For treatment of respiratory distress syndrome (RDS) in neonates.
Phospholipid fraction from bovine lung (surfactant) 54 mg
Up to 1 Month
Each dose of Alveofact is 54 mg of total phospholipids per kg body weight (1.2 ml per kg body weight).
Preventive use in premature neonates with a high risk of respiratory distress syndrome (RDS):
A single dose of Alveofact and application within the first hour after birth are recommended.
Treatment of respiratory distress syndrome (RDS) in premature neonates:
Alveofact should be administered early in the course of RDS i.e preferably less than 6 hours of age.
Treatment with Alveofact is given only by endotracheopulmonary instillation. A ready prepared catheter (e.g. umbilical catheter or gastric tube) is inserted through the positioned tracheal tube and the catheter opening positioned at the level of the tip of the tube. Using a syringe, the single dose of 1.2 ml Alveofact per kg body weight (corresponding to 54 mg total phospholipids per kg body weight) is administered as an intratracheal bolus via this catheter.
Additional injections of air are used to help ensure that instillation is complete. Upon removal of the catheter the patient is reconnected to the respirator. To promote the equal distribution of Alveofact, the patient may be gently turned from side to side every few seconds.
Duration of Treatment
Depending on the need for ventilation and on the initial dose, the following dosing scheme should be applied:
Initial dose 54 mg:
up to three subsequent applications of 54 mg.
Initial dose 108 mg:
up to one dose of 108 mg or up to two doses of 54 mg.
The total dose should not exceed 216 mg total phospholipids per kg body weight within the first 2 days of life.