Phospholipid Fraction FROM Bovine LUNG (Surfactant) 50 mg Suppliers & Bulk Manufacturers

Available Forms: For intratracheal administration

Available Strengths: 50 mg

Reference Brands:

Category: Respiratory Disorder

Phospholipid fraction from bovine lung, a natural calf-lung surfactant given intratracheally to preterm infants with respiratory distress syndrome, for neonatal units, hospital buyers and importers.

Product Description:

This is a natural lung surfactant prepared from cattle lung, a mix of phospholipids, neutral lipids, fatty acids and the surfactant-associated proteins SP-B and SP-C. It lowers surface tension in the alveoli of a premature baby whose lungs have not yet made enough surfactant. Bovine surfactants are one of three families, alongside porcine extracts and synthetic preparations, and they differ in concentration and volume per dose. The 50 mg strength is a vial quantity; despite the injection label, it is given into the trachea, never into a vein or muscle.

It is used in neonatal intensive care for respiratory distress syndrome in preterm infants, as rescue treatment and, in some labels, as prophylaxis in very low birth weight babies. The dose is calculated per kilogram of birth weight and instilled through an endotracheal tube, sometimes in aliquots with position changes between them. Bradycardia, desaturation and tube blockage can occur during dosing, so trained neonatal staff give it with continuous monitoring.

Sourcing notes. Bovine products differ in presentation, so confirm whether the 50 mg vial is a lyophilised powder for reconstitution or a ready suspension, its phospholipid content per millilitre and the dosing volume per kilogram, and match these to your registration. Bovine origin makes a TSE/BSE certificate of suitability, or an equivalent statement on source animals and processing, essential. Ready suspensions are normally kept at 2 to 8 °C away from light, so plan a cold chain unless the label says otherwise. Request a CoA for each surfactant batch, along with the GMP certificate and a CoPP. It is prescription-only.