País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW), RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G)
ALK-Abello, Inc.
ALTERNARIA ALTERNATA
ALTERNARIA ALTERNATA 0.1 g in 1 mL
PERCUTANEOUS
These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been exposed. By measuring skin test response, the physician may assess the degree of sensitivity that patients have to the allergens. For extracts standardized in AU and BAU, see individual directions for use. Allergenic extracts for diagnostic use only of coffee, mosquito, cottonseed, and flaxseed have not been shown by adequate data to be safe and effective for therapeutic use. Patients on beta blockers can be non-responsive to beta agonists that may be required to reverse a systemic reaction (also, see boxed WARNING statement and ADVERSE REACTIONS ). The physician should carefully weigh the benefit derived from skin testing vs. the risk to the patient should a systemic reaction arise. Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater
For scratch and prick testing: 5 mL dropper applicator vials in 50% v/v glycerin or 10mL stoppered vial in 50% v/v glycerin. Available individually and in a complete set of the most common allergens. Available in either Protein Nitrogen Units (PNU/mL) or weight to volume (w/v). For intracutaneous testing: 5 mL sterile vials, aqueous based, individually and in a complete set of the most common allergens. Available in either Protein Nitrogen Units (PNU/mL) or weight to volume (w/v). Histatrol ® Positive skin test control - histamine. 1 mg/mL and 0.1 mg/mL histamine base. See Product Catalog for specific diagnostic concentrations available.
Biologic Licensing Application
SORREL/DOCK MIX- RUMEX ACETOSELLA POLLEN AND RUMEX CRISPUS POLLEN INJECTION, SOLUTION MIXED MOLDS- ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM AND PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM INJECTION, SOLUTION MIXED PENICILLIUM- PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM INJECTION, SOLUTION MIXED RAGWEED- AMBROSIA ARTEMISIIFOLIA AND AMBROSIA TRIFIDA POLLEN INJECTION, SOLUTION MOLD MIX 2- AUREOBASIDIUM PULLULANS VAR. PULLUTANS, CURVULARIA INAEQUALIS, GIBBERELLA ZEAE, MUCOR PLUMBEUS AND RHIZOPUS ARRHIZUS INJECTION, SOLUTION ALK-ABELLO, INC. ---------- SCRATCH NONSTANDARDIZED PRODUCTS ALLERGENIC EXTRACTS, FOR DIAGNOSTIC USE ONLY DIRECTIONS FOR USE WARNING This 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. As with all allergenic extracts, severe systemic reactions may occur. In certain individuals these life-threatening reactions may result in death. Fatalities associated with skin testing have been reported. Patients should be observed for at least 20 - 30 minutes following testing. Emergency measures and adequately trained personnel should be immediately available in the event of a life-threatening reaction. Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk to a fatal outcome from a systemic allergic reaction. Sensitive patients may experience severe anaphlactic reactions resulting in respiratory obstruction, shock, coma and/or death. Adverse events are to be reported to MedWatch (1-800-FDA-1088), Adverse Event Reporting, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787. This product should not be injected intravenously. Patients receiving beta blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not respond Leia o documento completo