For the Prevention and Treatment of Respiratory Distress Syndrome (RDS) in Premature Infants

Survanta (beractant) intratracheal suspension is a surfactant replacement thereapy used by health care professionals for prevention and treatment of respiratory distress syndrome (RDS) in premature infants.

Since being introduced in 1991, over 800,000 infants have been treated with Survanta with over 1 million doses administered.

Important Safety Information about Survanta® (beractant)

SURVANTA is intended for intratracheal use only.

SURVANTA CAN RAPIDLY AFFECT OXYGENATION AND LUNG
COMPLIANCE. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide.

DURING THE DOSING PROCEDURE, TRANSIENT EPISODES OF BRADYCARDIA AND DECREASED OXYGEN SATURATION HAVE BEEN REPORTED. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure.

Full prescribing and safety information (Package Insert March, 2009) for Survanta has been provided in Adobe® Portable Document Format (PDF).