FrancophonIA/ELRC3.0 huggingface dataset:
English: * Includes acute kidney injury, renal impairment, and laboratory changes consistent with acute kidney injury.
Danish: * Inkluderer akutte nyreskader, nedsat nyrefunktion og ændringer i laboratorieværdier, som er konsistente med akut nyreskade.
English: Patients who develop adverse reactions should receive appropriate symptomatic treatment.
Danish: Patienter, som udvikler bivirkninger, bør modtage passende symptomatisk behandling.
English: Based on preclinical data and the human mass balance study, major part of vemurafenib is eliminated via the liver.
Danish: Baseret på prækliniske data og det humane massebalancestudie elimineres størstedelen af vemurafenib via leveren.
English: Radiation treatment
Danish: Strålebehandling
English: The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events v4.0 (CTC-AE).
Danish: Intensiteten af de kliniske bivirkninger graderet efter Common Terminology Criteria for Adverse Events v4.0
English: ● Inflammatory disease mainly affecting the skin, lung and eye (sarcoidosis)
Danish: · Inflammatorisk sygdom, der hovedsagelig påvirker hud, lunger og øjne (sarcoidose).
English: At steady state, the mean vemurafenib exposure in plasma is stable during the 24-hour interval as indicated by the mean ratio of 1.13 between the plasma concentrations before and 2-4 hours after the morning dose.
Danish: Ved steady-state er den gennemsnitlige vemurafenibeksponering i plasma stabil under 24-timers intervallet, som indikeret ved den gennemsnitlig ratio på 1,13 mellem plasmakoncentrationerne før og 2-4 timer efter morgendosis.
English: This test has CE marking and is used to assess the BRAF mutation status of DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumour tissue.
Danish: Denne test er CE-mærket og anvendes til at vurdere BRAF-mutationsstatus for DNA isoleret fra formalinfikseret, paraffin-indstøbt (FFPE) tumorvæv.
English: Based on the population PK analysis, age has no statistically significant effect on vemurafenib pharmacokinetics.
Danish: Baseret på den populationsfarmakokinetiske analyse, havde alder ingen statistisk signifikant virkning på vemurafenibs farmakokinetik.
English: Zelboraf is an anticancer medicine that contains the active substance vemurafenib.
Danish: Zelboraf er et lægemiddel mod kræft, som indeholder det aktive indholdsstof vemurafenib.
English: Hypersensitivity reactions (e)
Danish: Overfølsomhedsreaktioner (e)
English: The majority of the excised lesions reviewed by an independent central dermatopathology laboratory were classified as SCCkeratoacanthoma subtype or with mixed-keratoacanthoma features (52%).
Danish: Størstedelen af de eksicerede læsioner, som blev vurderet af et uafhængigt centralt dermatopatologisk laboratorium, blev klassificeret som SCC-keratoakantom-undertype eller med blandede keratoakantom egenskaber (52 %).
English: Hazard Ratio 95% Confidence Interval
Danish: Hazard ratio 95 % konfidensinterval
English: After cessation of vemurafenib treatment, a washout of 8 days might be necessary to avoid an interaction with a subsequent treatment.
Danish: Efter ophør af behandlingen med vemurafenib, kan en udvaskningsperiode på 8 dage være nødvendig, for at forhindre en interaktion med en efterfølgende behandling.
English: The safety and efficacy of vemurafenib has not been established in non-Caucasian patients.
Danish: Sikkerhed og virkning af vemurafenib er ikke blevet klarlagt hos patienter af ikke-kaukasisk herkomst.
English: ● A medicine called ipilimumab, another medicine for the treatment of melanoma.
Danish: · Lægemidlet ipilimumab, et andet lægemiddel, der bruges til at behandle melanom.
English: Injury, Poisoning, and Procedural Complications
Danish: Traumer, forgiftninger og behandlingskomplikationer
English: Cohort 2 Previously treated n = 56
Danish: Kohort 2 Tidligere behandling n = 56
English: Dupuytren's contracture and plantar fascial fibromatosis Dupuytren's contracture and plantar fascial fibromatosis have been reported with vemurafenib.
