FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients previously treated with chemotherapy, the initial dose is 150 mg/m2 once daily, to be increased in the second cycle to 200 mg/m2 once daily, for 5 days if there is no haematological toxicity (see section 4.4)
Croatian: U bolesnika koji su prethodno liječeni kemoterapijom početna doza iznosi 150 mg/m2 jedanput na dan, a u drugom ciklusu se povećava na 200 mg/m2 jedanput na dan tijekom 5 dana ako nema znakova hematološke toksičnosti (vidjeti dio 4.4).
English: If a capsule is damaged, avoid contact with your skin, eyes or nose.
Croatian: Ako je kapsula oštećena, izbjegavajte kontakt praška s kožom, očima ili nosom.
English: PET studies in humans and preclinical data suggest that TMZ crosses rapidly the blood-brain barrier and is present in the CSF.
Croatian: Ispitivanja u ljudi primjenom PET-a kao i neklinički podaci ukazuju na to da TMZ brzo prelazi krvnomoždanu barijeru i da je prisutan u cerebrospinalnom likvoru.
English: The addition of concomitant TMZ to RT, followed by TMZ monotherapy in the treatment of patients with newly diagnosed glioblastoma multiforme demonstrated a statistically significant improvement in overall survival (OS) compared with RT alone (Figure 1).
Croatian: Istodobna primjena TMZ-a i RT-a na koju se nastavila monoterapija TMZ-om u liječenju bolesnika s novodijagnosticiranim multiformnim glioblastomom dovela je do statistički značajnog poboljšanja ukupnog preživljenja (engl. overall survival, OS) u usporedbi s primjenom samo RT-a (Slika 1).
English: Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8).
Croatian: Vrlo su rijetko prijavljeni slučajevi mijelodisplastičnog sindroma i sekundarnih zloćudnih bolesti, uključujući mijeloičnu leukemiju (vidjeti dio 4.8).
English: If you develop fever or symptoms of an infection contact your doctor immediately.
Croatian: Ako dobijete vrućicu ili simptome infekcije, odmah se obratite
English: If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose.
Croatian: Ako je kapsula oštećena, izbjegavati kontakt praška s kožom, očima ili nosom.
English: Cases of diabetes insipidus have been uncommonly reported.
Croatian: Manje često su prijavljeni slučajevi dijabetes insipidusa.
English: Based on the pharmacokinetic properties of TMZ, it is unlikely that dose reductions are required in patients with severe hepatic impairment or any degree of renal impairment.
Croatian: S obzirom na farmakokinetička svojstva TMZ-a, vjerojatno neće biti potrebno smanjivati dozu u bolesnika s teškim oštećenjem funkcije jetre ili oštećenjem funkcije bubrega bilo kojeg stupnja.
English: The median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p = < 0.01 to 0.03).
Croatian: Medijan vremena do progresije bolesti prema ovim mjerama ishoda bio je za 0,7 do 2,1 mjeseca dulji u skupini koja je primala TMZ nego u skupini koja je primala prokarbazin (log-rang p = < 0,01 do 0,03).
English: • abnormal or blurred vision, double-vision
Croatian: • poremećen ili zamagljen vid, dvostruke slike
English: • muscle damage, back pain
Croatian: • oštećenje mišića, bol u leđima
English: Hearing impairment, tinnitus
Croatian: poremećaj sluha poremećaj sluha, tinitus
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Citotoksično
English: Cases of sepsis (when bacteria and their toxins circulate in the blood and start to damage the organs) have been uncommonly reported.
Croatian: Manje često su prijavljeni slučajevi sepse (stanja u kojem bakterije i njihovi toksini cirkuliraju krvotokom i počinju oštećivati organe).
English: When laboratory abnormalities and adverse reactions were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic reactions were observed in 8% of the patients.
