natgillin/translations-raw huggingface dataset:
Patienter med nedsat nyrefunktion (standardformel, der er udviklet af Cockcroft og Gault, eller glomerulær filtrationshastighed baseret på Tc99m-DPTA-serum-clearancemetoden)
Patients with renal impairment (Standard Cockcroft and Gault formula or glomerular filtration rate measured Tc99m DPTA serum clearance method)
Patienter med nedsat nyrefunktion (standardformel, der er udviklet af Cockcroft og Gault, eller glomerulær filtrationshastighed baseret på Tc99m-DPTA-serum-clearancemetoden):
Patients with renal impairment: (Standard Cockcroft and Gault formula or Glomerular Filtration Rate measured Tc99m-DPTA serum clearance method)
Patienter med nedsat nyrefunktion (standardformel, der er udviklet af Cockcroft og Gault, eller glomerulær filtrationshastighed baseret på Tc99m-DPTA-serum-clearancemetoden): Pemetrexed udskilles primært uforandret via nyrerne.
Patients with renal impairment (Standard Cockcroft and Gault formula or Glomerular Filtration Rate measured Tc99m-DPTA serum clearance method): Pemetrexed is primarily eliminated unchanged by renal excretion.
Patienter med nedsat nyrefunktion (standardformel, der er udviklet af Cockcroft og Gault, eller glomerulær filtrationshastighed baseret på Tc99m-DPTA-serum-clearancemetoden): Pemetrexed udskilles primært uforandret via nyrerne.
Patients with renal impairment: (Standard Cockcroft and Gault formula or Glomerular Filtration Rate measured Tc99m-DPTA serum clearance method): Pemetrexed is primarily eliminated unchanged by renal excretion.
Patienter med nedsat nyrefunktion ved baseline havde en større forekomst af grad 3 eller 4 hypertension, proteinuri, træthed, stomatitis, perifert ødem, trombocytopeni, dehydrering, QT- forlængelse på elektrokardiogram, hypotyreoidisme, hyponatriæmi, forhøjet niveau af tyreoideastimulerende hormon i blodet, pneumoni sammenlignet med personer med normal nyrefunktion.
Patients with baseline renal impairment had a higher incidence of Grade 3 or 4 hypertension, proteinuria, fatigue, stomatitis, oedema peripheral, thrombocytopenia, dehydration, prolonged electrocardiogram QT, hypothyroidism, hyponatraemia, blood thyroid stimulating hormone increased, pneumonia compared with subjects with normal renal function.
Patienter med nedsat nyrefunktion, 52 ugers placebokontrollerede data
Patients with renal impairment, 52 week placebo controlled data
Patienter med nedsat nyrefunktion, som kræver dialyse, er ikke undersøgt i kliniske studier.
Patients with renal insufficiency requiring dialysis have not been studied in clinical trials.
Patienter med nedsat nyrefunktion:
Renal impairment
Patienter med nedsat nyrefunktion:
Renal impairment:
Patienter med nedsat nyrefunktion: Nedsat nyrefunktion påvirker ikke entacapons farmakokinetik.
Patients with renal impairment: Renal impairment does not affect the pharmacokinetics of entacapone.
Patienter med nedsat nyrefunktion: Rasagilins farmakokinetiske egenskaber hos forsøgspersoner med let (CLcr 50-80 ml/min) og moderat (CLcr 30-49 ml/min) nedsat nyrefunktion var de samme, som sås hos raske forsøgspersoner.
Patients with renal impairment: Rasagiline's pharmacokinetics characteristics in subjects with mild (CLcr 50-80 ml/min) and moderate (CLcr 30-49 ml/min) renal impairment were similar to healthy subjects.
Patienter med nedsat nyrefunktion: Sikkerheden og effekten er ikke undersøgt hos patienter med nedsat nyrefunktion (se pkt.
Patients with renal impairment: The safety and efficacy have not been studied in patients with renal impairment (see section 5.2).
