FDA label 26d83173-bf33-4460-ac59-b46f052d9787

WARNING This product is intended for use by physicians who are experienced in the administration of allergenic extracts and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. Extracts standardized using Bioequivalent Allergy Unit (BAU/ml) may be more potent than nonstandardized cat extracts based on the weight to volume, or PNU methods. Allergy Laboratories' standardized cat hair extract is not interchangeable with standardized cat pelt extracts, and also not interchangeable with other standardized cat extracts labeled in Allergy Units (AU/ml). The initial dose must be based on skin testing as described in the dosage and administration section of this insert. Patients being switched from nonstandardized cat extracts to Allergy Laboratories' standardized cat extract should be started as though they were coming under treatment for the first time. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physicians office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur. In certain individuals these life threatening reactions may be fatal. Patients should be observed for at least 30 minutes following treatment and 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 not be injected intravenously. Subcutaneous injections are recommended. Patients who are taking 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. Refer also to the warnings, precautions, adverse reactions and dosage sections below.

WARNINGS See WARNING at the beginning of the instruction sheet. Extracts standardized using the Bioequivalent Allergy Unit (BAU/ml) may be more potent than extracts based on weight to volume, or PNU methods. Comparative skin tests can be performed to determine the relative potency before initial use of new extracts. DO NOT GIVE ALLERGY INJECTIONS INTRAVENOUSLY. Subcutaneous injections are recommended. Injections may produce large local reactions that may be painful to the patient. DO NOT GIVE FULL STRENGTH INJECTIONS UNTIL THE COMPARATIVE STRENGTH IS DETERMINED. After inserting the needle, but before injection of extract, withdraw the plunger slightly. If blood appears in the syringe, re-insert the needle at another site. Careful selection of dose and injection should prevent most systemic reactions.

ADVERSE REACTIONS Local reactions: Some swelling and redness at the site of injection is not unusual. Mild burning that occurs immediately after the injection is normal; this usually subsides in 10 to 20 seconds. If the swelling and redness persist for a period of 24 hours or longer this should be a sign to proceed with caution in increasing the dosage. With the next injection the dosage should remain the same or be decreased. Large local reactions may indicate that a systemic reaction could occur with the next injection if the dosage was increased. If a patient continues to have reactions at the maintenance dose, the patient is considered to have exceeded the maximum tolerated dosage. Systemic Reactions: Systemic reactions occur infrequently but must be looked for in all patients, especially highly sensitive patients. Anaphylactic shock and death are always possible. Therefore, physicians must be prepared for the treatment of these reactions. Systemic reactions can also be characterized by one or more of the following symptoms: angioedema, tachycardia, conjunctivitis, cough, fainting, hypotension, pallor, rhinitis, urticaria, and wheezing. Systemic reaction can be treated by the immediate application of a tourniquet above the site of injection and the administration of 0.3 to 0.5ml of 1:1000 Epinephrine - Hydrochloride subcutaneously or intramuscularly at the site of allergen injection. The dosage may be repeated two times at 15 minute intervals. Loosen the tourniquet at least every 10 minutes. The pediatric dosage for 1:1000 Epinephrine-Hydrochloride is 0.05 to 0.1ml for infants to 2 years of age; 0.15ml, for children 2 to 6 years; and 0.2ml, for children 6 to 12 years. Patients should always be observed for at least 30 minutes after any injection. Hypotension can be reversed by using vasopressor agents and volume expanders. Parenteral aminophylline and inhalation bronchodilators may be required for bronchospasm. Oxygen may also be needed. Maintenance of an open airway is critical if upper airway obstruction is present. Adrenal corticosteroids and intravenous antihistamine can be given after adequate epinephrine and circulatory support has been administered. Physicians must be familiar with these systemic reactions and have all the equipment and drugs necessary for proper treatment. (7)