Perfadex
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Perfadexsolution for organ preservation
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml contains
Dextran 40 50 g
Sodium chloride 8 g
Glucose monohydrate 1 g
Potassium chloride 0.4 g
Magneium sulphate 7 H2O 0.098 g
Disodium phosphate 12 H2O 0.046 g
Monopotassium phosphate 0.063 g
Perfadex contains Na+ 138 mmol, K+6 mmol, Mg2+0.8 mmol, Cl-142 mmol, SO4- 0.8 mmol, phosphate 0.8 mmol / 1000 ml
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL form
Solution for organ preservation
A clear colourless solution
pH ca. 5.4
4. Clinical particulars
4.1 Therapeutic indications
Perfusion and storage of lungs before organ transplantation.
Posology and method of administration
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 1st flush while the organ is still in situ and the 2nd flush 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 5 ± 3°C in a sterile container appropriately sized for the organ. The organ must be completely covered by the cooled 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.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
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.
4.5 Interaction with other medicinal products and other forms of interaction
No clinical interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Not relevant
4.7 Effects on ability to drive and use machines
Not applicable
Undesirable 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 suspected adverse reactions
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 via the national reporting system listed in Appendix V.*
4.9 Overdose
Not applicable when used as directed.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: All other non-therapeutic products; solvents and diluting agents, including irrigating solutions.
ATC code: V07AB
Perfadex is a dextran-electrolyte solution intended for perfusion and storage of lungs before transplantation.
The solution is somewhat hyperoncotic in order to prevent oedema. Dextran 40 will prevent blood cell aggregation and thrombos.
5.2 Pharmacokinetic properties
Not relevant
5.3 Preclinical safety data
No relevant data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injection
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Addition of calcium ions in quantities exceeding 1 mmol/l may cause a smoky precipitation.
6.3 Shelf life
3 years
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.
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 stability refers to the drug product with pH ca. 5.4 and not to the ready-to-use solution.
6.4 Special precautions for storage
Store below 30ºC. Do not freeze.
The bag should not be put directly on ice.
For storage of the diluted product, see section 6.3.
Nature and contents of container and special equipment for use, administration or implantation
PVC bags
Pack sizes: 8 x 1000 ml, 2 x 2800 ml
6.6 Special precautions for disposal and other 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.
7. MARKETING AUTHORISATION HOLDER
To be completed nationally.
8. MARKETING AUTHORISATION NUMBER(S)
To be completed nationally.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
To be completed nationally.
10. DATE OF REVISION OF THE TEXT
21 March 2016
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