AbbVie Duodopa Скачать руководство пользователя страница 32

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Marketing Authorisation Holder

AbbVie Limited, Citywest Business Campus, Dublin 24, Ireland

Manufacturer

Fresenius Kabi Norge AS, Svinesundsveien 80, NO-1788 Halden, Norway

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

Содержание Duodopa

Страница 1: ...Important Risk Minimisation Information Patient PocketGuide EDUCATIONAL MATERIAL FOR RISK MINIMISATION Duodopa...

Страница 2: ...a Patient Pocket Guide Introduction to Duodopa 1 The Duodopa System 2 Daytime Treatment 3 Stoma Care 9 Important Information 11 About the Pump 19 Operating the Pump 19 Caution 21 Showering 21 Travelli...

Страница 3: ...r 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 Introduction to Duodopa What Duod...

Страница 4: ...a of your small intestine called the jejunum The Duodopa medicine is a gel contained in a plastic cassette The cassette is connected to a pump The pump is connected to the PEG J tube which is placed i...

Страница 5: ...tion leaflet Morning Procedure Getting Started 1 Attach a new cassette to the pump see below Place the pump in your carrying accessory before you put it on Fit the hooks of the cassette onto the pivot...

Страница 6: ...cassette tube and open any tube clamps 4 Connect the cassette tube to the intestinal port of the PEG J Do this by holding the PEG J with one hand securely whilst gently rotating clockwise the cassette...

Страница 7: ...ory mobility within one hour If there is intense dyskinesia unwanted or uncontrolled movements the pump may be turned off for 5 30 minutes or until you feel the dyskinesia wearing off If problems with...

Страница 8: ...has passed If the need for extra doses exceeds five per day the maintenance dose should be increased as long as there is no dyskinesia And for this you should contact your doctor PD Nurse or the AbbVi...

Страница 9: ...erating 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 Figure 3 3 Disconnect the cassette from t...

Страница 10: ...ight 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 Remove the hooks...

Страница 11: ...d to do to care for your stoma After the procedure you and your healthcare provider will need to regularly check the stoma for any signs of infection Observe for signs of complications such as pain an...

Страница 12: ...on plate to allow free movement of the PEG J tube 3 Carefully push the tube 3 to 4 cm into the stomach and gently pull back until you feel resistance of the internal retention plate Do not twist the t...

Страница 13: ...s been prescribed for you Do not pass it on to others It may harm them even if their symptoms are the same as yours If you get any side effects talk to your doctor pharmacist or nurse This includes an...

Страница 14: ...until you feel fully awake again or you no longer feel light headed or dizzy If you have had more Duodopa than you should talk to your doctor or go directly to a hospital Take the medicine pack with y...

Страница 15: ...s lower consciousness and coma Higher levels of a protein in your blood an enzyme called creatine phosphokinase This is measured by your doctor This problem is more likely to happen if you are also ta...

Страница 16: ...he blockage flush again with 40 mL drinking water When trying to flush use a pumping action with the plunger on the syringe If you fail to unblock the tube on the first attempt repeat the procedure 30...

Страница 17: ...n with your physician Signs of inflammation if there are signs of inflammation consult your physician Severe discharge consult your physician The wound should be kept as dry as possible Side Effects F...

Страница 18: ...n or swelling injury to the throat mouth or stomach bleeding being sick vomiting wind flatulence or anxiety Problems around where the tube goes into your stomach red or raw skin sores discharge pain o...

Страница 19: ...around the tube causing it to block Sliding of one part of the gut into an adjacent part of the gut intussusception Pocket of infection abscess this could happen after the tube is placed in your stoma...

Страница 20: ...be used for up to 16 hours once it is out of the refrigerator The drug cassettes are for single use only and should not be used for longer than 16 hours even if some gel remains Do not re use an open...

Страница 21: ...lays the set values This takes approx 30 seconds 2 Press the key MORNING DOSE NEXT PRIME ON OFF STOP START ENTER CLEAR EXTRA DOSE and hold it down for three seconds until the three dashes in the displ...

Страница 22: ...e to the pump Stopping the pump Turning the pump off Stop the pump switch it off and rinse the tube 1 Stop the pump by pressing the key MORNING DOSE NEXT PRIME ON OFF STOP START ENTER CLEAR EXTRA DOSE...

Страница 23: ...is very important to leave the area clean and dry Bathing and swimming after complete initial wound healing is possible Early in the morning you may find that you feel stiffer than normal At this poi...

Страница 24: ...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 6 After showering be very careful to e...

Страница 25: ...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 Duodopa...

Страница 26: ...hin approximately 15 seconds after stopping the pump Install the batteries to silence the alarm High pressure Two tone alarm signal The pump has detected high pressure which may be resulting from a do...

Страница 27: ...STOP START to restart the pump Reservoir Volume Empty Two tone alarm signal The reservoir volume has reached 0 0 mL Press STOP START or NEXT to silence the alarm Change to a new cassette if necessary...

Страница 28: ...alarm The batteries have been removed while the pump is running or you have tried to start the pump with depleted batteries The pump is now stopped Press STOP START or NEXT to stop the alarm Reinstal...

Страница 29: ...in No Disposable Clamp Tubing Two tone alarm signal The cassette has been removed Close the tube clamp immediately or disconnect it from the tube A cassette must be connected before the pump can be st...

Страница 30: ...nal Batteries are depleted and the pump was powered up via the AC adapter Install new batteries reconnect the AC adapter and restart the pump Programming Incomplete Two tone alarm signal when starting...

Страница 31: ...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 a...

Страница 32: ...i Norge AS Svinesundsveien 80 NO 1788 Halden Norway 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...

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