Sugar Beet Pollen
Allergenic Extract
c7d383a6-94b8-4101-8a4c-fa7747a21468
HUMAN PRESCRIPTION DRUG LABEL
Nov 13, 2009
Antigen Laboratories, Inc.
DUNS: 030705628
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Number Fourteen Grass Mixture
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FDA regulatory identification and product classification information
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INGREDIENTS (18)
Bahia Grass
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INGREDIENTS (5)
Bahia Grass
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INGREDIENTS (5)
Johnson Grass Pollen
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INGREDIENTS (5)
Sweet Clover Mixture
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INGREDIENTS (6)
Western Wheatgrass
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INGREDIENTS (5)
Sudan Grass
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INGREDIENTS (5)
Cultivated Oat Pollen
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INGREDIENTS (5)
Velvet Grass
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INGREDIENTS (5)
Cultivated Wheat
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INGREDIENTS (5)
Drug Labeling Information
BOXED WARNING SECTION
WARNINGS
ADVERSE REACTIONS SECTION
ADVERSE REACTIONS
Adverse reactions include, but are not limited to urticaria; itching; edema of extremities; respiratory wheezing or asthma; dyspnea; cyanosis; tachycardia; lacrimation; marked perspiration; flushing of face, neck or upper chest; mild persistent clearing of throat; hacking cough or persistent sneezing.
- Local Reactions
A mild burning immediately after injection is expected; this usually subsides in 10-20 seconds. Prolonged pain or pain radiating up arm is usually the result of intramuscular injection, making this injection route undesirable. Subcutaneous injection is the recommended route.
Small amounts of erythema and swelling at the site of injection are common. Reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm in diameter.
Larger local reactions are not only uncomfortable, but indicate the possibility of a severe systemic reaction if dosage is increased. In such cases dosage should be reduced to the last level not causing reaction and maintained for two or three treatments before cautiously increasing.
Large, persistent local reactions or minor exacerbations of the patient’s allergic symptoms may be treated by local cold applications and/or use of oral antihistamines.
- Systemic Reactions
Systemic reactions range from mild exaggeration of patient’s allergic symptoms to anaphylactic reactions.14 Very sensitive patients may show a rapid response. It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. Fatalities are rare but can occur.5 Other possible systemic reaction symptoms are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis,and urticaria.13, 14
Careful attention to dosage and administration limit such reactions. Allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and prepare for treatment of severe reactions. Refer to “OVERDOSAGE” section.