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lioresal 4 and 4 . Hence, the Committee lioresal is of the view that amendments to sections 4 . 9 lioresal are required with the addition of “rhabdomyolysis” as a possible consequence of abrupt baclofen withdrawal and baclofen overdose respectively .
Finally, based on the review of cases of toxic encephalopathy with baclofen, the PRAC noted that the majority of the reported cases occurred due to the administration of baclofen to patients with end stage renal disease or compromised renal function at a dose in excess of that recommended in the SmPC; the patients presented with symptoms of lioresal baclofen overdose, the majority of which were neurological in nature .
4 is required to optimise the warnings and precautions for use in the intrathecal baclofen and pregnancy lioresal manufacturer lioresal dosaggio lioresal for migraines population with renal impairment . lioresal Hence, the Committee is of the view that an amendment to the section 4 .
Therefore, in view of the data presented in the reviewed PSURs, the PRAC considered that changes to the product information lioresal of medicinal products containing oral baclofen, were warranted .
The CMDh agrees with the lioresal scientific conclusions made by the PRAC .
Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of the scientific conclusions for lioresal sovradosaggio lioresal medicament prospect lioresal generic lioresal comprimate intrathecal baclofen (oral) the CMDh is of the opinion that the benefitrisk balance of the medicinal product(s) containing baclofen (oral) is unchanged subject to the proposed changes to the product information .
The CMDh reaches lioresal baclofen baclofen (lioresal) side effects baclofen intrathecal trial lioresal 5 zuzahlung the position that the marketing authorisation(s) of products in the scope of this single PSUR assessment should be varied .

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