FDA label afc65820-1d95-4bc6-81a6-ef5ca82cbd81

WARNINGS Allergenic extract is intended for use by physicians or under the guidance of physicians who are experienced in the administration of allergenic extracts for diagnosis and the emergency care of anaphylaxis. This extract is not directly interchangeable with other allergenic extracts. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur. In certain individuals, especially in steroid-dependent/unstable asthmatics, these life-threatening reactions may result in death . Patients should be observed for at least 20 minutes following testing. Emergency measures, as well as trained personnel, should be immediately available in the event of a life-threatening reaction. This product should not be injected intravenously. See the "WARNINGS", "PRECAUTIONS", "ADVERSE REACTIONS" and "OVERDOSAGE" sections. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. Report serious adverse events to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, phone 1-800-FDA-1088. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators . Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously. Refer to ''WARNINGS", "PRECAUTIONS" and "ADVERSE REACTIONS" sections below.

WARNINGS Extreme caution is necessary when using diagnostic skin tests 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 MUST BE ADJUSTED TO THE PATIENT'S SENSITIVITY AND TOLERANCE. Refer to boxed “WARNINGS" and “OVERDOSAGE" sections. Epinephrine 1:1000 should be available when a new lot of allergenic extract is utilized. Patient re-evaluation may be necessary. Injections should never be given intravenously. Adverse reactions to allergenic extracts are usually apparent within 20-30 minutes following skin testing. Patients should be observed for 20-30 minutes after skin testing.

ADVERSE REACTIONS Adverse reactions include, but are not necessarily limited to urticaria, itching, edema of the extremities, respiratory wheezing or asthma, dyspnea, cyanosis, tachycardia, lacrimation, marked perspiration, flushing of the face, neck or upper chest, mild persistent clearing of the throat, hacking cough or persistent sneezing. 1) Local Reactions A small amount of erythema and swelling at the site of injection is common, the extent varying with the patient. Such reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm in diameter. Large, persistent local reactions or minor exacerbations of the patient's allergic symptoms may be treated by local cold applications and/or the use of oral antihistamines, but they should be considered a warning of possible severe systemic reactions. A mild burning immediately after the injection is to be expected; this usually is relieved in 10-20 seconds. 2) Systemic Reactions Systemic reactions may range from mild exaggeration of the patient's allergic symptoms to anaphylactic reactions. Very sensitive patients may show a rapid response. In some instances, a severe systemic reaction with blood pressure fall and/or shock may occur. Quantitation of patient's sensitivity combined with careful early observation is essential for safe skin testing. 9 Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. The following are commonly prescribed beta-blockers : Levatol, Lopressor, Propanolol Intersol, Propanolol HCL, Blocadren, Propanolol, Inderal-LA, Visken, Corgard, Ipran, Tenormin, Timoptic. Ophthalmic beta-blockers: Betaxolol, Levobunolol, Timolol, Timoptic. Chemicals that are beta-blockers and may be components of other drugs: Acebutolol, Atenolol, Esmolol, Metoprolol, Nadolol, Penbutolol, Pindolol, Propanolol, Timolol, Labetalol, Carteolol.