Danish: Dupuytrens kontraktur og plantar fasciitis fibromatosis Dupuytrens kontraktur og plantar fasciitis fibromatosis er rapporteret med vemurafenib.
English: Within each frequency grouping, ADRs are presented in order of decreasing severity and were reported using NCI-CTCAE v 4.0 (common toxicity criteria) for assessment of toxicity.
Danish: Inden for hver hyppighedsgruppe er bivirkninger præsenteret i rækkefølge efter faldende alvorlighed og blev rapporteret ved anvendelse af NCI-CTCAE v. 4.0 (fælles toksicitetskriterium) for vurdering af toksicitet.
English: Food (high fat meal) increases the relative bioavailability of a single 960 mg dose of vemurafenib.
Danish: Mad (fedtrigt måltid) øger den relative biotilgængelighed af en enkelt 960 mg dosis vemurafenib.
English: Of the specimens available from the non-clinical and clinical studies (n=920), that were mutation-positive by the cobas test and additionally analyzed by sequencing, no specimen was identified as being wild type by both Sanger and 454 sequencing.
Danish: Af de prøver, der var tilgængelige fra de ikke-kliniske og kliniske studier (n=920), og som var mutationspositive i cobas-testen samt yderligere analyseret ved sekventering, blev ingen identificeret som værende vildtype ved både Sanger og 454-sekventering.
English: While taking the medicinal product, patients should be advised to wear protective clothing and use a broad spectrum Ultraviolet A (UVA)/Ultraviolet B (UVB) sunscreen and lip balm (Sun Protection Factor ≥ 30) when outdoors to help protect against sunburn.
Danish: Under behandlingen bør patienterne rådes til at iklæde sig beskyttende tøj og bruge en bredspektret ultraviolet A (UVA)/ultraviolet B (UVB) solcreme og læbepomade (solbeskyttelsesfaktor ≥ 30), når de er udendørs, for at beskytte mod solskoldning.
English: Stratification variable
Danish: Stratificeringsvariabel
English: Breast-feeding is not recommended during treatment with Zelboraf.
Danish: Amning anbefales ikke under behandling med Zelboraf.
English: In addition ADRs originating from safety reports across all clinical trials and post-marketing sources are reported.
Danish: Derudover er der rapporteret bivirkninger, som stammer fra sikkerhedsrapporter på tværs af alle kliniske studier samt fra indberetninger efter markedsføring.
English: Sarcoidosis (j)
Danish: Sarcoidose (j)
English: ● use a lip balm and a broad spectrum sunscreen (minimum of Sun Protection Factor (SPF) 30, re-applied every 2 to 3 hours).
Danish: · brug læbepomade og en solcreme med høj beskyttelsesfaktor (minimum solbeskyttelsesfaktor (SPF) på 30, smøres på hver 2. til 3. time).
English: The effects of vemurafenib on medicinal products that are substrates of BCRP are unknown.
Danish: Vemurafenibs virkning på lægemidler, som er substrater for BCRP, er ukendt.
English: It is currently unknown whether vemurafenib at a plasma level of 100 µM observed in patients at steady state (approximately 50 µg/ml) may decrease plasma concentrations of concomitantly administered CYP2B6 substrates, such as bupropion.
Danish: Det vides ikke på nuværende tidspunkt om plasmakoncentrationer af vemurafenib på 100 µM, observeret hos patienter ved steady-state (ca. 50 µg/ml), kan formindske plasmakoncentrationerne af samtidig administrerede CYP2B6-substrater, såsom bupropion.
English: All patients treated were at least 15 years of age and weighed at least 45 kg. Three patients were treated with vemurafenib 720 mg twice daily, and three patients were treated with vemurafenib 960 mg twice daily.
Danish: Alle de behandlede patienter var mindst 15 år og vejede mindst 45 kg. 3 patienter blev behandlet med 720 mg vemurafenib to gange dagligt, og 3 patienter blev behandlet med 960 mg vemurafenib to gange dagligt.
English: There are no data regarding the use of vemurafenib in pregnant women.
Danish: Der foreligger ingen data vedrørende anvendelse af vemurafenib hos gravide kvinder.
