Posology : מינונים

4.2   Posology and method of administration

CUROSURF should only be administered in hospital, by those trained and experienced in the care and resuscitation of preterm infants, having available suitable equipment for ventilation and monitoring of infants with RDS.

Rescue Treatment: the recommended dose is a single dose of 100-200 mg/kg (1.25-2.5 ml/kg) of body weight administered in a single dose. It is possible to administer additional doses of 100 mg/kg, each one at about 12 hour intervals, in infants still requiring assisted ventilation and supplementary oxygen (maximum total dose: 300-400 mg/kg).
It is recommended to start treatment as soon as possible after diagnosing RDS.
Prophylaxis: a single dose of 100-200 mg/kg (1.25-2.5 ml/kg) should be administered as soon as possible (within 15 minutes) after birth. Further doses of 100 mg/kg can be given 6-12 hours after the first dose, and then at 12 hour intervals in case of occurrence of RDS requiring mechanical ventilation (maximum total dose: 300-400 mg/kg).

METHOD OF ADMINISTRATION
CUROSURF is available in ready-to-use vials that should be stored in a refrigerator at +2°C to +8°C.
The vial should be warmed to room temperature before use, for example by holding it in the hand for a few minutes, and gently turned upside down a few times, without shaking, in order to obtain a uniform suspension.
The suspension should be withdrawn from the vial by using a sterile needle and syringe following the instruction described in section 6.6.


CUROSURF can be administered either by: a. Disconnecting the infant from the ventilator
Disconnect the infant momentarily from the ventilator and administer 1.25 to 2.5 ml/kg (100-200 mg/kg) of the suspension, as a single bolus, directly into the lower trachea via the endotracheal tube.
Perform approximately one minute of hand-bagging and then reconnect the infant to the ventilator at the same settings as before administration. Further doses (1.25 ml/kg equivalent to 100 mg/kg) that may be required can be administered in the same manner;
 or
 b. Without disconnecting the infant from the ventilator
Administer 1.25 to 2.5 ml/kg (100-200 mg/kg) of the suspension, as a single bolus, directly into the lower trachea by passing a catheter through the suction port and into the endotracheal tube.

Further doses (1.25 ml/kg equivalent to 100 mg/kg) that may be required can be administered in the same manner.
 c. Intubation Surfactant Extubation (INSURE)
A third method consists of intubating the neonate for the sole purpose of administering the surfactant.
The doses are the same as those indicated at points a) and b). In this case the neonate is ventilated manually and after administration of the surfactant and extubation, nasal CPAP (Continuous Positive Airway Pressure) may be applied.

It is recommended to frequently control blood gases whatever administration is used, as, after administration, an immediate increase of PaO2 or oxygen saturation is generally observed.

It is however advisable to continuously monitor transcutaneous PaO2 or oxygen saturation to avoid hyperoxia.