natgillin/translations-raw huggingface dataset:
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.
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.
You must use an effective method of contraception during and after treatment with AUBAGIO.
Med zdravljenjem z zdravilom AUBAGIO ter po njem morate uporabljati učinkovito metodo kontracepcije.
The educational card for the patients will include the following key elements:
Opozorilna kartica za bolnika mora vključevati naslednje bistvene elemente: 1.
Each tablet contains 14 mg of teriflunomide.
Vsaka tableta vsebuje 14 mg teriflunomida.
How to take AUBAGIO 4.
Kako jemati zdravilo AUBAGIO 4.
AUBAGIO contains lactose
Zdravilo AUBAGIO vsebuje laktozo
AUBAGIO is used in adults to treat relapsing remitting multiple sclerosis (MS).
Zdravilo AUBAGIO se uporablja za zdravljenje odraslih bolnikov z recidivno reminitentno multiplo sklerozo (MS).
Treatment with AUBAGIO will be overseen by a doctor who is experienced in the treatment of multiple sclerosis.
Zdravljenje z zdravilom AUBAGIO mora nadzorovati zdravnik z izkušnjami pri obravnavi multiple skleroze.
Adverse effects on the offspring were also seen when teriflunomide was administered to pregnant rats during gestation and lactation.
Neželene učinke na potomce so ugotovili tudi, če so teriflunomid dali brejim podganam med brejostjo ali laktacijo.
Teriflunomide was not mutagenic in vitro or clastogenic in vivo.
Teriflunomid ni bil mutagen in vitro ali klastogen in vivo.
If you forget to take AUBAGIO
Če ste pozabili uporabiti zdravilo AUBAGIO
Post-traumatic pain a: please refer to the detailed description section b: see section 4.4
Poškodbe in zastrupitve in zapleti pri posegih posttravmat ska bolečina a: Prosimo glejte poglavje s podrobnim opisom b: glejte poglavje 4.4
In placebo-controlled studies, no increase in serious infections was observed with teriflunomide (see section 4.8).
V s placebom kontroliranih študijah pri teriflunomidu niso ugotovili povečanja resnih okužb (glejte poglavje 4.8).
Nevertheless, their impact remains limited (31%).
Vendar vpliv teh dejavnikov ostaja omejen
Patients with severe renal impairment undergoing dialysis were not evaluated.
Uporaba pri bolnikih s hudo okvarjenim delovanjem ledvic, ki se zdravijo z dializo, ni bila preučena.
Teriflunomide 70 mg daily was administered up to 14 days in healthy subjects.
Zdrave osebe so prejemale 70 mg teriflunomida na dan do 14 dni.
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.
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.
Clinical Outcomes
KLINIČNI PODATKI
• vision problems
• težave z vidom,
Mean decrease in serum phosphorus was around 10% in the teriflunomide group compared to placebo.
Povprečno znižanje serumskega fosforja je bilo v skupini bolnikov, ki je jemala teriflunomid, okoli 10 % v primerjavi z bolniki, ki so jemali placebo.
Sanofi Winthrop Industrie 56, route de Choisy au Bac 60205 Compiègne France
Sanofi Winthrop Industrie 56, route de Choisy au Bac 60205 Compiègne Francija
To encourage the patients to read the PIL thoroughly 4.
Spodbudo za bolnike, da temeljito preberejo Navodilo za uporabo.
Pharmacokinetic interactions of teriflunomide on other substances
Farmakokinetične interakcije teriflunomida na druge snovi
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.
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.
During treatment During treatment with teriflunomide the following should be monitored:
Med zdravljenjem s teriflunomidom je treba spremljati naslednje:
AUBAGIO should not be used in children and adolescents under 18 years of age.
Zdravilo AUBAGIO se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let, ker učinki tega zdravila v tej starostni skupini niso znani.
Breast-feeding women (see section 4.6).
Doječe matere (glejte poglavje 4.6).
Pharmacokinetic interactions of other substances on teriflunomide
Farmakokinetične interakcije drugih snovi na teriflunomid
• 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,
• se daje holestiramin 8 g trikrat dnevno, 11 dni oz. 4 g trikrat dnevno, če odmerjanja 8 g trikrat dnevno bolnik ne prenaša dobro,
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.
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.
Starting AUBAGIO during this interval will result in concomitant exposure to fingolimod.
Če se zdravljenje z zdravilom AUBAGIO začne v tem obdobju, bo bolnik sočasno izpostavljen fingolimodu.
As leflunomide is the parent compound of teriflunomide, co-administration of teriflunomide with leflunomide is not recommended.
Ker je leflunomid starševska spojina teriflunomida, sočasna uporaba teriflunomida in leflunomida ni priporočljiva.
Blood pressure must be checked before the start of teriflunomide treatment and periodically thereafter.
Krvni tlak morate preveriti pred začetkom zdravljenja s teriflunomidom in redno med zdravljenjem.
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.
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.
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.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in po njem, dokler so plazemske ravni teriflunomida nad 0,02 mg/l.
Do not take AUBAGIO when you are breast-feeding, as teriflunomide passes into the breast milk.
Zdravila AUBAGIO ne jemljite, če dojite, saj teriflunomid prehaja v vaše mleko.
How AUBAGIO works
Kako zdravilo AUBAGIO deluje
• Of the need for the procedures/tests before and during teriflunomide treatment
• da je treba pred uvedbo zdravljenja s teriflunomidom in med njim opravljati preiskave / teste
Alternatively, when cholestyramine is not available, activated charcoal 50 g twice a day for 11 days may also be used.
Če holestiramin ni na voljo, se lahko uporabi aktivirano oglje 50 g dvakrat na dan, 11 dni.
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.
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.
If cholestyramine 8 g three times a day is not well-tolerated, cholestyramine 4 g three times a day can be used.
Če bolnik odmerka holestiramina 8 g trikrat dnevno ne prenaša dobro, se lahko uporabi odmerek holestiramina 4 g trikrat dnevno.
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.
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.
Tablet core lactose monohydrate maize starch microcrystalline cellulose sodium starch glycolate (Type A) hydroxypropylcellulose magnesium stearate
Jedro tablete laktoza monohidrat koruzni škrob mikrokristalna celuloza natrijev karboksimetilškrob (vrsta A) hidroksipropilceluloza magnezijev stearat
Your doctor may do blood tests to check your white blood cells if you think you have an infection.
Če zdravnik meni, da imate okužbo, bo morda naročil krvne preiskave, s katerimi bo preveril bele krvničke.
However, teriflunomide is contraindicated in patients with severe hepatic impairment (see sections 4.2 and 4.3).
Vendar je teriflunomid kontraindiciran pri bolnikih s hudo okvarjenim delovanjem jeter (glejte poglavji 4.2 in 4.3).
If you have taken too much AUBAGIO, call your doctor straight away.
Če ste vzeli večji odmerek zdravila AUBAGIO, kot bi smeli Če ste vzeli prevelik odmerek zdravila AUBAGIO, nemudoma pokličite svojega zdravnika.
The risk of male-mediated embryo-foetal toxicity through teriflunomide treatment is considered low (see section 5.3).
Tveganje za zarodek-plod, ki ga posreduje moški, ki se zdravi s teriflunomidom, se šteje za nizko (glejte poglavje 5.3).
Patients with active acute or chronic infections should not start treatment with AUBAGIO until the infection(s) is resolved.
Pri bolnikih z aktivno ali kronično okužbo je treba zdravljenje z zdravilom AUBAGIO odložiti do resolucije okužbe.
• difficulty walking
• oteženo hojo,
Treatment was discontinued in 5 patients with peripheral neuropathy on teriflunomide 14 mg. Recovery following treatment discontinuation was reported in 4 of these patients.
Zdravljenje je bilo prekinjeno pri 5 bolnikih s periferno nevropatijo, ki so prejemali odmerek 14 mg teriflunomida.
AUBAGIO might make you feel dizzy which may impair your ability to concentrate and react.
Vpliv na sposobnost upravljanja vozil in strojev Zaradi zdravila AUBAGIO se boste mogoče počutili omotični, kar lahko zmanjša vašo sposobnost koncentracije in reakcije.
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.
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.
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.
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.
The primary biotransformation pathway for teriflunomide is hydrolysis, with oxidation being a minor pathway.
Primarna pot biotransformacije teriflunomida je hidroliza, manj prisotna pa je oksidacija.
Weight decrease, Neutrophil count decreaseb, White blood cell count decreaseb, Blood creatine phosphokinase increased
Preiskave zmanjšanje telesne mase, zmanjšanje števila nevtrofilcevb, zmanjšanje števila levkocitovb, zvišana raven kreatin fosfokinaze v krvi
There is no relevant use of teriflunomide in children aged from birth to less than 10 years for the treatment of multiple sclerosis.
Zdravilo teriflunomid ni primerno za zdravljenje multiple skleroze pri otrocih od rojstva do starosti manj kot 10 let.
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.
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.
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.
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.
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.
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.
Mild and moderate hepatic impairment had no impact on the pharmacokinetic of teriflunomide.
Blaga in zmerna okvara jeter nista vplivali na farmakokinetiko teriflunomida.
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.
Možnost prekinitve zdravljenja s teriflunomidom preučite, če potrdite zvišanje ravni jetrnih encimov (višje od 3-kratnika zgornje meje normalnih vrednosti).
Clastogenicity observed in vitro was considered to be an indirect effect related to nucleotide pool imbalance resulting from the pharmacology of DHO-DH inhibition.
Klastogenost, opaženo in vitro, so prišteli posrednim učinkom zaradi neravnovesja nukleotidne rezerve, ki je posledica farmakologije zaviranja DHODH.
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.
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.
• Risk of hematologic effects o the need for complete blood cell counts before treatment and periodically during treatment based on signs and symptoms
• tveganje za hematološke učinke o pred uvedbo zdravljenja in redno med zdravljenjem, glede na znake in simptome, je treba določiti celotno krvno sliko,
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.
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).
The risk of male-mediated embryo-fetal toxicity through teriflunomide treatment is considered low.
Tveganje za zarodek-plod, ki ga posreduje moški, ki se zdravi s teriflunomidom, se šteje za nizko.
Cases of peripheral neuropathy have been reported in patients receiving AUBAGIO (see section 4.8).
Pri bolnikih, ki so prejemali zdravilo AUBAGIO, so ugotovili primere periferne nevropatije (glejte poglavje 4.8).
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.
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.
Due to the long half-life of natalizumab, concomitant exposure, and thus concomitant immune effects, could occur for up to 2-3 months following discontinuation of natalizumab if AUBAGIO was immediately started.
Če po prekinitvi zdravljenja z natalizumabom nemudoma začnete z dajanjem zdravila AUBAGIO, lahko zaradi dolge razpolovne dobe natalizumaba do sočasne izpostavljenosti in s tem sočasnih imunskih učinkov prihaja do 2-3 mesece po prekinitvi zdravljenja z natalizumabom.
The primary biotransformation pathway for teriflunomide is hydrolysis with oxidation being a minor pathway.
Primarna pot biotransformacije teriflunomida je hidroliza, manj pomembna presnovna pot je oksidacija.
Median time to reach maximum plasma concentrations occurs between 1 to 4 hours post-dose following repeated oral administration of teriflunomide, with high bioavailability (approximately 100%).
Mediana časa do najvišjih plazemskih koncentracij je od 1 do 4 ur po odmerku pri ponavljajočem se peroralnem odmerjanju teriflunomida.
Teriflunomide is excreted in the gastrointestinal tract mainly through the bile as unchanged medicinal product and most likely by direct secretion.
Teriflunomid se izloča v prebavila v glavnem z žolčem v nespremenjeni obliki, najverjetneje z neposrednim izločanjem.
In particular, tell your doctor or pharmacist if you are taking any of the following: - leflunomide, methotrexate and other medicines that affect the immune system (often called immunosuppressants or immunomodulators) - rifampicin (a medicine used to treat tuberculosis and other infections) - carbamazepine, phenobarbital, phenytoin for epilepsy - St John's wort (a herbal medicine for depression) - repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - duloxetine for depression, urinary incontinenece or in kidney disease in diabetics - alosetron for the management of severe diarrhea - theophylline for asthma - tizanidine, a muscle relaxant - warfarin, an anticoagulant used to make the blood thinner (i.e. more fluid) in order to avoid blood clots - oral contraceptives (containing ethinylestradiol and levonorgestrel)
Zdravniku ali farmacevtu morate obvezno povedati, če jemljete katerega od naslednjih zdravil: - leflunomid, metotreksat ali druga zdravila, ki vplivajo na imunski sistem (pogosto jim pravimo imunosupresivna zdravila ali imunomodulatorji), - rifampicin (zdravilo, ki se uporablja za zdravljenje tuberkuloze in drugih okužb), - karbamazepin, fenobarbital, fenitoin za epilepsijo, - šentjanževko (zeliščno zdravilo za depresijo), - repaglinid, pioglitazon, nateglinid ali rosiglitazon za sladkorno bolezen, - daunorubicin, doksorubicin, paklitaksel ali topotekan za zdravljenje raka, - duloksetin za depresijo, urinsko inkontinenco ali pri ledvični bolezni pri diabetikih, - alosetron za obvladovanje hude driske, - teofilin za astmo, - tizanidin, mišični relaksant, - varfarin, antikoagulacijsko zdravilo za redčenje krvi, ki preprečuje nastajanje krvnih strdkov,
Mild increases in transaminase, ALT below or equal to 3-fold ULN were more frequently seen in teriflunomide-treated groups as compared to placebo.
