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Calfactant

Generic Name
Calfactant
Brand Names
Infasurf
Drug Type
Small Molecule
CAS Number
183325-78-2
Unique Ingredient Identifier
Q4K217VGA9

Overview

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.

Background

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.

Indication

用于预防和治疗早产儿呼吸窘迫综合征(RDS)。

Associated Conditions

  • Respiratory Distress Syndrome

FDA Approved Products

INFASURF
Manufacturer:ONY Biotech Inc.
Route:ENDOTRACHEAL
Strength:35.7 mg in 1 mL
Approved: 2023/09/26
NDC:61938-456

Singapore Approved Products

Infasurf Intratracheal Suspension 35mg/mL
Manufacturer:ONY Biotech Inc. (Parametric Release)
Form:SUSPENSION, STERILE
Strength:35mg/mL
Online:Yes
Approved: 2013/03/26
Approval:SIN14333P

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