Infasurf Intratracheal Suspension 35mgmL

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Calfactant (CLSE) eqv to Phospholipid

Διαθέσιμο από:

TRANSMEDIC PTE LTD

Φαρμακολογική κατηγορία (ATC):

R07AA02

Δοσολογία:

35mg/mL

Φαρμακοτεχνική μορφή:

SUSPENSION, STERILE

Σύνθεση:

Calfactant (CLSE) eqv to Phospholipid 35mg/mL

Οδός χορήγησης:

INTRATRACHEAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

ONY Biotech Inc. (Parametric Release)

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2013-03-26

Φύλλο οδηγιών χρήσης

SINGAPORE INFASURF PACKAGE INSERT, REV. 02/13 - PAGE 1 OF 4

INFASURF
 ® 
(calfactant) 
Intratracheal Suspension 
Sterile Suspension for Intratracheal Use Only 

 RX 
ONLY 
Rev. 02/13 (Singapore) 

DESCRIPTION

Infasurf® (calfactant) Intratracheal Suspension is a sterile,
non-pyrogenic lung surfactant intended for intratracheal
instillation only. It is 
an extract of natural surfactant from calf lungs which includes
phospholipids, neutral lipids, and hydrophobic
surfactant-associated 
proteins B and C (SP-B and SP-C). It contains no preservatives.  
Infasurf is an off-white suspension of calfactant in 0.9% aqueous
sodium chloride solution. It has a pH of 5.0 - 6.2 (target pH 5.7).
Each 
milliliter of Infasurf contains 35
mg total phospholipids (including 26 mg
phosphatidylcholine of which 16 mg is disaturated 
phosphatidylcholine) and 0.7 mg proteins including 0.26 mg of
SP-B. 

CLINICAL PHARMACOLOGY

Endogenous lung surfactant is essential for effective
ventilation because it modifies alveolar surface tension
thereby stabilizing the 
alveoli. Lung surfactant deficiency is the cause of
Respiratory Distress Syndrome (RDS) in premature infants. Infasurf
restores surface 
activity to the lungs of these infants. 
ACTIVITY:
 Infasurf
adsorbs rapidly to the surface of the air:liquid interface and modifies surface tension similarly
to natural lung 
surfactant. A minimum surface tension of ≤3 mN/m is produced_ in
vitr_o by Infasurf as measured on a pulsating bubble
surfactometer._ Ex _
_vivo_
, Infasurf restores the pressure volume mechanics and compliance
of surfactant-deficient rat lungs._ In vivo_, Infasurf improves
lung 
compliance, respiratory gas exchange, and survival in preterm
lambs with profound surfactant deficiency. 
ANIMAL METABOLISM:
 Infasurf is administered directly to the lung lumen surface, its
site of action. No human studies of absorption, 
biotransformation, or excretion of I

Αρχείο Π.Χ.Π.

INFASURF
®
(calfactant)
Intratracheal
Suspension
Sterile Suspension for
Intratracheal
Use Only
R
X ONLY
DESCRIPTION
Infasurf
®
(calfactant) Intratracheal
Suspension
is
a
sterile,
non-pyrogenic
lung
surfactant
intended for intratracheal instillation only. It is an
extract
of
natural
surfactant
from calf
lungs
which includes
phospholipids,
neutral
lipids,
and hydrophobic surfactant-associated proteins
B and C (SP-B and SP-C).
It
contains
no
preservatives.
Infasurf is an off-white suspension of calfactant
in 0.9% aqueous sodium chloride solution. It has
a pH of 5.0 - 6.2 (target pH 5.7). Each milliliter of
Infasurf
contains
35 mg total
phospholipids
(including 26 mg phosphatidylcholine of
which
16 mg is disaturated phosphatidylcholine)
and
0.7 mg proteins including 0.26 mg of SP-B.
CLINICAL PHARMACOLOGY
Endogenous
lung surfactant
is
essential
for
effective ventilation because it modifies alveolar
surface tension thereby stabilizing the alveoli.
Lung surfactant
deficiency
is
the cause of
Respiratory
Distress
Syndrome
(RDS)
in
premature
infants.
Infasurf
restores
surface
activity to the lungs of these infants.
ACTIVITY: Infasurf adsorbs rapidly to the surface of
the
air:liquid
interface
and
modifies
surface
tension
similarly
to
natural
lung
surfactant.
A minimum surface tension of
≤3 mN/m is
produced_ in vitro_ by Infasurf
as measured on a
pulsating bubble surfactometer._ Ex vivo,_ Infasurf
restores the pressure volume mechanics and
compliance
of
surfactant-deficient
rat
lungs.
_In_
_vivo,_
Infasurf
improves
lung
compliance,
respiratory gas exchange, and survival in preterm
lambs with profound surfactant deficiency.
ANIMAL
METABOLISM:
Infasurf
is administered
directly to the lung lumen surface,
its site of
action.
No
human
studies
of
absorption,
biotransformation, or excretion of Infasurf have
been performed. The administration of Infasurf
with radiolabeled phospholipids into the lungs
of
adult
rabbits results in the persistence of
50% of
radioactivity in the lung alveolar lining
and 25% of
radioactivity in the lu