Drug information for CUROSURF

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
SUSPENSION; INTRATRACHEAL	80MG/ML	Prescription	(Reference Drug)	PORACTANT ALFA	poractant alfa	CORNERSTONE THERAP	20744 2008-10-03 Label 2008-10-01 Letter 2004-03-03 Letter 2002-03-01 Letter 2001-07-02 Review 1999-11-18 Letter 1999-11-18 Label

Drug Adverse Effects information for CUROSURF

Role code	Indications	Reaction	# Reports
PS	DYSPNOEA	C-REACTIVE PROTEIN INCREASED	1
PS	NEONATAL RESPIRATORY DISTRESS SYNDROME	APNOEA	1
PS	NEONATAL RESPIRATORY DISTRESS SYNDROME	BRADYCARDIA	1
PS	NEONATAL RESPIRATORY DISTRESS SYNDROME	C-REACTIVE PROTEIN INCREASED	3
PS	NEONATAL RESPIRATORY DISTRESS SYNDROME	CONJUNCTIVITIS	1
PS	NEONATAL RESPIRATORY DISTRESS SYNDROME	HYPERBILIRUBINAEMIA NEONATAL	1
PS	NEONATAL RESPIRATORY DISTRESS SYNDROME	INTERLEUKIN LEVEL INCREASED	2
PS	NEONATAL RESPIRATORY DISTRESS SYNDROME	LEUKOPENIA	2
PS	NEONATAL RESPIRATORY DISTRESS SYNDROME	OXYGEN SATURATION DECREASED	1
PS	NEONATAL RESPIRATORY DISTRESS SYNDROME	RESPIRATORY FAILURE	1
PS	NEONATAL RESPIRATORY DISTRESS SYNDROME	THROMBOCYTOPENIA	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	EXPIRED DRUG ADMINISTERED	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	INCORRECT ROUTE OF DRUG ADMINISTRATION	1

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