FrancophonIA/ELRC3.0 huggingface dataset:
English: No adjustment of starting dose is required on the basis of race (see section 5.2).
Danish: Justering af startdosis er ikke nødvendig på basis af race (se pkt.
English: The toxicity of lenvatinib was more prominent in younger rats (dosing initiated on PND7) compared with those with dosing initiated on PND21 and mortality and some toxicities were observed earlier in the juvenile rats at 10 mg/kg compared with adult rats administered the same dose level.
Danish: Toksiciteten af lenvatinib var mere fremtrædende hos yngre rotter (dosering påbegyndt PND7) sammenlignet med rotter, hvor dosering blev påbegyndt PND21, og mortalitet og nogle toksiciteter blev observeret tidligere hos juvenile rotter ved 10 mg/kg sammenlignet med voksne rotter, der fik samme dosisniveau.
English: Mortality was the dose-limiting toxicity in juvenile rats in which dosing was initiated on postnatal day (PND) 7 or PND21 and was observed at exposures that were respectively 125- or 12-fold lower compared with the exposure at which mortality was observed in adult rats, suggesting an increasing sensitivity to toxicity with decreasing age.
Danish: Mortalitet var den dosisbegrænsende toksicitet hos juvenile rotter, hvor dosering blev påbegyndt på den 7. postnatale dag (PND7) eller PND21, og blev observeret ved eksponeringer, der var hhv. 125 eller 12 gange lavere sammenlignet med eksponeringen, hvor der blev observeret mortalitet hos voksne rotter, hvilket tyder på en øget følsomhed for toksicitet ved faldende alder.
English: In vitro, the lenvatinib blood-to-plasma concentration ratio ranged from 0.589 to 0.608 (0.1 - 10 μg/mL, mesylate).
Danish: In vitro var blod-plasma-koncentrationsforholdet for lenvatinib i intervallet fra 0,589 til 0,608 (0,110 μg/ml, mesilat).
English: Antihypertensive agents should be started as soon as elevated BP is confirmed.
Danish: Behandling med antihypertensiva skal startes, så snart et forhøjet blodtryk er blevet bekræftet.
English: It is currently unknown whether lenvatinib may reduce the effectiveness of hormonal contraceptives, and therefore women using oral hormonal contraceptives should add a barrier method.
Danish: Det er aktuelt ukendt, om lenvatinib kan reducere virkningen af hormonale kontraceptiva, og derfor skal kvinder, der anvender orale hormonale kontraceptiva, tilføje en barrieremetode.
English: • Do not store above 25°C.
Danish: • Må ikke opbevares ved temperaturer over 25°C.
English: Adverse reactions that occur more frequently with combination therapy compared to lenvatinib monotherapy are hypothyroidism, (including increased blood thyroid stimulating hormone), hypercholesterolaemia, and severe diarrhoea.
Danish: Bivirkninger, der opstår hyppigere med kombinationsbehandling sammenlignet med lenvatinib-monoterapi, er hypotyreoidisme (herunder forhøjet thyreoideastimulerende hormon i blodet), hyperkolesterolæmi og svær diarré.
English: Hypercholesterolaemia includes hypercholesterolaemia and increased blood cholesterol.
Danish: Hyperkolesterolæmi omfatter hyperkolesterolæmi og forhøjet niveau af kolesterol i blodet.
English: The lenvatinib arm also showed an improvement in PFS compared with the everolimus arm.
Danish: Lenvatinib-armen viste også en forbedring i PFS sammenlignet med everolimus-armen.
English: • underactive thyroid (tiredness, weight gain, constipation, feeling cold, dry skin)
Danish: • nedsat aktivitet af skjoldbruskkirtlen (træthed, vægtstigning, forstoppelse, kuldefølelse, tør hud)
English: • Uncommon (≥1/1,000 to <1/100)
Danish: • Ikke almindelig (1/1.000 til <1/100)
English: When administered with food to healthy subjects, peak plasma concentrations are delayed by 2 hours.
Danish: Når lenvatinib administreres sammen med mad til raske personer, forlænges tiden til maksimal plasmakoncentration med 2 timer.
