FDA label bc075035-e18d-4cbd-be9d-d4d75cb7c2d1

WARNINGS Standardized cat hair and cat pelt extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with each other and are not interchangeable with cat extracts labeled in Allergy Units (AU/ml). Standardized Cat allergenic extract is intended for use by physicians who are experienced in the administration of allergenic extracts for diagnosis, immunotherapy and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. This extract is not directly interchangeable with other allergenic extracts. Patients being switched from other types of extract to Antigen Laboratories’ allergenic extracts should be started as though they were coming under treatment for the first time. See “WARNINGS” section. As with all allergenic extracts, severe systemic reactions may occur. In certain individuals, these life-threatening reactions may result in death. Patients should be observed for at least 20 minutes following allergenic extract injections. Treatment and emergency measures, as well as personnel trained in their use, should be immediately available in the event of a life-threatening reaction. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. Patients being switched from one lot of extract to another from the same manufacturer should have the dose reduced by 75%. This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe, see “WARNINGS”, “PRECAUTIONS”, “ADVERSE REACTIONS” and “OVERDOSAGE” sections. 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 “ADVERSE REACTIONS” section.

WARNINGS Allergenic extracts should be used by physicians with experience in maximal dose immunotherapy and treatment of anaphylaxis. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators . Epinephrine 1:1000 should be available. When changing from one lot to another of allergenic extract, dose adjustment, if indicated, should be based on such considerations, as the results of skin endpoint titration (see “INDICATIONS AND USAGE” section). Patient re-evaluation may be necessary. Injections should never be given intravenously. A 5/8 inch, 25 gauge needle on a sterile syringe will allow deep subcutaneous injection. Precaution of withdrawing the plunger slightly after inserting the needle is advisable to determine if a blood vessel has been entered. DO NOT INJECT INTRAVENOUSLY. Proper measurement of the dose and caution in making the injection will minimize reactions. Adverse reactions to allergenic extracts are usually apparent within 20-30 minutes following injection. Patients should be detained for 20-30 minutes after injection and advised to notify the office immediately if symptoms or reactions occur. Patients being switched from one lot of extract to another from the same manufacturer should have the dose reduced by 75%. This extract should be temporarily withheld or dosage reduced in the following conditions: 1) flu or other infection with fever; 2) exposure to excessive amounts of allergen prior to injection; 3) rhinitis and/or asthma exhibiting severe symptoms; 4) adverse reaction to previous injection until cause of reaction has been evaluated by the physician supervising the patient’s immunotherapy program.

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 Small amounts of erythema and swelling at the site of injection are 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. Larger local reactions are not only uncomfortable, but indicate the possibility of a systemic reaction if dosage is increased. In such cases the dosage should be reduced to the last level not causing the reaction and maintained at this level for two or three treatments before cautiously increasing again. 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 and the need for temporarily reduced dosages. A mild burning immediately after the injection is to be expected; this usually leaves in 10-20 seconds. Prolonged pain, or pain radiating up the arm, is usually the result of intramuscular injection, making this injection route undesirable. Subcutaneous injection is the recommended route. 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 and treatment. With careful attention to dosage and administration, such reactions occur infrequently, but it must be remembered that 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 be prepared for the treatment of severe reactions. 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. It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. Other possible systemic reaction symptoms are, in varying degrees of severity, fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis, and urticaria. 13, 14