FrancophonIA/ELRC3.0 huggingface dataset:
English: Upon Data Safety Monitoring Board (DSMB) recommendation, those results were released in January 2011 and the study was modified to permit dacarbazine patients to cross over to receive vemurafenib.
Danish: Efter anbefaling fra Drug Safety Monitoring Board (DSMB), blev disse resultater offentliggjort i januar 2011 og studiet blev modificeret for at tillade dacarbazin-patienter at krydse over til behandling med vemurafenib.
English: Zelboraf is not recommended for children and adolescents.
Danish: Zelboraf anbefales ikke til børn og unge.
English: Inhibitory Concentration 50 (nM)
Danish: Hæmmende koncentration 50 (nM)
English: If you stop taking Zelboraf
Danish: Hvis du holder op med at tage Zelboraf
English: Vemurafenib is a Class IV substance (low solubility and permeability), using the criteria described in the Biopharmaceutics Classification System.
Danish: Vemurafenib er et klasse IV-stof (lav opløselighed og permeabilitet) ved anvendelse af de kriterier, der beskrives i Biopharmaceutics Classification System.
English: In the majority of cases, patients received radiotherapy regimens greater than or equal to 2 Gy/day (hypofractionated regimens).
Danish: I størstedelen af tilfældene havde patienterne fået strålebehandlingsregimer, som var større eller lig med 2 Gy/dag (hypofraktionerede regimer).
English: Taking too much Zelboraf may increase the likelihood and severity of side effects.
Danish: Indtagelse af for meget Zelboraf kan øge risikoen og alvorligheden af bivirkninger.
English: Forty-nine percent of patients failed ≥ 2 prior therapies.
Danish: 49 % af patienterne havde ≥ 2 mislykkede tidligere behandlinger.
English: Stage MIC
Danish: Stadie MIC
English: ● A medicine used to prevent blood clots called warfarin
Danish: · Medicin, som bruges til at forhindre blodpropper, kaldet warfarin.
English: Like all medicines, Zelboraf can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: There is no information about the safety of Zelboraf in pregnant women.
Danish: Der er ingen information vedrørende sikkerheden af Zelboraf hos gravide kvinder.
English: ● Zelboraf is not recommended for use during pregnancy unless your doctor considers that the benefit for the mother outweighs the risk for the baby.
Danish: · Zelboraf anbefales ikke til brug under graviditet, medmindre din læge mener, at fordelen for moderen opvejer risikoen for barnet.
English: Temporarily interrupt treatment until QTc decreases below 500 ms.
Danish: Afbryd behandling midlertidigt indtil QTc falder til under 500 ms.
English: The effects of Zelboraf in people younger than 18 years old are not known.
Danish: Virkningen af Zelboraf er ikke kendt hos personer yngre end 18 år.
English: Vemurafenib (%) Dacarbazine (%)
Danish: Vemurafenib (%) Dacarbazin (%)
English: However, the parent compound was the predominant component (95%) in plasma.
Danish: Moderstoffet var dog den overvejende komponent (95 %) i plasma.
English: At the pre-specified interim analysis with a December 30, 2010 data cut-off, significant improvements in the co-primary endpoints of OS (p<0.0001) and PFS (p<0.0001) (unstratified log-rank test) were observed.
Danish: Ved den præspecificerede interim-analyse med data cut-off den 30. december 2010, blev der observeret signifikante forbedringer for de co-primære endepunkter OS (p < 0,0001) og PFS (p < 0,0001) (ikke-stratificeret log-rank test).
English: Therefore an effect of vemurafenib on the foetus cannot be excluded.
Danish: Effekt af vemurafenib på fostret kan derfor ikke udelukkes.
English: ● You may develop new melanoma lesions while taking Zelboraf.
Danish: · Du kan udvikle nye melanom-læsioner, mens du tager Zelboraf.
English: New primary melanomas have been reported in clinical trials.
Danish: Der er blevet rapporteret nye primære melanomer i kliniske studier.
