Lysosafe in practice

Property of HRA PharmaDo not copy without permission LYS-PPT-0111-EU

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: [email protected]

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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: [email protected]

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Lysosafe : 6 consecutive steps

1. The samples: blood sample instructions

2. The preparation for shipment

3. The shipment of samples

4. The reception of samples

5. The test and validation of the results

6. The reporting back of the results

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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.

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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

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Part A: pack the samples in the DHL kit provided

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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

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Part C: complete the DHL Air Way Bill (AWB)

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1. Name of the contact person

2. Name of the hospital

3. Complete address of the hospital

4. Post code

5. Telephone number

6. Date and Signature


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

Country and DHL national phone number

Austria 0820 55 05 05 Norway 810 01345

Belgium +32 (2) 715 50 50 The Netherlands 0800 0552

Czech Rep. 800 103 000 Poland 0 0801 345 345

Denmark 70 345 345 Portugal 707 505 606

Germany (0 18 05) 3 45 22 55 Slovakia 0800 100 300

Finland +358 (0) 30 45 345 Slovenia 01 5887 800

Greece 210 989 0000 Spain 902 12 24 24

Hungary 06 40/45 45 45 Sweden 0771 345 345

Ireland 1 800 725 725 Switzerland 0848 711 711

Italy 199 199 345 United Kingdom 08 701 100 300

Bulgaria 0700 17 700 Romania 1 222 1777

Luxembourg +352 35 09 09

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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

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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

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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

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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:

[email protected]

Or after receiving a fax sent to:

Fax: 00 33 1 42 77 18 83

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Lysosafe in practice

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