Croatian: Kad su se objedinila odstupanja laboratorijskih nalaza i nuspojava iz faze istodobnog liječenja i faze monoterapije, poremećaji broja neutrofila stupnja 3 ili 4, uključujući neutropeniju, zabilježeni su u 8% bolesnika.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE
English: Table 6.
Croatian: Tablica 6.
English: Experts in liver disease should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease).
Croatian: Prije započinjanja liječenja u bolesnika koji su seropozitivni na hepatitis B (uključujući i one s aktivnom bolešću) potrebno je konzultirati stručnjaka za bolesti jetre.
English: • discolouration of your tongue
Croatian: • promjena boje jezika
English: Type III amber glass bottles with polypropylene child-resistant closures and a desiccant, containing 5 or 20 capsules.
Croatian: Bočice od smeđeg stakla tipa III, s polipropilenskim sigurnosnim zatvaračima za djecu i sredstvom za sušenje, koje sadrže 5 ili 20 kapsula.
English: New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported.
Croatian: Manje često su prijavljene nove ili reaktivirane (ponavljajuće) infekcije citomegalovirusom te reaktivirane infekcije virusom hepatitisa B.
English: Temozolomide should only be prescribed by specialists experienced in brain tumours.
Croatian: Temozolomid smije propisati samo specijalist iskusan u liječenju tumora mozga.
English: After oral administration to adult patients, TMZ is absorbed rapidly, with peak concentrations reached as early as 20 minutes post administration (mean times between 0.5 and 1.5 hours).
Croatian: Nakon peroralne primjene u odraslih bolesnika TMZ se brzo apsorbira te postiže vršne koncentracije već 20 minuta nakon primjene (prosječno vrijeme između 0,5 i 1,5 sati).
English: Women of child bearing should be advised to use effective contraception to avoid pregnancy while they are receiving TMZ.
Croatian: Ženama reproduktivne dobi potrebno je savjetovati da koriste pouzdanu kontracepciju kako bi izbjegle trudnoću za vrijeme liječenja temozolomidom.
English: prolonged pancytopenia, aplastic anaemia† Neoplasm benign, malignant and unspecified Very rare:
Croatian: produljena pancitopenija, aplastična anemija† Dobroćudne, zloćudne i nespecificirane novotvorine Vrlo rijetko:
English: Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
Croatian: infekcija, Herpes simplex, infekcija rane, faringitis, oralna kandidijaza infekcija, oralna kandidijaza
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic reactions were observed in 14% of the patients who received TMZ.
Croatian: Poremećaji broja trombocita stupnja 3 ili 4, uključujući trombocitopeniju, opaženi su u 14% bolesnika koji su primili TMZ.
English: Oral TMZ has been studied in paediatric patients (age 3-18 years) with recurrent brainstem glioma or recurrent high grade astrocytoma, in a regimen administered daily for 5 days every 28 days.
Croatian: Peroralno primijenjen TMZ ispitivan je u pedijatrijskih bolesnika (u dobi od 3 do 18 godina) s recidivirajućim gliomom moždanog debla ili recidivirajućim astrocitomom visokog stupnja prema protokolu doziranja jedanput na dan tijekom 5 dana svakih 28 dana.
English: Stearic acid
Croatian: A tartaratna kiselina stearatna kiselina
English: • shortness of breath, cough
Croatian: • nedostatak zraka, kašalj
English: Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of TMZ.
Croatian: U Tablici 5 obuhvaćene su nuspojave prijavljene tijekom kliničkih ispitivanja recidivirajućeg ili progresivnog malignog glioma te nakon stavljanja u promet lijeka TMZ-a.
English: This was followed by monotherapy TMZ (150 - 200 mg/m2) on Days 1 - 5 of every 28-day cycle for up to 6 cycles, starting 4 weeks after the end of RT.
Croatian: Nakon toga slijedila je monoterapija TMZ-om (150-200 mg/m2) od 1. do 5. dana svakog ciklusa od 28 dana do najviše 6 ciklusa, a monoterapija bi započela 4 tjedna nakon završetka radioterapije.
