Allergen Pack Dermatophagoides Farinae Kit Recall
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Greer Standardized Mite (Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for:
- skin test diagnosis of mite allergy
- treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.
For Immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae (D. farinae) or Dermatophagoides pteronyssinus (D. pteronyssinus) based on their clinical history, allergen exposure history, and skin test reactivity.
There is currently no drug history available for this drug.
Greer Standardized Mite (Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,000, or 30,000 Allergy units/mL of sterile mite extract (D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient’s reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline.
Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium contains no material of human origin.
The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Unit/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Unit/mL.