FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients taking cladribine compared to the placebo treatment group had 86% relative reduction in the mean number of T1 Gd+ lesions (adjusted mean number for cladribine 3.5 mg/kg, and placebo groups were 0.12 and 0.91, respectively), 73% relative reduction in the mean number of active T2 lesions (adjusted mean number for cladribine 3.5 mg/kg, and placebo groups were 0.38 and 1.43, respectively) and 74% relative reduction in the mean number of combined unique lesions per patient per scan (adjusted mean number for cladribine 3.5 mg/kg, and placebo groups were 0.43 and 1.72, respectively) (p <0.001 across all 3 MRI outcomes).
Danish: Patienter, der fik cladribin sammenlignet med placebogruppen havde en relativ reduktion på 86 % i det gennemsnitlige antal T1 Gd+ læsioner (det justerede gennemsnitlige antal for cladribin 3,5 mg/kg og placebogrupperne var hhv. 0,12 og 0,91), en relativ reduktion på 73 % i det gennemsnitlige antal aktive T2 læsioner (det justerede gennemsnitlige antal for cladribin 3,5 mg/kg og placebogrupperne var hhv. 0,38 og 1,43) og en relativ reduktion på 74 % i det gennemsnitlige antal kombinerede unikke læsioner pr. patient pr. scanning (det justerede gennemsnitlige antal for cladribin 3,5 mg/kg og placebogrupperne var hhv. 0,43 og 1,72) (p < 0,001 over alle 3 MR-scannings-udfald).
English: In clinical studies, 20% to 25% of the patients treated with a cumulative dose of cladribine 3.5 mg/kg over 2 years as monotherapy developed transient grade 3 or 4 lymphopenia.
Danish: I kliniske studier udviklede 20 % til 25 % af patienterne behandlet med kumulative doser af cladribin 3,5 mg/kg over 2 år som monoterapi forbigående grad 3 eller 4 lymfopeni.
English: Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding is contraindicated during treatment with MAVENCLAD and for 1 week after the last dose (see section 4.3).
Danish: Da der er mulighed for alvorlige bivirkninger hos ammede spædbørn, er amning kontraindiceret under behandling med MAVENCLAD og i 1 uge efter den sidste dosis (se pkt.
English: Initiation of MAVENCLAD should be delayed until the infection has been adequately treated.
Danish: MAVENCLAD skal udsættes, indtil infektionen er blevet behandlet tilstrækkeligt.
English: Across studies, the largest proportion of patients with grade 3 or 4 lymphopenia (<500 to 200 cells/mm³ or <200 cells/mm³) was seen 2 months after the first cladribine dose in each year, indicating a time gap between cladribine plasma concentrations and the maximum haematological effect.
Danish: I alle studierne blev hovedparten af patienter med grad 3 eller 4 lymfopeni (< 500 til 200 celler/mm³ eller < 200 celler/mm³) observeret 2 måneder efter den første cladribindosis i hvert år, hvilket indikerer et tidsinterval mellem plasmakoncentrationen af cladribin og den maksimale hæmatologiske virkning.
English: It is recommended that administration of any other oral medicinal product be separated from that of MAVENCLAD by at least 3 hours during the limited number of days of cladribine administration (see section 4.5).
Danish: Det anbefales, at administration af alle andre orale lægemidler adskilles fra administrationen af MAVENCLAD med mindst 3 timer i løbet af de få dage med administration af cladribin (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of cladribine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 10 mg cladribin.
English: In clinical studies, events of malignancies were observed more frequently in cladribine-treated patients compared to patients who received placebo (see section 4.8).
Danish: I et klinisk studie blev tilfælde af malignitet observeret hyppigere hos patienter behandlet med cladribin, sammenlignet med patienter, der fik placebo (se pkt.
English: Lymphocyte counts must be
Danish: Lymfocyttallet skal være
English: Adverse reactions described in the list below are derived from pooled data from clinical studies in MS in which oral cladribine was used as monotherapy at a cumulative dose of 3.5 mg/kg.
