Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Bovine lipids extract surfactant
AVERROES PHARMACEUTICALS SDN. BHD.
Bovine lipids extract surfactant
4 ml; 3 ml; 5 ml; 1 Vials; 2 Vials; 10 Vials
BLES Biochemicals Inc
BLES® (BOVINE LIPID EXTRACT SURFACTANT) 27 MG/ML SUSPENSION FOR INTRATRACHEAL INSTILLATION PHOSPHOLIPID 27MG SURFACTANT ASSOCIATED PROTEINS SP-B AND SP-C 176-500ΜG DESCRIPTION BLES® (bovine lipid extract surfactant) is extracted from bovine lung surfactant. The manufacturing process removes hydrophilic proteins, the majority of which would be surfactant-associated protein SP-A, and selects for hydrophobic phospholipids and surfactant-associated proteins SP-B and SP-C. COMPOSITION Each ml of suspension contains 27mg of phospholipid and 176-500μg of surfactant associated protein’s SP-B and SP-C. Contains no preservatives. Inactive ingredients: 0.1M Sodium chloride, 0.0015M Calcium chloride, Sterile water for Irrigation and Nitrogen. ACTION AND CLINICAL PHARMACOLOGY BLES® (bovine lipid extract surfactant) restores surfactant activity in neonates with respiratory distress syndrome (NRDS), thereby improving gaseous exchange by decreasing alveolar surface tension and promoting lung compliance in the infant with NRDS. BLES® is an extract of natural bovine surfactant which contains numerous phospholipids, with dipalmitoylphosphatidylcholine (DPPC) being the most abundant. It also includes hydrophobic surfactant- associated proteins SP-B and SP-C, which facilitate their dispersion. When administered intratracheally, BLES® is rapidly adsorbed, forming an active phospholipid monolayer at the air-fluid interface. The metabolic fate of BLES® has not been investigated. BLES® can have an immediate effect on lung compliance, usually within 5 to 30 minutes after treatment with a single dose. Clinical experience with BLES® has shown that BLES® significantly improved gas exchange and lung compliance by the 4-hour time-point. Fraction of inspired oxygen (Fi O2 ) and ventilatory requirements were significantly decreased, and there was a reduction in the severity of NRDS and its associated complications. INDICATIONS BLES® (bovine lipid extract surfactant) is indicated for rescue treatment of Neonatal Respiratory Distress Pročitajte cijeli dokument