|Manufacturer:||Bristol-Myers Squibb Medical Imaging|
Distributed By Bristol-Myers Squibb Medical Imaging 331 Treble Cove Road N.
Billerica, Massachusetts 01862 USA For ordering, tel.toll free: 800-225-1572 All Other Business: 800-362-2668 (For Massachusetts and International, call 978-667-9531)515188-1007
Serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following DEFINITY® administration.
Assess all patients for the presence of any condition that precludes DEFINITY® administration (see CONTRAINDICATIONS).
Monitor patients during and for 30 minutes following DEFINITY® administration, including vital sign measurements and electrocardiography in all patients and cutaneous oxygen saturation in patients at risk for hypoxemia.
Always have resuscitation equipment and trained personnel readily available.In postmarketing use, four patients experienced fatal cardiac arrests either during or within 30 minutes of DEFINITY® administration; one patient received DEFINITY® and underwent a cardiac stress test, two patients had severe congestive heart failure and the fourth was undergoing mechanical ventilation for respiratory failure.
Other uncommon but serious reactions observed during or shortly following DEFINITY® administration included cardiac or respiratory arrest, loss of consciousness, convulsions, symptomatic arrhythmias (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia or fibrillation), hypotension, respiratory distress or cardiac ischemia (see ADVERSE REACTIONS).Activated DEFINITY® given at a dose of 1 mL/kg (13.5x the maximum human dose based on body surface area) increased the respiratory rate and pulmonary arterial pressure (300% and 188%, respectively) in dogs.
One dog died displaying clinical signs consistent with cardiopulmonary collapse.
Signs consistent with cardiopulmonary collapse were also noted in rats dosed with activated DEFINITY® (multiple-dose study) and included deaths at doses >0.3 mL/kg (2.5x the maximum human dose based on body surface area).Additionally, histopathological pulmonary lesions were detected in rats at doses above 0.1 mL/kg (20% lower than the maximum human dose based on body surface area).