Alveofact Intratracheal Suspension 45 mg/ml

Uses

Each ml of Phospholipid contains 25 mg of phospholipids. It is an off-white to light brown liquid supplied in single use glass vials containing 8 ml (200 mg phospholipid).

Phospholipid (beractant) is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only. It is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins to which colfosceril palmitate (dipalmitoyl phosphatidylcholine), palmitic acid and tripalmitin are added to standardize the composition and to mimic the surface-tension lowering properties of natural lung surfactant. It is dispersed in 0.9% sodium chloride solution and heat-sterilized. Phospholipid contains no preservatives. It contains two, hydrophobic, low molecular weight, surfactant-associated proteins commonly known as SP-B and SP-C. It does not contain the hydrophilic, large molecular weight surfactant-associated protein known as SP-A.

Alveofact Intratracheal Suspension 45 mg/ml is used for prevention and treatment of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.

Prevention: In premature infants less than 1250 g birthweight, or with evidence of surfactant deficiency, give Alveofact Intratracheal Suspension 45 mg/ml as soon as possible, preferably within 15 minutes of birth.

Rescue: To treat infants with RDS confirmed by X-ray and requiring mechanical ventilation, give Alveofact Intratracheal Suspension 45 mg/ml as soon as possible, preferably by 8 hours of age.

Results from clinical studies suggest that little benefit is likely to be gained from giving Alveofact Intratracheal Suspension 45 mg/ml to infants who have completed a prenatal course of corticosteroids, unless they develop RDS within the first 6-8 hours of life.

The results of outborn compared to inborn infants were not analysed separately in the clinical trials.Outborn infants were distributed equally between the treatment groups and were not considered likely to bias the estimation of treatment effect. Therefore, there does not appear to be any evidence to suggest that outborn infants respond less well to treatment with Alveofact Intratracheal Suspension 45 mg/ml.

Dosage

Alveofact Intratracheal Suspension 45 mg/ml dosage

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.

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.

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.

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.

Directions for Use: 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.

Survanta is stored refrigerated (2- 8°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. ARTIFICIAL WARMING METHODS SHOULD NOT BE USED. If a prevention dose is to be given, preparation of Survanta should begin before the infant’s birth.

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. Used vials with residual drug should be discarded.

Dosing Precautions: 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.

Methods of Administration:

• Method A 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.
• Method B 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 methods. This reflux was not associated with any clinical consequence.
• Method C: 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° 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° 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.

Side Effects

Transient bradycardia. 02 desaturation, endotracheal tube reflux & blockage, pallor, vasoconstriction, hypotension, HTN, hypocarbia, hypercarbia & apnea.

Precaution

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 Phospholipid . Endotracheal suctioning or other remedial action is unnecessary unless clear-cut signs of airway obstruction are present.

Pregnancy & Breastfeeding use

Category not classified

Acute Overdose

Overdosage with Alveofact Intratracheal Suspension 45 mg/ml has not been reported. Based on animal data, overdosage might result in acute airway obstruction. Treatment should be symptomatic and supportive. Rales and moist breath sounds can transiently occur after Alveofact Intratracheal Suspension 45 mg/ml 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.

Storage Condition

Store unopened vials at refrigeration temperature (2-8°C). Protect from light. Store vials in carton until ready for use. Vials are for single use only. Upon opening, discard unused drug.

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