CUROSURF 80MG/ML SUSPENSION FOR INJECTION

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

ALVEOLAR SURFACE PHOSPHOLIPIDS (PIG)

Διαθέσιμο από:

CHIESI HELLAS A.E.B.E. (0000010963) GEROULANOU SQ. & 1 RENOU POGGI STR., ALIMOS, 17455

Φαρμακολογική κατηγορία (ATC):

R07AA02

INN (Διεθνής Όνομα):

NATURAL PHOSPHOLIPIDS

Δοσολογία:

80MG/ML

Φαρμακοτεχνική μορφή:

SUSPENSION FOR INJECTION

Σύνθεση:

ALVEOLAR SURFACE PHOSPHOLIPIDS (PIG) (8000001348) 120MG

Οδός χορήγησης:

ENDOTRACHEOPULMONARY USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

NATURAL PHOSPHOLIPIDS

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 1.5ML (930009301) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 3ML (930009303) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή

Φύλλο οδηγιών χρήσης

PATIENT INFORMATION LEAFLET
CUROSURF
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)
or 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
rabbit ventilated with
100% O
2
there was a dramatic improvement of tidal volume of about 10ml/kg,
treatment with
Curosurf increased the compliance of the lung-thorax system up to
level similar to that of mature
newborn animals. Large international clinical trials have documented
the therapeutical effects of
Curosurf in babies with RDS. Preterm newborn infants treated with a
single dose of Curosurf
(2.5ml/kg equal to 200mg/kg