natgillin/translations-raw huggingface dataset:
Grundet studiets design blev høj sygdomsaktivitet defineret som 2 eller flere attakker indenfor et år og med én eller flere Gd-forstærkede læsioner ved MR-scanning af hjernen.
Due to the design of the study, high disease activity was defined as 2 or more relapses in one year, and with one or more Gd-enhancing lesion on brain MRI.
Du skal anvende en sikker præventionsmetode under og efter behandlingen med AUBAGIO.
You must use an effective method of contraception during and after treatment with AUBAGIO.
Teriflunomid er substrat for efflux-transporteren BCRP, som kan være involveret i den direkte sekretion.
Teriflunomide is a substrate of the efflux transporter BCRP, which could be involved in direct secretion.
Der er ingen erfaring med overdosering af eller forgiftning med teriflunomid hos mennesker.
There is no experience regarding teriflunomide overdose or intoxication in humans.
Seponering af behandlingen og iværksættelse af en accelereret eliminationsprocedure kan overvejes, idet der skal tages hensyn til patientens sygdom og anamnese.
Treatment withdrawal and initiation of an accelerated elimination procedure may be considered taking into account patient's disease and medical history.
Hvis dine blodprøver viser, at der er et problem med din lever, vil lægen muligvis standse behandlingen med AUBAGIO.
If your test results show a problem with your liver, your doctor may stop your treatment with AUBAGIO.
I alle tilfælde skal der tages en blodprøve for at bekræfte, at det aktive stof i tilstrækkelig grad er fjernet fra kroppen, og du skal have en bekræftelse fra din læge på, at koncentrationen af AUBAGIO i blodet er lav nok til, at du kan forsøge at blive gravid.
In either case it should be confirmed by a blood test that the active substance has been sufficiently removed from your body and you need confirmation from your treating physician that the blood level of AUBAGIO is low enough to allow you to become pregnant.
Eftersom teriflunomid er stærkt proteinbundet, og da bindingen er afhængig af albuminkoncentrationen, forventes det, at plasmakoncentrationen af ubundet teriflunomid øges hos patienter med hypoproteinæmi, f.eks. ved nefrotisk syndrom.
Since teriflunomide is highly protein bound and as the binding is dependent upon the concentrations of albumin, unbound plasma teriflunomide concentrations are expected to be increased in patients with hypoproteinaemia, e.g. in nephrotic syndrome.
Posttraumatisk smerte a: Der henvises til beskrivelse i nedenstående afsnit b: Se pkt.
Post-traumatic pain a: please refer to the detailed description section b: see section 4.4
Påbegyndelse af behandling med AUBAGIO i løbet af denne periode vil resultere i samtidig eksponering for fingolimod.
Starting AUBAGIO during this interval will result in concomitant exposure to fingolimod.
Uge 1 (hylster med 14 og 28) Uge 2 (hylster med 14 og 28) Uge 3 (hylster med 28) Uge 4 (hylster med 28)
Week 1 (wallets of 14 and 28) Week 2 (wallets of 14 and 28) Week 3 (wallets of 28) Week 4 (wallets of 28)
Den systemiske eksponering øges proportionalt med dosis efter oral administration af fra 7 til 14 mg teriflunomid.
Systemic exposure increases in a dose proportional manner after oral administration teriflunomide from 7 to 14 mg.
Hjælpestof, som behandleren skal være opmærksom på: hver tablet indeholder 72 mg lactose (som monohydrat).
Excipient with known effect: each tablet contains 72 mg of lactose (as monohydrate).
Det er ikke relevant at anvende teriflunomid hos børn i alderen fra fødsel og til mindre end 10 år til multipel sklerose.
There is no relevant use of teriflunomide in children aged from birth to less than 10 years for the treatment of multiple sclerosis.
• nødvendigheden af procedurer/test før og under behandlingen med teriflunomid.
• Of the need for the procedures/tests before and during teriflunomide treatment
Graviditet skal udelukkes, før behandlingen påbegyndes (se pkt.
