FDA label f7d4e8ff-edb0-4e5c-a1b6-72635e9b2e3a

WARNINGS This product is intended for use by physicians who are experienced in the administration of allergenic extracts or for use under the guidance of an allergy specialist. Skin tests should be performed after the patient's physical well being and allergic history have been evaluated. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician if symptoms occur. As with all allergenic extracts, severe systemic reactions may occur, and in certain individuals these reactions may cause death. Patients should be observed for at least 20 minutes after skin tests have been completed. Emergency measures as well as personnel trained in their use should be immediately available in the event of a life threatening reaction. This product should never be injected intravenously (see DOSAGE AND ADMINISTRATION). Also, see WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and OVERDOSE Sections below.

WARNINGS Physicians who use allergenic extracts should have a knowledge and practical understanding of allergy skin testing as described in the published literature 6,7,8 . Allergenic extracts are manufactured to assure high potency and therefore have the ability to cause serious local and systemic reactions, including death in highly sensitive patients 5 . Patients should be informed of the risks of skin testing and instructed in the recognition of symptoms of an adverse allergic reaction (see PRECAUTIONS and ADVERSE REACTIONS below). Excessively large local reactions or systemic reactions are more likely to occur if the patient is skin tested shortly after exposure to allergens to which he or she is sensitive.

ADVERSE REACTIONS LOCAL REACTIONS 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 anti-histamines. SYSTEMIC REACTIONS Allergenic extracts are highly potent and in highly sensitive individuals can cause systemic symptoms, including anaphylaxis. It cannot be overemphasized that anaphylactic shock is always a possibility under certain unpredictable combinations of circumstances. Other possible systemic reaction symptoms may include fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria. Therefore, it is imperative that physicians administering skin tests understand and be prepared to treat severe allergic reactions. If a systemic or anaphylactic reaction occurs during or following skin testing, the patient should be treated with 1:1000 epinephrine hydrochloride. The recommended dose: infants to 2 years of age 0.05 to 0.1 mL, children 2 to 6 years, 0.15 mL, children 6 to 12 years, 0.2 mL, adults 0.3 - 0.5 mL. If necessary, treatment may be repeated up to three times every 10 - 15 minutes. After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids and possibly vasoactive drugs. Oxygen should be given by mask. Intravenous antihistamine, aminophylline, inhaled bronchodilators or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support have been given. Emergency resuscitation measures and personnel trained in their use should be available immediately. The physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment is of utmost importance 14 . Serious adverse reactions should be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program, Office Of The Center Director, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 5100, Rockville, MD 20852, Telephone (800) 332-1088.