Curosurf suspension endotracheal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

poractant alfa

Available from:

Chiesi Pharmaceuticals GmbH

ATC code:

R07AA02

INN (International Name):

poractant alfa

Dosage:

80mg/ml

Pharmaceutical form:

suspension endotracheal

Units in package:

1.5ml glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-11-23

Patient Information leaflet

INSTRUCTION
FOR MEDICAL USE OF MEDICINAL PRODUCT
CUROSURF
®
_ _
_COMPOSITION: _
_active ingredient: _poractant alfa (BAN);
1.5 ml of suspension contains 120 mg of phospholipid fraction
extracted from porcine lung;
_excipients: _sodium chloride, sodium bicarbonate (for pH-adjustment),
water for injections.
PHARMACEUTICAL FORM. Suspension for endotracheal administration.
_Main physicochemical properties:_ a white to yellow suspension.
PHARMACOTHERAPEUTIC GROUP. Lung surfactants. Natural phospholipids.
ATC code R07A A02.
_PHARMACOLOGICAL PROPERTIES. _
_Pharmacodynamics._ Lung surfactant supplements endogenous lung
surfactant deficiency with exogenous. It
is lining the internal surface of alveoli; it reduces pulmonary
surface tension, stabilises alveoli, and avoids
collapse at end-expiration, promotes adequate gas exchange, which is
maintained it throughout the whole
ventilatory cycle. Distributes evenly in the lungs and spreads on the
surface of the alveoli. In premature
infants, the level of oxygenation is restored, that requires a
decrease in the concentration of inhaled oxygen
in the gas mixture; reduces mortality and respiratory diseases.
Clinical efficacy and safety
A spontaneous clinical trial (NINSAPP) has compared the administration
of CUROSURF with the less
invasive surfactant administration with a thin catheter (LISA)
technique and the standard one (intubation,
administration and
artificial ventilator) in two groups of preterm newborns with
respiratory distress
syndrome and gestational age between 23 and 27 weeks (LISA group:
N=108, control group: N=105). LISA
technique
was
not
inferior
to
the
standard
one
on
the
primary
end-point
(survival
without
bronchopulmonary dysplasia at 36 gestational weeks). On the secondary
end-points LISA was superior in
increasing survival without major complications and in reducing the
frequency of other morbidities
associated with prematurity. The need of mechanical ventilation was
significantly reduced with LISA.
_Pharmacokinetics._ Following intratracheal administration th

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1
NAME OF THE MEDICINAL PRODUCT
CUROSURF
®
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: poractant alfa (BAN).
1.5 ml of suspension contains 120 mg of phospholipid fraction
extracted from porcine lung.
Composition per ml of suspension: phospholipid fraction from porcine
lung 80 mg/ml, equivalent to about
74 mg/ml of total phospholipids and 0.9 mg/ml of low molecular weight
hydrophobic proteins.
CUROSURF is a natural surfactant, prepared from porcine lungs,
containing almost exclusively polar
lipids, in particular phosphatidylcholine (about 70% of the total
phospholipid content) and about 1% of
specific low molecular weight hydrophobic proteins SP-B and SP-C.
3
PHARMACEUTICAL FORM
Suspension for endotracheal administration.
A white to yellow sterile suspension in single-dose vials for
endotracheopulmonary use.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
-
Treatment of respiratory distress syndrome (RDS) or disease of hyaline
membranes in newborns.
-
Preventive use of preterm infants with risk of developing RDS or with
established deficiency of
surfactant.
4.2
P
OSOLOGY AND METHOD OF ADMINISTRATION
4.2.1
POSOLOGY
4.2.1.1
RESCUE TREATMENT
The recommended starting dose is 100–200 mg/kg (1.25–2.5 ml/kg),
administered in a single dose right
after diagnosing RDS.
Additional doses of 100 mg/kg (1.25 ml/kg), each at about 12-hourly
intervals, may also be administered if
RDS is considered to be cause of persisting or deteriorating
respiratory status of the infants (maximum total
dose of 300–400 mg/kg).
4.2.1.2
PROPHYLAXIS
A single dose from 100 to 200 mg/kg should be administered as soon as
possible after birth (preferably
within 15 minutes). Further doses of 100 mg/kg can be given 6-12 hours
after the first dose and then 12
hours later in infants who have persistent signs of RDS and remain
ventilator-dependent (maximum total
dose: 300–400 mg/kg).
4.2.2
METHOD OF ADMINISTRATION
CUROSURF should only be administered by those trained and experienced
in th