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Summary of Contents for AbbVie Duodopa
- Page 1 Duodopa ® Important Risk Minimisation Information Patient Pocket Guide EDUCATIONAL MATERIAL FOR RISK MINIMISATION...
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Page 2: Table Of Contents
Index Duodopa ® Patient Pocket Guide Introduction to Duodopa � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 1 ®... -
Page 3: Introduction To Duodopa
For further information, please read the manual for each device and the Duodopa patient information leaflet. If you have any ® further questions, ask your doctor, pharmacist or nurse�... -
Page 4: The Duodopa ® System
The Duodopa System ® The Duodopa system (Figure 1) consists of a pump, ® intestinal tube and cassette (which contains the medication levodopa/carbidopa)� You will need to have a procedure to make a small hole (called a “stoma”) in your stomach wall to place a gastro-jejunostomy tube (called a PEG-J tube) in an area of your small intestine called the jejunum�... -
Page 5: Daytime Treatment
• Place the pump on a level surface� • Hold the cassette steadily and put a coin in the slot of the lock knob� • Lock the cassette by pushing the coin or the Duodopa ® key and turning it 90 degrees counter-clockwise until it stops�... - Page 6 Please note: It is absolutely essential that the cassette is properly attached, or the pump mechanism may not work� If the cassette comes loose you will hear an alarm signal, even if the pump is in stopped mode� 2� Undo the white cap of the PEG-J tube� 3�...
- Page 7 It is important that prior to any changes in your medication dosing, you should first contact your physician, PD Nurse or the AbbVie Care Support Team� EDUCATIONAL MATERIAL FOR RISK MINIMISATION...
- Page 8 And for this, you should contact your doctor, PD Nurse or the AbbVie Care Support Team� A preset extra dose can be programmed� It will always give the same dose when activated, but can be changed when needed�...
- Page 9 1� Stop the pump, switch it off (see ‘Operating the Pump’)� 2� Disconnect the Duodopa cassette tube from the ® intestinal port of the PEG-J� (Figure 2) Make sure to twist the cassette tube NOT the PEG-J tube�...
- Page 10 7� Detach the cassette from the pump: • Place the pump with the cassette upright on a hard level surface� • Put a coin or the Duodopa key in the slot of the lock ® knob and turn 90 degrees clockwise� The lock knob will pop out slightly when the cassette is unlocked�...
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Page 11: Stoma Care
Observe for signs of complications such as pain and bleeding First 24 hours after day of placement Duodopa treatment can normally be initiated directly after ® uncomplicated PEG/J placement, after consultation with the gastroenterologist�... - Page 12 Tube Mobilisation to Prevent Buried Bumper Syndrome After initial wound healing this procedure should be performed every two to three days� Daily dressing is no longer necessary� 1� Wash hands thoroughly with soap and water� 2� If dressing is used, remove the dressing and release the external retention plate to allow free movement of the PEG-J tube�...
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Page 13: Important Information
Parkinson’s symptoms or recurring movement problems (motor fluctuations). Call your doctor or nurse if your Parkinson’s symptoms get worse or you have slow movement while you are treated with Duodopa � ® EDUCATIONAL MATERIAL FOR RISK MINIMISATION... - Page 14 Do not drive or use any tools or machines until you feel fully awake again or you no longer feel light headed or dizzy� If you have had more Duodopa than you should, ®...
- Page 15 If You Stop or Lower Your Dose of Duodopa ® It is important that you do not stop having Duodopa ® lower your dose until told to do so by your doctor� Suddenly stopping or lowering your Duodopa dose may result in a ®...
- Page 16 If still unsuccessful, try gently pushing the PEG-J tube into the stomach 3-4cm, as described in “Stoma Care”� If this does not work contact your Doctor, PD Nurse or the AbbVie Care Support Nurse� EDUCATIONAL MATERIAL FOR RISK MINIMISATION...
- Page 17 Most common complications and actions to take A circular erythema (redness of the skin) with a diameter of less than 5mm is normal and not necessarily a sign of wound infection� Careful observation on a daily basis is advised� Never apply an ointment on a PEG-J stoma nor an inflamed PEG-J wound�...
