Standardized Short Ragweed Pollen Recall
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Questions & Answers
Side Effects & Adverse Reactions
Refer to boxed “WARNINGS”, “PRECAUTIONS”, “ADVERSE REACTIONS” and “OVERDOSAGE” sections.
Extreme caution is necessary when using diagnostic skin tests or injection treatment in highly sensitive patients who have experienced severe symptoms or anaphylaxis by natural exposure or previous skin testing or treatment. IN THESE CASES THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENT’S SENSITIVITY AND TOLERANCE.
Benefit versus risk needs to be evaluated in patients with unstable asthma, steroid dependent asthmatics or patients with underlying cardiovascular disease.
Injections should never be given intravenously. A 5/8 inch, 25 gauge needle on a sterile syringe allows deep subcutaneous injection. Withdraw plunger slightly after inserting needle to determine if a blood vessel has been entered.
Proper measurement of dose and caution in making injection will minimize reactions. Adverse reactions to allergenic extracts are usually apparent within 20-30 minutes following injection of immunotherapy.
Extract should be temporarily withheld or dosage reduced in case of any of the following conditions: 1) flu or other infection with fever; 2) exposure to excessive amounts of allergen prior to injection; 3) rhinitis and/or asthma exhibiting severe symptoms; 4) adverse reaction to previous injection until cause of reaction has been evaluated by physician supervising patient’s immunotherapy program.
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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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INDICATIONS AND USAGE
Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to short ragweed pollen. Confirmation is determined by skin testing.
There is currently no drug history available for this drug.
Antigen Laboratories’ Standardized Short Ragweed allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin.
Standardized Short Ragweed allergenic extract is assigned arbitrary Allergy Units of 100,000 AU/ml based on being equipotent by Enzyme-Linked Immunosorbent Assay (ELISA) to a Center for Biologics Evaluation and Research (CBER) reference.
The following testing is also performed:
1. Microscopic examination to confirm identity and purity of source pollen.
2. Isoelectric focusing (IEF) pattern of source material and final products are compared to respective CBER reference extract.
3. Antigen E (Amb a I) is considered to be the major allergenic protein of short ragweed. The Antigen E content of short ragweed extracts is determined by radial immunodiffusion assay using CBER standards and anti-serum. Standardized Short Ragweed (100,000 AU/ml) extracts contain 200-400 antigen E units per milliliter.
4. Ninhydrin protein analysis.
5. Glycerine analysis.
6. Sterility testing.
7. Safety testing.
Active ingredients: Allergens are described by common and scientific name on container label. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection.