BLES (bovine lipid extract surfactant) 27 mgml Suspension for Intratracheal Instillation

País: Malasia

Idioma: inglés

Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes activos:

Bovine lipids extract surfactant

Disponible desde:

AVERROES PHARMACEUTICALS SDN. BHD.

Designación común internacional (DCI):

Bovine lipids extract surfactant

Unidades en paquete:

4 ml; 3 ml; 5 ml; 1 Vials; 2 Vials; 10 Vials

Fabricado por:

BLES Biochemicals Inc

Ficha técnica

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