Danish: De beskrevne bivirkninger i listen nedenfor stammer fra samlede data fra kliniske MS-studier, hvor oralt cladribin blev anvendt som monoterapi med en kumulativ dosis på 3,5 mg/kg.
English: As cladribine interferes with DNA synthesis, adverse effects on human gametogenesis could be expected.
Danish: Da cladribin påvirker dna-syntesen, kan der forventes bivirkninger på den humane gametogenese.
English: Shingles will need to be treated, and MAVENCLAD treatment may need to be stopped until the infection is cleared.
Danish: Det er nødvendigt at behandle helvedesild, og det kan være nødvendigt at stoppe behandlingen med MAVENCLAD, indtil infektionen er væk.
English: - rifampicin (used to treat certain types of infection), St. John's wort (used to treat depression) or corticosteroids (used to suppress inflammation).
Danish: - rifampicin (anvendes til at behandle visse former for infektion), Johannesurt/prikbladet perikon (anvendes til at behandle depression) eller kortikosteroider (anvendes til at undertrykke betændelse).
English: LIST OF EXCIPIENTS Contains sorbitol.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder sorbitol.
English: CD8+ T cells have a less pronounced decrease and a faster recovery than CD4+ T cells, resulting in a temporarily decreased CD4 to CD8 ratio.
Danish: CD8+ T-cellernes reduktion er mindre markant, og antallet af dem stiger hurtigere igen end antallet af CD4+ T-cellerne, hvilket fører til en forbigående reduktion i forholdet mellem CD4 og CD8.
English: Cladribine was also assessed in a 1-year monkey study by the subcutaneous route.
Danish: Cladribin blev også vurderet i et etårigt studie hos aber med subkutan administration.
English: Before initiation of treatment both in year 1 and year 2, women of childbearing potential and males who could potentially father a child should be counselled regarding the potential for serious risk to the foetus and the need for effective contraception (see section 4.6).
Danish: Før behandlingen påbegyndes, både i år 1 og år 2, bør kvinder i den fertile alder og mænd, der potentielt kan blive fædre, rådgives angående muligheden for alvorlige risici for fosteret og behovet for sikker kontraception (se pkt.
English: Post-hoc analysis of time to 6-month confirmed EDSS progression resulted in a 47% reduction of the risk of disability progression in the cladribine 3.5 mg/kg compared to placebo (hazard ratio = 0.53, 95% CI [0.36, 0.79], p <0.05); in the placebo group the 10
Danish: Post-hoc-analyser af tiden til 6-måneder bekræftet EDSS-progression førte til en 47 % reduktion i risikoen for sygdomsprogression i gruppen med cladribin 3,5 mg/kg, sammenlignet med placebo (hazard ratio = 0,53, 95 % CI [0,36; 0,79], p < 0,05).
English: Take the missed dose on the next day and extend the number of days in that treatment week.
Danish: Tag den glemte dosis den næste dag, og forlæng antallet af dage i behandlingsugen.
English: Additive haematological adverse reactions may be expected if cladribine is administered prior to or concomitantly with other substances that affect the haematological profile (see section 4.5).
Danish: Additive hæmatologiske bivirkninger kan forventes, hvis cladribin administreres før eller sammen med andre stoffer, der påvirker den hæmatologiske profil (se pkt.
English: MAVENCLAD is contraindicated in MS patients with active malignancies (see section 4.3).
Danish: MAVENCLAD er kontraindiceret til MS-patienter med aktiv malignitet (se pkt.
English: If you are male, you must use effective methods of contraception to prevent your partner from getting pregnant, whilst you are treated with MAVENCLAD and for 6 months after the last dose.
Danish: Hvis du er en mand, skal du bruge sikre præventionsmetoder for at undgå, at din partner bliver gravid, mens du behandles med MAVENCLAD, og i 6 måneder efter den sidste dosis.
English: A Step-by-Step Guide to taking your MAVENCLAD 10 mg tablets
Danish: Trinvis vejledning til at tage dine MAVENCLAD 10 mg tabletter
English: An infection commonly seen with MAVENCLAD is shingles.
