FrancophonIA/ELRC3.0 huggingface dataset:
English: Amongst 1,166 patients treated with lenvatinib, there were 3 cases (0.3%) of hepatic failure, all with a fatal outcome.
Danish: Blandt 1.166 patienter i behandling med lenvatinib var der 3 tilfælde (0,3 %) af leversvigt, alle med dødelig udgang.
English: Do not take LENVIMA if:
Danish: Tag ikke LENVIMA:
English: chills, nausea and vomiting (splenic farction)
Danish: kulderystelser, kvalme og opkastning (miltinfarkt)
English: Number of complete responses Number of partial responses Median time to objective response,d months (95% CI) Duration of response,d months, median (95% CI)
Danish: Mediantid til objektivt respons,d måneder (95 % CI) Varighed af respons,d måneder, median (95 % CI)
English: The median time to onset of hepatotoxocity adverse reactions was 6.4 weeks.
Danish: Mediantiden til indtræden af bivirkninger med hepatotoksisitet var 6,4 uger.
English: Estimated using the Kaplan-Meier method; the 95% CI was constructed with a generalised Brookmeyer and Crowley method in patients with a best overall response of complete response or partial response.
Danish: 95 % CI blev dannet med en generaliseret Brookmeyer and Crowley-metode hos patienter med det bedste samlede respons på fuldstændigt respons eller delvist respons.
English: What LENVIMA contains
Danish: LENVIMA indeholder:
English: In patients with severe renal impairment, the recommended starting dose is 14 mg taken once daily.
Danish: Hos patienter med svært nedsat nyrefunktion er den anbefalede startdosis 14 mg én gang dagligt.
English: Cases of fistula formation or enlargement that involve areas of the body other 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 omfatter andre kropsområder end maven eller tarmen, er observeret i kliniske studier og efter markedsføring (f.eks. trakeal, trakeoøsofageal, øsofageal og kutan fistel samt fistel i de kvindelige kønsorganer).
English: Patients should be monitored for clinical symptoms or signs of cardiac decompensation, as dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Danish: Patienterne bør overvåges for kliniske symptomer eller tegn på hjertedekompensation, da det kan være nødvendigt med dosisafbrydelser, -justeringer eller -seponering (se pkt.
English: Palmar-plantar erythrodysaesthesia syndrome Rash Alopecia
Danish: Palmar-plantar erytrodysæstesisyndrom Udslæt Alopeci
English: * Identified from post-marketing use of lenvatinib
Danish: Identificeret ved anvendelse efter markedsføring af lenvatinib.
English: LENVIMA is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy (see section 5.1).
Danish: LENVIMA er indiceret som monoterapi til behandling af voksne patienter med fremskreden eller ikke-resektabelt hepatocellulært carcinom (HCC), som ikke tidligere har fået systemisk behandling (se pkt.
English: The most frequently reported adverse reactions (occurring in ≥30% of patients) are hypertension (44.0%), diarrhoea (38.1%), decreased appetite (34.9%), fatigue (30.6%), and decreased weight
Danish: De hyppigst rapporterede bivirkninger (forekom hos ≥ 30 % af patienterne) er hypertension (44,0 %), diarré (38,1 %), nedsat appetit (34,9 %), træthed (30,6 %) og vægttab (30,4 %),
English: The median time to onset was 6.7 weeks.
Danish: Den mediane tid til start var 6,7 uger.
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 om anvendelsen hos patienter af anden etnisk oprindelse end kaukasisk eller asiatisk (se også pkt.
English: The available very limited data are not sufficient to allow for a dosing recommendation for HCC patients with moderate hepatic impairment (Child-Pugh B).
Danish: De meget begrænsede tilgængelige data er ikke tilstrækkelige til at tillade en anbefaling af dosis hos HCCpatienter med moderat nedsat leverfunktion (Child-Pugh B).
English: Patients of age ≥75 years, of Asian race, with comorbidities (such as hypertension, and hepatic or renal impairment), or body weight below 60 kg appear to have reduced tolerability to lenvatinib (see section 4.8, Other special populations).
Danish: Asiatiske patienter i alderen ≥ 75 år med komorbiditeter (såsom hypertension samt nedsat lever- eller nyrefunktion) eller med en legemsvægt under 60 kg forekommer at have en reduceret tolerabilitet over for lenvatinib (se pkt.
English: The European Medicines Agency (EMA) has deferred the obligation to submit the results of a study with lenvatinib in one or more subsets of the paediatric population in the treatment of radioiodinerefractory differentiated thyroid cancer and has has waived the obligation to submit the results of studies with lenvatinib in one or more subsets of the paediatric population in the treatment of hepatocellular carcinoma (HCC).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af et studie med lenvatinib i en eller flere undergrupper af den pædiatriske population til behandling af radioaktivt
English: Cerebrovascular accident †
Danish: Cerebrovaskulært anfald †
English: Amongst 1,823 patients treated with lenvatinib monotherapy in clinical trials, there were 5 cases (0.3%) of PRES (0.2% were Grade 3 or 4), all of which resolved after treatment and/or dose interruption, or permanent discontinuation.
Danish: Blandt 1.823 patienter behandlet med lenvatinib monoterapi i kliniske undersøgelser var der 5 tilfælde (0,3 %) af PRES (0,2 % var grad 3 eller 4), som alle fortog sig efter behandling og/eller dosisafbrydelse eller permanent seponering.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eisai GmbH
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Eisai GmbH
English: Liverrelated reactions led to dose interruptions and reductions in 4.6% and 2.7% of patients, respectively, and to permanent discontinuation in 0.4%.
Danish: Leverrelaterede reaktioner førte til dosisafbrydelser og -reduktioner hos hhv. 4,6 % og 2,7 % af patienterne og til permanent seponering hos 0,4 %.
English: Progression-Free Survival (PFS)a Number of progressions or deaths (%) Median PFS in months (95% CI)
Danish: Progressionsfri overlevelse (PFS)a Antal progressioner eller dødsfald (%) Median PFS i måneder (95 % CI)
English: Table 3 Adverse reactions requiring dose modification of lenvatinib in DTC and HCC Adverse reaction Severity
Danish: Tabel 3 Bivirkninger, der kræver dosismodifikation af lenvatinib ved DTC og HCC Bivirkning
English: Efficacy Results from the REFLECT study in HCC Efficacy parameter
Danish: Tabel 7: Effektresulter fra REFLECT-studiet med HCC
English: Females had a higher incidence of hypertension (including Grade 3 or 4 hypertension), proteinuria, and PPE, while males had a higher incidence of decreased ejection fraction and gastrointestinal perforation and fistula formation.
Danish: Kvinder havde en større forekomst af hypertension (herunder grad 3 eller 4 hypertension), proteinuri og PPE, og mænd havde en større forekomst af nedsat uddrivningsfraktion og mave-tarm-perforation og fisteldannelse.
English: If patients have severe renal impairment, the initial dose of lenvatinib should be adjusted (see sections 4.2 and 5.2).
Danish: Hvis patienterne har svært nedsat nyrefunktion, bør den indledende dosis af lenvatinib justeres (se pkt.
English: Special populations Elderly population
Danish: Specielle populationer Ældre
English: Adjusted Doseb (≥60 kg BW)
Danish: Justeret Dosisb (≥60 kg kropsvægt)
English: Hepatic encephalopathyl,‡,†
Danish: Leversvigt k,‡,† Hepatisk encefalopati l,‡,†
English: The pharmacokinetics of lenvatinib following a single 10-mg dose were evaluated in 6 subjects each with mild and moderate hepatic impairment (Child-Pugh A and Child-Pugh B, respectively).
Danish: Lenvatinibs farmakokinetik efter en enkelt dosis på 10 mg blev evalueret hos 6 personer med let og moderat nedsat leverfunktion (Child-Pugh A hhv. Child-Pugh B).
English: Grade 3 reactions occurred in 3.4%, Grade 4 reactions in 0.2% and 7 patients (1.5%) had a grade 5 reaction including cerebral haemorrhage, upper gastrointestinal haemorrhage, intestinal haemorrhage and tumour haemorrhage.
Danish: Grad 3-reaktioner forekom hos 3,4 %, grad 4-reaktioner hos 0,2 %, og 7 patienter (1,5 %) havde en grad 5-reaktion inklusive hjerneblødning, øvre mave-tarm-blødning, tarmblødning og tumorblødning.
English: Radioiodine-refractory differentiated thyroid cancer
Danish: Radioaktivt jod-refraktær differentieret tyreoideacancer
English: QT interval prolongation (see section 4.4)
Danish: Forlængelse af QT-intervallet (se pkt.
English: The most frequently observed adverse drug reactions at these doses were hypertension, nausea, diarrhoea, fatigue, stomatitis, proteinuria, headache, and aggravation of PPE.
Danish: De hyppigst observerede bivirkninger ved disse doser var hypertension, kvalme, diarré, træthed, stomatitis, proteinuri, hovedpine og forværring af PPE.
English: How long to take LENVIMA You will usually carry on taking this medicine as long as you are getting benefit.
Danish: Du skal normalt blive ved med at tage dette lægemiddel, så længe du har fordele heraf.
English: Patients of age ≥75 years were more likely to experience Grade 3 or 4 hypertension, proteinuria, decreased appetite, and dehydration.
Danish: Patienter i alderen ≥ 75 år havde en større tendens til grad 3 eller 4 hypertension, proteinuri, nedsat appetit og dehydrering.
English: HCC patients other than those with moderate and severe hepatic impairment or severe renal impairment should initiate treatment at the recommended starting dose of 8 mg (two 4 mg capsules) for body weight < 60 kg and 12 mg (three 4 mg capsules) for body weight ≥ 60 kg, following which the dose should be further adjusted on the basis of individual tolerability.
Danish: Bortset fra patienter med moderat og svært nedsat leverfunktion skal HCC patienter initiere behandling med den anbefalede startdosis på 8 mg (to 4 mg kapsler) ved kropsvægt < 60 kg og 12 mg (tre 4 mg kapsler) ved kropsvægt ≥ 60 kg, hvorefter dosis skal justeres yderligere på basis af individuel tolerabilitet.
English: 24 mg orally once daily Two 10 mg capsules plus one 4 mg capsule
Danish: 24 mg oralt én gang dagligt To 10mg kapsler plus en 4 mg kapsel
English: Data in HCC patients with moderate hepatic impairment (Child-Pugh B) are very limited and there are currently no data available in HCC patients with severe hepatic impairment (Child-Pugh C).
Danish: Data hos HCC-patienter med moderat nedsat leverfunktion (Child-Pugh B) er meget begrænsede, og der foreligger aktuelt ingen data vedrørende HCC-patienter med svært nedsat leverfunktion (ChildPugh C).
English: The median time to onset was 6.1 weeks.
Danish: Mediantiden til indtræden var 6,1 uger.
English: • changes in blood test results for kidney function and kidney failure
Danish: • ændrede blodprøveresultater for nyrefunktionen og nyresvigt
English: Hypoalbuminaemia includes hypoalbuminaemia and decreased blood albumin.
Danish: Hypoalbuminæmi omfatter hypoalbuminæmi og et nedsat niveau af albumin i blodet.
English: Increased blood bilirubin j, ‡ Hypoalbuminaemiaj
Danish: Forhøjet niveau af bilirubin i blodetj,‡ Hypoalbuminæmij,‡
English: The available data do not allow for a dosing recommendation for patients with HCC and severe renal impairment.
Danish: De tilgængelige data tillader ikke en anbefaling af dosis hos HCC-patienter med svært nedsat nyrefunktion.
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: Fertile kvinder skal anvende meget sikker kontraception, mens de tager lenvatinib og i 1 måned efter behandlingsophør (se pkt.
English: Although not studied directly with lenvatinib, the mechanism of action (MOA) for hypertension is postulated to be mediated by the inhibition of VEGFR2 in vascular endothelial cells.
Danish: Selvom virkningsmekanismen for hypertension ikke blev undersøgt direkte med lenvatinib, postuleres det, at den er medieret via hæmningen af VEGFR2 i vaskulære endotelceller.
English: Grade 3 or greater reactions occurred in 1.9% of lenvatinib-treated patients.
Danish: Grad 3 eller værre reaktioner forekom hos 1,9 % af patienterne behandlet med lenvatinib.
English: Table 1 Dose modifications from recommended lenvatinib daily dose in DTC patientsa
Danish: Tabel 1 Dosismodifikationer fra den anbefalede daglige dosis lenvatinib hos DTC patienter Dosisniveau
English: Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leucoencephalopathy syndrome (RPLS) (see section 4.4)
Danish: Posteriort reversibelt encefalopatisyndrom (PRES)/reversibelt posteriort leukoencefalopatisyndrom (RPLS) (se pkt.
English: Hypomagnesaemia includes hypomagnesaemia and decreased blood magnesium.
Danish: Hypomagnesæmi omfatter hypomagnesæmi og et nedsat niveau af magnesium i blodet.
English: Reactions of Grade 3 or higher (including 1 reaction of Grade 4) occurred in 44.4% of lenvatinib-treated patients compared with 3.8% of placebo-treated patients.
Danish: Reaktioner af grad 3 eller derover (herunder 1 reaktion af grad 4) forekom hos 44,4 % af de lenvatinibbehandlede patienter sammenlignet med 3,8 % af de placebobehandlede patienter.
English: Black iron oxide (E172) Potassium hydroxide Propylene glycol
Danish: Sort jernoxid (E172) Kaliumhydroxid Propylenglycol
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med LENVIMA Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: Lenvatinib may adversely affect the wound healing process as for other agents of the same class.
Danish: Lenvatinib kan som andre stoffer i den samme klasse påvirke sårhelingsprocessen negativt.
English: No adjustment of starting dose is required on the basis of renal function in patients with mild or moderate renal impairment.
Danish: Der kræves ingen justering af startdosis på basis af nyrefunktionen hos patienter med let eller moderat nedsat nyrefunktion.
English: Serious tumour related bleeds, including fatal haemorrhagic events have occurred in clinical trials and have been reported in post-marketing experience (see section 4.8, Description of selected adverse reactions).
Danish: Alvorlige tumorrelaterede blødninger, herunder dødelige blødningshændelser, er forekommet i kliniske studier og er blevet rapporteret efter markedsføring (se pkt.
English: No formal studies of the effect of lenvatinib on wound healing have been conducted.
Danish: Der er ikke udført formelle studier af lenvatinibs indvirkning på sårheling.
English: For previously normotensive subjects, monotherapy with one of the classes of antihypertensives should be started when elevated BP is observed.
Danish: For patienter som tidligere var normotensive bør der startes monoterapi med et middel fra en af de antihypertensive klasser ved observation af forhøjet blodtryk.
English: Marketing Authorisation Holder Eisai GmbH
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Eisai GmbH
English: Gastrointestinal and abdominal pain includes: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, epigastric discomfort, and gastrointestinal pain.
Danish: Mave-tarm- og abdominalblødning omfatter: abdominalt besvær, abdominalsmerter, smerter i nedre del af abdomen, smerter i øvre del af abdomen, ømhed i abdomen, epigastrisk besvær og mave-tarm-smerter.
English: Hepatic encephalopathy includes: hepatic encephalopathy, coma hepatic, metabolic encephalopathy and encephalopathy.
Danish: Hepatisk encefalopati omfatter: hepatisk encefalopati, leverkoma, metabolisk encefalopati og encefalopati.
English: For lenvatinib related toxicities (see Table 3), upon resolution/improvement of an adverse reaction to Grade 0-1 or baseline, treatment should be resumed at a reduced dose of lenvatinib as suggested in Table 1.
Danish: For toksciteter, der er forbundet med lenvatinib (se tabel 3), kan behandlingen genoptages med en reduceret dosis lenvatinib, som foreslået i tabel 1, når en bivirkning har fortaget sig eller er bedret til grad 0-1 eller baseline.
