FrancophonIA/ELRC3.0 huggingface dataset:
English: • low levels of platelets in the blood which may lead to bruising and difficulty in wound healing
Danish: • lavt antal blodplader, hvilket kan medføre blå mærker og problemer med sårheling
English: What Kisplyx contains
Danish: Kisplyx indeholder:
English: Pulmonary embolism†,
Danish: Lungeemboli†
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 doseringsafbrydelse, dosisjustering eller seponering kan være nødvendig (se pkt.
English: Oral inflammation includes: aphthous ulcer, stomatitis, glossitis, mouth ulceration, and mucosal inflammation.
Danish: Oral inflammation omfatter: aftøs ulcus, stomatitis, glossitis, mundsår og mucosainflammation.
English: Treatment should be discontinued in case of life-threatening reactions (e.g., Grade 4) with the exception of laboratory abnormalities judged to be non-life-threatening, in which case they should be managed as severe reactions (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: No data with the combination is available in patients with hepatic impairment.
Danish: Der foreligger ingen data med kombinationen for patienter med nedsat leverfunktion.
English: The most frequently reported adverse reactions in the RCC and DTC patient populations (occurring in ≥30% of patients) were diarrhoea (80.6%), hypertension (70.1%)*, fatigue (59.7%), decreased appetite (53.7%), weight decreased (52.6%)*, vomiting (48.4%), nausea (45.2%), proteinuria (38.9%)*, stomatitis (36.9%)*, headache (35.8%)*, dysphonia (35.6%)*, palmar-plantar erythrodysaesthesia syndrome (PPE) (34.1%)*, peripheral oedema (33.9%), and hypercholesterolemia (30.6%).
Danish: De hyppigst rapporterede bivirkninger hos patientpopulationerne med RCC og DTC (forekom hos ≥ 30 % af patienterne) var diarré (80,6 %), hypertension (70,1 %)*, træthed (59,7 %), nedsat appetit (53,7 %), vægttab (52,6 %)*, opkastning (48,4 %), kvalme (45,2 %), proteinuri (38,9 %)*, stomatitis (36,9 %)*, hovedpine (35,8 %)*, dysfoni (35,6 %)*, palmoplantar erytrodysæstesisyndrom (PPE) (34,1 %)*, perifert ødem (33,9 %) og hyperkolesterolæmi (30,6 %).
English: How to take Kisplyx
Danish: Sådan skal du tage Kisplyx
English: The lenvatinib plus everolimus arm showed a statistically significant and clinically meaningful improvement in PFS compared with the everolimus arm.
Danish: Lenvatinib plus everolimus-armen viste en statistisk signifikant og klinisk meningsfuld forbedring i PFS sammenlignet med everolimus-armen.
English: QT interval prolongation
Danish: Forlængelse af QTinterval
English: The primary efficacy outcome measure, based on investigator assessed tumour response, was progression-free survival (PFS) of the lenvatinib plus everolimus arm vs the everolimus arm and of the lenvatinib arm vs the everolimus arm. Other efficacy outcome measures included overall survival (OS) and investigator-assessed objective response rate (ORR).
Danish: Det primære virkningsendepunkt, baseret på investigatorbedømt tumorrespons, var progressionsfri overlevelse (PFS), for lenvatinib plus everolimus-armen vs everolimus-armen og for lenvatinib-armen vs everolimus-armen.
English: Liver-related 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 medførte doseringsafbrydelse og dosisreduktion hos hhv. 4,6 % og 2,7 % af patienterne og permanent seponering hos 0,4 %.
English: Recommended management of hypertension
Danish: Tabel 3 Anbefalet behandling af hypertension
English: Liver-related reactions led to dose interruptions and reductions in 1.6% and 1.6% of patients, respectively, and to permanent discontinuation in 3.2% of patients.
Danish: Leverrelaterede reaktioner medførte doseringsafbrydelse og dosisreduktion hos hhv. 1,6 % og 1,6 % af patienterne og permanent seponering hos 3,2 % af patienterne.
