FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Javlor solution for infusion should be infused over 20 minutes.
Danish: • Javlor-opløsningen til infusion bør indgives i løbet af 20 minutter.
English: Respiratory, thoracic and mediastinal disorders Dyspnoea occurred in 3.2% of the patients but was rarely severe (Grade 3/4: 1.2%).
Danish: Dyspnø indtraf hos 3,2 % af patienterne, men var sjældent alvorlig (grad 3/4: 1,2%).
English: Vinflunine doses were adjusted according to 3 age groups as shown below:
Danish: Vinflunindosis blev justeret i forhold til de 3 nedenfor viste aldersgrupper:
English: Advice on conservation of sperm should be sought prior to treatment because of the possibility of irreversible infertility due to therapy with vinflunine.
Danish: Der bør søges rådgivning om nedfrysning af sæd inden behandling med vinflunin på grund af risikoen for irreversibel infertilitet.
English: Sensory peripheral neuropathy is a class effect of the vinca alkaloids.
Danish: Sensorisk perifer neuropati er en klasseeffekt af vinca-alkaloider.
English: Mucositis Grade 2 is defined as “moderate”, Grade 3 as “severe” and Grade 4 as “life-threatening”.
Danish: Mukositis grad 2 er defineret som “moderat”, grad 3 som “alvorlig” og grad 4 som ”livstruende”.
English: No modification of vinflunine and DVFL pharmacokinetics was observed in 25 patients presenting varying degrees of hepatic impairment, compared to patients with normal hepatic function.
Danish: Ingen ændringer af vinflunin og DVFL-farmakokinetik blev observeret hos 25 patienter, der udviste forskellige grader af nedsat leverfunktion sammenlignet med patienter med normal leverfunktion.
English: Vinflunine is moderately bound to human plasma proteins (67.2±1.1%) with a ratio between plasma and whole blood concentrations of 0.80±0.12.
Danish: Vinflunin er moderat bundet til humane plasmaproteiner (67,2±1,1 %) med et forhold mellem plasmaet og helblod-koncentrationerne på 0,80±0,12.
English: During the pre- and post-natal development study in rat, vinflunine induced malformations of the uterus and vagina in 2 females, and adversely affected mating and/or ovule implantation and markedly lowered the number of concepti.
Danish: I det præ- og postnatale udviklingsforsøg hos rotter medførte vinflunin misdannelser af uterus og vagina hos 2 hunner og havde en negativ påvirkning på parringen, og/eller den ovulare implantation og reducerede antallet af concepti betydeligt.
English: - The other ingredient is water for injections.
Danish: - Øvrige indholdsstoffer: Vand til injektionsvæsker.
English: Grade 3 vomiting as ≥ 6 episodes in 24 hours over pretreatment; or need for intravenous fluids.
Danish: Grad 3 opkastning som ≥ 6 episoder i løbet af 24 timer efter præmedikation eller behov for intravenøs væskebehandling.
English: The concomitant use of opioids could enhance the risk of constipation.
Danish: Samtidig brug af opioider kan øge risikoen for obstipation.
English: - if you are allergic to the active substance (vinflunine) or to other vinca alkaloids (vinblastine,
Danish: - hvis du er allergisk over for vinflunin eller over for andre vinca-alkaloider (vinblastin, vincristin,
English: 2nd consecutive event
Danish: 2. efterfølgende hændelse
English: Table 1: Dose delay for subsequent cycles due to toxicity
Danish: Tabel 1: Dosisudsættelse for efterfølgende cyklusser på grund af toksicitet
English: Vinflunine treatment should be initiated under the responsibility of a physician qualified in the use of anticancer chemotherapy and is confined to units specialised in the administration of cytotoxic chemotherapy.
Danish: Behandling med vinflunin bør indledes under tilsyn af en læge, der er kvalificeret i anvendelsen af anticancerkemoterapi, og begrænses til afdelinger specialiseret i administration af cytotoksisk kemoterapi.
English: The doses recommended in patients of at least 75 years old are as follows: - in patients of at least 75 years old but less than 80 years, the dose of vinflunine to be given is 280 mg/m² every 3 weeks.
