natgillin/translations-raw huggingface dataset:
I de kliniske 12-ugers akut fase duloxetin studier med patienter med diabetisk neuropatisk smerte blev der observeret en lille men statistisk signifikant stigning i faste blodglucose hos duloxetin-behandlede patienter.
In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine- treated patients.
I de kliniske 12-ugers akut fase duloxetin studier med patienter med diabetisk neuropatisk smerte blev der observeret en lille men statistisk signifikant stigning i faste blodglucose hos duloxetinbehandlede patienter.
In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine- treated patients.
I de kliniske fase 3-undersøgelser hos melanompatienter, som var kortlagt både med technetium Tc 99m- tilmanocept og blå vitalfarvning, blev der lokaliseret technetium Tc 99m-tilmanocept hos 99,89 % af patien- terne med gennemsnitligt 2,30 skildvagtlymfeknuder pr. patient ved metaanalyse af faste effekter.
In Phase 3 clinical studies in melanoma patients mapped with both technetium Tc 99m tilmanocept and vital blue dye, technetium Tc 99m tilmanocept localised in 99.89% of patients with a mean 2.30 localised sentinel lymph nodes per patient by fixed effects meta-analyses.
I de kliniske fase 3-undersøgelser kunne der detekteres technetium Tc 99m-tilmanocept i skildvagtlymfe- knuder i løbet af 10 minutter.
In Phase 3 clinical studies, technetium Tc 99m tilmanocept was detectable in sentinel lymph nodes within 10 minutes.
I de kliniske fase II- og fase III-studier blev egnede patienter identificeret ved brug af real-time polymerase-kædereaktionssassay (cobas 4800 BRAF-V600- mutationstest).
In the phase II and phase III clinical trials, eligible patients were identified using a real-time polymerase chain reaction assay (the cobas 4800 BRAF V600 Mutation Test).
I de kliniske fase II- og fase III-studier var der i screeningen for egnethed påkrævet en central test for BRAF V600-mutation ved brug af en BRAF-mutationsanalyse udført på den nyeste tilgængelige tumorprøve.
In the Phase II and III clinical trials, screening for eligibility required central testing for BRAF V600 mutation using a BRAF mutation assay conducted on the most recent tumour sample available.
I de kliniske fase III-forsøg var få patienter co-inficeret med hepatitis B/C.
Few patients included in the phase III trials were co-infected with hepatitis B/C.
I de kliniske fase III-studier blev median reduktion på cirka 80% opretholdt i uNTx/Cr efter 3 måneders behandling af 2.075 XGEVA-behandlede patienter med fremskreden cancer, der var behandlingsnaive over for i.v. bisfosfonater.
In the phase III clinical trials, median reductions of approximately 80% were maintained in uNTx/Cr after 3 months of treatment in 2075 XGEVA-treated advanced cancer patients’ naïve to IV- bisphosphonate.
I de kliniske fase III-studier hos akromegalipatienter blev der ikke identificeret klinisk signifikante forskelle med hensyn til forlænget QT-interval mellem pasireotid til intramuskulær anvendelse og de somatostatinanaloger, der blev anvendt som aktiv komparator.
The phase III clinical studies in acromegaly patients did not identify any clinically meaningful differences in the QT prolongation events between pasireotide intramuscular use and the somatostatin analogues which were tested as active comparator.
I de kliniske forsøg fik patienter, der udviklede thyreoidea-relaterede lidelser, lov til at få genbehandling med LEMTRADA.
In clinical trials, patients who developed thyroid events were permitted to receive re-treatment with LEMTRADA.
I de kliniske forsøg foretaget med IOA i Amerika, blev følgende Pearl Index for aldersgruppen 18-35 år beregnet:
In the clinical trial performed with IOA in the United States the following Pearl Indices for the age class 18-35 years were calculated:
I de kliniske forsøg foretaget med IOA i den Europæiske Union, blev følgende Pearl Index for aldersgruppen 18-35 år beregnet:
In the clinical trial performed with IOA in the European Union the following Pearl Indices for the age class 18-35 years were calculated:
I de kliniske forsøg har dyrets ejer givet Zubrin til hunden én gang dagligt i en dosis på 10 mg pr. kg af dyrets kropsvægt, med eller uden foder.
In these clinical studies, the animal owners gave Zubrin to their dogs, once daily at a dose of 10 mg per kg dog’s bodyweight with or without food.
I de kliniske forsøg med topotecan har man set dødsfald på grund af neutropenisk colitis.
Fatalities due to neutropenic colitis have been reported in clinical trials with topotecan.
I de kliniske forsøg var det daglige behov for p.n. opioider signifikant reduceret, når opioider blev anvendt sammen med paracoxib.
In clinical trials, the daily requirement for PRN opioids was significantly reduced when coadministered with parecoxib.
I de kliniske forsøg var klinisk betydningsfulde QTc-forlængelser usædvanlige (0,1 % til 1 %) hos de patienter, som blev behandlet med olanzapin.
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF]
I de kliniske forsøg, der blev udført hos spædbørn, børn og unge, svarede forekomsten og arten af bivirkninger efter den første og anden vaccination til dem, der blev set hos voksne og ældre personer.
In the clinical studies conducted in infants, children and adolescents, the incidence and nature of symptoms after the first and second vaccination were similar to those occurred in adults or older people.
I de kliniske studier af Dupuytrens kontraktur havde 92 % af patienterne udviklet cirkulerende antistoffer mod AUX-I 30 dage efter den første injektion, og 86 % af patienterne havde udviklet cirkulerende antistoffer mod AUX-II.
In the Dupuytren’s contracture clinical trials at 30 days post the first injection, 92% of patients had circulating antibodies detected against AUX-I and 86% of patients against AUX-II.
I de kliniske studier af kombinationsbehandling med topotecan og cisplatin til behandling af cervixcancer blev behandlingen kun initieret hos patienter med serumcreatinin ≤ 132 μmol /l.
In clinical studies with topotecan in combination with cisplatin for the treatment of cervical cancer, therapy was only initiated in patients with serum creatinine less than or equal to 132 μmol/l.
I de kliniske studier blev behandlingen med topotecan stoppet, hvis dosis var blevet reduceret til 1,0 mg/m2, og det blev nødvendigt med yderligere reduktion af dosis for at håndtere bivirkninger.
In clinical trials, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2 and a further dose reduction was required to manage adverse effects.
I de kliniske studier blev blodprøver fra patienter med Dupuytrens kontraktur og Peyronies sygdom undersøgt på forskellige tidspunkter for antistoffer overfor proteinkomponenterne i lægemidlet (AUX-I og AUX-II).
During clinical studies, blood samples from patients with Dupuytren’s contracture and Peyronie’s disease were tested at multiple time points for antibodies to the protein components of the medicinal product (AUX-I and AUX-II).
I de kliniske studier blev der ikke foretaget dosisjusteringer på baggrund af alder.
In the therapeutic studies no dosage adjustment was made on the basis of age.
I de kliniske studier blev der rapporteret om én overdosis, hvor en forsøgsperson indtog 5000 mg eltrombopag.
In the clinical studies there was one report of overdose where the subject ingested 5000 mg of eltrombopag.
I de kliniske studier blev følgende bivirkninger observeret som mulige eller sandsynlige i forbindelse med palonosetron.
In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to palonosetron.
I de kliniske studier blev Herceptin-dosis ikke reduceret.
No reductions in the dose of Herceptin were made during clinical trials.
I de kliniske studier blev kun patienter med kutant melanom undersøgt.
In the clinical studies only patients with cutaneous melanoma were studied.
I de kliniske studier fik 183 cancerpatienter og 96 raske frivillige forsøgspersoner Nivestim.
During clinical studies 183 cancer patients and 96 healthy volunteers were exposed to Nivestim.
I de kliniske studier fik patienterne profylaktisk acetylsalicylsyre eller alternativ antitrombotisk behandling.
In clinical studies, patients received prophylactic acetylsalicylic acid or alternative anti-thrombotic therapy.
I de kliniske studier forekom der ingen infusionsreaktioner blandt PNH- eller aHUS-patienterne, der gjorde det nødvendigt at afbryde Soliris-behandlingen.
In clinical trials, no PNH or aHUS patients experienced an infusion reaction which required discontinuation of Soliris.
I de kliniske studier foretaget med Zoely i Amerika, blev følgende Pearl Index for aldersgruppen 18- 35 år beregnet:
In the clinical trial performed with Zoely in the United States the following Pearl Indices for the age class 18-35 years were calculated:
I de kliniske studier fortsatte behandlingen indtil sygdomsprogression eller uacceptabel toksicitet.
In clinical trials, treatment with bosutinib continued until disease progression or until it was no longer tolerated by the patient.