- Page 18 Very Common: May Affect More Than 1 in 10 People • Stomach pain • Infection where the tube goes into your stomach — caused by surgery • Thick scarring where the tube goes in your stomach • Problems from having the tube put in (e�g�, pain or swelling in the mouth or throat, difficulty swallowing, stomach discomfort, pain or swelling, injury to the throat, mouth or stomach, bleeding, being sick/vomiting,...
- Page 19 • Reduced blood flow in the small intestine • Tube goes through the wall of the stomach or small intestine Please read the patient information leaflet for complete information including the side effects of Duodopa � ® EDUCATIONAL MATERIAL FOR RISK MINIMISATION...
- Page 20 How to Store Duodopa ® • Keep the cassettes with gel out of the reach and sight of children� • Do not use Duodopa after the expiry date which is stated ® on the carton label after EXP� • Store in a refrigerator (2ºC to 8ºC)�...
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Page 21: About The Pump
About the Pump MORNING MORNING DOSE DOSE Operating the Pump Morning Dose NEXT NEXT Switch on the pump, start it and give the morning dose� Make sure that there is no cap or locked tubing clamp on the tube� 1� Press the key and hold it down until the display turns on�... - Page 22 MORNING DOSE MORNING MORNING DOSE DOSE 5� If ‘LLO’ is shown in the display when pressing key, the pump is not running� NEXT NEXT NEXT Press the key and go back to step 2� See ‘Daytime Treatment’ on attaching the cassette to the pump�...
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Page 23: Caution
Caution Fluid and water can damage the pump� Before showering and bathing always disconnect the pump� Showering Washing or showering with regular soap and water will become possible again usually two weeks after insertion of the PEG tube� To reduce the risk of stoma infection, it is very important to leave the area clean and dry�... - Page 24 Showering Procedure 1� Press the STOP/START button and then turn off the pump with the ON/OFF button� 2� Disconnect the cassette tube� 3� Put the cap on the PEG tube� 4� Put the cap on the cassette tube� 5� Once the cap is in place, the tube may hang freely�...
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Page 25: Travelling
In case of doubt consult your physician� Plan your trip well in advance� Ensure that you have adequate cool packaging for the journey, and that you have refrigeration for the Duodopa cassettes at your destination� ® Take the following: 1�... -
Page 26: Examples Of Pump Alarms
Two-tone An error has occurred Contact the hospital/ alarm clinical department; signal the pump needs to be returned to AbbVie for service� No message Two-tone The batteries have Install the batteries alarm been removed while to silence the alarm� signal the pump is running�... - Page 27 Display Alarm Cause Action RunResVol Three single The reservoir volume Change the cassette signals is low� without delay� Two-tone You tried to start Press STOP/START disposable, alarm signal the pump without a or NEXT to stop the pump will properly connected alarm signal�...
- Page 28 Display Alarm Cause Action Battery Two tone alarm The battery power Change the depleted is too low to batteries operate the pump� immediately� Press and hold STOP/ The pump is now START to restart the stopped� pump� Battery Two tone alarm The batteries have Press STOP/START Removed...
- Page 29 Display Alarm Cause Action Upstream Two-tone Fluid is not flowing Press NEXT or STOP/ Occlusion alarm signal from the cassette to START to stop the the pump� pump and silence the alarm for two Check for a kink minutes� Remove in the tubing or the obstruction and a closed clamp...
- Page 30 Display Alarm Cause Action Key Pressed Two-tone alarm A key has stuck in Release the key Release Key signal its down position� if possible� If the alarm continues, close the tubing clamp and remove the pump from use� Contact the hospital/clinical department;...
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Page 31: Further Information
• Use a normal soap solution when cleaning the pump� Do not clean it with acetone, other plastic solvents, or abrasive cleaners� Like all medicines, Duodopa can cause side-effects, although ® not everybody gets them� If you get any side effects, talk to your doctor, pharmacist or nurse�... - Page 32 This medicinal product is authorised in the Member States of EEA under the following name: Duodopa � ® This material was developed by AbbVie, Inc� as part of the Risk Minimisation Plan for Levodopa/Carbidopa Intestinal Gel� IRERMPDUO160087(1) Date of Preparation: June 2017...
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