natgillin/translations-raw huggingface dataset:
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.
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.
Učinak teriflunomida na oralne kontraceptive: 0,03 mg etinilestradiola i 0,15 mg levonorgestrela Nakon ponovljenih doza teriflunomida povećali su se srednji Cmax i AUC0-24 etinilestradiola (1,58 puta odnosno 1,54 puta), dok se Cmax levonorgestrela povećao 1,33 puta, a AUC 0-24 1,41 puta.
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.
Osim ako je ubrzana eliminacija poželjna, ne preporučuje se bolesnike koji primaju teriflunomid liječiti kolestiraminom ili aktivnim ugljenom jer oni uzrokuju brzo i značajno smanjenja koncentracije lijeka u plazmi.
However, a 25% decrease in peak international normalised ratio (INR) was observed when teriflunomide was coadministered with warfarin as compared with warfarin alone.
Međutim, kada se teriflunomid primjenjivao istodobno s varfarinom, primijećeno je smanjenje vršnog internacionalnog normaliziranog omjera (INR) od 25% u odnosu na varfarin primijenjen samostalno.
During treatment During treatment with teriflunomide the following should be monitored:
Tijekom liječenja teriflunomidom treba kontrolirati:
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 u usporedbi s placebom (1) BOD (engl. burden of disease): opterećenje bolešću: ukupan volumen lezija (hipointenzivne lezije na T2 i T1) u ml
Alternatively, when cholestyramine is not available, activated charcoal 50 g twice a day for 11 days may also be used.
Ako kolestiramin nije dostupan, alternativno se može primijeniti aktivni ugljen u dozi od 50 g dvaput na dan tijekom 11 dana.
If this is not well tolerated, cholestyramine 4 g three times a day for 11 days can be used.
Ako se ta doza ne podnosi dobro, može se primijeniti kolestiramin u dozi od 4 g triput na dan tijekom 11 dana.
Treatment was discontinued in 5 patients with peripheral neuropathy on teriflunomide 14 mg. Recovery following treatment discontinuation was reported in 4 of these patients.
Liječenje je prekinuto u 5 bolesnika s perifernom neuropatijom koji su uzimali teriflunomid u dozi od 14 mg.
The frequency of elevations above 3-fold ULN and higher was balanced across treatment groups.
Učestalost povišenja iznad trostrukog GGN-a i više bila je podjednaka u svim liječenim skupinama.
• For women of child-bearing potential o to emphasise the need for effective contraception during treatment with teriflunomide o to stop treatment with teriflunomide immediately if they suspect they might be pregnant and also to contact their doctor immediately
• informacije za žene reproduktivne dobi o mora se naglasiti potreba za primjenom djelotvorne kontracepcije tijekom liječenja teriflunomidom o ako posumnja na trudnoću, bolesnica mora odmah prekinuti liječenje teriflunomidom i mora se odmah obratiti liječniku
• Complete blood cell count including differential white blood cell and platelet count.
• kompletnu krvnu sliku, uključujući diferencijalnu sliku leukocita i broj trombocita.
The median EDSS score at baseline was 2.50; 298 patients (25.5%) had an EDSS score › 3.5 at baseline.
Medijan EDSS rezultata na početku liječenja iznosio je 2,50: 298 bolesnika (25,5%) je na početku liječenja imalo EDSS rezultat > 3,5.
AUBAGIO should not be used in children and adolescents under 18 years of age.
AUBAGIO se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina jer učinci lijeka u toj dobnoj skupini nisu poznati.
The primary biotransformation pathway for teriflunomide is hydrolysis, with oxidation being a minor pathway.
Primarni biotransformacijski put teriflunomida je hidroliza, a oksidacija je sporedni put.
- severe skin reactions which might include symptoms of skin rash, blistering, or ulcers in your mouth - severe infections or sepsis (a potentially life-threatening type of infection) which might include symptoms of high fever, shaking, chills, reduced urine flow, or confusion - serious liver disease which might include symptoms of yellowing of your skin or the whites of your eyes, darker urine than normal, unexplained nausea and vomiting, or abdominal pain - inflammation of the lungs which might include symptoms of shortness of breath or persistent cough - inflammation of the pancreas which might include symptoms of severe pain in the upper abdominal area that may also be felt in your back, nausea, or vomiting
- teške kožne reakcije koje mogu uključivati simptome osipa na koži, mjehurića ili vrijedovi u ustima - teške infekcije ili sepsu (vrsta infekcije potencijalno opasna po život) koje mogu uključivati simptome visoke vrućice, drhtavice, zimice, smanjenog protoka mokraće ili smetenosti - ozbiljnu bolest jetre koja može uključivati simptome žute boje kože ili bjeloočnica, tamniju mokraću nego inače, neobjašnjivu mučninu i povraćanje ili bol u trbuhu - upalu pluća koja može uključivati simptome nedostatka zraka ili kašlja koji ne prolazi
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.
Bez postupka ubrzane eliminacije očekuje se da će koncentracija teriflunomida u plazmi biti iznad 0,02 mg/l tijekom prosječno 8 mjeseci, iako u pojedinih bolesnika može biti potrebno i do 2 godine kako bi se koncentracija lijeka u plazmi spustila ispod 0,02 mg/l.
Package leaflet: Information for the patient AUBAGIO 14 mg film-coated tablets teriflunomide
Uputa o lijeku: Informacije za bolesnika AUBAGIO 14 mg filmom obložene tablete teriflunomid
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.
Svi su bolesnici imali definitivno potvrđenu dijagnozu multiple skleroze (prema McDonaldovim kriterijima (2005)), relapsni klinički tijek bolesti, s progresijom ili bez nje te su imali najmanje 1 relaps u godini koja je prethodila ispitivanju ili najmanje 2 relapsa tijekom 2 godine koje su prethodile ispitivanju.
How to take AUBAGIO
Kako uzimati AUBAGIO
If cholestyramine 8 g three times a day is not well-tolerated, cholestyramine 4 g three times a day can be used.
Ako se kolestiramin u dozi od 8 g triput na dan ne podnosi dobro, može se primijeniti kolestiramin u dozi od 4 g triput na dan.
Hypersensitivity reactions (immediate or delayed) including anaphylaxis and angioedema
Poremećaji imunološko g sustava blage alergijske reakcije reakcije preosjetljivo sti (trenutne ili odgođene) uključujući anafilaksiju i angioedem
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.
Svi su bolesnici imali definitivno potvrđenu dijagnozu multiple skleroze (prema McDonaldovim kriterijima (2001)), relapsni klinički tijek bolesti, s progresijom ili bez nje te su imali najmanje 1 relaps u godini koja je prethodila ispitivanju ili najmanje 2 relapsa tijekom 2 godine koje su prethodile ispitivanju.
Tablet core lactose monohydrate maize starch microcrystalline cellulose sodium starch glycolate (Type A) hydroxypropylcellulose magnesium stearate
Jezgra tablete laktoza hidrat kukuruzni škrob celuloza, mikrokristalična natrijev škroboglikolat (vrste A) hidroksipropilceluloza magnezijev stearat
Each tablet contains 14 mg of teriflunomide.
Jedna tableta sadrži 14 mg teriflunomida.
How AUBAGIO works
Kako djeluje AUBAGIO
The patient must be advised that if there is any delay in onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician and patient must discuss the risk to the pregnancy.
Bolesnicu se mora upozoriti da se u slučaju bilo kakvog kašnjenja menstruacije ili bilo kojeg drugog razloga zbog kojeg se sumnja na trudnoću mora odmah obratiti liječniku radi testiranja na trudnoću.
The treatment should be initiated and supervised by a physician experienced in the management of multiple sclerosis.
4.2 Doziranje i način primjene Liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju multiple skleroze.
A mean decrease less than 15% from baseline affecting white blood cell count has been observed (see section 4.8).
Primijećena je srednja vrijednost smanjenja broja leukocita od manje od 15% u odnosu na početne vrijednosti (vidjeti dio 4.8).
• 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
• rizik od učinaka na jetru o prije liječenja te periodički tijekom liječenja treba provoditi testove jetrene funkcije o liječnik mora educirati bolesnike o znakovima i simptomima jetrene bolesti te o potrebi da sve znakove i simptome koje primijetite prijave zdravstvenom radniku
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.
U ispitivanju TOWER ukupno je 1169 bolesnika s RMS-om randomizirano u skupinu koja je primala teriflunomid u dozi od 7 mg (n=408) ili 14 mg (n=372) ili u skupinu koja je primala placebo (n=389) u sklopu liječenja čije je trajanje bilo varijabilno i koje je završavalo 48 tjedana nakon randomizacije posljednjeg bolesnika.