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Therakos e-learning platform

Still at your side during the COVID-19 health emergency

We are taking the necessary safety measures so we can continue to provide our comprehensive assistance, whenever you need it.

 

Our multi-lingual Customer, Clinical and Technical Services teams are still operating and available for you.

 

Do you need to get in contact with us?

 

For any enquiries relating to technical and clinical support please contact the Hotline at:

Support
in English:

  • +44 154 860 0009

    0808 238 6011
    (Toll-Free within the UK)

  • +44 208 338 0479

  • ecphelp@therakos.com
    (For enquiries only)

Unterstützung
auf Deutsch:

  • +49 32 221 093 619

    0800 181 1715
    (Gebührenfreie Telefonnummer von Deutschland aus)

  • +49 61 097 009 318

  • ecphelp@therakos.com
    (Nur für Informationsanfragen)

Support
en français:

Supporto
in italiano:

  • +39 05 1042 0666

    800 149 844
    (Numero verde gratuito dall’Italia)

  • ecphelp@therakos.com
    (Solo per richiesta di informazioni)

For any administrative enquiries, including product orders, deliveries and invoicing, please contact Customer Service at:

Support
in English:

Unterstützung
auf Deutsch:

Support
en français:

Supporto
in italiano:

For anything else you may need, you can find all our details on our contact us page or see our Frequently Asked Questions below.

 

FAQ

 

Frequently Asked Questions during COVID-19 health emergency

Is Mallinckrodt experiencing operational interruptions due to COVID-19?

No. There is currently no impact to our logistics or supply chain as a result of COVID-19.

Does Mallinckrodt have a disaster preparedness/pandemic readiness programme?

Yes. Mallinckrodt has a documented preparedness plan that guides our response to natural disasters and other crisis situations. We rely on close communication with our customers. We are monitoring the impact of COVID-19, and responding with appropriate inventory and supplies to meet patient and customer demand during this current situation.

How is Mallinckrodt supporting current demand for product during this time?

Mallinckrodt maintains a sufficient supply of THERAKOSTM Photopheresis Instruments, CELLEXTM kits and UVADEXTM and we are in constant communication with our supply chain partners to meet expected demand. If you wish to discuss your inventory needs at any time, you can speak to Therakos Customer Services.

Are the CELLEXTM kits used in the THERAKOSTM Photopheresis Systems cleaned, sanitised and customer/patient-ready before delivery to our centre?

CELLEXTM kits are manufactured in a controlled environment (class 8 clean room) and our manufacturing facilities follow multiple device manufacturing standards. In addition, all CELLEXTM kits are sterilised prior to delivery to customers. In addition, across our operations, we are focused on adhering to the rigorous, documented guidelines that we have in place to minimise contamination. Some examples include, but are not limited to, training on Good Manufacturing Practices and wearing personal protective equipment when handling medical devices.

How are you and your staff taking precautions against the spread of COVID-19?

  • Across our operations, we remain focused on adhering to approved guidelines published by recognised bodies such as the Center for Disease Control (CDC) and World Health Organization (WHO).
  • We have specific protocols in place to mitigate the spread of infectious viruses and pathogens.
  • All members of our staff have been trained on and adhere to workplace standards and wear the appropriate personal protective equipment (PPE) when managing equipment.
  • Mallinckrodt service centre staff have been trained on disinfection procedures for their work area.

Can I get a copy of Mallinckrodt’s documented preparedness plan that guides your response to natural disasters and other crisis situations?

These documents are confidential and not available for distribution.

How is Mallinckrodt supporting customers in being able to continue delivering treatment during this time?

Mallinckrodt is supporting its customers through our dedicated Customer, Clinical and Technical Services teams.

For any query related to a treatment or device functioning, our Clinical and Technical team is available Mon-Fri from 8.00-17.00 (GMT+1). Please refer to the top section of this page for contact details.
The Clinical and Technical teams will evaluate all requests for urgent training and critical technical interventions on a case-by-case basis and will support you on-site where necessary to help ensure patient access to therapy. In order to access your department, we will ask you to check and confirm if your Hospital policies allow vendor access and the associated conditions. On-site technical interventions will be scheduled in line with any local regulation for travel and work restriction.

