FrancophonIA/ELRC3.0 huggingface dataset:
English: To encourage patients to contact their MS physician and/or General Practitioner if they experience any of the signs and symptoms discussed in the Patient Education Card; 4.
Slovenian: Bolnike je treba spodbujati, da obvestijo svojega zdravnika, ki jih zdravi zaradi MS in /ali splošnega zdravnika, če opazijo znake in simptome, ki so opisani na Opozorilni kartici za bolnika; 4.
English: Rifampicin and other known potent CYP and transporter inducers such as carbamazepine, phenobarbital, phenytoin and St John's Wort should be used with caution during the treatment with teriflunomide.
Slovenian: Rifampicin in druge znane močne induktorje CYP in transporterjev, kot so karbamazepin, fenobarbital, fenitoin in šentjanževka, je treba med zdravljenjem s teriflunomidom uporabljati previdno.
English: 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).
Slovenian: Nosečnice ali ženske v rodni dobi, ki ne uporabljajo učinkovite kontracepcije med zdravljenjem s teriflunomidom in po njem, dokler so ravni zdravila v plazmi nad 0,02 mg/l (glejte poglavje 4.6).
English: Gadolinium-enhancing lesions at baseline: no data.
Slovenian: Lezije, povzročene z gadolinijem (v izhodišču): ni podatkov.
English: 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
Slovenian: Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) - hude okužbe (vključno s sepso), - hude alergijske reakcije (vključno z anafilaksijo), - pljučne reakcije (intersticijska pljučna bolezen, ILD), - vnetje jeter, trebušne slinavke ali ust/ustnic, - hude kožne reakcije, - nenormalne ravni maščob (lipidov) v krvi, - psoriaza.
English: If a decision is made to stop treatment with AUBAGIO, during the interval of 5 half-lives (approximately 3.5 months although may be longer in some patients), starting other therapies will result in concomitant exposure to AUBAGIO.
Slovenian: V primeru odločitve za prekinitev zdravljenja z zdravilom AUBAGIO, bo sočasna izpostavljenost zdravilu AUBAGIO možna, če se drugo zdravljenje začne v obdobju 5 razpolovnih dob (približno 3,5 mesecev, vendar je lahko pri določenih bolnikih to obdobje daljše).
English: AUBAGIO is for oral use.
Slovenian: Zdravilo AUBAGIO je za peroralno uporabo.
English: Teriflunomide is the main metabolite of leflunomide.
Slovenian: Teriflunomid je glavni presnovek leflunomida.
English: Cholestyramine or activated charcoal
Slovenian: Holestiramin ali aktivirano oglje
English: Before starting treatment with teriflunomide the following should be assessed:
Slovenian: Pred zdravljenjem s teriflunomidom je treba oceniti naslednje:
English: 14 film-coated tablets 28 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet
English: The median EDSS score at baseline was 2.50; 249 patients (22.9%) had an EDSS score › 3.5 at baseline.
Slovenian: Mediana vrednost EDSS v izhodišču je bila: 2,50; 249 bolnikov (22,9 %) je v izhodišču imelo vrednost EDSS > 3,5.
English: Therefore, medicinal products metabolised by CYP2C8, such as repaglinide, paclitaxel, pioglitazone or rosiglitazone, should be used with caution during treatment with teriflunomide.
Slovenian: Zato je treba zdravila, ki se presnavljajo s CYP2C8, kot so repaglinid, paklitaksel, pioglitazon ali rosiglitazon, med zdravljenjem s teriflunomidom uporabljati previdno.
English: The results from the TOPIC study confirmed the efficacy of teriflunomide in RRMS (including early RRMS with first clinical demyelinating event and MRI lesions disseminated in time and space).
Slovenian: Rezultati študije TOPIC so potrdili učinkovitost teriflunomida pri recidivno-remitentni multipli sklerozi (vključno z zgodnjo recidivnoremitentno multiplo sklerozo s prvim kliničnim demielinizirajočim dogodkom ter časovno in po legi diseminiranimi MR-spremembami).
English: 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.
Slovenian: Brez postopka pospešenega izločanja traja v povprečju 8 mesecev, da koncentracije v plazmi padejo pod 0,02 mg/l, čeprav lahko to zaradi individualnih razlik v očistku učinkovine traja do 2 let.
English: Evidence of an oxidative effect on red blood cells was also observed.
Slovenian: Ugotovili so tudi dokaze oksidativnega učinka na eritrocite.
