Curosurf 240mg Injection is used for:

• Treatment, including early rescue treatment, of Respiratory Distress Syndrome (RDS) or hyaline membrane disease in newborn babies

• Prevention of RDS in premature infants requiring intubation for stabilisation who are at risk of RDS or have evidence of surfactant deficiency

Pulmonary surfactant forms a layer over the inner surface of the alveoli and reduces surface tension. This helps keep the alveoli open during breathing and supports effective gas exchange.

Premature infants may have insufficient natural surfactant, causing the alveoli to become unstable and collapse, which contributes to RDS. Poractant alfa replaces deficient surfactant and helps restore surface activity in the lungs. This can improve lung expansion, pulmonary compliance and oxygenation.

No specific medicine interactions are known for Curosurf.

However, the infant may be receiving several medicines and forms of respiratory support as part of neonatal intensive care. The treating team should be informed about all medicines being given so that treatment can be appropriately coordinated.

• Store in a refrigerator at 2°C to 8°C.

• Keep the vial in the original package to protect it from light.

• Do not freeze.

• The vial should be warmed to room temperature before administration.

• Once warmed, an unopened unused vial can be returned to refrigerated storage within 24 hours if required.

• Do not warm the vial and return it to refrigeration more than once.

• Curosurf is supplied in single-dose vials. Discard any unused suspension after opening.

Curosurf 240mg Injection is administered directly into the infant's lungs through the endotracheopulmonary route. It should only be given by healthcare professionals trained and experienced in the care, resuscitation and stabilisation of premature infants.

For rescue treatment, the recommended starting dose is 100 to 200mg/kg, equivalent to 1.25 to 2.5mL/kg, given as soon as possible after RDS is diagnosed. Additional doses of 100mg/kg may be given at approximately 12-hour intervals when RDS continues to cause persistent or worsening respiratory problems. The maximum total dose is 300 to 400mg/kg.

For prophylaxis, a dose of 100 to 200mg/kg should be given as soon as possible after birth, preferably within 15 minutes. Further doses may be considered in infants with persistent RDS who remain ventilator-dependent.

The medicine may be administered through an endotracheal tube, including while the infant remains connected to a ventilator. It may also be administered using techniques such as INSURE or Less Invasive Surfactant Administration (LISA), depending on the clinical setting and expertise available.

After administration, lung compliance and oxygenation may improve rapidly. Ventilator settings and inspired oxygen concentration may therefore need prompt adjustment to avoid excessive oxygen exposure. Continuous monitoring of oxygen saturation and other vital parameters is required.

Curosurf may cause temporary changes during or shortly after administration. These can include:

• Bradycardia

• Hypotension

• Reduced oxygen saturation

• Apnoea

• Endotracheal tube obstruction

• Pneumothorax

• Pulmonary haemorrhage

• Intracranial haemorrhage

• Hyperoxia

• Cyanosis

• Bronchopulmonary dysplasia

• Sepsis

If bradycardia, hypotension or reduced oxygen saturation occurs during administration, treatment may need to be temporarily stopped and appropriate supportive measures provided. Rapid changes in lung compliance and oxygenation can also require adjustment of ventilator settings.

• Curosurf should only be administered by trained neonatal healthcare professionals.

• The infant's general condition should be stabilised before administration, including correction of significant acidosis, hypotension, anaemia, hypoglycaemia and hypothermia where appropriate.

• Monitor heart rate and oxygen saturation continuously during administration.

• Lung compliance and oxygenation can improve rapidly, so ventilator and oxygen settings may need prompt adjustment.

• If bradycardia, hypotension or oxygen desaturation occurs during administration, the procedure may need to be stopped until the infant is stabilised.

• Do not shake the vial. Gently turn it upside down several times after warming to room temperature to obtain a uniform suspension.

• Curosurf is for single use. Discard any unused suspension after administration.

• If the response is inadequate or RDS rapidly returns, the neonatal team should assess for other complications of prematurity or other lung conditions before giving another dose.