FrancophonIA/ELRC3.0 huggingface dataset:
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
Danish: • Når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Severe infections including sepsis, sometimes fatal have been reported postmarketing.
Danish: Alvorlige infektioner inklusive sepsis, sommetider fatale, er blevet rapporteret efter markedsføring.
English: Symptoms may disappear completely after the relapse is over, but over time, some problems may remain between relapses.
Danish: Symptomerne kan forsvinde fuldstændigt, når attakket er ovre, men med tiden kan nogle af problemerne fortsætte mellem attakkerne.
English: Effect of teriflunomide on warfarin
Danish: Virkningen af teriflunomid på warfarin
English: For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, monitoring must be performed weekly.
Danish: Ved ALAT (SGPT)- stigninger > 2-3 gange den øvre normalgrænse, skal monitorering foretages ugentligt.
English: Teriflunomide remains in your blood for a long time after you stop taking it. Continue to use effective contraception after you stop treatment.
Danish: Teriflunomid forbliver i blodet længe efter, at du er holdt op med at tage det. Bliv ved med at bruge sikker prævention, efter du har afsluttet behandlingen.
English: AUBAGIO should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy.
Danish: AUBAGIO skal anvendes med forsigtighed hos patienter på 65 år og derover på grund af utilstrækkelige data om sikkerhed og virkning.
English: Patients should be closely monitored for signs and symptoms of excessive exposure to the medicinal products and reduction of the dose of these medicinal products should be considered.
Danish: Patienterne skal overvåges tæt for tegn og symptomer på overdreven lægemiddeleksponering, og det skal overvejes at reducere dosis af disse lægemidler.
English: - you have respiratory symptoms.
Danish: - Hvis du har åndedrætssymptomer.
English: There are limited amount of data from the use of teriflunomide in pregnant women.
Danish: Der er begrænsede data fra anvendelse af teriflunomid til gravide kvinder.
English: This can cause physical disabilities that may interfere with your daily activities.
Danish: Dette kan medføre nedsat fysisk funktion, der kan gribe forstyrrende ind i dagligdagens aktiviteter.
English: Do not use this medicine after the expiry date which is stated on the carton, protective sleeve, and wallet after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på kartonen, det beskyttende omslag og hylsteret med blisterkort efter "EXP".
English: • Blood pressure o Check periodically
Danish: • Blodtryk o Kontrolleres med regelmæssige mellemrum
English: Frequencies were defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppigheder er defineret i henhold til følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Long term follow-up results from TEMSO long term extension safety study (overall median treatment duration approximately 5 years, maximum treatment duration approximately 8.5 years) did not present any new or unexpected safety findings.
Danish: Langsigtede opfølgningsresultater fra det langvarige, forlængede sikkerhedsstudie TEMSO (samlet gennemsnitlig behandlingsperiode ca. 5 år, maksimal behandlingsperiode ca. 8,5 år) fremviste ingen nye eller uventede sikkerhedsfund.
English: • Requires a pregnancy status check before treatment
Danish: • Kræver, at graviditetsstatus tjekkes før behandling.
English: The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal fremsende den første PSUR for dette præparat inden for 6 måneder efter godkendelsen.
English: Severe infections including sepsisa
Danish: Alvorlige infektioner herunder sepsisa
English: Teriflunomide is eliminated slowly from the plasma.
Danish: Teriflunomid elimineres langsomt fra plasma.
English: The mean number of relapses within the year before study inclusion was 1.4.
Danish: Det gennemsnitslige antal attakker i året inden studiestart var 1,4.
English: The primary endpoint was time to a second clinical episode (relapse).
Danish: Det primære endepunkt var tid til den anden kliniske episode (recidiv).
English: Alternatively, activated charcoal may also be used (the 11 days do not need to be consecutive unless there is a need to lower teriflunomide plasma concentration rapidly).
Danish: Alternativt kan aktivt kul også anvendes (de 11 dage behøver ikke være konsekutive, medmindre der er behov for at sænke plasmateriflunomid hurtigt).
English: Evidence of an oxidative effect on red blood cells was also observed.
Danish: Der observeredes tillige tegn på en oxidativ effekt på røde blodlegemer.
English: Mild allergic reactions
Danish: Lette allergiske reaktioner
English: • Educational material for Healthcare professionals
Danish: • Uddannelsesmateriale for sundhedspersoner
English: Do not stop taking AUBAGIO or change your dose without talking to your doctor first.
Danish: Du må ikke stoppe med at tage AUBAGIO eller ændre dosis uden først at tale med din læge.
English: Information to educate the patient:
Danish: Information, som oplyser patienten om:
English: Patients with severe hepatic impairment (Child-Pugh class C).
Danish: Patienter med alvorligt nedsat leverfunktion (Child-Pugh klasse C).
English: ILD may occur acutely at any time during therapy with a variable clinical presentation.
Danish: ILD kan forekomme akut når som helst under behandlingen med variabel klinisk præsentation.
English: The long term safety of these combinations in the treatment of multiple sclerosis has not been established.
Danish: Sikkerheden af disse kombinationer til behandling af multipel sklerose er ikke fastslået på lang sigt.
English: The use of live attenuated vaccines may carry a risk of infections and should therefore be avoided.
Danish: Vaccination med levende, svækkede vacciner kan indebære en risiko for infektion og bør derfor undgås.
English: • Educational card for patients
Danish: • Uddannelseskort for patienter
English: The following side effects may happen with this medicine.
Danish: Følgende bivirkninger kan forekomme med dette lægemiddel:
English: (pharmacovigilance or risk minimisation) milestone being reached.
Danish: (lægemiddelovervågning eller risikominimering) er nået.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
Danish: Før markedsføring skal indehaveren af markedsføringstilladelsen (MAH) i hvert enkelt land blive enige med de nationale myndigheder om et uddannelsesprogram.
English: Therefore, teriflunomide plasma concentrations should be measured before a woman begins to attempt to become pregnant.
Danish: Derfor skal plasma-teriflunomid måles, før kvinden prøver at blive gravid.
English: • Do this until the levels of AUBAGIO in your blood are low enough - your doctor will check this.
Danish: • Du skal fortsætte med dette, indtil koncentrationen af AUBAGIO i blodet er tilstrækkeligt lav - din læge kan kontrollere dette.
English: Pharmacotherapeutic group: Immunosuppressants, Selective immunosuppressants, ATC Code: L04AA31
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, Selektive immunsuppressiva, ATC-kode: L04AA31
English: However, a 25% decrease in peak international normalised ratio (INR) was observed when teriflunomide was coadministered with warfarin as compared with warfarin alone.
Danish: Der sås dog et fald på 25 % i peak international normalised ratio (INR), når teriflunomid blev administreret samtidigt med warfarin sammenlignet med warfarin alene.
English: This limits the inflammation that leads to nerve damage in MS.
Danish: Dette begrænser samtidig betændelsen, som leder til nervebeskadigelse ved MS.
English: Before you take AUBAGIO, your doctor will make sure you have enough white blood cells and platelets in your blood.
Danish: Før du tager AUBAGIO, vil lægen kontrollere, at du har et tilstrækkeligt antal hvide blodlegemer og blodplader i blodet.
English: Your doctor will carry out blood tests before and during treatment to check how well your liver is working.
Danish: Din læge vil muligvis tage blodprøver før og under behandlingen for at kontrollere, hvor godt din lever fungerer.
English: Talk to your doctor or pharmacist before taking AUBAGIO if: - you have liver problems and/or if you drink large amounts of alcohol.
Danish: Kontakt lægen eller apoteket, før du tager AUBAGIO: - Hvis du har leverproblemer og/eller indtager store mængder alkohol.
English: These effects are considered to be related to increase in renal tubular excretion and not related to changes in glomerular functions.
Danish: Disse virkninger betragtes som værende relateret til en øget renal tubulær udskillelse og ikke til ændringer i glomerulær funktion.
English: The safety and efficacy of teriflunomide in children aged from 10 to less than 18 years has not yet been established.
Danish: Teriflunomids sikkerhed og virkning hos børn og unge i alderen 10 til under 18 år er endnu ikke klarlagt.
English: Information on the optional service of a periodic reminder to patients about the continued need for effective contraception during treatment.
Danish: Information om den frivillig service om periodevis påmindelse til patienter om den fortsatte nødvendighed af at anvende effektiv prævention under behandling.
English: Teriflunomide is extensively bound to plasma protein (>99%), probably albumin and is mainly distributed in plasma.
Danish: Teriflunomid er stærkt bundet til plasmaprotein (>99 %), sandsynligvis albumin, og distribueres hovedsageligt til plasma.
English: Most patients improved after discontinuation of AUBAGIO.
Danish: De fleste patienter kom i bedring efter seponering af AUBAGIO.
English: The risk of failure (confirmed relapse or permanent treatment discontinuation whichever came first) was the primary endpoint.
Danish: Risikoen for behandlingssvigt (bekræftet recidiv eller permanent behandlingsophør, afhængig af hvad der opstod først) var det primære endepunkt.
English: If discontinuation of the medicinal product is necessary, initiation of an accelerated elimination procedure should be considered.
Danish: Hvis seponering af lægemidlet er nødvendigt bør påbegyndelse af accelereret eliminationsprocedure overvejes.
English: The safety of teriflunomide in individuals with latent tuberculosis infection is unknown, as tuberculosis screening was not systematically performed in clinical studies.
Danish: Teriflunomids sikkerhed hos personer med latent tuberkulose kendes ikke, eftersom der ikke blev udført systematisk screening for tuberkulose i de kliniske studier.
English: No similar subgroup analysis was performed in TOWER as no MRI data were obtained.
Danish: Der er ikke udarbejdet en tilsvarende undergruppeanalyse i TOWERstudiet, da der ikke foreligger MRI-data.
English: Pancreatitis, Stomatitis
Danish: Pankreatitis, Stomatitis
English: Gender, Elderly, Paediatric patients
Danish: Køn, ældre, pædiatriske patienter
English: The decrease in mean count from baseline occurred during the first 6 weeks then stabilised over time while on-treatment but at decreased levels (less than a 15% decrease from baseline).
Danish: Faldet i gennemsnitstallet fra baseline opstod i løbet af de første 6 uger, hvorefter det stabiliserede sig over tid, mens behandlingen stod på, men på et lavere niveau (mindre end et 15 % under baseline).
English: Effect of teriflunomide on BCRP and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates
Danish: Virkningen af teriflunomid på BCRP- og/eller organisk aniontransporterende polypeptid B1- og B3(OATP1B1/B3-) substrater
English: AUBAGIO has no or negligible influence on the ability to drive and use machines.
Danish: AUBAGIO påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Also contains: lactose.
Danish: Indeholder også lactose.
English: After the rapid elimination procedure with cholestyramine, an additional 23.1% was recovered (mostly in feces).
Danish: Efter den accelererede eliminationsprocedure med colestyramin fandtes yderligere 23,1 % (hovedsageligt i fæces).
English: • To remind both patients and HCP about the Pregnancy Registry (in countries where pregnancy registry is on-going)
Danish: • Informere både patient og sundhedspersonale om Graviditetsregistret (i lande, hvor et graviditetsregister er tilgængeligt).
English: Please read section 4.
Danish: Læs oplysningerne under punkt 4.
English: The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some other agents that affect the immune system (class effect).
Danish: Risikoen for malignitet, særligt lymfoproliferative lidelser, er øget ved anvendelse af visse andre lægemidler, der påvirker immunsystemet (klasseeffekt).
English: • To remind both patients and HCPs about the accelerated elimination procedure
Danish: • Informere både patient og sundhedspersonale om den accelerede eliminationsprocedure.
English: AUBAGIO contains lactose (a type of sugar).
Danish: AUBAGIO indeholder lactose (en type sukker).
English: If you have taken too much AUBAGIO, call your doctor straight away.
Danish: Hvis du har taget for meget AUBAGIO, skal du straks kontakte lægen.
English: Patients receiving AUBAGIO should be instructed to report symptoms of infections to a physician.
Danish: Patienter, der får AUBAGIO, skal informeres om at rapportere symptomer på infektioner til en læge.
English: • Affects blood cell counts and the immune system 2.
Danish: • Påvirker blodtallet og immunsystemet.
English: The estimated female plasma exposure via the semen of a treated patient is expected to be 100 times lower than the plasma exposure after 14 mg of oral teriflunomide.
Danish: Den estimerede kvindelige plasmaeksponering via sæden fra en behandlet patient forventes at være 100 gange lavere end plasmaeksponeringen efter 14 mg oral teriflunomid.
English: In such cases, patients should refrain from driving and using machines.
Danish: I sådanne tilfælde bør patienten ikke føre motorkøretøj eller betjene maskiner.
English: Immune system
Danish: Immunsystemet
English: You should swallow the tablet whole with some water.
Danish: Du skal synke tabletten hel med lidt vand.
English: The educational card for the patients will include the following key elements:
Danish: Patientuddannelseskortet skal indeholde følgende hovedelementer:
English: For rosuvastatin, a dose reduction by 50% is recommended for coadministration with teriflunomide.
Danish: For rosuvastatin anbefales en dosisreduktion på 50 % ved administration sammen med teriflunomid.
English: Therefore, caution is required when switching patients from natalizumab to AUBAGIO.
Danish: Der skal derfor udvises forsigtighed ved skift fra natalizumab til AUBAGIO.
English: The effect on red blood cell (RBC) (<2%) and platelet counts (<10%) was less pronounced.
Danish: Virkningen på antallet af røde blodlegemer (<2 %) og blodplader (<10 %) var mindre udtalt.
English: As a result, toxicity in animals was found at exposures equivalent or below human therapeutic levels.
Danish: Som et resultat heraf fandtes der toksiske virkninger hos dyr ved eksponeringer, der svarer til eller er lavere end det terapeutiske niveau hos mennesker.
English: Hepatic effects During placebo-controlled studies the following was detected:
Danish: Leverpåvirkning I placebokontrollerede studier sås følgende:
English: Animals are more sensitive to the pharmacology, and therefore toxicity, of teriflunomide than humans.
Danish: Dyr er mere følsomme for teriflunomids farmakologiske virkninger og dermed toksicitet end mennesker.
English: • Complete blood cell counts should be performed based on clinical signs and symptoms (e.g. infections) during treatment.
Danish: • Komplet blodtælling skal udføres på grundlag af på kliniske tegn og symptomer (f.eks. infektioner) under behandlingen.
English: - you are going to have a vaccination.
Danish: - Hvis du skal vaccineres.
English: If such effects occur, the accelerated elimination procedure (see above) to reduce plasma levels of teriflunomide should be considered.
Danish: Hvis sådanne reaktioner opstår, skal den accelererede eliminationsprocedure (se ovenfor) overvejes for at reducere plasma-teriflunomid.
English: AUBAGIO might make you feel dizzy which may impair your ability to concentrate and react.
Danish: AUBAGIO kan medføre svimmelhed, hvilket kan svække din evne til at reagere og koncentrere sig.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: Co-administration with antineoplastic or immunosuppressive therapies used for treatment of MS has not been evaluated.
Danish: Administration sammen med antineoplastiske eller immunsuppressive lægemidler til behandling af MS er ikke blevet undersøgt.
English: Severe skin reactionsa, Psoriasis (including pustular)b
Danish: Alvorlige hudreaktionera, Psoriasis (herunder pustuløs psoriasis)b
English: You may experience side effects similar to those described in section 4 below.
Danish: Du kan få bivirkninger svarende til de bivirkninger, der er beskrevet i punkt 4.
English: Acute hepatitis
Danish: Akut hepatitis
English: • To remind female patients to tell their doctor if breastfeeding
Danish: • at kvindelige patienter skal fortælle deres læge, hvis de ammer.
English: Two clinical studies have shown that vaccinations to inactivated neoantigen (first vaccination), or recall antigen (reexposure) were safe and effective during AUBAGIO treatment.
Danish: To kliniske studier har vist, at vaccination med inaktiveret neoantigen (første vaccination) eller ny dosis med antigen (re-eksponering) under behandling med AUBAGIO var sikker og effektiv.
English: Teriflunomide 14 mg (N=1002)
Danish: Teriflunomid 14 mg (N=1002)
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Patients with pre-existing liver disease and/or who consume substantial quantities of alcohol may be at increased risk of developing elevated liver enzymes when taking teriflunomide and should be closely monitored for signals of liver disease.
Danish: Patienter med eksisterende leversygdom og/eller som indtager store mængder alkohol kan have en øget risiko for at udvikle forhøjede leverenzymer, når de tager teriflunomid, og skal overvåges nøje for tegn på leversygdom.
English: While this interaction of teriflunomide is not expected to adversely impact the efficacy of oral contraceptives, it should be considered when selecting or adjusting oral contraceptive treatment used in combination with teriflunomide.
Danish: Omend denne interaktion med teriflunomid ikke forventes at påvirke orale kontraceptivas effekt negativt, skal det overvejes, når orale kontraceptiva, der anvendes i kombination med teriflunomid, vælges og justeres.
English: At entry, patients had an Expanded Disability Status Scale (EDSS) score ≤5.5.
Danish: Ved studiestart havde patienterne en EDSS-score (Expanded Disability Status Scale) ≤5,5.
English: If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove AUBAGIO rapidly and sufficiently from your body, as this may decrease the risk to your baby.
Danish: Hvis denne test bekræfter, at du er gravid, vil din læge muligvis foreslå en behandling med visse lægemidler, der kan sikre en hurtig og tilstrækkelig fjernelse af AUBAGIO fra din krop, da dette kan nedsætte risikoen for dit barn.
English: Secondary pathways involve oxidation, N-acetylation and sulfate conjugation.
Danish: Sekundære veje involverer oxidation, N-acetylering og sulfatkonjugering.
English: • Risk of infections/serious infections o To discuss the need to contact the doctor in the event of signs/symptoms of infection, or if the patient takes other medicines that affect the immune system 2.
Danish: • Risiko for infektioner/alvorlige infektioner o Drøfte nødvendigheden af at kontakte lægen i tilfælde af tegn og symptomer på infektion, eller hvis patienten tager andre lægemidler, som påvirker immunsystemet.
English: AUBAGIO helps to protect against attacks on the central nervous system by the immune system by limiting the increase of some white blood cells (lymphocytes).
Danish: AUBAGIO hjælper med at beskytte mod attakker på centralnervesystemet fra immunsystemet og ved at begrænse stigningen i visse hvide blodlegemer (lymfocytter).
English: 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.
Danish: 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.
English: You must use an effective method of contraception during and after treatment with AUBAGIO.
Danish: Du skal anvende en sikker præventionsmetode under og efter behandlingen med AUBAGIO.
English: Teriflunomide is a substrate of the efflux transporter BCRP, which could be involved in direct secretion.
Danish: Teriflunomid er substrat for efflux-transporteren BCRP, som kan være involveret i den direkte sekretion.
English: There is no experience regarding teriflunomide overdose or intoxication in humans.
Danish: Der er ingen erfaring med overdosering af eller forgiftning med teriflunomid hos mennesker.
English: Treatment withdrawal and initiation of an accelerated elimination procedure may be considered taking into account patient's disease and medical history.
Danish: Seponering af behandlingen og iværksættelse af en accelereret eliminationsprocedure kan overvejes, idet der skal tages hensyn til patientens sygdom og anamnese.
English: If your test results show a problem with your liver, your doctor may stop your treatment with AUBAGIO.
Danish: Hvis dine blodprøver viser, at der er et problem med din lever, vil lægen muligvis standse behandlingen med AUBAGIO.
English: 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.
Danish: 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.