English: • feeling and being sick, constipation, diarrhoea, abdominal pain, indigestion
Danish: • kvalme og opkastning, forstoppelse, diarré, mavesmerter, fordøjelsesbesvær
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Kisplyx 4 mg hard capsules
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Kisplyx 4 mg hårde kapsler
English: Progression-free survival (PFS)a by Post-hoc Retrospective Independent Review
Danish: Progressionsfri overlevelse (PFS)a efter en post-hoc, retrospektiv uafhængig gennemgang Median PFS i måneder (95 %
English: QT interval prolongation (see section 4.4)
Danish: Forlænget QT-interval (se pkt.
English: The incidence of QT interval prolongation of greater than 500 ms was 2% in the lenvatinib-treated patients compared to no reports in the placebo group.
Danish: Forekomsten af et længere QT-interval end 500 ms var 2 % i lenvatinib-gruppen sammenlignet med ingen rapporter i placebogruppen.
English: Percentages are based on the total number of subjects in the Full Analysis Set within relevant treatment group.
Danish: Data-afskæringsdato = 13. juni 2014 Procenterne er baseret på det totale antal personer i det fuldstændige analysesæt i den relevante behandlingsgruppe.
English: Women of childbearing potential/ Contraception in females Women of childbearing potential should avoid becoming pregnant and use highly effective contraception while on treatment with lenvatinib and for at least one month after finishing treatment.
Danish: Kvinder i den fertile alder skal undgå at blive gravide og anvende meget sikker kontraception, mens de er i behandling med lenvatinib og mindst en måned efter behandlingsophør.
English: Hepatocellular damage and hepatitis includes: drug-induced liver injury, hepatic steatosis, and cholestatic liver injury.
Danish: Hepatocellulær skade og hepatitis omfatter: lægemiddelinduceret leverskade, leversteatose og kolestatisk leverskade.
English: >500 ms
Danish: QT-interval >500 ms
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 i forbindelse med hypertension ikke blev undersøgt direkte med lenvatinib, postuleres det, at den er medieret via hæmning af VEGFR2 i vaskulære endotelceller.
English: In the DTC study (see Lenvima SmPC), hypertension (including hypertension, hypertensive crisis, blood pressure diastolic increased, and blood pressure increased) was reported in 72.8% of lenvatinib-treated patients and 16.0% of patients in the placebo-treated group.
Danish: I DTC-studiet (se produktresuméet for Lenvima) blev hypertension (herunder hypertension, hypertensiv krise, forhøjet diastolisk blodtryk og forhøjet blodtryk) rapporteret hos 72,8 % af patienterne i lenvatinib-gruppen og hos 16,0 % i placebogruppen.
English: Posterior reversible encephalopathy syndrome Monoparesis Transient ischaemic attack
Danish: Posteriort reversibelt encefalopatisynd rom Monoparese Transitorisk cerebral iskæmi
English: In the RCC study (see section 5.1), there was 1 event of PRES (Grade 3) in the lenvatinib-treated group, occurring after 18.4 weeks of treatment.
Danish: 5.1) var der 1 tilfælde af PRES (grad 3) i lenvatinib-gruppen, og dette opstod efter 18,4 ugers behandling.
English: In the DTC study (see Lenvima SmPC), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group and no reports in the placebo group.
Danish: I DTC-studiet (se produktresuméet for Lenvima) var der 1 tilfælde af PRES (grad 2) i lenvatinibgruppen, og ingen rapporter for placebogruppen.
English: In those patients with a normal TSH at baseline, elevation of TSH level above 0.5 mU/L was observed post baseline in 57% of lenvatinib-treated patients as compared with 14% of placebo-treated patients.
Danish: Blandt disse patienter med normal TSH ved baseline blev der observeret et forhøjet niveau af TSH over 0,5 mE/l efter baseline hos 57 % i lenvatinib-gruppen sammenlignet med 14 % i placebogruppen.
English: Amongst 1,166 patients treated with lenvatinib, Grade 3 or greater haemorrhage was reported in 2% of patients, 3 patients (0.3%) had a Grade 4 haemorrhage and 5 patients (0.4%) had a Grade 5 reaction including arterial haemorrhage, haemorrhagic stroke, intracranial tumour haemorrhage, haemoptysis and tumour haemorrhage.
Danish: Blandt 1.166 patienter i behandling med lenvatinib blev blødning af grad 3 eller højere rapporteret hos 2 % af patienterne, 3 patienter (0,3 %) havde en grad 4 blødning, og 5 patienter (0,4 %) havde en grad 5 reaktion, herunder arteriel blødning, hjerneblødning, intrakranial tumorblødning, hæmoptyse og tumorblødning.
English: Gastrointestinal perforation and fistula formation
Danish: Gastrointestinal perforation og fisteldannelse
English: Amongst 1,166 patients treated with lenvatinib, there were 5 cases (0.4%) of arterial thromboembolisms (3 cases of myocardial infarction and 2 cases of cerebrovascular accident) with a fatal outcome.
Danish: Blandt 1.166 patienter behandlet med lenvatinib var der 5 tilfælde (0,4 %) af arteriel tromboemboli (3 tilfælde af myokardieinfarkt og 2 cerebrovaskulære tilfælde) med dødelig udgang.
English: The incidence of QTc interval greater than 500 ms was 6% in the lenvatinib plus everolimus-treated group.
Danish: Forekomsten af QTc-interval på over 500 ms var 6 % i lenvatinib plus everolimus-gruppen.
English: The recommended daily dose of lenvatinib is 18 mg (one 10 mg capsule and two 4 mg capsules) once daily in combination with 5 mg of everolimus once daily.
Danish: Den anbefalede daglige dosis af lenvatinib er 18 mg (én 10 mg kapsel og to 4 mg kapsler) én gang dagligt i kombination med 5 mg everolimus én gang dagligt.
English: There were no reports in the lenvatinib plus everolimus or everolimus monotherapy groups.
Danish: Der var ingen rapporter i grupperne med lenvatinib plus everolimus eller everolimus-monoterapi.
English: Contraception, pregnancy and breast-feeding
Danish: Prævention, graviditet og amning
English: Kisplyx may be restarted once adequate wound healing is established.
Danish: Kisplyx kan startes igen, når det vurderes,
English: If you take more Kisplyx than you should
Danish: Hvis du har taget for meget Kisplyx
English: Reactions that occurred at an incidence of ≥2.0% were: epistaxis (22.6%), haematuria (4.8%), haematoma (3.2%), and gastric haemorrhage (3.2%).
Danish: Reaktioner, der opstod med en forekomst på ≥ 2,0 %, var: epistaxis (22,6 %), hæmaturi (4,8 %), hæmatom (3,2 %) og gastrisk blødning (3,2 %).
English: Grade 3 reactions occurred in 10.7% of lenvatinib-treated patients and none in placebo-treated patients.
Danish: Grad 3 reaktioner forekom hos 10,7 % af patienterne i lenvatinib-gruppen og hos ingen i placebogruppen.
English: However in DTC patients with low body weight (<60 kg) had a higher incidence of PPE, proteinuria, of Grade 3 or 4 hypocalcaemia and hyponatraemia, and a trend towards a higher incidence of Grade 3 or 4 decreased appetite.
Danish: Patienter med DTC og lav legemsvægt (< 60 kg) havde imidlertid en højere forekomst af PPE, proteinuri, grad 3 eller 4 hypokalcæmi og hyponatriæmi og en tendens til højere forekomst af grad 3 eller 4 appetitløshed.
English: If you take more Kisplyx than you should, talk to a doctor or pharmacist straight away.
Danish: Hvis du har taget for meget Kisplyx, skal du straks kontakte lægen eller apotekspersonalet.
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 6 personer med moderat nedsat leverfunktion (Child-Pugh A hhv. Child-Pugh B).
English: However, in DTC, patients of age ≥75 years were more likely to experience Grade 3 or 4 hypertension, proteinuria, decreased appetite, and dehydration.
Danish: Patienter ≥ 75 år med DTC havde imidlertid en større tendens til grad 3 eller 4 hypertension, proteinuri, nedsat appetit og dehydrering.
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 blødning med dødelig udgang, er forekommet i kliniske studier og er blevet rapporteret efter markedsføring (se pkt.
English: In the everolimus group, 6.0% of patients reported an arterial thromboembolism (4.0% were Grade ≥ 3).
Danish: I everolimus-gruppen blev der rapporteret arteriel tromboemboli hos 6,0 % af patienterne (4,0 % var grad ≥ 3).
English: Amongst 1,166 patients treated with lenvatinib, there were 4 cases (0.3%) of PRES (0.3% were Grade 3 or 4), all of which resolved after treatment and/or dose interruption, or permanent discontinuation.
Danish: Blandt 1.166 patienter behandlet med lenvatinib var der 4 tilfælde (0,3 %) af PRES (alle var grad 3 eller 4), som alle fortog sig efter behandling og/eller doseringsafbrydelse eller permanent seponering.
English: • The recommended daily dose of Kisplyx is 18 mg once a day (one 10 mg capsule and two 4 mg capsules) in combination with one 5 mg tablet of everolimus once a day.
Danish: • Den anbefalede daglige dosis af Kisplyx er 18 mg én gang dagligt (en 10 mg kapsel og to 4 mg kapsler) sammen med en 5 mg tablet everolimus én gang dagligt.
English: The majority of cases recovered or resolved following dose interruption or reduction, which occurred in 13.0% and 13.4% of patients, respectively.
Danish: De fleste tilfælde blev bedre eller fortog sig efter doseringsafbrydelse eller dosisreduktion, hos hhv. 13,0 % og 13,4 % af patienterne.
English: Back pain Arthralgia Myalgia Pain in extremity Musculoskeletal pain
Danish: Rygsmerter Artralgi Myalgi Ekstremitetssmerter Muskuloskeletale smerter
English: In patients with a normal TSH at baseline, an elevation of TSH level was observed post baseline in 60.5% of lenvatinib plus everolimus-treated patients as compared with none in patients receiving everolimus alone.
Danish: Hos patienter med en normal TSH ved baseline blev der observeret forhøjet TSH efter baseline hos 60,5 % af patienterne i lenvatinib plus everolimus-gruppen sammenlignet med ingen i everolimus-gruppen.
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 grad 4 reaktion) forekom hos 44,4 % af patienterne i lenvatinib-gruppen sammenlignet med 3,8 % i placebogruppen.
English: Results for ORR were consistent with that of the investigators' assessments, 35.3% in the lenvatinib plus everolimus arm, with one complete response and 17 partial responses; no subject had an objective response in the everolimus arm (P < 0.0001) in favour of the lenvatinib plus everolimus arm.
Danish: Resultater for ORR var i overensstemmelse med investigatorernes bedømmelser, 35,3 % i lenvatinib plus everolimus-armen med et fuldstændigt respons og 17 med delvist respons.
English: For toxicities thought to be related to lenvatinib (see Table 1), 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 2.
Danish: For toksiciteter, der menes at være forbundet med lenvatinib (se tabel 1), kan behandlingen genoptages med en reduceret dosis lenvatinib, som foreslået i tabel 2, når bivirkningen har fortaget sig eller er bedret til grad 0-1 eller baseline-niveau.
English: Reactions that occurred at an incidence of ≥0.75% above placebo were: epistaxis (11.9%), haematuria (6.5%), contusion (4.6%), gingival bleeding (2.3%), haematochezia (2.3%), rectal haemorrhage (1.5%), haematoma (1.1%), haemorrhoidal haemorrhage (1.1%), laryngeal haemorrhage (1.1%), petechiae (1.1%), and intracranial tumour haemorrhage (0.8%).
Danish: Reaktioner, der opstod med en forekomst på ≥ 0,75 % over placebo, var: epistaxis (11,9 %), hæmaturi (6,5 %), kontusion (4,6 %), gingivalblødning (2,3 %), hæmatokeksi (2,3 %), rektalblødning (1,5 %), hæmatom (1,1 %), blødende hæmorroider (1,1 %), laryngeal blødning (1,1 %), petekkier (1,1 %) og intrakranial tumorblødning (0,8 %).
English: Limited data are available on patients with a body weight below 60 kg with RCC (see also section 4.8, Other special populations).
Danish: Der er begrænsede data for patienter med legemsvægt under 60 kg med RCC (se også pkt.
English: Tabulated list of adverse reactions for RCC and DTC studies Similar adverse reactions were observed in clinical trials in RCC and DTC.
Danish: De observerede bivirkninger i kliniske studier med RCC og DTC var sammenlignelige.
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 (også kaldet RPLS) er blevet rapporteret hos patienter i behandling med lenvatinib (< 1 %, se pkt.
English: In human liver cytosol, lenvatinib did not inhibit aldehyde oxidase activity.
Danish: Lenvatinib hæmmede ikke aldehydoxidase-aktiviteten i human lever-cytosol.
English: Discontinue lenvatinib and institute appropriate medical management.
Danish: Seponer lenvatinib og påbegynd passende behandling.
English: In RCC, patients with baseline renal impairment had a higher incidence of Grade 3 fatigue.
Danish: Patienter med RCC og nedsat nyrefunktion ved baseline havde en højere forekomst af grad 3 træthed.
English: In patients with DTC, 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: Hos patienter med DTC havde kvinder en højere forekomst af hypertension (herunder grad 3 eller 4 hypertension), proteinuri og palmoplantar erytrodysæstesisyndrom (PPE), og mænd havde en højere forekomst af nedsat uddrivningsfraktion samt gastrointestinal perforation og fisteldannelse.
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 mave og tarme, såsom trakeal, trakeoøsofageal, øsofageal fistel samt fistel i de kvindelige kønsorganer og kutan fistel.
English: Gastrointestinal perforation and fistula formation (see section 4.4)
Danish: Gastrointestinal perforation og fisteldannelse (se pkt.
English: In the DTC study (see Lenvima SmPC), 88% of all patients had a baseline TSH level less than or equal to 0.5 mU/L.
Danish: I DTC-studiet (se produktresuméet for Lenvima) havde 88 % af alle patienter et baseline-niveau af TSH ≤ 0,5 mE/l.
English: In the DTC study, events of gastrointestinal perforation or fistula were reported in 1.9% of lenvatinib-treated patients and 0.8% of patients in the placebo group.
Danish: I DTC-studiet blev hændelser med gastrointestinal perforation eller fisteldannelse rapporteret hos 1,9 % af patienterne i lenvatinib-gruppen og hos 0,8 % i placebogruppen.
English: Each carton contains 30, 60, or 90hard capsules.Not all pack sizes may be marketed.
Danish: Hver karton indeholder 30, 60 eller 90 hårde kapsler.
English: Hypothyroidism** Blood thyroid stimulating hormone increased‡**
Danish: Det endokrine system Hypotyroidisme** Forhøjet niveau af thyreoideastimulere nde hormon i blodet‡**
English: In the DTC study (see Lenvima SmPC), the most commonly reported liver-related adverse reactions were hypoalbuminaemia (9.6% lenvatinib vs. 1.5% placebo) and elevations of liver enzyme levels, including increases in alanine aminotransferase (7.7% lenvatinib vs. 0 placebo), aspartate aminotransferase (6.9% lenvatinib vs. 1.5% placebo), and blood bilirubin (1.9% lenvatinib vs. 0 placebo).
