FrancophonIA/ELRC3.0 huggingface dataset:
English: These medicines affect cancer cell growth by stopping cell division, leading to cell death (cytotoxicity).
Danish: Disse lægemidler påvirker væksten af cancercellerne ved at stoppe celledeling, hvilket fører til celledød (cytotoksicitet).
English: All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Danish: Alle overførselsprocedurer kræver streng overholdelse af aseptiske teknikker, hvor der helst skal anvendes en vertikal laminar flow sikkerhedshætte.
English: From a microbiological point of view, the product should be used immediately after dilution.
Danish: Fra et mikrobiologisk synspunkt skal lægemidlet anvendes straks efter fortyndingen.
English: Vinflunine did not induce peripheral neuropathy in animals.
Danish: Vinflunin medførte ikke perifer neuropati hos dyr.
English: Chemical and physical in-use stability has been demonstrated for the diluted medicinal product as follows:
Danish: Kemisk og fysisk stabilitet under brugen er påvist for det fortyndede lægemiddel på følgende måde:
English: Other appropriate measures should be taken, such as blood transfusions, administration of antibiotics and growth factors.
Danish: Der skal tages andre passende forholdsregler som blodtransfusioner, indgift af antibiotika og vækstfaktorer.
English: If pregnancy occurs during treatment, the patient should be informed about the risk for the unborn child and be monitored carefully.
Danish: Hvis en kvinde bliver gravid under behandlingen, skal patienten oplyses om risikoen for det ufødte barn og overvåges omhyggeligt.
English: Vinflunine should therefore not be used during pregnancy, unless it is strictly necessary.
Danish: Vinflunin bør derfor ikke anvendes under graviditet, medmindre det er absolut nødvendigt.
English: Blood pressure should be controlled in patients developing symptoms of PRES. To confirm the diagnosis, brain imaging is recommended.
Danish: Blodtrykket bør kontrolleres hos patienter, der udvikler symptomer på PRES. For at bekræfte diagnosen anbefales scanning af hjernen.
English: Paediatric population There is no relevant use of Javlor in the paediatric population.
Danish: Pædiatrisk population Der er ingen relevante indikationer for Javlor i den pædiatriske population.
English: The carcinogenic potential of vinflunine has not been studied.
Danish: Vinflunins karcinogene potentiale er ikke blevet undersøgt.
English: If the solution comes into contact with the skin, this should be washed immediately and thoroughly with soap and water.
Danish: Hvis opløsningen kommer i kontakt med huden, skal denne straks vaskes omhyggeligt med vand og sæbe.
English: Storage conditions are detailed in the section intended for medicinal or heathcare professionals.
Danish: Opbevaringsforholdene er beskrevet i detaljer i det afsnit, der er tiltænkt læger eller kvalificeret sundhedspersonale.
English: The pharmacokinetic results of this study indicated a reduction of vinflunine clearance when CrCl is decreased.
Danish: De farmakokinetiske resultater af dette studie indikerede en reduktion af vinflunin-clearance, når CrCl er reduceret.
English: Cytotoxic: Handle with caution
Danish: Cytotoksisk: Håndter med forsigtighed.
English: In case of overdose, the patient should be kept in a specialised unit and vital functions should be closely monitored.
Danish: I tilfælde af overdosering skal patienten opholde sig på en specialafdeling, og de vitale funktioner skal nøje overvåges.
English: You should not be given Javlor if you are pregnant, unless it is absolutely necessary.
Danish: Du må ikke få Javlor, hvis du er gravid, medmindre det er absolut nødvendigt.
English: Overall 8 patients (0.6% of the treated population) died from infection as a complication occurring during neutropenia.
Danish: I alt 8 patienter (0,6 % af den behandlede population) døde af infektion, der indtraf under neutropeni.
English: Your blood cell counts will be checked regularly before and during your treatment, since low counts of blood cells is a very common side effect with Javlor.
Danish: Dine blodcelletal vil blive kontrolleret regelmæssigt inden og under behandlingen, da lave blodcelletal er en meget almindelig bivirkning ved Javlor.
English: There is no known antidote for vinflunine overdose.
Danish: Der er ingen kendt modgift mod vinflunin-overdosis.
English: Therefore, regular monitoring of serum sodium levels is recommended during treatment with vinflunine.
Danish: Det anbefales derfor at monitorere serumnatriumniveauerne regelmæssigt under behandling med vinflunin.
English: Myocardial infarction or ischaemia were experienced by 0.5% of the patients and most of them had a pre-existing cardiovascular disease or risk factors.
Danish: Myokardieinfarkt eller iskæmi blev diagnosticeret hos 0,5 % af patienterne, og de fleste af dem havde en allerede eksisterende kardiovaskulær sygdom eller risikofaktorer.
English: Do not drive or use machines if you experience side effects that affect your ability to concentrate and react.
Danish: Undlad at føre motorkøretøj eller betjene maskiner, hvis du får bivirkninger, der påvirker evnen til at koncentrere sig og reaktionsevnen.
English: Javlor should be administered by a 20-minute intravenous infusion and NOT be given by rapid intravenous bolus.
Danish: Javlor skal indgives ved hjælp af en 20 minutters intravenøs infusion og må IKKE gives ved en hurtig intravenøs bolus.
English: According to an in vitro study, such changes could be related to adsorption of vinflunine on the liposomes and a modified blood distribution of both compounds.
Danish: Ifølge et in vitro-forsøg kan sådanne ændringer have forbindelse med absorption af vinflunin på liposomerne og en ændret bloddistribution af begge stoffer.
English: During treatment, your doctor may reduce the dose of Javlor, delay or interrupt the treatment if you experience certain side effects.
Danish: Under behandlingen vil lægen eventuelt nedsætte dosen af Javlor eller udskyde eller afbryde behandlingen, hvis du får visse bivirkninger
English: EU/1/09/550/001 (box of 1 vial of 2 mL with grey stopper) EU/1/09/550/002 (box of 10 vials of 2 mL with grey stopper) EU/1/09/550/003 (box of 1 vial of 4 mL with grey stopper) EU/1/09/550/004 (box of 10 vials of 4 mL with grey stopper) EU/1/09/550/005 (box of 1 vial of 10 mL with grey stopper) EU/1/09/550/006 (box of 10 vials of 10 mL with grey stopper) EU/1/09/550/007 (box of 1 vial of 2 mL with black stopper) EU/1/09/550/008 (box of 10 vials of 2 mL with black stopper) EU/1/09/550/009 (box of 1 vial of 4 mL with black stopper) EU/1/09/550/010 (box of 10 vials of 4 mL with black stopper) EU/1/09/550/011 (box of 1 vial of 10 mL with black stopper) EU/1/09/550/012 (box of 10 vials of 10 mL with black stopper)
Danish: EU/1/09/550/001 (æske med 1 hætteglas à 2 ml med grå prop) EU/1/09/550/002 (æske med 10 hætteglas á 2 ml med grå prop) EU/1/09/550/003 (æske med 1 hætteglas à 4 ml med grå prop) EU/1/09/550/004 (æske med 10 hætteglas à 4 ml med grå prop) EU/1/09/550/005 (æske med 1 hætteglas à 10 ml med grå prop) EU/1/09/550/006 (æske med 10 hætteglas à 10 ml med grå prop) EU/1/09/550/007 (æske med 1 hætteglas à 2 ml med sort prop) EU/1/09/550/008 (æske med 10 hætteglas à 2 ml med sort prop) EU/1/09/550/009 (æske med 1 hætteglas à 4 ml med sort prop) EU/1/09/550/010 (æske med 10 hætteglas à 4 ml med sort prop) EU/1/09/550/011 (æske med 1 hætteglas à 10 ml med sort prop) EU/1/09/550/012 (æske med 10 hætteglas à 10 ml med sort prop)
English: This effect may lead to an increased risk of ventricular arrhythmias although no ventricular arrhythmias were observed with vinflunine.
Danish: Denne effekt kan føre til en øget risiko for ventrikulær arytmi, selv om der ikke blev observeret ventrikulære arytmier med vinflunin.
English: Efficacy was demonstrated in both patients with or without prior cisplatin use.
Danish: Effekt blev påvist hos patienter både med og uden tidligere behandling med cisplatin.
English: You may want to seek counseling on sperm storage before starting your therapy.
Danish: Du ønsker måske at søge råd om opbevaring af sæd, inden du starter behandlingen.
English: No specific clinical studies of vinflunine in combination with these compounds have been carried out yet.
Danish: Der er endnu ikke foretaget specifikke kliniske forsøg med vinflunin kombineret med disse stoffer.
English: Both male and female patients should take adequate contraceptive measures up to three months after the discontinuation of the therapy.
Danish: Både mandlige og kvindelige patienter bør anvende tilstrækkelige præventionsmidler i op til tre måneder efter behandlingens ophør.
English: • The patency should be assessed frequently and extravasation precautions should be maintained throughout the infusion.
Danish: • Passagen bør vurderes jævnligt, og sikkerhedsforanstaltningerne vedrørende ekstravasation bør fastholdes gennem hele infusionen.
English: On the basis of the results of animal studies and the pharmacological action of the medicinal product, there is a potential risk of embryonic and foetal abnormalities.
Danish: Baseret på resultater fra dyrestudier og lægemidlets farmakologiske virkning er der en potentiel risiko for embryonale/føtale misdannelser.
English: Radiological signs are white matter abnormalities in the posterior regions of the brain.
Danish: Radiologiske fund er abnormiteter i den hvide substans i de posteriore dele af hjernen.
English: Constipation is a class effect of the vinca alkaloids: 11.8% of patients experienced severe constipation during treatment with vinflunine.
Danish: Obstipation er en klasseeffekt af vinca-alkaloider: 11,8 % af patienterne oplevede svær obstipation under behandlingen med vinflunin.
English: In case of small or sclerosed veins, lymphoedema or recent venipuncture of the same vein, the use of a central catheter may be preferred.
Danish: I tilfælde af små eller skleroserede vener, lymfødem eller nylig venepunktur i den samme vene er anvendelsen af et centralt kateter at foretrække.
English: Frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Danish: Bivirkningernes hyppighed defineres ved hjælp af følgende konvention: Meget almindelige (≥ 1/10); almindelige (≥ 1/100 < 1/10); ikke almindelige (≥ 1/1.000 < 1/100); sjældne (≥ 1/10.000 < 1/1.000); meget sjældne (< 1/10.000), ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
English: Pharmacotherapeutic group: antineoplasic agents, vinca alkaloids and analogues, ATC code: L01CA05
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, vinca-alkaloider og analoger, ATC-kode: L01CA05
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before starting your therapy.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge til råds, før du begynder behandlingen.
English: Caution should be exercised in patients with a history of cardiac disease and the benefit / risk assessment should be carefully evaluated regularly.
Danish: Der bør udvises forsigtighed ved patienter med en tidligere forekomst af hjertesygdom, og risk/benefit bør vurderes omhyggeligt med jævne mellemrum.
English: Other side effects may include: Very common (may affect more than 1 in 10 people)
Danish: Andre bivirkninger kan indbefatte: Meget almindelige (kan påvirke flere end 1 ud af 10 personer):
English: Either peripheral lines or a central catheter can be used for vinflunine administration.
Danish: Der kan enten anvendes perifere katetre eller et centralt kateter til indgift af vinflunin.
English: Your doctor will adjust the starting dose of Javlor based on your age and physical conditions and in specific situations: - if you had a previous irradiation of the pelvis - if you have moderate or severe kidney problems - if you have liver problems.
Danish: Din læge vil justere startdosen af Javlor ud fra din alder og fysiske tilstand og i specifikke situationer: - hvis du tidligere har fået strålebehandling af bækkenet - hvis du har moderate eller svære nyreproblemer - hvis du har leverproblemer
English: Vinflunine is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Javlor.
Danish: Vinflunin er et cytotoksisk anticancerlægemiddel, og ligesom med andre potentielt toksiske stoffer skal der udvises forsigtighed ved håndteringen af Javlor.
English: Efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2.
Danish: Vinflunins effekt og sikkerhed er ikke blevet undersøgt hos patienter med performance status (PS) ≥ 2.
English: In vitro studies showed that vinflunine had neither inducing effects on CYP1A2, CYP2B6 or CYP3A4 activity nor inhibition effects on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.
Danish: In vitro-undersøgelser viste, at vinflunin hverken havde inducerende virkning på CYP1A2, CYP2B6 eller CYP3A4-aktivitet eller hæmmende virkning på CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4.
English: One patient died after myocardial infarction and another one due to a cardiopulmonary arrest.
Danish: Én patient døde efter myokardieinfarkt og en anden på grund af hjerte- og respirationsstop.
English: Grade 3/4 ileus reported in 1.9% of patients was reversible when managed by medical care.
Danish: Grad 3/4 ileus, rapporteret hos 1,9 % af patienterne, var reversibel, når det blev behandlet medicinsk.
English: The main toxic effect due to an overdose with vinflunine is bone marrow suppression with a risk of severe infection.
Danish: Den hovedsagelige toksiske effekt, som skyldes en overdosering af vinflunin, er knoglemarvssuppression med risiko for svær infektion.
English: Adverse reactions are listed below by System Organ Class, frequency and grade of severity (NCI CTC version 2.0).
Danish: Bivirkninger er anført herunder efter systemorganklasse, hyppighed og sværhedsgrad (NCI CTC version 2.0).
English: Uncommon Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) a
Danish: Uhensigtsmæssig produktion af antidiuretisk hormon (SIADH)a
English: What you need to know before you use Javlor Do not use Javlor
Danish: Det skal du vide, før du begynder at bruge Javlor Brug ikke Javlor
English: Constipation is a very common side effect of Javlor.
Danish: Forstoppelse er en meget almindelig bivirkning ved Javlor.
English: The terminal volume of distribution is large, 2422±676 litres (about 35 l/kg) suggesting extensive distribution into tissues.
Danish: Det terminale fordelingsvolumen er stort, 2422±676 liter (ca. 35 l/kg), hvilket tyder på en omfattende fordeling i vævene.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis lægemidlet ikke anvendes straks, er opbevaringstider og -forhold inden brugen brugerens ansvar og bør normalt ikke være længere end 24 timer ved 2°C - 8°C, medmindre fortyndingen er sket under kontrollerede og validerede aseptiske forhold.
English: The excretion of vinflunine and its metabolites occurs through faeces (2/3) and urine (1/3).
Danish: Udskillelsen af vinflunin og dens metabolitter sker gennem fæces (2/3) og urin (1/3).
English: Precautions to be taken before handling or administering the medicinal product Javlor must be diluted prior to administration.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Javlor skal fortyndes inden indgivelse.
English: vincristine, vindesine, vinorelbine), - if you have had (in the last 2 weeks) or currently have a severe infection, - if you are breast-feeding, - if your levels of white blood cells and/or platelets are too low
Danish: vindesin, vinorelbin), - hvis du har haft (i de sidste 2 uger) eller på nuværende tidspunkt har en svær infektion, - hvis du ammer, - hvis niveauet af hvide blodlegemer og/eller blodplader i dit blod er for lavt.
English: According to the population pharmacokinetic analysis, neither gender nor performance status (ECOG score) had an impact on vinflunine clearance which is directly proportional to body surface area.
Danish: Ifølge den populationsfarmakokinetiske analyse havde hverken køn eller performance status (ECOGscore) nogen indvirkning på vinflunin-clearance, som er direkte proportional med legemsoverfladen.
English: Used in children and adolescents
Danish: Børn og unge
English: Javlor contains the active substance vinflunine, which belongs to a group of anticancer medicines called vinca alkaloids.
Danish: Javlor indeholder det aktive stof vinflunin, som hører til en gruppe af anticancermedicin ved navn vinca-alkaloider.
English: In the reproduction studies, vinflunine appeared to be embryolethal and teratogenic in rabbits and teratogenic in rats.
Danish: I reproduktionsforsøgene viste vinflunin sig at være embryoletalt og teratogent hos kaniner og teratogent hos rotter.
English: Javlor may cause side effects such as tiredness and dizziness.
Danish: Javlor kan forårsage bivirkninger, såsom træthed og svimmelhed.
English: Median PFS was 3.0 months (vinflunine + BSC) vs 1.5 months (BSC) (p=0.0012).
Danish: Den mediane PFS var 3,0 måneder (vinflunin + BSC) i forhold til 1,5 måneder (BSC) (p=0,0012).
English: Protein binding mainly involves high density lipoproteins and serum albumin and is non-saturable on the range of vinflunine concentrations observed in patients.
Danish: Proteinbinding omfatter primært lipoproteiner med høj densitet og serumalbumin og er ikke-mættelige i det område af vinfluninkoncentrationer, der er observeret hos patienter.
English: Posterior Reversible Encephalopathy Syndromea
Danish: Posterior reversibel encefalopati syndroma
English: Procedure for proper handling and disposal of anticancer medicinal products should be considered.
Danish: Fremgangsmåden til korrekt håndtering og destruktion af anticancermedicin skal tages i betragtning.
English: Severe anaemia and thrombocytopenia were less common (respectively 8.8 and 3.1 %).
Danish: Svær anæmi og trombocytopeni var mindre almindelige (henholdsvis 8,8 og 3,1 %).
English: Javlor is not intended for use in children and adolescents.
Danish: Javlor-behandling er ikke beregnet til børn og unge.
English: In vitro studies showed that vinflunine is a Pgp-substrate like other vinca alkaloids, but with a lower affinity.
Danish: In vitro-undersøgelser viste, at vinflunin er et P-glykoprotein (Pgp)-substrat ligesom andre vincaalkaloider, men med en lavere affinitet.
English: Clinical and radiological features usually resolved rapidly without sequelae after treatment discontinuation.
Danish: De kliniske og radiologiske fund forsvinder normalt hurtigt efter seponering uden sequelae.
English: Vinflunine clearance was significantly decreased in patients ≥ 80 years old as compared to a control group of younger patients < 70 years.
Danish: Vinflunin-clearence var signifikant nedsat hos patienter > 80 år sammenlignet med en kontrolgruppe af yngre patienter < 70 år.
English: In the multi-centre, open-label controlled phase III clinical trial, 253 patients were randomised to treatment with vinflunine + BSC (best supportive care) and 117 patients to the BSC arm.
Danish: I det kliniske, åbne, kontrollerede, multicenter- fase III-forsøg blev 253 patienter randomiseret til behandling med vinflunin + BSC (best supportive care) og 117 patienter til BSC-gruppen.
English: The recommended dose in adult patients is 320 mg/m² body surface (this is calculated by the doctor based on your weight and your height).
Danish: Den anbefalede dosis til voksne patienter er 320 mg/m² kropsoverflade (dette beregnes af lægen ifølge din vægt og højde).
English: Javlor will be given to you by a qualified healthcare professional as an intravenous infusion (drip into your vein) lasting 20 minutes.
Danish: Javlor bliver givet til dig af kvalificeret sundhedspersonale som en intravenøs infusion (drop i venen), der varer i 20 minutter.
English: Vinflunine binds to tubulin at or near to the vinca binding sites inhibiting its polymerisation into microtubules, which results in treadmilling suppression, disruption of microtubule dynamic, mitotic arrest and apoptosis.
Danish: Vinflunin binder tubulin ved eller i nærheden af vinca-bindingssteder og hæmmer dermed dets polymerisering til mikrotubuli, hvilket resulterer i ”treadmilling-suppression”, forstyrrelse af den mikrotubulære dynamik, mitose-arrest og apoptose.
English: A possible interaction with paclitaxel and docetaxel (CYP3 substrates) has been suggested from an in vitro study (slight inhibition of vinflunine metabolism).
Danish: En mulig interaktion med paclitaxel og docetaxel (CYP3-substrater) er blevet foreslået på grundlag af et in vitro-forsøg (let hæmning af vinfluninmetabolisme).
English: Thus, patients receiving Javlor should be vigilantly monitored by physicians for the occurrence of cardiac events.
Danish: Patienter, der får Javlor, bør derfor monitoreres omhyggeligt af lægerne for forekomsten af hjertehændelser.
English: All metabolites identified are formed by the cytochrome CYP3A4 isoenzyme, except for 4-O-deacetylvinflunine (DVFL), the only active metabolite and main metabolite in blood which is formed by multiple esterases.
Danish: Alle identificerede metabolitter dannes af cytochrom CYP3A4-isoenzymer med undtagelse af 4-Odeacetylvinflunin (DVFL), som er den eneste aktive metabolit og hovedmetabolitten i blod, der dannes af multiple esteraser.
English: - with transaminases ≤ 2.5xULN ( < 5xULN only in case of liver metastases).
Danish: - med aminotransferaser ≤ 2,5xULN (< 5xULN kun i tilfælde af levermetastaser)
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.. En opdateret RMP skal fremsendes
English: Febrile neutropenia defined as ANC < 1,000/mm3and fever ≥ 38.5°C of unknown origin without clinically microbiologically documented infection (NCI CTC version 2.0) was observed in 5.2% of patients.
Danish: Febril neutropeni defineret som ANC < 1.000/mm3 og feber ≥ 38,5° C af ukendt oprindelse uden klinisk mikrobiologisk dokumenteret infektion (NCI CTC version 2.0) blev observeret hos 5,2 % af patienterne.
English: Ischaemic cardiac events may occur, especially in patients who have underlying cardiac disease.
Danish: Iskæmiske hjertehændelser kan forekomme, især hos patienter, som har en underliggende hjertesygdom.
English: Javlor is a concentrate that has to be diluted before administration.
Danish: Javlor er et koncentrat, der skal opløses inden indgiften.
English: Adverse reactions in all indications
Danish: Bivirkninger ved alle indikationer
English: Elderly (≥ 75 years)
Danish: Ældre(≥ 75 år)
English: - The active substance is vinflunine.
Danish: - Aktivt stof: vinflunin.
English: Dilution of the concentrate
Danish: Fortynding af koncentratet
English: In case of WHO/ECOG performance status (PS) of 1 or PS of 0 and prior pelvic irradiation, the treatment should be started at the dose of 280 mg/m².
Danish: I tilfælde af WHO/ECOG performance status (PS) på 1 eller 0 samt forudgående strålebehandling af bækkenet bør behandlingen indledes med en dosis på 280 mg/m².
English: Javlor is for single use only.
Danish: Javlor er kun til engangsbrug.
English: General precautions for preparation and administration.
Danish: Generelle forholdsregler ved forberedelse og indgift.
English: Content of the pack and other information What Javlor contains
Danish: Pakningsstørrelser og yderligere oplysninger Javlor indeholder