natgillin/translations-raw huggingface dataset:
Polyamid/aluminium/poly(vinylchlorid)-aluminium-blister indsat i hylster (14 og 28 filmovertrukne tabletter) og pakket i æsker med 14, 28, 84 (3 hylstre med 28) og 98 (7 hylstre med 14) filmovertrukne tabletter.
Polyamide/aluminium/poly(vinyl chloride) -aluminium blisters inserted in wallets (14 and 28 film-coated tablets) and packed in cartons containing 14, 28, 84 (3 wallets of 28), and 98 (7 wallets of 14) film-coated tablets.
Antallet af patienter med permanent behandlingsophør i gruppen med subkutan interferon beta-1a var 30 ud af 104 (28,8 %) med årsagerne bivirkninger (21,2 %), manglende effekt (1,9 %), andre årsager (4,8 %) og dårlig compliance til protokollen (1 %).
The number of patients with permanent treatment discontinuation in the subcutaneous interferon beta-1a group was 30 out of 104 (28 .8%), the reasons being adverse events (21.2%), lack of efficacy (1.9%), other reason (4.8%) and poor compliance to protocol (1%).
Størstedelen af patienterne (67,2 %) havde ikke fået nogen form for sygdomsbehandling i de 2 forudgående år op til studiestart.
A majority of patients (67.2%) had not received disease-modifying therapy during the 2 years before study entry.
• Risiko for hæmatologiske virkninger o Nødvendigheden af komplet blodtælling før behandlingen og periodevist under behandling baseret på tegn og symptomer.
• Risk of hematologic effects o the need for complete blood cell counts before treatment and periodically during treatment based on signs and symptoms
TOPIC var et dobbeltblindet, placebokontrolleret studie, som evaluerede doser af teriflunomid 7 mg og 14 mg indgivet en gang dagligt i op til 108 uger hos patienter med første kliniske demyeliniserende issolerede hændelse/syndrom (CIS) (gennemsnitsalder 32,1 år).
TOPIC was a double-blind, placebo-controlled study that evaluated once daily doses of teriflunomide 7 mg and 14 mg for up to 108 weeks in patients with first clinical demyelinating event (mean age 32.1 years).
I tilfælde af ulcerøs stomatitis skal teriflunomid seponeres.
In case of ulcerative stomatitis, teriflunomide administration should be discontinued.
14 filmovertrukne tabletter 28 filmovertrukne tabletter
14 film-coated tablets 28 film-coated tablets
- Hvis du har svære hudreaktioner.
- you have severe skin reactions.
Median EDSS-score ved bassisniveau var 2,50; 249 patienter (22,9 %) havde en EDSS-score > 3,5 ved baseline.
The median EDSS score at baseline was 2.50; 249 patients (22.9%) had an EDSS score › 3.5 at baseline.
Derfor skal lægemidler, der metaboliseres af CYP2C8, som f.eks. repaglinid, paclitaxel, pioglitazon og rosiglitazon, anvendes med forsigtighed under behandling med teriflunomid.
Therefore, medicinal products metabolised by CYP2C8, such as repaglinide, paclitaxel, pioglitazone or rosiglitazone, should be used with caution during treatment with teriflunomide.
Hyppigheden af stigning ≥ 3 gange ULN var jævnt fordelt på tværs af alle behandlingsgrupper.
The frequency of elevations above 3-fold ULN and higher was balanced across treatment groups.
Størstedelen af patienterne havde recidiverende remitterende multipel sklerose (97,5 %), men en undergruppe havde sekundær progressiv (0,8 %) ellerprogressiv recidiverende multipel sklerose (1,7 %).
The majority of patients had relapsing-remitting multiple sclerosis (97.5%), but a subgroup of patients had secondary progressive (0.8%) or progressive relapsing multiple sclerosis (1.7%).
Blodtrykket skal kontrolleres, før behandling med teriflunomid påbegyndes og periodisk derefter.
Blood pressure must be checked before the start of teriflunomide treatment and periodically thereafter.
Efter seponering af teriflunomid:
After stopping treatment with teriflunomide:
Hvis dette ikke tolereres godt, kan colestyramin 4 g tre gange dagligt i 11 dage anvendes.
If this is not well tolerated, cholestyramine 4 g three times a day for 11 days can be used.
AUBAGIO 14 mg filmovertrukne tabletter (tabletter) er svagt blå til pastelblå femkantede filmovertrukne tabletter med påtryk (‘14') på den ene side og præget med virksomhedens logo på den anden side.
AUBAGIO 14 mg film-coated tablets (tablets) are pale blue to pastel blue, pentagonal film-coated tablets with imprint on one side (‘14') and engraved with a corporate logo on the other side.
I de pivotale placebokontrollerede studier var forekomsten af perifer neuropati bekræftet med nerveimpulsoverlednings-studier henholdsvis 1,9 % (17 patienter ud af 898) for 14 mg teriflunomid, sammenlignet med 0,4 % (4 patienter ud af 898) for placebo.
In the pivotal, placebo-controlled studies, the incidence of peripheral neuropathy confirmed by nerve conduction studies was 1.9% (17 patients out of 898) on 14 mg of teriflunomide, compared with 0.4% (4 patients out of 898) on placebo.
Hver filmovertrukket tablet indeholder 14 mg teriflunomid.
Each film-coated tablet contains 14 mg of teriflunomide.
Uden en accelereret eliminationsprocedure tager det i gennemsnit 8 måneder at nå en plasmakoncentration på under 0,02 mg/l, men på grund af individuelle forskelle i clearance af stoffet kan det tage op til 2 år.
Without an accelerated elimination procedure, it takes an average of 8 months to reach plasma concentrations less than 0.02 mg/l, although due to individual variation in substance clearance it may take up to 2 years.
Efter markedsføringen er der rapporteret tilfælde om alvorlige hudreaktion med teriflunomid (herunder Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse).
Cases of severe skin reactions have been reported postmarketing (including Stevens-Johnson syndrome and toxic epidermal necrolysis).
Behandlingen med AUBAGIO vil blive styret af en læge, der har erfaring med behandling af multipel sclerose.
Treatment with AUBAGIO will be overseen by a doctor who is experienced in the treatment of multiple sclerosis.
Opfordre patienterne til at læse hele indlægssedlen igennem.
To encourage the patients to read the PIL thoroughly 4.
I placebokontrollerede studier var forekomsten af asteni 2,0 %, 1,6 % og 2,2 % i henholdsvis placebogruppen, gruppen med teriflunomid 7 mg og gruppen med teriflunomid 14 mg.
In placebo-controlled studies, frequencies for asthenia were 2.0%, 1.6% and 2.2% in the placebo, teriflunomide 7 mg and teriflunomide 14 mg group, respectively.
I alt 618 patienter blev randomiseret til at modtage 7 mg (n=205) eller 14 mg (n=216) teriflunomid eller placebo (n=197).
A total of 618 patients were randomised to receive 7 mg (n=205) or 14 mg (n=216) of teriflunomide or placebo (n=197).
Samtidig administration af gentagne doser (600 mg én gang dagligt i 22 dage) rifampicin (en CYP2B6-, 2C8-, 2C9-, 2C19- og 3A-induktor), samt en induktor af efflux-transporterne P-glykoprotein [P-gp] og brystcancer-resistent protein [BCRP] med teriflunomid (70 mg enkeltdosis) resulterede i et fald på cirka 40 % i teriflunomid-eksponeringen.
Potent cytochrome P450 (CYP) and transporter inducers Co-administration of repeated doses (600 mg once daily for 22 days) of rifampicin (a CYP2B6, 2C8, 2C9, 2C19, 3A inducer), as well as an inducer of the efflux transporters P-glycoprotein [P-gp] and breast cancer resistant protein [BCRP] with teriflunomide (70 mg single dose) resulted in an approximately 40% decrease in teriflunomide exposure.
Hver tablet indeholder 14 mg teriflunomid.
Each tablet contains 14 mg of teriflunomide.
For andre BCRP-substrater (f.eks. methotrexat, topotecan, sulfasalazin, daunorubicin, doxorubicin) og OATP-familien, særligt HMG-CoA-reduktaseinhibitorer (f.eks. simvastatin, atorvastatin, pravastatin, methotrexat, nateglinid, repaglinid, rifampicin) skal samtidig administration af teriflunomid også ske med forsigtighed.
For other substrates of BCRP (e.g., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-Co reductase inhibitors (e.g., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration of teriflunomide should also be undertaken with caution.
Medmindre en accelereret udvaskning er ønskelig, anbefales det, at patienter, der får teriflunomid, ikke behandles med colestyramin eller aktivt kul, da dette medfører et hurtigt og signifikant fald i plasmakoncentrationen.
It is recommended that patients receiving teriflunomide are not treated with cholestyramine or activated charcoal because this leads to a rapid and significant decrease in plasma concentration unless an accelerated elimination is desired.
Der var ingen ydre misdannelser hos afkommet fra hanrotter, der havde fået teriflunomid før parring med ubehandlede hunrotter.
There were no external malformations in the offspring of male rats administered teriflunomide prior to mating with untreated female rats.
Hvis en accelereret eliminationsprocedure ikke benyttes, må plasmakoncentrationen af teriflunomid forventes at være over 0,02 mg/l i gennemsnitligt 8 måneder, men hos nogle patienter kan det dog tage op til 2 år at nå plasmakoncentrationer under 0,02 mg/l.
If an accelerated elimination procedure is not used, teriflunomide plasma levels can be expected to be above 0.02 mg/l for an average of 8 months, however, in some patients it may take up to 2 years to reach plasma concentration below 0.02 mg/l.
I tilfælde af alvorlige hæmatologiske reaktioner, herunder pancytopeni, skal AUBAGIO og anden samtidig behandling med myelosuppressive lægemidler seponeres, og den accelererede eliminationsprocedure for teriflunomid overvejes.
In cases of severe haematological reactions, including pancytopenia, AUBAGIO and any concomitant myelosuppressive treatment must be discontinued and a teriflunomide accelerated elimination procedure should be considered.
Accelereret eliminationsprocedure: Colestyramin og aktivt kul Elimineringen af teriflunomid fra kredsløbet kan accelereres ved administration af colestyramin eller aktivt kul, sandsynligvis fordi dette afbryder reabsorptionsprocessen på intestinalt niveau.
The elimination of teriflunomide from the circulation can be accelerated by administration of cholestyramine or activated charcoal, presumably by interrupting the reabsorption processes at the intestinal level.
Antallet af patienter med permanent behandlingsophør i gruppen med 14 mg teriflunomid var 22 ud af 111 (19,8 %) med årsagerne bivirkninger (10,8 %), manglende effekt (3,6 %), andre årsager (4,5 %) og manglende opfølgning (0,9 %).
The number of patients with permanent treatment discontinuation in the teriflunomide 14 mg group was 22 out of 111 (19.8%), the reasons being adverse events (10.8%), lack of efficacy (3.6%), other reason (4.5%) and lost to follow-up (0.9%).
Alopeci blev indberettet som udtynding af håret, nedsat hårtæthed, hårtab, eventuelt med en ændring af hårets tekstur, hos 13,9 % af de patienter, der blev behandlet med 14 mg teriflunomid sammenlignet med 5,1 % hos placebobehandlede patienter.
Alopecia was reported as hair thinning, decreased hair density, hair loss, associated or not with hair texture change, in 13.9% of patients treated with 14 mg teriflunomide versus 5.1% in patients treated with placebo.
Virkningen af teriflunomid på orale kontraceptiva: 0,03 mg ethinylestradiol og 0,15 mg levonorgestrel Der var en stigning i middel-ethinylestradiol-Cmax og -AUC0-24 (henholdsvis 1,58 og 1,54 gange) og levonorgestrel-Cmax og -AUC0-24 (henholdsvis 1,33 og 1,41 gange) efter gentagne doser teriflunomid.
Effect of teriflunomide on oral contraceptives: 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel There was an increase in mean ethinylestradiol Cmax and AUC0-24 (1.58- and 1.54-fold, respectively) and levonorgestrel Cmax and AUC0-24 (1.33- and 1.41-fold, respectively) following repeated doses of teriflunomide.
ALAT-stigning (baseret på laboratoriedata) i forhold til baselineSikkerhedspopulation i placebokontrollerede studier placebo (N=997)
ALT increase (based on laboratory data) according to baseline status - Safety population in placebocontrolled studies
Patienter, der testes positive i en tuberkulosescreening, skal behandles i henhold til gældende retningslinjer før behandling med AUBAGIO.
For patients testing positive in tuberculosis screening, treat by standard medical practice prior to therapy with AUBAGIO.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet til at fremlægge resultaterne af studier med AUBAGIO hos børn fra fødslen til mindre end 10 år med multipel sklerose (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with AUBAGIO in children from birth to less than 10 years in treatment of multiple sclerosis (see section 4.2 for information on paediatric use).
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL HYLSTER
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR WALLET
• Komplet blodtælling inklusive differentialtælling og trombocyttal.
• Complete blood cell count including differential white blood cell and platelet count.
Systemorganklasse Megetalmindelig
System organ class
Risikoen for embryoføtal toksicitet på grund af mandlig partner i behandling med teriflunomid betragtes som lav.
The risk of male-mediated embryo-fetal toxicity through teriflunomide treatment is considered low.
Palpitation
Palpitations
Hvis du har glemt at tage AUBAGIO
If you forget to take AUBAGIO
Derfor tilrådes forsigtighed, når teriflunomid administreres samtidig med OAT3-substrater som f.eks. cefaclor, benzylpenicillin, ciprofloxacin, indomethacin, ketoprofen, furosemid, cimetidin, methotrexat og zidovudin.
Therefore, when teriflunomide is coadministered with substrates of OAT3, such as cefaclor, benzylpenicillin, ciprofloxacin, indometacin, ketoprofen, furosemide, cimetidine, methotrexate, zidovudine, caution is recommended.
Der foreligger ingen data om gadolinium-forstærkede læsioner ved baseline.
Gadolinium-enhancing lesions at baseline: no data.
Gravide kvinder og kvinder i den fertile alder, som ikke anvender pålidelig antikonception under behandlingen med teriflunomid og efterfølgende, så længe plasmaniveauet er over 0,02 mg/l (se pkt.
Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and thereafter as long as its plasma levels are above 0.02 mg/l (see section 4.6).
Hvis colestyramin 8 g tre gange dagligt ikke tolereres, kan colestyramin 4 g tre gange dagligt anvendes.
If cholestyramine 8 g three times a day is not well-tolerated, cholestyramine 4 g three times a day can be used.
Den primære metaboliseringsvej for teriflunomid er hydrolyse, mens oxidation udgør en sekundær omdannelsesvej.
The primary biotransformation pathway for teriflunomide is hydrolysis, with oxidation being a minor pathway.
Årlig attak-rate
Annualised relapse rate
En accelereret eliminationsprocedure kan anvendes på et hvilket som helst tidspunkt efter seponeringen af teriflunomid (se pkt.
An accelerated elimination procedure can be used at any time after discontinuation of teriflunomide (see sections 4.6 and 5.2 for procedural details).
Brug til mænd
Use in males
Sanofi Winthrop Industrie 56, route de Choisy au Bac 60205 Compiègne Frankrig
Sanofi Winthrop Industrie 56, route de Choisy au Bac 60205 Compiègne France
Ved multipel sclerose ødelægger betændelse den beskyttende kappe (kaldet myelin), som ligger omkring nerverne i centralnervestsyemet, hvilket forhindrer nerverne i at fungere normalt.
In multiple sclerosis, inflammation destroys the protective sheath (called myelin) around the nerves in the CNS.
Der var en stigning i middel-rosuvastatin-Cmax og -AUC (henholdsvis 2,65 og 2,51 gange) efter gentagne doser teriflunomid.
There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of teriflunomide.
Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) - Alvorlige infektioner (herunder blodforgiftning) - Alvorlige allergiske reaktioner (herunder anafylaksi) - Lungereaktion (interstitiel lungesygdom, ILD) - Betændelse i leveren, bugspytkirtlen eller munden/læberne - Alvorlige hudreaktioner - Unormalt indhold af fedt (lipider) i blodet - Psoriasis
Not known (frequency cannot be estimated from the available data) - Severe infections (including sepsis) - Severe allergic reactions (including anaphylaxis) - Pulmonary reaction (interstitial lung disease, ILD) - Inflammation of the liver, pancreas, or mouth/lips - Severe skin reactions - Abnormal levels of fats (lipids) in the blood - Psoriasis
Patienter med svær hypoproteinæmi, f.eks. ved nefrotisk syndrom.
Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome.
Svagt blå til pastelblå femkantede filmovertrukne tabletter med påtryk (‘14') på den ene side og præget med virksomhedens logo på den anden side.
Pale blue to pastel blue, pentagonal film-coated tablets with imprint on one side (‘14') and engraved with a corporate logo on the other side.
Hvis du holder op med at tage AUBAGIO
If you stop taking AUBAGIO
Teriflunomids farmakokinetiske interaktioner med andre stoffer - virkning på andre stoffer
Pharmacokinetic interactions of teriflunomide on other substances
Dosisjustering er ikke nødvendig til patienter med let, moderat eller alvorligt nedsat nyrefunktion, som ikke er i dialyse.
No dosage adjustment is necessary for patients with mild, moderate or severe renal impairment not undergoing dialysis.
Brug af anden medicin sammen med AUBAGIO
Other medicines and AUBAGIO
Hvis perifer neuropati diagnosticeres hos en patient i behandling med AUBAGIOi, bør det overvejes at seponere AUBAGIO og iværksætte den accelererede eliminationsprocedure.
If a patient taking AUBAGIO develops a confirmed peripheral neuropathy, consider discontinuing AUBAGIO therapy and performing the accelerated elimination procedure.
Let forhøjede aminotransferaser, ALAT ≤ med 3 gange ULN, sås hyppigere i de teriflunomid-behandlede grupper sammenlignet med placebo.
Mild increases in transaminase, ALT below or equal to 3-fold ULN were more frequently seen in teriflunomide-treated groups as compared to placebo.
Influenza, Infektion i de øvre luftveje, Urinvejsinfektion, Bronkitis, Sinusitis,
Influenza, Upper respiratory tract infection, Urinary tract infection, Bronchitis, Sinusitis, Pharyngitis, Cystitis, Gastroenteritis viral,
Alle patienter havde en klar diagnose på MS (baseret på McDonald kriterier (2005)), udviste et recidiverende klinisk forløb med eller uden progression og havde haft mindst 1 attak i løbet af året forud for undersøgelsen eller mindst 2 attakker i løbet af de sidste 2 år forud for undersøgelsen.
All patients had a definite diagnosis of MS (based on McDonald criteria (2005)), exhibited a relapsing clinical course, with or without progression, and experienced at least 1 relapse over the year preceding the trial or at least 2 relapses over the 2 years preceding the trial.
Kvinder i den fertile alder skal anvende sikker antikonception under og efter behandlingen, så længe plasmakoncentrationen af teriflunomid er over 0,02 mg/l.
Women of childbearing potential have to use effective contraception during treatment and after treatment as long as teriflunomide plasma concentration is above 0.02 mg/l.
Den normale udskillelse af det aktive stof kan vare op til 2 år, men tiden kan reduceres til nogle få uger ved at tage visse bestemte lægemidler, som øger den hastighed, hvormed AUBAGIO udskilles fra kroppen.
The time can be reduced to a few weeks by taking certain medicines which speed up removal of AUBAGIO from your body.
Indlægsseddel: Information til patienten AUBAGIO 14 mg filmovertrukne tabletter
Package leaflet: Information for the patient AUBAGIO 14 mg film-coated tablets teriflunomide
Fødeindtagelse har ingen klinisk relevant effekt på teriflunomids farmakokinetik.
Food does not have a clinically relevant effect on teriflunomide pharmacokinetics.
Forskel i BOD uge 108 Forskel relativ til placebo Gennemsnitligt antal Gdforstærkede læsioner ved uge 108
Change relative to placebo Mean Number of Gdenhancing lesions at week
I TOWER blev i alt 1.169 patienter med RMS randomiseret til 7 mg (n=408) eller 14 mg (n=372) teriflunomid eller placebo (n= 389) i en variabel behandlingsperiode, der sluttede 48 uger efter randomisering af den sidste patient.
A total of 1169 patients with RMS were randomised in TOWER to receive 7 mg (n=408) or 14 mg (n=372) of teriflunomide or placebo (n= 389) for a variable treatment duration ending at 48 weeks after last patient randomised.
Alle patienter havde en klar diagnose på MS (baseret på McDonald kriterier (2001)), udviste et recidiverende klinisk forløb med eller uden progression og havde haft mindst 1 attak i løbet af året forud for undersøgelsen eller mindst 2 attakker i løbet af de sidste 2 år forud for undersøgelsen.
All patients had a definite diagnosis of MS (based on McDonald criteria (2001)), exhibited a relapsing clinical course, with or without progression, and experienced at least 1 relapse over the year preceding the trial or at least 2 relapses over the 2 years preceding the trial.
AUBAGIO anvendes til behandling af voksne patienter med attakvis multipel sklerose (MS).
AUBAGIO is used in adults to treat relapsing remitting multiple sclerosis (MS).
Pakninger med perforerede en-dosis blister i polyamid/aluminium/poly(vinylchlorid)-aluminium i æsker med 10 x1 filmovertrukne tabletter.
Polyamide/aluminium/poly(vinyl chloride) -aluminium perforated unit-dose blister packs in cartons containing 10x1 film-coated tablets.
Der er rapporteret perifer neuropati hos patienter i behandling med AUBAGIO (se pkt.
Cases of peripheral neuropathy have been reported in patients receiving AUBAGIO (see section 4.8).
AUBAGIO leveres i kartonæsker indeholdende: - 14, 28, 84 og 98 tabletter i hylsterpakninger med integrerede aluminiumsblistere.
AUBAGIO is available in cardboard cartons containing: - 14, 28, 84 and 98 tablets in wallet packs with integrated aluminium blisters; - 10x1 tablet in all aluminium perforated unit-dose blisters.
Hos nogle patienter forsvandt neuropatien, mens andre patienter havde vedvarende symptomer.
However, there was a wide variability in final outcome, i.e. in some patients the neuropathy resolved and some patients had persistent symptoms.
Let trombocytopeni (trombocyttal <100x109/l)
Mild thrombocytopen ia (platelets <100G/l)
Et gennemsnitligt fald i antallet af hvide blodlegemer på mindre end 15 % i forhold til baseline er blevet observeret (se pkt.
A mean decrease less than 15% from baseline affecting white blood cell count has been observed (see section 4.8).
I TEMSO blev i alt 1.088 patienter med RMS randomiseret til 7 mg (n=366) eller 14 mg (n=359) teriflunomid eller placebo (n= 363) i 108 uger.
A total of 1088 patients with RMS were randomised in TEMSO to receive 7 mg (n=366) or 14 mg (n=359) of teriflunomide or placebo (n= 363) for 108 weeks duration.
Teriflunomid er kontraindiceret under graviditet (se pkt.
Teriflunomide is contraindicated in pregnancy (see section 4.3).
Let og moderat nedsat leverfunktion havde ingen indvirkning på teriflunomids farmakokinetik.
Mild and moderate hepatic impairment had no impact on the pharmacokinetic of teriflunomide.
Teriflunomids farmakokinetiske interaktioner med andre stoffer - virkning på teriflunomid
Pharmacokinetic interactions of other substances on teriflunomide
Ugedage Man Tir
Dyslipidaem ia
Baseret på en individuel forudsigelse af de farmakokinetiske parametre ved hjælp af PopPK-modellen for teriflunomid hos raske frivillige og MS-patienter var den gennemsnitlige halveringstid (t1/2z) cirka 19 dage efter gentagne doser på 14 mg.
Based on individual prediction of pharmacokinetic parameters using the PopPK model of teriflunomide in healthy volunteers and MS patients, median t1/2z was approximately 19 days after repeated doses of 14 mg. After a single intravenous administration, the total body clearance of teriflunomide is 30.5 ml/h.
Forhøjet blodtryk kan forekomme under behandling med AUBAGIO (se pkt.
Elevation of blood pressure may occur during treatment with teriflunomide (see section 4.8).
Før behandlingen med teriflunomid startes, skal følgende vurderes (se pkt.
Before starting treatment with teriflunomide the following should be assessed: