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1 US Investigator Meeting DIAS-4, Chicago, July 2011 DIAS 3&4 Investigational Medicinal Products (IMP)

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Presentation on theme: "1 US Investigator Meeting DIAS-4, Chicago, July 2011 DIAS 3&4 Investigational Medicinal Products (IMP)"— Presentation transcript:

1 1 US Investigator Meeting DIAS-4, Chicago, July 2011 DIAS 3&4 Investigational Medicinal Products (IMP)

2 US Investigator Meeting DIAS-4, Chicago, July Agenda IMP formulation IMP shipment and storage Dose Reconstitution of IMP IMP Accountability

3 US Investigator Meeting DIAS-4, Chicago, July IMP Formulation Supplied in vials containing white lyophilised powder for solution for injection Contains either 9 mg desmoteplase or placebo Reconstituted with 10 ml of WFI Each patient will receive: 90 μg/kg desmoteplase or placebo Single IV bolus injection over 1-2 minutes

4 US Investigator Meeting DIAS-4, Chicago, July This is how IMP looks! The initial supply of medication will consist of 2 packs. Dont break the silver seal until it is used 150 x 113 x 58 mm

5 US Investigator Meeting DIAS-4, Chicago, July IMP Storage IMP must be stored at 2-8 Temperature must be monitored at least every working day and documented. In case of temperature excursion CRA need to be notified immediately Temperature will be monitored during transportation as well

6 US Investigator Meeting DIAS-4, Chicago, July IMP Shipment Cold Chain Shipment Upon receipt: Check if the temperature during the transportation was within 2-8 Acknowledge the IMP receipt by making a medication arrival call in IVRS/IWRS

7 US Investigator Meeting DIAS-4, Chicago, July How to read TempTale 1.Hold down the stop button until the stop icon appears 2.No bell icon: IMP delivered within temperature range Bell icon present: IMP did not arrive within accepted temperature limits. Wait for confirmation from Lundbeck CSC TempTale needs to be returned to courier immediately!

8 US Investigator Meeting DIAS-4, Chicago, July Randomisation The IV/IWRS will be used for randomisation. - Screening number - Subjects Date Of Birth - Subjects NIHSS Score - Date of Stroke Onset - Time of Stroke Onset (24 hour clock format) - Subjects weight (in Kilograms) The IV/IWRS will instruct the site in an and/or fax: - The IMP number to use - The volume of mediciation to be administred

9 US Investigator Meeting DIAS-4, Chicago, July Reconstitute lyophilized powder with 10 ml Water For Injection Agitate gently until all particles of the study medication are dissolved Reconstitution of IMP 1.Choose assigned IMP number Check IMP number on IV/IWRS- Randomisation confirmation Check vial and remove blue cap Water For Injection 10 ml Version 2.0: 2-April-2009

10 US Investigator Meeting DIAS-4, Chicago, July Reconstitution of IMP 3. Prepare a syringe (accuracy 0,2ml) with volume of IMP as given by the IV/IWRS Randomisation confirmation RANDOMIZATION FAX Patient XXX Volume: X,y ml accuracy of 0,2 ml 4. Please flush i.v. line with 10 ml WFI or Normal Saline before and after IMP administration to avoid any interaction with infusion contents! X,y ml

11 US Investigator Meeting DIAS-4, Chicago, July IMP Inventory Form

12 US Investigator Meeting DIAS-4, Chicago, July IMP Inventory Log

13 US Investigator Meeting DIAS-4, Chicago, July IMP re-supply Randomisation will trigger the IMP re-supply After the 1st patient: 2 IMPs will be sent After the 2nd patient: 1 IMP will be sent

14 US Investigator Meeting DIAS-4, Chicago, July IMP return Used IMP must be stored in refrigerator at 2-8 on site until the patient has had the Day 90 visit After the patient has completed the study the IMP can be kept at ambient storage condition until it is returned CRA to check accountability before IMP return IMP to be returned to depot Please contact CRA when you return IMP

15 US Investigator Meeting DIAS-4, Chicago, July Thank you


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