natgillin/translations-raw huggingface dataset:
Der sås ikke signifikant forskel på virkningen i ”nevirapin 2 gange daglig”-regimegruppen og efavirenzregimegruppen (p = 0,091) bedømt ud fra behandlingssvigt, eller tilfælde af behandlingssvigt, herunder virologisk svigt.
The nevirapine twice daily regimen and the efavirenz regimen were not significantly different (p= 0.091) in terms of efficacy as measured by treatment failure, or any component of treatment failure including virological failure.
Der sås ikke signifikant forskel på virkningen i ”nevirapin 2 gange daglig”regimegruppen og efavirenz-regimegruppen (p = 0,091) bedømt ud fra behandlingssvigt, eller tilfælde af behandlingssvigt, herunder virologisk svigt.
The nevirapine twice daily regimen and the efavirenz regimen were not significantly different (p=0.091) in terms of efficacy as measured by treatment failure, or any component of treatment failure including virological failure.
Der sås imidlertid ingen tegn på organsvigt ved kliniske undersøgelser eller i de kliniske, kemiske parametre.
However there was no evidence in the clinical observations and clinical chemistry parameters that indicated any loss in organ function.
Der sås ingen akkumulering for Cmax.
No accumulation for Cmax was observed.
Der sås ingen betydningsfulde forskelle i sikkerhedsprofilen mellem den ældre patientpopulation og patienter i alderen 18-65 år.
No meaningful differences in the safety profiles were observed between the elderly subject population and subjects 18 to 65 years of age.
Der sås ingen bivirkninger hos rotter, som fik en enkelt dosis på 1000 µg/kg, eller hos aber efter gentagen indgivelse af 500 µg/kg romiplostim (henholdsvis 100 eller 50 gange den maksimale kliniske dosis på 10 µg/kg).
No adverse effects were seen in rats given a single dose of 1000 μg/kg or in monkeys after repeated administration of romiplostim at 500 µg/kg (100 or 50 times the maximum clinical dose of 10 µg/kg, respectively).
Der sås ingen effekt på blodtrykket når nitroglycerin blev indtaget 24 timer efter administration af en enkelt dosis vardenafil på 20 mg filmovertrukne tabletter.
No effect on blood pressure was observed when nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg film-coated tablets.
Der sås ingen effekt på blodtrykket når nitroglycerin blev indtaget 24 timer efter administration af en enkelt dosis vardenafil på 20 mg.
No effect on blood pressure was observed when nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg film-coated tablet.
Der sås ingen effekt på blodtrykket, når glyceryltrinitrat blev indtaget 24 timer efter administration af en enkelt dosis vardenafil 20 mg filmovertrukken tablet.
No effect on blood pressure was observed when nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg film-coated tablet.
Der sås ingen effekt på fertiliteten hos rotter behandlet med amlodipin (hanner i 64 dage og hunner i 14 dage før parring) ved doser op til 10 mg/kg/dag (8 gange* den maksimalt anbefalede dosis til mennesker på 10 mg baseret på mg/m2).
There was no effect on the fertility of rats treated with amlodipine (males for 64 days and females 14 days prior to mating) at doses up to 10 mg/kg/day (8 times* the maximum recommended human dose of 10 mg on a mg/m2 basis).
Der sås ingen embryotoksicitet eller misdannelser efter intramuskulær administration af paliperidonpalmitat til drægtige rotter i op til den højeste dosis (160 mg/kg/dag) svarende til 4,1 gange eksponeringsniveauet hos mennesker ved den maksimale anbefalede dosis på 150 mg.
No embryotoxicity or malformations were observed following intramuscular administration of paliperidone palmitate to pregnant rats up to the highest dose (160 mg/kg/day) corresponding to 4.1 times the exposure level in humans at the maximum recommended dose of 150 mg.
Der sås ingen farmakokinetisk interaktion mellem rivaroxaban (15 mg) og clopidogrel (initialdosis på 300 mg efterfulgt af en vedligeholdelsesdosis på 75 mg), men hos en undergruppe af patienter blev der observeret en relevant forlængelse af blødningstiden, der ikke var korreleret med trombocytaggregation, P-selektin eller GPIIb-/IIIa-receptorniveauerne.
