FDA label dc6a5149-0053-4ff0-8313-c8d49f1898d7

WARNINGS This product is intended for use only by physicians who are experienced in the use of allergenic extracts, or for use under the guidance of an allergist. Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death. 7 Therefore, emergency measures and personnel trained in their use should be available immediately in the event of such a reaction. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if symptoms occur. Scratch, prick or puncture test first. Test intradermally only to those antigens giving negative or questionable reactions on scratch, prick or puncture testing. This product should never be injected intravenously. Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions. 6 Refer also to the WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS Sections below for further discussion.

WARNINGS Scratch, prick or puncture test first. Test intradermally only to those antigens giving negative or questionable reactions on scratch, prick or puncture testing. Excessively large local reactions or systemic reactions are more likely to occur if the patient is skin tested shortly after exposure to large amounts of antigen to which he or she is sensitive. Therefore, use caution when applying pollen tests to patients during their active pollen season, or after an exposure to inhalant allergens that produce symptoms. Refer to boxed WARNINGS Section.

ADVERSE REACTIONS 1. 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 antihistamines, but they should be considered a warning of possible severe systemic reactions. 2. Systemic Reactions With careful attention to dosage and administration, such reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent in sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions. Adverse reaction frequency data for allergenic extract administration for testing and treatment show that risk is low. 7, 8 It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is a possibility. Other possible systemic reaction symptoms, in varying degrees of severity, are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria. If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection, if tests are performed on the arms, and inject the 1:1000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet. EPINEPHRINE: ADULT DOSAGE: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary. PEDIATRIC DOSAGE: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg (mL) per square meter of body surface area. Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient. 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, theophylline 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 in the event of a serious systemic or anaphylactic reaction not responsive to the above measures. [ Ref. J. Allergy Clin. Immunol. 77 (2): 271-273, 1986 ]. Rarely are all of the above measures necessary; the tourniquet and epinephrine usually produce prompt responses. However, the physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment measures is of utmost importance.