FrancophonIA/ELRC3.0 huggingface dataset:
English: Sixty-six per cent of placebo patients received post-study therapy compared to 30% of pazopanib patients.
Danish: 66 % af patienterne i placebo-armen fik behandling efter studiet sluttede sammenlignet med 30 % af patienterne i pazopanib-armen.
English: Baseline and periodic urinanalysis during treatment is recommended and patients should be monitored for worsening proteinuria.
Danish: Det anbefales at udføre urinanalyse ved behandlingsstart og periodisk i behandlingsforløbet, og patienterne skal monitoreres for tiltagende proteinuri.
English: These could be signs of a blood clot in your body (thromboembolism).
Danish: Dette kan være symptomer på en blodprop (trombe).
English: Very common Leukopenia
Danish: Meget almindelig Leukopeni
English: Deep vein thrombosis (DVT) and pulmonary embolism Votrient may cause blood clots in your veins, especially in your legs (deep vein thrombosis or DVT), which may also travel to your lungs (pulmonary embolism).
Danish: Votrient kan forårsage blodpropper i dine blodårer, især i dine ben (dyb venetrombose eller DVT), som også kan bevæge sig til dine lunger (lungeemboli).
English: Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy.
Danish: Votrient er indiceret til behandling af voksne patienter med udvalgte undertyper af avanceret bløddelssarkom (STS), der tidligere har fået kemoterapi for metastatisk sygdom eller haft progression inden for 12 måneder efter (neo-)adjuverende behandling.
English: Concomitant administration of pazopanib with uridine diphosphate glucuronosyl transferase 1A1 (UGT1A1) substrates (e.g. irinotecan) should be undertaken with caution since pazopanib is an inhibitor of UGT1A1 (see section 4.5).
Danish: Administration af pazopanib sammen med uridin-diphosphatglukuronosyl-transferase 1A1-substrater (UGT1A1-substrater) (f.eks. irinotecan) skal foretages med forsigtighed, da pazopanib hæmmer UGT1A1 (se pkt.
English: Grapefruit juice contains an inhibitor of CYP3A4 and may also increase plasma concentrations of pazopanib.
Danish: Grapefrugtjuice indeholder en hæmmer af CYP3A4 og kan også øge plasmakoncentrationen af pazopanib.
English: Common Hypothyroidism 18 (5%)
Danish: Hypotyroidisme 18 (5 %) 0
English: Results from population pharmacokinetic modelling (data from subjects with baseline CLCR values ranging from 30.8 ml/min to 150 ml/min) indicated that renal impairment is unlikely to have clinically relevant effect on pazopanib pharmacokinetics.
Danish: Resultater fra en farmakokinetisk model af populationen (data fra forsøgspersoner med kreatininclearance i intervallet 30,8 ml/minut til 150 ml/minut ved udgangsniveauet) indikerede, at nedsat nyrefunktion sandsynligvis ikke har en klinisk relevant effekt på pazopanibs farmakokinetik.
English: Signs and symptoms of stroke may include: - numbness or weakness on one side of your body - difficulty talking - headache - dizziness
Danish: Tegn og symptomer på slagtilfælde kan omfatte: - følelsesløshed eller svaghed i den ene side af din krop - problemer med at tale - hovedpine - svimmelhed
English: The efficacy and safety of pazopanib in STS were evaluated in a pivotal Phase III randomised, double-blind, placebo-controlled multicentre study (VEG110727).
Danish: Pazopanibs sikkerhed og virkning ved STS blev undersøgt i et pivotalt fase III randomiseret, dobbelt-blindet, placebokontrolleret multicenterstudie (VEG 110727).
English: In a Phase II study of 225 patients with locally recurrent or metastatic clear cell renal cell carcinoma, objective response rate was 35% and median duration of response was 68 weeks, as per independent review.
Danish: I et fase II-studie, der omfattede 225 patienter med lokalt tilbagefald eller metastatisk clear celle renalcellekarcinom, var den objektive responsrate 35 %.
English: In each treatment group, there was a slightly greater percentage of subjects in the 2+ lines of prior systemic therapy for advanced disease (58% and 55%, respectively, for placebo and pazopanib treatment arms) compared with 0 or 1 lines of prior systemic therapy (42% and 45%, respectively, for placebo and pazopanib treatment arms).
Danish: I hver behandlingsgruppe var der en lidt større procentdel af forsøgspersoner med 2+ linjer af tidligere systemisk behandling mod avanceret sygdom (58 % og 55 % i henholdsvis placebo- og pazopanib-armen) sammenlignet med 0 og 1 linjer af tidligere systemisk behandling (42 % og 45 % i henholdsvis placebo- og pazopanib-armen).
English: Not known (frequency cannot be estimated from the available data): - an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data): - en udvidelse og svækkelse af en blodårevæg eller en rift i en blodårevæg (aneurismer og arterielle dissektioner)
English: Pazopanib should be administered at least 1 hour before or 2 hours after administration of short-acting antacids.
Danish: Pazopanib skal administereres mindst 1 time før eller 2 timer efter administration af korttidsvirkende antacidum.
English: Votrient is indicated in adults for the first-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.
Danish: Votrient er indiceret til førstelinjebehandling af voksne patienter med avanceret renalcellekarcinom (RCC) og til RCC-patienter, som tidligere har fået cytokinbehandling for avanceret sygdom.
English: Clinical studies of pazopanib in combination with pemetrexed (non-small cell lung cancer [NSCLC]) and lapatinib (cervical cancer) were terminated early due to concerns over increased toxicity and/or mortality, and a safe and effective combination dose has not been established with these regimens.
Danish: Kliniske studier med pazopanib i kombination med pemetrexed (ikke-småcellet lungecancer [NSCLC]) og lapatinib (cervixcancer) blev afsluttet tidligere end planlagt pga. betænkelighed ved øget toksicitet og/eller mortalitet.
English: Interrupt pazopanib until transaminases return to Grade 1 or baseline.
Danish: Afbryd pazopanib, indtil aminotransferaserne vender tilbage til grad 1 eller udgangsniveauet.
English: Fatal events that were considered possibly related to pazopanib included gastrointestinal haemorrhage, pulmonary haemorrhage/haemoptysis, abnormal hepatic function, intestinal perforation and ischaemic stroke.
Danish: Letale bivirkninger, der blev anset for muligvis at være relateret til pazopanib, inkluderede gastrointestinal blødning, pulmonal blødning/hæmoptyse, abnorm leverfunktion, intestinal perforation og iskæmisk apopleksi.
English: Signs that your liver may not be working properly may include: - yellowing of your skin or the whites of your eyes (jaundice) - dark urine - tiredness - nausea - vomiting - loss of appetite - pain on the right side of your stomach area (abdomen) - bruising easily
Danish: Tegn på, at din lever muligvis ikke fungerer korrekt, kan omfatte: - gulfarvning af din hud eller af det hvide i dine øjne (gulsot) - mørk urin - træthed - kvalme - opkastning - appetitløshed - smerter i højre side af dit maveområde (abdomen) - tendens til blå mærker
English: In two-year carcinogenicity studies with pazopanib, there were increased numbers of liver adenomas noted in mice and duodenal adenocarcinomas noted in rats.
Danish: Karcinogenicitetsstudier med pazopanib af 2 års varighed viste et øget antal leveradenomer hos mus og duodenale adenokarcinomer hos rotter.
English: Pazopanib has not been studied in patients who had a history of haemoptysis, cerebral haemorrhage or clinically significant gastrointestinal (GI) haemorrhage in the past 6 months.
Danish: Pazopanib er ikke undersøgt hos patienter med hæmoptyse og cerebral blødning eller klinisk signifikant gastrointestinal (GI) blødning inden for de sidste 6 måneder.
