Human Allergy Catalog - Greer

More documents

Recommendations

Info

The dosage must be reduced: 1) when starting a patient on fresh extract; 2) whentransferring a patient from another form of extract to a BAU standardized extract;or 3) when modifying dosages or components in a mixture or an individualprescription, even though the labeled strength of the old and new vials may be thesame. This reduction in dosage may be necessary: 1) due to the previously usedextract having lost potency during storage; 2) due to the fact that standardizedextracts labeled in BAU/mL differ in potency in comparison to nonstandardizedextracts of the same species (see TABLE 3); or 3) due to different patientsensitivity to different components. The amount of new extract given should notexceed 25% of the last dose given from the old vial, assuming both extractscontain comparable amounts of allergen. Any evidence of a local or generalizedreaction requires a reduction in dosage during the initial stages of immunotherapy,as well as during maintenance therapy. The information about nonstandardizedextracts shown in TABLE 3 may be helpful in confirming the appropriateness ofthe initial dose. When a patient is first being administered a standardized extractlabeled in BAU/mL, the new dose can be selected based on a side-by-sidecomparison with the previously used nonstandardized extract. The availability of10,000 BAU/mL and 100,000 BAU/mL doses is intended to facilitate safeswitching by providing the physicians access to lower and higher dosages.Patients receiving beta blocker drugs may not be responsive to beta adrenergicdrugs used to treat anaphylaxis. The risks of anaphylaxis in these patients shouldbe carefully weighed against the benefits of immunotherapy.PRECAUTIONSGENERALNot for intravenous use!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. Because of the danger of seriousreactions, caution is needed in testing exquisitely sensitive patients or patientswith labile or steroid-dependent asthma. Review the patient’s history of reactionsto previous injections and adjust dosages accordingly.The physician must be prepared to treat anaphylaxis should it occur and have thenecessary drugs and equipment on hand to do so. 20,21,31 Extracts should not beadministered by the patient or other individuals who are not prepared to treatanaphylaxis should it occur.Patients receiving allergenic extracts should be kept under observation aminimum of twenty 20 minutes so that any adverse reaction can be observed andproperly handled.22 This time should be extended to at least 30 minutes forhigh-risk patients such as those with labile or steroid-dependent asthma or thosesuffering an exacerbation of their symptoms. 32 Airway obstruction in high riskpatients can be monitored by peak flow measurements before and afteradministration of allergens.7
Check the prescription or lot number, vial number, strength, and verify thedosage schedule of the prescription for the specific patient. Only after thisverification has been made 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 agentsfrom person to person. Needles should not be recapped and should be disposedof properly.Do not use the same syringe for different extracts, nor for the diluent after usingit for an extract.INFORMATION FOR PATIENTSMost serious reactions following the administration of allergenic extracts occurwithin 30 minutes. The patient should remain under observation for this periodof time or longer if instructed by the physician. The size of any local reactionshould be recorded. Large local reactions may be indicative of subsequentsystemic reactions as dosages increase. The patient should be instructed to reportany unusual reactions. In particular, this includes unusual swelling and/ortenderness at the injection site or reactions such as rhinorrhea, sneezing,coughing, wheezing, shortness of breath, nausea, dizziness, or faintness. Reactionsmay occur some time after leaving the physician’s office, in which case medicalattention should be sought immediately.DRUG INTERACTIONSSkin test diagnosis with Allergenic Extracts may result in false negative responseswhen used within 3-10 days of H1 -Blockers such as cetrizine, loratadine, andterfenadine. The inhibitory effect of astemizole may last up to 60 days. 33 Theseproducts suppress histamine skin test reactions and could mask a positiveresponse. The suppressive action of other drugs should be considered andemphasizes the need for a histamine positive-control test.Patients receiving beta blocker drugs may not be responsive to beta adrenergicdrugs used to treat anaphylaxis. The risks of anaphylaxis in these patients shouldbe carefully weighed against the benefits of immunotherapy.CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITYThere is no evidence of carcinogenicity, mutagenesis or impairment of fertilityin humans from Standardized Grass Pollen Extracts. No long-term studies inanimals have been performed to evaluate carcinogenic potential.8
Page 1 and 2: Human AllergyProducts and ServicesE
Page 3 and 4: Ordering InformationTo set up a new
Page 5 and 6: •— Item is offered in one or mo
Page 12 and 13: Visit our website for updates at ww
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 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 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

Human Allergy Catalog - Greer

Create successful ePaper yourself

Delete template?

Save as template?