Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
IV <strong>in</strong>fusion:<br />
The f<strong>in</strong>al 100ml <strong>in</strong>fusion bag should be adm<strong>in</strong>istered by IV <strong>in</strong>fusion over a one hour period1 !<br />
.<br />
Us<strong>in</strong>g IV Volumat Pump:<br />
The pump does not have a preset sett<strong>in</strong>g for Tocilizumab.<br />
Us<strong>in</strong>g Injectomat Syr<strong>in</strong>ge driver:<br />
The syr<strong>in</strong>ge driver does not have a preset sett<strong>in</strong>g for Tocilizumab.<br />
Example Calculation: (Adult Patients)<br />
For a 70kg, the dose is usually 560mg every 4 weeks (70kg x 8mg/kg). This dose requires 28ml of<br />
Tocilizumab concentrate – ie 20ml from a 1 x 400mg vial and 2 x 4ml (2 x 80mg) doses. Twenty<br />
eight ml is withdrawn form the 100ml <strong>in</strong>fusion bag and the 28ml form the vials added to the <strong>in</strong>fusion<br />
bag. The result<strong>in</strong>g solution is then given as an IV <strong>in</strong>fusion over a one hour period.<br />
Flushes Compatible:<br />
Sodium Chloride 0.9% 1<br />
Adverse effects which may be caused by IV adm<strong>in</strong>istration and suggested monitor<strong>in</strong>g:<br />
• Common side effects <strong>in</strong>clude abdom<strong>in</strong>al pa<strong>in</strong>, mouth ulceration, gastritis, raised hepatic<br />
transam<strong>in</strong>ases, dizz<strong>in</strong>ess, peripheral oedema, hypertension, hypercholesterolaemia,<br />
headache and <strong>in</strong>fection.<br />
Special Handl<strong>in</strong>g Precautions:<br />
The reconstituted solution should be used immediately due to sterile concentrate not conta<strong>in</strong><strong>in</strong>g<br />
any preservatives.<br />
The Tocilizumab will be adm<strong>in</strong>istered at room temperature by controlled <strong>in</strong>fusion <strong>in</strong>to an arm ve<strong>in</strong><br />
over a one hour period. In exceptional cases this time may be extended to up to 6 hours. The<br />
<strong>in</strong>fusion speed must be 10 mL/hour for 15 m<strong>in</strong>utes and then <strong>in</strong>creased to 130 mL/h to complete the<br />
dos<strong>in</strong>g over 1 hour. The entire 100 mL content of the <strong>in</strong>fusion bag must be adm<strong>in</strong>istered. 20 mL of<br />
normal sal<strong>in</strong>e will be adm<strong>in</strong>istered follow<strong>in</strong>g the <strong>in</strong>fusion of <strong>study</strong> medication to flush the rema<strong>in</strong><strong>in</strong>g<br />
<strong>study</strong> medication through the <strong>in</strong>travenous set.<br />
4.2 Accountability/Receipt /Storage and Handl<strong>in</strong>g of IMP<br />
The <strong>in</strong>vestigator is responsible for the control of drugs under <strong>in</strong>vestigation. Adequate<br />
records for the receipt (e.g. Drug Receipt Record) and disposition (e.g. Drug Dispens<strong>in</strong>g<br />
Log) of the <strong>study</strong> drug must be ma<strong>in</strong>ta<strong>in</strong>ed. Accountability will be assessed by ma<strong>in</strong>ta<strong>in</strong><strong>in</strong>g<br />
adequate drug dispens<strong>in</strong>g and return records. This will be delegated to the local site pharmacy.<br />
The IMP will be stored by the local pharmacy.<br />
Accurate records must be kept for each <strong>study</strong> drug provided. These records must conta<strong>in</strong> the<br />
follow<strong>in</strong>g:<br />
• Documentation of drug shipments received from the sponsor (date received and<br />
qu<strong>anti</strong>ty)<br />
• Disposition of unused <strong>study</strong> drug not dispensed to patient<br />
When the <strong>study</strong> is completed, the <strong>in</strong>vestigator will return all completed Drug Dispens<strong>in</strong>g<br />
Logs to the trial co-ord<strong>in</strong>ator. Also, any unused <strong>study</strong> drug and Drug Return Records should be<br />
returned to the Monitor. The <strong>in</strong>vestigator's copy of the Drug Return Record(s) must accurately<br />
document the return of all <strong>study</strong> drug supplied.<br />
4.3 Dispens<strong>in</strong>g of IMP<br />
A Drug Dispens<strong>in</strong>g Log will be kept current and will conta<strong>in</strong> the follow<strong>in</strong>g<br />
<strong>in</strong>formation:<br />
• the identification of the patient to whom the <strong>study</strong> medication was dispensed<br />
• the date[s], qu<strong>anti</strong>ty of the <strong>study</strong> medication dispensed to the patient<br />
• the date[s] and qu<strong>anti</strong>ty of the <strong>study</strong> medication returned by the patient.<br />
All records and drug supplies must be available for <strong>in</strong>spection by the Monitor at every<br />
monitor<strong>in</strong>g visit.<br />
When the <strong>study</strong> is completed, the <strong>in</strong>vestigator will return all completed Drug Dispens<strong>in</strong>g<br />
Logs to the monitors.<br />
Study: R4RA EudraCT: 2012-002535-28 20 / 34