natgillin/translations-raw huggingface dataset:
I et åbent, komparativt multicenterstudie, der sammenlignede voriconazol med itraconazol til primær profylakse hos voksne og unge, der har fået en allogen HSCT, uden forudgående påvist eller sandsynlig invasiv svampeinfektion, blev der rapporteret permanent seponering af voriconazol på grund af bivirkninger hos 39,3% af forsøgspersonerne i forhold til 39,6% af forsøgspersonerne i itraconazol-armen.
In an open-label, comparative, multicenter study comparing voriconazole and itraconazole as primary prophylaxis in adult and adolescent allogeneic HSCT recipients without prior proven or probable IFI, permanent discontinuation of voriconazole due to AEs was reported in 39.3% of subjects versus 39.6% of subjects in the itraconazole arm.
I et åbent, randomiseret studie fik 399 tidligere ubehandlede, ældre patienter (60 – 80 år) med diffust storcellet B-celle lymfom standard-CHOP kemoterapi (cyklophosphamid 750 mg/m2, doxorubicin 50 mg/m2, vinkristin 1,4 mg/m2 op til maksimalt 2 mg på dag 1 og prednison 40 mg/m2 på dag 1-5) hver 3. uge i 8 serier eller MabThera 375 mg/m2 plus CHOP (R-CHOP).
In a randomised, open-label trial, a total of 399 previously untreated elderly patients (age 60 to 80 years) with diffuse large B cell lymphoma received standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for eight cycles, or MabThera 375 mg/m2 plus CHOP (R-CHOP).
I et åbent, randomiseret studie var der ingen statistisk signifikante forskelle mellem voksne patienter, der blev behandlet i 52 uger med 0,2 mg/kg intravenøst hver anden uge (n = 20), og voksne patienter, der blev behandlet med 0,2 mg/kg én gang om ugen (n = 19), hvad angår den gennemsnitlige ændring i forhold til VVMI ved baseline eller andre effektmål (hjertefunktionsstatus, nyrefunktion og farmakodynamisk aktivitet).
In an open-label randomised study, there were no statistically significant differences between adult patients treated for 52 weeks with 0.2 mg/kg intravenously every other week (n=20) and those treated with 0.2 mg/kg weekly (n=19) in mean change from baseline LVMI or other endpoints (cardiac functional status, renal function, and pharmacodynamic activity).
I et åbent, randomiseret, klinisk studie (GS-01-934) med antiretroviral-naive patienter blev der foretaget genotypebestemmelser på plasma-hiv 1-isolater fra alle patienter med bekræftet hiv-RNA > 400 kopier/ml ved uge 48, 96 eller 144 eller på tidspunktet for tidlig seponering af forsøgsmedicinen.
In vivo:In an open-label randomised clinical study (GS-01-934) in antiretroviral-naïve patients, genotyping was performed on plasma HIV-1 isolates from all patients with confirmed HIV RNA > 400 copies/ml at weeks 48, 96 or 144 or at the time of early study drug discontinuation.
I et åbent, udvidet sikkerhedsstudie fortsatte 58 pædiatriske patienter fra ovenstående studie (i alderen fra 4 år ved studiestart) med at få Enbrel i op til 10 år.
In an open-label, safety extension study, 58 paediatric patients from the above study (from the age of 4 years at time of enrollment) continued to received Enbrel for up to 10 years.
I et ”crossover-studie” med 60 raske frivillige fandt man identiske intracellulære lamivudin-TP farmakokinetiske parametre (AUC24,ss og Cmax24,ss) eller lavere værdier (Ctrough – 24 %) ved behandling med lamivudin 300 mg én gang daglig sammenlignet med behandling med lamivudin 150 mg 2 gange daglig.
In a crossover study in 60 healthy volunteers, intracellular lamivudine-TP pharmacokinetic parameters were similar (AUC24,ss and Cmax24,ss) or lower (Ctrough – 24%) for the lamivudine 300 mg once daily regimen compared to the lamivudine 150 mg twice daily regimen.
I ethvert land, hvor Aubagio bliver markedsført, skal MAH efter diskussion og enighed med de nationale myndigheder sikre, at alle sundhedspersoner, som forventes at anvende Aubagio, i forbindelse med markedsføring og efter markedsføring får udleveret følgende materialer:
The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where Aubagio is marketed, at launch and after launch, all healthcare professionals who are expected to use Aubagio are provided with the following items:
I EU er lægemidler indeholdende mercaptopurin i tabletform alle- rede i mange år blevet anvendt til behandling af ALL.
Medicines containing mercaptopurine in tablet form have been already used in the EU for many years to treat patients with ALL.
I EU-hovedundersøgelsen var Broadline 86-87 % effektivt over for voksne lopper i hele 30-dages perioden efter behandlingen, mod 76-82 % for katte, der kun var blevet behandlet med fipronil og (S)- methopren.
The main EU study showed effectiveness of 86 to 87% against adult fleas for Broadline throughout the 30 day post-treatment period compared with between 76 and 82% for the cats treated with just fipronil and (S)-methoprene.
I EU-ormeundersøgelsen var både Broadline og sammenligningsproduktet næsten 100 % effektivt mod bændelorm og rundorm.
The EU worm study showed almost 100% effectiveness against tapeworms and roundworms for both Broadline and the comparator product.
I euglykæmiske clamp-forsøg på raske forsøgspersoner og type 1-diabetikere var tidspunktet for virkningens indtræden af subkutant insulin glargin langsommere end ved humant NPH insulin, og virkningsprofilen var jævn og uden koncentrationstoppe, og virkningens varighed var forlænget.
In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was smooth and peakless, and the duration of its effect was prolonged.
I euglykæmiske clamp-forsøg på raske forsøgspersoner og type 1-diabetikere var tidspunktet for virkningens indtræden af subkutant insulin glargin langsommere end ved humant NPH insulin, virkningsprofilen var jævn og uden koncentrationstoppe, og virkningens varighed var forlænget.
In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was smooth and peakless, and the duration of its effect was prolonged.
I EURIDIS og ADONIS blev sammenlagt 1237 patienter med tidligere AF eller AFL randomiseret ambulant og behandlet med enten dronedaron 400 mg to gange daglig (n= 828) eller placebo (n= 409) foruden konventionel behandling (inklusive orale antikoagulantia, betablokkere, ACE-hæmmere eller AIIRA’er, kronisk antitrombotika, diuretika, statiner, digitalis og calciumantagonister).
In EURIDIS and ADONIS, a total of 1,237 patients with a prior episode of AF or AFL were randomised in an outpatient setting and treated with either dronedarone 400 mg twice daily (n = 828) or placebo (n = 409) on top of conventional therapies (including oral anticoagulants, beta-blockers, ACE inhibitors or AIIRAs, chronic antiplatelet agents, diuretics, statins, digitalis, and calcium antagonists).
I Europa anslås det, at disse er ansvarlige for mellem 56 % og 90 % af alle tilfælde af invasiv sygdom forårsaget af S. pneumoniae hos børn under fem år.
In Europe, it is estimated that these are responsible for about 56 to 90% of the cases of invasive disease caused by S. pneumoniae in children under the age of five years.
I Europa anslås det, at disse er ansvarlige for mellem 73 og 100 % af tilfældene af invasiv sygdom hos børn under fem år og mindst 50-76 % af tilfælde af invasiv sygdom hos voksne, afhængigt af det pågældende land.
In Europe, it is estimated that these are responsible for between 73 and 100% of the cases of invasive disease in children under the age of five years, and at least 50 – 76% of the cases of invasive disease in adults, depending on the country.
I Europa var prævalensen lavere; 19% (73/377) hos patienter med HCV- genotype 1a og 0,3% (3/877) hos patienter med HCV-genotype 1b.
In Europe, the prevalence was lower, 19% (73/377) in patients with HCV genotype 1a and 0.3% (3/877) in genotype 1b.
