ALLERGENIC EXTRACT

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

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Productkenmerken Productkenmerken (SPC)
10-08-2009

Werkstoffen:

CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10)

Beschikbaar vanaf:

Antigen Laboratories, Inc.

INN (Algemene Internationale Benaming):

CYNODON DACTYLON POLLEN

Samenstelling:

CYNODON DACTYLON POLLEN 10000 [BAU] in 1 mL

Toedieningsweg:

SUBCUTANEOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts. CONTRAINDICATIONS     Do not administer in the presence of diseases characterized by bleeding diathesis. Individuals with autoimmune disease may be at risk of exacerbating symptoms of underly

Product samenvatting:

HOW SUPPLIED     Standardized Grass Pollen allergenic extract concentration is expressed in BAU/ml. It is supplied in 100,000 BAU/ml and 10,000 BAU/ml in 10, 30 and 50 ml containers. Standardized Bermuda Grass is only available as 10,000 BAU/ml concentrate. Stock mixtures of Standardized Grass Pollens and mixtures of standardized and non-standardized grass pollens are available at various concentrations. Extracts in 5 ml dropper bottles are available for prick-puncture testing. To insure maximum potency for the entire dating period, all stock concentrates contain 50% v/v glycerine.

Autorisatie-status:

Biologic Licensing Application

Productkenmerken

                                STANDARDIZED BERMUDA GRASS POLLEN - STANDARDIZED BERMUDA GRASS POLLEN
INJECTION,
SOLUTION
STANDARDIZED MEADOW FESCUE GRASS POLLEN - STANDARDIZED MEADOW FESCUE
GRASS
POLLEN INJECTION, SOLUTION
STANDARDIZED ORCHARD GRASS POLLEN - STANDARDIZED ORCHARD GRASS POLLEN
INJECTION,
SOLUTION
STANDARDIZED REDTOP GRASS POLLEN - STANDARDIZED REDTOP GRASS POLLEN
INJECTION,
SOLUTION
STANDARDIZED PERENNIAL RYE GRASS POLLEN - STANDARDIZED PERENNIAL RYE
GRASS
POLLEN INJECTION, SOLUTION
STANDARDIZED TIMOTHY GRASS POLLEN - STANDARDIZED TIMOTHY GRASS POLLEN
INJECTION,
SOLUTION
STANDARDIZED KENTUCKY (JUNE) BLUEGRASS - STANDARDIZED KENTUCKY (JUNE)
BLUEGRASS INJECTION, SOLUTION
STANDARDIZED SWEET VERNAL GRASS POLLEN - STANDARDIZED SWEET VERNAL
GRASS
POLLEN INJECTION, SOLUTION
MIXTURE OF FOUR STANDARDIZED GRASSES - MIXTURE OF FOUR STANDARDIZED
GRASSES INJECTION, SOLUTION
MIXTURE OF FIVE STANDARDIZED GRASSES - MIXTURE OF FIVE STANDARDIZED
GRASSES INJECTION, SOLUTION
MIXTURE OF SIX STANDARDIZED GRASSES - MIXTURE OF SIX STANDARDIZED
GRASSES INJECTION,
SOLUTION
MIXTURE OF SEVEN STANDARDIZED GRASSES - MIXTURE OF SEVEN STANDARDIZED
GRASSES INJECTION, SOLUTION
MIXTURE OF EIGHT STANDARDIZED GRASSES - MIXTURE OF EIGHT STANDARDIZED
GRASSES INJECTION, SOLUTION
MIXTURE OF TWENTY-TWO STANDARDIZED AND NON-STANDARDIZED GRASSES -
MIXTURE OF TWENTY-TWO STANDARDIZED AND NON-STANDARDIZED GRASSES
INJECTION, SOLUTION
MIXTURE OF STANDARDIZED AND NON-STANDARDIZED SOUTHERN GRASSES -
MIXTURE OF STANDARDIZED AND NON-STANDARDIZED SOUTHERN GRASSES
INJECTION, SOLUTION
MIXTURE OF STANDARDIZED AND NON-STANDARDIZED INLAND GRASSES - MIXTURE
OF STANDARDIZED AND NON-STANDARDIZED INLAND GRASSES INJECTION,
SOLUTION
MIXTURE OF STANDARDIZED AND NON-STANDARDIZED SOUTHEASTERN
GRASSES - MIXTURE OF STANDARDIZED AND NON-STANDARDIZED SOUTHEASTERN
GRASSES INJECTION,
SOLUTION
MIXTURE OF STANDARDIZED AND NON-STANDARDIZED COASTAL GRASSES -
MIXTURE OF STANDARDIZED AND NON-STANDARDIZED COASTAL GRASSES
INJECTION, SOLUTION
ANTIGEN LABORATORIES, INC.
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ALLERGENIC EXTRACT
WARNINGS ST
                                
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