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Prophylaxis/risk of respiratory distress syndrome-neonates
Respiratory distress syndrome - neonates
For use in newborn babies to treat Respiratory Distress Syndrome (RDS) or hyaline membrane disease.
For prevention of RDS in premature babies at risk of RDS or with evidence of surfactant deficiency.
Poractant should only be administered by those experienced in the care, resuscitation and stabilisation of preterm infants.
The baby's general condition should be stabilised before treatment.
A single dose of 100 to 200mg/kg should be administered as soon as possible after birth (preferably within 15 minutes). Subsequent doses of 100mg/kg can be given 6 to 12 hours after the initial dose and then 12 hours later in neonates who have continuous signs of RDS and remain dependent on a ventilator (maximum total dose of 300 to 400mg/kg).
Rescue Treatment - commence treatment as soon as possible after diagnosing RDS:
Initially, a single dose of 100 to 200mg/kg (1.25 to 2.5ml/kg) is advised.
Up to two further doses of 100mg/kg, administered at about 12 hourly intervals, may also be indicated in infants who remain intubated and in whom RDS is considered responsible for their persisting or deteriorating respiratory status (maximum total dose of 300 to 400mg/kg).
For full details see the manufacturers product information.
Precautions and Warnings
Neonates with acidosis
Consider suction of endotracheal tube prior to administration
Treatment to be prescribed under the supervision of a specialist
Monitor blood gases regularly
Monitor heart rate
Monitor patient constantly for signs of new infection
Suspend treatment if bradycardia, hypotension or reduced oxygen saturation
Suspend treatment if reflux occurs & ensure clearance of endotracheal tube
Correction of acidosis, hypotension, anaemia, hypoglycaemia and hypothermia is recommended.
In the event of reflux, administration should be stopped and, if necessary, peak inspiratory pressure on the ventilator should be increased until clearing of the endotracheal tube occurs.
In the event of bradycardia, hypotension and reduced oxygen saturation, administration should be stopped and suitable measures taken to normalise heart rate. After stabilisation, treatment with poractant may be continued with appropriate monitoring of vital signs.
Impaired ventilation may be due to blockage of the endotracheal tube. Suctioning prior to dose may decrease the risk of obstruction. If endotracheal tube obstruction is suspected and suctioning is unsuccessful in clearing the blockage, the tube should be replaced immediately.
Aspiration of tracheal secretions is not recommended for at least 6 hours after administration with the exception of life-threatening conditions.
Neonates born following very prolonged rupture of the membranes (greater than 3 weeks) may not show optimal response.
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 babies may be exposed to other complications of the immaturity. After administration, a transient depression of cerebro-electrical activity has been recorded lasting 2 to 10 minutes. The impact of this is not clear.
Following administration of poractant, ventilator settings require prompt adjustment due to improvement in respiratory functions.
Continuous monitoring of transcutaneous PaO2 or oxygen saturation is advised due to the potential for rapid increase in arterial oxygen concentration.
In cases of unsatisfactory response to treatment with poractant or rapid relapse, it is advisable to consider other complications of immaturity such as patent ductus arteriosus or other lung diseases such as pneumonia before the administration of the next dose.
When solution administered with the LISA technique, an increase in frequency of bradycardia, apnoea and reduced oxygen saturation has been reported. If these events become serious, stop treatment and treat the complications.
Complications associated with the administration device
Oxygen saturation decreased
Transient depression of cerebro electrical activity
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: July 2021
Summary of Product Characteristics: Curosurf. Chiesi Limited. Revised June 2018.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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