Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H), ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48), CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO), PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG)
ALK-Abello, Inc.
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
MOLD MIX A- ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, CLADOSPORIUM CLADOSPORIOIDES AND PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM INJECTION, SOLUTION MOLD MIX B- EPICOCCUM NIGRUM, GIBBERELLA ZEAE AND MUCOR PLUMBEUS INJECTION, SOLUTION MOLD MIX C- BOTRYTIS CINEREA, CANDIDA ALBICANS, RHODOTORULA MUCILAGINOSA, AND TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION ALK-ABELLO, INC. ---------- AQUEOUS THERAPEUTIC MOLD MIXES 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), Adverse Event Reporting , Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787. This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for the treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously. Refer to WARNINGS, PRECAUTIONS, and ADVER Läs hela dokumentet