natgillin/translations-raw huggingface dataset:
I kliniske studier af mere end 2 års varighed med 351 patienter med ankyloserende spondylitis blev der rapporteret om 6 maligniteter hos patienter behandlet med Enbrel..
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in Enbrel-treated patients.
I kliniske studier af patienter med HIV var de eneste bivirkninger, der konsekvent blev anset for at være forbundet med indgift af filgrastim, muskel- og knoglesmerter, 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 af patienter med non-Hodgkins lymfom havde samtidig behandling med rituximab i et mobiliseringsregimen med plerixafor og G-CSF ingen betydning for patienternes sikkerhed eller udbytte af CD34+-celler.
In clinical studies of patients with Non-Hodgkin’s lymphoma, the addition of rituximab to a mobilisation regimen of plerixafor and G-CSF did not impact patient safety or CD34+ cell yield.
I kliniske studier af patienter med non-Hodgkins lymfom og multipelt myelom er der ikke observeret mobilisering af tumorceller i forbindelse med behandling med plerixafor.
In clinical studies of patients with non-Hodgkin’s lymphoma and multiple myeloma, mobilisation of tumour cells has not been observed with plerixafor.
I kliniske studier af pioglitazon var forekomsten af forhøjede ALAT-tal tre gange den øvre normalgrænse identisk med placebo, men lavere end i komparatorgrupperne, der fik metformin eller sulfonylurinstof.
In clinical trials with pioglitazone, the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
I kliniske studier af prolifererende infantil hæmangiom er de oftest rapporterede bivirkninger hos spædbørn behandlet med HEMANGIOL søvnforstyrrelser, forværret infektion i åndedrætsorganerne, så som bronkitis og bronchiolitis forbundet med hoste og feber, diarré, og opkast.
In clinical trials for proliferating infantile haemangioma, the most frequently reported adverse reactions in infant treated with HEMANGIOL were sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhoea, and vomiting.
I kliniske studier af psoriasis og psoriasisartrit udviklede færre end 8 % af de patienter, der blev behandlet med ustekinumab, antistoffer mod ustekinumab.
In psoriasis and psoriatic arthritis clinical studies less than 8% of ustekinumab-treated patients developed antibodies to ustekinumab.
I kliniske studier af psoriasis og psoriasisartrit udviklede færre end 8% af de patienter, der blev behandlet med ustekinumab, antistoffer mod ustekinumab.
In psoriasis and psoriatic arthritis clinical studies less than 8% of ustekinumab-treated patients developed antibodies to ustekinumab.
I kliniske studier af reumatoid arthritis var hyppigheden af alvorlige infektioner højere hos infliximab- plus methotrexatbehandlede patienter på 65 år og derover (11,3 %) sammenlignet med patienter under 65 år (4,6 %).
In rheumatoid arthritis clinical studies, the incidence of serious infections was greater in infliximab plus methotrexate-treated patients 65 years and older (11.3%) than in those under 65 years of age (4.6%).
I kliniske studier besvimede et mindre antal patienter.
In clinical studies, a small number of patients fainted.
I kliniske studier blev 69 patienter, som fik recidiv eller som var refraktære over for den indledende behandling (zoledronsyre 4 mg, 8 mg eller pamidronat 90 mg), genbehandlet med zoledronsyre 8 mg.
In clinical trials 69 patients who relapsed or were refractory to initial treatment (zoledronic acid 4 mg, 8 mg or pamidronate 90 mg) were retreated with zoledronic acid 8 mg.
I kliniske studier blev 99,6% til 100% af dem, som fik Gardasil 9, seropositive for antistoffer mod alle 9 vaccinetyper ved måned 7 på tværs af alle de testede grupper.
In clinical studies 99.6% to 100% who received Gardasil 9 became seropositive for antibodies against all 9 vaccine types by Month 7 across all groups tested.
I kliniske studier blev behandling med Zoledronsyre Teva først genoptaget når kreatinin-niveauet faldt inden for 10% over baselineværdien (se afsnit 4.4).
In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
I kliniske studier blev både 650 mg/m2 og 1.500 mg/m2 anvendt til patienter i aldersgruppen 16 til 21 år.
In clinical studies, the 650 mg/m2 and 1,500 mg/m2 dose have both been used in patients in the age range 16 to 21 years.
I kliniske studier blev den beskyttelse, som opnåedes med Silgard, ikke nedsat af præventionsmidler i tabletform (f.eks. p-piller) eller andre svangerskabsforebyggende midler.
In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by Silgard.
