FrancophonIA/ELRC3.0 huggingface dataset:
English: Cabozantinib should be discontinued in patients with wound healing complications requiring medical intervention.
Danish: Cabozantinib skal seponeres hos patienter med sårhelingskomplikationer, der kræver intervention.
English: MARKETING AUTHORISATION NUMBER(S) Cabometyx 20 mg film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) CABOMETYX 20 mg filmovertrukne tabletter
English: In rats, cabozantinib caused postimplantation loss, foetal oedema, cleft palate/lip, dermal aplasia and kinked or rudimentary tail.
Danish: Hos rotter medførte cabozantinib postimplantationstab, føtalt ødem, hareskår/ganespalte, dermal aplasi og krøllet eller rudimentær hale.
English: Therefore, administration of MRP2 inhibitors may result in increases in cabozantinib plasma concentrations.
Danish: Administration af MRP2-hæmmere kan derfor resultere i øgede cabozantinib-plasmakoncentrationer.
English: Metabolism and nutrition disorders decreased appetite, hypomagnesaemia, hypokalaemia dehydration, hypoalbuminaemia, hypophosphataemia, hyponatraemia, hypocalcaemia, hyperkalaemia, hyperbilirubinemia hyperglycaemia, hypoglycaemia
Danish: Dehydrering, hypoalbuminæmi, hypofosfatæmi, hyponatriæmi, hypocalcæmi, hyperkaliæmi, hyperbilirubinæmi, hyperglykæmi, hypoglykæmi
English: In the HCC study (CELESTIAL), thrombocytopenia and decreased platelets were reported.
Danish: I HCC-studiet (CELESTIAL) blev trombocytopeni og nedsat antal blodplader rapporteret.
English: Biochemical laboratory test abnormalities
Danish: Afvigelser i biokemiske laboratorieværdier
English: In the treatment-naïve RCC study (CABOSUN), GI perforations were reported in 2.6% (2/78) of cabozantinib-treated patients.
Danish: I studiet af behandlingsnaivt RCC (CABOSUN), blev der rapporteret GI-perforationer hos 2,6 % (2/78) af de cabozantinib-behandlede patienter.
English: Centralpharma Communications OÜ Ipsen Poland Sp. z o.o.
Danish: Ipsen Poland Sp. z o.o.
English: Tablet content Microcrystalline cellulose Anhydrous lactose Hydroxypropyl cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Danish: Tablettens indhold Mikrokrystallinsk cellulose Vandfri lactose Hypromellose Croscarmellosenatrium Silica, kolloid vandfri Magnesiumstearat
English: The safety and efficacy of CABOMETYX for the treatment of renal cell carcinoma following prior vascular endothelial growth factor (VEGF)-targeted therapy were evaluated in a randomized, openlabel, multicenter Phase 3 study (METEOR).
Danish: CABOMETYX' sikkerhed og virkning, ved behandling af nyrecellekarcinom efter tidligere vaskulær endothelvækstfaktor (VEGF) målrettet behandling, blev evalueret i et randomiseret, åbent fase IIImulticenterstudie (METEOR).
English: Concurrent administration of cabozantinib with the strong CYP3A4 inducer rifampicin resulted in a decrease in cabozantinib plasma exposure.
Danish: Samtidig administration af cabozantinib og den potente CYP3A4-induktor rifampicin resulterede i en nedsættelse af cabozantinibs plasmaeksponering.
English: Median time to onset was 10.0 weeks.
Danish: Mediantiden til opståen var 10,0 uger.
English: Hypertension has been observed with cabozantinib.
Danish: Der er blevet observeret hypertension med cabozantinib.
English: Concurrent administration of cabozantinib with the strong CYP3A4 inhibitor ketoconazole resulted in an increase in cabozantinib plasma exposure.
Danish: Samtidig administration af cabozantinib og den potente CYP3A4-hæmmer ketoconazol resulterede i en stigning i cabozantinibs plasmaeksponering.
English: and 5.2).There is no clinical experience in patients with severe hepatic impairment (Child Pugh C), so cabozantinib is not recommended for use in these patients (see section 5.2).