I de kliniske studier havde patienterne LVEF 50% ved baseline.
In clinical studies, patients had a LVEF  50% at baseline.
I de kliniske studier indgik patienter med solide tumorer (f.eks. lunge-, bryst-, tyktarms-, ovariekræft) og lymfoide maligne sygdomme (f.eks. lymfom, multipelt myeloma).
Patients with solid tumours (e.g., lung, breast, colon, ovarian cancers) and lymphoid malignancies (e.g., lymphoma, multiple myeloma) were enrolled in the clinical studies.
I de kliniske studier med eltrombopag sås generelt ingen klinisk signifikante forskelle i sikkerheden ved eltrombopag mellem forsøgspersoner, der var 65 år eller ældre og yngre forsøgspersoner.
In the clinical studies of eltrombopag, overall no clinically significant differences in safety of eltrombopag were observed between subjects aged at least 65 years and younger subjects.
I de kliniske studier med Galafold indgik et lille antal patienter over 65 år.
Clinical studies of Galafold included small number of patients aged 65 and over.
I de 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 de kliniske studier med MabThera monoterapi giver i 4 uger forekom hæmatologiske bivirkninger hos en minoritet af patienterne og var sædvanligvis lette og reversible.
In clinical trials with MabThera monotherapy given for 4 weeks, haematological abnormalities occurred in a minority of patients and were usually mild and reversible.
I de kliniske studier med MabThera-monoterapi givet i 4 uger forekom hæmatologiske bivirkninger hos en minoritet af patienterne; bivirkningerne var sædvanligvis lette og reversible.
In clinical trials with MabThera monotherapy given for 4 weeks, haematological abnormalities occurred in a minority of patients and were usually mild and reversible.
I de kliniske studier med tocilizumab er der set et hurtigt fald i CRP, erytrocyt- sedimentationsreaktionen (ESR) og serumamyloid A (SAA).
In clinical studies with tocilizumab, rapid decreases in CRP, erythrocyte sedimentation rate (ESR) and serum amyloid A (SAA) were observed.
I de kliniske studier med trametinib-monoterapi blev der rapporteret ét tilfælde af utilsigtet overdosering; en enkeltdosis på 4 mg.
In clinical trials with trametinib monotherapy one case of accidental overdose was reported; a single dose of 4 mg.
I de kliniske studier sås infektioner som anført nedenfor.
Infections were seen in the clinical studies as stated below.
I de 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 de 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 de kliniske studier sås slimhindeblødninger (f.eks. epistaxis, blødning fra mave-tarm- kanalen, genitalier og urinveje) og anæmi hyppigere under langtidsbehandling med edoxaban i sammenligning 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 de kliniske studier var 24 % af de MIRCERA-behandlede patienter mellem 65 og 74 år, mens 20 % var 75 år og derover.
In clinical studies 24% of patients treated with MIRCERA were ageg 65 to 74 years, while 20% were ageg 75 years and over.
I de kliniske studier var de fleste bivirkninger lette eller moderate i intensitet og forsvandt ved fortsat Zurampic- behandling.
In clinical trials, most adverse reactions were mild or moderate in intensity and resolved while continuing Zurampic therapy.
I de kliniske studier, der er gennemført med regadenoson, var patienter med nyligt (inden for 3 måneder) myokardieinfarkt ekskluderet.
Clinical trials conducted with regadenoson excluded patients with recent (within 3 months) myocardial infarction.
I de kliniske studier, der er udført med HEMANGIOL, findes der ingen klinisk effektivitet eller sikkerhedsdata, som kan begrunde en anbefaling af initiering hos børn over 5 måneder.
There is no clinical efficacy and safety data in the clinical studies carried out with HEMANGIOL to recommend its initiation in children aged above 5 months.
I de kliniske undersøgelser blev Comfortis sammenlignet med et lægemiddel til dyr ("sammenligningsprodukt") godkendt i EU til behandling og forebyggelse af loppeangreb (selamectin, et "spot-on"-middel, der påføres dyrets hud).
In the clinical studies, Comfortis was compared with a veterinary medicine authorised in the EU for the treatment and prevention of flea infestations (selamectin, a ‘spot-on’ applied to the skin of the dog or cat).
I de kliniske undersøgelser blev der hyppigt indberettet forbigående hævelse på injektionsstedet efter subkutan administration hos kvæg.