Blago zvišanje ravni transaminaz, ALT nižji ali enak 3-kratniku zgornje meje normalnih vrednosti (ULNUpper limit of Normal), so pogosteje ugotovili pri bolnikih, ki so prejemali teriflunomid, kot pri bolnikih, ki so prejemali placebo.
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.
V primerih hudih hematoloških reakcij, vključno s pancitopenijo, je treba prekiniti zdravljenje z zdravilom AUBAGIO in vsa sočasna mielosupresivna zdravljenja.
AUBAGIO is taken every day as a single daily dose at any time of the day.
Zdravilo AUBAGIO jemljete vsak dan.
Severe renal impairment had no impact on the pharmacokinetic of teriflunomide.
Huda okvara ledvic ni vplivala na farmakokinetiko teriflunomida.
Initiation of treatment with teriflunomide should be delayed in patients with severe active infection until resolution.
Pri bolnikih s hudo aktivno okužbo je treba zdravljenje s teriflunomidom odložiti do resolucije.
Change relative to placebo (CI95%) Number of unique active lesions /scan Change relative to placebo (CI95%)  p<0.0001  p<0.001  p<0.01  p<0.05 compared to placebo (1) BOD: burden of disease: total lesion volume (T2 and T1 hypointense) in ml
 p < 0,0001  p < 0,001  p < 0,01  p < 0,05 v primerjavi s placebom
However, a 25% decrease in peak international normalised ratio (INR) was observed when teriflunomide was coadministered with warfarin as compared with warfarin alone.
Vendar so pri sočasnem jemanju teriflunomida in varfarina ugotovili 25-odstotno znižanje vrha internacionalnega normaliziranega razmerja (INR) v primerjavi z jemanjem varfarina samega.
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.
Pri drugih substratih BCRP (npr. metotreksatu, topotekanu, sulfasalazinu, daunorubicinu, doksorubicinu) in družine OATP, zlasti zaviralcih HMG-Coreduktaze, je potrebna previdnost pri sočasni uporabi s teriflunomidom.
- you take leflunomide with AUBAGIO.
- če ob zdravilu AUBAGIO jemljete tudi leflunomid.
Severe skin reactionsa, Psoriasis (including pustular)b
Bolezni kože in podkožja alopecija izpuščaj, akne bolezni nohtov hude kožne reakcijea, psoriaza (vključno s pustulozno psoriazo)b
Uncommon (may affect up to 1 in 100 people) - Decrease in the number of blood platelets (mild thrombocytopenia) - Increased feeling or sensitivity, especially in the skin; stabbing or throbbing pain along one or more nerves, problems in the nerves of the arms or legs (peripheral neuropathy) - Nail disorders - Post-traumatic pain
Občasni (pojavijo se lahko pri največ 1 od 100 uporabnikov) - zmanjšanje števila krvnih ploščic (blaga trombocitopenija), - povečano čutenje ali občutljivost, zlasti kože; ostra ali utripajoča bolečina vzdolž enega ali več živcev,
In the placebo-controlled studies, mean decreases in serum uric acid at a range of 20 to 30% were observed in patients treated with teriflunomide compared to placebo.
V s placebom kontroliranih študijah so pri bolnikih, ki so prejemali teriflunomid, ugotovili povprečno znižanje serumske sečne kisline v razponu od 20 do 30 %.
Teriflunomide is contraindicated in this population (see section 4.3).
Teriflunomid je v tej populaciji kontraindiciran (glejte poglavje 4.3).