Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
COTTON FIBER (UNII: 70LDW53ROO) (COTTON FIBER - UNII:70LDW53ROO)
Greer Laboratories, Inc.
PERCUTANEOUS
Non-Standardized Allergenic Extracts are indicated for: - Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens. - Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. Food extracts have not been proven safe or effective in allergen immunotherapy. Non-Standardized Allergenic Extracts are contraindicated in patients with: - Severe, unstable or uncontrolled asthma - History of any severe systemic or local allergic reaction to an allergen extract 8.1 Pregnancy Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There are no human or animal data to establish the presence or absence of Non-Standardize
Non-Standardized Allergenic Extracts and mixes may be supplied as aqueous stock concentrates of up to 1:10 weight/volume or 40,000 PNU/milliliter for intradermal and subcutaneous testing. The extracts may also be supplied as 50% glycerin stock concentrates of up to 1:20 weight/volume for use in percutaneous skin testing and subcutaneous immunotherapy. Non-Standardized Allergenic Extracts are labeled in weight/volume and/or PNU/milliliter and may be provided in 5, 10, and 50 milliliter vials. Glycerinated extracts are also supplied in 5 milliliter dropper vials for prick or puncture testing. Non-Standardized Allergenic Extracts available are as follows: *SFS – Sodium Formadehyde Sulfoxylate 16.2 Storage and Handling Maintain at 2 to 8°C (36 to 46°F) during storage and use. Dilutions of concentrated extracts that result in a glycerin content of less than 50% can reduce extract stability. Extract dilutions at 1:100 volume to volume 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 allergic patient.
Biologic Licensing Application
COTTON LINTERS- GOSSYPIUM HIRSUTUM SOLUTION KAPOK- CEIBA PENTANDRA SOLUTION TOBACCO, LEAF- NICOTIANA TABACUM SOLUTION COTTONSEED- GOSSYPIUM HIRSUTUM SOLUTION FLAXSEED- LINUM USITATISSIMUM SOLUTION GUM ARABIC- ACACIA SENEGAL SOLUTION KARAYA GUM- STERCULIA URENS SOLUTION TRAGACANTH GUM- ASTRAGALUS GUMMIFER SOLUTION ORRIS ROOT- IRIS GERMANICA SOLUTION PYRETHRUM- CHRYSANTHEMUM CINERARIIFOLIUM SOLUTION GREER LABORATORIES, INC. ---------- NON STANDARDIZED ALLERGENIC EXTRACTS POLLENS, MOLDS, EPIDERMALS, INSECTS, DUSTS, FOODS, AND MISCELLANEOUS INHALANTS HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NON- STANDARDIZED ALLERGENIC EXTRACTS (POLLENS, MOLDS, EPIDERMALS, INSECTS, FOODS AND MISCELLANEOUS INHALANTS) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NON-STANDARDIZED ALLERGENIC EXTRACTS. NON-STANDARDIZED ALLERGENIC EXTRACTS (POLLENS, MOLDS, EPIDERMALS, INSECTS, FOODS, AND MISCELLANEOUS INHALANTS) SOLUTIONS FOR PERCUTANEOUS, INTRADERMAL OR SUBCUTANEOUS ADMINISTRATION. INITIAL U.S. APPROVAL: 1968 WARNING: SEVERE ALLERGIC REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ NON-STANDARDIZED ALLERGENIC EXTRACTS CAN CAUSE SEVERE LIFE-THREATENING SYSTEMIC REACTIONS, INCLUDING ANAPHYLAXIS. (5.1) DO NOT ADMINISTER THESE PRODUCTS TO PATIENTS WITH SEVERE, UNSTABLE OR UNCONTROLLED ASTHMA. (4) OBSERVE PATIENTS IN THE OFFICE FOR AT LEAST 30 MINUTES FOLLOWING TREATMENT.EMERGENCY MEASURES AND PERSONNEL TRAINED IN THEIR USE MUST BE AVAILABLE IMMEDIATELY IN THE EVENT OF A LIFE-THREATENING REACTION. (5.1) PATIENTS WITH EXTREME SENSITIVITY TO THESE PRODUCTS, ON AN ACCELERATED IMMUNOTHERAPY BUILD-UP, SWITCHING TO ANOTHER LOT, RECEIVING HIGH DOSES OF THESE PRODUCTS, AND PATIENTS EXPOSED TO SIMILAR ALLERGENS MAY BE AT INCREASED RISK OF A SEVERE ALLERGIC REACTION. (5.1) THESE PRODUCTS MAY NOT BE SUITABLE FOR PATIENTS WITH CERTAIN UNDERLYING MEDICAL CONDITIONS THAT MAY REDUCE THEIR ABILITY TO SURVIVE A SYSTEMIC A Baca dokumen lengkapnya