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To the extent that additional medicinal products containing baclofen (oral) are currently authorised in the EU or are subject to future authorisation procedures lioresal in the EU, the CMDh recommends that such marketing authorisations are varied accordingly .
Amendments to the product information of the nationally authorised medicinal product(s) Amendments to be included in the relevant sections of the Product baclofen dea classification lioresal overdose intrathecal baclofen pump surgery lioresal ultrafarma Information (new text underlined and in bold, deleted text strike through) Summary of Product Characteristics A warning should be revised as follows: Abrupt withdrawal: “Treatment should always, (unless serious adverse effects occur), be gradually discontinued by successively reducing the dosage over a period of about 1-2 weeks .
2 Posology and method of lioresal intrathecal lioresal ve yan etkileri intrathecal baclofen infusion lioresal efecte adverse administration) . Anxiety and confusional state, delirium, hallucinations, psychotic disorder, mania or paranoia, convulsion (status epilepticus), dyskinesia, tachycardia, hyperthermia, rhabdomyolysis and temporary aggravation of spasticity as a rebound phenomenon have been reported with abrupt withdrawal of Lioresal, especially after long lioresal term A warning should be revised as follows: Renal impairment: “Baclofen should be used with caution in patients with renal impairment and should be administered to end stage renal failure patients only if the expected benefit outweighs the potential risk (See section 4 .
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