Danish: I DTC-studiet (se produktresuméet for Lenvima) var de hyppigst rapporterede leverrelaterede bivirkninger hypoalbuminæmi (9,6 % lenvatinib versus 1,5 % placebo) og forhøjede leverenzymer, herunder forhøjet alanin-aminotransferase (7,7 % lenvatinib versus 0 placebo), aspartataminotransferase (6,9 % lenvatinib versus 1,5 % placebo) og blod-bilirubin (1,9 % lenvatinib versus 0 placebo).
English: The adverse reactions presented in this section are based on the combined safety data of 62 RCC patients (see section 5.1) and 458 DTC patients (see Lenvima SmPC).
Danish: Bivirkningerne opstillet i dette afsnit er baseret på de kombinerede sikkerhedsdata fra 62 RCCpatienter (se pkt.
English: The majority of cases had an outcome of recovered or resolved following dose interruption or reduction, which occurred in 16.9% and 10.7% of patients, respectively.
Danish: Hovedparten af tilfælden blev bedre eller fortog sig efter doseringsafbrydelse eller dosisreduktion, hos hhv. 16,9 % og 10,7 % af patienterne.
English: Lenvatinib may adversely affect the wound healing process as do other agents of the same class.
Danish: Lenvatinib kan som andre stoffer i den samme klasse have negativ indvirkning på sårhelingsprocessen.
English: After drinking, add the same amount of water or apple juice, swirl and swallow.
Danish: Efter du har drukket den, hælder du samme mængde vand eller æblejuice i glasset, hvirvler væsken rundt og drikker den.
English: In patients with severe renal impairment, the recommended starting dose is 10 mg of lenvatinib with 5 mg of everolimus taken once daily.
Danish: Hos patienter med svært nedsat nyrefunktion er den anbefalede startdosis 10 mg lenvatinib med 5 mg everolimus én gang dagligt.
English: Caution should be taken in patients receiving agents acting on the renin-angiotensin aldosterone system given a potentially higher risk for acute renal failure with the combination treatment.
Danish: Der skal udvises forsigtighed hos patienter, der får lægemidler med virkning på renin-angiotension-aldosteron systemet, da der er en potentielt højere risiko for akut nyresvigt med denne kombinationsbehandling.Doseringsafbrydelse, dosisjustering eller seponering kan være nødvendig (se pkt.
English: In patients, the median apparent volume of distribution (Vz/F) of the first dose ranged from 50.5 L to 92 L and was generally consistent across the dose groups from 3.2 mg to 32 mg.
Danish: Hos patienter lå medianen for det tilsyneladende fordelingsvolumen (Vz/F) for den første dosis i intervallet fra 50,5 l til 92 l, og det var generelt konsistent i dosisgrupper fra 3,2 mg til 32 mg. Analogt hermed var det mediane tilsyneladende fordelingsvolumen ved steady state (Vz/Fss) også generelt konsistent og i intervallet fra 43,2 l til 121 l.
English: Table 2 Dose modifications from recommended lenvatinib daily dose a
Danish: Tabel 2 Dosisjustering i forhold til den anbefalede daglige dosis lenvatiniba Dosisniveau
English: In DTC, patients with baseline hypertension had a higher incidence of Grade 3 or 4 hypertension, proteinuria, diarrhoea, and dehydration, and experienced more serious cases of dehydration, hypotension, pulmonary embolism, malignant pleural effusion, atrial fibrillation, and GI symptoms (abdominal pain, diarrhoea, vomiting).
Danish: Patienter med DTC og hypertension ved baseline havde en højere forekomst af grad 3 eller 4 hypertension, proteinuri, diarré og dehydrering og oplevede mere alvorlige tilfælde af dehydrering, hypotension, lungeemboli, malign pleuraeffusion, atrieflimmer og gastrointestinale symptomer (abdominalsmerter, diarré, opkastning).
English: Caregivers should not open the capsule, in order to avoid repeated exposure to the contents of the capsule.
Danish: For at undgå gentagen eksponering for indholdet må omsorgspersoner ikke åbne kapslerne.