Curosurf

/ Abic

This medical product 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-hourly 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 (max.
total dose: 300-400 mg/kg).
Method of administration: this medical product 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 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The suspension should be withdrawn from the vial by using a sterile needle and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.
See prescribing information for full details.

Preterm babies with RDS (Respiratory Stress Syndrome).
Prophylactic use in premature infants at high risk for RDS.

Hypersensitivity to the active substance or to any of the excipients.
No specific contraindications to Curosurf are yet known.

Treatment
Prior to starting the treatment neonates general conditions should be stabilised. Correction of acidosis, hypotension, anaemia, hypoglycaemia and hypothermia is also recommended.
In the event of reflux, administration should be stopped and, if necessary, peak inspiratory pressure should be increased until the obstruction in the endotracheal tube has been cleared.
Infants whose ventilation becomes markedly impaired during or shortly after instillation may have mucus plugging the endotracheal tube, particularly if pulmonary secretions were prominent prior to drug administration.
Suctioning of infants prior to dosing may lessen the probability of mucus plugs obstructing the endotracheal tube. If endotracheal tube obstruction is suspected, and suctioning is unsuccessful in clearing the obstruction, the endotracheal tube should be replaced immediately. However, aspiration of tracheal secretions is not recommended for at least 6 hours after administration, with the exception of life-threatening conditions.
In the event of episodes of bradycardia, hypotension, and reduced oxygen saturation administration should be stopped and suitable measures to normalize heart rate should be considered and undertaken. After stabilisation, the infant can still be treated with appropriate monitoring of vital signs.
After administration pulmonary compliance can improve rapidly, thus requiring prompt reduction of the inspiratory pressure peak without waiting for confirmation from a check of blood gases.
The improvement of alveolar gas exchange can result in a rapid increase of arterial oxygen concentration: therefore a rapid adjustment of the inspired oxygen concentration should be made to avoid hyperoxia. In order to maintain proper blood oxygenation values, in addition to periodic blood gas analysis, continuous monitoring of transcutaneous PaO2 or oxygen saturation is also advisable.
Nasal continuous positive airway pressure (nasal-CPAP) can be used in maintenance therapy of neonates treated with surfactant, but only in units equipped to perform this technique.
New-borns treated with surfactant should be carefully monitored with respect to signs of infection. At the earliest signs of infection the infant should immediately be given appropriate antibiotic therapy.
In cases of unsatisfactory response to treatment or of rapid relapse, it is advisable to consider the possibility of other complications of immaturity such as patent ductus arteriosus or other lung diseases such as pneumonia, before the administration of the next dose.
Particular attention must be paid to infants born following a prolonged rupture of the membranes (greater than 3 weeks) since they may have some degree of pulmonary hypoplasia and may not show an optimal response to exogenous surfactant.
Surfactant administration can be expected to reduce the severity of RDS but cannot be expected to eliminate entirely the mortality and morbidity associated with preterm birth, as preterm new-borns may present other complications associated with their immaturity.
When this medical product is administered by the LISA technique, an increased frequency of bradycardia, apnoea and reduced oxygen saturation can occur. These events are generally short-lasting, without consequences during administration and easily managed. In the event of their exacerbation, it is necessary to discontinue the therapy in place and treat the ongoing complications.
See prescribing information for full details.

No common side effects were observed.
See prescribing information for full details.

Not known.

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 infant should be managed with supportive treatment, with particular attention to fluid and electrolyte balance.

Storage: The product must be stored at +2 to +8°C, protected from light.
Do not use any residual quantity in the vial after the first aspiration. Unopened, unused vials of Curosurf that have been warmed to room temperature
can be returned to refrigerated storage within 24 hours for future use.
Do not warm to room temperature and return to refrigerated storage more than
once.