natgillin/translations-raw huggingface dataset:
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)
Osobito recite liječniku ili ljekarniku ako uzimate neki od sljedećih lijekova: - leflunomid, metotreksat i druge lijekove koji utječu na imunološki sustav (često se nazivaju imunosupresivima ili imunomodulatorima) - rifampicin (lijek koji se koristi za liječenje tuberkuloze i drugih infekcija) - karbamazepin, fenobarbital, fenitoin za epilepsiju - gospinu travu (biljni lijek za depresiju) - repaglinid, pioglitazon, nateglinid ili roziglitazon za šećernu bolest - danorubicin, doksorubicin, paklitaksel ili topotekan za rak
The risk of a second clinical attack over 2 years was 35.9% in the placebo group and 24.0% in the teriflunomide 14 mg treatment group (hazard ratio: 0.57, 95% confidence interval: 0.38 to 0.87, p=0.0087).
Rizik od drugog kliničkog napadaja tijekom 2 godine bio je 35,9% u placebo skupini i 24,0% u skupini liječenoj teriflunomidom u dozi od 14 mg (omjer hazarda:
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 temelju pojedinačnih previđanja farmakokinetičkih parametara dobivenih modelom populacijske farmakokinetičke analize primjene teriflunomida u zdravih dobrovoljaca i oboljelih od multiple skleroze, medijan t1/2z iznosio je približno 19 dana nakon ponovljenih doza od 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.
U placebom kontroliranim ispitivanjima lijeka AUBAGIO primijećeno je smanjenje srednje vrijednosti broja leukocita (<15% u odnosu na početne vrijednosti, uglavnom pad broja neutrofila i limfocita), a u nekih je bolesnika to smanjenje bilo još i veće.
Teriflunomide is contraindicated in this population (see section 4.3).
Teriflunomid je kontraindiciran u toj populaciji (vidjeti dio 4.3).
AUBAGIO 14 mg tablets teriflunomide
AUBAGIO 14 mg tablete teriflunomid
Pharmacokinetic interactions of teriflunomide on other substances
Farmakokinetičke interakcije teriflunomida s drugim tvarima
- you have severe skin reactions.
- teške kožne reakcije
- if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6), - if you have severe liver problems, - if you are pregnant, think you may be pregnant, or are breast-feeding, - if you suffer from a serious problem which affects your immune system e.g. acquired immunodeficiency syndrome (AIDS), - if you have a serious problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets, - if you are suffering from a serious infection, - if you have severe kidney problems which require dialysis, - if you have very low levels of proteins in your blood (hypoproteinaemia), If you are not sure, talk to your doctor or pharmacist before taking this medicine.
- ako patite od ozbiljne bolesti koja utječe na vaš imunološki sustav (npr. sindroma stečene imunodeficijencije (AIDS-a)), - ako imate ozbiljnih tegoba s koštanom srži ili ako imate nizak broj crvenih ili bijelih krvnih stanica u krvi ili smanjen broj krvnih pločica, - ako bolujete od ozbiljne infekcije, - ako imate teških problema s bubrezima koji zahtijevaju dijalizu, - ako imate vrlo nisku razinu proteina u krvi (hipoproteinemija).
What AUBAGIO is used for
Za što se AUBAGIO koristi
Before starting treatment with teriflunomide the following should be assessed:
Prije liječenja Prije početka liječenja teriflunomidom treba provjeriti:
• Potential risk of teratogenicity o To check pregnancy status before starting treatment o To educate female patients of child-bearing potential on the need for effective contraception before starting, and during treatment with teriflunomide o To inform their doctor immediately if they stop contraception, or prior to changing contraceptive measures o If female patients become pregnant despite using contraceptive measures, they should stop teriflunomide and contact their doctor immediately who should: Consider and discuss with the patient the accelerated elimination procedure encourage them to enrol in a pregnancy registry (in countries where a pregnancy registry is on-going),
• potencijalan rizik od teratogenih učinaka o liječnik mora provjeriti status trudnoće prije početka liječenja o liječnik mora educirati bolesnice reproduktivne dobi o potrebi primjene djelotvorne kontracepcije prije početka liječenja teriflunomidom te za vrijeme njegova trajanja o liječnik mora reći bolesnicima da odmah obavijeste svoga liječnika ako prestanu koristiti kontracepciju ili namjeravaju promijeniti metodu kontracepcije o ako bolesnica zatrudni unatoč primjeni kontracepcije, mora prekinuti liječenje teriflunomidom i odmah se obratiti svome liječniku.
For patients testing positive in tuberculosis screening, treat by standard medical practice prior to therapy with AUBAGIO.
Prije liječenja lijekom AUBAGIO bolesnike s pozitivnim nalazom testa na tuberkulozu liječite sukladno standardnoj medicinskoj praksi.
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.
Učinak teriflunomida na supstrat izoenzima CYP1A2: kofein Nakon ponovljenih doza teriflunomida srednji Cmax kofeina (supstrata CYP1A2) smanjio se za 18%, a srednji AUC za 55%, što upućuje na to da bi teriflunomid mogao biti slab induktor izoenzima CYP1A2 in vivo.
Most cases were described as diffuse or generalised over the scalp (no complete hair loss reported) and occurred most often during the first 6 months and with resolution in 121 of 139 (87.1%) patients treated with teriflunomide 14 mg. Discontinuation because of alopecia was 1.3% in the teriflunomide 14 mg teriflunomide group, versus 0.1% in the placebo group.
Većina slučajeva opisana je kao raširena ili generalizirana pojava na tjemenu (nije prijavljen potpun gubitak kose), koja se najčešće javila tijekom prvih 6 mjeseci, a povukla se u 121 od 139 (87,1%) bolesnika liječenih teriflunomidom u dozi od 14 mg.
Severe renal impairment had no impact on the pharmacokinetic of teriflunomide.
Teško oštećenje bubrežne funkcije nije utjecalo na farmakokinetiku teriflunomida.
Influenza, Upper respiratory tract infection, Urinary tract infection, Bronchitis, Sinusitis, Pharyngitis, Cystitis, Gastroenteritis viral,
Infekcije i infestacije gripa, infekcija gornjih dišnih putova, infekcija mokraćnih putova, bronhitis, sinusitis, faringitis, cistitis, virusni gastroenteritis, oralni herpes, infekcija zuba, laringitis, atletsko stopalo teške infekcije,
Tell your doctor immediately, if you notice any of the following serious side effects: - allergic reactions which might include symptoms of rash, hives, swelling of lips, tongue or face or sudden difficulty breathing.
- alergijsku reakciju koja može uključivati simptome osipa, koprivnjače, oticanja usana, jezika ili lica ili naglo otežanog disanja.
The elimination of teriflunomide from the circulation can be accelerated by administration of cholestyramine or activated charcoal, presumably by interrupting the reabsorption processes at the intestinal level.
Postupak ubrzane eliminacije: kolestiramin i aktivni ugljen Eliminacija teriflunomida iz krvotoka može se ubrzati primjenom kolestiramina ili aktivnog ugljena, koji najvjerojatnije prekidaju postupak ponovne apsorpcije u crijevima.
Route/method of administration
Put/način primjene lijeka
Effect of teriflunomide on CYP2C8 substrate: repaglinide There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of CYP2C8 in vivo.
Učinak teriflunomida na supstrat izoenzima CYP2C8: repaglinid Nakon ponovljenih doza teriflunomida srednji Cmax repaglinida povećao se 1,7 puta, a srednji AUC 2,4 puta, što upućuje na to da je teriflunomid inhibitor CYP2C8 in vivo.
Your doctor may do blood tests to check your white blood cells if you think you have an infection.
Ako mislite da imate infekciju, liječnik će možda napraviti krvne pretrage kako bi provjerio broj bijelih krvnih stanica.
The safety of teriflunomide in individuals with latent tuberculosis infection is unknown, as tuberculosis screening was not systematically performed in clinical studies.
Budući da se u kliničkim ispitivanjima nije provodio sustavni probir na tuberkulozu, sigurnost teriflunomida u osoba s latentnom tuberkulozom nije poznata.
This loss of myelin is called demyelination.
Taj gubitak mijelina naziva se demijelinizacijom i onemogućuje pravilan rad živaca.
Effect of teriflunomide on organic anion transporter 3 (OAT3) substrates There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of OAT3 in vivo.
Učinak teriflunomida na supstrate organskog anionskog transportera 3 (OAT3) Nakon ponovljenih doza teriflunomida srednji Cmax cefaklora povećao se 1,43 puta, a srednji AUC 1,54 puta, što upućuje na to da je teriflunomid inhibitor OAT3 in vivo.
Teriflunomide is contraindicated in patients with severe hepatic impairment (see section 4.3).
Teriflunomid je kontraindiciran u bolesnika s teškim oštećenjem jetrene funkcije (vidjeti dio 4.3).
ILD may be fatal.
Intersticijska plućna bolest može biti smrtonosna.
A consistent treatment effect on relapses and time to 3-month sustained disability progression in a subgroup of patients in TEMSO (n 127) with high disease activity was observed.
U ispitivanju TEMSO je u podskupini bolesnika s bolešću visokoga stupnja aktivnosti primijećen konzistentan učinak liječenja na relapse i vrijeme do tromjesečne trajne progresije onesposobljenosti.
Severe skin reactions Cases of severe skin reactions have been reported with teriflunomide post-marketing (see section 4.4).
Tijekom primjene teriflunomida nakon stavljanja lijeka u promet prijavljeni su slučajevi teških kožnih reakcija (vidjeti dio 4.4).
- cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indometacin, ketoprofen for pain or inflammation - furosemide for heart disease - cimetidine for reducing gastric acid - zidovudine for HIV infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - cholestyramine for high cholesterol or relief from itching in liver disease - activated charcoal to reduce absorption of medicines or other substances
- zidovudin za HIV infekciju - rosuvastatin, simvastatin, atorvastatin, pravastatin za hiperkolesterolemiju (visok kolesterol) - sulfasalazin za upalnu bolest debelog crijeva ili reumatoidni artritis - kolestiramin za visok kolesterol ili ublažavanje svrbeža kod bolesti jetre - aktivni ugljen za smanjenje apsorpcije lijekova ili drugih tvari.
Teriflunomide is contraindicated in pregnancy (see section 4.3).
Teriflunomid je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
Vomiting, Toothache
- proljev, mučnina
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.
U ispitivanju TEMSO ukupno je 1088 bolesnika s RMS-om randomizirano u skupinu koja je primala teriflunomid u dozi od 7 mg (n=366) ili 14 mg (n=359) ili u skupinu koja je primala placebo (n=363) tijekom 108 tjedana.
Fertility was unaffected in rats despite adverse effects of teriflunomide on male reproductive organs, including reduced sperm count.
Unatoč štetnim učincima teriflunomida na reproduktivne organe u mužjaka, uključujući i smanjeni broj spermatozoida, teriflunomid nije utjecao na plodnost u štakora.
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET
PODACI KOJI SE MORAJU NALAZITI NA SREDNJEM PAKIRANJU KARTONSKI OVITAK
However, teriflunomide is contraindicated in patients with severe hepatic impairment (see sections 4.2 and 4.3).
Međutim, teriflunomid je kontraindiciran u bolesnika s teškim oštećenjem jetrene funkcije (vidjeti dijelove 4.2 i
• Complete blood cell counts should be performed based on clinical signs and symptoms (e.g. infections) during treatment.
• tijekom liječenja treba napraviti kompletnu krvnu sliku na temelju kliničkih znakova i simptoma
Since teriflunomide is highly protein bound and as the binding is dependent upon the concentrations of albumin, unbound plasma teriflunomide concentrations are expected to be increased in patients with hypoproteinaemia, e.g. in nephrotic syndrome.
očekuje se da će koncentracije nevezanog teriflunomida u plazmi biti povišene u bolesnika s hipoproteinemijom, npr. u nefrotskom sindromu.
No dosage adjustment is necessary for patients with mild and moderate hepatic impairment.
Nije potrebno prilagođavati dozu u bolesnika s blagim i umjerenim oštećenjem jetrene funkcije.
Hyperaesthesia, Neuralgia, Peripheral neuropathy
Poremećaji živčanog sustava glavobolja parestezija, ishijas, sindrom karpalnog kanala hiperestezija, neuralgija, periferna neuropatija
Initiation of treatment with teriflunomide should be delayed in patients with severe active infection until resolution.
U bolesnika s teškom aktivnom infekcijom početak liječenja teriflunomidom treba odgoditi do izlječenja infekcije.
Abdominal pain upper,
mučnina bol u gornjem dijelu abdomena,
- The active substance is teriflunomide.
- Djelatna tvar je teriflunomid.
For rosuvastatin, a dose reduction by 50% is recommended for coadministration with teriflunomide.
Kada se primjenjuje istodobno s teriflunomidom, preporučuje se smanjenje doze rosuvastatina za 50%.
AUBAGIO 14 mg film-coated tablets
AUBAGIO 14 mg filmom obložene tablete
The median EDSS score at baseline was 2.50; 249 patients (22.9%) had an EDSS score › 3.5 at baseline.
EDSS rezultata na početku liječenja iznosio je 2,50; 249 bolesnika (22,9%) je na početku liječenja imalo
Menorrhagia
Cijepljenje
You must use an effective method of contraception during and after treatment with AUBAGIO.
Tijekom liječenja lijekom AUBAGIO i po njegovu završetku morate koristiti djelotvornu metodu kontracepcije.
Calendar days Mon
Dani u tjednu PON
The adverse reactions were consistent with the safety profile for teriflunomide in MS patients.
Nuspojave su bile sukladne sigurnosnom profilu teriflunomida u bolesnika s multiplom sklerozom.
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.
Također je potreban oprez kada se teriflunomid primjenjuje istodobno s drugim supstratima BCRP-a (npr. metotreksatom, topotekanom, sulfasalazinom, daunorubicinom, doksorubicinom) i lijekovima iz skupine organskih anionskih transportnih polipeptida, osobito inhibitorima HMG-CoA reduktaze (npr. simvastatinom, atorvastatinom, pravastatinom, metotreksatom, nateglinidom, repaglinidom, rifampicinom).
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
- pojačani osjeti ili osjetljivost, osobito na koži; probadajuća ili pulsirajuća bol duž jednog ili više živaca, problemi sa živcima u rukama ili nogama (periferna neuropatija)
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.
3. Liječnik mora bolesnike potaknuti da se obrate liječniku koji ih liječi zbog MS-a i/ili liječniku opće prakse u slučaju pojave znakova i simptoma koji se navode u Edukacijskoj kartici za bolesnike
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.
U slučajevima teških hematoloških reakcija, uključujući pancitopeniju, mora se prekinuti primjena lijeka
AUBAGIO is for oral use.
AUBAGIO se uzima kroz usta.
Elevations of liver enzymes have been observed in patients receiving teriflunomide (see section 4.8).
U bolesnika koji primaju teriflunomid primijećeno je povećanje razina jetrenih enzima (vidjeti dio 4.8).
What AUBAGIO is and what it is used for 2.
Što je AUBAGIO i za što se koristi
The recommended elimination procedure is cholestyramine 8 g three times a day for 11 days.
8 g triput na dan tijekom 11 dana.
Repeated oral administration of teriflunomide to mice, rats and dogs for up to 3, 6, and 12 months, respectively, revealed that the major targets of toxicity were the bone marrow, lymphoid organs, oral cavity/ gastro intestinal tract, reproductive organs, and pancreas.
odnosno 12 mjeseci pokazala je da su glavni ciljevi toksičnosti koštana srž, limfoidni organi, usna šupljina/probavni sustav, reproduktivni organi i gušterača.
cysts and polyps) There does not appear to be an increased risk of malignancy with teriflunomide in the clinical trial experience.
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Iskustvo iz kliničkih ispitivanja nije pokazalo povećan rizik od malignih bolesti kod primjene teriflunomida.
No dosage adjustment is necessary for patients with mild, moderate or severe renal impairment not undergoing dialysis.
Oštećenje bubrežne funkcije Nije potrebno prilagođavati dozu u bolesnika s blagim, umjerenim ili teškim oštećenjem bubrežne funkcije koji se ne liječe dijalizom.
Therefore no dose adjustment is anticipated in mild, moderate and severe renal-impaired patients.
Stoga se ne očekuje prilagođavanje doze u bolesnika s blagim, umjerenim i teškim oštećenjem bubrežne funkcije.
Use in males
Primjena u muškaraca
Risk difference (CI95%) Relapse-free week 108
Godišnja stopa relapsa Razlika u riziku (CI95%)
Interstitial lung disease (ILD) has been reported with teriflunomide in the postmarketing setting.
Respiratorne reakcije Nakon stavljanja teriflunomida u promet prijavljena je intersticijska plućna bolest.
AUBAGIO 14 mg film-coated tablets teriflunomide
AUBAGIO 14 mg filmom obložene tablete teriflunomid
Respiratory, thoracic and mediastinal disorders
Poremećaji dišnog sustava, prsišta i sredoprsja intersticijska plućna bolest
Teriflunomide 14 mg
teriflunomide 14 mg placebo teriflunomide 14 mg placebo
Switching to or from AUBAGIO
Prelazak na AUBAGIO ili prelazak s lijeka AUBAGIO na neki drugi lijek
ALT >3 ULN and TBILI >2 ULN
ALT >3 GGN i TBILI >2 GGN 5/994 (0,5%)
Severe infections including sepsisa
uključujući sepsua
Therefore, teriflunomide plasma concentrations should be measured before a woman begins to attempt to become pregnant.
Stoga se prije pokušaja začeća moraju izmjeriti koncentracije teriflunomida u plazmi.
In placebo-controlled studies, frequencies for asthenia were 2.0%, 1.6% and 2.2% in the placebo, teriflunomide 7 mg and teriflunomide 14 mg group, respectively.
1,6% u skupini koja je primala 7 mg teriflunomida i 2,2% u skupini koja je primala 14 mg teriflunomida.
ILD and worsening of pre-existing ILD have been reported during treatment with leflunomide, the parent compound of teriflunomide.
Intersticijska plućna bolest i pogoršanje postojeće intersticijske plućne bolesti prijavljeni su tijekom liječenja leflunomidom,
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Ako se podnošenje periodičkog izvješća o neškodljivosti (PSUR) podudara s nadopunama Plana (RMP),
Teriflunomide is contraindicated during breast-feeding (see section 4.3).
Teriflunomid je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
Annualised relapse rate
Tablični prikaz nuspojava
The following side effects may happen with this medicine.
Kod primjene ovoga lijeka primijećene su sljedeće nuspojave.
To encourage the patients to read the PIL thoroughly 4.
Edukacijska kartica mora potaknuti bolesnike da pažljivo pročitaju Uputu o lijeku
- Mild allergic reactions - Feeling anxious - Pins and needles, feeling weak, numb, tingling or pain in the lower back or leg (sciatica); feeling numb, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome)
- osjećaj tjeskobe - trnci i bockanje, osjećaj slabosti, utrnulost, trnci ili bol u donjem dijelu leđa ili noge (išijas); osjećaj utrnulosti, žarenje, trnci ili bol u rukama i prstima (sindrom karpalnog tunela) - osjećanje vlastitih otkucaja srca - povišeni krvni tlak - povraćanje, zubobolja, bol u gornjem dijelu trbuha - osip, akne - bol u tetivama, zglobovima, kostima, bol u mišićima (mišićno-koštana bol)
- you have respiratory symptoms.
- ako imate teške kožne reakcije. - ako imate dišne simptome.
Blood and lymphatic system disorders
Krvožilni poremećaji hipertenzijab
Polska sanofi-aventis Sp. z o.o.
Polska sanofi-aventis Sp. z o.o. Tel: +48 22 280 00 00
• Of the need for the procedures/tests before and during teriflunomide treatment
• informacije o potrebi provođenja pretraga/testova prije i tijekom liječenja teriflunomidom • podsjetnik za bolesnice da obavijeste liječnika ako doje
Hazard ratio (CI95%) 3-month Sustained Disability Progression week
Tromjesečna trajna progresija onesposobljenosti 108. tjedan
Therefore, when warfarin is co-administered with teriflunomide, close INR follow-up and monitoring is recommended.
Stoga se preporučuje pomna kontrola i praćenje INR-a kada se varfarin primjenjuje istodobno s teriflunomidom.
Posology
Medijan
There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of teriflunomide.
Nakon ponovljenih doza teriflunomida srednja vrijednost Cmax rosuvastatina povećala se 2,65 puta, a AUC 2,51 puta.
Hazard ratio (CI95%) 6-month Sustained Disability Progression week
Šestomjesečna trajna progresija onesposobljenosti 108. tjedan
Description of selected adverse reactions
Opis odabranih nuspojava Alopecija
Interference with determination of ionised calcium levels
- cimetidin za smanjenje želučane kiseline
Mild and moderate hepatic impairment had no impact on the pharmacokinetic of teriflunomide.
Blago i umjereno oštećenje jetrene funkcije nije imalo učinka na farmakokinetiku teriflunomida pa se ne očekuje prilagođavanje doze u bolesnika s blagim i umjerenim oštećenjem jetrene funkcije.
• Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) o Liver enzymes should be assessed every two weeks during the first 6 months of treatment, and every 8 weeks thereafter or as indicated by clinical signs and symptoms such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.
tjedana nakon toga ili po potrebi u skladu s kliničkim znakovima i simptomima kao što su neobjašnjiva mučnina, povraćanje, bol u abdomenu, umor, anoreksija ili žutica i/ili tamna mokraća.
Change relative to placebo Mean Number of Gdenhancing lesions at week
Promjena u odnosu na placebo