Clopidogrel (300 mg loading dose followed by 75 mg maintenance dose) did not show a pharmacokinetic interaction with rivaroxaban (15 mg) but a relevant increase in bleeding time was observed in a subset of patients which was not correlated to platelet aggregation, P-selectin or GPIIb/IIIa receptor levels.
Der sås ingen farmakokinetiske interaktioner mellem PegIntron og ribavirin i et flerdosis farmakokinetisk forsøg.
No pharmacokinetic interactions were noted between PegIntron and ribavirin in a multiple-dose pharmacokinetic study.
Der sås ingen fordel i forbindelse med Extavia med hensyn til livskvaliteten (som den er målt efter FAMS – Functional Assessment of MS: Treatment Outcomes Index).
No benefit, attributable to Extavia, in quality of life (as measured by FAMS – Functional Assessment of MS: Treatment Outcomes Index) was seen.
Der sås ingen fordele i forhold til livskvalitet (målt ved hjælp af FAMS – Functional Assessment of MS: Treatment Outcome Index), der kunne tilskrives tidlig Betaferon-behandling.
No benefit, attributable to immediate Betaferon treatment, in quality of life (as measured by FAMS - Functional Assessment of MS: Treatment Outcomes Index) was seen.
Der sås ingen fordele i forhold til livskvalitet (målt ved hjælp af FAMS – Functional Assessment of MS: Treatment Outcome Index), der kunne tilskrives tidlig Betaferon-behandling.
No benefit, attributable to immediate Betaferon treatment, in quality of life (as measured by FAMS – Functional Assessment of MS: Treatment Outcomes Index) was seen.
Der sås ingen forskel i antallet af vigtigste primære endepunkt- hændelser efter behandling med rosiglitazon (321/2220) over for den aktive kontrolgruppe (323/2227) (HR 0,99, CI 0,85-1,16), der lever op til det forud definerede non-inferiøritetskriterium på 1,20 (non-inferiøritet p = 0,02).
No difference in the number of adjudicated primary endpoint events for rosiglitazone (321/2220) versus active control (323/2227) (HR 0.99, CI 0.85-1.16) was observed, meeting the pre-defined non- inferiority criterion of 1.20 (non-inferiority p = 0.02).
Der sås ingen forskel i antallet af vigtigste primære endepunkt-hændelser efter behandling med rosiglitazon (321/2.220) over for den aktive kontrolgruppe (323/2.227) (HR 0,99, CI 0,85-1,16), der lever op til det forud definerede non-inferiøritetskriterium på 1,20 (non-inferiøritet p = 0,02).
No difference in the number of adjudicated primary endpoint events for rosiglitazone (321/2220) versus active control (323/2227) (HR 0.99, CI 0.85-1.16) was observed, meeting the pre-defined non- inferiority criterion of 1.20 (non-inferiority p = 0.02).
Der sås ingen forskel i antallet af vigtigste primære endepunkt-hændelser efter behandling med rosiglitazon (321/2220) over for den aktive kontrolgruppe (323/2227) (HR 0,99, CI 0,85-1,16), der lever op til det forud definerede non-inferiøritetskriterium på 1,20 (non-inferiøritet p = 0,02).
No difference in the number of adjudicated primary endpoint events for rosiglitazone (321/2220) versus active control (323/2227) (HR 0.99, CI 0.85-1.16) was observed, meeting the pre-defined non- inferiority criterion of 1.20 (non-inferiority p = 0.02).
Der sås ingen forskelle i behandlingen med ivacaftor versus placebo med undtagelse af CFQ-R-score for respirationssymptomer (forskellen i behandlingen til og med uge 24 med ivacaftor versus placebo var 8,4 [2,2, 14,6] points), og for den gennemsnitlige ændring fra baseline i sved- chlorid (se Farmakodynamisk virkning).
No treatment differences for ivacaftor versus placebo were observed except for the respiratory domain of the CFQ-R (the treatment difference through 24 weeks of ivacaftor versus placebo was 8.4 [2.2, 14.6] points) and for the mean change from baseline in sweat chloride (see Pharmacodynamic effects).
Der sås ingen forskelle i de farmakodynamiske egenskaber hos voksne og pædiatriske forsøgspersoner.
No differences were seen in the pharmacodynamic properties between adult and paediatric study patients.
Der sås ingen forskelle i de farmakodynamiske egenskaber hos voksne og ældre forsøgspersoner.
No differences were seen in the pharmacodynamic properties between adult and elderly study patients.
Der sås ingen forskelle i de farmakokinetiske parametre mellem voksne og pædiatriske forsøgspersoner.
No differences were seen in the pharmacokinetic parameters between adult and paediatric study patients.
Der sås ingen forskelle i de farmakokinetiske parametre mellem voskne og ældre forsøgspersoner.
No differences were seen in the pharmacokinetic parameters between adult and elderly study patients.
Der sås ingen forværring til grad 3 eller 4 af forhøjet ALAT, forhøjet alkalisk fosfatase og forhøjet kreatinin.
There was no worsening to Grade 3 or 4 in increased ALT, increased alkaline phosphatase, and increased creatinine.
Der sås ingen generelle forskelle i effektivitet hos patienter over 65 år i forhold til yngre voksne patienter.
No overall differences in effectiveness were observed between patients over 65 years and younger adult patients.
Der sås ingen indvirkning på reproduktionsevnen og ingen indvirkning af betydning på hvalpes levedygtighed, når fluralaner blev administreret oralt til Beagle-hunde ved en overdosis op til 3 gange den højeste anbefalede dosis (op til 168 mg fluralaner/kg kropsvægt).
There were no findings on reproductive performance and no findings of concern on offspring viability when fluralaner was administered orally to Beagle dogs at overdoses of up to 3 times the maximum recommended dose (up to 168 mg/kg bodyweight of fluralaner).
Der sås ingen interaktion mellem dronedaron og metformin (et OCT1- og OCT2-substrat).
No interaction was observed between dronedarone and metformin, an OCT1 and OCT2 substrate.
Der sås ingen klinisk relevant effekt efter administration af gentagne doser vortioxetin til raske forsøgspersoner, eksponeret for lithium ved steady state.
No clinically relevant effect was observed during steady-state lithium exposure following co- administration with multiple doses of vortioxetine in healthy subjects.
Der sås ingen klinisk relevant farmakokinetisk virkning, når valaciclovir blev administreret samtidig med tripranavir plus lavdosis ritonavir.
Co-administration of valaciclovir, tipranavir and low dose ritonavir was not associated with clinically relevant pharmacokinetic effects.
Der sås ingen klinisk relevante ændringer i dasabuvir-, paritaprevir- og ombitasvir-eksponeringen (baseret på en sammenligning med historiske data) ved samtidig administration.
No clinically relevant changes in dasabuvir, paritaprevir, and ombitasvir exposures (based on comparison with historical data) were observed during the co- administration.
Der sås ingen klinisk signifikante ændringer i valproat-, lithium- eller lamotriginkoncentrationer ved samtidig administration af Aripiprazole og valproat, lithium eller lamotrigin.
When aripiprazole was administered concomitantly with either valproate, lithium or lamotrigine, there was no clinically important change in valproate, lithium or lamotrigine concentrations.
Der sås ingen lokal irritation af blodkar efter i.v.- eller paravenøs administration af idarucizumab.
No local irritation of the blood vessel was observed after i.v. or paravenous administration of idarucizumab.
Der sås ingen lægemiddelrelaterede bivirkninger eller klinisk signifikante laboratorieanomalier.
No study drug-related adverse reactions or clinically significant laboratory abnormalities were observed.
Der sås ingen mutagene virkninger i en undersøgelse med bakteriel tilbagemutation (“Ames test”) af det cysteaminbitartrat, der anvendes til PROCYSBI.
