FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not open, crush or chew the capsules, swallow whole.
Croatian: Nemojte otvarati, drobiti niti žvakati kapsule; treba ih progutati cijele.
English: Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Croatian: Preporučuje se primjena antiemetičke profilakse prije početne doze temozolomida u fazi istodobnog liječenja, a osobito se preporučuje u fazi monoterapije.
English: In post marketing cases, meningoencephalitis herpetic (including fatal cases) has been observed in patients receiving TMZ in combination with radiotherapy, including cases of concomitant steroids administration.
Croatian: U slučajevima nakon stavljanja lijeka u promet, herpesni meningoencefalitis (uključujući slučajeve sa smrtnim ishodom) opažen je kod bolesnika koji primaju terapiju TMZ-om u kombinaciji s radioterapijom, uključujući slučajeve istodobne primjene steroida.
English: Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Croatian: Na temelju rezultata analize populacijske farmakokinetike u kliničkim ispitivanjima faze II, istodobna primjena s deksametazonom, proklorperazinom, fenitoinom, karbamazepinom, ondansetronom, antagonistima H2 receptora te fenobarbitalom nije promijenila klirens TMZ-a.
English: Side effects from clinical studies:
Croatian: Nuspojave iz kliničkih ispitivanja:
English: If a capsule is damaged, avoid contact with your skin, eyes or nose.
Croatian: Ako je kapsula oštećena, izbjegavajte kontakt s kožom, očima ili nosom.
English: Take your prescribed dose of Temozolomide Sandoz once a day, preferably at the same time each day.
Croatian: Uzmite propisanu dozu Temozolomida Sandoz jedanput na dan, po mogućnosti svakoga dana u isto vrijeme.
English: Dose-related 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: In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
Croatian: In vivo je t1/2 MTIC-a bio sličan onomu TMZ-a, odnosno 1,8 sati.
English: In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
Croatian: U zasebnom ispitivanju faze I primjena TMZ-a s ranitidinom nije izazvala promjene u opsegu apsorpcije temozolomida niti u izloženosti njegovu aktivnom metabolitu monometil-triazenoimidazolkarboksamidu (MTIC).
English: The Temozolomide Sandoz dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Croatian: Doza Temozolomida Sandoz se može odgoditi ili prekinuti, ovisno o broju krvnih stanica i o tome kako podnosite lijek tijekom faze istodobnog liječenja.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2.
English: Pack-size of 5 or 20 hard capsules individually sealed in sachets.
Croatian: Pakiranje sadrži 5 ili 20 tvrdih kapsula, pojedinačno zatvorenih u vrećice.
English: Depending on your blood test results, your doctor may adjust your dose for the next cycle.
Croatian: Vaš liječnik može prilagoditi dozu lijeka za sljedeći ciklus.
English: Monotherapy phase
Croatian: Faza monoterapije
English: Accidental ingestion can be lethal for children.
Croatian: Nehotično gutanje kapsula može biti smrtonosno za djecu.
English: The safety and efficacy of TMZ in children under the age of 3 years have not been established.
Croatian: Sigurnost i djelotvornost TMZ-a u djece mlađe od 3 godine nisu ustanovljene.
English: Rash, pruritus, alopecia
Croatian: Osip, pruritus, alopecija
English: Clinical trial experience
Croatian: Iskustvo iz kliničkih ispitivanja
English: Other medicines and Temozolomide Sandoz
Croatian: Drugi lijekovi i Temozolomid Sandoz
English: Your doctor may decide to reduce the dose, interrupt, stop or change your treatment.
Croatian: U teškim slučajevima liječnik može privremeno prekinuti, trajno prekinuti ili promijeniti Vaše liječenje.
English: Dose during Cycles 2-6 in absence of toxicity
Croatian: Doza tijekom 2.-6. ciklusa ako nema toksičnih učinaka
English: If abnormal, physicians should assess the benefit/risk prior to initiating temozolomide including the potential for fatal hepatic failure.
Croatian: U slučaju njihovog odstupanja od normalnih vrijednosti liječnici moraju procijeniti omjer koristi/rizika prije započinjanja liječenja temozolomidom uključujući i mogućnost zatajenja jetre sa smrtnim ishodom.