I kliniske studier blev der ikke observeret relevante forskelle i eksponering, sikkerhed eller effekt hos patienter med let nedsat nyrefunktion (estimeret glomerulær filtrationshastighed [eGFR]
In clinical studies, no relevant differences in exposure, safety or efficacy were observed between patients with mild renal impairment (estimated Glomerular Filtration Rate [eGFR]
I kliniske studier blev der ikke rapporteret om anfylaksi.
In clinical studies, there were no reports of anaphylaxis.
I kliniske studier blev der meget hyppigt observeret mindre subkutane noduli på injektionsstedet, hvilket stemmer overens med de kendte egenskaber for formuleringen af poly (D,L-laktid-coglycolid)- polymermikrokugler.
Small subcutaneous injection site nodules were observed very frequently in clinical trials, consistent with the known properties of poly (D,L-lactide co-glycolide) polymer microsphere formulations.
I kliniske studier blev der observeret krampeanfald hos 1,4 % af de patienter, der blev behandlet med Mimpara, og hos 0,7 % af patienterne i placebogruppen.
In clinical studies seizures were observed in 1.4% of Mimpara treated patients and 0.7% of placebo-treated patients.
I kliniske studier blev der observeret krampeanfald hos 1,4% af de patienter, der blev behandlet med cinacalcet, og hos 0,7% af patienterne i placebogruppen.
In clinical studies seizures were observed in 1.4% of cinacalcet treated patients and 0.7% of placebo- treated patients.
I kliniske studier blev der observeret reduceret systolisk blodtryk (> 35 mmHg) hos 7% af patienterne og reduceret diastolisk blodtryk (> 25 mmHg) hos 4% af patienterne inden for 45 minutter efter indgivelse af Rapiscan.
In clinical trials, decreased systolic blood pressure (> 35 mm Hg) was observed in 7% of patients and decreased diastolic blood pressure (> 25 mm Hg) was observed in 4% of patients within 45 minutes of Rapiscan administration.
I kliniske studier blev der på tværs af doser og tumortyper rapporteret følgende immunrelaterede bivirkninger hos færre end 1% af de patienter, der blev behandlet med nivolumab-monoterapi: pancreatitis, uveitis, demyelinisering, autoimmun neuropati (herunder facial og nervus abducens parese), Guillain-Barré syndrom, hypopituitarisme og myastenisk syndrom.
The following immune-related adverse reactions were reported in less than 1% of patients treated with nivolumab monotherapy in clinical trials across doses and tumour types: pancreatitis, uveitis, demyelination, autoimmune neuropathy (including facial and abducens nerve paresis), Guillain-Barré syndrome, hypopituitarism, and myasthenic syndrome.
I kliniske studier blev der udført en central test for BRAF V600-mutation ved brug af en BRAF- mutationsanalyse på den nyeste tumorprøve.
In clinical trials, central testing for BRAF V600 mutation using a BRAF mutation assay was conducted on the most recent tumour sample available.
I kliniske studier blev følgende bivirkninger rapporteret som almindelige: træthed, luftvejsinfektioner, ondt i halsen, hovedpine, mavepine eller - ubehag, kvalme, opkastning og diarré, stigning i leverenzymer og enzymer produceret i musklerne (se nedenfor).
Side effects that were commonly reported in Lamivudine clinical trials were tiredness, respiratory tract infections, throat discomfort, headache, stomach discomfort and pain, nausea, vomiting and diarrhoea, increases in liver enzymes and enzymes produced in the muscles (see below).
I kliniske studier blev Orgalutran anvendt sammen med rekombinant follikelstimulerende hormon (FSH) eller corifollitropin alfa, et follikelstimulerende stof med langtidsvirkning.
In clinical studies Orgalutran was used with recombinant follicle stimulating hormone (FSH) or corifollitropin alfa, a follicle stimulant with a long duration of action.
I kliniske studier blev Orgalutran anvendt sammen med rekombinant humant follikelstimulerende hormon (FSH) eller corifollitropin alfa, en follikelstimulant med forlænget virkning.
In clinical studies Orgalutran was used with recombinant human follicle stimulating hormone (FSH) or corifollitropin alfa, the sustained follicle stimulant.
I kliniske studier blev patienter behandlet med 200 mg aciclovir to gange om dagen eller behandling ækvivalent hermed.
In clinical trials, patients were administered aciclovir 200 mg twice a day or equivalent.
I kliniske studier blev patienter med ukontrolleret eller væsentlig hjertesygdom (f.eks. nylig myokardieinfarkt, kronisk venstresidig hjerteinsufficiens, ustabil angina eller klinisk signifikant bradykardi) ekskluderet.
In clinical studies, patients with uncontrolled or significant cardiac disease (e.g. recent myocardial infarction, congestive heart failure, unstable angina or clinically significant bradycardia) were excluded.
