Human Allergy Catalog - Greer

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WARNINGTHIS ALLERGENIC PRODUCT IS INTENDED FOR DIAGNOSTIC USEONLY. THIS PRODUCT IS INTENDED FOR USE BY PHYSICIANS WHOARE EXPERIENCED IN THE ADMINISTRATION OF ALLERGENICEXTRACTS AND THE EMERGENCY CARE OF ANAPHYLAXIS, ORFOR USE UNDER THE GUIDANCE OF AN ALLERGY SPECIALIST.ALLERGENIC EXTRACTS MAY CAUSE SEVERE OR FATALANAPHYLAXIS IN EXTREMELY SENSITIVE PATIENTS. THIS PRODUCTSHOULD NOT BE INJECTED INTRAVENOUSLY. REFER ALSO TO THEWARNINGS, PRECAUTIONS, ADVERSE REACTIONS AND OVERDOSAGESECTION BELOW.DESCRIPTIONAllergenic Extracts intended for diagnostic skin testing are for scratch, prick,puncture or intradermal use only. The extracts are supplied as sterile solutionswhich contain the soluble extractants of the allergen source material in abuffered saline solution with or without glycerin (50% v/v) added as a stabilizer.Concentrated aqueous extracts contain the soluble extractants of the sourcematerial with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of6.8 to 8.4 in water for injection. Dilutions of aqueous extracts are made withbuffered saline (0.5% sodium chloride, 0.04% potassium phosphate, 0.11%sodium phosphate heptahydrate, and 0.4% phenol in water for injection).Glycerinated extracts are concentrated aqueous extracts diluted to 50% v/vwith USP Glycerin. Aqueous extracts contain 0.4% phenol as a preservative(0.2% phenol if glycerinated). Certain food extracts contain 0.1% sodiumformaldehyde sulfoxylate as an antioxidant. Extracted source material substancesare obtained as near as possible in the naturally occurring form to which a patientmay be exposed.Extracts labeled for diagnostic use only include the following foods: Barley,Coffee, Oat, Pineapple, Rye, Spinach, and Wheat. Other extracts for diagnosticonly are Flea, House Fly, Mosquito, Moth, Cottonseed, and Flax Seed.Extracts are labeled either by weight-to-volume (w/v) based on the weight of thesource material to the volume of the extracting fluid, or in protein nitrogen units(PNU) based on assay with one PNU representing 10 micrograms of proteinnitrogen. (See separate package inserts for standardized extracts such as cat hair,mite, or ragweed.)CLINICAL PHARMACOLOGYAllergen specific skin test reactions are mediated by specific immunoglobulin E(IgE) antibodies on the surface of mast cells. Interaction of allergens withcell-bound IgE induces cross linking of the IgE receptor which triggers therelease of inflammatory mediators, particularly histamine. The characteristicmediator-induced induration (wheal) and erythema (flare) reaction observedupon diagnostic skin testing is an indication of specific allergy. 1 Allergenpharmacokinetics have not been characterized.1
INDICATIONS AND USAGEFOR DIAGNOSTIC USE ONLY - Allergenic Extracts are indicated for skin testassessment of the allergic state in patients with suspected IgE-mediated,immediate hypersensitivity allergy to the respective allergens when inhaled,ingested, or otherwise introduced into contact with sensitive tissues. Thediagnosis of allergy may be established by the allergy history, clinical evaluation,and skin test reactivity.There are no reported limitations such as age group orprogression of disease.Extracts labeled FOR DIAGNOSTIC USE ONLY have not been shown byadequate data to be safe and effective for therapeutic use.The use of Allergenic Extracts for the above purposes should be made onlyby physicians with special familiarity and knowledge of allergy. (See DOSAGEAND ADMINISTRATION)CONTRAINDICATIONSThere are no known absolute contraindications to the use of Allergenic Extractsfor skin test diagnosis.Use of diagnostic extracts may be contraindicated in individuals with bleedingdisorders or skin disease.Skin test reactions can be suppressed when patients have received antihistaminemedications within 24 hours, within 48 hours for terfenadine, or within 21 daysor longer for astemizole. See DRUG INTERACTIONS.WARNINGSConcentrated extracts must be diluted with a sterile diluent (such as normalsaline, buffered saline, saline with human serum albumin, or saline with 10%glycerin) prior to use in a patient for intradermal testing. Concentrates ofAllergenic Extracts are manufactured to assure high potency and have the abilityto cause serious local and systemic reactions including death in sensitive patients.Most reactions occur within 20 minutes after injection, but may occur later.To minimize the potential for local or systemic reactions, the relative sensitivityof the patient must be assessed from the allergic history and from clinicalobservations. Patients should be informed of the possibility of these reactionsand the precautions should be discussed prior to testing (see PRECAUTIONSand ADVERSE REACTIONS below).PRECAUTIONSGENERALNot for intravenous or intramuscular use!Systemic allergic reactions may occur as a result of the use of Allergenic Extracts.The physician must be prepared to treat anaphylaxis should it occur and havethe necessary drugs, such as epinephrine, and equipment on hand to do so.Extracts should not be administered by individuals who are not prepared to treatanaphylaxis should it occur. 2 2
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Page 40 and 41: TABLE 1Puncture Skin Tests with 10,
Page 42 and 43: *CAUTION: Only a few lots of each n
Page 44 and 45: The dosage must be reduced: 1) when
Page 46 and 47: PREGNANCYTERATOGENIC EFFECTSPREGNAN
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Page 50 and 51: The initial dose of the extract may
Page 52 and 53: 6 Elgefors, B., Julin, A., Johansso
Page 54 and 55: GH APR04L-516Rev 10/0417
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Page 58 and 59: Children with nephrotic syndrome re
Page 60 and 61: The suppressive action of other dru
Page 62 and 63: determine the degree of sensitivity
Page 64 and 65: To prepare dilutions for intraderma
Page 66 and 67: 18. Executive Committee, American A
Page 68 and 69: a 1:10 dilution by adding 0.5 mL of
Page 70 and 71: WARNINGAllergenic extracts can elic
Page 72 and 73: DOSAGE AND ADMINISTRATIONA. Testing
Page 74: STORAGEShort Ragweed containing ext
Page 80 and 81: A separate, sterile testing device,
Page 82 and 83: DOSAGE AND ADMINISTRATIONTECHNIQUES
Page 84: RESPONSESTests should be read 15 to
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Human Allergy Catalog - Greer

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