TREATMENT SET TS345463 injection, solution TREATMENT SET TS345476 injection, solution TREATMENT SET TS345694 injection, soluti

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10), CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y), CARYA TOMENTOSA POLLEN (UNII: G2A764T54B) (CARYA TOMENTOSA POLLEN - UNII:G2A764T54B), AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW), AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3), RUMEX ACETOSELLA POLLEN (UNII: N52MIQ

Tilgængelig fra:

Antigen Laboratories, Inc.

INN (International Name):

CYNODON DACTYLON POLLEN

Sammensætning:

CYNODON DACTYLON POLLEN 16 [BAU] in 1 mL

Indgivelsesvej:

SUBCUTANEOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

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.

Autorisation status:

Biologic Licensing Application

Produktets egenskaber

TREATMENT SET TS345463 - TREATMENT SET TS345463 INJECTION, SOLUTION
TREATMENT SET TS345476 - TREATMENT SET TS345476 INJECTION, SOLUTION
TREATMENT SET TS345694 - TREATMENT SET TS345694 INJECTION, SOLUTION
TREATMENT SET TS345784 - TREATMENT SET TS345784 INJECTION, SOLUTION
TREATMENT SET TS345825 - TREATMENT SET TS345825 INJECTION, SOLUTION
TREATMENT SET TS345883 - TREATMENT SET TS345883 INJECTION, SOLUTION
TREATMENT SET TS346157 - TREATMENT SET TS346157 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 comple