natgillin/translations-raw huggingface dataset:
Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4), in addition to other proangiogenic and oncogenic pathway-related RTKs including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4, the platelet derived growth factor (PDGF) receptor PDGFRα, KIT, and RET. 
Lenvatinib je inhibitor receptorjev tirozin-kinaze (RTK), ki selektivno inhibira kinazne aktivnosti receptorjev rastnega faktorja vaskularnega endotelija (vascular endothelial growth factor ali VEGF) VEGFR1 (FLT1), VEGFR2 (KDR) in VEGFR3 (FLT4), poleg drugih RTK, povezanih z drugimi proangiogenimi in onkogenimi potmi, vključno z receptorji za fibroblastni rastni faktor (fibroblast growth factor ali FGF) FGFR1, 2, 3 in 4, receptorjem za rastni faktor iz trombocitov (platelet derived growth factor ali PDGF) PDGFRα, KIT in RET.
Lenvatinib should not be started in patients with fistula to avoid worsening and lenvatinib should be permanently discontinued in patients with oesophageal or tracheobronchial tract involvement and any Grade 4 fistula (see section 4.2); limited information is available on the use of dose interruption or reduction in management of other events, but worsening was observed in some cases and caution should be taken. 
Lenvatiniba ne smemo začeti dajati bolnikom s fistulo, da se izognemo poslabšanju, trajno pa ga moramo ukiniti pri bolnikih s prizadetostjo ezofagealnega ali traheobronhialnega trakta in kakršno koli fistulo stopnje 4 (glejte poglavje 4.2); o uporabi prekinitve ali zmanjšanja odmerjanja za zdravljenje drugih dogodkov je na voljo malo podatkov, vendar so v nekaterih primerih opazili poslabšanje, zato je potrebna previdnost.
No adjustment of starting dose is required on the basis of age. 
Na podlagi starosti prilagoditev začetnega odmerka ni potrebna.
Patients were excluded who had prior systemic anticancer therapy for advanced/unresectable HCC or any prior anti-VEGF therapy. 
Bolniki so bili izključeni, če so imeli predhodno sistemsko terapijo proti raku za napredovali/neoperabilni HCC ali katero koli predhodno zdravljenje z zdravili, usmerjenimi proti VEGF.
Following administration of radiolabelled lenvatinib to 6 patients with solid tumours, approximately two-thirds and one-quarter of the radiolabel were eliminated in the faeces and urine, respectively. 
Po dajanju radioaktivno označenega lenvatiniba 6 bolnikom s čvrstimi tumorji se je približno dve tretjini oziroma ena četrtina radioaktivnega označevalca odstranila iz telesa z blatom oziroma urinom.
LENVIMA may cause side effects that can affect your ability to drive or use machines. 
Zdravilo LENVIMA lahko povzroči neželene učinke, ki lahko vplivajo na vašo sposobnost upravljanja vozil ali strojev.
Posterior reversible encephalopathy syndrome Monoparesis Transient ischaemic attack 
sindrom posteriorne reverzibilne encefalopatije monopareza tranzitorna ishemična ataka
Data from a human mass balance/excretion study indicate lenvatinib is extensively metabolised in humans. 
Podatki iz študije masnega ravnovesja/izločanja pri ljudeh kažejo, da se lenvatinib pri ljudeh intenzivno presnavlja.
The objective response rate (complete response [CR] plus partial response [PR]) per independent radiological review was significantly (p<0.0001) higher in the lenvatinib-treated group (64.8%) than in the placebo-treated group (1.5%). 
Objektivna odzivnost (popolni odziv [CR] plus delni odziv [PR]) po neodvisnem radiološkem pregledu je bila značilno (p < 0,0001) večja v skupini, zdravljeni z lenvatinibom (64,8 %), kot v skupini, ki je prejemala placebo (1,5 %).
In this trial, there was 1 case of fatal intracranial haemorrhage among 16 patients who received lenvatinib and had CNS metastases at baseline. 
V tem preskušanju je bil 1 primer smrtne znotrajlobanjske krvavitve med 16 bolniki, ki so prejemali lenvatinib in so v izhodišču imeli zasevke v centralnem živčevju.
Based on a population pharmacokinetic analysis of patients receiving up to 24 mg lenvatinib once daily, age, sex, weight, and race (Japanese vs. other, Caucasian vs. other) had no significant effects on clearance (see section 4.2). 
Na podlagi populacijske farmakokinetične analize bolnikov, ki so prejemali do 24 mg lenvatiniba enkrat na dan, starost, spol, telesna masa in rasa (Japonci v primerjavi z drugimi, belci v primerjavi z drugimi) niso značilno vplivali na očistek (glejte poglavje 4.2).
Liver function tests should be monitored before initiation of treatment, then every 2 weeks for the first 2 months and monthly thereafter during treatment. 
Teste funkcije jeter je treba spremljati pred začetkom zdravljenja, med zdravljenjem pa prva 2 meseca vsaka 2 tedna in nato enkrat na mesec.
LENVIMA is a medicine that contains the active substance lenvatinib. 
LENVIMA je zdravilo, ki vsebuje zdravilno učinkovino lenvatinib.
Most reactions resolved following supportive treatment, without dose interruption or reduction, which occurred in 1.5% and 1.1% of patients, respectively; 1 patient with Grade 4 hypocalcaemia discontinued treatment permanently. 
Večina neželenih učinkov je po podpornem zdravljenju izginila brez prekinitve ali zmanjšanja odmerka, do katerih je prišlo pri 1,5 % oziroma 1,1 % bolnikov; pri enem bolniku s hipokalciemijo stopnje 4 so zdravljenje trajno ukinili.
Carcinogenicity studies have not been conducted with lenvatinib. 
Študij kancerogenosti za lenvatinib niso opravili.
The results for surrogate endpoints (PFS and ORR) are presented in Table 7 below. 
Rezultati za nadomestne opazovane dogodke (PFS in objektivno odzivnost) so predstavljeni v preglednici 7 v nadaljevanju.
Dose adjustments and discontinuations for DTC 
Prilagajanje odmerka in ukinitev pri DTC
Pharmacokinetic parameters of lenvatinib have been studied in healthy adult subjects, adult subjects with hepatic impairment, renal impairment, and solid tumours. 
Farmakokinetične parametre lenvatiniba so proučevali pri zdravih odraslih preiskovancih, odraslih preiskovancih z okvaro jeter, okvaro ledvic in čvrstimi tumorji.
• dry, sore, or inflamed mouth, odd taste sensation 
• suha, boleča ali vneta usta, občutek čudnega okusa,
Patients with hypertension 
Bolniki s hipertenzijo
• If it is less than 12 hours until your next dose: skip the missed dose. 
• Če do naslednjega odmerka manjka manj kot 12 ur: pozabljeni odmerek izpustite.
• dry skin, thickening and itching of the skin 
• suha koža, zadebelitev in srbenje kože,
The median OS had not been reached for either the lenvatinib group or the placebo crossover group. 
Mediano OS ni bilo doseženo niti pri skupini z lenvatinibom niti pri skupini, ki je s placeba prešla na lenvatinib.
Hepatic encephalopathy tended to be associated with adverse disease characteristics at baseline or with the use of concomitant medications. 
Jetrna encefalopatija je bila večinoma povezana z neugodnimi značilnostmi bolezni v izhodišču ali s sočasno uporabo zdravil.
What LENVIMA is and what it is used for What you need to know before you take LENVIMA How to take LENVIMA 
Kaj je zdravilo LENVIMA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo LENVIMA Kako jemati zdravilo LENVIMA Možni neželeni učinki
The toxicity of lenvatinib was more prominent in younger rats (dosing initiated on PND7) compared with those with dosing initiated on PND21 and mortality and some toxicities were observed earlier in the juvenile rats at 10 mg/kg compared with adult rats administered the same dose level. 
Toksičnost lenvatiniba je bila izrazitejša pri mlajših podganah (odmerjanje se je začelo na PND7) kot pri tistih, pri katerih se je odmerjanje začelo na PND21, in so smrtnost in nekatere toksičnosti prej opazili pri mladih podganah pri odmerku 10 mg/kg v primerjavi z odraslimi podganami, ki so prejemale enako raven odmerkov.
Other medicines and LENVIMA 
Druga zdravila in zdravilo LENVIMA
In vitro, cytochrome P450 3A4 was demonstrated as the predominant (>80%) isoform involved in the P450-mediated metabolism of lenvatinib. 
In vitro so pokazali, da je citokrom P450 3A4 prevladujoča (> 80 %) izooblika vpletena v presnovo lenvatiniba, ki poteka preko P450.
Lenvatinib has not been studied in patients who have had an arterial thromboembolism within the previous 6 months, and therefore should be used with caution in such patients. 
Pri bolnikih, ki so imeli v predhodnih 6 mesecih arterijsko trombembolijo, lenvatiniba niso proučevali, zato ga je treba pri takih bolnikih previdno uporabljati.
Gastrointestinal toxicity should be actively managed in order to reduce the risk of development of renal impairment or renal failure. 
Toksičnost za prebavila je treba aktivno obvladovati, da se zmanjša tveganje nastanka okvare ledvic ali odpovedi ledvic.
P-value d 
Vrednost pd
• If you become pregnant while being treated with LENVIMA, tell your doctor immediately. 
• Če med zdravljenjem z zdravilom LENVIMA zanosite, to takoj povejte zdravniku.
PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, altered mental function, blindness, and other visual or neurological disturbances. 
PRES je nevrološka bolezen, ki se lahko kaže z glavobolom, epileptičnim napadom, letargijo, zmedenostjo, spremenjenim duševnim stanjem, slepoto in drugimi motnjami vida ali nevrološkimi motnjami.
The capsules must be left in the liquid for at least 10 minutes and stirred for at least 3 minutes to dissolve the capsule shells. 
Kapsule pustimo v tekočini vsaj 10 minut in mešamo vsaj 3 minute, da se ovojnica kapsule raztopi.
Kaplan-Meier Curve of Progression-Free Survival - DTC 
Slika 1 Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni - DTC
These patients also had a higher incidence of renal reactions and arterial thromboembolic events. 
Ti bolniki so imeli tudi večjo incidenco neželenih učinkov na ledvice in arterijskih tromboemboličnih dogodkov.
There was also a case of acute hepatitis in a patient without liver metastases. 
Tudi en primer akutnega hepatitisa je nastopil pri bolniku brez metastaz v jetrih.
Your doctor may consider stopping LENVIMA if you will be undergoing a major surgical procedure as LENVIMA may affect wound healing. 
Zdravnik bo morda razmislil o prekinitvi zdravljenja z zdravilom LENVIMA, če boste imeli večji kirurški poseg, saj zdravilo LENVIMA lahko vpliva na celjenje ran.
Consider resuming at reduced dose if resolves to Grade 0-1. 
Ponoven začetek zdravljenja z zmanjšanim odmerkom pride v poštev, če se izboljša na stopnjo 0-1
LENVIMA is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). 
Zdravilo LENVIMA je indicirano kot monoterapija za zdravljenje odraslih bolnikov s progresivnim, lokalno napredovalim ali metastatičnim, diferenciranim (papilarnim/folikularnim/Hürthle-celičnim) karcinomom ščitnice (DTC - differentiated thyroid carcinoma), odpornim proti radioaktivnemu jodu (RAI - refractory to radioactive iodine).
Continue lenvatinib and increase the dose of the current antihypertensive therapy or initiate additional antihypertensive therapy 
Nadaljujte z lenvatinibom in zvečajte odmerek trenutnega antihipertenzivnega zdravila ali uvedite dodatno antihipertenzivno zdravilo.
Overall Survival Number of deaths (%) Median OS in months (95% CI) 
Celotno preživetje število smrti (%) mediano OS v mesecih (95 % IZ)
Patients with ≥50% liver occupation, clear invasion into the bile duct or a main branch of the portal vein (Vp4) on imaging were also excluded. 
Izključeni so bili tudi bolniki s prisotnostjo karconoma v ≥ 50 % jeter, jasnim vdorom v žolčni kanal ali glavno vejo portalne vene (Vp4) pri slikanju.
The M3 metabolite was the predominant analyte in excreta (~17% of the dose), followed by M2' (~11% of the dose) and M2 (~4.4 of the dose). 
Kot analit v izločkih je prevladoval presnovek M3 (~17 % odmerka), presnovkov M2' (~11 % odmerka) in M2 (~4,4 % odmerka) je bilo manj.
However, testicular (hypocellularity of the seminiferous epithelium) and ovarian changes (follicular atresia) were observed in repeated-dose toxicity studies in animals at exposures 11 to 15 times (rat) or 0.6 to 7 times (monkey) the anticipated clinical exposure (based on AUC) at the maximum tolerated human dose. 
Vendar so opazili testikularne (hipocelularnost seminifernega epitelija) in ovarijske (folikularna atrezija) spremembe v študijah toksičnosti ponavljajočih se odmerkov pri živalih pri izpostavljenostih, ki so bile 11-krat do 15-krat večje (podgana) ali 0,6-krat do 7-krat večje (opica) od predvidene klinične izpostavljenosti (na podlagi AUC) pri največjem toleriranem odmerku za ljudi.
In case of suspected overdose, lenvatinib should be withheld and appropriate supportive care given as required. 
V primeru suma na prevelik odmerek moramo prenehati dajati lenvatinib in po potrebi zagotoviti ustrezno podporno nego.
• changes in blood test results for magnesium (low), cholesterol (high) and thyroid stimulating hormone (high) 
• spremembe rezultatov krvnih preiskav glede magnezija v krvi (znižana), holesterola (zvišan) in tirotropnega hormona (zvišan),
Mortality was the dose-limiting toxicity in juvenile rats in which dosing was initiated on postnatal day (PND) 7 or PND21 and was observed at exposures that were respectively 125- or 12-fold lower compared with the exposure at which mortality was observed in adult rats, suggesting an increasing sensitivity to toxicity with decreasing age. 
Smrtnost je bila toksičnost, ki je omejevala odmerke pri mladih podganah, pri katerih se je odmerjanje začelo na postnatalni dan (PND) 7 ali PND21 in so jo opazovali pri izpostavljenostih, ki so bile 125-krat oziroma 12-krat manjše od izpostavljenosti, pri kateri so ugotavljali smrtnost pri odraslih podganah, kar kaže, da občutljivost za toksičnost raste s padanjem starosti.
• feeling numb or weak on one side of your body, severe headache, seizure, confusion, difficulty talking, vision changes or feeling dizzy - these may be signs of a stroke, bleeding on your brain, or the effect on your brain of a severe increase in blood pressure. 
• občutek odrevenelosti ali šibkosti na eni strani telesa, močan glavobol, napad krčev, zmedenost, otežen govor, spremembe vida ali občutek omotice - to so lahko znaki možganske kapi, krvavitve v možganih ali učinki močnega zvišanja krvnega tlaka na vaše možgane;
Median OS was longer by approximately 2.5 months in the lenvatinib compared with the sorafenib arm in both subsets of subjects (with or without post-treatment anticancer therapy). 
Mediano OS je bila za približno 2,5 meseca daljše v kraku z lenvatinibom v primerjavi s krakom s sorafenibom v obeh podskupinah oseb (z onkološkim zdravljenjem po zdravljenju ali brez njega).
Randomisation was stratified by geographic region (Europe, North America, and Other), prior VEGF/VEGFR-targeted therapy (patients may have received 0 or 1 prior VEGF/VEGFR-targeted therapy), and age (≤65 years or >65 years). 
Randomizacija je bila stratificirana po zemljepisnih regijah (Evropa, Severna Amerika, drugo), predhodnem zdravljenju, usmerjenem v VEGF/VEGFR (bolniki so lahko prejeli 0 ali 1 predhodno zdravljenje, usmerjeno v VEGF/VEGFR), in starosti (≤ 65 let ali > 65 let).
Women of childbearing potential must use highly effective contraception while taking lenvatinib and for one month after stopping treatment (see section 4.6). 
Ženske v rodni dobi morajo med jemanjem lenvatiniba in še en mesec po končanem zdravljenju uporabljati zelo učinkovito kontracepcijo (glejte poglavje 4.6).
In human liver microsomes, the demethylated form of lenvatinib (M2) was identified as the main metabolite. 
V mikrosomih človeških jeter so ugotovili, da je poglavitni presnovek demetilirana oblika lenvatiniba (M2).
• An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections). 
• razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij).
Increased blood thyroid stimulating hormone (see section 4.4 Impairment of thyroid stimulating hormone suppression / Thyroid dysfunction) 
Zvišan tirotropni hormon v krvi (glejte poglavje 4.4 Okvara supresije tirotropnega hormona / disfunkcija ščitnice)
In subgroup analyses by stratification factors (presence or absence of MPVI or EHS or both, ECOG PS 0 or 1, BW <60 kg or ≥60 kg and region) the HR consistently favoured lenvatinib over sorafenib, with the exception of Western region [HR of 1.08 (95% CI 0.82, 1.42], patients without EHS [HR of 1.01 (95% CI 0.78, 1.30)] and patients without MPVI, EHS or both [HR of 1.05 (0.79, 1.40)]. 
Pri analizah podskupin po faktorjih stratifikacije (prisotnost ali odsotnost MPVI ali EHS ali obeh, ECOG PS 0 ali 1, TM < 60 kg ali ≥ 60 kg in regija) je bila vrednost HR dosledno boljša za lenvatinib kot za sorafenib, razen v zahodni regiji [HR 1,08 (95-odstotni IZ 0,82; 1,42), pri bolnikih brez EHS [HR 1,01 (95-odstotni IZ 0,78; 1,30)] in pri bolnikih brez MPVI, EHS ali obeh [HR 1,05 (0,79; 1,40)].
Continue lenvatinib and initiate antihypertensive therapy, if not already receiving 
Nadaljujte z lenvatinibom in začnite z antihipertenzivnim zdravljenjem, če ga bolnik še ne prejema.
Lenvatinib is rapidly absorbed after oral administration with tmax typically observed from 1 to 4 hours postdose. 
Lenvatinib se po peroralnem dajanju hitro absorbira, tmax je navadno od 1 do 4 ure po odmerku.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0: 63%, ECOG PS of 
• stanje po lestvici ECOG PS 0: 63 %, ECOG PS 1: 37 %,
In the repeated-dose toxicity studies (up to 39 weeks), lenvatinib caused toxicologic changes in various organs and tissues related to the expected pharmacologic effects of lenvatinib including glomerulopathy, testicular hypocellularity, ovarian follicular atresia, gastrointestinal changes, bone changes, changes to the adrenals (rats and dogs), and arterial (arterial fibrinoid necrosis, medial degeneration, or haemorrhage) lesions in rats, dogs, and cynomolgus monkeys. 
V študijah toksičnosti ponavljajočih se odmerkov (do 39 tednov) je lenvatinib povzročal toksikološke spremembe v različnih organih in tkivih, ki so bile povezane s pričakovanimi farmakološkimi učinki lenvatiniba, vključno z glomerulopatijo, testikularno hipocelularnostjo, atrezijo ovarijskih foliklov, spremembami prebavil, spremembami kosti, spremembami nadledvičnic (pri podganah in psih) in arterijskimi (arterijska fibrinoidna nekroza, degeneracija medije ali krvavitev) lezijami pri podganah, psih in opicah Cynomolgus.
The median time to objective responsive was 2.0 (95% CI: 1.9, 3.5) months; however, of the patients who experienced a complete or partial response to lenvatinib, 70.4% were observed to develop the response on or within 30 days of being on the 24-mg dose. 
Mediani čas do objektivnega odziva je bil 2,0 meseca (95 % IZ: 1,9; 3,5); vendar so opazili, da je od bolnikov, ki so imeli popoln ali delen odziv na lenvatinib, 70,4 % razvilo odziv v 30 dneh prejemanja 24-miligramskega odmerka ali prej.
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Recommended daily dose 
Priporočeni dnevni odmerek
Histologically, 66.1% had a confirmed diagnosis of papillary thyroid cancer and 33.9% had follicular thyroid cancer which included Hürthle cell 14.8% and clear cell 3.8%. 
Histološko jih je imelo 66,1 % potrjeno diagnozo papilarnega raka ščitnice, 33,9 % pa diagnozo folikularnega raka ščitnice, ki je vključeval raka Hürthleovih celic (14,8 %) in svetlih celic (3,8 %).
• chest pain or pressure, pain in your arms, back, neck or jaw, being short of breath, rapid or irregular heart rate, coughing, bluish colour to lips or fingers, feeling very tired - these may be signs of a heart problem, a blood clot in your lung or a leak of air from your lung into your chest so your lung cannot inflate. 
• bolečina ali stiskanje v prsih, bolečina v zgornjih udih, hrbtu, vratu ali čeljusti, kratka sapa, hiter ali nereden srčni utrip, kašelj, modrikasta barva ustnic ali prstov, občutek močne utrujenosti - to so lahko znaki težav s srcem, krvnega strdka v vaših pljučih ali uhajanja zraka iz pljuč v prsni koš, tako da se pljuča ne morejo napihniti;
The dose is usually 12 mg once a day (3 capsules of 4 mg) if you weigh 60 kg or more and 8 mg once a day (2 capsules of 4 mg) if you weigh less than 60kg. 
Odmerek navadno 12 mg enkrat na dan (3 kapsule po 4 mg), če ste težki 60 kg ali več oz. 8 mg enkrat na dan (2 kapsuli po 4 mg), če ste težki manj kot 60 kg.
Reproductive and developmental toxicity 
Vpliv na sposobnost razmnoževanja in razvoj
LENVIMA is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy (see section 5.1). 
Zdravilo LENVIMA je indicirano kot monoterapija za zdravljenje odraslih bolnikov z napredovalim ali neoperabilnim heptocelularnim karcinomom (HCC - hepatocellular carcinoma), ki predhodno niso bili sistemsko zdravljeni (glejte poglavje 5.1)
Lenvatinib exposure, based on AUC0-inf data, was 101%, 90%, and 122% of normal for subjects with mild, moderate, and severe renal impairment, respectively. 
Izpostavljenost lenvatinibu na podlagi podatkov AUC0-inf je bila 101 %, 90 % oziroma 122 % normalne vrednosti pri preiskovancih z blago, zmerno oziroma hudo okvaro ledvic.
What LENVIMA looks like and contents of the pack 
Izgled zdravila LENVIMA in vsebina pakiranja
• changes in blood test results for liver function 
• sprememba rezultatov krvnih preiskav za delovanje jeter,
(1 capsule of 10 mg and 1 capsule of 4 mg). 
(1 kapsula z 10 mg in 1 kapsula s 4 mg).
4.5 Interaction with other medicinal products and other forms of interaction Effect of other medicinal products on lenvatinib 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Treatment should be discontinued in case of life-threatening reactions (e.g., Grade 4) with the exception of laboratory abnormality judged to be non-life-threatening, in which case they should be managed as severe reaction (e.g., Grade 3). 
Zdravljenje je treba prekiniti v primeru življenjsko nevarnih neželenih učinkov (npr. stopnje 4), z izjemo laboratorijskih nenormalnosti, za katere sodimo, da niso življenjsko nevarne; v tem primeru jih obravnavajte kot hude neželene učinke (npr.stopnje 3).
The incidence of QT interval prolongation of greater than 500 ms was 2% in the lenvatinib-treated patients compared to no reports in the placebo group. 
Pogostnost podaljšanja intervala QT, večjega od 500 ms, je bila 2 % pri bolnikih, zdravljenih z lenvatinibom, v skupini s placebom pa o tem niso poročali.
Arterial thromboembolic events also occurred at an increased incidence in this age group. 
V tej starostni skupini so se pogosteje pojavljali tudi arterijski tromboembolični dogodki.
Adjusted Doseb (≥60 kg BW) 
Prilagojen odmerekb (≥ 60 kg TM)
All patients other than those with severe hepatic or renal impairment (see below) should initiate treatment at the recommended 24 mg dose, following which the dose should be further adjusted on the basis of individual tolerability. 
Vsi bolniki razen tistih, ki imajo hudo okvaro jeter ali ledvic (glejte v nadaljevanju), naj začnejo z zdravljenjem s priporočenim odmerkom 24 mg, nato pa naj se odmerek nadalje prilagaja na podlagi prenašanja vsakega bolnika posebej.