natgillin/translations-raw huggingface dataset:
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. 
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.
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. 
These may be signs of a gastrointestinal perforation, a hole that develops in your stomach or intestine that could be life-threatening.
Cabozantinib bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver behandling med cabozantinib. 
Cabozantinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with cabozantinib.
• Øgning i niveauet af bilirubin i dit blod (hvilket kan resultere i gulsot/gulfarvning af hud og øjne) 
• Increase in the level of bilirubin in your blood (which may result in jaundice/yellow skin or eyes)
Kontakt lægen eller apotekspersonalet, før du tager COMETRIQ, hvis du: 
Talk to your doctor or pharmacist before taking COMETRIQ if you:
P-glykoprotein-substrater 
P-glycoprotein substrates
Effektive antikonceptionsmetoder bør anvendes af mandlige og kvindelige patienter og deres partnere under behandlingen og i mindst 4 måneder efter fuldførelsen af behandlingen. 
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.
Et primært mål var at sammenligne progressions-fri overlevelse (PFS) hos patienter, der fik cabozantinib versus patienter, der fik placebo. 
The primary objective was to compare progression-free survival (PFS) in patients receiving cabozantinib versus patients receiving placebo.
De resulterende DNA-prøver vil blive evalueret for kvalitet ved en PCR-baseret forstærkningstest og ved Sanger-sekvensering for RET-M918T. 
The resulting DNA samples will be evaluated for quality by a PCR-based amplification test, and by Sanger sequencing for RET M918T.
• Angst, depression, konfusion 
• Anxiety, depression, confusion
Virkningen af cabozantinib på farmakokinetikken for antikonceptionssteroider er ikke blevet undersøgt. 
The effect of cabozantinib on the pharmacokinetics of contraceptive steroids has not been investigated.
Figur 3: Kaplan-Meier analyse af OS blandt forsøgspersoner med en RET-M918T-mutation 
Figure 3: Kaplan-Meier Analysis of OS Among Subjects with a RET M918T Mutation
Kapslen indeholder et elfenbenshvidt til hvidt pulver. 
The capsule contains an off-white to white powder.
Der findes ingen studier med gravide kvinder, der bruger cabozantinib. 
There are no studies in pregnant women using cabozantinib.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Der henvises til de individuelle blisterkort for dispenseringsinstruktioner. 
OTHER SPECIAL WARNING(S), IF NECESSARY Refer to individual blister cards for dispensing instructions.
Cabozantinib påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner. 
Cabozantinib has a minor influence on the ability to drive and use machines.
Cabonazinib bør genstartes med en lavere dosis, når PPES er reduceret til grad 1. 
Cabozantinib should be restarted with a lower dose when PPES has been resolved to grade 1.
• Hypertension (øgning i blodtryk) 
• Hypertension (increase in blood pressure)
Hvert blisterkort har nok kapsler til til at vare syv dage (én uge). 
Each blister card has enough capsules to last for seven days (one week).
Sandsynlighed 
Probability
Tag ikke COMETRIQ • hvis du er allergisk over for cabozantinib eller et af de øvrige indholdsstoffer (angivet i pkt. 
Do not take COMETRIQ - if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed in section 6).
Hvis du får bivirkninger, vil din læge måske bede dig om at tage COMETRIQ i en lavere dosis. 
If you get side effects, your doctor may tell you to take COMETRIQ at a lower dose.
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. 
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.
• 60 mg (3 grå 20 mg kapsler) Din læge vil afgøre, hvad der er den rette dosis for dig. 
• 60 mg (3 grey 20 mg capsules) Your doctor will decide on the right dose for you.
Dine kapsler vil komme i et blisterkort organiseret efter den ordinerede dosis. 
Your capsules will come in a blister card organised by prescribed dose.
Der er begrænsede data for patienter med nedsat hjertefunktion. 
There is limited data in patients with cardiac impairment.
Sygdoms kontrolrate b (95 % CI) Calcitonin responsa 
Disease Control Rate b (95% CI) Calcitonin Responsea
Plasmakoncentrations-tids-profiler viser endnu en absorptionstop cirka 24 timer efter administration, hvilket antyder, at cabozantinib kan gennemgå enterohepatisk recirkulation. 
Plasma-concentration time profiles show a second absorption peak approximately 24 hours after administration, which suggests that cabozantinib may undergo enterohepatic recirculation.
Baseret på ikke-kliniske sikkerhedsfund, kan mandlig og kvindelig fertilitet blive kompromitteret af behandling med cabozantinib (se pkt. 
Based on non-clinical safety findings, male and female fertility may be compromised by treatment with cabozantinib (see section 5.3).
• Atrieflimmer (hurtige og uregelmæssige hjerteslag) 
• Atrial fibrillation (a fast and erratic heartbeat)
• Svampeinfektioner, der kan være i huden, munden eller kønsorganerne 
• Fungal infection that can be in the skin, mouth, or genitals
Tooghalvfems procent af patienterne i cabozantinib armen havde en forudgående thyroidektomi, og 89 % tog thyroideahormoner forud for den første dosis. 
Ninety-two percent of patients on the cabozantinib arm had a prior thyroidectomy, and 89% were taking thyroid hormones prior to first dose.
COMETRIQ kapsler er pakket på blisterkort organiseret efter den ordinerede dosis. 
COMETRIQ capsules are packaged in blister cards organised by prescribed dose.
Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the blister card after EXP.
• Ændringer i hårfarve (lysner), hårtab 
• Hair colour changes (lightening), hair loss
Plasma terminal halveringstid for cabozantinib i studier med enkeltdosis hos raske frivillige er cirka 120 timer. 
The plasma terminal half-life of cabozantinib in single dose studies in healthy volunteers is approximately 120 hours.
Wingate Industrial Park Westhoughton 
Wingates Industrial Park Westhoughton
Derudover vil prøver blive evalueret for mutationer i RAS-gen hotspots (HRAS-, KRAS- og NRAS-gener). 
In addition, samples will be evaluated for mutations in RAS gene hotspots (HRAS, KRAS, and NRAS genes).
• Tab af opmærksomhed, bevidsthedstab, ændringer i tale, delirium, abnorme drømme 
• Loss of attention, loss of consciousness, changes in speech, delirium, abnormal dreams
Figur 2: Kaplan-Meier kurve for samlet overlevelse 
Figure 2: Kaplan-Meier curve of overall survival
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 %. 
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.
Friske tumorprøver til tumorgenetisk analyse fra det seneste metastatiske sted bør indsamles hos patienter tilmeldt det dosissammenlignede studie. 
Fresh tumour samples for tumour genetic analysis from the most recent metastatic site in patients enrolled in the dose-comparison study should be collected.
Hos patienter med let eller moderat nedsat leverfunktion er den anbefalede dosis cabozantinib 60 mg én gang daglig. 
In patients with mild or moderate hepatic impairment the recommended dose of cabozantinib is 60 mg once daily.
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. 
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.
Hver række på blisterkortet indeholder den daglige dosis. 
Each row of the blister card contains the daily dose.
• Ophør af menstruation, vaginalblødning 
• Stopping menstruation, vaginal bleeding
Fund i uterus/ovarier og nedsat hæmatopoiese syntes at være forbigående, mens virkninger på knogleparametre og leverpigmentering var vedblivende. 
Findings in uterus/ovaries and decreased haematopoiesis appeared to be transient, while effects on bone parameters and liver pigmentation were sustained.
• Inflammation ved hårrødderne, acne, blistere (på dele af kroppen udover hænder og fødder) 
• Inflammation at the root of your hair, acne, blisters (on parts of your body other than the hands or feet)
Cabozantinib blev metaboliseret in vivo. 
Cabozantinib was metabolized in vivo.
65 quai Georges Gorse 92100 Boulogne-Billancourt Frankrig 
65 quai Georges Gorse 92100 Boulogne-Billancourt France
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. 
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.
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. 
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.
Ikke-GI fistler bør udelukkes i tilfælde med indtræden af mucositis efter behandlingens start. 
Non-GI fistula should be ruled out as appropriate in cases of onset of mucositis after start of therapy.
Blisterkort indeholdende enten: 
Blister cards containing either:
Beslutningen om at genoptage behandling med cabozantinib efter operation bør baseres på klinisk bedømmelse af tilstrækkelig sårheling. 
The decision to resume cabozantinib therapy after surgery should be based on clinical judgment of adequate wound healing.
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: 
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
Der bør udvises forsigtighed hos patienter, der får midler forbundet med ONJ, såsom bisfosfonater. 
Caution should be used in patients receiving agents associated with ONJ, such as bisphosphonates.
Der er vigtigt for dig, at du udøver god mundpleje under behandling med COMETRIQ. 
It is important for you to practice good mouth care during treatment with COMETRIQ.
Cabozantinib er et CYP3A4-substrat. 
Cabozantinib is a CYP3A4 substrate.
Der er kun lille erfaring med cabozantinib hos ikke-kaukasiske patienter. 
There is little experience with cabozantinib in non-White patients.
Der er en mulighed for, at din frugtbarhed kunne blive påvirket af behandlingen med COMETRIQ. 
There is a possibility your fertility could be affected by treatment with COMETRIQ.
Alvorlige GI perforationer og fistler, af og til med dødelig udgang, og intra-abdominale abscesser er blevet observeret med cabozantinib. 
Serious GI perforations and fistulas, sometimes fatal, and intra-abdominal abscesses have been observed with cabozantinib.
Figur 1: Kaplan Meier kurve for progressionfri overlevelse 
Figure 1: Kaplan Meier curve of progression free survival
Vævsprøver fra tumor vil indledningsvis gennemgå histologisk evaluering, manuel tumor opformering og DNA-isolation. 
Tumor tissue samples initially will undergo histological evaluation, manual tumor enrichment, and DNA isolation.
RPLS er ikke almindelig (påvirker færre end 1 ud af 100 mennesker). 
RPLS is uncommon (it affects less than 1 in 100 people).
Hver 28-dages pakning indeholder medicin nok til 28 dage. 
Each 28 day pack contains enough medicine for 28 days.
• Hypotension (fald i blodtryk) 
• Hypotension (decrease in blood pressure)
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. 
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.
Median varigheden af objektivt respons var 14,6 måneder (95 % CI: 11,1-17,5) for forsøgspersoner i cabozantinib-armen. 
The median duration of objective responses was 14.6 months (95% CI: 11.1, 17.5) for subjects in the cabozantinib arm.
In vitro data viser, at cabozantinib er substrat for MRP2. 
In vitro data demonstrate that cabozantinib is a substrate of MRP2.
COMETRIQ kan sinke eller stoppe væksten af medullær thyroideacancer. 
COMETRIQ may slow or stop the growth of medullary thyroid cancer.
Et neutraliserende antistof over for CYP2C9 viste en minimal effekt på dannelse af cabozantinib metabolit (dvs. en <20 % reduktion). 
A neutralizing antibody to CYP2C9 showed a minimal effect on cabozantinib metabolite formation (ie, a <20% reduction).
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). 
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).
Når PPES er alvorlig, bør seponering af behandling med cabozantinib overvejes. 
When PPES is severe, interruption of treatment with cabozantinib should be considered.
Bivirkninger såsom træthed og svaghed er blevet forbundet med cabozantinib. 
Adverse reactions such as fatigue and weakness have been associated with cabozantinib.
Disse kan være tegn på en tilstand, der kaldes reversibel posterior leukoencefalopati syndrom (RPLS). 
These may be signs of a condition called reversible posterior leukoencephalopathy syndrome (RPLS).
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. 
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.
Fortæl det til lægen, hvis du eller din partner er gravid eller planlægger at blive gravid, mens du tager COMETRIQ. 
Tell your doctor if you or your partner become pregnant or plan to become pregnant while you are being treated with COMETRIQ.
Valg af et alternativt samtidigt administreret lægemiddel uden eller med minimalt potentiale til at inducere eller hæmme CYP3A4 bør overvejes. 
Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
Samlet responsratea (95 % CI) 
Overall Response Ratea (95% CI)
• En rift i eller abnorm forbindelse af væv i dit fordøjelsessystem; symptomer kan omfatte kraftig eller vedblivende mavepine 
• A tear or abnormal connection of the tissue in your digestive system; symptoms can include severe or persistent stomach ache
Inden indledning af behandling med cabozantinib bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme. 
Before initiating cabozantinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Farmakoterapeutisk klassifikation: antineoplastisk middel, proteinkinase-hæmmer, ATC-kode: L01XE26 
Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE26.
Cabozantinib var ikke karcinogent i rasH2-musemodellen ved en eksponering, der var anelse højere end den tilsigtede terapeutiske eksponering hos mennesker. 
Cabozantinib was not carcinogenic in the rasH2 mouse model at a slightly higher exposure than the intended human therapeutic exposure.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS), også kendt som Posterior Reversible Encephalopathy Syndrome (PRES) er blevet observeret med cabozantinib. 
Reversible Posterior Leukoencephalopathy Syndrome (RPLS), also known as Posterior Reversible Encephalopathy Syndrome (PRES) has been observed with cabozantinib.
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. 
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.
Et dosissammenlignende studie (XL-184-401) (140 mg vs 60 mg) hos 112 patienter med nedarvet eller sporadisk medullær thyroideacancer. 
A dose-comparison study (XL-184-401) (140 mg vs 60 mg) in 112 patients with hereditary or sporadic medullary thyroid cancer.
Fertilitetsstudier hos rotter har vist reduceret fertilitet hos hanner og hunner. 
Fertility studies in rats have shown reduced male and female fertility.
Cabozantinib har ikke udvist mutagent eller klastogent potentiale i et standardbatteri af analyser til bestemmelse af genotoksicitet. 
Cabozantinib has shown no mutagenic or clastogenic potential in a standard battery of genotoxicity assays.
Virkning med cabozantinib blev observeret hos patienter med medullær thyroideacancer med vildttype eller mutant RET. 
Efficacy with cabozantinib was observed in medullary thyroid cancer patients with wild-type or mutant RET.
Reduktioner af dosis og seponering forekom hos henholdsvis 79 % og 72 % af patienter behandlet med cabozantinib i det pivotale kliniske studie. 
Dose reductions and dose interruptions occurred in 79% and 72%, respectively, of cabozantinib-treated patients in the pivotal clinical trial.
• Absces (ansamling af pus, med hævelse og inflammation) i abdomen eller underlivsområdet eller i dine tænder/gummer 
• Abscess (collection of pus, with swelling and inflammation) in the abdomen or pelvis area or in your teeth/gums
Galdesyrebindende midler såsom colestyramin og colesevelam kan interagere med cabozantinib og kan påvirke absorptionen (eller reabsorptionen) resulterende i potentielt nedsat eksponering (se pkt. 
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).
Median for samlet overlevelse 
Median Overall Survival
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. 
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).
• Nedsat hørelse 
• Impaired hearing
Efter oral administration af cabozantinib opnås cabozantinib-peak-plasmakoncentrationer 2 til 5 timer efter dosering. 
Following oral administration of cabozantinib, peak cabozantinib plasma concentrations are reached at 2 to 5 hours post-dose.
Cabozantinib (S)-malat 
Cabozantinib (S)-malate
Derudover hæmmer cabozantinib andre tyrosinkinaser inklusive RET, GAS6receptoren (AXL), stamcellefaktor receptoren (KIT) og Fms-lignende tyrosinkinase-3 (FLT3). 
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).
• Smerter i armene, hænderne, benene eller fødderne 
• Pain in the arms, hands, legs or feet
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). 
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).
Patienterne bør instrueres i ikke at spise noget i mindst 2 timer før og til og med 1 time efter at have taget COMETRIQ. 
Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking COMETRIQ.
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. 
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.
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. 
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.
Ved brug af cabozantinib bør man overveje periodisk monitorering med EKG'er under behandlingen og elektrolytter (serum calcium, kalium og magnesium). 
When using cabozantinib, periodic monitoring with on-treatment ECGs and electrolytes (serum calcium, potassium, and magnesium) should be considered.
Tæt monitorering af patienterne anbefales derfor under de første 8 ugers behandling (se pkt. 
Close monitoring of patients is therefore recommended during the first eight weeks of therapy (see section 4.2).
Protein i urinen bør monitoreres regelmæssigt under behandling med cabozantinib. 
Urine protein should be monitored regularly during cabozantinib treatment.
• Protein eller blod i urinen, galdesten, smertefuld vandladning 
• Protein or blood in the urine, gallstones, painful urination
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. 
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.
Monitorér for bivirkninger og justér dosis eller anvend dosisafbrydelse efter behov (se pkt. 
Monitor for adverse events and adjust dose or use dosing interruption as needed (see section 4.2).