FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe diarrhoea can cause loss of body fluid (dehydration).
Danish: Svær diarré kan forårsage væsketab (dehydrering).
English: This is because it could increase the amount of Cotellic in your blood.
Danish: Det kan øge mængden af Cotellic i blodet.
English: · This medicine has been prescribed for you only.
Danish: · Lægen har ordineret dette lægemiddel dig personligt.
English: Scores for all functioning domains and most symptoms (appetite loss, constipation, nausea and vomiting, dyspnoea, pain, fatigue) showed that the mean change from baseline was similar between the two treatment arms and did not demonstrate a clinically meaningful change (all scores were ≤ 10 point change from baseline).
Danish: Score fra alle funktionsområder og de fleste symptomer (appetitmangel, obstipation, kvalme og opkastning, dyspnø, smerter, træthed) viste at den gennemsnitlige ændring fra baseline var sammenlignelig i de to behandlingsarme og viste ingen klinisk betydningsfuld ændring ( alle score havde ≤10 points ændring i forhold til baseline).
English: Follow your doctor's instructions for what to do to help prevent or treat diarrhoea.
Danish: Følg lægens anvisning om, hvordan diarréen kan forhindres eller behandles.
English: In Study GO28141, there were 89 patients (18.1%) aged 65-74, 38 patients (7.7%) aged 75-84 and 5 patients (1.0%) aged 85 years and older.
Danish: I studie GO28141 var 89 patienter (18,1%) i alderen 65-74 år, 38 patienter (7,7%) i alderen 75-84 år og 5 patienter (1,0%) 85 år og ældre.
English: When Cotellic is used in combination with vemurafenib (which targets the changed “BRAF” protein), it further slows down or stops the growth of your cancer.
Danish: Når Cotellic tages sammen med vemurafenib (som virker på det muterede BRAF-protein), vil det yderligere nedsætte eller stoppe væksten af kræftcellerne.
English: In vitro, cobimetinib is a potential inducer of CYP1A2 and may therefore reduce the exposure of substrates of this enzyme e.g., theophylline.
Danish: Cobimetinib er en potentiel inducer af CYP1A2 in vitro og kan derfor nedsætte eksponeringen af substrater for dette enzym, f.eks. theophyllin.
English: Take the medicine package and this leaflet with you.
Danish: Tag medicinpakningen og denne indlægsseddel med.
English: Talk to your doctor before taking Cotellic if you are taking: Medicine or active substance
Danish: Kontakt lægen, inden du tager Cotellic, hvis du får: Medicin eller aktivt indholdsstof
English: Cotellic contain lactose
Danish: Cotellic indeholder lactose
English: Figure 1 Kaplan-Meier curves of final overall survival - Intent to treat population (cut-off date: 28 August 2015)
Danish: Figur 1 Kaplan-Meier kurver over den endelige samlede overlevelse - intent-to-treat- population (cut-off dato: 28. august 2015)
English: Among the 63 BRAFi naïve patients, 20 patients had received prior systemic therapy for advanced melanoma with the majority (80%) being immunotherapy.
Danish: Blandt de 63 patienter, der ikke tidligere havde fået BRAF-hæmmer, havde 20 patienter tidligere fået systemisk behandling for fremskredent melanom, størstedelen (80%) immunterapi.
English: Oxidation by CYP3A and glucuronidation by UGT2B7 appear to be the major pathways of cobimetinib metabolism.
Danish: Oxidering via CYP3A og glukuronidering via UGT2B7 synes at være de primære metaboliseringsveje for cobimetinib.
English: Cardiovascular safety of cobimetinib in combination with vemurafenib has not been evaluated in vivo.
Danish: Den kardiovaskulære sikkerhed af cobimetinib i kombination med vemurafenib er ikke evalueret in vivo.
English: Therefore, concomitant use of moderate and strong CYP3A inducers (e.g. carbamazepine, rifampicin, phenytoin, and St. John's Wort) should be avoided.
Danish: Samtidig brug af moderate og potente CYP3A-inducerer (fx carbamazepin, rifampicin, phenytoin og perikon) bør derfor undgås.
