FrancophonIA/ELRC3.0 huggingface dataset:
English: No specific dose adjustment for the use of cabozantinib in older people (≥ 65 years) is recommended.
Danish: Der anbefales ikke nogen specifik dosisjustering ved brugen af cabozantinib til ældre mennesker (≥ 65 år).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering præsenteres bivirkningerne i rækkefølge af faldende alvorlighed.
English: If you experience serious side effects, your doctor may decide to change your dose or stop treatment earlier than originally planned.
Danish: Hvis du oplever alvorlige bivirkninger, kan din læge beslutte at ændre din dosis eller stoppe behandlingen tidligere end oprindelig planlagt.
English: Based on the populationpharmacokinetic (PK) model, the volume of distribution (V/F) is approximately 349 L (SE: ± 2.73%).
Danish: Baseret på den populationsfarmakokinetiske (PK) model, er fordelingsvolumen (V/F) cirka 349 liter (SE: ± 2,73 %).
English: It is not known whether cabozantinib and/or its metabolites are excreted in human milk.
Danish: Det vides ikke, om cabozantinib og/eller dets metaboliter udskilles i humant mælk.
English: Median Progression-Free Survival
Danish: Median for progressionsfri overlevelse
English: Therefore, caution should be recommended when driving or operating machines.
Danish: Der bør derfor anbefales forsigtighed, når der køres eller betjenes maskiner.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch
English: This effect was not associated with a change in cardiac wave form morphology or new rhythms.
Danish: Denne effekt var ikke forbundet med en ændring i morfologien i hjertekurveformen eller nye rytmer.
English: Take all capsules in one row each day without food (patients should fast for at least 2 hours before through 1 hour after taking the capsules).
Danish: Tag alle kapsler i én række hver dag uden mad (patienten bør faste mindst 2 timer inden til og med 1 time efter at have taget kapslen).
English: All patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy.
Danish: Alle patienter bør monitoreres for hypertension og om nødvendigt behandles med standard anti-hypertensiv terapi.
English: Talk to your doctor about which methods of contraception are appropriate while you are taking COMETRIQ.
Danish: Tal med din læge om, hvilke antikonceptionsmetoder er passende, mens du tager COMETRIQ.
English: You should also tell your dentist that you are taking COMETRIQ.
Danish: Du bør også fortælle din tandlæge, at du tager COMETRIQ.
English: Patients with both sporadic and hereditary forms of MTC will be eligible for the study.
Danish: Patienter med både sporadiske og nedarvede former for MTC vil være egnede til studie.
English: As most events can occur early in the course of treatment, the physician should evaluate the patient closely during the first eight weeks of treatment to determine if dose modifications are warranted.
Danish: Da de fleste bivirkninger kan forekomme tidligt i behandlingsforløbet, bør lægen nøje evaluere behandlingen af patienten i de første 8 uger af behandlingen for at afgøre, om dosismodifikationer er nødvendige.
English: Adverse reactions associated with overdose are to be treated symptomatically.
Danish: Bivirkninger forbundet med overdosering skal behandles symptomatisk.
English: PVC/PE/PCTFE-Al blisters with foil backing, sealed into a secondary heat-sealed card packaging.
Danish: PVC/PE/PCTFE-Al blisterpakninger med folie bagside, forseglet på en sekundær, varmeforseglet kortpakning.
English: Use caution when driving or using machines.
Danish: Udvis forsigtighed under kørsel eller ved brug af maskiner.
English: This is because COMETRIQ can affect the way some other medicines work.
Danish: Dette er fordi, at COMETRIQ kan påvirke den måde, visse andre lægemidler fungerer.
English: There is no specific treatment for cabozantinib overdose and possible symptoms of overdose have not been established.
Danish: Der er ingen specific behandling for overdosering med cabozantinib og mulige symptomer på overdosering er ikke blevet fastslået.
English: COMETRIQ is not recommended for children or adolescents.
Danish: COMETRIQ anbefales ikke til børn eller unge.
English: • Swelling in the face and in other parts of the body
Danish: • Hævelse i ansigtet og i andre dele af kroppen
English: The safety and efficacy of cabozantinib in children aged <18 years have not yet been established.
Danish: Sikkerheden og virkningen ved cabozantinib hos børn i alderen < 18 år er endnu ikke blevet fastslået.
English: These patients (n=16) showed significant prolongation of PFS (HR of 0.15) and an objective response rate of 31%.
Danish: Disse patienter (n=16) udviste signifikant forlængelse af PFS (HR på 0,15) og en objektiv responsrate på 31 %.
English: Samples will undergo thorough evaluation for RET and RAS mutations.
Danish: Prøverne vil gennemgå grundig evaluering for RET- og RAS-mutationer.
English: Cabozantinib is highly protein bound in vitro in human plasma (≥ 99.7%).
Danish: Cabozantinib er yderst proteinbundet in vitro i humant plasma (≥ 99,7 %).
English: No specific dosing recommendations can be made.
Danish: Der kan ikke gives specifikke anbefalinger for dosering.
English: • Loss of coordination in your muscles, damage to skeletal muscles
Danish: • Tab af koordination i dine muskler, skade på skeletmuskulatur
English: The carcinogenic potential of cabozantinib has been evaluated in two species: rasH2 transgenic mice and Sprague-Dawley rats.
Danish: Cabozantinibs karcinogene potentiale er blevet evalueret hos to arter: rasH2-transgene mus og Sprague-Dawley-rotter.
English: Pharmacokinetics in special patient populations
Danish: Farmakokinetik i specielle patientpopulationer
English: No cabozantinib-treated subjects had a QTcF >500 ms.
Danish: Ingen cabozantinib-behandlede patienter havde en QTcF >500 ms.
English: Female partners of male patients taking cabozantinib must also avoid pregnancy.
Danish: Kvindelige partnere til mandlige patienter, der tager cabozantinib, skal også undgå graviditet.
English: Further genetic analysis showed that a small proportion of patients harboured somatic tumour mutations in HRAS, KRAS, or NRAS.
Danish: Yderligere genetisk analyse viste, at en lille del af patienterne husede somatiske tumormutationer i HRAS, KRAS eller NRAS.
English: If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose.
Danish: Hvis patienten glemmer at tage en dosis, bør den manglende dosis ikke tages, hvis der er mindre end 12 timer til den næste dosis.
English: Push capsule through foil
Danish: Tryk kapslen gennem folien
English: A replacement sample will be requested if an original sample fails during the PCR quality or the Sanger sequencing tests.
Danish: Der vil blive anmodet om en erstatningsprøve, hvis en oprindelig prøve mislykkes under PCR kvalitetseller Sanger sekvenseringstest.
English: Results will be used to evaluate the exposure to cabozantinib at the 60 and 140 mg dose levels and to further characterize the population PK models and exposure response relationships of cabozantinib and possible metabolites in this population.
Danish: Resultaterne vil blive anvendt til at evaluere eksponeringen over for cabozantinib ved 60 og 140 mg dosisniveauerne og til yderligere at karakterisere population PK-modellerne og eksponeringsrespons forhold for cabozantinib og mulige metabolitter i denne population.
English: Duration of Response; Median (95% CI)
Danish: Varighed af respons; median (95 % CI)
English: Studies in animals have shown embryo-foetal and teratogenic effects (see section 5.3).
Danish: Studier af dyr har vist embryo-føtale og teratogene virkninger (se pkt.
English: The occurrence of some serious adverse reactions (like GI fistula) might be dependent on the cumulative dose and might present in a later stage of treatment.
Danish: Forekomsten af visse alvorlige bivirkninger (såsom GI-fistel) kan være afhængige af den kumulative dosis og kan fremkomme på et senere trin i behandlingen.
English: Perforations, fistulas, and intra-abdominal abscesses
Danish: Perforationer, fistler og intra-abdominale abscesser
English: If you or your partner could become pregnant, use adequate contraception during treatment and for at least 4 months after treatment has finished.
Danish: Hvis du eller din partner kan blive gravid, så anvend passende antikonception under behandlingen og mindst 4 måneder efter at behandlingen er afsluttet.
English: Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Danish: Behandlingen bør fortsættes, indtil patienten ikke længere har klinisk fordel af behandlingen, eller indtil der forekommer uacceptabel toksicitet.
English: Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities.
Danish: Seponeringer af dosering anbefales til kontrol af CTCAE grad 3 eller højere toksiciteter eller uudholdelige grad 2 toksiciteter.
English: This could mean that your doctor needs to change the dose(s) that you take.
Danish: Dette kunne betyde, at din læge er nødt til at ændre den dosis, du tager.
English: Table 2: Summary of key efficacy findings
Danish: Tabel 2: Resumé af nøgle virkningsfund
English: CEA Responsea
Danish: CEA responsa
English: You may need treatment for them, or your doctor may decide to change your dose of COMETRIQ, or stop treatment altogether.
Danish: Du har måske behov for behandling for dem, eller din læge kan beslutte at ændre din dosis af COMETRIQ eller helt stoppe behandlingen.
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 oral antikonception muligvis ikke kan betragtes som ”effektive metoder for antikonception”, bør de anvendes sammen med en anden metode, såsom en barrieremetode (se pkt.
English: Common (1/100 to <1/10)
Danish: Almindelig (≥1/100 til <1/10)
English: RET mutation status
Danish: RET-mutationsstatus
English: Effect of cabozantinib on other medicinal products
Danish: Virkning af cabozantinib på andre lægemidler
English: For patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in sections 4.4 and 5.1).
Danish: For patienter, hos hvem Rearranged during Transfection (RET) mutationsstatus ikke er kendt eller negativ, bør en mulig nedsat virkning af behandlingen tages i betragtning, inden der tages beslutning om individuel behandling (se vigtige oplysninger i pkt.
English: • Vomiting or coughing up blood, which may be bright red or look like coffee grounds.
Danish: • Opkastning eller hosten blod op, hvilket kan være klart rødt eller ligne kaffegrums.
English: • Abnormal hair growth
Danish: • Abnorm hårvækst
English: If your next dose is due in less than 12 hours then do not take the dose that you have missed.
Danish: Hvis din næste dosis skal tages inden mindre end 12 timer, så lad være at tage den dosis, som du har glemt.
English: If you have taken more COMETRIQ than you have been instructed to, talk to a doctor or go to the hospital with the capsules and this leaflet straight away.
Danish: Hvis du har taget flere COMETRIQ, end du har fået besked på, så kontakt en læge eller tag på hospitalet med kapslerne og denne indlægsseddel med det samme.
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 stadig er 12 timer eller mere inden din næste dosis, så tag den glemte dosis lige så snart, du husker det.
English: • Changes in blood tests used to monitor general health and the liver, low levels of electrolytes (like magnesium, calcium or potassium)
Danish: • Ændringer i blodtest, der bruges til at overvåge den almene helbredstilstand og leveren, lave niveauer af elektrolytter (som magnesium, calcium eller kalium)
English: No data are available to determine a difference in PK based on race.
Danish: Ingen data er tilgængelige for at kunne bestemme en forskel i farmakokinetikken baseret på race.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Ipsen Pharma
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Ipsen Pharma
English: More information on the blister cards including how many capsules you will take and how many capsules there are in total in each blister card are described below in section 6.
Danish: Flere oplysninger på blisterkortene omfatter, hvor mange kapsler du skal tage og hvor mange kapsler ialt, der er i hvert blisterkort, er beskrevet nedenfor under pkt.
English: Frequencies are based on all grades and defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not known (cannot be estimated from the available data).
Danish: Hyppigheder er baseret på alle grader og defineret som: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100) , ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • Changes in test results that measure blood clotting or blood cells
Danish: • Ændringer i testresultater, der måler blodkoagulation eller blodlegemer
English: Talk to your doctor BEFORE taking COMETRIQ if you or your partner are considering or planning to have a baby after your treatment has finished.
Danish: Tal med din læge INDEN du tager COMETRIQ hvis du eller din partner overvejer eller planlægger at få en baby efter at din behandling er afsluttet.
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 en perforation af mave-tarm-kanalen, et hul, der udvikler sig i din mave eller tarm, som kunne være livstruende.
English: Cabozantinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with cabozantinib.
Danish: Cabozantinib bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver behandling med cabozantinib.
English: • Increase in the level of bilirubin in your blood (which may result in jaundice/yellow skin or eyes)
Danish: • Øgning i niveauet af bilirubin i dit blod (hvilket kan resultere i gulsot/gulfarvning af hud og øjne)
English: Talk to your doctor or pharmacist before taking COMETRIQ if you:
Danish: Kontakt lægen eller apotekspersonalet, før du tager COMETRIQ, hvis du:
English: P-glycoprotein substrates
Danish: P-glykoprotein-substrater
English: Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least 4 months after completing therapy.
Danish: Effektive antikonceptionsmetoder bør anvendes af mandlige og kvindelige patienter og deres partnere under behandlingen og i mindst 4 måneder efter fuldførelsen af behandlingen.
English: The primary objective was to compare progression-free survival (PFS) in patients receiving cabozantinib versus patients receiving placebo.
Danish: Et primært mål var at sammenligne progressions-fri overlevelse (PFS) hos patienter, der fik cabozantinib versus patienter, der fik placebo.
English: The resulting DNA samples will be evaluated for quality by a PCR-based amplification test, and by Sanger sequencing for RET M918T.
Danish: De resulterende DNA-prøver vil blive evalueret for kvalitet ved en PCR-baseret forstærkningstest og ved Sanger-sekvensering for RET-M918T.
English: • Anxiety, depression, confusion
Danish: • Angst, depression, konfusion
English: The effect of cabozantinib on the pharmacokinetics of contraceptive steroids has not been investigated.
Danish: Virkningen af cabozantinib på farmakokinetikken for antikonceptionssteroider er ikke blevet undersøgt.
English: Figure 3: Kaplan-Meier Analysis of OS Among Subjects with a RET M918T Mutation
Danish: Figur 3: Kaplan-Meier analyse af OS blandt forsøgspersoner med en RET-M918T-mutation
English: The capsule contains an off-white to white powder.
Danish: Kapslen indeholder et elfenbenshvidt til hvidt pulver.
English: There are no studies in pregnant women using cabozantinib.
Danish: Der findes ingen studier med gravide kvinder, der bruger cabozantinib.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Refer to individual blister cards for dispensing instructions.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Der henvises til de individuelle blisterkort for dispenseringsinstruktioner.
English: Cabozantinib has a 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: Cabozantinib should be restarted with a lower dose when PPES has been resolved to grade 1.
Danish: Cabonazinib bør genstartes med en lavere dosis, når PPES er reduceret til grad 1.
English: • Hypertension (increase in blood pressure)
Danish: • Hypertension (øgning i blodtryk)
English: Each blister card has enough capsules to last for seven days (one week).
Danish: Hvert blisterkort har nok kapsler til til at vare syv dage (én uge).
English: Probability
Danish: Sandsynlighed
English: Do not take COMETRIQ - if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke COMETRIQ • hvis du er allergisk over for cabozantinib eller et af de øvrige indholdsstoffer (angivet i pkt.
English: If you get side effects, your doctor may tell you to take COMETRIQ at a lower dose.
Danish: Hvis du får bivirkninger, vil din læge måske bede dig om at tage COMETRIQ i en lavere dosis.
English: Women taking COMETRIQ 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 COMETRIQ, bør ikke amme under behandlingen og i mindst 4 måneder efter, at behandlingen er afsluttet, da cabozantinib og/eller dets metaboliter kan udskilles i brystmælk og være skadeligt for dit barn.
English: • 60 mg (3 grey 20 mg capsules) Your doctor will decide on the right dose for you.
Danish: • 60 mg (3 grå 20 mg kapsler) Din læge vil afgøre, hvad der er den rette dosis for dig.
English: Your capsules will come in a blister card organised by prescribed dose.
Danish: Dine kapsler vil komme i et blisterkort organiseret efter den ordinerede dosis.
English: There is limited data in patients with cardiac impairment.
Danish: Der er begrænsede data for patienter med nedsat hjertefunktion.
English: Disease Control Rate b (95% CI) Calcitonin Responsea
Danish: Sygdoms kontrolrate b (95 % CI) Calcitonin responsa
English: Plasma-concentration time profiles show a second absorption peak approximately 24 hours after administration, which suggests that cabozantinib may undergo enterohepatic recirculation.
Danish: Plasmakoncentrations-tids-profiler viser endnu en absorptionstop cirka 24 timer efter administration, hvilket antyder, at cabozantinib kan gennemgå enterohepatisk recirkulation.
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: • Atrial fibrillation (a fast and erratic heartbeat)
Danish: • Atrieflimmer (hurtige og uregelmæssige hjerteslag)
English: • Fungal infection that can be in the skin, mouth, or genitals
Danish: • Svampeinfektioner, der kan være i huden, munden eller kønsorganerne
English: Ninety-two percent of patients on the cabozantinib arm had a prior thyroidectomy, and 89% were taking thyroid hormones prior to first dose.
Danish: Tooghalvfems procent af patienterne i cabozantinib armen havde en forudgående thyroidektomi, og 89 % tog thyroideahormoner forud for den første dosis.
English: COMETRIQ capsules are packaged in blister cards organised by prescribed dose.
Danish: COMETRIQ kapsler er pakket på blisterkort organiseret efter den ordinerede dosis.
English: Do not use this medicine after the expiry date which is stated on the blister card after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • Hair colour changes (lightening), hair loss
Danish: • Ændringer i hårfarve (lysner), hårtab
English: The plasma terminal half-life of cabozantinib in single dose studies in healthy volunteers is approximately 120 hours.
Danish: Plasma terminal halveringstid for cabozantinib i studier med enkeltdosis hos raske frivillige er cirka 120 timer.
English: Wingates Industrial Park Westhoughton
Danish: Wingate Industrial Park Westhoughton
English: In addition, samples will be evaluated for mutations in RAS gene hotspots (HRAS, KRAS, and NRAS genes).
Danish: Derudover vil prøver blive evalueret for mutationer i RAS-gen hotspots (HRAS-, KRAS- og NRAS-gener).
English: • Loss of attention, loss of consciousness, changes in speech, delirium, abnormal dreams
Danish: • Tab af opmærksomhed, bevidsthedstab, ændringer i tale, delirium, abnorme drømme
English: Figure 2: Kaplan-Meier curve of overall survival
Danish: Figur 2: Kaplan-Meier kurve for samlet overlevelse
English: The objective response rates measured in these subgroups were generally consistent with the PFS results, with the RET mutation positive, negative, and unknown subgroups showing tumour response rates of 32%, 22%, and 25%, respectively.
Danish: De objektive responsrater målt i disse undergrupper var generelt konsistente med PFS-resultaterne, med RET-mutationspositive, -negative og ukendte undergrupper udvisende tumorresponsrater på henholdsvis 32 %, 22 % og 25 %.
English: Fresh tumour samples for tumour genetic analysis from the most recent metastatic site in patients enrolled in the dose-comparison study should be collected.
Danish: Friske tumorprøver til tumorgenetisk analyse fra det seneste metastatiske sted bør indsamles hos patienter tilmeldt det dosissammenlignede studie.
English: In patients with mild or moderate hepatic impairment the recommended dose of cabozantinib is 60 mg once daily.
Danish: Hos patienter med let eller moderat nedsat leverfunktion er den anbefalede dosis cabozantinib 60 mg én gang daglig.
English: You should also use a barrier contraceptive (e.g. condom or diaphragm) whilst taking COMETRIQ and for at least 4 months after treatment has finished.
Danish: Du skal også anvende en barriere antikonception (f.eks. kondom eller pessar), mens du tager COMETRIQ og i mindst 4 måneder efter, at behandlingen er afsluttet.
English: Each row of the blister card contains the daily dose.
Danish: Hver række på blisterkortet indeholder den daglige dosis.
English: • Stopping menstruation, vaginal bleeding
Danish: • Ophør af menstruation, vaginalblødning
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 vedblivende.
English: • Inflammation at the root of your hair, acne, blisters (on parts of your body other than the hands or feet)
Danish: • Inflammation ved hårrødderne, acne, blistere (på dele af kroppen udover hænder og fødder)
English: Cabozantinib was metabolized in vivo.
Danish: Cabozantinib blev metaboliseret in vivo.
English: 65 quai Georges Gorse 92100 Boulogne-Billancourt France
Danish: 65 quai Georges Gorse 92100 Boulogne-Billancourt Frankrig