<p>Each dose of Phospholipid is 100 mg of phospholipid/kg birth weight (4 mL/kg). The Phospholipid Dosage Chart shows the total dosage for a range of birth weights.<br />
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Four doses of Phospholipid can be administered in the first 48 hours of life. Doses should be given no more frequently than every 6 hours.<br />
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For Intratracheal Administration Only. Phospholipid should be administered by or under the supervision of clinicians experienced in intubation, ventilator management and general care of premature infants.<br />
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Marked improvements in oxygenation may occur within minutes of administration of Phospholipid. Therefore, frequent and careful clinical observation and monitoring of systemic oxygenation are essential to avoid hyperoxia.</p>

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<p>Administration</p>

<p><strong>Directions for Use:</strong>&nbsp;Phospholipid should be inspected visually for discolouration prior to administration. The colour of Phospholipid is off-white to light brown. If settling occurs during storage, swirl the vial gently (DO NOT SHAKE) to redisperse. Some foaming at the surface may occur during handling and is inherent in the nature of the product.<br />
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Survanta is stored refrigerated (2- 8&deg;C). Before administration, Survanta should be warmed by standing at room temperature for at least 20 minutes or warmed in the hand for at least 8 minutes. If a prevention dose is to be given, preparation of Survanta should begin before the infant&rsquo;s birth.<br />
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Unopened, unused vials of Survanta that have been warmed to room temperature may be returned to the refrigerator within 8 hours of warming and stored for future use. Drug should not be warmed and returned to the refrigerator more than once. Each single-use vial of Survanta should be entered only once. &nbsp;Used vials with residual drug should be discarded.<br />
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<strong>Dosing Precautions</strong>: If an infant experiences bradycardia or oxygen desaturation during the dosing procedure, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After the infant has stabilised, resume the dosing procedure. Rales and moist breath sounds can occur transiently after administration of Survanta. Endotracheal suctioning or other remedial action is unnecessary unless clear-cut signs of airway obstruction are present.<br />
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Methods of Administration:</p>

<ul>
	<li><strong>Method A</strong>&nbsp;outlined below was the original method of administration in all the controlled clinical studies that established the efficacy and safety of Phospholipid. The two additional methods of administering Phospholipid were compared to the original method in a multi-centre, randomised clinical trial involving 299 infants weighing 600g or more with RDS requiring mechanical ventilation. There were no significant differences among the three methods in average FiO2 a/A PO2 or MAP at 72 hours of age, or in the incidence of pulmonary air leaks, pulmonary interstitial emphysema, patent ductus arteriosus, or mortality at 72 hours of age.</li>
	<li><strong>Method B</strong>&nbsp;keeping the infant on the ventilator is considered the delivery method of choice as it was associated with less clinical deterioration (expressed as falls in heart rate and in oxygen saturation) during and immediately following treatment. Method B was associated with a greater degree of Phospholipid reflux than the other&nbsp; methods. This&nbsp; reflux was&nbsp; not associated with any clinical consequence.</li>
	<li><strong>Method C</strong>: Survanta can be administered by inserting the 5 French catheter through the endotracheal tube while the endotracheal tube is briefly disconnected from the ventilator. The half doses were administered in the two positions described as for Method B. The procedure for dosing is similar to Method A, the only difference being the use of two half doses instead of four quarter doses. With the infant supine, the head and body of the infant were turned approximately 45&deg; to the right. The infant is removed from the ventilator and the primed catheter inserted into the endotracheal tube. The first half of the Survanta is then delivered and the catheter withdrawn. The infant is then returned to the ventilator for at least 30 seconds of mechanical ventilation. The head and body of the infant is turned approximately 45&deg; to the left. The second half dose of Survanta is delivered in the same manner as the first. The catheter is withdrawn and the infant returned to mechanical ventilation.</li>
</ul>