natgillin/translations-raw huggingface dataset:
I kliniske studier og efter markedsføring er der set tilfælde af pulmonalblødninger, som i nogle tilfælde var letale, hos patienter, der er blevet behandlet med sunitinib mod mRCC, GIST og lungecancer.
Cases of pulmonary haemorrhage, some with a fatal outcome, have been observed in clinical trials and have been reported in post-marketing experience in patients treated with sunitinib for MRCC, GIST and lung cancer.
I kliniske studier og post-marketing har man observeret sjældne tilfælde af opportunistiske infektioner, herunder bl.a. svampe-, mykobakterielle, bakterielle og virale infektioner.
In clinical studies and post-marketing experience, rare cases of opportunistic infections have been observed and included fungal, mycobacterial, bacterial, and viral pathogens.
I kliniske studier og spontane rapporter modtaget efter markedsføring er everolimus blevet associeret med tilfælde af pneumocystis jirovecii (carinii) pneumoni (PJP, PCP), hvoraf nogle var med fatal udgang (se punkt 4.4).
In clinical studies and post-marketing spontaneous reports, everolimus has been associated with cases of pneumocystis jirovecii (carinii) pneumonia (PJP, PCP), some with fatal outcome (see section 4.4).
I kliniske studier om osteoporose var ændringen i kreatininclearance (målt årligt før dosering) og incidensen af nyresvigt og nedsat nyrefunktion sammenlignelig for Aclasta- og placebobehandlings- gruppen over tre år.
In clinical trials in osteoporosis, the change in creatinine clearance (measured annually prior to dosing) and the incidence of renal failure and impairment was comparable for both the Aclasta and placebo treatment groups over three years.
I kliniske studier omfattede baggrundsbehandling med metformin, et sulfonylurinstof, en thiazolidindion eller en kombination af orale glucosesænkende lægemidler.
In clinical trials, background therapies included metformin, a sulfonylurea, a thiazolidinedione, or a combination of oral glucose-lowering medicinal products.
I kliniske studier omhandlende lokalt recidiverende eller metastatisk brystkræft blev der observeret sårhelingskomplikationer af grad 3-5 hos op til 1,1 % af patienterne, som fik Avastin, og hos op til 0,9 % af patienterne i kontrolarmene (NCI-CTCAE v.
In locally recurrent and metastatic breast cancer trials, Grade 3-5 wound healing complications were observed in up to 1.1% of patients receiving Avastin compared with up to 0.9% of patients in the control arms (NCI-CTCAE v.3).
I kliniske studier omkring juvenil idiopatisk artrit var der 4 indberetninger om makrofag- aktiveringssyndrom.
There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials.
I kliniske studier omkring juvenil idiopatisk artrit var der 4 indberetninger om makrofag-aktiverings- syndrom.
There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials.
I kliniske studier op til 12 uger af både perifere og neuropatiske smerter ses en reduktion af smerter efter 1 uge, og denne reduktion opretholdes gennem hele behandlingsperioden.
In clinical trials up to 12 weeks for both peripheral and central neuropathic pain, a reduction in pain was seen by week 1 and was maintained throughout the treatment period.
I kliniske studier oplevede 3 ud af i alt af 2.560 patienter behandlet med Tecfidera alvorlig rødme, der formodentlig var overfølsomheds- eller anafylaktoide reaktioner.
In clinical trials, 3 patients out of a total of 2,560 patients treated with Tecfidera experienced serious flushing symptoms that were probable hypersensitivity or anaphylactoid reactions.
I kliniske studier oplevede patienter, der blev behandlet med LEMTRADA, færre attakker og havde mindre sandsynlighed for at opleve yderligere funktionsnedsættelse end patienter, der blev behandlet med et beta-interferon, der blev givet flere gange om ugen som indsprøjtning.
In clinical studies, patients treated with LEMTRADA had fewer relapses and were less likely to experience worsening of their disability compared to patients treated with a beta-interferon injected multiple times per week.
