Drug Information for Nonstandardized Allergenic Products (ALK-Abello, Inc.): DESCRIPTION

  • Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. Inactive ingredients in mold extracts may include residual: Potassium Phosphate, Citrate, Magnesium Phosphate and Calcium Carbonate from growth media. These products are compounded and diluted on a w/v or PNU basis.

    Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety.

    House Dust, a heterogenous, widely distributed allergen, is among the most frequently encountered allergens that can be a primary or accompanying cause of allergic symptoms. Allergens found in house dust may include mites, insects, mold spores, feathers, animal dander, pollens, hairs, and foods. Individual environs may contain certain items not ordinarily found so that a stock house dust extract may not elicit a response on testing. House Dust Extracts are prepared from dust collected from homes and from establishments which clean household rugs. It is extracted with buffered, aqueous extracting fluid. House Dust Extract is dialyzed, filtered aseptically, and is tested for sterility and safety.

    Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously.

    Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety.

  • Drug Information Provided by National Library of Medicine (NLM).