Product Manuals
For HCPs / Product Manuals
CHEMOSAT is not yet available in all regions. If your country is not listed below, please contact customer service on + 353 91 746200
For all medical enquiries relating to CHEMOSAT, please contact EUMedicalAffairs@delcath.com
Product Manuals
Instructions for Use for Healthcare Professionals
United Kingdom (English)
Publication Date: 24-JUL-2024
Document and Revision number
120078 Rev A
Switzerland (French)
Publication Date: 08-AUG-2024
Document and Revision number
120074 Rev A
Switzerland (German)
Publication Date: 08-AUG-2024
Document and Revision number
120074 Rev A
Switzerland (Italian)
Publication Date: 08-AUG-2024
Document and Revision number
120074 Rev A
Switzerland (English)
Publication Date: 08-AUG-2024
Document and Revision number
120074 Rev A
Oncologist
A medical oncologist will usually be responsible for ensuring that CHEMOSAT is the right treatment approach for their patient. They are experienced in the monitoring of toxicities of chemotherapy and are responsible for the complete medical management of the patient, including, but not limited to, pre- and postoperative care. They may also be responsible for monitoring the patient during the immediate post-procedure period.
Intensivist/critical care specialist
A qualified intensivist, or appropriately qualified critical care specialist, is responsible for providing medical management of the patient in the immediate post-procedure period, during which the patient is in the intensive care unit or step down unit.
lnterventional radiologist
A qualified interventional radiologist with the knowledge, skills, experience, and hospital privileges required to perform advanced vascular interventional procedures.
Nurse
A qualified chemotherapy healthcare professional certified by the site to deliver chemotherapy, such as Interventional Radiology Technician or Registered Nurse.
Perfusionist
A qualified perfusionist is required to establish, monitor, and control the extracorporeal pump and veno-venous bypass circuit.
Anaesthesiologist
A qualified anaesthetist (anaesthesiologist) and/or nurse anaesthetist responsible for the management of sedation, analgesia, respiratory and cardiovascular support.
Pharmacist
A qualified pharmacist, on call during the procedure, to reconstitute the chemotherapeutic agent (melphalan hydrochloride), using national and local safety guidelines. The pharmacist should be aware of the rapid preparation time required for the preparation and administration of melphalan for use with CHEMOSAT.
Assess Eligibility 7
*Patients with 50% or greater tumour burden of the liver on imaging should have a laparoscopy and normal liver biopsied for both visual inspection of liver parenchyma and histological examination of the liver to rule out hepatocellular dysfunction at a subclinical level
Clinical Assessment
Assessment by Expert CHEMOSAT Team
Post Treatment Assessment
Week 1 - blood tests
Week 2 - blood tests
Week 3 - blood tests
Week 6-8 - post treatment MRI to assess response
CHEMOSAT: A 3 Step Process
Czech Republic
Publication Date | Document and Revision number | Language |
---|---|---|
26-JUL-2023 | 120056 Rev E | Czech • Download |
26-JUL-2023 | 120056 Rev E | English • Download |
21-APR-2022 | 120056 Rev D | Czech • Download |
21-APR-2022 | 120056 Rev D | English • Download |
08-MAR-2021 | 120056 Rev C | Czech • Download |
08-MAR-2021 | 120056 Rev C | English • Download |
France
Publication Date | Document and Revision number | Language |
---|---|---|
22-JAN-2024 | 120057 Rev F | French • Download |
22-JAN-2024 | 120057 Rev F | English • Download |
26-JUL-2023 | 120057 Rev E | French • Download |
26-JUL-2023 | 120057 Rev E | English • Download |
21-APR-2022 | 120057 Rev D | French • Download |
21-APR-2022 | 120057 Rev D | English • Download |
08-MAR-2021 | 120057 Rev C | French • Download |
08-MAR-2021 | 120057 Rev C | English • Download |
Germany
Publication Date | Document and Revision number | Language |
---|---|---|
26-JUL-2023 | 120055 Rev F | German • Download |
26-JUL-2023 | 120054 Rev F | English • Download |
21-APR-2022 | 120055 Rev E | German • Download |
04-APR-2022 | 120054 Rev E | English • Download |
08-MAR-2021 | 120055 Rev D | German • Download |
08-MAR-2021 | 120054 Rev D | English • Download |
Italy
Publication Date | Document and Revision number | Language |
---|---|---|
26-JUL-2023 | 120056 Rev E | Italian • Download |
26-JUL-2023 | 120056 Rev E | English • Download |
21-APR-2022 | 120056 Rev D | Italian • Download |
21-APR-2022 | 120056 Rev D | English • Download |
08-MAR-2021 | 120056 Rev C | Italian • Download |
08-MAR-2021 | 120056 Rev C | English • Download |
The Netherlands
Publication Date | Document and Revision number | Language |
---|---|---|
26-JUL-2023 | 120055 Rev F | Dutch • Download |
26-JUL-2023 | 120054 Rev F | English • Download |
21-APR-2022 | 120055 Rev E | Dutch • Download |
04-APR-2022 | 120054 Rev E | English • Download |
08-MAR-2021 | 120055 Rev D | Dutch • Download |
08-MAR-2021 | 120054 Rev D | English • Download |
Portugal
Publication Date | Document and Revision number | Language |
---|---|---|
26-JUL-2023 | 120056 Rev E | Portuguese • Download |
26-JUL-2023 | 120056 Rev E | English • Download |
21-APR-2022 | 120056 Rev D | Portuguese • Download |
21-APR-2022 | 120056 Rev D | English • Download |
08-MAR-2021 | 120056 Rev C | Portuguese • Download |
08-MAR-2021 | 120056 Rev C | English • Download |
Spain
Publication Date | Document and Revision number | Language |
---|---|---|
22-JAN-2024 | 120057 Rev F | Spanish • Download |
22-JAN-2024 | 120057 Rev F | English • Download |
26-JUL-2023 | 120057 Rev E | Spanish • Download |
26-JUL-2023 | 120057 Rev E | English • Download |
21-APR-2022 | 120057 Rev D | Spanish • Download |
21-APR-2022 | 120057 Rev D | English • Download |
08-MAR-2021 | 120057 Rev C | Spanish • Download |
08-MAR-2021 | 120057 Rev C | English • Download |
References
References
References
References
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