natgillin/translations-raw huggingface dataset:
Ud af de 511 patienter, der fik ofatumumab i de kliniske studier, fik 300 patienter (59 %) en infektion.
Of the 511 patients receiving ofatumumab in clinical trials, 300 patients (59%) experienced an infection.
Ud af de 511 patienter, der fik ofatumumab i de kliniske studier, fik 300 patienter (59 %) infektion.
Of the 511 patients receiving ofatumumab in clinical trials, 300 patients (59%) experienced an infection.
Ud af de 52 identificerede patienter var der 36 patienter i CP CML-underpopulationen (21 havde tidligere fået 2 TKI'er, og 15 tidligere fået en TKI).
Of the 52 patients identified, 36 patients were in the CP CML subpopulation (21 who had previously received 2 prior TKIs and 15 who had received 1 prior TKI).
Ud af de 59 patienter, behandlet med Naglazyme i de kliniske studier, blev 54 testet for IgG- antistoffer.
Out of the 59 patients treated with Naglazyme in the clinical studies, 54 were tested for IgG antibodies.
Ud af de 611 patienter, som blev behandlet med ZALTRAP/FOLFIRI-regimet i det pivotale studie med mCRC-patienter, var 172 (28,2 %) i alderen ≥65 og <75, og 33 (5,4 %) var ≥75.
Of the 611 patients treated with the ZALTRAP/FOLFIRI regimen in the pivotal study of MCRC patients, 172 (28.2%) were aged ≥65 and <75 and 33 (5.4%) were age ≥75.
Ud af de 681 patienter (78 %), der oplevede diarré, havde 665 patienter lægemiddelrelateret diarré, og 8 patienter seponerede bosutinib på grund af diarré.
Of the 681 (78%) patients that experienced diarrhoea, 665 patients had drug-related events of diarrhoea and 8 patients discontinued bosutinib due to this event.
ud af de 77 patienter, der var randomiseret til gruppen med standardbehandling, fik ingen standardbehandling.
Of the 77 subjects randomised to the SOC group, two subjects did not receive any SOC.
Ud af de 94 forsøgspersoner, som rapporterede en alvorlig bivirking, var 14/55 (25,5%) forsøgspersoner i lavdosis-gruppen, 35/74 (47%) i middeldosis-gruppen og 45/100 (45%) i højdosis- gruppen.
Of the 94 subjects reporting a serious adverse event, 14/55 (25.5%) subjects were in the low dose group, 35/74 (47.3%) in the medium dose group, and 45/100 (45%) in the high dose group.
Ud af de CP-CML-patienter, som tidligere blev behandlet med én, to, tre eller fire tidligere TKI'er, opnåede hhv.75 % (12/16), 67 % (66/98), 45 % (64/141) og 58 % (7/12) et MCyR under behandling med Iclusig.
Of the CP-CML patients previously treated with one, two, three or four prior TKIs, 75% (12/16), 67% (66/98), 45% (64/141), and 58% (7/12)) achieved a MCyR while on Iclusig, respectively.
Ud af de i alt 435 patienter i studiet, var 233 af patienterne ikke tidligere behandlet (behandlingsnaive), og 202 af patienterne var tidligere behandlet med cytokiner (IL-2- eller INFα- baseret behandling).
From the total of 435 patients in this study, 233 patients were treatment naïve and 202 were second line patients who received one prior IL-2 or INF-based therapy.
Ud af de patienter, der nåede målet, havde 90 % et program med dosering 3 gange om ugen.
Of the patients who achieved the target, 90% did so on a 3 times-per-week dosing regimen.
Ud af de tre tilfælde, der svarede til LSCD, blev der for det ene rapporteret positiv dechallenge og ingen andre samtidige lægemidler eller komorbiditeter.
Of the 3 cases consistent with LSCD, one case reported a positive dechallenge and no other concomitant drugs or comorbidity.
Ud af det samlede antal forsøgspersoner i kliniske studier med Velphoro var 29,7 % 65 år og derover, mens 8,7 % var 75 år og derover.
Of the total number of subjects in clinical studies of Velphoro, 29.7 % were aged 65 and over, while 8.7% were aged 75 and over.
