Perfadex
Package leaflet: Information for the user
Perfadex solution for organ preservation
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Perfadex is and what it is used for
2. What you need to know before Perfadex is used
3. How to use Perfadex
4. Possible side effects
5. How to store Perfadex
6. Contents of the pack and other information
1. What Perfadex is and what it is used for
Perfadex is a solution for the preservation of the lungs. It is used after the removal of the organ from the donor, during storage and transportation of the organ, until transplantation.
2. What you need to know before Perfadex is used
Do NOT use Perfadex
Perfadex must not be used for preserving donor organs if the recipient(s) is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Perfadex must not be used for direct injection or for intravenous use in the recipient of an organ. The product should only be used for the flushing and cold storage of lungs.
Perfadex is for single use only. It is not suitable for use in machines with continuous flow of the preservation solution through the organ in order to imitate blood circulation.
Other medicines and Perfadex
There are no known interactions with Perfadex, but no clinical studies have been performed.
Pregnancy and breast-feeding
Not relevant.
3. How to use Perfadex
Perfadex is solely for use by trained medical staff as described in the section titled: The following information is intended for medical or healthcare professionals only.
Route of administration not applicable.
Once the organ has been removed from the donor, before its transplantation into the recipient, it does not have a supply of blood or oxygen and needs to be preserved at a temperature of 2 - 8 °C in order for it to work well in the recipient. An organ is usually flushed in order to remove blood and cool it in order to slow down the metabolism.The organ(s) is immediately placed in a sterile container filled with Perfadex and kept cool, but not frozen.
4. Possible side effects
There are no known undesirable effects and, since Perfadex is not administered to organ recipients themselves, no solution-specific side effects are to be expected.
However, you must report all side effects immediately including those known to be related to other medicines taken during your transplant procedure to assess whether adaptive measures are required.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.*By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Perfadex
- Keep out of the sight and reach of children.
- Do not use Perfadex after the expiry date which is stated on the bag. The expiry date refers to the last day of that month.
- Do not store and transport above 30ºC. Do not freeze.
- The product should be used immediately after the administration or additive ports have been accessed. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8ºC
- The bag should not be put directly on ice.
- Perfadex should not be used if the solution contains any particles or is not clear.
- Perfadex should not be disposed via wastewater or household waste. These measures will help to protect the environment.
6. Contents of the pack and other information
What Perfadex contains
The active substances are dextran 40, sodium chloride, glucose monohydrate, potassium chloride, magnesium sulphate heptahydrate, disodium phosphate dodekahydrate, monopotassium phosphate.
1000 ml contains:
|
Dextran 40 |
50 g |
|
Sodium chloride |
8 g |
|
Glucose monohydrate |
1 g |
|
Potassium chloride |
0.4 g |
|
Magnesium sulphate heptahydrat |
0.098 g |
|
Disodium phosphate dodekahydrat |
0.046 g |
|
Monopotassium phosphate |
0.063 g |
The other ingredient is: Water for Injection
What Perfadex looks like and contents of the packs
Solution for organ preservation.
Perfadex is a clear, colourless solution.
pH ca. 5.4.
PVC bags
Pack sizes: 8 x 1000 ml, 2 x 2800 ml.
Marketing Authorisation Holder
XVIVO Perfusion AB
Box 53015
400 14 Göteborg
Sverige
Manufacturer:
Fresenius Kabi Norge AS
Box 430
NO 1753 Halden
Norge
This medicinal product is authorized in the Member States of the EEA under the following names:
Sweden Perfadex
Germany Perfadex Organkonservierungslösung
Austria Perfadex Organkonservierungslösung
This leaflet was last revised in
21 March 2016
The following information is intended for healthcare professionals only:
Instructions for use and administration
Perfadex is not suitable for direct injection or for intravenous use in the recipient, and must only be used in the flushing and cold storage of lungs.
There is a theoretical possibility of residual Perfadex being released into the general circulation of the recipient on declamping, which could provoke hypersensibility reactions of anaphylactic type, in patients with high titres of preformed antibodies towards dextran.
Handling
Use only clear solution and unopened containers. Aseptic technique should be used when making additions and during administration.
The pH should be adjusted to 7.4 shortly before use by the aseptic addition of a suitable buffer such as trometamol (THAM), 1 mmol per litre of Perfadex. Once the buffer or other additives have been added to Perfadex, the contents should be chilled and used within 24 hours. The buffer is not supplied together with Perfadex.
If additions are used they should be made by aseptic technique and thoroughly mixed with the solution immediately before use.
- There is no need to filter the solution before use.
- For single use only. Do not reuse.
- A careful visual inspection of the solution for turbidity should be carried out. Only clear and colourless solutions should be used. If any turbidity, precipitates or contamination is evident, the solution must be discarded.
- Not suitable for continuous machine perfusion.
Administration/Posology
The volume of flushing solution depends on the organ(s). For perfusion in lung transplantation 50-75 ml/kg body weight of the donor is generally used, usually 3-8 litre of the solution for an adult donor. Suspend the Perfadex® container at a height, 12 inches or 30 cm is usually sufficient, to produce a continuous flow.
The exact flushing method depends on the centre and on whether or not several organs are to be removed at the same time. Flushing is often carried out in two stages: the 1stflush while the organ is still in situ and the 2ndflush once the organ has been removed.
Prior to use, the pH of Perfadex should be adjusted to approx 7.4 by addition of a suitable buffer.
For instructions on dilution of the medicinal product before administration, see section 6.6.
The organ is flushed via a cannula inserted into an artery, while maintaining sufficient pressure to obtain a steady stream of solution in order to produce adequate flushing.
Flushing should be continued until the organ is uniformly pale and the effluent is relatively clear.
After removal from cold storage (2-8°C), the cooled solution should be used immediately.
There have been no adequate clinical studies of the use of Perfadex for organ transplantation in children.
Storage under cold conditions:
The organ is stored at 2-8°C in a sterile container appropriately sized for the organ. The organ must be completely covered by thecooled solution. The organ storage container must be aseptically sealed.
The container should then be placed in at least a second container. This should be filled with ice, but no ice must enter the organ storage container, where the ice could come into direct contact with the organ. Care must be taken to ensure that the organ is aseptically stored in its container, i.e. the inside of the organ storage container and its contents must remain sterile.
The additional container(s) must be securely sealed.
The organ storage containers must then be maintained within a well-insulated transport container. The organ storage containers should be surrounded by ice.
Transport times must be as short as possible.