natgillin/translations-raw huggingface dataset:
I kliniske forsøg med ADVATE hos 233 pædiatriske og voksne patienter [pædiatriske patienter (0-16 år) og voksne (ældre end 16 år)] med diagnosen svær hæmofili A (faktor VIII <1 %) og med tidligere eksponering for faktor VIII-koncentrat ≥150 dage hos voksne og ældre børn og ≥50 dage hos børn <6 år udviklede én patient en lav-titer-inhibitor (2,4 BE i den modificerede Bethesda-test) efter 26 eksponeringsdage med ADVATE.
During clinical trials with ADVATE in 233 paediatric and adult patients [paediatric patients (age 0 –16 years) and adult patients (age over 16 years)] diagnosed with severe haemophilia A (factor VIII < 1%), with previous exposure to factor VIII concentrates ≥ 150 days for adults and older children and ≥ 50 days for children < 6 years of age, one patient developed a low-titre inhibitor (2.4 BU in the modified Bethesda assay) after 26 exposure days to ADVATE.
I kliniske forsøg med cancerpatienter er 100 og 200 mikrogram de hyppigst anvendte doser.
In the clinical studies in cancer patients, the most frequent strengths used were 100 and 200 micrograms.
I kliniske forsøg med cancerpatienter var den hyppigste bivirkning smerter i bevægeapparatet, som var milde eller moderate hos 10 % og svære hos 3 % af patienterne.
In clinical trials on cancer patients, the most frequent undesirable effect was musculoskeletal pain which was mild or moderate in 10%, and severe in 3% of patients.
I kliniske forsøg med epilepsipatienter er hyppigheden af første grads AV-blok ikke almindelig: henholdsvis 0,7%, 0%, 0,5% og 0% for lacosamid 200 mg, 400 mg, 600 mg eller placebo.
In clinical trials in epilepsy patients the incidence rate of reported first degree AV Block is uncommon, 0.7%, 0%, 0.5% and 0% for lacosamide 200 mg, 400 mg, 600 mg or placebo, respectively.
I kliniske forsøg med filgrastim indgik et mindre antal ældre patienter, men særlige undersøgelser er ikke udført i denne gruppe, og derfor kan specifikke anbefalinger vedrørende dosering ikke gives
Clinical trials with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific posology recommendations cannot be made.
I kliniske forsøg med filgrastim indgik et mindre antal ældre patienter, men særlige undersøgelser er ikke udført i denne gruppe, og derfor kan specifikke anbefalinger vedrørende dosering ikke gives Patienter med nedsat nyre- eller leverfunktion
Clinical trials with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific posology recommendations cannot be made.
I kliniske forsøg med katte reducerede dette produkt smerter og betændelse i forbindelse med sygdomme i muskler og knogler og nedsatte behovet for nødvendig supplerende behandling, når det blev givet som premedicinering ved ortopædkirurgi, i kombination med opioider.
In clinical trials in cats this product reduced pain and inflammation associated with musculoskeletal disorders and reduced the need for rescue treatment when given as premedication in case of orthopaedic surgery, in combination with opioids.
I kliniske forsøg med katte reducerede robenacoxib tabletter smerter og inflammation forbundet med muskuloskeletale sygdomme, og nedsatte behovet for nødvendig supplerende behandling, når det blev givet som premedicinering ved ortopædkirurgi, i kombination med opioider.
In clinical trials in cats, robenacoxib tablets reduced pain and inflammation associated with musculoskeletal disorders and reduced the need for rescue treatment when given as premedication in case of orthopaedic surgery, in combination with opioids.
I kliniske forsøg med lamivudin-refraktære patienter havde 4% af patienterne ALAT-
In clinical studies with lamivudine-refractory patients, 4% had ALT elevations > 3 times baseline, and
I kliniske forsøg med lamivudin-refraktære patienter havde 4% af patienterne ALAT-stigninger
In clinical studies with lamivudine-refractory patients, 4% had ALT elevations > 3 times baseline, and
I kliniske forsøg med Nonafact har man ikke observeret udvikling af inhibitorer hos tidligere behandlede patienter.
During clinical trials with Nonafact conducted in previously treated patients development of inhibitors was not reported.
I kliniske forsøg med patienter med Duchennes muskeldystrofi (nmDMD) forårsaget af en nonsense- mutation er de hyppigste bivirkninger ved den anbefalede dosis kvalme, opkastning og hovedpine.
