natgillin/translations-raw huggingface dataset:
Patienter med leverinsufficiens med en højere sværhedsgrad end moderat og/eller med mere end 70% af leveren opfyldt af metastaser og/eller vena porta-trombose/obstruktion er ikke undersøgt.
Patients with hepatic impairment of a higher severity grade than moderate and / or with more than 70% of the liver metastasised and / or portal vein thrombosis / obstruction have not been investigated.
Patienter med leverinsufficiens pga. levermetastaser
Patients with hepatic impairment due to liver metastases.
Patienter med leverinsufficiens pga. levermetastaser.
Patients with hepatic impairment due to liver metastases.
Patienter med leverinsufficiens:
Patients with hepatic insufficiency:
Patienter med leverproblemer (herunder hepatitis B eller C) kan have forhøjet risiko for leverskade, når de får Combivir.
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Combivir.
Patienter med leverproblemer (herunder hepatitis B eller C) kan have forhøjet risiko for leverskade, når de får Crixivan.
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Crixivan.
Patienter med leverproblemer (herunder hepatitis B eller C) kan have forhøjet risiko for leverskade, når de får Emtriva.
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Emtriva.
patienter med leverproblemer patienter med forandringer i de røde blodlegemer, der skyldes en sygdom (homozygot seglcelleanæmi).
patients with liver problems, patients with pathological changes in their red blood cells (homozygous sickle cell anaemia).
Patienter med leversygdom forbundet med koagulopati og klinisk relevant blødningsrisiko.
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
Patienter med leversygdom:
Patients with liver disease
Patienter med lille tumorbyrde (< 50 %) reagerede bedst på behandling med BLINCYTO med en CR/CRh*-rate på 72,9 % (CI: 59,7 - 83,6).
Patients with low tumour burden (< 50%) responded best to BLINCYTO treatment with CR/CRh* rate of 72.9% (CI 59.7 – 83.6).
Patienter med livstruende arytmier
Patients with life-threatening arrhythmias
Patienter med lungeinfiltrater eller pneumoni i anamnesen kan have øget risiko.
Patients with a recent history of lung infiltrates or pneumonia may be at higher risk.
Patienter med maligne lidelser i skelettet eller knoglemetastaser frarådes behandling med teriparatid.
Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide.
Patienter med manglende cirrose-status blev ekskluderet fra denne undergruppeanalyse.
Patients with missing cirrhosis status were excluded from this subgroup analysis.
Patienter med manglende respons
Non-responder
Patienter med manglende respons i uge 6, forblev i studiet og fik vedolizumab hver 4. uge.
Patients who failed to demonstrate response at Week 6 remained in the study and received vedolizumab every four weeks.
Patienter med markant væskemangel eller patienter med natriummangel (fx patienter, der får høje doser diuretika) eller
Patients with marked volume depletion or patients with salt depletion (e.g. those receiving high doses of diuretics) or
Patienter med mastocytose, hos hvem brug af acetylsalicylsyre kan fremkalde alvorlige overfølsomhedsreaktioner (inklusive kredsløbsshock med ansigtsrødmen, hypotension, takykardi og opkastning).
Patients with pre-existing mastocytosis, in whom the use of acetylsalicylic acid may induce severe hypersensitivity reactions (including circulatory shock with flushing, hypotension, tachycardia and vomiting).
Patienter med MDRH&R-TB
Patients with MDRH&R-TB
Patienter med medfødt aids (erhvervet immundefektsyndrom) og tilbagevendende infektioner.
Patients with inborn AIDS (Acquired Immunodeficiency Syndrome) and recurrent infections.
patienter med medfødt manglende eller nedsat evne til at producere antistoffer (primære immundefekter).
patients with an inborn inability or reduced ability to produce antibodies (primary immunodeficiencies).
Patienter med mekaniske hjerteklapper
Patients with prosthetic heart valves
Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få lymfomer (en form for kræft, som påvirker lymfesystemet) og leukæmi (en form for kræft) som påvirker blod og knoglemarv).
People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a kind of cancer that affects the lymph system), and leukaemia (a kind of cancer that affects the blood and bone marrow).
Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få lymfomer (en form for kræft, som påvirker lymfesystemet) og leukæmi (en form for kræft) som påvirker blod og knoglemarv).
People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a kind of cancer that affects the lymph system), and leukemia (a kind of cancer that affects the blood and bone marrow).
Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få lymfomer (en form for kræft, som påvirker lymfesystemet), og leukæmi (en form for kræft) som påvirker blod og knoglemarv).
People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a kind of cancer that affects the lymph system), and leukemia (a kind of cancer that affects the blood and bone marrow).
Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få lymfomer (en form for kræft, som påvirker lymfesystemt) og leukæmi (en form for kræft) som påvirker blod og knoglemarv).
People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a kind of cancer that affects the lymph system), and leukemia (a kind of cancer that affects the blood and bone marrow).
patienter med metastaserende ovariekarcinom, hvor 1. linje-behandling eller efterfølgende behandling er slået fejl. patienter med recidiverende småcellet lungecancer (SCLC) for hvem gentagelse af 1. linje- behandling ikke anses for hensigtsmæssig (se pkt.
patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Patienter med metastaserende ovariekarcinom, hvor 1. linje-behandling eller efterfølgende har slået fejl patienter med recidiverende småcellet lungecancer (SCLC) for hvem gentagelse af 1. linje- behandling ikke anses for hensigtsmæssig (se pkt.
patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Patienter med metastaserende ovariekarcinom, hvor 1. linje-behandling eller efterfølgende har slået fejl patienter med recidiverende småcellet lungecancer [SCLC] for hvem gentagelse af 1. linje- behandling ikke anses for hensigtsmæssig (se pkt.
patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
patienter med metastaterande ovariekarcinom, hvor 1. linje-behandling eller efterfølgende behandling er slået fejl.patienter med recidiverende, småcellet lungecancer (SCLC) for hvem gentagelse af behandling med første linie behandling ikke anses for hensigtsmæssig (se pkt.
patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Patienter med methæmoglobinæmi som følge af chloratforgiftning
Patients with methaemoglobinaemia due to chlorate poisoning
patienter med middelsvært eller svært nedsat nyrefunktion eller med svære tilstande, der kan ændre nyrefunktionen, såsom væskemangel (dehydrering) eller svær infektion
patients with moderately or severely reduced kidney function or with severe conditions that could affect the kidneys such as dehydration or severe infection.
Patienter med mikrobiologisk bekræftet candidiasis (MITT-population) og neutropeni blev identificeret i en analyse af indsamlede data fra 4 prospektive, åbne, non-komparative studier med sammenligneligt design.
Patients with microbiologically confirmed invasive candidiasis (MITT population) and neutropenia were identified in an analysis of pooled data from 4 similarly designed prospective, open-label, non- comparative studies.
Patienter med mild nyreinsufficiens havde ikke en klinisk relevant stigning i plasmakoncentrationen af sitagliptin sammenlignet med de normale raske kontrolpersoner.
Patients with mild renal impairment did not have a clinically meaningful increase in the plasma concentration of sitagliptin as compared to normal healthy control subjects.
Patienter med mild til moderat kronisk obstruktiv lungesygdom (KOL)
Subjects with mild-moderate chronic obstructive pulmonary disease (COPD)
Patienter med mildt eller moderat nedsat leverfunktion bør starte med en lavere dosis.
Patients with mild or moderate impairment of liver function should be started at a lower dose.
Patienter med mildt til moderat nedsat nyrefunktion kan derfor få normal startdosis (se pkt 4.2 og 4.4).
Patients with mild to moderate renal impairment may therefore receive the usual initial dose (see sections 4.2 and 4.4).
Patienter med moderat eller svær leverinsufficiens (Child-Pugh- klasse B eller C) blev udelukket fra fase III-studierne (Kodiac 4 og 5).
Patients with moderate or severe hepatic insufficiency (Child’s-Pugh Class B or C) were excluded from the Phase III studies (Kodiac 4 and 5).
Patienter med moderat eller svær nyresygdom skal have lavere dosis.
A lower dose should also be used in patients who have moderate or more severe problems with their kidneys.
Patienter med moderat eller svært nedsat nyrefunktion blev udelukket fra studier af kombinationsbehandling med Kyprolis og lenalidomid.
