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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/03/04 | Not Applicable | Completed | |||
2007/12/07 | Phase 3 | Completed | Roberta Ballard | ||
2005/09/21 | Not Applicable | Completed | |||
2005/09/14 | Not Applicable | Completed | |||
2004/08/23 | Phase 2 | Completed |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
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No FDA products found
No FDA products found for this drug
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
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No EMA products found
No EMA products found for this drug
Singapore Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. | Online |
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No Singapore products found
No Singapore products found for this drug
China Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
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No China products found
No China products found for this drug
Australia Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
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No Australia products found
No Australia products found for this drug