Adverse reactions : תופעות לוואי

ADVERSE REACTIONS
The most common adverse reactions associated with Infasurf dosing procedures in the controlled trials were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%). These events were generally transient and not associated with serious complications or death.
The incidence of common complications of prematurity and RDS in the four controlled Infasurf trials are presented in Table 3. Prophylaxis and treatment study results for each surfactant are combined.

Table 3 – Common Complications of Prematurity and RDS in Controlled Trials Infasurf    Exosurf Neonatal®    Infasurf     Survanta®
Complication                           (N=1001)         (N=978)          (N=553)       (N=566) %                %               %            %
Apnea                                              61                    61          76    76 Patent ductus arteriosus                           47                    48          45    48 Intracranial hemorrhage                            29                    31          36    36 Severe intracranial hemorrhagea                  12                    10           9    7 IVH and PVLb                                      7                     3           5    5 Sepsis                                             20                    22          28    27 Pulmonary air leaks                                12                    22          15    15 Pulmonary interstitial emphysema                  7                    17          10    10 Pulmonary hemorrhage                                7                     7           7    6 Necrotizing enterocolitis                           5                     5          17    18 a
Grade III and IV by the method of Papile.
b
Patients with both intraventricular hemorrhage and periventricular leukomalacia.
Follow-up Evaluations
Two-year follow-up data of neurodevelopmental outcomes in 415 infants enrolled in 5 centers that participated in the Infasurf vs. Exosurf Neonatal® controlled trials demonstrated significant developmental delays in equal percentages of Infasurf and Exosurf Neonatal® patients.