Transient swelling at the injection site was commonly reported in clinical studies following subcutaneous administration in cattle.
I de kliniske undersøgelser blev der iagttaget forbigående hævelse på injektionsstedet efter intramuskulær administration hos grise.
Transient swelling at the injection site was observed in clinical studies following intramuscular administration in pigs.
I de kliniske undersøgelser blev Onsior sammenlignet med andre veterinærlægemidler indeholdende ikke-steroide antiinflammatoriske lægemidler (ketoprofen, meloxicam eller carprofen) eller placebo (en virkningsløs behandling).
In the clinical studies, Onsior was compared with other veterinary medicines containing NSAIDs (ketoprofen, meloxicam or carprofen) or a placebo (dummy treatment).
I de kliniske undersøgelser er anvendt doser på op til 2 250 mg dagligt med en sikkerhedsprofil svarende til den, der angives i punkt 4.8.
Doses up to 2250 mg/day have been administered in clinical studies showing a safety profile consistent with that reported in section 4.8.
I de kliniske undersøgelser er der foretaget en vurdering af nedenstående bivirkninger hos 553 personer over 18 år, som fik Lymphoseek.
Clinical studies have evaluated the incidence of adverse reactions listed below in 553 subjects 18 years and above who received Lymphoseek.
I de kliniske undersøgelser er der rapporteret om hududslæt hos 4 % af patienterne og pruritus hos 1,5 % af patienterne.
In clinical trials, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
I de kliniske undersøgelser fik patienterne Lymphoseek op til 30 timer før operationen.
In clinical studies, patients received Lymphoseek up to 30 hours before surgery.
I de kliniske undersøgelser fik svinene udelukkende medicineret foder med valnemulin i forskellige koncentrationer (afhængigt af sygdommen) i indtil 4 uger (også afhængigt af sygdommen).
During the clinical trials, pigs were only fed with medicated feeding stuff containing valnemulin in different concentrations (depending on the disease) for up to 4 weeks (depending on the disease).
I de kliniske undersøgelser med rasagilin var samtidig brug af fluoxetin eller fluvoxamin ikke tilladt, men det var tilladt at anvende følgende antidepressiva og doser: amitriptylin ≤ 50 mg dagligt, trazodon
Rasagiline clinical trials did not allow concomitant use of fluoxetine or fluvoxamine with rasagiline, but the following antidepressants and doses were allowed in the rasagiline trials: amitriptyline
I de kliniske undersøgelser var 38–40 % af patienterne ≥ 60 år, og 10–12 % af patienterne var ≥ 70 år.
In the clinical study 38% of patients were ≥ 60 years of age and 12% of patients were ≥ 70 years of age.
I de kliniske undersøgelser var 38–40% af patienterne 60 år, og 10–12% af patienterne var 70 år.
In all clinical studies 38–40% of patients were > 60 years of age and 10–12% of patients were >70 years of age.
I de kombinerede kortvarige og langvarige studier af skizofreni og bipolar mani hos voksne var den gennemsnitlige ændring i kropsvægt for asenapin-behandlede 0,8 kg.
In the combined short-term and long-term schizophrenia and bipolar mania trials in adults, the mean change in body weight for asenapine was 0.8 kg.
I de kombinerede kortvarige og langvarige studier af skizofreni- og bipolar mani hos voksne, var den gennemsnitlige ændring i kropsvægt for asenapin-behandlede 0,8 kg.
In the combined short-term and long-term schizophrenia and bipolar mania trials in adults, the mean change in body weight for asenapine was 0.8 kg.
I de koncentrationer og aktivitetsmængder der bruges til diagnostiske procedurer ser det ikke ud til at LeukoScan har nogen farmakodynamisk effekt.
At the concentrations and activities used for diagnostic procedures, LeukoScan does not appear to exert any pharmacodynamic effects.
I de kontrollerede dele af de kliniske fase IIb- og fase III-studier med Simponi af RA, PsA, AS og UC var der ikke forskel i antallet af non-lymfom-maligniteter (eksklusive non-melanom hudkræft) mellem Simponi- og kontrolgruppen.
In the controlled portions of the Simponi Phase IIb and Phase III clinical trials in RA, PsA, AS, and UC, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the Simponi and the control groups.
I de kontrollerede dele af fase IIb og fase III af kliniske studier med Simponi af RA, PsA, AS og UC var der ikke forskel i antallet af non-lymfom maligniteter (eksklusive nonmelanom hudkræft) mellem Simponi- og kontrolgruppen.
