Survanta 200mg Injection is used for:

• Treatment of Respiratory Distress Syndrome in premature newborns with a birth weight of 700g or greater

• Prevention of RDS in premature infants born before 32 weeks of gestation who are at risk of developing RDS and require intubation for stabilisation or have evidence of surfactant deficiency

Treatment is given in a highly monitored neonatal setting because the medicine can rapidly change lung compliance and oxygenation.

Survanta replaces pulmonary surfactant that is deficient in the immature lungs of premature infants.

Pulmonary surfactant reduces surface tension inside the alveoli and helps keep the air sacs open during breathing. In premature infants with insufficient surfactant, the alveoli can collapse more easily, making breathing difficult and contributing to RDS.

After administration, beractant restores surface activity in the lungs, improves lung compliance and can improve oxygenation.

There are no known drug interactions with Survanta. However, the infant may be receiving other medicines and respiratory treatments as part of neonatal intensive care.

Tell the treating neonatal team about all medicines and treatments being given to the infant so that respiratory support and other aspects of care can be appropriately monitored.

• Store Survanta at 2°C to 8°C.

• Do not freeze.

• Protect the vial from light and keep it in the original carton.

• Before administration, the vial should be warmed to room temperature by standing for 20 minutes or by warming it in the hand for 8 minutes.

• Do not use artificial warming methods.

• Do not shake the vial. If settling occurs, gently swirl or invert it to redisperse the suspension.

• A vial should not be returned to the refrigerator after warming.

• Use the warmed vial within the period specified in the applicable product information.

• Each vial is for single use only. Discard any unused medicine remaining after administration.

Survanta is administered intratracheally through an endotracheal tube. It must be given by or under the supervision of healthcare professionals experienced in neonatal intubation, ventilator management and the care of premature infants.

The recommended dose is 100mg of phospholipids per kg of birth weight, equivalent to 4ml/kg. Depending on the infant's clinical condition, up to four doses may be given during the first 48 hours of life, with doses administered no more frequently than every 6 hours.

For prevention, the first dose is given as soon as possible after birth, preferably within 15 minutes. For treatment of established RDS, the first dose should be given as soon as possible after RDS is confirmed, preferably by 8 hours of age.

The treating neonatal team will determine the dose and need for additional doses based on the infant's birth weight and respiratory condition.

Survanta can cause temporary reactions during or shortly after administration. These are generally associated with the dosing procedure and the rapid changes in lung function.

Common side effects

• Slow heartbeat (bradycardia)

• Decreased oxygen saturation

• Reflux of Survanta into the endotracheal tube

• Changes in blood pressure

• Temporary breathing changes

Bradycardia and oxygen desaturation are among the more frequently reported reactions during the dosing procedure. If they occur, administration may be temporarily stopped until the infant is stabilised.

Serious side effects

The treating medical team will monitor for complications such as:

• Significant airway obstruction

• Apnoea

• Severe oxygen desaturation

• Respiratory deterioration

• Pulmonary air leak

• Pulmonary haemorrhage

• Infection or sepsis

These complications can also occur in premature infants because of their underlying condition and cannot always be attributed directly to Survanta.

• Survanta should only be administered in a neonatal intensive care setting with appropriate respiratory support and monitoring.

• The infant's oxygenation and ventilation should be monitored closely during and after administration.

• Transient bradycardia or oxygen desaturation can occur during dosing. The healthcare team may pause administration and stabilise the infant before continuing.

• Survanta can produce rapid improvements in oxygenation, so ventilator settings and oxygen requirements may need to be adjusted by the neonatal team.

• Do not shake the vial. Gently swirl it if settling occurs.

• The vial is intended for single use and any remaining medicine should be discarded.

• Parents and caregivers should not attempt to administer Survanta themselves.

• Follow-up respiratory care and monitoring remain essential even after surfactant treatment.