Danish: De anbefalede doser til patienter på mindst 75 år er følgende: - til patienter, der er mindst 75 år, men under 80 år, bør vinflunindosis være 280 mg/m² hver 3. uge.
English: A pharmacokinetic phase I study of vinflunine was performed in elderly patients (n=46).
Danish: Et farmakokinetisk fase I-forsøg er blevet udført med ældre patienter (n = 46).
English: Store in the original packaging in order to protect from light.
Danish: Opbevares i den originale pakning for at beskytte mod lys.
English: In clinical studies, patients with CrCl (creatinine clearance) > 60 mL/min were included and treated at the recommended dose.
Danish: I kliniske forsøg blev patienter med kreatinin-clearance (CrCl) > 60 ml/min inkluderet og behandlet med den anbefalede dosis.
English: Pack size of 1 and 10 vials.
Danish: Pakningsstørrelser med 1 og 10 hætteglas.
English: Infection with Grade 3/4 neutropenia was observed in 2.8 % of patients.
Danish: Infektion med grad 3/4 neutropeni blev observeret hos 2,8 % af patienterne.
English: Patients at high risk of constipation (concomitant treatment with opiates, peritoneal carcinomas, abdominal masses, prior major abdominal surgery) should be medicated with an osmotic laxative from day 1 to day 7 administered once a day in the morning before breakfast.
Danish: Patienter med høj risiko for obstipation (samtidig behandling med opiater, peritoneale karcinomer, abdominale forandringer/forstørrelser, tidligere større abdominale operationer) bør medicineres med et osmotisk virkende laksans fra dag 1 til dag 7, indgivet én gang dagligt inden morgenmaden.
English: When infused through a peripheral vein, vinflunine can induce Grade 1 (22% of the patients, 14.1% of the cycles), Grade 2 (11.0% of the patients, 6.8% of the cycles) or Grade 3 (0.8% of the patients, 0.2% of the cycles) venous irritation.
Danish: Når vinflunin indgives gennem en perifer vene, kan det medføre grad 1 (22 % af patienterne; 14,1 % af cyklusserne), grad 2 (11,0 % af patienterne; 6,8 % af cyklusserne) eller grad 3 (0,8 % af patienterne; 0,2 % af cyklusserne) venøs irritation.
English: Store in the original package in order to protect from light.
Danish: Opbevares i originalpakningen for at beskytte mod lys.
English: The veins of the hand dorsum and those close to joints should be avoided.
Danish: Vener på håndryggen og dem, der er tæt på leddene, bør undgås.
English: In vivo, vinflunine displays significant antitumor activity against a broad spectrum of human xenografts in mice both in terms of survival prolongation and tumour growth inhibition.
Danish: In vivo udviser vinflunin en signifikant antitumoraktivitet mod et bredt spektrum af humane xenografter hos mus, både i forbindelse med længere overlevelse og hæmning af tumorvæksten.
English: How Javlor is given
Danish: Sådan indgives Javlor
English: In the absence of any haematological toxicity during the first cycle causing treatment delay or dose reduction, the dose will be increased to 320 mg/m² every 3 weeks for the subsequent cycles.
Danish: Ved total mangel på hæmatologisk toksicitet, som giver anledning til behandlingsforsinkelse eller dosisreduktion, under den første cyklus skal dosis øges til 320 mg/m² hver 3. uge i de efterfølgende cyklusser.
English: Grade ≥ 3 constipation occurred in 15.3% of treated patients.
Danish: Obstipation ≥ grad 3 forekom hos 15,3 % af de behandlede patienter.
English: Vinflunine pharmacokinetics is linear in the range of administered doses (from 30 mg/m² to 400 mg/m2) in cancer patients.
Danish: Vinflunins farmakokinetik er lineær inden for området af indgivne doser (fra 30 mg/m² til 400 mg/m²) hos cancerpatienter.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Neutropenia Grade 4 (ANC < 500/mm3) > 7 days
Danish: Neutropeni grad 4 (ANC< 500/mm3) > 7 dage
English: This is further confirmed by the population pharmacokinetic analysis (56 patients with CrCl between 20 mL/min and 60 mL/min), showing that vinflunine clearance is influenced by the creatinine clearance value (Cockcroft and Gault formula).