Ud af det samlede antal kvinder i kliniske fase-III studier, der fik konjugeret østrogen/bazedoxifen 20 mg, var 2,4 % (n=77) ≥ 65 år.
Of the total number of women in Phase 3 clinical trials who received CE/bazedoxifene 20 mg, 2.4% (n=77) were aged ≥65 years.
Ud af disse 15 patienter med udækket medicinsk behov, som forinden havde fået imatinib alene, var der 9 patienter, der responderede på Bosulif-behandlingen med MCyR eller bedre, herunder 3 patienter med CMR, 1 patient med MMR, 4 patienter med CCyR og 1 patient med PCyR med en varighed af MCyR, der varierede fra 12 til 155 uger, og med en behandlingsvarighed, der varierede fra 24 til >197 uger.
Of these 15 patients with unmet medical need who had received prior imatinib only, patients had a response on Bosulif treatment of MCyR or better, including 3 patients with CMR, 1 patient with MMR, 4 patients with CCyR, and 1 patients with PCyR with a duration of MCyR ranging from 12 to 155 weeks and a treatment duration ranging from 24 to 197+ weeks.
Ud af disse 517 patienter havde 159 patienter (HBeAg- positive=135, HBeAg-negative=24) målbart HBV-DNA.
Out of these 517 patients 159 patients (HBeAg-positive=135, HBeAg-negative=24) had detectable HBV DNA.
Ud af disse 692 patienter fik 613 (300 atazanavir/cobicistat og 313 atazanavir/ritonavir) og 496 (250 atazanavir/cobicistat og
Of these 692 patients, 613 (300 atazanavir/cobicistat and 313 atazanavir/ritonavir) and 496 (250 atazanavir/cobicistat and
Ud af disse blev 3.671 patienter eksponeret for Cosentyx i mindst et år, svarende til eksponering i 6.450 patientår.
Of these, 3,671 patients were exposed to Cosentyx for at least one year, representing 6,450 patient years of exposure.
Ud af disse havde 6 (40%) normaliseret LVM ved studiets afslutning.
Of these 6 (40%) had normalised LVM by the end of the study.
Ud af disse hændelser er 40,5 % af hændelserne i Stivarga-armen og 66,7 % i placeboarmen blevet rapporteret som ikke helbredt / ikke afklaret.
Of these events, 40.5% in the Stivarga arm and 66.7% in the placebo arm have been reported as not recovered / not resolved.
Ud af disse opnåede 28 patienter (93 %) en reduktion i parenteral støtte på 20 % eller derover.
Of these, 28 patients (93%) achieved a 20% or greater reduction of parenteral support.
Ud af disse patienter mobiliserede 100 % (7 ud af 7) ≥ 2 x106/kg CD34+ celler og gennemgik transplantation med vellykket resultat.
Of these patients, 100% (7 out of 7) mobilised ≥ 2 x106/kg CD34+ cells and had successful engraftment.
Ud af disse patienter mobiliserede 55 % (34 ud af 62) ≥ 2 x106/kg CD34+ celler og gennemgik transplantation med vellykket resultat.
Of these patients, 55 % (34 out of 62) mobilised ≥ 2 x106/kg CD34+ cells and had successful engraftment.
Ud af disse patienter opnåede 12 % et PASI-75-respons efter uge 52 med apremilast plus topikal behandling og/eller lysbehandling.
Of these patients, 12% achieved a PASI-75 response at Week 52 with apremilast plus topical and/or phototherapy treatment.
Ud af disse patienter var 1.139 ≥ 65 år, hvoraf 115 var ≥ 75 år.
Of these, 1,139 were ≥ 65 years of which 115 were ≥ 75 years.
Ud af disse patienter var de fleste unge eller unge voksne mænd og de fleste havde enten Crohns sygdom eller colitis ulcerosa.
Of these patients, most were adolescent or young adult males and most had either Crohn’s disease or ulcerative colitis.