English: Hypokalemia, alkaline phosphatase increased, weight increased
Croatian: hipokalijemija, povišene vrijednosti alkalne fosfataze, povećanje tjelesne težine hiperglikemija, povećanje tjelesne težine
English: • sexual impotence, vaginal bleeding, absent or heavy menstrual periods, vaginal irritation, breast pain,
Croatian: • impotencija, krvarenje iz rodnice, izostanak ili obilne menstruacije, nadraženost rodnice, bol u dojkama
English: TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC).
Croatian: TMZ se spontano hidrolizira pri fiziološkom pH prvenstveno u aktivni spoj 3-metil-(triazen1-il)imidazol-4-karboksamid (MTIC).
English: a severe allergic reaction (rash which might be itchy, wheezing or other breathing difficulty), - uncontrolled bleeding, - Seizures (convulsions), - fever, - chills, - severe headache that does not go away.
Croatian: Odmah se obratite liječniku ako imate nešto od sljedećeg: - jaku alergijsku reakciju (reakciju preosjetljivosti) (koprivnjača, piskanje pri disanju ili druge tegobe s disanjem), - nekontrolirano krvarenje, - napadaje (konvulzije), - vrućicu, - zimicu, - jaku glavobolju koja ne prestaje.
English: Prior to dosing, the following laboratory parameters must be met: ANC ≥1.5 x 109/l and platelet count ≥ 100 x 109/l.
Croatian: Prije primjene temozolomida moraju biti zadovoljeni sljedeći laboratorijski parametri: ABN ≥ 1,5 x 109/l i broj trombocita ≥ 100 x 109/l.
English: CSF penetration was confirmed in one patient; CSF exposure based on AUC of TMZ was approximately 30% of that in plasma, which is consistent with animal data.
Croatian: Izloženost u cerebrospinalnom likvoru, izračunata na temelju AUC-a temozolomida, iznosila je približno 30% one u plazmi, što je u skladu s podacima dobivenima u istraživanjima na životinjama.
English: Store in the original bottle in order to protect from moisture.
Croatian: Čuvati u originalnoj bočici radi zaštite od vlage.
English: • fits, change in mental status or alertness, sleepiness, difficulty with your balance, dizziness,
Croatian: • napadaji, promjena mentalnog statusa ili budnosti, pospanost, poremećaj ravnoteže, omaglica,
English: • weakness, swollen face, shivering, change in your sense of taste, tooth disorder
Croatian: • slabost, oticanje lica, drhtanje, poremećaj osjeta okusa, promjene na zubima
English: Pregnancy,breast-feeding and fertility
Croatian: Trudnoća, dojenje i plodnost
English: • sores or ulcers in the mouth, diarrhoea, stomach pain, heartburn, difficulty swallowing, dry mouth
Croatian: • rane ili ulceracije u ustima, proljev, bol u trbuhu, žgaravica, otežano gutanje, suha usta
English: • pneumonia, inflammation of your sinuses, bronchitis, blocked nose, a cold or the flu
Croatian: • upala pluća, upala sinusa, bronhitis, začepljen nos, prehlada ili gripa
English: If abnormal, physicians should assess the benefit/risk prior to initiating temozolomide including the potential for fatal hepatic failure.
Croatian: U slučaju odstupanja od normalnih vrijednosti, liječnici trebaju pažljivo razmotriti odluku o započinjanju liječenja temozolomidom temeljem procjene odnosa koristi i rizika, uključujući i potencijal zatajenja jetre sa smrtnim ishodom.
English: How to take Temozolomide Accord
Croatian: Kako uzimati Temozolomid Accord
English: Other side effects:
Croatian: - Ostali sastojci su:
English: Men being treated with TMZ should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment (see section 4.6).
Croatian: Muškarcima koji se liječe TMZ-om treba savjetovati da ne začinju dijete do 6 mjeseci nakon primanja posljednje doze lijeka te da se prije početka liječenja posavjetuju oko pohrane sperme zamrzavanjem (vidjeti dio 4.6).
English: Endocrine disorders* Uncommon:
Croatian: Endokrini poremećaji* Manje često:
English: Vomiting, nausea, constipation
Croatian: povraćanje, mučnina, konstipacija
English: Palpitation
Croatian: palpitacije
English: Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
Croatian: Lijek čuvajte izvan pogleda i dohvata djece, najbolje u zaključanom ormariću.
English: • infection of the middle ear, pain or discomfort in the ears from loud noises, earache, deafness,
Croatian: • infekcija srednjeg uha, bol ili neugoda u ušima zbog buke, bol u uhu, gluhoća, osjećaj vrtenja okoline
English: • infections, wound infection, sore throat, fungal infections in the mouth, cold sores
Croatian: • infekcije, infekcija rane, bolno grlo, gljivične infekcije usta, herpes
English: Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.
Croatian: Manje često su zabilježeni slučajevi povišenja bilirubina, poteškoća s protokom žuči (kolestaza), hepatitisa i oštećenja jetre, uključujući i zatajenje jetre sa smrtnim ishodom.
English: The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O6 position of guanine with additional alkylation also occurring at the N7 position.
Croatian: Smatra se da je za citotoksičnost MTIC-a primarno odgovorna alkilacija na položaju gvanina O6, uz dodatnu alkilaciju na položaju N7. U nastanak citotoksičnih lezija vjerojatno je uključen poremećaj mehanizma za popravak metilne skupine.
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8%
Croatian: Nakon peroralne primjene temozolomida označenog radioizotopom 14C, u fecesu je tijekom 7 dana nakon primjene doze izlučeno prosječno 0,8% radioizotopa 14C, što upućuje na potpunu apsorpciju.
English: CTC non-haematological toxicity (except for alopecia, nausea, vomiting) CTC Grade 2
Croatian: CTC stupanj nehematološke toksičnosti (osim alopecije, mučnine i povraćanja) CTC stupnja 2
English: You will take the capsules once daily for the first five days (“dosing days”) followed by 23 days without temozolomide, adding up to the 28 day treatment cycle.
Croatian: Uzimat ćete kapsule jedanput na dan prvih 5 dana nakon čega slijede 23 dana bez temozolomida, što čini ukupno 28 dana terapijskog ciklusa.
English: Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
Croatian: povišene vrijednosti jetrenih enzima, povišene vrijednosti gama-GT-a, povišene vrijednosti AST-a *Jedan bolesnik koji je bio randomiziran u skupinu koja je primala samo RT, primio je TMZ + RT.
English: Therefore, men being treated with it should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment, because of the possibility of irreversible infertility due to therapy with TMZ.
Croatian: Stoga, muškarcima koji se liječe ovim lijekom treba savjetovati da ne začinju dijete do 6 mjeseci nakon primanja posljednje doze lijeka te da se prije početka liječenja posavjetuju oko pohrane sperme zamrzavanjem jer postoji mogućnost da terapija TMZ-om dovede do trajne neplodnosti.
English: Cases of brain infections caused by herpes virus (meningoencephalitis herpetic), including fatal cases, have been uncommonly reported.
Croatian: Manje često su prijavljeni slučajevi infekcija mozga izazvani virusom herpesa (herpesni meningoencefalitis), uključujući slučajeve sa smrtnim ishodom.
English: toxic epidermal necrolysis, Stevens-Johnson syndrome
Croatian: Poremećaji kože i potkožnog tkiva Vrlo rijetko toksična epidermalna nekroliza, Stevens-Johnson sindrom
English: Rash, alopecia
Croatian: osip, alopecija osip, alopecija
English: Dermatitis, dry skin, erythema, pruritus
Croatian: dermatitis, suha koža, eritem, pruritus suha koža, pruritus
English: • muscle weakness, painful joints, muscle aches and pains
Croatian: • mišićna slabost, bolni zglobovi, bol u mišićima
English: Agitation, apathy, behaviour disorder, depression, hallucination
Croatian: agitiranost, apatija, poremećaji ponašanja, depresija, halucinacije halucinacije, amnezija
English: Marketing Authorisation Holder and Manufacturer
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač:
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: PRILOG III OZNAČIVANJE I UPUTA O LIJEKU
English: - if you have had an allergic reaction to another anti-cancer medicine called dacarbazine.
Croatian: - ako ste alergični na temozolomid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako ste imali alergijsku reakciju na drugi lijek protiv raka koji se zove dakarbazin.
English: There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12% vs 5%, and thrombocytopenia (< 20 x 109/l), 9% vs 3 %, in women vs men in the first cycle of therapy.
Croatian: U prvom ciklusu terapije stopa neutropenije (ABN < 0,5 x 109/l) i trombocitopenije (< 20 x 109/l) stupnja 4 bila je viša u žena nego u muškaraca: 12% naspram 5% kod neutropenije i 9% naspram 3% kod trombocitopenije.
English: You will take your new dose of temozolomide capsules initially at 150 mg/m² once daily for the first five days (“dosing days”) of each cycle, followed by 23 days without temozolomide; this adds up to a 28 day treatment cycle.
Croatian: Uzimat ćete novu dozu temozolomid kapsula u početnoj dozi od 150 mg/m2 jedanput na dan prvih 5 dana svakog ciklusa („dani doziranja“), nakon čega slijede 23 dana bez uzimanja lijeka temozolomida, što čini ukupno 28 dana terapijskog ciklusa.
English: Summary of events reported with temozolomide in the post-marketing setting*
Croatian: Popis nuspojava prijavljenih nakon stavljanja lijeka u promet*
English: Abdominal distension, faecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Croatian: abdominalna distenzija, inkontinencija stolice, nespecificirani gastrointestinalni poremećaj, gastroenteritis, hemoroidi
English: Infections including agents causing pneumonia.
Croatian: kašalj, infekcije, uključujući infekcije uzročnicima upale pluća.
English: In a study of 288 subjects with newly diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3 % of female vs 0% of male subjects and Grade 4 thrombocytopenia in 1% of female vs 0% of male subjects in the first cycle of therapy.
Croatian: U kliničkom ispitivanju s 288 ispitanika s novodijagnosticiranim multiformnim glioblastomom neutropenija stupnja 4 nastupila je u 3% žena naspram 0% muškaraca, a trombocitopenija stupnja 4 u 1% žena naspram 0% muškaraca tijekom prvog ciklusa terapije.
English: At 6 months, the fraction of surviving patients was significantly higher in the TMZ arm (60%) compared with the procarbazine arm (44%) (chi-square p = 0.019).
Croatian: Nakon 6 mjeseci je udio bolesnika koji su preživjeli bio značajno veći u skupini bolesnika koji su primali TMZ (60%) nego u skupini bolesnika koji su primali prokarbazin (44%) (hi-kvadrat p = 0,019).
English: • bleeding, fluid retention, swollen legs, blood clots
Croatian: • krvarenje, zadržavanje tekućine, oticanje nogu, krvni ugrušci
English: • feeling and/or being sick
Croatian: • mučnina i/ili povraćanje
English: Diarrhoea, abdominal pain, dyspepsia
Croatian: proljev, bolovi u abdomenu, dispepsija
English: - The other ingredients are: capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Croatian: Sadržaj kapsule: bezvodna laktoza, koloidni, bezvodni silicijev dioksid, natrijev škroboglikolat, vrste A, tartaratna kiselina, stearatna kiselina.
English: Investigations Common:
Croatian: Pretrage Često:
English: 4.2 Posology and method of administration Temozolomide Accord should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Croatian: Temozolomid Accord smiju propisivati samo liječnici s iskustvom u onkološkom liječenju tumora mozga.
