Please see full ISI below, at the end of the above video, and on the website: [ Ссылка ]
This user guide outlines the important safety information (ISI) for CUROSURF, an intratracheal suspension indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants.
*IMPORTANT SAFETY INFORMATION*
CUROSURF® (poractant alfa) is intended for intratracheal use only. The administration of exogenous surfactants, including CUROSURF, can rapidly affect oxygenation and lung compliance. Therefore, infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes.
CUROSURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm infants.
Transient adverse reactions associated with administration of CUROSURF include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. These events require stopping CUROSURF administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring.
Pulmonary hemorrhage, a known complication of premature birth and very low birth-weight, has been reported with CUROSURF. The rates of common complications of prematurity observed in a multicenter single-dose study that enrolled infants 700–2000 g birth weight with RDS requiring mechanical ventilation and FiO2 greater than or equal to 0.60 are as follows for CUROSURF 2.5 mL/kg (200 mg/kg) (n=78) and control (n=66; no surfactant) respectively: acquired pneumonia (17% vs. 21%), acquired septicemia (14% vs. 18%), bronchopulmonary dysplasia (18% vs. 22%), intracranial hemorrhage (51% vs. 64%), patent ductus arteriosus (60% vs. 48%), pneumothorax (21% vs. 36%) and pulmonary interstitial emphysema (21% vs. 38%).
*INDICATION*
CUROSURF® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS.
*Please see full prescribing information: [ Ссылка ]*
This site is intended for United States residents only.
CUROSURF® is a registered trademark of Chiesi Farmaceutici, S.p.A.
PP-C-0630 V1.0
Important Safety Information: CUROSURF® (poractant alfa)
Теги
“respiratory distress syndrome”“RDS”“neonatal respiratory distress syndrome”“respiratory distress syndrome of newborn”“surfactant deficiency disorder”“SDD”“surfactant”“CUROSURF”“surfactant deficiency”“surfactant in newborns”“surfactant therapy”“RDS in newborns”“poractant alfa”“infant respiratory distress syndrome”“surfactant treatment”“CUROSURF indication”“CUROSURF ISI”“CUROSURF important safety information”
