Țară: Armenia
Limbă: engleză
Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
poractant alfa
Chiesi Pharmaceuticals GmbH
R07AA02
poractant alfa
80mg/ml
suspension endotracheal
1.5ml glass vial
Prescription
Registered
2016-11-23
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 Citiți documentul complet
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 Citiți documentul complet