Patienter med nedsat nyrefunktion: Sikkerheden og virkningen af erlotinib er ikke undersøgt hos patienter med nedsat nyrefunktion (koncentrationen af serumkreatinin >1,5 gang den øvre referencegrænse).
Patients with renal impairment: The safety and efficacy of erlotinib has not been studied in patients with renal impairment (serum creatinine concentration >1.5 times the upper normal limit).
Patienter med negativ FNA bør følges op klinisk, idet nogle FNA biopsier kan give falsk negative resultater.
Patients with a negative FNA should be followed up clinically as some FNA biopsies may give false negative results.
Patienter med nitritinduceret methæmoglobinæmi fremkaldt under behandling af cyanidforgiftning
Patients with nitrite-induced methaemoglobinaemia during treatment of cyanide poisoning
Patienter med normalisering af trombocyttal, n (%)
Patients with platelet count normalization, n (%)
Patienter med nydiagnosticeret ALL fik en enkelt intramuskulær injektion med Oncaspar (2.500 E pr. m² legemsoverfladeareal) eller naturligt forekommende asparaginase fra E. coli (25.000 E pr. m² legemsoverfladeareal) eller fra Erwinia (25.000 E pr. m² legemsoverfladeareal).
Patients with newly diagnosed ALL received a single intramuscular injection of Oncaspar (2500 U/m² body surface area) or native asparaginase from E. coli (25000 U/m² body surface area) or from Erwinia (25000 U/m² body surface area).
Patienter med nydiagnosticeret glioblastoma multiforme:
Adult patients with newly-diagnosed glioblastoma multiforme
Patienter med nydiagnosticeret hypertriglyceridæmi eller eller med familiær hypertriglyceridæmi kan have dårlig absorption af cholsyre fra tarmen.
Patients with newly diagnosed or a family history of familial hypertriglyceridaemia may have poor absorption of cholic acid from the intestine.
Patienter med nye eller forstørrede T2-
Patients with new or enlarging T2 lesions through Year 2
Patienter med nylig alvorlig pulmonal, gastrointestinal eller postoperativ blødning, tegn på CNS-blødning, tumor involverende de større luftveje eller blodårer, intra- tumorkavitation og tidligere signifikant blødning eller ukontrollerede trombotiske sygdomme blev ekskluderet.
Patients with recent serious pulmonary, gastrointestinal, or postoperative bleeding, evidence of CNS haemorrhage, tumour involvement of major airway or blood vessel, intra-tumour cavitation, and history of significant bleeding or uncontrolled thrombotic disorders were excluded.
Patienter med nylig eller nuværende klinisk signifikant gastrointestinal sygdom (f.eks. svær opkastning og/eller diarré) blev udelukket fra de kliniske studier.
In clinical studies, patients with recent or ongoing clinically significant gastrointestinal disorder (e.g., severe vomiting and/or diarrhea) were excluded.
Patienter med nylige lungeinfiltrater eller lungebetændelse kan have en højere risiko.
Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
Patienter med nyligt myokardieinfarkt eller apopleksi i anamnesen blev ekskluderet fra INPULSIS- studierne.
Patients with a recent history of myocardial infarction or stroke were excluded from the INPULSIS trials.
Patienter med nyligt myokardieinfarkt eller slagtilfælde i anamnesen blev ekskluderet fra dette studie.
Patients with a recent history of myocardial infarction or stroke were excluded from this study.
Patienter med nyre- og leverinsufficiens
Renal and hepatic impairment
Patienter med nyre- og/eller leverfunktion
Patients with renal and/or hepatic impairment
Patienter med nyre- og/eller leverfunktion
Patients with renal and/or hepatic impairment:
Patienter med nyreinsufficiens
Patients with renal impairment.
Patienter med nyreinsufficiens
Renal impairment
Patienter med nyreinsufficiens af en højere grad end let er ikke blevet undersøgt.
Patients with renal impairment of a higher severity grade than mild have not been investigated.
Patienter med nyreinsufficiens kan også behandles ved indgivelse af Emtriva 10 mg/ml oral opløsning for at give en reduceret daglig dosis af emtricitabin.
