FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no relevant use of AMGEVITA in children aged less than 2 years in this indication.
Danish: Det er ikke relevant at bruge AMGEVITA til børn under 2 år til denne indikation.
English: The usual AMGEVITA dose for adults with ulcerative colitis is 160 mg initially (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later, then 40 mg every other week.
Danish: Den anbefalede dosis AMGEVITA til voksne med colitis ulcerosa er 160 mg i starten (som fire 40 mginjektioner på en dag eller to 40 mg-injektioner om dagen i to på hinanden følgende dage) efterfulgt af 80 mg (som to 40 mg injektioner om dagen) 2 uger senere og derefter 40 mg hver anden uge.
English: AMGEVITA therapy should not be continued in patients failing to respond within this time period.
Danish: Fortsat behandling med AMGEVITA anbefales ikke til patienter, der ikke responderer inden for denne tidsperiode.
English: If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Danish: Hvis hurtigere behandlingsrespons er nødvendigt, kan dit barns læge ordinere en startdosis på 160 mg (som fire 40 mg-injektioner samme dag eller to 40 mg-injektioner på to på hinanden følgende dage) efterfulgt af 80 mg (som to 40 mg injektioner om dagen) to uger senere.
English: The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections in one day) two weeks later.
Danish: Startdosis ved hidrosadenitis suppurativa er sædvanligvis 160 mg (som fire 40 mg-injektioner på en dag eller to 40 mg-injektioner pr. dag i to på hinanden følgende dage), efterfulgt af 80 mg 2 uger senere (som to 40 mg-injektioner på en dag).
English: Maintenance Dose
Danish: Vedligeholdt slimhindeheling
English: if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating AMGEVITA therapy.
Danish: Det anbefales, at børn føres a jour, hvad angår vaccinationer i overensstemmelse med gældende retningslinjer for vaccinationer, før behandlingen med AMGEVITA indledes.
English: Inflammation
Danish: Sprøjtehus
English: • low blood measurements for platelets;
Danish: • nedsat antal blodplader,
English: Beyond 16 weeks, patients with inadequate response to AMGEVITA 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Danish: Patienter med utilstrækkeligt respons på AMGEVITA 40 mg hver anden uge efter 16 ugers behandling eller mere kan have fordel af en stigning i dosis til 40 mg hver uge eller 80 mg hver anden uge.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen contains 40 mg of adalimumab in 0.8 mL of solution.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt pen indeholder 40 mg adalimumab i 0,8 ml opløsning.
English: • high blood measurements for white blood cells;
Danish: • forhøjet antal hvide blodlegemer,
English: The recommended dose of AMGEVITA for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Danish: Den anbefalede AMGEVITA-dosis til voksne patienter er en startdosis på 80 mg subkutant, efterfulgt af 40 mg subkutant hver anden uge med start en uge efter den første dosis.
English: Idiopathic thrombocytopenic purpura
Danish: Leukocytose, Trombocytopeni Ikke almindelig Idiopatisk trombocytopenisk purpura Sjælden
English: • fungal infections;
Danish: • ledinfektioner,
English: There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Danish: Det er ikke relevant at bruge adalimumab hos børn under 4 år til denne indikation Psoriasisartrit og aksial spondyloartritis inklusive ankyloserende spondylitis Det er ikke relevant at bruge adalimumab til den pædiatriske population i indikationerne ankyloserende spondylitis og psoriasisartrit.
English: Pancreatitis, Dysphagia, Face oedema
Danish: Nyreinsufficiens, Hæmaturi
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 20 mg of adalimumab in 0.4 mL of solution.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt injektionssprøjte indeholder 20 mg adalimumab i 0,4 ml opløsning.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/002 1 pack
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1164/002 pakning med 1
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/009
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1164/009
English: • heart attack;
Danish: • hjertestop,
English: 20 mg eow
Danish: ≥90 dagea
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1164/005
English: EU/1/16/1164/007 2 pack
Danish: EU/1/16/1164/007 pakning med 2
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK CARTON PRE-FILLED SYRINGE (with blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING KARTON MED FYLDT INJEKTIONSSPRØJTE (med blå boks)
English: Sarcoidosis1), Vasculitis
Danish: Kutan vaskulitis1) Lichenoid hudreaktion1)
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret AMGEVITA til dig personligt.
English: • ear infections;
Danish: • øreinfektioner,
English: ACR 50 6 months 12 months
Danish: ACR 50 Uge 12 Uge 24
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/006 1 pack
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1164/006 pakning med 1
English: Inspect the AMGEVITA pre-filled syringe.
Danish: Kontrollér den fyldte injektionssprøjte.
English: EU/1/16/1164/003 2 pack
Danish: EU/1/16/1164/003 pakning med 2
English: • haematoma;
Danish: • ødem,
English: ● Do not twist or bend the yellow cap.
Danish: ● Den gule hætte må ikke snos eller bøjes.
English: • night sweats;
Danish: • nattesved,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1164/001
English: On a clean, well-lit work surface, place a new, pre-filled syringe.
Danish: Læg en ny, fyldt injektionssprøjte klar på en ren overflade med god belysning.
English: • dehydration;
Danish: • dehydrering (væskemangel),
English: Solution for injection.
Danish: 1 fyldt injektionssprøjte.
English: • dyspepsia (indigestion, bloating, heart burn);
Danish: • sure opstød (fordøjelsesbesvær, oppustethed, halsbrand),
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.4 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Low dose 20/10 mg eow
Danish: Lav-dosis 20/10 mg hver anden uge
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 40 mg of adalimumab in 0.8 mL of solution.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt injektionssprøjte indeholder 40 mg adalimumab i 0,8 ml opløsning.
English: Night sweats, Scar
Danish: Ikke almindelig Nattesved, Ar
English: EU/1/16/1164/004 4 pack
Danish: EU/1/16/1164/004 pakning med 4
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON PRE-FILLED SYRINGE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON MED FYLDT INJEKTIONSSPRØJTE
English: EU/1/16/1164/008 4 pack
Danish: EU/1/16/1164/008 pakning med 4
English: 0.4 mL of solution or 40 mg of adalimumab in 0.8 mL of solution.
Danish: Hver fyldt injektionssprøjte indeholder 20 mg adalimumab i 0,4 ml opløsning eller 40 mg adalimumab i 0,8 ml opløsning.
English: • vision disturbances;
Danish: • synsforstyrrelser,
English: Paediatric CD study PCDAI clinical remission and response Standard dose 40/20 mg eow N = 93
Danish: Pædiatrisk CD-studie PCDAI klinisk remission og respons
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON PRE-FILLED SYRINGE (without blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON MED FYLDT INJEKTIONSSPRØJTE (uden blå boks)
English: AMGEVITA may have a minor influence on your ability to drive, cycle or use machines.
Danish: AMGEVITA kan påvirke din evne til at føre motorkøretøj, cykle eller betjene maskiner i mindre grad. Du kan få synsforstyrrelser og en fornemmelse af, at rummet drejer rundt, efter, at AMGEVITA er taget.
English: • tremor;
Danish: • slagtilfælde,
English: EU/1/16/1164/007 - 2 pack
Danish: EU/1/16/1164/007 - pakning med 2
English: Myocardial infarction1), Arrhythmia, Congestive heart failure
Danish: Ikke almindelig Myokardieinfarkt1), Arytmi,
English: Using your AMGEVITA pre-filled syringe
Danish: Anvendelse af AMGEVITA fyldte injektionssprøjter
English: • diverticulitis (inflammation and infection of the large intestine);
Danish: • irritation og infektion i tyktarmen (diverticulitis),
English: • cough;
Danish: • hoste,
English: Placebo Adalimumab 40 mg weekly
Danish: Adalimumab 40 mg ugentlig
English: NAME OF THE MEDICINAL PRODUCT AMGEVITA 20 mg solution for injection in pre-filled syringe adalimumab
Danish: AMGEVITA 20 mg injektionsvæske, opløsning i fyldt injektionssprøjte adalimumab
English: Gastrointestinal disorders
Danish: Gastrointestinal blødning, Dyspepsi,
English: • fatty liver;
Danish: • syrereflukssygdom,
English: • eye inflammation;
Danish: • betændelse i øjet,
English: • elevated liver enzymes.
Danish: • forhøjede leverenzymer.
English: Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg/kg/day or 10 mg/day maximum).
Danish: Patienterne fortsatte på faste doser NSAID og/eller prednison (≤ 0,2 mg/kg/dag eller maksimalt 10 mg/dag) I den åbne indkøringsfase fik alle patienter 24 mg/m2 op til maksimalt 40 mg adalimumab hver anden uge i 16 uger.
English: ● Do not put the needle cap back onto the syringe.
Danish: ● Sæt ikke kanylehætten på injektionssprøjten igen.
English: EU/1/16/1164/008 - 4 pack
Danish: EU/1/16/1164/008 - pakning med 4
English: EU/1/16/1164/003 - 2 pack
Danish: EU/1/16/1164/003 - pakning med 2
English: NAME OF THE MEDICINAL PRODUCT AMGEVITA 40 mg solution for injection in pre-filled syringe adalimumab
Danish: AMGEVITA 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte adalimumab
English: EU/1/16/1164/004 - 4 pack
Danish: EU/1/16/1164/004 - pakning med 4
English: • skin infections (including cellulitis and shingles);
Danish: • hudinfektioner (inklusive bindevævsbetændelse og helvedsild),
English: • liver failure;
Danish: • fedtholdig lever,
English: • reproductive tract infections;
Danish: • infektioner i kønsvejene,
English: Urticaria,
Danish: • udslæt,
English: Muscle spasms (including blood creatine phosphokinase increased)
Danish: Muskelspasmer (inklusive forhøjet niveau af kreatinfosfokinase i blodet) Ikke almindelig Rabdomyolyse, Systemisk lupus erythematosus
English: • cutaneous vasculitis (inflammation of blood vessels in the skin);
Danish: • inflammation/betændelse i hudens blodkar (kutan vaskulitis),
English: In some cases, serious complications have occurred.
Danish: I visse tilfælde er der forekommet alvorlige komplikationer.
English: This may also help to delay future worsening of your MS.
Danish: Dette kan også hjælpe med til at forsinke fremtidig forværring af MS.
English: Patients subsequently entered an extension study for a further 96 weeks.
Danish: Patienterne indgik efterfølgende i et forlængelsesstudie i yderligere 96 uger.
English: Sun as a symbol Moon as a symbol
Danish: Sol som symbol Måne som symbol
English: Your doctor will advise whether other types of vaccines (non-live vaccines) should be given.
Danish: Din læge vil rådgive dig om, hvorvidt andre typer vacciner (ikke-levende vacciner) skal gives.
English: Morning Evening Mon.
Danish: Morgen Aften Man.
English: Date of first authorisation: 30 January 2014 Date of latest renewal: 20 September 2018
Danish: Dato for første markedsføringstilladelse: 30 januar 2014 Dato for seneste fornyelse: 20 september 2018
English: The need for further MRI scanning should be considered in accordance with national and local recommendations.
Danish: Behovet for yderligere MR-scanning bør overvejes i overensstemmelse med nationale og lokale anbefalinger.
English: Take this starting dose for the first 7 days, then take the regular dose.
Danish: Tag denne startdosis de første 7 dage og tag derefter den normale dosis.
English: Your doctor may reduce your dose.
Danish: Lægen sætter muligvis din dosis ned.
English: Do not use Tecfidera if you are pregnant unless you have discussed this with your doctor.
Danish: Tag ikke Tecfidera, hvis du er gravid, medmindre du har drøftet det med din læge.
English: The capsule should be swallowed whole.
Danish: Kapslen skal sluges hel.
English: The Package leaflet should be updated accordingly.
Danish: Indlægssedlen skal opdateres i overensstemmelse hermed.
English: DK - 3400 Hillerød Denmark
Danish: DK - 3400 Hillerød Danmark
English: These events were not life-threatening, but led to hospitalisation.
Danish: Tilfældene var ikke livstruende, men førte til indlæggelse.
English: However, these changes did not affect fertility or the number of viable fetuses produced.
Danish: Disse forandringer påvirkede dog ikke fertiliteten eller antallet af producerede levedygtige fostre.
English: The time to onset can be directly, several weeks or longer.
Danish: Dette kan opstå umiddelbart, efter adskillige uger eller efter længere tid.
English: Reactions generally occur after the first dose, but may also occur at any time during treatment, and may be serious and life threatening.
Danish: Generelt opstår disse reaktioner efter den første dosis, men de kan også opstå når som helst i løbet af behandlingen og kan være alvorlige og livstruende.
English: Clinical factors, evaluation of any laboratory and imaging investigations could be included as part of this reconsideration.
Danish: Kliniske faktorer samt evaluering af eventuelle laboratorie- og diagnostiske billedundersøgelser kan inkluderes som en del af denne overvejelse.
English: Mean values for both parameters remained within normal range.
Danish: Middelværdierne for begge parametre forblev inden for normalværdierne.
English: You may experience side effects similar to those described below in section 4.
Danish: Du kan opleve bivirkninger, som ligner dem, der beskrives herunder i punkt 4.
English: Do not reduce your dose unless your doctor tells you to.
Danish: Sæt ikke dosis ned, medmindre din læge beder dig om det.
English:  Stop taking Tecfidera and call a doctor straight away Very common side effects
Danish:  Stop med at tage Tecfidera, og ring omgående til en læge Meget almindelige bivirkninger
English: Talk to your doctor about how to manage these side effects.
Danish: Tal med lægen om, hvordan disse bivirkninger skal håndteres.
English: Your doctor will test these periodically during treatment.
Danish: Din læge vil tage disse blodprøver regelmæssigt under behandlingen.
English: Otherwise the patient should wait until the next scheduled dose.
Danish: Ellers skal patienten vente indtil den næste planlagte dosis.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterpakningen og kartonen efter “EXP”.
English: There were no effects on fertility in the F1 offspring.
Danish: Der var ingen virkning på fertiliteten hos F1-afkommet.
English: PML is an opportunistic infection caused by John-Cunningham virus (JCV), which may be fatal or result in severe disability.
Danish: PML er en opportunistisk infektion forårsaget af John-Cunningham-virus (JCV), som kan være dødelig eller resultere i svær invaliditet.
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendt (hyppighed kan ikke estimeres ud fra forhåndenværende data)
English: Blood/laboratory tests
Danish: Blodprøver/laboratorietests
English: The Tmax of monomethyl fumarate is 2 to 2.5 hours.
Danish: Monomethylfumarats Tmax er 2 til 2,5 timer.
English: These symptoms may disappear completely when the relapse is over, but some problems may remain.
Danish: Disse symptomer kan forsvinde helt, når tilbagefaldet er overstået, men nogle gener kan vare ved.
English: Approximately 1,056 patients have received more than 2 years of treatment with Tecfidera.
Danish: Cirka 1.056 patienter har fået behandling med Tecfidera i mere end 2 år.
English: Tecfidera seems to work by stopping the body's defence system from damaging your brain and spinal cord.
Danish: Tecfidera lader til at virke ved at forhindre kroppens forsvarssystem i at skade din hjerne og rygmarv.
English: A complete blood count is recommended prior to initiating Tecfidera and regularly during treatment (see Blood/laboratory tests above).
Danish: Det anbefales at foretage en komplet blodtælling, før behandling med Tecfidera indledes og regelmæssigt under behandlingen (se Blodprøver/laboratorietests ovenfor).
English: Glatiramer acetate
Danish: Glatiramer acetat
English: The symptoms described in these cases were consistent with the known adverse reaction profile of Tecfidera.
Danish: Symptomerne beskrevet i disse tilfælde var i overensstemmelse med den kendte bivirkningsprofil for Tecfidera.
English: Live vaccines might carry an increased risk of clinical infection and should not be given to patients treated with Tecfidera unless, in exceptional cases, this potential risk is considered to be outweighed by the risk to the individual of not vaccinating.
Danish: Levende vacciner kan medføre en øget risiko for klinisk infektion og bør ikke gives til patienter i behandling med Tecfidera, medmindre denne potentielle risiko i ganske særlige tilfælde anses for at blive opvejet af risikoen for den enkelte ved ikke at blive vaccineret.
English: Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis.
Danish: Behandling skal påbegyndes under supervision af en læge med erfaring i behandling af multipel sklerose.
English: Reduced white blood cells could mean your body is less able to fight an infection.
Danish: Nedsat antal hvide blodlegemer kan betyde, at din krop er dårligere i stand til at bekæmpe en infektion.
English: If your number of white blood cells decreases during treatment, your doctor may consider interrupting your treatment
Danish: Hvis antallet af dine hvide blodlegemer falder under behandlingen, vil din læge muligvis overveje at afbryde behandlingen.
English: The safety and efficacy of Tecfidera in children and adolescents aged 10 to 18 years have not yet been established.
Danish: Tecfideras sikkerhed og virkning hos børn og unge i alderen 10-18 år er endnu ikke klarlagt.
English: Tecfidera is not recommended for use in children and adolescents because there is limited experience in the use of Tecfidera in this population.
Danish: Tecfidera anbefales ikke til brug hos børn og unge, da der er begrænset erfaring med brug af Tecfidera hos denne aldersgruppe.
English: Tecfidera is for oral use
Danish: Tecfidera er til oral brug
English: If a patient misses a dose, a double dose should not be taken.
Danish: Hvis en patient glemmer en dosis, må der ikke tages en dobbeltdosis.
English: These may affect up to 1 in 100 people: - Allergic reactions (hypersensitivity) - reduction in blood platelets
Danish: Disse kan påvirke op til 1 ud af 100 personer: - Allergiske reaktioner (overfølsomhed) - nedsat antal blodplader
English:  Taking your medicine with food can help to reduce the side effects above
Danish:  Hvis du tager medicinen sammen med mad, kan det hjælpe med at reducere ovennævnte bivirkninger
English: Read the package leaflet before use Oral use
Danish: Læs indlægssedlen inden brug Til oral brug
English: Tecfidera with alcohol
Danish: Brug af Tecfidera sammen med alkohol
English: Take Tecfidera with food - it may help to reduce some of the very common side effects (listed in section 4).
Danish: Tag Tecfidera sammen med mad - det kan hjælpe med at reducere nogle af de meget almindelige bivirkninger (angivet i punkt 4).
English: If you notice you are passing more urine, are more thirsty and drinking more than normal, your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.
Danish: Hvis du bemærker, at du tisser mere, er mere tørstig og drikker mere end normalt, at dine muskler virker svagere, du brækker en knogle eller blot har ømhed og smerter, skal du kontakte lægen hurtigst muligt, så det kan blive undersøgt nærmere.
English: Concomitant administration of non-live vaccines according to national vaccination schedules may be considered during Tecfidera therapy.
Danish: Samtidig administration af ikke-levende vacciner i henhold til nationale vaccinationsprogrammer kan overvejes under behandling med Tecfidera.
English: The clinical implications of these changes are unknown.
Danish: Den kliniske betydning af disse ændringer kendes ikke.
English: Treatment initiation
Danish: Påbegyndelse af behandlingen
English: The lower offspring body weight was considered secondary to maternal toxicity.
Danish: Den lavere kropsvægt hos afkommet blev betragtet som værende sekundær til maternel toksicitet.
English: The frequency of severe allergic reactions cannot be estimated from the available data (not known).
Danish: Hyppigheden af svære overfølsomhedsreaktioner kan ikke estimeres ud fra forhåndenværende data (ikke kendt).
English: Efficacy in patients with high disease activity: Consistent treatment effect on relapses in a subgroup of patients with high disease activity was observed, whilst the effect on time to 3-month sustained disability progression was not clearly established.
Danish: Effekt hos patienter med høj sygdomsaktivitet: Der blev observeret en konsistent behandlingseffekt på attaker i en undergruppe af patienter med høj sygdomsaktivitet, mens effekten på tiden til 3-måneders vedvarende sygdomsprogression blev ikke klart fastlagt.
English: Before initiating treatment with Tecfidera, a baseline MRI should be available (usually within 3 months) as a reference.
Danish: Før behandlingen med Tecfidera indledes, skal en baseline-MR-skanning være til rådighed (sædvanligvis inden for 3 måneder) som reference.
English: Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms.
Danish: Attakvis remitterende MS er kendetegnet ved gentagne attakker (tilbagefald) af symptomer fra nervesystemet.
English: Renal and faecal elimination are secondary routes of elimination, accounting for 15.5% and 0.9% of the dose respectively.
Danish: Renal og fækal elimination er sekundære eliminationsveje og står for en udskillelse af henholdsvist 15,5% og 0,9% af dosis.
English: Dimethyl fumarate is not quantifiable in plasma following oral administration of Tecfidera.
Danish: Dimethylfumarat kan ikke kvantificeres i plasma efter oral administration af Tecfidera.
English: A positive immune response defined as a ≥4-fold increase in antibody titer to the three vaccines, was achieved by fewer subjects in both treatment groups.
Danish: Et positivt immunrespons defineret som en ≥ firedobling af antigentiter over for de tre vacciner, blev opnået hos færre personer i begge behandlingsgrupper.
English: Your doctor will help you decide whether you should stop breastfeeding, or stop using Tecfidera.
Danish: Din læge vil hjælpe dig med at afgøre, hvorvidt du skal stoppe med at amme eller med at tage Tecfidera.
English: Renal tubular hyperplasia was observed in rats with life time dosing (2-year study).
Danish: Renal tubulær hyperplasi blev observeret hos rotter med livstidsdosering (2-års studie).
English: Prior treatment with immunosuppressive or immunomodulating therapies
Danish: Tidligere behandling med immunsuppressive eller immunmodulerende præparater
English: There are no known therapeutic interventions to enhance elimination of Tecfidera nor is there a known antidote.
Danish: Der er ingen kendte terapeutiske interventioner, som forstærker elimineringen af Tecfidera, og der er heller ingen kendt antidot.