Curosurf suspension endotracheal

Country: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

poractant alfa

Доступно од:

Chiesi Farmaceutici S.p.A.

АТЦ код:

R07AA02

INN (Међународно име):

poractant alfa

Дозирање:

80mg/ml

Фармацеутски облик:

suspension endotracheal

Јединице у пакету:

glass vial 1,5ml

Тип рецептора:

Prescription

Статус ауторизације:

Registered

Датум одобрења:

2023-04-21

Информативни летак

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, water for injections, sodium hydrogen
carbonate (for pH adjustment).
PHARMACEUTICAL FORM. Endotracheal instillation suspension.
_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 LISA
technique and the standard one (intubation, administration and
artificial ventilator) in two groups of preterm
newborns with RDS 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 the main
amount is found in the lungs. A half-
life is 67 hours. Only traces of surfactant

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1
NAME OF THE MEDICINAL PRODUCT
CUROSURF
®
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 1.5 ml vial contains:
phospholipid fraction from porcine lung 120 mg.
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
Endotracheopulmonary instillation suspension.
A white to yellow sterile suspension in single-dose vials for
endotracheopulmonary use.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
-
Treatment of premature infants with, or at risk for Respiratory
Distress Syndrome (RDS);
-
Treatment of premature infants with other evidences of surfactant
deficiency.
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 the care, resuscitation and
stabilisation of preterm infants.
CUROSURF is administered via th