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STORAGE AND STABILITY

BLES® (bovine lipid extract surfactant) has a shelf life of 36 months when stored frozen below -10°C. Do not use past expiry date on label. Store vials in cartons until ready to use. Frozen product may have two excursions to 2°-8°C for a combined maximum of two weeks. Alternately, BLES® may be stored refrigerated (2°– 8ºC) upon receipt, for up to 10 months. In the space provided on the vial labelling, record the new expiry date of up to 10 months from the day it is received. Refrigerated vials should not be returned to the freezer. 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. In the space provided on the vial labelling, record the number of times the vial has been warmed and returned to storage.

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 5mL/kg at 27mg of phospholipids/mL, which equals 135mg phospholipid/kg. As many as 3 subsequent doses of BLES® can be given within the first 5 days of life.

INDICATIONS AND CLINICAL USE

NRDS/Hyaline Membrane Disease
• Administer BLES® in a highly supervised clinical setting as soon as possible once oxygenation criteria are met
• Due to the immediate effect of BLES® (usually within 5 to 30 minutes) vigilantly monitor respiratory parameters post-administration

DESCRIPTION

BLES® (bovine lipid extract surfactant) is extracted from bovine lung surfactant. The manufacturing process removes hydrophilic proteins, the majority of which is SP-A, and selects for hydrophobic phospholipids and SP-B and SP-C.

BLES® can rapidly affect oxygenation and lung compliance.

SUMMARY PRODUCT INFORMATION

Route of administration: Intratracheal instillation
Dosage Form / Strength: Suspension / 27mg phospholipid/mL

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