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Abbott Laboratories Ireland Limited
4051 Kingswood Drive, Citywest Business Campus, Dublin 24,
Telephone: +353 1 469 1500
Fax: +353 1 469 1501
Summary of Product Characteristics last updated on medicines.ie: 19/04/2012
SPC Duodopa intestinal gel

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 19/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   16-Apr-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 4.2

Dosage:

The following statement was added: " The maximum recommended daily dose is 200 ml (see section 4.4)

Section 4.8

Undesirable effects:

The following statement was added below the MEDRA table:

"Other adverse reactions have been reported in association with levodopa/ carbidopa combinations including Duodopa:

Patients treated with dopamine agonists for treatment of Parkinson´s disease, including levodopa/ carbidopa, especially at high doses, have been reported as showing pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation"

The following statement was removed:
"Patients treated with dopamine agonists for treatment of Parkinson´s disease, including levodopa/carbidopa, especially at high doses, have been reported as showing pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation"
Updated on 05/10/2010 and displayed until 19/04/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   01-Oct-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Section 4.2

 

From:

 

Morning bolus dose: 140 mg = 7 ml (including the volume to fill the intestinal tube)

 

To:

 

Morning bolus dose: 140 mg = 7 ml (excluding the volume to fill the intestinal tube)

 

 

Section 4.4

 

The following statement has been included;

 

Duodopa contains hydrazine, a degradation product of carbidopa that can be genotoxic and possibly carcinogenic. The average recommended daily dose of Duodopa is 100 ml, containing 2 g levodopa and 0.5 g carbidopa. The maximum recommended daily dose is 200 ml. This includes hydrazine at up to an average exposure of 4 mg/day, with a maximum of 8 mg/day. The clinical significance of this hydrazine exposure is not known.

 

 

Section 4.8

 

The frequency sub headings have been updated.

 

 

Section 5.3

 

The following statement has been included;

 

Hydrazine is a degradation product of Carbidopa. In animal studies, hydrazine showed notable systemic toxicity, particularly by inhalation exposure. These studies reported that hydrazine is hepatotoxic, has CNS toxicities (although not described after oral treatment), and is genotoxic as well as carcinogenic (see also section 4.4).

 

Section 7:

 

From:

 

Solvay Pharmaceuticals GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Germany

 

 

To:

 

Abbott Products GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Germany

 

 

 
Updated on 12/07/2010 and displayed until 05/10/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   10-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
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:

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:

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.


Section 9:

From:
21 January 2004

To:
Date of first authorisation: 18 November 2005
Date of last renewal: 21 January 2009

Updated on 27/08/2008 and displayed until 12/07/2010
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Levodopa
  Carbidopa Monohydrate