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Non-Standardized Extracts

Non-standardized

Extracts Allergenic extracts that are considered

Non-standardized

do not undergo additional laboratory testing to verify relative biologic strength. Instead,

Non-standardized

extracts are assigned potency values based on either the product’s extraction ratio (source material-to-extracting solution) or on an estimated measure of total protein. Weight-to-Volume (w/v): This is simply a ratio of grams of dry… read more 705357C1-B577-4332-A248-2D41FB183786Created with sketchtool.

References

Home  >  References References General References Used Throughout Stability References Painful Injection From 50% Glycerin FDA Standardization Major Allergen And Standardization Regional Relevance Of Allergens Cross-Reactivity Management Of Anaphylaxis Coring & Syringe Technique Skin Testing USP 797 References – Beyond Use Date, Pharmacy Compounding Rules Allergen Information General References Used Throughout Cox, L, et al.… read more 705357C1-B577-4332-A248-2D41FB183786Created with sketchtool.

W/V

w/v, weight to volume. A ratio of the weight of dry raw material per volume of extracting fluid, expressed in grams per mL or kg per L. For example, 1:10 w/v implies that one gram of dry allergenic material (e.g. pollen) was extracted in 10 mL of extracting solution. A 1:20 w/v extract is half… read more 705357C1-B577-4332-A248-2D41FB183786Created with sketchtool.

Anaphylaxis Crash Cart

Anaphylaxis Crash Cart In addition to the recommended routine supplies, every practice that intends to perform allergen immunotherapy must be supplied and trained for possible severe systemic reactions, such as anaphylaxis. Below is a list of recommended emergency supplies that should be stocked separately from the routine supplies. Modifications may be necessary depending on the… read more 705357C1-B577-4332-A248-2D41FB183786Created with sketchtool.

Dosing

Dosing One of the primary objectives when mixing allergenic extracts is to prepare a patient’s treatment set in a way that ensures an optimal therapeutic dose of each allergen in the patient’s allergen extract vial. Therefore, the limiting step when mixing is deciding what volume of each allergen to add to a patient’s maintenance vial.… read more 705357C1-B577-4332-A248-2D41FB183786Created with sketchtool.

Effect of Formulation on Stability

Effect of Formulation on Stability Below is a figure that shows how expiration dating varies by formulation. For standardized products, these dates were established through FDA-approved testing methods. For

Non-standardized

products, these dates were established by the FDA. For more information on extract formulation, please see the section on Extract Formulations Expiration dates for bulk… read more 705357C1-B577-4332-A248-2D41FB183786Created with sketchtool.