English: Cotellic can affect your ability to drive or use machines.
Danish: Cotellic kan påvirke din evne til at køre motorkøretøj eller anvende maskiner.
English: ADR frequencies are based upon the safety analysis of patients treated with cobimetinib plus vemurafenib with a median follow up of 11.2 months (data cut-off date of 19 September 2014).
Danish: Bivirkningsfrekvenserne er baseret på sikkerhedsanalyser hos patienter behandlet med cobimetinib plus vemurafenib med median opfølgning på 11, 2 måneder (data cut-off dato 19. september 2014).
English: ADRs which were reported in melanoma patients are listed below by MedDRA body system organ class, frequency and grade of severity.
Danish: De bivirkninger, der er indberettet hos melanompatienter, angives nedenfor i overensstemmelse med MedDRA's organklassesystem og efter hyppighed og sværhedsgrad.
English: Grade 2 (intolerable) or Grade 3/4 1st Appearance
Danish: Grad 2 (intolerabel) eller grad 3 /4 1.
English: Following oral dosing of 60 mg in cancer patients, cobimetinib showed a moderate rate of absorption with a median Tmax of 2.4 hours.
Danish: Efter en oral dosis på 60 mg til kræftpatienter har cobimetinib en moderat absorptionshastighed med en median Tmax på 2,4 timer.
English: There is no experience with overdose in human clinical trials.
Danish: Der er ingen erfaring med overdosering fra kliniske studier med mennesker.
English: Table 3 lists adverse reactions considered associated with the use of Cotellic.
Danish: Tabel 3 angiver bivirkninger, der vurderes at være forbundet med brug af Cotellic.
English: The absolute bioavailability of cobimetinib was 45.9% (90% CI: 39.7%, 53.1%) in healthy subjects.
Danish: Den absolutte biotilgængelighed af cobimetinib er 45,9% (90% konfidensinterval: 39,7%; 53,1%) hos raske frivillige.
English: Most events observed in clinical trials were resolved, or improved to asymptomatic Grade 1, following dose interruption or reduction.
Danish: De fleste af disse bivirkninger, der blev observeret i kliniske forsøg, forsvandt eller forbedredes til asymptomatisk grad 1 efter behandlingsafbrydelse eller dosisreduktion.
English: Diarrhoea should be managed with anti-diarrhoeal agents and supportive care.
Danish: Diarré skal håndteres med midler mod diarré og understøttende behandling.
English: Concomitant administration of P-gp inhibitors such as ciclosporin and verapamil may have the potential to increase plasma concentrations of cobimetinib.
Danish: Samtidig administration af P-gp-hæmmere som ciclosporin og verapamil kan potentielt øge plasmakoncentrationen af cobimetinib.
English: The BRAFi-naïve patients (n=63) attained an 87% objective response rate, including a complete response in 16% of patients.
Danish: De patienter, der ikke tidligere havde fået BRAF-hæmmer (n꞊63), opnåede en objektiv responsrate på 87%, inklusive komplet respons hos 16% af patienterne.
English: However, sensitivity analysis suggests neither of these covariates had clinically significant impact on steady state exposure.
Danish: Sensitivitetsanalyser har dog ikke vist, at disse covariater har klinisk signifikant betydning for eksponeringen ved steady-state.
English: Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break).
Danish: Hver dosis består af 3 tabletter på 20 mg (60 mg) og skal tages én gang dagligt i 21 på hinanden følgende dage (dag 1-21 behandlingsperiode), efterfulgt af 7 dages pause (dag 22-28 behandlingspause).
English: In a repeat dose toxicity study in juvenile rats, cobimetinib systemic exposures were 2 to11 fold higher on post natal day 10 than on post natal day 38 when exposures were similar to those in adult rats.
Danish: I et toksicitetsstudie med gentagne doser hos unge rotter var den systemiske eksponering af cobimetinib 2-11 gange højere på postnatal dag 10 end på postnatal dag 38, hvor eksponeringen svarede til den hos voksne rotter.
English: Tell your doctor straight away if you notice any of the side effects listed below or if these get worse during treatment.
Danish: Fortæl straks lægen, hvis du oplever en eller flere af bivirkningerne nedenfor, eller hvis den/disse forværres under behandlingen.
English: The difference in ORR was 22.9 % (p-value<0.0001).
Danish: Forskellen i objektiv responsrate var 22,9% (p <0,0001).
English: There were no apparent trends in the time of onset of Grade ≥3 events.
Danish: Der var ingen klar tendens med hensyn til tid til debut af bivirkninger grad ≥ 3.
English: These data show that the efficacy of the combination will be lower in these patients (see section 5.1).
Danish: Disse data viser, at virkningen af kombinationsbehandlingen er ringere hos disse patienter (se pkt.
English: Your doctor should examine your eyes if you have any new or worsening problems with your sight while you are taking Cotellic.
Danish: Lægen skal undersøge dine øjne, hvis du får nye problemer eller forværring af dit syn under behandling med Cotellic.
English: Each subsequent Cotellic treatment cycle should start after the 7-day treatment break has elapsed.
Danish: Alle efterfølgende Cotellic-behandlingscykler skal starte efter den 7 dages behandlingspause.
English: There is no specific antidote for overdosage with cobimetinib.
Danish: Der er ingen specifik antidot for overdosering med cobimetinib.
English: Based on a population pharmacokinetic analysis, gender, race, ethnicity, baseline ECOG, mild and moderate renal impairment did not affect the pharmacokinetic of cobimetinib.
Danish: Baseret på en farmakokinetisk populationsanalyse påvirker køn, race, etnicitet, baseline-ECOG samt let og moderat nedsat nyrefunktion ikke cobimetinibs farmakokinetik.
English: Cobimetinib and its metabolites were characterised in a mass balance study in healthy subjects.
Danish: Cobimetinib og dets metabolitter er karakteriseret i en massebalance-undersøgelse hos raske frivillige.
English: Cotellic is for oral use.
Danish: Cotellic anvendes oralt.
English: In vitro data indicate cobimetinib is not an inhibitor of OAT1, OAT3 or OCT2.
Danish: In vitro data tyder på, at cobimetinib ikke hæmmer OAT1, OAT3 eller OCT2.
English: Signs include yellowing of the skin or eyes · inflammation of the lungs that may cause difficulty breathing, and can be life-threatening (called “pneumonitis”).
Danish: Symptomerne inkluderer gulfarvning af hud og øjne · irritation (inflammation) af vævet i lungerne, hvilket kan give vejrtrækningsbesvær og kan være livstruende (kaldes ”pneumonitis”)
English: If you stop taking Cotellic
Danish: Hvis du holder op med at tage Cotellic
English: The mean steady-state Cmax and AUC0-24 were 273 ng/mL and 4340 ng.h/mL respectively.
Danish: De gennemsnitlige Cmax og AUC0-24 ved steady state er henholdsvis 273 ng/ml og 4.340 ng∙t/ml.
English: The primary analysis for Study GO28141 was conducted with a data cut-off date of 09 May 2014.
Danish: Den primære analyse for studie GO28141 blev udført ved cut-off dato den 9. maj 2014.
English: Only patients with ECOG performance status 0 and 1 were enrolled in Study GO28141.
Danish: Kun patienter med ECOG-performancestatus 0 og 1 blev inkluderet i studie GO28141.
English: Cases of Grade ≥3 and serious diarrhoea have been reported in patients treated with Cotellic.
Danish: Der er rapporteret tilfælde af grad ≥3 og svær diarré hos patienter, som behandles med Cotellic.
English: Each film-coated tablet contains 36 mg lactose monohydrate.
Danish: Hver filmovertrukken tablet indeholder 36 mg lactosemonohydrat.
English: Table 5 Efficacy results from Study GO28141 (coBRIM)
Danish: Tabel 5 Effektresultater fra studie GO28141 (coBRIM)
English: The pharmacokinetics of cobimetinib were evaluated in 6 subjects with mild hepatic impairment (Child Pugh A), 6 subjects with moderate hepatic impairment (Child Pugh B), 6 subjects with severe hepatic impairment (Child Pugh C) and 10 healthy subjects.
Danish: Cobimetinibs farmakokinetik blev evalueret hos 6 forsøgspersoner med let nedsat leverfunktion (Child Pugh A), 6 forsøgspersoner med moderat nedsat leverfunktion (Child Pugh B), 6 forsøgspersoner med svært nedsat leverfunktion (Child Pugh C) og 10 raske forsøgspersoner.
English: Treatment with Cotellic in combination with vemurafenib should only be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products.
Danish: Behandling med Cotellic i kombination med vemurafenib bør udelukkende initieres og superviseres af en kvalificeret læge, der har erfaring med onkologiske lægemidler.
English: Very rare < 1/10,000
Danish: Meget sjælden < 1/10.000
English: No clinical DDI studies have been conducted to assess this finding, and clinically relevant inhibition of intestinal BCRP cannot be ruled out.
Danish: Der er ikke gennemført kliniske interaktionsstudier for at vurdere dette fund, og klinisk relevant hæmning af intestinal BCRP kan derfor ikke udelukkes.
English: Dehydration, Hypophosphataemia, Hyponatremia, Hyperglycaemia
Danish: Dehydrering, hypofosfatæmi, hyponatriæmi, hyperglykæmi
English: There are minimal data for Cotellic in patients with severe renal impairment, therefore an effect cannot be excluded.
Danish: Der er kun ganske få data vedrørende Cotellic til patienter med svært nedsat nyrefunktion, og derfor kan en påvirkning ikke udelukkes.
English: Grade 3 events: Cotellic treatment should be interrupted during evaluation to avoid any potential contribution to the event.
Danish: Grad 3 bivirkninger: Cotellic-behandling skal afbrydes under evaluering for at undgå yderligere medvirken til bivirkningen.
English: A clinical drug-drug interaction (DDI) study in cancer patients showed that plasma concentrations of midazolam (a sensitive CYP3A substrate) and dextromethorphan (a sensitive CYP2D6 substrate) were not altered in the presence of cobimetinib.
Danish: Et klinisk interaktionsstudie med kræftpatienter har vist, at plasmakoncentrationen af midazolam (et følsomt CYP3A-substrat) og dextromethorphan (et følsomt CYP2D6-substrat) ikke ændredes ved tilstedeværelse af cobimetinib.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Cotellic in one or more subsets of the paediatric population in malignant solid tumours (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Cotellic i en eller flere undergrupper af den pædiatriske population med maligne, solide tumorer (se pkt.
English: In the Phase III study with Cotellic in combination with vemurafenib in patients with unresectable or metastatic melanoma (n=247), 183 patients (74%) were <65 years of age, and 44 patients (18%) were 65-74 years of age, 16 (6%) were 75-84 years of age, and 4 patients (2%) were aged ³85 years.
Danish: I fase III-studiet med Cotellic i kombination med vemurafenib hos patienter med ikke-operabelt eller metastatisk melanom (n=247) var 183 patienter (74%) < 65 år, 44 patienter (18%) var 65-74 år, 16 patienter (6%) var 75-84 år, og 4 patienter (2%) var ≥ 85 år.
English: Patients with a baseline LVEF either below institutional lower limit of normal (LLN) or below 50% have not been studied.
Danish: Patienter med baseline-LVEF under den nedre grænseværdi eller under 50% af forventet er ikke undersøgt.
English: A risk to the newborns/infants cannot be excluded.
Danish: Det kan ikke udelukkes, at amning er forbundet med en risiko for den nyfødte/barnet.
English: In vitro, cobimetinib is a moderate inhibitor of BCRP (Breast Cancer Resistance Protein).
Danish: In vitro er cobimetinib en moderat hæmmer af BCRP (Breast Cancer Resistance Protein).
English: White, round film-coated tablets of approximately 6.6 mm diameter, with “COB” debossed on one side.
Danish: Hvide, runde, filmovertrukne tabletter, ca. 6,6 mm i diameter med “COB” præget på den ene side.
English: Following intravenous administration of a 2 mg dose of cobimetinib, the mean plasma clearance (CL) was 10.7 L/hr.