I ex vivo-plasmaprøver fra patienter med kolorektalcancer ved steady-state- eksponering efter 300 mg én gang dagligt var den gennemsnitlige procentvise proteinbinding 93,7 % (i området 92,2 til 95,7%).
In ex vivo plasma samples from colorectal cancer patients at steady state exposure after 300 mg once daily, the mean percentage protein binding was 93.7% (range 92.2 to 95.7%).
I ex vivo-plasmaprøver fra patienter med kolorektalcancer ved steady-state- eksponering efter 300 mg én gang dagligt var den gennemsnitlige procentvise proteinbinding 93,7% (i området 92,2 til 95,7%).
In ex vivo plasma samples from colorectal cancer patients at steady state exposure after 300 mg once daily, the mean percentage protein binding was 93.7% (range 92.2 to 95.7%).
I exenatid opløsning til injektion-armen blev insulindosis øget med 13 enheder/dag sammenlignet med 20 enheder/dag for placebo-armen.
In the immediate-release exenatide arm the insulin dose increased by 13 units/day compared to 20 units/day on the placebo arm.
I Exjade EU RMP (V12) er risikoen for TEN blevet klassiferet som en vigtig identificeret risiko.
The risk of TEN has been classified as an important identified risk Exjade EU RMP (V12).
I Eylea-gruppen blev andelen af patienter med perfusion opretholdt til uge 52.
In the Eylea group the proportion of perfused patients was maintained through week 52).
i f.eks. hæmartrose, muskelblødning
i e.g. haemarthrosis, muscle haemorrhage
I F1 - afkommet var den gennemsnitlige kropsvægt ved samme dosisniveau reduceret fra fødsel til aflivning og antallet af kuld der opfyldte kriteriet for præputial separation var let nedsat.
In the F1 offspring, at the same dose level, mean body weights were reduced from birth until terminal sacrifice and the number of litters achieving criterion for preputial separation was slightly decreased.
I familier, hvor et familiemedlem havde influenza, blev der konstateret influenza hos 7 % af de familiemedlemmer i samme husstand, der fik Tamiflu, sammenlignet med 20 % af dem, der ikke fik forebyggende behandling.
In families with one flu patient, 7% of the family members in the household developed flu when receiving Tamiflu, compared with 20% of those receiving no preventative treatment.
I farmakodynamiske undersøgelser på kaniner og marsvin viste det sig, at thrombogeniciteten af Nonafact var minimal.
In pharmacodynamic studies in rabbits and guinea pigs, the thrombogenicity of Nonafact was shown to be minimal.
I farmakokinetiske studier med Corbilta var biotilgængeligheden af levodopa højere for kvinder end for mænd, hovedsageligt p.g.a. forskellen i kropsvægt, mens der ikke sås kønsforskelle med carbidopa og entacapon.
In the pharmacokinetic studies with Corbilta the bioavailability of levodopa is higher in women than in men, primarily due to the difference in body weight, while there is no gender difference with carbidopa and entacapone.
I farmakokinetiske studier med Levodopa/Carbidopa/Entacapone Orion var biotilgængeligheden af levodopa højere for kvinder end for mænd, hovedsageligt p.g.a. forskellen i kropsvægt, mens der ikke sås kønsforskelle med carbidopa og entacapon.
In the pharmacokinetic studies with Levodopa/Carbidopa/Entacapone Orion the bioavailability of levodopa is higher in women than in men, primarily due to the difference in body weight, while there is no gender difference with carbidopa and entacapone.
I farmakokinetiske studier med Stalevo var biotilgængeligheden af levodopa højere for kvinder end for mænd, hovedsageligt p.g.a. forskellen i kropsvægt, mens der ikke sås kønsforskelle med carbidopa og entacapon.
In the pharmacokinetic studies with Stalevo the bioavailability of levodopa is higher in women than in men, primarily due to the difference in body weight, while there is no gender difference with carbidopa and entacapone.
I fase 1-4-studier var de hyppigste bivirkninger, der blev rapporteret i forbindelse med DepoCyte, hovedpine (23 %), araknoiditis (16 %), feber (14 %), svaghed (13 %), kvalme (13 %), opkastning (12 %), konfusion (11 %), diarré (11 %), trombocytopeni (10 %) og træthed (6 %).
In Phase 1-4 studies the most commonly reported adverse reactions associated with DepoCyte were headache (23%), arachnoiditis (16%), pyrexia (14%), weakness (13%), nausea (13%), vomiting (12%), confusion (11%), diarrhoea (11%), thrombocytopenia (10%), and fatigue (6%).
I fase 1-studier er raske forsøgspersoner blevet givet enkeltdoser på op til 1.500 mg og kumulative doser på op til 4.500 mg i en periode på op til 8 uger uden tegn på toksicitet eller laboratorieafvigelser af klinisk betydning.
In Phase 1 studies, healthy volunteers have been administered single doses of up to 1500 mg, and cumulative doses up to 4500 mg over a period of up to 8 weeks, with no signs of toxicity or laboratory results of clinical concern.
I fase 2 og fase 3 kliniske studier blev generelle infektioner (ikke sårrelaterede, f.eks. urinvejsinfektioner, virale infektioner) rapporteret hyppigere i NexoBrid-gruppen (0,147 hændelser pr. patient) end i gruppen, der blev behandlet i henhold til SOC (0,079 hændelser pr. patient).
In phase 2 and phase 3 clinical studies general infections (not wound related. e.g. urinary tract infections, viral infections) were reported more frequently in the NexoBrid group (0.147 events per patient) than in the group treated according to SOC (0.079 events per patient).
I fase 2- og fase 3 kliniske studier blev der hyppigere rapporteret visse former for sårkomplikationer i NexoBrid-gruppen end i den gruppe, der blev behandlet i henhold til studiecentrenes standardbehandling (Standard of Care, SOC).
In phase 2 and phase 3 clinical studies, certain types of wound complications were reported more frequently in the NexoBrid group than in the group treated according to the study sites’ Standard of Care (SOC).
I fase 2/3 forsøg afbrød 9 ud af 2498 forsøgspersoner behandlingen med EXUBERA på grund af fald i lungefunktionen, og hvis FEV1 ved forsøgsafslutningen viste et fald på ≥ 15% i forhold til baseline.
In Phase 2/3 trials, 9 out of 2498 subjects treated with EXUBERA were discontinued from trials due to a decline in pulmonary function whose end of study FEV1 showed a decline of  15% from baseline.
I fase 2–studier var denne stigning dosisafhængig.
In Phase 2 studies, this increase was dose-dependent.
I fase 3 GIST-studiet forekom letal gastrointestinal blødning hos 0,98% af patienterne i placebogruppen.
Fatal gastrointestinal bleeding occurred in 0.98% of patients receiving placebo in the GIST phase 3 study.
I fase 3 pNET-studiet er der rapporteret om hypotyreose hos 6 patienter (7,2%), som fik sunitinib, og hos 1 patient (1,2%), som fik placebo.
In the phase 3 pNET study hypothyroidism was reported in 6 patients (7.2%) receiving sunitinib and in one patient (1.2%) on placebo.
I fase 3 pNET-studiet fik 1 (1%) patient, som fik sunitinib, behandlingsrelateret letalt hjertesvigt.
In the phase 3 pNET study, one (1%) patient who received sunitinib had treatment-related fatal cardiac failure.
I fase 3- studier anvendtes en sensitiv real-time PCR-analyse med en kvantificeringsgrænse på 25 IE/ml og en detektionsgrænse på 10-15 IE/ml til at bestemme, om HCV-RNA-niveauer var ikke-detekterbare (HCV-RNA ikke påvist) (se pkt.
In Phase 3 studies, a sensitive real-time PCR assay with a limit of quantification of 25 IU/ml and a limit of detection of 10-15 IU/ml was used to determine whether HCV RNA levels were undetectable (target not detected) (see section 5.1).
