FrancophonIA/ELRC3.0 huggingface dataset:
English: Tumour assessments were conducted every 8 weeks.
Danish: Tumorvurderinger blev udført hver 8. uge.
English: Talk to your doctor or pharmacist before taking CABOMETYX if you:
Danish: Kontakt lægen eller apotekspersonalet, før du tager CABOMETYX, hvis du:
English: Cabozantinib should be restarted with a lower dose when PPES has been resolved to grade 1.
Danish: Cabozantinib bør genstartes med en lavere dosis, når PPES er reduceret til grad 1.
English: Therapy with CABOMETYX should be initiated by a physician experienced in the administration of anticancer medicinal products.
Danish: Behandling med CABOMETYX bør indledes af en læge med erfaring i anticancerlægemidler.
English: If you get side effects, your doctor may tell you to take CABOMETYX at a lower dose.
Danish: Hvis du får bivirkninger, vil din læge måske bede dig om at tage CABOMETYX i en lavere dosis.
English: Close monitoring of overall safety is recommended in these patients (see sections 4.4
Danish: En tæt overvågning af den samlede sikkerhed anbefales til disse patienter (se pkt.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne vist efter faldende alvorlighed.
English: Crossover from placebo to cabozantinib was not allowed during theblinded treatment phase.
Danish: Crossover fra placebo til cabozantinib var ikke tilladt i den blindede behandlingsfase.
English: Cabozantinib was not carcinogenic in the rasH2 mouse model at a slightly higher exposure than the intended human therapeutic exposure.
Danish: Cabozantinib var ikke karcinogent i rasH2-musemodellen ved en lidt højere eksponering end den tilsigtede humane terapeutiske eksponering.
English: CABOMETYX treatment was associated with a trend for longer survival compared to sunitinib (Table 5).
Danish: CABOMETYX-behandling var forbundet med en tendens til længere overlevelse sammenlignet med sunitinib (tabel 5).
English: Cabozantinib is highly protein bound in vitro in human plasma (≥ 99.7%).
Danish: Cabozantinib har høj bindingsgrad til humane plasmaproteiner in vitro (≥ 99,7 %).
English: The effects of CABOMETYX in people younger than 18 years old are not known.
Danish: Virkningen af CABOMETYX hos børn og unge under 18 år er ikke kendt.
English: The safety and efficacy of cabozantinib in children and adolescents aged <18 years have not yet been established.
Danish: Cabozantinibs sikkerhed og virkning hos børn og unge i alderen <18 år er endnu ikke klarlagt.
English: Avoid consuming grapefruitcontaining products for as long as you are using this medicine, as they may increase the levels of CABOMETYX in your blood.
Danish: Du skal undgå at indtage produkter, der indeholder grapefrugt, i den periode, hvor du tager dette lægemiddel, da grapefrugt kan øge mængden af CABOMETYX i dit blod.
English: For patients with worsening of liver function tests considered related to cabozantinib treatment (i.e. where no alternative cause is evident), the dose modification advice in Table 1 should be followed (see section
Danish: For patienter med forværrede leverfunktionstests, der anses for at være relateret til cabozantinib-behandling (dvs. hvor ingen alternativ årsag er tydelig), bør rådgivningen om dosisændring i tabel 1 følges (se pkt.
English: Patients were stratified by IMDC risk group and presence of bone metastases (yes/no).
Danish: Patienterne blev stratificeret efter IMDC-risikogruppe og tilstedeværelse af knoglemetastaser (ja/nej).
English: The median time to first dose reduction was 38 days, and to first dose interruption was 28 days.
Danish: Mediantid til første dosisreduktion var 38 dage og til første dosisafbrydelse 28 dage.
English: If a patient must switch from cabozantinib capsules to cabozantinib tablets, the patient should continue at a CABOMETYX dose not to exceed 60 mg or the current COMETRIQ dose (whichever is lower).
Danish: Hvis en patient skal skifte fra cabozantinib-kapsler til cabozantinibtabletter, skal patienten fortsætte med en CABOMETYX-dosis, der ikke overstiger 60 mg eller den aktuelle COMETRIQ-dosis (alt efter, hvad der er lavest).
