STANDARDIZED MEADOW FESCUE POLLEN- festuca elatior solution TIMOTHY-ORCHARD STANDARDIZED GRASS POLLEN MIX- phleum pratense and

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

FESTUCA PRATENSIS POLLEN (UNII: A0WFQ8P6N1) (FESTUCA PRATENSIS POLLEN - UNII:A0WFQ8P6N1)

Dostupno od:

Greer Laboratories, Inc.

INN (International ime):

FESTUCA PRATENSIS POLLEN

Sastav:

FESTUCA PRATENSIS POLLEN 10000 [BAU] in 1 mL

Administracija rute:

PERCUTANEOUS

Terapijske indikacije:

GREER Standardized Grass Pollen Allergenic Extracts are indicated for: - Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy. - Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. Standardized Grass Pollen Allergenic Extracts are contraindicated in patients with: - Severe, unstable or uncontrolled asthma - History of any severe systemic allergic reaction or any severe local reaction to subcutaneous allergen immunotherapy 8.1 Pregnancy Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. I

Proizvod sažetak:

16.1 How Supplied GREER Standardized Grass Pollen Allergenic Extracts and mixes are supplied as stock concentrates at 10,000 BAU/milliliter and 100,000 BAU/milliliter in 50% glycerin for use in percutaneous skin testing, intradermal testing, and subcutaneous immunotherapy. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter and are provided in 5, 10, and 50 milliliter vials. Note, the total potency of mixes containing standardized grasses may be cumulative. Standardized Bermuda Grass Pollen Allergenic Extract solution is available only at 10,000 BAU/milliliter. GREER Standardized Grass Pollen Allergenic Extracts and mixes are supplied as follows: 16.2 Storage and Handling Maintain at 2 to 8°C (36 to 46°F) during storage and use. Dilutions of concentrated extract result in a glycerin content of less than 50%, which can result in reduced stability. Extract dilutions at 1:100 volume/volume of the 10,000 BAU/milliliter or 100,000 BAU/milliliter should be kept no longer than a month, and more dilute solutions no more than a week. The potency of a dilution can be checked by skin test comparison to a fresh dilution of the extract on a known grass-allergic patient.

Status autorizacije:

Biologic Licensing Application

Svojstava lijeka

STANDARDIZED MEADOW FESCUE POLLEN- FESTUCA ELATIOR SOLUTION
TIMOTHY-ORCHARD STANDARDIZED GRASS POLLEN MIX- PHLEUM PRATENSE
AND DACTYLIS GLOMERATA SOLUTION
7 STANDARDIZED GRASS POLLEN MIX- POA PRATENSIS, FESTUCA ELATIOR,
DACTYLIS
GLOMERATA, LOLIUM PERENNE, AGROSITIS ALBA, ANTHOXANTHUM ODORATUM, AND
PHLEUM PRATENSE SOLUTION
K-O-R-T STANDARDIZED GRASS POLLEN MIX- POA PRATENSIS, DACTYLIS
GLOMERATA, AGROSTIS ALBA AND PHLEUM PRATENSE SOLUTION
K-O-T STANDARDIZED GRASS POLLEN MIX- POA PRATENSIS, DACTYLIS GLOMERATA
AND PHLEUM PRATENSE SOLUTION
T-O-S STANDARDIZED GRASS POLLEN MIX- PHLEUM PRATENSE, DACTYLIS
GLOMERATA AND ANTHOXANTHUM ODORATUM SOLUTION
STANDARDIZED KENTUCKY (JUNE) BLUEGRASS POLLEN- POA
PRATENSIS SOLUTION
STANDARDIZED BERMUDA GRASS POLLEN- CYNODON DACTYLON SOLUTION
K-O-R-T AND SWEET VERNAL STANDARDIZED GRASS POLLEN MIX- POA
PRATENSIS, DACTYLIS GLOMERATA, AGROSTIS ALBA, PHLEUM PRATENSE, AND
ANTHOXANTHUM ODORATUM SOLUTION
STANDARDIZED ORCHARD GRASS POLLEN- DACTYLIS GLOMERATA SOLUTION
STANDARDIZED REDTOP POLLEN- AGROSTIS ALBA SOLUTION
STANDARDIZED SWEET VERNAL GRASS POLLEN- ANTHOXANTHUM
ODORATUM SOLUTION
STANDARDIZED TIMOTHY POLLEN- PHLEUM PRATENSE SOLUTION
STANDARDIZED PERENNIAL RYEGRASS POLLEN- LOLIUM PERENNE SOLUTION
9 SOUTHERN GRASS POLLEN MIX- POA PRATENSIS, FESTUCA ELATIOR, DACTYLIS
GLOMERATA, LOLIUM PERENNE, AGROSITIS ALBA, ANTHOXANTHUM ODORATUM, AND
PHLEUM PRATENSE SOLUTION
GREER LABORATORIES, INC.
----------
STANDARDIZED GRASS POLLEN ALLERGENIC EXTRACTS
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
STANDARDIZED GRASS POLLEN ALLERGENIC EXTRACTS SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR STANDARDIZED GRASS POLLEN ALLERGENIC
EXTRACTS.
STANDARDIZED BERMUDA GRASS POLLEN (CYNODON DACTYLON)
STANDARDIZED KENTUCKY BLUE (JUNE) GRASS POLLEN (POA PRATENSIS)
STANDARDIZED MEADOW FESCUE GRASS POLLEN (FESTUCA ELATIOR)
STANDARDIZED ORCHARD GRASS POLLEN (DACTYLIS GLOMERATA)
STANDARDIZED PERENNIAL RYE GRASS POLLEN (LOLIUM PERENNE)
STANDARDIZED RED