I fase 3-studier faldt middel-lymfocyttallet i gennemsnit med cirka 30% i forhold til baseline-værdien i løbet af det første år med Tecfiderabehandling med et efterfølgende plateau.
In Phase 3 studies, upon treatment with Tecfidera mean lymphocyte counts decreased on average by approximately 30% of their baseline value over the first year with a subsequent plateau.
I fase 3-studier har patienter fået enkeltdoser på op til 1.500 mg.
In Phase 3 studies, patients have been administered single doses of up to 1500 mg.
I fase 3-studierne havde 12 % af patienterne i gennemsnit højere antistoftitre.
On average in the phase 3 studies, 12 % of the patients had higher titre antibodies.
I fase 3-studiet 1199.13 (LUME-Lung 1) var hyppigheden af arterielle tromboemboliske hændelser sammenlignelig i de to behandlingsgrupper.
The frequency of arterial thromboembolic events was comparable between the two treatment arms in the phase 3 study 1199.13 (LUME-Lung 1).
I fase 3-studiet GS-US-236-0103 blev knoglemineraltætheden (BMD) vurderet hos en ikke- randomiseret undergruppe med 120 personer (Stribild-gruppe n = 54, gruppe med ritonavir-boosted atazanavir (ATV/r) plus emtricitabin/tenofovirdisoproxilfumarat (FTC/TDF) n = 66).
In the Phase 3 study GS-US-236-0103, bone mineral density (BMD) was assessed in a non-random subset of 120 subjects (Stribild group n = 54; ritonavir-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) group n = 66).
I fase 3-studiet med Humira hos patienter med pædiatrisk Crohns sygdom, der evaluerede effekten og sikkerheden af to vedligeholdelsesdosisregimer tilpasset legemsvægt (efter induktionsbehandling tilpasset legemsvægt) i op til 52 ugers behandling, forekom ALAT-stigninger ≥ 3 x ULN hos 2,6% (5/192) af patienterne, hvoraf 4 havde fået samtidig behandling med immunsuppressiva ved baseline.
In the Phase 3 trial of Humira in patients with paediatric Crohn’s disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
I fase 3-undersøgelsen fik patienterne dagligt tilskud af vitamin E, linolsyre, ALA, EPA og DHA.
In the Phase 3 trial, patients were provided daily dietary supplements of vitamin E, linoleic acid, ALA, EPA and DHA.
I fase I doseringsundersøgelser i patienter med mild til moderat tumorindiceret hyperkalcæmi (TIH), var den afprøvede effektive dosis cirka 1,2–2,5 mg.
In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2–2.5 mg.
I fase I-studier hos raske personer lå inter-individ-variabiliteten (CVb%) for AUC og Cmax i intervallet ~20-40 % og C i intervallet 30-65 % på tværs af studierne.
In Phase I studies in healthy subjects, between-subject CVb% for AUC and Cmax ranged from ~20 to 40% and C from 30 to 65% across studies.
I fase I-undersøgelser af farmakokinetik iagttoges proportionalt stigende plasmakoncentrationer af idebenon ved doser fra 150 mg til 1 050 mg.
In phase I pharmacokinetic studies, proportional increases in plasma concentrations of idebenone were observed for doses from 150 mg to 1050 mg.
I fase I/II-studiet satte virkningen af Ilaris-behandlingen hurtigt ind, således at symptomerne forsvandt eller bedredes klinisk signifikant inden for en dag efter dosering.
In the Phase I/II study, treatment with Ilaris had a rapid onset of action, with disappearance or clinically significant improvement of symptoms within one day after dosing.
I fase II var alle 148 patienter i behandling med lenalidomid.
In the Phase II, all 148 patients were on lenalidomide treatment.
I fase II- hovedforsøget var muskelspasmer de mest almindelige “muskelrelaterede” bivirkninger og blev indberettet hos færre patienter i gruppen, der fik Odomzo 200 mg (54 %), end i gruppen, der fik Odomzo 800 mg (69 %).
In the phase II pivotal study muscle spasms were the most common “muscle-related” adverse events, and were reported in fewer patients in the Odomzo 200 mg group (54%) than in the Odomzo 800 mg group (69%).
