Allergen Pack Eastern Cottonwood Kit Recall
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Questions & Answers
Side Effects & Adverse Reactions
Concentrated extracts must be diluted with a sterile diluent prior to first use on a patient for treatment or intradermal testing. Allergenic Extracts are manufactured to assure high potency and have the ability during skin testing and immunotherapy to cause serious local and systemic reactions including death in sensitive patients. Most reactions occur within 20 minutes after injection,(15) but may occur later.(16) To minimize the potential for local or systemic reactions, the relative sensitivity of the patient must be assessed from the allergic history and from clinical observations. Patients should be informed of these risks prior to skin testing and immunotherapy (see PRECAUTIONS and ADVERSE REACTIONS below).
Allergenic Extract immunotherapy doses should be lowered or temporarily withheld from patients if any of the following conditions exist:
(1) severe symptoms of rhinitis and/or asthma
(2) infection or flu accompanied by fever
(3) exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection
(4) evidence of a local or systemic reaction to the preceding extract injection during a course of immunotherapy
The dosage must be reduced when modifying dosages or components in a mixture or an individual prescription, or when starting a patient on fresh extract, even though the labeled strength of the old and new vials may be the same. This reduction in dosage may be necessary due to the older vial losing potency during storage, or due to different sensitivities to different components. The amount of new extract given should not exceed 25% of the last dose given from the old vial, assuming both extracts contain comparable amounts of allergen. Any evidence of a local or generalized reaction requires a reduction in dosage during the initial stages of immunotherapy, as well as during maintenance therapy.
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FDA Safety Alerts
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FDA Labeling Changes
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Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE-mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity.(4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens.(12-14) Food extracts have not been proven effective in immunotherapy.
The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION)
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Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection.
Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low-molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed.
Extracts are labeled either by weight-to-volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen.