FrancophonIA/ELRC3.0 huggingface dataset:
English: The tablets must be taken with water, and swallowed without chewing.
Danish: Tabletterne skal tages sammen med vand, og sluges uden at tygge.
English: Table 2 shows how the total number of tablets per treatment week is distributed over the individual days.
Danish: Tabel 2 viser, hvordan det totale antal tabletter pr. behandlingsuge fordeles over de enkelte dage i forløbet.
English: Short-term corticosteroids can be used when advised by your doctor.
Danish: Kortvarige kortikosteroider kan anvendes efter din læges anvisning.
English: There was no difference in annualised relapse rate between patients with relapsing-remitting MS and patients with secondary progressive MS with relapses.
Danish: Der var ingen forskel i den årlige attakrate mellem patienter med attakvis MS og patienter med sekundær progressiv MS med attakker.
English: Although cladribine may have a potential for genotoxicity, long-term data in mice and monkeys did not provide any evidence of a relevant increased carcinogenicity risk in humans.
Danish: Selvom cladribin kan have et genotoksisk potentiale, gav langvarige data fra mus og aber ikke nogen evidens for en relevant øget carcinogen risiko hos mennesker.
English: If you have been vaccinated within the last 4 to 6 weeks, MAVENCLAD therapy must be delayed.
Danish: Hvis du er blevet vaccineret i løbet af de sidste 4 til 6 uger, skal behandling med MAVENCLAD udskydes.
English: Tablets must be swallowed whole and not chewed or allowed to dissolve in your mouth.
Danish: Tabletterne skal synkes hele og må ikke tygges eller opløses i din mund.
English: Oriented polyamide (OPA)/aluminium (Al)/polyvinyl chloride (PVC) - aluminium (Al) blister sealed in a cardboard wallet and fixed in a child-resistant outer carton.
Danish: Orienteret polyamid (OPA)/aluminium (Al)/polyvinylchlorid (PVC) - aluminium (Al blisterforseglet i en æske af pap, og fikseret i en børnesikret yderkarton.
English: A potential additive effect on the immune system should also be considered when such medicinal products are used after treatment with MAVENCLAD (see section 4.5).
Danish: En mulig additiv virkning på immunsystemet bør også vurderes, når sådanne lægemidler anvendes efter behandling med MAVENCLAD (se pkt.
English: Patients with current active malignancies must not receive Mavenclad treatment;
Danish: Patienter med aktuelle, aktive maligniteter ikke må få behandling med Mavenclad,
English: Pharmacotherapeutic group: Selective Immunosuppressants, ATC code: L04AA40
Danish: Farmakoterapeutisk klassifikation: Selektive immunosuppressiva, ATC-kode: L04AA40 Virkningsmekanisme
English: The mean duration of MS prior to study enrolment was 8.7 years, and the median baseline neurological disability based on Kurtzke Expanded Disability Status Scale (EDSS) score across all treatment groups was 3.0 (range 0 to 6.0).
Danish: Den gennemsnitlige varighed af MS før inklusion i studiet var 8,7 år, og det mediane neurologiske funktionsniveau ved baseline baseret på Kurtzke Expanded Disability Status Scale (EDSS)-score i alle behandlingsgrupper var 3,0 (interval 0 til 6,0).
English: The Patient Guide should include an introduction to Mavenclad treatment, its side effects, potential risks and information on pregnancy prevention.
Danish: Patientguiden skal omfatte en introduktion til behandlingen med Mavenclad, bivirkninger, mulige risici og information om at undgå graviditet.
English: Child-resistant packaging.
Danish: Børnesikret pakning.
English: As the tablets are uncoated, they must be swallowed immediately once removed from the blister and not be left exposed on surfaces or handled for any period of time greater than that required for dosing.
Danish: Da tabletterne ikke er filmovertrukne, skal de synkes, straks de er blevet fjernet fra blisteren, og de må ikke efterlades på overflader eller håndteres i længere perioder, end det er nødvendigt for indtagelsen.