Patients with moderate or severe renal impairment were excluded from Kyprolis-lenalidomide combination studies.
patienter med moderat eller svært nedsat nyrefunktion eller med akutte tilstande, der kan ændre nyrefunktionen, såsom dehydrering, svær infektion eller chok,
patients with moderate or severe reduction in kidney function or with acute conditions that could potentially alter kidney function such as dehydration, severe infection or shock;
patienter med moderat eller svært nedsat nyrefunktion eller med akutte tilstande, der kan ændre nyrefunktionen, såsom dehydrering, svær infektion eller chok,
patients with moderate or severe reductions in kidney function or with acute conditions that could potentially alter kidney function such as dehydration, severe infection or shock;
Patienter med moderat nedsat leverfunktion (Child Pugh B) viste en højere eksponering for dette lægemiddel (se pkt.
Patients with moderate hepatic impairment (Child Pugh B) showed a higher exposure to this medicine (see section 5.2).
Patienter med moderat nedsat leverfunktion bør vurderes før behandlingsstart og under behandlingen.
Patients with moderate hepatic impairment should be evaluated prior to initiation and during treatment.
Patienter med moderat nedsat nyrefunktion
Patients with moderate renal impairment
Patienter med moderat nedsat nyrefunktion (CrCl 30 til 50 ml/min.), som fik en reduceret dosis på 20 mg/m2 to gange dagligt, viste ingen signifikant stigning i gennemsnitlig 5-FU AUC0-inf i forhold til den normale gruppe.
Patients with moderate renal impairment (CrCl 30 to 50 ml/min) who received a reduced dose of 20 mg/m2 twice daily showed no significant increase in mean 5-FU AUC0-inf relative to that of the normal group.
Patienter med moderat nedsat nyrefunktion (CrCl mellem 30–50 ml/min) havde i gennemsnit mellem 2,29 gange og 1,81 gange højere præ- og post-dosis dabigatran- plasmakoncentrationer, i forhold til patienter uden nedsat nyrefunktion (CrCl ≥ 80 ml/min).
Patients with moderate renal impairment (CrCL between 30 and 50 mL/min) had on average 2.29-fold and 1.81-fold higher pre- and post-dose dabigatran plasma concentrations, respectively, when compared with patients without renal impairment (CrCL ≥ 80 mL/min).
Patienter med moderat nedsat nyrefunktion (CrCl mellem 30–50 ml/min) havde i gennemsnit mellem 2,29 gange og 1,81 gange højere præ- og post-dosis dabigatran- plasmakoncentrationer, i forhold til patienter uden nedsat nyrefunktion (CrCl ≥ 80 ml/min).
Patients with moderate renal impairment (CrCL between 30-50 mL/min) had on average 2.29-fold and 1.81-fold higher pre- and post-dose dabigatran plasma concentrations, respectively, when compared with patients without renal impairment (CrCL ≥ 80 mL/min).
Patienter med moderat nedsat nyrefunktion (kreatininclearance (CrCL) 30-50 ml/min) [se afsnittet Nedsat nyrefunktion (primær forebyggelse af VTE ved ortopædkirurgi)]
Patients with moderate renal impairment (creatinine clearance (CrCL) 30-50 mL/min) [see Renal impairment (pVTEp orthopaedic surgery)]
Patienter med moderat nedsat nyrefunktion (kreatininclearance < 50-30 ml/min) viste en højere eksponering over for dette lægemiddel (se pkt.
Patients with moderate renal impairment (creatinine clearance <50 - 30 mL/min) showed a higher exposure to this medicine (see section 5.2).
Patienter med moderat nedsat nyrefunktion (kreatininclearance ≥ 30 til ≤ 50 ml/min) bør have dosis halveret til halvdelen af den anbefalede dosis alogliptin.
For patients with moderate renal impairment (creatinine clearance ≥ 30 to ≤ 50 mL/min), one-half of the recommended dose of alogliptin should be administered.
Patienter med moderat nedsat nyrefunktion bør overvåges oftere for hæmatologisk toksicitet.
Patients with moderate renal impairment should be more frequently monitored for haematological toxicities.
Patienter med moderat nedsat nyrefunktion havde en højere forekomst af gastrointestinale og centralnervesystemsrelaterede bivirkninger, disse patienter havde således generelt lavere tolerabilitet af naltrexon/bupropion.
Patients with moderate renal impairment had a higher incidence of gastrointestinal and central nervous system-related adverse events, thus these patients generally had lower tolerability of naltrexone / bupropion.
Patienter med moderat nedsat nyrefunktion skulle have en lavere startdosis af lenalidomid på 10 mg dagligt med det samme skema.