A bacterial reverse mutation assay study (“Ames test”) was performed with the cysteamine bitartrate used for PROCYSBI and cysteamine bitartrate did not show any mutagenic effects in this test.
Der sås ingen nævneværdige ændringer i blodtryk og hjertefrekvens ved samtidig administration af pseudoephedrin hos raske forsøgspersoner, og der sås ingen klinisk relevant øget tyramin-følsomhed.
No meaningful changes in blood pressure, heart rate with pseudoephedrine were observed in the healthy volunteers, and no clinically relevant increase in tyramine sensitivity were observed.
Der sås ingen reduktion i seroptype 3, og for serotype 5’s vedkommende var kolonisering for sjælden til at eventuel indflydelse kunne vurderes.
There was no reduction seen in serotype 3 and for serotype 5 the colonization was too infrequent to assess impact.
Der sås ingen relevant effekt pga. køn.
No relevant effect of gender was identified.
Der sås ingen relevant virkning af memantin på galantamins farmakokinetik i et klinisk studie med yngre, raske frivillige forsøgspersoner.
In a clinical study in young healthy subjects, no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
Der sås ingen relevante forskelle mellem Filgrastim ratiopharm og referenceproduktet, hvad angår varighed af svær neutropeni og incidens af febril neutropeni.
There were no relevant differences between Filgrastim ratiopharm and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Der sås ingen relevante interaktioner mellem de aktive stoffer i memantin og glyburid/metformin henholdsvist donepezil i enkeltdosis farmakokinetiske (PK)-studier hos yngre, raske forsøgspersoner.
In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance – active substance interaction of memantine with glyburide/metformin or donepezil was observed.
Der sås ingen relevante interaktioner mellem de aktive stoffer i memantin og glyburid/metformin henholdsvist donepezil i enkeltdosis farmakokinetiske (PK)-studier hos yngre, raske forsøgspersoner.
In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance- active substance interaction of memantine with glyburide/metformin or donepezil was observed.
Der sås ingen relevante interaktioner mellem de aktive stoffer i memantin og glyburid/metformin henholdsvist donepezil i enkeltdosis farmakokinetiske (PK)-studier hos yngre, raske forsøgspersoner.
In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance-active substance interaction of memantine with glyburide/metformin or donepezil was observed.
Der sås ingen relevante interaktioner mellem de aktive stoffer i memantin og glyburid/metformin henholdsvist donepezil i farmakokinetiske enkeltdosis -studier hos yngre, raske forsøgspersoner.
In single-dose pharmacokinetic (PK) studies in young healthy subjects no relevant active substance- active substance interaction of memantine with glyburide/metformin or donepezil was observed.
Der sås ingen relevante interaktioner mellem de aktive stoffer i memantin og glyburid/metformin henholdsvist donepezil i farmakokinetiske enkeltdosis -studier hos yngre, raske forsøgspersoner.
In single-dose pharmacokinetic (PK) studies in young healthy subjects no relevant active substance-active substance interaction of memantine with glyburide/metformin or donepezil was observed.
Der sås ingen relevante interaktioner mellem de aktive stoffer i memantin og glyburid/metformin henholdsvist donepezil i farmakokinetiske enkeltdosis-studier hos yngre, raske forsøgspersoner.
In single-dose pharmacokinetic (PK) studies in young healthy subjects no relevant active substance- active substance interaction of memantine with glyburide/metformin or donepezil was observed.
Der sås ingen relevante interaktioner mellem de aktive stoffer memantin og glyburid/metformin eller donepezil i enkeltdosis farmakokinetiske (PK)-studier hos yngre, raske forsøgspersoner.
In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance- active substance interaction of memantine with glyburide/metformin or donepezil was observed.
Der sås ingen signifikant nedsættelse af den kognitive funktion i forhold til placebo efter samtidig administration af vortioxetin og en enkelt dosis diazepam på 10 mg.
