Human Allergy Catalog - Greer

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WARNINGAllergenic extracts can elicit severe adverse reactions when improperly administered(see below under Warnings). Any person administering allergenic extracts should beexperienced in their use, aware of the risk of adverse reactions, and capable ofproperly handling such reactions.DESCRIPTIONEach vial contains an extract of Short Ragweed (Ambrosia elatior) pollen or ofequal parts Short and Giant Ragweed (A. trifida) pollen extracts. Extracts aresupplied in a buffered saline solution with or without glycerin (50%) added as astabilizer. Extracts are supplied as a sterile solution intended for subcutaneous orintracutaneous administration.Each lot of Short Ragweed extract or Mixed Ragweed extract is assayed forAntigen E content using a radial immunodiffusion test 1 employing known Antigen Estandards and anti-Antigen E antisera. Extracts containing Short Ragweed at aconcentration of 1:20 or stronger are assayed for Antigen E. Extracts more dilutethan this are not assayed but the Antigen E content is obtained by calculation basedon the Antigen E content of the concentrate.Antigen E, a protein with a molecular weight of approximately 38,000, has beenfound to be a major antigenic component of Short Ragweed pollen. 2,3 Antigen Econtent has been shown to correlate well with skin test reactivity of ragweedextracts. 4 For this reason, Antigen E content is being used to standardize ShortRagweed extracts in addition to the protein nitrogen content or weight to volumeratios as have been used.When transferring patients from non-standardized extracts to a standardized extract,it is advisable to compare the potency of the different lots by comparative skin testingusing the same concentrations of each extract. Marked differences in skin reactivitywill indicate differences in potency and the need to adjust dosages so as to avoidpossible severe reaction.CLINICAL PHARMACOLOGYControlled studies employing Ragweed extracts and Antigen E immunotherapy havedemonstrated an increase in Ragweed antigen-specific blocking antibodies. Thesestudies also demonstrated significant symptom amelioration in Ragweed allergicindividuals. 5,6 The total mechanism of immunotherapy is not yet known and is stillbeing investigated.INDICATIONSHyposensitization is indicated when careful testing and patient history can pinpointallergens responsible for allergic symptoms, and when it is not possible or practical toavoid these allergens. Allergenic extracts are administered to reduce symptoms ofallergy of a seasonal or perennial nature.
CONTRAINDICATIONSImmunotherapy with Ragweed antigens is contraindicated in those individuals whodo not exhibit skin test or clinical sensitivity to Ragweed antigens. (See below underWarnings and Precautions)WARNINGSAllergenic extracts can elicit adverse local and systemic reactions if initial dosage orrate of dosage increase is too high. These factors must be carefully evaluated by thephysician based on history, degree of sensitivity, and skin test results prior tocommencement or continuation of therapy. Any person administering a biologicalproduct should be aware of the risk of local or systemic reactions if improperly usedand be capable of handling such reactions. (See below under Adverse Reactions.)Patients receiving allergenic extracts should be kept under observation a minimum ofthirty (30) minutes so that any adverse reaction can be observed and properlyhandled. See information above in Description category for information ontransferring patients from non-standardized to standardized extracts.PRECAUTIONSCheck lot number and dosage schedule of patient to verify correctness ofprescription number or vial number. Only after this verification has been made shouldan appropriate injection be given. A separate sterile needle and syringe should beused for each patient to prevent transmission of homologous serum hepatitis andother infectious agents.Pregnancy Category C. Animal reproduction studies have not been conducted withallergenic extracts. It is also not known whether allergenic extracts can cause fetalharm when administered to a pregnant woman or whether it can affect reproductioncapacity.ADVERSE REACTIONS:Allergic reactions following injections of allergens include generalized erythema,pruritis, rhinitis, asthma, and laryngeal edema. Syncope, shock, and hypotensionhave also been reported. Adverse reactions should be treated as follows:A. A tourniquet should be immediately applied to the extremity above the siteof injection. Release tourniquet every few minutes for a few seconds.B. Epinephrine 1:1000 should be injected immediately in the opposite arm inamounts of 0.3 to 0.5 mL and 0.2 mL epinephrine should be administeredat the site of injection. For children below the age of 6 years, adjustdosage of epinephrine to 0.005 mL per pound of body weight per dose.Repeat epinephrine dosage in 15 minutes if necessary and if symptomspersist.C. Adverse reactions not responding to epinephrine therapy may require theuse of parenteral bronchodilators, vasopressors, oxygen, or volumereplacement therapy.
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Page 36 and 37: GREER Human AllergyPO Box 800639 Nu
Page 38 and 39: WARNINGTHIS ALLERGENIC PRODUCT IS I
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
Page 48 and 49: dilution, testing with individual e
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
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 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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