Danish: Efter intravenøs administration af 2 mg cobimetinib var den gennemsnitlige plasma-clearance 10,7 l/t.
English: Based on preclinical data and the human mass balance study, cobimetinib is mainly metabolised, with minimal renal elimination.
Danish: Baseret på prækliniske data og den humane massebalance-undersøgelse metaboliseres cobimetinib med minimal renal elimination.
English: Alternative agents with no or minimal CYP3A induction should be considered.
Danish: Andre lægemidler med ingen eller minimal CYP3A-induktion bør i stedet overvejes.
English: A population pharmacokinetic analysis using data from 151 patients with mild renal impairment (creatinine clearance (CRCL) 60 to less than 90 mL/min), 48 patients with moderate renal impairment (CRCL 30 to less than 60 mL/min), and 286 patients with normal renal function (CRCL greater than or equal to 90 mL/min), showed that CRCL had no meaningful influence on exposure of cobimetinib.
Danish: En farmakokinetisk populationsanalyse med data fra 151 patienter med let nedsat nyrefunktion (kreatinin-clearance (CRCL) 60 til < 90 ml/min), 48 patienter med moderat nedsat nyrefunktion (CRCL 30 til < 60 ml/min) og 286 patienter med normal nyrefunktion (CRCL ≥ 90 ml/min) viste, at CRCL ikke påvirkede eksponeringen af cobimetinib i signifikant grad.
English: The tablets contain lactose (a type of sugar).
Danish: Tabletterne indeholder lactose (en sukkerart).
English: Rhabdomyolysis has been reported in the post-marketing setting.
Danish: Rabdomyolyse er blevet observeret efter markedsføring.
English: Continue to take Cotellic as normal, the next day.
Danish: Tag Cotellic igen næste dag, helt som du plejer.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Cotellic.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er usikker), skal du tale med lægen, apotekspersonalet eller sygeplejersken, inden du tager Cotellic.
English: Cobimetinib has linear pharmacokinetics in the dose range of ~3.5 mg to 100 mg.
Danish: Cobimetinibs farmakokinetik er lineær i dosisområdet ~3,5 mg til 100 mg.
English: Cotellic is not recommended for children and adolescents.
Danish: Det frarådes at bruge Cotellic til børn og unge.
English: Talk to your doctor, pharmacist or nurse before taking Cotellic if you have: · bleeding or are taking any medications that may cause bleeding · an eye problem · heart problems · liver problems · muscle problems.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Cotellic, hvis du har problemer med: · blødning eller tager medicin, der kan forårsage blødning · øjnene · hjertet · leveren · muskler
English: Dose modification advice for left ventricular dysfunction Permanent discontinuation of Cotellic treatment should be considered if cardiac symptoms are attributed to Cotellic and do not improve after temporary interruption.
Danish: Vejledning i dosisændringer ved nedsat funktion af venstre ventrikel Permanent seponering af Cotellic-behandling bør overvejes, hvis hjertesymptomerne tilskrives Cotellic og ikke forbedres efter midlertidig behandlingsafbrydelse.
English: What you need to know before you take Cotellic Do not take Cotellic: · if you are allergic to cobimetinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal du vide, før du begynder at tage Cotellic Tag ikke Cotellic: · hvis du er allergisk over for cobimetinib eller et af de øvrige indholdsstoffer i medicinen
English: · If you get side effects, your doctor may decide to lower your dose, stop treatment temporarily or permanently.
Danish: · Hvis du får bivirkninger, kan lægen beslutte at nedsætte dosis eller afbryde behandlingen midlertidigt eller permanent.
English: CYP3A and CYP2D6 substrates
Danish: CYP3A- og CYP2D6-substrater
English: Consider permanent discontinuation *The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events v4.0 (CTC-AE)
Danish: *Bivirkningsintensitet gradueret efter CTC-AE (Common Terminology Criteria for Adverse Events v4.0)
English: Effects of cobimetinib on drug transport systems
Danish: Cobimetinibs virkning på lægemiddeltransport-systemer
English: Cotellic can cause severe bleeding, especially in your brain or stomach (see also “Severe bleeding” in Section 4).
