Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
BROWN RICE (UNII: 659G217HPG) (BROWN RICE - UNII:659G217HPG)
Greer Laboratories, Inc.
SUBCUTANEOUS
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-Standardized A
16.1 How Supplied 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
RICE FOOD- ORYZA SATIVA SOLUTION RYE FOOD- SECALE CEREALE SOLUTION SESAME SEED- SESAMUM INDICUM SOLUTION BROCCOLI- BRASSICA OLERACEA VAR. BOTRYTIS SOLUTION BUCKWHEAT- FAGOPYRUM ESCULENTUM SOLUTION CASHEW NUT- ANACARDIUM OCCIDENTALE SOLUTION CAULIFLOWER- BRASSICA OLERACEA VAR. BOTRYTIS SOLUTION CHOCOLATE CACAO BEAN- THEOBROMA CACAO SOLUTION CANTALOUPE MUSKMELON- CUCUMIS MELO SOLUTION CARROT- DAUCUS CAROTA SOLUTION CELERY- APIUM GRAVEOLENS VAR. DULCE SOLUTION LETTUCE- LACTUCA SATIVA SOLUTION FILBERT HAZELNUT FOOD- CORYLUS AMERICANA SOLUTION VANILLA- VANILLA PLANIFOLIA SOLUTION WHOLE WHEAT- TRITICUM AESTIVUM SOLUTION APRICOT- PRUNUS ARMENIACA SOLUTION WHOLE GRAIN BARLEY- HORDEUM VULGARE SOLUTION NAVY BEAN- PHASEOLUS VULGARIS SOLUTION STRING GREEN BEAN- PHASEOLUS VULGARIS SOLUTION CABBAGE- BRASSICA OLERACEA VAR. CAPITATA SOLUTION CINNAMON- CINNAMOMUM VERUM SOLUTION COFFEE- COFFEA ARABICA SOLUTION MUSHROOM- AGARICUS CAMPESTRIS SOLUTION MUSTARD FOOD- SINAPIS ALBA SOLUTION BANANA- MUSA ACUMINATA SOLUTION COCONUT- COCOS NUCIFERA SOLUTION CORN FOOD- ZEA MAYS SOLUTION MALT- HORDEUM VULGARE SOLUTION BLACK PEPPER- PIPER NIGRUM SOLUTION LEMON- CITRUS X LIMON SOLUTION OAT FOOD- AVENA SATIVA SOLUTION ONION- ALLIUM CEPA SOLUTION CUCUMBER- CUCUMIS SATIVUS SOLUTION BLUEBERRY- VACCINIUM MYRTILLOIDES SOLUTION GINGER- ZINGIBER OFFICINALE SOLUTION WHITE SEEDLESS GRAPE- VITIS VINIFERA SOLUTION TOMATO- SOLANUM LYCOPERSICUM SOLUTION GARLIC- ALLIUM SATIVUM SOLUTION SOYBEAN FOOD- GLYCINE MAX SOLUTION SPINACH- SPINACIA OLERACEA SOLUTION GREEN PEPPER- PIPER NIGRUM SOLUTION PINEAPPLE- ANANAS COMOSUS SOLUTION STRAWBERRY- FRAGARIA X ANANASSA SOLUTION YELLOW SUMMER SQUASH- CUCURBITA PEPO VAR. OVIFERA SOLUTION BRAZIL NUT- BERTHOLLETIA EXCELSA SOLUTION CRANBERRY- VACCINIUM MACROCARPON SOLUTION GREEN OLIVE- OLEA EUROPAEA SOLUTION CHERRY- PRUNUS AVIUM SOLUTION LIMA BEAN- PHASEOLUS LUNATUS SOLUTION HOPS FOOD- HUMULUS LUPULUS SOLUTION NUTMEG- MYRISTICA FRAGRANS SOLUTION PECAN FOOD- CARYA ILLINOINENSIS SOLUTION SWEET POTATO- IPOMOEA BATATAS SOLUTION WH Perskaitykite visą dokumentą