FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypromellose acetate succinate Sodium laurilsulfate (E487) Hypromellose (E464) Microcrystalline cellulose (E460(i)) Croscarmellose sodium (E468) Magnesium stearate (E470b)
Danish: Hypromelloseacetatsuccinat Natriumlaurilsulfat (E487) Hypromellose (E464) Mikrokrystallinsk cellulose (E460(i)) Croscarmellosenatrium (E468) Magnesiumstearat (E470b)
English: Laboratory abnormalities
Danish: Unormale laboratorieresultater
English: The mean treatment difference between Symkevi and placebo-treated patients for absolute change in ppFEV1 through Week 24 in this subgroup was 3.5 percentage points (95% CI: 1.0, 6.1).
Danish: Den gennemsnitlige behandlingsforskel mellem Symkevi- og placebobehandlede patienter for absolut ændring i ppFEV1 til og med uge 24 i denne undergruppe var 3,5 procentpoint (95 % CI: 1,0; 6,1).
English: • Ear pain, ear discomfort
Danish: • ørepine, øregener
English: Examples of strong CYP3A inducers include:
Danish: Eksempler på potente CYP3A-induktorer omfatter:
English: • Blocked nose (sinus congestion)
Danish: • tilstoppet næse (tilstoppede bihuler)
English: Absolute change from baseline to the average of Week 4 and Week 8 (percentage points)**
Danish: Absolut ændring fra baseline til gennemsnittet af uge 4 og uge 8 (procentpoint)**
English: − Tablet film coating: Hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), talc (E553b), and iron oxide yellow (E172).
Danish: − Tabletfilmovertræk: Hypromellose (E464), hydroxypropylcellulose (E463), titandioxid (E171), talcum (E553b) og jernoxid, gul (E172).
English: Pulmonary exacerbations requiring IV antibiotic therapy were lower in the treatment group compared to placebo (RR: 0.53 [95% CI: 0.34, 0.82]; nominal P=0.0042).
Danish: antibiotika, var lavere i behandlingsgruppen sammenlignet med placebo (RR: 0,53 [95 % CI: 0,34; 0,82], nominel P= 0,0042).
English: The treatment difference between Symkevi (in combination with ivacaftor) and placebo for the primary endpoint of mean absolute change (95% CI) in ppFEV1 from baseline through Week 24 was 4.0 percentage points (95% CI: 3.1, 4.8; P<0.0001).
Danish: Behandlingsforskellen mellem Symkevi (i kombination med ivacaftor) og placebo for det primære endepunkt på den gennemsnitlige absolutte ændring (95 % CI) i ppFEV1 fra baseline til og med uge 24 var 4,0 procentpoint (95 % CI: 3,1; 4,8, P<0,0001).
English: Ivacaftor may inhibit CYP2C9; therefore, monitoring of the international normalized ratio (INR) is recommended during co-administration of warfarin with Symkevi given in combination with ivacaftor.
Danish: Derfor anbefales det at monitorere den internationale normaliserede ratio (INR) under administration af warfarin sammen med Symkevi i kombination med ivacaftor.
English: The dose of Symkevi and ivacaftor should be adjusted when co-administered with moderate and strong CYP3A inhibitors.
Danish: Dosis af Symkevi og ivacaftor skal justeres ved administration sammen med moderate og potente CYP3A-hæmmere.
English: Sinus congestion, Pharyngeal erythema common
Danish: Tilstoppede bihuler, faryngealt erytem almindelig
English: The mean treatment difference between Symkevi and placebo-treated patients for absolute change in ppFEV1 through the average of Week 4 and Week 8 was 4.4 percentage points (95% CI: 1.1, 7.8).
Danish: Den gennemsnitlige behandlingsforskel mellem Symkevi- og placebobehandlede patienter for absolut ændring i ppFEV1 til og med gennemsnittet af uge 4 og uge 8 var 4,4 procentpoint (95 % CI: 1,1; 7,8).
English: Caution is recommended in patients with severe renal impairment or end-stage renal disease (see sections 4.4 and
Danish: Der rådes til forsigtighed hos patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet (se pkt.
English: The AUC of ivacaftor when given in combination with tezacaftor increased approximately 3-fold when given with fat-containing food; therefore, Symkevi and ivacaftor should be administered with fat-containing food.
Danish: AUC for ivacaftor administreret i kombination med tezacaftor steg ca. 3 gange, når det blev administreret med fedtholdig mad.
English: Symkevi 100 mg/150 mg film-coated tablets
Danish: Symkevi 100 mg/150 mg filmovertrukne tabletter
English: The mean absolute change (SE) from baseline in BMI z-value was -0.01(0.05) kg/m2 in the Symkevi in combination with ivacaftor group and 0.00 (0.05) kg/m2 in the placebo group in Study 1.
Danish: Den gennemsnitlige absolutte ændring (SE) fra baseline i BMI z-værdi var-0,01 (0,05) kg/m2 i gruppen med Symkevi i kombination med ivacaftor, og 0,00 (0,05) kg/m2 i placebogruppen i studie 1.
English: Dizziness has been reported in patients receiving Symkevi in combination with ivacaftor, as well as ivacaftor monotherapy (see section 4.8).
Danish: Der er blevet rapporteret svimmelhed hos patienter, der fik Symkevi i kombination med ivacaftor samt ivacaftor som monoterapi (se pkt.
English: In Study 1 (patients homozygous for the F508del mutation), the treatment difference between Symkevi in combination with ivacaftor and placebo in mean absolute change from baseline in sweat chloride through Week 24, was -10.1 mmol/L (95% CI: -11.4, -8.8; nominal P<0.0001*).
Danish: I studie 1 (patienter, der var homozygote for F508del-mutationen) var behandlingsforskellen mellem Symkevi i kombination med ivacaftor og placebo i gennemsnitlig absolut ændring fra baseline i svedchlorid til og med uge 24, -10,1 mmol/l (95 % CI: -11,4; -8,8, nominel P<0,0001*).
English: Examples of moderate CYP3A inhibitors include:
Danish: Eksempler på moderate CYP3A-hæmmere omfatter:
English: Starting dose: One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily.
Danish: Startdosis: Én tablet med tezacaftor 100 mg/ivacaftor 150 mg en gang dagligt.
English: CYP3A substrates
Danish: CYP3A4-substrater
English: How to take Symkevi
Danish: Sådan skal du tage Symkevi
English: Warnings and precautions • Talk to your doctor if you have liver problems, or have had them previously.
Danish: • Kontakt lægen, hvis du har leverproblemer eller har haft det tidligere.
English: Patients who received Symkevi in combination with ivacaftor in Study 1 and continued on treatment showed sustained improvements in ppFEV1 through 48 weeks [within-group change=-0.8 (0.8) percentage points from Study 3 baseline].
Danish: Patienter, der fik Symkevi i kombination med ivacaftor i studie 1, og fortsatte med behandlingen viste vedvarende forbedringer i ppFEV1 til og med 48 uger [ændring indenfor- gruppen = 0,8 (0,8) procentpoints fra studie 3 baseline].
English: Breast inflammation, Gynaecomastia, Nipple disorder, Nipple pain uncommon
Danish: Brystbetændelse, gynækomasti, sygdom i brystvorter, smerter i brystvorter ikke almindelig
English: • Antifungal medicines (used for the treatment of fungal infections).
Danish: • Antimykotika (anvendes til behandling af svampeinfektioner).
English: Package leaflet: Information for the patient Symkevi 100 mg/150 mg film-coated tablets tezacaftor/ivacaftor
Danish: Indlægsseddel: Information til patienten Symkevi 100 mg/150 mg filmovertrukne tabletter tezacaftor/ivacaftor
English: Patients who received Symkevi in combination with ivacaftor in Study 2 and continued on treatment showed sustained improvements in ppFEV1 through 24 weeks [within-group change=0.7 (1.5) percentage points from Study 3 baseline].
Danish: Patienter, der fik Symkevi i kombination med ivacaftor i studie 2, og fortsatte med behandlingen viste vedvarende forbedringer i ppFEV1 til og med 24 uger [ændring indenfor gruppen = 0,7 (1,5) procentpoints fra studie 3 baseline].
English: Hypromellose (E464) Hydroxypropyl cellulose (E463) Titanium dioxide (E171) Talc (E553b)
Danish: Tabletfilmovertræk Hypromellose (E464) Hydroxypropylcellulose (E463) Titandioxid (E171) Talcum (E553b) Jernoxid, gul (E172)
English: The dose of Symkevi should be adjusted when co-administered with strong CYP3A inhibitors (see Table 1 in section 4.2).
Danish: Dosis af Symkevi bør justeres, når det administreres sammen med potente CYP3A-hæmmere (se tabel 1, pkt.
English: Absolute change from baseline to the average of Week 4 and Week 8 (points)**
Danish: Absolut ændring fra baseline til gennemsnittet af uge 4 og uge 8 (point)**
English: Headache, Dizziness very common
Danish: Hovedpine, svimmelhed meget almindelig
English: After oral administration of tezacaftor 100 mg once daily in combination with ivacaftor 150 mg every 12 hours in patients with CF in the fed state, the mean (±SD) for apparent volume of distribution of tezacaftor and ivacaftor was 271 (157) L and 206 (82.9) L, respectively.
Danish: Efter oral administration af tezacaftor 100 mg en gang dagligt i kombination med ivacaftor 150 mg hver 12. time til patienter med CF efter indtagelse af mad var gennemsnittet (±SD) for det tilsyneladende fordelingsvolumen hhv. tezacaftor og ivacaftor 271 (157) l og 206 (82,9) l. Hverken tezacaftor eller ivacaftor fordeles præferentielt til humane røde blodlegemer.
English: n/N Mean (SD) n/N Within-group change LS mean (95% CI) Treatment difference LS mean (95% CI) P value nominal P<0.0001±
Danish: n/N Gennemsnit (SD) n/N Ændring inden for gruppen LS-gennemsnit (95 % CI) Behandlingsforskel LS-gennemsnit (95 % CI) P værdi nominel P<0,0001±
English: Caution is recommended while using Symkevi in combination with ivacaftor in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Danish: Forsigtighed anbefales, når Symkevi anvendes i kombination med ivacaftor til patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet(se pkt.
English: Primary ppFEV1 Baseline value
Danish: Primært ppFEV1 Baseline-værdi
English: No dose adjustment One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily
Danish: Ingen dosisjustering Én tablet med tezacaftor 100 mg/ivacaftor 150 mg en gang dagligt
English: • Cardiac glycosides (used for the treatment of some heart conditions).
Danish: • Hjerteglykosider (anvendes til behandling af nogle hjerteproblemer).
English: The dose of Symkevi and ivacaftor should be adjusted when co-administered with moderate CYP3A inhibitors (see Table 1 in section 4.2).
Danish: Dosis af Symkevi og ivacaftor bør justeres, når de administreres sammen med moderate CYP3A-hæmmere (se tabel 1, pkt.
English: Co-administration with grapefruit juice, which contains one or more components that moderately inhibit CYP3A, may increase exposure of ivacaftor and tezacaftor; therefore, food or drink containing grapefruit or Seville oranges should be avoided during treatment (see section 4.2).
Danish: Administration sammen med grapefrugtjuice, som indeholder en eller flere komponenter, der i moderat grad hæmmer CYP3A, kan øge eksponeringen for ivacaftor og tezacaftor.
English: Patients had a percent predicted forced expiratory volume in one second (ppFEV1) at screening between 40 to 90%.
Danish: Patienterne havde et procent forventet forceret eksspiratorisk volumen i ét sekund
English: • Enlargement of the breast in males
Danish: • brystforstørrelse hos mænd
English: Symkevi is indicated in a combination regimen with ivacaftor 150 mg tablets for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W,
Danish: Symkevi er indiceret i et kombinationsprogram med ivacaftor 150 mg tabletter til behandling af patienter med cystisk fibrose (CF) i alderen 12 år og ældre, som er homozygote for F508delmutationen, eller som er heterozygote for F508del-mutationen og har en af de følgende mutationer i det cystiske fibrose konduktansregulatorgen (CFTR-gen): P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G og 3849+10kbC→T.
English: n/N Mean (SD) n/N Within-group change LS mean (95% CI) Treatment difference versus placebo LS mean (95% CI) P value
Danish: n/N Gennemsnit (SD) n/N Ændring inden for gruppen LS-gennemsnit (95 % CI) Behandlingsforskel versus placebo LSgennemsnit (95 % CI) P-værdi
English: Dizziness common
Danish: Svimmelhed almindelig
English: Symkevi 100 mg/150 mg tablets tezacaftor/ivacaftor
Danish: Symkevi 100 mg/150 mg tabletter tezacaftor/ivacaftor
English: NA 1.4 (-1.0, 3.9)
Danish: 4.4 og 4.5).
English: Ivacaftor 1.28 (0.440) 9.3 (1.7) *AUC0-24h for tezacaftor and AUC0-12h for ivacaftor
Danish: *AUC0-24t for tezacaftor og AUC0-12t for ivacaftor
English: Key Secondary ppFEV1 Baseline value
Danish: Vigtigste sekundære ppFEV1
English: For CFQ-R respiratory domain score (a measure of respiratory symptoms relevant to patients with CF including cough, sputum production, and difficulty breathing) the percentage of subjects with at least a
Danish: For CFQ-R respiratorisk domænescore (en måling af respiratoriske symptomer relevante for patienter med CF, herunder hoste, spytproduktion og vejrtrækningsbesvær) var procentdelen af personer med mindst en 4 point-stigning fra baseline (minimal klinisk vigtig forskel) 51,1 % for Symkevi og 35,7 % for placebo ved uge 24.
English: Symkevi 100 mg/150 mg film-coated tablets tezacaftor/ivacaftor
Danish: Symkevi 100 mg/150 mg filmovertrukne tabletter tezacaftor/ivacaftor
English: R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A,
Danish: Studie hos patienter med CF, som var heterozygote for F508del- mutationen og en anden mutation forbundet med resterende CFTR-aktivitet (studie 2) Ud af de 244 patienter, der indgik i studie 2, var de følgende indicerede mutationer forbundet med resterende CFTR-aktivitet repræsenteret: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G og 3849+10kbC→T.
English: n/N Mean (SD) n/N Within-group change LS mean (95% CI) Treatment difference LS mean (95% CI) P value
Danish: n/N Gennemsnit (SD) n/N Ændring inden for gruppen LS-gennemsnit (95 % CI) Behandlingsforskel LS-gennemsnit (95 % CI) P værdi
English: Ear congestion uncommon
Danish: Propper i ørerne ikke almindelig
English: Adolescent patients with CF who were homozygous for the F508del mutation in the CFTR gene The mean absolute change (SE) from baseline in ppFEV1 was 3.5 (0.6) percentage points in the Symkevi in combination with ivacaftor group and -0.4 (0.6) percentage points in the placebo group in Study 1.
Danish: Den gennemsnitlige absolutte ændring (SE) fra baseline i ppFEV1 var 3,5 (0,6) procentpoints i gruppen med Symkevi i kombination med ivacaftor, og -0,4 (0,6) procentpoints i placebogruppen i studie 1.
English: Average absolute change from baseline through Week 24 (percentage points)**
Danish: Gennemsnitlig absolut ændring i ppFEV1 fra baseline til og med uge 24 (procentpoint)**
English: If you take more Symkevi than you should
Danish: Hvis du har taget for meget Symkevi
English: The dose of Symkevi and ivacaftor should be adjusted when used concomitantly with strong or moderate CYP3A inhibitors (see section 4.5 and Table 1 in section 4.2).
Danish: Dosis af Symkevi og ivacaftor bør justeres, når de anvendes sammen med potente eller moderate CYP3A-hæmmere (se pkt.
English: The treatment difference between Symkevi in combination with ivacaftor- and placebo-treated patients for the primary endpoint of mean absolute change in ppFEV1 from study baseline to the average of Week 4 and Week 8 was 6.8 percentage points (95% CI: 5.7, 7.8; P<0.0001).
Danish: Behandlingsforskellen mellem Symkevi i kombination med ivacaftor- og placebobehandlede patienter for det primære endepunkt på den gennemsnitlige absolutte ændring i ppFEV1 fra studiets baseline til gennemsnittet af uge 4 og uge 8 var 6,8 procentpoint
English: NA
Danish: A.
English: Oropharyngeal pain, Nasal congestion very common
Danish: Orofaryngeale smerter, tilstoppet næse meget almindelig
English: Adolescents TEZ 100 mg qd/IVA 150 mg q12h Adults
Danish: Unge TEZ 100 mg en gang dagligt/IVA 150 mg hver 12. t Voksne TEZ 100 mg en gang dagligt/IVA 150 mg hver 12. t
English: Tablet core
Danish: 1 tabl.
English: Treatment difference versus IVA LS mean
Danish: Behandlingsforskel versus IVA LSgennemsnit (95 % CI)
English: Rash very common
Danish: Udslæt meget almindelig
English: --1 Modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9: 104.0-106.0 TCID50*, Modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93: 104.0-106.0 TCID50*.
Danish: 104,0-106,0 TCID50*, Modificeret levende bovin virus diarré type 2, ikke-cytopatisk moderstamme NY-93: 104,0-106,0 TCID50*.
English: ** Tissue culture infectious dose 50%
Danish: * Vævskultur - infektiøs dosis 50 %
English: 100 mg / 150 mg Film-coated tablet Oral use blister (PCTFE/PVC/alu)
Danish: Blister (PCTFE/PVC/alu)
English: The recommended dose is 14 mg once a day.
Danish: Den anbefalede dosis er 14 mg én gang dagligt.
English: The study lasted for up to two years.
Danish: Undersøgelsen varede i op til to år.
English: The results of the study were inconclusive.
Danish: Undersøgelsens resultater var uklare.
English: Treatment lasted for up to about three years (152 weeks).
Danish: Behandlingen varede i op til ca. 3 år (152 uger).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aubagio on 26 August 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aubagio den 26. august 2013.
English: Aubagio teriflunomide
Danish: Aubagio teriflunomid
English: • serious infections;
Danish: • alvorlige infektioner,
English: Aubagio must not be used in patients with:
Danish: Aubagio må ikke anvendes til patienter med:
English: The full EPAR for Aubagio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Aubagio findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Aubagio.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aubagio.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Aubagio's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Aubagio er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Other information about Aubagio
Danish: Andre oplysninger om Aubagio
English: Women who can become pregnant must not take Aubagio without using reliable contraceptive measures.
Danish: Kvinder, som kan blive gravide, må ikke tage Aubagio uden at anvende pålidelig svangerskabsforebyggelse.
English: Aubagio is available as tablets (14 mg).
Danish: Aubagio leveres som tabletter (14 mg).
English: Aubagio is a medicine that contains the active substance teriflunomide.
Danish: Aubagio er et lægemiddel, der indeholder det aktive stof teriflunomid.
English: • severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);
Danish: • svære immundefekter såsom erhvervet immundefektsyndrom (aids),
English: The risk of serious side effects affecting the liver and bone marrow was considered manageable and adequately addressed by risk minimisation measures.
Danish: Risikoen for alvorlige bivirkninger, der påvirker lever og knoglemarv, blev anset for at kunne behandles og håndteres tilstrækkeligt gennem risikominimeringsforanstaltninger.
English: A risk management plan has been developed to ensure that Aubagio is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Aubagio anvendes så risikofrit som muligt.
English: In general, headache, diarrhoea, nausea and alopecia are mild to moderate, resolve with time and do not usually lead to treatment being stopped.
Danish: Hovedpine, diarré, kvalme og hårtab er sædvanligvis af mild til moderat grad, svinder med tiden og kræver normalt ikke ophør af behandlingen.
English: • poor bone marrow function or low blood cell counts (red cells, white cells or platelets);
Danish: • dårligt fungerende knoglemarv eller lavt antal blodlegemer (røde blodlegemer, hvide blodlegemer eller blodplader),
English: It is used to treat adults with multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves.
Danish: Det anvendes til behandling af voksne med multipel sklerose (MS), en sygdom, hvor inflammation ødelægger den beskyttende skede, der omgiver nerverne.
English: What measures are being taken to ensure the safe and effective use of Aubagio?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Aubagio?
English: Regarding its safety, side effects were similar to the immunosuppressant leflunomide, as leflunomide is converted into teriflunomide in the body.
Danish: Vedrørende sikkerheden svarede bivirkningerne til det immundæmpende middel leflunomid, da dette omdannes til teriflunomid i kroppen.
English: The most commonly reported side effects with Aubagio (which may affect more than 1 in 10 people) are headache, diarrhoea, increased liver enzymes, nausea (feeling sick), and alopecia (hair loss).
Danish: De hyppigst indberettede bivirkninger ved Aubagio (som kan forekomme hos mere end én af hver 10 behandlede) er hovedpine, diarré, forhøjede leverenzymer, kvalme og alopeci (hårtab.
English: Aubagio is given by mouth which was considered to be an advantage over other medicines such as interferon beta-1a.
Danish: Aubagio indgives gennem munden, hvilket blev betragtet som en fordel i forhold til andre lægemidler såsom interferon beta-1a.
English: The active substance in Aubagio, teriflunomide, blocks an enzyme called ‘dihydro-orotate dehydrogenase' which is necessary for cells to multiply.
Danish: Det aktive stof i Aubagio, teriflunomid, blokerer enzymet dihydroorotat dehydrogenase, der er nødvendigt for cellers deling.
English: The exact way teriflunomide works in MS is not known but it is thought to reduce the number of lymphocytes which form part of the immune system and are involved in the inflammation process.
Danish: Det vides ikke nøjagtigt, hvordan teriflunomid virker ved multipel sklerose, men det menes at nedsætte antallet af lymfocytter, der er en del af immunsystemet og medvirker ved inflammationsprocessen.
English: Why is Aubagio approved?
Danish: Hvorfor er Aubagio blevet godkendt?
English: What is Aubagio and what is it used for?
Danish: Hvad er Aubagio, og hvad anvendes det til?
English: In addition, the company that markets Aubagio must ensure that all healthcare professionals who are expected to use Aubagio receive an information pack containing important safety information, including the tests and monitoring that should be carried out in patients before and after starting treatment.
Danish: Desuden skal virksomheden, der markedsfører Aubagio, sørge for, at alle sundhedspersoner, der forventes at anvende Aubagio, modtager en informationspakke med vigtige sikkerhedsoplysninger, bl.a. om de prøver, der skal tages, og den overvågning, der skal finde sted før og efter påbegyndelse af behandlingen.
English: It is not intended to provide practical advice on how to use Aubagio.
Danish: Det er ikke en praktisk vejledning i, hvordan Aubagio bør anvendes.
English: Aubagio can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the management of MS.
Danish: Aubagio fås kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af multipel sklerose.
English: With fewer lymphocytes, there is less inflammation, helping to control the symptoms of MS.
Danish: Med færre lymfocytter er der mindre inflammation, hvorved symptomerne på multipel sklerose begrænses.
English: In MS, the body's immune system malfunctions and attacks parts of the central nervous system (the brain and spinal cord), causing the inflammation that damages the nerve sheaths.
Danish: Ved multipel sklerose fungerer kroppens immunsystem forkert og angriber dele af centralnervesystemet (hjernen og rygmarven), så der opstår inflammation, der beskadiger nervernes skeder.