English: The main metabolic pathways in humans were identified as oxidation by aldehyde oxidase, demethylation via CYP3A4, glutathione conjugation with elimination of the O-aryl group (chlorophenyl moiety), and combinations of these pathways followed by further biotransformations (e.g., glucuronidation, hydrolysis of the glutathione moiety, degradation of the cysteine moiety, and intramolecular rearrangement of the cysteinylglycine and cysteine conjugates with subsequent dimerisation).
Danish: De primære metaboliseringsveje hos mennesker blev identificeret som oxidation ved aldehydoxidase, demethylering via CYP3A4, glutationkonjugering med elimination af O-arylgruppen (chlorphenyl-delen) og kombinationer af disse metaboliseringsveje efterfulgt af videre biotransformationer (f.eks. glukuronisation, hydrolyse af glutation-delen, nedbrydning af cysteindelen og intramolekulær omlejring af cysteinylglycin- og cysteinkonjugater med efterfølgende dimerisering).
English: EU/1/16/1128/002 (Pack size of 30 hard capsules) EU/1/16/1128/005 (Pack size of 60 hard capsules) EU/1/16/1128/006 (Pack size of 90 hard capsules)
Danish: EU/1/16/1128/002 (pakningsstørrelse på 30 hårde kapsler) EU/1/16/1128/005 (pakningsstørrelse på 60 hårde kapsler) EU/1/16/1128/006 (pakningsstørrelse på 90 hårde kapsler)
English: In vitro, cytochrome P450 3A4 was demonstrated as the predominant (>80%) isoform involved in the P450-mediated metabolism of lenvatinib.
Danish: CYP3A4 blev in vitro vist som den primære (> 80 %) isoform involveret i den CYP-medierede metabolisering af lenvatinib.
English: In the repeated-dose toxicity studies (up to 39 weeks), lenvatinib caused toxicologic changes in various organs and tissues related to the expected pharmacologic effects of lenvatinib including glomerulopathy, testicular hypocellularity, ovarian follicular atresia, gastrointestinal changes, bone changes, changes to the adrenals (rats and dogs), and arterial (arterial fibrinoid necrosis, medial degeneration, or haemorrhage) lesions in rats, dogs, and cynomolgus monkeys.
Danish: I toksicitetsstudier med gentagne doser (op til 39 uger) forårsagede lenvatinib toksikologiske ændringer i forskellige organer og væv relateret til lenvatinibs forventede farmakologiske virkninger, herunder glomerulopati, testikulær hypocellularitet, follikulær atresi, gastrointestinale ændringer, knogleændringer, ændringer i binyrerne (rotter og hunde) og arterielle læsioner (arteriel fibrinoid nekrose, medial degeneration eller blødning) hos rotter, hunde og cynomolgus-aber.
English: Table 5 Efficacy results in renal cell carcinoma lenvatinib 18 mg + everolimus 5 mg (N=51)
Danish: Tabel 5 Virkningsresultater for nyrecellekarcinom lenvatinib 18 mg + everolimus 5 mg (N = 51)
English: EU/1/16/1128/001 (Pack size of 30 hard capsules) EU/1/16/1128/003 (Pack size of 60 hard capsules) EU/1/16/1128/004 (Pack size of 90 hard capsules)
Danish: EU/1/16/1128/001 (pakningsstørrelse på 30 hårde kapsler) EU/1/16/1128/003 (pakningsstørrelse på 60 hårde kapsler) EU/1/16/1128/004 (pakningsstørrelse på 90 hårde kapsler)
English: Lenvatinib use has been associated with cases of fistulae including reactions resulting in death.
Danish: Behandling med lenvatinib har været forbundet med tilfælde af fistler, herunder tilfælde med dødelig udgang.
English: Cardiac dysfunction
Danish: Kardial dysfunktion
English: To dissolve them, pour a tablespoon of water or apple juice into a small glass and put the capsules into the liquid without breaking or crushing them.
Danish: De opløses, ved at du hælder en spiseskefuld vand eller æblejuice i et lille glas og kommer kapslerne i væsken uden at knække eller knuse dem.
English: Gastrointestinal and abdominal pain includes: abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, abdominal tenderness, epigastric discomfort, and gastrointestinal pain.
Danish: Gastrointestinale og abdominale smerter omfatter: abdominalt ubehag, abdominalsmerter, smerter i nedre del af abdomen, smerter i øvre del af abdomen, ømhed i abdomen, epigastriske gener og gastrointestinale smerter.
English: There was one case of fatal cerebral haemorrhage in the lenvatinib plus everolimus-treated group and one case of fatal intracranial haemorrhage in the lenvatinib-treated group.
Danish: Der var et tilfælde af dødelig cerebral blødning i lenvatinib plus everolimus-gruppen og et tilfælde af dødelig intrakranial blødning i lenvatinib-gruppen.
English: • changes in blood test results for kidney function and kidney failure
Danish: • ændrede resultater af blodprøve for nyrefunktion samt nyresvigt
English: The median of average daily dose in the combination arm per subject was 13.5 mg of lenvatinib (75.0% of the intended dose of 18 mg) and 4.7 mg of everolimus (93.6% of the intended dose of 5 mg).
Danish: Medianen for den gennemsnitlige individuelle daglige dosis i kombinationsarmen var 13,5 mg lenvatinib (75,0 % af den tilsigtede dosis på 18 mg) og 4,7 mg everolimus (93,6 % af den tilsigtede dosis på 5 mg).
English: For toxicities thought to be related to everolimus, treatment should be interrupted, reduced to alternate day dosing, or discontinued (see the everolimus SmPC for advice on specific adverse reactions).
Danish: For toksiciteter, der menes at være forbundet med everolimus, bør behandlingen afbrydes, reduceres til dosering hver 2. dag eller seponeres (se produktresuméet for everolimus for rådgivning om særlige bivirkninger).
English: • chest pain or pressure, pain in your arms, back, neck or jaw, being short of breath, rapid or irregular heart rate, coughing, bluish colour to lips or fingers, feeling very tired - these may be signs of a heart problem a blood clot in your lung or a leak of air from your lung into your chest so your lung cannot inflate.
Danish: • brystsmerter eller trykken for brystet, smerter i armene, ryggen, halsen eller kæben, stakåndethed, hurtig eller uregelmæssig puls, hoste, blåfarvning af læber eller fingre, udpræget træthed - dette kan være tegn på et hjerteproblem, en blodprop i lungerne eller udsivning af luft fra din lunge og ud i brystet, således at der ikke kan komme luft i lungen.
English: The following information is derived from the clinical experience on single agent lenvatinib in patients with differentiated thyroid cancer (DTC; see Lenvima SmPC).
Danish: Nedenstående oplysninger er afledt fra den kliniske erfaring med enkeltstoffet lenvatinib hos patienter med differentieret thyreoideacancer (DTC, se produktresuméet for Lenvima).
English: The pharmacokinetics of lenvatinib following a single 24-mg dose were evaluated in 6 subjects each with mild, moderate, and severe renal impairment, and compared with 8 healthy, demographically matched subjects.
Danish: Lenvatinibs farmakokinetik efter en enkelt dosis på 24 mg blev evalueret hos 6 personer med henholdsvis let, moderat og svært nedsat nyrefunktion og sammenlignet med 8 raske, demografisk matchede personer.
English: Although not studied directly, the MOA for the worsening of diarrhoea with the combination is postulated to be mediated by the impairment of intestinal function related to the MOAs for the individual agentsVEGF/VEGFR and c-KIT inhibition by lenvatinib coupled with mTOR/NHE3 inhibition by everolimus.
Danish: Selvom det ikke blev undersøgt direkte, postuleres det, at virkningsmekanismen i forbindelse med forværring af diarré med kombinationen er medieret af hæmning af tarmfunktionen relateret til virkningsmekanismerne for de enkelte stoffer - lenvatinibs hæmning af VEGF/VEGFR- og c-KIT koblet med everolimus' hæmning af mTOR/NHE3.
English: • anal fistula (a small channel that forms between the anus and the surrounding skin)
Danish: • analfistel (en lille passage, der dannes mellem endetarmsåbningen og den omgivende hud)
English: Other medicines and Kisplyx
Danish: Brug af anden medicin sammen med Kisplyx
English: When systolic BP ≤150 mmHg, diastolic BP ≤95 mmHg, and patient has been on a stable dose of antihypertensive therapy for at least 48 hours, resume lenvatinib at a reduced dose (see section 4.2)
Danish: Når systolisk blodtryk ≤ 150 mmHg, diastolisk blodtryk ≤ 95 mmHg og patienten har været på en stabil dosis af antihypertensiv behandling i mindst 48 timer, skal lenvatinib genoptages med en reduceret dosis (se pkt.
English: • have a history of abnormal passageways (known as a fistula) between different organs in the body or from an organ to the skin
Danish: • tidligere har haft unormale passager (såkaldte fistler) mellem forskellige organer i kroppen eller fra et organ til huden.
English: No adjustment of starting dose of the combination is required on the basis of hepatic function in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
Danish: Justering af startdosis af kombinationen på basis af leverfunktion er ikke nødvendig hos patienter med let (Child-Pugh A) eller moderat (Child-Pugh B) nedsat leverfunktion.
English: Lenvatinib exposure, based on AUC0-inf data, was 101%, 90%, and 122% of normal for subjects with mild, moderate, and severe renal impairment, respectively.
Danish: Baseret på data for AUC0-inf var lenvatinib-eksponeringen henholdsvis 101 %, 90 % og 122 % af det normale for personer med let, moderat og svært nedsat nyrefunktion.
English: • dry skin, thickening and itching of the skin
Danish: • tør hud, fortykning af huden og hudkløe
English: Hypocalcaemia‡ Hypercholesterolaemiab**
Danish: Hypokalcæmi‡ Hyperkolesterolæmi b**
English: Haemorrhage includes: epistaxis, haemoptysis, haematuria, contusion, haematochezia, gingival bleeding, petechiae, pulmonary haemorrhage, rectal haemorrhage, blood urine present, haematoma, vaginal haemorrhage, conjunctival haemorrhage, haemorrhoidal haemorrhage, intracranial tumour haemorrhage, laryngeal haemorrhage, ecchymosis, increased tendency to bruise, post procedural haemorrhage, purpura, skin haemorrhage, aneurysm ruptured, arterial haemorrhage, eye haemorrhage, gastric haemorrhage, gastroduodenitis haemorrhagic, gastrointestinal haemorrhage, haematemesis, haemorrhage, haemorrhagic stroke, melaena, metrorrhagia, nail bed bleeding, haemothorax, postmenopausal haemorrhage, proctitis haemorrhagic, renal haematoma, splenic haemorrhage, splinter haemorrhages, subarachnoid haemorrhage, tracheal haemorrhage, tumour haemorrhage.
Danish: Blødning omfatter: epistaxis, hæmoptyse, hæmaturi, kontusion, hæmatokeksi, gingivalblødning, petekkier, pulmonal blødning, rektalblødning, blod i urinen, hæmatom, vaginalblødning, konjunktival blødning, blødende hæmorroider, intrakranial tumorblødning, laryngeal blødning, ekkymose, øget tendens til at få blå mærker, blødning efter indgreb, purpura, hudblødning, aneurismeruptur, arteriel blødning, øjenblødning, gastrisk blødning, blødende gastroduodenitis, gastrointestinal blødning, hæmatemese, blødning, hjerneblødning, melæna, metroragi, blødning i neglebånd, hæmothorax, postmenopausal blødning, blødende proktitis, renalt hæmatom, miltblødning, splinterblødninger, subaraknoid blødning, trakeal blødning, tumorblødning.
English: Proteinuria led to permanent treatment discontinuation in 4.8% of patients.
Danish: Proteinuri medførte permanent seponering hos 4,8 % af patienterne.
English: BP should be monitored after 1 week of treatment with lenvatinib, then every 2 weeks for the first 2 months, and monthly thereafter.
Danish: 1 uges behandling med lenvatinib, derefter hver 2. uge i de første 2 måneder og derefter månedligt.
English: Administration of lenvatinib during organogenesis resulted in embryolethality and teratogenicity in rats (foetal external and skeletal anomalies) at exposures below the clinical exposure (based on AUC) at the maximum tolerated human dose, and rabbits (foetal external, visceral or skeletal anomalies) based on body surface area; mg/m2 at the maximum tolerated human dose.
Danish: Administration af lenvatinib under organogenesen medførte embryoletalitet og teratogenicitet hos rotter (føtale eksterne anomalier og skeleletanomalier) ved eksponeringer under den kliniske eksponering (baseret på AUC) ved den maksimalt tolererede humane dosis og hos kaniner (føtale eksterne, viscerale anomalier eller skeletanomalier) ved eksponeringer under den kliniske eksponering (baseret på legemsoverfladeareal, mg/m2) ved den maksimalt tolererede humane dosis.
English: (≥1/100 to <1/10)
Danish: • Almindelig (≥ 1/100 til < 1/10)
English: Liver-related adverse reactions most commonly reported in patients treated with lenvatinib included increases in alanine aminotransferase, increases in aspartate aminotransferase, and increases in blood bilirubin.
Danish: De leverrelaterede bivirkninger, der hyppigst blev rapporteret hos patienter i behandling med lenvatinib, omfattede forhøjet alanin-aminotransferase, forhøjet aspartat-aminotransferase og forhøjet bilirubin i blodet.
English: Absolute bioavailability has not been determined in humans; however, data from a mass-balance study suggests that it is in the order of 85%.
Danish: Data fra et masse-balance-studie tyder imidlertid på, at den er i størrelsesordenen 85 %.
English: Patients were randomly allocated to one of 3 arms: 18 mg of lenvatinib plus 5 mg of everolimus, 24 mg of lenvatinib or 10 mg of everolimus using a 1:1:1 ratio.
Danish: Patienterne blev randomiseret til en af 3 arme: 18 mg lenvatinib plus 5 mg everolimus, 24 mg lenvatinib eller 10 mg everolimus i forholdet 1:1:1.
English: Renal failure includes: acute prerenal failure, renal failure, acute kidney injury, and renal tubular necrosis.
Danish: Nyresvigt omfatter: akut prærenalt svigt, nyresvigt, akut nyreskade og renal tubulær nekrose.
English: Consequently, in vivo, inducers and inhibitors of CYP 3A4 had a minimal effect on lenvatinib exposure (see section 4.5).
Danish: Som følge heraf havde CYP3A4-induktorer og CYP3A4-hæmmere in vivo en minimal virkning på lenvatinibeksponeringen (se pkt.
English: Oral pain includes: oral pain, glossodynia, and oropharyngeal pain.
Danish: Orale smerter omfatter: orale smerter, glossodyni og orofaryngeale smerter.
English: • Caregivers should not open capsules to avoid exposure to the contents of the capsule.
Danish: • For at undgå at blive udsat for indholdet i kapslerne må omsorgspersoner ikke åbne kapslerne.
English: • bleeding (most commonly nose bleeds, but also other types of bleeding such as blood in the urine,
Danish: • blødning (hyppigst næseblod, men også andre former for blødninger, såsom blod i urinen, blå mærker, blødning fra tandkød eller tarmvæg)
English: Hypomagnesaemia includes hypomagnesaemia and decreased blood magnesium.
Danish: Hypomagnesiæmi omfatter hypomagnesiæmi og nedsat niveau af magnesium i blodet.
English: There are limited data on patients with body weight <60 kg in RCC.
Danish: Der er begrænsede data for patienter med legemsvægt < 60 kg og RCC.
English: It is currently unknown whether lenvatinib may reduce the effectiveness of hormonal contraceptives, and therefore women using oral hormonal contraceptives should add a barrier method (see section 4.6).
Danish: Det er aktuelt ukendt, om lenvatinib kan reducere virkningen af hormonale kontraceptiva, og derfor skal kvinder, der anvender orale hormonale kontraceptiva, tilføje en barrieremetode (se pkt.
English: It has been determined that plasma protein binding in plasma from hepatically impaired subjects was similar to the respective matched healthy subjects and no concentration dependency was observed.
Danish: Det er blevet fastslået, at plasmaproteinbindingen i plasma fra personer med nedsat leverfunktion lignede de respektive matchede raske personer, og der blev ikke observeret nogen koncentrationsafhængighed.
English: Cases of fistula formation or enlargement that involve other areas of the body than stomach or intestines were observed in clinical trials and in post-marketing experience (e.g. tracheal, tracheo-oesophageal, oesophageal, cutaneous, female genital tract fistulae).
Danish: Tilfælde af fisteldannelse eller forstørrelse, der involverer andre dele af kroppen end mave eller tarme, er observeret i kliniske studier og efter markedsføring (f.eks. trakeal, trakeoøsofageal, øsofageal og kutan fistel samt fistel i de kvindelige kønsorganer).
English: **:These adverse reactions occur more frequently with combination therapy compared to lenvatinib monotherapy.
