CUROSURF VIAL 3.0ML

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PIG LUNG SURFACTANT (PHOSPHOLIPID

Boleh didapati daripada:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

PIG LUNG SURFACTANT (PHOSPHOLIPID

Unit dalam pakej:

3.0ml mL

Dikeluarkan oleh:

CHIESI FARMACEUTICI SPA

Risalah maklumat

CUROSURF
®
3.0ML
SUSPENSION
_Consumer Medication Information Leaflet (RiMUP)_
(Suspension containing phospholipid fraction from porcine
lung(poractant alfa)
1
WHAT IS IN THIS LEAFLET
- What Curosurf
®
is used for
- How Curosurf
®
works
- Before you use Curosurf
®
- How to use Curosurf
®
- While you are using Curosurf
®
- Side effects
-
Storage
and
disposal
of
Curosurf
®
- Product description
- Manufacturer and
product
registration holder
- Date of revision
WHAT
CUROSURF
®
IS
USED
FOR
Curosurf
®
contained
active
substance,
poractant-alfa
extracted
from pig’s lung. It is used to treat or
prevent
Respiratory
Distress
Syndrome (RDS) in newborn babies.
Most
babies
are
born
with
a
substance in their lungs known as
‘surfactant’. This substance lines the
lungs and stops them from sticking
together
and
so
makes
normal
breathing
possible.
Some
babies,
however,
particularly
premature
babies, do not have enough of this
surfactant when they are born, which
causes RDS.
Curosurf
®
is
a
natural
surfactant,
which works in the same way as
your baby’s own surfactant would
have done and, therefore, will help
your baby to breathe normally until
your baby produces his or her own
surfactant.
HOW CUROSURF® WORKS
Curosurf
®
is a p ulmonary surfactant
consisting of natural phospholipids
extracted from pig’s lung.
- It
was
developed
to
replace
deficiency of endogenous pulmonary
surfactant
by
intratracheal
administration
of
exogenous
surfactant.
-
It acts by lowering surface tension of
premature
babies
lung
which
is
essential to stabilise premature lung
and
to
avoid
collapse
at
end-
expiration so that adequate gas
exchange is maintained throughout
the ventilatory cycle.
BEFORE
YOU
USE
CUROSURF®
WHEN YOU MUST NOT USE IT
DO NOT USE CUROSURF®:
-
If
you
are
allergic
(hypersensitive)
to
the
active
substance or any excipients of
Curosurf®
BEFORE YOU START TO USE IT
Your
baby
will
only
be
given
Curosurf
®
if the equipment for
ventilation and monitoring babies
with
Respiratory
Distress
Syndrome is available.
After
being
gi

Ciri produk

1. CLINICAL PARTICULARS
Curosurf 80 mg/ml suspension for endotracheobronchial instillation.
Active ingredient: One 1.5 ml vial contains 120mg of phospholipid
fraction from porcine lung (poractant alfa).
One 3.0ml vial contains 240mg of phospholipid fraction from porcine
lung (poractant alfa)
CUROSURF® is a natural surfactant prepared from the alveolar surface
of porcine lungs, mainly containing
phospholipids,
especially
phosphatidylcholine
(70%
approx.
of
the
total
phospholipid
content)
and
1-2%
approximately of surfactant specific hydrophobic low-molecular weight
proteins SP-B and SP-C. Lung surfactant is a
mixture of substances, chiefly phospholipids and specific proteins
that coats the internal surface of lung alveoli
lowering the surface tension. This action is essential to stabilise
alveoli, avoiding collapse at end-expiration so that
adequate gas exchange is maintained throughout the ventilatory cycle.
Deficiency of lung surfactant, from whatever
cause, leads to severe respiratory failure named Respiratory Distress
Syndrome (RDS) of Hyaline Membrane Disease
(HMD). In premature babies, RDS is the major cause of mortality and
morbidity in the first days of life being also
responsible for long term respiratory and neurologic sequelae.
CUROSURF® has been developed to replace the
deficiency of endogenous pulmonary surfactant by administration of
exogenous surfactant into the lower airways.
The tensioactive properties of CUROSURF® favour its uniform
distribution into the lungs and spreading at the air-
liquid interface in the alveoli. Both physiological and therapeutical
effects of CUROSURF® in surfactant deficiency
have
been
extensively
documented
in
various
animal
patterns.
In
premature
rabbit
foetuses
obtained
by
hysterectomy and immediately sacrificed, the administration of
CUROSURF® caused a marked improvement in lung
expansion. In premature rabbits ventilated with 100% O2 there was a
dramatic improvement of tidal volume and
lung-thorax compliance compared to the control animals, after
administration of