natgillin/translations-raw huggingface dataset:
I psoriasisartrit-studie 1 (PsA-studie 1) og psoriasisartrit-studie 2 (PsA-studie 2) var henholdsvis 29 % og 35 % af patienterne tidligere blevet behandlet med et anti-TNFα-middel, og anti-TNFα-midlet var blevet seponeret enten pga. manglende effekt eller intolerans (anti-TNFα-IR-patienter).
In Psoriatic Arthritis Study 1 (PsA Study 1) and Psoriatic Arthritis Study 2 (PsA Study 2) 29% and 35% of patients, respectively, were previously treated with an anti-TNFα agent and discontinued the anti-TNFα agent for either lack of efficacy or intolerance (anti-TNFα-IR patients).
I psoriasisstudier er sikkerhed og virkning af Cosentyx i kombination med immunosuppressiver, herunder biologiske, eller lysbehandling ikke blevet evalueret (se også pkt.
In psoriasis studies, the safety and efficacy of Cosentyx in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated (see also section 4.5).
I publicerede rapporter har tilfælde af ikke-mandibulær osteonekrose været observeret hos patienter under 18 år behandlet med Avastin (se pkt.
In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years treated with Avastin (please see section 5.3).
I publicerede undersøgelser med cysteamin er beskrevet kromosomforandringer i dyrkede eukaryote cellelinier, men specifikke undersøgelser med cysteamin viste hverken mutagene effekter ved Ames test eller klastogene effekter i mikronucleustest hos mus.
Genotoxicity studies have been published using cysteamine, induction of chromosome aberrations in cultured eukaryotic cell lines has been reported, specific studies with cysteamine did not show any mutagenic effects in the Ames test or any clastogenic effect in the mouse micronucleus test.
I publicerede, prospektive undersøgelser var oral Prograf primært immunsuppressivum hos omkring 175 lungetransplanterede patienter, 475 pancreastransplanterede patienter og 630 intestinaltransplanterede patienter.
In prospective studies oral Prograf was investigated as primary immunosuppressant in approximately 175 patients following lung, 475 patients following pancreas and 630 patients following intestinal transplantation.
I puljede analyser af forsøgspersoner, som opnåede SVR12 (vedvarende virologisk respons (sustained virologic response, SVR) 12 uger efter behandlingsophør) eller opfyldte kriterierne for virologisk svigt, blev prævalensen og indvirkningen af NS5A-polymorfismer (inklusive L/M28T/A, R/Q30E/H/R/G/K/L/D, L31M/V/F, H58D og Y93C/H/N) og NS3-polymorfismer (substitutioner i position 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170 og 175), der giver mere en 5 gange reduktion i hhv. elbasvirs og grazoprevirs antivirale aktivitet in vitro, evalueret.
In pooled analyses of subjects who achieved SVR12 or met criteria for virologic failure, the prevalence and impact of NS5A polymorphisms (including L/M28T/A, R/Q30E/H/R/G/K/L/D, L31M/V/F, H58D, and Y93C/H/N) and NS3 polymorphisms (substitutions at positions 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170, and 175) that confer greater than 5-fold reduction of elbasvir and grazoprevir antiviral activity respectively in vitro were evaluated.
i pulveret: mannitol og humant albumin i solvensen (natriumchloridopløsning 5,4 mg/ml (0,54 % (vægt/vol.)): natriumchlorid, vand til injektionsvæsker.
in the powder: mannitol and human albumin, in the solvent (sodium chloride solution 5.4 mg/ml (0.54% w/v)): sodium chloride, water for injection.
i pulveret: mannitol og humant albumin i solvensen natriumchloridopløsning 5,4 mg/ml (0,54 % (vægt/vol.)): natriumchlorid, vand til injektionsvæsker.
in the powder: mannitol and human albumin, in the solvent (sodium chloride solution 5.4 mg/ml (0.54% w/v)): sodium chloride, water for injection.
i pulveret: mannitol og humant albumin i solvensen: natriumchlorid, vand til injektionsvæsker.
in the powder: mannitol and human albumin. in the solvent: sodium chloride, water for injection.
I pulveret: poly (D,L-laktid-coglycolid) og saccharose.
In the powder: poly (D,L-lactide-co-glycolide) and sucrose.
I pulveret: poly(D,L-lactid-co-glycolid) (50-60:40-50), poly(D,L-lactid-co-glycolid) (50:50)
In the powder: poly(D,L-lactide-co-glycolide) (50-60:40-50), poly(D,L-lactide-co-glycolide) (50:50).
I pumpen
In the pump
I PV-populationen blev CTCAE grad 3 og 4 rapporteret hos 1,8%, mens frekvensen var 42,56% for MF-patienter.
In the PV population, the CTCAE grade 3 and 4 events were reported in 1.8%, while in the MF patients the frequency was 42.56%.
I PX-171-011 blev monoterapi med Kyprolis sammenlignet med en kontrolarm (kortikosteroider og cyclophosphamid).
PX 171-011 evaluated Kyprolis monotherapy versus a control arm (corticosteroids and cyclophosphamide).
I pædiatriske kliniske forsøg af op til 12 ugers varighed var forekomsten af epistaxis den samme hos patienter, der fik fluticasonfuroat, og hos patienter, der fik placebo.
In paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between patients receiving fluticasone furoate and patients receiving placebo.
I QD-gruppen, viste 6/75 (8%) patienter nye primære proteasehæmmer mutationer (codon 30, 32, 48, 50, 82, 84, 90), ligesom 12/77 (16%) patienter i BID-gruppen.
In the QD group, 6/75 (8%) patients demonstrated new primary protease inhibitor mutations (codons 30, 32, 48, 50, 82, 84, 90), as did 12/77 (16%) patients in the BID group.
I RA-forsøg III opretholdt de fleste af de patienter, der opnåede forbedringer i fysisk funktion og fortsatte behandlingen forbedring gennem 520 uger (120 måneder) med åben behandling.
In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through Week 520 (120 months) of open-label treatment.
I RA-I og RA-II rapporterede patienter behandlet med Cimzia signifikante forbedringer i fysisk funktion, som vurderet ved Health Assessment Questionnaire – Disability Index (HAQ-DI) og ved træthed (fatigue), som rapporteret af Fatigue Assessment Scale (FAS), fra uge 1 frem til slutningen af studierne sammenlignet med placebo.
In RA-I and RA-II, Cimzia-treated patients reported significant improvements in physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and in tiredness (fatigue) as reported by the Fatigue Assessment Scale (FAS) from Week 1 through to the end of the studies compared to placebo.
I RA-studie III opretholdt de fleste af de patienter, der opnåede forbedringer i fysisk funktion og fortsatte behandlingen forbedring gennem 520 uger (120 måneder) med åben behandling.
In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through Week 520 (120 months) of open-label treatment.
I RA-studie III, hvor de Humira-behandlede patienter havde haft reumatoid artrit gennemsnitlig i 11 år, blev den strukturelle ødelæggelse af leddene vurderet radiografisk og udtrykt som ændringer i modificeret Sharp Score (TSS) og dennes delkomponenter, erosionsscore og ledspalteforsnævring (JSN).
In RA study III, where Humira treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score.
I RA-studie IV var ACR 20-respons for patienter behandlet med Humira plus standardpleje statistisk signifikant bedre end for patienter behandlet med placebo plus standardpleje (p  0,001).
In RA study IV, the ACR 20 response of patients treated with Humira plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
I RA-studie V blev strukturel ledskade vurderet radiografisk og udtrykt som ændringer i modificeret Total Sharp Score (se tabel 5).
In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 5).
I RA-studie V blev strukturel ledskade vurderet radiografisk og udtrykt som ændringer i modificeret Total Sharp Score (se tabel 9).
In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 9).
I RA-studie V med patienter med reumatoid artrit på et tidligt stadium, som var methotrexat-naive, førte kombinationsbehandlingen med Humira og methotrexat til hurtigere og signifikant større ACR- respons end methotrexat-monoterapi og Humira-monoterapi i uge 52, og effekten blev opretholdt i 104 uger (se tabel 3).
In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Humira and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Humira monotherapy at week 52 and responses were sustained at Week 104 (see Table 3).
I RA-studie V med patienter med reumatoid artrit på et tidligt stadium, som var methotrexat-naive, førte kombinationsbehandlingen med Humira og methotrexat til hurtigere og signifikant større ACR- respons end methotrexat-monoterapi og Humira-monoterapi i uge 52, og effekten blev opretholdt i 104 uger (se tabel 5).
In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Humira and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Humira monotherapy at Week 52 and responses were sustained at Week 104 (see Table 5).
I RA-studie V med patienter med reumatoid artrit på et tidligt stadium, som var methotrexat-naive, førte kombinationsbehandlingen med Humira og methotrexat til hurtigere og signifikant større ACR- respons end methotrexat-monoterapi og Humira-monoterapi i uge 52, og effekten blev opretholdt i 104 uger (se tabel 7).
In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Humira and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Humira monotherapy at Week 52 and responses were sustained at Week 104 (see Table 7).
I RA-studierne I-IV opnåede Humira-behandlede patienter statistisk signifikant ACR 20- og 50- respons sammenlignet med placebo allerede én til to uger efter behandlingsstart.
In RA studies I-IV, Humira-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
I rammerne af neoadjuverende behandling vurderes lokalt avanceret og inflammatorisk brystkræft at indebære høj risiko, uafhængig af hormonreceptorstatus.
In the neoadjuvant setting, locally advanced and inflammatory breast cancers are considered as high- risk irrespective of hormone receptor status.
I randomiserede kliniske forsøg anvendtes en subkutan dosis på 23 mio.
In randomised clinical trials, a subcutaneous dose of 23 MIU
I randomiserede kliniske studier anvendtes en subkutan dosis på 23 mio.
In randomised clinical trials, a subcutaneous dose of 23 MIU
I randomiserede kliniske studier blev der anvendt en subkutan dosis på 23 ME/m2/dag (230 mikrogram/m2/dag) eller snarere 0,4-0,84 ME/kg/dag (4-8,4 mikrogram/kg/dag).
In randomised clinical studies, a subcutaneous dose of 23 MU/m2/day (230 micrograms/m2/day) or rather 4-8.4 micrograms/kg/day was used.
I randomiserede kliniske studier blev der anvendt en subkutan dosis på 230 mikrogram/m2/dag (4,0 til 8,4 mikrogram/kg/dag).
In randomised clinical trials, a subcutaneous dose of 230 micrograms/m2/day (4.0 to 8.4 micrograms/kg/day) was used.
I randomiserede, dobbeltblinde fase II-III-studier med monoterapi var der henholdsvise forhøjelser i QTc-intervalforlængelse, der overskred ændringer fra baseline over 60 ms Fridericia-korrektion og Bazett-korrektion 0 (0,0 %) og 2 (0,3 %) hos placebopatienter og 1 (0,1 %) og 1 (0,1 %) hos Intuniv- patienter.
In phase II-III randomised double-blind monotherapy studies respective increases in QTc interval prolongation that exceeded change from baseline greater than 60 ms Fridericia-correction and Bazett-correction were 0 (0.0%) and 2 (0.3%) among placebo and 1 (0.1%) and 1 (0.1%) among Intuniv patients.
I randomiserede, kontrollerede, dobbeltblinde kliniske studier (herunder udviklingsmæssig erfaring og erfaring efter markedsføring) er mere end 17.000 patienter med type 2-diabetes blevet behandlet med Onglyza.
In randomised, controlled, double-blind clinical trials (including developmental and postmarketing experience), over 17,000 patients with type 2 diabetes have been treated with Onglyza .
I randomiserede, placebokontrollerede kliniske forsøg øgede filgrastim ikke forekomsten af bivirkninger forbundet med cytotoksisk kemoterapi.
In randomised, placebo-controlled clinical trials, filgrastim did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy.
I randomiseringsperioden i det pivotale studie med PV-patienter steg det gennemsnitlige systoliske blodtryk med 0,65 mmHg i Jakavi-armen mod et fald på 2 mmHg i BAT-armen.
In the randomised period of the pivotal study in PV patients, the mean systolic blood pressure increased by 0.65 mmHg in the Jakavi arm versus a decrease of 2 mmHg in the BAT arm.
I rapporter efter markedsføring er det observeret, at andelen af hæmolysetilfælde i forhold til alle bivirkningsrapporter blandt børn er lidt større end hos voksne.
In postmarketing reports it is observed that the proportion of haemolysis cases to all case reports occurring in children is slightly higher than in adults.
I rapporteringsperioden blev 35 tilfælde af mareridt rapporteret og 324 kumulativt (124 med orale formuleringer, 176 med patch formuleringer, 16 med ukendt formulering og 4 med mundtlig plus plaster formulering).
During the reporting period 35 cases of nightmares were reported and 324 cumulatively (124 with oral formulations, 176 with patch formulations, 16 with unknown formulation and 4 with oral plus patch formulation).
I rapporteringsperioden blev der rapporteret i alt 8 nye tilfælde af alvorlige gastrointestinale lidelser associeret med tilstedeværelsen af sevelamer krystaller.
During the reporting period, a total of 8 new cases of serious gastrointestinal disorders associated with the presence of sevelamer crystals were reported.
I rapporteringsperioden blev der udarbejdet fire case-rapporter (2 publicerede), der i høj grad tydede p å kausal sammenhæng mellem rabdomyolyse og brug af levetiracetam.
Four case reports (2 published) with very suggestive causal association were issued during the reporting period regarding rhabdomyolysis in association with levetiracetam use.
I rapporteringsperioden har et antal alvorlige og ikke-alvorlige bivirkninger (ADRs) i form af ”hyponatriæmi” i datakilder for tiden efter markedsføring givet anledning til bekymring, og ført til, at indehaveren af markedsføringstilladelsen (MAH) har indsendt en kumulativ oversigt.
During the reporting a number of serious and non-serious adverse drug reactions (ADRs) from post- marketing data sources regarding “hyponatraemia” raised a concern that led to the submission of a cumulative review from the Marketing Authorisation Holder (MAH).
I rapporteringsperioden resulterede samtidig brug af ACE-hæmmere og vildagliptin i en lidt højere forekomst af angioødem i vildagliptin-gruppen vs. sammenliningsgruppen.
During the reporting period concomitant use of ACE inhibitors and vildagliptin resulted in a slightly higher incidence of angioedema in the vildagliptin group versus the comparator group.
I RCC- studier med pazopanib sås ingen klinisk signifikant forskel i sikkerheden ved pazopanib mellem forsøgspersoner i alderen 65 år og derover sammenlignet med yngre forsøgspersoner.
In the RCC studies of pazopanib, overall no clinically significant differences in safety of pazopanib were observed between subjects aged at least 65 years and younger subjects.
I RCC-klinisk studie 1 var 31% af patienterne, der blev behandlet med temsirolimus, 65 eller ældre.
In RCC Clinical Trial 1, 31% of patients treated with temsirolimus were 65 or older.
I RCC-studiet, et fase 3 klinisk studie vedrørende renalcellekarcinom, rapporterede 26 % af patienterne hyperglykæmi som bivirkning.
In the RCC Clinical Trial, a Phase 3 clinical trial for renal cell carcinoma, 26% of patients reported hyperglycaemia as an adverse event.
I RE-LY-studiet øgede SSRI og SNRI risikoen for blødning i alle behandlingsarmene.
SSRIs and SNRIs increased the risk of bleeding in RE-LY in all treatment groups.
I RE-MEDY, som er et warfarinkontrolleret studie, indgik patienter tidligere behandlet i 3 til 12 måneder og med behov for yderligere antikoagulansbehandling og i RE-SONATE, som er et placebokontrolleret studie, indgik patienter tidligere behandlet i 6 til 18 måneder med vitamin K- antagonist.
RE-MEDY, warfarin controlled study, enrolled patients already treated for 3 to 12 months with the need for further anticoagulant treatment and RE-SONATE, the placebo controlled study, enrolled patients already treated for 6 to 18 months with Vitamin K inhibitors.
I REACH-studiet fik 112 patienter (6 til 17 år, median alder 13,0 år) med moderat til svæ r aktiv Crohns sygdom (median pæ diatrisk CDAI på 40) og utilstræ kkelig respons på konventionel behandling 5 mg infliximab/kg i ugerne 0, 2 og 6.
In the REACH study, 112 patients (6 to 17 years, median age 13.0 years) with moderate to severe, active Crohn’s disease (median paediatric CDAI of 40) and an inadequate response to conventional therapies were to receive 5 mg/kg infliximab at weeks 0, 2, and 6.
I REACH-studiet fik 112 patienter (6 til 17 år, median alder 13,0 år) med moderat til svær aktiv Crohns sygdom (median pædiatrisk CDAI på 40) og utilstrækkelig respons på konventionel behandling 5 mg infliximab/kg i ugerne 0, 2 og 6.
In the REACH study, 112 patients (6 to 17 years, median age 13.0 years) with moderate to severe, active Crohn’s disease (median paediatric CDAI of 40) and an inadequate response to conventional therapies were to receive 5 mg/kg infliximab at weeks 0, 2, and 6.
I RECOURSE-studiet fik 9,4% af patienterne i Lonsurf- gruppen G-CSF, hovedsageligt anvendt terapeutisk.
In the RECOURSE study, 9.4% of patients in the Lonsurf group received G-CSF mainly for therapeutic use.
I registerundersøgelsen med patienter med PHN, som aldrig havde fået blodtransfusion, oplevede de patienter, der blev behandlet med Soliris, en klinisk betydningsfuld nedgang i niveauet af laktatdehydrogenase efter seks måneders behandling, hvilket indikerede, at nedbrydelsen af røde blodlegemer var reduceret.
In the registry study of patients with PNH who had never had a blood transfusion, patients treated with Soliris had clinically meaningful reductions in levels of lactate dehydrogenase (LDH) after 6 months of treatment, indicating reduced breakdown of red blood cells.
I relaps/refraktær CLL-studiet blev trombocytopeni af grad 3/4 rapporteret hos 11 % af patienterne i R-FC-gruppen sammenlignet med 9 % af patienterne i FC- gruppen.
In the relapsed/refractory CLL study grade 3/4 thrombocytopenia was reported in 11% of patients in the R-FC group compared to 9% of patients in the FC group.
I relaps/refraktær-studiet var medianen for progressionsfri overlevelse (det primære endepunkt) 30,6 måneder i R-FC-gruppen og 20,6 måneder i FC-gruppen (p=0,0002, log-rank test).
In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log--rank test).
i remission ved initiering af vedligeholdelsesbehandling
in remission at the start of maintenance therapy
I reproduktions- og udviklingstoksicitetsstudie sås reduktion i føtal vækst og overlevelse og nogle dødfødsler sekundært til maternel toksicitet.
In reproductive and developmental toxicity studies, there were reductions in foetal growth and survival, and some stillbirths secondary to maternal toxicity.
I reproduktions- toksicitetsundersøgelser på dyr forårsagede administration af capecitabin embryoletalitet og teratogenicitet.
In reproductive toxicity studies in animals, capecitabine administration caused embryolethality and teratogenicity.
I reproduktionsstudier har voriconazol vist sig at være teratogent hos rotter og embryotoksisk hos kaniner ved systemisk optagelse svarende til den der ses ved terapeutiske doser hos mennesker.
In reproduction studies, voriconazole was shown to be teratogenic in rats and embryotoxic in rabbits at systemic exposures equal to those obtained in humans with therapeutic doses.
I reproduktionsstudier med hanrotter blev der ikke observeret nogen virkninger på fertiliteten hos hanner.
No effects on male fertility were seen in reproductive studies in male rats.
I reproduktionsstudier med nepafenac hos rotter var maternelle toksiske doser ≥ 10 mg/kg forbundet med dystoci, øget post-implantation tab, reduceret fostervægt og -vækst og nedsat fosteroverlevelse.
In reproduction studies performed with nepafenac in rats, maternally toxic doses ≥ 10 mg/kg were associated with dystocia, increased postimplantation loss, reduced foetal weights and growth, and reduced foetal survival.
I reproduktionstoksicitetsforsøg er der set nedsat fertilitet hos hanrotter.
In reproduction toxicity studies decreased fertility in male rats was observed.
I reproduktionstoksikologiske studier fandt man tilfælde af nedsat fertilitet hos rotter.
In reproductive toxicology studies, evidence of impaired fertility was seen in rats.
I reproduktionstoksiske forsøg med rotter er der ikke fundet påvirkning af fertilitet hos hverken hanner eller hunner (se pkt.
No effects on male or female fertility have been observed in reproductive toxicity studies in rats (see section 5.3).
I reproduktionstoksiske forsøg med rotter er der ikke fundet påvirkning af fertilitet hos hverken hanner eller hunner.
No effects on male or female fertility have been observed in reproductive toxicity studies in rats (see section 5.3).
I reproduktionstoksiske forsøg med rotter er der ikke set påvirkning af fertilitet hos hverken hanner eller hunner (se pkt.
No effects on male or female fertility have been observed in reproductive toxicity studies in rats (see section 5.3).
I reproduktionstoxicitetsstudier var administration af rosiglitazon til rotter i anden halvdel af dræktighedsperioden associeret til fosterdød og forsinket fosterudvikling.
In reproductive toxicity studies, administration of rosiglitazone to rats during mid-late gestation was
I RHODOS og programmet til udvidet adgang (EAP) ved LHON fik i alt 3 patienter i alderen 9-11 år og 27 patienter i alderen 12-17 år idebenon i en dosis af 900 mg dagligt i op til 33 måneder.
In RHODOS and the EAP in LHON, a total of 3 patients between the ages of 9 and 11 years and 27 patients between the ages of 12 and 17 years received idebenone at 900 mg/day for up to 33 months.
I rottemælk blev der set et højt mælk/maternal plasma-ratio (Cmax omkring 8, AUC omkring 30), hvilket muligvis skyldes aktiv transport til modermælken.
In rat milk, a high milk to maternal plasma ratio (Cmax about 8, AUC about 30) was found, possibly due to active transport into the milk.
I rottemælk blev der set høj mælk/maternal plasma-ratio (Cmax omkring 8, AUC omkring 30), hvilket muligvis skyldes aktiv transport til modermælken.
In rat milk, a high milk to maternal plasma ratio (Cmax about 8, AUC about 30) was found, possibly due to active transport into the milk.
I rotter forøges blødningsrisikoen, når tipranavir og vitamin E administreres samtidig (se pkt.
In rats, co-administration with vitamin E increased the bleeding effects of tipranavir (see section 5.3).
I rotter med plasmakoncentrationer 5,5 gange højere end human eksponering medfører sunitinib- behandling ved >5 mg/kg/dag under organogenesen en forøget forekomst af skeletforandringer hos fostrene, fortrinsvis forsinket ossifikation af bryst- og lændehvirvlerne.
Sunitinib treatment in rats during organogenesis resulted in developmental effects at 5 mg/kg/day consisting of increased incidence of foetal skeletal malformations, predominantly characterized as retarded ossification of thoracic/lumbar vertebrae and occurred at plasma exposure levels 5.5 times the systemic exposure in humans.