In clinical trials of patients with Duchenne muscular dystrophy (nmDMD) caused by a nonsense mutation, the most frequent adverse reactions at the recommended dose were nausea, vomiting, and headache.
I kliniske forsøg med patienter med lægemiddelinduceret psykose (dopaminagonist) i forbindelse med Parkinsons sygdom, blev der rapporteret forværring af Parkinson symptomatologi og hallucinationer meget almindeligt og hyppigere end med placebo.
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’s disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
I kliniske forsøg med patienter med lægemiddelinduceret psykose (dopaminagonist) i forbindelse med Parkinsons sygdom, blev der rapporteret forværring af Parkinson-symptomatologi og hallucinationer meget almindeligt og hyppigere end med placebo.
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’s disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
I kliniske forsøg med patienter med lægemiddelinduceret psykose (dopaminagonist) i forbindelse med Parkinsons sygdom, var hyppigheden af rapporter om forværring af Parkinson symptomatologi og hallucinationer meget almindeligt og oftere end med placebo.
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’s disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
I kliniske forsøg med pioglitazon var der tegn på dosisrelateret vægtøgning, hvilket kan skyldes fedtophobning og i nogle tilfælde som følge afvæskeretention.
In clinical trials with pioglitazone there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention.
I kliniske forsøg med Rebif var en asymptomatisk forhøjelse af hepatisk aminotransferase (især alanin- aminotransferase (ALAT)) almindelig, og 1-3% af patienterne fik forhøjelser af hepatisk aminotransferase fem gange over den øvre normalgrænse.
In clinical trials with Rebif, asymptomatic elevations of hepatic transaminases (particularly alanine aminotransferase (ALT)) were common and 1-3% of patients developed elevations of hepatic transaminases above 5 times the upper limit of normal (ULN).
I kliniske forsøg med TOBI viste de fleste patienter med P. aeruginosa isolater med tobramycin MIC’er < 128 µg/ml ved baseline forbedret lungefunktion efter behandling med TOBI.
In clinical studies with TOBI, most patients with P. aeruginosa isolates with tobramycin MICs < 128 µg/ml at baseline showed improved lung function following treatment with TOBI.
I kliniske forsøg med topikal okulær administration, hvor den systemiske farmakokinetik for SIMBRINZA administreres to eller tre gange om dagen i forhold til brinzolamid og brimonidin, der administreres individuelt ved de samme to doser, steady-state i helblod for brinzolamid og N-desethylbrinzolamid- farmakokinetik svarede til hinanden for kombinationsproduktet og brinzolamid givet alene.
In a topical ocular clinical study comparing the systemic pharmacokinetics of SIMBRINZA administered two or three times daily to brinzolamide and brimonidine administered individually using the same two posologies, the steady-state whole blood brinzolamide and N-desethylbrinzolamide pharmacokinetics were similar between the combination product and brinzolamide administered alone.
I kliniske forsøg med topotecan er der set dødsfald på grund af neutropen colitis.
Fatalities due to neutropenic colitis have been reported in clinical trials with topotecan.
I kliniske forsøg med zoledronsyre blev patienter med serum- kreatinin >265 mol/l eller >3,0 mg/dl ekskluderet.
In clinical trials with zoledronic acid, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
I kliniske forsøg med zoledronsyre blev patienter med serum-kreatinin >265 mol/l eller >3,0 mg/dl ekskluderet.
In clinical trials with zoledronic acid, patients with serum creatinine > 265 μmol/l or > 3.0 mg/dl were excluded.
I kliniske forsøg med Zoledronsyre Teva blev patienter med serum-kreatinin >265 mol/l eller >3,0 mg/dl ekskluderet.
In clinical trials with zoledronic acid, patients with serum creatinine > 265 μmol/l or > 3.0 mg/dl were excluded.
I kliniske forsøg med Zometa blev patienter med serum-kreatinin >265 mol/l eller
In clinical trials with Zometa, patients with serum creatinine
I kliniske forsøg og anvendelse efter markedsføring varierer hyppigheden mellem patientpopulation og doseringsregimer.
In clinical studies and during marketed use, the frequency varies with patient population and dose regimens.
I kliniske forsøg opnåede 97 % af respondenterne fuldstændigt respons ved doser på 2,4 mio.