Danish: En almindelig infektion med MAVENCLAD er helvedesild.
English: Swallow tablet(s) with water.
Danish: Synk tabletten/tabletterne med vand.
English: Talk to your doctor, if you are or have been treated with: - medicines which may affect your blood cells (for example carbamazepine, used to treat epilepsy).
Danish: - medicin, som kan påvirke dine blodlegemer (f.eks. carbamazepin, som anvendes til at behandle epilepsi).
English: Renal clearance of cladribine was shown to be dependent on creatinine clearance.
Danish: Det er blevet vist, at nyrernes cladribinclearance er afhængig af kreatininclearance.
English: A chlorine substitution in the purine ring protects cladribine from degradation by adenosine deaminase, increasing the intracellular residence time of the cladribine prodrug.
Danish: En chlorsubstitution i purinringen beskytter cladribin mod at blive nedbrudt af adenosindeaminase, hvilket øger den tid, hvor cladribin prodrug er til stede intracellulært.
English: In women of childbearing potential, pregnancy must be excluded before the initiation of MAVENCLAD in year 1 and year 2, and prevented by use of effective contraception during cladribine treatment and for at least 6 months after the last dose.
Danish: Hos kvinder i den fertile alder skal graviditet udelukkes, før MAVENCLAD påbegyndes i år 1 og år 2, og forhindres ved at bruge sikker kontraception i løbet af behandlingen med cladribin, og i mindst 6 måneder efter den sidste dosis.
English: Treatment week 1
Danish: Behandlingsuge 1
English: Each tablet contains 10 mg cladribine.
Danish: Hver tablet indeholder 10 mg cladribin.
English: Year 2
Danish: År 2
English: Total number of tablets per treatment week
Danish: Tabel 3 Totale antal tabletter pr. behandlingsuge
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 10 mg cladribine.
Danish: ANGIVELSE AF AKTIVT STOF Hver tablet indeholder 10 mg cladribin.
English: What you need to know before you take MAVENCLAD
Danish: Det skal du vide, før du begynder at tage MAVENCLAD
English: Pregnancy and breast-feeding (see section 4.6).
Danish: Graviditet og amning (se pkt.
English: As cladribine interferes with DNA synthesis, adverse effects on human gametogenesis could be expected (see section 5.3).
Danish: Da cladribin påvirker dna-syntesen, kan der forventes bvirkninger på den humane gametogenese (se pkt.
English: Year 1
Danish: År 1
English: • The Patient Guide The Prescriber Guide should include:
Danish: Ordinationsguiden skal indeholde:
English: Do not take MAVENCLAD, if you are breast-feeding.
Danish: Tag ikke MAVENCLAD, hvis du ammer.
English: No studies have been conducted in patients with hepatic impairment.
Danish: Der er ikke udført studier hos patienter med nedsat nyrefunktion.
English: You need a second method of contraception during MAVENCLAD treatment and for at least 4 weeks after the last dose.
Danish: Du skal bruge endnu en præventionsmetode under behandlingen med MAVENCLAD, og i mindst 4 uger efter den sidste dosis.
English: MAVENCLAD contains sorbitol.
Danish: MAVENCLAD indeholder sorbitol.
English: See also 'Pregnancy and breast-feeding'.
Danish: Se også 'Graviditet og amning'.
English: MAVENCLAD 10 mg tablets cladribine
Danish: MAVENCLAD 10 mg tabletter cladribin
English: Therefore women of child bearing potential, using systemically acting hormonal contraceptives, should add a barrier method during cladribine treatment and up to 4 weeks after the last dose.
Danish: Derfor bør kvinder i den fertile alder, der anvender systemisk virkende hormonal kontraception, tilføje en barrieremetode under behandlingen med cladribin, og i op til 4 uger efter den sidste dosis.
English: Take the leaflet from the tray.
Danish: Tag indlægssedlen fra bakken.
English: Patients who had completed the CLARITY study could be enrolled in CLARITY Extension.
Danish: Patienter, der gennemførte CLARITY-studiet, kunne indgå i CLARITY-EXT-studiet.
English: The role of hepatic function for the elimination of cladribine is considered negligible.
Danish: Leverfunktionens rolle i udskillelse af cladribin anses for at være ubetydelig.
English: Treatment courses
Danish: Behandlingsforløb
English: See package leaflet for guidance.
Danish: Læs indlægssedlen for retningslinjer.
English: If you have taken more tablets than you should, contact your doctor immediately.
Danish: Hvis du har taget for mange MAVENCLAD-tabletter, skal du straks kontakte din læge.
English: 90 to <100
Danish: 90 til < 100
English: Men and women must use effective contraception during MAVENCLAD treatment and for at least 6 months after the last dose.
Danish: Mænd og kvinder skal anvende sikker prævention under behandlingen med MAVENCLAD og i mindst 6 måneder efter den sidste dosis.
English: • normal before initiating MAVENCLAD in year 1,
Danish: • normalt, før MAVENCLAD påbegyndes i år 1
English: 40 to <50
Danish: 40 til < 50
English: Treatment week 2
Danish: Behandlingsuge 2
English: Other medicines and MAVENCLAD
Danish: Brug af anden medicin sammen med MAVENCLAD
English: Lymphopenia
Danish: Lymfopeni
English: However, considering cladribine genotoxicity, male-mediated effects related to potential genetic alteration of differentiating sperm cells cannot be excluded.
Danish: Der kan imidlertid ikke udelukkes en virkning medieret fra hannen relateret til en mulig genetisk ændring af differentierende sædceller, når genotoksiciteten af cladribin tages i betragtning.
English: 50 to <60
Danish: 50 til < 60
English: Day 3
Danish: Dag 3
English: To decrease the risk for severe lymphopenia, lymphocyte counts must be determined before, during and after cladribine treatment (see section 4.4) and strict criteria for initiating and continuing cladribine treatment must be followed (see section 4.2).
Danish: For at nedsætte risikoen for svær lymfopeni skal lymfocyttallet bestemmes før, under og efter behandlingen med cladribin (se pkt.
English: Reproduction toxicity
Danish: Reproduktionstoksitet
English: Blood and lymphatic system disorders Very common: Lymphopenia.
Danish: Meget almindelig: Lymfopeni.
English: 70 to <80
Danish: 70 til < 80
English: What MAVENCLAD is and what it is used for What you need to know before you take MAVENCLAD How to take MAVENCLAD Possible side effects
Danish: Det skal du vide, før du begynder at tage MAVENCLAD Sådan skal du tage MAVENCLAD Bivirkninger
English: 80 to <90
Danish: 80 til < 90
English: th percentile (months) Hazard ratio (95% CI) * p <0.001 compared to placebo
Danish: Hazard ratio (95 % CI)
English: Day 1
Danish: Dag 1
English: - Ensure your hands are dry before picking up your tablet(s).
Danish: - Sørg for, at dine hænder er tørre, før du håndterer tabletten/tabletterne.
English: MAVENCLAD contains sorbitol
Danish: MAVENCLAD indeholder sorbitol
English: 1st treatment week 1 or 2 tablets daily for 4 or 5 days, mid April
Danish: 1. behandlingsuge 1 eller 2 tabletter dagligt i 4 eller 5 dage, midten af april
English: Rare (≥1/10,000 to <1/1,000)
Danish: Ikke almindelig (≥ 1/1.000 til < 1/100) Sjælden (≥ 1/10.000 til < 1/1.000)
English: • before initiating MAVENCLAD in year 2,
Danish: • før MAVENCLAD påbegyndes i år 2
English: Relapsing-remitting MS
Danish: Attakvis MS
English: 60 to <70
Danish: 60 til < 70
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS CARDBOARD WALLET
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ÆSKE AF PAP
English: • before initiating MAVENCLAD in year 1,
Danish: • før MAVENCLAD påbegyndes i år 1
English: 70 mg (7 tablets)
Danish: 70 mg (7 tabletter)
English: 80 mg (8 tablets)
Danish: 80 mg (8 tabletter)
English: What MAVENCLAD contains
Danish: MAVENCLAD indeholder:
English: NAME OF THE MEDICINAL PRODUCT MAVENCLAD 10 mg tablets
Danish: LÆGEMIDLETS NAVN MAVENCLAD 10 mg tabletter
English: Clinical studies with oral cladribine in MS did not include patients over 65 years of age; therefore, it is not known whether they respond differently from younger patients.
Danish: Kliniske studier med oralt cladribin i MS omfattede ikke patienter over 65 år.
English: • In the long-term carcinogenicity study in mice, the highest dose used was 10 mg/kg, which was seen to be genotoxic in the mouse micronucleus study (equivalent to approximately 16-fold the expected human exposure in AUC in patients taking the maximum daily dose of 20 mg cladribine).
Danish: • I det langvarige carcinogenicitetsstudie hos mus var den højeste anvendte dosis 10 mg/kg, hvor der blev observeret en genotoksisk virkning i mikronukleusstudiet hos mus (svarende til ca.
English: 100 mg (10 tablets)
Danish: 100 mg (10 tabletter)
English: 90 mg (9 tablets)
Danish: 90 mg (9 tabletter)
English: Day 2
Danish: Dag 2
English: 2nd treatment week 1 or 2 tablets daily for 4 or 5 days, mid May
Danish: 2. behandlingsuge 1 eller 2 tabletter dagligt i 4 eller 5 dage, midten af maj
English: Women using systemically acting hormonal contraceptives should add a barrier method during cladribine treatment and for at least 4 weeks after the last dose in each treatment year (see section 4.5).
Danish: Kvinder, der anvender systemisk virkende hormonel kontraception, bør tilføje en barrieremetode under behandlingen med cladribin og i mindst 4 uger efter den sidste dosis i hvert behandlingsår (se pkt.
English: 40 mg (4 tablets)
Danish: 40 mg (4 tabletter)
English: Therefore, women using systemically acting hormonal contraceptives should add a barrier method during cladribine treatment and for at least 4 weeks after the last dose in each treatment year (see section 4.6).
Danish: Derfor bør kvinder, der anvender systemisk virkende hormonel kontraception, tilføje en barrieremetode under behandlingen med cladribin og i mindst 4 uger efter den sidste dosis i hvert behandlingsår (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Cladribine 10 mg
Danish: LÆGEMIDLETS NAVN Cladribine 10 mg
English: 50 mg (5 tablets)
Danish: 50 mg (5 tabletter)
English: Therefore, male patients must take precautions to prevent pregnancy of their partner during cladribine treatment and for at least 6 months after the last dose (see above).
Danish: Derfor skal mandlige patienter tage forholdsregler for at undgå, at deres partner bliver gravid under behandling med cladribin, og i mindst 6 måneder efter den sidste dosis (se ovenfor).
English: How to take MAVENCLAD
Danish: Sådan skal du tage MAVENCLAD
English: You must use effective methods of contraception to avoid becoming pregnant during MAVENCLAD treatment and for 6 months after taking the last dose.
Danish: Du skal bruge sikker prævention for at undgå at blive gravid under behandlingen med MAVENCLAD, og i mindst 6 måneder efter, du har taget den sidste dosis.
English: Lymphopenia and shingles
Danish: Lymfopeni og helvedesild
English: 60 mg (6 tablets)
Danish: 60 mg (6 tabletter)
English: Each tablet contains 64 mg sorbitol.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver tablet indeholder 64 mg sorbitol.
English: NAME OF THE MEDICINAL PRODUCT MAVENCLAD 10 mg tablets cladribine
Danish: LÆGEMIDLETS NAVN MAVENCLAD 10 mg tabletter cladribin
English: Male patients must take precautions to prevent pregnancy of their female partner during cladribine treatment and for at least 6 months after the last dose.
Danish: Mandlige patienter skal tage forholdsregler for at undgå, at deres kvindelige partner bliver gravid i løbet af behandlingen med cladribin, og i mindst 6 måneder efter den sidste dosis.
English: Posology
Danish: Dosisfordeling
English: Women of childbearing potential must prevent pregnancy by use of effective contraception during cladribine treatment and for at least 6 months after the last dose (see section 4.5).
Danish: Kvinder i den fertile alder skal undgå at blive gravide ved at bruge sikker kontraception i behandlingen med cladribin, og i mindst 6 måneder efter den sidste dosis (se pkt.
English: Therefore, male patients must take precautions to prevent pregnancy of their partner during cladribine treatment and for at least 6 months after the last dose.
Danish: Derfor skal mandlige patienter tage forholdsregler for at undgå, at deres kvindelige partner bliver gravid i løbet af behandlingen med cladribin, og i mindst 6 måneder efter den sidste dosis.
English: Studies revealed a mean volume of distribution of cladribine in the range of 480 to 490 L. The plasma protein binding of cladribine is 20%, and independent of plasma concentration.
Danish: Studier viser et gennemsnitligt fordelingsvolumen for cladribin i området fra 480 til 490 l.
English: Dose
Danish: Dosis
English: These include: ciclosporin, cyclophosphamide and azathioprine (used to suppress the immune system, for example after organ transplantation); methotrexate (used to treat conditions such as psoriasis or rheumatoid arthritis); long-term corticosteroids (used to reduce inflammation, for example in asthma).
Danish: Disse omfatter: ciclosporin, cyclophosphamid og azathioprin (anvendes til at undertrykke immunsystemet, for eksempel efter organtransplantation).
English: Active malignancy.
Danish: Aktiv malignitet
English: Haematotoxic medicinal products
Danish: Hæmatotoksiske lægemidler
English: Although the importance of hepatic function for the elimination of cladribine is considered negligible (see section 5.2), in the absence of data, use of MAVENCLAD is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh score >6) (see section 4.2).
Danish: 5.2), bør MAVENCLAD ikke anvendes til patienter med moderat eller svært nedsat leverfunktion (Child-Pugh-score > 6), da der ikke foreligger nogen data (se pkt.
English: • Important identified risks Severe (Grade ≥ 3) lymphopenia, to ensure compliance to haematological testing and treatment requirements; Herpes zoster infections, to ensure awareness of signs and symptoms suggestive for these infections; Tuberculosis, to raise awareness about this risk.
Danish: Svær (grad ≥ 3) lymfopeni, for at sikre en overholdelse af hæmatologiske tests og behandlingsbehov,
English: For treatment decisions based on the patient's lymphocyte counts, see section 4.2 and subsection 'Infections' below.
Danish: 'Infektioner' nedenfor for behandlingsvalg baseret på patientens lymfocyttal.
English: Tuberculosis (see section 4.4).
Danish: Meget sjælden: Tuberkulose (se pkt.
English: If you take more MAVENCLAD than you should
Danish: Hvis du har taget for meget MAVENCLAD
English: 6.3 Shelf-life
Danish: 6.1 Hjælpestoffer
English: Lymphopenia is known to be dosedependent (see sections 4.4 and 4.8).
Danish: 4.4 og 4.8).
English: while on therapy with other DMDs,
Danish: mens de fik behandling med andre DMD'er
English: This summary was last updated in 04-2013.
Danish: Dette sammendrag blev sidst ajourført i 04-2013.
English: Nemdatine should be given once a day at the same time every day.
Danish: Nemdatine bør gives én gang dagligt på samme tidspunkt hver dag.
English: EPAR summary for the public
Danish: EPAR - Sammendrag for offentligheden
English: This is a summary of the European public assessment report (EPAR) for Nemdatine.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nemdatine.
English: The full EPAR for Nemdatine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Nemdatine findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nemdatine on 22 April 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nemdatine den 22. april 2013.
English: Other information about Nemdatine
Danish: Andre oplysninger om Nemdatine
English: Nemdatine memantine
Danish: Nemdatine memantin
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Danish: To lægemidler er bioækvivalente, når de danner samme mængder af det aktive stof i kroppen.