English: Women of childbearing potential / Contraception in females Women of childbearing potential have to use effective contraception during treatment and for at least 6 months after treatment.
Danish: Kvinder i den fertile alder/Kontraception til kvinder Kvinder i den fertile alder skal bruge effektiv prævention under behandling og i mindst 6 måneder efter behandlingen.
English: Severe hypersensitivity reactions may include Stevens-Johnson syndrome, generalised rash, erythema or hypotension.
Danish: Alvorlige overfølsomhedsreaktioner kan inkludere Stevens-Johnsons syndrom, generaliseret udslæt, erytem eller hypotension.
English: Vemurafenib should be used with caution when given concomitantly or sequentially with radiation treatment.
Danish: Vemurafenib skal anvendes med forsigtighed, når det anvendes samtidig med eller sekventielt med strålebehandling.
English: ● You should have your eyes examined by your doctor while you are taking Zelboraf.
Danish: Øjenproblemer · Du bør få dine øjne undersøgt af din læge, mens du tager Zelboraf.
English: ● Allergic reactions can happen while taking Zelboraf and may be severe.
Danish: Allergiske reaktioner · Allergiske reaktioner kan forekomme, mens du tager Zelboraf, og de kan være alvorlige.
English: Two patients (1.5%) developed treatment-emergent absolute QTc values >500 ms (CTC Grade 3), and only one patient (0.8%) exhibited a QTc change from baseline of >60 ms (see section 4.4).
Danish: To patienter (1,5 %) udviklede behandlingskrævende absolutte QTc-værdier > 500 ms (CTC grad 3) og kun én patient (0,8 %) udviste en QTc-ændring fra baseline på > 60 ms (se pkt.
English: Anticipated frequency in V600 mutation-positive melanoma (t)
Danish: Antaget hyppighed i V600mutationspositivt melanom (t)
English: (neuropathy peripheral)
Danish: perifer neuropati
English: The prescriber should examine the patient monthly during and up to six months after treatment for cuSCC.
Danish: Den ordinerende læge bør undersøge patienten for cuSCC månedligt under og i op til 6 måneder efter behandlingen.
English: It is not known whether vemurafenib is excreted in human milk.
Danish: Det vides ikke om vemurafenib udskilles i human mælk.
English: It is recommended that all patients receive a dermatologic evaluation prior to initiation of therapy and be monitored routinely while on therapy.
Danish: Det anbefales, at alle patienter får en dermatologisk vurdering før igangsættelse af behandling og at patienterne monitoreres rutinemæssigt under behandlingen.
English: Rash papular, panniculitis (including erythema nodosum), keratosis pilaris
Danish: Papuløst udslæt, panniculit (inklusive erythema nodosum), keratosis pilaris
English: Carefully consider benefits and risks before administering vemurafenib to patients with a prior or concurrent cancer associated with RAS mutation.
Danish: Overvej nøje fordele og risici før administration af vemurafenib til patienter med kræftsygdomme associeret med RAS-mutationer i anamnesen.
English: Best overall confirmed response rate as assessed by independent review committee, number of responders n (%) b Two-sided 95% Clopper-Pearson Confidence Interval (CI) c Duration of response as assessed by an Independent Review Committee d Kaplan-Meier estimate e Assessed by investigator
Danish: Bedste samlede bekræftede responsrate vurderet af en uafhængig komité (IRC); antal respondenter (%) b To-sidet 95% Clopper-Pearson konfidensinterval (KI) c Responsvarighed vurderet af en uafhængig komité (IRC) d Kaplan-Meier estimat e Vurderet af investigator
English: Based on its mechanism of action, vemurafenib could cause fetal harm when administered to a pregnant woman.
Danish: Baseret på virkningsmekanismen kan vemurafenib forårsage fosterskader, når det gives til en gravid kvinde.
English: In majority of the cases, vemurafenib was maintained and the event of sarcoidosis either resolved or persisted.
Danish: I de fleste tilfælde fortsatte vemurafenib-behandlingen og sarcoidose enten forsvandt eller blev vedvarende.
English: In case of suspected overdose, vemurafenib should be withheld and supportive care initiated.
Danish: I tilfælde af mistanke om overdosering, bør vemurafenib seponeres og understøttende behandling igangsættes.
English: Please talk to your doctor as soon as possible if you notice any changes in your skin.
Danish: Tal omgående med din læge, hvis du lægger mærke til forandringer i din hud.
English: No specific studies with vemurafenib have been conducted in animals to evaluate the effect on fertility.
Danish: Ingen specifikke studier med vemurafenib er blevet udført i dyr for at vurdere virkningen på fertilitet.
English: Estimated from 16,403 melanomas with annotated BRAF codon 600 mutations in the public COSMIC database, release 71 (November 2014).
Danish: Ikke relevant (t) Estimeret udfra 16,403 melanomer med annoterede BRAF-kodon 600-mutationer i den offentlige COSMIC database,udgivelse 71 (november 2014).
English: CYP3A4 is the primary enzyme responsible for the metabolism of vemurafenib in vitro.
Danish: CYP3A4 er det primære enzym ansvarligt for metabolisering af vemurafenib in vitro.
English: A total of 675 patients were randomised to vemurafenib (n=337) or dacarbazine (n=338).
Danish: Sammenlagt blev 675 patienter randomiseret til vemurafenib (n=337) eller dacarbazin (n=338).
English: The incidence of cuSCC in vemurafenib-treated patients across studies was approximately 20%.
Danish: Hyppigheden af cuSCC hos patienter behandlet med vemurafenib var på tværs af studier ca. 20 %.
English: Although transient tumour regressions were seen, the best overall response rate (BORR) was 0% (95% CI: 0%, 46%) based on confirmed responses.
Danish: Selvom der blev set midlertidig tumorregression, var den bedste samlede responsrate 0% (95% konfidensinterval: 0% ; 46%) baseret på konfirmerede responser.
English: Due to the long half-life of vemurafenib, the full inhibitory effect of vemurafenib on a concomitant medicinal product might not be observed before 8 days of vemurafenib treatment.
Danish: På grund af vemurafenibs lange halveringstid kan den fulde hæmmende effekt af vemurafenib på et samtidig administreret lægemiddel ikke observeres før dag 8 af behandlingen med vemurafenib.
English: Non-clinical and clinical studies with retrospective sequencing analyses have shown that the test also detects the less common BRAF V600D mutations and V600K mutations with lower sensitivity.
Danish: Ikke-kliniske og kliniske studier med retrospektive sekventeringsanalyser har vist, at testen også påviser de mindre almindelige BRAFV600D-mutationer og V600K-mutationer med lavere følsomhed.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor, ATC code: L01XE15
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, proteinkinasehæmmer, ATC-kode: L01XE15
English: Before starting treatment, tell your doctor if you are taking, have recently taken or might use any other medicines (including those you have bought for yourself from a pharmacy, supermarket or health store).
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig (inklusive ikke-receptpligtig medicin købt på et apotek, et supermarked eller andre steder).
English: Treatment with vemurafenib is not recommended in patients with uncorrectable electrolyte abnormalities (including magnesium), long QT syndrome or who are taking medicinal products known to prolong the QT interval.
Danish: Behandling med vemurafenib anbefales ikke hos patienter med ukorrigerbare elektrolytanormaliteter (inklusive magnesium), langt QT-syndrom, eller som tager lægemidler, der er kendt for at forlænge QTintervallet.
English: Results from the phase I study (NO25390) in paediatric patients
Danish: Resultater fra fase I-studiet (NO25390) hos pædiatriske patienter
English: It was designed to detect the predominant BRAF V600E mutation with high sensitivity (down to 5% V600E sequence in a background of wild type sequence from FFPE-derived DNA).
Danish: Den blev designet til at påvise den altdominerende BRAF-V600E-mutation med høj følsomhed (ned til 5 % V600E-sekvens i en baggrund af vildtype-sekvens DNA stammende fra FFPE).
English: The relative proportions of vemurafenib and its metabolites were characterised in a human mass balance study with a single dose of 14C-labeled vemurafenib administered orally.
Danish: De relative andele af vemurafenib og dets metabolitter blev karakteriseret i et humant massebalancestudie med en enkeltdosis 14C-mærket vemurafenib administreret oralt.
English: If during treatment the QTc exceeds 500 ms, vemurafenib treatment should be temporarily interrupted, electrolyte abnormalities (including magnesium) should be corrected, and cardiac risk factors for QT prolongation (e.g. congestive heart failure, bradyarrhythmias) should be controlled.
Danish: Hvis QTc overstiger 500 ms under behandling, bør behandling med vemurafenib afbrydes midlertidigt, elektrolytanormaliteter (inklusive magnesium) bør korrigeres og kardielle risikofaktorer for QT-forlængelse (f.eks. kongestiv hjerteinsufficiens, bradyarytmier) bør kontrolleres.
English: The mean QTc effect remained stable between 12-15 ms beyond the first month of treatment, with the largest mean QTc prolongation (15.1 ms; upper 95% CI: 17.7 ms) observed within the first 6 months (n=90 patients).
Danish: Den gennemsnitlige QTc-virkning forblev stabil mellem 12-15 ms efter den første behandlingsmåned, med den største gennemsnitlige QTc-forlængelse (15,1 ms; øvre 95 % konfidensinterval: 17,7 ms) observeret inden for de første 6 måneder (n=90 patienter).
English: No cases of overdose have been observed with Zelboraf.
Danish: Der er ikke blevet observeret tilfælde af overdosering med Zelboraf.
English: Accumulation occurs upon multiple twice daily dosing of vemurafenib.
Danish: Akkumulering forekommer ved flere to-gange-dagligt-doseringer af vemurafenib.
English: Median overall survival was 15.9 months (95% CI: 11.6, 18.3).
Danish: Den mediane samlede overlevelse var 15,9 måneder (95 % konfidensinterval: 11,6, 18,3).
English: Patients were randomised to treatment with vemurafenib (960 mg twice daily) or dacarbazine (1000 mg/m2 on day 1 every 3 weeks).
Danish: Patienterne blev randomiseret til behandling med vemurafenib (960 mg to gange dagligt) eller dacarbazin (1000 mg/m2 på dag 1 hver 3. uge).
English: Co-administration of vemurafenib resulted in an 18% increase in AUC of S-warfarin (CYP2C9 substrate).
Danish: Samtidig administration af vemurafenib resulterede i en18 % stigning i AUC for S-warfarin (CYP2C9 substrat).
English: Vemurafenib may increase the plasma exposure of medicinal products that are P-gp substrates.
Danish: Vemurafenib kan øge plasma-eksponeringen af lægemidler, som er P-gp-substrater.
English: For patients treated with stereotactic radiotherapy (SRT) or surgery, a new RECIST-assessable brain lesion must have developed following this prior therapy.
Danish: Hos patienter, som havde fået stereotaktisk strålebehandling (SRT) eller operation, skulle en ny hjernelæsion, som kunne evalueres i henhold til RECIST, være opstået efter denne forudgående behandling.
English: Based on mechanism of action, vemurafenib may cause progression of cancers associated with RAS mutations (see section 4.8).
Danish: Baseret på virkningsmekanismen kan vemurafenib forårsage progression af kræft associeret med RAS-mutationer (se pkt.
English: The majority of patients were male (61.6%), and Caucasian (92.5%), and the median age was 54 years (range 26 to 83 years), similarly distributed between the two cohorts.
Danish: Størstedelen af patienterne var mænd (61,6%), kaukasier (92,5%), medianalderen var 54 år (mellem 26 til 83 år), og fordelingen var lige mellem de to kohorter.
English: The overall survival rate at 6 months was 77% (95% CI: 70%, 85%) and at 12 months was 58% (95% CI: 49%,
Danish: Den samlede overlevelsesrate var ved 6 måneder 77 % (95 % konfidensinterval: 70 %, 85 %) og ved 12 måneder 58 % (95 % konfidensinterval: 49 %, 67 %).
English: Table 3: ADRs occurring in patients treated with vemurafenib in the phase II or phase III study and events originating from safety reports across all trials(1) and post-marketing sources(2).
Danish: Tabel 3: Bivirkninger, som forekom hos patienter behandlet med vemurafenib i fase II- og fase III-studiet og bivirkninger, som stammer fra sikkerhedsrapporter på tværs af alle studier(1) samt fra indberetninger efter markedsføring(2).
English: What you need to know before you take Zelboraf
Danish: Det skal du vide, før du begynder at tage Zelboraf
English: Drug reaction with eosinophilia and systemic symptoms(1)(2)
Danish: Medikamentel reaktion med eosinofili og systemiske symptomer(1)(2)
English: Electrocardiogram (ECG) and electrolytes (including magnesium) must be monitored in all patients before treatment with vemurafenib, after one month of treatment and after dose modification.
Danish: Elektrokardiogram (ekg) og elektrolytter (inklusive magnesium) skal monitoreres hos alle patienter før igangsættelse af behandling med vemurafenib, efter én måneds behandling og efter dosisjustering.
English: This change may have led to the development of melanoma.
Danish: Denne ændring kan have ført til udviklingen af modermærkekræft.
English: Tell your doctor immediately if you get eye pain, swelling, redness, blurred vision or other vision changes during your treatment.
Danish: Fortæl omgående din læge, hvis du oplever øjensmerte, hævelse, rødme, sløret syn eller andre synsforandringer under din behandling.
English: Worsening of radiation treatment side effects can occur in patients who are treated with radiation before, during, or after Zelboraf treatment.
Danish: Forværring af bivirkninger af strålebehandling kan forekomme hos patienter, som får strålebehandling før, under og efter behandling med Zelboraf.
English: Dupuytren's contracture(1)(2)
Danish: Dupuytrens kontraktur(1)(2)
English: With a median follow-up of 12.9 months (range, 0.6 to 20.1), the primary endpoint of confirmed best overall response rate (CR + PR) as assessed by an independent review committee (IRC) was 53% (95% CI: 44%, 62%).
Danish: Med en median varighed af follow-up på 12,9 måneder (interval 0,6 til 20,1), var det primære endepunkt for bekræftet bedste samlede responsrate (komplet respons + partielt respons), som vurderet af en uafhængig vurderingskomité (IRC), 53 % (95 % konfidensinterval: 44 %, 62 %).
English: Recommended dose modification
Danish: Anbefalet dosisjustering
English: In cellular anti-proliferation assays the inhibitory concentration 50 (IC50) against V600 mutated cell lines (V600E, V600R, V600D and V600K mutated cell lines) ranged from 0.016 to 1.131 µM whereas the IC50 against BRAF wild type cell lines were 12.06 and 14.32 µM, respectively.
Danish: I de cellulære anti-proliferationsanalyser var hæmmende koncentration 50 (IC50) mod V600-muterede cellelinjer (V600E-,V600R-, V600D- og V600K-muterede cellelinjer) fra 0,016 til 1,131 µM, hvorimod IC50 mod BRAF vildtype-cellelinjer var henholdsvis 12,06 og 14,32 µM.
English: In the phase III study, ninety-four (28%) of 336 patients with unresectable or metastatic melanoma treated with vemurafenib were ≥ 65 years.
Danish: Ældre I fase III-studiet var 94 (28 %) ud af 336 patienter med ikke-operabelt eller metastatisk melanom behandlet med vemurafenib ≥ 65 år.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE PERFORATED BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS ENKELTDOSIS PERFORERET BLISTER
English: Plantar fascial fibromatosis(1)(2)
Danish: Plantar fasciitis fibromatosis(1)(2),
English: ● If it is less than 4 hours before your next dose, skip the missed dose.
Danish: · Hvis der er mindre end 4 timer til den næste dosis, skal du springe den glemte dosis over.
English: • To grade 4
Danish: Grad 4
English: Cases of sarcoidosis have been reported in patients treated with vemurafenib, mostly involving the skin, lung and eye.
Danish: Der har været rapporteret tilfælde af sarcoidose hos patienter, som var behandlet med vemurafenib, oftest med påvirkning af hud, lunger og øjne.