English: The in vivo relevance of this finding is unknown, but a risk for a clinically relevant effect on concomitantly administered CYP2C8 substrates cannot be excluded.
Danish: Relevansen af dette fund in vivo er ukendt, men risiko for en klinisk relevant virkning på samtidigt administrerede CYP2C8-substrater kan ikke udelukkes.
English: Film-coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Danish: Filmovertræk Polyvinylalkohol Titandioxid (E171) Macrogol 3350
English: Other malignancies
Danish: Andre maligniteter
English: Treatment with vemurafenib should continue until disease progression or the development of unacceptable toxicity (see tables 1 and 2 below).
Danish: Behandling med vemurafenib bør fortsætte indtil sygdomsprogression eller udvikling af uacceptabel toksicitet (se tabel 1 og 2 nedenfor).
English: Vemurafenib may be taken with or without food, but consistent intake of both daily doses on an empty stomach should be avoided (see section 5.2).
Danish: Vemurafenib kan indtages med eller uden mad, men konsekvent indtagelse af begge daglige doser på tom mave bør undgås (se pkt.
English: Zelboraf targets proteins made from this modified gene and slows down or stops the development of your cancer.
Danish: Zelboraf virker på proteiner, som er lavet af det ændrede gen og forsinker eller stopper udviklingen af din kræftsygdom.
English: Many anticancer medicinal products are substrates of BCRP and therefore there is a theoretical risk for an interaction with vemurafenib.
Danish: Mange kræftlægemidler er substrater for BCRP, og der er derfor en teoretisk risiko for interaktion med vemurafenib.
English: Of the patients who experienced cuSCC, approximately 33% experienced > 1 occurrence with median time between occurrences of 6 weeks.
Danish: Af de patienter, som oplevede cuSCC, oplevede ca. 33 % > 1 forekomst med en mediantid mellem forekomsterne på 6 uger.
English: Although metabolism does not appear to result in a relevant amount of metabolites in plasma, the importance of metabolism for excretion cannot be excluded.
Danish: På trods af at metabolisering ikke synes, at resultere i relevante mængder af metabolitter i plasma, kan det ikke udelukkes, at metabolisering har en betydning for udskillelsen.
English: Mutations in the BRAF gene result in constitutive activation of BRAF proteins, which can cause cell proliferation without associated growth factors.
Danish: Mutationer i BRAF-genet resulterer i konstitutiv aktivering af BRAF-proteiner, som kan forårsage celleproliferation uden associerede vækstfaktorer.
English: The preclinical safety profile of vemurafenib was assessed in rats, dogs, and rabbits.
Danish: Den prækliniske sikkerhedsprofil for vemurafenib blev vurderet i rotter, hunde og kaniner.
English: The median number of brain target lesions at baseline was 2 (range 1 to 5), in both cohorts.
Danish: Det mediane antal hjernelæsioner ved baseline var 2 (mellem 1 to 5) i begge kohorter.
English: Treatment with vemurafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products.
Danish: Behandling med vemurafenib bør initieres og overvåges af en kvalificeret læge med erfaring i anvendelse af kræftlægemidler.
English: Alternative treatment with less inducing potential should be considered to maintain the efficacy of vemurafenib.
Danish: Alternativt, bør behandling med mindre inducerende potentiale overvejes for at opretholde virkningen af vemurafenib.
English: The possible effect of vemurafenib on other transporters is currently unknown.
Danish: Den mulige virkning af vemurafenib på andre transportere er ikke kendt på nuværende tidspunkt.
English: Further monitoring is recommended in particular in patients with moderate to severe hepatic impairment monthly during the first 3 months of treatment followed by every 3 months thereafter or more often as clinically indicated.
Danish: Yderligere monitorering anbefales især hos patienter med moderat til svær nedsat leverfunktion månedligt under de første 3 måneder af behandlingen, derefter efterfulgt af hver 3. måned eller oftere, som klinisk indiceret.