I kliniske studier blev Rapiscan indgivet til patienter, som fik andre kardioaktive lægemidler (dvs. β- blokkere, calciumkanalblokkere, ACE-hæmmere, nitrater, hjerteglykosider og angiotensinreceptorhæmmere), uden tydelig virkning på sikkerheds- og virkningsprofilen for Rapiscan.
In clinical studies, Rapiscan was administered to patients taking other cardioactive medicinal products (i.e., β-blockers, calcium channel blockers, ACE inhibitors, nitrates, cardiac glycosides, and angiotensin receptor blockers) without apparent effects on the safety or efficacy profile of Rapiscan.
I kliniske studier blev siltuximab associeret med en infusionsrelaret reaktion eller overfølsomhedsreaktion hos 4,8 % (svær reaktion hos 0,8 %) af de patienter, der fik siltuximab som monoterapi.
In clinical studies, siltuximab was associated with an infusion related reaction or hypersensitivity reaction in 4.8% (severe reaction in 0.8%) of patients treated with siltuximab monotherapy.
I kliniske studier blev støtte i lutealfasen givet i henhold til centrets praksis eller i henhold til den kliniske protokol.
In clinical studies, luteal phase support was given according to study centres’ practice or according to the clinical protocol.
I kliniske studier blev ticagrelor ofte administreret sammen med ASA, syrepumpehæmmere, statiner, betablokkere, angiotensinkonverterende enzymhæmmere (ACE-hæmmere) og angiotensin II- receptorantagonister efter behov for samtidige sygdomme gennem længere tid og ligeledes sammen med heparin, lavmolekylært heparin og intravenøse GpIIb/IIIa-hæmmere i kortere tid (se pkt.
In clinical studies, ticagrelor was commonly administered with ASA, proton pump inhibitors, statins, beta-blockers, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers as needed for concomitant conditions for long-term and also heparin, low molecular weight heparin and intravenous GpIIb/IIIa inhibitors for short durations (see section 5.1).
I kliniske studier blev Xtandi administreret uden hensyntagen til fødeindtagelse.
In clinical trials, Xtandi was administered without regard to food.
I kliniske studier er apremilast blevet administreret sammen med topikal behandling (herunder kortikosteroider, tjæreshampoo og præparater til hårbunden med salicylsyre) samt UVB lysbehandling.
In clinical studies, apremilast has been administered concomitantly with topical therapy (including corticosteroids, coal tar shampoo and saliycyilic acid scalp preparations) and UVB phototherapy.
I kliniske studier er behandling med SPRYCEL fortsat indtil sygdomsprogression, eller indtil patienten ikke længere tålte behandlingen.
In clinical studies, treatment with SPRYCEL was continued until disease progression or until no longer tolerated by the patient.
I kliniske studier er bivirkningerne hovedsagelig set, mens patienterne fik medicinen eller kort tid efter (”infusionsrelaterede reaktioner”).
In clinical studies side effects were mainly seen while patients were being given the medicine or shortly after (“infusion related reactions”).
I kliniske studier er de hyppigst indberettede okulære bivirkninger efter injektion af Macugen: inflammation i forreste øjenkammer, øjensmerter, øget intraokulært tryk, punktat keratitis, flyvende myg og uklarheder i glaslegemet.
In clinical trials the most frequently reported ocular adverse reactions following injection of Macugen are: anterior chamber inflammation, eye pain, increased intraocular pressure, punctate keratitis, vitreous floaters and vitreous opacities.
I kliniske studier er den generelle sikkerhed blevet undersøgt på flere end 57.000 voksne vaccineret med ZOSTAVAX.
In clinical trials, general safety has been evaluated in more than 57000 adults vaccinated with ZOSTAVAX.
I kliniske studier er der også rapporteret uveitis og iridocyklitis hos patienter, der fik trametinib i kombination med dabrafenib.
In clincial trials uveitis and iridocyclitis have also been reported in patients treated with trametinib in combination with dabrafenib.
I kliniske studier er der rapporteret oftalmologiske reaktioner, herunder uveitis, iridocyklitis og iritis hos patienter, behandlet med dabrafenib som monoterapi og i kombination med trametinib.
In clincial trials ophthalmologic reactions, including uveitis, iridocyclitis and iritis, have been reported in patients treated with dabrafenib as monotherapy and in combination with trametinib.
I kliniske studier er der set kræft hos patienter, der fik Isentress i samme omfang som hos patienter, der fik anden hiv-behandling, som ikke indeholdt Isentress.
