Source: FDA, National Drug Code (US) Revision Year: 2020
Infasurf (calfactant) Intratracheal Suspension is a sterile, non-pyrogenic lung surfactant intended for intratracheal instillation only. It is an extract of natural surfactant from calf lungs which includes phospholipids, neutral lipids, and hydrophobic surfactant-associated proteins B and C (SP-B and SP-C). It contains no preservatives.
Infasurf is an off-white suspension of calfactant in 0.9% aqueous sodium chloride solution. It has a pH of 5.0 – 6.2 (target pH 5.7). Each milliliter of Infasurf contains 35 mg total phospholipids (including 26 mg phosphatidylcholine of which 16 mg is disaturated phosphatidylcholine) and 0.7 mg proteins including 0.26 mg of SP-B.
| How Supplied |
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Infasurf (calfactant) Intratracheal Suspension is supplied sterile in single-use, rubber-stoppered glass vials containing 3 mL (NDC 61938-456-03) and 6 mL (NDC 61938-456-06) off-white suspension. Rx only Manufactured by: ONY Biotech Inc., Amherst, NY 14228 Rev. 03/18 |
| Drug | Countries | |
|---|---|---|
| INFASURF | Singapore, Tunisia, Turkey, United States |
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