Patients with moderate renal insufficiency were to receive a lower starting dose of lenalidomide 10 mg daily on the same schedule.
Patienter med moderat nyreinsufficiens fik hyppigere dosis reduceret (44 %) vs.
Patients with moderately impaired renal function show an increased rate of dose reduction (44%) vs.
Patienter med moderat til svær nyreinsufficiens, da der ikke findes tilstrækkelig klinisk erfaring hos denne patientgruppe
Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group,
Patienter med moderat til svær nyreinsufficiens, da der ikke findes tilstrækkelig klinisk erfaring hos denne patientgruppe
Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group.
Patienter med moderat til svær nyreinsufficiens, da der ikke findes tilstrækkelig klinisk erfaring hos denne patientgruppe,
Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group.
Patienter med moderat til svær nyreinsufficiens, da der ikke findes tilstrækkelig klinisk erfaring hos denne patientgruppe.
Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group.
Patienter med moderat til svært nedsat leverfunktion
Patients with moderate to severe hepatic impairment
Patienter med myelomatose har tendens til at udvikle infektioner, herunder lungebetændelse.
Patients with multiple myeloma are prone to develop infections including pneumonia.
Patienter med myokardieinfarkt (fra få dage, men ikke over 35 dage), iskæmisk slagtilfælde (fra 7 dage, men ikke over 6 måneder) eller påviste perifere kredsløbsforstyrrelser.
Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
Patienter med myokardieinfarkt indenfor de seneste 90 dage
patients with myocardial infarction within the last 90 days,
Patienter med nedsat bilirubinglukuronidering, f.eks. med Gilberts syndrom, kan have øget risiko for myelosuppression ved behandling med ONIVYDE.
Patients with deficient glucuronidation of bilirubin, such as those with Gilbert’s syndrome, may be at greater risk of myelosuppression when receiving therapy with ONIVYDE.
Patienter med nedsat CYP2C9-metabolisering bør behandles med forsigtighed (se pkt.
Patients known to be CYP2C9 poor metabolisers should be treated with caution (see section 5.2).
Patienter med nedsat funktion af ét eller flere individuelle organer svarende til en score på 4 vurderet ved CIRS, undtagen øjne, øre, næse, hals og svælg, kunne heller ikke deltage i studIet.
Patients with one or more individual organ/system impairment score of 4 as assessed by the CIRS definition, excluding eyes, ears, nose, throat and larynx organ system, were excluded.
Patienter med nedsat lever- eller nyrefunktion
Renally and hepatically impaired patients
Patienter med nedsat lever- og/eller nyrefunktion
Patients with hepatic and/or renal impairment
Patienter med nedsat leverfunktion
Hepatic impairment
Patienter med nedsat leverfunktion
Hepatically-impaired patients
Patienter med nedsat leverfunktion
Patients with hepatic impairment:
Patienter med nedsat leverfunktion
Patients with impairment of liver function,
Patienter med nedsat leverfunktion
Patients with impairment of liver function.
Patienter med nedsat leverfunktion
Patients with liver impairment
Patienter med nedsat leverfunktion (grad 3 ved NCI’s definition (ASAT/ALAT >5 x øvre grænseværdi i >2 uger; bilirubin >3 x øvre grænseværdi) og nedsat nyrefunktion (CrCl <30 ml/min) kunne ikke deltage i studiet.
Patients with inadequate liver function (National Cancer Institute – Common Terminology Criteria for Adverse Events Grade 3 liver function tests (AST, ALT > 5 x ULN for > 2 weeks; bilirubin > 3 x ULN) and renal function (CrCl < 30 mL/min) were excluded.
Patienter med nedsat leverfunktion (se afsnit 4.3)
Patients with hepatic impairment (see section 4.3)
Patienter med nedsat leverfunktion bør dog overvåges nøje for bivirkninger, og dosis af pomalidomid bør reduceres eller behandlingen seponeres, såfremt det er nødvendigt.
However, patients with hepatic impairment should be carefully monitored for adverse reactions and dose reduction or interruption of pomalidomide should be used as needed.
Patienter med nedsat leverfunktion bør ikke gives colchicin sammen med VIRACEPT.
Patients with hepatic impairment should not be given colchicine with VIRACEPT.
Patienter med nedsat leverfunktion er ikke blevet undersøgt systematisk (se pkt.
Patients with hepatic impairment have not been systematically evaluated (see section 5.2).
Patienter med nedsat leverfunktion har nedsat udskillelse af amlodipin, hvilket medfører et øget AUC på ca.
Patients with hepatic impairment have decreased clearance of amlodipine with resulting increase of approximately 40–60 % in AUC.
Patienter med nedsat leverfunktion har nedsat udskillelse af amlodipin, hvilket medfører et øget AUC på ca.
Patients with hepatic impairment have decreased clearance of amlodipine with resulting increase of approximately 40–60% in AUC.
Patienter med nedsat leverfunktion har nedsat udskillelse af amlodipin, hvilket medfører et øget AUC på ca.
Patients with hepatic insufficiency have decreased clearance of amlodipine with resulting increase of approximately 40–60% in AUC.
Patienter med nedsat leverfunktion,
Patients with impairment of liver function.
patienter med nedsat leverfunktion,
patients with reduced liver function;
Patienter med nedsat leverfunktion.
Patients with impairment of liver function.
Patienter med nedsat leverfunktion:
Hepatic impairment
Patienter med nedsat leverfunktion: Der er ikke fundet nogen sammenhæng mellem ASAT, ALAT eller total-bilirubin og pemetrexeds farmakokinetik.
Patients with hepatic impairment: No relationships between AST (SGOT), ALT (SGPT), or total bilirubin and pemetrexed pharmacokinetics were identified.
Patienter med nedsat leverfunktion: Det anbefales at Corbilta administreres med forsigtighed til patienter med mild til moderat leversvigt.
Patients with hepatic impairment: It is advised that Corbilta should be administered cautiously to patients with mild to moderate hepatic impairment.
Patienter med nedsat leverfunktion: Det anbefales at Levodopa/Carbidopa/Entacapone Orion administreres med forsigtighed til patienter med mild til moderat leversvigt.
Patients with hepatic impairment: It is advised that Levodopa/Carbidopa/Entacapone Orion should be administered cautiously to patients with mild to moderate hepatic impairment.
Patienter med nedsat leverfunktion: Det anbefales at Stalevo administreres med forsigtighed til patienter med mild til moderat leversvigt.
Patients with hepatic impairment: It is advised that Stalevo should be administered cautiously to patients with mild to moderate hepatic impairment.
Patienter med nedsat leverfunktion: Erlotinib udskilles ved hepatisk metabolisme og biliær udskillelse.
Patients with hepatic impairment: Erlotinib is eliminated by hepatic metabolism and biliary excretion.
Patienter med nedsat leverfunktion: Sikkerheden og effekten er ikke undersøgt hos patienter med nedsat leverfunktion (se pkt.
Patients with hepatic impairment: The safety and efficacy have not been studied in patients with hepatic impairment (see section 5.2).
Patienter med nedsat leverfuntion
Patients with hepatic impairment
Patienter med nedsat nyre- eller leverfunktion bør ikke ordineres colchicin sammen med INCIVO på grund af risikoen for colchicin- toksicitet.
Patients with renal or hepatic impairment should not be given colchicine with INCIVO, due to the risk of colchicine toxicity.
Patienter med nedsat nyre- eller leverfunktion skal overvåges nøje.
Patients with renal or hepatic impairment should be monitored closely.
Patienter med nedsat nyre- eller leverfunktion: Dosisjustering er ikke nødvendig.
Renally or hepatically impaired patients: No dose adjustment is necessary.
Patienter med nedsat nyre- og leverfunktion
Renal or hepatic impairment
Patienter med nedsat nyre- og leverfunktion skal nøje overvåges.
Patients with renal and hepatic impairments should be closely monitored.
Patienter med nedsat nyre- og/eller leverfunktion
Patients with renal and/or hepatic impairment:
Patienter med nedsat nyrefunktion
Patients with impaired kidney function
Patienter med nedsat nyrefunktion
Patients with renal impairment:
Patienter med nedsat nyrefunktion
Renal impairment
Patienter med nedsat nyrefunktion
Renally-impaired patients
Patienter med nedsat nyrefunktion (se afsnit 4.4 Væskeretention og hjerteinsufficiens):
Patients with renal impairment (see section 4.4 Fluid retention and cardiac failure)
Patienter med nedsat nyrefunktion (se afsnit 5.2)
Patients with renal impairement (see section 5.2)
Patienter med nedsat nyrefunktion (se afsnit 5.2)
Patients with renal impairment (see section 5.2)