FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, published studies on Ferriprox together with deferoxamine reported greater reductions in blood ferritin levels when both medicines were used in combination compared with using either medicine on its own.
Danish: Offentliggjorte studier om anvendelsen af Ferriprox sammen med deferoxamin har desuden vist større fald i jernniveauerne , når begge lægemidler blev taget sammen, end når de blev taget hver for sig.
English: How is Ferriprox used?
Danish: Hvordan anvendes Ferriprox?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ferriprox have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Ferriprox.
English: Ferriprox is an ‘iron chelator' (a substance that attaches to iron) that is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major.
Danish: Lægemidlet anvendes til behandling af jernophobning (overskud af jern i kroppen) hos patienter med thalassæmi major.
English: How does Ferriprox work?
Danish: Hvordan virker Ferriprox?
English: What benefits of Ferriprox have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Ferriprox?
English: It is not yet known how well it works in this age group.
Danish: Det vides ikke på nuværende tidspunkt, hvor godt det virker hos denne aldersgruppe.
English: Median PFS was 11.9 months.
Danish: Median PFS var 11,9 måneder.
English: This is the maximum dose per day.
Danish: Dette er den maksimale dosis pr. dag.
English: This is known as a hypertensive crisis.
Danish: Dette er kendt som en hypertensiv krise.
English: Take Votrient at about the same time each day.
Danish: Tag Votrient på omtrent samme tidspunkt hver dag.
English: The following terms have been combined:
Danish: Følgende begreber er blevet kombineret:
English: Conditions you need to look out for
Danish: Tilstande, som du skal holde øje med
English: Date of first authorisation: 14 June 2010 Date of latest renewal: 08 January 2018
Danish: Dato for første markedsføringstilladelse: 14. juni 2010 Dato for seneste fornyelse: 8. januar 2018
English: Subgroup analyses of PFS were performed for 20 demographic and prognostic factors.
Danish: Undergruppeanalyser af PFS blev udført for 20 demografiske og prognostiske faktorer.
English: Your treatment will be restarted when the wound has adequately healed.
Danish: Behandlingen genoptages, når såret er helet tilstrækkeligt.
English: Votrient is not recommended for people aged under 18.
Danish: Votrient anbefales ikke til personer under 18 år.
English: The risks of these problems may be higher for people with an existing heart problem, or who are taking other medicines.
Danish: Risikoen for disse problemer kan være højere for personer, som allerede har hjerteproblemer eller som tager andre lægemidler.
English: Your doctor will inform you of the results of the blood tests
Danish: Lægen vil informere dig om resultaterne af dine blodprøver
English: Periodic testing should then continue after month 4.
Danish: Efter måned 4 fortsættes med periodiske undersøgelser.
English: One subject did not recover and follow-up data were not available for the other 5 subjects.
Danish: Én forsøgsperson kom sig ikke, og follow-up data for de sidste 5 forsøgspersoner var ikke tilgængelige.
English: - Tell your doctor if you are pregnant or planning to get pregnant.
Danish: - Fortæl det til lægen, hvis du er gravid eller planlægger at blive gravid.
English: 09400 Aranda De Duero, Burgos Spain
Danish: 09400 Aranda De Duero, Burgos Spanien
English: Your doctor will decide whether Votrient is suitable for you.
Danish: Lægen vil afgøre, om Votrient er egnet til dig.
English: - nefazodone (used to treat depression).
Danish: - nefazodon (bruges til behandling af depression).
English: Combination with other systemic anti-cancer therapies
Danish: Kombination med anden systemisk anti-cancer-terapi
English: You may need extra tests to check that your heart and liver are working properly.
Danish: Det kan være nødvendigt at foretage nogle ekstra undersøgelser for at kontrollere, om dit hjerte og din lever fungerer, som de skal.
English: Swallow the tablets whole with water, one after the other.
Danish: Tabletterne skal synkes hele med vand, én ad gangen.
English: Risk factors
Danish: Risikofaktorer
English: Frequency (all grades)
Danish: Hyppighed (alle grader)
English: Tell your doctor if you notice any unusual changes in your heart beat, such as beating too fast or too slow.
Danish: Fortæl det til lægen, hvis du bemærker usædvanlige ændringer i dine hjerteslag, f.eks. at hjertet slår for hurtigt eller for langsomt.
English: It works by preventing the activity of proteins that are involved in the growth and spread of cancer cells.
Danish: Det virker ved at forhindre aktiviteten af proteiner, der er involveret i kræftcellers udvikling og evne til at sprede sig.
English: Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly patients cannot be ruled out.
Danish: Med den nuværende kliniske erfaring er der ikke set forskelle i respons mellem ældre og yngre patienter, men det kan ikke udelukkes, at nogle ældre patienter har en større følsomhed.
English: - simvastatin and possibly other statins (used to treat high cholesterol levels).
Danish: - simvastatin og muligvis også andre statiner (bruges til behandling af forhøjet kolesteroltal).
English: Votrient with food and drink
Danish: Brug af Votrient sammen med mad og drikke
English: Overall efficacy results are summarised in Table 5.
Danish: Samlede effektresultater er vist i tabel 5.
English: The 95% confidence intervals for all subgroups include a hazard ratio of 1.
Danish: 95 % konfidensintervallet inkluderede en hazard ratio på 1 for alle undergrupperne.
English: Categories have been assigned based on absolute frequencies in the clinical trial data.
Danish: Kategorierne er tildelt på basis af absolutte hyppigheder fra data fra de kliniske studier.
English: If you are going to have an operation
Danish: Hvis du skal opereres
English: Stop taking Votrient and seek medical help immediately if you develop hypertensive crisis.
Danish: Stop med at tage Votrient og søg straks lægehjælp, hvis du udvikler hypertensiv krise.
English: Titanium dioxide (E171)
Danish: Titandioxid (E 171)
English: Investigations h
Danish: Undersøgelser h
English: Medicinal products that raise gastric pH
Danish: Lægemidler, der øger gastrisk pH
English: Votrient treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products.
Danish: Behandling med Votrient må kun indledes af en læge med erfaring i administration af lægemidler til behandling af cancer.
English: Cases of serious infections (with or without neutropenia), in some cases with fatal outcome, have been reported.
Danish: Tilfælde af alvorlige infektioner (med eller uden neutropeni), i nogle tilfælde med letal udgang, er rapporteret.
English: Demographic characteristics were similar between the treatment arms.
Danish: Demografiske karakteristika var ens for begge behandlingsarme.
English: Not known Not known Not known
Danish: Ikke kendt Ikke kendt Ikke kendt
English: Exposure at a 200 mg dose is markedly reduced, though highly variable, in these patients, with values considered insufficient to obtain a clinically relevant effect.
Danish: Eksponeringen ved en dosis på 200 mg er markant reduceret, men stærkt variabel hos disse patienter med værdier, der anses for at være utilstrækkelige til at opnå en relevant klinisk effekt.
English: - if you have had heart failure or a heart attack.
Danish: - hvis du har haft hjertesvigt eller et hjertetilfælde.
English: Symptoms include shortness of breath or cough that will not go away.
Danish: Symptomerne inkluderer åndenød eller hoste, der ikke går væk.
English: No statistical differences were observed between treatment groups for Global Quality of Life using EORTC QLQ-C30 and EuroQoL EQ-5D.
Danish: Der blev ikke observeret nogen statistisk forskel mellem behandlingsgrupperne i forbindelse med vurderingen af livskvaliteten (Global Quality of Life), vurderet ved hjælp af EORTC QLQ-C30 og EuroQoL EQ-5D.
English: * - treatment-naïve and cytokine pre-treated populations
Danish: * - behandlingsnaiv og cytokin-behandlet population.
English: Possible side effects (including possible serious side effects under the relevant frequency category).
Danish: Bivirkninger (herunder alvorlige bivirkninger under den relevante frekvenskategori)
English: Infections (with or without neutropenia)†
Danish: Almindelig Infektioner (med eller uden neutropeni)†
English: - Avoid driving or using machines if you feel dizzy, tired or weak, or if your energy levels are low.
Danish: - Lad være med at føre motorkøretøjer eller betjene maskiner, hvis du føler dig svimmel, træt eller svag, eller hvis dit energiniveau er lavt.
English: Pazopanib is for oral use.
Danish: Pazopanib er til oral anvendelse.
English: High blood pressure and Votrient
Danish: Højt blodtryk og Votrient
English: Patients should avoid driving or using machines if they feel dizzy, tired or weak.
Danish: Patienter skal undgå at føre motorkøretøj eller betjene maskiner, hvis de føler sig svimle, trætte eller svage.
English: In the cytokine pre-treated subgroup, the majority (75%) had received interferon-based treatment.
Danish: I sub-gruppen af cytokin-behandlede patienter, havde størstedelen (75 %) fået interferon-baseret behandling.
English: In such cases there should be close attention to adverse drug reaction, and further dose reduction may be considered if possible drug-related adverse events are observed.
Danish: I sådanne tilfælde skal der være særlig opmærksomhed på bivirkninger, og yderligere dosisreduktion skal overvejes, hvis der observeres potentielt lægemiddelrelaterede bivirkninger.
English: 99% of patients (243/246) enrolled in the STS Phase III study, including the 15 subjects, received anthracycline.
Danish: 99 % af patienterne (243/246), der var indskrevet i STS fase III-studiet, inklusive de 15 forsøgspersoner, fik antracyklin.
English: Votrient is not recommended if you are pregnant.
Danish: Votrient bør ikke anvendes, hvis du er gravid.
English: - If you do become pregnant during treatment with Votrient, tell your doctor.
Danish: - Hvis du bliver gravid under behandlingen med Votrient, skal du fortælle det til lægen.
English: Your doctor may need to reduce your dose if you get side effects.
Danish: Lægen kan nedsætte din dosis, hvis du får bivirkninger.
English: Votrient can raise your blood pressure.
Danish: Votrient kan øge dit blodtryk.
English: The safety and efficacy of pazopanib in children aged 2 to 18 years of age have not yet been established.
Danish: Pazopanibs sikkerhed og virkning hos børn i alderen 2 til 18 år er endnu ikke klarlagt.
English: Tell your doctor if you notice any change in your vision.
Danish: Fortæl det til lægen, hvis du oplever ændringer ved dit syn.
English: The effect of Votrient during pregnancy is not known.
Danish: Votrients virkning under graviditet kendes ikke.
English: Pregnancy/ Contraception in males and females
Danish: Graviditet/kontraception hos mænd og kvinder
English: Table 2 Treatment-related adverse reactions reported in RCC studies (n = 1149) or during post-marketing period
Danish: Tabel 2 Behandlingsrelaterede bivirkninger rapporteret i RCC-studier (n = 1149) eller i perioden efter markedsføring
English: All patients had clear cell histology or predominantly clear cell histology.
Danish: Alle patienter havde en clear celle-histologi eller en overvejende clear celle-histologi.
English: For patients who responded to treatment, the median time to response was 11.9 weeks and the median duration of response was 58.7 weeks as per independent review (VEG105192).
Danish: For de patienter, der responderede på behandlingen, var mediantiden til respons 11,9 uger, og medianvarigheden af respons var 58,7 uger bedømt ved en uafhængig gennemgang (VEG105192).
English: Check with your doctor if you think this applies to you.
Danish: Tal med lægen, hvis du mener, at dette gælder for dig.
English: Hypertensive crisis (sudden and severe rise in blood pressure) Votrient can on occasion cause a sudden and severe rise in blood pressure.
Danish: Hypertensiv krise (pludselig og alvorlig blodtryksstigning) Votrient kan til tider forårsage en pludselig og alvorlig blodtryksstigning.
English: The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysm and/or artery dissections.
Danish: Brug af VEGF-hæmmere hos patienter med eller uden hypertension kan fremme dannelse af aneurismer og/eller arterielle dissektioner.
English: Based on the rodent-specific pathogenesis and mechanism for these findings, they are not considered to represent an increased carcinogenic risk for patients taking pazopanib.
Danish: Baseret på den gnaverspecifikke patogenese og mekanisme for disse fund anses de ikke for at repræsentere en øget karcinogen risiko hos patienter, der tager pazopanib.
English: Don't take Votrient with food.
Danish: Du må ikke tage Votrient sammen med mad.
English: The primary objective of this study was to evaluate and compare PFS in patients treated with pazopanib to those treated with sunitinib.
Danish: Det primære mål med dette studie var at evaluere og sammenligne PFS hos patienter behandlet med pazopanib i forhold til patienter behandlet med sunitinib.
English: - if you have liver disease.
Danish: - hvis du har en leversygdom.
English: Not all pack sizes or tablet strengths may be available in your country.
Danish: Ikke alle pakningsstørrelser eller tabletstyrker er nødvendigvis markedsført i dit land.
English: Binding of pazopanib to human plasma protein in vivo was greater than 99% with no concentration dependence over the range of 10-100 g/ml.
Danish: Binding af pazopanib til humant plasmaprotein in vivo var over 99 %, og der var ingen koncentrationsafhængighed i intervallet 10-100 g/ml.
English: Table 3 Treatment-related adverse reactions reported in STS studies (n=382)
Danish: Tabel 3 Behandlingsrelaterede bivirkninger rapporteret i STS-studier (n = 382)
English: The four principle pazopanib metabolites account for only 6% of the exposure in plasma.
Danish: Pazopanibs fire hovedmetabolitter bidrager kun til 6 % af eksponeringen i plasma.
English: The dose of pazopanib should not exceed 800 mg.
Danish: Dosis af pazopanib må ikke overskride 800 mg.
English: The majority of patients had either favourable (39%) or intermediate (54%), MSKCC (Memorial Sloan Kettering Cancer Centre) / Motzer prognostic factors.
Danish: Størstedelen af patienterne havde enten gunstige (39 %) eller intermediære (54 %) MSKCC- (Memorial Sloan Kettering Cancer Centre)/Motzer-prognostiske faktorer.
English: The recommendations for how PPIs and H2-receptor antagonists are co-administered are based on physiological considerations.
Danish: Anbefalinger for samtidig administration af PPI´er og H2-receptorantagonister er baseret på fysiologiske overvejelser.
English: There are limited data on the use of pazopanib in patients aged 65 years and older.
Danish: Der foreligger begrænsede data om brugen af pazopanib til patienter på 65 år og derover.
English: The film-coated tablets should be taken whole with water and not broken or crushed (see section 5.2).
Danish: De filmovertrukne tabletter skal tages hele med vand og må ikke deles eller knuses (se pkt.
English: Results indicate that less than 4% of an orally administered pazopanib dose is excreted in the urine as pazopanib and metabolites.
Danish: Resultater tyder på, at mindre end 4 % af en oralt administreret dosis af pazopanib udskilles i urinen som pazopanib og metabolitter.
English: AUC (0-24) (µg x hr/ml)
Danish: AUC (0-24) (µg x time/ml)
English: Median (weeks)
Danish: Median (uger)
English: Extremadura, 3, 09400 Aranda De Duero, Burgos, Spain Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Danish: Extremadura, 3, 09400 Aranda De Duero, Burgos, Spanien Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Storbritannien
English: In addition, concomitant use of pazopanib and other statins should be undertaken with caution as there are insufficient data available to assess their impact on ALT levels.
Danish: Herudover bør samtidig administration af pazopanib og andre statiner ske med forsigtighed, da data er utilstrækkelige til at kunne afgøre påvirkningen af ALAT-niveauet.
English: Cases of hyperglycaemia have been observed during concomitant treatment with ketoconazole.
Danish: Der er observeret tilfælde af hyperglykæmi ved samtidig behandling med ketoconazol.
English: VEG108844 achieved its primary endpoint of PFS and demonstrated that pazopanib was non-inferior to sunitinib, as the upper bound of the 95% CI for the hazard ratio was less than the protocol-specified non-inferiority margin of 1.25.
Danish: VEG108844 opnåede det primære endepunkt med hensyn til PFS og demonstrerede at pazopanib var non-inferior i forhold til sunitinib, idet det øvre bånd af 95 % konfidensintervallet for hazard ratio var mindre end den protokol specificerede non-inferioritets margen på 1,25.
English: Moreover it should not be used in children younger than 2 years of age because of safety concerns.
Danish: Votrient må ikke anvendes til børn under 2 år på grund af betænkeligheder omkring sikkerheden.
English: not known not known not known
Danish: Ikke kendt Ikke kendt
English: Prior anthracycline therapy may be a risk factor for cardiac dysfunction.
Danish: Tidligere antracyklin-behandlig kan være en risikofaktor for kardiel dysfunktion.
English: The majority of these cases describe mucositis f Frequency is based on laboratory value tables from VEG110727 (N=240).
Danish: Størstedelen af disse tilfælde beskriver mucositis f Hyppigheden er baseret på laboratorietabel-værdier VEG110727 (n = 240).
English: PFS Overall* ITT
Danish: PFS Samlet* ITT
English: Within each system organ class, adverse reactions with the same frequency are presented in order of decreasing seriousness.
Danish: Inden for hver systemorganklasse er bivirkninger med den samme hyppighed opstillet efter, hvor alvorlige de er.
English: Your doctor will stop Votrient at least 7 days before your operation as it may affect wound healing.
Danish: Lægen vil stoppe din behandling med Votrient mindst 7 dage før din operation, da Votrient kan påvirke sårhelingen.
English: Daily dosing results in 1.23- to 4-fold increase in AUC0-T.
Danish: Daglig dosering resulterer i en øgning af AUC0-T på 1,23 til 4 gange.
English: Endpoints/Study population
Danish: Endepunkter/studiepopulation
English: Endpoints / study population
Danish: Endepunkter / studiepopulation
English: Peripheral sensory neuropathy
Danish: Perifer sensorisk neuropati
English: However, the UGT1A1 genotype was not always predictive of the effect of pazopanib on SN-38 disposition.
Danish: Dog var UGT1A1-genotypen ikke altid prædiktiv for pazopanibs indvirkning på SN-38-fordelingen.
English: In the majority of the cases, isolated increases in ALT and AST have been reported, without concomitant elevations of alkaline phosphatase or bilirubin.
Danish: I de fleste tilfælde blev der rapporteret om isolerede stigninger i niveauet af ALAT og ASAT uden samtidige stigninger i niveauet af basisk fosfatase eller bilirubin.
English: Patients should be monitored until return to Grade 1 or baseline.
Danish: Patienterne skal monitoreres, indtil de vender tilbage til grad 1 eller udgangsniveauet.
English: This can result in weight increase and tiredness.
Danish: Det kan medføre vægtøgning og træthed.
English: Mild, indirect (unconjugated) hyperbilirubinaemia may occur in patients with Gilbert's syndrome.
Danish: Let, indirekte (ukonjugeret) hyperbilirubinæmi kan forekomme hos patienter med Gilberts syndrom.
English: Fertility may be affected by treatment with Votrient.
Danish: Frugtbarheden kan påvirkes ved behandling med Votrient.
English: This can result in a very fast heartbeat causing a sudden loss of consciousness.
Danish: Dette kan resultere i en meget hurtig hjerterytme (puls) og medføre pludseligt bevidsthedstab.
English: Votrient can lower the amount of thyroid hormone produced in your body.
Danish: Votrient kan nedsætte mængden af det hormon, der produceres i skjoldbruskkirtlen i kroppen.
English: Do not take Votrient - if you are allergic to pazopanib or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Votrient: - hvis du er allergisk over for pazopanib eller et af de øvrige indholdsstoffer i Votrient (angivet i punkt 6).
English: Table 5 Overall efficacy results (VEG108844)
Danish: Tabel 5 Samlede effektresultater (VEG108844)
English: Tablet coating Hypromellose Macrogol 400
Danish: Tabletovertræk Hypromellose Macrogol 400
English: Votrient can make some conditions worse or cause serious side effects.
Danish: Votrient kan forværre nogle tilstande eller give alvorlige bivirkninger.
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street
Danish: Glaxo Operations UK Ltd (under forretningsnavnet Glaxo Wellcome Operations) Priory Street
English: The following tumour types were not eligible:
Danish: Følgende tumortyper var ikke inkluderet:
English: OS Overall ITT
Danish: OS Overordnet ITT
English: PFS Overall ITT
Danish: PFS Overordnet ITT
English: Patients over 60 years of age may be at greater risk for mild (>3 x ULN) to severe (>8 x ULN) elevation of ALT.
Danish: Patienter over 60 år kan have en større risiko for let (>3 x den øvre normalgrænse) til alvorlig (>8 x den øvre normalgrænse) stigning i ALAT.
English: Pazopanib doses up to 2000 mg have been evaluated in clinical studies.
Danish: Pazopanib er blevet undersøgt i doser på op til 2000 mg i kliniske studier.
English: Some patients however may have systemic pazopanib exposure greater than what has been observed after administration of 800 mg pazopanib alone.
Danish: Den systemiske eksponering af pazopanib kan dog hos nogle patienter være større end den, der er blevet observeret efter administration af 800 mg pazopanib alene.
English: Based on in vitro IC50 and in vivo plasma Cmax values, pazopanib metabolites GSK1268992 and GSK1268997 may contribute to the net inhibitory effect of pazopanib towards BCRP.
Danish: På basis af in vitro IC50-værdier og in vivo Cmax-værdier i plasma kan pazopanib-metabolitterne GSK1268992 og GSK1268997 bidrage til pazopanibs hæmmende effekt af BCRP.
English: Votrient is a type of medicine called a protein kinase inhibitor.
Danish: Votrient tilhører en gruppe af medicin, der kaldes proteinkinasehæmmere.
English: Four of the 15 subjects had full recovery (within 5% of baseline) and 5 had partial recovery (within the normal range, but >5% below baseline).
Danish: Fire af de 15 forsøgspersoner kom sig helt (inden for 5 % af udgangsniveauet), og 5 havde delvis bedring (inden for normalområdet, men >5 % under udgangsniveauet).
English: Pazopanib Placebo HR (95% CI)
Danish: Pazopanib Placebo HR (95 % konfidensinterval)
English: - medicines that reduce stomach acid.
Danish: - medicin, som nedsætter mængden af mavesyre.
English: These may harm organs such as the brain and kidneys.
Danish: Blodpropper kan skade organer, såsom hjernen eller nyrerne.
English: Swelling of the brain (reversible posterior leukoencephalopathy syndrome) Votrient can, on rare occasions, cause swelling of the brain, which may be life threatening.
Danish: Hævelse af hjernen (reversibel posterior leukoencefalopati-syndrom) Votrient kan, i sjældne tilfælde, give hævelse af hjernen, hvilket kan være livstruende.
English: Renal cell carcinoma (RCC)
Danish: Renalcellekarcinom (RCC)
English: The preclinical safety profile of pazopanib was assessed in mice, rats, rabbits and monkeys.
Danish: Pazopanibs prækliniske sikkerhedsprofil er bestemt hos mus, rotter, kaniner og aber.