No significant impairment, relative to placebo, in cognitive function was observed for vortioxetine following co-administration with a single 10 mg dose of diazepam.
Der sås ingen signifikante interaktioner ved indgift af vardenafil (20 mg) sammen med warfarin (25 mg), som metaboliseres via CYP2C9, eller digoxin (0,375 mg).
No significant interactions were shown when warfarin (25 mg), which is metabolised by CYP2C9, or digoxin (0.375 mg) was co-administered with vardenafil (20 mg film-coated tablets).
Der sås ingen stigning i gennemsnitlig hjertefrekvens hos patienter med type 2-diabetes i alle placebokontrollerede fase III-studier.
No increase in mean heart rate patients with type 2 diabetes was seen in all placebo controlled phase III studies.
Der sås ingen tegn på genotoksicitet i Ames mikrobielle mutagenicitetsassay, en genmutations-assay med pattedyrsceller og en transformations-assay med embryoceller fra syrisk hamster.
No evidence of genotoxicity was observed in an Ames microbial mutagenicity assay, a mammalian- cell gene mutation assay, and a transformation assay with Syrian hamster embryo cells.
Der sås ingen tegn på ændret farmakokinetisk profil eller sikkerhedsprofil i forbindelse med dannelse af antistoffer mod pembrolizumab.
There was no evidence of an altered pharmacokinetic or safety profile with anti-pembrolizumab binding antibody development.
Der sås ingen tegn på ændret farmakokinetisk profil eller toksicitetsprofil i forbindelse med dannelsen af antistoffer mod lægemidlet.
There was no evidence of altered pharmacokinetic or toxicity profile associated with anti-product-antibody development.
Der sås ingen teratogen effekt hos kaniner ved
No teratogenic effects were seen in rabbits at
Der sås ingen teratogen effekt, dog var der mindre anomalier (venstresidig umbilicus- arterie, cervikalt ribben og tidlig knogledannelse) hos rotter ved ≥ 60 mg/kg/døgn (4 gange den forventede, kliniske optagelse hos mennesker).
There were no teratogenic effects; however, minor anomalies (left-sided umbilical artery, cervical rib and precocious ossification) occurred in rats at ≥60 mg/kg/day (4 times the expected human clinical exposure).
Der sås ingen udviklingstoksisitet ved 1 mg/kg/dag (eksponering ca. >0,9 gange AUC hos patienter behandlet med ADD).
No development toxicity was observed at 1 mg/kg/day (approximate exposure ≥0.9 times the AUC in patients administered the RDD).
Der sås ingen uønskede virkninger af canakinumab efter administration til egernaber to gange ugentligt i op til 26 uger eller i et studie vedrørende embryoføtal udviklingstoksicitet hos drægtige egernaber.
No undesirable effects of canakinumab were seen following twice weekly administration to marmosets for up to 26 weeks or in an embryofoetal developmental toxicity study in pregnant marmosets.
Der sås ingen uønskede virkninger af et murint anti-murin IL-1 beta-antistof i et komplet sæt af studier vedrørende reproduktion og det juvenile stadium hos mus.
No undesirable effects of a murine anti-murine IL-1 beta antibody were seen in a complete set of reproductive and juvenile studies in mice.
Der sås ingen virkning på parametrene for hanrotters fertilitet.
There were no effects on male rat fertility parameters.
Der sås ingen virkning på R- warfarins farmakokinetik eller på koagulationen.
There was no effect on the R- warfarin pharmacokinetics or on coagulation.
Der sås ingen virkning på R- warfarins farmakokinetik eller på koagulationen.
There was no effect on the R-warfarin pharmacokinetics or on coagulation.
Der sås ingen væsentlig akkumulering af ceftolozan/tazobactam efter flere intravenøse infusioner af 1 times varighed med 1 g / 0,5 g ceftolozan/tazobactam administreret hver 8. time i op til 10 dage hos raske voksne med normal nyrefunktion.
No appreciable accumulation of ceftolozane/tazobactam is observed following multiple 1-hour IV infusions of 1 g / 0.5 g ceftolozane/tazobactam administered every 8 hours for up to 10 days in healthy adults with normal renal function.
