药物信息为Allergenic Extracts For Diagnostic Use Only (ALK-Abello, Inc.): WARNINGS

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.

As with all allergenic extracts, severe systemic reactions may occur. In certain individuals these life-threatening reactions may result in death. Fatalities associated with skin testing have been reported. Patients should be observed for at least 20 - 30 minutes following testing. Emergency measures and adequately trained personnel should be immediately available in the event of a life-threatening reaction.

Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk to a fatal outcome from a systemic allergic reaction.

Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. Adverse events are to be reported to MedWatch (1-800-FDA-1088), Adverse Experience Reporting, HFM-210 Center for Biologics Evaluation & Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.

This product should not be injected intravenously. 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 the treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously.

Refer to WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections below.