English: If a dose is missed, it can be taken up to 4 hours prior to the next dose to maintain the twice daily regimen.
Danish: Hvis en dosis bliver glemt, kan den tages i op til 4 timer før den næste dosis for at opretholde et doseringsregime på to gange dagligt.
English: See section 4.2 for information on paediatric use.
Danish: 4.2. for information om pædiatrisk anvendelse.
English: It is used to treat adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery.
Danish: Det bruges til at behandle voksne patienter med melanom (modermærkekræft), som har spredt sig til andre dele af kroppen, eller som ikke kan fjernes ved en operation.
English: ● Tell your doctor if you have a heart disorder, such as an alteration of the electrical activity of your heart called “QT prolongation”.
Danish: Hjertelidelser · Fortæl din læge, hvis du har en hjertelidelse, såsom en ændring i den elektriske aktivitet i dit hjerte kaldet ”QT-forlængelse”.
English: Important information about some of the ingredients of Zelboraf This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Danish: Vigtig information om nogle af hjælpestofferne i Zelboraf Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per tablet, dvs. den er i det væsentlige natriumfrit.
English: Unexplained abdominal pain should be promptly investigated (including measurement of serum amylase and lipase).
Danish: Uforklarlige abdominal-smerter bør straks undersøges (herunder måling af amylase og lipase i serum).
English: This is a precautionary measure in case a squamous cell carcinoma lesion would develop inside your body.
Danish: Dette er en sikkerhedsforanstaltning i tilfælde af, at et kutant planocellulært karcinom skulle udvikle sig i din krop.
English: ● If you are taking Zelboraf, you may become more sensitive to sunlight and get sunburns that can be severe.
Danish: Solbeskyttelse · Mens du tager Zelboraf, kan du blive mere følsom over for sollys, og få solskoldninger, som kan være alvorlige.
English: Cohort 1 No previous treatment n = 90
Danish: Kohort 1 Ingen tidligere behandling n = 90
English: Conjugation metabolites (glucuronidation and glycosylation) were also identified in humans.
Danish: Konjugerede metabolitter (glukuronidering og glykosylering) blev også identificeret hos mennesker.
English: (z) As of February 01, 2012, a total of 675 patients were evaluable for the post-hoc analysis update of PFS.
Danish: Per 1. februar 2012 var i alt 675 patienter evaluerbare for opdatering af post hoc-analyse af PFS.
English: Toxic epidermal necrolysis (e), StevensJohnson syndrome (f)
Danish: Toksisk epidermal nekrolyse (e), StevensJohnsons syndrom (f)
English: Management of QTc prolongation may require specific monitoring measures (see section 4.4).
Danish: Håndtering af QTc-forlængelse kan kræve specifikke monitoreringstiltag (se pkt.
English: Re-initiation of treatment should occur once the QTc decreases below 500 ms and at a lower dose as described in table 2.
Danish: Genoptagelse af behandling bør forekomme, så snart QTc er faldet til under 500 ms og ved en lavere dosis, som beskrevet i tabel 2.
English: ● In case of vomiting, continue to take Zelboraf as usual and do not take an additional dose.
Danish: · I tilfælde af opkastning, skal du fortsætte med at tage Zelboraf som normalt, og du må ikke tage en yderligere dosis.
English: All patients should be advised to avoid sun exposure while taking vemurafenib.
Danish: Alle patienter bør rådes til at undgå soleksponering, mens de tager vemurafenib.
English: Total n = 146
Danish: Ialt n = 146
English: Grade (CTC-AE) (a)
Danish: Grad (CTC-AE) (a)
English: ● This medicine has been prescribed for you only.
Danish: · Lægen har ordineret dette lægemiddel til dig personligt.
English: In case of vomiting after vemurafenib administration the patient should not take an additional dose of the medicinal product but the treatment should be continued as usual.
Danish: I tilfælde af opkastning efter administration af vemurafenib bør patienten ikke tage en yderligere dosis af lægemidlet, men bør fortsætte behandlingen som normalt.
English: Patients should be made aware of the potential fatigue or eye problems that could be a reason for not driving.
Danish: Patienter bør gøres opmærksomme på de potentielle trætheds- eller øjenproblemer, som kan være en årsag til ikke at føre motorkøretøj.
English: The majority of vemurafenib-related material (94%) was recovered in faeces, and <1% in urine.
Danish: Størstedelen af vemurafenib-relateret materiale (94 %) blev udskilt i fæces og <1 % i urinen.
English: Your doctor will run tests to check that your heart is working properly before and during your treatment with Zelboraf.
Danish: Lægen vil foretage nogle test for at undersøge, om dit hjerte fungerer ordentligt før og under din behandling med Zelboraf.
English: Beware of fatigue or eye problems that could be a reason for not driving.
Danish: Vær opmærksom på træthed og øjenproblemer, som kan være årsagen til ikke at føre motorkøretøjer.
English: Table 2: Dose modification schedule based on prolongation of the QT interval QTc value
Danish: Tabel 2: Dosisjusteringsskema baseret på forlængelse af QT-intervallet QTc-værdi
English: There were no increases to Grade 4 ALT, alkaline phosphatase or bilirubin.
Danish: Der var ingen stigninger til grad 4 for ALAT, alkalisk fosfatase eller bilirubin.
English: Genital examinations (for women) and anal examinations are also recommended before and at the end of your treatment.
Danish: Undersøgelser af kønsorganer (for kvinder) og anale undersøgelser anbefales også før og ved afslutning af din behandling.
English: Unstratified log-rank test for PFS and Chi-squared test for Overall Response Rate.
Danish: (x) Ikke-stratificeret log-rank test for PFS og Chi-kvadrat-test for samlet responsrate.
English: Patients with mild hepatic impairment due to liver metastases without hyperbilirubinaemia may be monitored according to the general recommendations.
Danish: Patienter med let nedsat leverfunktion på grund af levermetastaser uden hyperbilirubinæmi kan monitoreres i henhold til generelle anbefalinger.
English: Carcinogenicity studies have not been conducted with vemurafenib.
Danish: Carcinogenicitetstudier er ikke blevet udført med vemurafenib.
English: Elderly No special dose adjustment is required in patients aged > 65 years old.
Danish: Ældre Ingen speciel dosisjustering er påkrævet hos patienter over 65 år.
English: - Cohort 2 with previously treated patients (N = 56): Patients who had been previously treated for their brain metastases and had progressed following this treatment.
Danish: - Kohort 2 med tidligere behandlede patienter (n = 56): Patienter, som tidligere havde været behandlet for hjernemetastaser og havde progredieret efter denne behandling.
English: CuSCC was most commonly treated by local excision.
Danish: CuSCC blev sædvanligvis behandlet ved lokal eksicion.
English: ● Regularly during your treatment and up to 6 months after your treatment, your doctor needs to check your skin for a type of cancer called “cutaneous squamous cell carcinoma”.
Danish: · Lægen vil under og i op til 6 måneder efter behandlingen regelmæssigt undersøge din hud for en type kræft, som kaldes ”kutant planocellulært karcinom”.
English: The majority of cases were mild to moderate, but severe, disabling cases of Dupuytren's contracture have also been reported (see section 4.8).
Danish: Størstedelen af tilfældene var milde til moderate, men svære, invaliderende tilfælde af Dupuytrens kontraktur har også været rapporteret (se pkt.
English: Posology adjustments resulting in a dose below 480 mg twice daily are not recommended.
Danish: Dosisjusteringer, som resulterer i en dosis på under 480 mg to gange dagligt, anbefales ikke.
English: Currently available data are described in sections 4.8, 5.1, and 5.2, but no recommendation on a posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Date of latest renewal: 22 September 2016
Danish: Dato for første markedsføringstilladelse: 17. februar 2012 Dato for seneste fornyelse: 22. september 2016
English: Safety and efficacy data from pivotal studies were collected from patients taking vemurafenib with or without food.
Danish: Fra pivotale studier blev data omkring sikkerhed og effekt samlet fra patienter, som tog vemurafenib med eller uden mad.
English: There is no specific antidote for overdose of vemurafenib.
Danish: Der er ingen specifik antidot for overdosering af vemurafenib.
English: Grenzach-Wyhlen Germany
Danish: Grenzach-Wyhlen Tyskland
English: Although limited by the low number of patients, efficacy analyses among these patients with V600K-positive tumours suggested similar treatment benefit of vemurafenib in terms of OS, PFS and confirmed best overall response.
Danish: Omend begrænset af det lave antal patienter tydede virkningsanalyser blandt disse patienter med V600K-positive tumorer på en lignende behandlingsfordel af vemurafenib med hensyn til OS, PFS og bekræftet bedste samlede responsrate.
English: The median Tmax was increased from 4 to 7.5 hours when a single vemurafenib dose was taken with food.
Danish: Tmax-medianen øgedes fra 4 til 7,5 timer, når en enkelt vemurafenib-dosis blev taget sammen med mad.
English: Amongst these patients, 3 had a PR, 3 had SD, 2 had PD and one was not evaluable.
Danish: Blandt disse patienter havde 3 partielt respons, 3 havde stabil sygdom, 2 havde progressiv sygdom og en var ikke evaluerbar.
English: Zelboraf has side effects that can affect your ability to drive or to operate machines.
Danish: Zelboraf har bivirkninger som kan påvirke din evne til føre motorkøretøjer eller arbejde med maskiner.
English: Pinkish white to orange white, oval, biconvex film-coated tablets of approximately 19 mm, with ‘VEM' engraved on one side.
Danish: Lyserøde-hvide til orange-hvide, ovale, bikonvekse filmovertrukne tabletter på ca. 19 mm, mærket med ”VEM” på den ene side.
English: ● Usually, this lesion appears on sun-damaged skin, remains local and can be cured by surgical removal.
Danish: · Denne læsion forekommer normalt på solskadet hud, forbliver lokal og kan helbredes ved at blive fjernet ved en operation.
English: Serum creatinine elevations were mostly mild (>1-1.5x ULN) to moderate (>1.5-3x ULN) and observed to be reversible in nature (see table 4).
Danish: Stigningerne i serumkreatinin var oftest lette (>1-1,5 x ULN) til moderate (>1,5-3 x ULN) og blev observeret som værende reversible (se tabel 4).
English: ● Tell your doctor if you have had a different type of cancer than melanoma, as Zelboraf may cause progression of certain types of cancers.
Danish: Tidligere kræfttilfælde · Fortæl det til din læge, hvis du har haft en anden type kræft end melanom, da Zelboraf kan forårsage udvikling af visse typer kræft.
English: Variability in exposure may also occur due to differences in gastro-intestinal fluid content, volumes, pH, motility and transition time and bile composition.
Danish: Variabilitet i eksponering kan også forekomme på grund af forskelle i indholdet i den gastrointestinale væske, volumen, pH, motilitet og transitionstid og galdesammensætning.
English: Change ≥ 1 grade from baseline to any grade Change ≥ 1 grade from baseline to grade 3 or higher
Danish: Ændring ³ 1 grad fra baseline til alle grader Ændring ³ 1 grad fra baseline til grad 3 eller højere · Til grad 3 · Til grad 4
English: Figure 1: Kaplan-Meier curves of overall survival - previously untreated patients (December 20, 2012 cut-off)
Danish: Figur 1: Kaplan-Meier kurver over samlet overlevelse - tidligere ubehandlede patienter (cut-off 20. december 2012)
English: If you are taking any of these medicines (or if you are not sure), please talk to your doctor before taking Zelboraf.
Danish: Hvis du tager noget af ovenstående medicin (eller hvis du er i tvivl), så tal med lægen, før du tager Zelboraf.
