FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you are HIV positive, meaning you are infected with the human immunodeficiency virus (HIV).
Danish: - hvis du er hiv-positiv, hvilket betyder, at du er inficeret med human immundefektvirus (hiv).
English: • 2 and 6 months after start of treatment in each treatment year.
Danish: • 2 og 6 måneder efter behandlingsstart i hvert behandlingsår.
English: Your doctor will tell you what to do if you have to take these medicines.
Danish: Lægen vil fortælle dig, hvad du skal gøre, hvis det er nødvendigt, at du tager disse lægemidler.
English: Patients were required to have at least 1 relapse in the previous 12 months.
Danish: Det var et krav, at patienterne havde haft mindst 1 attak i løbet af de foregående 12 måneder.
English: 1 tablet 4 tablets 5 tablets 6 tablets 7 tablets 8 tablets
Danish: 1 tablet 4 tabletter 5 tabletter 6 tabletter 7 tabletter 8 tabletter
English: • patients with 1 relapse in the previous year and at least 1 T1 Gd+ lesion or 9 or more T2 lesions,
Danish: • patienter med 1 attak i året forinden, og mindst 1 T1 Gd+-læsion eller 9 eller flere T2 læsioner,
English: If this is not possible, dose reduction to the minimum mandatory dose of medicinal products containing these compounds, separation in the timing of administration and careful patient monitoring is recommended.
Danish: Hvis dette ikke er muligt, anbefales dosisreduktion til den minimalt obligatoriske dosis for lægemidler, der indeholder disse stoffer, tidsmæssige intervaller mellem administrationerne og nøje overvågning af patienten.
English: Your doctor will decide the best treatment options for you.
Danish: Lægen vil bestemme, hvilke behandlingsmuligheder er de bedste for dig.
English: Do not take MAVENCLAD if you are pregnant or trying to become pregnant.
Danish: Tag ikke MAVENCLAD, hvis du er gravid eller prøver på at blive gravid.
English: Push the tray back into the carton.
Danish: Skub bakken tilbage i kartonen.
English: Because of these expression levels, cells of the innate immune system are less affected than cells of the adaptive immune system.
Danish: På grund af disse ekspressionsniveauer er cellerne i det innate immunsystem mindre påvirket end cellerne i det adaptive immunsystem.
English: It is known that the more medicine you take the less lymphocytes may be present in your body, resulting in lymphopenia (see section 4).
Danish: Det er kendt, at jo mere medicin, du tager, jo færre lymfocytter kan være til stede i kroppen, hvilket kan føre til lymfopeni (se pkt.
English: - if you are pregnant or breast-feeding (see also 'Pregnancy and breast-feeding').
Danish: - hvis du er gravid eller ammer (se også “Graviditet og amning”).
English: OTHER SPECIAL WARNING, IF NECESSARY Cytotoxic: Handle with caution.
Danish: EVENTUEL ANDEN SÆRLIG ADVARSEL Cytotoksisk: Håndteres varsomt.
English: These included
Danish: Disse omfattede
English: Harderian gland tumours are not considered to be of clinical relevance, as humans do not have comparable anatomical structures.
Danish: Tumorer i Harders kirtler anses ikke for at være af klinisk relevans, da mennesker ikke har sammenlignelige anatomiske strukturer.
English: You will be prescribed the correct number of tablets for each treatment week, based on your body weight as shown in Table 2.
Danish: Du vil få ordineret det korrekte antal tabletter til hver behandlingsuge, baseret på din legemsvægt, som vist i Tabel 2.
English: Read the package leaflet for further information.
Danish: Læs indlægssedlen for yderligere oplysninger.
English: Therefore, screening for latent infections, in particular tuberculosis and hepatitis B and C, must be performed prior to initiation of therapy in year 1 and year 2.
Danish: Derfor skal der udføres screening for latente infektioner, især tuberkulose og hepatitis B og C før behandlingen påbegyndes i år 1 og år 2.
English: If a daily dose consists of two tablets, both tablets are taken together as a single dose.
Danish: Hvis en daglig dosis består af to tabletter, skal begge tabletter tages sammen som en enkelt dosis.
