Application Nr Approved Date Route Status External Links
BLA103058 None Subcutaneous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Indicated Use Of Allergenic Extracts Is For The Diagnosis And Treatment (hyposensitization Therapy) Of Patients Who Experience Allergic Symptoms Due To Exposure To Grass Pollen And Who Exhibit Type I Skin Sensitivity When Tested To Those Specific Allergens. Hyposensitization (injection) Therapy Is A Treatment For Patients Exhibiting Allergic Reactions To Seasonal Pollens, Dust Mites, Molds, Animal Danders, And Various Other Inhalants In Situations Where The Offending Allergen Cannot Be Avoided. For Previously Untreated Patients, Prior To The Initiation Of Therapy, Clinical Sensitivity To The Standardized Grass Pollen Extract Should Be Established By Careful Evaluation Of The Patient's History Confirmed By Diagnostic Skin Testing. Hyposensitization Should Not Be Prescribed For Sensitivities To Allergens Which Can Easily Be Avoided. Standardized Grass Pollen Extracts Labeled In Bau/ml Are Not Interchangeable With Grass Pollen Extracts Labeled In Au/ml Or Non-Standardized Grass Pollen Extracts. 10,000 Bau/ml Extracts Are Indicated For Percutaneous Testing. If Negative, The 100,000 Bau/ml Dose May Be Used. Availability Of 10,000 And 100,000 Bau/ml Dosages Facilitate Safe Switching. Patients Who Tolerate Dilutions Prepared From The 10,000 Bau/ml Dosage And Require A Higher Dose May Be Treated With Dilutions Prepared From The 100,000 Bau/ml Dosage. 100,000 Bau/ml Concentrations May Be Especially Useful When Patients Are Hyposensitized To Numerous Allergens. Mixing Of Allergenic Extracts Dilutes The Potency Of Each Constituent. Using Higher Concentrations Such As 100,000 Bau/ml Allows For Dilution With Other Extracts Without Sacrificing Immunizing Properties. Caution: The Final Potency Of Each Individual Component In A Patient Mixture Should Never Exceed 10,000 Bau/ml. See Also, Dosage And Administration Section For Discussion Of Mixture Labeling.

All Formulated Excipients (0 Total)


Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Phleum Pratense Pollen