FrancophonIA/ELRC3.0 huggingface dataset:
English: The other objectives were to evaluate the overall response rate and duration of response.
Danish: Endvidere var ønsket at evaluere den samlede responsrate og responsvarigheden.
English: Pazopanib is not indicated for use in combination with other agents.
Danish: Pazopanib er ikke indiceret til brug i kombination med andre lægemidler.
English: Permanently discontinue pazopanib.
Danish: Seponer pazopanib permanent.
English: Patients should be monitored for hypertension early after starting treatment (no longer than one week after starting pazopanib) and frequently thereafter to ensure blood pressure control.
Danish: Patienterne skal undersøges for hypertension i starten af behandlingen (højst én uge efter initiering af pazopanib) og regelmæssigt herefter for at sikre blodtrykskontrol.
English: There are no adequate data from the use of pazopanib in pregnant women.
Danish: Der er utilstrækkelige data for anvendelse af pazopanib til gravide kvinder.
English: PRES/RPLS can present with headache, hypertension, seizure, lethargy, confusion, blindness and other visual and neurological disturbances, and can be fatal.
Danish: PRES/RPLS kan give hovedpine, hypertension, kramper, sløvhed, konfusion, blindhed og andre visuelle og neurologiske forstyrrelser og kan være dødelig.
English: Very common Decreased appetite Hypoalbuminemia f
Danish: Meget almindelig Nedsat appetit Hypoalbuminæmi f
English: Patients should be carefully monitored for clinical signs or symptoms of congestive heart failure.
Danish: Patienterne skal monitoreres omhyggeligt for kliniske tegn eller symptomer på kongestiv hjerteinsufficiens.
English: Neutropenia, thrombocytopenia and palmar-plantar erythrodysaethesia syndrome were observed more frequently in patients of East Asian descent.
Danish: Neutropeni, trombocytopeni og palmoplantar erytrodysæstesi blev set oftere hos patienter af østasiatisk oprindelse.
English: If the concomitant administration of an H2-receptor antagonist is medically necessary, pazopanib should be taken without food at least 2 hours before or at least 10 hours after a dose of an H2-receptor antagonist.
Danish: Hvis samtidig administration af en H2-receptorantagonist er nødvendig, skal pazopanib tages uden føde mindst 2 timer før eller mindst 10 timer efter dosis af H2-receptorantagonist.
English: Pazopanib should not be used during pregnancy unless the clinical condition of the woman requires treatment with pazopanib.
Danish: Pazopanib bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver behandling med pazopanib.
English: There was no consistent increase in AUC or Cmax at pazopanib doses above 800 mg.
Danish: Der var ingen konsistent øgning af AUC eller Cmax ved administration af doser på over 800 mg pazopanib.
English: - atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV).
Danish: - atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (bruges til behandling af hiv).
English: - if you have had stomach or bowel problems such as perforation (hole) or fistula (abnormal passages forming between parts of the intestine).
Danish: - hvis du har haft mave- eller tarmproblemer, f.eks. en perforation (et hul) eller fistler (dannelse af unormale passager mellem dele af tarmen).
English: For example, you could take it two hours after breakfast or one hour before lunch.
Danish: Du kan for eksempel tage Votrient 2 timer efter morgenmaden eller 1 time før frokosten.
English: Other key eligibility criteria of the VEG110727 study were: histological evidence of high or intermediate grade malignant STS and disease progression within 6 months of therapy for metastatic disease, or recurrence within 12 months of (neo) -/adjuvant therapy.
Danish: Andre hovedkvalifikationskriterier for VEG110727-studiet var: histologisk bevis på malignt STS af høj eller mellem grad og sygdomsprogression inden for 6 måneder med behandling for metastatisk sygdom eller tilbagefald inden for 12 måneder med (neo -)/adjuverende behandling.
English: Disease characteristics at initial diagnosis and at screening were balanced between the treatment arms with the majority of patients having clear cell histology and Stage IV disease.
Danish: Sygdomskarakteristika ved initial diagnose og ved screening blev balanceret mellem de to behandlingsarme med størstedelen af patienterne havende en clear-celle-histologi og stadie IV sygdom.
English: The active metabolite of irinotecan, SN-38, is a substrate for OATP1B1 and UGT1A1.
Danish: Den aktive metabolit af irinotecan, SN-38, er substrat for OATP1B1 og UGT1A1.
English: Do not drink grapefruit juice while you are being treated with Votrient as this may increase the chance of side effects.
Danish: Du må ikke drikke grapefrugtjuice, mens du er i behandling med Votrient, da det kan øge risikoen for at få bivirkninger.
