natgillin/translations-raw huggingface dataset:
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). 
Ispitivanje TOPIC bilo je dvostruko slijepo, placebom kontrolirano ispitivanje koje je procijenilo doze teriflunomida od 7 mg i 14 mg jednom dnevno tijekom najviše 108 tjedana u bolesnika s prvim kliničkim demijelinizirajućim događajem (prosječna dob 32,1 godina).
Both cholestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the accelerated elimination procedure with cholestyramine or activated powdered charcoal. 
I kolestiramin i aktivni ugljen u prahu mogu utjecati na apsorpciju estrogena i progesterona pa se ne može jamčiti pouzdana zaštita od trudnoće primjenom oralnih kontraceptiva tijekom postupka ubrzane eliminacije kolestiraminom ili aktivnom ugljenom u prahu.
If you forget to take AUBAGIO 
Ako ste zaboravili uzeti AUBAGIO
There are limited amount of data from the use of teriflunomide in pregnant women. 
Postoje malobrojni podaci o primjeni teriflunomida u trudnica.
Teriflunomide was embryotoxic and teratogenic in rats and rabbits at doses in the human therapeutic range. 
Teriflunomid je bio embriotoksičan i teratogen u štakora i kunića pri dozama koje su bile unutar raspona doza koje se primjenjuju za liječenje u ljudi.
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%). 
U skupini liječenoj supkutanim interferonom beta-1a došlo je do trajnog prekida liječenja u 30 od 104 bolesnika (28,8%), a uzrok tome bile su nuspojave (21,2%), nedostatna djelotvornost (1,9%), drugi razlozi (4,8%) i slabo pridržavanje protokola (1%).
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%). 
Medijan za postizanje maksimalnih koncentracija u plazmi je između 1 i 4 sata nakon primjene doze i ponovljene peroralne primjene teriflunomida, pri čemu se postiže visoka bioraspoloživost (približno
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). 
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka AUBAGIO u djece od rođenja do manje od 10 godina starosti u liječenju multiple skleroze (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
No data are available in patients who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon, having had at least 1 relapse in the previous year while on therapy, and at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gd-enhancing lesion, or patients having an unchanged or increased relapse rate in the prior year as compared to the previous 2 years. 
Nema podataka u bolesnika koji nisu odgovorili na cjeloviti i odgovarajući ciklus liječenja beta-interferonom (liječenje obično traje najmanje godinu dana) i koji su imali najmanje 1 relaps u prethodnoj godini tijekom liječenja te najmanje 9 hiperintenzivnih lezija na T2 pri MRI oslikavanju lubanje ili najmanje 1 leziju imbibiranu gadolinijem, niti u bolesnika koji su u prethodnoj godini imali neizmijenjenu ili povećanu stopu relapsa u odnosu na prethodne 2 godine.
As a precaution, a recent complete blood cell count, including differential white blood cell count and platelets, should be available before the initiation of treatment with AUBAGIO and the complete blood cell count should be assessed during AUBAGIO therapy as indicated by clinical signs and symptoms (e.g., infections). 
Kao mjera opreza, prije početka liječenja lijekom AUBAGIO na raspolaganju se mora imati novija kompletna krvna slika, uključujući diferencijalnu krvnu sliku leukocita i trombocita, a tijekom liječenja lijekom AUBAGIO treba određivati kompletnu krvnu sliku sukladno kliničkim znakovima i simptomima (npr. u slučaju infekcija).
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. 
Bez postupka ubrzane eliminacije u prosjeku je potrebno 8 mjeseci da se koncentracija u plazmi spusti ispod 0,02 mg/l, premda zbog individualnih varijacija u klirensu tvari to može potrajati i do 2 godine.
Polyamide/aluminium/poly(vinyl chloride) -aluminium perforated unit-dose blister packs in cartons containing 10x1 film-coated tablets. 
Poliamid/aluminij/poli(vinil klorid)-aluminij perforirani blisteri s jediničnim dozama u kutijama koje sadrže 10x1 filmom obloženu tabletu.
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. 
Alopecija je prijavljena kao prorjeđivanje kose, smanjena gustoća kose, gubitak kose (povezan ili nepovezan s promjenom teksture kose) u 13,9% bolesnika liječenih teriflunomidom u dozi od 14 mg u usporedbi s 5,1% bolesnika koji su primali placebo.