I kliniske studier responderede mere end 90 % af patienterne på disse doser og opnåede en revertering af neutropeni på 2 dage (median).
In clinical studies, more than 90% of patients responded at these doses, achieving a reversal of neutropenia in a median of 2 days.
I kliniske studier skiftede patienter fra Prograf to gange dagligt til en dosis Envarsus på 1:0,85 (mg:mg).
In clinical studies patients converted from twice daily Prograf were converted to Envarsus at 1: 0.85(mg:mg).
I kliniske studier så man ingen alvorlige bivirkninger, som kunne tilskrives kombinationen af afoxolaner og milbemycinoxim.
In clinical studies, no serious adverse reactions were attributed to the combination of afoxolaner with milbemycin oxime.
I kliniske studier sås der utilstrækkeligt respons hos 10 – 15 % af hundene.
In clinical studies, inadequate response to treatment was seen in 10–15% of the dogs.
I kliniske studier sås slimhindeblødninger (f.eks. blødning fra næse, tandkød, mave-tarm-kanalen, genitalier og urinveje) og anæmi hyppigere under langtidsbehandling med rivaroxaban i sammenligning med VKA-behandling.
In the clinical studies mucosal bleedings (i.e. epistaxis, gingival, gastrointestinal, genito urinary) and anaemia were seen more frequently during long term rivaroxaban treatment compared with VKA treatment.
I kliniske studier sås slimhindeblødninger (f.eks. blødning fra næse, tandkød, mave-tarm-kanalen, genitalier og urinveje) og anæmi hyppigere under langtidsbehandling med rivaroxaban i tillæg til enkelt eller dobbelt antitrombotisk behandling.
In the clinical studies mucosal bleedings (i.e. epistaxis, gingival, gastrointestinal, genito urinary) and anaemia were seen more frequently during long term rivaroxaban treatment on top of single or dual anti-platelet therapy.
I kliniske studier sås slimhindeblødninger (f.eks. epistaxis, blødning fra mave-tarm-kanalen, genitalier og urinveje) og anæmi hyppigere under langtidsbehandling med edoxaban, sammenlignet med VKA-behandling.
In the clinical studies mucosal bleedings (e.g. epistaxis, gastrointestinal, genitourinary) and anaemia were seen more frequently during long term edoxaban treatment compared with VKA treatment.
I kliniske studier udført hos patienter med tumorinduceret hyperkalcæmi (TIH) var den samlede sikkerhedsprofil mellem de tre behandlingsgrupper (zoledronsyre 4 og 8 mg og pamidronat 90 mg) sammenlignelige i art og alvorlighed.
In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
I kliniske studier udviklede 96 % af 1497 raske spædbørn, børn, unge og voksne en beskyttende antistoftiter ( 10 IE/l) efter et vaccinationsprogram med 3 doser af en tidligere formulering af Mercks rekombinant hepatitis B vaccine.
In clinical trials, 96 % of 1,497 healthy infants, children, adolescents and adults given a 3 dose course of a previous formulation of Merck’s recombinant hepatitis B vaccine developed a protective level of antibodies against hepatitis B virus surface antigen ( 10 IU/l).
I kliniske studier udviklede 96 % af 1497 raske spædbørn, børn, unge og voksne en beskyttende niveau af antistoffer mod hepatitis B virus overflade-antigen ( 10 IE/l) efter et vaccinationsprogram med 3 doser af en tidligere formulering af Mercks rekombinant hepatitis B vaccine.
In clinical trials, 96 % of 1,497 healthy infants, children, adolescents and adults given a 3 dose course of a previous formulation of Merck’s recombinant hepatitis B vaccine developed a protective level of antibodies against hepatitis B virus surface antigen ( 10 IU/l).
I kliniske studier udviklede 96 % af 1497 raske spædbørn, børn, unge og voksne et beskyttende niveau af antistoffer mod hepatitis B virus overflade-antigen ( 10 IE/l) efter et vaccinationsprogram med 3 doser af en tidligere formulering af Mercks rekombinant hepatitis B vaccine.
In clinical trials, 96 % of 1,497 healthy infants, children, adolescents and adults given a 3 dose course of a previous formulation of Merck’s recombinant hepatitis B vaccine developed a protective level of antibodies against hepatitis B virus surface antigen ( 10 IU/l).
I kliniske studier udvikledes 1. grads AV-blok (PR-forlængelse > 220 msek.) hos 3% af patienterne i løbet af 2 timer efter indgivelse af Rapiscan; forbigående 2. grads AV-blok, med et tabt slag, blev observeret hos en patient, der fik Rapiscan.
In clinical trials first degree AV block (PR prolongation > 220 msec) developed in 3% of patients within 2 hours of Rapiscan administration; transient second degree AV block with one dropped beat was observed in one patient receiving Rapiscan.
I kliniske studier udviste CAPS-patienter med ukontrolleret overproduktion af IL-1 beta hurtig respons på behandling med canakinumab, dvs. laboratorieparametre såsom højt C-reaktivt protein (CRP)-niveau og højt serumamyloid A (SAA)-niveau, højt neutrofil- og trombocyttal, samt leukocytose normaliseredes hurtigt.
In clinical studies, CAPS patients who have uncontrolled over-production of IL-1 beta show a rapid response to therapy with canakinumab, i.e. laboratory parameters such as high C-reactive protein (CRP) and serum amyloid A (SAA), high neutrophil and platelet counts, and leukocytosis rapidly returned to normal.
I kliniske studier var antallet af herpes zoster/herpes zoster-lignende udslæt inden for 42 dage efter vaccination lav i både ZOSTAVAX-gruppen og placebogruppen.
In clinical trials the number of herpes zoster/herpes zoster-like rashes within the 42-day postvaccination was low in both ZOSTAVAX and placebo groups.
I kliniske studier var antallet af hiv-patienter, der fik raltegravir, og som fik cancer, det samme som for patienter, der fik anden hiv-medicin.
In clinical studies, the number of HIV patients taking raltegravir who developed cancer was similar to that of patients taking other HIV medicines.
I kliniske studier var antallet af hvide blodlegemer lavt hos 2,1% af patienterne, der fik Fampyra, mod 1,9% af patienterne, der fik placebo.
In clinical studies low white blood cell counts were seen in 2.1% of Fampyra patients versus 1.9% of patients on placebo.
I kliniske studier var blødninger den hyppigst indberettede bivirkning.
In clinical studies, haemorrhages were the most commonly reported reaction.
I kliniske studier var blødninger den hyppigst indberettede reaktion.
In clinical studies, haemorrhages were the most commonly reported reaction.
I kliniske studier var blødninger den mest almindeligt indberettede reaktion.
In clinical studies, haemorrhages were the most commonly reported reaction.
I kliniske studier var den samlede andel af forsøgspersoner med maligne eller uspecificerede tumorer den samme blandt dem, der blev behandlet med dapagliflozin (1,50 %) og placebo/komparator (1,50 %), og der sås ingen tegn på karcinogenicitet eller mutagenicitet i dyredata (se pkt.
During clinical trials, the overall proportion of subjects with malignant or unspecified tumours was similar between those treated with dapagliflozin (1.50%) and placebo/comparator (1.50%), and there was no carcinogenicity or mutagenicity signal in animal data (see section 5.3).
I kliniske studier var der en højere forekomst af svær leverskade med dødeligt udfald hos japanske patienter (~1.5%), der blev behandlet med Stivaga, sammenlignet med ikke-japanske patienter (<0.1%).
In clinical trials, a higher incidence of severe liver injury with fatal outcome was observed in Japanese patients (~1.5%) treated with Stivarga compared with non- Japanese patients (<0.1%).
I kliniske studier var der ingen dosisjustering af belatacept ved ændringer i kropsvægten på under 10%.
During clinical studies, there was no dose modification of belatacept for a change in body weight of less than 10%.
I kliniske studier var der til patienter med en kreatininclearance på ≥ 45 ml/min. ikke behov for særlige dosisjusteringer ud over de, der anbefales til alle patienter.
In clinical studies, patients with creatinine clearance of ≥ 45 ml/min required no dose adjustments other than those recommended for all patients.
I kliniske studier var det nødvendigt at give 30 ME/dag (300 mikrogram/dag) i 1 til 7dage pr. uge for at opretholde et ANC > 2,0 x 109/l med en mediane doseringshyppighed på 3 dage pr. uge.
In clinical studies, dosing with 30 MU/day (300 micrograms/day) on 1 - 7 days per week was required to maintain the ANC > 2.0 x 109/L, with the median dose frequency being 3 days per week.
I kliniske studier var dosisjustering ikke nødvendig hos ældre (> 65 år) patienter, der fik pomalidomid.
In clinical studies, no dosage adjustment was required in elderly (> 65 years) patients exposed to pomalidomide.
I kliniske studier var dulaglutids sikkerhedsprofil hos patienter med moderat nyreinsufficiens sammenlignelig med den samlede type 2 diabetes population.
In clinical studies, the dulaglutide safety profile in patients with moderate renal impairment was similar to the overall type 2 diabetes population.
I kliniske studier var hypoxæmi almindeligt forekommende, især inden for de første 15 minutter efter påbegyndt dexmedetomidin- ketamin anæstesi.
In clinical trials the incidence of hypoxaemia was common, especially within the 15 first minutes into dexmedetomidine-ketamine anaesthesia.
I kliniske studier var hypoxæmi almindeligt forekommende, især inden for de første 15 minutter efter påbegyndt dexmedetomidin- ketamin-anæstesi.
In clinical trials the incidence of hypoxaemia was common, especially within the 15 first minutes into dexmedetomidine-ketamine anaesthesia.
I kliniske studier var hypoxæmi almindeligt forekommende, især indenfor de første 15 minutter efter påbegyndt dexmedetomidin- ketamin anæstesi.
In clinical trials the incidence of hypoxaemia was common, especially within the 15 first minutes into dexmedetomidine-ketamine anaesthesia.
I kliniske studier var mediantiden til første forekomst af dysfunktion af venstre ventrikel, hjertesvigt eller reduktion af LVEF mellem 2 og 5 måneder.
In clinical trials, the median time to first occurrence of left ventricular dysfunction, cardiac failure and LVEF decrease was between 2 to 5 months.
I kliniske studier var mediantiden til første indtrædelse af dysfunktion af venstre ventrikel, hjertesvigt eller reduktion af LVEF mellem 2 og 5 måneder.
In clinical trials, the median time to onset of the first occurrence of left ventricular dysfunction, cardiac failure and LVEF decrease was between 2 and 5 months.
I kliniske studier var virkningen af ceftolozan/tazobactam mindre hos patienter med moderat nedsat nyrefunktion sammenlignet med patienter med normal eller let nedsat nyrefunktion ved baseline.
In clinical trials the efficacy of ceftolozane/tazobactam was lower in patients with moderate renal impairment compared with those with normal or mildly impaired renal function at baseline.
I kliniske studier ved en række indikationer omfattende allergisk rhinitis og kronisk idiopatisk urticaria, ved den anbefalede dosis på 5 mg daglig, blev bivirkninger med Aerius rapporteret hos 3 % flere patienter end hos dem, der behandledes med placebo.
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Aerius were reported in 3 % of patients in excess of those treated with placebo.
I kliniske studier ved en række indikationer omfattende allergisk rhinitis og kronisk idiopatisk urticaria, ved den anbefalede dosis på 5 mg daglig, blev bivirkninger med Azomyr rapporteret hos 3 % flere patienter end hos dem, der behandledes med placebo.
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Azomyr were reported in 3 % of patients in excess of those treated with placebo.
I kliniske studier ved en række indikationer omfattende allergisk rhinitis og kronisk idiopatisk urticaria, ved den anbefalede dosis på 5 mg daglig, blev bivirkninger med Neoclarityn rapporteret hos 3 % flere patienter end hos dem, der behandledes med placebo.
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Neoclarityn were reported in 3 % of patients in excess of those treated with placebo.
I kliniske studier vedrørende behandling af nedsat syn grundet DME var resultatet med hensyn til synsstyrke eller central retinadelfelttykkelse (CSFT) hos patienter, der blev behandlet med Lucentis, ikke påvirket af samtidig behandling med thiazolidindioner.
In clinical studies for the treatment of visual impairment due to DME, the outcome with regard to visual acuity or central retinal subfield thickness (CSFT) in patients treated with Lucentis was not affected by concomitant treatment with thiazolidinediones.
I kliniske studier vedrørende psoriasis, psoriasisartrit og ankyloserende spondylitis udviklede under 1 % af de patienter, der blev behandlet med Cosentyx i op til 52 uger, antistoffer over for secukinumab.
In psoriasis, psoriatic arthritis and ankylosing spondylitis clinical studies, less than 1% of patients treated with Cosentyx developed antibodies to secukinumab up to 52 weeks of treatment.
I kliniske studier vedrørende psoriasis, psoriasisartrit og ankyloserende spondylitis udviklede under 1 % af de patienter, der blev behandlet med Cosentyx i op til 52 uger, udviklede antistoffer over for secukinumab.
In psoriasis, psoriatic arthritis and ankylosing spondylitis clinical studies, less than 1% of patients treated with Cosentyx developed antibodies to secukinumab up to 52 weeks of treatment.
I kliniske studier viste maropitant plasmaniveauerne effekt fra 1 time efter administrationen.
During clinical studies maropitant plasma levels conferred efficacy from 1 hour after administration..
I kliniske studier – genotype 1
In clinical studies – Genotype 1
I kliniske studier – genotype 2, 3, 4, 5 og 6
In clinical studies – Genotype 2, 3, 4, 5 and 6
I kliniske studier, der omfattede 2.170 patienter, som blev behandlet med DuoTrav, var den hyppigst rapporterede behandlingsrelaterede bivirkning okulær hyperæmi (12,0 %).
In clinical studies involving 2170 patients treated with DuoTrav the most frequently reported treatment-related adverse reaction was ocular hyperaemia (12.0%)..
I kliniske studier, der sammenlignede r-hFSH (follitropin alfa) og u-FSH i ART (se tabel 1 nedenfor) og i ovulationsinduktion, var follitropin alfa mere potent end u-FSH i form af en lavere total dosis og en kortere behandlingsperiode til at udløse follikulær modning.
In clinical studies comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table 1 below) and in ovulation induction, follitropin alfa was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation.
I kliniske studier, hvor degenerativ diskussygdom blev behandlet ved hjælp af en posterior lumbal interkorporal fusionsprocedure med dibotermin alfa, observeredes posterior knogledannelse i CT- scanninger.
In clinical trials when degenerative disc disease was treated by a posterior lumbar interbody fusion procedure with dibotermin alfa, posterior bone formation was observed in CT scans.
I kliniske studier, hvor der kun er analyseret et begrænset antal isolater, er resistens overfor lopinavir kun observeret hos naïve patienter, som havde væsentlig proteasehæmmerresistens ved baseline.
In clinical studies with a limited number of isolates analysed, the selection of resistance to lopinavir has not been observed in naïve patients without significant protease inhibitor resistance at baseline.
I kliniske studier, hvor nogle af de vaccinerede personer fik Infanrix hexa samtidig med Prevenar (PCV7) som den fjerde boosterdosis for begge vacciner, blev feber  38,0 °C rapporteret hos 43,4 % af de børn, som fik Prevenar og Infanrix hexa samtidig, sammenlignet med hos 30,5 % af de spædbørn, som fik den hexavalente vaccine alene.
In clinical studies in which some of the vaccinees received Infanrix hexa concomitantly with Prevenar (PCV7) as a booster (4th) dose of both vaccines, fever  38.0°C was reported in 43.4% of infants receiving Prevenar and Infanrix hexa at the same time as compared to 30.5% of infants receiving the hexavalent vaccine alone.
I kliniske studier, hvor Prevenar 13 blev administreret 1 år efter 23-valent pneumokok polysaccharidvaccine, var immunresponset lavere for alle serotyper, sammenlignet med Prevenar 13 givet til personer, der ikke tidligere var blevet immuniseret med 23-valent pneumokok polysaccharidvaccine.
In clinical studies when Prevenar 13 was given 1 year after 23-valent pneumococcal polysaccharide vaccine the immune responses were lower for all serotypes compared to when Prevenar 13 was given to subjects not previously immunised with 23-valent pneumococcal polysaccharide vaccine.
I kliniske titreringsforsøg sås en effekt allerede ved en daglig dosis på 1,05 mg base (1,5 mg salt).
During dose escalation in pivotal studies, efficacy was observed starting at a daily dose of 1.05 mg of base (1.5 mg of salt).
I kliniske undersøgelser af cancerpatienter var den hyppigste bivirkning muskel- og knoglesmerter, var milde til moderate hos 10 % og svære hos 3 % af patienterne.
In clinical trials in cancer patients the most frequent undesirable effect was musculoskeletal pain which was mild or moderate in 10%, and severe in 3% of patients.
I kliniske undersøgelser af patienter med HIV var de eneste bivirkninger, som konsekvent blev anset for at være relateret til administration af filgrastim, muskuloskeletale smerter, knoglesmerter og myalgi.
In clinical studies in patients with HIV, the only undesirable effects that were consistently considered to be related to filgrastim administration were musculoskeletal pain, bone pain and myalgia.
I kliniske undersøgelser blandt frivillige er rosiglitazon blevet givet som enkeltdoser op til 20 mg og var godt tålt.
In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated.
I kliniske undersøgelser blev der udført post-mortem-undersøgelse af injektionsstedet højst 50 dage efter vaccination af søer.
In clinical studies, the post-mortem examination of the injection sites performed in sows at most
I kliniske undersøgelser blev et lille antal patienter opereret, mens de fik vandetanib, og der blev ikke rapporteret om sårhelingskomplikationer.
In clinical studies, a small number of patients had surgery while receiving vandetanib and there were no reported wound healing complications.
I kliniske undersøgelser blev LUMIGAN anvendt samtidig med et antal forskellige oftalmiske beta- blokerende øjenmidler uden tegn på interaktioner.
In clinical studies, LUMIGAN was used concomitantly with a number of different ophthalmic beta-blocking agents without evidence of interactions.
I kliniske undersøgelser blev patienter, som ikke udviste virologisk respons efter 6 måneders behandling (HCV-RNA under nedre detektionsgrænse), ikke vedvarende virologiske respondere (HCV- RNA under nedre detektionsgrænse 6 måneder efter ophørt behandling).
During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV-RNA below lower limit of detection) did not become sustained virologic responders (HCV- RNA below lower limit of detection six months after withdrawal of treatment).
I kliniske undersøgelser blev patienter, som ikke udviste virologisk respons efter 6 måneders behandling (HCV-RNA under nedre detektionsgrænse), ikke vedvarende virologiske respondere (HCV-RNA under nedre detektionsgrænse 6 måneder efter ophørt behandling).
During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV- RNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).