English: The most important side effect is a reduction in the number of white blood cells called lymphocytes (lymphopenia), which is very common (may affect more than 1 in 10 people) and may be severe.
Danish: Den vigtigste bivirkning er en reduktion af antallet af hvide blodlegemer, der kaldes lymfocytter (lymfopeni), hvilket kan forekomme meget almindeligt (kan forekomme hos mere end 1 ud af 10 personer) og kan være alvorligt.
English: Pack sizes of 1, 4, 5, 6, 7 or 8 tablets.
Danish: Pakningsstørrelser på 1, 4, 5, 6, 7 eller 8 tabletter.
English: Your doctor will tell you the number of tablets to take
Danish: Lægen vil fortælle dig, hvor mange tabletter du skal tage
English: Each pack contains 1, 4, 5, 6, 7 or 8 tablets in a blister, sealed in a cardboard wallet and fixed in a child-resistant carton.
Danish: Hver pakning indeholder 1, 4, 5, 6, 7 eller 8 tabletter i en blister, forseglet i en æske af pap og fikseret i en børnesikret karton.
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Læs indlægssedlen inden brug.
English: The doctor will also do blood tests during and after treatment to check that you can continue to take MAVENCLAD, and that you are not developing any complications from the treatment.
Danish: Lægen vil også tage blodprøver under og efter behandlingen for at kontrollere, at du kan fortsætte med at tage MAVENCLAD, og at du ikke udvikler komplikationer fra behandlingen.
English: It is expected that most patients recover to either normal lymphocyte counts or grade 1 lymphopenia within 9 months.
Danish: Det forventes, at de fleste patienter får et normalt lymfocyttal igen eller grad 1 lymfopeni inden for 9 måneder.
English: Receive counselling before starting the treatment (consisting of two treatment courses administered at the beginning of two consecutive years) both in year 1 and year 2;
Danish: Får rådgivning, inden de starter behandlingen (der består af to behandlingsforløb, som administreres i begyndelsen af to på hinanden følgende år), både i år 1 og år 2,
English: Place your hand under the blister pack and push 1 or 2 tablet(s) into your hand, according to your prescribed dose.
Danish: Placer din hånd under blisterpakningen, og tryk 1 eller 2 tabletter ud i hånden, i henhold til din ordinerede dosis.
English: Secondary progressive MS with relapses
Danish: Sekundær progressiv MS med attakker
English: If this recovery takes more than 6 months, the patient should not receive MAVENCLAD anymore.
Danish: Hvis dette tager mere end 6 måneder, må patienten ikke længere få MAVENCLAD.
English: Use of oral cladribine in patients weighing less than 40 kg has not been investigated.
Danish: Anvendelse af oralt cladribin til patienter, der vejer under 40 kg, er ikke undersøgt.
English: Concomitant use of other oral medicinal products
Danish: Samtidig anvendelse af andre orale lægemidler
English: - if you are allergic to cladribine or any of the other ingredients of MAVENCLAD (listed in section 6).
Danish: - hvis du er allergisk over for cladribin eller et af de øvrige indholdsstoffer i MAVENCLAD (angivet i punkt 6).
English: In patients who require blood transfusion, irradiation of cellular blood components is recommended prior to administration to prevent transfusion-related graft-versus-host disease.
Danish: For patienter, som har behov for blodtransfusion, anbefales bestråling af cellulære komponenter i blodet før administration, for at forhindre transfusionsrelateret graft-versus-host-sygdom.
English: The patient's hands must be dry when handling the tablets and washed thoroughly afterwards.
Danish: Patientens hænder skal være tørre, når tabletterne håndteres, og de skal vaskes grundigt bagefter.
English: (2) Push in the hooks on the sides of the carton simultaneously with your index finger and thumb, and keep hooks pushed.
Danish: (2) Tryk hægterne på siderne af kartonen ned samtidigt med tommel- og pegefinger, og bliv ved med at trykke dem ned.
English: Do not pop the tablets out of the blister.
Danish: Tryk ikke tabletterne ud af blisteren.