However, also following either of the accelerated elimination procedures, verification by 2 separate tests at an interval of at least 14 days and a waiting period of one-and-a-half months between the first occurrence of a plasma concentration below 0.02 mg/l and fertilisation is required. 
Međutim, nakon bilo kojega od navedenih dvaju postupka ubrzane eliminacije rezultate također treba provjeriti dvjema zasebnim pretragama u razmaku od najmanje 14 dana te pričekati najmanje 1,5 mjeseci od prve pojave koncentracije u plazmi ispod 0,02 mg/l do začeća.
Other side effects can occur with the following frequencies: Very common (may affect more than 1 in 10 people) Headache 
Vrlo često (mogu se javiti u više od 1 na 10 osoba) - glavobolja
What AUBAGIO is and what it is used for What AUBAGIO is 
Što je AUBAGIO i za što se koristi Što je AUBAGIO
A total of 618 patients were randomised to receive 7 mg (n=205) or 14 mg (n=216) of teriflunomide or placebo (n=197). 
Ukupno 618 bolesnika randomizirano je kako bi primalo 7 mg (n=205) ili 14 mg (n=216) teriflunomida ili placebo ( n=197).
Once the teriflunomide plasma concentration is determined to be below 0.02 mg/l, the plasma concentration must be determined again after an interval of at least 14 days. 
Kada izmjerena koncentracija teriflunomida u plazmi bude manja od 0,02 mg/l, koncentraciju u plazmi ponovno se mora izmjeriti nakon razdoblja od najmanje 14 dana.
Increase in ALT (increase in blood levels of certain hepatic enzymes) shown in tests Hair thinning 
- povišene razine ALT-a (povišene razine određenih jetrenih enzima u krvi) vidljive iz nalaza pretraga
HCPs should discuss with their patients the specific safety concerns of AUBAGIO detailed below including the tests and precautions needed for safe use as follows: 
Zdravstveni radnici moraju sa svojim bolesnicima razgovarati o specifičnim sigurnosnim problemima kod primjene lijeka AUBAGIO navedenima u nastavku te o sljedećim pretragama i mjerama opreza neophodnima za sigurnu primjenu lijeka:
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. 
AUBAGIO 14 mg filmom obložene tablete (tablete) su blijedo plave do pastelno plave peterokutne filmom obložene tablete s otisnutom oznakom na jednoj strani ("14") i ugraviranim logotipom tvrtke na drugoj strani.
Evidence of an oxidative effect on red blood cells was also observed. 
Pronađeni su i dokazi oksidacijskog učinka na eritrocite.
The efficacy of AUBAGIO was demonstrated in two placebo controlled studies, the TEMSO and the TOWER study, that evaluated once daily doses of teriflunomide 7 mg and 14 mg in patients with RMS. 
Djelotvornost lijeka AUBAGIO dokazana je u dvama placebom kontroliranim ispitivanjima, TEMSO i TOWER, u kojima se ispitivala primjena teriflunomida u dozama od 7 mg na dan i 14 mg jedanput na dan u bolesnika s RMS-om.
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. 
Blijedo plave do pastelno plave peterokutne filmom obložene tablete, s otisnutom oznakom na jednoj strani ("14") i ugraviranim logotipom tvrtke na drugoj strani.
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%). 
Većina bolesnika imala je relapsno-remitirajuću multiplu sklerozu (97,5%), a jedna podskupina bolesnika imala je sekundarnu progresivnu (0,8%) ili progresivnu relapsnu multiplu sklerozu (1,7%).
Based on the half-life of fingolimod, a 6-week interval without therapy is needed for clearance from the circulation and a 1 to 2 month period is needed for lymphocytes to return to normal range following discontinuation of fingolimod. 
S obzirom na poluvijek fingolimoda, nakon prekida njegove primjene potrebno je 6 tjedana bez liječenja kako bi se lijek uklonio iz krvotoka te 1 do 2 mjeseca kako bi se limfociti vratili na normalne vrijednosti.
Mean decrease in serum phosphorus was around 10% in the teriflunomide group compared to placebo. 
Srednje smanjenje koncentracije fosfora u serumu iznosilo je približno 10% u skupini koja je primala teriflunomid u usporedbi s placebom.
Food does not have a clinically relevant effect on teriflunomide pharmacokinetics. 
Hrana nema klinički značajan utjecaj na farmakokinetiku teriflunomida.
Metabolism and nutrition disorders 
Poremećaji metabolizm a i prehrane dislipidemija
The majority of patients had relapsing-remitting multiple sclerosis (91.5%), but a subgroup of patients had secondary progressive (4.7%) or progressive relapsing multiple sclerosis (3.9%). 
Većina bolesnika imala je relapsno-remitirajuću multiplu sklerozu (91,5%), a jedna podskupina bolesnika imala je sekundarnu progresivnu (4,7%) ili progresivnu relapsnu multiplu sklerozu (3,9%).
Haematological effects 
Hematološki učinci
The risk of male-mediated embryo-fetal toxicity through teriflunomide treatment is considered low. 
Rizik od embriofetalne toksičnosti uzrokovane muškim spolnim stanicama uslijed liječenja teriflunomidom smatra se niskim.
Elevation of blood pressure may occur during treatment with teriflunomide (see section 4.8). 
Krvni tlak Tijekom liječenja teriflunomidom može doći do povišenja krvnoga tlaka (vidjeti dio 4.8).
• To remind both patients and HCPs about the accelerated elimination procedure 
• podsjetnik i za bolesnicu i za zdravstvenog radnika o postupku ubrzane eliminacije lijeka
The risk of male-mediated embryo-foetal toxicity through teriflunomide treatment is considered low (see section 5.3). 
Rizik od embriofetalne toksičnosti uslijed liječenja muškaraca teriflunomidom smatra se niskim (vidjeti dio 5.3).
In placebo-controlled studies the following was established: - systolic blood pressure was >140 mm Hg in 19.9% of patients receiving 14 mg/day teriflunomide as compared to 15.5% receiving placebo; - systolic blood pressure was >160 mm Hg in 3.8% of patients receiving 14 mg/day teriflunomide as compared to 2.0% receiving placebo; - diastolic blood pressure was >90 mm Hg in 21.4% of patients receiving 14 mg/day teriflunomide as compared to 13.6% receiving placebo. 
- sistolički krvni tlak bio je >140 mm Hg u 19,9% bolesnika koji su primali teriflunomid u dozi od 14 mg/dan u usporedbi sa 15,5% bolesnika koji su primali placebo; - sistolički krvni tlak bio je >160 mm Hg u 3,8% bolesnika koji su primali teriflunomid u dozi od 14 mg/dan u usporedbi s 2,0% bolesnika koji su primali placebo; - dijastolički krvni tlak bio je >90 mm Hg u 21,4% bolesnika koji su primali teriflunomid u dozi od 14 mg/dan u usporedbi sa 13,6% bolesnika koji su primali placebo;
- you have an infection. 
(npr. infekcija).
Clinical Outcomes 
Klinički ishodi
Teriflunomide remains in your blood for a long time after you stop taking it. Continue to use effective contraception after you stop treatment. 
Teriflunomid se zadržava u krvi još dugo nakon što ga prestanete uzimati.
As leflunomide is the parent compound of teriflunomide, co-administration of teriflunomide with leflunomide is not recommended. 
Budući da je leflunomid ishodišni spoj teriflunomida, istodobna primjena teriflunomida s leflunomidom nije preporučena.
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. 
U pivotalnim, placebom kontroliranim ispitivanjima incidencija periferne neuropatije potvrđene kliničkim ispitivanjima provodljivosti živaca iznosila je 1,9% (17 od 898 bolesnika) kod primjene teriflunomida u dozi od 14 mg u usporedbi s 0,4% (4 od 898) bolesnika koji su primali placebo.
Do not take AUBAGIO when you are breast-feeding, as teriflunomide passes into the breast milk. 
Nemojte uzimati AUBAGIO dok dojite jer se teriflunomid izlučuje u majčino mlijeko.
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. 
U placebom kontroliranim ispitivanjima primijećeno je srednje smanjenje koncentracije mokraćne kiseline u serumu od 20-30% u bolesnika liječenih teriflunomidom u usporedbi s onima koji su primali placebo.
In such cases patients should not be re-exposed to teriflunomide (see section 4.3). 
U takvim se slučajevima bolesnike ne smije ponovno izlagati teriflunomidu (vidjeti dio 4.3).
In case of ulcerative stomatitis, teriflunomide administration should be discontinued. 
U slučaju ulceroznog stomatitisa primjena teriflunomida mora se prekinuti.
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). 
Trudnice ili žene reproduktivne dobi koje ne upotrebljavaju pouzdanu kontracepciju tijekom liječenja teriflunomidom i nakon liječenja sve dok su koncentracije lijeka u plazmi iznad 0,02 mg/l (vidjeti dio 4.6).
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. 
Žene reproduktivne dobi moraju koristiti djelotvornu kontracepciju tijekom liječenja i nakon liječenja, sve dok je razina teriflunomida u plazmi iznad 0,02 mg/l.
Pharmacokinetic interactions of other substances on teriflunomide 
Farmakokinetičke interakcije drugih tvari s teriflunomidom
Therefore, medicinal products metabolised by CYP2C8, such as repaglinide, paclitaxel, pioglitazone or rosiglitazone, should be used with caution during treatment with teriflunomide. 
Stoga se lijekovi koji se metaboliziraju putem CYP2C8, poput repaglinida, paklitaksela, pioglitazona ili roziglitazona, moraju primjenjivati uz oprez tijekom liječenja teriflunomidom.
Week 1 (wallets of 14 and 28) Week 2 (wallets of 14 and 28) Week 3 (wallets of 28) Week 4 (wallets of 28) 
1. tjedan (kartonski ovici s 14 i 28 tableta) 2. tjedan (kartonski ovici s 14 i 28 tableta) 3. tjedan (kartonski ovici s 28 tableta) 4. tjedan (kartonski ovici s 28 tableta)
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. 
U bolesnika s postojećom anemijom, leukopenijom i/ili trombocitopenijom te u bolesnika s poremećenom funkcijom koštane srži ili onih u kojih postoji rizik od supresije koštane srži povećan je rizik od hematoloških poremećaja.
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%). 
U skupini liječenoj teriflunomidom u dozi od 14 mg došlo je do trajnog prekida liječenja u 22 od 111 bolesnika (19,8%), a uzrok tome bile su nuspojave (10,8%), nedostatna djelotvornost (3,6%), drugi razlozi (4,5%) i gubitak iz praćenja (0,9%).
Patients with severe renal impairment undergoing dialysis were not evaluated. 
Bolesnici s teškim oštećenjem bubrežne funkcije koji se liječe dijalizom nisu ispitivani.
Teriflunomide 14 mg/day was not superior to interferon beta1a on the primary endpoint: the estimated percentage of patients with treatment failure at 96 weeks using the Kaplan-Meier method was 41.1% versus 44.4% (teriflunomide 14 mg versus interferon beta-1a group, p=0.595). 
Teriflunomid u dozi od 14 mg na dan nije bio statistički superioran interferonu beta-1a u primarnoj mjeri ishoda: procijenjeni postotak bolesnika koji nisu odgovorili na liječenje u 96. tjednu, određen Kaplan-Meierovom metodom, iznosio je 41,1% naspram 44,4% (teriflunomid u dozi od 14 mg naspram interferona beta-1a, p=0,595).
Gadolinium-enhancing lesions at baseline: no data. 
Lezije koje se imbibiraju gadolinijem na početku liječenja: nema podataka.
Severe skin reactionsa, Psoriasis (including pustular)b 
(uključujući pustularnu psorijazu)b
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR WALLET 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ZA KARTONSKI OVITAK
At entry, patients had an Expanded Disability Status Scale (EDSS) score ≤5.5. 
Bolesnici su pri ulasku u ispitivanje imali rezultat ≤ 5,5 na proširenoj ljestvici stupnja onesposobljenosti (EDSS).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT-DOSE BLISTER 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S JEDINIČNIM DOZAMA
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. 
Zbog dugog poluvijeka natalizumaba, tijekom 2 do 3 mjeseca nakon prekida njegove primjene može doći do istodobne izloženosti, a time i do imunoloških učinaka, ako se liječenje lijekom AUBAGIO započne odmah.
Therefore, when teriflunomide is coadministered with substrates of OAT3, such as cefaclor, benzylpenicillin, ciprofloxacin, indometacin, ketoprofen, furosemide, cimetidine, methotrexate, zidovudine, caution is recommended. 
Stoga je potreban oprez kada se teriflunomid primjenjuje istodobno sa supstratima OAT3, kao što su cefaklor, benzilpenicilin, ciprofloksacin, indometacin, ketoprofen, furosemid, cimetidin, metotreksat i zidovudin.