In clinical studies, cancers were observed in patients receiving Isentress at a rate similar to that observed in the patients receiving other HIV treatment that doesn’t contain Isentress.
I kliniske Studier er der set sjældne tilfælde af TLS, nogle var letale, og hos patienter efter markedsføring, der er blevet behandlet med sunitinib.
Cases of TLS, some fatal, have been rarely observed in clinical trials and have been reported in post-marketing experience in patients treated with sunitinib.
I kliniske studier er en sammenlignelig sikkerhedsprofil set for personer, der tidligere har haft eller har en HPV-infektion sammenlignet med personer, der var negative for onkogen HPV-DNA eller seronegative for HPV-16 og HPV-18 antistof.
In clinical trials a similar safety profile has been observed in subjects with prior or current HPV infection as compared to subjects negative for oncogenic HPV DNA or seronegative for HPV-16 and HPV-18 antibodies.
I kliniske studier er everolimus blevet forbundet med alvorlige tilfælde af hepatitis B reaktivering, inklusive letale tilfælde.
In clinical studies, everolimus has been associated with serious cases of hepatitis B reactivation, including fatal outcome.
I kliniske studier er forskellige formuleringer af fosaprepitant blevet administreret til i alt 2.687 personer herunder 371 raske forsøgspersoner og 2.084 patienter med kemoterapiinduceret kvalme og opkastning (CINV).
In clinical studies, various formulations of fosaprepitant have been administered to a total of 2,687 individuals including 371 healthy subjects and 2,084 patients with chemotherapy induced nausea and vomiting (CINV).
I kliniske studier er Ilaris blevet sikkert administreret sammen med ULT.
In clinical studies, Ilaris has been safely administered with ULT.
I kliniske studier er NovoThirteen givet til 56 patienter med medfødt mangel på faktor XIII A-subunit (1043 doser NovoThirteen).
In clinical trials, NovoThirteen has been administered to 56 patients with congenital factor XIII A- subunit deficiency (1043 doses of NovoThirteen).
I kliniske studier er Zoledronsyre Teva indgivet samtidig med almindeligt anvendte anticancerlægemidler, diuretika, antibiotika og analgesika uden tilsyneladende kliniske interaktioner.
In clinical studies, zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
I kliniske studier fik 30 % af de patienter, der fik Dacogen, og 25 % af patienterne i komparator- gruppen bivirkninger med dødeligt udfald i løbet af behandlingen eller inden for 30 dage efter den sidste dosis studiemedicin.
In clinical studies, 30% of patients treated with Dacogen and 25% of patients treated in the comparator arm had adverse events with an outcome of death during treatment or within 30 days after the last dose of study drug.
I kliniske studier for metastatisk kolorektalkræft var der ingen forøget risiko for postoperativ blødning eller sårhelingskomplikationer hos patienter, der fik foretaget større kirurgiske indgreb mellem 28 og 60 dage før påbegyndelsen af behandlingen med Avastin.
In clinical trials of metastatic carcinoma of the colon or rectum, there was no increased risk of post- operative bleeding or wound healing complications observed in patients who underwent major surgery 28-60 days prior to starting Avastin.
I kliniske studier for svær sepsis er frekvensen af anti-human aktiveret protein C IgA/IgG/IgM antistoffer eller neutraliserende antistoffer lav hos voksne patienter og er omtrent ens for de testede drotrecogin alfa (aktiveret)- og placebobehandlede patienter.
In adult patients in severe sepsis clinical studies, the frequency of anti-human Activated Protein C IgA/IgG/IgM antibodies or neutralizing antibodies is low and is similar between drotrecogin alfa (activated) and placebo-treated patients tested.
I kliniske studier for svær sepsis er frekvensen af anti-human aktiveret protein C IgA/IgG/IgM- antistoffer eller neutraliserende antistoffer lav hos voksne patienter og er ens for de testede drotrecogin alfa (aktiveret)- og placebobehandlede patienter.
In adult patients in severe sepsis clinical studies, the frequency of anti-human Activated Protein C IgA/IgG/IgM antibodies or neutralizing antibodies is low and is similar between drotrecogin alfa (activated) and placebo-treated patients tested.
I kliniske studier forekom forhøjede aminotransferaser i serum under behandlingen og i op til 4 måneder efter sidste Zinbryta-dosis.
In clinical studies, serum transaminase elevations occurred during treatment and up to 4 months after the last dose of Zinbryta.
I kliniske studier har 1.565 forsøgspersoner fået enkeltdoser eller gentagne doser af intravenøst anidulafungin: 1.308 patienter i fase 2/3-studie (923 patienter med candidæmi/invasiv candidiasis, 355 patienter med oral/øsofageal candidiasis, 30 patienter med invasiv aspergillose) og 257 patienter i fase 1-studier.