English: • Risk of hepatic effects o liver function tests are needed prior to treatment and periodically during treatment o To educate the patient about the signs and symptoms of liver disease and the need to report to their HCP if they experience any of them
Slovenian: • tveganje za učinke na jetrih o teste delovanja jeter je treba opraviti pred zdravljenjem in redno med zdravljenjem, o bolnike je treba poučiti o znakih in simptomih bolezni jeter in potrebi, da se posvetujejo z zdravnikom, če opazijo katerega od njih,
English: Each film-coated tablet contains 14 mg of teriflunomide.
Slovenian: Vsaka filmsko obložena tableta vsebuje 14 mg teriflunomida.
English: What AUBAGIO looks like and contents of the pack
Slovenian: Izgled zdravila AUBAGIO in vsebina pakiranja
English: Severe infections including sepsis, sometimes fatal have been reported postmarketing.
Slovenian: V obdobju po prihodu zdravila na trg so poročali o hudih okužbah, vključno s sepso, ki so bile včasih smrtne.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslovproizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanj serij
English: However, based on the immunomodulatory effect of teriflunomide, if a patient develops a serious infection, suspending treatment with AUBAGIO should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy.
Slovenian: Vendar je treba v primeru pojava resne okužbe zaradi imunomodulatornega učinka teriflunomida preučiti možnost začasne prekinitve zdravljenja z zdravilom AUBAGIO ter pred ponovno uvedbo zdravljenja pretehtati koristi in tveganja.
English: You must use an effective method of contraception during and after treatment with AUBAGIO.
Slovenian: Med zdravljenjem z zdravilom AUBAGIO ter po njem morate uporabljati učinkovito metodo kontracepcije.
English: The educational card for the patients will include the following key elements:
Slovenian: Opozorilna kartica za bolnika mora vključevati naslednje bistvene elemente: 1.
English: Each tablet contains 14 mg of teriflunomide.
Slovenian: Vsaka tableta vsebuje 14 mg teriflunomida.
English: How to take AUBAGIO 4.
Slovenian: Kako jemati zdravilo AUBAGIO 4.
English: AUBAGIO contains lactose
Slovenian: Zdravilo AUBAGIO vsebuje laktozo
English: AUBAGIO is used in adults to treat relapsing remitting multiple sclerosis (MS).
Slovenian: Zdravilo AUBAGIO se uporablja za zdravljenje odraslih bolnikov z recidivno reminitentno multiplo sklerozo (MS).
English: Treatment with AUBAGIO will be overseen by a doctor who is experienced in the treatment of multiple sclerosis.
Slovenian: Zdravljenje z zdravilom AUBAGIO mora nadzorovati zdravnik z izkušnjami pri obravnavi multiple skleroze.
English: Adverse effects on the offspring were also seen when teriflunomide was administered to pregnant rats during gestation and lactation.
Slovenian: Neželene učinke na potomce so ugotovili tudi, če so teriflunomid dali brejim podganam med brejostjo ali laktacijo.
English: Teriflunomide was not mutagenic in vitro or clastogenic in vivo.
Slovenian: Teriflunomid ni bil mutagen in vitro ali klastogen in vivo.
English: If you forget to take AUBAGIO
Slovenian: Če ste pozabili uporabiti zdravilo AUBAGIO
English: Post-traumatic pain a: please refer to the detailed description section b: see section 4.4
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih posttravmat ska bolečina a: Prosimo glejte poglavje s podrobnim opisom b: glejte poglavje 4.4
English: In placebo-controlled studies, no increase in serious infections was observed with teriflunomide (see section 4.8).
Slovenian: V s placebom kontroliranih študijah pri teriflunomidu niso ugotovili povečanja resnih okužb (glejte poglavje 4.8).
English: Nevertheless, their impact remains limited (31%).
Slovenian: Vendar vpliv teh dejavnikov ostaja omejen
English: Patients with severe renal impairment undergoing dialysis were not evaluated.
Slovenian: Uporaba pri bolnikih s hudo okvarjenim delovanjem ledvic, ki se zdravijo z dializo, ni bila preučena.
English: Teriflunomide 70 mg daily was administered up to 14 days in healthy subjects.
Slovenian: Zdrave osebe so prejemale 70 mg teriflunomida na dan do 14 dni.
English: Hypoproteinaemia
Slovenian: Hipoproteinemija
English: 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.
Slovenian: Alopecijo so navedli kot tanjšanje las, redčenje gostote las, izpadanje las, ki so bili povezani s spremembo teksture las ali ne, pri 13,9 % bolnikov, zdravljenih z odmerkom 14 mg teriflunomida, ter pri 5,1 % bolnikov, ki so prejemali placebo.
English: Clinical Outcomes
Slovenian: KLINIČNI PODATKI
English: • vision problems
Slovenian: • težave z vidom,
English: Mean decrease in serum phosphorus was around 10% in the teriflunomide group compared to placebo.
Slovenian: Povprečno znižanje serumskega fosforja je bilo v skupini bolnikov, ki je jemala teriflunomid, okoli 10 % v primerjavi z bolniki, ki so jemali placebo.
English: Sanofi Winthrop Industrie 56, route de Choisy au Bac 60205 Compiègne France
Slovenian: Sanofi Winthrop Industrie 56, route de Choisy au Bac 60205 Compiègne Francija
English: To encourage the patients to read the PIL thoroughly 4.
Slovenian: Spodbudo za bolnike, da temeljito preberejo Navodilo za uporabo.
English: Pharmacokinetic interactions of teriflunomide on other substances
Slovenian: Farmakokinetične interakcije teriflunomida na druge snovi
English: 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.
Slovenian: Zdravilo AUBAGIO 14 mg filmsko obložene tablete (tablete) so bledomodre do pastelnomodre, petkotne filmsko obložene tablete z napisom (‘14') na eni strani in vtisnjenim logotipom na drugi strani.
English: During treatment During treatment with teriflunomide the following should be monitored:
Slovenian: Med zdravljenjem s teriflunomidom je treba spremljati naslednje:
English: AUBAGIO should not be used in children and adolescents under 18 years of age.
Slovenian: Zdravilo AUBAGIO se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let, ker učinki tega zdravila v tej starostni skupini niso znani.
English: Breast-feeding women (see section 4.6).
Slovenian: Doječe matere (glejte poglavje 4.6).
English: Pharmacokinetic interactions of other substances on teriflunomide
Slovenian: Farmakokinetične interakcije drugih snovi na teriflunomid
English: • cholestyramine 8 g is administered 3 times daily for a period of 11 days, or cholestyramine 4 g three times a day can be used, if cholestyramine 8 g three times a day is not well tolerated,
Slovenian: • se daje holestiramin 8 g trikrat dnevno, 11 dni oz. 4 g trikrat dnevno, če odmerjanja 8 g trikrat dnevno bolnik ne prenaša dobro,
English: 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.
Slovenian: Pretisni omoti poliamid/aluminij/polivinilklorid v pretisnih zgibankah (14 in 28 filmsko obloženih tablet) in pakirani v škatle po 14, 28, 84 (3 pretisne zgibanke po 28) in 98 (7 pretisnih zgibank po 14) filmsko obloženih tablet.
English: Starting AUBAGIO during this interval will result in concomitant exposure to fingolimod.
Slovenian: Če se zdravljenje z zdravilom AUBAGIO začne v tem obdobju, bo bolnik sočasno izpostavljen fingolimodu.
English: As leflunomide is the parent compound of teriflunomide, co-administration of teriflunomide with leflunomide is not recommended.
Slovenian: Ker je leflunomid starševska spojina teriflunomida, sočasna uporaba teriflunomida in leflunomida ni priporočljiva.
English: Blood pressure must be checked before the start of teriflunomide treatment and periodically thereafter.
Slovenian: Krvni tlak morate preveriti pred začetkom zdravljenja s teriflunomidom in redno med zdravljenjem.
English: Sanofi Tel +44 (0)845 372 7101
Slovenian: Tel +44 (0)845 372 7101
English: 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.
Slovenian: V ključnih s placebom kontroliranih študijah so s preiskavami prevajanja živcev potrdili periferno nevropatijo pri 1,9 % bolnikov (17 od 898), ki so prejemali odmerek 14 mg teriflunomida, in pri 0,4 % bolnikov (4 od 898), ki so prejemali placebo.
English: 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.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in po njem, dokler so plazemske ravni teriflunomida nad 0,02 mg/l.
English: Do not take AUBAGIO when you are breast-feeding, as teriflunomide passes into the breast milk.
Slovenian: Zdravila AUBAGIO ne jemljite, če dojite, saj teriflunomid prehaja v vaše mleko.
English: How AUBAGIO works
Slovenian: Kako zdravilo AUBAGIO deluje
English: • Of the need for the procedures/tests before and during teriflunomide treatment
Slovenian: • da je treba pred uvedbo zdravljenja s teriflunomidom in med njim opravljati preiskave / teste
English: Alternatively, when cholestyramine is not available, activated charcoal 50 g twice a day for 11 days may also be used.
Slovenian: Če holestiramin ni na voljo, se lahko uporabi aktivirano oglje 50 g dvakrat na dan, 11 dni.
English: 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.
Slovenian: Vsi bolniki so imeli potrjeno diagnozo MS (na osnovi kriterijev McDonald (2005)), klinični potek z recidivi z napredovanjem ali brez napredovanja in so v enem letu pred preskušanjem imeli vsaj 1 recidiv ali v dveh letih pred preskušanjem vsaj 2 recidiva.
English: If cholestyramine 8 g three times a day is not well-tolerated, cholestyramine 4 g three times a day can be used.
Slovenian: Če bolnik odmerka holestiramina 8 g trikrat dnevno ne prenaša dobro, se lahko uporabi odmerek holestiramina 4 g trikrat dnevno.
English: 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.
Slovenian: Vsi bolniki so imeli potrjeno diagnozo MS (na osnovi kriterijev McDonald (2001)), klinični potek z recidivi z napredovanjem ali brez napredovanja in so v enem letu pred preskušanjem imeli vsaj 1 recidiv ali v dveh letih pred preskušanjem vsaj 2 recidiva.
English: Tablet core lactose monohydrate maize starch microcrystalline cellulose sodium starch glycolate (Type A) hydroxypropylcellulose magnesium stearate
Slovenian: Jedro tablete laktoza monohidrat koruzni škrob mikrokristalna celuloza natrijev karboksimetilškrob (vrsta A) hidroksipropilceluloza magnezijev stearat
English: Your doctor may do blood tests to check your white blood cells if you think you have an infection.
Slovenian: Če zdravnik meni, da imate okužbo, bo morda naročil krvne preiskave, s katerimi bo preveril bele krvničke.
English: However, teriflunomide is contraindicated in patients with severe hepatic impairment (see sections 4.2 and 4.3).
Slovenian: Vendar je teriflunomid kontraindiciran pri bolnikih s hudo okvarjenim delovanjem jeter (glejte poglavji 4.2 in 4.3).
English: If you have taken too much AUBAGIO, call your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila AUBAGIO, kot bi smeli Če ste vzeli prevelik odmerek zdravila AUBAGIO, nemudoma pokličite svojega zdravnika.
English: The risk of male-mediated embryo-foetal toxicity through teriflunomide treatment is considered low (see section 5.3).
Slovenian: Tveganje za zarodek-plod, ki ga posreduje moški, ki se zdravi s teriflunomidom, se šteje za nizko (glejte poglavje 5.3).
English: Patients with active acute or chronic infections should not start treatment with AUBAGIO until the infection(s) is resolved.
Slovenian: Pri bolnikih z aktivno ali kronično okužbo je treba zdravljenje z zdravilom AUBAGIO odložiti do resolucije okužbe.
English: • difficulty walking
Slovenian: • oteženo hojo,
English: Treatment was discontinued in 5 patients with peripheral neuropathy on teriflunomide 14 mg. Recovery following treatment discontinuation was reported in 4 of these patients.
Slovenian: Zdravljenje je bilo prekinjeno pri 5 bolnikih s periferno nevropatijo, ki so prejemali odmerek 14 mg teriflunomida.
English: AUBAGIO might make you feel dizzy which may impair your ability to concentrate and react.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zaradi zdravila AUBAGIO se boste mogoče počutili omotični, kar lahko zmanjša vašo sposobnost koncentracije in reakcije.
English: 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.
Slovenian: V študijo TOWER so naključno razporedili skupno 1169 bolnikov z RMS, ki so prejemali 7 mg (n=408) ali 14 mg (n=372) teriflunomida ali placebo (n=389) za različna obdobja, ki so se končala 48 tednov po naključni razporeditvi zadnjega bolnika.
English: In patients with pre-existing anaemia, leucopenia, and /or thrombocytopenia as well as in patients with impaired bone marrow function or those at risk of bone marrow suppression, the risk of haematological disorders is increased.
Slovenian: Tveganje za hematološke bolezni je povečano pri bolnikih z obstoječo anemijo, levkopenijo in/ali trombocitopenijo ter pri bolnikih z okvarjeno funkcijo kostnega mozga in bolnikih s tveganjem za supresijo kostnega mozga.
English: The primary biotransformation pathway for teriflunomide is hydrolysis, with oxidation being a minor pathway.
Slovenian: Primarna pot biotransformacije teriflunomida je hidroliza, manj prisotna pa je oksidacija.
English: Weight decrease, Neutrophil count decreaseb, White blood cell count decreaseb, Blood creatine phosphokinase increased
Slovenian: Preiskave zmanjšanje telesne mase, zmanjšanje števila nevtrofilcevb, zmanjšanje števila levkocitovb, zvišana raven kreatin fosfokinaze v krvi
English: There is no relevant use of teriflunomide in children aged from birth to less than 10 years for the treatment of multiple sclerosis.
Slovenian: Zdravilo teriflunomid ni primerno za zdravljenje multiple skleroze pri otrocih od rojstva do starosti manj kot 10 let.
English: 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.
Slovenian: Na osnovi individualnega napovedovanja farmakokinetičnih parametrov z modelom PopPK na teriflunomidu pri zdravih prostovoljcih in bolnikih z MS so določili mediano t1/2z približno 19 dni po ponavljajočih se odmerkih 14 mg.
English: A mean decrease affecting white blood cell (WBC) count (<15% from baseline levels, mainly neutrophil and lymphocytes decrease) was observed in placebo-controlled trials with AUBAGIO, although a greater decrease was observed in some patients.
Slovenian: V s placebom kontroliranih študijah zdravila AUBAGIO so ugotovili povprečno zmanjšanje števila levkocitov (< 15 % z izhodiščnih ravni, zlasti zmanjšanje nevtrofilcev in limfocitov), čeprav so pri določenih bolnikih ugotovili večji upad.
English: 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.
Slovenian: Brez postopka pospešenega izločanja se lahko pričakuje, da bodo koncentracije teriflunomida v plazmi v povprečju 8 mesecev nad 0,02 mg/l, čeprav lahko pri določenih bolnikih koncentracije v plazmi upadejo pod 0,02 mg/l šele po 2 letih.
English: Mild and moderate hepatic impairment had no impact on the pharmacokinetic of teriflunomide.
Slovenian: Blaga in zmerna okvara jeter nista vplivali na farmakokinetiko teriflunomida.
English: Teriflunomide therapy should be discontinued if liver injury is suspected; consider discontinuing teriflunomide therapy if elevated liver enzymes (greater than 3-fold ULN) are confirmed.
Slovenian: Možnost prekinitve zdravljenja s teriflunomidom preučite, če potrdite zvišanje ravni jetrnih encimov (višje od 3-kratnika zgornje meje normalnih vrednosti).
English: Clastogenicity observed in vitro was considered to be an indirect effect related to nucleotide pool imbalance resulting from the pharmacology of DHO-DH inhibition.
Slovenian: Klastogenost, opaženo in vitro, so prišteli posrednim učinkom zaradi neravnovesja nukleotidne rezerve, ki je posledica farmakologije zaviranja DHODH.
English: Adverse reactions reported with AUBAGIO in placebo-controlled studies, reported for teriflunomide 7 mg or 14 mg at ≥ 1% higher rate than for placebo, are shown below.
Slovenian: V nadaljevanju so navedeni neželeni učinki, o katerih so poročali po uporabi zdravila AUBAGIO v s placebom kontroliranih študijah, ki so bile poročane za teriflunomid 7 mg ali 14 mg po ≥ 1% višji stopnji kot pri placebu.
English: • Risk of hematologic effects o the need for complete blood cell counts before treatment and periodically during treatment based on signs and symptoms
Slovenian: • tveganje za hematološke učinke o pred uvedbo zdravljenja in redno med zdravljenjem, glede na znake in simptome, je treba določiti celotno krvno sliko,
English: 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.
Slovenian: V študijo TEMSO so naključno razporedili skupno 1088 bolnikov z RMS, ki so 108 tednov prejemali 7 mg (n = 366) ali 14 mg (n = 359) teriflunomida ali placebo (n = 363).
English: The risk of male-mediated embryo-fetal toxicity through teriflunomide treatment is considered low.
Slovenian: Tveganje za zarodek-plod, ki ga posreduje moški, ki se zdravi s teriflunomidom, se šteje za nizko.
English: Cases of peripheral neuropathy have been reported in patients receiving AUBAGIO (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo AUBAGIO, so ugotovili primere periferne nevropatije (glejte poglavje 4.8).
English: Repeated doses of teriflunomide decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that teriflunomide may be a weak inducer of CYP1A2 in vivo.
Slovenian: Po ponavljajočih se odmerkih teriflunomida so ugotovili znižanje povprečnih vrednosti Cmax (za 18 %) in AUC (za 55 %) za kofein (substrat CYP1A2), kar nakazuje, da je teriflunomid šibek induktor CYP1A2 in vivo.