Hypoproteinaemia 
Hipoproteinemija
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. 
Rifampicin i drugi poznati snažni induktori citokroma i prijenosnika, kao što su karbamazepin, fenobarbital, fenitoin i gospina trava, moraju se primjenjivati uz oprez tijekom liječenja teriflunomidom.
Sanofi Winthrop Industrie 56, route de Choisy au Bac 60205 Compiègne France 
Sanofi Winthrop Industrie 56, route de Choisy au Bac 60205 Compiègne Francuska
In placebo-controlled studies, no increase in serious infections was observed with teriflunomide (see section 4.8). 
U placebom kontroliranim ispitivanjima nije primijećen porast broja ozbiljnih infekcija kod primjene teriflunomida (vidjeti dio 4.8).
Teriflunomide should not be used in patients with conditions of severe hypoproteinaemia. 
Teriflunomid se ne smije primjenjivati u bolesnika s teškom hipoproteinemijom.
Weight decrease, Neutrophil count decreaseb, White blood cell count decreaseb, Blood creatine phosphokinase increased 
Pretrage smanjenje tjelesne težine, smanjenje broja neutrofilab, smanjenje broja leukocitab, povišene vrijednosti kreatinfosfokinaze u krvi
If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove AUBAGIO rapidly and sufficiently from your body, as this may decrease the risk to your baby. 
Ako test potvrdi trudnoću, liječnik će Vam možda predložiti liječenje određenim lijekovima za brzo uklanjanje dostatne količine lijeka AUBAGIO iz
Sanofi Winthrop Industrie 56, Route de Choisy au Bac F-60205 Compiegne Cedex France 
Sanofi Winthrop Industrie 56, Route de Choisy au Bac F-60205 Compiegne Cedex Francuska
Cases of peripheral neuropathy have been reported in patients receiving AUBAGIO (see section 4.8). 
U bolesnika koji su primali AUBAGIO prijavljeni su slučajevi periferne neuropatije (vidjeti dio 4.8).
The placebo-controlled pooled analysis was based on 2047 patients with Relapsing Multiple Sclerosis treated with teriflunomide once daily. 
Analiza objedinjenih podataka iz placebom kontroliranih ispitivanja temeljila se na podacima prikupljenima u 2047 bolesnika s relapsnom multiplom sklerozom liječenih teriflunomidom jedanput na dan.
Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia. 
Bolesnici sa značajno oštećenom funkcijom koštane srži ili značajnom anemijom, leukopenijom,
Breast-feeding women (see section 4.6). 
Dojilje (vidjeti dio 4.6).
• 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, 
• može se primijeniti kolestiramin u dozi od 8 g triput na dan tijekom 11 dana ili kolestiramin u dozi od 4 g triput na dan, ako se kolestiramin u dozi od 8 g triput na dan ne podnosi dobro
Each film-coated tablet contains 14 mg of teriflunomide. 
Jedna filmom obložena tableta sadrži 14 mg teriflunomida.
Post-traumatic pain a: please refer to the detailed description section b: see section 4.4 
Ozljede, trovanja i proceduraln e komplikacij e posttraumats ka bol a: vidjeti dio s detaljnim opisom b: vidjeti dio 4.4
• To record the first date of prescription and the contact details of their prescriber 3. 
• bolesnici moraju zabilježiti datum prvoga propisivanja lijeka i kontakt podatke osobe koja im je lijek propisala
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 
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) - teške infekcije (uključujući sepsu) - teške alergijske reakcije (uključujući anafilaksiju) - plućne reakcije (intersticijska plućna bolest) - upala jetre, gušterače i/ili usta/usnica
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING PROTECTIVE SLEEVE CONTAINING WALLET 
PODACI KOJI SE MORAJU NALAZITI NA SREDNJEM PAKIRANJU ZAŠTITNA KOŠULJICA KOJA SADRŽI KARTONSKI OVITAK
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. 
Treba razmotriti prekid liječenja teriflunomidom ako su potvrđene povišene razine jetrenih enzima (više od 3 puta iznad GGN-a).
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 povišenje razine transaminaze, ALT manji ili jednak trostrukom GGN-u češće je primijećen u skupinama liječenim teriflunomidom u usporedbi sa skupinama koje su primale placebo.