English: Anti-emetic therapy may be administered prior to or following administration of TMZ.
Croatian: Antiemetici se mogu primijeniti prije ili nakon uzimanja TMZ-a.
English: Four weeks after completing the TMZ + RT concomitant phase, TMZ is administered for up to 6 cycles of monotherapy treatment.
Croatian: Četiri tjedna nakon završetka faze istodobnog liječenja TMZ-om + RT, TMZ se primjenjuje kao monoterapija u najviše 6 ciklusa.
English: Do not store above 25 °C.
Croatian: Ne čuvati na temperaturi iznad 25 °C.
English: For all patients, liver function tests should be checked after each treatment cycle.
Croatian: Nakon svakog terapijskog ciklusa svim bolesnicima je potrebno provjeriti pretrage funkcije jetre.
English: This adds up to a 28-day treatment cycle.
Croatian: To čini ukupno 28 dana terapijskog ciklusa.
English: It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
Croatian: Nije poznato izlučuje li se TMZ u majčino mlijeko; stoga dojenje treba prekinuti tijekom liječenja
English: Elderly patients appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients.
Croatian: Stariji bolesnici izloženi su povećanom riziku od razvoja neutropenije i trombocitopenije u odnosu na mlađe bolesnike.
English: Dry skin, pruritus
Croatian: Suha koža, pruritus
English: Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
Croatian: Neutropenija ili limfopenija (stupanj 3-4), trombocitopenija (stupanj 3-4)
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temozolomide Sandoz for 42 days in combination with radiotherapy.
Croatian: Ako ste bolesnik s novodijagnosticiranim multiformnim glioblastomom, primat ćete Temozolomid Sandoz u kombinaciji sa zračenjem tijekom 42 dana.
English: If you accidentally take more Temozolomide Sandoz capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Croatian: Ako uzmete više Temozolomid Sandoz kapsula nego što ste trebali, odmah se javite svom liječniku,
English: Metabolism and nutrition disorders Very common:
Croatian: Poremećaji metabolizma i prehrane Vrlo često:
English: • cough • infections including pneumonia.
Croatian: kašalj infekcije uključujući upalu pluća.
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: Impotence
Croatian: Impotencija
English: CTC Grade 3
Croatian: CTC stupanj 3
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: The estimated probability of surviving 2 years or more (26 % vs 10 %) is higher for the RT + TMZ arm.
Croatian: Procijenjena vjerojatnost preživljenja od 2 godine ili dulje veća je za skupinu koja je primala RT + TMZ (26 % naspram 10 %).
English: Temozolomide Sandoz is used for the treatment of specific forms of brain tumours:
Croatian: Temozolomid Sandoz se koristi za liječenje određenih vrsta tumora mozga:
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 su često prijavljeni slučajevi sepse (kad bakterije i njihovi toksini cirkuliraju u krvi i počnu oštećivati organe).
English: However, all patients receiving TMZ, particularly patients receiving steroids, should be observed closely for the development of PCP, regardless of the regimen.
Croatian: No sve bolesnike koji primaju TMZ, a osobito bolesnike koji primaju steroide, treba pomno nadzirati zbog mogućeg razvoja Pneumocystis jirovecii pneumonije, bez obzira na režim doziranja.
English: • if you have liver or kidney problems.
Croatian: ako imate problema s jetrom ili bubrezima.
English: Hypokalemia, alkaline phosphatase increased, weight increased
Croatian: Hipokalijemija, povišene vrijednosti alkalne fosfataze, povećanje tjelesne težine
English: Temozolomide Sandoz may cause permanent infertility.
Croatian: Temozolomid Sandoz može uzrokovati trajnu neplodnost.
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: 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 standardnim antiemeticima.
English: No data are available on the administration of TMZ in patients with severe hepatic impairment (Child's Class C) or with renal impairment.
Croatian: Nema dostupnih podataka o primjeni TMZ-a u bolesnika s teškim oštećenjem funkcije jetre (stadij C po Childu) ili s oštećenom funkcijom bubrega.
English: Capsule shell Gelatin
Croatian: Ovojnica kapsule Želatina
English: In some cases, your Temozolomide Sandoz dose will be reduced or treatment stopped.