Patients with renal insufficiency can also be managed by administration of Emtriva 10 mg/ml oral solution to provide a reduced daily dose of emtricitabine.
Patienter med nyreinsufficiens kan også behandles ved indgivelse af Emtriva 200 mg hårde kapsler med ændrede dosisintervaller.
Patients with renal insufficiency can also be managed by administration of Emtriva 200 mg hard capsules at modified dose intervals.
Patienter med nyreinsufficiens med estimeret kreatinclearance <30 ml/min.
Patients with renal insufficiency with estimated creatinine clearance <30 ml/ min.
Patienter med nyreinsufficiens.
Patients with renal impairment.
Patienter med nyreproblemer
People with kidney problems
Patienter med obstruktion af venstresidig ventrikulær udløb, f.eks. aorta stenose og idiopatisk hypertrofisk subaorta stenose, kan være følsomme over for virkningen af vasodilatorer inklusiv phosphodiesterase type 5 inhibitorer.
Patients with left ventricular outflow obstruction, e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors.
Patienter med obstruktion af venstresidig ventrikulær udløb, f.eks. aorta stenose og idiopatisk hypertrofisk subaorta stenose, kan være følsomme over for virkningen af vasodilatorer inklusiv phosphodiesterase type 5-inhibitorer.
Patients with left ventricular outflow obstruction, e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors.
Patienter med okulært melanom, primært CNS–melanom og aktive hjernemetastaser blev ikke inkluderet i det pivotale kliniske forsøg (se pkt.
Patients with ocular melanoma, primary CNS melanoma and active brain metastases were not included in the pivotal clinical trial (see section 5.1).
Patienter med okulært melanom, primært CNS–melanom, aktive hjernemetastaser, human immundefekt virus (HIV), hepatitis B og hepatitis C blev ikke inkluderet i det pivotale kliniske forsøg.
Patients with ocular melanoma, primary CNS melanoma, active brain metastases, human immunodeficiency virus (HIV), hepatitis B, and hepatitis C were not included in the pivotal clinical trial.
Patienter med operabel, lymfeknude-positiv brystkræft (TAX 316)
Patients with operable node-negative breast cancer eligible to receive chemotherapy (GEICAM 9805)
Patienter med PAD, men uden apopleksi eller TCI i anamnesen, som var randomiseret til vorapaxar, gennemgik færre perifere revaskulariseringsprocedurer (15,4% versus 19,3%, 3-års-KM-rater; HR: 0,82 [0,71-0,94; 95% CI]; P=0,005) og havde færre hospitalsindlæggelser for akut ekstremitetsiskæmi (2,0% versus 3,3%; HR: 0,59 [0,40–0,86]; P=0,007) end patienter, som var randomiseret til placebo.
Patients with a history of PAD but without a history of stroke or TIA randomized to vorapaxar had fewer peripheral revascularization procedures (15.4% v 19.3%, 3-year KM rates; HR 0.82 [0.71-0.94, 95% CI]; P=0.005) and fewer hospitalizations for acute limb ischemia (2.0% v 3.3%; HR 0.59 [0.40 – 0.86]; P=0.007) than patients randomized to placebo.
Patienter med pancreascancer:
Patients with pancreatic cancer:
Patienter med Parkinsons sygdom er særligt sårbare over for hypotension på grund af deres eksisterende gangforstyrrelser.
Patients with Parkinson’s disease are particularly vulnerable to the adverse effects of hypotension due to existing gait issues.
patienter med perifer ateriesygdom (problemer med blodgennemstrømningen i arterierne) patienter, der lider af ”akut koronarsyndrom”, når patienterne skal indtage det i kombination med aspirin (et andet lægemiddel, som forebygger blodpropper), herunder patienter, der har fået indsat en stent (et kort rør, der anbringes i arterien for at forhindre den i at tillukkes).
patients with peripheral arterial disease (problems with blood flow in the arteries); patients who have a condition known as ‘acute coronary syndrome’, when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
patienter med perifere kredsløbsforstyrrelser (problemer med blodgennemstrømningen i arterierne) patienter, der lider af ”akut koronarsyndrom”, når patienterne skal indtage det i kombination med aspirin (et andet lægemiddel, som forebygger blodpropper), herunder patienter, der har fået indsat en stent (et kort rør, der anbringes i arterien for at forhindre den i at tillukkes).
patients with peripheral arterial disease (problems with blood flow in the arteries); patients who have a condition known as ‘acute coronary syndrome’, when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
patienter med perifere kredsløbsforstyrrelser (problemer med blodgennemstrømningen i arterierne), patienter, der lider af ”akut koronarsyndrom”, når patienterne skal indtage det i kombination med aspirin (et andet lægemiddel, som forebygger blodpropper), herunder patienter, der har fået indsat en stent (et kort rør, der anbringes i arterien for at forhindre den i at tillukkes).
patients with peripheral arterial disease (problems with blood flow in the arteries); patients who have a condition known as ‘acute coronary syndrome’, when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Patienter med perikardial konstriktion
Patients with pericardial constriction
Patienter med permanent atrieflimren
Patients with Permanent Atrial Fibrillation:
Patienter med persisterende forhøjede aminotransferaseværdier > 3 x ULN henvises til nærmere undersøgelse ved hepatolog.
Refer patients with persistent elevations in aminotransferase >3x ULN to a hepatologist for further investigation.
Patienter med PKU har defekte udgaver af enzymet, og patienter med BH4-mangel har lave koncentrationer af BH4, som er en "medvirkende faktor", enzymet skal bruge for at fungere korrekt.
Patients with PKU have defective versions of the enzyme, and patients with BH4 deficiency have low levels of BH4, a ‘cofactor’ that this enzyme needs to work properly.
Patienter med plasma hiv-1 RNA < 400 kopier/ml, snapshot analyse
Patients with plasma HIV-1 RNA <400 copies/ml, Snapshot analysis
patienter med polyartikulær juvenil idiopatisk artrit og entesopatirelateret artrit
CPatients for Polyarticular Juvenile Idiopathic Arthritis and Enthesitis-Related Arthritis
patienter med polyartikulær juvenil idiopatisk artrit og entesopatirelateret artrit
Patients for Polyarticular Juvenile Idiopathic Arthritis and Enthesitis-Related Arthritis
Patienter med Pompes sygdom har risiko for luftvejsinfektioner på grund af sygdommens progressive virkninger på åndedrætsmusklerne.
Patients with Pompe disease are at risk of respiratory infections due to the progressive effects of the disease on the respiratory muscles.
Patienter med porfyri eller med porfyri i familieanamnesen skal monitoreres nøje under behandlingen med Gonal-f.
Patients with porphyria or a family history of porphyria should be closely monitored during treatment with GONAL-f.
Patienter med positiv serologisk test for humant immundefektvirus (HIV) 1 og 2, humant T-celle- lymfotropt virus (HTLV) 1 og hepatitis B og C blev ekskluderet fra de kontrollerede kliniske studier.
Patients with positive serology tests for human immunodeficiency virus [HIV] 1 and 2, human T cell lymphotropic virus [HTLV] 1, and hepatitis B and C were excluded from controlled clinical trials.
Patienter med Prader-Willi syndrom bør ikke behandles med Valtropin, medmindre de også har mangel på væksthormon.
Patients with Prader-Willi syndrome should not be treated with Valtropin unless they are also suffering from growth hormone failure.
Patienter med primær immundefektsyndrom (PID), en medfødt mangel på antistoffer.
Patients with Primary Immunodeficiency Syndromes (PID), an inborn lack of antibodies.
Patienter med procent af forventet FEV1 under 40 % blev ikke inkluderet i studiet hos CF-patienter med non-G551D gating- mutationer, studie 5 (se pkt.
Patients with a percent predicted FEV1 below 40% were not included in the study of patients with CF with non-G551D gating mutations, study 5 (see section 5.1).
