Beractant

SURVANTA (beractant, intratracheal suspension) is indicated for: • Prevention (prophylaxis) and • Treatment (rescue) of Respiratory Distress Syndrome (RDS/Hyaline Membrane Disease) in premature infants Prevention For prophylactic treatment of infants at risk of developing RDS or who have evidence of pulmonary immaturity.

In premature infants less than 1250 g birth weight or with evidence of surfactant deficiency, give SURVANTA as soon as possible after an airway has been established, preferably within 15 minutes of birth. Rescue Treatment For rescue treatment of infants who have developed RDS.

To treat infants with RDS confirmed by X-ray and who require mechanical ventilation, give SURVANTA as soon as possible after an airway has been established, preferably by 8 hours of age. SURVANTA significantly reduces the incidence of RDS, mortality due to RDS and air leak complications.

The use of SURVANTA in infants less than 600 g birth weight or greater than 1750 g birth weight has not been evaluated in controlled trials. , high frequency ventilation or extra-corporeal membrane oxygenation). 1 Pediatrics Pediatrics (premature infants): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of SURVANTA in pediatric patients has been established.

Survanta is indicated for treatment of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in new born premature infants with a birth weight of 700g or greater. Survanta is also indicated for the prophylactic treatment of premature infants <32 weeks gestational age at risk of developing RDS who require intubation for stabilisation or with evidence of surfactant deficiency.