FrancophonIA/ELRC3.0 huggingface dataset:
English: Vinflunine has shown to be clastogenic (induces chromosome breakage) in the in vivo micronucleus test in rat as well as mutagenic and clastogenic in a mouse lymphoma assay (without metabolic activation).
Danish: Vinflunin har vist sig at være klastogen (medfører kromosombrud) i in vivo mikronukleus test på rotter samt mutagene og klastogene i en muselymfomtest (uden metabolsk aktivering).
English: B. CONDITIONS OR RESTRICTIONS REGARDING THE SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: The median overall survival was 6.9 months (vinflunine + BSC) vs. 4.6 months (BSC), but the difference did not reach statistical significance; hazard ratio 0.88 (95% CI 0.69, 1.12).
Danish: Den mediane samlede overlevelse var 6,9 måneder (vinflunin + BSC) vs. 4,6 måneder (BSC), men forskellen var ikke statistisk signifikant; hazard ratio 0,88 (95%-konfidensinterval (CI) 0,69-1,12).
English: In addition a pre-specified multivariate analysis performed on the ITT population demonstrated that vinflunine had a statistically significant treatment effect (p=0.036) on overall survival when prognostic factors (PS, visceral involvement, alkaline phosphatases, haemoglobin, pelvic irradiation) were taken into consideration; hazard ratio 0.77 (95% CI 0.61, 0.98).
Danish: Desuden viste en forudspecificeret multivariat-analyse, som blev udført på ITT-populationen, at vinflunin havde en statistisk signifikant behandlingseffekt (p=0,036) på den samlede overlevelse, når de prognostiske faktorer (PS, visceral afficering, alkaliske fosfataser, hæmoglobin, strålebehandling af bækkenet) blev taget med i betragtning; hazard ratio 0,77 (95% CI 0,61-0,98).
English: Javlor solution for infusion should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Danish: Javlor-opløsningen til infusion bør kun tilberedes og indgives af kvalificeret personale, der er instrueret i håndteringen af cytotoksiske stoffer.
English: Blood exposure to vinflunine (AUC), significantly correlated with severity of leucopenia, neutropenia and fatigue.
Danish: AUC for vinflunin korrelerede signifikant med sværhedsgraden af leukopeni, neutropeni og træthed.
English: 2 NCI CTC Grade 3 nausea is defined as no significant intake, requiring intravenous fluids.
Danish: 2 NCI CTC grad 3 kvalme er defineret som ingen signifikant indtagelse, kræver intravenøs væskebehandling.
English: Very common Weight decreased Uncommon Transaminases increased Weight increased aadverse reactions reported from post-marketing experience bfrequency calculated on the basis of non-TCCU clinical trial
Danish: Vægtøgning a bivirkninger rapporteret fra post-marketing erfaring bfrekvens beregnet på grundlag af non-TCCU kliniske forsøg
English: Nevertheless, vinflunine should be used with caution in patients with increase of the proarrhythmic risk (e.g. congestive heart failure, known history of QT interval prolongation, hypokalaemia) (see section 4.8).
Danish: Alligevel bør Javlor bruges med forsigtighed til patienter med forøget proarytmisk risiko (f.eks. hjerteinsufficiens, tidligere forekomst af forlængelse af QT-interval, hypokaliæmi) (se pkt.
English: Clear, colourless to pale yellow solution.
Danish: Klar, farveløs til bleggul opløsning.
English: In case of Grade 2 constipation, defined as requiring laxatives, for 5 days or more or Grade ≥ 3 of any duration, the dose of vinflunine should be adjusted (see section 4.2).
Danish: Ved grad 2 obstipation, defineret som krævende afføringsmiddel i 5 dage eller mere, eller grad ≥ 3 af en hvilken som helst varighed, bør vinflunindosis justeres (se pkt.
English: In a population pharmacokinetic analysis in 372 patients (656 pharmacokinetic profiles), the total blood clearance was 40 l/h with low inter and intra-individual variability (25% and 8%, respectively, expressed as coefficient of variation).
Danish: I en populationsfarmakokinetisk analyse af 372 patienter (656 farmakokinetiske profiler) var den totale clearance i blodet 40 l/t med lav inter- og intra-individuel variabilitet (henh.
English: - with a prothrombin time > 70% NV (Normal Value) and presenting at least one of the following criteria: [ ULN (Upper Limit of Normal) < bilirubin ≤ 1.5×ULN and/or 1.5xULN < transaminases ≤ 2.5×ULN and/or ULN < GGT ≤ 5×ULN ].
Danish: - med en protrombintid > 70 % NV (normal værdi), og som opfylder mindst et af følgende kriterier: [ULN (upper limit of normal) < bilirubin ≤ 1,5×ULN og/eller 1,5×ULN < aminotransferaser ≤ 2,5×ULN og/eller ULN < GGT ≤ 5×ULN].
English: Bronchospam was reported in one patient treated with vinflunine for a different setting from the indication.
Danish: Bronkospasmer blev rapporteret hos én patient, som blev behandlet med vinflunin i en anden sammenhæng end indikationen.
English: Javlor is used to treat advanced or metastatic cancer of the bladder and urinary tract when a previous therapy with platinum-containing medicines has failed.
Danish: Javlor anvendes til behandling af fremskreden eller metastatisk cancer i blæren og urinvejene, hvor en tidligere behandling med platinholdige medicin har slået fejl.
English: Special attention is recommended when vinflunine is administered to patients with prior history of myocardial infarction/ischaemia or angina pectoris (see section 4.8).
Danish: Særlig opmærksomhed anbefales, når vinflunin indgives til patienter med en tidligere forekomst af myokardieinfarkt/iskæmi eller angina pectoris (se pkt.
English: NCI CTC Grade 3 constipation is defined as an obstipation requiring manual evacuation or enema, Grade 4 constipation as an obstruction or toxic megacolon.
Danish: NCI CTC grad 3 obstipation er defineret som obstipation, som kræver manuel fjernelse eller lavement, grad 4 obstipation som obstruktion eller toksisk megacolon.
English: Men and women with reproductive potential must use an effective method of contraception during the treatment and up to 3 months after the last vinflunine administration (see section 4.6).
Danish: Mænd, der er fertile, og kvinder i den fødedygtige alder skal bruge en effektiv præventionsmetode under behandlingen og i op til 3 måneder efter den sidste indgift af vinflunin (se pkt.
English: A statistically significant difference on overall survival (p=0.040) was also seen in the eligible population (which excluded 13 patients with clinically significant protocol violations at baseline who were not eligible for treatment); hazard ratio 0.78 (95% CI 0.61, 0.99).
Danish: En statistisk signifikant forskel på den samlede overlevelse (p=0,040) blev også set i den population, der var egnet til behandling (hvilket udelukkede 13 patienter med klinisk signifikante protokolbrud ved baseline, som ikke var egnede til behandling); risikoforhold 0,78 (95% CI 0,61-0,99).
English: Other medicines and Javlor
Danish: Brug af anden medicin sammen med Javlor
English: Neutropenia, leucopenia, anaemia and thrombocytopenia are frequent adverse reactions of vinflunine.
Danish: Neutropeni, leukopeni, anæmi og trombocytopeni er hyppige bivirkninger ved vinflunin.
English: Before each cycle, adequate monitoring of complete blood counts should be conducted to verify the absolute neutrophil count (ANC), platelets and haemoglobin as neutropenia, thrombocytopenia and anaemia are frequent adverse reactions of vinflunine.
Danish: Inden hver cyklus bør der gennemføres passende monitorering af komplette blodtal for at verificere de absolutte neutrofiltal (ANC), blodplader og hæmoglobin, da neutropeni, trombocytopeni og anæmi er hyppige bivirkninger ved vinflunin.
English: In particular, you should tell your doctor if you are taking medicines containing any of the following active substances: - ketoconazole and itraconazole, used to treat fungal infection, - opioids, used to treat pain, - ritonavir, used to treat HIV infection, - doxorubicin and pegylated liposomal doxorubicin, used to treat some kinds of cancer, - rifampicin, used to treat tuberculosis or meningitis, - herbal preparation containing hypericum perforatum (St John's wort) used to treat minor to moderate depression.
Danish: Du skal især tale med din læge, hvis du tager medicin, der indeholder et eller flere af følgende aktive stoffer: - ketoconazol og itraconazol, som bruges til at behandle svampeinfektioner, - opioider, som bruges til at behandle smerter, - ritonavir, som bruges til at behandle hiv-infektion, - doxorubicin og pegyleret liposomal doxorubicin, som bruges til at behandle visse typer cancer, - rifampicin, som bruges til at behandle tuberkulose eller meningitis - naturlægemidler, som indeholder perikon (Hypericum perforatum), som bruges til at behandle lettere eller moderate depressioner.
English: In patients with moderate renal impairment (40 mL/min ≤ CrCl ≤ 60 mL/min), the recommended dose is 280 mg/m² given once every 3 weeks.
Danish: Til patienter med moderat nedsat nyrefunktion (40 ml/min ≤ CrCl ≤ 60 ml/min) er den anbefalede dosis 280 mg/m², som indgives én gang hver 3. uge.
English: One phase III and two phase II trials support the use of Javlor for treatment of advanced or metastatic transitional cell carcinoma of the urothelium as second-line therapy after failure of a prior platinumcontaining regimen.
Danish: Et fase III-forsøg og to fase II-forsøg understøtter anvendelsen af Javlor til behandling af fremskreden eller metastatisk transitionalcellekarcinom i urinvejene som andenvalgsbehandling, hvor et tidligere platinholdig behandlingsregime har svigtet.
English: The concomitant use of vinflunine with others QT/QTc interval prolonging medicinal products should be avoided (see section 4.4).
Danish: Samtidig brug af vinflunin med andre QT-/QTc-interval-forlængende lægemidler bør undgås (se pkt.
English: A pharmacokinetic and tolerability phase I study in patients with altered liver functions test has been completed (see section 5.2).
Danish: Et fase I-forsøg, der undersøgte farmakokinetik og tolerabilitet hos patienter med påvirkede leverfunktionsprøver, er afsluttet (se afsnit 5.2).
English: The concomitant use of potent inhibitors or potent inducers of CYP3A4 with vinflunine should be avoided (see section 4.5).
Danish: Interaktioner Samtidig brug af stærke hæmmere eller stærke inducere af CYP3A4 med vinflunin bør undgås (se pkt.
English: Glucose 50 mg/mL (5%) solution for infusion may also be used.
Danish: Glucose 50 mg/ml (5 %) infusionsvæske, opløsning, kan også anvendes.
English: If you have any further questions, ask your doctor.
Danish: - Spørg lægen, hvis der er mere, du vil vide.
English: Vinflunine pharmacokinetics was not modified in those patients, however based on hepatic biologic parameter modifications following vinflunine administration (gamma glutamyl transferases (GGT), transaminases, bilirubin), the dose recommendations are as follows:
Danish: Vinflunins farmakokinetik var uændret hos disse patienter, dog er der fastlagt følgende dosisanbefalinger baseret på ændringer i hepatiske biologiske parametre (gammaglutamyltransferaser (GGT), aminotransferaser, bilirubin) som følge af indgift af vinflunin: - Dosisjustering er ikke nødvendig hos patienter:
English: Water for injections as excipient.
Danish: Vand til injektionsvæsker som hjælpestof.
English: - protected from light in polyethylene or polyvinylchloride infusion bag: for up to 6 days in a refrigerator (2°C-8°C) or for up to 24 hours at 25°C;
Danish: - beskyttet mod lys i polyethylen- eller polyvinylchlorid-infusionsposer i op til 6 dage i køleskab (2 °C - 8 °C) eller i op til 24 timer ved 25 °C.
English: Febrile Neutropenia (ANC < 1,000/mm3 and fever ≥ 38,5 °C)
Danish: Febril neutropeni (ANC< 1.000/mm3 og feber ≥ 38,5 °C)
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer for cytotoksiske lægemidler.
English: Dose delay or discontinuation due to toxicity
Danish: Dosisudsættelse eller seponering på grund af toksicitet
English: Very common Myalgia Common Muscular weakness Arthralgia
Danish: Almindelige Muskelsvaghed Artralgi
English: Tell your doctor immediately if you develop any of the following serious side effects while being treated with Javlor: - fever and / or chills which could be signs of infection, - chest pain which could be sign of heart attack, - constipation that resists to laxative treatment, - headaches, changed mental state which may lead to confusion and coma, convulsions, blurred vision and high blood pressure, which could be sign of a neurological disorder such as “posterior reversible encephalopathy syndrome” (see section 2 “warnings and precautions”).
Danish: Fortæl straks lægen, hvis du udvikler nogen af følgende alvorlige bivirkninger, mens du bliver behandlet med Javlor: - Feber og/eller kuldegysninger, som kan være tegn på infektion, - Brystsmerter, som kan være tegn på hjerteanfald, - Forstoppelse, hvor behandling med afføringsmidler ikke er tilstrækkeligt, - Hovedpine, ændret mental tilstand (kan medføre forvirring og koma), kramper, sløret syn og højt blodtryk, hvilket kan være tegn på en neurologisk lidelse, såsom ”posteriort reversibelt encefalopatisyndrom” (se afsnit 2 "Advarsler og forsigtighedsregler").
English: Vinflunine (mg/m²)
Danish: Alder (år) Antal patienter Vinflunin (mg/m²)
English: Table 2: Dose adjustments due to toxicity
Danish: Tabel 2: Dosisjustering på grund af toksicitet
English: The following information is intended for medical or healthcare professionals only:
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: INSTRUKTION VEDRØRENDE ANVENDELSEN
English: Any other toxicity Grade ≥ 3 (severe or life-threatening) (except Grade 3 vomiting or nausea2) *National Cancer Institute, Common Toxicity Criteria Version 2.0 (NCI CTC v 2.0) 1 NCI CTC Grade 2 constipation is defined as requiring laxatives, Grade 3 as an obstipation requiring manual evacuation or enema, Grade 4 as an obstruction or toxic megacolon.
Danish: Enhver anden toksicitet grad ≥ 3 (alvorlig eller livstruende) (undtaget grad 3 opkastning eller kvalme2) *National Cancer Institute, Common Toxicity Criteria Version 2.0 (NCICTC v 2.0) 1 NCI CTC grad 2 obstipation er defineret som krævende laksans, grad 3 kræver manuel fjernelse eller lavement, grad 4 som obstruktion eller toksisk megacolon.
English: It comes in clear glass vials closed by a rubber stopper containing 2 mL, 4 mL or 10 mL of concentrate.
Danish: Det leveres i et klart hætteglas, der indeholder 2 ml, 4 ml eller 10 ml koncentrat og lukkes med en gummiprop.
English: Discontinuation of vinflunine should be considered in patients who develop cardiac ischaemia.
Danish: Afbrydelse af behandlingen med vinflunin bør overvejes for patienter, der udvikler hjerteiskæmi.
English: The diluted solution should be protected from light until administration (see section 6.3).
Danish: Den fortyndede opløsning skal beskyttes mod lys indtil infusion: se pkt.
English: Posterior Reversible Encephalopathy Syndrome (PRES) Cases of PRES have been observed after administration of vinflunine.
Danish: Tilfælde af PRES er blevet observeret efter administration af vinflunin.
English: Hematological toxicity
Danish: Hæmatologisk toksicitet
English: - Delay until recovery to mild toxicity or none, or to initial baseline status and adjust the dose if necessary (see table 2) - Discontinuation if recovery has not occurred within 2 weeks
Danish: - Udsættelse indtil bedring til ingen eller let toksicitet eller til initial baseline-status; juster dosis hvis nødvendigt (se tabel
English: Storage conditions
Danish: Opbevaringsbetingelser:
English: No age-related dose modification is required in patients less than 75 years old (see section 5.2).
Danish: Aldersrelateret dosisjustering er ikke nødvendig til patienter under 75 år (se pkt.
English: All resolved during the study.
Danish: Disse tilfælde forsvandt igen under forsøget.
English: Vinflunine has not been evaluated in patients with severe hepatic impairment (Child-Pugh grade C), or in patients with a prothrombin time < 50%NV or with bilirubin > 5xULN or with isolated transaminases > 2.5xULN ( ≥ 5xULN only in case of liver metastases) or with GGT > 15xULN.
Danish: Vinflunin er ikke blevet evalueret hos patienter med svært nedsat leverfunktion (Child-Pugh grad C) eller hos patienter med protrombintid < 50 % NV eller med bilirubin > 5×ULN eller med isolerede aminotransferaser > 2,5×ULN (≥ 5×ULN kun i tilfælde af levermetastaser) med GGT > 15×ULN.
English: - in patients 80 years old and above, the dose of vinflunine to be given is 250 mg/m² every 3 weeks.
Danish: - til patienter, der er 80 år eller derover, bør vinflunindosis være 250 mg/m² hver 3. uge.
English: - exposed to light in polyethylene or polyvinylchloride infusion set for up to 1 hour at 25°C.
Danish: - udsat for lys i polyethylen- eller polyvinylchlorid-infusionssæt i op til 1 time ved 25 °C.
English: Uncommon Odynophagia Gastric disorders Oesophagitis
Danish: Odynofagi Gastriske forstyrrelser Oesophagitis Gingivale sygdomme
English: Instructions for administration should be followed as described in section 6.6.
Danish: Anvisningerne til indgift bør følges, som beskrevet i pkt.
English: Vinflunine is eliminated following a multi-exponential concentration decay, with a terminal half-life (t1/2) close to 40 h. DVFL is slowly formed and more slowly eliminated than vinflunine (t1/2 of approximately 120 h).
Danish: Vinflunin elimineres efter et multi-eksponentielt koncentrationshenfald med en terminal halveringstid (t1/2) tæt på 40 timer.
English: For further cycles, the dose should be adjusted in the event of toxicities, as shown in table 3 below.
Danish: I efterfølgende cyklusser skal dosis justeres i henhold til toksicitet, som vist i nedenstående tabel 3.
English: For detailed instructions on administration, see section 6.6.
Danish: 6.6 for detaljerede instruktioner i indgiften.
English: For subsequent administrations, vinflunine is contraindicated in subjects with baseline ANC < 1,000/mm3 or platelets < 100,000/mm3.
Danish: For de efterfølgende administrationer er vinflunin kontraindiceret til patienter med baseline ANC < 1.000/mm3 eller blodplader < 100.000/mm3.
English: For further cycles, the dose should be adjusted in the event of toxicities, as shown in table 3 below:
Danish: I efterfølgende cyklusser skal dosis justeres i henhold til toksicitet, som vist i nedenstående tabel 3:
English: Common Ileus Dysphagia
Danish: Almindelige Ileus Dysfagi
English: Javlor 25 mg/mL sterile concentrate vinflunine
Danish: Javlor 25 mg/ml sterilt koncentrat vinflunin
English: Constipation is managed by medical care (see section 4.4).
Danish: Obstipation behandles medicinsk (se pkt.
English: 1 vial of 2 mL 10 vials of 2 mL 1 vial of 4 mL 10 vials of 4 mL 1 vial of 10 mL 10 vials of 10 mL
Danish: 1 hætteglas à 2 ml 10 hætteglas à 2 ml 1 hætteglas à 4 ml 10 hætteglas à 4 ml 1 hætteglas à 10 ml 10 hætteglas à 10 ml
English: One 2 mL vial contains 50 mg of vinflunine (as ditartrate) One 4 mL vial contains 100 mg of vinflunine (as ditartrate) One 10 mL vial contains 250 mg of vinflunine (as ditartrate)
Danish: Et 2 ml hætteglas indeholder 50 mg vinflunin (som ditartrat) Et 4 ml hætteglas indeholder 100 mg vinflunin (som ditartrat) Et 10 ml hætteglas indeholder 250 mg vinflunin (som ditartrat)
English: Dose adjustments due to toxicity
Danish: Dosisjustering på grund af toksicitet
English: - abdominal pain, nausea, vomiting - constipation, diarrhoea - inflammation of the mucosa of the mouth - tiredness, muscle pain - lack of sense of touch - weight decrease, decrease of appetite - loss of hair - reactions at injection site (pain, redness, swelling) - fever - low levels of white blood cells, red blood cells and/or platelets (seen in blood test) - low levels of blood sodium (hyponatraemia).
Danish: - mavesmerter, kvalme, opkastning - forstoppelse, diarré - betændelse i mundens slimhinde - træthed, muskelsmerter - manglende følesans - vægttab, nedsat appetit - hårtab - reaktioner på injektionsstedet (smerte, rødme, hævelse) - feber - lave niveauer af hvide blodlegemer, røde blodlegemer og/eller blodplader (ses i blodprøve) - lave niveauer af natrium i blodet (hyponatriæmi).
English: In patients with severe renal impairment (20 mL/min ≤ CrCl < 40 mL/min) the recommended dose is 250 mg/m² every 3 weeks (see section 5.2).
Danish: Til patienter med svært nedsat nyrefunktion (20 ml/min ≤ CrCl < 40 ml/min) er den anbefalede dosis 250 mg/m² hver 3. uge.
English: Initiation of vinflunine is contraindicated in subjects with baseline ANC < 1,500/mm3 or platelets < 100,000/mm3.
Danish: Initiering af vinflunin er kontraindiceret til patienter med baseline ANC < 1.500/mm3 eller blodplader < 100.000/mm3.
English: - visual disturbances - dry skin, redness of the skin - muscle contraction disorders - pain in the throat, gum disorders - weight increase - urinary problems - ringing or buzzing in the ears (tinnitus) - increase in liver enzymes (seen in blood test)
Danish: - synsforstyrrelser - tør hud, hudrødme - forstyrrelser i musklernes sammentrækning - halssmerter, tandkødsproblemer - vægtstigning - vandladningsproblemer - ringen eller summen for ørerne (tinnitus) - øgede leverenzymer (ses i blodprøve)
English: 3rd consecutive event
Danish: 3. efterfølgende hændelse
English: - The recommended dose of vinflunine is 200 mg/m² given once every 3 weeks in patients with moderate liver impairment (Child-Pugh grade B) or in patients with a prothrombin time ≥ 50% NV and bilirubin > 3×ULN and transaminases > ULN and GGT > ULN.
Danish: - Den anbefalede vinflunindosis er 200 mg/m² en gang hver 3. uge hos patienter med moderat nedsat leverfunktion (Child-Pugh grad B) eller hos patienter med protrombintid ≥ 50 % NV og bilirubin > 3×ULN og aminotransferaser > ULN og GGT > ULN.
English: - The recommended dose of vinflunine is 250 mg/m² given once every 3 weeks in patients with mild liver impairment (Child-Pugh grade A) or in patients with a prothrombin time ≥ 60% NV and 1.5×ULN < bilirubin ≤ 3×ULN and presenting at least one of the following criteria: [ transaminases > ULN and/or GGT > 5×ULN ].
Danish: - Den anbefalede vinflunindosis er 250 mg/m² en gang hver 3. uge hos patienter med let nedsat leverfunktion (Child-Pugh grad A) eller hos patienter med en protrombintid ≥ 60 % NV og 1,5×ULN ≤ bilirubin ≤ 3×ULN, og som opfylder mindst et af følgende kriterier: [aminotransferaser > ULN og/eller GGT > 5×ULN].
English: Package Leaflet: Information for the user Javlor 25 mg/mL concentrate for solution for infusion vinflunine
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Javlor 25 mg/ml koncentrat til infusionsvæske, opløsning vinflunin
English: For further cycles the dose should be adjusted in the event of toxicities (see section 4.2).
Danish: Ved efterfølgende cyklusser skal dosis justeres i forhold til toksiciteten (se pkt.
English: Platelets < 100,000/mm3(see section 4.4).
Danish: Trombocytter < 100.000/mm3 (se pkt.
English: Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen
Danish: Javlor er indiceret som monoterapi til behandling af voksne patienter med fremskredent eller metastaserende transitionalcellekarcinom i urinvejene, hvor tidligere platinholdigt behandlingsregime har svigtet.
English: Pain in jaw
Danish: Nyrer og urinveje
English: The volume of Javlor (concentrate) corresponding to the calculated dose of vinflunine should be mixed in a 100 mL bag of sodium chloride 9 mg/mL (0.9%) solution for infusion.
Danish: Den mængde Javlor (koncentrat), der svarer til den beregnede dosis vinflunin, bør blandes i en 100 ml pose med natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning.