Each 1.5 mL and 3 mL vial contains phospholipidic fraction from pig lung (poractant α) 120 mg and 240 mg, respectively.
Pharmacotherapeutic Group: Pulmonary surfactant containing natural phospholipids.
Treatment of respiratory distress syndrome (RDS) in pre-term babies. Prophylactic use in premature infants at risk of RDS.
Rescue Treatment: Recommended Dose: Single dose of 100-200 mg/kg (1.25-2.5 mL/kg) of body weight. It is possible to administer additional doses of 100 mg/kg, each 1 at about 12-hourly intervals, in infants still requiring assisted ventilation and supplementary and oxygen (maximum total dose: 300-400 mg/kg). It is recommended to start treatment as soon as possible after diagnosing RDS.
Prophylaxis: Single dose of 100-200 mg/kg (1.25-2.5 mL/kg) should be administered as soon as possible (within 15 min) after birth. Further doses of 100 mg/kg can be given 6-12 hrs after the 1st dose and then at 12-hr intervals in case of occurrence of RDS requiring mechanical ventilation (maximum total dose: 300-400 mg/kg).
Administration: Curosurf is available in ready-to-use vials that should be stored in a refrigerator at +2 to +8°C. The vial should be warmed to 37°C before use and gently turned upside down, without shaking, in order to obtain homogeneous suspension.
The suspension should be withdrawn from the vial by using a sterile needle and syringe.
In order to draw the suspension, locate the notch on the colored plastic cap.
Lift the notch and pull upwards.
Pull the plastic cap with the aluminum portion downwards, and remove the whole ring by pulling off the aluminum wrapper. And, remove the rubber cap to extract content.
Curosurf can be directly administered, via intratracheal tube, as a single dose into the lower part of trachea, or as 2 halved doses in the main right and left bronchial tubes, respectively. Perform approximately 1 min of hand-bagging with the same percentage of oxygen as before administration, in order to favour uniform distribution. Reconnect then the baby to the ventilator, whose parameters must be suitably adjusted to the clinical response and to the changes of blood gases. Further doses that may be required are administered in the same manner. Babies not requiring assisted ventilation can be disconnected from the ventilator after Curosurf administration. It is recommended to frequently control blood gases, as, after administration, an immediate increase of PaO2 or oxygen saturation is generally observed. It is however advisable to continuously monitor transcutaneous PO2 or oxygen saturation to avoid hyperoxia.
There have been no reports of overdosage following the administration of Curosurf. However, in the unlikely event of accidental overdose and only if there are clear clinical effects on the infant's respiration, ventilation or oxygenation, as much of the suspension as possible should be aspirated and the baby should be managed with supportive treatment with particular attention to the fluid and electrolyte balance.
Babies born following very prolonged rupture of the membranes (>3 weeks) may not show optimal response to the exogenous surfactant.
Surfactant administration can be expected to reduce the severity of RDS or the risk of its ocurrence, but cannot be expected to completely eliminate mortality and morbidity associated with pre-term birth, as pre-term babies may be exposed to other complications due to their immaturity.
Curosurf should only be administered in hospital, by those trained and experienced in the care and resuscitation of pre-term infants, having available suitable equipment for ventilation and monitoring of babies with RDS. The baby's general condition should be stabilised.
Correction of acidosis, hypotension, anaemia, hypoglycaemia and hypothermia is also recommended.
Pulmonary haemorrhage, whose incidence increases the more immature the infant is, it is a rare and sometimes fatal complication of pre-term delivery. No evidence exists of any increased risk of this event following the administration of Curosurf. No other adverse events have been reported.
Do not use any residual quantity in the vial after the 1st aspiration.
Unopened, unused vials of Curosurf that have warmed to room temperature can be returned to refrigerated storage within 24 hrs for future use.
Do not warm to room temperature and return to refrigerated storage more than once.
Store at +2 to +8°C. Protect from light.
R07AA02 - natural phospholipids ; Belongs to the class of lung surfactants. Used in the treatment of respiratory diseases.
Vial 120 mg/1.5 mL x 1's. 240 mg/3 mL x 1's.