Section 4.8:
- Flare ups have been removed
- The following has also changed from (changes in bold):
The device: Complications with the device are very common (>1/10), e.g. connector leakage, dislocation of the intestinal tube. Dislocation of the intestinal tube backwards into the stomach leads to reappearance of motor fluctuations (due to erratic gastric emptying of Duodopa into the small intestines). In general, relocation of the tube can be done using a guide-wire to steer the tube into the duodenum under fluoroscopy. Occlusion, kinks, or knots of the intestinal tube lead to high pressure signals from the pump. Occlusions are usually remedied by flushing the tube with tap water; kinking, knotting, or a tube replacement may need readjustment of the tubing. Should complete failure of the intestinal tube or pump occur the patient must be treated with oral levodopa/carbidopa until the problem is solved. The stoma usually heals without complications. However, abdominal pain, infection and leakage of gastric fluid may occur shortly after surgery; it is rarely a problem long-term. Reported complications include wound infection (the most common complication) and peritonitis. Local infections around the stoma are treated conservatively with a disinfectant. Treatment with antibiotics is rarely needed.
To:
The device: Complications with the device are very common (>1/10), e.g. connector leakage, dislocation of the intestinal tube. Dislocation of the intestinal tube backwards into the stomach leads to reappearance of motor fluctuations (due to erratic gastric emptying of Duodopa into the small intestines). In general, relocation of the tube can be done using a guide-wire to steer the tube into the duodenum under fluoroscopy. Occlusion, kinks, or knots of the intestinal tube lead to high pressure signals from the pump. Occlusions are usually remedied by flushing the tube with tap water; kinking, knotting, or a tube displacement may need readjustment of the tubing. Should complete failure of the intestinal tube or pump occur the patient must be treated with oral levodopa/carbidopa until the problem is solved. The stoma usually heals without complications. However, abdominal pain, infection and leakage of gastric fluid may occur shortly after surgery; it is rarely a problem long-term. Reported complications include perforation of adjacent anatomical structures especially during PEG placement and bleeding, wound infection (the most common complication) and peritonitis. Local infections around the stoma are treated conservatively with a disinfectant. Treatment with antibiotics is rarely needed.
Section 6.3 changes from:
15 weeks.
Chemical and physical in-use stability has been demonstrated for 16 hours at 40°C.
To:
Unopened: 15 weeks.
Once opened: Use immediately. Discard any unused portion.
Chemical and physical in-use stability has been demonstrated for 16 hours at 40°C.
Section 6.6 changes from:
Any unused product or waste material should be disposed of in accordance with local requirements.
Empty/used cassettes should be returned to the pharmacy for destruction.
To:
Cassettes are for single use only.
Do not re-use an opened cassette.
Any unused product or waste material should be disposed of in accordance with local requirements.
Empty/used cassettes should be returned to the pharmacy for destruction.
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