国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W)
ALK-Abello, Inc.
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
SAROCLADIUM STRICTUM- SAROCLADIUM STRICTUM INJECTION, SOLUTION ALTERNARIA ALTERNATA- ALTERNARIA ALTERNATA INJECTION, SOLUTION ASPERGILLUS FUMIGATUS- ASPERGILLUS FUMIGATUS INJECTION, SOLUTION AUREOBASIDIUM PULLULANS- AUREOBASIDIUM PULLULANS VAR. PULLUTANS INJECTION, SOLUTION BIPOLARIS SOROKINIANA- COCHLIOBOLUS SATIVUS INJECTION, SOLUTION BOTRYTIS CINEREA- BOTRYTIS CINEREA INJECTION, SOLUTION CANDIDA ALBICANS- CANDIDA ALBICANS INJECTION, SOLUTION CLADOSPORIUM CLADOSPORIOIDES- CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION EPICOCCUM NIGRUM- EPICOCCUM NIGRUM INJECTION, SOLUTION GIBBERELLA PULICARIS- GIBBERELLA ZEAE INJECTION, SOLUTION MUCOR PLUMBEUS- MUCOR PLUMBEUS INJECTION, SOLUTION PENICILLIUM NOTATUM- PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM INJECTION, SOLUTION RHODOTORULA MUCILAGINOSA- RHODOTORULA MUCILAGINOSA INJECTION, SOLUTION SACCHAROMYCES CEREVISIAE- SACCHAROMYCES CEREVISIAE INJECTION, SOLUTION TRICHOPHYTON MENTAGROPHYTES- TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION ALK-ABELLO, INC. ---------- DIAGNOSTIC MOLD 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. Adver 完全なドキュメントを読む