Danish: **: Disse bivirkninger forekommer hyppigere med kombinationsbehandling sammenlignet med lenvatinib-monoterapi ***: Identificeret ved anvendelse efter markedsføring af lenvatinib.
English: No differences between lenvatinib- and placebo-treated patients were observed in the incidences of serious reactions (3.4% vs. 3.8%), reactions leading to premature discontinuation (1.1% vs. 1.5%), or reactions leading to dose interruption (3.4% vs. 3.8%) or reduction (0.4% vs. 0).
Danish: Der blev ikke observeret nogen forskelle mellem lenvatinib- og placebogruppen hvad angår alvorlige reaktioner (3,4 % versus 3,8 %), reaktioner, der medførte for tidlig seponering (1,1 % versus 1,5 %), eller reaktioner, der medførte doseringsafbrydelse (3,4 % versus 3,8 %) eller dosisreduktion (0,4 %
English: Lenvatinib exposure, based on dose-adjusted AUC0-t and AUC0-inf data, was 119%, 107%, and 180% of normal for subjects with mild, moderate, and severe hepatic impairment, respectively.
Danish: Baseret på dosisjusterede data for AUC0-t og AUC0-inf var lenvatinib-eksponeringen henholdsvis 119 %, 107 % og 180 % af det normale for personer med let, moderat og svært nedsat leverfunktion.
English: All patients other than those with severe hepatic or renal impairment (see below) should initiate treatment at the recommended dose of 18 mg of lenvatinib with 5 mg of everolimus taken once daily, following which the dose should be further adjusted on the basis of individual tolerability.
Danish: Alle andre patienter end patienter med svært nedsat lever- eller nyrefunktion (se nedenfor) bør påbegynde behandlingen med den anbefalede dosis på 18 mg lenvatinib og 5 mg everolimus taget én gang dagligt, hvorefter dosis bør justeres på basis af individuel tolerabilitet.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Danish: Må ikke opbevares ved temperaturer over 25°C.
English: It has been determined that plasma protein binding in plasma from renally impaired subjects was similar to the respective matched healthy subjects and no concentration dependency was observed.
Danish: Det er blevet fastslået, at plasmaproteinbindingen i plasma fra personer med nedsat nyrefunktion lignede de respektive matchede raske personer, og der blev ikke observeret nogen koncentrationsafhængighed.
English: The lenvatinib plus everolimus arm showed a statistically significant and clinically meaningful improvement in PFS compared with the everolimus arm (see Table 5 and Figure 1).
Danish: Lenvatinib plus everolimus-armen viste en statistisk signifikant og klinisk meningsfuld forbedring i PFS sammenlignet med everolimus-armen (se tabel 5 og figur 1).
English: Proteinuria led to permanent treatment discontinuation in 0.8% of patients.
Danish: Proteinuri medførte permanent seponering hos 0,8 % af patienterne.
English: Lymphopenia includes lymphopenia and decreased lymphocyte count.
Danish: Lymfopeni omfatter lymfopeni og nedsat antal lymfocytter.
English: Women of childbearing potential must use highly effective contraception while taking lenvatinib and for one month after stopping treatment (see section 4.6).
Danish: Kvinder i den fertile alder skal anvende meget sikker kontraception, mens de tager lenvatinib og i 1 måned efter behandlingsophør (se pkt.
English: The most common adverse reactions (≥5%) resulting in dose reductions in the lenvatinib plus everolimus treated group were diarrhoea (21.0%), thrombocytopenia (6.5%), and vomiting (6.5%).
Danish: De hyppigste bivirkninger (≥5 %), der medførte dosisreduktion i gruppen behandlet med lenvatinib plus everolimus, var diarré (21,0 %), trombocytopeni (6,5 %) og opkastning
English: Some cases of bleeding have occurred secondarily to tumour shrinkage and fistula formation, e.g. tracheooesophageal fistulae.
Danish: Nogle tilfælde af blødning er opstået sekundært til tumorsvind og fisteldannelse, f.eks. trakeoøsofageale fistler.
English: Limited data are available on use in patients from ethnic origins other than Caucasian or Asian (see also section 4.8, Other special populations).
Danish: Der foreligger begrænsede data fra anvendelse til patienter af anden etnisk oprindelse end kaukasisk eller asiatisk (se også pkt.
English: • have liver or kidney problems
Danish: • har problemer med leveren eller nyrerne