STANDARDIZED CAT HAIR injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96)

थमां उपलब्ध:

Jubilant HollisterStier LLC

INN (इंटरनेशनल नाम):

FELIS CATUS HAIR

रचना:

FELIS CATUS HAIR 10000 [BAU] in 1 mL

प्रशासन का मार्ग:

PERCUTANEOUS

चिकित्सीय संकेत:

3, 16, 17, 18 Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.19, 20 The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Avoidance of allergens is to be advocated if possible, but cannot always be attained, e.g., allergy to cat dander in kennel

उत्पाद समीक्षा:

Standardized Cat Hair allergenic extract is supplied for diagnostic and therapeutic use: Diagnostics: Prick or puncture testing, 10,000 BAU/mL [50% glycerin (v/v)] in 5 mL dropper vial. Bulk Therapeutics, multiple dose vials in 50% glycerin (v/v). 10 mL vial, 10,000 BAU/mL 30 mL vial, 10,000 BAU/mL 50 mL vial, 10,000 BAU/mL

प्राधिकरण का दर्जा:

Biologic Licensing Application

उत्पाद विशेषताएं

STANDARDIZED CAT HAIR- STANDARDIZED CAT HAIR INJECTION, SOLUTION
JUBILANT HOLLISTERSTIER LLC
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ALLERGENIC EXTRACT STANDARDIZED CAT HAIR AP ACETONE PRECIPITATED
WARNINGS
This product is intended for use only by licensed medical personnel
experienced in
administering allergenic extracts and trained to provide immediate
emergency
treatment in the event of a life-threatening reaction.
Allergenic extracts may potentially elicit a severe life-threatening
systemic reaction,
rarely resulting in death.1 Therefore, emergency measures and
personnel trained in
their use must be available immediately in the event of such a
reaction. Patients
should be instructed to recognize adverse reaction symptoms and
cautioned to
contact the physician’s office if symptoms occur.
This standardized extract may be more potent than regular extracts and
therefore
is not directly interchangeable with Jubilant HollisterStier LLC
non-standardized
extracts, or other manufacturers’ products. Standardized pelt and
hair extracts
are manufactured from different source materials and are not
interchangeable.
Standardized cat extracts labeled in AU/mL are not interchangeable
with extracts
labeled in BAU/mL. See DESCRIPTION Section.
This product should never be injected intravenously.
Refer also to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and
OVERDOSE Sections for further discussion.
DESCRIPTION
Allergenic extracts are sterile solutions containing the extractables
of the source
material and components of the extraction fluid. Standardized Cat Hair
is available as an
extract from acetone precipitated source material in the extraction
fluid described
below.
SOURCE MATERIAL:
Cat Hair Source Material consists of hair clippings and/or shavings
which have
undergone an acetone precipitation process. AP™ Acetone Precipitated
Cat Hair is
derived from the precipitate formed when acetone is added to an
aqueous extract.
EXTRACTING FLUID:
Glycero-Coca’s: Contains 0.5% sodium chloride, 0.275% sodium
bicarbonate, and 50%
glycerin (v/v) as a preserva