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2009 Organ Donation Congress 10Th ISODP & 16Th ETCO

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Design: Fleck · Zimmermann | Berlin Fotos: © bcc (1) | © Land Berlin (1) | © Photopolis (2) | © BTM, Koch (1) October 4 – 7, 2009 | Berlin, Germany 2009 Organ Donation Congress 10 th ISODP & 16th E T C O Congress Program Congress | Congress Program ETCO th www.isodp2009.org ISODP & 16 th 10 | 2009 Organ Donation Congress Agentur WOK GmbH | Palisadenstr. 48 | 10243 Berlin – Germany | [email protected] 2009Congress OrganDonation Guide to safety and quality assurance Anzeige for the transplantation of organs, tissues and cells Organ transplantation is in many cases the only available treatment for end-organ failure. The transplantation of tissues and cells offers major therapeutic benefits and improvement of the quality of life, but raises a number of questions of principle. The Council of Europe is the leading standard- setting institution in the field. It approaches organ transplantation from an ethical and human rights perspective, taking compliance with the principles of non-commercialisation and voluntary donation of substances of human origin as the basis for all ethical concerns in this respect. Its work includes assuring the safety and quality of organs, tissues and cells, meeting the organ shortage, living donation and preventing and minimising organ trafficking. The 3rd edition of the Guide to safety and quality assurance for the transplantation of organs, tissues and cells is now available. Its aim is to provide guidance for all those involved in order to maximise the quality of organs, tissues and cells and to minimise risks, and thereby increase the success rate of transplants. It includes safety and quality assurance standards for procurement, preservation, processing and distribution of organs, tissues and cells of human origin (allogenic and autologous) used for transplantation purposes. An addendum has been added to the 3rd edition of this guide (2009), in order to specifically address criteria for preventing the transmission of neoplastic diseases in organ donation. This addendum was finalised in the framework of the European Committee (Partial Agreement) on Organ Transplantation (CD-P-TO), a new committee operating under the aegis of the European Directorate for the Quality of Medicines & HealthCare (EDQM) since 2007. If you would like to know more about how to order the guide, please go to the EDQM’s website: www.edqm.eu. EDQM, Council of Europe 7 allée Kastner, CS30026 If you would like to learn more about the activities of F-67081 Strasbourg the Council of Europe and the EDQM, come and visit Tel: +33 (0)3 88 41 30 30 our stand in the exhibition area on Floor B. Fax: +33 (0)3 88 41 27 71 Website: www.edqm.eu Helpdesk: http://www.edqm.eu/en/FAQ_Helpdesk-521.html European Directorate for the Quality of Medicines & HealthCare Passender Spender. Erfahrene Ärzte. JETZT BLOSS KEIN RISIKO MEHR. CellCept ® in der Nieren-, Herz- und Lebertransplantation: ✓ Sicherheit durch zuverlässige Resorption1 ✓ höhere Patienten- und Transplantatüberlebensrate* 2, 3, 4 Bewährter Schutz in der Langzeittherapie. * Im Vergleich zu Azathioprin bzw. einer Therapie ohne CellCept®. 1 Cattaneo et al., Clin J Am Soc Nephrol 2007. 2 Ojo et al., Transplantation 2000. 3 Eisen et al., J Heart Lung Transplant 2005; 24: 517. 4 Wiesner et al., Liver Transplant 2005; 11: 750. Anzeige CEL_17_Ueberarb_Fachanzeige_A4.i1 1 23.09.2009 9:02:19 Uhr LASERS PRINTED AT 100% First round mechanical built by: DS Prints: 4/0: 4C — Live Size: 204mm h w x 139mm h w x Size: 145mm 210mm Trim h Bleed w x Size: 151mm 216mm Job #: MREU-0295 Organ Donation Congress Program Ad (resize from ACEU-0054) Anzeige Changing tomorrow •C •M •Y •Y •K Magenta rules indicate BLEED – TRIM – LIVE — DO NOT PRINT Astellas (formerly Fujisawa) has been committed to the European transplant community since the early 1990s, with the aim of CHANGING TOMORROW for surgeons, physicians and patients alike. Through sustained investment in almost 100 European clinical studies, we are continually striving to advance transplant care by developing both new treatment regimens and innovative therapies that target specific pathways. We are also proud to be able to support many patient organisations, helping to offer hope for the future. However, it is only as your partner that we are able to change tomorrow in transplantation. www.astellas-europe.co.uk © December 2008 Astellas Pharma Europe Ltd. CSC0037 ASTELLAS, LEADING LIGHT FOR LIFE, CHANGING TOMORROW and the Star logo are trade marks of Astellas Pharma, Inc. and its related entities. Anzeige MREU-0295_Donor_Ad_resize-m1.indd 1 MECHANICAL9/9/09 10:02:35 AM CellCept® 250 mg Kapseln, CellCept® 500 mg Tabletten, CellCept® 1 g/5 ml Pulver zur Herstellung einer Suspension zum Einnehmen, CellCept® 