Ud af disse var 12 spontane rapporter detaljerede nok til at en fuld evaluering kunne laves og rapporterne omfattede 13 bivirkninger i urinvejene: 8 alvorlige tilfælde af urinretention, 2 alvorlige tilfælde af obstruktion af urinvejene, 2 ikke alvorlige tilfælde af nedsat vandladningskraft og 1 nedsat hyppighed af vandladning.
From those, a total of 12 spontaneous case reports were considered detailed enough to perform a full evaluation, and they comprised 13 urinary adverse events: 8 serious events of urinary retention, 2 serious events of urinary tract obstruction reported, 2 non-serious cases of urine flow decreased and 1 micturition frequency decreased.
Ud af i alt 123 patienter døde 26; alle dødsfald kunne enten tilskrives en komplikation i forbindelse med den oprindelige hændelse eller komorbiditeter.
Of the total 123 patients, 26 patients died; each of these deaths could be attributed either as a complication of the index event or associated with co-morbidities.
Ud af i alt 3.262 personer i 23 randomiserede, dobbeltblinde kontrollerede studier med placebo eller standardbehandling blev den samlede sikkerhedsprofil for epoetin alfa evalueret hos 1.992 personer med anæmi.
Of a total 3,262 subjects in 23 randomised, double-blinded, placebo or standard of care controlled studies, the overall safety profile of epoetin alfa was evaluated in 1,992 anaemic subjects.
Ud af patienterne med mindst et PASI-50-respons, der igen blev randomiseret til placebo efter uge 32, var 24,2 % PASI-50-responders efter uge 52.
Of the patients with at least a PASI-50 response who were re-randomized to placebo at Week 32, 24.2% were PASI-50 responders at Week 52.
Ud af patienterne med mindst et PASI-75-respons, der igen blev randomiseret til placebo efter uge 32 i løbet af en randomiseret seponeringsfase af behandlingen, var 11,7 % PASI-75-responders efter uge 52.
Of the patients with at least a PASI-75 response who were re-randomized to placebo at Week 32 during a Randomized Treatment Withdrawal Phase, 11.7% were PASI-75 responders at Week 52.
Ud fra antallet af rapporterede tilfælde af hikke ved (primært oral) administration af aripiprazol, ud fra tidspunktet, hvor hikken opstår efter påbegyndelse af aripiprazol-behandlingen, samt på baggrund af de mange rapporter om positiv seponering og positiv geneksponering synes der at være en vis grad af årsagssammenhæng mellem aripiprazol-eksponering og hikke.
Considering the number of case reports of hiccups with aripiprazole (primarily oral formulation), the time to onset of hiccups from the start of the aripiprazole therapy, several reports of positive dechallenge and of positive rechallenge, there appears to be some degree of causal association between aripiprazole exposure and hiccups.
Ud fra Benlystas farmakologi forventes ingen påvirkning af evnen.
No detrimental effects on such activities are predicted from the pharmacology of Benlysta.
Ud fra blodprøveresultater har Deres læge vurderet, at De har behov for Aranesp, fordi Deres hæmoglobinkoncentration er på 10 g/dl (6,2 mmol/l) eller derunder.
Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 10 g/dl or less.
Ud fra de kliniske undersøgelser og data efter markedsføringen er der ikke noget, der tyder på, at sikkerhedsprofilen er forskellig i forskellige undergrupper af den pædiatriske population eller forskellig fra sikkerhedsprofilen hos voksne patienter.
From clinical study and post marketing data there are no indications that the safety profile is different in different subsets of the paediatric population or different from the safety profile in adult patients.
Ud fra de tre studier med aktiv komparator, blev risikoen for en KOL-eksacerbation reduceret med 50 % i et studie (HR 0,5, p = 0,044) sammenlignet med tiotropium og øget med 20 % og 90 % i to studier (HR 1,2, p = 0,709 og HR 1,9, p = 0,062).
From the three active-comparator studies, the risk of a COPD exacerbation compared with tiotropium was reduced by 50% in one study (HR 0.5, p=0.044) and was increased by 20% and 90% in two studies (HR 1.2, p=0.709 and HR 1.9, p=0.062 respectively).