I fase II-hovedforsøget blev ingen indberettede rhabdomyolysetilfælde bekræftet (defineret som CK-værdier
In the phase II pivotal study, no reported cases of rhabdomyolysis were confirmed (defined as CK levels
I fase II-studierne var forekomsten af ILD 6,2 % hos patienter af japansk etnicitet, 1,2 % hos patienter af ikke-japansk asiatisk etnicitet og 2,4 % hos ikke-asiatiske patienter.
In the Phase II studies, the incidence of ILD was 6.2% in patients of Japanese ethnicity, 1.2% in patients of non-Japanese Asian ethnicity and 2.4% in non-Asian patients.
I fase III FLAGS forsøget var der intet åbenbart forhold mellem AUC for 5-FU (Teysuno/cisplatin- armen) og koncentrationen af 5-FU (5-FU/cisplatin-armen) under behandlingsforløb 1 og effektresultaterne af den samlede overlevelse eller progressionsfri overlevelse.
In the Phase III FLAGS study, there was no apparent relationship between 5-FU AUC (Teysuno/cisplatin arm) and 5-FU concentration (5-FU/cisplatin arm) during Cycle 1 and efficacy outcomes of overall survival (OS) or progression-free survival (PFS).
I fase III forsøgene var ACR responsraterne for leflunomid 20 mg daglig versus placebo 54,6% versus 28,6% (forsøg MN301) og 49,4% versus 26,3% (forsøg US301).
In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6 % versus 28.6 % (study MN301), and 49.4 % versus 26.3 % (study US301).After 12 months with active treatment, the ACR response rates in leflunomide patients were
I fase III forsøgene var ACR responsraterne for leflunomid 20 mg daglig versus placebo 54,6% versus.
In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% vs.
I fase III forsøgene var ACR responsraterne for leflunomid 20 mg daglig vs. placebo 54,6 % vs.
In the phase III trials, the ACR response rates for leflunomide 20 mg/day vs. placebo were 54.6 % vs.
I fase III forsøgene var ACR responsraterne for leflunomid 20 mg daglig vs. placebo 54,6% vs.
In the phase III trials, the ACR response rates for leflunomide 20 mg/day vs. placebo were 54.6 % vs.
I fase III forsøgene var ACR-responsraterne for leflunomid 20 mg daglig versus placebo 54,6% versus 28,6% (forsøg MN301) og 49,4% versus 26,3% (forsøg US301).
In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% versus 28.6% (study MN301), and 49.4% versus 26.3% (study US301).After
I fase III IMpact-RSV- studiet med præmature børn og børn med bronkopulmonal dysplasi var andelen af børn, som fik de sædvanlige børnevaccinationer, influenzavaccination, bronkodilatatorer eller kortikosteroider, ens i placebo- og palivizumabgrupperne, og der blev ikke observeret en merstigning i bivirkninger hos børn, der fik disse lægemidler.
In the phase III IMpact-RSV study in the premature and bronchopulmonary dysplasia paediatric populations, the proportions of patients in the placebo and palivizumab groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.
I fase III RESIST-studierne var frekvensen af forhøjet aminotransferase signifikant forøget i tipranavir med ritonavir-gruppen sammenlignet med komparatorgruppen.
In Phase III RESIST trials, the frequency of transaminase elevations was significantly increased in the tipranavir with ritonavir arm compared to the comparator arm.
I fase III-dosisoptimeringsstudiet med patienter med CML i fremskreden fase og Ph+ ALL var den mediane behandlingsvarighed 14 måneder for CML i fremskreden fase, 3 måneder for CML i myeloid blastfase, 4 måneder for CML i lymfoid blastfase og 3 måneder for Ph+ ALL.
In the Phase III dose-optimisation study in patients with advanced phase CML and Ph+ ALL, the median duration of treatment was 14 months for accelerated phase CML, 3 months for myeloid blast CML, 4 months for lymphoid blast CML and 3 months for Ph+ ALL.