In clinical trials, 97% of patients who responded had a complete response at doses of
I kliniske forsøg opretholdt de fleste hunde af mindre størrelse (<10 kg) supprimerede testosteronniveauer i mere end 12 måneder efter implantation.
During clinical trials, most of the smaller size dogs (<10 kg) maintained suppressed levels of testosterone for more than 12 months following implantation.
I kliniske forsøg opstod der meget sjældent anafylaksi eller alvorlige reaktioner, som nødvendiggjorde behandlingsafbrydelse.
Within the clinical trials, anaphylaxis or serious reactions that necessitated treatment discontinuation were very rare.
I kliniske forsøg på op til 2 år ses intet accelereret fald efter 3- 6 måneder.
In clinical studies of up to two years duration, there was no accelerated decline beyond 3-6 months.
I kliniske forsøg på type 1 diabetes har patienter, der er i EXUBERA-behandling i kombination med langtids- eller middellangtidsvirkende insulin, et lignende fald i HbA1c som patienter, der tager subkutant insulin alene.
In clinical trials in type 1 diabetes, patients using a regimen of EXUBERA in combination with long- or intermediate-acting insulin had similar reductions in HbA1c compared with patients taking subcutaneous insulin alone.
I kliniske forsøg udført på raske forsøgspersoner blev hverken farmakokinetikken af saxagliptin eller dets hovedmetabolit betydeligt ændret af metformin, glibenclamid, pioglitazon, digoxin, simvastatin, omeprazol, antacida eller famotidin.
In studies conducted in healthy subjects, neither the pharmacokinetics of saxagliptin and its major metabolite, were meaningfully altered by metformin, glibenclamide, pioglitazone, digoxin, simvastatin, omeprazole, antacids or famotidine.
I kliniske forsøg var de hyppigst forekommende behandlingsrelaterede bivirkninger mave-tarm- kanalen, særligt kvalme (43 %) og opkastninger (36 %).
In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43 %) and vomiting (36 %).
I kliniske forsøg var de hyppigst forekommende behandlingsrelaterede bivirkninger mave-tarm- lidelser, særligt kvalme (43 %) og opkastninger (36 %).
In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43 %) and vomiting (36 %).
I kliniske forsøg var de mest almindelige bivirkninger sløret syn, øjenirritation og øjensmerter, som opstod hos omtrent 2 til 7 % af patienterne.
In clinical trials, the most common adverse reactions were blurred vision, eye irritation and eye pain, occurring in approximately 2% to 7% patients.
I kliniske forsøg var der ingen forskel på den samlede hyppighed af hypoglykæmi hos patienter, som blev behandlet med insulin aspart, sammenlignet med patienter, som blev behandlet med humant insulin.
During clinical trials, the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
I kliniske forsøg var mediantiden indtil respons 7,6-11,6 uger.
The median time to response in clinical trials was 7.6-11.6 weeks.
I kliniske forsøg var mediantiden tid indtil respons 7,6-11,6 uger.
The median time to response in clinical trials was 7.6-11.6 weeks.
I kliniske forsøg var patientens anti-tyreoid-peroxidase (anti-TPO) antistofstatus forud for behandlingen ikke indikativ for udviklingen af en thyreoidea-relateret bivirkning.
In clinical trials, a patient’s anti-thyroid peroxidase (anti-TPO) antibody status prior to treatment was not indicative for the development of a thyroid related adverse event.
I kliniske forsøg var vægttabet ved orlistatbehandling mindre hos type 2-diabetikere end hos ikke- diabetikere.
In clinical trials, the decrease in bodyweight with orlistat treatment was less in type II diabetic patients than in non-diabetic patients.
I kliniske forsøg variererede frekvensen af hypoglykæmi afhængigt af patientgruppe, dosisregime og niveau af glykæmisk kontrol.
In clinical trials, the frequency of hypoglycaemia varied with patient population, dose regimens and level of glycaemic control.
I kliniske forsøg, af en varighed på et år eller kortere, er der kun sjældent indberettet behandlingsbetingede dyskinesier under behandling med Aripiprazole.
In clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
I kliniske forsøg, hvor Onsenal blev givet i op til 3 år til forebyggelse af spontane tarmpolypper, blev yderligere bivirkninger set (bivirkninger markeret med en stjerne ses hyppigere i disse forsøg end i forsøg ved gigtrelaterede sygdomme):
In clinical studies where Onsenal was taken for up to 3 years to prevent spontaneous colon polyps, the following additional side effects have been observed (side effects marked with an asterisk were more common in these studies than in arthritis studies):
I kliniske immunogenicitetsstudier med AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1) hos personer i alderen 18-60 år er følgende anti-hæmagglutinin (anti- HA)-antistofrespons set:
In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) in subjects 18-60 years old, the anti-haemagglutinin (anti-HA) antibody responses were as follows:
I kliniske immunogenisitetsstudier med AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 til personer i alderen 18-60 år er følgende anti-hæmagglutinin (anti-HA)- antistof set:
In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 in subjects aged 18-60 years the anti-haemagglutinin (anti- HA) antibody responses were as follows:
I kliniske interaktionsforsøg hos raske forsøgspersoner blev delamanid administreret alene (100 mg to gange dagligt) og sammen med tenofovir (300 mg dagligt) eller lopinavir/ritonavir (400/100 mg dagligt) i 14 dage og sammen med efavirenz i 10 dage (600 mg dagligt).
In clinical drug-drug interaction studies in healthy subjects, delamanid was administered alone (100 mg twice daily) and with tenofovir (300 mg daily) or lopinavir/ritonavir (400/100 mg daily) for 14 days and with efavirenz for 10 days (600 mg daily).
I kliniske interaktionsstudier påvirkede amlodipin ikke farmakokinetikken af atorvastatin, digoxin, warfarin eller  ciclosporin.
In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or  ciclosporin.
I kliniske interaktionsundersøgelser havde aprepitant ingen vigtig klinisk virkning på farmakokinetikken for ondansetron, granisetron eller hydrodolasetron (dolasetrons aktive metabolit).
In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).
I kliniske ITP-studier med eltrombopag blev tromboemboliske hændelser observeret ved lave og normale trombocyttal.
In eltrombopag clinical trials in ITP thromboembolic events were observed at low and normal platelet counts.
I kliniske multipel sklerosestudier er atrioventrikulært blok af 1. grad (forlænget PR-interval i ekg) registreret efter initiering af behandling hos 4,7 % af de patienter, der fik fingolimod 0,5 mg, hos 2,8 % af de patienter, der fik intramuskulært interferon beta-1a, og hos 1,6 % af de patienter, der fik placebo.
In multiple sclerosis clinical studies first-degree atrioventricular block (prolonged PR interval on ECG) was detected after treatment initiation in 4.7% of patients on fingolimod 0.5 mg, in 2.8% of patients on intramuscular interferon beta-1a, and in 1.6% of patients on placebo.
I kliniske optrapningsforsøg sås en effekt allerede ved en daglig dosis på 1,1 mg base (1,5 mg salt).
During dose escalation in three pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt).
I kliniske RA-forsøg blev op til 3 % af de voksne patienter testet seropositive mindst én gang i løbet af undersøgelsen for antistoffer, som er i stand til at neutralisere de biologiske effekter af anakinra.
In clinical trials in RA, up to 3% of adult patients tested seropositive at least once during the study for antibodies capable of neutralising the biologic effects of anakinra.
I kliniske RA-undersøgelser og erfaring efter markedsføringen har man observeret sjældne tilfælde af opportunistiske infektioner, herunder bl.a. svampe-, mykobakterielle, bakterielle og virale infektioner.
In clinical RA studies and post-marketing experience, rare cases of opportunistic infections have been observed and included fungal, mycobacterial, bacterial, and viral pathogens.
I kliniske registreringsstudier var forekomsten af cholecystitis 0,5%.
In clinical registrational studies the incidence of cholecystitis was 0.5%.
I kliniske SAA-studier med eltrombopag blev 4 % af patienterne (5/133) diagnosticeret med MDS.
In clinical trials with eltrombopag in SAA, 4% of patients (5/133) were diagnosed with MDS.
I kliniske studer er der rapporteret 8 tilfælde af PRES.
Across clinical trials, 8 cases of PRES have been reported.
I kliniske studie af SUTENT og fra erfaringer efter markedsføring er der set kramper hos forsøgspersoner med eller uden radiologisk evidens på metastaser i hjernen.
In clinical studies of sunitinib and from post-marketing experience, seizures have been observed in subjects with or without radiological evidence of brain metastases.