English: Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Very common side effects that may show up in your blood or urine tests: - increase in liver enzymes - decrease in albumin in the blood - protein in the urine - decrease in the number of blood platelets (cells that help blood to clot) - decrease in the number of white blood cells
Danish: Meget almindelige bivirkninger, der kan ses i blod- eller urinprøver: - forhøjede leverenzymer - nedsat albumin i blodet - protein i urinen - nedsat antal blodplader (celler, der hjælper blodet til at størkne) - nedsat antal hvide blodlegemer
English: Don't take Votrient with food, as it affects the way the medicine is absorbed.
Danish: Du må ikke tage Votrient sammen med mad, da det påvirker optagelsen af Votrient.
English: In juvenile toxicity studies, when pre-weaning rats were dosed from day 9 post partum through to day 14 post partum, pazopanib caused mortalities and abnormal organ growth/maturation in kidney, lung, liver and heart, at a dose approximately 0.1 times the clinical exposure based on AUC in adult humans.
Danish: I juvenile toksicitetsstudier, hvor rotter i præ-afvænningsfasen fik pazopanib fra dag 9 til dag 14 efter fødslen, sås dødsfald og unormal organvækst/modning af nyrer, lunger, lever og hjerte ved en dosis på ca. 0,1 gang den kliniske eksponering, baseret på AUC hos voksne mennesker.
English: Very common Dysgeusia c
Danish: Dysgeusi c
English: Based on safety and tolerability data, the dose of pazopanib should be reduced to 200 mg once daily in subjects with moderate hepatic impairment (see section 4.2).
Danish: Baseret på sikkerheds- og tolerabilitetsdata anbefales det, at pazopanibdosis reduceres til 200 mg én gang daglig hos patienter med moderat nedsat leverfunktion (se pkt.
English: Concomitant treatment with strong inhibitors of CYP3A4, P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) should be avoided due to risk of increased exposure to pazopanib (see section 4.5).
Danish: Samtidig behandling med kraftige hæmmere af CYP3A4, P-glycoprotein (P-gp) eller brystcancer-resistent protein (BCRP) skal undgås på grund af risikoen for en øget pazopanib-eksponering (se pkt.
English: Thrombotic microangiopathy (TMA)
Danish: Trombotisk mikroangiopati (TMA)
English: Tell your doctor or pharmacist if you take any of these.
Danish: Fortæl det til lægen eller på apoteket, hvis du tager et eller flere af disse lægemidler.
English: Perforation and fistula
Danish: Perforering og fistler
English: Very common Hair colour change 404 (35%) 1 (<1%) Palmar-plantar erythrodysaesthesia syndrome
Danish: Ændring i hårfarve 404 (35 %) 1 (<1 %) 0 Palmoplantar erytrodysæestesi (PPE) (hånd-fodsyndrom)
English: Do not use this medicine after the expiry date (EXP) which is stated on the bottle and the carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Votrient can cause separation or tear of the lining of the back part of the eye (retinal detachment or tear).
Danish: Votrient kan forårsage løsning af eller rift i hinden bagerst i øjet (nethindeløsning eller rift i nethinden).
English: Common Dehydration Uncommon Hypomagnesaemia
Danish: Dehydrering Ikke almindelig Hypomagnesiæmi
English: Posterior reversible encephalopathy / reversible posterior leukoencephalopathy syndrome†
Danish: Posterior reversibel encefalopati/reversibel posterior leukoencefalopatisyndrom †
English: Dysgeusia, ageusia and hypogeusia d White cell count decreased, neutrophil count decreased and leukocyte count decreased e
Danish: Dysgeusi, ageusi og hypogeusi d Fald i antallet af hvide blodlegemer, fald i neutrofil- og leukocyttallet e
English: They are supplied in bottles of 30 or 60 tablets.
Danish: De fås i beholdere med 30 eller 60 tabletter.
English: Effects of other medicinal products on pazopanib
Danish: Andre lægemidlers effekt på pazopanib
English: Results from a meta-analysis using pooled data from clinical studies with pazopanib show that ALT >3x ULN was reported in 126/895 (14%) of patients who did not use statins, compared with 11/41 (27%) of patients who had concomitant use of simvastatin (p = 0.038).
Danish: Resultater fra en meta-analyse af pooled data fra kliniske studier med pazopanib, viser et forhøjet ALAT-niveau > 3 gange den øvre normalgrænse hos 126 ud af 895 patienter (14 %), der ikke fik statiner, sammenlignet med hos 11 ud af 41 patienter (27 %), der samtidig fik simvastatin (p = 0,038).
English: Some medicines may affect how Votrient works or make it more likely that you'll have side effects.
Danish: Nogle typer af medicin kan påvirke Votrients virkning eller øge sandsynligheden for, at du får bivirkninger.
English: Care should be taken when pazopanib is co-administered with other oral BCRP and P-gp substrates.
Danish: Pazopanib skal administreres med forsigtighed sammen med andre orale BCRP- og P-gp-substrater.
English: Inhibition of P-gp and/or BCRP by lapatinib likely contributed to the increased exposure to pazopanib.
Danish: Lapatinibs hæmning af P-gp og/eller BCRP bidrog sandsynligvis til den øgede pazopanib-eksponering.
English: Furthermore, inhibition of BCRP and P-gp by pazopanib in the gastrointestinal tract cannot be excluded.
Danish: Endvidere kan en hæmning af BCRP og P-gp i mave-tarmkanalen af pazopanib ikke udelukkes.
English: CYP3A4, P-gp, BCRP inhibitors Pazopanib is a substrate for CYP3A4, P-gp and BCRP.
Danish: CYP3A4-, P-gp- og BCRP-hæmmere Pazopanib er et CYP3A4-, P-gp- og BCRP-substrat.
English: TMA has been reported in clinical studies of pazopanib as monotherapy, in combination with bevacizumab, and in combination with topotecan (see section 4.8).
Danish: TMA er rapporteret i kliniske studier med pazopanib som monoterapi, i kombination med bevacizumab og i kombination med topotecan (se pkt.
English: Blood pressure should be monitored and managed promptly using a combination of anti-hypertensive therapy and dose modification of pazopanib (interruption and re-initiation at a reduced dose based on clinical judgement) (see sections 4.2 and 4.8).
Danish: Blodtrykket skal monitoreres og reguleres omgående ved en kombination af anti-hypertensiv behandling og dosistilpasning af pazopanib (pausering og genopstart med en reduceret dosis baseret på klinisk vurdering) (se pkt.
English: Administration of pazopanib with a high-fat or low-fat meal results in an approximately 2-fold increase in AUC and Cmax.
Danish: Administration af pazopanib sammen med måltider med et højt eller lavt fedtindhold resulterer i en 2-folds stigning i AUC og Cmax.
English: Co-administration with potent P-gp or BCRP inhibitors may also alter the exposure and distribution of pazopanib, including distribution into the central nervous systems (CNS).
Danish: Samtidig administration med kraftige P-gp- eller BCRP-hæmmere kan også ændre eksponeringen for og fordelingen af pazopanib, herunder fordelingen i centralnervesystemet (CNS).
English: Cardiac dysfunction/Heart failure
Danish: Kardiel dysfunktion/hjerteinsufficiens
English: Caution is advised in patients with creatinine clearance below 30 ml/min as there is no experience of pazopanib in this patient population.
Danish: Der skal udvises forsigtighed ved behandling af patienter med en kreatininclearance på under 30 ml/minut, da der ikke er erfaring med anvendelse af pazopanib hos denne patientpopulation.
English: Effect of food on pazopanib
Danish: Fødevarers indvirkning på pazopanib
English: Patients with only a mild indirect hyperbilirubinaemia, known or suspected Gilbert's syndrome, and elevation in ALT >3 x ULN should be managed as per the recommendations outlined for isolated ALT elevations.
Danish: Patienter med kendt eller formodet Gilberts syndrom med kun en let indirekte hyperbilirubinæmi og forhøjet ALAT >3 gange den øvre normalgrænse skal behandles efter anbefalingerne for isoleret forhøjet ALAT.
English: A similar proportion of patients in each arm were treatment-naïve and cytokine pre-treated (53% and 47% in pazopanib arm, 54% and 46% in placebo arm).
Danish: Hver behandlingsarm omfattede samme antal behandlingsnaive patienter som patienter, der tidligere var behandlet med cytokiner (53 % og 47 % i pazopanib-armen, 54 % og 46 % i placebo-armen).
English: Your blood pressure will be checked before you take Votrient and while you are taking it.
Danish: Dit blodtryk vil blive målt, før du får Votrient, og mens du er i behandling.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: ILD, which can be fatal, has been reported in association with pazopanib (see section 4.8).
Danish: ILD, som kan være dødelig, er blevet rapporteret i forbindelse med pazopanib (se pkt.
English: Common side effects that may show up in your blood or urine tests: - underactive thyroid gland - abnormal liver function - increase in bilirubin (a substance produced by the liver) - increase in lipase (an enzyme involved in digestion - increase in creatinine (a substance produced in muscles) - changes in the levels of other different chemicals / enzymes in the blood.
Danish: Almindelige bivirkninger, der kan ses i dine blod- eller urinprøver: - nedsat aktivitet af skjoldbruskkirtlen - unormal leverfunktion - forhøjet bilirubin-niveau (et stof, der dannes af leveren) - forhøjet lipase-niveau (et fordøjelsesenzym) - forhøjet kreatinin-niveau (et stof, der dannes i musklerne) - ændringer i niveauet af andre stoffer/enzymer i blodet.
English: Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided (see section 4.4).
Danish: Samtidig brug af pazopanib og en kraftig CYP3A4-hæmmer bør undgås (se pkt.
English: They are supplied in bottles of 30 or 90 tablets.
Danish: De fås i beholdere med 30 eller 90 tabletter.
English: Laboratory abnormalities were reported as adverse events less frequently by investigators than as indicated by laboratory value tables.
Danish: Investigatorerne indberettede sjældnere unormale laboratorieværdier som en bivirkning, end laboratorieværdi-tabellerne giver udtryk for.
English: Therefore, inhibitors and inducers of CYP3A4 may alter the metabolism of pazopanib.
Danish: Hæmmere og induktorer af CYP3A4 kan derfor ændre metaboliseringen af pazopanib.
English: Pooled data from the pivotal RCC study (VEG105192, n=290), the extension study (VEG107769, n=71), the supportive Phase II study (VEG102616, n=225) and the randomised, open-label, parallel group Phase III non-inferiority study (VEG108844, n=557) were evaluated in the overall evaluation of safety and tolerability of pazopanib (total n=1149) in subjects with RCC (see section 5.1).
Danish: Samlede data fra det centrale RCC-studie (VEG105192, n = 290), det forlængede studie (VEG107769, n = 71), det understøttende fase II-studie (VEG102616, n = 225) og det randomiserede, ublindede, parallelgruppe fase III non-inferioritets studie (VEG108844, n = 557) blev vurderet i den overordnede evaluering af sikkerheden ved og tolerancen over for pazopanib (i alt n = 1149) hos forsøgspersoner med RCC (se pkt.
English: Concomitant treatment with inducers of CYP3A4 should be avoided due to risk of decreased exposure to pazopanib (see section 4.5).
Danish: Samtidig behandling med induktorer af CYP3A4 skal undgås på grund af risikoen for en nedsat pazopanib-eksponering (se pkt.
English: QT prolongation and torsade de pointes
Danish: Forlængelse af QT-intervallet og torsades de pointes
English: Administration of a pazopanib 400 mg crushed tablet increased AUC(0-72) by 46% and Cmax by approximately 2 fold and decreased tmax by approximately 2 hours compared to administration of the whole tablet.
Danish: Administration af en knust 400 mg pazopanib-tablet øgede AUC(0-72) med 46 %, resulterede i en 2-folds stigning i Cmax og nedsatte tmax med ca. 2 timer sammenlignet med administration af en hel tablet.
English: In vitro studies suggest that pazopanib is a substrate for P-gp and BCRP.
Danish: In vitro-forsøg tyder på, at pazopanib er et P-gp-substrat og et BCRP-substrat.
English: Hyperbilirubinaemia 38 (3%) Hepatic function abnormal
Danish: Almindelig Hyperbilirubinæmi Abnorm leverfunktion 29 (3 %) Hepatotoksicitet
English: HDPE bottles with polypropylene child resistant closures containing either 30 or 90 tablets.
Danish: HDPE-beholder med børnesikret låg af polypropylen, som indeholder enten 30 eller 90 tabletter.
English: In the three smallest of these 20 subgroups, the point estimate of the hazard ratio exceeded 1.25; i.e. in subjects with no prior nephrectomy (n=186, HR=1.403, 95% CI (0.955, 2.061)), baseline LDH >1.5 x ULN (n=68, HR=1.72, 95% CI (0.943, 3.139)), and MSKCC: poor risk (n=119, HR=1.472, 95% CI (0.937, 2.313)).
Danish: I de tre mindste af disse 20 undergrupper oversteg hazad ratioens punktestimat 1,25; dvs. hos personer uden tidligere nefrektomi (n = 186, HR = 1,403, 95 % konfidensinterval (0,995-2,061)), med baseline-LDH > 1,5 x ULN (n = 68, HR = 1,72, 95 % konfidensinterval (0,943-3,139)), og MSKCC: lav risiko (n = 119, HR = 1,472, 95 % konfidensinterval (0,937-2,313)).
English: Oedema b
Danish: Ødem b
English: Table 4 Overall efficacy results in RCC by independent assessment (VEG105192)
Danish: Tabel 4 Samlede effektresultater fra RCC bedømt ved uafhængig vurdering (VEG105192)
English: Uncommon side effects (may affect up to 1 in 100 people): - stroke - temporary fall in blood supply to the brain (transient ischaemic attack) - interruption of blood supply to part of the heart or heart attack (myocardial infarction) - partial interruption of blood supply to part of the heart (myocardial ischaemia) - blood clots accompanied by a decrease in red blood cells and cells involved in clotting
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer): - slagtilfælde - midlertidigt fald i blodtilførslen til hjernen (forbigående iskæmisk anfald) - afbrydelse af blodtilførslen til en del af hjertet eller blodprop i hjertet (myokardieinfarkt) - delvis afbrydelse af blodtilførslen til en del af hjertet (myokardieiskæmi) - blodpropper, ledsaget af nedsat antal røde blodlegemer og celler involveret i blodets evne til at størkne (trombotisk mikroangiopati, TMA).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Votrient in one or more subsets of the paediatric population in the treatment of rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcoma and Ewing sarcoma family of tumours (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Votrient i en eller flere undergrupper af den pædiatriske population ved rabdomyosarkom, non-rabdomyosarkom bløddelssarkom og familien af Ewing sarkomer (se pkt.
English: HDPE bottles with polypropylene child resistant closures containing either 30 or 60 tablets.
Danish: HDPE-beholder med børnesikret låg af polypropylen, som indeholder enten 30 eller 60 tabletter.
English: When using pazopanib, baseline and periodic monitoring of electrocardiograms and maintenance of electrolytes (e.g. calcium, magnesium, potassium) within normal range is recommended.
Danish: Ved behandling med pazopanib anbefales det at udføre et EKG ved opstart og regelmæssigt i behandlingsforløbet samt at sikre, at niveauet af elektrolytter (f.eks. calcium, magnesium og kalium) holdes inden for normalområdet.
English: - certain forms of soft-tissue sarcoma, which is a type of cancer that affects the supportive tissues of the body.
Danish: - Visse former for bløddelssarkom, som er en kræfttype, der opstår i kroppens muskler, blodårer,
English: Uncommon Somnolence
Danish: Almindelig Søvnløshed
English: The primary objective of the study was to evaluate and compare the two treatment arms for progression-free survival (PFS) and the principle secondary endpoint was overall survival (OS).
Danish: Det primære formål med studiet var at evaluere og sammenligne den progressionsfrie overlevelse (PFS) i de to behandlingsarme.