Ud fra den beregnede mængde ramucirumab fjernes den tilsvarende mængde 9 mg/ml (0,9 %) natriumchloridinjektionsvæske fra den forfyldte 250 ml intravenøse beholder.
Based on the calculated volume of ramucirumab, remove the corresponding volume of sodium chloride 9 mg/ml (0.9%) solution for injection from the prefilled 250 ml intravenous container.
Ud fra den beregnede mængde ramucirumab fjernes den tilsvarende mængde 9 mg/ml (0,9 %) natriumchloridinjektionsvæske fra den fyldte 250 ml intravenøse beholder.
Based on the calculated volume of ramucirumab, remove the corresponding volume of sodium chloride 9 mg/ml (0.9%) solution for injection from the prefilled 250 ml intravenous container.
Ud fra dets virkningsmekanisme og fund i dyrestudier kan Kyprolis beskadige fosteret, hvis det administreres til gravide kvinder.
Based on its mechanism of action and findings in animals, Kyprolis can cause foetal harm when administered to a pregnant woman.
Ud fra dette studie kan det således forventes, at Aptivus oral opløsning har samme interaktionsprofil som kapslerne.
Based on the results from this study, Aptivus oral solution might be expected to have a similar interaction profile as the capsules.
Ud fra disse resultater kan det konkluderes med 95 % konfidens at den sande forskel ikke større end 8,4 % til fordel for 2 gange daglig regimet.
From these results, it can be concluded with 95% confidence that the true difference is no greater than 8.4% in favour of the twice daily regimen.
Ud fra en evaluering af disse undersøgelser vil lægen afgøre, om De bør fortsætte med at bruge Thymanax eller ej (se også punkt 3, ’Sådan skal De tage Thymanax’).
Based on the evaluation of these tests your doctor will decide whether you should receive or continue using Thymanax (see also under “How to take Valdoxan” in section 3).
Ud fra en evaluering af disse undersøgelser vil lægen afgøre, om De bør fortsætte med at bruge Valdoxan eller ej (se også punkt 3, ’Sådan skal De tage Valdoxan’).
Based on the evaluation of these tests your doctor will decide whether you should receive or continue using Valdoxan (see also under “How to take Valdoxan” in section 3).
Ud fra en immunologisk ekstrapolation af det funktionelle vaccinerespons (OPA) af Synflorix med 11- valent-formuleringen, som blev anvendt i POET-studiet, forventes det, at Synflorix har tilsvarende effekt ved beskyttelse mod AOM, der er forårsaget af pneumokokker.
Based on immunological bridging of the functional vaccine response (OPA) of Synflorix with the 11- valent formulation used within POET, it is expected that Synflorix provides similar protective efficacy against pneumococcal AOM.
Ud fra en klinisk undersøgelse af patienter med AIDS-KS, hvor Caelyx er sammenlignet med en anden behandling (bleomycin/vincristine), kan der være en højere risiko for visse infektioner med Caelyx.
From a clinical study in patients with AIDS-KS comparing Caelyx against another treatment (bleomycin/vincristine), there may be a higher chance of some infections with Caelyx.
Ud fra en mikrobiologisk betragtning bør lægemidlet infunderes eller fortyndes og infunderes umiddelbart efter åbning.
From a microbiological point of view, once opened, the medicinal product should be infused or diluted and infused immediately.
Ud fra en mikrobiologisk synsvinkel bør præparatet anvendes hurtigst muligt efter fortynding.
From a microbiological point of view, the product should be used as soon as possible after dilution.
Ud fra en neurokognitiv og udviklingsmæssig vurdering blev der ikke observeret en overordnet klinisk relevant negativ indvirkning på pædiatriske patienter i alderen 6 til 17 år efter behandling med aliskiren i op til et år.
No overall clinically relevant adverse impact in paediatric patients aged 6 to 17 years was observed after treatment with aliskiren for up to one year based on neurocognitive and developmental assessment.
Ud fra en neurokognitiv og udviklingsmæssig vurdering blev der ikke observeret en overordnet klinisk relevant negativ indvirkning på pædiatriske patienter i alderen 6 til 17 år efter behandling med aliskiren i op til et år.
No overall clinically relevant adverse impact on paediatric patients aged 6 to 17 years was observed after treatment with aliskiren for up to one year based on neurocognitive and developmental assessment.
Ud fra et mikrobiologisk synspunkt bør lægemidlet anvendes med det samme.
From a microbiological point of view, the medicine should be used immediately.
Ud fra et mikrobiologisk synspunkt bør produktet anvendes straks efter første anbrud eller umiddelbart efter fortynding.
From a microbiological point of view, the product should be used immediately after first opening or immediately after dilution.
Ud fra et mikrobiologisk synspunkt bør produktet anvendes straks efter rekonstitution.
From a microbiological point of view, the product should be used immediately after reconstitution.
Ud fra et mikrobiologisk synspunkt bør produktet anvendes straks.
From a bacteriological point of view, the product should be used immediately.
Ud fra et mikrobiologisk synspunkt bør produktet dog anvendes med det samme.
However, from a microbiological point of view the product should be used immediately.
Ud fra et mikrobiologisk synspunkt er brugeren ansvarlig for opbevaringstid og -betingelser efter anbrud, som normalt ikke bør overstige 28 timer ved 25 ºC.
From a microbiological point of view, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 28 days at 25C.
Ud fra et mikrobiologisk synspunkt skal den fortyndede infusionsvæske, opløsning, anvendes straks.
From a microbiological point of view, the diluted solution for infusion should be used immediately.
Ud fra et mikrobiologisk synspunkt skal den rekonstituerede og fortyndede opløsning til infusion anvendes straks.
From a microbiological point of view, the solution for infusion should be used immediately after dilution.
Ud fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning anvendes umiddelbart efter præparering.
From a microbiological point of view, the reconstituted solution should be used immediately after preparation.
Ud fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning til infusion anvendes straks.
From a microbiological point of view, the diluted solution for infusion should be used immediately.
Ud fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning til infusion anvendes.
From a microbiological point of view, the diluted solution for infusion should be used immediately.
Ud fra et mikrobiologisk synspunkt skal infusionsvæske, opløsning anvendes straks.
From a microbiological point of view, the solution for infusion should be used immediately.
Ud fra et mikrobiologisk synspunkt skal infusionsvæske, opløsning, anvendes straks efter første anbrud.
From a microbiological point of view, the solution for infusion should be used immediately, after first opening.
Ud fra et mikrobiologisk synspunkt skal lægemidlet anvendes straks.
From a microbiological point of view, the product must be used immediately.
Ud fra et mikrobiologisk synspunkt skal opløsningen anvendes straks efter genfortynding.
After reconstitution, from a microbiological point of view, the product should be used immediately.
Ud fra et mikrobiologisk synspunkt skal opløsningen til infusion anvendes straks efter åbning.
From a microbiological point of view, the diluted solution for infusion should be used immediately.
Ud fra et mikrobiologisk synspunkt skal produktet anvendes straks efter åbning.
From a microbiological point of view, the product should be used immediately.
Ud fra et mikrobiologisk synspunkt skal produktet bruges med det samme.
From a microbiological point of view, the product should be used immediately.
Ud fra et mikrobiologisk synspunkt skal produktet bruges umiddelbart efter, at det er opløst, men ikke mere end 3 timer efter rekonstituering.
From a microbiological point of view the product, once dissolved, should be used immediately, but no longer than 3 hours after reconstitution.
Ud fra et mikrobiologisk synspunkt skal præparatet anvendes straks.
From a microbiological point of view, the product should be used immediately.
Ud fra et mikrobiologisk synspunkt skal præparatet derfor bruges med det samme efter rekonsti- tuering.
From a microbiological point of view, once reconstituted, the product must be used immediately.
Ud fra et mikrobiologisk synspunkt skal Vistide bruges umiddelbart efter opblandingen.
From a microbiological point of view, the product must be used immediately.
Ud fra farmakokinetiske data for 68 patienter med forskellige grader af nedsat nyrefunktion (median kreatininclearance 19,2-126 ml/min) skønnes det, at den gennemsnitlige eksponering for idarucizumab (AUC0-24 h) øges med 26 % hos patienter med let nedsat nyrefunktion (CrCl 60-90 ml/min), med 78 % hos patienter med moderat nedsat nyrefunktion (30-60 ml/min) og med 199 % hos patienter med svært nedsat nyrefunktion (0-30 ml/min).