English: How to store Temozolomide Accord
Croatian: Kako čuvati Temozolomid Accord
English: Sleepiness, dizziness, tingling sensation, diarrhoea, stomach pain, indigestion, rash, itching, hair loss, weight loss, fever, weakness, shivering, feeling unwell, pain, change in taste, shortness of breath
Croatian: pospanost, omaglica, trnci, proljev, bol u trbuhu, loša probava, osip, svrbež, gubitak kose, gubitak tjelesne težine, vrućica, slabost, drhtanje, loše osjećanje, bol, promjene osjeta okusa, nedostatak zraka.
English: Hyperglycaemia, weight decreased
Croatian: hiperglikemija, smanjenje tjelesne težine smanjenje tjelesne težine
English: ≥ 0.5 and < 1.5 x 109/l
Croatian:  0,5 i < 1,5 x 109/l
English: Pneumocystis jirovecii pneumonia
Croatian: Pneumonija uzrokovana Pneumocystis jirovecii
English: For all patients, liver function tests should be checked after each treatment cycle.
Croatian: Nakon svakog terapijskog ciklusa potrebno je napraviti ispitivanje funkcije jetre u svih bolesnika liječenih temozolomidom.
English: TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see section 4.8).
Croatian: TMZ malo utječe na sposobnost upravljanja vozilima i rada sa strojevima zbog umora i somnolencije (vidjeti dio 4.8).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 hard capsules
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 5 tvrdih kapsula 20 tvrdih kapsula DRUGO
English: Constipation, nausea, vomiting Constipation, nausea, vomiting
Croatian: konstipacija, mučnina, povraćanje konstipacija, mučnina, povraćanje
English: Patients who received concomitant TMZ and RT in a pilot trial for the prolonged 42 day schedule were shown to be at particular risk for developing Pneumocystis jirovecii pneumonia (PCP).
Croatian: Bolesnici koji su u pilot istraživanju istodobno primali TMZ i RT prema produljenom 42-dnevnom protokolu liječenja bili su izloženi osobitom riziku od razvoja pneumonije uzrokovane Pneumocystis jirovecii (engl.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Temozolomide Accord is indicated for the treatment of: adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Croatian: Temozolomid Accord je indiciran za liječenje: - odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom, istodobno s radioterapijom (RT), a zatim kao monoterapija.
English: Muscle weakness, arthralgia Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Croatian: mišićna slabost, artralgija mišićna slabost, artralgija, bol u mišićima i kostima, mialgija
English: Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
Croatian: U prvom ciklusu monoterapije TMZ se daje u dozi od 150 mg/m2 jedanput na dan tijekom 5 dana, nakon čega slijede 23 dana bez terapije.
English: Endocrine disorders Uncommon:
Croatian: Endokrini poremećaji Manje često:
English: Response rate, based on the central reviewer assessment, was 35% (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Croatian: Stopa odgovora na liječenje prema procjeni glavnog recenzenta iznosila je 35% (13 potpunih odgovora i 43 djelomična odgovora) populacije koju se namjeravalo liječiti (engl. intent-to-treat, ITT) n = 162.
English: Do not open, crush or chew the capsules, swallow whole.
Croatian: Kapsule ne otvarati, žvakati ili drobiti, progutati ih cijele.
English: In the tables, undesirable effects are classified according to System Organ Class and frequency.
Croatian: U tablicama su nuspojave razvrstane prema organskim sustavima i učestalosti pojavljivanja.
English: • low potassium level in the blood, weight gain
Croatian: • niska razina kalija u krvi, povećanje tjelesne težine
English: Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain
Croatian: hemianopija, smanjena oštrina vida, poremećaj vida, ispad vidnog polja, bol u oku smanjena oštrina vida, bol u oku, suhoća oka
English: Anxiety, depression, emotional lability, insomnia
Croatian: anksioznost, emocionalna labilnost, nesanica anksioznost, depresija, emocionalna labilnost, nesanica