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Outline
What is the generic name?
CALFACTANT
What is the Trade Name for CALFACTANT?
INFASURF
What are the Indications for CALFACTANT?
- INDICATIONS AND USAGE Infasurf is indicated for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment (“rescue”) of premature infants who develop RDS. Infasurf decreases the incidence of RDS, mortality due to RDS, and air leaks associated with RDS. Prophylaxis Prophylaxis therapy at birth with Infasurf is indicated for premature infants less than 29 weeks of gestational age at significant risk for RDS. Infasurf prophylaxis should be administered as soon as possible, preferably within 30 minutes after birth. Treatment Infasurf therapy is indicated for infants less than or equal to 72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.
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References: https://open.fda.gov/
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