FrancophonIA/ELRC3.0 huggingface dataset:
English: Cabozantinib is eliminated mainly via the hepatic route.
Danish: Cabozantinib elimineres hovedsageligt via leveren.
English: • Fits, headaches, confusion, or finding it difficult to concentrate.
Danish: • Kramper, hovedpine, forvirring eller problemer med at koncentrere sig.
English: Secondary efficacy endpoints were objective response rate (ORR) and overall survival (OS).
Danish: Sekundære effekt-endepunkter var objektiv responsrate (ORR) og samlet overlevelse (OS).
English: Four metabolites were present in plasma at exposures (AUC) greater than 10% of parent: XL184-N-oxide, XL184 amide cleavage product, XL184 monohydroxy sulfate, and 6-desmethyl amide cleavage product sulfate.
Danish: 4 metabolitter var til stede i plasma med eksponeringer (AUC), der var >10 % af cabozantinibs: XL184-N-oxid, XL184-amid spaltningsprodukt, XL184monohydroxysulfat og XL184-6-desmethylamid spaltningsprodukt sulfat.
English: Sverige/Ruotsi/Svíþjóð Tlf/Puh/Tel/Sími: +46 8 451 60 00
Danish: Tlf/Puh/Tel/Sími: +46 8 451 60 00
English: Hypertension was observed more frequently in the treatment naïve RCC population (67%) compared to RCC patients following prior VEGF-targeted therapy
Danish: Hypertension blev observeret oftere i gruppen af behandlings-naive RCC-patienter (67 %) sammenlignet med RCC-patienter efter tidligere VEGF-målrettet behandling (37 %).
English: Platelet levels should be monitored during cabozantinib treatment and the dose modified according to the severity of the thrombocytopenia (see Table 1).
Danish: Antallet af blodplader bør monitoreres under behandling med cabozantinib og dosis justeres i overensstemmelse med sværhedsgraden af trombocytopeni (se tabel 1).
English: Table 2: Adverse drug reactions (ADRs) reported in clinical trials in patients treated with cabozantinib
Danish: Tabel 2: Bivirkninger indberettet i kliniske forsøg hos patienter i behandling med cabozantinib
English: Table 1: Recommended CABOMETYX dose modifications for adverse reactions Adverse reaction and severity
Danish: Tabel 1: Anbefalede dosisændringer af CABOMETYX ved bivirkninger Bivirkning og sværhedsgrad
English: A planned interim analysis of OS was conducted at the time of the PFS analysis and did not reach the interim boundary for statistical significance (202 events, HR=0.68 [0.51, 0.90], p=0.006).
Danish: En planlagt interimanalyse af OS, udført på tidspunktet for PFS-analysen, nåede ikke interimgrænsen for statistisk signifikans (202 hændelser, HR=0,68 [0,51-0,90], p=0,006).
English: A high-fat meal moderately increased Cmax and AUC values (41% and 57%, respectively) relative to fasted conditions in healthy volunteers administered a single 140 mg oral cabozantinib dose.
Danish: Et måltid med højt fedtindhold øgede Cmax og AUC moderat (henholdsvis 41 % og 57 %) i forhold til fastende tilstand hos raske frivillige, der fik en enkelt oral dosis på 140 mg cabozantinib.
English: In a population PK analysis of cabozantinib using data collected from 1883 patients and 140 healthy volunteers following oral administration of a range of doses from 20 to 140 mg, the plasma terminal half-life of cabozantinib is approximately 110 hours.
Danish: I en populationsfarmakokinetisk analyse af cabozantinib med anvendelse af data fra oral administration af cabozantinibdoser fra 20 til 140 mg til 1883 patienter og 140 raske frivillige var cabozantinibs terminale halveringstid i plasma ca. 110 timer.
English: • Numbness, tingling, burning sensation or pain in the limbs
Danish: • Følelsesløshed, prikkende, brændende fornemmelse eller smerter i lemmerne
English: Figure 3: Kaplan Meier curve for progression-free survival by IRC in treatment-naïve RCC subjects
Danish: Figur 3: Kaplan-Meier-kurve for progressionsfri overlevelse ved IRC hos behandlings-naive RCCpatienter
English: The safety and efficacy of CABOMETYX for the treatment of treatment-naïve renal cell carcinoma were evaluated in a randomized, open-label, multicenter study (CABOSUN).
Danish: Sikkerhed og effekt af CABOMETYX til behandling af behandlingsnaivt nyrecellekarcinom blev evalueret i et randomiseret, open-label, multicenter studie (CABOSUN).
English: An exploratory OS analysis censoring for the use of NPACT supported the primary analysis: the HR, adjusted for stratification factors (per IxRS), was 0.66 (95% CI: 0.52, 0.84; stratified logrank p-value = 0.0005).
Danish: En eksploratorisk OS-analyse censureret til anvendelsen af NPACT understøttede den primære analyse: HR, justeret for stratifikationsfaktorer (pr. IxRS), var 0,66 (95 % CI: 0,52; 0,84; stratificeret logrank p-værdi = 0,0005).
English: Table 5: Efficacy results in treatment-naïve RCC subjects (ITT population, CABOSUN) CABOMETYX (N=79)
Danish: Tabel 5: Resultat af effekt på behandlingsnaive RCC-patienter (ITT-population, CABOSUN) CABOMETYX (N=79)
English: CYP3A4 inhibitors and inducers
Danish: CYP3A4-hæmmere og -induktorer
English: Each bottle contains 30 film-coated tablets.
Danish: Hver beholder indeholder 30 filmovertrukne tabletter.
English: Patients who have inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, peritonitis, diverticulitis, or appendicitis), have tumour infiltration in the GI tract, or have complications from prior GI surgery (particularly when associated with delayed or incomplete healing) should be carefully evaluated before initiating cabozantinib therapy and subsequently they should be monitored closely for symptoms of perforations and fistulas including abscesses and sepsis.
Danish: Patienter, som har inflammatorisk tarmsygdom (f.eks. Crohns sygdom, ulcerativ colitis, peritonitis eller diverticulitis eller appendicitis), tumorinfiltration i gastrointestinalkanalen eller komplikationer fra tidligere gastrointestinalkirurgi (især forbundet med forsinket eller ufuldstændig heling), skal evalueres omhyggeligt inden indledning af behandling med cabozantinib og monitoreres tæt for symptomer på perforation og fisteldannelse, herunder absces og sepsis.
English: Progressive Disease a in accord with EU censoring b Stratification factors per IxRS comprise IMDC risk categories (intermediate risk, poor risk and bone metastasis (yes, no) c Estimated using the Cox proportional hazard model adjusted for stratification factors per IxRS.
Danish: Delvis respons ORR (Kun delvis respons) Stabil sygdom Progressiv sygdom a i overensstemmelse med EU-censurering b Stratificeringsfaktorer pr. IxRS omfatter IMDC-risikokategorier (middel risiko, høj risiko og knoglemetastaser (ja,nej) c Estimeret ved hjælp af Cox proportionel risikomodel justeret for stratificeringsfaktorer pr. IxRS.
English: Palmar-plantar erythrodysaesthesia syndrome (PPES) has been observed with cabozantinib.
Danish: Der er blevet observeret palmoplantar erytrodysæstesi-syndrom (PPES) med cabozantinib.
English: Juvenile rats (comparable to a >2 year- old paediatric population) administered cabozantinib showed increased WBC parameters, decreased haematopoiesis, pubescent/immature female reproductive system (without delayed vaginal opening), tooth abnormalities, reduced bone mineral content and density, liver pigmentation and lymph node lymphoid hyperplasia.
Danish: Juvenile rotter (sammenlignelige med en >2 årig pædiatrisk population), der fik cabozantinib, udviste forhøjede leukocyt-parametre, nedsat hæmatopoiese, pubertært/umodent hunligt reproduktionssystem (uden forsinket vaginalåbning), abnormiteter i tænderne, reduceret mineralindhold i og densitet af knoglerne, leverpigmentering og lymfoid lymfeknudehyperplasi.
English: Further, hypospermatogenesis was observed in male dogs at exposure levels below human clinical exposure levels at intended therapeutic dose.
Danish: Ydermere blev der observeret hypospermatogenese hos hanhunde ved eksponeringsniveauer under det humane kliniske eksponeringsniveau ved den tilsigtede terapeutiske dosis.
English: • Pain in arms, legs and joints, muscle spasms
Danish: • Smerter i arme, ben og led, muskelkramper
English: In rat and dog repeat-dose toxicity studies up to 6 months duration, target organs for toxicity were GI tract, bone marrow, lymphoid tissues, kidney, adrenal and reproductive tract tissues.
Danish: I toksicitetsstudier med gentagne doser hos rotter og hunde af op til 6 måneders varighed var målorganer for toksicitet mave-tarmkanal, knoglemarv, lymfevæv, nyrer, binyrer og reproduktionsorganer.
English: CABOMETYX contains lactose
Danish: CABOMETYX indeholder lactose
English: CABOMETYX should not be taken with food.
Danish: CABOMETYX må ikke tages sammen med mad.
English: Taking CABOMETYX with food
Danish: Brug af CABOMETYX sammen med mad
English: Consider re-initiating at a reduced dose.
Danish: Overvej at genstarte behandlingen ved en reduceret dosis.
English: Hepatocellular Carcinoma (HCC)
Danish: Hepatocellulært karcinom (HCC)
English: Closer monitoring of the overall safety is recommended in patients with mild or moderate hepatic impairment (see also sections 4.2 and 5.2).
Danish: Tættere monitorering af den samlede sikkerhed anbefales til patienter med let eller moderat nedsat leverfunktion (se også pkt.
English: In a subsequent unplanned interim analysis of OS, a statistically significant improvement was demonstrated for patients randomized to CABOMETYX as compared with everolimus (320 events, median of 21.4 months vs. 16.5 months; HR=0.66 [0.53, 0.83], p=0.0003; Figure 2).
Danish: ikke-planlagt interimanalyse af OS blev der påvist en statistisk signifikant forbedring hos patienter, der var randomiseret til CABOMETYX, sammenlignet med everolimus (320 hændelser, median på 21,4 måneder vs. 16,5 måneder; HR=0,66 [0,53- 0,83]; p=0,0003; Figur 2).
English: - - if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke CABOMETYX - hvis du er allergisk over for cabozantinib eller et af de øvrige indholdsstoffer i CABOMETYX (angivet i punkt 6).
English: - have high blood pressure - have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall - have diarrhoea - have a recent history of significant bleeding - have had surgery within the last month (or if surgical procedures are planned), including dental surgery - have inflammatory bowel disease (for example, Crohn's disease or ulcerative colitis,
Danish: - har forhøjet blodtryk - har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg - har diarré - for nyligt har haft en større blødning - har gennemgået en operation inden for den sidste måned (eller hvis et kirurgisk indgreb er planlagt),
English: Cabozantinib should not be administered to patients that have or are at risk for severe haemorrhage.
Danish: Cabozantinib bør ikke gives til patienter, der har eller har risikofaktorer for alvorlig blødning.
English: Renal Cell Carcinoma (RCC)
Danish: Nyrecellekarcinom (RCC)
English: If you take CABOMETYX whilst using oral contraceptives, the oral contraceptives may be ineffective.
Danish: Hvis du tager CABOMETYX samtidig med, at du tager svangerskabsforebyggende piller (p-piller), er p-pillerne måske ikke tilstrækkeligt effektive.
English: Cabozantinib should be discontinued if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of cabozantinib.
Danish: Cabozantinib skal seponeres ved vedvarende svær hypertension på trods af antihypertensiv behandling og reduktion af cabozantinibdosis.
English: Objective Response Rate n (%) by Investigator Complete responses
Danish: Objektiv responsrate n (%) pr. Investigator Fuldstændig respons
English: How to take CABOMETYX 4.
Danish: Sådan skal du tage CABOMETYX 4.
English: A statistically significant improvement in PFS was demonstrated for CABOMETYX compared to everolimus (Figure 1 and Table 3).
Danish: Der blev påvist en statistisk signifikant forbedring i PFS for CABOMETYX sammenlignet med everolimus (Figur 1 og Tabel 3).
English: Gastrointestinal (GI) disorders
Danish: Gastrointestinale (GI) lidelser
English: You should not take CABOMETYX with food.
Danish: Du må ikke tage CABOMETYX sammen med mad.
English: Cardiac electrophysiology An increase from baseline in corrected QT interval by Fridericia (QTcF) of 10 - 15 ms on Day 29 (but not on Day 1) following initiation of cabozantinib treatment (at a dose of 140 mg qd) was observed in a controlled clinical study in medullary thyroid cancer patients.
Danish: En forlængelse i forhold til baseline i korrigeret QT-interval efter Fridericia (QTcF) på 10-15 ms på dag 29 (men ikke på dag 1) efter indledning af behandling med cabozantinib (ved en dosis på 140 mg dagligt) blev observeret i et kontrolleret klinisk studie med patienter med medullær thyroideacancer.
English: • Dry skin, severe itching of skin, acne
Danish: • Tør hud, kraftig kløe i huden, akne
English: In the event of suspected overdose, cabozantinib should be withheld and supportive care instituted.
Danish: Ved mistanke om overdosering bør behandlingen med cabozantinib afbrydes og understøttende behandling initieres.
English: Cabozantinib exhibited dose-related tumour growth inhibition, tumour regression, and/or inhibited metastasis in a broad range of preclinical tumour models.
Danish: Cabozantinib udviste dosis-relateret hæmning af tumorvækst og tumorregression og/eller hæmmede metastase i en lang række præ-kliniske tumormodeller.
English: Cabozantinib should be discontinued in patients who experience a GI perforation or a fistula that cannot be adequately managed.
Danish: Cabozantinib skal seponeres hos patienter, der får gastrointestinal perforation eller en fistel, der ikke kan behandles tilfredsstillende.
English: • Reduced thyroid activity; symptoms can include: tiredness, weight gain, constipation, feeling cold and dry skin
Danish: • Nedsat aktivitet af skjoldbruskkirtlen; symptomerne kan omfatte: træthed, vægtstigning, forstoppelse,
English: Median time to onset was 14 weeks.
Danish: Mediantiden til opståen var 14 uger.
English: Dose interruption or reduction, or permanent discontinuation of cabozantinib should be considered in case of persistent or recurrent significant abnormalities (see Table 1).
Danish: Dosisafbrydelse eller -reduktion eller permanent seponering af cabozantinib bør overvejes ved vedvarende eller tilbagevendende signifikante afvigelser (se tabel 1).
English: • Gastro-oesophageal reflux disease (bringing up stomach acid)
Danish: • Gastro-øsofageal refluks (tilbageløb af mavesyre fra mavesækken til spiserøret)
English: • Blood clots in the veins, arteries and lungs
Danish: • Blodpropper i blodårerne (vener og arterier) og i lungerne
English: ORR (partial responses only) (95% CI) p-value1
Danish: ORR (kun delvise responser) (95 % CI) p-værdi1
English: Grade 4 adverse reactions (except clinically nonrelevant laboratory abnormalities)
Danish: Bivirkninger grad 4 (undtagen klinisk irrelevante laboratorieanormaliteter).
English: NOAEL for embryofoetal toxicity and teratogenic findings were below human clinical exposure levels at intended therapeutic dose.
Danish: NOAEL for embryo-føtal toksicitet og teratogene fund var lavere end det humane kliniske eksponeringsniveau ved den tilsigtede terapeutiske dosis.
English: The no observed adverse effect level (NOAEL) for these findings were below human clinical exposure levels at intended therapeutic dose.
Danish: Niveauet uden observerede bivirkninger (NOAEL) for disse fund var lavere end det humane kliniske eksponeringsniveau ved den tilsigtede terapeutiske dosis.
English: In the HCC study (CELESTIAL), fistulas were reported in 1.5% (7/467) of the HCC patients.
Danish: I HCC-studiet (CELESTIAL) blev fistler rapporteret hos 1,5 % (7/467) af HCC-patienterne.
English: Grade 3 adverse reactions (except clinically nonrelevant laboratory abnormalities)
Danish: Bivirkninger grad 3 (undtagen klinisk irrelevante laboratorieanormaliteter).
English: The pharmacokinetics of cabozantinib was not evaluated in patients with severe hepatic impairment.
Danish: Cabozantinibs farmakokinetik blev ikke undersøgt hos patienter med svært nedsat leverfunktion.
English: Co-administration of proton pump inhibitor (PPI) esomeprazole (40 mg daily for 6 days) with a single dose of 100 mg cabozantinib to healthy volunteers resulted in no clinically-significant effect on plasma cabozantinib exposure (AUC).
Danish: Administration af protonpumpe-hæmmeren (PPI) esomeprazol (40 mg dagligt i 6 dage) sammen med en enkelt dosis 100 mg cabozantinib til raske frivillige resulterede ikke i nogen klinisk signifikant virkning på cabozantinibs plasmaeksponering (AUC).
English: Thirty-six percent (36%) of patients had bone metastases.
Danish: 36 % af patienterne havde knoglemetastaser.
English: Investigations weight decreased, serum ALT increased, AST increased blood ALP increased, GGT increased, blood creatinine increased, amylase increased, lipase increased, blood cholesterol increased, white blood cell count decreased blood triglycerides increased
Danish: Forhøjet alkalisk fosfatase (ALP), forhøjet GGT, forhøjet kreatinin i blodet, forhøjet amylase, forhøjet lipase, forhøjet niveau af kolesterol i blodet, fald i antal hvide blodlegemer
English: MARKETING AUTHORISATION HOLDER Ipsen Pharma
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Ipsen Pharma
English: Events of venous thromboembolism, including pulmonary embolism, and arterial thromboembolism, sometimes fatal, have been observed with cabozantinib.
Danish: Der er blevet observeret tilfælde af venøs tromboemboli, herunder lungeemboli og arteriel tromboemboli, nogle gange letale, med cabozantinib.
English: Infections and infestations abscess
Danish: Infektioner og parasitære sygdomme
English: Clinical data in Hepatocellular Carcinoma
Danish: Kliniske data ved hepatocellulært karcinom
English: Cardiac disorders myocardial infarction
Danish: Hjerte myokardieinfarkt
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet 28 film-coated tablets 30 film-coated tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: 28 filmovertrukne tabletter 30 filmovertrukne tabletter ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse.
English: No dose adjustment is indicated when gastric pH modifying agents (i.e., PPIs, H2 receptor antagonists, and antacids) are co-administered with cabozantinib.
Danish: Dosisjustering er ikke nødvendig, når lægemidler til modificering af gastrisk pH (dvs. PPI'er, H2-receptorantagonister og antacida) administreres sammen med cabozantinib.
English: In the HCC study (CELESTIAL), fatal haemorrhagic events were reported at a higher incidence with cabozantinib than placebo.
Danish: I HCC-studiet (CELESTIAL) blev letale hæmoragiske hændelser rapporteret med en højere forekomst med cabozantinib end med placebo.
English: The baseline demographic and disease characteristics were similar between the CABOMETYX and sunitinib arms.
Danish: De grundlæggende demografiske og sygdomskarakteristika var ens mellem CABOMETYX og sunitinibarmene ved baseline.
English: Caution is required when administering cabozantinib with agents that are strong CYP3A4 inhibitors.
Danish: Forsigtighed er nødvendig ved administration af cabozantinib sammen med lægemidler, der er potente CYP3A4-hæmmere.
English: Concomitant medicinal products
Danish: Samtidigt administrerede lægemidler
English: There are no studies in pregnant women using cabozantinib.
Danish: Der er ingen data fra anvendelse af cabozantinib til gravide kvinder.
English: Dose interruption or reduction, or permanent discontinuation of cabozantinib should be considered in case of persistent or recurrent significant GI adverse reactions (see Table 1).
Danish: Dosisafbrydelse eller -reduktion eller permanent seponering af cabozantinib bør overvejes ved vedvarende eller tilbagevendende signifikante GI-bivirkninger (se tabel 1).
English: Cabozantinib was metabolized in vivo.
Danish: Cabozantinib (XL184) blev metaboliseret in vivo.
English: Concomitant medicinal products that are strong inhibitors of CYP3A4 should be used with caution, and chronic use of concomitant medicinal products that are strong inducers of CYP3A4 should be avoided (see sections 4.4 and 4.5).
Danish: Samtidig administration af lægemidler, der er potente CYP3A4-hæmmere, bør ske med forsigtighed, og langvarig administration af lægemidler, der er potente CYP3A4-induktorer, bør undgås (se pkt.
English: Other medicines and CABOMETYX
Danish: Brug af anden medicin sammen med CABOMETYX
English: In the HCC study (CELESTIAL), hepatic encephalopathy (hepatic encephalopathy, encephalopathy, hyperammonaemic encephalopathy) was reported in 5.6% of cabozantinib-treated patients (26/467); Grade 3-4 events in 2.8%, and one (0.2%) Grade 5 event.
Danish: I HCC-studiet (CELESTIAL) blev hepatisk encefalopati (hepatisk encefalopati, encefalopati, hyperammonæmisk encefalopati) rapporteret hos 5,6 % af de cabozantinib-behandlede patienter (26/467); Grad 3-4-hændelser hos 2,8 % og én (0,2 %) grad 5-hændelse.
English: The European Medicines Agency has waived the obligation to submit the results of studies with CABOMETYX in all subsets of the paediatric population in treatment of hepatocellular carcinoma, and kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med CABOMETYX i en eller flere undergrupper af den pædiatriske population ved behandlingen af hepatocellulært karcinom og nyre- og nyrebækkenkarcinom (undtagen nefroblastom, nefroblastomatose, clearcelle-sarkom, mesoblastisk nefrom, medullært karcinom i nyrerne og rabdoid tumor i nyrerne) (se pkt.
English: In the HCC study (CELESTIAL), portal vein thrombosis was observed with cabozantinib, including one fatal event.
Danish: I HCC-studiet (CELESTIAL) blev der observeret portal venetrombose med cabozantinib, herunder et letalt tilfælde.
English: Very common side effects (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 mennesker)
English: Number at risk: CABOMETYX Everolimus
Danish: Antal i risikogruppe: CABOMETYX Everolimus
English: • Redness, swelling or pain in the mouth or throat, Difficulty in speaking, hoarseness, cough
Danish: • Rødme, hævelse eller smerter i munden eller svælget, taleproblemer, hæshed, hoste
English: Median time to onset was 20.9 weeks.
Danish: Mediantiden til opståen var 20,9 uger.
English: Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-glycoprotein (P-gp) transport activities in a bi-directional assay system using MDCK-MDR1 cells.
Danish: Cabozantinib var en hæmmer (IC50 = 7,0 μM) af, men ikke et substrat for P-glykoprotein (P-gp) transportaktivitet i et to-rettet assay-system, der anvendte MDCK-MDR1-celler.
English: Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-gp transport activities in a bi-directional assay system using MDCK-MDR1 cells.
Danish: Cabozantinib var en hæmmer (IC50 = 7,0 μM) af, men ikke et substrat for P-gp-transportaktivitet i et to-rettet assay-system, der anvendte MDCK-MDR1-celler.
English: Median time to onset was 30.3 weeks.
Danish: Mediantiden til opståen var 30,3 uger.
English: The most common serious adverse drug reactions in the HCC population (≥1% incidence) are hepatic encephalopathy, palmar-plantar erythrodysaesthesia syndrome, asthenia and diarrhoea.
Danish: De mest almindelige alvorlige bivirkninger i HCC-populationen (≥1 % incidens) er hepatisk encefalopati, palmoplantar erytrodysætesisyndrom, asteni og diarré.
English: During treatment with cabozantinib, all patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy.
Danish: Alle patienter bør monitoreres for hypertension under behandling med cabozantinib og om nødvendigt have standard antihypertensiv behandling.
English: • Swelling, pain in your hands and feet, or shortness of breath.
Danish: • Hævelse, smerter i dine hænder og fødder eller kortåndethed.
English: Administration of MRP2 inhibitors may result in increases in cabozantinib plasma concentrations.
Danish: Administration af MRP2-hæmmere kan resultere i øgede cabozantinib-plasmakoncentrationer.