English: This is important because MAVENCLAD can seriously harm your baby.
Danish: Det er vigtigt, da MAVENCLAD kan skade dit barn alvorligt.
English: Only traces of other metabolites could be found in plasma and in urine.
Danish: Der fandtes kun spor af andre metabolitter i plasma og urin.
English: Table 3 shows how many tablets (1 or 2 tablets) you have to take on each day.
Danish: Tabel 3 viser hvor mange tabletter (1 eller 2 tabletter), du skal tage hver dag.
English: Have a glass of water ready and make sure your hands are clean and dry before taking the tablet(s).
Danish: Sørg for at have et glas vand parat og at dine hænder er rene og tørre, før du tager tabletten (tabletterne).
English: Lymphopenia may increase the risk of getting an infection.
Danish: Lymfopeni kan forøge risikoen for at få en infektion.
English: MS is a disease in which inflammation destroys the protective sheath around the nerves.
Danish: MS er en sygdom, der ødelægger beskyttelseslaget rundt om nerverne.
English: Caution: Do not remove the tray from the carton.
Danish: Forsigtig: Bakken må ikke fjernes fra kartonen.
English: Cladribine has the potential to penetrate the blood brain barrier.
Danish: Cladribin har potentialet til at passere blod-hjerne-barrieren.
English: 110 and above
Danish: 110 og derover
English: These may be the symptoms of a rare brain disorder caused by infection and called progressive multifocal leukoencephalopathy (PML).
Danish: Det kan være symptomer på en sjælden hjernesygdom, der forårsages af en infektion og kaldes progressiv multifokal leukoencefalopati (PML).
English: Latent infections may be activated, including tuberculosis or hepatitis.
Danish: Latente infektioner kan blive aktiveret, herunder tuberkulose eller hepatitis.
English: Use of MAVENCLAD is not recommended in patients below the age of 18 years, because it has not been investigated in this age group.
Danish: MAVENCLAD bør ikke anvendes til patienter under 18 år, da det ikke er blevet undersøgt til denne aldersgruppe.
English: Vaccination with live or attenuated live vaccines should be avoided during and after cladribine treatment as long as the patient's white blood cell counts are not within normal limits.
Danish: Vaccination med levende eller levende svækket vacciner bør undgås, under og efter behandling med cladribin, så længe patientens hvide blodlegemer ikke er inden for normalområdet.
English: You will be given MAVENCLAD as two treatment courses over 2 years.
Danish: Du vil få MAVENCLAD som to behandlingsforløb i løbet af 2 år.
English: The volume of distribution is large, indicating extensive tissue distribution and intracellular uptake.
Danish: Fordelingsvolumenet er stort, hvilket indikerer en udbredt vævsfordeling og intracellulær optagelse.
English: Example: if you have to take 8 tablets, you would take 2 tablets on Day 1, Day 2, Day 3, then 1 tablet on Day 4 and Day 5.
Danish: Eksempel: hvis du skal tage 8 tabletter, vil du tage 2 tabletter på Dag 1, Dag 2, Dag 3, og dernæst 1 tablet på Dag 4 og Dag 5.
English: 500 cells/mm³, it should be actively monitored until values increase again.
Danish: 3, skal det aktivt overvåges, indtil værdierne igen stiger.
English: Tell your doctor immediately if you get symptoms of shingles, a common complication of MAVENCLAD (see section 4), which may need specific treatment.
Danish: Fortæl det straks til lægen, hvis du får symptomer på helvedesild, en almindelig komplikation ved MAVENCLAD (se punkt 4), hvor der kan være behov for specifik behandling.
English: - Push your tablet(s) through the blister and swallow immediately.
Danish: - Tryk din tablet (dine tabletter) gennem blisteren og slug dem straks.
English: Live or live attenuated vaccines
Danish: Levende eller levende svækkede vacciner
English: How to take your medicine
Danish: Sådan skal du tage lægemidlet
English: • The treatment regimens;
Danish: • Behandlingsprogrammerne,
English: (3) Pull the tray out until it stops.
Danish: (3) Træk bakken ud, indtil den ikke kan trækkes længere ud.
English: Other common side effects - may affect up to 1 in 10 people - cold sore (oral herpes) - rash - hair loss - reduction in the number of certain white blood cells (neutrophils)
Danish: Andre almindelige bivirkninger - kan forekomme hos op til 1 ud af 10 personer) - forkølelsessår (oral herpes) - udslæt - hårtab - nedsat antal af visse hvide blodlegemer (neutrofiler)
English: A delay in initiation of cladribine should also be considered in patients with an acute infection until the infection is fully controlled.
Danish: En udsættelse af initiering af cladribin bør også overvejes hos patienter med en akut infektion, indtil infektionen er helt under kontrol.
English: However, a baseline magnetic resonance imaging (MRI) should be performed before initiating MAVENCLAD (usually within 3 months).
Danish: Der bør imidlertid udføres en magnetisk resonansscanning (MRscanning) ved baseline, før MAVENCLAD påbegyndes (normalt inden for 3 måneder).
English: If you require blood transfusions, tell the doctor that you are taking MAVENCLAD.
Danish: Hvis du har behov for blodtransfusioner, skal du fortælle lægen, at du tager MAVENCLAD.
English: Patients with secondary progressive MS were excluded in the CLARITY study.
Danish: Patienter med sekundær progressiv MS blev ekskluderet i CLARITY-studiet.
English: If your doctor believes that MAVENCLAD is essential for you, your doctor will advise you to stop breast-feeding.
Danish: Hvis din læge mener, at MAVENCLAD er nødvendigt for dig, vil lægen råde dig til at stoppe med at amme.
English: In the clinical study data base of cladribine in MS (1,976 patients, 8,650 patient years) no case of PML has been reported.
Danish: I den kliniske studiedatabase med cladribin til MS (1.976 patienter, 8.650 patientår) er der ikke rapporteret nogen tilfælde af PML.
English: Number of tablets to take Year 1 treatment course
Danish: Antal tabletter, du skal tage År 1 behandlingsforløb
English: Take the missed dose on that day.
Danish: Tag den glemte dosis den dag.
English: - if you have a weakened immune system due to medical conditions or because you are taking other medicines that weaken your immune system or reduce the production of blood cells in your bone marrow.
Danish: - hvis du har et svækket immunsystem pga. medicinske tilstande eller fordi du tager anden medicin, som svækker dit immunsystem eller nedsætter produktionen af blodlegemer i din knoglemarv.
English: Treatment with MAVENCLAD should not be initiated within 4 to 6 weeks after vaccination with live or attenuated live vaccines because of a risk of active vaccine infection.
Danish: Behandling med MAVENCLAD bør ikke påbegyndes inden for 4 til 6 uger efter vaccination med levende eller levende svækket vacciner på grund af risikoen for infektion med aktiv vaccine.
English: In mice, there were no effects on fertility or the reproductive function of offspring.
Danish: Hos mus var der ingen virkning på fertilitet eller den reproduktive funktion hos afkom af mus.
English: Gustav Mahlerplein 102 1082 MA Amsterdam The Netherlands
Danish: Gustav Mahlerplein 102 1082 MA Amsterdam Holland
English: Histologically, testicular degeneration was only seen in one male monkey in a 1-year subcutaneous toxicity study.
Danish: Histologisk blev testikulær degeneration kun observeret hos en hanabe i et 1-års subkutant toksicitetsstudie.
English: You will need to wait between 4 and 6 weeks for the vaccination to take effect.
Danish: Du skal vente i 4 til 6 uger, før vaccinationen virker.
English: Patients with lymphocyte counts below 500 cells/mm³ should be actively monitored for signs and symptoms suggestive of infections, in particular herpes zoster.
Danish: Patienterne med lymfocyttal under 500 celler/ mm³ skal aktivt overvåges for tegn og symptomer, som kunne tyde på infektioner, især herpes zoster.
English: MAVENCLAD is a medicine used to treat multiple sclerosis (MS) in adults.
Danish: MAVENCLAD er et lægemiddel, anvendes til at behandle multipel sklerose (MS) hos voksne.
English: Based on pooled population pharmacokinetic data from various studies, the median values for elimination were 22.2 L/h for renal clearance and 23.4 L/h for non-renal clearance.
Danish: Baseret på samlede populationsfarmakokinetiske data fra forskellige studier var medianværdierne for elimination 22,2 l/t for clearance og 23,4 l/t for non-renal clearance.
English: Following both oral and intravenous administration, the parent compound cladribine was the main component present in plasma and urine.
Danish: Efter både oral og intravenøs administration var udgangsstoffet cladribin hovedkomponenten, som var til stede i plasma og urin.
English: If your daily dose is 2 tablets, take them at the same time.
Danish: Hvis din daglige dosis er 2 tabletter, skal du tage dem på samme tidspunkt:
English: Patients treated with MAVENCLAD should be advised to follow standard cancer screening guidelines.
Danish: Patienter i behandling med MAVENCLAD skal rådes til at følge standard-retningslinjer for cancerscreening.
English: If you get pregnant more than 6 months after the last dose in year 1, no safety risk is expected but this will mean that you cannot receive treatment with MAVENCLAD while you are pregnant.
Danish: Hvis du bliver gravid mere end 6 måneder efter den sidste dosis i år 1, forventes der ingen sikkerhedsrisiko, men det vil betyde, at du ikke kan blive behandlet med MAVENCLAD, mens du er gravid.
English: If necessary, the treatment course in year 2 can be delayed for up to 6 months to allow for recovery of lymphocytes.
Danish: Hvis det er nødvendigt, kan behandlingsforløbet i år 2 udsættes med op til 6 måneder, så lymfocyttallet kan normaliseres.
English: - Thoroughly wash your hands after handling the tablets.
Danish: - Vask dine hænder grundigt, efter du har håndteret tabletterne.
English: No increased incidence in lymphoproliferative disorders and no tumours were seen in this study.
Danish: Der blev ikke observeret nogen øget forekomst af lymfoproliferative sygdomme, og ingen tumorer i dette studie.
English: A small study in cancer patients has shown a cerebrospinal fluid/plasma concentration ratio of approximately 0.25.
Danish: Et lille studie med cancerpatienter har vist et forhold mellem cerebrospinalvæske/plasmakoncentration på ca. 0,25.
English: Your doctor may delay treatment, or interrupt it, until the infection clears up.
Danish: Lægen kan udsætte behandlingen eller afbryde den, indtil infektionen går væk.
English: 1 Open flap
Danish: 1 Åbn flig
English: EU/1/17/1212/001 - 1 tablet EU/1/17/1212/002 - 4 tablets EU/1/17/1212/003 - 5 tablets EU/1/17/1212/004 - 6 tablets EU/1/17/1212/005 - 7 tablets EU/1/17/1212/006 - 8 tablets
Danish: EU/1/17/1212/001 - 1 tablet EU/1/17/1212/002 - 4 tabletterr EU/1/17/1212/003 - 5 tabletter EU/1/17/1212/004 - 6 tabletter EU/1/17/1212/005 - 7 tabletter EU/1/17/1212/006 - 8 tabletter
English: • An introduction to Mavenclad, reminding the prescriber to consider the Patient Guide while discussing Mavenclad treatment with the patient, to support the early identification of sign and symptoms of adverse reactions and their timely treatment;
Danish: • En introduktion til Mavenclad, der påminder den ordinerende læge om at tage Patientguiden i betragtning, når de diskuterer behandlingen med Mavenclad med patienten, for at støtte den tidlige identifikation af tegn og symptomer på bivirkninger og deres rettidige behandling,
English: In the left column of the table below find the row that fits your body weight (in kg), and then check the number of tablets that should be in the pack(s) for the treatment week you will be starting.
Danish: I den venstre søjle i tabellen nedenfor finder du den række, der passer til din legemsvægt (i kg), og så kontrollerer du antallet af tabletter, der skal være i pakningen/pakningerne til den behandlingsuge, du starter.
English: Treatment with MAVENCLAD must be initiated and supervised by a physician experienced in the treatment of MS.
Danish: Behandling med MAVENCLAD skal initeres og superviseres af en læge med erfaring i behandling af MS.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Merck Europe B.V.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Merck Europe B.V.
English: A population kinetic analysis did not show any effect of age (range 18 to 65 years) or gender on cladribine pharmacokinetics.
Danish: En populationskinetisk analyse viste ikke nogen virkning af alder (interval fra 18 til 65 år) eller køn på farmakokinetikken af cladribin.
English: In the overall study population, the median age was 39 years (range 18 to 65), and the female to male ratio was approximately 2:1.
Danish: I den samlede studiepopulation var medianalderen 39 år (interval 18 til 65), og forholdet mellem kvinder og mænd var ca. 2:1.
English: If you miss a dose and you remember on the same day you were supposed to take it
Danish: Hvis du glemmer en dosis, og du kommer i tanke om det den samme dag, som du skulle have taget den
English: Safety and efficacy of MAVENCLAD in combination with other disease-modifying treatments for MS have not been established.
Danish: MAVENCLAD's sikkerhed og virkning i kombination med andre sygdomsmodificerende behandlinger for MS er ikke klarlagt.
English: No significant accumulation of cladribine concentration in plasma has been observed after repeated dosing.
Danish: Der er ikke observeret nogen signifikant akkumulation af cladribinkoncentration i plasma efter gentagen dosering.
English: The metabolite 2-chloroadenine was a minor metabolite both in plasma and in urine, e.g. accounting only for ≤3% of plasma parent drug exposure after oral administration.
Danish: Metabolitten 2-chloradenin var en mindre metabolit i både plasma og urin, og udgør f.eks. kun ≤3 % af udgangslægemidlet i plasma efter oral administration.
English: The bioavailability of 10 mg oral cladribine was approximately 40%.
Danish: Biotilgængeligheden af 10 mg oralt cladribin var ca. 40 %.
English: It is not known whether cladribine is excreted in human milk.
Danish: Det er ukendt, om cladribin udskilles i human mælk.
English: Cladribine can reduce the body's immune defence and may increase the likelihood of infections.
Danish: Cladribin kan reducere kroppens immunforsvar og øge sandsynligheden for infektioner.
English: Concomitant treatment is not recommended.
Danish: Samtidig behandling frarådes.
English: Tell your doctor immediately if you have symptoms of shingles such as a 'band' of severe pain and blistering rash, typically on one side of the upper body or the face.
Danish: Fortæl det straks til lægen, hvis du har symptomer på helvedesild, såsom et 'bånd' med svære smerter og udslæt med blærer, typisk på den ene side af overkroppen eller i ansigtet.
English: Very rare (<1/10,000)
Danish: Meget sjælden (< 1/10.000)
English: Table 1 Dose of MAVENCLAD per treatment week by patient weight in each treatment year
Danish: Tabel 1: MAVENCLAD-dosis pr. behandlingsuge efter patientens vægt i hvert behandlingsår Vægtgruppe
English: Each treatment week consists of 4 or 5 days on which a patient receives 10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body weight.
Danish: Hver behandlingsuge består af 4 eller 5 dage, hvor en patient får 10 mg eller 20 mg (en eller to tabletter) som en enkelt daglig dosis, afhængigt af legemsvægten.
English: Testicular degeneration and reversible decrease in spermatozoa with rapid progressive motility were also seen in the monkey.
Danish: Testikulær degeneration og reversibel reduktion af sædceller med hurtig progressiv bevægelighed blev også observeret hos aber.
English: The remaining patients were pre-treated with either interferon beta-1a, interferon beta-1b, glatiramer acetate or natalizumab.
Danish: De resterende patienter var tidligere behandlet med enten interferon beta-1a, interferon beta-1b, glatirameracetat eller natalizumab.
English: The observed embryolethal and teratogenic effects are consistent with the pharmacologic mechanisms of cladribine.
Danish: De observerede embryoletale og teratogene virkninger er i overensstemmelse med den farmakologiske mekanisme for cladribin.