500 mg Pulver zur Her- stellung eines Infusionslösungskonzentrates; Wirkstoff: orale Darreichungsformen: Mycophenolatmofetil; i.v.: Mycophenolatmofetilhydrochlorid, entsprechend 500 mg Mycophenolatmofetil. Sonstige Bestandteile: Kapseln: Povidon (K-90), Croscarmellose-Na, Mg-Stearat, Maisquellstärke. Kapselhülle: Gelatine, Indigocarmin (E132), Eisenoxidhydrat (E172), Eisen(II, III)-oxid (E172), Titandioxid (E171), Kaliumhydroxid, Schellack Maisquellstärke. Kapselhülle: Gelatine, Indigocarmin (E132), Eisenoxid- hydrat (E172), Eisen(II, III)-oxid (E172), Titandioxid (E171), Kaliumhydroxid, Schellack. Tabletten: Povidon (K-90), Croscarmellose-Na, Mg-Stearat, Cellulose. Tabletten- überzug: Methylhydroxypropylcellulose, Hydroxypropylcellulose, Titandioxid (E171), Macrogol 400, Indigocarmin, Aluminiumsalz (E132), Eisen(III)-oxid (E172), Eisen(II, III)-oxid (E172), Schellack. Pulver zur Herstellung eines Infusionslösungskonzentrates: Polysorbat 80, Zitronensäure, Salzsäure, NaCl CellCept® 1 g/5 ml Pulver zur Herstel- lung einer Suspension zum Einnehmen: Sorbitol, hochdisperses Siliciumdioxid, Natriumcitrat, Phospholipide aus Sojabohnen, gemischtes Fruchtaroma, Xanthan-Gummi, Aspartam (E951), Methyl-4-hydroxybenzoat (E218) und wasserfreie Zitronensäure. Aspartam enthält Phenylalanin entsprechend 2,78 mg/5 ml Suspension. Anwen- dungsgebiete: CellCept® ist in Kombination mit Ciclosporin und Kortikosteroiden zur Prophylaxe von akuten Transplantatabstoßungsreaktionen bei Patienten mit allo- gener Nieren-, Herz- (nicht i.v.) oder Lebertransplantation angezeigt; bei Kindern und Jugendlichen (2–18 Jahre) nur nach Nierentransplantation und nicht i.v. Dosie- rung, Art und Dauer der Anwendung: Empfohlene Dosis: Nach Nierentransplantation bei Erwachsenen sowohl i.v. als auch oral zweimal täglich 1 g (Tagesdosis 2 g), bei Kindern und Jugendlichen oral zweimal täglich 600 mg/m2 (max. Tagesdosis 2 g), nach Herztransplantation oral zweimal täglich 1,5 g (Tagesdosis 3 g), nach Lebertransplantation i.v. für die ersten 4 Tage zweimal täglich 1 g (Tagesdosis 2 g), danach oral zweimal täglich 1,5 g (Tagesdosis 3 g). CellCept® 500 mg Pulver zur Herstellung eines Infusionslösungskonzentrates ist eine alternative Darreichungsform zu den oralen Formen und kann über einen Zeitraum von bis zu 14 Tagen nach der Transplantation eingesetzt werden. Anwendung der Infusionslösung in eine periphere oder zentrale Vene über 2 Stunden (niemals als Bolus); nicht mit anderen intravenös zu verabreichenden Arzneimitteln oder Infusionszusätzen mischen oder mit diesen gleichzeitig durch dieselbe Infusionsleitung infundieren. Gegenanzeigen: Überemp- findlichkeit gegen Mycophenolatmofetil, Mycophenolsäure oder Hilfsstoffe. CellCept® ist bei stillenden Frauen kontraindiziert. CellCept® darf während der Schwanger- schaft nicht angewendet werden, es sei denn, der Arzt hat es ausdrücklich verordnet. Nebenwirkungen: Zu den häufigeren Problemen gehören Durchfall, Verminde- rung der weißen und/oder roten Blutkörperchen, Infektionen und Erbrechen. Es sind regelmäßige Blutuntersuchungen durchzuführen, um Veränderungen zeitnah festzustellen. Kinder haben möglicherweise häufiger als Erwachsene Nebenwirkungen wie Durchfall, Infektionen, weniger weiße Blutkörperchen und weniger rote Blutkör- perchen. CellCept® schränkt die körpereigenen Abwehrmechanismen ein und verhindert dadurch, dass der Organismus die verpflanzte Niere, das verpflanzte Herz oder die verpflanzte Leber abstößt. Infolgedessen ist der Körper aber auch nicht mehr in der Lage, Infektionen so wirksam wie sonst abzuwehren. Es ist daher möglich, dass Personen während der Behandlung mit CellCept® mehr Infektionen bekommen als gewöhnlich, wie Infektionen des Gehirns, der Haut, des Mundes, des Magens und des Darmes, der Lungen und des Harntraktes. Wie es bei Patienten, die mit dieser Art von Medikamenten behandelt werden, vorkommen kann, ist eine kleine Anzahl der CellCept® Patienten an Krebs des Lymphgewebes oder der Haut erkrankt. Nebenwirkungen, die den Körper allgemein betreffen, könnten Überempfindlichkeit (wie Ana- phylaxie, Angioödem), Fieber, Lethargie, Schlafstörungen, Schmerzen (wie Bauch-, Brust-, Gelenk-/Muskelschmerzen oder Schmerzen beim Wasserlassen), Kopfschmerzen, grippeartige Symptome und Schwellungen sein. Des Weiteren können folgende Nebenwirkungen auftreten: Störungen der Haut wie Akne, Fieberbläschen, Gürtelrose, Hautwachstum, Haarverlust, Hautausschlag, Juckreiz. Störungen des Harntrakts wie Nierenprobleme oder Harndrang. Störungen des Verdauungstrakts und des Mundes wie Verstopfung, Übelkeit, Verdauungsstörungen, Entzündung der Bauchspeicheldrüse, intestinale Störungen einschließlich Blutungen, Entzündungen des Magens, Leber- probleme, Entzündung des Dickdarms, Appetitverlust, Blähungen, Zahnfleischverdickung und Geschwüre im Mund. Störungen
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