Survanta
Beractant
IMPORTANT INFORMATION
Read all of this leaflet carefully before this medicine is used.
Keep this leaflet; you may want to read it again later.
If you have any questions, please ask your doctor or pharmacist (chemist).
This medicine has been prescribed for your child. It should not be given to anyone else. It may harm them, even if their symptoms are similar to those of your child.
In this leaflet:
1. Why does this medicine need to be used?
2. How does this medicine work?
3. Before Survanta is used
4. How Survanta is used
5. Possible side effects
6. Storing Survanta
7. What is in Survanta?
8. Addresses
Why does this medicine need to be used?
Your baby will be/has been given Survanta because he or she is at risk of developing, or is suffering from, a condition called Respiratory Distress Syndrome (hyaline membrane disease) which may cause severe breathing difficulties.
Survanta is indicated for treatment of Respiratory Distress Syndrome (RDS) in newborn premature infants with a birth weight of 700 g or greater and who have had a tube inserted and are on a mechanical ventilator to help them breathe.
Survanta is also used for the treatment of premature babies, when the pregnancy has lasted for less than 32 weeks, at risk of developing RDS.
How does this medicine work?
Respiratory Distress Syndrome occurs in some babies, particularly premature babies, who lack a substance usually produced in the lungs known as surfactant. This surfactant lines the inside of the lungs, stopping them from sticking together, so that the baby can breathe normally.
Survanta is a natural surfactant extracted from cows lungs (See Section 7) and it acts in a similar way to your baby's own surfactant, helping your baby to breathe normally.
Before Survanta is used
Your baby will only be given Survanta if the equipment for ventilation and monitoring babies with Respiratory Distress Syndrome is available.
How Survanta is used
The dosage of Survanta varies for each child depending on their body weight. The usual dose is 100 mg Survanta per kg body weight. The doctor will calculate the right dose. Usually the first dose will be given as soon as possible after birth (usually within 15 minutes) or as soon as possible after Respiratory Distress Syndrome has been diagnosed (usually within 8 hours of birth).
The dose of Survanta will be administered to your baby via a tube already in place in your baby's windpipe. Do not be concerned if your baby is disconnected from its ventilator while Survanta is being administered. To make sure that Survanta reaches all parts of your baby’s lungs, the dose is split into smaller doses and your baby’s position altered before each part of the dose is given.
The dose may be repeated up to three times at six hourly intervals within 48 hours. Survanta will be warmed to room temperature before administration to your baby.
Survanta Side Effects
Like all medicines, Survanta can cause side effects although not everybody gets them. Some side effects that have been seen with Survanta are as follows:
- Cases of bleeding in the lungs have been reported with Survanta.
- Bleeding in the brain has been observed in babies who received Survanta but the occurrence of this is no different from what would be expected in untreated babies of the same age.
- Blockage of the breathing tube that has been inserted into your baby's windpipe, has been reported.
If you have any questions about your baby's treatment which are not answered by this leaflet, ask the doctor.
During the dosing procedure, occasional episodes of slow heartbeat (bradycardia) and/or oxygen reduction in the circulation have been reported. If these occur, dosing will be stopped and appropriate measures to relieve the condition will be started. After stabilisation, the dosing procedure will be resumed.
Storing Survanta
- Survanta should not be used after the expiry date shown on the label.
- Survanta should have been stored in a refrigerator and protected from light; however before it is given to your baby it will be warmed to room temperature.
- Survanta must not be frozen. Any product that has been frozen by mistake should be thrown away.
- Each vial of Survanta is for single use only. Used vials with medicine left in them should be thrown away.
- If any vial is not used within 8 hours of re-warming to room temperature it should be thrown away. Vials should not be returned to the refrigerator once warmed.
What is in Survanta?
Survanta contains the active ingredient 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). In addition to the active ingredient Survanta also contains sodium chloride, sodium hydroxide, hydrochloric acid, palmitic acid, dipalmitoyl phosphatidylcholine, tripalmitin and water.
Survanta is a sterile suspension and is supplied in a single use glass vial containing 8 ml (200 mg phospholipids). Packs of l, 3, and 10 vials are available.*
*Not all pack sizes may be marketed.
Addresses
Marketing Authorisation Holder:
Berkshire
The company responsible for manufacture is
This leaflet was last approved in: July 2010
List 1039-53
03-A372
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