• Keep this leaflet; you may need to read it again.
• If you have any questions, please ask your doctor or nurse.

1. What Survanta is and what it is used for
2. What you need to know before Survanta is used
3. How to use Survanta
4. Possible side effects
5. How to store Survanta
6. Contents of the pack and other information

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

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or search for MHRA Yellow Card in the Google Play or Apple App Store.

• The active substance is beractant which is a mixture containing phospholipids (25 mg/ml), free fatty acids (1.4 -3.5 mg/ml), triglycerides (0.5 -1.75 mg/ml) and protein (0.1 -1.0 mg/ml).
• The other excipients are sodium chloride, sodium hydroxide, hydrochloric acid, palmitic acid, dipalmitoyl phosphatidylcholine, tripalmitin and water.

• It is a sterile off-white to light brown suspension and is supplied in a single use glass vial containing 8 ml (200 mg phospholipids). Packs of 1, 3, and 10 vials are available*.

*Not all pack sizes may be marketed.

Survanta is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only.

It is a bovine lung extract containing phospholipids, neutral lipids, fatty acids and surfactant associated proteins to which have been added dipalmitoyl phosphatidylcholine, palmitic acid and tripalmitin.

The resulting composition provides:

phospholipids 25 mg/ml (including 11.0 - 15.5 mg/ml disaturated phosphatidylcholine)

triglycerides 0.5 - 1.75 mg/ml

free fatty acids 1.4 - 3.5 mg/ml

protein less than 1.0 mg/ml

It is suspended in 0.9% sodium chloride (Ph Eur) solution. It also contains sodium hydroxide and hydrochloric acid.

Each milliliter of Survanta contains 25 mg phospholipids. It is an off-white to light brown liquid supplied in single-use glass vials containing 8 ml (200 mg phospholipids).

Endogenous pulmonary surfactant lowers surface tension on alveolar surfaces during respiration and stabilises the alveoli against collapse at resting transpulmonary pressures. Deficiency of pulmonary surfactant causes Respiratory Distress Syndrome (RDS) in premature infants. Survanta replenishes surfactant and restores surface activity to lungs of these infants.

Survanta is indicated for the treatment of Respiratory Distress Syndrome (RDS) in newborn premature infants with birth weight of 700 g or greater.

Survanta is also indicated for the prophylactic treatment of premature infants <32 weeks gestational age at risk of developing RDS who require intubation for stabilisation or with evidence of surfactant deficiency.

No specific contraindications for Survanta have been defined by the clinical studies.

Special Precautions for Use:

Survanta should only be administered with adequate facilities for ventilation and monitoring of babies with RDS. Marked improvements in oxygenation may occur within minutes of the administration of Survanta. Therefore, frequent and careful monitoring of systemic oxygenation is essential to avoid hyperoxia. Following Survanta administration, monitoring of the arterial blood gases, the fraction of inspired oxygen and ventilatory change is required to ensure appropriate adjustments.

During the dosing procedure, transient episodes of bradycardia and/or oxygen desaturation have been reported. If these occur, dosing should be stopped and appropriate measures to alleviate the condition should be initiated. After stabilisation the dosing procedure should be resumed.

Survanta is stored refrigerated (2-8°C). Before administration, Survanta should be warmed by standing at room temperature for 20 minutes or warmed in the hand for 8 minutes. ARTIFICIAL WARMING METHODS SHOULD NOT BE USED.

Discard each vial if not used within 8 hours of warming to room temperature. Vials should not be returned to the refrigerator once warmed.

Each vial of Survanta is for single use. Used vials with residual drug should be discarded. Survanta should be inspected visually for discolouration prior to administration. The colour of Survanta is off-white to light brown. Some settling may occur during storage.

If this occurs, gently invert the vial several times (DO NOT SHAKE) to redisperse.

None known to date.

Unless otherwise prescribed, 4 ml suspension per kg birth weight is the normal dose to be administered via the trachea (intratracheal administration).

Higher doses should not be used.

The dosing chart below shows the total dosage for a range of birth weights.

If the weight is between 701 – 750 grammes then total dosage should be 3.0 ml.

If the weight is between 751 – 800 grammes then total dosage should be 3.2 ml.

If the weight is between 801-850 grammes then total dosage should be 3.4 ml.

If the weight is between 851-900 grammes then total dosage should be 3.6 ml.

If the weight is between 901-950 grammes then total dosage should be 3.8 ml.

If the weight is between 951-1000 grammes then total dosage should be 4.0 ml.

If the weight is between 1001-1050 grammes then total dosage should be 4.2 ml.

If the weight is between 1051-1100 grammes then total dosage should be 4.4 ml.

If the weight is between 1101-1150 grammes then total dosage should be 4.6 ml.

If the weight is between 1151-1200 grammes then total dosage should be 4.8 ml.

If the weight is between 1201-1250 grammes then total dosage should be 5.0 ml.

If the weight is between 1251-1300 grammes then total dosage should be 5.2 ml.

If the weight is between 1301-1350grammes then total dosage should be 5.4 ml.

If the weight is between 1351-1400grammes then total dosage should be 5.6 ml.

If the weight is between 1401-1450grammes then total dosage should be 5.8 ml.

If the weight is between 1451-1500grammes then total dosage should be 6.0 ml.

If the weight is between 1501-1550 grammes then total dosage should be 6.2 ml.

If the weight is between 1551-1600 grammes then total dosage should be 6.4 ml.

If the weight is between 1601-1650 grammes then total dosage should be 6.6 ml.

If the weight is between 1651-1700 grammes then total dosage should be 6.8 ml.

If the weight is between 1701-1750 grammes then total dosage should be 7.0 ml.

If the weight is between 1751-1800 grammes then total dosage should be 7.2 ml.

If the weight is between 1801-1850 grammes then total dosage should be 7.4 ml.

If the weight is between 1851-1900 grammes then total dosage should be 7.6 ml.

If the weight is between 1901-1950 grammes then total dosage should be 7.8 ml.

If the weight is between 1951-2000 grammes then total dosage should be 8.0 ml.

Survanta should be administered via the endotracheopulmonary route.

The dosing procedure is facilitated if one person administers the dose while another person positions and monitors the infant.

Survanta should be warmed to room temperature before administration (see section 6.3).

Instillation in Mechanically Ventilated Infants

Before administering Survanta to infants on mechanical ventilation, suggested settings include respiratory frequency at 60/minute, inspiration time 0.5s, and Fi02 at 1.0. Inspiratory pressure needs no change at this point.

There are 2 alternative methods of administration for mechanically ventilated infants:

i. The dose is administered by disconnecting the endotracheal tube from the ventilator, inserting a small diameter catheter and administering the dose with the infant in a neutral position. The tip of the catheter should lie at the end of the endotracheal tube.

Alternatively:

ii. The dose can be administered by inserting a small diameter catheter through a suction port connector without disconnection from the ventilator with the infant in a neutral position. The tip of the catheter should lie at the end of the endotracheal tube.

After the dose is administered, the catheter is then withdrawn completely, and the ventilator is reconnected if necessary.

Instillation in Spontaneously Breathing Infants

Intubation Surfactant Extubation (INSURE)

Following intubation and insertion of the catheter as described above, place the infant in a neutral position and gently inject the dose as a single bolus over 1 to 3 minutes in the delivery room or later after admission to the neonatal unit. After instillation, use a bagging technique and proceed to extubation and CPAP as clinically indicated.

Less Invasive Surfactant Administration (LISA)

A small diameter catheter may be used to administer the dose without intubation. In such cases, place the catheter directly into the trachea of infants on CPAP with direct visualization of the vocal cords by laryngoscopy and gently inject the dose as a single bolus over 1 to 3 minutes. After instillation, immediately remove the catheter. Ensure continuous spontaneous breathing and continue CPAP treatment during the entire procedure.

Control arterial blood gas values and the inspiratory oxygen concentration, and check for changes in ventilatory parameters immediately after finishing the dosing with Survanta.

The dosage for repeat doses of Survanta is also 100 mg phospholipids per kg and is based on the infant’s birth weight. The need for additional doses of Survanta should be determined by evidence of continuing respiratory distress. Dose no sooner than 6 hours after the previous dose. Up to 3 additional doses may be given in the first 48 hours.

Mechanically Ventilated Infants

Intracranial haemorrhage has been observed in patients who received either beractant or placebo. The incidence of intracranial haemorrhage in all patients is similar to that reported in the literature in this patient population. Pulmonary haemorrhage has also been reported. Blockage of the endotracheal tube by mucous secretions has been reported. No other serious adverse reactions have been reported.

INSURE and LISA Techniques

Safety results with the INSURE and LISA techniques were comparable to those of the control groups, although bradycardia and hypoxemia were reported more frequently in some cases with LISA.

The following adverse reactions were identified in patients treated with Survanta. The adverse reactions are listed below by body system organ class and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data).

For Vascular disorders frequency is very common for Intracranial haemorrhage.

For Respiratory disorders frequency common for Pulmonary haemorrhage.

For Surgical and Medical Procedures frequency is uncommon for Blockage of endotracheal tube by mucous secretions.

No antibody production to Survanta proteins has been observed.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions direct to:

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or search for MHRA Yellow Card in the Google Play or Apple App Store.

If an excessively large dose of Survanta is given, observe the infant for signs of acute airway obstruction. Treatment should be symptomatic and supportive. Rales and moist breath sounds can transiently occur after Survanta is given, and do not indicate overdosage. Endo-tracheal suctioning or other remedial action is not required unless clear-cut signs of airway obstruction are present.

This drug should not be used after the expiry date falls due (see vial label for expiry date).

Remaining amounts of Survanta should be disposed of.

Survanta must be protected from light and stored under refrigeration at 2 - 8 °C. DO NOT FREEZE. Any inadvertently frozen product should be discarded.

Survanta should be inspected visually for discolouration prior to administration. The colour of Survanta is off-white to light brown.

Legal Category: POM

Product Licence

Number (UK): PL 41042/0003