Der sås ingen åbenlyse forskelle i effekt af entecavir baseret på køn ( 25% kvinder i de kliniske forsøg) eller alder ( 5% af patienter var > 65 år).
There was no apparent difference in efficacy for entecavir based on gender (≈ 25% women in the clinical trials) or age (≈ 5% of patients > 65 years of age).
Der sås ingen øget hyppighed af frakturer hos mænd i behandling med pioglitazon (1,7%) sammenlignet med komparator (2,1%).
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Der sås ingen øget hyppighed af frakturer hos mænd, der blev behandllet med pioglitazon (1,7%) sammenlignet med komparator (2,1%).
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Der sås ingen øgning i dødeligheden som følge af hjerteinsvigt.
No increase in mortality from heart failure was observed.
Der sås intet reboundfæ nomen.
No rebound was observed.
Der sås ligeledes signifikant fordel ved vedligeholdelsesbehandling med MabThera for de sekundære effektmål: hændelsesfri overlevelse (EFS), tid til næste lymfombehandling (TNLT), tid til næste kemoterapi (TNCT) og samlet responsrate (ORR) (Tabel 4).
Significant benefit from maintenance treatment with MabThera was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) (Table 4).
Der sås lignende respons med hensyn til % med hSBA-titre ≥8 mod gruppe A og C (Tabel 4).
Similar responses in terms of % with hSBA titre ≥8 were observed with groups A and C (Table 4).
Der sås nedsat TSH hos 3 (1,3%) patienter på sunitinib, men ikke hos patienter på capecitabin.
Blood TSH decrease was reported in 3 (1.3%) sunitinib subjects and no capecitabine subjects.
Der sås nyretoksicitet hos aber behandlet i 2 uger, inkluderende fokal mineralisering og dilatering af nyretubuli samt tubulær nefrose.
Renal toxicity was observed in monkeys treated for 2weeks, with focal mineralisation and dilation of the renal tubules and tubular nephrosis.
Der sås også en let til moderat reduktion i spermatogenesen hos hunde ved orale doser ≤ 30 mg/kg.
A slight to moderate reduction in spermatogenesis was also observed in the dog at oral doses ≥ 30 mg/kg.
Der sås også en statistisk signifikant forbedring i forhold til placebo i rasagilin 0,5 mg gruppen, men forbedringen var mindre.
[-1.36, -0.51], p<0.0001. There was also a statistically significant improvement over placebo with the rasagiline 0.5 mg group, yet the magnitude of improvement was lower.
Der sås også hyppigere forekomst af infektioner med grad ≥ 3 neutropeni (24 % kontra 19 % i blok 1 og 22 % kontra 11 % i blok 2), forhøjet ALAT (17 %
Higher incidences were also noted for infections with Grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in
Der sås også hyppigere forekomst af infektioner med grad ≥ 3 neutropeni (24 % kontra 19 % i blok 1 og 22 % kontra 11 % i blok 2), forhøjet ALAT (17 % kontra 8 % i blok 2),
Higher incidences were also noted for infections with Grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus
Der sås positiv genotoksisk effekt med imatinib i en in vitro pattedyrscelleundersøgelse (kinesisk hamsterovarium) for clastogenicitet (kromosomafvigelser) ved metabolisk aktivering ved en koncentration på 125 μg/ml.
Positive genotoxic effects were obtained for imatinib in an in vitro mammalian cell assay (Chinese hamster ovary) for clastogenicity (chromosome aberration) in the presence of metabolic activation at a concentration of 125 μg/ml.
Der sås proportionale stigninger i plasmakoncentrationen for doser fra 2-60 mg.
Proportional increases of the plasma concentration were observed for doses from 2-60 mg.
Der sås reduceret neonatal vægt under og efter afvænningsperioden ved 3 mg/kg/dag.
Reduced offspring body weights were observed during the pre-weaning and post-weaning periods at 3 mg/kg/day.