FrancophonIA/ELRC3.0 huggingface dataset:
English: Contents of the pack and other information What Temozolomide Teva contains
Croatian: Sadržaj pakiranja i druge informacije Što Temozolomid Teva sadrži
English: If Temozolomide Teva comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Croatian: Ako Temozolomid Teva dođe u kontakt s kožom ili sluznicom, to područje treba odmah temeljito isprati sapunom i vodom.
English: In very rare cases, patients taking Temozolomide Teva and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
Croatian: U vrlo rijetkim slučajevima, bolesnici koji uzimaju Temozolomid Teva i slične lijekove mogu imati malen rizik od razvoja sekundarnih vrsta raka, uključujući leukemiju.
English: TMZ demonstrates low protein binding (10% to 20%), and thus it is not expected to interact with highly protein-bound substances.
Croatian: TMZ se slabo veže za proteine (10 do 20%), pa se stoga ne očekuje da ulazi u interakcije s tvarima koje imaju visok afinitet vezanja za proteine.
English: Other medicines and Temozolomide Teva
Croatian: Drugi lijekovi i Temozolomid Teva
English: Paediatric patients had a higher AUC than adult patients; however, the maximum tolerated dose (MTD) was 1,000 mg/m² per cycle both in children and in adults.
Croatian: Pedijatrijski bolesnici imali su veći AUC nego odrasli bolesnici; međutim, maksimalna podnošljiva doza iznosila je 1000 mg/m2 po ciklusu kako u djece, tako i u odraslih bolesnika.
English: drug reaction with eosinophilia and systemic symptons (DRESS)
Croatian: reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS)
English: Most haematologic adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5); the frequency of grade 3-4 laboratory findings is presented after each table.
Croatian: Većina hematoloških nuspojava prijavljena je često ili vrlo često u obje indikacije (Tablice 4 i 5); iza svake tablice navedena je učestalost poremećaja laboratorijskih nalaza stupnja 3-4.
English: In some cases, it may be necessary to stop treatment with Temozolomide Teva.
Croatian: U nekim će slučajevima možda biti neophodno prekinuti liječenje lijekom Temozolomid Teva.
English: There are reports of patients who have taken the recommended dose for more than 5 days of treatment (up to 64 days) with adverse events reported including bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death.
Croatian: Prijavljeno je da su neki bolesnici uzimali preporučenu dozu dulje od 5 dana liječenja (do 64 dana), pri čemu su prijavljene nuspojave obuhvaćale supresiju koštane srži, sa ili bez infekcije, koja je u nekim slučajevima bila teška i dugotrajna te završila smrću.
English: Temozolomide Teva may cause permanent infertility.
Croatian: Temozolomid Teva može uzrokovati trajnu neplodnost.
English: A treatment cycle with Temozolomide Teva lasts 28 days.
Croatian: Ciklus liječenja lijekom Temozolomid Teva traje 28 dana.
English: Administration of TMZ with food resulted in a 33% decrease in Cmax and a 9% decrease in area under the curve (AUC).
Croatian: Primjena TMZ-a s hranom dovela je do smanjenja Cmax za 33%, a površine ispod krivulje (AUC) za
English: In the noncomparative trial, the PFS at 6 months was 19%, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
Croatian: U nekomparativnom ispitivanju je PFS nakon šest mjeseci iznosio 19%, medijan preživljenja bez progresije bolesti bio je 2,1 mjesec, a medijan ukupnog preživljenja 5,4 mjeseca.
English: Take your prescribed dose of Temozolomide Teva once a day, preferably at the same time each day.
Croatian: Uzmite propisanu dozu lijeka Temozolomid Teva jedanput na dan, po mogućnosti svakoga dana u isto vrijeme.
English: What Temozolomide Teva looks like and contents of the pack
Croatian: Kako Temozolomid Teva izgleda i sadržaj pakiranja
English: Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100) ); Rare (≥1/10,000 to <1/1,000);
Croatian: < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000).
English: TMZ Dose (mg/m²/day)
Croatian: Doza TMZ-a (mg/m2/dan)
English: The lowest recommended dose is 100 mg/m².
Croatian: Najniža preporučena doza iznosi 100 mg/m2.