English: Please tell your doctor if you are taking an oral contraceptive.
Danish: Fortæl din læge, hvis du tager orale præventionsmidler.
English: Consistent intake of vemurafenib on an empty stomach may lead to significantly lower steady state exposure than consistent intake of vemurafenib with or a short time after a meal.
Danish: Konsekvent indtagelse af vemurafenib på tom mave kan føre til signifikant lavere steadystate eksponering end konsekvent indtagelse af vemurafenib med mad eller kort tid efter et måltid.
English: During treatment, avoid exposing your skin to direct sunlight.
Danish: Undgå at udsætte din hud for direkte sollys under behandlingen.
English: Initiation of treatment with vemurafenib is not recommended in patients with QTc>500 milliseconds (ms).
Danish: Igangsættelse af behandling med vemurafenib anbefales ikke hos patienter med QTc > 500 millisekunder (ms).
English: Retinal vein occlusion, iridocyclitis
Danish: Retinal veneokklusion, iridocyclitis
English: Vemurafenib should not be used in patients with wild type BRAF malignant melanoma.
Danish: Vemurafenib bør ikke anvendes hos patienter med vildtype BRAF malignt melanom.
English: These lesions are usually removed by surgery and patients continue their treatment.
Danish: Disse læsioner bliver normalt fjernet ved en operation og patienter fortsætter deres behandling.
English: A decision must be made whether to discontinue breast-feeding or to discontinue vemurafenib therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Der skal tages en beslutning om, hvorvidt amning eller behandling med vemurafenib skal ophøre, idet der tages hensyn til fordelen af amning for barnet og fordelen af behandling for kvinden.
English: ● Tell your doctor if you observe any unusual thickening of the palms of your hands accompanied by tightening of the fingers inward or any unusual thickening of the soles of your feet which may be painful.
Danish: ● Fortæl lægen, hvis du observerer en usædvanlig fortykkelse af håndfladerne ledsaget af, at fingrene trækkes indad, eller en usædvanlig fortykkelse af fodsålen, som kan være smertefuld.
English: The population pharmacokinetic analysis indicated a 17% greater apparent clearance (CL/F) and a 48% greater apparent volume of distribution (V/F) in males than in females.
Danish: Den populationsfarmakokinetiske analyse indikerede en 17 % større tilsyneladende clearance (CL/F) og 48 % større tilsyneladende fordelingsvolumen (V/F) hos mænd i forhold til kvinder.
English: Any suspicious skin lesions should be excised, sent for dermatopathologic evaluation and treated as per local standard of care.
Danish: Alle mistænkelige hudlæsioner bør ekscideres, sendes til dermatopatologisk vurdering og behandles efter lokale behandlingsvejledninger.
English: It is highly bound to human plasma proteins in vitro (>99%).
Danish: In vitro er vemurafenib stærkt bundet til humane plasmaproteiner (> 99 %).
English: If you take more Zelboraf than you should, talk to your doctor immediately.
Danish: Hvis du har taget mere Zelboraf end foreskrevet, skal du omgående tale med din læge.
English: Concurrent administration with ipilimumab
Danish: Samtidig administration af ipilimumab
English: Vemurafenib should not be administered to pregnant women unless the possible benefit to the mother outweighs the possible risk to the foetus.
Danish: Vemurafenib bør ikke administreres til gravide kvinder, medmindre den mulige fordel for moderen opvejer den mulige risiko for fosteret.
English: ADRs which were reported in melanoma patients are listed below by MedDRA body system organ class, frequency and grade of severity.
Danish: Bivirkninger, som blev rapporteret hos patienter med melanom, er anført nedenfor efter MedDRA systemorganklasse, hyppighed og grad af alvorlighed.
English: In the human mass balance study with vemurafenib administered orally, on average 95% of the dose was recovered within 18 days.
Danish: I det humane massebalancestudie med oralt administreret vemurafenib, var der i gennemsnittet udskilt 95 % af dosis inden for 18 dage.