Danish: Dette er yderligere bekræftet af den populationsfarmakokinetiske analyse (56 patienter med CrCl mellem 20 ml/min og 60 ml/min), som viser, at vinflunin-clearance påvirkes af kreatinin-clearance (Cockcroft-Gault-formlen).
English: Studies in animals have shown embryotoxicity and teratogenicity (see section 5.3).
Danish: Dyrestudier har påvist embryotoksicitet og teratogenicitet (se pkt.
English: Diluted solution The diluted solution should be use immediately
Danish: Fortyndet opløsning Den fortyndede opløsning skal anvendes straks.
English: Posology The recommended dose is 320 mg/m² vinflunine as a 20 minute intravenous infusion every 3 weeks.
Danish: Dosering Den anbefalede dosis er 320 mg/m² vinflunin som en 20-minutters intravenøs infusion hver 3. uge.
English: - Delay until recovery (ANC ≥ 1,000/mm3 and platelets ≥ 100,000/mm3) and adjust the dose if necessary (see table 2) - Discontinuation if recovery has not occurred within 2 weeks
Danish: - Udsættelse indtil bedring (ANC ≥ 1.000/mm3 og blodplader ≥ 100.000/mm3); juster dosis hvis nødvendigt (se tabel 2) - Seponering, hvis ikke bedring inden for 2 uger
English: Rare cases of Posterior Reversible Encephalopathy Syndrome have been reported (see section 4.4).
Danish: Sjældne tilfælde af posterior reversibel encefalopatisyndrom er blevet rapporteret (se pkt.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige (kan påvirke op til 1 ud af 10 personer):
English: Binding to alpha-1 acid glycoprotein and to platelets is negligible (< 5%).
Danish: Binding til alfa-1 syreglykoprotein og til trombocytter er ubetydelig (< 5
English: No pharmacokinetic interaction was observed in patients when vinflunine was combined with doxorubicin.
Danish: Ingen farmakokinetisk interaktion blev observeret hos patienter, når vinflunin blev kombineret med doxorubicin.
English: Grade 2 is defined as “moderate”, Grade 3 as “severe” and Grade 4 as “life-threatening” (see Table 2 in section 4.2).
Danish: Grad 2 er defineres som ”moderat”, grad 3 som ”svær” og grad 4 som ”livstruende” (se tabel 2 i pkt.
English: If you are a woman or a man of reproductive potential, you should use an adequate method of contraception during treatment and for 3 months after your last dose of Javlor.
Danish: Hvis du er en kvinde i den fødedygtige alder eller en mand, der er i stand til at få børn, skal du bruge en sikker prævention under behandlingen og 3 måneder efter din sidste dosis af Javlor.
English: Pharmacokinetics of vinflunine was not modified for patients 70 ≤ age < 75 years and 75 ≤ age < 80 years.
Danish: Vinflunins farmakokinetik var ikke ændret hos patienter 70 år ≤ alder < 75 år og 75 år ≤ alder < 80 år.
English: In the two multi-centre open-label, single-arm phase II clinical trials a total of 202 patients were treated with vinflunine.
Danish: I de to kliniske, åbne, multicenter-, enkeltgruppe- fase II-forsøg blev i alt 202 patienter behandlet med vinflunin.
English: A pharmacokinetic interaction between vinflunine and pegylated/liposomal doxorubicin was observed, resulting in a 15% to 30% apparent increase in vinflunine exposure and a 2 to 3-fold apparent decrease of doxorubicin AUC, whereas for doxorubicinol, the concentrations of the metabolite were not affected.
Danish: En farmakokinetisk interaktion mellem vinflunin og pegyleret/liposomal doxorubicin blev observeret; dette resulterede i en 15-30 % tilsyneladende stigning i vinflunineksponering og et 2-3-fold tilsyneladende fald i doxorubicin-AUC, mens koncentrationen af doxorubicinols metabolit ikke blev påvirket.
English: Grade 3/4 neutropenia was observed in 43.8% of patients.