Based on pharmacokinetic data from 68 patients with different degrees of renal function (median creatinine clearance 19.2 - 126 mL/min) it is estimated that mean idarucizumab exposure (AUC0–24h) increases by 26% in patients with mild (CrCl 60-90 mL/min), by 78% in moderate (30-60 mL/min) and by 199% in severe (0-30 mL/min) renal impairment.
Ud fra foreliggende farmakodynamiske data, bør Agenerase bruges i kombination med mindst 2 andre antiretrovirale midler.
On the basis of current pharmacodynamic data amprenavir should be used in combination with at least two other antiretrovirals.
Ud fra in vitro-data er der mulighed for, at tedizolidphosphat hæmmer den organiske anion- transportprotein OATP1B1.
There is a potential for tedizolid phosphate to inhibit organic anion transporter (OATP1B1) based on in vitro data.
Ud fra in vitro-data er der mulighed for, at tedizolidphosphat hæmmer organisk anion-transportprotein OATP1B1.
There is a potential for tedizolid phosphate to inhibit organic anion transporter (OATP1B1) based on in vitro data.
Ud fra in vitro-resultater er der risiko for, at tedizolidphosphat kan have enzym-inducerende virkning.
Based on in vitro results, there is a risk for enzyme induction by tedizolid phosphate.
Ud fra in vitro-studier er det usandsynligt, at mirabegron hæmmer metabolismen af samtidigt administrerede lægemidler, der metaboliseres af følgende cytochrom P450-enzymer: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 og CYP2E1, eftersom mirabegron ikke hæmmede aktiviteten af disse enzymer ved klinisk relevante koncentrationer.
Based on in vitro studies, mirabegron is unlikely to inhibit the metabolism of co-administered medicinal products metabolized by the following cytochrome P450 enzymes: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP2E1 because mirabegron did not inhibit the activity of these enzymes at clinically relevant concentrations.
Ud fra kliniske studieresultater for lægemiddelinteraktion (f.eks. med escitalopram, zolpidem, ethinylestradiol) kan det ikke udelukkes, at telaprevir inducerer metaboliske enzymer.
Based on the results of drug-drug clinical interaction studies (e.g., escitalopram, zolpidem, ethinylestradiol), induction of metabolic enzymes by telaprevir cannot be excluded.
Ud fra koncentrationen af dabigatran og en klinisk evaluering blev dosis efterfølgende justeret til måldosis af dabigatranetexilat på 2,14 (± 10 %) mg/kg kropsvægt (100 % af voksendosis justeret i forhold til patientens vægt).
Based on dabigatran concentrations and clinical assessment, the dose was subsequently modified to a target dose of 2.14 (± 10 %) mg/kg of dabigatran etexilate (100 % of the adult dose adjusted for the patient’s weight).
Ud fra litteratur cases, kan para-aminosalicylsyre være forbundet med en øget risiko for hypothyreoidisme hos HIV-smittede patienter.
Para-aminosalicylic acid may be associated with an increased risk of hypothyroidism in HIV co- infected patients.
Ud fra metaboliseringsvejen for GRANUPAS forventes ingen nævneværdig lægemiddelinteraktion.
Given the metabolic pathway of GRANUPAS no significant drug interaction is anticipated.
Ud fra observationer med andre alfa- og beta-interferoner kan en øget risiko for abort ikke udelukkes.
Based on observations with other alpha and beta interferons, an increased risk of abortions cannot be excluded.
Ud fra ofatumumabs farmakologi forventes ingen skadelig påvirkning af evnen til at føre motorkøretøj eller betjene maskiner.
No detrimental effects on such activities are predicted from the pharmacology of ofatumumab.
Ud fra pazopanibs farmakologi forudses ingen indvirkning på evnen til at føre motorkøretøj eller betjene maskiner.
A detrimental effect on such activities cannot be predicted from the pharmacology of pazopanib.