BLES® (bovine lipid extract surfactant)
SUMMARY PRODUCT INFORMATION
Route of Administration: Intratracheal instillation
Dosage Form / Strength: Suspension / 27 mg phospholipid/mL
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.
INDICATIONS AND CLINICAL USE
BLES® (bovine lipid extract surfactant) is indicated for rescue treatment of Neonatal Respiratory Distress Syndrome (NRDS/Hyaline Membrane Disease). For infants with NRDS
confirmed by x-ray and who require mechanical ventilation, with arterial to alveolar oxygen ratio (PaO2/PAO2) < 0.22, BLES® is to be given as soon as possible after the oxygenation criteria are met. The use of BLES® in infants less than 380 g or greater than 4460 g birth weight has not been evaluated in controlled trials.
Use of BLES® (bovine lipid extract surfactant) is contraindicated in infants with active pulmonary haemorrhage.
DOSAGE AND ADMINISTRATION
BLES® (bovine lipid extract surfactant) is intended for intratracheal instillation only after an endotracheal airway has been established. The recommended dosage of BLES® is 5 mL/kg at 27 mg of phospholipids/mL, which equals 135 mg phospholipid/kg. As many as 3 subsequent doses of BLES® can be given within the first 5 days of life.
STORAGE AND STABILITY
BLES® (bovine lipid extract surfactant) has a shelf life of 36 months when stored frozen below -10ºC. Do not use past expiry date on label. Store vials in cartons until ready for use. Frozen product may have two excursions to 2º–8ºC for a combined maximum of two weeks. Alternately, BLES® may be stored refrigerated (2º– 8ºC) upon receipt, for up to 10 months. An unopened vial warmed to room temperature for less than 6 hours, may be returned to its previous storage condition a maximum of 2 times.
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