Transcript VA UF presentation

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:
Laboratoire HRA Pharma – Lysosafe Service
Tel: 00 33 1 40 33 11 30
Fax: 00 33 1 42 77 18 83
Email: [email protected]
Property of HRA Pharma
Do not copy without permission LYS-PPT-0111-EU
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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
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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]
Property of HRA Pharma
Do not copy without permission LYS-PPT-0111-EU
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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
Property of HRA Pharma
Do not copy without permission LYS-PPT-0111-EU
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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.
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Within 30 min of sampling, centrifuge samples at approximately
3000 rpm at 4°C for 15 min.
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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.
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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
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Part B: Complete the tracking document (provided by HRA Pharma)
and add it to the DHL kit before closing it
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Part C: Complete the DHL AWB (Air Way Bill) provided by HRA
Pharma
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Part D: Contact DHL for the sample collection
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The samples will not be accepted:

without the kit provided by HRA Pharma

without the tracking document completed in its entirety
Property of HRA Pharma
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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
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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
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The tracking document should
then be inserted with the labeled
sample in the DHL kit
Property of HRA Pharma
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Part C: complete the DHL Air Way Bill (AWB)
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
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Part D: contact DHL for the sample collection
Country and DHL national phone number
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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
Property of HRA Pharma
Do not copy without permission LYS-PPT-0111-EU
Austria
0820 55 05 05
Belgium
+32 (2) 715 50 50
Norway
810 01345
The Netherlands
0800 0552
Czech Rep.
800 103 000
Poland
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
Bulgaria
0700 17 700
Romania
Luxembourg
0 0801 345 345
08 701 100 300
1 222 1777
+352 35 09 09
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Step 3: The shipment of the sample
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For an immediate collection,
please contact DHL as soon
as:

The sample is completely
packed

The DHL AWB (Air Way
Bill) is completed
Property of HRA Pharma
Do not copy without permission LYS-PPT-0111-EU
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Steps 4 and 5: The test and the validation
of the results
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Reception of the sample in Atlanbio 1 to 2 days after the shipment
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Atlanbio will only accept samples for assay if :
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The sample is correctly packed in the DHL kit
The tracking document is completed in its entirety
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After acceptance, immediate freezing and storage of the samples
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Analysis of the sample:
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Within one week from the sample collection
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Test carried out in accordance with the internationally validated method
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Validation and record of the results on the same day
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Step 6 : Reporting the results
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Reporting back of the results the same day as validation of the test (or
within 24 hours at the latest) :
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to the prescriber of Lysodren
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to a health professional designated in the tracking document
The results can be sent:
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either by fax or by email
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a copy will also be sent by regular mail
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no results communicated by phone
The results will be sent back with the original completed tracking
document
Property of HRA Pharma
Do not copy without permission LYS-PPT-0111-EU
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Lysosafe – further supplies
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HRA Pharma’s Lysodren team will provide you immediatly with all
supplies needed for continuation of LYSOSAFE.
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Either after receiving an email sent to:
[email protected]
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Or after receiving a fax sent to:
Fax: 00 33 1 42 77 18 83
Property of HRA Pharma
Do not copy without permission LYS-PPT-0111-EU
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