Pregnancy must be excluded before start of treatment (see section 4.6).
Den sekundære metabolit TFMA (4-trifluormethylanilin) forårsagede mutagenicitet og klastogenicitet in vitro, men ikke in vivo.
The minor metabolite TFMA (4-trifluoromethylaniline) caused mutagenicity and clastogenicity in vitro but not in vivo.
Leflunomids sikkerhedsprofil hos patienter med reumatoid arthritis eller arthritis psoriatica kan være relevant ved ordinering af teriflunomid til MS-patienter.
The safety profile of leflunomide in patients suffering from rheumatoid arthritis or psoriatic arthritis may be pertinent when prescribing teriflunomide in MS patients.
Hvis du har fået at vide af lægen, at du ikke kan tåle visse sukkerarter, skal du kontakte lægen, før du tager dette lægemiddel.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Generelt var hovedpine, diarre, kvalme og alopeci let til moderat, forbigående og medførte sjældent seponering.
In general, headache, diarrhoea, nausea and alopecia, were mild to moderate, transient and infrequently led to treatment discontinuation.
Patienter med alvorligt nedsat nyrefunktion, som er i dialyse, på grund af utilstrækkelig klinisk erfaring med denne patientgruppe.
Patients with severe renal impairment undergoing dialysis, because insufficient clinical experience is available in this patient group.
En påmindelse for både patienterne og alle sundhedspersoner, der er involverede i deres behandling, med information om, at patienten er i behandling med lægemidlet teriflunomid, som:
A reminder for both patients and all HCPs involved in their treatment that the patient is being treated with teriflunomide, a medicine which:
Målingen af ioniserede caliumniveauer kan vise fejlagtige reducerede værdier under behandling med leflunomid og/eller teriflunomid (leflunomids aktive metabolit), afhængigt af typen af apparat, der anvendes til analyse af ioniseret calcium (f.eks. blodgasanalyseapparat).
The measurement of ionised calcium levels might show falsely decreased values under treatment with leflunomide and/or teriflunomide (the active metabolite of leflunomide) depending on the type of ionised calcium analyser used (e.g. blood gas analyser).
Hvis du har mistanke om, at du er blevet gravid, mens du tager AUBAGIO eller i en periode på to år efter, du har stoppet behandlingen, skal du straks henvende dig til din læge med henblik på at få lavet en graviditetstest.
If you suspect that you are pregnant while taking AUBAGIO or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Behandlingen bør indledes og superviseres af en læge med erfaring i behandling af multipel sklerose.
The treatment should be initiated and supervised by a physician experienced in the management of multiple sclerosis.
Personer, der lider af attakvis multipel sclerose, oplever gentagne anfald (attakker) med fysiske symptomer, der skyldes, at nerverne ikke fungerer, som de skal.
People with relapsing form of multiple sclerosis will have repeated attacks (relapses) of physical symptoms caused by their nerves not working properly.
Kliniske resultater
Clinical Outcomes
Tiden, det tog at vende tilbage til baselineværdien, varierede fra måneder til år.
The recovery time varied between months and years.
Bivirkningerne stemte overens med sikkerhedsprofilen for teriflunomid hos MS-patienter.
The adverse reactions were consistent with the safety profile for teriflunomide in MS patients.
Hvis dette sker for dig, må du ikke køre motorkøretøj eller betjene maskiner.
If you are affected, do not drive or use machines.
Dyrestudier har vist, at teriflunomid udskilles i mælken.
Animal studies have shown excretion of teriflunomide in milk.
Denne stigning i plasma-rosuvastatin havde imidlertid ingen åbenlys indvirkning på HMG-CoA-reduktaseaktiviteten.
However, there was no apparent impact of this increase in plasma rosuvastatin exposure on the HMG-CoA reductase activity.
Teriflunomid var embryotoksisk og teratogent hos rotter og kaniner ved doser i det humane terapeutiske dosisinterval.
Teriflunomide was embryotoxic and teratogenic in rats and rabbits at doses in the human therapeutic range.
• synsproblemer
• vision problems
Da Aubagio nedsætter antallet af hvide blodlegemer i blodet, kan det have betydning for bekæmpelse af infektionen.
As AUBAGIO decreases the number of white cells in the blood this may affect your ability to fight the infection.
Det menes, at mekanismen bag dette er afbrydelse af det enterohepatiske kredsløb og/eller gastrointestinal dialyse af teriflunomid.
The mechanism is thought to be by interruption of enterohepatic recycling and/or gastrointestinal dialysis of teriflunomide.
Teriflunomid er et immunmodulerende middel med antiinflammatoriske egenskaber, som selektivt og reversibelt hæmmer det mitokondrielle enzym dihydroorotatdehydrogenase (DHO-DH), der kræves til de novo pyrimidinsyntesen.
Teriflunomide is an immunomodulatory agent with anti-inflammatory properties that selectively and reversibly inhibits the mitochondrial enzyme dihydroorotate dehydrogenase (DHO-DH), required for the de novo pyrimidine synthesis.
Klastogenicitet, der observeredes in vitro, betragtedes som værende en indirekte effekt relateret til ubalance i nukleotid-poolen, der skyldes den farmakologiske effekt af DHO-DH-hæmningen.
Clastogenicity observed in vitro was considered to be an indirect effect related to nucleotide pool imbalance resulting from the pharmacology of DHO-DH inhibition.
Teriflunomid er leflunomids hovedmetabolit.
Teriflunomide is the main metabolite of leflunomide.
• Kræver samtidig brug af effektiv antikonception for kvinder i den fødedygtige alder.
• Requires concomitant use of effective contraception in women of child-bearing potential
Der blev identificeret adskillige kilder til biologisk variabilitet hos raske frivillige og MS-patienter baseret på PopPK-analysen: alder, kropsvægt, køn, race samt albumin- og bilirubinkoncentration.
Several sources of intrinsic variability were identified in healthy subjects and MS patients based on the PopPK analysis: age, body weight, gender, race, and albumin and bilirubin levels.
Teriflunomid 70 mg dagligt blev givet i op til 14 dage til raske forsøgspersoner.
Teriflunomide 70 mg daily was administered up to 14 days in healthy subjects.
• at nedskrive datoen for første recept og kontaktoplysninger på den ordinerende læge.
• To record the first date of prescription and the contact details of their prescriber 3.
Den gennemsnitslige sygdomsvarighed fra de første symptomer var 8,7 år.
The mean duration of disease, since first symptoms, was 8.7 years.
De fleste af disse virkninger afspejler stoffets grundlæggende virkningsmekanisme (hæmning af celler i deling).
The majority of effects reflect the basic mode of action of the compound (inhibition of dividing cells).
Teriflunomid var ikke mutagent in vitro eller klastogent in vivo.
Teriflunomide was not mutagenic in vitro or clastogenic in vivo.
Sikkerhedsstudier, i hvilke teriflunomid blev administreret samtidigt med interferon beta eller med glatirameracetat i op til ét år, afslørede ingen specifikke sikkerhedsrisici, men der observeredes en højere bivirkningshyppighed sammenlignet med teriflunomid-monoterapi.
Safety studies, in which teriflunomide was concomitantly administered with interferon beta or with glatiramer acetate for up to one year did not reveal any specific safety concerns, but a higher adverse reaction rate as compared to teriflunomide monotherapy was observed.
Opfordre patienter til at kontakte deres MS-læge og/eller praktiserende læge, hvis de oplever nogen af de tegn eller symptomer, der er nævnt i Patientuddannelseskortet.
To encourage patients to contact their MS physician and/or General Practitioner if they experience any of the signs and symptoms discussed in the Patient Education Card; 4.
AUBAGIO indeholder det aktive stof teriflunomid, som er et immunmodulerende middel, der justerer immunsystemet til at begrænse sit angreb på nervesystemet..
AUBAGIO contains the active substance teriflunomide which is an immunomodulatory agent and adjusts the immune system to limit its attack on the nervous system.
Patienter med aktive akutte eller kroniske infektioner bør ikke påbegynde behandling med AUBAGIO, før infektionen/infektionerne er ophørt.
Patients with active acute or chronic infections should not start treatment with AUBAGIO until the infection(s) is resolved.
Teriflunomid metaboliseres moderat og er den eneste komponent, der kan spores i plasma.
Teriflunomide is moderately metabolised and is the only component detected in plasma.
I placebokontrollerede studier blev perifer neuropati, herunder både polyneuropati og mononeuropati (f.eks. karpaltunnelsyndrom) indberettet hyppigere hos patienter, der fik teriflunomid, end hos patienter, der fik placebo.
In placebo-controlled studies, peripheral neuropathy, including both polyneuropathy and mononeuropathy (e.g., carpal tunnel syndrome), was reported more frequently in patients taking teriflunomide than in patients taking placebo.
Efter seponering af teriflunomid og administration af colestyramin 8 g tre gange dagligt var plasma-teriflunomid faldet med 52 % ved slutningen af dag 1, med 91 % ved slutningen af dag 3, med 99,2 % ved slutningen af dag 7 og med 99,9 % på den sidste dag, dag 11.
Following discontinuation of teriflunomide and the administration of cholestyramine 8 g three times a day, the plasma concentration of teriflunomide is reduced 52% at the end of day 1, 91% at the end of day 3, 99.2% at the end of day 7, and 99.9% at the completion of day 11.
Traumer, forgiftninger og behandlingskomplik ationer
Injury, poisoning and procedural complications
- Hvis du tager leflunomid sammen med AUBAGIO.
- you take leflunomide with AUBAGIO.
På grund af natalizumabs lange halveringstid kan der opstå samtidig eksponering og således samtidige immuneffekter i op til 2-3 måneder efter seponering af natalizumab, hvis behandling med AUBAGIO påbegyndes øjeblikkeligt.
Due to the long half-life of natalizumab, concomitant exposure, and thus concomitant immune effects, could occur for up to 2-3 months following discontinuation of natalizumab if AUBAGIO was immediately started.
Gentagen oral administration af teriflunomid til mus, rotter og hunde i op til henholdsvis 3, 6 og 12 måneder afslørede, at de væsentligste målorganer for toksicitet var knoglemarven, lymfatiske organer, mundhulen/ mave-tarm-kanalen, forplantningsorganer og pancreas.
Repeated oral administration of teriflunomide to mice, rats and dogs for up to 3, 6, and 12 months, respectively, revealed that the major targets of toxicity were the bone marrow, lymphoid organs, oral cavity/ gastro intestinal tract, reproductive organs, and pancreas.
Et gennemsnitligt fald i antallet af hvide blodlegemer (<15 % fra baseline, hovedsageligt fald i neutrofil- og lymfocyttal) observeredes i placebokontrollerede forsøg med AUBAGIO, omend der sås et større fald hos visse patienter.
A mean decrease affecting white blood cell (WBC) count (<15% from baseline levels, mainly neutrophil and lymphocytes decrease) was observed in placebo-controlled trials with AUBAGIO, although a greater decrease was observed in some patients.
Eftersom AUBAGIO-tabletterne indeholder lactose, bør patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption ikke tage dette lægemiddel.
Since AUBAGIO tablets contain lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, should not take this medicinal product.
• at holde øje med bestemte tegn og symptomer, som kan indikere leversygdom eller infektion, og hvis nogen af disse opstår, om at kontakte lægen med det samme.
• To pay attention to certain signs and symptoms which might indicate liver disease or infection, and if any of these occur, to contact their doctor/HCP promptly
Den præcise mekanisme, der ligger til grund for teriflunomids effekt på MS, er ikke til fulde klarlagt, men omfatter et reduceret antallet lymfocytter.
The exact mechanism by which teriflunomide exerts its therapeutic effect in MS is not fully understood, but this is mediated by a reduced number of lymphocytes.
Teriflunomid må ikke bruges til patienter med svær hypoproteinæmi.
Teriflunomide should not be used in patients with conditions of severe hypoproteinaemia.
Immunsuppressive og immunmodulerende behandlinger
Immunosuppressive or immunomodulating therapies
I sådanne tilfælde må patienten ikke på ny eksponeres for teriflunomid (se pkt.
In such cases patients should not be re-exposed to teriflunomide (see section 4.3).
Den gennemsnitslige sygdomsvarighed fra de første symptomer var 8,0 år.
The mean duration of disease, since first symptoms, was 8.0 years.
EU/1/13/838/001 14 tabletter EU/1/13/838/002 28 tabletter EU/1/13/838/003 84 tabletter EU/1/13/838/004 98 tabletter EU/1/13/838/005 10x1 tabletter
EU/1/13/838/001 14 tablets EU/1/13/838/002 28 tablets EU/1/13/838/003 84 tablets EU/1/13/838/004 98 tablets EU/1/13/838/005 10x1 tablet
Hvis begge plasmakoncentrationer er under 0,02 mg/l, forventes der ingen risiko for fosteret.
If both plasma concentrations are below 0.02 mg/l, no risk to the foetus is to be expected.
MRI-endepunkter
MRI endpoints
• at vise Patientuddannelseskortet til læger/sundhedspersonale involveret i deres pleje (specielt i nødsituationer, og/eller hvis deres læge/ sundhedspersonale er nye).
• To remind patients to show the Patient Education Card to Doctors/HCPs involved with their medical care (especially in the event of medical emergencies and/or if new Doctors/HCPs are involved.)
Pakningsstørrelser og yderligere oplysninger AUBAGIO indeholder
Contents of the pack and other information What AUBAGIO contains
• Alanin-aminotransferase/serum glutamopyruvat transferase (ALAT/SGPT)
• Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT)
Det er muligt, at en hurtig sænkning af teriflunomid-koncentrationen i blodet ved iværksættelse af den accelererede eliminationsprocedure, der er beskrevet herunder, så snart den forsinkede menstruation bemærkes, kan mindske risikoen for fosteret.
It is possible that rapidly lowering the blood level of teriflunomide, by instituting the accelerated elimination procedure described below, at the first delay of menses, may decrease the risk to the foetus.
Den placebokontrollerede poolede analyse var baseret på 2047 patienter med recidiverende multipel sklerose behandlet med teriflunomid én gang dagligt.
The placebo-controlled pooled analysis was based on 2047 patients with Relapsing Multiple Sclerosis treated with teriflunomide once daily.
Disse aminotransferaseforhøjelser opstod for det meste inden for de første 6 måneders behandling og var reversible efter behandlingsophør.
These elevations in transaminase occurred mostly within the first 6 months of treatment and were reversible after treatment cessation.
Resultater fra dyrestudier viser ingen effekt på fertiliteten (se pkt.
Results of studies in animals have not shown an effect on fertility (see section 5.3).
Hertil kommer, at administrationen af colestyramin eller aktivt kul, hvis det er nødvendigt af hensyn til tolerabiliteten, ikke behøver at ske på konsekutive dage (se pkt.
In addition, if required for tolerability reasons, administration of cholestyramine or activated charcoal does not need to occur on consecutive days (see section 5.2).
I tilfælde af relevant overdosering eller forgiftning anbefales colestyramin eller aktivt kul for at accelerere udskillelsen.
In the event of relevant overdose or toxicity, cholestyramine or activated charcoal is recommended to accelerate elimination.
Gentagne doser teriflunomid havde ingen virkning på S-warfarins farmakokinetik, hvilket tyder på, at teriflunomid hverken hæmmer eller inducerer CYP2C9.
Repeated doses of teriflunomide had no effect on the pharmacokinetics of S-warfarin, indicating that teriflunomide is not an inhibitor or an inducer of CYP2C9.
Hvis det besluttes at seponere AUBAGIO, vil påbegyndelse af andre behandlinger i en periode på 5 gange halveringstiden (cirka 3,5 måneder eller længere hos visse patienter) resultere i samtidig eksponering for AUBAGIO.
If a decision is made to stop treatment with AUBAGIO, during the interval of 5 half-lives (approximately 3.5 months although may be longer in some patients), starting other therapies will result in concomitant exposure to AUBAGIO.
Interstitiel lungesygdom (ILD) har været rapporteret med teriflunomid efter markedsføring.
Interstitial lung disease (ILD) has been reported with teriflunomide in the postmarketing setting.
Anæmi, reduceret blodpladetal og virkninger på immunsystemet herunder leukopeni, lymfopeni og sekundære infektioner var relateret til indvirkningen på knoglemarven og/eller lymfatiske organer.
Anemia, decreased platelet counts and effects on the immune system, including leukopenia, lymphopenia and secondary infections, were related to the effects on the bone marrow and/or lymphoid organs.
Initiering af behandling med teriflunomid skal udsættes hos patienter med svær aktiv infektion, indtil infektionen er ophørt.
Initiation of treatment with teriflunomide should be delayed in patients with severe active infection until resolution.
ILD og forværring af allerede eksisterende ILD er blevet rapporteret under behandling med leflunomid, som er prodrug til teriflunomid.
ILD and worsening of pre-existing ILD have been reported during treatment with leflunomide, the parent compound of teriflunomide.
Fertiliteten var upåvirket hos rotter til trods for teriflunomids ugunstige virkninger på handyrenes forplantningsorganer, herunder nedsat sædcelletal.
Fertility was unaffected in rats despite adverse effects of teriflunomide on male reproductive organs, including reduced sperm count.
MS er en kronisk sygdom, der påvirker centralnervesystemet.
MS is a long-term illness that affects the central nervous system (CNS).
Risikoen er øget hos patienter, der har fået ILD ved behandling med leflunomid.
The risk is increased in patients who had a history of ILD when treated with leflunomide.
Herpes labialis, Tandinfektion, Laryngitis, Tinea pedis
Oral herpes, Tooth infection, Laryngitis, Tinea pedis
Du må ikke tage AUBAGIO, når du ammer, da teriflunomid udskilles i mælken.
Do not take AUBAGIO when you are breast-feeding, as teriflunomide passes into the breast milk.
• alternativt administreres 50 g aktivt kul som pulver hver 12. time i 11 dage.
• alternatively, 50 g of activated powdered charcoal is administered every 12 hours for a period of 11
Inden for denne sikkerhedspopulation var de hyppigst indberettede bivirkninger fra patienter, der blev behandlet med teriflunomid: hovedpine, diarre, forhøjet ALAT, kvalme og alopeci.
Within this safety population, the most commonly reported adverse reactions in the teriflunomide treated patients were: headache, diarrhoea, increased ALT, nausea, and alopecia.
• Tal med din læge om, hvilken præventionsmetode der passer bedst til dig og muligheden for at skifte til en anden præventionsmetode, hvis der er behov for dette.
• Talk with your doctor about the best method of contraception for you and any potential need for contraception change.
Under behandling Under behandlingen med teriflunomid skal følgende kontrolleres:
During treatment During treatment with teriflunomide the following should be monitored:
I placebokontrollerede studier observeredes der ingen stigning i alvorlige infektioner med teriflunomid 14 mg (2,7 %) sammenlignet med placebo (2,2 %).
In placebo-controlled studies, no increase in serious infections was observed with teriflunomide 14 mg (2.7%) as compared to placebo (2.2%).
Hos patienter med eksisterende anæmi, leukopeni og/eller trombocytopeni og hos patienter med nedsat knoglemarvsfunktion eller patienter med risiko for knoglemarvssuppression er risikoen for hæmatologiske forstyrrelser øget.
In patients with pre-existing anaemia, leucopenia, and /or thrombocytopenia as well as in patients with impaired bone marrow function or those at risk of bone marrow suppression, the risk of haematological disorders is increased.
Skift til eller fra AUBAGIO
Switching to or from AUBAGIO
Neutropenib, Anæmi
Neutropeniab, Anaemia