English: How to store Temozolomide Teva Contents of the pack and other information
Croatian: Kako čuvati Temozolomid Teva Sadržaj pakiranja i druge informacije
English: Temozolomide Teva is used in these tumours if they return or get worse after standard treatment.
Croatian: U ovom slučaju Temozolomid Teva se koristi ako se tumor ponovno pojavio ili se pogoršava nakon standardne terapije.
English: Your doctor will work out your exact dose.
Croatian: Liječnik će izračunati točnu dozu lijeka koja Vam je potrebna.
English: Herpes simplex, Herpes zoster, influenza-like symptoms
Croatian: Herpes simplex, herpes zoster, simptomi nalik gripi
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide Teva to prevent or control nausea and vomiting.
Croatian: Liječnik Vam može dati i neke druge lijekove (antiemetike) koje ćete uzimati prije i/ili nakon što uzmete Temozolomid Teva radi izbjegavanja ili kontrole mučnine i povraćanja.
English: Before each new treatment cycle, your blood will be tested to see if the Temozolomide Teva dose needs to be adjusted.
Croatian: Prije svakog novog terapijskog ciklusa napravit će Vam se krvne pretrage kako bi se utvrdilo treba li prilagoditi dozu lijeka Temozolomid Teva.
English: In a multicentre, prospective phase II trial evaluating the safety and efficacy of oral TMZ in the treatment of patients with anaplastic astrocytoma at first relapse, the 6 month PFS was 46%.
Croatian: U multicentričnom prospektivnom ispitivanju faze II u kojemu se procjenjivala sigurnost i djelotvornost peroralno primijenjenog TMZ-a u liječenju bolesnika s prvim relapsom anaplastičnog astrocitoma, šestomjesečni PFS iznosio je 46%.
English: Temozolomide Teva should not be administered to pregnant women.
Croatian: Temozolomid Teva se ne smije davati trudnicama.
English: The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60% to 100% of rats and dogs tested, degeneration of the retina occurred.
Croatian: Toksični učinci primarno su zahvaćali koštanu srž, limforetikularni sustav, testise i gastrointestinalni trakt, a pri većim dozama koje su bile letalne za 60% do 100% ispitanih štakora i pasa razvila se degeneracija mrežnice.
English: Frequency groupings are defined according to the following convention: Very common (≥ 1/10);
Croatian: Učestalost pojavljivanja razvrstana je prema sljedećoj konvenciji: vrlo često (≥ 1/10); često (≥1/100 i
English: If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus.
Croatian: Ako je nužno razmatrati mogućnost primjene tijekom trudnoće, bolesnicu se mora upoznati s potencijalnim rizikom za plod.
English: In some cases, exposure to concomitant medicinal products associated with aplastic anaemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment.
Croatian: nekim slučajevima istodobna izloženost lijekovima povezanima s razvojem aplastične anemije, uključujući karbamazepin, fenitoin i sulfametoksazol/trimetoprim, otežava procjenu.
English: The hazard ratio (HR) for overall survival was 1.59 (95% CI for HR=1.33 -1.91) with a log-rank p < 0.0001 in favour of the TMZ arm.
Croatian: Omjer hazarda (engl. hazard ratio, HR) za ukupno preživljenje iznosio je 1,59 (95% CI za HR = 1,33-1,91), uz log-rang p < 0,0001 u korist skupine koja je primala TMZ.
English: Patients with recurrent or progressive malignant glioma Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.
Croatian: Bolesnici s recidivirajućim ili progresivnim malignim gliomom Bolesnicima koji su jako povraćali (stupanj 3 ili 4) tijekom prethodnog ciklusa liječenja možda će biti potrebno dati antiemetik.
English: If you forget to take Temozolomide Teva
Croatian: Ako ste zaboravili uzeti Temozolomid Teva
English: No dose reductionsare recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non-haematological toxicity criteria.
Croatian: Ne preporučuje se smanjivanje doze lijeka, ali svakog tjedna treba odlučiti o odgodi ili prekidu primjene TMZ-a prema kriterijima hematološke i nehematološke toksičnosti.
English: You will take your new dose of Temozolomide Teva alone once daily for the first 5 days (“dosing days”) of each cycle.
