Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Calfactant
Drug ID BADD_D00342
Description Calfactant is a sterile, non-pyrogenic lung surfactant intended for intratracheal instillation. It is an off-white suspension of an extract of natural surfactant from calf lungs suspended in 0.9% saline. Each milliliter of calfactant contains 35mg of phospholipids (including 26 mg phosphatidylcholine of which 16 mg is disaturated phosphatidylcholine) and 0.65mg of proteins including surfactant-associated proteins B and C. Calfactant is approved for use in the United States of America. It is used to prevent or treat respiratory distress syndrome in premature infants with lung surfactant deficiency. Calfactant has been shown to decrease the incidence of respiratory distress syndrome, mortality due to respiratory distress syndrome, and air leaks associated with respiratory distress syndrome in clinical trials. It adsorbs to the air:fluid interface in the lungs and works to reduce surface tension, in a manner similar to endogenous pulmonary surfactant.
Indications and Usage Calfactant is indicated for prophylaxis therapy to prevent respiratory distress syndrome (RDS) in premature infants <29 weeks of gestational age with low lung surfactant and at high risk for RDS. Calfactant therapy is also indicated for the treatment of respiratory distress syndrome in infants 72 hours or less of age with RDS confirmed by clinical and radiologic findings and requiring endotracheal intubation.
Marketing Status Prescription
ATC Code Not Available
DrugBank ID DB06415
KEGG ID D03317
MeSH ID C117342
PubChem ID Not Available
NDC Product Code 61938-456
Synonyms calfactant | bovine lung surfactant | Infasurf
Chemical Information
Molecular Formula Not Available
CAS Registry Number 183325-78-2
SMILES Not Available
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Bradycardia02.03.02.002-Not Available
Cardio-respiratory arrest22.02.06.007; Available
Haemorrhage intracranial24.07.04.003;
Heart rate decreased13.14.04.001-Not Available
Hypoventilation22.02.01.007-Not Available
Intraventricular haemorrhage24.07.04.008; Available
Oxygen saturation decreased13.02.01.004-Not Available
Patent ductus arteriosus03.07.01.001;; Available
Pulmonary haemorrhage24.07.01.016;
Pulmonary interstitial emphysema syndrome22.01.02.012--Not Available
Neonatal hypoxia22.11.02.002; Available
Necrotising colitis07.08.01.013--Not Available
Periventricular leukomalacia18.04.07.003; Available
Obstruction08.01.03.023-Not Available
Obstructive airways disorder22.03.01.011--Not Available
Endotracheal intubation complication22.04.07.001;; Available
Mechanical ventilation25.13.01.001--Not Available
Pulmonary air leakage22.01.02.011;; Available
Bradycardia neonatal18.04.07.004; Available
Foaming at mouth17.02.05.056;; Available
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