Human Allergy Catalog - Greer

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Children with nephrotic syndrome require careful consideration and probably shouldnot receive injection therapy because a variety of seemingly unrelated events, such asimmunization, can cause an exacerbation of their nephrotic disease.Other contraindications include:EXTREME SENSITIVITY TO CAT - Determined from previous anaphylaxis followingskin testing.AUTOIMMUNE DISEASE - Individuals with autoimmune disease may be at risk, dueto the possibility of routine immunizations exacerbating symptoms of the underlyingdisease.WARNINGSPlease also refer to warning box at beginning of package insert.Concentrated extracts must be diluted with sterile diluent prior to first use ona patient for immunotherapy or intradermal testing. All concentrates of allergenicextracts are manufactured to assure high potency and therefore have the ability duringskin testing and immunotherapy to cause serious local and systemic reactions includingdeath in sensitive patients. Most reactions occur within 20 minutes after injection, (18)but may occur later. (19) To minimize the potential for local or systemic reactions, therelative sensitivity of the patient must be assessed from the allergic history and fromclinical observations. Patients should be informed of this and the precautions should bediscussed prior to immunotherapy (see PRECAUTIONS below).Standardized Cat Hair Extract labeled in Bioequivalent Allergy Units is notinterchangeable with Standardized Cat Pelt Extract or with cat extracts labeled inAllergy Units. Patient doses stated or calculated in Allergy Units should not beconfused with Bioequivalent Allergy Units because the BAU is ten times as potent asthe Allergy Unit used for cat extracts before September 1992.The dosage must be reduced when starting a patient on fresh Standardized Cat HairExtract or when transferring a patient from any other cat extract product to StandardizedCat Hair Extract (even though the labeled strength of the old and new vials may be thesame). This reduction in dosage may be necessary due to a loss of extract potencyduring storage in the physician's office. The cat allergen content of old and newextracts must be compared and adjusted by dosage reduction and/or dilutionbefore the new extract is administered. The amount of new extract given should notexceed 25% of the last dose given from the old vial, assuming both extracts containcomparable amounts of cat allergens. Any evidence of a local or generalized reactionrequires a reduction in dosage during the initial stages of immunotherapy, as well asduring maintenance therapy.Allergenic extracts should be temporarily withheld from patients or the dose adjusteddownward if any of the following conditions exist:(1) severe symptoms of rhinitis and/or asthma(2) infection or flu accompanied by fever(3) exposure to excessive amounts of clinically relevant allergen prior to a scheduledinjection.
Risk of anaphylaxis should be weighed against benefits of immunotherapy: inpatients receiving beta blockers as they may not be responsive to beta adrenergicdrugs should anaphylaxis occur; in patients with unstable or steroid-dependent asthma;or in patients with cardiovascular disease.Not for intravenous use!PRECAUTIONSGENERAL:Systemic allergic reactions may occur as a result of immunotherapy. The risk canbe minimized by adherence to a careful injection schedule, which starts with a lowconcentration of extract and is increased slowly. The physician must be prepared totreat anaphylaxis should it occur and have the necessary drugs and equipment on handto do so. (20) Extracts should not be administered by the patient or other individuals whoare not prepared to treat anaphylaxis should it occur.Patients receiving allergenic extracts should be kept under observation a minimumof 20 minutes so that any adverse reaction can be observed and properly handled. Thistime should be extended to at least 30 minutes for high-risk patients such as those withlabile or steroid-dependent asthma or those suffering an exacerbation of theirsymptoms. (24) Airway obstruction in high risk patients can be monitored by peak flowmeasurements before and after administration of allergens.Check the prescription or lot number, vial number, strength, and verify the dosageschedule of the prescription for the specific patient. Only after this verification has beenmade should an injection be given.A separate, sterile syringe and needle or sterile disposable unit must be used foreach patient to prevent the transmission of hepatitis or other infectious agents fromperson to person. Needles should not be recapped and should be disposed of properly.Do not use the same syringe for different extracts, nor for the diluent after using it foran extract.INFORMATION FOR PATIENTS:Most serious reactions following the administration of allergenic extracts occur within20 minutes; the patient should remain under observation for this period of time or longerif instructed by the physician. (18) The size of the local reaction should be recorded,because increasingly large local reactions may precede a subsequent systemic reactionwith increasing dosage. In particular, this includes unusual swelling and/or tendernessat the injection site or reactions such as shortness of breath, rhinorrhea, sneezing,coughing, wheezing, nausea, dizziness or faintness. Reactions may occur some timeafter leaving the physician's office, in which case medical attention should be soughtimmediately.The patient should be instructed to report any unusual reactions to the physician.DRUG INTERACTIONS:Skin test diagnosis with Allergenic Extracts may result in false negative responseswhen used within 3-10 days of H 1 -Blockers such as cetrizine, loratadine, andterfenadine. The inhibitory effect of astemizole may last up to 60 days. (25) Theseproducts suppress histamine skin test reactions and could mask a positive response.
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Page 82 and 83: DOSAGE AND ADMINISTRATIONTECHNIQUES
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Human Allergy Catalog - Greer

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