English: Treatment should be discontinued in case of life-threatening reactions (e.g., Grade 4) with the exception of laboratory abnormality judged to be non-life-threatening, in which case they should be managed as severe reaction (e.g., Grade 3).
Danish: Behandlingen skal seponeres i tilfælde af livstruende reaktioner (f.eks. grad 4), med undtagelse af laboratorieanomalier, der bedømmes til ikke at være livstruende.
English: Cases of nephrotic syndrome have been reported in patients using lenvatinib.
Danish: Der er blevet rapporteret om tilfælde af nefrotisk syndrom hos patienter, som fik lenvatinib.
English: Gastrointestinal perforation and fistula formation
Danish: Mave-tarm-perforation og fisteldannelse
English: Patients with baseline hepatic impairment had a higher incidence of hypertension and PPE, and a higher incidence of Grade 3 or 4 hypertension, asthenia, fatigue, and hypocalcaemia compared with patients with normal hepatic function.
Danish: Patienter med nedsat leverfunktion ved baseline havde en større forekomst af hypertension og PPE og en større forekomst af grad 3 eller 4 hypertension, asteni, træthed og hypocalcæmi sammenlignet med patienter med normal leverfunktion.
English: Some cases of bleeding have occurred secondarily to tumour shrinkage and fistula formation, e.g. tracheo-oesophageal fistulae.
Danish: Nogle tilfælde af blødning er opstået sekundært til tumorsvind og fisteldannelse, f.eks. trakeoøsofageale fistler.
English: Lenvatinib and its metabolites are excreted in rat milk (see section 5.3).
Danish: Lenvatinib og dets metabolitter udskilles i rottemælk (se pkt.
English: In the pivotal Phase 3 SELECT trial (see section 5.1), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group and no reports in the placebo group.
Danish: 5.1) var der 1 hændelse med PRES (grad 2) i gruppen behandlet med lenvatinib og ingen rapporter i placebogruppen.
English: Reactions of Grade 3 or 4 severity occurred in 5.0% of lenvatinibtreated vs 0 placebo-treated patients.
Danish: Reaktioner af sværhedsgrad 3 eller 4 forekom hos 5,0 % af lenvatinibbehandlede patienter versus 0 placebobehandlede patienter.
English: After drinking, add the same amount of water or apple juice, swirl and swallow.
Danish: Efter du har drukket den, hælder du den samme mængde vand eller æblejuice i glasset, drejer det rundt og sluger det.
English: Renal failure cases includes: acute prerenal failure, renal failure, renal failure acute, acute kidney injury and renal tubular necrosis.
Danish: Tilfælde af nyresvigt omfatter: akut prærenalt svigt, nyresvigt, akut nyresvigt, akut nyreskade og renal tubulær nekrose.
English: In the Phase 3 -REFLECT trial (see section 5.1), hypertension (including hypertension, increased blood pressure, increased diastolic blood pressure and orthostatic hypertension) was reported in 44.5% of lenvatinib-treated patients and Grade 3 hypertension occurred in 23.5%.
Danish: 5.1) blev hypertension (inklusive hypertension, øget blodtryk, øget diastolsk blodtryk og ortostatisk hypertension) rapporteret hos 44,5 % af lenvatinib-behandlede patienter og grad 3 hypertension forekom hos 23,5 %.
English: Capsule shell Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Danish: Kapselskal Hypromellose Titandioxid (E171) Gul jernoxid (E172) Rød jernoxid (E172)
English: If you take more LENVIMA than you should, talk to a doctor or pharmacist straight away.
Danish: Hvis du har taget for meget LENVIMA, skal du straks kontakte lægen eller apotekspersonalet.
English: Lymphopeniaa
Danish: Lymfopenia
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer):
English: • feeling sick and being sick, constipation, diarrhoea, abdominal pain, indigestion
Danish: • kvalme og opkastning, forstoppelse, diarré, mavesmerter, fordøjelsesbesvær
English: Adjusted Doseb (<60 kg BW)
Danish: Justeret Dosisb (<60 kg kropsvægt)
English: Oral pain includes: oral pain, glossodynia, gingival pain, oropharyngeal discomfort, oropharyngeal pain and tongue discomfort.
