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Lysosafe in practice

Lysosafe in practice. How can your patients benefit from Lysosafe?. This service is offered to all hospitals in Europe using the European approved Lysodren (mitotane, 500mg tablets) in the treatment of Adrenal Cortical Carcinoma. For any information please contact HRA Pharma:

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Lysosafe in practice

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  1. Lysosafe in practice

  2. How can your patients benefit from Lysosafe? • This service is offered to all hospitals in Europe using the European approved Lysodren (mitotane, 500mg tablets) in the treatment of Adrenal Cortical Carcinoma. • For any information please contact HRA Pharma: Laboratoire HRA Pharma – Lysosafe Service Tel: 00 33 1 40 33 11 30 Fax: 00 33 1 42 77 18 83 Email: lysosafe@hra-pharma.com

  3. HRA Pharma’s Lysodren team will assist you • HRA Pharma’s Lysosafe team will immediately assist you in starting Lysosafe: • With a complete presentation of the service • With a personalized set up adapted to the functioning of your hospital • All the elements required to begin Lysosafe will be sent to you for commencement within a week • HRA Pharma will assist you in using Lysosafe: Lysosafe Service Email: lysosafe@hra-pharma.com

  4. Lysosafe : 6 consecutive steps • The samples: blood sample instructions • The preparation for shipment • The shipment of samples • The reception of samples • The test and validation of the results • The reporting back of the results

  5. Step 1: The samples (blood samples instructions) • Collect 3 ml of blood into dry sodium heparin, lithium heparin or EDTA collection vials. • Within 30 min of sampling, centrifuge samples at approximately 3000 rpm at 4°C for 15 min. • Divide the plasma into 2 aliquots and transfer into two polypropylene tubes labelled with the initials and date of birth of the patient and the date of the blood sample. • Prepare the tubes for shipment as soon as possible using the kits provided (see instructions in kit). The samples, as prepared, are stable for a maximum of 14 days at room temperature (including shipment and transportation). • Ship samples within a maximum of 72 hours of sample collection.

  6. Step 2: The preparation for the shipment • Part A : Pack the sample(s) in the DHL Kit provided by HRA Pharma • Part B: Complete the tracking document (provided by HRA Pharma) and add it to the DHL kit before closing it • Part C: Complete the DHL AWB (Air Way Bill) provided by HRA Pharma • Part D: Contact DHL for the sample collection • The samples will not be accepted: • without the kit provided by HRA Pharma • without the tracking document completed in its entirety

  7. Part A: pack the samples in the DHL kit provided

  8. Part B: complete the tracking document • One tracking document / patient • Atlanbio will only accept samples for assay if the tracking document is completed in its entirety Please note that HRA-Pharma is NOT interested in accumulating any patient data. These data are just needed to guarantee the clear sample identification • The tracking document should then be inserted with the labeled sample in the DHL kit

  9. Part C: complete the DHL Air Way Bill (AWB) • Name of the contact person • Name of the hospital • Complete address of the hospital • Post code • Telephone number • Date and Signature

  10. Part D: contact DHL for the sample collection • Contact DHL by phone at a unique national phone number: • Give the following account number: 961 415 886 • The DHL pack will then be collected during the next few hours

  11. Step 3: The shipment of the sample • For an immediate collection, please contact DHL as soon as: • The sample is completely packed • The DHL AWB (Air Way Bill) is completed

  12. Steps 4 and 5: The test and the validation of the results • Reception of the sample in Atlanbio 1 to 2 days after the shipment • Atlanbio will only accept samples for assay if : • The sample is correctly packed in the DHL kit • The tracking document is completed in its entirety • After acceptance, immediate freezing and storage of the samples • Analysis of the sample: • Within one week from the sample collection • Test carried out in accordance with the internationally validated method • Validation and record of the results on the same day

  13. Step 6 : Reporting the results • Reporting back of the results the same day as validation of the test (or within 24 hours at the latest) : • to the prescriber of Lysodren • to a health professional designated in the tracking document • The results can be sent: • either by fax or by email • a copy will also be sent by regular mail • no results communicated by phone • The results will be sent back with the original completed tracking document

  14. Lysosafe – further supplies • HRA Pharma’s Lysodren team will provide you immediatly with all supplies needed for continuation of LYSOSAFE. • Either after receiving an email sent to: lysosafe@hra-pharma.com • Or after receiving a fax sent to: Fax: 00 33 1 42 77 18 83

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