natgillin/translations-raw huggingface dataset:
De behandlede patienter (N = 305) havde en median alder på 54 år (interval: 19-70); 65,2 % var mænd; 11,8 % var sorte; 19,7 % havde et BMI på mindst 30 kg/m2; 20,7 % havde depression eller bipolar lidelse i anamnesen; 69,2 % havde genotype IL28B non-C/C; 86,6 % havde et HCV-rna- niveau på mindst 800.000 IE/ml ved baseline; 18,4 % havde portal fibrose (F2), og 17,7 % havde bridging fibrose (F3).
Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 19.7% had a body mass index of at least 30 kg/m2; 20.7% had a history of depression or bipolar disorder; 69.2% had IL28B non-CC genotype; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
De behandlede patienter (N = 305) havde en median alder på 54 år (interval: 19-70); 65,2 % var mænd; 11,8 % var sorte; 20,7 % havde depression eller bipolar lidelse i anamnesen;; 86,6 % havde et HCV-rna- niveau på mindst 800.000 IE/ml ved baseline; 18,4 % havde portal fibrose (F2), og 17,7 % havde bridging fibrose (F3).
Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 20.7% had a history of depression or bipolar disorder; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
De behandlede patienter (N = 419) havde en median alder på 50 år (interval: 19-70); 45,8 % var mænd; 4,8 % var sorte; 16,5 % havde et BMI på mindst 30 kg/m2; 9,3 % havde depression eller bipolar lidelse i anamnesen; 79,0 % havde genotype IL28B non-C/C; 73,3 % havde et HCV-rna- niveau på mindst 800.000 IE/ml ved baseline; 20,3 % havde portal fibrose (F2), og 10,0 % havde bridging fibrose (F3).
Treated subjects (N=419) had a median age of 50 years (range: 19 to 70); 45.8% were male; 4.8% were Black; 16.5% had a body mass index of at least 30 kg/m2; 9.3% had a history of depression or bipolar disorder; 79.0% had IL28B non-CC genotype; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3).
De behandlede patienter (N = 419) havde en median alder på 50 år (interval: 19-70); 45,8 % var mænd; 4,8 % var sorte; 9,3 % havde depression eller bipolar lidelse i anamnesen; 73,3 % havde et HCV-rna- niveau på mindst 800.000 IE/ml ved baseline; 20,3 % havde portal fibrose (F2), og 10,0 % havde bridging fibrose (F3).
Treated subjects (N=419) had a median age of 50 years (range: 19 to 70), 45.8% were male; 4.8% were Black; 9.3% had a history of depression or bipolar disorder; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3).
De behandlede patienter (N = 63) havde en gennemsnitsalder på 51 år (interval: 31-69), 24 % var sorte, 81 % havde genotype IL28B non-C/C, 19 % havde kompenseret cirrose, 67 % var HCV- behandlingsnaive, 33 % havde oplevet behandlingssvigt med pegIFN/RBV, og 89 % havde HCV genotype 1a-infektion.
Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% of subjects were Black; 81% of subjects had IL28B non-CC genotype; 19% of subjects had compensated cirrhosis; 67% of subjects were HCV treatment-naïve; 33% of subjects had failed prior treatment with pegIFN/RBV; 89% of subjects had HCV genotype 1a infection.
De behandlede patienter (N = 631) havde en median alder på 52 år (interval: 18-70); 54,5 % var mænd; 5,4 % var sorte; 15,2 % havde depression eller bipolar lidelse i anamnesen; 79,1 % havde et HCV-rna- niveau på mindst 800.000 IE/ml ved baseline; 15,4 % havde portal fibrose (F2), og 8,7 % havde bridging fibrose (F3); 67,7 % havde HCV genotype 1a-infektion; 32,3 % havde HCV genotype 1b-infektion.
Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 15.2% had a history of depression or bipolar disorder; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
De behandlede patienter (N = 631) havde en median alder på 52 år (interval: 18-70); 54,5 % var mænd; 5,4 % var sorte; 16,2 % havde et BMI på mindst 30 kg/m2; 15,2 % havde depression eller bipolar lidelse i anamnesen; 69,3 % havde genotype IL28B non-C/C; 79,1 % havde et HCV-rna- niveau på mindst 800.000 IE/ml ved baseline; 15,4 % havde portal fibrose (F2), og 8,7 % havde bridging fibrose (F3); 67,7 % havde HCV genotype 1a-infektion; 32,3 % havde HCV genotype 1b- infektion.
Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 16.2% had a body mass index of at least 30 kg/m2; 15.2% had a history of depression or bipolar disorder; 69.3% had IL28B non-CC genotype; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
De behandlede patienter havde en gennemsnitsalder på 50 år (interval: 18 til 67); 79% af patienterne var hvide; 13% var sorte/afroamerikanere; 1% var asiatere og 9% var latinamerikanere.
Treated patients had a median age of 50 years (range: 18 to 67); 79% of patients were white; 13% were black/African-American; 1% were Asian; 9% were Hispanic or Latino.
De behøver ikke at fjeren luftboblerne, før De injicerer Dem.
You do not have to remove the air bubble before injecting.
De behøver normalt ikke at blive behandlet.
They don’t usually need any treatment.
De belangrijkste exclusiecriteria voor patiënten waren gedocumenteerd ulcus pepticum tijdens de voorbije 6 maanden; een vroegere intracerebrale bloeding; significante trombocytopenie (aantal plaatjes < 50 x 109/l); noodzaak voor clopidogrel of orale anticoagulantia (OAC); of intolerantie voor één van de twee verbindingen.
The major exclusion criteria for patients were documented peptic ulcer disease within the previous months; prior intracerebral hemorrhage; significant thrombocytopenia (platelet count < 50 x 109/l); requirement for clopidogrel or oral anticoagulants (OAC); or intolerance to any of the two compounds.
De beskrevne bivirkninger inkluderer stimulering af centralnervesystemet (CNS) såsom krampeanfald, irritabilitet, rastløshed og anspændthed, kardielle virkninger som for eksempel takykardi, arytmi, hypertension samt øget slagvolumen, metaboliserings- og ernæringsforstyrrelser såsom hyperglykæmi.
Effects described include central nervous system (CNS) stimulation such as convulsion, irritability, restlessness and jitteriness, cardiac effects such as tachycardia, arrhythmia, hypertension and increased stroke volume, metabolism and nutrition disorders such as hyperglycaemia.
De beskrevne tilfælde omfattede positiv reeksponering og tæt tidsmæssig forbindelse til administrationen af aflibercept samt manglende alternative forklaringer.
Cases described included positive rechallenged, close temporal relationship to the administration of aflibercept and lack of alternative explanations.
De bijwerkingen die waargenomen werden tijdens klinische studies of die spontaan werden gerapporteerd, worden hieronder weergegeven.
Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in the table below.
De binding is in vitro niet verzadigbaar binnen een brede concentratiespreiding.
The binding is non-saturable in vitro over a wide concentration range.
De bittesmå partikler med medicin i kapslen hvirvles op af luftstrømmen og inhaleres gennem dine luftveje til lungerne.
The tiny particles of medicine in the capsule are picked up by the airflow and carried down your airway into your lungs.
De bivirkninger af eculizumab, der blev rapporteret med en hyppighed svarende til meget almindelige (1/10), almindelige (≥1/100 til <1/10) eller ikke almindelige (≥1/1.000 til < 1/100), er opført iht. organklasse og foretrukket betegnelse.
Adverse reactions reported at a very common (≥1/10), common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100) frequency with eculizumab are listed by system organ class and preferred term.
De bivirkninger, der blev indberettet med Vivanza filmovertrukne tabletter eller vardenafil 10 mg smeltetabletter i kliniske studier, var generelt forbigående og lette til moderate.
The adverse reactions reported with Vivanza film-coated tablets or vardenafil 10 mg orodispersible tablets in clinical trials were generally transient and mild to moderate in nature.
De bivirkninger, der blev observeret hos 533 patienter med metastatisk kolorektal cancer, behandlet med en startdosis Lonsurf på 35 mg/m2/dosis i et placebokontrolleret klinisk fase III-forsøg (RECOURSE), er vist i tabel 5.
The adverse drug reactions observed from the 533 patients with metastatic colorectal cancer, treated with a starting dose of 35 mg/m2/dose of Lonsurf, in the placebo-controlled Phase III (RECOURSE) clinical trial, are shown in Table 5.
De bivirkninger, der blev observeret hos pædiatriske forsøgspersoner, som fik behandling med entecavir, var de samme som de bivirkninger, der blev observeret hos voksne i kliniske forsøg med entecavir (se a.
The adverse reactions observed in paediatric subjects who received treatment with entecavir were consistent with those observed in clinical trials of entecavir in adults.(see a.
De bivirkninger, der blev observeret i kliniske studier og indberettet efter markedsføringen, er anført nedenfor.
The adverse reactions observed in clinical studies and reported in post-marketing experience are detailed below.
De bivirkninger, der blev observeret ved fortsat behandling i 384 uger, var i overensstemmelse med sikkerhedsprofilen for tenofovirdisoproxilfumarat.
The adverse reactions observed with continued treatment for 384 weeks were consistent with the safety profile of tenofovir disoproxil fumarate.
De bivirkninger, der blev observeret ved kombinationen af dolutegravir + abacavir/lamivudin i analysen af sammenlagte data fra kliniske fase IIb til IIIb-studier, var generelt i overensstemmelse med bivirkningsprofilerne for de enkelte komponenter dolutegravir, abacavir og lamivudin.
The adverse reactions observed for the combination of dolutegravir + abacavir/lamivudine in an analysis of pooled data from Phase IIb to Phase IIIb clinical trials were generally consistent with the adverse reaction profiles for the individual components dolutegravir, abacavir and lamivudine.
De bivirkninger, der blev rapporteret hos 2.799 patienter, som blev behandlet med pembrolizumab i kliniske studier, er opført i tabel 2.
Adverse reactions reported in 2,799 patients treated with pembrolizumab in clinical trials are reported in Table 2.
De bivirkninger, der blev rapporteret hos den største procentdel af patienterne, var hæmatologiske (anæmi, leukopeni, neutropeni og trombocytopeni), metaboliske (hyperkolesterolæmi, hyperlipidæmi, hyperglykæmi, øgede serum-aspartataminotransferase-(ASAT)- og serum-alaninaminotransferase- (ALAT)-plasmaniveauer samt gastrointestinale (mucositis, stomatitis, kvalme og opkastning).
The adverse reactions reported by the highest percentage of patients were haematologic (anaemia, leukopaenia, neutropaenia, and thrombocytopaenia), metabolic (hypercholesterolaemia, hyperlipaemia, hyperglycaemia, increase of serum aspartate amino transferase (AST) and serum alanine aminotransferase (ALT) plasma levels), and digestive (mucositis, stomatitis, nausea, and vomiting).
De bivirkninger, der blev rapporteret i disse tre kliniske studier, er opsummeret og kategoriseret i henhold til MedDRA- systemorganklasser og hyppighed nedenfor.
The ARs reported in these three clinical studies are summarised and categorised according to the MedDRA System Organ Class and frequency below.
De bivirkninger, der blev rapporteret med idelalisib alene eller i kombination med anti-CD20 et monoklonalt antistof (rituximab eller ofatumumab), er opstillet i tabel 2.
The adverse drug reactions reported with idelalisib alone or in combination with anti-CD20 monoclonal antibodies (rituximab or ofatumumab) are provided in Table 2.
De bivirkninger, der blev rapporteret, er anført nedenfor efter systemorganklasse i henhold til MedDRA og efter hyppighed.
ADRs which were reported are listed below by MedDRA body system organ class and by frequency.
De bivirkninger, der er anført nedenfor, er set hos patienter med gigt, som er behandlet med medicin, der indeholder det samme aktive stof som findes i Onsenal.
The side effects listed below were observed in arthritis patients who took medicines with the same active ingredient as Onsenal:
De bivirkninger, der er anført nedenfor, er set hos patienter med gigt, som er behandlet med medicin, der indeholder det samme aktive stof, som findes i Onsenal.
The side effects listed below were observed in arthritis patients who took medicines with the same active ingredient as Onsenal:
De bivirkninger, der er beskrevet i dette afsnit, er identificeret i det pivotale kliniske studie (N = 189).
The adverse reactions described in this section were identified in the pivotal clinical study (N = 189).
De bivirkninger, der er beskrevet under dette punkt, er indsamlet fra en kombination af bivirkninger hos ALL-patienter fra data fra kliniske studier og fra rapportering efter markedsføringen af Oncaspar.
The adverse reaction described in this section is gathered from a combination of adverse reactions from clinical trial data and the post-marketing experience of Oncaspar in ALL patients.
De bivirkninger, der er forbundet med Xultophy, er anført nedenfor efter systemorganklasse og hyppighed.
Adverse reactions associated with Xultophy are given below, listed by system organ class and frequency.
De bivirkninger, der er iagttaget med Omnitrope, var af samme art og sværhedsgrad som med referencelægemidlet Genotropin.
The side effects seen with Omnitrope were similar in type and severity to those seen with the reference medicine Genotropin.
De bivirkninger, der er identificeret i disse kliniske studier og efter markedsføring, vises i tabel 1.
The adverse reactions identified in these clinical trials and from post-marketing experience are presented in table 1.
De bivirkninger, der er indberettet fra de 1.871 patienter behandlet med trastuzumabemtansin, vises i tabel 6.
The ADRs in1871 patients treated with trastuzumab emtansine are presented in Table 6.
De bivirkninger, der er indberettet hos melanompatienter, angives nedenfor i overensstemmelse med MedDRA’s organklassesystem og efter hyppighed og sværhedsgrad.
ADRs which were reported in melanoma patients are listed below by MedDRA body system organ class, frequency and grade of severity.
De bivirkninger, der er markeret med *, kan skyldes behandlingen med busulfan.
The ones marked may be related to busulfan.
De bivirkninger, der er nævnt i dette afsnit, er primært afledt af kliniske forsøg og/eller bivirkninger fra spontane indberetninger, når ribavirin anvendt i kombination med interferon alfa-2b eller peginterferon alfa-2b.
The adverse reactions listed in this section are primarily derived from clinical trials and/or as adverse drug reactions from spontaneous reports when ribavirin was used in combination with interferon alfa- 2b or peginterferon alfa-2b.
De bivirkninger, der er observeret hos børn og unge med børnegigt svarer til dem, der er set hos voksne med leddegigt, med følgende undtagelser:
The side effects experienced in children and adolescents with polyarticular juvenile idiopathic arthritis are similar to those experienced in adults with rheumatoid arthritis, with the following differences:
De bivirkninger, der er observeret i kliniske studier med mock-up-vaccinen Foclivia er opført nedenfor.
Adverse reactions from clinical trials with the mock-up vaccine Foclivia are listed below.
De bivirkninger, der er observeret i kliniske studier med mock-up-vaccinen Foclivia, er opført nedenfor.
Adverse reactions from clinical trials with the mock-up vaccine Foclivia are listed below.
De bivirkninger, der er opført i tabel 1, er samlet både fra poolede data fra elleve dobbeltblinde kliniske studier omfattende 3.230 patienter (1.810 behandlet med Corbilta eller entacapon i kombination med levodopa/DDC-hæmmer og 1.420 patienter behandlet med placebo i kombination med levodopa/DDC-hæmmer eller cabergolin i kombination med levodopa/DDC-hæmmer) og fra post-marketing data efter introduktion af entacapon på markedet til anvendelse i kombination med levodopa/DDC-hæmmer.
The following adverse reactions, listed in Table 1, have been accumulated both from a pooled data of eleven double-blind clinical trials consisting of 3230 patients (1810 treated with Corbilta or entacapone combined with levodopa/DDC inhibitor, and 1420 treated with placebo combined with levodopa/DDC inhibitor or cabergoline combined with levodopa/ DDC inhibitor), and from the post- marketing data since the introduction of entacapone into the market for the combination use of entacapone with levodopa/DDC inhibitor.
De bivirkninger, der er opført i tabel 1, er samlet både fra poolede data fra elleve dobbeltblinde kliniske studier omfattende 3.230 patienter (1.810 behandlet med Stalevo eller entacapon i kombination med levodopa/DDC-hæmmer og 1.420 patienter behandlet med placebo i kombination med levodopa/DDC-hæmmer eller cabergolin i kombination med levodopa/DDC-hæmmer) og fra post-marketing data efter introduktion af entacapon på markedet til anvendelse i kombination med levodopa/DDC-hæmmer.
The following adverse reactions, listed in Table 1, have been accumulated both from a pooled data of eleven double-blind clinical trials consisting of 3230 patients (1810 treated with Stalevo or entacapone combined with levodopa/DDC inhibitor, and 1420 treated with placebo combined with levodopa/DDC inhibitor or cabergoline combined with levodopa/ DDC inhibitor), and from the post- marketing data since the introduction of entacapone into the market for the combination use of entacapone with levodopa/DDC inhibitor.
De bivirkninger, der er opført i tabel 1, er samlet både fra poolede data fra elleve dobbletblinde kliniske studier omfattende 3.230 patienter (1.810 behandlet med Corbilta eller entacapon i kombination med levodopa/DDC-hæmmer og 1.420 patienter behandlet med placebo i kombination med levodopa/DDC-hæmmer eller cabergolin i kombination med levodopa/DDC-hæmmer) og fra post-marketing data efter introduktion af entacapon på markedet til anvendelse i kombination med levodopa/DDC-hæmmer.
The following adverse reactions, listed in Table 1, have been accumulated both from a pooled data of eleven double-blind clinical trials consisting of 3230 patients (1810 treated with Corbilta or entacapone combined with levodopa/DDC inhibitor, and 1420 treated with placebo combined with levodopa/DDC inhibitor or cabergoline combined with levodopa/ DDC inhibitor), and from the post- marketing data since the introduction of entacapone into the market for the combination use of entacapone with levodopa/DDC inhibitor.
De bivirkninger, der er rapporteret hos patienter med fremskreden melanom, som blev behandlet med ipilimumab 3 mg/kg i kliniske forsøg (n= 767) er opstillet i Tabel 2.
Adverse reactions reported in patients with advanced melanoma who were treated with ipilimumab 3 mg/kg in clinical trials (n= 767) are presented in Table 2.
De bivirkninger, der er set med Xarelto , er sammenfattet i tabel 2 nedenfor efter systemorganklasse (i henhold til MedDRA) og hyppighed.
The frequencies of adverse reactions reported with Xarelto are summarised in table 2 below by system organ class (in MedDRA) and by frequency.
De bivirkninger, der forekom oftest og med en højere incidens i Memantine Merz-gruppen end i placebogruppen, var svimmelhed (hhv.
The most frequently occurring adverse reactions with a higher incidence in the Memantine
De bivirkninger, der havde den største stigning, var diaré hos patienter, der blev behandlet med Vectibix i kombination med enten FOLFOX eller FOLFIRI, samt dehydrering og lungeemboli hos patienter, der blev behandlet med Vectibix i kombination med FOLFIRI.
The most increased serious adverse events were diarrhoea in patients treated with Vectibix in combination with either FOLFOX or FOLFIRI, and dehydration and pulmonary embolism when patients were treated with Vectibix in combination with FOLFIRI.
De bivirkninger, der hyppigst (≥1 % i den samlede perampanel-gruppe og højere end placebo) førte til seponering var svimmelhed og døsighed.
The adverse reactions most commonly (≥1% in the total perampanel group and greater than placebo) leading to discontinuation were dizziness and somnolence.
De bivirkninger, der hyppigst førte til seponering af hhv.
The most frequent adverse reactions leading to discontinuation for
De bivirkninger, der hyppigst førte til seponering for patienter behandlet med liraglutid, var kvalme (2,8 % af patienterne) og opkastning (1,5 %).
The most frequent adverse reactions leading to withdrawal for liraglutide­treated patients were nausea (2.8% of patients) and vomiting (1.5%).
De bivirkninger, der muligvis er relateret til behandling med filgrastim, og som typisk forekommer hos < 2 % af SCN-patienter, er reaktioner på injektionsstedet, hovedpine, hepatomegali, artralgi, alopeci, osteoporose og udslæt.
Undesirable effects possibly related to filgrastim therapy and typically occurring in < 2% of SCN patients were injection site reaction, headache, hepatomegaly, arthralgia, alopecia, osteoporosis, and rash.
De bivirkninger, der muligvis er relateret til behandling med filgrastim, og som typisk forekommer hos < 2 % af SCN-patienter, er reaktioner på injektionsstedet, hovedpine, hepatomegali, artralgi, alopeci, osteoporose og udslæt.
Undesirable effects possibly related to filgrastim therapy and typically occurring in <2% of SCN patients were injection site reaction, headache, hepatomegaly, arthralgia, alopecia, osteoporosis, and rash.
De bivirkninger, der oftest opstår, er som følger: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til
Adverse reactions encountered most often are as follows: very common (≥ 1/10), common (≥ 1/100 to
De bivirkninger, der opsummeres i tabel 3, forekom alle med en hyppighed ≥ 5 % i MabThera- gruppen.
The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the MabThera group.
De bivirkninger, der sås i et farmakokinetikstudie og et tolerabilitetsstudie omfattende patienter i alderen fra 3 måneder til 16 år (n=65), var de samme som dem, der sås hos voksne.
The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) were similar to those observed in adults.
De bivirkninger, der sås med celecoxib i disse supplerende forsøg, var de samme som dem, der blev set hos patienterne med osteoarthrosis og reumatoid artrit anført i tabel 1.
The adverse reactions observed with celecoxib in these additional studies were consistent with those for osteoarthritis and rheumatoid arthritis patients listed in Table 1.
De bivirkninger, der sås ved Fampyra, er hovedsageligt neurologiske (vedrører hjernen eller nerverne), og omfatter krampeanfald, søvnbesvær, angst, balanceproblemer, svimmelhed, usædvanlige prikkende og snurrende fornemmelser (paræstesi), rysten, hovedpine og afkræftelse (asteni).
The side effects seen with Fampyra are mostly neurological (relating to the brain or nerves) and include seizures (fits), insomnia (difficulty sleeping), anxiety, problems with balance, dizziness, paraesthesia (unusual sensations like pins and needles), tremor, headache and asthenia (weakness).
De bivirkninger, der undertiden ses med Melosus, er de samme som dem, der normalt ses med NSAID'er, såsom nedsat appetit, opkastning, diarré, blod i afføringen, nyreinsufficiens og apati (mangel på vitalitet).
Occasional side effects of Melosus are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, renal failure and apathy (lack of vitality).