Survanta 1 ml Sterile Dispersion

Survanta is indicated in the treatment and prevention of neonatal respiratory distress syndrome (RDS).

Posology
Paediatric population
The recommended dose of Survanta is 100 mg phospholipid/kg body weight in a volume not exceeding 4 ml/kg. Treatment should be administered early in the course of Respiratory Distress Syndrome, i.e. preferably babies less than 8 hours of age. For treatment and prophylaxis of RDS in high-risk infants, up to four doses of Survanta may be administered within 48 hours. The first dose is given at 15 minutes postpartum, with up to three additional doses at intervals of at least six hours.

Method of administration
Before administration, Survanta should be warmed by standing at room temperature for about 20 minutes or warmed in the hand for 8 minutes. ARTIFICIAL METHODS OF WARMING SHOULD NOT BE USED. If settling has occurred during storage, redisperse by swirling the vial gently. Slowly withdraw the entire contents of the vial into a plastic syringe through a large-gauge needle, i.e. 20 gauge or larger. DO NOT FILTER SURVANTA. Survanta is administered intratracheally. It can be instilled 1) through a 5 French end-hole catheter inserted into the infant's endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator or 2) by inserting the catheter through a neonatal suction valve without disconnecting the endotracheal tube from the ventilator. If the medicine is instilled through an end-hole catheter, the length of the catheter should be shortened so that the tip of the catheter protrudes just beyond the end of the endotracheal tube above the infant's carina. Survanta should not be instilled into a mainstream bronchus. To ensure homogenous distribution of Survanta throughout the lungs, each dose is divided into fractional doses. Each dose can be administered in two half-doses or in four quarter-doses. Each fractional dose is administered with the infant in a different position. To administer Survanta in two half-doses, the recommended positions are:
- Head and body turned approximately 45 deg. to the right.
- Head and body turned approximately 45 deg. to the left.
To administer Survanta in four quarter-doses, the recommended positions are:
- Head and body inclined slightly downwards, head and body turned to the right.
- Head and body inclined slightly downwards, head and body turned to the left.
- Head and body inclined slightly upwards, head and body turned to the right.
- Head and body inclined slightly upwards, head and body turned to the left.
It is recommended that Survanta be administered in two half-doses through a neonatal suction valve. AFTER COMPLETION OF THE DOSING PROCEDURE, RESUME USUAL VENTILATOR MANAGEMENT AND CLINICAL CARE.

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

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.

Interactions between Survanta and other medicines commonly used concomitantly in neonatal intensive care, e.g. catecholamines, indomethacin, tolazoline, pancuronium, phenobarbital, opiates, antibiotics and parenteral nutrients, have not been observed. Additionally, medicines such as tocolytics and corticosteroids given prenatally to mothers did not interfere with the use of Survanta in the neonate.

Not applicable.

Not relevant.

Paediatric population
a. 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.
b. 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 (u2265 1/10), common (u2265 1/100 to < 1/10), uncommon (u2265 1/1,000 to < 1/100), rare (u2265 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 medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

Paediatric population
If an excessively large dose of Survanta is given, observe the infant for signs of acute airway obstruction. Treatment should be symptomatic and supportive. Rales and moist breath sounds may occur transiently after Survanta is given and do not indicate overdosage. Endotracheal suctioning or other remedial action is not required unless clear-cut signs of airway obstruction are present.