Croatian: U nekim slučajevima će smanjiti dozu Temozolomida Sandoz ili prekinuti liječenje.
English: Hepatitis due to hepatitis B virus (HBV) reactivation, in some cases resulting in death, has been reported.
Croatian: Prijavljen je hepatitis uzrokovan reaktivacijom virusa hepatitisa B (HBV), koji je u nekim slučajevima imao smrtni ishod.
English: Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01AX03 Mechanism of action
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Antineoplastici - ostali alkilirajući pripravci, ATK oznaka: L01AX03
English: Sandoz Polska Sp. z o.o.
Croatian: Sandoz Polska Sp. z o.o. ul.
English: TMZ.
Croatian: TMZ-om.
English: liver enzymes elevations
Croatian: povišene vrijednosti jetrenih enzima
English: Infection, candidiasis oral
Croatian: Infekcija, oralna kandidijaza
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: Edvard Thomsens Vej 14 DK-2300 København S
Croatian: Edvard Thomsens Vej 14 DK-2300 København
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 TMZ-a.
English: If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose.
Croatian: Ako je kapsula oštećena, izbjegavajte kontakt praška s kožom, očima ili nosom.
English: Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and Day 28), and recovery was rapid, usually within 1-2 weeks.
Croatian: Mijelosupresija mogla se predvidjeti (obično se javljala u prvih nekoliko ciklusa liječenja, a bila je najizraženija između 21. i 28. dana), a oporavak je bio brz, obično u roku od 1-2 tjedna.
English: Patients usually present with shortness of breath and cough.
Croatian: Obično se javljaju nedostatak zraka i kašalj.
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 i slučajevi mijelodisplastičnog sindroma i sekundarnih zloćudnih bolesti, uključujući mijeloičnu leukemiju (vidjeti dio 4.8).
English: Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
Croatian: Infekcija, Herpes simplex, infekcija rane, faringitis, oralna kandidijaza
English: Cases of diabetes insipidus have been uncommonly reported.
Croatian: Manje često su prijavljeni slučajevi insipidnog dijabetesa.
English: You should make sure you fully understand and remember the following:
Croatian: Budite sigurni da ste u potpunosti razumjeli i zapamtili sljedeće: koliko kapsula morate uzeti svakoga dana.
English: Patients treated with TMZ may experience myelosuppression, including prolonged pancytopenia, which may result in aplastic anaemia, which in some cases has resulted in a fatal outcome.
Croatian: U bolesnika liječenih TMZ-om može se razviti mijelosupresija uključujući produljenu pancitopeniju koja može dovesti do razvoja aplastične anemije, koja je u nekim slučajevima imala smrtni ishod.
English: Reduce TMZ by 1 dose levela
Croatian: Smanjiti dozu TMZ-a za jednu razinua
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
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: 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: Nakon peroralne primjene u odraslih bolesnika TMZ se brzo apsorbira te postiže vršne koncentracije već 20 minuta nakon primjene (srednje vrijeme između 0,5 i 1,5 sati).
English: 5 hard capsules 20 hard capsules
Croatian: 5 tvrdih kapsula 20 tvrdih kapsula
English: MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4-carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Croatian: MTIC se spontano hidrolizira u 5-amino imidazol-4-karboksamid (AIC), poznati međuspoj u biosintezi purina i nukleinskih kiselina, te u metilhidrazin, za koji se vjeruje da je aktivan alkilirajući spoj.
English: 5 x 1 hard capsule in sachet 20 x 1 hard capsule in sachet
Croatian: 5 x 1 tvrda kapsula u vrećici 20 x 1 tvrda kapsula u vrećici
English: Psychiatric disorders Common:
Croatian: Psihijatrijski poremećaji Često:
English: You will take your new dose of Temozolomide Sandoz alone once daily for the first 5 days (“dosing days”) of each cycle.
Croatian: Uzimat ćete novu dozu Temozolomida Sandoz jedanput na dan prvih 5 dana svakog ciklusa („dani doziranja“).
English: Before each new treatment cycle, your blood will be tested to see if the Temozolomide 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 Temozolomida Sandoz.