English: An individual benefit-risk evaluation should be performed before initiating MAVENCLAD in patients with prior malignancy.
Danish: En individuel benefit/risk-evaluering skal udføres, før MAVENCLAD påbegyndes hos patienter med tidligere malignitet.
English: Prior to launch of Mavenclad (cladribine) in each Member State (MS) the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials (EM), including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Danish: Før Mavenclad (cladribin) markedsføres i hvert medlemsland skal indehaveren af markedsføringstilladelsen nå til enighed med den nationale kompetente myndighed om indholdet og formatet af uddannelsesmaterialet, herunder kommunikationsmedier, udleveringskanaler samt alle andre aspekter af programmet.
English: Decrease in neutrophil count.
Danish: Reduktion af neutrofiltal.
English: You must not receive such vaccines during MAVENCLAD treatment.
Danish: Du må ikke få sådanne vaccinationer under behandling med MAVENCLAD.
English: Do not use MAVENCLAD together with other medicines for MS unless specifically advised by your doctor.
Danish: Brug ikke MAVENCLAD sammen med andre lægemidler mod MS, medmindre lægen specifikt har rådet dig til det.
English: • patients with 2 or more relapses in the previous year, whether on DMD treatment or not.
Danish: • patienter med 2 eller flere attakker i det foregående år, uanset om de var i behandling med
English: Women who become pregnant under therapy with MAVENCLAD should discontinue treatment.
Danish: Kvinder, som bliver gravide under behandlingen med MAVENCLAD, bør seponere behandlingen.
English: Blood transfusions
Danish: Blodtransfusioner
English: MAVENCLAD tablets are white, round, biconvex tablets engraved with 'C' on one side and '10' on the other side.
Danish: MAVENCLAD tabletter er hvide, runde, bikonvekse tabletter præget med “C” på den ene side og med “10” på den anden side.
English: In vitro, intra- versus extracellular accumulation ratios were found to be around 30 to 40 already 1 hour after cladribine exposure.
Danish: In vitro blev det vist, at forholdet mellem intra- versus ekstracellulære ophobninger var omkring 30 til 40 allerede 1 time efter cladribineksponeringen.
English: Safety and efficacy in patients with moderate or severe renal impairment have not been established.
Danish: Sikkerhed og virkning hos patienter med moderat eller svært nedsat nyrefunktion er ikke klarlagt.
English: Teratogenicity/adverse pregnancy outcomes, to ensure that female patients of child bearing potential / partners of male patients receiving Mavenclad: a.
Danish: Teratogenicitet/uønskede graviditetsudfald, for at sikre, at kvindelige patienter i den fertile alder / partnere af mandlige patienter, der får Mavenclad: a.
English: Known BCRP inhibitors, which may alter the pharmacokinetics of BCRP substrates by 20% in vivo, include eltrombopag.
Danish: Kendte BCRP-hæmmere, som kan ændre farmakokinetikken for BCRP-substrater med 20 % in vivo, omfatter eltrombopag.
English: MAVENCLAD contains hydroxypropylbetadex, which may be available for complex formation with other medicinal products, potentially leading to an increase in bioavailability of such a product (especially medicinal products with low solubility, see section 5.2).
Danish: MAVENCLAD indeholder hydroxypropylbetadex, hvilket kan være tilgængeligt for kompleksdannelse med andre lægemidler, og evt. føre til en øget biotilgængelighed for sådanne præparater (især lægemidler med lav opløselighed, se pkt.
English: Talk to your doctor if you take hormonal contraceptives (e.g. "the pill").
Danish: Kontakt lægen, hvis du tager hormonel prævention (f.eks. p-piller).
English: Do not take MAVENCLAD at the same time as any other medicine.
Danish: Tag ikke MAVENCLAD på samme tid som anden medicin.
English: Particularly close monitoring of haematological parameters is recommended in patients who have been exposed to an overdose of cladribine.
Danish: Særlig nøje overvågning af hæmatologiske parametre anbefales hos patienter, som har været eksponeret for en overdosis af cladribin.
English: MS pathology involves a complex chain of events in which different immune cell types, including autoreactive T and B cells play a key role.
Danish: MS patologien involverer en kompleks kædereaktion af hændelser, hvor forskellige typer immunceller, herunder autoreaktive T- og B-celler spiller en afgørende rolle.
English: Decreases in neutrophil count, red blood cell count, haematocrit, haemoglobin or platelet count compared to baseline values have also been observed in clinical studies, although these parameters usually remain within normal limits.
Danish: Der er ligeledes observeret reduktion af neutrofiltallet, antallet af røde blodlegemer, hæmatokrit, hæmoglobin eller antallet af blodplader sammenlignet med værdier ved baseline i kliniske studier, selvom disse parametre normalt forbliver inden for normalområdet.
English: Based on human experience with other substances inhibiting DNA synthesis, cladribine could cause congenital malformations when administered during pregnancy.
Danish: Baseret på humane data med andre stoffer, der hæmmer dna-syntesen, kan cladribin forårsage medfødte misdannelser, når det administreres under graviditeten.
English: Do not start MAVENCLAD together with medicines that weaken your immune system or reduce the production of blood cells by your bone marrow.
Danish: Start ikke MAVENCLAD sammen med medicin, der svækker dit immunsystem eller nedsætter din knoglemarvs produktion af blodlegemer.
English: Symptoms of infections can include: fever, aching, painful muscles, headache, generally feeling unwell or loss of appetite.
Danish: Symptomer på infektioner kan omfatte: feber, ømhed, smertende muskler, hovedpine, generel utilpashed og manglende appetit.
English: The primary apoptosis-inducing mechanism of action of Cd-ATP has direct and indirect actions on DNA synthesis and mitochondrial function.
Danish: Den primære apoptose-inducerende virkningsmekanisme af Cd-ATP har direkte og indirekte virkninger på dna-syntesen og mitokondriefunktionen.
English: Inhibition of these enzymes or genetic polymorphisms (e.g. CYP2D6, CYP2C9 or CYP2C19) are not expected to result in clinically significant effects on cladribine pharmacokinetics or exposure.
Danish: Hæmningen af disse enzymer eller genetiske polymorfismer (f.eks. CYP2D6, CYP2C9 eller CYP2C19) forventes ikke at resultere i kliniske signifikante virkninger på farmakokinetikken eller eksponeringen af cladribin.
English: Do not use this medicine after the expiry date which is stated on the label and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: As a precautionary measure, you should follow standard cancer screening recommendations, as advised by your doctor.
Danish: Som en forsigtighedsregel bør du følge standardanbefalinger for kræftscreening, efter rådgivning med lægen.
English: Cladribine cumulative dose 3.5 mg/kg (n = 433)
Danish: Cladribin kumulativ dosis 3,5 mg/kg (n = 433)
English: Hormonal contraceptives
Danish: Hormonel kontraception
English: The use of MAVENCLAD with interferon beta results in an increased risk of lymphopenia.
Danish: Anvendelsen af MAVENCLAD sammen med interferon beta fører til en øget risiko for lymfopeni.
English: Particular attention is recommended for patients who have no history of exposure to varicella zoster virus.
Danish: Det anbefales at tage særligt hensyn til patienter, som ikke tidligere er blevet eksponeret for varicella zoster-virus.
English: Blood tests
Danish: Blodprøver
English: In a study of the intracellular pharmacokinetics of Cd-AMP and Cd-ATP in patients with chronic myelogenous leukaemia, the levels of Cd-ATP were approximately half of the Cd-AMP levels.
Danish: I et studie af den intracellulære farmakokinetik af Cd-AMP og Cd-ATP hos patienter med kronisk myelogen leukæmi, var niveauerne af Cd-ATP ca. halvdelen af Cd-AMP-niveauerne.
English: The metabolism of cladribine was studied in MS patients following the administration of a single 10-mg tablet and a single 3-mg intravenous dose.
Danish: Cladribins metabolisme blev undersøgt hos patienter med MS efter administration af en enkelt 10 mg tablet og en enkelt 3 mg intravenøs dosis.
English: The carcinogenic potential of cladribine was assessed in a long-term 22-month study with subcutaneous administration in mice and in a short-term 26-week study by oral route in transgenic mice.
Danish: Det carcinogene potentiale af cladribin blev vurderet i et langvarigt 22-måneders studie med subkutan administration hos mus, og i et kortvarigt 26-ugers studie med oral administration hos transgene mus.
English: Non-clinical safety pharmacological and toxicological assessment of cladribine in animal models relevant for the safety assessment of cladribine did not yield significant findings other than those predicted by the pharmacologic mechanism of cladribine.
Danish: En præklinisk sikkerhedsfarmakologisk og toksikologisk vurdering af cladribin i relevante dyremodeller for vurdering af cladribins sikkerhed førte ikke til andre signifikante fund end dem, der kunne forudsiges af cladribins farmakologiske mekanisme.
English: Do not take MAVENCLAD and talk to your doctor or pharmacist if you are unsure if any of the above applies to you.
Danish: Tag ikke MAVENCLAD og kontakt lægen eller apotekspersonalet, hvis du er i tvivl om, at noget af det ovenstående gælder for dig.
English: There is evidence that cladribine can also cause direct caspase-dependent and -independent apoptosis via the release of cytochrome c and apoptosis-inducing factor into the cytosol of non-dividing cells.
Danish: Der er evidens for, at cladribin også kan forårsage direkte caspase-afhængig og -uafhængig apoptose via frigivelsen af cytokrom c og apoptose-inducerende faktor i cytosolet hos de hvilende celler.
English: The lymphocyte counts of more than 75% of patients returned to the normal range by week 144 from the first dose of cladribine (approximately 90 weeks after the last dose of cladribine).
Danish: Lymfocyttallet for over 75 % af patienterne var igen inden for normalområdet ved uge 144 fra den første dosis af cladribin (ca. 90 uger efter den sidste dosis af cladribin).
English: However, net effects in terms of potential cladribine exposure alterations are difficult to predict.
Danish: Nettovirkningen hvad angår mulige ændringer i cladribineksponeringen er svær at forudsige.
English: It is recommended that the daily cladribine doses in each treatment week be taken at intervals of 24 hours at approximately the same time each day.
Danish: Det anbefales, at de daglige doser med cladribin i hver behandlingsuge tages med intervaller på 24 timer på ca. samme tidspunkt hver dag.
English: The distribution of cladribine across biological membranes is facilitated by various transport proteins, including ENT1, CNT3 and BCRP.
Danish: Fordelingen af cladribin gennem biologiske membraner er faciliteret af forskellige transportproteiner, herunder ENT1, CNT3 og BCRP.
English: Duration of a treatment week
Danish: Varigheden af en behandlingsuge
English: Caution is recommended when MAVENCLAD is used in elderly patients, taking into account the potential greater frequency of decreased hepatic or renal function, concomitant diseases and other medicinal therapies.
Danish: Det anbefales at udvise forsigtighed, når MAVENCLAD anvendes hos ældre patienter, og overveje den mulige større hyppighed af nedsat lever- eller nyrefunktion, samtidige sygdomme og andre lægemiddelbehandlinger.
English: In vitro studies showed negligible transporter-mediated uptake of cladribine into human hepatocytes.
Danish: In vitro-studier viste en ubetydelig transportermedieret optagelse af cladribin i humane hepatocytter.
English: There is no indication that cladribine pharmacokinetics might change in a time-dependent fashion after repeated administration.
Danish: Der er ingen indikation for, at farmakokinetikken for cladribin kan ændre sig på en tidsafhængig facon efter gentagen administration.
English: Progressive multifocal leukoencephalopathy (PML) If you believe your MS is getting worse or if you notice any new symptoms, for example changes in mood or behaviour, memory lapses, speech and communication difficulties, talk to your doctor as soon as possible.
Danish: Hvis du mener, at din MS bliver værre, eller hvis du bemærker nye symptomer, for eksempel humørsvingninger eller ændret adfærd, hukommelsessvigt, problemer med at tale eller kommunikere, skal du kontakte lægen snarest muligt.
English: In hepatic in vitro systems, negligible metabolism of cladribine was observed (at least 90% was unchanged cladribine).
Danish: I hepatiske in vitro-systemer blev en ubetydelig metabolisme af cladribin observeret (mindst 90 % var uomdannet cladribin).
English: Carcinogenicity
Danish: Carcinogenicitet
English: Discontinuation of MAVENCLAD may need to be considered.
Danish: Det kan være nødvendigt at overveje en seponering af MAVENCLAD.
English: Subsequent phosphorylation of cladribine to its active triphosphate form, 2-chlorodeoxyadenosine triphosphate (Cd-ATP), is particularly efficiently achieved in lymphocytes, due to their constitutively high deoxycytidine kinase (DCK) and relatively low 5'-nucleotidase (5'-NTase) levels.
Danish: En efterfølgende fosforylering af cladribin til den aktive trifosfat-form, 2-chlordeoxyadenosintrifosfat (Cd-ATP), opnås særligt effektivt i lymfocytter, på grund af disses grundlæggende høje niveauer af deoxycytidinkinase (DCK) og relativt lave niveauer af 5'-nukleotidase (5'-NTase).
English: A supportive study in patients treated with cladribine as an add-on to interferon-beta vs. placebo + interferon-beta also included a limited number of patients with secondary progressive MS (26 patients).
Danish: Et støttende studie hos patienter i behandling med cladribin som tillægsbehandling til interferon-beta versus placebo + interferon-beta omfattede også et begrænset antal patienter med sekundær progressiv MS (26 patienter).
English: Very common (≥1/10)
Danish: Meget almindelig (≥ 1/10)
English: Do not take the missed dose along with the next scheduled dose.
Danish: Tag ikke den glemte dosis sammen med den næste skemalagte dosis.
English: White, round, biconvex tablets of 8.5 mm diameter, engraved with 'C' on one side and '10' on the other side.
Danish: Hvid, rund, bikonveks tablet på 8,5 mm i diameter, præget med “C” på den ene side og med “10” på den anden side.
English: In patients who have previously been treated with immunomodulatory or immunosuppressive medicinal products the mode of action and duration of effect of the other medicinal product should be considered prior to initiation of MAVENCLAD (see section 4.2).
Danish: Hos patienter, der tidligere er blevet behandlet med immunmodulerende eller immunsuppressive lægemidler, skal andre lægemidlers virkningsmekanisme og varighed af virkningen vurderes før MAVENCLAD påbegyndes (se pkt.
English: At the level of cladribine absorption, the only conceivable interaction pathway of clinical relevance appears to be the breast cancer resistance protein (BCRP or ABCG2).
Danish: I forhold til absorptionen af cladribin forekommer den eneste mulige interaktionsvej af klinisk betydning at være brystcancer-resistensproteinet (BCRP eller ABCG2).
English: Cladribine is a prodrug that has to be phosphorylated intracellularly to become biologically active.
Danish: Cladribin er et prodrug, der skal fosforyleres intracellulært for at blive biologisk aktivt.
English: Immunosuppressive medicinal products
Danish: Immunsuppressive lægemidler
English: Treatment with MAVENCLAD has been shown to reduce flare-ups of symptoms and to slow down progression of disability.
Danish: Behandling med MAVENCLAD er påvist at nedsætte opblussen af symptomer og forsinke forværringen af sygdommen.
English: Do not store the tablets in a different container.
Danish: Opbevar ikke tabletterne i en anden beholder.
English: In vivo clastogenicity in mice was detected at 10 mg/kg, which was the lowest dose tested.
Danish: In vivo klastogenicitet hos mus blev detekteret ved 10 mg/kg, som var den laveste undersøgte dosis.
English: Do not take MAVENCLAD:
Danish: Tag ikke MAVENCLAD:
English: HIV infection, active tuberculosis and active hepatitis must be excluded before initiation of cladribine (see section 4.3).
Danish: En hivinfektion, aktiv tuberkulose og aktiv hepatitis skal udelukkes, før cladribin påbegyndes (se pkt.
English: If you change from other MS treatments to MAVENCLAD, your doctor will check that your blood cell counts (lymphocytes) are normal before you start treatment.
Danish: Hvis du skifter fra andre behandlinger mod MS til MAVENCLAD, vil lægen kontrollere, at dit antal af blodlegemer (lymfocytter) er normalt, før du starter behandlingen.
English: After oral administration of cladribine across a dose range from 3 to 20 mg, Cmax and AUC increased in a dose-proportional fashion, suggesting that absorption is not affected by rate- or capacity-limited processes up to a 20 mg oral dose.
Danish: Efter oral indgivelse af cladribin over et dosisinterval fra 3 til 20 mg var Cmax og AUC forhøjet på en dosis-proportional facon, hvilket antyder, at absorptionen ikke er påvirket af hastigheds- eller kapacitetsbegrænsende processer op til en 20 mg oral dosis.
English: The dephosphorylation and deactivation of Cd-AMP is catalysed by cytoplasmic 5'-NTase.
Danish: Defosforyleringen og deaktiveringen af Cd-AMP katalyseres af cytoplasmisk 5'-NTase.
English: If necessary, you will be vaccinated against shingles before you start treatment.
Danish: Hvis det er nødvendigt, vil du blive vaccineret mod helvedesild, før du starter behandlingen.
English: Acute short-term therapy with systemic corticosteroids can be administered during cladribine treatment.
Danish: Akut kortvarig behandling med systemiske kortikosteroider kan administreres under behandling med cladribin.
English: Although PML has not been observed with MAVENCLAD, as a precaution, you may have a head MRI (magnetic resonance imaging) before you start treatment.
Danish: Selvom PML ikke er blevet observeret med MAVENCLAD, kan det som en forsigtighedsregel være nødvendigt, at du får udført en MR-scanning (en magnetisk resonansscanning) af hjernen, før du starter behandlingen.
English: See below for a step-by-step guide on how to handle the package and to take the MAVENCLAD tablets.
Danish: Se nedenfor for en trinvis vejledning i hvordan pakningen skal håndteres, og hvordan MAVENCLAD-tabletterne skal tages.
English: Example: If you forget to take the Day 3 dose and do not remember it until Day 4, take the Day 3 dose on Day 4, and extend the total number of days in the treatment week by 1 day.
Danish: Eksempel: Hvis du glemmer at tage dosen for Dag 3 og ikke husker det før Dag 4, skal du tage dosen for Dag 3 på Dag 4, og forlænge antallet af dage i behandlingsugen med 1 dag.
English: Initiation of treatment with MAVENCLAD must be postponed for 4 to 6 weeks to allow for the full effect of vaccination to occur.
Danish: Initiering af behandlingen med MAVENCLAD skal udsættes i 4 til 6 uger, så vaccinationen kan opnå sin fulde virkning.
English: MAVENCLAD contains the active substance cladribine, a cytotoxic (cell killing) substance that works mostly on lymphocytes, cells of the immune system that are involved in inflammation.
Danish: MAVENCLAD indeholder det aktive stof cladribin, et cytotoksisk (celledræbende) stof, der hovedsageligt virker på lymfocytterne, celler i immunsystemet, der er involveret i betændelse.
English: Based on a population pharmacokinetic analysis including patients with normal renal function and with mild renal impairment, total clearance in patients with mild renal impairment (CLCR = 60 mL/min) is expected to decrease moderately, leading to an increase in exposure of 25%.
Danish: Baseret på en populationsfarmakokinetisk analyse, som omfattede patienter med normal nyrefunktion og med let nedsat nyrefunktion, forventes den totale clearance hos patienter med let nedsat nyrefunktion (CLCR = 60 ml/min) at falde moderat og føre til en øget eksponering på 25 %.