ALLERGEN PACK ALTERNARIA TENUIS

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H)

متاح من:

Alvix Laboratories, LLC

INN (الاسم الدولي):

ALTERNARIA ALTERNATA

تركيب:

ALTERNARIA ALTERNATA 20000 [PNU] in 1 mL

الوضع إذن:

Biologic Licensing Application

خصائص المنتج

ALLERGEN PACK ALTERNARIA TENUIS- ALLERGEN PACK ALTERNARIA TENUIS
ALVIX LABORATORIES, LLC
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ALLERGEN PACK ALTERNARIA TENUIS
BOXED WARNING
WARNING
THIS ALLERGENIC PRODUCT IS INTENDED FOR USE BY PHYSICIANS WHO ARE
EXPERIENCED IN THE ADMINISTRATION OF ALLERGENIC EXTRACTS AND THE
EMERGENCY CARE OF ANAPHYLAXIS, OR FOR USE UNDER THE GUIDANCE OF AN
ALLERGY SPECIALIST.
ALLERGENIC EXTRACTS MAY CAUSE SEVERE OR FATAL ANAPHYLAXIS IN
EXTREMELY SENSITIVE PATIENTS. THE INITIAL DOSE MUST BE BASED ON SKIN
TESTING AS DESCRIBED IN THE DOSAGE AND ADMINISTRATION SECTION OF THIS
INSERT. PATIENTS SHOULD BE INSTRUCTED TO RECOGNIZE ADVERSE REACTION
SYMPTOMS AND CAUTIONED TO CONTACT THE PHYSICIAN'S OFFICE IF REACTION
SYMPTOMS OCCUR. IN CERTAIN INDIVIDUALS, THESE REACTIONS COULD BE
FATAL. PATIENTS SHOULD BE OBSERVED FOR AT LEAST 20 MINUTES FOLLOWING
TREATMENT.
EMERGENCY MEASURES, AS WELL AS PERSONNEL TRAINED IN THEIR USE,
SHOULD BE IMMEDIATELY AVAILABLE IN THE EVENT OF A LIFE- THREATENING
REACTION. PATIENTS BEING SWITCHED FROM ONE LOT OF EXTRACT TO
ANOTHER FROM THE SAME MANUFACTURER SHOULD HAVE THEIR DOSE
REDUCED BY 75%.
THIS PRODUCT SHOULD NOT BE INJECTED INTRAVENOUSLY.
REFER ALSO TO THE WARNINGS, PRECAUTIONS, ADVERSE REACTIONS AND
OVERDOSAGE SECTION BELOW.
DESCRIPTION
Allergenic Extracts are supplied as a sterile solution for
intracutaneous or subcutaneous administration.
Concentrates contain the soluble extractants of the source material
with 0.5% sodium chloride and
0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in
water for injection or in 50%
glycerin. Aqueous extracts contain 0.4% phenol as a preservative and
50% glycerinated extracts contain
0.2% phenol. Diluted aqueous extracts contain Buffered Saline with
0.5% sodium chloride, 0.04%
potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4%
phenol in water for injection.
Source materials for these extracts are as follows: Pollens are
collected from the respective grasses,
weeds, trees, shrubs, cultured plants and flowers. Mold extracts are
prod