Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6), ASPERGILLUS REPENS (UNII: SQ89E6LOME) (ASPERGILLUS REPENS - UNII:SQ89E6LOME), ASPERGILLUS FLAVUS VAR. ORYZAE (UNII: Q6Z8UK5R3G) (ASPERGILLUS FLAVUS VAR. ORYZAE - UNII:Q6Z8UK5R3G), ASPERGILLUS TERREUS (UNII: QBN8K7055X) (ASPERGILLUS TERREUS - UNII:QBN8K7055X)
ALK-Abello, Inc.
FRAXINUS AMERICANA POLLEN
FRAXINUS AMERICANA POLLEN 0.05 g in 1 mL
SUBCUTANEOUS
Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. A patient should not be immunized with preparations of allergens to which the patient has not demonstrated symptoms, IgE antibodies, positive skin tests, or properly controlled challenge testing. In most cases, immunotherapy is not indicated for those allergens that can be eliminated or minimized by environmental control. Patients on beta-blockers are not candidates for immunotherapy, as they can be non-responsive to beta-agonists that may be required to reverse a systemic reaction (also see WARNINGS AND ADVERSE
10 mL and 50 mL, single antigens or specified mixtures, potency expressed in PNU/mL (up to and including 100,000 PNU/mL) or W/V (up to and including 1:10 W/V), aqueous or in 50% glycerin, to be diluted prior to use. 1:10 w/v short ragweed extracts contain ≥ 300 units/mL of AgE. STORAGE: To maintain stability of allergenic extracts, proper storage conditions are essential. Bulk concentrates and diluted extracts are to be stored at 2° to 8° C even during use. Bulk or diluted extracts are not to be frozen. Do not use after the expiration date shown on the vial label.
Biologic Licensing Application
MIXED ASPERGILLUS- ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS INJECTION, SOLUTION MIXED FEATHERS- GALLUS GALLUS FEATHER, ANAS PLATYRHYNCHOS FEATHER, ANSER ANSER FEATHER INJECTION, SOLUTION MIXED MOLDS- ALTERNARIA ALTERNATA, CLADOSPORIUM SPHAEROSPERMUM, ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS, PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM INJECTION, SOLUTION MIXED PENICILLIUM- PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM INJECTION, SOLUTION 10 TREE MIX- ACER NEGUNDO POLLEN, BETULA NIGRA POLLEN, BLACK WALNUT, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, QUERCUS RUBRA POLLEN, SALIX NIGRA POLLEN AND ULMUS AMERICANA POLLEN INJECTION, SOLUTION 4 WEED MIX- AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, XANTHIUM STRUMARIUM POLLEN INJECTION, SOLUTION BIRCH MIX- BETULA NIGRA, BETULA POPULIFOLIA INJECTION, SOLUTION ALK-ABELLO, INC. ---------- THERAPEUTIC ALLERGENIC EXTRACTS- GLYCERIN PRODUCTS DIRECTIONS FOR USE OF THERAPEUTIC ALLERGENIC EXTRACTS 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. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician’s office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur. In certain individuals, these reactions may rarely result in death. Patients should be observed for 20 to 30 minutes following treatment, and emergency measures, as well as personnel trained in their use, 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. Adverse events are to be reported to Med Watch (1-800-FDA-1088) Läs hela dokumentet