In the controlled portions of the Simponi Phase IIb and Phase III clinical trials in RA, PsA, AS, and UC, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the Simponi and the control groups.
I de kontrollerede dele af kliniske studier med alle TNF-blokerende midler inklusive Simponi er der set flere tilfælde af lymfomer blandt patienter, som fik en TNF-blokker sammenlignet med patienter i kontrolgruppen.
In the controlled portions of clinical trials of all the TNF-blocking agents including Simponi, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with control patients.
I de kontrollerede dele af kliniske studier med TNF-blokerende midler er der set flere maligne tilfæ lde, inklusive lymfom, blandt patienter, som fik en TNF-blokker sammenlignet med patienter i kontrolgruppen.
In the controlled portions of clinical studies of TNF-blocking agents, more cases of malignancies including lymphoma have been observed among patients receiving a TNF blocker compared with control patients.
I de kontrollerede fase III-studier blev forbigående positivitet over for anti-icatibant-antistoffer efter gentagne behandlinger observeret i sjældne tilfælde.
Across repeated treatment in the controlled phase III trials, transient positivity to anti-icatibant antibodies was observed in rare cases.
I de kontrollerede kliniske fase 3-studier af Humira hos patienter med reumatoid artrit og psoriasisartrit med en kontrolperiode på 4 til 104 uger forekom ALAT- stigninger ≥ 3 x ULN hos 3,7% af de Humira-behandlede patienter og 1,6% af de kontrol-behandlede patienter.
In controlled Phase 3 trials of Humira in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7% of Humira-treated patients and 1.6% of control-treated patients.
I de kontrollerede kliniske studier (af 4-8 ugers varighed) opnåede 52 % af patienterne behandlet med pregabalin og 38 % af patienterne på placebo mindst en 50 % forbedring i HAM-A totalscore fra baseline til endpoint.
In controlled clinical trials (4 – 8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.
I de kontrollerede kliniske studier forekom der et krampeanfald hos 10 patienter (0,5 %) ud af 2.051 patienter, som blev behandlet med en daglig dosis på 160 mg enzalutamid, hos én patient (<0,1 %) i placebogruppen, og hos én patient (0,3 %), som blev behandlet med bicalutamid.
In controlled clinical studies, 10 patients (0.5%) experienced a seizure out of 2051 patients treated with a daily dose of 160 mg enzalutamide, whereas one patient (< 0.1%) receiving placebo and one patient (0.3%) receiving bicalutamide, experienced a seizure.
I de kontrollerede kliniske studier var inkluderet for få patienter over 65 år eller sorte/afroamerikanske patienter til at drage meningsfulde konklusioner om effekten af alder eller etnisk baggrund på de kliniske udfald.
There were too few patients over 65 years of age, or black/African American patients enrolled in the controlled clinical trials to draw meaningful conclusions about the effects of age or race on clinical outcomes.
I de kontrollerede og ikke-kontrollerede perioder i de kliniske studier af psoriasis, psoriasisartrit og Crohns sygdom, der repræsenterede eksponering i 10.953 patientår hos 5.884 patienter, var den mediane opfølgningsperiode 0,99 år – 3,2 år i psoriasisstudier, 1,0 år i psoriasisartritstudier og 0,6 år i studier med Crohns sygdom.
In the controlled and non-controlled periods of psoriasis, psoriatic arthritis and Crohn’s disease clinical studies, representing 10,953 patient-years of exposure in 5,884 patients, the median follow up was 0.99 years; 3.2 years for psoriasis studies, 1.0 year for psoriatic arthritis studies and 0.6 year for Crohn’s disease studies.
I de kontrollerede og ikke-kontrollerede perioder i de kliniske studier af psoriasis, psoriasisartrit og Crohns sygdom, der udgjorde 10.953 patientårs eksponering af 5.884 patienter, var den mediane opfølgningsperiode 0,99 år – 3,2 år i psoriasisstudier, 1,0 år i psoriasisartritstudier og 0,6 år i Crohns sygdom studier.
In the controlled and non-controlled periods of psoriasis, psoriatic arthritis and Crohn’s disease clinical studies, representing 10,953 patient-years of exposure in 5,884 patients, the median follow up was 0.99 years; 3.2 years for psoriasis studies, 1.0 year for psoriatic arthritis studies and 0.6 year for Crohn’s disease studies.