FrancophonIA/ELRC3.0 huggingface dataset:
English: Teriflunomide concentrations measured during an 11-day procedure to accelerate teriflunomide elimination with either 8 g cholestyramine three times a day, 4 g cholestyramine three times a day or 50 g activated charcoal twice a day following cessation of teriflunomide treatment have shown that these regimens were effective in accelerating teriflunomide elimination, leading to more than 98% decrease in teriflunomide plasma concentrations, with cholestyramine being faster than charcoal.
Danish: Teriflunomidkoncentrationer, der blev målt under en 11-dages periode med henblik på at accelerere udskillelsen af teriflunomid enten med 8 g colestyramin tre gange dagligt, 4 g colestyramin tre gange dagligt eller 50 g aktivt kul to gange dagligt efter seponering af teriflunomid, viste, at disse regimer var effektive til at accelerere teriflunomidudskillelsen, idet de medførte et fald på mere end 98 % i plasma-teriflunomid, hvor colestyramin var hurtigere end aktivt kul.
English: Teriflunomide effectiveness was compared to that of a subcutaneous interferon beta-1a (at the recommended dose of 44 µg three times a week) in 324 randomised patients in a study (TENERE) with minimum treatment duration of 48 weeks (maximum 114 weeks).
Danish: Teriflunomids effektivitet blev sammenlignet med effektiviteten af subkutant interferon beta-1a (ved den anbefalede dosis på 44 µg tre gange ugentligt) hos 324 randomiserede patienter i en undersøgelse (TENERE) med en minimum behandlingsvarighed på 48 uger (maksimum 114 uger).
English: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet i rækkefølge efter, hvor alvorlige de er.
English: The results from the TOPIC study confirmed the efficacy of teriflunomide in RRMS (including early RRMS with first clinical demyelinating event and MRI lesions disseminated in time and space).
Danish: Resultaterne fra TOPIC studiet bekræftede effekten af teriflunomid i RRMS (inklusive tidlig RRMS med første kliniske demyeliniserende issolerede hændelse/syndrom (CIS) og læsioner ved MR-scanning dissemineret i forhold til tid og rum).
English: • Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) o Liver enzymes should be assessed every two weeks during the first 6 months of treatment, and every 8 weeks thereafter or as indicated by clinical signs and symptoms such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.
Danish: • Alanin-aminotransferase/ serum glutamopyruvat transferase (ALAT/SGPT) o Leverenzymer skal kontrolleres hver anden uge de første seks måneder af behandlingen og derefter hver 8. uge eller efter behov i henhold til kliniske tegn og symptomer som f.eks. uforklarlig kvalme, opkastning, abdominalsmerter, træthed, anoreksi eller gulsot og/eller mørkfarvet urin.
English: New onset or worsening pulmonary symptoms, such as persistent cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate.
Danish: Ny indtræden eller forværring af lungerelaterede symptomer som f.eks. persisterende hoste og dyspnø kan være en grund til at seponere behandlingen og efter behov iværksætte yderligere undersøgelser.
English: Both cholestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the accelerated elimination procedure with cholestyramine or activated powdered charcoal.
Danish: Både colestyramin og aktivt kulpulver kan have indflydelse på absorptionen af østrogener og progesteroner, hvorfor det ikke er sikkerhed for, at orale kontraceptiva giver sikker beskyttelse under den accelererede eliminationsprocedure med colestyramin og aktivt kulpulver.
English: The CNS is made up of the brain and spinal cord.
Danish: Centralnervestsyemet består af hjernen og rygmarven.
English: In a placebo-controlled thorough QT study performed in healthy subjects, teriflunomide at mean steady-state concentrations did not show any potential for prolonging the QTcF interval compared with placebo: the largest time matched mean difference between teriflunomide and placebo was 3.45 ms with the upper bound of the 90% CI being 6.45 ms.
Danish: I et placebokontrolleret, QT-studie, der blev udført med raske forsøgspersoner, viste teriflunomid ved middel-steady-state-koncentration intet potentiale for at forlænge QTcF-intervallet sammenlignet med placebo: den største tidsmatchede middelforskel mellem teriflunomid og placebo var 3,45 msek., med den øvre grænse for 90 % KI på 6,45 msek.
English: Your doctor will check your blood pressure before the start of treatment and regularly thereafter.
Danish: Lægen vil tjekke dit blodtryk før behandlingsstart og regelmæssigt derefter.
English: Hyperaesthesia, Neuralgia, Peripheral neuropathy
Danish: Hyperæstesi, Neuralgi, Perifer neuropati
English: Based on the clinical data related to concomitant administration of teriflunomide with interferon beta or with glatiramer acetate, no waiting period is required when initiating teriflunomide after interferon beta or glatiramer acetate or when starting interferon beta or glatiramer acetate, after teriflunomide.
Danish: Baseret på de kliniske data vedrørende samtidig administration af teriflunomid og interferon beta eller glatirameracetat er et behandlingsfrit interval ikke nødvendig ved påbegyndelse af teriflunomid efter interferon beta eller glatirameracetat eller ved påbegyndelse af interferon beta eller glatirameracetat efter teriflunomid.
English: Treatment was discontinued in 5 patients with peripheral neuropathy on teriflunomide 14 mg. Recovery following treatment discontinuation was reported in 4 of these patients.
Danish: Behandlingen blev seponeret hos 5 patienter med perifer neuropati på teriflunomid 14 mg. 4 af disse patienter kom sig efter seponering af behandlingen.
English: If skin and /or mucosal reactions are observed which raise the suspicion of severe generalised major skin reactions (Stevens-Johnson syndrome, or toxic epidermal necrolysis-Lyell's syndrome), teriflunomide and any other possibly associated treatment must be discontinued, and an accelerated procedure initiated immediately.
Danish: Hvis der observeres hud- og/eller slimhindereaktioner, der giver anledning til mistanke om svære, generaliserede hudreaktioner (StevensJohnsons syndrom eller toksisk epidermal nekrolyse (Lyells syndrom)), skal teriflunomid og eventuelle andre tilsvarende behandlinger seponeres, og en accelereret eliminationsprocedure øjeblikkeligt indledes.
English: AUBAGIO contains lactose
Danish: AUBAGIO indeholder lactose
English: Therefore, medicinal products metabolised by CYP1A2 (such as duloxetin, alosetron, theophylline and tizanidine) should be used with caution during treatment with teriflunomide, as it could lead to the reduction of the efficacy of these medicinal products.
Danish: Derfor skal lægemidler, der metaboliseres af CYP1A2 (som f.eks. duloxetin, alosetron, theophyllin og tizanidin), anvendes med forsigtighed under behandling med teriflunomid, da det kan medføre nedsat virkning af disse lægemidler.
English: A total of 2267 patients were exposed to teriflunomide (1155 on teriflunomide 7 mg and 1112 on teriflunomide 14 mg) once daily for a median duration of about 672 days in four placebo-controlled studies (1045 and 1002 patients for teriflunomide 7 mg and 14 mg, respectively) and one active comparator study (110 patients in each of the teriflunomide treatment groups) in patients with relapsing forms of MS (Relapsing Multiple Sclerosis, RMS).
Danish: I alt 2267 patienter blev eksponeret for teriflunomid (1155 for teriflunomid 7 mg og 1112 for teriflunomid 14 mg) én gang dagligt med en gennemsnitlig varighed på omkring 672 dage i fire placebokontrollerede studier (1045 og 1002 patienter med henholdsvis teriflunomid 7 mg og 14 mg) og et studie med aktiv komparator (110 patienter i hver af teriflunomid-behandlingsgrupperne) hos patienter med attakvise former for MS (recidiverende multipel sklerose, RMS).
English: Teriflunomide is excreted in the gastrointestinal tract mainly through the bile as unchanged medicinal product and most likely by direct secretion.
Danish: Teriflunomid udskilles i mave-tarm-kanalen hovedsageligt via galden som uomdannet lægemiddel og sandsynligvis via direkte sekretion.
English: How AUBAGIO works
Danish: Hvordan AUBAGIO virker
English: AUBAGIO is taken every day as a single daily dose at any time of the day.
Danish: Du skal tage AUBAGIO hver dag som en enkelt dosis.
English: Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia.
Danish: Patienter med alvorligt nedsat knoglemarvsfunktion eller signifikant anæmi, leukopeni, neutropeni eller trombocytopeni.
English: The recommended elimination procedure is cholestyramine 8 g three times a day for 11 days.
Danish: Den anbefalede eliminationsprocedure er colestyramin 8 g tre gange dagligt i 11 dage.
English: Tell your your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig.
English: Risk difference (CI95%) Relapse-free week 108
Danish: Risikoforskel (95 % KI) Attakfri uge 108
English: In the case of adverse reactions such as dizziness, which has been reported with leflunomide, the parent compound, the patient's ability to concentrate and to react properly may be impaired.
Danish: I tilfælde af bivirkninger som f.eks. svimmelhed, som er blevet indberettet med leflunomid, der er prodrug til teriflunomid, kan patientens evne til at koncentrere sig og reagere på passende måde være nedsat.
English: Teriflunomide 14 mg/day was not superior to interferon beta1a on the primary endpoint: the estimated percentage of patients with treatment failure at 96 weeks using the Kaplan-Meier method was 41.1% versus 44.4% (teriflunomide 14 mg versus interferon beta-1a group, p=0.595).
Danish: Teriflunomid 14 mg/dag var ikke superiort til interferon beta-1a for så vidt angår det primære endepunkt: den estimerede procentdel af patienter med behandlingssvigt ved uge 96, beregnet med Kaplan-Meier-metoden, var 41,1 % versus 44,4 % (teriflunomid 14 mg versus interferon beta-1a, p=0,5953).
English: From the mean predicted pharmacokinetic parameters calculated from the population pharmacokinetic (PopPK) analysis using data from healthy volunteers and MS patients, there is a slow approach to steadystate concentration (i.e., approximately 100 days (3.5 months) to attain 95% of steady-state concentrations) and the estimated AUC accumulation ratio is approximately 34-fold.
Danish: Baseret på de gennemsnitlige forventede farmakokinetiske parametre, beregnet ud fra en farmakokinetisk populationsanalyse (PopPK) med data fra raske frivillige og MS-patienter, er der en langsom tilnærmelse til steady state-koncentration (dvs. cirka 100 dage (3,5 måneder) til opnåelse af 95 % af steady statekoncentrationen), og den estimerede AUC-akkumulationsratio er cirka 34 gange.
English: 14 film-coated tablets 28 film-coated tablets 84 (3 wallets of 28) film-coated tablets 98 (7 wallets of 14) film-coated tablets 10x1 film-coated tablet
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 84 (3 hylstre med 28) filmovertrukne tabletter 98 (7 hylstre med 14) filmovertrukne tabletter 10x1 filmovertrukne tabletter
English: Cholestyramine or activated charcoal
Danish: Colestyramin og aktivt kul
English: Patients with severe immunodeficiency states, e.g. acquired immunodeficiency syndrome (AIDS).
Danish: Patienter med svær immundefekt, f.eks. erhvervet immundefekt syndrom (AIDS).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT-DOSE BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP UNIT-DOSE BLISTER
English: Patients with severe renal impairment undergoing dialysis were not evaluated.
Danish: Patienter med alvorligt nedsat nyrefunktion, som er i dialyse, er ikke blevet evalueret.
English: Effects on immune cell numbers in the blood: In the placebo-controlled studies, teriflunomide 14 mg once a day led to a mild mean reduction in lymphocyte count, of less than 0.3 x 109/l, which occurred over the first 3 months of treatment and levels were maintained until the end of the treatment.
Danish: Virkning på antallet af immunceller i blodet: I de placebokontrollerede studier medførte teriflunomid 14 mg én gang dagligt en mindre middelreduktion i lymfocyttallet, mindre end 0,3 x 109/l, hvilket skete i løbet af de første 3 måneder af behandlingen, hvorefter niveauet blev opretholdt, til behandlingen stoppede.
English: - The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (Type A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol 8000, indigo carmine aluminum lake (E132).
Danish: - Øvrige indholdsstoffer: lactosemonohydrat, majsstivelse, mikrokrystallinsk cellulose, natriumstivelsesglycolat (type A), hydroxypropylcellulose, magnesiumstearat, hypromellose, titanidioxid (E171), talcum, macrogol 8000, indigocarmin-aluminiumpigment (E132).
English: Hypersensitivity reactions (immediate or delayed) including anaphylaxis and angioedema
Danish: (øjeblikkelig eller forsinket) herunder anafylaksi og angioødem
English: In patients treated with leflunomide, the parent compound, very rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported.
Danish: Hos patienter i behandling med leflunomid, der er prodrug til teriflunomid, er der også rapporteret om sjældne tilfælde af lægemiddelreaktion med eosinofili og systemiske symptomer (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS).
English: As a consequence teriflunomide reduces the proliferation of dividing cells that need de novo synthesis of pyrimidine to expand.
Danish: Som en konsekvens heraf hæmmer teriflunomid proliferationen af celler i deling, som er afhængige af de novo syntese af pyrimidin.
English: The educational material for HealthCare Professionals (HCP) will include the following key elements:
Danish: Uddannelsesmaterialet for sundhedspersonerne skal omfatte følgende hovedelementer:
English: During this period women should discuss any plans to stop or change contraception with the treating physician.
Danish: I denne periode skal kvinden tale med den behandlende læge om eventuelle planer om at stoppe med eller skifte til andre kontraceptiva.
English: - you are switching to or from AUBAGIO.
Danish: - Hvis du skifter til eller fra AUBAGIO.
English: Alternatively, when cholestyramine is not available, activated charcoal 50 g twice a day for 11 days may also be used.
Danish: Alternativt, hvis der ikke er adgang til colestyramin, kan aktivt kul 50 g to gange dagligt i 11 dage også anvendes.
English: Not measured
Danish: Ikke vurderet
English: In MS patients, the median t1/2z was approximately 19 days after repeated doses of 14 mg.
Danish: Hos MS-patienter var den mediane terminale halveringstid (t1/2) cirka 19 dage efter gentagne doser på 14 mg.
English: As a precaution, a recent complete blood cell count, including differential white blood cell count and platelets, should be available before the initiation of treatment with AUBAGIO and the complete blood cell count should be assessed during AUBAGIO therapy as indicated by clinical signs and symptoms (e.g., infections).
Danish: For en sikkerheds skyld skal der foreligge en nyere komplet blodtælling inklusive differentialtælling og trombocyttal før igangsættelse af behandling med AUBAGIO, og blodtallet skal kontrolleres under behandlingen på baggrund af kliniske tegn og symptomer (f.eks. infektioner).
English: A reminder to provide patients with a Patient Education Card, including filling-in their contact details, and to provide replacement Patient Education Cards as necessary; 3.
Danish: En påmindelse om at udlevere et ”Patientuddannelseskort” til patienter, inklusive om at udfylde kontaktoplysninger og at udlevere et nyt Patientuddannelseskort om nødvendigt.
English: If you are pregnant or become pregnant while taking AUBAGIO, the risk of having a baby with birth defects is increased.
Danish: Hvis du er gravid eller bliver gravid, mens du tager AUBAGIO, er der en øget risiko for, at dit barn kan tage skade.
English: What you need to know before you take AUBAGIO Do not take AUBAGIO:
Danish: Det skal du vide, før du begynder at tage AUBAGIO Tag ikke AUBAGIO:
English: The median EDSS score at baseline was 2.50; 298 patients (25.5%) had an EDSS score › 3.5 at baseline.
Danish: Median EDSS-score ved baseline var 2,50; 298 patienter (25,5 % ) havde en EDSS-score på > 3,5 ved baseline.
English: The recommended dose of teriflunomide is 14 mg once daily.
Danish: Dosering Den anbefalede dosis af teriflunomid er 14 mg én gang dagligt.
English: A majority of patients (73%) had not received disease-modifying therapy during the 2 years before study entry.
Danish: Størstedelen af patienterne (73 %) havde ikke fået nogen form for sygdomsbehandling i de 2 forudgående år op til studiestart.
English: However, based on the immunomodulatory effect of teriflunomide, if a patient develops a serious infection, suspending treatment with AUBAGIO should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy.
Danish: På grund af teriflunomids immunmodulerende effekt skal det dog overvejes at seponere AUBAGIO, hvis en patient udvikler en alvorlig infektion, og fordele og risici bør vurderes på ny, før behandlingen genoptages.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with AUBAGIO in one or more subsets of the paediatric population in multiple sclerosis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med AUBAGIO i en eller flere undergrupper af den pædiatriske population med multipel sklerose (se pkt.
English: The efficacy of AUBAGIO was demonstrated in two placebo controlled studies, the TEMSO and the TOWER study, that evaluated once daily doses of teriflunomide 7 mg and 14 mg in patients with RMS.
Danish: AUBAGIOs virkning blev påvist i to placebokontrollerede undersøgelser, TEMSO og TOWER studierne, som evaluerede teriflunomiddoser på 7 mg og 14 mg én gang dagligt til patienter med RMS.
English: No data are available in patients who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon, having had at least 1 relapse in the previous year while on therapy, and at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gd-enhancing lesion, or patients having an unchanged or increased relapse rate in the prior year as compared to the previous 2 years.
Danish: Der foreligger ingen data for patienter, som ikke responderede på et fuldt og tilstrækkeligt behandlingsforløb (normalt mindst et års behandling) med beta-interferon, som mindst havde haft et attak i det forgående år i behandling og mindst 9 T2hyperintense læsoner ved kraniel MRscanning eller mindst 1 Gd-forstærket læsion, eller for patienter, der havde en uforandret eller øget attak-rate i det forgangne år sammenlignet med de 2 forudgående år.
English: AUBAGIO should not be used in children and adolescents under 18 years of age.
Danish: AUBAGIO må ikke anvendes til børn og teenagere under 18 år, da medicinens virkning i denne aldersgruppe ikke kendes.
English: Adverse reactions reported with AUBAGIO in placebo-controlled studies, reported for teriflunomide 7 mg or 14 mg at ≥ 1% higher rate than for placebo, are shown below.
Danish: Bivirkninger indberettet fra placebokontrollerede studiermed AUBAGIO, rapporteret for teriflunomid 7 mg eller 14 mg ved ≥ 1 % højere rate end for placebo, er vist herunder.
English: For women receiving teriflunomide treatment, who wish to become pregnant, the medicinal product should be stopped and an accelerated elimination procedure is recommended in order to more rapidly achieve concentration below 0.02 mg/l (see below).
Danish: Hvis en kvinde i behandling med teriflunomid ønsker at blive gravid, skal lægemidlet seponeres, hvorefter det anbefales at udføre en accelereret eliminationsprocedure med henblik på hurtigere at opnå en koncentration under 0,02 mg/l (se herunder).
English: Teriflunomide may cause serious birth defects when administered during pregnancy.
Danish: Teriflunomid kan give alvorlige fosterskader ved anvendelse under graviditet.
English: For further information on the sample testing please contact the Marketing Authorisation Holder or its local representative (see section 7).
Danish: Kontakt indehaveren af markedsføringstilladelsen eller dennes lokale repræsentant (se pkt.
English: • Affects liver function
Danish: • Påvirker leverfunktionen.
English: Due to the prolonged half-life, accelerated elimination with cholestyramine or charcoal may be considered.
Danish: På grund af den lange halveringstid kan accelereret udvaskning med colestyramin eller aktivt kul overvejes.
English: In the placebo-controlled studies, mean decreases in serum uric acid at a range of 20 to 30% were observed in patients treated with teriflunomide compared to placebo.
Danish: I de placebokontrollerede studier observeredes der et middelfald i serum-urinsyre i størrelsesordenen 20 til 30 % hos patienter, der blev behandlet med teriflunomid, sammenlignet med placebo.
English: Adverse effects on the offspring were also seen when teriflunomide was administered to pregnant rats during gestation and lactation.
Danish: Der sås også ugunstige virkninger hos afkommet, når teriflunomid blev givet til drægtige rotter i drægtigheds- og diegivningsperioden.
English: What AUBAGIO is used for
Danish: Hvad anvendes AUBAGIO til
English: Tablet core lactose monohydrate maize starch microcrystalline cellulose sodium starch glycolate (Type A) hydroxypropylcellulose magnesium stearate
Danish: Mikrokrystallinsk cellulose Natriumstivelsesglycolat (type A) Hydroxypropylcellulose Magnesiumstearat
English: The risk of a second clinical attack over 2 years was 35.9% in the placebo group and 24.0% in the teriflunomide 14 mg treatment group (hazard ratio: 0.57, 95% confidence interval: 0.38 to 0.87, p=0.0087).
Danish: Risikoen for et andet klinisk anfald (attak) over en periode på 2 år var 35,9 % hos placebogruppen og 24,0 % hos behandlingsgruppen, som fik teriflunomid 14 mg (relativ risiko: 0,57, 95 % konfidensinterval: 0,38 til 0,87, p=0,0087).
English: Blood pressure effects
Danish: Virkninger på blodtrykket
English: - The active substance is teriflunomide.
Danish: - Aktivt stof: teriflunomid.
English: Hazard ratio (CI95%)
Danish: Relativ risiko (95 % KI)
English: Once the teriflunomide plasma concentration is determined to be below 0.02 mg/l, the plasma concentration must be determined again after an interval of at least 14 days.
Danish: Når det er konstateret, at plasma-teriflunomid er under 0,02 mg/l, skal plasmakoncentrationen bestemmes igen efter mindst 14 dage.
English: Mean decrease in serum phosphorus was around 10% in the teriflunomide group compared to placebo.
Danish: Middelfaldet i serumphosphor var omkring 10 % i teriflunomid-gruppen sammenlignet med placebo.
English: Rifampicin and other known potent CYP and transporter inducers such as carbamazepine, phenobarbital, phenytoin and St John's Wort should be used with caution during the treatment with teriflunomide.
Danish: Rifampicin og andre kendte, potente CYP- og transportinduktorer som f.eks. carbamazepin, phenobarbital, phenytoin og perikon skal anvendes med forsigtighed under behandlingen med teriflunomid.
English: As leflunomide is the parent compound of teriflunomide, co-administration of teriflunomide with leflunomide is not recommended.
Danish: Eftersom leflunomid er prodrug til teriflunomid, frarådes samtidig administration af teriflunomid og leflunomid.