English: PRES/RPLS has been reported in association with pazopanib.
Danish: PRES/RPLS er rapporteret i forbindelse med pazopanib.
English: It is not known whether pazopanib or its metabolites are excreted in human milk.
Danish: Det er ukendt, om pazopanib eller dets metabolitter bliver udskilt i human modermælk.
English: Pazopanib may have a greater impact on SN-38 disposition in subjects with the UGT1A1*28 polymorphism relative to subjects with the wild-type allele.
Danish: Pazopanib kan have en større indvirkning på SN-38-fordelingen hos personer med UGT1A1*28-polymorfisme i forhold til personer med vild-type-allel.
English: Patients were stratified by the factors of WHO performance status (WHO PS) (0 or 1) at baseline and the number of lines of prior systemic therapy for advanced disease (0 or 1 vs. 2+).
Danish: Patienterne blev stratificeret i forhold til WHO's performancestatus (WHO PS) (0 eller 1) ved baseline og antal tidligere linjer af systemisk behandling for avanceret sygdom (0 eller 1 vs 2+).
English: The clinical status of the patient and the adverse event profile of pazopanib should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Danish: Der skal tages højde for patientens kliniske status og pazopanibs bivirkningsprofil ved vurdering af patientens evne til at udføre opgaver, der kræver dømmekraft samt motoriske eller kognitive færdigheder.
English: - The other ingredients in the 200 mg and 400 mg tablets are: hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone (K30), sodium starch glycolate, titanium dioxide (E171).
Danish: - Øvrige indholdsstoffer i tabletterne på 200 mg og 400 mg er: hypromellose, macrogol 400, magnesiumstearat, mikrokrystallinsk cellulose, polysorbat 80, povidon (K30), natriumstivelsesglycolat, titandioxid (E171).
English: P value (two-sided)
Danish: P-værdi (to-sidet)
English: Elevated blood pressure levels (systolic blood pressure ≥150 mm Hg or diastolic blood pressure ≥100 mm Hg) occurred early in the course of treatment (approximately 40% of cases occurred by day 9 and approximately 90% of cases occurred in the first 18 weeks).
Danish: Forhøjet blodtryk (systolisk blodtryk ≥150 mmHg eller diastolisk blodtryk ≥100 mmHg) forekommer tidligt i behandlingsforløbet (ca. 40 % af tilfældene opstod inden dag 9 og ca. 90 % af tilfældene i løbet af de første 18 uger).
English: - Tell your doctor if you have high blood pressure.
Danish: - Fortæl det til lægen, hvis du har forhøjet blodtryk.
English: Thirteen of the 15 subjects in the pazopanib arm of the STS Phase III study had concurrent hypertension which may have exacerbated cardiac dysfunction in patients at risk by increasing cardiac after-load.
Danish: I STS fase III-studiet havde tretten af de 15 forsøgspersoner i pazopanib-armen samtidig hypertension, hvilket kan have forværret den kardielle dysfunktion hos disse risikopatienter ved at øge hjertets after-load.
English: Ninety-eight percent (98%) of subjects received prior doxorubicin, 70% prior ifosfamide, and 65% of subjects had received at least three or more chemotherapeutic agents prior to study enrolment.
Danish: Otteoghalvfems procent (98 %) af forsøgspersonerne havde tidligere fået doxorubicin, 70 % havde tidligere fået ifosfamid, og 65 % havde tidligere fået mindst tre eller flere kemoterapeutiske midler inden indskrivning i studiet.
English: Pazopanib has been shown to be embryotoxic and teratogenic when administered to rats and rabbits at exposures more than 300-fold lower than the human exposure (based on AUC).
Danish: Pazopanib har vist sig at være embryotoksisk og teratogent hos rotter og kaniner ved eksponeringer på mere end 300 gange lavere end den humane eksponering (baseret på AUC).
English: HR = hazard ratio; ITT = intent to treat; PFS = progression-free survival.
Danish: HR = hazard ratio, ITT = intent to treat, PFS = progressionsfri overlevelse.
English: Grade 3 fatigue (dose-limiting toxicity) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2000 mg and 1000 mg daily, respectively.
Danish: Grad 3 træthed (dosisbegrænsende toksicitet) og grad 3 hypertension blev hver for sig set hos 1 ud af 3 patienter, som fik henholdsvis 2000 mg og 1000 mg dagligt.
English: Pazopanib should not be used in children younger than 2 years of age because of safety concerns with regard to organ growth and maturation (see sections 4.4 and 5.3).