I kliniske studier af 24 til 52 ugers varighed fik sammenlagt 915 personer med svær refraktær eosinofil astma enten en subkutan eller en intravenøs dosis mepolizumab.
A total of 915 subjects with severe refractory eosinophilic asthma have received either a subcutaneous or an intravenous dose of mepolizumab during clinical studies of 24 to 52 weeks duration.
I kliniske studier af 63 pædiatriske patienter mellem 0 til 12 år og 24 unge mellem 12 og 18 år med svær hæmofili A, blev der ikke observeret nogen forskel i sikkerhedsprofilen af NovoEight mellem pædiatriske patienter og voksne.
In clinical studies involving 63 paediatric patients between 0 and 12 years of age and 24 adolescents between 12 and 18 years of age with severe haemophilia A no difference in the safety profile of NovoEight was observed between paediatric patients and adults.
I kliniske studier af Abilify Maintena er der ikke rapporteret om bivirkninger, som var forbundet med tilfælde af overdosering.
No cases of overdose associated with adverse reactions were reported in clinical studies with Abilify Maintena.
I kliniske studier af aripiprazol er der ikke set nogen signifikante forskelle i incidensen af hyperglykæmirelaterede bivirkninger (herunder diabetes) eller i abnorme glykæmiske laboratorieværdier sammenholdt med placebo.
In clinical trials with aripiprazole, there were no significant differences in the incidence rates of hyperglycaemia-related adverse reactions (including diabetes) or in abnormal glycaemia laboratory values compared to placebo.
I kliniske studier af Crohns sygdom udviklede færre end 3% af de patienter, der blev behandlet med ustekinumab, antistoffer mod ustekinumab.
In Crohn’s disease clinical studies, less than 3% of patients treated with ustekinumab developed antibodies to ustekinumab.
I kliniske studier af denne population blev der anvendt ribavirin og interferon alfa-2b i doser på henholdsvis 15 mg/kg/dag og 3 millioner internationale enheder (MIE)/m2 tre gange ugenligt (Tabel 1).
In clinical studies performed in this population ribavirin and interferon alfa-2b were used in doses of 15 mg/kg/day and 3 million international units (MIU)/m2 three times a week respectively (Table 1).
I kliniske studier af en varighed på op til to år reducerede pioglitazon totalplasmatriglycerider og frie fedtsyrer og forøgede HDL-kolesterolniveauet sammenlignet med placebo, metformin eller gliclazid.
In clinical trials of up to two years duration, pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels compared to placebo, metformin or gliclazide.
I kliniske studier af Genvoya forekom stigningen i serum-kreatinin ved uge 2 af behandlingen, og den forblev stabil til og med uge 96.
In clinical studies of Genvoya, increases in serum creatinine occurred by Week 2 of treatment and remained stable through 96 weeks.
I kliniske studier af hypertensive patienter havde aliskiren ingen klinisk signifikant virkning på total kolesterol, HDL- kolesterol, fastende triglycerider, fastende glukose eller urinsyre.
In clinical studies in hypertensive patients, aliskiren had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
I kliniske studier af hypertensive patienter havde aliskiren ingen klinisk signifikant virkning på total kolesterol, HDL-kolesterol, fastende triglycerider, fastende glukose eller urinsyre.
In clinical studies in hypertensive patients, aliskiren had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
I kliniske studier af hypertensive patienter havde Enviage ingen klinisk signifikant virkning på total kolesterol, HDL-kolesterol, fastende triglycerider, fastende glukose eller urinsyre.
In clinical studies in hypertensive patients, Enviage had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
I kliniske studier af hypertensive patienter havde Riprazo ingen klinisk signifikant virkning på total kolesterol, HDL-kolesterol, fastende triglycerider, fastende glukose eller urinsyre.
In clinical studies in hypertensive patients, Riprazo had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
I kliniske studier af hypertensive patienter havde Tekturna ingen klinisk signifikant virkning på total kolesterol, HDL-kolesterol, fastende triglycerider, fastende glukose eller urinsyre.
In clinical studies in hypertensive patients, Tekturna had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
I kliniske studier af mere end 2 års varighed med 351 patienter me ankyloserende spondylitis blev der rapporteret om 6 maligniteter hos patienter behandlet med Enbrel.
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in Enbrel-treated patients.