Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
SCHINUS TEREBINTHIFOLIA POLLEN (UNII: 21MID214D4) (SCHINUS TEREBINTHIFOLIA POLLEN - UNII:21MID214D4), SCHINUS MOLLE POLLEN (UNII: M0G28FH9K1) (SCHINUS MOLLE POLLEN - UNII:M0G28FH9K1)
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-Standardized Alle
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
PEPPERTREE POLLEN MIX- SCHINUS MOLLE, SCHINUS TEREBINTHIFOLIA SOLUTION HICKORY POLLEN MIX- CARYA GLABRA, CARYA OVATA, CARYA LACINIOSA AND CARYA TOMENTOSA SOLUTION WESTERN WALNUT POLLEN MIX- JUGLANS CALIFORNICA AND JUGLANS REGIA SOLUTION WESTERN OAK POLLEN MIX- QUERCUS KELLOGGII, QUERCUS AGRIFOLIA AND QUERCUS GARRYANA SOLUTION EASTERN OAK POLLEN MIX- QUERCUS VELUTINA, QUERCUS RUBRA AND QUERCUS ALBA SOLUTION EASTERN 8 TREE POLLEN MIX- ULMUS AMERICANA, FAGUS GRANDIFOLIA, POPULUS DELTOIDES, QUERCUS RUBRA, BETULA NIGRA, CARYA OVATA, FRAXINUS AMERICANA AND ACER SACCHARUM SOLUTION WESTERN 3 TREE POLLEN MIX- OLEA EUROPAEA, ULMUS PUMILA AND PLATANUS RACEMOSA SOLUTION HICKORY-PECAN POLLEN MIX- CARYA ILLINOINENSIS AND CARYA OVATA SOLUTION ASH POLLEN MIX- FRAXINUS PENNSYLVANICA, FRAXINUS AMERICANA SOLUTION BIRCH POLLEN MIX- BETULA LENTA, BETULA NIGRA AND BETULA POPULIFOLIA SOLUTION PINE POLLEN MIX- PINUS TAEDA, PINUS STROBUS AND PINUS ECHINATA SOLUTION 11 TREE POLLEN MIX- FAGUS GRANDIFOLIA, PLATANUS OCCIDENTALIS, ULMUS AMERICANA, JUGLANS NIGRA, SALIX NIGRA, POPULUS DELTOIDES, QUERCUS RUBRA, BETULA NIGRA, CARYA OVATA, ACER SACCHARUM AND FRAXINUS AMERICANA SOLUTION EASTERN 6 TREE POLLEN MIX- FAGUS GRANDIFOLIA, POPULUS DELTOIDES, QUERCUS RUBRA, BETULA NIGRA, CARYA OVATA AND FRAXINUS AMERICANA SOLUTION JUNIPER POLLEN MIX- JUNIPERUS MONOSPERMA AND JUNIPERUS SCOPULORUM SOLUTION WESTERN 10 TREE POLLEN MIX- ACACIA DEALBATA, ACER NEGUNDO, POPULUS FREMONTII, OLEA EUROPAEA, ULMUS PUMILA, BETULA OCCIDENTALIS, JUNIPERUS OCCIDENTALIS, PLATANUS RACEMOSA, QUERCUS GARRYANA AND MORUS ALBA SOLUTION WESTERN 10 TREE POLLEN MIX- ACACIA DEALBATA, ACER NEGUNDO, POPULUS FREMONTII, OLEA EUROPAEA, ULMUS PUMILA, BETULA OCCIDENTALIS, JUNIPERUS OCCIDENTALIS, PLATANUS RACEMOSA, QUERCUS GARRYANA AND MORUS ALBA SOLUTION 11 TREE POLLEN MIX- FAGUS GRANDIFOLIA, PLATANUS OCCIDENTALIS, ULMUS AMERICANA, JUGLANS NIGRA, SALIX NIGRA, POPULUS DELTOIDES, QUERCUS RUBRA, BETULA NIGRA, CARYA OVATA, ACER SACCHARUM AND FRAXINUS AMERICANA SOLUTION 2 MAPLE POLLEN MIX- ACER R Läs hela dokumentet