FrancophonIA/ELRC3.0 huggingface dataset:
English: COMETRIQ is a medicine used to treat medullary thyroid cancer, a rare type of thyroid cancer, that cannot be removed by surgery or that has spread to other parts of the body.
Danish: COMETRIQ er et lægemiddel, der anvendes til behandling af medullær thyroideacancer, en sjælden type thyroideacancer, der ikke kan fjernes ved operation eller som har spredt sig til andre dele af kroppen.
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 fuldførelsen af behandlingen.
English: Non-GI fistula should be ruled out as appropriate in cases of onset of mucositis after start of therapy.
Danish: Ikke-GI fistler bør udelukkes i tilfælde med indtræden af mucositis efter behandlingens start.
English: Blister cards containing either:
Danish: Blisterkort indeholdende enten:
English: The decision to resume cabozantinib therapy after surgery should be based on clinical judgment of adequate wound healing.
Danish: Beslutningen om at genoptage behandling med cabozantinib efter operation bør baseres på klinisk bedømmelse af tilstrækkelig sårheling.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14, stk. 7, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Caution should be used in patients receiving agents associated with ONJ, such as bisphosphonates.
Danish: Der bør udvises forsigtighed hos patienter, der får midler forbundet med ONJ, såsom bisfosfonater.
English: It is important for you to practice good mouth care during treatment with COMETRIQ.
Danish: Der er vigtigt for dig, at du udøver god mundpleje under behandling med COMETRIQ.
English: Cabozantinib is a CYP3A4 substrate.
Danish: Cabozantinib er et CYP3A4-substrat.
English: There is little experience with cabozantinib in non-White patients.
Danish: Der er kun lille erfaring med cabozantinib hos ikke-kaukasiske patienter.
English: There is a possibility your fertility could be affected by treatment with COMETRIQ.
Danish: Der er en mulighed for, at din frugtbarhed kunne blive påvirket af behandlingen med COMETRIQ.
English: Serious GI perforations and fistulas, sometimes fatal, and intra-abdominal abscesses have been observed with cabozantinib.
Danish: Alvorlige GI perforationer og fistler, af og til med dødelig udgang, og intra-abdominale abscesser er blevet observeret med cabozantinib.
English: Figure 1: Kaplan Meier curve of progression free survival
Danish: Figur 1: Kaplan Meier kurve for progressionfri overlevelse
English: Tumor tissue samples initially will undergo histological evaluation, manual tumor enrichment, and DNA isolation.
Danish: Vævsprøver fra tumor vil indledningsvis gennemgå histologisk evaluering, manuel tumor opformering og DNA-isolation.
English: RPLS is uncommon (it affects less than 1 in 100 people).
Danish: RPLS er ikke almindelig (påvirker færre end 1 ud af 100 mennesker).
English: Each 28 day pack contains enough medicine for 28 days.
Danish: Hver 28-dages pakning indeholder medicin nok til 28 dage.
English: • Hypotension (decrease in blood pressure)
Danish: • Hypotension (fald i blodtryk)
English: Of the 215 subjects with sufficient data to determine mutational status, 78.6% (n=169) were classified as RET mutation positive (126 of which were positive for the M918T mutation), and 21.4% (n=46) were classified as RET mutation negative.
Danish: Af de 215 forsøgspersoner med tilstrækkelige data til bestemmelse af mutationsstatus blev 78,6 % (n=169) klassificeret som RET-mutationspositive (hvoraf 126 var positive for M918T-mutationen), og 21,4 % (n=46) blev klassificeret som RET-mutationsnegative.
English: The median duration of objective responses was 14.6 months (95% CI: 11.1, 17.5) for subjects in the cabozantinib arm.
Danish: Median varigheden af objektivt respons var 14,6 måneder (95 % CI: 11,1-17,5) for forsøgspersoner i cabozantinib-armen.
English: In vitro data demonstrate that cabozantinib is a substrate of MRP2.
Danish: In vitro data viser, at cabozantinib er substrat for MRP2.
English: COMETRIQ may slow or stop the growth of medullary thyroid cancer.
Danish: COMETRIQ kan sinke eller stoppe væksten af medullær thyroideacancer.
English: A neutralizing antibody to CYP2C9 showed a minimal effect on cabozantinib metabolite formation (ie, a <20% reduction).
Danish: Et neutraliserende antistof over for CYP2C9 viste en minimal effekt på dannelse af cabozantinib metabolit (dvs. en <20 % reduktion).
English: A thyroid stimulating hormone (TSH) value above normal after first dose was observed in 57% of patients on cabozantinib versus 19% of patients on placebo (regardless of baseline values).
Danish: En værdi for thyroideastimulerende hormon (TSH) over normalen efter den første dosis blev observeret hos 57 % af patienterne på cabozantinib versus 19 % af patienterne på placebo (uanset baseline værdier).
English: When PPES is severe, interruption of treatment with cabozantinib should be considered.
Danish: Når PPES er alvorlig, bør seponering af behandling med cabozantinib overvejes.
English: Adverse reactions such as fatigue and weakness have been associated with cabozantinib.
Danish: Bivirkninger såsom træthed og svaghed er blevet forbundet med cabozantinib.
English: These may be signs of a condition called reversible posterior leukoencephalopathy syndrome (RPLS).
Danish: Disse kan være tegn på en tilstand, der kaldes reversibel posterior leukoencefalopati syndrom (RPLS).
English: Your capsules are also available as a 28 day pack, which contains enough capsules to last for 28 days, in 4 blister cards with seven days of capsules on each card.
Danish: Dine kapsler findes også som en 28-dages pakning, der indeholder kapsler nok til at vare 28 dage, i 4 blisterkort med kapsler til 7 dage på hvert kort.
English: Tell your doctor if you or your partner become pregnant or plan to become pregnant while you are being treated with COMETRIQ.
Danish: Fortæl det til lægen, hvis du eller din partner er gravid eller planlægger at blive gravid, mens du tager COMETRIQ.
English: Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
Danish: Valg af et alternativt samtidigt administreret lægemiddel uden eller med minimalt potentiale til at inducere eller hæmme CYP3A4 bør overvejes.
English: Overall Response Ratea (95% CI)
Danish: Samlet responsratea (95 % CI)
English: • A tear or abnormal connection of the tissue in your digestive system; symptoms can include severe or persistent stomach ache
Danish: • En rift i eller abnorm forbindelse af væv i dit fordøjelsessystem; symptomer kan omfatte kraftig eller vedblivende mavepine
English: Before initiating cabozantinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med cabozantinib bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE26.
Danish: Farmakoterapeutisk klassifikation: antineoplastisk middel, proteinkinase-hæmmer, ATC-kode: L01XE26
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 eksponering, der var anelse højere end den tilsigtede terapeutiske eksponering hos mennesker.
English: Reversible Posterior Leukoencephalopathy Syndrome (RPLS), also known as Posterior Reversible Encephalopathy Syndrome (PRES) has been observed with cabozantinib.
Danish: Reversible Posterior Leukoencephalopathy Syndrome (RPLS), også kendt som Posterior Reversible Encephalopathy Syndrome (PRES) er blevet observeret med cabozantinib.
English: Cabozantinib was evaluated for its inhibitory activity against a variety of kinases and was identified as an inhibitor of MET (hepatocyte growth factor receptor protein) and VEGF (vascular endothelial growth factor) receptors.
Danish: Cabozantinib blev evalueret for dets hæmmende aktivitet mod en række kinaser og blev identificeret som en hæmmer af MET (hepatocyt vækstfaktor receptorprotein) og VEGF (vaskulær endothelial vækstfaktor) receptorer.
English: A dose-comparison study (XL-184-401) (140 mg vs 60 mg) in 112 patients with hereditary or sporadic medullary thyroid cancer.
Danish: Et dosissammenlignende studie (XL-184-401) (140 mg vs 60 mg) hos 112 patienter med nedarvet eller sporadisk medullær thyroideacancer.
English: Fertility studies in rats have shown reduced male and female fertility.
Danish: Fertilitetsstudier hos rotter har vist reduceret fertilitet hos hanner og hunner.
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 analyser til bestemmelse af genotoksicitet.
English: Efficacy with cabozantinib was observed in medullary thyroid cancer patients with wild-type or mutant RET.
Danish: Virkning med cabozantinib blev observeret hos patienter med medullær thyroideacancer med vildttype eller mutant RET.
English: Dose reductions and dose interruptions occurred in 79% and 72%, respectively, of cabozantinib-treated patients in the pivotal clinical trial.
Danish: Reduktioner af dosis og seponering forekom hos henholdsvis 79 % og 72 % af patienter behandlet med cabozantinib i det pivotale kliniske studie.
English: • Abscess (collection of pus, with swelling and inflammation) in the abdomen or pelvis area or in your teeth/gums
Danish: • Absces (ansamling af pus, med hævelse og inflammation) i abdomen eller underlivsområdet eller i dine tænder/gummer
English: Bile salt-sequestering agents such as cholestyramine and cholestagel may interact with cabozantinib and may impact absorption (or reabsorption) resulting in potentially decreased exposure (see section 5.2).
Danish: Galdesyrebindende midler såsom colestyramin og colesevelam kan interagere med cabozantinib og kan påvirke absorptionen (eller reabsorptionen) resulterende i potentielt nedsat eksponering (se pkt.
English: Median Overall Survival
Danish: Median for samlet overlevelse
English: The European Medicines Agency has deferred the obligation to submit the results of studies with cabozantinib in one or more subsets of the paediatric population in the treatment of malignant solid tumours (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udskudt forpligtelsen at indsende resultaterne af studier med cabozantinib i en eller flere undergrupper af den pædiatriske population ved behandlingen af maligne, faste tumorer (se pkt.
English: • Impaired hearing
Danish: • Nedsat hørelse
English: Following oral administration of cabozantinib, peak cabozantinib plasma concentrations are reached at 2 to 5 hours post-dose.
Danish: Efter oral administration af cabozantinib opnås cabozantinib-peak-plasmakoncentrationer 2 til 5 timer efter dosering.
English: Cabozantinib (S)-malate
Danish: Cabozantinib (S)-malat
English: In addition, cabozantinib inhibits other tyrosine kinases including RET, the GAS6 receptor (AXL), the stem cell factor receptor (KIT), and Fms-like tyrosine kinase-3 (FLT3).
Danish: Derudover hæmmer cabozantinib andre tyrosinkinaser inklusive RET, GAS6receptoren (AXL), stamcellefaktor receptoren (KIT) og Fms-lignende tyrosinkinase-3 (FLT3).
English: • Pain in the arms, hands, legs or feet
Danish: • Smerter i armene, hænderne, benene eller fødderne
English: All three subgroups showed increased PFS in the cabozantinib arm compared to the placebo arm (HRs of 0.23, 0.53, and 0.30 for RET mutation positive, negative, and unknown subgroups, respectively).
Danish: Alle tre undergrupper viste øget PFS i cabozantinib-armen sammenlignet med placebo-armen (HR'er på henholdsvis 0,23, 0,53, og 0,30 for RET-mutationspositive, -negative og ukendte undergrupper).
English: Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking COMETRIQ.
Danish: Patienterne bør instrueres i ikke at spise noget i mindst 2 timer før og til og med 1 time efter at have taget COMETRIQ.
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 et substrat for CYP3A4-metabolisme in vitro, som et neutraliserende antistof til CYP3A4-hæmmet dannelse af metabolit XL184 N-oxid med >80 % i en NADPH-katalyseret human lever mikrosomal (HLM) inkubation; som en kontrast havde neutraliserende antistoffer over for CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 og CYP2E1 ingen effekt på dannelse af cabozantinib metabolit.
English: 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 cancer patients.
Danish: En øgning fra 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 qd) blev observeret i et kontrolleret klinisk studie med cancerpatienter.
English: When using cabozantinib, periodic monitoring with on-treatment ECGs and electrolytes (serum calcium, potassium, and magnesium) should be considered.
Danish: Ved brug af cabozantinib bør man overveje periodisk monitorering med EKG'er under behandlingen og elektrolytter (serum calcium, kalium og magnesium).
English: Close monitoring of patients is therefore recommended during the first eight weeks of therapy (see section 4.2).
Danish: Tæt monitorering af patienterne anbefales derfor under de første 8 ugers behandling (se pkt.
English: Urine protein should be monitored regularly during cabozantinib treatment.
Danish: Protein i urinen bør monitoreres regelmæssigt under behandling med cabozantinib.
English: • Protein or blood in the urine, gallstones, painful urination
Danish: • Protein eller blod i urinen, galdesten, smertefuld vandladning
English: Patients who have evidence of involvement of the trachea or bronchi by tumour or a history of haemoptysis prior to treatment initiation should be carefully evaluated before initiating cabozantinib therapy.
Danish: Patienter, der har bevis for involvering af trachea eller bronkierne af tumor eller en anamnese med hæmoptyse forud for indledning af behandlingen, bør evalueres omhyggeligt inden indledning af behandling med cabozantinib.
English: Monitor for adverse events and adjust dose or use dosing interruption as needed (see section 4.2).
Danish: Monitorér for bivirkninger og justér dosis eller anvend dosisafbrydelse efter behov (se pkt.
English: A multi-center, randomized double-blind study comparing cabozantinib (N = 219) with placebo (N = 111) was conducted in patients with unresectable locally advanced or metastatic MTC and documented radiographic disease progression within 14 months prior to study entry.
Danish: Et multi-center, randomiseret dobbelt-blindet studie sammenlignende cabozantinib (N = 219) med placebo (N = 111) blev gennemført hos patienter med inoperable, lokalt fremskreden eller metastatisk MTC og dokumenteret radiografisk sygdomsprogression inden for 14 måneder forud for indtræden i studie.
English: The ORR was 27.9% and 0% for subjects in the cabozantinib arm and placebo arm, respectively (p<0.0001; Table 2).
Danish: ORR var henholdsvis 27,9 % og 0 % for forsøgspersoner i cabozantinib-armen og placebo-armen (p<0,0001; Tabel 2).
English: • Weakness or reduced sensation or tingling in the limbs
Danish: • Svaghed eller nedsat følelse eller prikken i lemmerne
English: In the case of persistent hypertension despite use of anti-hypertensives, the cabozantinib dose should be reduced.
Danish: I tilfælde af vedvarende hypertension på trods af anti-hypertensiver, bør dosis af cabozantinib reduceres.
English: Avoid becoming pregnant while being treated with COMETRIQ.
Danish: Undgå at blive gravid under behandlingen med COMETRIQ.
English: RET mutation negative patients with no evidence of RAS mutation (n=33) showed a decreased PFS benefit on cabozantinib (HR of 0.87) and a lower response rate of 18% compared to other mutational subgroups.
Danish: RET-mutation negative patienter uden bevis for RAS mutation (n=33) udviste en nedsat PFS-fordel på cabozantinib (HR på 0,87) og en lavere responsrate på 18 % sammenlignet med andre mutationsundergrupper.
English: • Lightening of skin, flakey skin, unusual pale skin
Danish: • Lysnen af huden, hud i flager, usædvanlig bleg hud
English: Store in the original package in order to protect from moisture.
Danish: Opbevares i den originale emballage til beskyttelse mod fugt.
English: Repeat daily dosing of cabozantinib at 140 mg for 19 days resulted in an approximately a 4- to 5-fold mean cabozantinib accumulation (based on AUC) compared to a single dose administration; steady state is achieved by approximately Day 15.
Danish: Gentagen daglig dosering af cabozantinib på 140 mg i 19 dage resulterede i circa en 4- til 5-dobbelt middel cabozantinib akkumulation (baseret på AUC) sammenlignet med administration af en enkelt dosis; steady state opnås på cirka dag 15.
English: • A condition called posterior reversible encephalopathy syndrome (PRES) or reversible posterior leukoencephalopathy syndrome (RPLS), which has symptoms such as seizures, headaches,
Danish: • En tilstand, der kaldes posterior reversibel encefalopati syndrom (PRES) eller reversibel posterior leukoencefalopati syndrom (RPLS), der har symptomer såsom krampeanfald,
English: Cabozantinib should be used with caution in patients with a history of QT interval prolongation, patients who are taking antiarrhythmics, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances.
Danish: Cabozantinib bør anvendes med forsigtighed til patienter med en anamnese for forlængelse af QTinterval, patienter, der tager anti-arytmetika, eller patienter med præ-eksisterende hjertelidelse, bradykardi eller elektrolytforstyrrelser.
English: An oral examination should be performed prior to initiation of cabozantinib and periodically during cabozantinib therapy.
Danish: En oral undersøgelse børe foretages forud for start med cabozantinib og periodisk under behandlingen med cabozantinib.
English: Table 1: Adverse reactions reported with cabozantinib
Danish: Tabel 1: Bivirkninger rapporteret med cabozantinib
English: • Wounds that have difficulties healing
Danish: • Sår, der har svært ved at hele op
English: • Blood clots in the arteries
Danish: • Blodpropper i arterierne
English: Cabozantinib should be discontinued in patients who develop an acute myocardial infarction or any other clinically significant arterial thromboembolic complication.
Danish: Cabozantinib bør seponeres hos patienter, som udvikler et akut myokardieinfarkt eller nogen anden klinisk signifikant arteriel thromboembolisk komplikation.
English: Psychiatric disorders anxiety, depression, confusional state abnormal dreams, delirium
Danish: Psykiske forstyrrelser angst, depression, konfus tilstand abnorme drømme, delirium
English: Cabozantinib should be discontinued if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of cabozantinib.
Danish: Cabozantinib bør seponeres, hvis hypertension er svær og vedvarende på trods af anti-hypertensiv terapi og dosisreduktion af cabozantinib.
English: Patients should therefore be closely monitored during the first eight weeks of therapy (see section 4.4).
Danish: Patienterne bør derfor overvåges nøje under de første otte ugers behandling (se pkt.
English: 4.0 months
Danish: 4,0 måneder
English: Cardiac disorders atrial fibrillation angina pectoris, supraventricular tachycardia myocardial infarction
Danish: Hjerte atrieflimmer angina pectoris, supraventrikulær takykardi myokardieinfarkt
English: 20 mg and 80 mg
Danish: 20 mg og 80 mg
English: Cabozantinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumour growth and angiogenesis, pathologic bone remodeling, and metastatic progression of cancer.
Danish: Cabozantinib er et lille molekyle, der hæmmer multiple receptortyrosinkinaser (RTK'er) impliceret i tumorvækst og angiogenese, patologisk knogle genmodellering og metastatisk progression af cancer.
English: Each blister card contains enough medicine for 7 days.
Danish: Hvert blisterkort indeholder tilstrækkelig medicin til 7 dage.
English: Concomitant medicinal products
Danish: Samtidige administreret lægemidler
English: Also, some medicines can affect the way COMETRIQ works.
Danish: Ligeledes kan visse andre lægemidler påvirke den måde, som COMETRIQ fungerer.
English: Clinical data in medullary thyroid cancer
Danish: Kliniske data i medullær thyroideacancer
English: 4.5 Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Virkningen af andre lægemidler på cabozantinib
English: In rabbits, cabozantinib produced foetal soft tissue changes (reduced spleen size, small or missing intermediate lung lobe) and increased foetal incidence of total malformations.
Danish: Hos kaniner producerede cabozantinib ændringer i føtalt bløddelsvæv (reduceret størrelse på milten, lille eller manglende intermediær lunge-del) og øget føtal incidens af totale misdannelser.
English: Cabozantinib should be discontinued in patients who experience a GI perforation or a GI or non-GI fistula.
Danish: Cabozantinib bør seponeres hos patienter, der oplever en GI perforation eller en GI eller ikke-GI fistel.
English: Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction of COMETRIQ therapy.
Danish: Kontrol af formodede lægemiddelbivirkninger kan betyde midlertidig seponering og/eller dosisreduktion ved behandlingen med COMETRIQ.
English: What COMETRIQ contains
Danish: COMETRIQ indeholder
English: If you forget to take COMETRIQ
Danish: Hvis du har glemt at tage COMETRIQ
English: Uncommon (1/1,000 to
Danish: Ikke almindelig (≥1/1.000 til
English: Cabozantinib treatment should be stopped at least 28 days prior to scheduled surgery, if possible.
Danish: Behandling med cabozantinib bør om muligt stoppes mindst 28 dage forud for planlagt operation.
English: In the event of suspected overdose, cabozantinib should be withheld and supportive care instituted.
Danish: I tilfælde af mistanke om overdosering bør cabozantinib seponeres og understøttende behandling skal indledes.
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential must be advised to avoid pregnancy while on cabozantinib.
Danish: Kvinder i den fertile alder/antikonception hos mænd og kvinder Kvinder i den fertile alder skal tilrådes at undgå graviditet, mens de får cabozantinib.
English: Thromboembolic events
Danish: Thromboemboliske bivirkninger
English: Therefore, cabozantinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp.
Danish: Cabozantinib kan derfor have potentialet til at øge plasmakoncentrationerne af co-administrerede substrater af P-gp.