Danish: Der er ingen klinisk erfaring hos patienter med svært nedsat leverfunktion (Child Pugh C), hvorfor cabozantinib ikke anbefales til disse patienter (se pkt.
English: Severe haemorrhage, sometimes fatal, has been observed with cabozantinib.
Danish: Der er blevet observeret alvorlig blødning, nogle gange letal, med cabozantinib.
English: In hepatocellular carcinoma following prior systemic therapy, dose reductions and dose interruptions occurred in 62% and 84%, respectively, of cabozantinib-treated patients in the clinical trial (CELESTIAL).
Danish: Ved hepatocellulært karcinom efter forudgående systemisk behandling forekom dosisreduktioner og dosisafbrydelser hos henholdsvis 62 % og 84 % af de cabozantinib-behandlede patienter i det kliniske forsøg (CELESTIAL).
English: In renal cell carcinoma following prior vascular endothelial growth factor (VEGF)-targeted therapy, dose reductions and dose interruptions due to an AE occurred in 59.8% and 70%, respectively, of cabozantinib-treated patients in the pivotal clinical trial (METEOR).
Danish: Ved nyrecellekarcinom efter tidligere vaskulær endothelial vækstfaktor (VEGF) målrettet behandling, forekom dosisreduktion og behandlingsafbrydelse på grund af en bivirkning hos henholdsvis 59,8 % og 70 % af de cabozantinibbehandlede patienter i det pivotale kliniske studie (METEOR).
English: The baseline demographic and disease characteristics were similar between the CABOMETYX and everolimus arms.
Danish: De demografiske data ved baseline og sygdomskarakteristika var sammenlignelige mellem CABOMETYXog everolimus-gruppen.
English: In the HCC study (CELESTIAL), GI perforations were reported in 0.9% of cabozantinib-treated patients (4/467).
Danish: I HCC-studiet (CELESTIAL) blev GI-perforeringer rapporteret hos 0,9 % af de cabozantinib-behandlede patienter (4/467).
English: Therefore, concomitant use of MRP2 inhibitors (e.g. cyclosporine, efavirenz, emtricitabine) should be approached with caution (see section 4.5).
Danish: Derfor skal der udvises forsigtighed ved samtidig anvendelse af MRP2-hæmmere (f.eks. ciclosporin, efavirenz, emtricitabin) (se pkt.
English: The most frequent adverse reactions of any grade (experienced by at least 25% of patients) in the RCC population included diarrhoea, hypertension, fatigue, AST increased, ALT increased, nausea, decreased appetite, PPES, dysgeusia, platelet count decreased, stomatitis, anaemia, vomiting, weight decreased, dyspepsia, and constipation.
Danish: De hyppigste bivirkninger af en hvilken som helst grad (oplevet af mindst 25 % af patienterne) i RCCpopulationen inkluderede diarré, hypertension, træthed, forhøjet ASAT, forhøjet ALAT, kvalme, nedsat appetit, PPES, dysgeusi, nedsat trombocyttal, stomatitis, anæmi, opkastninger, vægttab, dyspepsi og forstoppelse.
English: Administration of the strong CYP3A4 inhibitor ketoconazole (400 mg daily for 27 days) to healthy volunteers decreased cabozantinib clearance (by 29%) and increased single-dose plasma cabozantinib exposure (AUC) by 38%.
Danish: Administration af den potente CYP3A4-hæmmer ketoconazol (400 mg dagligt i 27 dage) til raske frivillige nedsatte cabozantinib-clearance (med 29 %) og øgede cabozantinibs plasmaeksponering (AUC) (efter en enkelt dosis) med 38 %.
English: The most common serious adverse drug reactions in the RCC population (≥1% incidence) are diarrhoea, hypertension, dehydration, hyponatraemia, nausea, decreased appetite, embolism, fatigue, hypomagnesaemia, palmar-plantar erythrodysaesthesia syndrome (PPES).
Danish: De mest almindelige alvorlige bivirkninger i RCC-populationen (≥1 % incidens) er diarré, hypertension, dehydrering, hyponatriæmi, kvalme, nedsat appetit, emboli, træthed, hypomagnesiæmi, palmoplantar erytrodysæstesisyndrom (PPES).
