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English to Slovak: EMA documents (SPC, PIL, EPARs...), protocols of clinical studies, patents General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English The clinical development program has included over 1,900 patients, with different types of epilepsy, exposed to rufinamide. The most commonly reported adverse reactions overall were headache, dizziness, fatigue, and somnolence. The most common adverse reactions observed at a higher incidence than placebo in patients with Lennox-Gastaut syndrome were somnolence and vomiting. Adverse reactions were usually mild to moderate in severity. The discontinuation rate in Lennox Gastaut syndrome due to adverse reactions was 8.2% for patients receiving Inovelon and 0% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from the Inovelon treatment group were rash and vomiting.
Translation - Slovak Klinický vývojový program zahŕňal viac ako 1 900 pacientov s rôznymi typmi epilepsie vystavených rufinamidu. K najčastejšie hláseným nežiaducim reakciám patrila bolesť hlavy, závraty, únava a ospalosť. Najčastejšou nežiaducou reakciou pozorovanou vo vyššej frekvencii ako pri užívaní placeba v prípade pacientov s Lennoxovým-Gastautovým syndrómom bola ospalosť a vracanie. Nežiaduce reakcie boli zvyčajne mierne až stredne závažné. Miera prerušenia liečby v prípade Lennoxovho Gastautovho syndrómu v dôsledku nežiaducich reakcií bola 8,2 % u pacientov užívajúcich Inovelon a 0 % u pacientov užívajúcich placebo. Najčastejšie nežiaduce reakcie vedúce k prerušeniu liečby v liečebnej skupine liečenej liekom Inovelon bola vyrážka a vracanie.
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PhD - Slovak Academy of Sciences (Department of languages)
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Years of experience: 33. Registered at ProZ.com: May 2013.
Adobe Acrobat, memoQ, MemSource Cloud, Microsoft Excel, Microsoft Word, Powerpoint, SDLX, Trados Studio
Bio
More than 20 years of translation experience in various fields (in the beginning: technical, administrative, commercial, scientific and legal materials)
Last 18 years - specialization in:
Medicine - cooperation with well-known pharmaceutical companies (ROCHE, GlaxoSmithKline - e. g. Dictionary of Oncology - 300 pages, medicinal product brochures), scientific papers, protocols of clinical studies, websites, patents (biochemistry, pharmacology)
Pharmacology - EMA documents: SmPCs, Labellings and PILs (human and veterinary medicines) - more than 20,000 pages translated, Biology, Chemistry
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