Danish: Orale smerter omfatter: orale smerter, glossodyni, smerter i tandkødet, orofaryngeale gener, orofaryngeale smerter og ubehag i tungen.
English: The capsule shell contains hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Danish: Kapselskallen indeholder hypromellose, titandioxid (E171), gul jernoxid (E172), rød jernoxid (E172).
English: The most frequently reported adverse reactions (occurring in ≥30% of patients) are hypertension (68.6%), diarrhoea (62.8%), decreased appetite (51.5%), decreased weight (49.1%), fatigue (45.8%), nausea (44.5%), proteinuria 36.9%), stomatitis (35.8%), vomiting (34.5%), dysphonia (34.1%), headache (34.1%), and palmar-plantar erythrodysaesthesia syndrome (PPE) (32.7%).
Danish: De hyppigst rapporterede bivirkninger (der forekom hos ≥ 30 % af patienterne) er hypertension (68,6 %), diarré (62,8 %), nedsat appetit (51,5 %), vægttab (49,1 %), træthed (45,8 %), kvalme (44,5 %), proteinuri (36,9 %), stomatitis (35,8 %), opkastning (34,5 %), dysfoni (34,1 %), hovedpine (34,1 %) og palmar-plantar erytrodysæstesisyndrom (PPE) (32,7 %).
English: Non-gastrointestinal fistula includes cases of fistula occurring outside of the stomach and intestines such as tracheal, tracheo-oesophageal, oesophageal, female genital tract fistula, and cutaneous fistula.
Danish: Fistel uden for mave-tarm-kanalen omfatter tilfælde af fistler uden for maven og tarmen, såsom trakeal, trakeoøsofageal, øsofageal fistel samt fistel i de kvindelige kønsorganer og kutan fistel.
English: In HCC patients treated with lenvatinib in the REFLECT trial, liver-related adverse reactions including hepatic encephalopathy and hepatic failure (including fatal reactions) were reported at a higher frequency (see Section 4.8) compared to patients treated with sorafenib .
Danish: Hos HCC-patienter, der blev behandlet med lenvatinib i REFLECT-undersøgelsen, blev leverrelaterede bivirkninger inklusive hepatisk encefalopati og nedsat leverfunktion (herunder dødelige tilfælde) rapporteret med en højere frekvens (se pkt.
English: • feeling very tired or weak
Danish: • udpræget træthed eller svækkelse
English: In the pivotal Phase 3 SELECT trial (see section 5.1), hypertension (including hypertension, hypertensive crisis, increased diastolic blood pressure , and increased blood pressure) was reported in 72.8% of lenvatinib-treated patients and 16.0% of patients in the placebo-treated group.
Danish: 5.1) blev hypertension (herunder hypertension, hypertensiv krise, forhøjet diastolisk blodtryk og forhøjet blodtryk) rapporteret hos 72,8 % af de lenvatinibbehandlede patienter og hos 16,0 % af patienterne i gruppen, der fik placebo.
English: • headache and back pain
Danish: • hovedpine og rygsmerter
English: PRES, also known as RPLS, has been reported in patients treated with lenvatinib (<1%; see section 4.8, Description of selected adverse reactions).
Danish: PRES, kaldes også RPLS, er blevet rapporteret hos patienter i behandling med lenvatinib (< 1 %, se pkt.
English: The printing ink contains shellac, black iron oxide (E172), potassium hydroxide, propylene glycol.
Danish: Prægeblækket indeholder: shellac, sort jernoxid (172), kaliumhydroxid, propylenglycol.
English: The median time to onset in lenvatinib-treated patients was 16 days.
Danish: Den mediane tid til start hos lenvatinibbehandlede patienter var 16 dage.
English: • have a history of heart problems or stroke
Danish: • tidligere har haft hjerteproblemer eller slagtilfælde