Croatian: Uzimat ćete novu dozu lijeka Temozolomid Teva jedanput na dan prvih 5 dana svakog ciklusa ("dani doziranja").
English: If you take more Temozolomide Teva than you should
Croatian: Ako uzmete više Temozolomid Teva kapsula nego što ste trebali
English: If you accidentally take more Temozolomide Teva capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Croatian: Ako uzmete više Temozolomid Teva kapsula nego što ste trebali, odmah se javite liječniku, ljekarniku ili medicinskoj sestri.
English: Post-marketing experience
Croatian: Iskustvo nakon stavljanja u promet
English: The colour and marking of the capsule is different for each strength (see table below).
Croatian: Svaka jačina kapsule ima kapicu druge boje (vidjeti tablicu u nastavku).
English: A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC > 1.5 x 109/l and platelet count > 100 x109/l.
Croatian: Kompletna krvna slika mora se napraviti 22. dana (21 dan nakon prve doze) ili unutar 48 sati od tog dana, a zatim jednom tjedno sve dok ABN ne bude > 1,5 x 109/l, a broj trombocita > 100 x 109/l.
English: *A patient who was randomised to the RT arm only, received TMZ + RT.
Croatian: *Jedan je bolesnik koji je bio randomiziran u krak koji je primao samo RT, primio TMZ + RT.
English: Amber glass bottle with white polypropylene child-resistant screw cap equipped with an induction seal of polyethylene containing 5 or 20 capsules.
Croatian: Bočica od smeđeg stakla s bijelim polipropilenskim sigurnosnim zatvaračem za djecu s navojem, opremljenim polietilenskom zaštitnom folijom, koja sadrži 5 ili 20 kapsula.
English: Dose levels include 100 mg/m², 150 mg/m², and 200 mg/m².
Croatian: Razine doza su 100 mg/m2, 150 mg/m2 i 200 mg/m2.
English: Patients receiving Temozolomide Teva in combination with radiotherapy may experience different side effects than patients taking Temozolomide Teva alone.
Croatian: Bolesnici koji uzimaju Temozolomid Teva u kombinaciji sa zračenjem mogu imati drugačije nuspojave od bolesnika koji uzimaju samo Temozolomid Teva.
English: This is bedcause you must not be treated with Temozolomide Teva during pregnancy unless clearly indicated by your doctor.
Croatian: Temozolomid Teva tijekom trudnoće, osim ako ga Vaš liječnik nije izričito propisao.
English: Date of first authorisation: 28 January 2010 Date of latest renewal:
Croatian: Datum posljednje obnove odobrenja: 28. kolovoza 2014.
English: Opportunistic infections and reactivation of infections Opportunistic infections (such as Pneumocystis jirovecii pneumonia) and reactivation of infections (such as HBV, CMV) have been observed during the treatment with TMZ (see section 4.8).
Croatian: Oportunističke infekcije (kao što su Pneumocystis jirovecii penumonija) i reaktivacija infekcija (kao što su HBV, CMV) primijećene su tijekom liječenja TMZ-om (vidjeti dio 4.8).
English: Contact your doctor immediately if you have any of the following: - a severe allergic (hypersensitive) reaction (hives, 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 neki od sljedećih simptoma: - jaku alergijsku reakciju (reakciju preosjetljivosti) (koprivnjača, piskanje pri disanju ili druge tegobe s disanjem), - nekontrolirano krvarenje, - napadaje (konvulzije),
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide Teva only
Croatian: Bolesnici s tumorom koji se ponovno pojavio ili pogoršao (malignim gliomom, poput multiformnog glioblastoma ili anaplastičnog astrocitoma) koji uzimaju samo Temozolomid Teva:
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 ispitivanju sa 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: One was a non-comparative trial in 138 patients (29% received prior chemotherapy), and the other was a randomised active-controlled trial of TMZ vs procarbazine in a total of 225 patients (67% received prior treatment with nitrosourea based chemotherapy).
Croatian: Prvo nekomparativno ispitivanje provedeno je u 138 bolesnika (29% ih je prethodno primalo kemoterapiju), a u drugo randomizirano ispitivanje s aktivnom kontrolom TMZ-a naspram prokarbazina uključeno je ukupno 225 bolesnika (67% ih je prethodno primalo kemoterapiju koja se temeljila na nitrozoureji).
English: Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
Croatian: Znakovi alergijske reakcije obuhvaćaju svrbež, nedostatak daha ili piskanje pri disanju, oticanje lica, usana, jezika ili grla.
English: The estimated probability of surviving 2 years or more (26% vs 10%) is higher for the RT + TMZ arm.
Croatian: Procijenjena vjerojatnost preživljenja 2 godine ili dulje veća je za skupinu koja je primala RT + TMZ (26%
English: In some cases, your Temozolomide Teva dose will be reduced or treatment stopped.
Croatian: U nekim će slučajevima smanjiti dozu lijeka Temozolomid Teva ili prekinuti liječenje ovim lijekom.
English: In preclinical studies in rats and rabbits receiving 150 mg/m² TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Croatian: U pretkliničkim istraživanjima na štakorima i kunićima koji su primali TMZ u dozi od 150 mg/m2 pokazalo se da lijek ima teratogen i/ili fetotoksičan učinak (vidjeti dio 5.3).
English: The Temozolomide Teva dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Croatian: Uzimanje lijeka Temozolomid Teva može se odgoditi ili prekinuti ovisno o broju Vaših krvnih stanica i o tome kako podnosite lijek tijekom faze istodobnog liječenja.
English: In the randomised active-controlled trial, the PFS at 6 months was significantly greater for TMZ than for procarbazine (21% vs 8%, respectively - chi-square p = 0.008) with median PFS of 2.89 and 1.88 months respectively (log rank p = 0.0063).
Croatian: U randomiziranom ispitivanju s aktivnom kontrolom je PFS nakon 6 mjeseci bio značajno veći u skupini koja je primala TMZ nego u skupini koja je primala prokarbazin (21% naspram 8%; hi-kvadrat p = 0,008), uz medijan PFS-a od 2,89 mjeseci u prvoj odnosno 1,88 mjeseci u drugoj skupini (log rang p = 0,0063).
English: Hepatitis due to hepatitis B virus (HBV) reactivation, in some cases resulting in death, has been reported.
Croatian: HBV Prijavljen je hepatitis B uzrokovan reaktivacijom virusa hepatitisa B (HBV), koji je u nekim slučajevima imao smrtni ishod.
English: Doserelated reductions in leukocytes and platelets appear to be sensitive indicators of toxicity.
Croatian: Čini se da su o dozi ovisna smanjenja broja leukocita i trombocita osjetljivi pokazatelji toksičnosti.
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temozolomide Teva for 42 days in combination with radiotherapy.
Croatian: Ako ste bolesnik s novodijagnosticiranim multiformnim glioblastomom, uzimat ćete Temozolomid Teva u kombinaciji sa zračenjem tijekom 42 dana.
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: Prodor u cerebrospinalni likvor potvrđen je u jednog bolesnika; 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: This is because Temozolomide Teva could cause hepatitis B to become active again, which can be fatal in some cases.
Croatian: Temozolomid Teva može uzrokovati ponovnu aktivaciju hepatitisa B, što u nekim slučajevima može imati smrtni ishod.
English: Haupt Pharma Amareg GmbH Donaustaufer Straβe 378 93055 Regensburg Germany
Croatian: Haupt Pharma Amareg GmbH Donaustaufer Straβe 378
English: You will again receive Temozolomide Teva once daily for 5 days, followed by 23 days without Temozolomide Teva.
Croatian: Ponovno ćete uzimati Temozolomid Teva jedanput na dan tijekom 5 dana, nakon čega slijede 23 dana bez lijeka Temozolomid Teva.
English: PET studies in humans and preclinical data suggest that TMZ crosses the blood-brain barrier rapidly and is present in the CSF.
Croatian: Ispitivanja u ljudi primjenom PET-a kao i neklinički podaci ukazuju na to da TMZ brzo prelazi krvno moždanu barijeru i da je prisutan u cerebrospinalnom likvoru.
English: The excipient sunset yellow FCF (E110) is also included in the capsule shell of Temozolomide Teva 20 mg hard capsules and may cause allergic reactions.
Croatian: Pomoćna tvar sunset yellow FCF (E110) se nalazi u ovojnici kapsule Temozolomid Teva 20 mg tvrdih kapsula i može uzrokovati alergijske reakcije.
