Allergen Pack Gs Ragweed Mix Kit Recall
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Questions & Answers
Side Effects & Adverse Reactions
Allergenic extracts can elicit adverse local and systemic reactions if initial dosage or rate of dosage increase is too high. These factors must be carefully evaluated by the
physician based on history, degree of sensitivity, and skin test results prior to commencement or continuation of therapy. Any person administering a biological
product should be aware of the risk of local or systemic reactions if improperly used and be capable of handling such reactions. (See below under Adverse Reactions.)
Patients receiving allergenic extracts should be kept under observation a minimum of thirty (30) minutes so that any adverse reaction can be observed and properly
handled. See information above in Description category for information on transferring patients from non-standardized to standardized extracts.
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
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Hyposensitization is indicated when careful testing and patient history can pinpoint allergens responsible for allergic symptoms, and when it is not possible or practical to
avoid these allergens. Allergenic extracts are administered to reduce symptoms of allergy of a seasonal or perennial nature.
There is currently no drug history available for this drug.
Each vial contains an extract of Short Ragweed (Ambrosia elatior) pollen or of equal parts Short and Giant Ragweed (A. trifida) pollen extracts. Extracts are supplied in a buffered saline solution with or without glycerin (50%) added as a stabilizer. Extracts are supplied as a sterile solution intended for subcutaneous or intracutaneous administration.
Each lot of Short Ragweed extract or Mixed Ragweed extract is assayed for Antigen E content using a radial immunodiffusion test1 employing known Antigen E
standards and anti-Antigen E antisera. Extracts containing Short Ragweed at a concentration of 1:20 or stronger are assayed for Antigen E. Extracts more dilute
than this are not assayed but the Antigen E content is obtained by calculation based on the Antigen E content of the concentrate.
Antigen E, a protein with a molecular weight of approximately 38,000, has been found to be a major antigenic component of Short Ragweed pollen.2,3 Antigen E
content has been shown to correlate well with skin test reactivity of ragweed extracts.4 For this reason, Antigen E content is being used to standardize Short
Ragweed extracts in addition to the protein nitrogen content or weight to volume ratios as have been used.
When transferring patients from non-standardized extracts to a standardized extract, it is advisable to compare the potency of the different lots by comparative skin testing
using the same concentrations of each extract. Marked differences in skin reactivity will indicate differences in potency and the need to adjust dosages so as to avoid
possible severe reaction.