natgillin/translations-raw huggingface dataset:
På baggrund af den farmakodynamiske og farmakokinetiske profil og de rapporterede bivirkninger forventes Iasibon ikke eller kun i ubetydelig grad at påvirke evnen til at føre motorkøretøj eller betjene maskiner.
On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Iasibon has no or negligible influence on the ability to drive and use machines
På baggrund af den farmakokinetiske populationsanalyse var eksponeringen for daratumumab den samme hos hvide (n = 197) og ikke-hvide (n = 26) forsøgspersoner.
Based on the population PK analysis the exposure to daratumumab was similar between white (n = 197) and non-white (n = 26) subjects.
På baggrund af den kendte risiko for udsættelser for stråling gennem radioaktiv mærkning fastslog udvalget, at Cuprymina kun må anvendes, når den forventede helbredsmæssige fordel berettiger det.
Given the well-known risks of exposure to radiation through radiolabeling, the Committee decided that Cuprymina is only to be used if justified by the likely medical benefit.
På baggrund af den metaboliske vej for Aripiprazole, er dosisjustering for rygere ikke påkrævet (se pkt.
According to the metabolic pathway of aripiprazole no dosage adjustment is required for smokers (see section 4.5).
På baggrund af den toksiske grænseværdi for myelosuppression blev den maksimalt tolererede dosis (MTD) fastsat til
Based on the dose- limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at
På baggrund af den toksiske grænseværdi for myelosuppression blev den maksimalt tolererede dosis (MTD) fastsat til 2,0 mg/m2/dag med G- CSF og 1,4 mg/m2/dag uden G-CSF i et farmakokinetisk forsøg hos børn med refraktære solide tumorer (se pkt.
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G- CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
På baggrund af den toksiske grænseværdi for myelosuppression blev den maksimalt tolererede dosis (MTD) fastsat til 2,0 mg/m2/dag med G- CSF og 1,4 mg/m2/dag uden G-CSF i et farmakokinetisk forsøg hos børn med refraktære solide tumorer (se pkt.
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
På baggrund af den toksiske grænseværdi for myelosuppression blev den maximalt tolererede dosis (MTD) fastsat til 2,0 mg/m2/dag med
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without
På baggrund af den toksiske grænseværdi for myelosuppression blev den maximalt tolererede dosis (MTD) fastsat til 2,0 mg/m2/dag med G-CSF og 1,4-mg/m2/dag uden GCSF i et farmakokinetisk studie af børn med refraktære solide tumorer (se pkt.
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
På baggrund af den vurderede litteratur, kunne en kausal sammenhæng med deferasirox ikke udelukkes.
Given the reviewed literature, causal association with deferasirox could not be ruled out.
På baggrund af denne bridging i immunogenicitet kan effekten af Gardasil 9 udledes hos piger og drenge på mellem 9 og 15 år.
On the basis of this immunogenicity bridging, the efficacy of Gardasil 9 in 9- through 15-year-old girls and boys is inferred.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Abilify, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abilify, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Abseamed, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abseamed, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Actraphane, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Actraphane, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Anoro, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Anoro, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Arzerra, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Arzerra, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Atriance, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Atriance, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Avastin, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Avastin, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Benepali, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Benepali, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Bexsero, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bexsero, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Binocrit, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Binocrit, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Blincyto, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Blincyto, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Bortezomib Accord, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bortezomib Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Bosulif foruden passende forholdsregler for patienter og sundhedspersonale.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bosulif, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Briviact, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Briviact, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Bydureon, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bydureon, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Celvapan, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Celvapan, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Ceplene, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ceplene, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cerdelga, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cerdelga, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cimzia, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cimzia, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Clopidogrel ratiopharm, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Clopidogrel ratiopharm, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Coagadex, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Coagadex, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Corlentor, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Corlentor, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cubicin, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cubicin, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cyramza, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cyramza, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Darzalex, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Darzalex, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Daxas, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, the safety information has been included in the summary of product characteristics and the package leaflet for Daxas, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Ebymect, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ebymect, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Edistride, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Edistride, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Eliquis, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Eliquis, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Elocta, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Elocta, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Empliciti, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Empliciti, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Epoetin Alfa Hexal, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Epoetin Alfa Hexal, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Esmya, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Esmya, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Eylea, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Eylea, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Feraccru, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Feraccru, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Fexeric, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fexeric, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Foclivia, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Foclivia, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Genvoya, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Genvoya, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Gilenya, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Gilenya, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Grastofil, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Grastofil, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Harvoni, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Harvoni, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Hizentra, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Hizentra, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Iclusig, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Iclusig, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Imatinib Accord, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imatinib Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Imatinib Actavis, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imatinib Actavis, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Imnovid, herunder passende forholdsregler, som patienter og sundhedspersonale skal overholde.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imnovid, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Incruse, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Incruse, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Instanyl, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Instanyl, including the appropriate precautions to be followed by healthcare professionals and patients.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Intelence, herunder passende forholdsregler, som patienter og sundhedspersonale bør træffe.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Intelence, including the appropriate precautions to be followed by healthcare professionals and patients.