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TIXTAR (rifaximin), intestinal anti-infective agent
HEPATOLOGY - New medicinal product
Opinions on drugs -
Posted on
Mar 14 2016
Reason for request
Inclusion
Minor improvement in the prevention of relapse of episodes of recurrent clinical hepatic encephalopathy with at least 2 prior episodes of hepatic encephalopathy and provided that triggers have been eliminated
- TIXTAR has Marketing Authorisation in the prevention of relapse of episodes of clinical 5eh° hepatic encephalopathy in adults.
- Its efficacy has been demonstrated versus placebo in terms of risk of onset of recurrent clinical hepatic encephalopathy, in combination with lactulose at 6 months with continued efficacy at 2 years.
- There are no data available related to the risk of selection of resistant bacteria.
- Considering the clinical data available, it should be reserved for recurrent clinical hepatic encephalopathies, i.e. adults who have had at least two prior episodes of hepatic encephalopathy and only after eliminating the factors likely to trigger the encephalopathy.
Clinical Benefit
| Substantial |
- |
| Insufficient |
Clinical Added Value
| minor |
- |
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