English: There is limited data in patients with moderate hepatic impairment (n=15) as per NCI-ODWG (National Cancer Institute - Organ Dysfunction working Group) criteria.
Danish: Der er begrænsede data fra patienter med moderat nedsat leverfunktion (n=15) i henhold til NCI-ODWG (National Cancer Institute - Organ Dysfunction Working Group)kriterierne.
English: Effect of other medicinal products on cabozantinib
Danish: Virkning af andre lægemidler på cabozantinib
English: Diarrhoea led to dose modifications, interruptions and discontinuations in 84/467 (18%), 69/467 (15%) and 5/467 (1%) of subjects, respectively.
Danish: Diarré førte til dosisændringer, -afbrydelser og -seponeringer hos henholdsvis 84/467 (18 %), 69/467 (15 %) og 5/467 (1 %) af forsøgspersonerne.
English: Use caution when driving or using machines.
Danish: Udvis forsigtighed, når du kører motorkøretøjer eller betjener maskiner.
English: The incidence of systemic non-radiation and local liver-directed systemic non-protocol anticancer therapy (NPACT) was 26% in the cabozantinib arm and 33% in the placebo arm.
Danish: Forekomsten af systemisk ikke-strålebehandling og lokal leverrettet systemisk anticancerbehandling uden for protokollen (NPACT) var 26 % i cabozantinib-armen og 33 % i placebo-armen.
English: These may be signs of a gastrointestinal perforation, a hole that develops in your stomach or intestine that could be life-threatening.
Danish: Disse kan være tegn på perforation af mave-tarm-kanalen (et hul i din mave eller tarm), hvilket kan være livstruende.
English: Stable disease Progressive Disease
Danish: Stabil sygdom Progredierende sygdom
English: HR (95% CI); stratified b,c
Danish: HR (95% CI) ; stratificeret b,c
English: Women taking CABOMETYX should not breast-feed during treatment and for at least 4 months after treatment has finished, as cabozantinib and/or its metabolites may be excreted in breast milk and be harmful to your child.
Danish: Kvinder, der tager CABOMETYX, bør ikke amme under behandlingen og i mindst 4 måneder efter, at behandlingen er afsluttet, da cabozantinib og/eller dets metabolitter kan udskilles i mælken og være skadeligt for barnet.
English: Table 6: Efficacy results in HCC (ITT population, CELESTIAL) CABOMETYX (N=470)
Danish: Tabel 6: Effektresultater ved HCC (ITT population, CELESTIAL) CABOMETYX (N=470)
English: Grade 1 and Grade 2 adverse reactions which are tolerable and easily managed
Danish: Bivirkninger af grad 1 og grad 2, som er tålelige og nemme at håndtere
English: Most patients (87%) had ECOG performance status of 0 or 1; 13% had an ECOG performance status of 2.
Danish: De fleste patienter (87 %) havde en Eastern Cooperative Oncology Group (ECOG) performance status på 0 eller 1; 13 % havde en ECOG performance status på 2.
English: Progression-free survival (PFS) was assessed by a blinded independent radiology review committee, and the primary analysis was conducted among the first 375 subjects randomized.
Danish: Progressionsfri overlevelse (PFS) blev vurderet radiologisk af en blindet uafhængig komité, og den primære analyse blev udført blandt de første 375 randomiserede patienter.
English: Objective response rate findings are summarized in Table 4.
Danish: Objektive responsrater er opsummeret i Tabel 4.
English: Cabozantinib has minor influence on the ability to drive and use machines.
Danish: Cabozantinib påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: CABOMETYX should be taken once a day.
Danish: Du skal tage CABOMETYX en gang dagligt.
English: The study was not powered for the OS analysis and the data are immature.
Danish: Undersøgelsen var ikke designet med henblik på OS-analyse og data er ikke fuldt udviklet.
English: Patients could have received other prior therapies, including cytokines, and antibodies targeting VEGF, the programmed death 1 (PD-1) receptor, or its ligands.
Danish: Patienterne kunne have fået andre tidligere behandlinger, herunder cytokiner, og antistoffer rettet mod VEGF- eller PD-1- (programmeret celledød-1) receptoren eller dens ligander.
English: Based on non-clinical safety findings, male and female fertility may be compromised by treatment with cabozantinib (see section 5.3).
Danish: Baseret på ikke-kliniske sikkerhedsfund kan mandlig og kvindelig fertilitet blive kompromitteret af behandling med cabozantinib (se pkt.
English: Avoid becoming pregnant while being treated with CABOMETYX.
Danish: Undgå at blive gravid under behandlingen med CABOMETYX.
English: Presence of macroscopic vascular invasion and/ or extra-hepatic tumour spread:78%, Alfa-fetoprotein (AFP) levels ≥400 μg/L: 41%.
Danish: Tilstedeværelse af makroskopisk vaskulær invasion og/eller ekstrahepatisk tumorspredning: 78 %, alfafetoprotein (AFP)-niveauer ≥400 µg/l: 41 %.
English: Tell your doctor if you or your partner become pregnant or plan to become pregnant while you are being treated with CABOMETYX.
Danish: Fortæl det til lægen, hvis du eller din partner bliver gravid eller planlægger at blive gravid, mens du tager CABOMETYX.
English: Patients with treated brain metastases were allowed.
Danish: Patienter med behandlede hjernemetastaser blev inkluderet.
English: Tell your doctor if any of these affect you.
Danish: Fortæl det til din læge, hvis noget af ovenstående gælder for dig.
English: Seventy-one percent (71%) received only one prior VEGFR TKI; 41% of patients received sunitinib as their only prior VEGFR TKI.
Danish: 71 % havde fået kun én tidligere VEGFR TKI; 41 % af patienterne havde fået sunitinib som deres eneste tidligere VEGFR TKI.
English: No specific dose adjustment for the use of cabozantinib in older people (≥ 65 years) is recommended.
Danish: En specifik justering af cabozantinibdosis er ikke nødvendig til ældre mennesker (≥65 år).
English: PFS and ORR findings are summarized in Table 6.
Danish: PFS og ORR-fund er opsummeret i tabel 6.
English: • Low level of a type of white blood cell (lymphocytes)
Danish: • Lavt niveau af en type hvide blodlegemer (lymfocytter)
English: Plasma-concentration time profiles show a second absorption peak approximately 24 hours after administration, which suggests that cabozantinib may undergo enterohepatic recirculation.
Danish: Plasmakoncentration-tid-kurver viser endnu en absorptionstop cirka 24 timer efter administration, hvilket antyder, at cabozantinib kan gennemgå enterohepatisk recirkulation.
English: A negative effect of Cabometyx versus placebo on the EQ-5D utility index score was observed during the first weeks of treatment.
Danish: Der blev observeret en negativ effekt af Cabometyx i forhold til placebo på EQ-5D-brugsindeksresultatet i løbet af de første ugers behandling.
English: Findings in uterus/ovaries and decreased haematopoiesis appeared to be transient, while effects on bone parameters and liver pigmentation were sustained.
Danish: Fund i uterus/ovarier og nedsat hæmatopoiese syntes at være forbigående, mens virkninger på knogleparametre og leverpigmentering var vedvarende.
English: Juvenile rats (correlating to a <2- year paediatric population) showed similar treatment-related findings but appeared to be more sensitive to cabozantinib-related toxicity at comparable dose levels.
Danish: Juvenile rotter (sammenlignelige med en < 2 årig pædiatrisk population) udviste lignende behandlingsrelaterede fund, men syntes at være mere sensitive for cabozantinib-relateret toksicitet ved sammenlignelige dosisniveauer.
English: Cabozantinib has shown no mutagenic or clastogenic potential in a standard battery of genotoxicity assays.
Danish: Cabozantinib har ikke udvist mutagent eller klastogent potentiale i et standardbatteri af genotoksicitetsassays.
English: A less than 10% difference in the AUC was observed between cabozantinib tablet (CABOMETYX) and capsule (COMETRIQ) formulations.
Danish: Der blev observeret en mindre end 10 % forskel i AUC mellem cabozantinibtablet- (CABOMETYX) og kapsel- (COMETRIQ) formuleringerne.
English: It is recommended to monitor biochemical parameters during cabozantinib treatment and to institute appropriate replacement therapy according to standard clinical practice if required.
Danish: Det anbefales at monitorere de biokemiske parametre under cabozantinib-behandling og anvende passende erstatningsterapi i overensstemmelse med klinisk standardpraksis, hvis det er nødvendigt.
English: Mean clearance (CL/F) at steady-state was estimated to be 2.48 L/hr .
Danish: Den gennemsnitlige estimerede clearance (CL/F) ved steady state var 2,48 l/time.
English: Patient distribution by IMDC risk groups was 81% intermediate (1-2 risk factors) and 19% poor (≥3 risk factors).
Danish: Patientfordelingen ifølge IMDC risikogrupperne var 81 % middel risiko (1-2 risikofaktorer) og 19 % høj risiko (≥ 3 risikofaktorer).
English: • Severe or uncontrollable bleeding with symptoms such as: vomiting blood, black stolls, bloody urine, headache, coughing up blood.
Danish: • Alvorlig eller ukontrollerbar blødning med symptomer såsom opkastning af blod, sort afføring, blod i urinen, hovedpine, ophostning af blod.
English: For intermediate risk disease, one or two of the following risk factors were met, while for poor risk, three or more factors were met: time from diagnosis of RCC to systemic treatment < 1 year, Hgb < LLN, Corrected calcium > ULN, KPS < 80%, Neutrophil count > ULN and Platelet count > ULN.
Danish: For middel sygdomsrisiko, blev en eller to af de følgende faktorer mødt, mens der for høj risiko blev mødt tre eller flere faktorer: tid fra diagnose af RCC til systemisk behandling < 1 år, Hgb < LLN, korrigeret calcium > ULN, KPS < 80 %, neutrofiltælling > ULN og trombocyttal > ULN.
English: Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking CABOMETYX.
Danish: Patienterne skal informeres om ikke at spise noget i mindst 2 timer før og 1 time efter at have taget CABOMETYX.
English: Management of suspected adverse drug reactions may require temporary treatment interruption and/or dose reduction of CABOMETYX therapy (see Table 1).
Danish: Håndtering af formodede lægemiddelbivirkninger kan nødvendiggøre midlertidig behandlingsafbrydelse og/eller dosisreduktion af CABOMETYX (se Tabel 1).
English: Therefore, caution should be recommended when driving or operating machines.
Danish: Det anbefales derfor at udvise forsigtighed, når der føres motorkøretøj eller betjenes maskiner.
English: These may be signs of a condition called reversible posterior leukoencephalopathy syndrome (RPLS).
Danish: Disse kan være tegn på en tilstand, der kaldes reversibelt posteriort leukoencefalopatisyndrom (RPLS).
English: If you have taken more CABOMETYX than you have been instructed to, talk to a doctor or go to the hospital with the tablets and this leaflet straight away.
Danish: Hvis du har taget flere CABOMETYX, end du har fået besked på, så kontakt en læge eller tag på hospitalet med det samme.
English: Persistent or recurring diarrhoea while on treatment may be a risk factor for the development of anal fistula.
Danish: Vedvarende eller tilbagevendende diarré under behandlingen kan være en risikofaktor for udvikling af en analfistel.
English: Cases of hepatic encephalopathy in HCC patients can be attributed to the development of electrolyte disturbances.
Danish: Tilfælde af hepatisk encefalopati hos HCC-patienter kan tilskrives udviklingen af elektrolytforstyrrelser.
English: Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
Danish: Det bør overvejes i stedet at vælge et lægemiddel med intet eller minimalt potentiale til at inducere eller hæmme CYP3A4.
English: You should also use a barrier contraceptive (e.g. condom or diaphragm) whilst taking CABOMETYX and for at least 4 months after treatment has finished.
Danish: Du skal også anvende en barrieremetode (f.eks. kondom eller pessar), mens du tager CABOMETYX og i mindst 4 måneder efter, at behandlingen er afsluttet.
English: • Dry mouth and pain in the mouth
Danish: • Mundtørhed og smerter i munden
English: Since only limited data are available for patients with moderate hepatic impairment (Child Pugh B), no dosing recommendation can be provided.
Danish: Da der kun foreligger begrænsede data for patienter med moderat nedsat leverfunktion (Child Pugh B), kan der ikke gives en doseringsanbefaling.
English: Loco-regional transarterial embolisation or chemoinfusion procedures: 44% Radiotherapy prior to cabozantinib treatment: 37% Median duration of sorafenib treatment: 5.32 months
Danish: Lokalregionale transarterielle emboliseringsprocedurer eller infusion af kemoterapi: 44 % Strålebehandling før cabozantinib-behandling: 37 % Median varighed af sorafenib-behandling: 5,32 måneder
English: Events were Grade 4 and 5.
Danish: Tilfældene var af grad 4 og 5.
English: Bioequivalence could not be demonstrated between the cabozantinib capsule and tablet formulations following a single 140 mg dose in healthy subjects.
Danish: Der kunne ikke påvises bioækvivalens mellem cabozantinibkapslen og tabletformuleringerne efter en enkelt dosis på 140 mg hos raske frivillige.
English: A neutralizing antibody to CYP2C9 showed a minimal effect on cabozantinib metabolite formation (ie, a <20% reduction).
Danish: Et neutraliserende antistof mod CYP2C9 viste en minimal indvirkning på dannelsen af cabozantinibmetabolitter (dvs. en <20 % reduktion).
English: The median duration of treatment was 7.6 months (range 0.3 - 20.5) for patients receiving CABOMETYX and 4.4 months (range 0.21 - 18.9) for patients receiving everolimus.
Danish: Den mediane behandlingsvarighed var 7,6 måneder (0,3-20,5) for patienter, der fik CABOMETYX, og 4,4 måneder (0,21-18,9) for patienter, der fik everolimus.
English: The CELESTIAL study excluded patients with concomitant anticoagulation treatment or antiplatelet agents.
Danish: CELESTIAL-studiet ekskluderede patienter med samtidig antikoagulationsbehandling eller trombocythæmmende midler.
English: Because of the potential harm to the infant, mothers should discontinue breast-feeding during treatment with cabozantinib, and for at least 4 months after completing therapy.
Danish: På grund af den potentielle skade for spædbarnet, bør mødre stoppe med at amme under behandling med cabozantinib og i mindst 4 måneder efter afsluttet behandling.
English: A higher relative proportion of patients with moderate hepatic impairment (Child-Pugh B) developed hepatic encephalopathy with cabozantinib treatment.
Danish: En højere relativ andel af patienter med moderat nedsat leverfunktion (Child-Pugh B) udviklede hepatisk encefalopati med cabozantinib-behandling.
English: No case of RPLS was reported in the METEOR or CABOSUN or CELESTIAL studies, but RPLS has been reported rarely in other clinical studies (in 2/4872 subjects; 0.04%).
Danish: Der blev ikke rapporteret tilfælde af RPLS i METEOR-, CABOSUN- eller CELESTIAL-studierne, men RPLS er i sjældne tilfælde blevet rapporteret i andre kliniske studier (hos 2/4872 forsøgspersoner; 0,04 %).
English: Fifty-four percent (54%) of patients had 3 or more organs with metastatic disease, including lung (63%), lymph nodes (62%), liver (29%), and bone (22%).
Danish: 54 % af patienterne havde 3 eller flere organer med metastatisk sygdom, herunder lunger (63 %), lymfekirtler (62 %), lever (29 %) og knogler (22 %).
English: When PPES is severe, interruption of treatment with cabozantinib should be considered.
Danish: Hvis PPES er alvorligt, bør det overvejes at afbryde behandlingen med cabozantinib.
English: Blood pressure should be well-controlled prior to initiating cabozantinib.
Danish: Blodtrykket skal være velkontrolleret før påbegyndelse af cabozantinib.
English: If you forget to take CABOMETYX
Danish: Hvis du har glemt at tage CABOMETYX
English: A 19% increase in the Cmax of the tablet formulation (CABOMETYX) compared to the capsule formulation (COMETRIQ) was observed.
Danish: Der blev observeret en 19 % stigning i Cmax i tabletformuleringen (CABOMETYX) sammenlignet med kapselformuleringen (COMETRIQ).
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE26.
Danish: Farmakoterapeutisk klassifikation: antineoplastisk middel, proteinkinase-hæmmer, ATC-kode: L01XE26.
English: Al. Jana Pawła II 29 Selise 26-11,
Danish: Al. Jana Pawła II 29
English: The primary efficacy endpoint was overall survival (OS).
Danish: Det primære effekt-endpoint var samlet overlevelse (OS).
English: CABOMETYX is a cancer medicine that contains the active substance cabozantinib.
Danish: CABOMETYX er et lægemiddelmod kræft, der indeholder det aktive stof cabozantinib.
English: 40 Boulevard de Champaret 38300 Bourgoin Jallieu, France
Danish: 40 Boulevard de Champaret 38300 Bourgoin Jallieu, Frankrig
English: In HCC patients with compromised livers, these non-hepatic effects may be precipitating factors for the development of hepatic encephalopathy.
Danish: Hos HCC-patienter med nedsat leverfunktion kan disse ikke-hepatiske virkninger være risikofaktorer for udviklingen af hepatisk encefalopati.
English: The baseline demographic and disease characteristics were similar between the CABOMETYX and placebo arms and are shown below for all 707 randomised patients:
Danish: Demografiske og sygdomskarakteristika ved baseline var ens for CABOMETYX- og placebo-armene og er vist nedenfor for alle 707 randomiserede patienter:
English: The decision to resume cabozantinib therapy after surgery should be based on clinical judgment of adequate wound healing.
Danish: Beslutningen om at genoptage behandlingen med cabozantinib efter operation skal baseres på klinisk bedømmelse af tilstrækkelig sårheling.
English: Because oral contraceptives might possibly not be considered as “effective methods of contraception”, they should be used together with another method, such as a barrier method (see section 4.5).
Danish: Da orale kontraceptiva muligvis ikke kan betragtes som ”effektive kontraceptionsmetoder”, bør der samtidig anvendes en anden metode, fx en barrieremetode (se pkt.
English: No cases of hepatic encephalopathy were reported in the RCC studies (METEOR and CABOSUN).
Danish: Der blev ikke rapporteret tilfælde af hepatisk encefalopati i RCC-studierne (METEOR og CABOSUN).
English: PVC/PCTFE blister with push-through aluminum foil backing containing 7 film-coated tablets.
Danish: PVC/PCTFE-blister med aluminiumsfoliebagside indeholdende 7 filmovertrukne tabletter.
English: If adverse reaction does not resolve, permanently discontinue CABOMETYX.
Danish: Hvis bivirkningerne ikke forsvinder, seponeres CABOMETYX permanent.
English: Based on the populationpharmacokinetic (PK) model, the volume of distribution of the central compartment (Vc/F) was estimated to be 212 L. Protein binding was not altered in subjects with mild or moderately impaired renal or hepatic function.
Danish: Baseret på den populationsfarmakokinetiske (PK) model blev fordelingsvoluminet af det centrale rum (Vc/F) estimeret til at være 212 l. Proteinbindingen var ikke ændret hos forsøgspersoner med let til moderat nedsat nyre- eller leverfunktion.
English: If there are still 12 hours or more before your next dose is due, then take the missed dose as soon as you remember.
Danish: Hvis der er 12 timer eller mere til din næste dosis, så tag den glemte dosis lige så snart, du kommer i tanker om det.
English: CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.
Danish: CABOMETYX er indiceret som monoterapi til behandling af hepatocellulært karcinom (HCC) hos voksne, der tidligere er blevet behandlet med sorafenib.
English: Objective Response Rate n (%)3
Danish: Objektiv responsrate n (%)3
English: • Increased or decreased blood glucose level
Danish: • Forhøjet eller nedsat blodsukkerniveau
English: It is recommended to perform liver function tests (ALT, AST and bilirubin) before initiation of cabozantinib treatment and to monitor closely during treatment.
Danish: Det anbefales at udføre leverfunktionstests (ALAT, ASAT og bilirubin) inden initiering af behandling med cabozantinib samt at monitorere tæt under behandlingen.