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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