Fifteen hundred sixty five (1565) subjects received single or multiple doses of intravenous anidulafungin in clinical trials: 1308 in Phase 2/3 trials (923 patients with candidaemia/invasive candidiasis, 355 patients with oral/oesophageal candidiasis, 30 patients with invasive aspergillosis), and 257 in Phase I studies.
I kliniske studier har 8,0 % og 1,8 % af de patienter, der blev behandlet med Gilenya 0,5 mg, oplevet en asymptomatisk stigning i serum-ALAT til henholdsvis ≥3 x ULN (upper limit of normal) og ≥5 x ULN.
In clinical studies 8.0% and 1.8% of patients treated with Gilenya 0.5 mg experienced an asymptomatic elevation in serum levels of ALT of ≥3x ULN (upper limit of normal) and ≥5x ULN, respectively.
I kliniske studier har den gennemsnitlige tilsyneladende clearance af exenatid hos mennesker været 9 l/t, og den gennemsnitlige terminale halveringstid er 2,4 t.
In clinical studies the mean apparent clearance of exenatide is 9 l/h and the mean terminal half-life is 2.4 h.
I kliniske studier har dopaminerge bivirkninger, f.eks. dyskinesier, vist sig at forekomme oftere hos patienter i behandling med entacapon og dopaminagonister (som bromokriptin), selegilin eller amantadin sammenlignet med de, der fik placebo i kombination med de samme stoffer.
In clinical studies, dopaminergic adverse reactions, e.g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
I kliniske studier har dopaminerge bivirkninger, f.eks. dyskinesier, vist sig at forekomme oftere hos patienter i behandling med entacapon og dopaminagonister (som bromokriptin), selegilin eller amantadin sammenlignet med de, der fik placebo i kombination med de samme stoffer.
In clinical studies, undesirable dopaminergic adverse reactions, e.g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
I kliniske studier har forsinkede overfølsomhedsreaktioner væ ret rapporteret.
In clinical studies, delayed hypersensitivity reactions have been reported.
I kliniske studier har forsinkede overfølsomhedsreaktioner væ ret usæ dvanlige og er forekommet efter infliximab-fri perioder på mindre end 1 år.
In clinical studies delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year.
I kliniske studier har symptomerne på hypokalcæmi omfattet paræstesier eller muskelstivhed, muskelspjæt, spasmer og muskelkramper.
Symptoms of hypocalcaemia in clinical studies included paresthesias or muscle stiffness, twitching, spasms and muscle cramps.
I kliniske studier havde 97 % af de patienter, der responderede, komplet respons efter doser ≤ 2,4 ME/kg/dag (24 mikrogram/kg/dag).
In clinical studies, 97% of patients who responded had a complete response at doses of ≤ 2.4 MU/kg/day (24 micrograms/kg/day).
I kliniske studier havde belatacept-behandlede transplantatrecipienter med EBV-seronegativ status en øget risiko for PTLD sammenlignet med de transplantationspatienter, der var EBV-positive (henholdsvis 7,7%; 7/91 versus 0,7%; 6/810).
In clinical studies, belatacept-treated transplant recipients with EBV seronegative status were at an increased risk for PTLD compared with those who were EBV positive (7.7%; 7/91 versus 0.7%; 6/810, respectively).
I kliniske studier havde de fleste patienter grad 3/4 -myelodepression ved baseline.
In clinical studies, the majority of patients had baseline Grade 3/4 myelosuppression.
I kliniske studier havde mere end 99 % af initialt seronegative personer serokonverteret for både HPV- type 16 og 18 en måned efter 3. dosis.
In clinical trials, more than 99% of initially seronegative subjects had seroconverted to both HPV types 16 and 18 one month after the third dose.
I kliniske studier havde orale aripiprazol-doser på 10-30 mg/dag ingen signifikant virkning på metaboliseringen af følgende substrater: CYP2D6-substrat (dextromethorphan/3-methoxymorphinan ratio), CYP2C9-substrat (warfarin), CYP2C19-substrat (omeprazol) og CYP3A4-substrat (dextromethorphan).
In clinical studies, oral doses of 10-30 mg/day of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan).
I kliniske studier havde patienter med nedsat nyrefunktion (kreatininclearance < 30 ml/min) eller patienter i dialyse forhøjet risiko for at udvikle hypokalcæmi, når der ikke blev givet tilskud af calcium.
In clinical studies, patients with severe renal impairment (creatinine clearance < 30 ml/min) or receiving dialysis were at greater risk of developing hypocalcaemia in the absence of calcium supplementation.