Respiratory distress syndrome (hyaline membrane disease) in preterm infants weighing more than 700 g.
1 ml contains Poractant alpha (phospholipid fraction isolated from pig lung) 80 mg (composition per 1 ml of suspension: phospholipid fraction isolated from pig lung – 80 mg/mL, equivalent to approximately 74 mg/mL total phospholipids and 0.9 mg of low molecular weight hydrophobic proteins).
How to take, the dosage
Curosurf is administered endotracheally to intubated children on artificial ventilation (IV).
The initial single dose is 100-200 mg/kg (1.25-2.5 ml/kg), repeatedly at a dose of 100 mg/kg 1 or 2 times with an interval of at least 12 hours.
The maximum total dose is 300-400 mg/kg.
The initial dose is given bolus in the lower trachea through the endotracheal tube, having disconnected the child from the ventilator.
After injection, manual ventilation is performed for 1 minute, after which the child is reconnected to the ventilator, maintaining the previously established ventilation rates.
The reintroduction is done similarly.
The correction of acidosis, arterial hypotension, anemia, hypoglycemia and hypothermia should be performed before starting Curosurf therapy.
If reflux occurs, the drug administration should be suspended and, if necessary, the peak inspiratory pressure on the ventilator should be increased to the level necessary to clear the endotracheal tube.
In case of endotracheal tube blockage due to mucus accumulation in children, ventilation may be markedly impaired during administration or immediately after administration, which occurs when there is pulmonary secretion in the child prior to administration. Suctioning mucus prior to drug administration may reduce the likelihood of endotracheal tube obstruction. If the obstruction cannot be removed, the endotracheal tube should be replaced immediately.
A aspiration of tracheobronchial secretions for at least 6 h after drug administration is not recommended, except under life-threatening conditions.
In case of bradycardia, arterial hypotension and decreased oxygen saturation, the drug administration should be suspended and necessary measures taken to normalize heart rate, after which the treatment can be continued.
Children born after a long period of water shortage (more than 3 weeks) may respond poorly to Curosurf replacement therapy, which may be associated with pulmonary hypoplasia.
The administration of the drug can be expected to reduce the severity of or risk of RDS, but therapy cannot be expected to completely eliminate the mortality and morbidity associated with preterm birth, as preterm infants may be subject to other complications due to their immaturity.
Pulmonary bleeding (especially with pronounced signs of pulmonary immaturity).
To date, there have been no overdose events with the use of Curosurf.
However, in case of overdose and only if there are clear clinical manifestations (respiratory, ventilation or oxygenation) aspiration of suspended contents from the lungs and therapy aimed at maintaining water-electrolyte balance should be performed as far as possible.
|Conditions of storage|
In a dark place at a temperature of 2-8 °C.
Chiesi Pharmaceutici S.p.A., Italy
suspension for endotracheal administration
Chiesi Pharmaceutici S.p.A.
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