Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Undesirable side effects observed during treatment in clinical trials and integrated with those collected during post-marketing experience are listed in the table below according to System Organ Class (showed with the MedDRA Preferred Term) and to the following frequency: very common (≥ 1/10); common (≥1/100 and <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

System Organ Class according to                   Adverse reaction               Frequency MedDRA
Infections and infestations                  Sepsis                                Uncommon 
Nervous system disorders                     Intracranial haemorrhage              Uncommon 
Cardiac disorders                            Bradycardia                           Rare 
Vascular disorders                           Hypotension                           Rare 
Respiratory, thoracic and mediastinal        Bronchopulmonary dysplasia            Rare disorders                                    Pneumothorax                          Uncommon Pulmonary haemorrhage                 Rare
Hyperoxia                             Not known
Neonatal cyanosis                     Not known
Apnoea                                Not known
Investigations                               Oxygen saturation decreased           Rare Abnormal electroencephalogram         Not known
Injury,   poisoning     and     procedural   Endotracheal intubation               Not known complications                                complication

Apnoea and sepsis may occur as consequences of the immaturity of neonates.

The occurrence of intracranial haemorrhages after CUROSURF instillation has been related to reduction in mean arterial blood pressure and early peaks in arterial oxygenation (PaO2). Avoidance of high PaO2 peaks by ventilator adjustment immediately after instillation is recommended.

In clinical studies performed to date a slight tendency towards an increased incidence of patent ductus arteriosus has been reported in infants treated with CUROSURF.
This phenomenon has also been reported with other exogenous surfactants and is attributed to haemodynamic changes induced by the rapid expansion of the lungs with surfactant administration.


Formation of antibodies against the protein components of CUROSURF has been observed, but so far without any evidence of clinical relevance.

Preterm neonates have relatively high incidences of cerebral haemorrhages and cerebral ischemia, reported as periventricular leukomalacia and haemodynamic anomalies such as patent ductus arteriosus and persistence of foetal circulation despite the provision of intensive care. These infants are also at high risk of developing infections such as pneumonia and bacteraemia (or septicaemia).
Seizures may also occur in the perinatal period. Preterm neonates also commonly develop haematological and electrolyte disorders which may be worsened by severe illness and mechanical ventilation. To complete the picture of complications of prematurity, the following disorders directly related to illness severity and use of mechanical ventilation, necessary for reoxygenation, may occur: pneumothorax, interstitial pulmonary emphysema and pulmonary haemorrhage. Finally, the prolonged use of high concentrations of oxygen and mechanical ventilation are associated with the development of bronchopulmonary dysplasia and retinopathy of prematurity.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il