SURVANTA

Posology Paediatric population 100 mg phosholipid/kg birth weight in a volume not exceeding 4ml/kg.

Treatment:

The first dose of Survanta should be given as soon as possible after RDS is confirmed by radiographic or clinical findings. Depending on clinical course, this dose may be repeated within 48 hours at intervals of at least six hours for up to 4 doses.

Prophylaxis:

The first dose of Survanta should be administered as soon as possible after birth, preferably within 15 minutes. Depending on clinical course, this dose may be repeated within 48 hours at intervals of at least six hours for up to 4 doses.

Method of Administration Survanta should be administered via the endotracheopulmonary route. The dosing procedure is facilitated if one person administers the dose while another person positions and monitors the infant. 3). 0. Inspiratory pressure needs no change at this point.

There are 2 alternative methods of administration for mechanically ventilated infants: i. The dose is administered by disconnecting the endotracheal tube from the ventilator, inserting a small diameter catheter and administering the dose with the infant in a neutral position.

The tip of the catheter should lie at the end of the endotracheal tube. Alternatively: ii. The dose can be administered by inserting a small diameter catheter through a suction port connector without disconnection from the ventilator with the infant in a neutral position.

The tip of the catheter should lie at the end of the endotracheal tube. After the dose is administered, the catheter is then withdrawn completely, and the ventilator is reconnected if necessary. Instillation in Spontaneously Breathing Infants Intubation Surfactant Extubation (INSURE) Following intubation and insertion of the catheter as described above, place the infant in a neutral position and gently inject the dose as a single bolus over 1 to 3 minutes in the delivery room or later after admission to the neonatal unit.

After instillation, use a bagging technique and proceed to extubation and CPAP as clinically indicated. Less Invasive Surfactant Administration (LISA) A small diameter catheter may be used to administer the dose without intubation. In such cases, place the catheter directly into the trachea of infants on CPAP with direct visualization of the vocal cords by laryngoscopy and gently inject the dose as a single bolus over 1 to 3 minutes.

Paediatric population Summary of the safety profile Mechanically Ventilated Infants Intracranial haemorrhage has been observed in patients who received either beractant or placebo. The incidence of intracranial haemorrhage in all patients is similar to that reported in the literature in this patient population.

Pulmonary haemorrhage has also been reported. Blockage of the endotracheal tube by mucous secretions has been reported. No other serious adverse reactions have been reported. INSURE and LISA Techniques Safety results with the INSURE and LISA techniques were comparable to those of the control groups, although bradycardia and hypoxemia were reported more frequently in some cases with LISA.

Tabulated summary of adverse reactions The following adverse reactions were identified in patients treated with Survanta. The adverse reactions are listed below by body system organ class and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data).

These are presented in the following table:

System Organ Class Frequency Adverse Reactions Vascular disorders Very common Intracranial haemorrhage Respiratory Common Pulmonary haemorrhage Surgical and Medical Procedures Uncommon Blockage of endotracheal tube by mucous secretions No antibody production to Survanta proteins has been observed.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Survanta should only be administered with adequate facilities for ventilation and monitoring of babies with RDS. Marked improvements in oxygenation may occur within minutes of the administration of Survanta. Therefore, frequent and careful monitoring of systemic oxygenation is essential to avoid hyperoxia.

Following Survanta administration, monitoring of the arterial blood gases, the fraction of inspired oxygen and ventilatory change is required to ensure appropriate adjustments. During the dosing procedure, transient episodes of bradycardia and/or oxygen desaturation have been reported.

If these occur, dosing should be stopped and appropriate measures to alleviate the condition should be initiated. After stabilisation, the dosing procedure should be resumed.

No specific contraindications for Survanta have been defined by the clinical studies.