For any administrative query related to product ordering, supply or invoicing, our dedicated multilingual Customer Service team is available Mon-Fri from 9.00-18.00 (GMT+1). Please refer to the top section of this page for contact details.

Are there any specific instructions to clean the CELLEXTM device after treating a patient affected by COVID-19?

We ask you to continue to follow the cleaning procedures listed in the operator manual and your centre’s cleaning policy.
The CELLEXTM kit is for single use and should be disposed of after each treatment using the centre’s routine practice for disposal of potentially contaminated material.

For further advice and information, please contact ecphelp@therakos.com or telephone the Clinical/Technical Support Line on 00800 84372567.

 

Take care and stay safe.

The Therakos Team

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Therakos does not review or control the content of non-Therakos websites, and this hyperlink does not constitute an endorsement by Therakos of the site’s content. Therakos privacy procedures do not apply to the owners of a non-Therakos website.

Important Safety Information
For the TherakosTM Photopheresis
Procedure

Indications

The THERAKOSTM CELLEXTM Photopheresis System is indicated for the administration of photopheresis. Please refer to the appropriate product labelling for a complete list of warnings and precautions.

Contraindications

THERAKOSTM Photopheresis is contraindicated in:

  • Patients possessing a specific history of a light sensitive disease.
  • Patients who cannot tolerate extracorporeal volume loss or who have white blood cell counts greater than 25,000 / mm3.
  • Patients who have coagulation disorders or who have previously had a splenectomy.

Warnings and Precautions

THERAKOSTM Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure. Safety in children has not been established.

  • Do not expose the device to a magnetic resonance (MR) environment. The device may present a risk of projectile injury, and thermal injury and burns may occur. The device may generate artifacts in the MR image, or may not function properly.
  • Thromboembolic events, including pulmonary embolism and deep vein thrombosis, have been reported in the treatment of Graft versus Host Disease (GvHD). Special attention to adequate anticoagulation is advised when treating patients with GvHD.
  • When prescribing and administering THERAKOSTM Photopheresis for patients receiving concomitant therapy, exercise caution when changing treatment schedules to avoid increased disease activity that may be caused by abrupt withdrawal of previous therapy.

Adverse Events

  • Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for hypotension.
  • Transient pyretic reactions, 37.7–38.9°C (100–102°F), have been observed in some patients within six to eight hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction.
  • Treatment frequency exceeding labelling recommendations may result in anaemia.
  • Venous access carries a small risk of infection and pain.

Please refer to the THERAKOSTM CELLEXTM Photopheresis System Operator Manual for a complete list of warnings and precautions.

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOSTM PHOTOPHERESIS

Contraindications

Methoxsalen is contraindicated in:

  • Patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, psoralen compounds, or any of the excipients
  • Patients with co-existing melanoma, basal cell or squamous cell skin carcinoma
  • Patients who are pregnant, and sexually active men and women of childbearing potential unless adequate contraception is used during treatment
  • Patients with aphakia because of the significantly increased risk of retinal damage due to the absence of a lens

Warnings and Precautions

  • Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents.
  • Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic.
  • Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after methoxsalen treatment. They should wear these glasses any time they are exposed to direct or indirect sunlight, whether they are outdoors or exposed through a window.
  • Safety in children has not been established.

Refer to the package insert for methoxsalen sterile solution (20 micrograms / mL) or the oral 8-methoxypsoralen dosage formulation for a list of all warnings and precautions.

Please refer to the THERAKOSTM CELLEXTM Photopheresis System Operator Manual for a complete list of warnings, precautions and adverse events.

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Applications for the 2022 EIA are now closed.
The 2022 ECP Immunomodulation Investigator Award has been awarded to Professor Andrew Fisher, Professor of Respiratory Transplant Medicine at Newcastle University, and Honorary Consultant Respiratory and Transplant Physician at The Newcastle upon Tyne Hospitals NHS Foundation Trust's Institute of Transplantation. The objective of his project is to perform an in depth mechanistic assessment of Extracorporeal Photopheresis (ECP) treatment in patients suffering from Chronic lung Allograft Dysfunction (CLAD).

Full details are available on our press release page.

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