English: Clinical data in renal cell carcinoma following prior vascular endothelial growth factor (VEGF)targeted therapy
Danish: Kliniske data ved nyrecellekarcinom efter tidligere vaskulær endothelvækstfaktor (VEGF) målrettet behandling:
English: Progression-free survival (PFS)3 Median PFS in months (95% CI) HR (95% CI)1 p-value1
Danish: Progressionsfri overlevelse (PFS)3 Median PFS i måneder (95 % CI) HR (95 % CI)1 p-værdi1
English: Subjects with severe renal impairment have not been studied.
Danish: Der er ikke udført studier med forsøgspersoner med svært nedsat nyrefunktion.
English: Events that generally have early onset include hypocalcaemia, hypokalaemia, thrombocytopenia, hypertension, palmar-plantar erythrodysaesthesia syndrome (PPES), proteinuria, and gastrointestinal (GI) events (abdominal pain, mucosal inflammation, constipation, diarrhoea, vomiting).
Danish: Bivirkninger, der generelt ses tidligt, omfatter hypokalcæmi, hypokaliæmi, trombocytopeni, hypertension, palmoplantar erytrodysæstesisyndrom (PPES), proteinuri og gastrointestinale bivirkninger (abdominalsmerter, slimhindeinflammation, obstipation, diarré, opkastninger).
English: Overall Survival Median OS (95% CI), months HR (95% CI)1,2 p-value1
Danish: Samlet overlevelse (OS) Median OS (95% CI), måneder HR (95 % CI)1,2 p-værdi1
English: Subjects should be cautioned regarding taking a P-gp substrate (e.g., fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) while receiving cabozantinib.
Danish: Patienter skal advares ved indtagelse af et P-gp-substrat (f.eks. fexofenadin, aliskiren, ambrisentan, dabigatranetexilat, digoxin, colchicin, maraviroc, posaconazol, ranolazin, saxagliptin, sitagliptin, talinolol, tolvaptan), mens de får cabozantinib.
English: Administration of the strong CYP3A4 inducer rifampicin (600 mg daily for 31 days) to healthy volunteers increased cabozantinib clearance (4.3-fold) and decreased single-dose plasma cabozantinib exposure (AUC) by 77%.
Danish: Administration af den potente CYP3A4-induktor rifampicin (600 mg dagligt i 31 dage) til raske frivillige øgede cabozantinib-clearance (4,3 gange) og sænkede cabozantinibs plasmaeksponering (AUC) (efter en enkeltdosis) med 77 %.
English: In the HCC study (CELESTIAL), diarrhoea was reported in 54% of cabozantinib-treated patients (251/467);Grade 3- 4 events in 9.9%.
Danish: I HCC-studiet (CELESTIAL) blev diarré rapporteret hos 54 % af de cabozantinib-behandlede patienter (251/467), grad 3-4-hændelser hos 9,9 %.
English: Chronic co-administration of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing St. John's Wort [Hypericum perforatum]) with cabozantinib should therefore be avoided.
Danish: Langvarig samtidig administration af cabozantinib og potente CYP3A4-induktorer (f.eks. phenytoin, carbamazepin, rifampicin, phenobarbital eller naturlægemidler, der indeholder perikon [Hypericum perforatum]) bør derfor undgås.
English: Median time to onset was 5.9 weeks.
Danish: Mediantiden til opståen var 5,9 uger.
English: Median time to onset was 9.1 weeks.
Danish: Mediantiden til opståen var 9,1 uger.
English: In treatment-naïve renal cell carcinoma, dose reductions and dose interruptions occurred in 46% and 73%, respectively, of cabozantinib-treated patients in the clinical trial (CABOSUN).
Danish: Ved behandlingsnaivt nyrecellekarcinom forekom dosisreduktioner og dosisafbrydelser hos henholdsvis 46 % og 73 % af de cabozantinib-behandlede patienter i det kliniske forsøg (CABOSUN).
English: • Increase in amylase levels in the blood
Danish: • Stigning af mængden af amylase i blodet
English: Figure 1: Kaplan Meier curve for progression-free survival by independent radiology review committee, in RCC subjects following prior vascular endothelial growth factor (VEGF)targeted therapy (first 375 subjects randomized) (METEOR)
Danish: Figur 1: Kaplan-Meier-kurver for progressionsfri overlevelse bedømt radiologisk af en uafhængig komité, hos RCC patienter efter tidligere vaskulær endothelvækstfaktor (VEGF) målrettet behandling (første 375 randomiserede patienter) (METEOR)
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 mennesker)
English: Vascular disorders hypertension, haemorrhage venous thrombosis arterial thrombosis
Danish: Venetrombose, arteriel trombose
English: Cabozantinib should be used with caution in patients who are at risk for, or who have a history of, these events.
Danish: Cabozantinib skal anvendes med forsigtighed hos patienter med en anamnese med eller risikofaktorer for disse hændelser.
English: What you need to know before you take CABOMETYX Do not take CABOMETYX
Danish: Det skal du vide, før du begynder at tage CABOMETYX
English: ECOG performance status (PS) 0: 53% or ECOG PS 1: 47%.
Danish: Kaukasisk: 56 %, asiatisk: 34 % ECOG performance status (PS) 0: 53 % eller ECOG PS 1: 47 % Child Pugh A: 99 %, Child Pugh B: 1 %
English: Figure 2: Kaplan-Meier curve of overall survival in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy (METEOR)
Danish: Figur 2: Kaplan-Meier-kurver for samlet overlevelse hos RCC patienter efter tidligere vaskulær endothelvækstfaktor (VEGF) målrettet behandling (METEOR)
English: In the HCC study (CELESTIAL), the incidence of severe haemorrhagic events (Grade ≥ 3) was 7.3% in cabozantinib-treated patients (34/467).
Danish: I HCC-studiet (CELESTIAL) var forekomsten af alvorlige hæmoragiske hændelser (grad ≥ 3) 7,3 % hos cabozantinib-behandlede patienter (34/467).
English: In the treatment-naïve RCC study (CABOSUN), diarrhoea was reported in 73% of cabozantinibtreated patients (57/78);Grade 3-4 events in 10%..
Danish: I det behandlingsnaive RCC-studie (CABOSUN) blev diarré rapporteret hos 73 % af de cabozantinibbehandlede patienter (57/78), grad 3-4-hændelser hos 10 %.
English: Hepatic encephalopathy
Danish: Hepatisk encefalopati
English: Subjects should be cautioned regarding taking a P-gp substrate (e.g., fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) while receiving cabozantinib (see section 4.5).
Danish: Patienter skal advares ved indtagelse af et P-gp-substrat (f.eks. fexofenadin, aliskiren, ambrisentan, dabigatranetexilat, digoxin, colchicin, maraviroc, posaconazol, ranolazin, saxagliptin, sitagliptin, talinolol, tolvaptan), mens de får cabozantinib (se pkt.
English: Uncommon side effects (may affect 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan forekomme hos 1 ud af 100 mennesker)
English: Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4)
Danish: Bemærk: Toksicitetsgrader er i henhold til National Cancer Institute Common Terminology Criteria for
English: Median PFS (95% CI), months HR (95% CI), p-value1
Danish: Middel-PFS (95 % CI), måneder HR (95 % CI), p-værdi1
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), diarrhoea was reported in 74% of cabozantinib-treated RCC patients (245/331); Grade 3-4 events in 11%.
Danish: I studiet af RCC efter forudgående VEGF-målrettet behandling (METEOR) blev diarré rapporteret hos 74 % af de cabozantinib-behandlede RCC-patienter (245/331); Grad 3-4-hændelser hos 11 %.
English: Progression-free survival (PFS) by Investigator Median PFS in months (95% CI) HR (95% CI); stratified b,c Two-sided log-rank p-value: stratified b p=0.0042
Danish: Progressionsfri overlevelse (PFS) pr. Investigator Median PFS i måneder (95% CI) HR (95% CI); stratificeret b,c Tosidet stratificeret log-rank p-værdi b p=0,0042
English: Gastric pH modifying agents
Danish: Lægemidler til modificering af gastrisk pH
English: CYP3A4 inducers and inhibitors Cabozantinib is a CYP3A4 substrate.
Danish: Cabozantinib er et CYP3A4-substrat.
English: Wound complications have been observed with cabozantinib.
Danish: Der er blevet observeret sårkomplikationer med cabozantinib.
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), GI perforations were reported in 0.9% (3/331) of cabozantinib-treated RCC patients.
Danish: I studiet af RCC efter tidligere VEGF-målrettet behandling (METEOR) blev der rapporteret GI-perforation hos 0,9 % (3/331) af de cabozantinib-behandlede RCC-patienter.
English: Median time to onset was 4.9 weeks.
Danish: Mediantiden til opståen var 4,9 uger.
English: • Stomach upset, including diarrhoea, nausea, vomiting, constipation, indigestion, abdominal pain,
Danish: • Gener fra maven, herunder diarré, kvalme, opkastning, forstoppelse, fordøjelsesbesvær og mavesmerter
English: • Increase in blood triglyceride levels in the blood
Danish: • Stigning af triglyceridniveauet i blodet
English: When using cabozantinib, periodic monitoring with ontreatment ECGs and electrolytes (serum calcium, potassium, and magnesium) should be considered.
Danish: Regelmæssig monitorering af ekg og elektrolytter (serumcalcium, -kalium og -magnesium) under behandlingen med cabozantinib skal overvejes.
English: • Increase in lipase levels in the blood
Danish: • Stigning af mængden af lipase i blodet
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Cabometyx indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Excipient related warnings
Danish: Advarsler relateret til hjælpestof
English: Progression-free survival (PFS) by IRC a Median PFS in months (95% CI) HR (95% CI); stratified b,c Two-sided log-rank p-value: stratified b p=0.0005
Danish: Progressionsfri overlevelse (PFS) pr. IRCa Median PFS i måneder (95% CI) HR (95% CI); stratificeret b,c Tosidet stratificeret log-rank p-værdi b p=0,0005
English: • Anaemia (low levels of red blood cells)
Danish: • Anæmi (blodmangel)
English: • Increase in cholesterol levels in the blood
Danish: • Stigning af mængden af kolesterol i blodet
English: • Wound complications
Danish: • Sårkomplikationer.
English: In the treatment-naïve RCC study (CABOSUN), the incidence of severe haemorrhagic events (Grade ≥ 3) was 5.1% (4/78) in cabozantinib-treated RCC patients.
Danish: I studiet af behandlingsnaivt RCC (CABOSUN) var forekomsten af alvorlige blødningshændelse (grad ≥ 3) 5,1 % (4/78) hos cabozantinib-behandlede RCC patienter.
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Filmovertrukne tabletter.
English: Therefore, co-administration of strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) with cabozantinib should be approached with caution.
Danish: Derfor skal der udvises forsigtighed ved samtidig administration af cabozantinib og potente CYP3A4-hæmmere (f.eks. ritonavir, itraconazol, erythromycin, clarithromycin, grapefrugtjuice).
English: • Decrease in bile flow from the liver
Danish: • Nedsat mængde galde, der udtømmes fra leveren
English: The other ingredients are: - Tablet contents: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide anhydrous, magnesium stearate.
Danish: - Tabletindhold: mikrokrystallinsk cellulose, vandfri lactose, hypromellose, croscarmellosenatrium, kolloid vandfri silica og magnesiumstearat.
English: In patients with mild hepatic impairment no dose adjustment is required.
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion.
English: The most frequent adverse reactions of any grade (experienced by at least 25% of patients) in the HCC population included diarrhoea, palmar-plantar erythrodysaesthesia syndrome, fatigue, decreased appetite hypertension and nausea.
Danish: De hyppigste bivirkninger af en hvilken som helst grad (set hos mindst 25 % af patienterne) i HCCpopulationen omfattede diarré, palmoplantar erytrodysætesisyndrom, træthed, nedsat appetit, hypertension og kvalme.
English: CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets cabozantinib
Danish: CABOMETYX 20 mg filmovertrukne tabletter CABOMETYX 40 mg filmovertrukne tabletter CABOMETYX 60 mg filmovertrukne tabletter cabozantinib
English: Interrupt treatment until the adverse reaction resolves to Grade ≤1.
Danish: Afbryd behandlingen, indtil bivirkningerne er reduceret til grad Tilføj understøttende behandling som indiceret.
English: Cabozantinib is a substrate for CYP3A4 metabolism in vitro, as a neutralizing antibody to CYP3A4 inhibited formation of metabolite XL184 N-oxide by >80% in a NADPH-catalyzed human liver microsomal (HLM) incubation; in contrast, neutralizing antibodies to CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 and CYP2E1 had no effect on cabozantinib metabolite formation.
Danish: Cabozantinib er substrat for CYP3A4-metabolisme in vitro, eftersom et neutraliserende antistof mod CYP3A4 hæmmede dannelsen af metabolitten XL184 N-oxid med >80 % i en NADPH-katalyseret inkubation med humane levermikrosomer (HLM).
English: Hepatic encephalopathy hepatitis cholestatic
Danish: Kolestatisk hepatitis
English: Fistulas
Danish: Fistler
English: Ipsen NV Guldensporenpark 87
Danish: België/Belgique/Belgien, Luxembourg/Luxemburg Italia Ipsen NV Guldensporenpark 87
English: CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets
Danish: CABOMETYX 20 mg filmovertrukne tabletter CABOMETYX 40 mg filmovertrukne tabletter CABOMETYX 60 mg filmovertrukne tabletter
English: It is used to treat: - advanced stages of a type of kidney cancer called renal cell carcinoma - liver cancer in adults who have been previously treated with a specific anticancer medicine (sorafenib).
Danish: - leverkræft hos voksne, der tidligere har været behandlet med en specifik kræftmedicin (sorafenib).
English: - Medicines that treat fungal infections, such as itraconazole, ketoconazole, and posaconazole - Medicines used to treat bacterial infections (antibiotics) such as erythromycin, clarithromycin,
Danish: - Lægemidler til behandling af svampeinfektioner, såsom itraconazol, ketoconazol og posaconazol.
English: • Symptoms including pain in the abdomen, nausea (feeling sick), vomiting, constipation, or fever.
Danish: • Smerter i maven, kvalme, opkastning, forstoppelse eller feber.
English: Skin and subcutaneous tissue disorders palmar-plantar erythrodysaesthesia syndrome, rash pruritus, alopecia, dry skin, dermatitis acneiform, hair colour change
Danish: Pruritus, alopecia, tør hud, acneiform dermatitis, ændret hårfarve
English: CABOMETYX 40 mg film-coated tablets are yellow, triangle shaped with no score, and identified with “XL” on one side and “40” on the other side.
Danish: CABOMETYX 40 mg filmovertrukne tabletter er gule og trekantede, uden delekærv og præget med "XL" på den ene side og "40" på den anden side.
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), fistulas were reported in 1.2% (4/331) of cabozantinib-treated patients and included anal fistulas in 0.6% (2/331) cabozantinibtreated patients.
Danish: I studiet af RCC efter tidligere VEGF-målrettet behandling (METEOR) blev der rapporteret fistler hos 1,2 % (4/331) af de cabozantinib-behandlede patienter, herunder analfistler hos 0,6 % (2/331).
English: Proteinuria has been observed with cabozantinib.
Danish: Der er blevet observeret proteinuri med cabozantinib.
English: Danmark, Norge, Suomi/Finland, Sverige, Ísland
Danish: Danmark, Norge, Suomi/Finland, Sverige, Ísland Magyarország Institut Produits Synthèse (IPSEN) AB Kista Science Tower
English: Patients (N=157) with previously untreated, locally advanced or metastatic RCC with a clear cell component were randomized (1:1) to receive CABOMETYX (N=79) or sunitinib (N=78).
Danish: Patienter (N=157) med tidligere ubehandlet, lokal fremskreden eller metastatisk RCC med en klar cellekomponent blev randomiseret (1:1) til behandling
English: Fatal perforations have occurred in the cabozantinib clinical program.
Danish: Der er set dødelige perforationstilfælde i det kliniske cabozantinib-program.
English: • Blisters, pain of the hands or soles of the feet, rash or redness of the skin
Danish: • Vabler, smerter i hænder eller fodsåler, udslæt på huden eller hudrødme
English: How to take CABOMETYX
Danish: Sådan skal du tage CABOMETYX
English: ORR per Investigator Review Intent-To-Treat Population
Danish: investigator ITT-population