Product Information
Registration Status: ActiveINFASURF INTRATRACHEAL SUSPENSION 35MG/ML is approved to be sold in Singapore with effective from 2013-03-26. It is marketed by TRANSMEDIC PTE LTD, with the registration number of SIN14333P.
This product contains Calfactant 35mg/mL in the form of SUSPENSION, STERILE. It is approved for INTRATRACHEAL use.
This product is manufactured by ONY in UNITED STATES.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
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.
Indication
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.
Mechanism of Action
Pulmonary surfactant is an endogenous substance produced in the lungs that functions to decrease surface tension at the air:fluid interface on the alveolar surface. In premature infants with pulmonary surfactant deficiency, surface tension can increase to the point where sections of lung collapse and respiratory distress syndrome (RDS) develops. Calfactant adsorbs rapidly to the surface of the alveolar air:fluid interface and modifies surface tension to a minimum of less than 3 mN/m. It acts in a manner similar to natural lung surfactant, thus preventing or treating respiratory distress syndrome.
Pharmacokinetics
- Absorption
- Calfactant is administered directly to the lung lumen surface where it acts. No human studies on absorption have been completed.
- Distribution
- No human studies on the distribution of calfactant have been performed.
- Metabolism
- Endogenous lung surfactant is produced and excreted by Type II alveolar pneumocytes to form a surface monolayer across the alveoli through adsorption. Through repeated contraction and expansion of an alveolus, this monolayer degrades and the surfactant is taken back up into the Type II alveolar pneumocyte for re-packaging. No human studies on the metabolism of calfactant have been completed, but it is likely metabolized through a similar mechanism to endogenous pulmonary surfactant.
- Elimination
Clearance
No human studies on the metabolism and elimination of calfactant have been performed.
Toxicity
Carcinogenesis and animal reproduction studies have not been performed with calfactant. A single mutagenicity study produced a negative Ames assay. Overdose with calfactant has not yet been reported, but it is recommended that in the case of an overdose ventilation should be supported until all excess fluid is cleared from the lungs. Cyanosis, bradycardia and airway obstruction have been reported with administration of calfactant.
Active Ingredient/Synonyms
Bovactant | Calf lung surfactant extract (CLSE) | Calfactant |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.