Patienter med procent af forventet FEV1 under 40 % blev ikke inkluderet i studiet hos CF-patienter med non-G551D gating-mutationer, studie 5 (se pkt.
Patients with a percent predicted FEV1 below 40% were not included in the study of patients with CF with non-G551D gating mutations, study 5 (see section 5.1).
Patienter med præeksisterende let eller moderat nedsat leverfunktion skal monitoreres for tegn og symptomer på leverdysfunktion under behandlingen med Zinbryta.
Patients with pre-existing mild or moderate hepatic impairment should be monitored for signs and symptoms of hepatic dysfunction during treatment with Zinbryta.
Patienter med præeksisterende leversygdom og patienter, som fik ikke-konventionelle PAH-behandlinger (f.eks. iloprost), var ekskluderede.
Patients with pre-existent hepatic disease and patients using non- conventional PAH treatments (eg, iloprost) were excluded.
Patienter med præeksisterende tumorer eller væksthormonmangel sekundært til en intrakraniel læsion bør rutinemæssigt undersøges for progression eller recidiv af den underliggende sygdomsproces.
Patients with pre-existing tumours or growth hormone deficiency secondary to an intracranial lesion should be examined routinely for progression or recurrence of the underlying disease process.
Patienter med psykiske lidelser i anamnesen synes at have en større risiko for disse alvorlige, psykiske bivirkninger med en hyppighed for hver af de ovennævnte hændelser varierende fra 0,3% for maniske reaktioner til 2,0% for både svær depression og suicidale tanker..
Patients with a history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions with frequencies of each of the above events ranging from 0.3 % for manic reactions to 2.0 % for both severe depression and suicidal ideation.
Patienter med psykiske lidelser i anamnesen synes at have en større risiko for disse alvorlige, psykiske bivirkninger med en hyppighed for hver af de ovennævnte hændelser, der varierer fra 0,3 % for maniske reaktioner til 2,0 % for både svær depression og suicidale tanker.
Patients with a history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions with frequencies ranging from 0.3% for manic reactions to 2.0% for both severe depression and suicidal ideation.
Patienter med psykiske lidelser i anamnesen synes at have en større risiko for disse alvorlige, psykiske bivirkninger med en hyppighed for hver af de ovennævnte hændelser, der varierer fra 0,3% for maniske reaktioner til 2,0% for både svær depression og suicidale tanker.hvor hyppigheden af hvert af de ovenstående tilfælde varierer fra 0,3% for maniske reaktioner til 2,0% for både svær depression og suicidaltanker.
Patients with a history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions with frequencies of each of the above events ranging from 0.3 % for manic reactions to 2.0 % for both severe depression and suicidal ideation.
Patienter med psykiske lidelser i anamnesen synes at have større risiko for disse alvorlige, psykiske bivirkninger med en hyppighed for hver af de ovennævnte hændelser varierende fra 0,3 % for maniske reaktioner til 2,0 % for både svær depression og suicidale tanker..
Patients with a history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions with frequencies ranging from 0.3% for manic reactions to 2.0% for both severe depression and suicidal ideation.
Patienter med påvirket syn bør omgående gennemgå en fuldstændig oftalmologisk undersøgelse.
Patients with impaired vision should undergo a prompt and complete ophthalmologic examiniation.
Patienter med påvist nedbrydning af cornea-epitelet skal straks ophøre med at bruge Nevanac, og corneas tilstand skal undersøges nøje.
Patients with evidence of corneal epithelial breakdown should immediately discontinue use of NEVANAC and should be monitored closely for corneal health.
Patienter med QTc-interval > 480 ms.
Patients with a QTc interval over 480 msec.
Patienter med QTc-interval over 480 ms.
Patients with a QTc interval over 480 msec.
Patienter med rebound
Rebounder
Patienter med recidiv
Relapsing
patienter med recidiverende dissemineret sklerose (MS).
patients with relapsing multiple sclerosis (MS).
Patienter med recidiverende-remitterende dissemineret sklerose, som har haft to eller flere relapser inden for de seneste to år.
Patients with relapsing remitting multiple sclerosis and two or more relapses within the last two years.
Patienter med reducerede hæmatologiske parametre ved baseline (dvs.
Patients with reduced baseline blood counts (i.e.
Patienter med renal angiomyolipom forbundet med TSC:
Patients with renal angiomyolipoma associated with TSC:
Patienter med resistensmutationer (%)
Patients with Resistance Mutations (%)
Patienter med restriktiv eller dilateret kardiomyopati
Patients with restrictive or congestive cardiomyopathy
Patienter med reumatoid artrit
RA Patients
Patienter med reumatoid artrit Dosering
RA Patients Posology
Patienter med reumatoid artrit Farmakodynamisk virkning
RA Patients Pharmacodynamic effects
Patienter med reumatoid artrit samt sJIA- og pJIA-patienter ≥ 30 kg
RA, sJIA and pJIA Patients ≥ 30 kg
Patienter med reumatoid artritis, GPA eller MPA må ikke modtage MabThera, hvis de har svære hjerteproblemer.
Patients with rheumatoid arthritis, GPA or MPA must not receive MabThera if they have severe heart problems.
Patienter med ringe interferonrespons
Poorly interferon-responsive patients
Patienter med ringe tolerabilitet vil stadig have væsentlig fordel af at få sænket leukocytternes cystinindhold til under 2 nmol hemicystin/mg protein.
Patients with poorer tolerability still receive significant benefit if white blood cell cystine levels are below 2 nmol hemicystine/mg protein.
Patienter med risiko for blødning (SPAF, DVT/LE)
Patients at risk of bleeding (SPAF, DVT/PE
Patienter med risiko for blødning eller patienter med risiko for overeksponering, især patienter med moderat nedsat nyrefunktion (CrCl 30-50 ml / min), bør behandles med forsigtighed (se pkt 4.4 og 5.1).
Patients at risk for bleeding or patients at risk of overexposure, notably patients with moderate renal impairment (CrCL 30-50 mL/min), should be treated with caution (see sections 4.4 and 5.1).
Patienter med risiko for blødning eller patienter med risiko for overeksponering, især patienter med moderat nedsat nyrefunktion (CrCl 30-50 ml/min), bør behandles med forsigtighed (se pkt 4,4 og 5,1).
Patients at risk for bleeding or patients at risk of overexposure, notably patients with moderate renal impairment (CrCL 30-50 mL/min), should be treated with caution (see sections 4.4 and 5.1).
Patienter med risiko for VTE.
Patients at risk of VTE.
Patienter med risiko-faktorer for QTc-forlængelse eller risikofaktorer for torsades de pointes bør observeres med kontinuerlig hjerteovervågning (ekg).
Patients with risk factors of QTc prolongation or risk factors of torsade de pointes should be monitored with continuous cardiac monitoring (ECG).
Patienter med risikofaktorer bør kontrolleres nøje for respiratoriske symptomer før og under ONIVYDE-behandlingen.
Patients with risk factors should be closely monitored for respiratory symptoms before and during ONIVYDE therapy.
Patienter med samtidig administration af lægemidler, der kan øge blødningsrisikoen (f.eks. non- steroide antiinflammatoriske stoffer (NSAID), orale antikoagulantia og/eller fibrinolytika) inden for 24 timer fra dosering af Possia.
Patients with concomitant administration of medicinal products that may increase the risk of bleeding (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulants and/or fibrinolytics) within 24 hours of Possia dosing.
Patienter med samtidig administration af lægemidler, der kan øge blødningsrisikoen (f.eks. non- steroide antiinflammatoriske stoffer (NSAID), orale antikoagulantia og/eller fibrinolytika) inden for 24 timer fra dosering af ticagrelor.
Patients with concomitant administration of medicinal products that may increase the risk of bleeding (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulants and/or fibrinolytics) within 24 hours of ticagrelor dosing.