FDA label a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c

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. STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/ml ARE NOT INTERCHANGEABLE WITH G RASS POLLEN EXTRACTS LABELED IN AU/ml OR WITH NON-STANDARDIZED (WEIGHT/VOLUME) GRASS POLLEN EXTR A CT S. For guidance in selecting dose, refer to Table A in the Clinical Pharmacology section that describes the potency of non-standardized grass pollen extracts. Comparative skin tests can be performed to determine the relative potency before initial use of new extracts. For previously untreated patents, initial dose must be based on skin testing as described in the Dosage and Administration section of this insert. Patients being switched from other types of extracts to Allergy Laboratories should have their dose adjusted. Extracts standardized in BAU (Bioequivalent Allergy Unit) may differ in potency from non-standardized extracts. Comparative skin tests can be performed to determine relative potency of standardized versus non-standardized extracts. The dosage should be reduced 75% when switching from one lot of standardized grass pollen extract to another Iot. Patients with unstable or severe asthma, including steroid-dependent asthma, are at increased risk for more frequent and more severe reactions from allergy extract injections. Greater caution must be exerted with such patients at all phases of extract administration, but particularly during build up. For example, extract therapy might be initiated at weaker concentrations and built by smaller dosage increments than in comparably allergic rhinitis patients without asthma. Also when asthma is poorly controlled, the injection regimen might be temporarily interrupted (at the discretion of the physician) until control of asthma is re-established. Whenever a reaction occurs in such patients their asthma should be medically stabilized before injections are resumed with an appropriate dosage reduction. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact physician's 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. Serious adverse reactions can be reported to the U S Food and Drug Administration MedWatch Program. The MedWatch forms can be obtained by calling 1-800-FDA-1088. The address is MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787. 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.

WARNIN GS See WARNINGS box at the beginning of the instruction sheet. Extracts standardized using the Bioequivalent Allergy Unit may be more or less potent than extracts based on AU/ml, weight to volume, or PNU methods of expressing potency. See Adverse Reactions section in this insert for a description of the possible local reactions and systemic reactions. 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 COMPARATIVE SKIN TESTING IS PERFORMED. After inserting the needle, but before injecting 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: (1) 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. (2) 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 in the opposite arm. 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 0.1 ml 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. (8) Serious adverse reactions can be reported to the US Food and Drug Administration MedWatch Program. The MedWatch forms can be obtained by calling 1-800-FDA-1088. The address is: MedWatch, 5600 Fishers Lane, Rockville, MD, 20852-9787.