English: Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age.
Croatian: Na temelju farmakokinetičke analize populacije bolesnika u dobi od 19 do 78 godina, dob ne utječe na klirens TMZ-a.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava
English: An overdose of 10,000 mg (total dose in a single cycle, over 5 days) was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi-organ failure and death.
Croatian: 10 000 mg (ukupna doza tijekom 5 dana u jednom ciklusu), a prijavljene nuspojave bile su pancitopenija, pireksija, višeorgansko zatajenje i smrt.
English: Recurrent or progressive malignant glioma
Croatian: Recidivirajući ili progresivni maligni gliom
English: You should stop breast-feeding while receiving treatment with Temozolomide Sandoz.
Croatian: Morate prekinuti dojenje dok se liječite Temozolomidom Sandoz.
English: See package leaflet for further information.
Croatian: Vidjeti Uputu o lijeku za dodatne informacije.
English: reduced blood cell counts (pancytopenia, anaemia, leukopenia).
Croatian: smanjen broj krvnih stanica (pancitopenija, anemija, leukopenija).
English: Agitation, apathy, behaviour disorder, depression, hallucination
Croatian: Agitiranost, apatija, poremećaji ponašanja, depresija, halucinacije
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 napucima u Tablicama 2 i 3.
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 you forget to take Temozolomide Sandoz
Croatian: Ako ste zaboravili uzeti Temozolomid Sandoz
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 i rekativirane infekcije virsuom hepatitisa B.
English: • The active substance is temozolomide.
Croatian: Djelatna tvar je temozolomid.
English: Allergic reactions, including anaphylaxis, angioedema
Croatian: Alergijske reakcije uključujući anafilaksiju, angioedem
English: Myopathy, back pain
Croatian: Miopatija, bol u leđima
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, Sepsis†
Croatian: infekcija citomegalovirusom, reaktivacija infekcije kao što je citomegalovirus, virus hepatitisa B†, herpesni meningoencefalitis†, sepsa†
English: In patients treated with TMZ, whether used in combination with RT or as monotherapy following RT for newly-diagnosed glioblastoma multiforme, or as monotherapy in patients with recurrent or progressive glioma, the reported very common adverse reactions were similar: nausea, vomiting, constipation, anorexia, headache and fatigue.
Croatian: U bolesnika koji uzimaju TMZ za liječenje novodijagnosticiranog multiformnog glioblastoma, bilo u kombinaciji s RT-om ili u monoterapiji nakon RT-a, te u bolesnika koji uzimaju TMZ u monoterapiji za liječenje recidivirajućeg ili progresivnog malignog glioma prijavljene su slične vrlo česte nuspojave: mučnina, povraćanje, konstipacija, anoreksija, glavobolja i umor.
English: • fever,
Croatian: vrućicu,
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 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: The major route of 14C elimination is renal.
Croatian: Glavnina eliminacije radioizotopa 14C odvija se putem bubrega.
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 (ITT) n = 162.
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: • if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Temozolomid Sandoz ako ste alergični na temozolomid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Temozolomide in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Croatian: Temozolomid u kombinaciji sa zračenjem u liječenju novodijagnosticiranog glioblastoma
English: Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
Croatian: Laboratorijski nalazi Trombocitopenija stupnja 3 ili 4 razvila se u 19 %, a neutropenija stupnja 3 ili 4 u 17 % bolesnika liječenih zbog malignog glioma.
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: Sudeći prema farmakokinetičkim svojstvima TMZ-a, vjerojatno neće biti potrebno smanjivati dozu u bolesnika s teškim oštećenjem funkcije jetre ili oštećenjem funkcije bubrega bilo kojeg stupnja.
English: Skin exfoliation, photosensitivity reaction, pigmentation abnormal
Croatian: Eksfolijacija kože, reakcija fotoosjetljivosti, poremećaj pigmentacije
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: Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Croatian: Opažena je mijelosupresija (neutropenija i trombocitopenija), što je poznat toksičan učinak koji ograničava jačinu doze većine citotoksičnih lijekova, uključujući TMZ-a.
English: Nervous system disorders Very common:
Croatian: Poremećaji živčanog sustava Vrlo često: