natgillin/translations-raw huggingface dataset:
I kliniske studier hos cancerpatienter var de hyppigste bivirkninger lette til moderate muskel- og ledsmerter, som var lette 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 studier hos mennesker resulterede en 10 mg oral dosis af tenofoviralafenamid givet sammen med emtricitabin, cobicistat og elvitegravir, i tenofovirdiphosphatkoncentrationer > 4 gange højere i PBMC’er og > 90 % lavere koncentrationer af tenofovir i plasma sammenlignet med en 245 mg oral dosis af tenofovirdisoproxil (som fumarat) givet sammen med emtricitabin, cobicistat og elvitegravir
In human clinical studies, a 10 mg oral dose of tenofovir alafenamide given with emtricitabine, cobicistat and elvitegravir resulted in tenofovir diphosphate concentrations > 4-fold higher in PBMCs and > 90% lower concentrations of tenofovir in plasma as compared to a 245 mg oral dose of tenofovir disoproxil (as fumarate) given with emtricitabine, cobicistat and elvitegravir.
I kliniske studier hos patienter med Crohns sygdom udviklede færre end 3 % af de patienter, der blev behandlet med ustekinumab, antistoffer mod ustekinumab.
In Crohn’s disease clinical studies, less than 3% of patients treated with ustekinumab developed antibodies to ustekinumab.
I kliniske studier hos patienter med hiv var de eneste bivirkninger, der vedvarende blev anset som at være relateret til administration af filgrastim muskel- og ledsmerter, 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 studier hos patienter med nydiagnosticeret myelomatose, som ikke var egnede til transplantation, var kombinationsbehandling med lenalidomid mindre tolereret hos patienter over 75 år, sammenlignet med den yngre population.
In clinical trials of newly diagnosed multiple myeloma in transplant non eligible patients, lenalidomide combined therapy was less tolerated in patients older than 75 years of age compared to the younger population.
I kliniske studier hos patienter med psoriasis reducerede apremilast epidermis-fortykkelse af hudlæsionerne, inflammatorisk celleinfiltration og ekspressionen af proinflammatoriske gener, herunder generne for inducerbart nitrogenoxidsyntase (iNOS), IL-12/IL- 23p40, IL-17A, IL-22 og IL-8.
In clinical trials in patients with psoriasis, apremilast decreased lesional skin epidermal thickness, inflammatory cell infiltration, and expression of pro-inflammatory genes, including those for inducible nitric oxide synthase (iNOS), IL-12/IL-23p40, IL-17A, IL-22 and IL-8.
I kliniske studier hos patienter med psoriatisk artritis modulerede apremilast signifikant, men det hæmmede ikke fuldstændigt plasmaproteinniveauerne af IL-1α, IL-6, IL-8, MCP-1, MIP-1β, MMP-3 og TNF-α.
In clinical studies in patients with psoriatic arthritis, apremilast significantly modulated, but did not fully inhibit, plasma protein levels of IL-1α, IL-6, IL-8, MCP-1, MIP-1β, MMP-3, and TNF-α.
I kliniske studier hos voksne med en dosering på 250 mikrogram (totalt 633 patienter) var de hyppigst observerede bivirkninger, der i det mindste muligvis var relaterede til Aloxi, hovedpine (9 %) og obstipation (5 %).
In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to Aloxi, were headache (9 %) and constipation (5 %).
I kliniske studier hos voksne med en dosering på 250 mikrogram (totalt 633 patienter) var de hyppigst observerede bivirkninger, der i det mindste muligvis var relaterede til palonosetron, hovedpine (9 %) og obstipation (5 %).
In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to palonosetron, were headache (9 %) and constipation (5 %).
I kliniske studier krævede patienter med en kreatinin- clearance på  45 ml/min ingen 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 krævede patienter med en kreatinin-clearance på  45 ml/min ingen 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 krævede patienter med en kreatinin-clearance på  45 ml/min ingen 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 med 1.900 patienter, der blev behandlet med Nevanac 3 mg/ml øjendråber, suspension, var de hyppigst indberettede bivirkninger punktformet keratitis, keratitis, fornemmelse af fremmedlegemer i øjet og smerter i øjet, hvilket forekom hos mellem 0,4 % og 0,1 % af patienterne.
In clinical studies involving over 1900 patients receiving NEVANAC 3 mg/ml eye drops, suspension, the most frequently reported adverse reactions were punctate keratitis, keratitis, foreign body sensation in eyes and eye pain which occurred in between 0.4% and 0.1% of patients.
I kliniske studier med 1680 patienter blev OPATANOL administreret fra 1 til 4 gange dagligt i begge øjne i op til 4 måneder som monoterapi eller som supplerende terapi til 10 mg loratadin.
In clinical studies involving 1680 patients, OPATANOL was administered one to four times daily in both eyes for up to four months as monotherapy or adjunctive therapy to loratadine 10 mg.
I kliniske studier med 2.314 patienter, der blev behandlet med Nevanac 1 mg/ml øjendråber, var de hyppigste bivirkninger, der forekom hos mellem 0,4 % og 0,2% af patienterne, punktformet keratitis, fornemmelse af fremmedlegeme i øjet og skorper på øjenlågsranden.
In clinical studies involving 2314 patients receiving NEVANAC 1 mg/ml the most common adverse reactions were punctate keratitis, foreign body sensation and eyelid margin crusting which occurred in between 0.4% and 0.2% of patients.
I kliniske studier med 48 ugers behandling og 24 ugers follow-up svarede sikkerhedsprofilen for Pegasys ved kronisk hepatitis B til sikkerhedsprofilen for kronisk hepatitis C. Med undtagelse af pyreksi var frekvensen for størstedelen af de rapporterede bivirkninger markant mindre for patienter med kronisk hepatitis B, der blev behandlet med Pegasys-monoterapi sammenlignet med HCV- patienter, der blev behandlet med Pegasys-monoterapi (se tabel 9).
In clinical trials of 48 weeks treatment and 24 weeks follow-up, the safety profile for Pegasys in chronic hepatitis B was similar to that seen in chronic hepatitis C. With the exception of pyrexia the frequency of the majority of the reported adverse reactions was notably less in CHB patients treated with Pegasys monotherapy compared with HCV patients treated with Pegasys monotherapy (see Table
I kliniske studier med 48 ugers behandling og 24 ugers follow-up svarede sikkerhedsprofilen for Pegasys ved kronisk hepatitis B til sikkerhedsprofilen for kronisk hepatitis C. Med undtagelse af pyreksi var frekvensen for størstedelen af de rapporterede bivirkninger markant mindre for patienter med kronisk hepatitis B, der blev behandlet med Pegasys-monoterapi sammenlignet med HCV- patienter, der blev behandlet med Pegasys-monoterapi (se tabel 9).
In clinical trials of 48 weeks treatment and 24 weeks follow-up, the safety profile for Pegasys in chronic hepatitis B was similar to that seen in chronic hepatitis C. With the exception of pyrexia the frequency of the majority of the reported adverse reactions was notably less in CHB patients treated with Pegasys monotherapy compared with HCV patients treated with Pegasys monotherapy (see Table 9).
I kliniske studier med 866 behandlingsnaive voksne patienter, der fik emtricitabin og tenofoviralafenamid sammen med elvitegravir og cobicistat som en fastdosis kombinationstablet med elvitegravir 150 mg/cobicistat 150 mg/emtricitabin 200 mg/tenofoviralafenamid (som fumarat) 10 mg (E/C/F/TAF) i 96 uger, var de hyppigst indberettede bivirkninger diarré (7 %), kvalme (10 %) og hovedpine (6 %).
In clinical studies of 866 treatment-naïve adult patients receiving emtricitabine and tenofovir alafenamide with elvitegravir and cobicistat as the fixed-dose combination tablet elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (as fumarate) 10 mg (E/C/F/TAF) through 96 weeks, the most frequently reported adverse reactions were diarrhoea (7%), nausea (10%), and headache (6%).
I kliniske studier med Aerius er følgende bivirkninger blevet rapporteret som: Almindelige: følgende kan forekomme hos op til 1 ud af 10 personer
In clinical studies with Aerius, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
I kliniske studier med Aerius er følgende bivirkninger blevet rapporteret som: Børn
In clinical studies with Aerius, the following side effects were reported as: Children
I kliniske studier med Ameluz sås hudreaktioner lokalt på applikationsstedet hos op til 96 % af de undersøgte personer.
In clinical trials with Ameluz, local skin reactions at the application site were observed in up to 96% of the subjects.
I kliniske studier med asfotase alfa er der blevet rapporteret uønskede hændelser med kraniosynostose (forbundet med øget intrakranielt tryk), herunder forværring af eksisterende kraniosynostose hos patienter med hypophosphatasi < 5 år.
In asfotase alfa clinical studies adverse events of craniosynostosis (associated with increased intracranial pressure), including worsening of pre-existing craniosynostosis have been reported in hypophosphatasia patients < 5 years of age.
I kliniske studier med Azomyr er følgende bivirkninger blevet rapporteret som: Almindelige: følgende kan forekomme hos op til 1 ud af 10 personer
In clinical studies with Azomyr, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
I kliniske studier med Azomyr er følgende bivirkninger blevet rapporteret som: Børn
In clinical studies with Azomyr, the following side effects were reported as: Children
I kliniske studier med behandlingserfarne patienter sås udslæt oftere, uanset kausalitet, ved behandlingsregimer med ISENTRESS og darunavir end ved de regimer, der indeholdt ISENTRESS uden darunavir eller darunavir uden ISENTRESS.
In clinical studies of treatment-experienced patients, rash, irrespective of causality, was more commonly observed with regimens containing ISENTRESS and darunavir compared to those containing ISENTRESS without darunavir or darunavir without ISENTRESS.
I kliniske studier med Cayston førte isolering af MRSA ikke til en forværring af lungefunktionen.
During clinical studies of Cayston, isolation of MRSA did not result in worsening of lung function.
I kliniske studier med CSU-patienter blev Xolair brugt sammen med antihistaminer (anti-H1, anti-H2) og leukotrienreceptor-antagonister (LTRA’er).
In clinical studies in CSU, Xolair was used in conjunction with antihistamines (anti-H1, anti-H2) and leukotriene receptor antagonists (LTRAs).
I kliniske studier med Dasselta er følgende bivirkninger blevet rapporteret som: Almindelige: følgende kan forekomme hos op til 1 ud af 10 personer
In clinical studies with desloratadine, the following side effects were reported as: Common (the following may affect up to 1 in 10 people):
I kliniske studier med denosumab har symptomerne på hypokalcæmi omfattet paræstesier eller muskelstivhed, muskelspjæt, spasmer og muskelkramper.
Symptoms of hypocalcaemia in denosumab clinical studies included paresthesias or muscle stiffness, twitching, spasms and muscle cramps.
I kliniske studier med depotformulering af exenatid havde cirka 45 % af patienterne lave antistoftitre mod exenatid ved studiets afslutning.
In clinical studies of prolonged-release exenatide, approximately 45 % of patients had low titre antibodies to exenatide at study endpoint.
I kliniske studier med desloratadin er følgende bivirkninger blevet rapporteret som: Almindelige: følgende kan forekomme hos op til 1 ud af 10 personer
In clinical studies with desloratadine, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
I kliniske studier med desloratadin er følgende bivirkninger blevet rapporteret: Almindelig: følgende kan forekomme hos op til 1 ud af 10 personer
In clinical studies with desloratadine, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
I kliniske studier med desloratadin er følgende bivirkninger blevet rapporteret: Almindelige: følgende kan forekomme hos op til 1 ud af 10 personer
In clinical studies with desloratadine, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
I kliniske studier med GONAL-f, der sammenlignede r-hFSH (follitropin alfa) og u-FSH i ART (se tabel 3 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 with GONAL-f comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table 3 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 med HBV-inficerede patienter, var den hyppigst forekommende bivirkning med tenofovirdisoproxilfumarat kvalme (5,4%).
In clinical trials of HBV infected patients, the most frequently occurring adverse reaction to tenofovir disoproxil fumarate was nausea (5.4%).
I kliniske studier med HCV-patienter blev gastrointestinal blødning, herunder alvorlige og dødelige tilfælde, rapporteret med en højere incidens efter seponering af peginterferon, ribavirin og eltrombopag.
In HCV clinical trials, a higher incidence of gastrointestinal bleeding, including serious and fatal cases, was reported following discontinuation of peginterferon, ribavirin, and eltrombopag.
I kliniske studier med hæmodialysepatienter havde sevelamer alene ikke nogen vedvarende og klinisk signifikant virkning på intakt paratyroideahormon (iPTH) i serum.
In the clinical studies in haemodialysis patients, sevelamer alone did not have a consistent and clinically significant effect on serum intact parathyroid hormone (iPTH).
I kliniske studier med Ilaris hos CAPS-patienter steg middelværdierne for hæmoglobin, og middelværdierne for hvide blodlegemer, neutrofile og blodplader faldt.
During clinical trials with Ilaris in CAPS patients mean values for haemoglobin increased and those for white blood cell, neutrophils and platelets decreased.
I kliniske studier med infliximab hvori 5.780 patienter blev behandlet, svarende til 5.494 patientår, sås 5 tilfælde af lymfomer og 26 non-lymfom maligniteter sammenlignet med ingen lymfom og 1 non- lymfom malignitet hos 1.600 placebobehandlede patienter svarende til 941 patientår.
In clinical studies with infliximab in which 5,780 patients were treated, representing 5,494 patient years, 5 cases of lymphomas and 26 non-lymphoma malignancies were detected as compared with no lymphomas and 1 non-lymphoma malignancy in 1,600 placebo-treated patients representing
I kliniske studier med MabThera som vedligeholdelsesbehandling af recidiveret/refraktært follikulært lymfom var de mediane IgG-niveauer under nedre referencegrænse (< 7 g/l) i både observationsgruppen og MabThera-gruppen efter induktionsbehandlingen.
In the clinical trial evaluating MabThera maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction treatment in both the observation and the MabThera groups.
I kliniske studier med Neoclarityn er følgende bivirkninger blevet rapporteret som: Almindelige: følgende kan forekomme hos op til 1 ud af 10 personer
In clinical studies with Neoclarityn, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
I kliniske studier med Neoclarityn er følgende bivirkninger blevet rapporteret som: Børn
In clinical studies with Neoclarityn, the following side effects were reported as: Children
I kliniske studier med Nuwiq på tidligere behandlede pædiatriske patienter (2 - 11 år, n = 58), unge patienter (12 - 17 år, n = 3) og voksne patienter (n = 74) med svær hæmofili A blev der indberettet i alt 8 bivirkninger (6 hos voksne, 2 hos børn) for 5 patienter (3 voksne, 2 børn).
During clinical studies with Nuwiq in previously treated paediatric (2 to 11 years, n = 58), adolescent (12 to 17 years, n = 3) and adult patients (n = 74) with severe haemophilia A, a total of 8 adverse drug reactions (ADRs) (6 in adults, 2 in children) were reported in 5 patients (3 adults, 2 children).
I kliniske studier med Pandemisk influenzavaccine H5N1 MedImmune forekom den højeste udskillelse af vaccinevirus 1-2 dage efter vaccinationen.
Peak incidence of vaccine virus recovery occurred 1-2 days post-vaccination in clinical studies with Pandemic influenza vaccine H5N1 MedImmune.
I kliniske studier med patienter med CML i fremskreden fase, der fik SPRYCEL ved de anbefalede doser (n=304), sås væskeretention grad 3 eller 4 hos 8% af patienterne, inklusive pleura- og perikardie-effusion grad 3 eller 4, som blev indberettet hos henholdsvis 7% og 1% af patienterne.
In clinical studies in patients with advanced phase CML receiving SPRYCEL at the recommended dose (n=304), grade 3 or 4 fluid retention was reported in 8% of patients, including grade 3 or 4 pleural and pericardial effusion reported in 7% and 1% of patients, respectively.
I kliniske studier med patienter med Cushings sygdom er der observeret QTcF >500 msek hos to ud af 201 patienter.
In clinical studies in Cushing’s disease patients, QTcF of >500 msec was observed in two out of 201 patients.
I kliniske studier med patienter med resistens eller intolerans over for tidligere behandling med imatinib blev det anbefalet, at behandling med imatinib afbrydes mindst 7 dage, inden behandlingen med SPRYCEL påbegyndes.
In clinical studies with patients with resistance or intolerance to prior imatinib therapy, it was recommended that treatment with imatinib be discontinued at least 7 days before starting treatment with SPRYCEL.
I kliniske studier med patienter, der ikke tidligere har modtaget antiretroviral behandling, og som behandles med boostet atazanavir, forekom der ikke I50Lsubstitution hos nogen af patienterne uden baseline PI-substitution.
In clinical trials of antiretroviral treatment naive patients treated with boosted atazanavir, the I50L substitution did not emerge in any patient without baseline PI substitutions.
I kliniske studier med patienter, der ikke tidligere har modtaget antiretroviral behandling, og som behandles med ikke-boostet atazanavir, er I50L-substitutionen, nogle gange i kombination med A71V- ændring, den kendetegnende resistenssubstitution for atazanavir.
In clinical trials of antiretroviral treatment naive patients treated with unboosted atazanavir, the I50L substitution, sometimes in combination with an A71V change, is the signature resistance substitution for atazanavir.
I kliniske studier med patienter, som blev behandlet med pembrolizumab 2 mg/kg hver 3. uge eller 10 mg/kg hver 2. eller 3. uge, havde 19 (1,7%) ud af 1.087 evaluerbare patienter en positiv test for antistoffer mod pembrolizumab udviklet under behandlingen.
In clinical studies in patients treated with pembrolizumab 2 mg/kg every 3 weeks or 10 mg/kg every two or three weeks, 19 (1.7%) of 1,087 evaluable patients tested positive for treatment-emergent antibodies to pembrolizumab.
I kliniske studier med piger og kvinder i alderen 10 til 72 år, (hvor 79,2 % var i alderen 10 til 25 år ved inklusion), blev Cervarix administreret til 16.142 piger og kvinder, mens 13.811 fik kontrolvaccine.
In clinical studies that enrolled girls and women aged from 10 up to 72 years (of which 79.2% were aged 10-25 years at the time of enrolment), Cervarix was administered to 16,142 females whilst
I kliniske studier med pioglitazon var der tegn på dosisrelateret vægtøgning, hvilket kan skyldes fedtophobning og i nogle tilfælde væskeretention.
In clinical trials with pioglitazone, there was evidence of dose-related weight gain, which may be due to fat accumulation and, in some cases, associated with fluid retention.
I kliniske studier med psoriasis-patienter påvirkede dimethylfumarat lymfocytfenotyper via en nedregulering af pro- inflammatoriske cytokinprofiler (TH1, TH17) og viste tendens til antiinflammatorisk produktion (TH2).
In clinical studies with psoriasis patients, dimethyl fumarate affected lymphocyte phenotypes through a down-regulation of pro- inflammatory cytokine profiles (TH1, TH17), and biased towards anti-inflammatory production (TH2).
I kliniske studier med RA- og CAPS-patienter er der i sjældne tilfælde set forbigående forhøjelser af leverenzymer.
In clinical studies in RA and CAPS patients, transient elevations of liver enzymes have been seen uncommonly.
I kliniske studier med raske frivillige forsøgspersoner inducerer eller hæmmer tafamidismeglumin ikke CYP-enzymet CYP3A4.
In a clinical study in healthy volunteers, tafamidis meglumine did not induce or inhibit the cytochrome P450 enzyme CYP3A4.
I kliniske studier med sevelamer reduceredes det gennemsnitlige total-kolesterol og LDL-kolesterol med 15-39 %.
In clinical trials of sevelamer, both the mean total-cholesterol and LDL-cholesterol declined by 15-39%.
I kliniske studier med svær kronisk neutropeni behandlet med filgrastin blev der observeret en lav frekvens (cirka 3%) af myelodysplastiske syndromer (MDS) eller leukæmi hos patienter.
There was a low frequency (approximately 3%) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
I kliniske studier med Toujeo hos voksne patienter var forekomsten af allergiske reaktioner ens hos patienter behandlet med Toujeo (5,3 %) og patienter behandlet med insulin glargin 100 enheder/ml (4,5 %).
In Toujeo clinical studies in adult patients, the incidence of allergic reactions was similar in Toujeo-treated patients (5.3%) and insulin glargine 100 units/ml-treated patients (4.5%).
I kliniske studier med unge patienter med bipolær mani er Aripiprazole vist at være forbundet med vægtstigning efter 4 ugers behandling.
In clinical trials of adolescent patients with bipolar mania, aripiprazole has been shown to be associated with weight gain after 4 weeks of treatment.
I kliniske studier med voksne CML- og Ph+ ALL-patienter var dosistitrering til 140 mg 1 gang dagligt (CML i kronisk fase) eller 180 mg én gang dagligt (fremskreden CML eller Ph+ ALL) tilladt hos patienter, som ikke opnåede hæmatologisk eller cytogenetisk respons ved den anbefalede startdosis.
In clinical studies in adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response at the recommended starting dose.
I kliniske studier med voksne, som fik Pandemisk influenzavaccine H5N1 MedImmune, var de hyppigste bivirkninger hovedpine og infektion i de øvre luftveje (betændelse eller betændelseslignende reaktioner i næsen, halsen og bihulerne).
In clinical studies with adults who received Pandemic influenza vaccine H5N1 MedImmune, the most common side effects were headache and upper respiratory tract infection (inflammation of the nose, throat, and sinuses).
I kliniske studier medfører behandling med [90Y] radioaktivt mærket Zevalin efter forbehandling med rituximab en signifikant strålingsdosis af testes.
In clinical studies, the [90Y]-radiolabelled Zevalin after pretreatment with rituximab results in a significant radiation dose to the testes.