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Registration Date 8 Oct 2016
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Curosurf

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Medicine Pharmaceuticals Product Number : 10122-510-03

Lung Surfactants

Drug Information

Generic
Poractant alfa
NDC Code
10122-510-03
Drug Class
Lung surfactants
Therapeutic Class
Lung surfactants
Dosage form
Suspension
Route of Administration
ENDOTRACHEAL
Therapeutic Area
1.respiratory Distress Syndrome

Indication

Neonatal respiratory distress (Curosurf® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants.  Curosurf reduces mortality and pneumothoraces associated with RDS.)

Benefit

•In some clinical studies, infants treated with CUROSURF using the INSURE strategy were generally extubated within approximately 5 to 10 minutes following surfactant administration9-12 •Extubation should be performed when the infant is stable at the discretion of the clinician •Early rescue INSURE strategy following nCPAP failure may help avoid potential for respiratory insufficiency and the need for subsequent MV8 •In studies, early rescue INSURE strategy (FiO2<0.45) was associated with improved outcomes vs late selective therapy (FiO2>0.45)8 •Rapid extubation after surfactant administration may not be achievable or desirable in the most immature infants, and decisions to extubate should be individualized