Danish: Pazopanib bør ikke anvendes til børn under 2 år på grund af sikkerhedsproblemer vedrørende organvækst og udvikling (se pkt.
English: Post-marketing data on safety and tolerability across all pazopanib clinical studies and from spontaneous reports have also been evaluated.
Danish: Sikkerheds- og tolerabilitetsdata rapporteret efter markedsføring fra alle kliniske studier med pazopanib og fra spontane rapporter er også undersøgt.
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom.
Danish: Glaxo Operations UK Ltd (under forretningsnavnet Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, Storbritannien
English: Effect of concomitant use of pazopanib and simvastatin
Danish: Effekt ved samtidig brug af pazopanib og simvastatin
English: Cardiac dysfunction g
Danish: Kardiel dysfunktion g
English: Reproductive, fertility and teratogenic effects
Danish: Påvirkning af reproduktionsevnen og fertiliteten samt teratogene effekter
English: Votrient can also affect how some other medicines work.
Danish: Votrient kan også påvirke anden medicins virkning.
English: If no medically acceptable alternative to a strong CYP34A inhibitor is available, the dose of pazopanib should be reduced to 400 mg daily during concomitant administration.
Danish: Hvis der ikke findes et medicinsk acceptabelt alternativ til en kraftig CYP3A4-hæmmer, bør pazopanibdosis reduceres til 400 mg daglig ved samtidig administration.
English: The usual dose is two Votrient 400 mg tablets (800 mg pazopanib) taken once a day.
Danish: Den sædvanlige dosis er to Votrient 400 mg tabletter (800 mg pazopanib), som tages én gang om dagen.
English: The primary objective of the study was progression-free survival (PFS assessed by independent radiological review); the secondary endpoints included overall survival (OS), overall response rate and duration of response.
Danish: Studiets primære mål var progressionsfri overlevelse (PFS) baseret på uafhængig radiologisk vurdering; de sekundære endepunkter omfattede samlet overlevelse (OS), samlet responsrate og responsvarighed.
English: It is not known whether the ingredients in Votrient pass into breast milk.
Danish: Det vides ikke, om indholdsstofferne i Votrient går over i modermælken.
English: Patients who carry the HLA-B*57:01 allele have an increased risk of pazopanib-associated ALT elevations.
Danish: Patienter, der bærer HLA-B*57:01-allellen har også en øget risiko for pazopanib-associeret forhøjet ALAT.
English: Since vascular endothelial growth factor (VEGF) inhibitors may impair wound healing, treatment with pazopanib should be stopped at least 7 days prior to scheduled surgery.
Danish: Da hæmmere af vaskulær endotelial vækstfaktor (VEGF) kan hæmme sårheling, skal behandlingen med pazopanib stoppes mindst 7 dage før en planlagt operation.
English: Votrient can have side effects that may affect your ability to drive or use machines.
Danish: Votrient kan give bivirkninger, der kan påvirke din evne til at føre motorkøretøjer eller betjene maskiner.
English: If the clot breaks off, it may travel to your lungs and this may be life threatening or even fatal.
Danish: Hvis blodproppen river sig løs, kan den føres med blodet til lungerne, og dette kan være livstruende og endda dødeligt.
English: Pazopanib should be discontinued if there is evidence of hypertensive crisis or if hypertension is severe and persists despite anti-hypertensive therapy and pazopanib dose reduction.
Danish: Pazopanib skal seponeres, hvis der er tegn på hypertensiv krise, eller hvis der er svær og vedvarende hypertension til trods for antihypertensiv behandling og reduktion af pazopanibdosis.
English: Potential induction of human CYP3A4 was demonstrated in an in vitro human PXR assay.
Danish: En potentiel induktion af humant CYP3A4 blev vist in vitro i en human PXR-analyse.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper)
English: The primary analysis of the primary endpoint PFS is based on disease assessment by independent radiological review in the entire study population (treatment-naïve and cytokine pre-treated).
Danish: Den primære analyse af det primære endepunkt, PFS, er baseret på en sygdomsvurdering ved en uafhængig radiologisk gennemgang af hele patientpopulationen (både behandlingsnaive og cytokin-behandlede patienter).
English: Votrient can affect heart rhythm which in some people can develop into a potentially serious heart condition known as torsade de pointes.
Danish: Votrient kan påvirke hjerterytmen, hvilket hos nogle personer kan udvikle sig til en potentiel alvorlig hjertetilstand, der er kendt som torsades de pointes.
English: Rare side effects (may affect up to 1 in 1,000 people): - inflammation of the lung (pneumonitis)
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer): - betændelseslignende reaktion (inflammation) i lungerne
English: The OS results are subject to potential bias as 54% of patients in the placebo arm also received pazopanib in the extension part of this study following disease progression.
Danish: OS-resultaterne kan være biased, idet 54 % af patienterne i placebo-armen fik pazopanib efter sygdomsprogression som en del af forlængelses-studiet.
English: The decision to resume pazopanib after surgery should be based on clinical judgement of adequate wound healing.
Danish: Beslutningen om at genoptage behandlingen med pazopanib efter operation skal baseres på en klinisk bedømmelse af, om sårhelingen er tilstrækkelig.
English: From the total of 435 patients in this study, 233 patients were treatment-naïve and 202 were second-line patients who had received one prior IL-2 or INF-based therapy.
Danish: Ud af de i alt 435 patienter i studiet, var 233 af patienterne ikke tidligere behandlet (behandlingsnaive), og 202 af patienterne var tidligere behandlet med cytokiner (IL-2-eller INFα-baseret behandling).
English: If you have high blood pressure you will be treated with medicines to reduce it.
Danish: Hvis du har forhøjet blodtryk, vil du blive behandlet med blodtrykssænkende medicin.
English: If you forget to take Votrient Do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Effects of pazopanib on other medicinal products
Danish: Pazopanibs effekt på andre lægemidler
English: - if you have had problems with bleeding, blood clots or narrowing of the arteries
Danish: - hvis du har haft problemer med blødning, blodpropper eller forsnævring af pulsårerne.
English: Before initiating pazopanib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med pazopanib bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: If the potential benefit of reinitiating pazopanib treatment is considered to outweigh the risk for hepatotoxicity, then reintroduce pazopanib at a reduced dose of 400 mg daily and perform serum liver tests weekly for 8 weeks.
Danish: Hvis fordelene ved at genoptage pazopanib-behandling overstiger risikoen for hepatotoksicitet, kan pazopanib genoptages med en reduceret dosis på 400 mg dagligt samtidig med, at der foretages en serumleverundersøgelse ugentligt i 8 uger.
English: Pazopanib should be discontinued if the patient develops nephrotic syndrome.
Danish: Pazopanib skal seponeres, hvis patienten udvikler nefrotisk syndrom.
English: Votrient may cause blood clots in the small blood vessels in the kidneys and brain accompanied by a decrease in red blood cells and cells involved in clotting (thrombotic microangiopathy, TMA).
Danish: Votrient kan forårsage blodpropper i de små blodkar i nyrerne og hjernen, ledsaget af et fald i røde blodlegemer og celler involveret i koagulering (trombotisk mikroangiopati, TMA).
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE11
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, andre antineoplastiske midler, proteinkinasehæmmere, ATC-kode: L01XE11
English: Abdominal pain a
Danish: Opkastning Abdominalsmerter a
English: Tell your doctor if you notice significant weight gain or tiredness.
Danish: Fortæl det til lægen, hvis du oplever markant vægtøgning eller træthed.
English: Photosensitivity reaction
Danish: Lysfølsomhedsreaktion
English: Animal studies indicate that male and female fertility may be affected by treatment with pazopanib (see section 5.3).
Danish: Dyreforsøg tyder på, at fertiliteten hos mænd og kvinder kan påvirkes af behandling med pazopanib (se pkt.
English: What you need to know before you take Votrient
Danish: Det skal du vide, før du begynder at tage Votrient
English: There are no animal data on the excretion of pazopanib in animal milk.
Danish: Der findes ingen data fra dyreforsøg vedrørende udskillelse af pazopanib i mælk hos dyr.
English: This can result in blurry or impaired vision.
Danish: Dette kan give sløret eller forringet syn.
English: The safety and pharmacokinetics of pazopanib in patients with moderate to severe heart failure or those with a below normal left ventricular ejection fraction (LVEF) have not been studied.
Danish: Pazopanibs sikkerhed og farmakokinetik hos patienter med moderat til svær hjerteinsufficiens eller med nedsat venstre ventrikel uddrivningsfraktion (LVEF) er ikke undersøgt.
English: Interruption of pazopanib and/or dose reduction should be combined with treatment of hypertension (if present, refer to hypertension warning section above) in patients with significant reductions in LVEF, as clinically indicated.
Danish: Pausering og/eller dosisreduktion af pazopanib skal kombineres med hypertensionsbehandling (hvis hypertension er til stede, henvises til afsnittet ovenfor med advarsler om hypertension) til patienter med signifikant reduktion i LVEF som klinisk indiceret.
English: While observed in both RCC and STS studies, the incidence was higher in the STS population (5%) than in the RCC population (2%).
Danish: Der blev set en højere incidens i STS-populationen (5 %) end i RCC-populationen (2 %).
English: - if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Danish: - hvis du har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg.
English: Votrient has no or negligible influence on the ability to drive and use machines.
Danish: Votrient påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: It cannot be excluded that pazopanib will affect the pharmacokinetics of other statins (e.g. atorvastatin, fluvastatin, pravastatin, rosuvastatin).
Danish: Det kan ikke udelukkes, at pazopanib vil påvirke farmakokinetikken af andre statiner (f.eks. atorvastatin, fluvastatin, pravastatin, rosuvastatin).
English: These include: - clarithromycin, ketoconazole, itraconazole, rifamicin, telithromycin, voriconazzole (used to treat infection).
Danish: Disse omfatter: - clarithromycin, ketoconazol, itraconazol, rifampicin, telithromycin, voriconazol (bruges til behandling af infektioner).
English: Magnesium stearate Microcrystalline cellulose Povidone (K30) Sodium starch glycolate
Danish: Magnesiumstearat Mikrokrystallinsk cellulose Povidon (K30) Natriumstivelsesglycolat
English: Of note, patients with adipocytic sarcoma were excluded from the pivotal Phase III study as in a preliminary Phase II study (VEG20002) activity (PFS at week 12) observed with pazopanib in adipocytic did not meet the prerequisite rate to allow further clinical testing.
Danish: Bemærk, patienter med adipocytisk sarkom blev ekskluderet fra det pivotale fase III-studie, da aktiviteten af pazopanib (PFS ved uge 12) ved adipocytiske sarkomer i et indledende fase II-studie (VEG20002) ikke opfyldte den forudbestemte rate til at tillade videre klinisk afprøvning.
English: Adults The recommended dose of pazopanib for the treatment of RCC or STS is 800 mg once daily.
Danish: Voksne Den anbefalede pazopanibdosis til behandling af RCC eller STS er 800 mg én gang daglig.
English: See section 4.4 for liver monitoring and dose modification for patients with drug-induced hepatotoxicity.
Danish: 4.4 for monitorering af leverfunktion og dosisjustering hos patienter med lægemiddelinduceret nedsat leverfunktion.
English: Infections occurring while you take Votrient may possibly become serious.
Danish: Infektioner, der opstår under behandling med Votrient, kan muligvis blive alvorlige.
English: Very common Hypertension Common
Danish: Meget almindelig Hypertension Almindelig
English: One of these metabolites inhibits the proliferation of VEGF-stimulated human umbilical vein endothelial cells with a similar potency to that of pazopanib, the others are 10- to 20-fold less active.
Danish: Én af disse metabolitter hæmmer proliferation af VEGF-stimulerede, humane endotelceller i vena umbilicalis i samme grad som pazopanib, mens de andre er 10 til 20 gange mindre aktive.
English: Seek medical help immediately if you get any of these symptoms.
Danish: Søg straks lægehjælp, hvis du får nogen af disse symptomer.
English: In the RCC studies of pazopanib, overall no clinically significant differences in safety of pazopanib were observed between subjects aged at least 65 years and younger subjects.
Danish: I RCC-studier med pazopanib sås ingen klinisk signifikant forskel i sikkerheden ved pazopanib mellem forsøgspersoner i alderen 65 år og derover sammenlignet med yngre forsøgspersoner.
English: If the concomitant use of a proton-pump inhibitor (PPI) is medically necessary, it is recommended that the dose of pazopanib be taken without food once daily in the evening concomitantly with the PPI.
Danish: Hvis det er nødvendigt at anvende en protonpumpehæmmer (PPI), anbefales det, at pazopanib tages uden føde én gang daglig om aftenen samtidig med PPI´en.
English: In this dataset, 133/2235 (6%) of the patients carried the HLA-B*57:01 allele (see section 4.4).
Danish: I dette datasæt bar 133/2235 (6 %) af patienterne HLA-B*57:01-allellen (se pkt.
English: Posterior reversible encephalopathy syndrome (PRES)/Reversible posterior leukoencephalopathy syndrome (RPLS)
Danish: Posterior reversibel encefalopatisyndrom (PRES)/Reversibel posterior leukoencefalopati-syndrom (RPLS)
English: The safety and efficacy of pazopanib in RCC were evaluated in a randomised, double-blind, placebo-controlled multicentre study.
Danish: Sikkerheden ved og effekten af pazopanib ved RCC er evalueret i et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie.