FrancophonIA/ELRC3.0 huggingface dataset:
English: In VEG108844, patients (N = 1110) with locally advanced and/or metastatic RCC who had not received prior systemic therapy, were randomised to receive either pazopanib 800 mg once daily continuously or sunitinib 50 mg once daily in 6-week cycles of dosing with 4 weeks on treatment followed by 2 weeks without treatment.
Danish: I VEG108844 blev patienter (n = 1110) med lokalt avanceret og/eller metastatisk RCC, som ikke tidligere havde fået systemisk behandling, randomiseret til enten pazopanib 800 mg én gang daglig kontinuert eller sunitinib 50 mg én gang daglig i en 6-ugers cyklus med 4 uger med behandling efterfulgt af 2 uger uden behandling.
English: Gastrointestinal (GI) perforations and fistula
Danish: Gastrointestinale (GI) perforationer og fistler
English: Patients on pazopanib treatment should be observed closely for signs and symptoms of pneumothorax.
Danish: Patienter, som behandles med pazopanib, skal følges nøje for tegn og symptomer på pneumothorax.
English: Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis and discontinue pazopanib in patients developing ILD or pneumonitis.
Danish: Undersøg patienten for lungesymptomer, som kan indikere ILD/pneumonitis, og seponer pazopanib hos patienter, som udvikler ILD eller pneumonitis.
English: In vivo, pazopanib inhibited VEGF-induced VEGFR-2 phosphorylation in mouse lungs, angiogenesis in various animal models, and the growth of multiple human tumour xenografts in mice.
Danish: In vivo hæmmede pazopanib VEGF-induceret fosforylering af VEGFR-2 i muselunger, angiogenese i forskellige dyremodeller og vækst af flere humane tumor xenografter hos mus.
English: Votrient can cause severe bleeding in the digestive system (such as stomach, oesophagus, rectum or intestine), or the lungs, kidneys, mouth, vagina and brain, although this is uncommon.
Danish: Votrient kan medføre alvorlig blødning i fordøjelsessystemet (f.eks. maven, spiserøret, endetarmen eller tarmen) eller i lungerne, nyrerne, munden, vagina og hjernen, selvom dette ikke er almindeligt.
English: The safety, efficacy and quality of life of pazopanib versus sunitinib was evaluated in a randomised, open-label, parallel group Phase III non-inferiority study (VEG108844).
Danish: Sikkerhed, effekt og livskvalitet med pazopanib blev målt over for sunitinib i et randomiseret, ublindet, parallelgruppe fase III non-inferioritets studie (VEG108844).
English: Votrient is used in adults to treat: - kidney cancer that is advanced or has spread to other organs.
Danish: Votrient anvendes til voksne til behandling af: - Fremskreden nyrekræft eller nyrekræft, der har spredt sig til andre organer.
English: Male patients (including those who have had vasectomies) should use condoms during sexual intercourse while taking pazopanib and for at least 2 weeks after the last dose of pazopanib to avoid potential exposure to the medicinal product for pregnant partners and female partners of reproductive potential.
Danish: Mandlige patienter (inklusive mænd, der har fået foretaget vasektomi) skal anvende kondom under samleje så længe de tager pazopanib samt i mindst 2 uger efter sidste dosis af pazopanib for at undgå potentiel lægemiddeleksponering af en gravid partner og kvindlige partnere med reproduktivt potentiale.
English: Pazopanib has not been studied in patients who have had an event within the previous 6 months.
Danish: Pazopanib er ikke undersøgt hos patienter, som har haft en trombotisk hændelse inden for de sidste 6 måneder.
English: The median duration of follow-up of subjects (defined as date of randomisation to date of last contact or death) was similar for both treatment arms (9.36 months for placebo [range 0.69 to 23.0 months] and 10.04 months for pazopanib [range 0.2 to 24.3 months].
Danish: Medianvarigheden for opfølgning på forsøgspersonerne (defineret som datoen for randomisering til datoen for sidste kontakt eller død) var ens i de to arme (9,36 måneder for placebo [interval 0,69 til 23,0 måneder] og 10,04 måneder for pazopanib [interval 0,2 til 24,3 måneder]).
English: No significant difference in OS was observed between the two treatment arms at the final OS analysis performed after 76% (280/369) of the events had occurred (HR 0.87, 95% CI 0.67, 1.12 p=0.256).
Danish: Der blev ikke set en signifikant forskel i OS mellem de to behandlingsarme i den sidste OS-analyse, udført efter 76 % (280/369) af hændelserne var forekommet (HR 0,87, 95 % konfidensinterval 0,67-1,12, p = 0,256).
English: CYP3A4, P-gp, BCRP inducers
Danish: CYP3A4-, P-gp- og BCRP-induktorer
English: Leiomyosarcoma*
Danish: Leiomyosarkom*
English: These were reported as adverse events less frequently by investigators than as indicated by laboratory value tables.
Danish: Disse blev sjældnere rapporteret som bivirkninger af investigatorerne, end laboratorietabel-værdierne giver udtryk for.
English: P value (one-sided)
Danish: P-værdi (én-sidet)
English: A similar improvement in PFS based on investigator assessments was observed in the pazopanib arm compared with the placebo arm (in the overall ITT population HR: 0.39; 95% CI, 0.30 to 0.52, p <0.001).
Danish: En tilsvarende forbedring i PFS, baseret på investigators vurdering, blev observeret i pazopanib-armen sammenlignet med placebo-armen (i den totale ITT-population HR: 0,39; 95 % konfidensinterval, 0,30 til 0,52, p <0,001).
English: Decreased appetite and anorexia f Cardiac dysfunction, left ventricular dysfunction, cardiac failure and restrictive cardiomyopathy g
Danish: Nedsat appetit og anoreksi f Kardiel dysfunktion, venstre ventrikel dysfunktion, hjerteinsufficiens og restriktiv kardiomyopati g
English: Common Epistaxis Dysphonia
Danish: Almindelig Epistaxis Dysfoni
English: It cannot be excluded that pazopanib will affect the pharmacokinetics of substrates of OATP1B1 (e.g. statins, see “Effect of concomitant use of pazopanib and simvastatin” below).
Danish: Det kan ikke udelukkes, at pazopanib vil påvirke farmakokinetikken af OATP1B1-substrater (f.eks. statiner, se ”Effekt ved samtidig brug af pazopanib og simvastatin” nedenfor).
English: Blood pressure should be well controlled prior to initiating pazopanib.
Danish: Blodtrykket skal være velkontrolleret, inden behandling med pazopanib indledes.
English: In a randomised study comparing pazopanib and sunitinib in RCC (VEG108844), subjects had baseline and follow up LVEF measurements.
Danish: I et randomiseret studie, som sammenlignede pazopanib og sunitinib hos RCC-patienter (VEG108844), blev patienternes LVEF målt ved baseline og i forbindelse med followup.
English: The risks and benefits of pazopanib should be considered before beginning therapy in patients who have pre-existing cardiac dysfunction.
Danish: Pazopanibs fordele og risici skal overvejes inden behandling af patienter, der tidligere har haft kardiel dysfunktion.
English: Changes in heart rhythm (QT prolongation)
Danish: Ændringer i hjerterytmen (QT forlængelse)
English: A synthetic intermediate in manufacture of pazopanib, which is also present in the final drug substance in low amounts, was not mutagenic in the Ames assay but genotoxic in the mouse lymphoma assay and in vivo mouse micronucleus assay.
Danish: Et syntetisk mellemprodukt i fremstillingen af pazopanib, der også er til stede i det færdige produkt i små mængder, var ikke mutagent i Ames-testen, men genotoksisk i lymfom-assayet hos mus og i mikronukleus-assayet hos mus in vivo.
English: The following tumour types were eligible:
Danish: Følgende tumortyper var inkluderet:
English: Don't stop Votrient without advice Take Votrient for as long as your doctor recommends.
Danish: Du må ikke stoppe med at tage Votrient uden at tale med lægen først Tag Votrient i den periode, lægen har foreskrevet.
English: Votrient can increase your likelihood of having a stroke.
Danish: Votrient kan øge din sandsynlighed for at få et slagtilfælde.
English: These results indicate that the bioavailability and the rate of pazopanib oral absorption are increased after administration of the crushed tablet relative to administration of the whole tablet (see section 4.2).
Danish: Disse resultater tyder på, at biotilgængeligheden af pazopanib, og hastigheden af den orale absorption af pazopanib, øges ved administration af en knust tablet sammenlignet med administration af en hel tablet (se pkt.
English: Interstitial lung disease (ILD)/Pneumonitis
Danish: Interstitiel lungesygdom (ILD)/pneumonitis
English: In clinical studies with pazopanib, events of hypertension including newly diagnosed symptomatic episodes of elevated blood pressure (hypertensive crisis) have occurred.
Danish: I kliniske studier med pazopanib er set tilfælde af hypertension, herunder ny-diagnosticerede, symptomatiske tilfælde af forhøjet blodtryk (hypertensiv krise).
English: Clinical pharmacology studies, using pazopanib 800 mg once daily, have demonstrated that pazopanib does not have a clinically relevant effect on the pharmacokinetics of caffeine (CYP1A2 probe substrate), warfarin (CYP2C9 probe substrate), or omeprazole (CYP2C19 probe substrate) in cancer patients.
Danish: I kliniske farmakologistudier, hvor der blev administreret 800 mg pazopanib én gang daglig, er det vist, at pazopanib ikke har en klinisk relevant effekt på farmakokinetikken af koffein (CYP1A2-substrat), warfarin (CYP2C9-substrat) eller omeprazol (CYP2C19-substrat) hos patienter med cancer.
English: In vitro studies with human liver microsomes showed that pazopanib inhibited CYP enzymes 1A2, 3A4, 2B6, 2C8, 2C9, 2C19, and 2E1.
Danish: In vitro-forsøg med humane levermikrosomer viste, at pazopanib hæmmede CYP-enzymerne 1A2, 3A4, 2B6, 2C8, 2C9, 2C19 og 2E1.
English: Efficacy and safety has only been established in certain STS histological tumour subtypes (see section 5.1).
Danish: Virkning og sikkerhed er kun fastslået for bestemte histologiske STS-tumor-undertyper (se pkt.
English: A total of 369 patients with advanced STS were randomised to receive pazopanib 800 mg once daily or placebo.
Danish: I alt 369 patienter med avanceret STS blev randomiseret til at få pazopanib 800 mg én gang daglig eller placebo.
English: Investigated dose
Danish: Undersøgte dosis
English: Left ventricular dysfunction
Danish: Venstre ventrikel dysfunktion
English: Systemic exposure to pazopanib is increased when administered with food.
Danish: Den systemiske pazopanib-eksponering stiger, når pazopanib administreres sammen med mad.
English: Concomitant administration of pazopanib with esomeprazole decreases the bioavailability of pazopanib by approximately 40% (AUC and Cmax), and co-administration of pazopanib with medicines that increase gastric pH should be avoided.
Danish: Samtidig administration af pazopanib og esomeprazol nedsætter biotilgængeligheden af pazopanib med ca. 40 % (AUC og Cmax), og samtidig administration af pazopanib med medicin, der øger gastrisk pH, skal undgås.
English: Upon oral administration of a single pazopanib 800 mg dose to patients with solid tumours, maximum plasma concentration (Cmax) of approximately 19 ± 13 µg/ml was obtained after median 3.5 hours (range 1.0-11.9 hours) and an AUC0-∞ of approximately 650 ± 500 µg.h/ml was obtained.
Danish: Efter oral administration af en enkelt dosis af pazopanib på 800 mg til patienter med solide tumorer blev der opnået en maksimal plasmakoncentration (Cmax) på ca. 19 ± 13 µg/ml efter en mediantid på 3,5 timer (i intervallet 1,0-11,9 timer) og en AUC0-∞-værdi på ca. 650 ± 500 µg time/ml.
English: Don't breast-feed while taking Votrient.
Danish: Du må ikke amme, mens du tager Votrient.
English: Votrient can cause problems with your liver which may develop into serious conditions such as liver dysfunction and liver failure, which may be fatal.
Danish: Votrient kan forårsage problemer med din lever, som kan udvikle sig til alvorlige tilstande, som fx nedsat leverfunktion og leversvigt, som kan være dødelig.
English: Liver function should be monitored in all subjects receiving pazopanib, regardless of genotype or age (see section 5.1).
Danish: Leverfunktionen skal monitoreres hos alle forsøgspersoner, der får pazopanib, uanset genotype og alder (se pkt.
English: Tell your doctor or pharmacist if any of these effects become troublesome.
Danish: Fortæl det til lægen eller på apoteket, hvis en eller flere af disse bivirkninger bliver generende.
English: In a pharmacogenetic meta-analysis of data from 31 clinical studies of pazopanib administered either as monotherapy or in combination with other agents, ALT >5 x ULN (NCI CTC Grade 3) occurred in 19% of HLA-B*57:01 allele carriers and in 10% of non-carriers.
Danish: I en farmakogenetisk meta-analyse af data fra 31 kliniske studier med pazopanib administreret enten som monoterapi eller i kombination med andre lægemidler forekom ALAT > 5 x ULN (NCI CTC grad 3) hos 19 % af bærerne af HLA-B*57:01-allellen og hos 10 % af ikke-bærere.
English: The 200 mg tablets also contain iron oxide red (E172).
Danish: Votrient 200 mg tabletter indeholder endvidere rød jernoxid (E172).
English: Cases of hepatic failure (including fatalities) have been reported during use of pazopanib.
Danish: Der er indberettet tilfælde af leversvigt (herunder letale) ved brug af pazopanib.
English: Please consult your doctor or nurse for advice.
Danish: Kontakt lægen eller sundhedspersonalet for rådgivning.
English: Stop taking Votrient and seek medical help immediately if you get any of these symptoms, or if you get headache accompanied with any of these symptoms.
Danish: Stop med at tage Votrient og søg straks læge, hvis du oplever nogle af disse symptomer, eller hvis du får hovedpine i forbindelse med nogle af symptomerne.
English: Concomitant use of pazopanib and simvastatin increases the incidence of ALT elevations.
Danish: Samtidig brug af pazopanib og simvastatin øger forekomsten af et forhøjet ALAT-niveau.
English: Talk to your doctor before taking Votrient: - if you have heart disease.
Danish: Advarsler og forsigtighedsregler Kontakt lægen før du tager Votrient: - hvis du har en hjertesygdom.
English: You must look out for certain symptoms while you are taking Votrient to reduce the risk of any problems.
Danish: Du skal holde øje med bestemte symptomer, mens du er i behandling med Votrient, for at nedsætte risikoen.
English: Dose modification (decrease or increase) should be in 200 mg decrements or increments in a stepwise fashion based on individual tolerability in order to manage adverse reactions.
Danish: Dosisjusteringer (reduktion eller øgning) foretages i trin med reduktion eller øgning på 200 mg på basis af den individuelle tolerance.
English: Votrient can cause a tear (perforation) in your stomach or intestinal wall or the development of an abnormal connection between two parts of your digestive tract (a fistula).
Danish: Votrient kan forårsage en rift (perforering) i maven eller tarmvæggen eller udvikling af en unormal forbindelse mellem to dele af fordøjelseskanalen (en fistel).
English: Human paediatric patients are at increased risk for bone and teeth effects as compared to adults, as these changes, including inhibition of growth (shortened limbs), fragile bones and remodelling of teeth, were present in juvenile rats at ≥10 mg/kg/day (equal to approximately 0.1-0.2 times the clinical exposure based on AUC in adult humans) (see section 4.4).
Danish: Pædiatriske patienter har øget risiko for påvirkning af knogler og tænder i forhold til voksne, da disse forandringer, inklusive væksthæmning (kortere ekstremiteter), skrøbelige knogler og ændring af tænderne, sås hos ungrotter ved ≥10 mg/kg/dag (svarende til ca. 0,1-0,2 gange den kliniske eksponering baseret på AUC hos voksne mennesker) (se pkt.
English: What Votrient contains - The active substance is pazopanib (as hydrochloride).
Danish: Votrient indeholder: - Aktivt stof: pazopanib (som hydrochlorid).
English: Women of childbearing potential should be advised to use adequate contraception during treatment and for at least 2 weeks after the last dose of pazopanib and to avoid becoming pregnant while receiving treatment with pazopanib.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i mindst 2 uger efter den sidste dosis af pazopanib og at undgå at blive gravide under behandlingen med pazopanib.
English: Fatal perforation events have occurred.
Danish: Der er set dødelige hændelser med perforation.
English: Proliferative hepatic lesions (eosinophilic foci and adenoma) were seen in female mice at exposures 2.5 times human exposure based on AUC.
Danish: Der blev set proliferative leverlæsioner (eosinofile foci og adenomer) hos hunmus ved eksponeringer på 2,5 gange den humane eksponering (baseret på AUC).
English: The following convention has been utilised for the classification of frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
Danish: Alle typer af bivirkninger, som er rapporteret hos RCC- og STS-forsøgspersoner eller i perioden efter markedsføring, er anført nedenfor efter systemorganklasse, hyppighed og sværhedsgrad i henhold til MedDRA. Der er benyttet følgende hyppighed i henhold til MedDRA-konventionen: Meget almindelig (1/10); almindelig (1/100 til <1/10); ikke almindelig (1/1.000 til 1/100); sjælden (1/10.000 til 1/1.000); meget sjælden (1/10.000); og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Pazopanib should be used with caution in patients with a history of QT interval prolongation, in patients taking antiarrhythmics or other medicinal products that may prolong QT interval and in patients with relevant pre-existing cardiac disease.
Danish: Pazopanib skal anvendes med forsigtighed til patienter, der tidligere har haft QT-forlængelse, patienter i behandling med antiarytmika eller andre lægemidler, som kan medføre QT-forlængelse samt til patienter med eksisterende hjertesygdom.
English: Other observed effects include body weight loss, diarrhoea and/or morbidity that were either secondary to local gastrointestinal effects caused by high local mucosal medicinal product exposure (monkeys) or pharmacological effects (rodents).
Danish: Herudover blev observeret vægttab, diarré og/eller morbiditet, der enten var sekundære til lokale gastrointestinale påvirkninger, som følge af en høj lokal eksponering for lægemidlet i slimhinderne (aber) eller farmakologiske effekter (gnavere).
English: †Treatment-related adverse reaction reported during post-marketing period (spontaneous case reports and serious adverse reactions from all pazopanib clinical studies).
Danish: †Behandlingsrelaterede bivirkninger rapporteret efter markedsføring (spontane case-rapporter og alvorlige bivirkninger fra alle kliniske studier med pazopanib).
English: When post-weaning rats were dosed from day 21 post partum to day 62 post partum, toxicological findings were similar to adult rats at comparable exposures.
Danish: Når rotter i post-afvænningsfasen fik pazopanib fra dag 21 til dag 62 efter fødslen, sås de samme toksikologiske fund som ved sammenlignelige eksponeringer hos voksne rotter.
English: Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family (e.g. itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase pazopanib concentrations.
Danish: Samtidig administration af pazopanib og andre kraftige hæmmere af CYP3A4-familien (f.eks. itraconazol, clarithromycin, atazanavir, indinavir, nefazodon, nelfinavir, ritonavir, saquinavir, telithromycin og voriconazol) kan øge koncentrationen af pazopanib.
English: Care should be taken when pazopanib is co-administered with substrates of UGT1A1.
Danish: Der skal udvises forsigtighed, når pazopanib administreres sammen med UGT1A1-substrater.
English: Patients (N = 435) with locally advanced and/or metastatic RCC were randomised to receive pazopanib 800 mg once daily or placebo.
Danish: Patienter (n = 435) med lokal avanceret og/eller metastatisk RCC blev randomiseret til at få 800 mg pazopanib én gang daglig eller placebo.
English: Overall Survival Median (months) (95% CI)
Danish: Samlet overlevelse Median (måneder) (95 % konfidensinterval)
English: Effects included reduced female fertility, increased pre- and post-implantation loss, early resorptions, embryo lethality, decreased foetal body weight and cardiovascular malformation.
Danish: Pazopanib medførte nedsat fertilitet hos hunner, øget tab af pre- og post-implantation, tidlige resorptioner, embryoletalitet, nedsat føtal vægt og kardiovaskulære misdannelser.
English: Your doctor will monitor your blood pressure while you are taking Votrient.
Danish: Din læge vil overvåge dit blodtryk, mens du tager Votrient.
English: The performance status (ECOG) was similar between the pazopanib and placebo groups (ECOG 0: 42% vs. 41%, ECOG 1: 58% vs. 59%).
Danish: Patienternes performancestatus (ECOG) var ens i pazopanib-gruppen og i placebogruppen (ECOG 0: 42 % i forhold til 41 %, ECOG 1: 58 % i forhold til 59 %).
English: Blood and lymphatic system disorders f
Danish: Blod og lymfesystem f
English: Dosing recommendations in hepatically impaired patients are based on pharmacokinetic studies of pazopanib in patients with varying degrees of hepatic dysfunction (see section 5.2).
Danish: Doseringsanbefalinger til patienter med nedsat leverfunktion er baseret på farmakokinetiske studier af pazopanib til patienter med varierende grader af hepatisk dysfunktion (se pkt.
English: Symptoms of infections may include: - fever - flu-like symptoms such as cough, tiredness and body aches that do not go away - shortness of breath and/or wheezing - pain while urinating - cuts, scrapes or wounds that are red, warm, swollen or painful Seek medical help immediately if you get any of these symptoms.
Danish: Symptomer på infektioner kan omfatte: - feber - influenza-lignende symptomer som fx hoste, træthed og kropssmerter, der ikke går væk - stakåndethed og/eller hvæsende vejrtrækning - smerter, når du tisser - rifter, hudafskrabninger eller sår der er røde, varme, hævede eller smertefulde Søg straks lægehjælp, hvis du får nogen af disse symptomer.
English: Pooled data from the pivotal STS study (VEG110727, n=369) and the supportive Phase II study (VEG20002, n=142) was evaluated in the overall evaluation of safety and tolerability of pazopanib (total safety population n=382) in subjects with STS (see section 5.1).
Danish: Samlede data fra det pivotale STS-studie (VEG110727, n = 369) og det understøttende fase II-studie (VEG20002, n = 142) blev vurderet i den overordnede evaluering af sikkerhed og tolerabilitet af pazopanib (i alt n = 382) hos forsøgspersoner med STS (se pkt.
English: Table 7 Median steady-state pazopanib pharmacokinetics measured in subjects with hepatic impairment.
Danish: Tabel 7 Median steady-state farmakokinetik for pazopanib målt hos patienter med nedsat leverfunktion
English: PFS Overall Median (months) (95% CI)
Danish: PFS Samlet Median (måneder) (95 % konfidensinterval)
English: Blurry or impaired vision
Danish: Uskarpt eller forringet syn
English: Do not break or crush the tablets as this affects the way the medicine is absorbed and may increase the chance of side effects.
Danish: Tabletterne må ikke deles eller knuses, da dette påvirker optagelsen af Votrient og kan øge risikoen for bivirkninger.
English: Table 1 Dose modifications for drug-induced hepatotoxicity
Danish: Tabel 1 Dosisjusteringer ved lægemiddelinduceret nedsat leverfunktion
English: Pazopanib is an inhibitor of the uridine diphosphoglucuronosyl-transferase 1A1 (UGT1A1) enzyme in vitro.
Danish: Pazopanib hæmmer uridin-diphosphatglukuronosyl-transferase 1A1- (UGT1A1-) enzymet in vitro.
English: The majority of these cases were Palmar-plantar erythrodysaesthesia syndrome d Venous thromboembolic events - includes Deep vein thrombosis, Pulmonary embolism and Thrombosis terms e
Danish: Størstedelen af disse tilfælde var palmoplantar erytrodysæstesi-syndrom d Venøs tromboembolisk bivirkning - inkluderer dyb venetrombose, lungeemboli og trombose-termer e
English: Tablet coating Hypromellose Iron oxide red (E172) Macrogol 400
Danish: Tabletovertræk Hypromellose Rød jernoxid (E 172) Macrogol 400