One 1.5 ml vial contains 120 mg of phospholipid fraction from porcine lung along with Sodium Chloride EP 13.5 mg and Water for Injections EP 1.5 ml.

One 3 ml vial contains 240 mg of phospholipid fraction from porcine lung along with Sodium Chloride EP 27 mg and Water for Injections EP 3 ml.

Curosurf is a natural surfactant used for the treatment of respiratory distress syndrome (RDS or hyaline membrane disease) in newborn babies, who have a minimum birthweight of 700 g.

Curosurf should only be administered by those trained and experienced in the care and resuscitation of preterm infants. It is administered via the intratracheal route in intubated infants undergoing mechanical ventilation for respiratory distress syndrome and whose heart and arterial oxygen saturation are being continuously monitored. Intubation should not be undertaken merely to administer surfactant.

It is advisable to commence the treatment as soon as possible after diagnosing RDS. Therapy with Curosurf starting more than 48 hours after diagnosing RDS has not been investigated.

Curosurf is available in ready-to-use vials that should be stored in a refrigerator at +2 to +8 C. The vial should be slowly warmed to 37 C before use, e.g. by holding it in an incubator for about one hour or in a thermostated bath for about three minutes, and gently turned upside down, without shaking, in order to obtain a uniform suspension.

The suspension should be withdrawn from the vial using a sterile needle and syringe.

Initially, a single dose of 100-200 mg/kg (1.252.5 ml/kg) is advised.

Up to two further doses of 100 mg/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 300-400 mg/kg).

The initial dose is administered as follows: Disconnect the baby momentarily from the ventilator and administer 1.25 to 2.5ml/kg of 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 baby to the ventilator at the same settings as before administration.

Further doses (1.25 ml/kg) that may be required are administered in the same manner.

After administration of Curosurf and upon reconnection to the ventilator or immediately after pulmonary compliance (chest expansion) can improve rapidly thus requiring prompt adjustment of the ventilator settings.

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 haemo-gas analysis, continuous monitoring of transcutaneous PaO₂ or oxygen saturation, is also advisable.

Contra-indications: No specific contra-indications are yet known.

Babies 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 their 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.

Use in pregnancy and lactation: Not applicable.

Drug interactions: None known.

Side-effects: Pulmonary haemorrhage, the incidence of which increases the more immature is the infant, is a rare and sometimes fatal complication of preterm delivery. No evidence exists of any increased risk of this event following the administration of Curosurf .

No other undesirable effects have been reported.

Overdosage: 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 fluid and electrolyte balance.

Pharmaceutical precautions The product must be stored in a refrigerator at +2 to +8°C protected from light until the moment of use.

Any residual quantity in the vial must not be used after the first aspiration.

Warmed vials should not be returned to the refrigerator.

A slight colour change towards yellow may occur on ageing without denoting the product’s impairment.

Legal category POM

Package quantities Single dose vials containing either 1.5 ml or 3 ml.

Further information Nil.

Serono Laboratories (U.K.) Ltd

99 Bridge Road East

Welwyn Garden City

Hertfordshire AL7 1BG

Allphar Services Ltd

Pharmaceutical Agents and Distributors

Burton Hall Park

Sandyford Industrial Estate

Foxrock

Dublin 18

PL 3400/0041

PA 285/7/1-2

Date of preparation: June 1996

The name of your baby's medicine is Curosurf. It is available as a sterile suspension containing 120 or 240 mg of its active ingredient which is the phospho-lipid fraction from porcine lung.

In addition to the active ingredient Curosurf also contains sodium chloride and water for injections.

Serono Laboratories (U.K.) Ltd

99 Bridge Road East

Welwyn Garden City

Your baby has been given Curosurf because he/she is suffering from a condition called respiratory distress syndrome (RDS).

Most babies are born with a substance known as surfactant in their lungs. This substance lines the lungs and stops them from sticking together and so makes normal breathing (respiration) possible. Some babies, however, particularly premature babies, are born with a lack of this surfactant which causes RDS.

Curosurf is a natural surfactant which works in the same way as your baby's own surfactant would have done and, therefore, will help your baby to breathe normally until your baby produces his or her own surfactant.

Curosurf is given to your baby whilst it is in the incubator. It is given through tubes into the baby's trachea (windpipe).

All medicines can cause side-effects. However, clinical studies on several thousands of newborn babies with RDS did not demonstrate any side effects of surfactant therapy.

This leaflet provides a summary of the information available on your baby’s medicine. If you have questions or are not sure of anything, then please ask your doctor who will have access to additional information.

The information on this leaflet applies only to Curosurf.