English: You will take Temozolomide Teva alone once daily for the first 5 days.
Croatian: Uzimat ćete samo Temozolomid Teva jedanput na dan prvih 5 dana.
English: Dose reductions and discontinuations during the monotherapy phase should be applied according to Tables 2 and 3.
Croatian: Smanjenje doze i prekid davanja lijeka tijekom faze monoterapije treba provesti sukladno naputcima u Tablicama 2 i 3.
English: Pharmacotherapeutic group: Antineoplastic agents-other alkylating agents, ATC code: L01A X03
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Antineoplastici - ostali alkilirajući pripravci, ATK oznaka: L01A X03.
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic† , sepsis†
Croatian: infekcija citomegalovirusom, reaktivacija infekcija poput infekcije citomegalovirusom, virusom hepatitisa B†, herpesni meningoencefalitis†, sepsa†
English: What you need to know before you take Temozolomide Teva Do not take Temozolomide Teva
Croatian: Što morate znati prije nego počnete uzimati Temozolomid Teva
English: - if you have liver or kidney problems, your dose of Temozolomide Teva may need to be adjusted.
Croatian: - ako imate problema s jetrom ili bubrezima, možda će biti potrebno prilagoditi dozu lijeka
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 kriokonzervacije sperme, jer postoji mogućnost da terapija TMZ-om dovede do trajne neplodnosti.
English: The first dose will be 150 mg/m².
Croatian: Prva doza iznosit će 150 mg/m2.
English: You should stop breast-feeding while receiving treatment with Temozolomide Teva.
Croatian: Morate prekinuti dojenje dok se liječite lijekom Temozolomid Teva.
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 režimu liječenja bili su izloženi osobitom riziku od razvoja pneumonije uzrokovane s Pneumocystis jirovecii.
English: Temozolomide Teva is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme.
Croatian: Temozolomid Teva se koristi za liječenje određenih vrsta tumora mozga: - u odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom.
English: The excipient sunset yellow FCF (E110) included in the capsules shell may cause allergic reactions.
Croatian: Pomoćna tvar sunset yellow FCF (E110) nalazi se u ovojnici kapsule i može uzrokovati alergijske reakcije.
English: These reactions were usually Grade 1 or 2 (0 - 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Croatian: (0-5 epizoda povraćanja u 24 sata) i prestale bi same od sebe ili su se mogle lako kontrolirati standardnom terapijom antiemeticima.
English: See footnote b
Croatian: Vidjeti fusnotu b
English: Uncommon (may affect up to 1 in 100 people): reduced number of blood cell counts (pancytopenia, anaemia, leukopenia).
Croatian: Manje česte (mogu se javiti u do 1 na 100 osoba): smanjen broj krvnih stanica (pancitopenija, anemija, leukopenija).
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) Special populations
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: After oral administration to adult patients, TMZ is absorbed rapidly, with peak concentrations reached as early as 20 minutes post-administration (mean time between 0.5 and 1.5 hours).
Croatian: Apsorpcija 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: TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Croatian: Privremen ili trajan prekid primjene TMZ-a tijekom istodobnog liječenja radioterapijom i TMZ-om
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: Temozolomide Teva contains a medicine called temozolomide.
Croatian: Temozolomid Teva sadrži lijek pod nazivom temozolomid.
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events 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: When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8% of the patients.
Croatian: Kad su se objedinila odstupanja laboratorijskih nalaza i štetni događaji iz faze istodobnog liječenja i faze monoterapije, poremećaji broja neutrofila stupnja 3 ili 4, uključujući neutropeniju, zabilježeni su u 8% bolesnika.
English: Hearing impairment, tinnitus
Croatian: Oštećenje sluha, tinitus
English: Doses of 500, 750, 1,000, and 1,250 mg/m² (total dose per cycle over 5 days) have been evaluated clinically in patients.
Croatian: U bolesnika su klinički ocijenjene doze od 500, 750, 1000 i 1250 mg/m2 (ukupna doza po ciklusu tijekom 5 dana).
English: Cases of elevations of liver enzymes have been commonly reported.
Croatian: Često su zabilježene povišene razine jetrenih enzima.