TREATMENT SET TS340796 injection, solution TREATMENT SET TS340826 injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q), DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K), PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089), JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR), CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10), PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE P

Available from:

Antigen Laboratories, Inc.

INN (International Name):

DERMATOPHAGOIDES FARINAE

Composition:

DERMATOPHAGOIDES FARINAE 400 [AU] in 1 mL

Administration route:

INTRADERMAL

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 TS340796 - TREATMENT SET TS340796 INJECTION, SOLUTION
TREATMENT SET TS340826 - TREATMENT SET TS340826 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, ADVERSE REACTIONS AND
OVERDOSAGE SECTIONS
BELOW.
DESCRIPTION
Allergenic extract in this vial is referred to as an individual
treatment vial since it is designed primarily
for the physician equipped to complete skin testing and supervise
allergenic extract immunotherapy.
The extract is sterile and intended for subcutaneous injection. The
concentration of allergenic extract
supplied will be based on the individual physician's prescription
order and will be expressed in most
cases on a weight/volume basis (or AU/ml with standardized extract)
di