Danish: Grad 3/4 neutropeni blev observeret hos 43,8 % af patienterne.
English: Baseline ANC < 1,500/mm3 for the first administration, baseline ANC < 1,000/mm3 for subsequent administrations (see section 4.4).
Danish: Baseline ANC < 1.500/mm3 ved den første administration, baseline ANC < 1.000/mm3 ved efterfølgende administrationer (se pkt.
English: Constipation is reversible and can be prevented by special dietary measures such as oral hydration and fibre intake, and by administration of laxatives such as stimulant laxatives or faecal softners from day 1 to day 5 or 7 of the treatment cycle.
Danish: Obstipation er reversibel og kan forebygges ved specielle diætetiske tiltag som f.eks. oral hydrering og indtagelse af fibre, og ved indtagelse af afføringsmidler såsom stimulerende eller blødgørende laksantia fra dag 1 til dag 5 eller 7 i behandlingscyklussen.
English: When infused through a peripheral vein, vinflunine can induce venous irritation (see section 4.4).
Danish: Ved indgift gennem en perifer vene kan vinflunin medføre venøs irritation (se pkt.
English: Javlor is a clear, colourless to pale yellow solution.
Danish: Javlor er en klar, farveløs til bleggul opløsning.
English: After dilution of the Javlor concentrate, the solution for infusion will be administered as follows:
Danish: Efter opløsning af Javlor-koncentratet indgives opløsningen til infusion på følgende måde:
English: Discontinuation of vinflunine should be considered in patients who develop neurological signs of PRES (see section 4.8).
Danish: Seponering af vinflunin bør overvejes hos patienter, der udvikler neurologiske tegn på PRES (se pkt.
English: Hypersensitivity to the active substance or other vinca alkaloids.
Danish: Overfølsomhed over for det aktive stof eller over for andre vinca-alkaloider.
English: The typical clinical symptoms are, with various degrees: neurological (headache, confusion, seizure, visual disorders), systemic (hypertension), and gastrointestinal (nausea, vomiting).
Danish: De typiske kliniske symptomer er forskellige grader af: Neurologiske (hovedpine, forvirring, kramper, synsforstyrrelser), systemiske (hypertension), og gastrointestinale symptomer (kvalme, opkastning).
English: Preclinical data revealed moderate to severe neutropenia and mild anaemia, in all species tested, with liver toxicity in dogs and rats (characterized by dose-dependent increases in liver transaminases and hepatic necrosis/hepatocellular alterations at high doses).
Danish: Prækliniske data viste moderat til svær neutropeni og mild anæmi i alle testede arter med levertoksicitet hos hunde og rotter (karakteriseret ved dosisafhængige stigninger i leveraminotransferaser og levernekrose/hepatocellulare ændringer ved høje doser).
English: Elderly patients (≥ 75 years) The recommended dose should be reduced in patients 75 years old and beyond (see section 4.2).
Danish: Ældre patienter (≥ 75 år) Den anbefalede dosis bør reduceres til patienter, der er 75 år eller ældre (se pkt.
English: Table 3: Dose adjustments due to toxicity in renal impaired or elderly patients
Danish: Tabel 3: Dosisjustering på grund af toksicitet hos patienter med nedsat nyrefunktion og hos ældre patienter
English: Javlor MUST ONLY be administered intravenously.
Danish: Javlor MÅ KUN indgives intravenøst.
English: Few QT interval prolongations have been observed after the administration of vinflunine.
Danish: Der er blevet observeret få forlængelser af QT-interval efter indgift af vinflunin.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Javlor in all subsets of the paediatric population in the treatment of ureter and bladder carcinoma and the treatment of breast carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Javlor i alle undergrupper af den pædiatriske population ved behandling af urinleder- og blærekarcinom og behandling af brystkarcinom (se pkt.
English: If it comes into contact with mucous membranes, the membranes should be flushed thoroughly with water.
Danish: Hvis den kommer i kontakt med slimhinderne, skal disse skylles grundigt med vand.
English: In case of any Grade ≥ 3 gastrointestinal toxicity (except vomiting or nausea) or of mucositis (Grade 2 for 5 days or more or Grade ≥ 3 of any duration) dose adjustment is required.
Danish: Ved grad ≥ 3 gastrointestinal toksicitet (undtagen opkastning eller kvalme) eller ved mukositis (grad 2 i 5 dage eller mere eller grad ≥ 3 af en hvilken som helst varighed) er dosisjustering påkrævet.
English: This was further confirmed by the population pharmacokinetic analysis (absence of relationship between vinflunine clearance and biology markers of hepatic impairment).
Danish: Dette blev bekræftet yderligere af den populationsfarmakokinetiske analyse (intet forhold mellem vinflunin-clearance og biologiske markører ved den nedsatte leverfunktion).
English: No pharmacokinetic interaction was observed in patients when vinflunine was combined with either cisplatin, carboplatin, capecitabine or gemcitabine.
Danish: Ingen farmakokinetisk interaktion blev observeret hos patienter, da vinflunin blev kombineret med enten cisplatin, carboplatin, capecitabin eller gemcitabin.
English: The most frequent treatment-related adverse reactions reported in the two phase II and one phase III trials in patients with transitional cell carcinoma of the urothelium (450 patients treated with vinflunine) were haematological disorders, mainly neutropenia and anaemia; gastrointestinal disorders, especially constipation, anorexia, nausea, stomatitis/mucositis, vomiting, abdominal pain and diarrhoea, and general disorders such as asthenia/fatigue.
Danish: De hyppigste behandlingsrelaterede bivirkninger, som er rapporteret i de to fase II-forsøg og det ene fase III-forsøg for patienter med transitionalcellekarcinom i urinvejene (TCCU) (450 patienter behandlet med vinflunin), var hæmatologiske lidelser, især neutropeni og anæmi; mave-tarmlidelser, især obstipation, anoreksi, kvalme, stomatitis/mukositis, opkastninger, mavesmerter og diarré samt almene lidelser som asteni/træthed.
English: Due to the possible very harmful effects on the infants, breast-feeding during treatment with vinflunine is contraindicated (see section 4.3).
Danish: På grund af risiko for meget skadelige virkninger på spædbørn er amning kontraindiceret under behandling med vinflunin (se pkt.
English: Adverse reactions occurring in patients with transitional cell carcinoma of the urothelium and in patients with other disease than this indication and potentially severe or adverse reactions that are a class effect of the vinca alkaloids are described below:
Danish: Herunder beskrives bivirkninger, der kan forekomme hos patienter med transitionalcellekarcinom i urinvejene, og hos patienter med andre sygdomme end denne indikation og som er potentielt alvorlige, eller bivirkninger, der er en klasseeffekt ved vinca-alkaloiderne:
English: Based on both PK and safety data, dose reductions are recommended in the elder groups: 75 ≤ age < 80 years; and age ≥ 80 years.
Danish: Baseret både på farmakokinetik og sikkerhedsdata anbefales dosisreduktion hos ældre: 75 år ≤ alder < 80 år og alder ≥ 80 år.
English: The concomittant use of two or more QT/QTc interval prolonging substances is not recommended (see section 4.5).
Danish: Samtidig anvendelse af to eller flere lægemidler til forlængelse af QT/QTc-intervallet anbefales ikke (se pkt.
English: A phase I study evaluating the effect of ketoconazole treatment (a potent CYP3A4 inhibitor) on vinflunine pharmacokinetics indicated that co-administration of ketoconazole (400 mg orally once daily for 8 days) resulted in a 30% and 50% increase in blood exposures to vinflunine and its metabolite 4Odeacetyl-vinflunine (DVFL), respectively.
Danish: Et fase I-forsøg til evaluering af effekten af ketoconazol-behandling (en stærk CYP3A4-hæmmer) på vinflunins farmakokinetik antydede, at samtidig indgift af ketoconazol (400 mg peroralt én gang dagligt i 8 dage) resulterede i en 30 % og 50 % stigning i eksponering for henholdsvis vinflunin og dets metabolit 4-O-deacetyl-vinflunin (DVFL) i blodet.
English: A pharmacokinetic phase I study was performed in 2 groups of patients with renal impairment classified according to the calculated creatinine clearance (CrCl) values: group 1 (n=13 patients) with moderate impairment (40 mL/min ≤ CrCl ≤ 60 mL/min) and group 2 (n=20 patients) with severe impairment (20 mL/min ≤ CrCl < 40 mL/min).
Danish: Et farmakokinetisk fase I-studie blev udført med 2 grupper patienter med nedsat nyrefunktion klassificeret i henhold til den kalkulerede kreatinin-clearance (CrCl): Gruppe 1 (n=13 patienter) med moderat nedsat nyrefunktion (40 ml/min ≤ CrCl ≤ 60 ml/min) og gruppe 2 (n=20 patienter) med svært nedsat nyrefunktion (20 ml/min ≤ CrCl < 40 ml/min.).
English: Imaging distribution studies following radioactive vinflunine in rats, illustrated that the compound levels in lungs, kidneys, liver, salivary and endocrine glands, and gastrointestinal tract were rapidly higher than those in blood.
Danish: Skanningsforsøg, der undersøgte fordelingen af radioaktivt vinflunin i rotter, viste, at vinfluninniveauet i lunger, nyrer, lever, spytkirtler og endokrine kirtler samt mave-tarmkanalen hurtigt blev højere end i blodet.
English: • The Javlor solution for infusion should be piggy-backed to the side injection port closest to the 500 mL bag to further dilute Javlor during administration.
Danish: • Javlor-opløsningen til infusion bør anbringes ved injektionsporten i den side, der er tættest på 500 ml posen, for yderligere at fortynde Javlor under indgiften.
English: Therefore the concomitant use of vinflunine and potent CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole and grapefruit juice) or inducers (such as rifampicin and Hypericum perforatum (St John's wort)) should be avoided since they may increase or decrease vinflunine and DVFL concentrations (see section 4.4 and 5.2).
Danish: Derfor bør brugen af vinflunin samtidig med stærke CYP3A4-hæmmere (som ritonavir, ketoconazol, itraconazol og grapefrugtjuice) eller induktorer (som rifampicin og Hypericum perforatum (perikon)) undgås, eftersom de kan øge eller sænke vinflunin- og DVFL-koncentrationerne (se pkt.
English: Adequate monitoring of complete blood counts should be conducted to verify the ANC, platelet and haemoglobin values before each vinflunine infusion (see section 4.3).
Danish: Passende monitorering af det totale blodbillede bør gennemføres for at verificere ANC, blodplader og hæmoglobin-værdier inden hver vinflunin-infusion (se pkt.
English: In order to prevent constipation, laxatives and dietary measures including oral hydration are recommended from day 1 to day 5 or 7 after each vinflunine administration (see section 4.4).
Danish: For at undgå obstipation anbefales afføringsmidler og kostmæssige forholdsregler, herunder oral hydrering, fra dag 1 til dag 5 eller 7 efter hver indgift af vinflunin (se pkt.
English: - “Syndrome of inappropriate antidiuretic hormone secretion”, which is a condition that causes low levels of blood sodium - tumour pain.
Danish: - uhensigtsmæssig produktion af antidiuretisk hormon, som er en sygdom der forårsager lave niveauer af natrium i blodet.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Danish: Brug ikke Javlor efter den udløbsdato, der står på pakningen efter Udl.
English: Definitive Treatment discontinuation
Danish: Permanent afbrydelse af behandlingen
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige (kan påvirke op til 1 ud af 100 personer):
English: Severe hyponatraemia, including cases due to syndrome of inappropriate antidiuretic hormone secretion (SIADH), has been observed with the use of vinflunine (see section 4.8).
Danish: Der er set svær hyponatriæmi, herunder tilfælde forårsaget af uhensigtsmæssig produktion af antidiuretisk hormon (SIADH), ved brug af vinflunin (se pkt.
English: Cardiac ischaemia in patients with prior history of myocardial infarction or angina pectoris
Danish: Kardiel iskæmi hos patienter med myokardieinfarkt eller angina pectoris i anamnesen
English: Cardiac effects are a known class effect of the vinca alkaloids.
Danish: Påvirkninger af hjertet er kendte klasseeffekter af vinca-alkaloider.