FrancophonIA/ELRC3.0 huggingface dataset:
English: Before you start a treatment course, your doctor will do a blood test to check that the levels of lymphocytes (a type of white blood cells) are in an acceptable range.
Danish: Din læge vil tage en blodprøve, før du kan begynde et behandlingsforløb for at kontrollere, at dit niveau af lymfocytter (en type hvide blodlegemer) er inden for et acceptabelt område.
English: In patients with mild renal impairment (creatinine clearance 60 to 89 mL/min), no dosage adjustment is considered necessary (see section 5.2).
Danish: Hos patienter med let nedsat nyrefunktion (kreatininclearance 60 til 89 ml/min), anses det ikke at være nødvendigt med en doseringsjustering (se pkt.
English: There is limited experience with overdose of MAVENCLAD.
Danish: Der er begrænset erfaring med en overdosis MAVENCLAD.
English: If two consecutive doses are missed, the same rule applies, and the number of days in the treatment week is extended by two days.
Danish: Hvis to på hinanden følgende doser glemmes, gælder den samme regel, og antallet af dage i behandlingsugen forlænges med to dage.
English: You will be tested to see if you have any infections before you start MAVENCLAD treatment.
Danish: Du vil blive testet for at se, om du har nogle infektioner, før du starter behandlingen med MAVENCLAD.
English: Cases of progressive multifocal leukoencephalopathy (PML) have been reported for parenteral cladribine in patients treated for hairy cell leukaemia with a different treatment regimen.
Danish: Tilfælde af progressiv multifokal leukoencefalopati (PML) er blevet rapporteret for parenteral cladribin hos patienter i behandling mod hårcelleleukæmi med et andet behandlingsprogram.
English: Clinically relevant interactions with inhibitors of P-gp are not expected.
Danish: Der forventes ikke kliniske relevante interaktioner med P-gp hæmmere.
English: - if you have active tuberculosis or liver inflammation (hepatitis).
Danish: - hvis du har aktiv tuberkulose eller leverbetændelse (hepatitis).
English: The distribution of the total dose over the 2 years of treatment is provided in Table 1.
Danish: Fordelingen af den totale dosis i løbet af 2 års behandlingen kan ses i Tabel 1.
English: MAVENCLAD does not affect your ability to drive or use machines.
Danish: MAVENCLAD påvirker ikke din evne til at føre motorkøretøj eller betjene maskiner.
English: Push (text to indicate the two hooks that have to be pressed for opening) QR code to be included www.mavenclad-instructions.com
Danish: 3 Træk bakken ud, indtil den ikke kan trækkes længere ud Tryk (tekst for at indikere de to hægter, der skal trykkes ned for at åbne) QR-kode, der skal indsættes www.mavenclad-instructions.com
English: Variations in the expression levels of DCK and 5'-NTases between immune cell subtypes may explain differences in immune cell sensitivity to cladribine.
Danish: Variationer i ekspressionsniveauerne af DCK og 5'-Ntaser mellem forskellige undertyper af immunceller kan forklare forskellene i immuncellernes følsomhed over for cladribin.
English: Cd-AMP is further phosphorylated to cladribine diphosphate (Cd-ADP) and cladribine triphosphate (Cd-ATP).
Danish: Cd-AMP fosforyleres yderligere til cladribindifosfat (Cd-ADP) og cladribintrifosfat (Cd-ATP).
English: - If a tablet is left on a surface or if it breaks and fragments fall from the blister, the area must be thoroughly washed.
Danish: - Hvis en tablet efterlades på en overflade, eller hvis den knækker, og der falder stykker ud af blisteren, skal området vaskes grundigt.
English: Cladribine is a nucleoside analogue of deoxyadenosine.
Danish: Cladribin er en nukleosidanalog af deoxyadenosin.
English: A drug interaction study in MS patients showed that the bioavailability of 10 mg oral cladribine was not altered when co-administered with pantoprazole.
Danish: Et lægemiddelinteraktionsstudie hos MS-patienter viste, at biotilgængeligheden af 10 mg cladribin ikke var ændret ved samtidig administration af pantoprazol.
English: Pick up carton with the opening instructions facing up.
Danish: Tag fat i kartonen med anvisningerne i at åbne den vendt opad.
English: Take the tablet(s) at about the same time each day.
Danish: Tag tabletten/tabletterne på ca. samme tidspunkt hver dag.
English: Effects on the kidneys were also seen in mice.
Danish: Der blev også observeret virkninger på nyrerne hos mus.
English: A high DCK to 5'-NTase ratio favours the accumulation of Cd-ATP, making lymphocytes particularly susceptible to cell death.
Danish: En høj DCK til 5'-NTase ratio favoriserer akkumulationen af Cd-ATP, og gør lymfocytterne særligt udsatte for celledød.
English: • at least 800 cells/mm³ before initiating MAVENCLAD in year 2.
Danish: • mindst 800 celler/mm³ før MAVENCLAD påbegyndes i år 2.
English: Leave a gap of at least 3 hours between taking MAVENCLAD and other medicines taken by mouth.
Danish: Der skal være mindst 3 timer mellem indtagelse af MAVENCLAD og anden medicin, der tages gennem munden.
English: Active chronic infection (tuberculosis or hepatitis).
Danish: Aktiv kronisk infektion (tuberkulose eller hepatitis)
English: Pharmacokinetic interactions
Danish: Farmakokinetiske interaktioner
English: While there were no effects on female fertility, reproductive function or general performance of offspring, cladribine was shown to be embryolethal when administered to pregnant mice, and the compound was teratogenic in mice (also following treatment of the males only) and rabbits.
Danish: Selvom der ikke var nogen virkning på fertilitet af hunmus, reproduktiv funktion og afkommets generelle formåen, viste cladribin sig at være embryoletalt, når det blev administreret til drægtige mus, og stoffet var teratogent hos mus (også når kun hanner blev behandlet) og kaniner.
English: Liver problems
Danish: Leverproblemer
English: Other disease-modifying medicinal products
Danish: Andre sygdomsmodificerende lægemidler
English: Read the 'Step-by-Step Guide' at the end of this package leaflet on how to handle the childresistant package and how to take the tablets included in the pack.
Danish: Læs 'Trinvis Vejledning' til sidst i denne indlægsseddel for information om at håndtere den børnesikrede pakning, og hvordan du skal tage de tabletter, der findes i pakningen.
English: th percentile was reached at 245 days, and not reached at all during the study period in the cladribine 3.5 mg/kg group.
Danish: I placebogruppen blev det 10. percentil nået efter 245 dage, og det blev slet ikke nået i løbet af studieperioden i gruppen med 3,5 mg/kg cladribin.
English: Changing treatments
Danish: Skift af behandlinger
English: Cladribine and/or its phosphorylated metabolites are substantially accumulated and retained in human lymphocytes.
Danish: Cladribin og/eller dets fosforylerede metabolitter akkumuleres betydeligt, og ophobes i humane lymfocytter.
English: MAVENCLAD contains hydroxypropylbetadex that may interact with other medicines in your stomach.
Danish: MAVENCLAD indeholder hydroxypropylbetadex, der kan påvirke andre lægemidler i maven.
English: Vaccination of antibody-negative patients is recommended prior to initiation of cladribine therapy.
Danish: Vaccination af antistof-negative patienter anbefales før behandling med cladribin påbegyndes.
English: The recommended cumulative dose of MAVENCLAD is 3.5 mg/kg body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
Danish: Den anbefalede kumulative dosis af MAVENCLAD er 3,5 mg/kg legemsvægt i løbet af 2 år, administreret som 1 behandlingsforløb på 1,75 mg/kg pr. år.
English: A missed dose must not be taken together with the next scheduled dose on the following day.
Danish: En glemt dosis må ikke tages sammen med den næste skemalagte dosis den følgende dag.
English: Intracellular half-life of Cd-AMP was 15 h. Intracellular half-life of Cd-ATP was 10 h.
Danish: Intracellulær halveringstid for Cd-AMP var 15 t. Intracellulær halveringstid for Cd-ATP var 10 t.
English: Haematological monitoring
Danish: Hæmatologisk monitorering
English: The incidence of affected mouse foetuses in this study was in the same range of spontaneous incidence of amelia and phocomelia in this strain of mice.
Danish: Forekomsten af påvirkede musefostre i dette studie var i det samme interval som for spontan forekomst af ameli og fokomeli hos denne museart.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Accordingly, the bioavailability, intracellular distribution and renal elimination of cladribine may theoretically be altered by potent ENT1 and CNT3 transporter inhibitors such as dilazep, nifedipine, nimodipine, cilostazol, sulindac or reserpine.
Danish: Således kan biotilgængeligheden, den intracellulære fordeling og den renale elimination af cladribin teoretisk ændres af potente ENT1- og CNT3-transporter-hæmmere, såsom dilazep, nifedipin, nimodipin, cilostazol, sulindac eller reserpin.
English: Treatment with oral cladribine leads to rapid reductions in circulating CD4+ and CD8+ T cells.
Danish: Behandling med oralt cladribin fører til hurtige reduktioner i cirkulerende CD4+ og CD8+ T-celler.
English: If you change from MAVENCLAD to other MS treatments, talk to your doctor.
Danish: Hvis du skifter fra MAVENCLAD til andre behandlinger mod MS, skal du kontakte lægen.
English: Cladribine did not induce gene mutation in bacteria or mammalian cells, but it was clastogenic causing chromosomal damage in mammalian cells in vitro at a concentration which was 17-fold above the expected clinical Cmax.
Danish: Cladribin inducerede ikke genmutation i bakterie- eller pattedyrsceller, men det var klastogent, og forårsagede kromosomskade på pattedyrsceller in vitro ved en koncentration, som var 17 gange over den forventede kliniske Cmax.
English: As shown in Table 3 above, higher cumulative doses did not add any clinically meaningful benefit, but were associated with a higher incidence in ≥grade 3 lymphopenia (44.9% in the 5.25 mg/kg group vs. 25.6 % in the 3.5 mg/kg group).
Danish: Som vist i Tabel 3 ovenfor tilføjede højere kumulative doser ingen klinisk meningsfyldt fordel, men de blev forbundet med en større forekomst af ≥grad 3 lymfopeni (44,9 % i gruppen med 5,25 mg/kg vs. 25,6 % i gruppen med 3,5 mg/kg).
English: Table 2 MAVENCLAD 10 mg tablets per week day Total number of tablets per week
Danish: Tabel 2: MAVENCLAD 10 mg tabletter pr. ugedag Totalt antal tabletter pr. uge
English: INFORMATION IN BRAILLE mavenclad
Danish: INFORMATION I BRAILLESKRIFT mavenclad
English: When switching from another MS medicinal product, a baseline MRI should be performed (see subsection 'Infections' above).
Danish: Når der skiftes fra et andet MS-lægemiddel, bør der udføres en baseline MR-scanning (se underpkt.
English: In vitro studies indicate that cladribine is a substrate of the equilibrative nucleoside (ENT1) and concentrative nucleoside (CNT3) transport proteins.
Danish: In vitro-studier indikerer, at cladribin er et substrat for transportproteinerne for det ækvilibrerende nukleosid (ENT1) og det koncentrative nukleosid (CNT3).
English: Talk to your doctor or pharmacist before taking MAVENCLAD.
Danish: Kontakt lægen eller apotekspersonalet, før du tager MAVENCLAD.
English: - The other ingredients are hydroxypropylbetadex, sorbitol and magnesium stearate.
Danish: - Øvrige indholdsstoffer: hydroxypropylbetadex, sorbitol og magnesiumstearat.
English: Each treatment course consists of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective treatment year.
Danish: Hvert behandlingsforløb består af 2 behandlingsuger, én i begyndelsen af den første måned og én i begyndelsen af den anden måned i det pågældende behandlingsår.
English: MAVENCLAD is packed in a reclosable, child-resistant carton and must be kept out of the sight and reach of children.
Danish: MAVENCLAD er pakket i en genlukkelig, børnesikret karton, og skal opbevares utilgængeligt for børn.
English: However, a post-hoc analysis of a mixed cohort including CLARITY and ONWARD patients, defined by a baseline EDSS score of ≥3.5 as a proxy for secondary progressive MS, showed a similar reduction in annualised relapse rate compared to patients with an EDSS score below 3.
Danish: En post-hoc-analyse af en blandet kohorte, der omfattede patienter fra CLARITY og ONWARD, defineret ved en baseline EDSS-score på ≥3,5 som en proxy for sekundær progressiv MS, viste imidlertid en tilsvarende reduktion i årlig attakrate, sammenlignet med patienter med en EDSS-score under 3.
English: The non-renal part of the elimination of cladribine (approximately 50%) consists of negligible hepatic metabolism and of extensive intracellular distribution and trapping of the active cladribine principle (Cd-ATP) within the targeted intracellular compartment (i.e. the lymphocytes) and subsequent elimination of intracellular Cd-ATP according to the life-cycle and elimination pathways of these cells.
Danish: Den non-renale del af eliminationen af cladribin (ca. 50 %) består af en ubetydelig levermetabolisme og af en omfattende intracellulær fordeling og indfangning af det aktive, primære cladribinformat (Cd-ATP) i det målrettede intracellulære rum (dvs. i lymfocytterne), og efterfølgende elimination af intracellulært Cd-ATP i henhold til livscyklussen og eliminationsvejene for disse celler.
English: Cladribine reduces CD19+ B cells and CD16+/CD56+ natural killer cells, which also recover faster than CD4+ T cells.
Danish: Cladribin reducerer antallet af CD19+ B-celler og CD16+/CD56+ naturlige dræberceller, og antallet af dem stiger også hurtigere igen end antallet af CD4+ T-celler.
English: Talk to your doctor before taking MAVENCLAD if you have liver problems.
Danish: Kontakt lægen, før du tager MAVENCLAD, hvis du har leverproblemer.
English: A treatment week consists of 4 or 5 days on which you receive 1 or 2 tablets daily (see Table 1).
Danish: En behandlingsuge består af 4 eller 5 dage, hvor du vil få 1 eller 2 tabletter dagligt (se Tabel 1).
English: If this is not possible, selection of alternative concomitant medicinal products with no, or minimal ENT1, CNT3 or BCRP transporter inhibiting properties should be considered.
Danish: Hvis dette ikke er muligt, skal det overvejes at vælge samtidigt administrerede lægemidler med ingen, eller minimale ENT1-, CNT3- eller BCRP-transporter-hæmmende egenskaber.
English: Cladribine has no clinically meaningful inductive effect on CYP1A2, CYP2B6 and CYP3A4 enzymes.
Danish: Cladribin har ingen klinisk meningsfyldt induktiv virkning på CYP1A2-, CYP2B6- og CYP3A4-enzymer.
English: Cladribine has been shown to exert long-lasting effects by preferentially targeting lymphocytes and the autoimmune processes involved in the pathophysiology of MS.
Danish: Det er påvist, at cladribin udøver en langvarig virkning ved fortrinsvis at påvirke lymfocytter og de autoimmune processer, som er involveret i patofysiologien af MS.
English: Fructose intolerance
Danish: Fructoseintolerans
English: The European Medicines Agency has waived the obligation to submit the results of studies with MAVENCLAD in all subsets of the paediatric population in multiple sclerosis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med MAVENCLAD i alle undergrupper af den pædiatriske population ved multipel sklerose (se pkt.
English: Single events of cancer have been observed in patients who had received cladribine in clinical studies.
Danish: Der er set enkelte tilfælde af kræft hos patienter, der havde fået cladribin i kliniske studier.
English: As a result of a lower DCK/5'-NTase ratio other bone marrow derived cells are less affected than lymphocytes.
Danish: Som følge af et lavere forhold mellem DCK og 5'-Ntase, er andre celler, der stammer fra knoglemarven, mindre påvirkede end lymfocytterne.
English: Note that for some weight ranges the number of tablets may vary from one treatment week to the next.
Danish: Bemærk, at for nogle vægtkategorier kan antallet af tabletter variere fra en behandlingsuge til den næste.
English: Initiation of cladribine treatment in immunocompromised patients, including patients currently receiving immunosuppressive or myelosuppressive therapy (see section 4.5).
Danish: Initiering af behandling med cladribin hos immunkompromitterede patienter, herunder patienter, der aktuelt får immunsuppressiv eller myelosuppressiv behandling (se pkt.
English: If the lymphocyte count is below
Danish: Hvis lymfocyttallet er under
English: Cladribine is not a relevant substrate to cytochrome P450 enzymes and does not show significant potential to act as inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4.
Danish: Cladribin er ikke et relevant substrat for cytokrom P450-enzymer, og viser ikke signifikant potentiale til at virke som en hæmmer af CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 og CYP3A4.
English: th percentile for disability progression was reached between 16 and 23 weeks, while for the cladribine groups it was not reached during the entire study.
Danish: For placebo blev det 10. percentil for sygdomsprogression nået mellem 16 og 23 uger, mens det ikke blev nået i hele studiet for cladribingrupperne.
English: • The Prescriber Guide
Danish: • Ordinationsguiden
English: No increased incidence of lymphoproliferative disorders or other tumour types (apart from Harderian gland tumours, predominantly adenomas) was seen in mice.
Danish: Der blev ikke observeret en øget forekomst af lymfoproliferative sygdomme eller andre tumortyper (udover tumorer i Harders kirtler, hovedsageligt adenomer) hos mus.
English: Cladribine pharmacokinetics were studied following oral and intravenous administration in MS patients and patients with malignancies, and in in vitro systems.
Danish: Farmakokinetikken for cladribin er undersøgt efter oral og intravenøs administration til patienter med MS og til patienter med cancersygdom samt i in vitro-systemer.
English: Efficacy and safety of oral cladribine were evaluated in a randomised, double-blind, placebocontrolled clinical study (CLARITY) in 1,326 patients with relapsing-remitting MS. Study objectives were to evaluate the efficacy of cladribine versus placebo in reducing the annualised relapse rate (ARR) (primary endpoint), slowing disability progression and decreasing active lesions as measured by MRI.
Danish: Sikkerhed og virkning af oralt cladribin blev evalueret i et randomiseret, dobbeltblindet, placebokontrolleret klinisk studie (CLARITY) hos 1.326 patienter med attakvis MS. Studiets formål var at evaluere virkningen af cladribin versus placebo på en reduktion af den årlige attakrate (annual relapse rate (ARR)) (primært endepunkt), opbremsning af sygdomsprogression og en reduktion af aktive læsioner målt ved MR-scanning.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Cladribine's mode of action is closely linked to a reduction in lymphocyte count.
Danish: Cladribins virkningsmekanisme er tæt forbundet med en reduktion af lymfocyttallet.
English: In addition, the cladribine 3.5 mg/kg treatment group was statistically significantly superior to placebo with regard to number and relative reduction of T1 Gd+ lesions, active T2 lesions and combined unique lesions as demonstrated in brain MRI over the entire 96 weeks of the study.
Danish: Desuden var behandlingsgruppen med 3,5 mg/kg cladribin statistisk signifikant bedre end placebo med hensyn til antal og relativ reduktion af T1 Gd+ læsioner, aktive T2 læsioner og kombinerede unikke læsioner, som vist ved MR-scanning af hjernen i løbet af de fulde 96 uger i studiet.
English: Moderate or severe renal impairment (creatinine clearance <60 mL/min) (see section 5.2).
Danish: Moderat eller svært nedsat nyrefunktion (kreatininclearance < 60 ml/min) (se pkt.
English: The primary target organs identified in the repeat-dose toxicology studies by parenteral routes (intravenous or subcutaneous) up to 1-year duration in mice and monkeys were the lymphoid and haematopoietic system.
Danish: De primære målorganer identificeret i toksikologistudier med gentagne doser via parenteral administration (intravenøs eller subkutan) af op til 1-års varighed hos mus og aber var det lymfoide og hæmatopoietiske system.
English: Consultation with a haematologist is advised.
Danish: Der tilrådes konsultation med en hæmatolog.
English: - dilazep, nifedipine, nimodipine, reserpine, cilostazol or sulindac (used to treat the heart, high blood pressure, vascular conditions or inflammation), or eltrombopag (used to treat conditions associated with bleeding).
Danish: - dilazep, nifedipin, nimodipin, reserpin, cilostazol eller sulindac (anvendes til at behandle hjerte, forhøjet blodtryk, karsygdomme eller betændelse) eller eltrombopag (anvendes til at behandle tilstande forbundet med blødning).
English: It is currently unknown whether Mavenclad may reduce the effectiveness of systemically acting hormonal contraceptives.
Danish: Det er aktuelt ukendt, om Mavenclad kan nedsætte virkningen af systemisk virkende hormonel kontraception.
English: No studies have been conducted to evaluate the pharmacokinetics of cladribine in elderly or in paediatric MS patients, or in subjects with renal or hepatic impairment.
Danish: Der er ikke udført studier for at evaluere cladribins farmakokinetik hos ældre eller hos pædiatriske patienter med MS, eller hos patienter med nedsat nyre- eller leverfunktion.
English: Although the clinical relevance of such interactions is unknown, it is recommended that coadministration of potent ENT1, CNT3 or BCRP inhibitors be avoided during the 4- to 5-day cladribine treatment.
Danish: Selvom den kliniske betydning af sådanne interaktioner er ukendt, bør samtidig administration af ENT1-, CNT3- eller BCRP-hæmmere undgås i de 4 - 5 dages behandling med cladribin.
English: In this extension study, 806 patients received either placebo or a cumulative dose of cladribine 3.5 mg/kg (in a regimen similar to that used in CLARITY) over the 96-week study period.
Danish: I dette extension-studie fik 806 patienter enten placebo eller en kumulativ dosis af cladribin på 3,5 mg/kg (i et program, der svarede til det, der blev brugt i CLARITY) i løbet af studieperioden på 96 uger.
English: See also 'Other medicines and MAVENCLAD'.
Danish: Se også “Brug af anden medicin sammen med MAVENCLAD”.
English: Dose in mg (number of 10 mg tablets) per treatment week kg
Danish: Dosis i mg (antal 10 mg tabletter) pr. behandlingsuge kg
English: A missed dose must be taken as soon as remembered on the same day according to the treatment schedule.
Danish: En glemt dosis skal tages, så snart patienten kommer i tanke om det, på den samme dag i henhold til behandlingsprogrammet.
English: The MAH shall ensure that in each MS where Mavenclad is marketed, all prescribers and patients who are expected to prescribe / use Mavenclad are provided with:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle ordinerende læger, som forventes at ordinere Mavenclad / patienter, der forventes at bruge Mavenclad, forsynes med:
English: In the case of a missed dose, the patient must take the missed dose on the following day, and extend the number of days in that treatment week.
Danish: I tilfælde af en glemt dosis, skal patienten tage den glemte dosis den følgende dag, og forlænge antallet af dage i denne behandlingsuge.
English: The effects of potent inducers of the efflux transporters BCRP and P-glycoprotein (P-gp) on the bioavailability and disposition of cladribine have not been formally studied.
Danish: Virkningen af potente induktorer af effluxtransporterne BCRP og P-glykoprotein (P-gp) på biotilgængeligheden og dispositionen af cladribin er ikke blevet formelt undersøgt.