DEEP SUBCUTANEOUS
ROUTES HAVE PROVEN
TO BE SAFE. SEE THE WARNINGS, PRECAUTIONS, ADV