Danish: Cotellic kan forårsage svær blødning, især i hjernen eller maven (se også ”Svær blødning” i afsnit 4).
English: Cotellic has minor influence on the ability to drive or use machines.
Danish: Cotellic påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Median time to initial onset of events was 4 months (1-13 months).
Danish: Mediantiden til debut af bivirkningen var 4 måneder (1-13 måneder).
English: Table 4 provides the frequency of measured liver laboratory abnormalities and elevated creatine phosphokinase for all Grades and Grades 3-4.
Danish: I tabel 4 angives hyppighed af målte abnorme leverværdier og forhøjet kreatinkinase af alle grader samt grad 3-4.
English: Caution should be used in patients with additional risk factors for bleeding, such as brain metastases, and/or in patients that use concomitant medications that increase the risk of bleeding (including antiplatelet or anticoagulant therapy).
Danish: Der bør udvises forsigtighed hos patienter med flere risikofaktorer for blødning såsom hjernemetastaser, og/eller hos patienter, der samtidig tager medicin, som øger risikoen for blødning (inkluderer antitrombotisk og antikoagulerende behandling).For håndtering af blødning se pkt.
English: It is not known whether cobimetinib is excreted in human breast milk.
Danish: Det vides ikke, om cobimetinib udskilles i human mælk.
English: If symptoms of new or worsening visual disturbances are identified, an ophthalmologic examination is recommended.
Danish: Hvis nye eller forværrede synsforstyrrelser identificeres, anbefales en oftalmologisk undersøgelse.
English: There are no data on the safety or efficacy of Cotellic in combination with vemurafenib in patients with central nervous system metastasis or in patients with non-cutaneous malignant melanoma.
Danish: Der findes ingen data om sikkerheden og virkningen af Cotellic i kombination med vemurafenib hos patienter med metastaser i centralnervesystemet eller hos patienter med ikke-kutant malignt melanom.
English: The safety and efficacy of Cotellic in children and adolescents below 18 years of age have not been established.
Danish: Cotellics sikkerhed og virkning hos børn og unge i alderen < 18 år er ikke klarlagt.
English: Severe bleeding (common: may affect up to 1 in 10 people) Cotellic can cause severe bleeding, especially in your brain or stomach.
Danish: Svær blødning (almindelige: kan optræde hos op til 1 ud af 10 patienter) Cotellic kan give svær blødning, især i din hjerne eller mave.
English: Cotellic can increase the amount of some liver enzymes in your blood during treatment.
Danish: Cotellic kan medføre forhøjede niveauer af nogle leverenzymer i blodet under behandlingen.
English: The risk of haemorrhage may be increased with concomitant use of antiplatelet or anticoagulant therapy.
Danish: Risikoen for blødninger øges muligvis ved samtidig brug af antitrombotisk og antikoagulerende behandling.
English: Please refer to the vemurafenib SmPC for complete descriptions of all undesirable effects associated with vemurafenib treatment.
Danish: Se produktresuméet for vemurafenib for fuldstændig beskrivelse af alle bivirkninger, som er forbundet med vemurafenib-behandling.
English: Cobimetinib was extensively metabolised and eliminated in faeces.
Danish: Cobimetinib blev i høj grad metaboliseret og elimineret via fæces.
English: Figure 2: Forest plot for hazard ratios of final overall survival subgroup analyses - Intent to treat population (cut-off date: 28 August 2015)
Danish: Figur 2 Forest-plot for hazard ratioer for den endelige samlede overlevelse, subgruppeanalyser- intent-to-treat-population (cut-off dato 28. august 2015)
English: The 1-year (75 %) and 2-year (48 %) OS estimates for the Cotellic plus vemurafenib arm were greater than those for placebo plus vemurafenib arm (64 % and 38 % respectively).
Danish: 1 års (75%) og 2 års (48%) estimat for den samlede overlevelse for Cotellic plus vemurafenib-armen var højere end estimatet for placebo plus vemurafenib-armen (henholdsvis 64% og 38%).