FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving temozolomide for 42 days in combination with radiotherapy.
Croatian: Ako ste novodijagnosticirani bolesnik (multiformni glioblastom), mogli biste primati temozolomid tijekom 42 dana u kombinaciji s radioterapijom.
English: A treatment cycle with Temozolomide Accord comprises 28 days.
Croatian: Ciklus liječenja lijekom Temozolomidom Accord traje 28 dana.
English: What Temozolomide Accord looks like and contents of the pack
Croatian: Kako Temozolomid Accord izgleda i sadržaj pakiranja
English: - if you have anaemia, low blood count (such as white blood cell count and platelet count), or blood clotting problems before treatment, or develop them during treatment.
Croatian: - ako imate anemiju, smanjen broj krvnih stanica (poput bijelih krvnih stanica i tombocita) ili probleme sa zgrušavanjem krvi prije početka liječenja, ili se ti poremećaji razviju tijekom liječenja.
English: While the radiotherapy is ongoing your doctor will start temozolomide at a dose of 75 mg/m² and the actual daily dose you take will depend on your height and weight.
Croatian: Za vrijeme zračenja liječnik će započeti primjenu temozolomida u dozi od 75 mg/m2, a stvarna dnevna doza ovisti će o Vašoj visini i težini.
English: • mood swings, depression, hallucination and memory loss
Croatian: • promjene raspoloženja, depresija, halucinacije i gubitak pamćenja
English: Changes in blood cells
Croatian: promjene krvnih stanica
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 izrazito se preporučuje u fazi monoterapije.
English: Rash, pruritus, alopecia
Croatian: osip, pruritus, alopecija
English: If you forget to take Temozolomide Accord
Croatian: Ako ste zaboravili uzeti Temozolomid Accord
English: What Temozolomide Accord contains
Croatian: Što Temozolomid Accord sadrži
English: The hard capsules are dispensed in sachet containing 1 capsule.
Croatian: Tvrde kapsule dostupne su u vrećici koja sadrži 1 kapsulu.
English: Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Croatian: Rezultati testa Ames/salmonela i testa kromosomskih aberacija limfocita u perifernoj krvi čovjeka pokazali su pozitivan mutageni odgovor.
English: - if you feel sick or vomit, which are very common side effects of Temozolomide (see section 4).
Croatian: - ako imate mučninu ili povraćate što su vrlo česte nuspojave Temozolomida (vidjeti dio 4.).
English: Temozolomide Accord should not be administered to pregnant women.
Croatian: Temozolomid Accord se ne smije davati trudnicama.
English: Temozolomide Accord capsules are taken to treat specific forms of brain tumours: - adults with newly diagnosed specific form of brain tumour (glioblastoma multiforme).
Croatian: Temozolomid Accord kapsule se koriste za liječenje specifičnih vrsta tumora mozga: - odraslih bolesnika s novodijagnosticiranim specifičnim oblikom tumora mozga (multiformnim glioblastomom).
English: Very rare cases of rash with skin swelling, including on the palms of the hands and soles of the feet, or painful reddening of the skin and/or blisters on the body or in the mouth have been observed.
Croatian: Vrlo rijetko su opaženi slučajevi osipa s oticanjem kože, uključujući dlanove i tabane, ili bolno crvenilo kože i/ili mjehurići po tijelu ili u ustima.
English: Temozolomide Accord 5 mg hard capsules Temozolomide Accord 20 mg hard capsules Temozolomide Accord 100 mg hard capsules Temozolomide Accord 140 mg hard capsules Temozolomide Accord 180 mg hard capsules Temozolomide Accord 250 mg hard capsules temozolomide
Croatian: Temozolomid Accord 5 mg tvrde kapsule Temozolomid Accord 20 mg tvrde kapsule Temozolomid Accord 100 mg tvrde kapsule Temozolomid Accord 140 mg tvrde kapsule Temozolomid Accord 180 mg tvrde kapsule Temozolomid Accord 250 mg tvrde kapsule temozolomid
English: • Abnormal liver function tests,
Croatian: • odstupanja od normalnih vrijednosti testova funkcije jetre
English: The results from the trial were not consistent in the subgroup of patients with a poor performance status (WHO PS=2, n=70), where overall survival and time to progression were similar in both arms.
Croatian: Rezultati ispitivanja nisu bili konzistentni u podskupini bolesnika s lošim izvedbenim statusom (SZO PS = 2, n = 70), za koje su ukupno preživljenje i vrijeme do progresije bolesti bili slični u obje ispitivane skupine.
English: In a population pharmacokinetics analysis of clinical trial experience there were 101 female and 169 male subjects for whom nadir neutrophil counts were available and 110 female and 174 male subjects for whom nadir platelet counts were available.
Croatian: U analizi populacijske farmakokinetike temeljenoj na podacima iz kliničkih ispitivanja, podaci o najnižem broju neutrofila bili su dostupni za 101 ženu i 169 muškaraca, a podaci o najnižem broju trombocita za 110 žena i 174 muškarca.
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: Then there may be up to 6 treatment cycles, and each one lasts 28 days.
Croatian: Nakon toga liječenje se može odvijati do ukupno 6 terapijskih razdoblja (ciklusa), od kojih svaki traje 28 dana.
English: Hepatitis due to hepatitis B virus (HBV) reactivation, in some cases resulting in death, has been reported.
Croatian: Prijavljen je hepatitis B uzrokovan reaktivacijom virusa hepatitisa B (HBV), koji je u nekim slučajevima imao smrtni ishod.
English: You may be given other medicines to take before and/or after temozolomide to avoid or control vomiting.
Croatian: Liječnik Vam može dati i neke druge lijekove koje ćete uzimati prije i/ili nakon što uzmete lijek temozolomid radi izbjegavanja ili kontrole povraćanja.
English: Patients usually present with shortness of breath and cough.
Croatian: Kod bolesnika se obično javljaju nedostatak zraka i kašalj.
English: In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening.
Croatian: U oba je ispitivanja primarna mjera ishoda bilo vrijeme preživljenja bez progresije bolesti (engl. progression-free survival, PFS), određeno nalazom magnetske rezonancije (MR) ili neurološkim pogoršanjem.
English: Pancytopenia, anaemia (grade 3-4), leukopenia
Croatian: pancitopenija, anemija (stupanj 3-4), leukopenija
English: Patients taking temozolomide in combination with radiation therapy may experience different side effects than patients taking temozolomide alone.
Croatian: Bolesnici koji uzimaju temozolomid u kombinaciji sa zračenjem mogu imati drugačije nuspojave od bolesnika koji uzimaju samo temozolomid.
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: 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 (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: You must not breast-feed whilst you are being treated with Temozolomide Accord.
Croatian: Ne smijete dojiti dok se liječite Temozolomidom Accord.
English: The hard capsules are dispensed in amber glass bottles containing 5 or 20 capsules.
Croatian: Tvrde kapsule dostupne su u smeđim staklenim bočicama koje sadrže 5 ili 20 kapsula.
English: However, all patients receiving TMZ, particularly patients receiving steroids, should be observed closely for the development of PCP, regardless of the regimen.
Croatian: Međutim, sve bolesnike koji primaju TMZ, a osobito bolesnike koji primaju steroide, treba pomno nadzirati zbog mogućeg razvoja PCP-a, bez obzira na režim doziranja.
English: Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population) The results from the trial were not consistent in the subgroup of patients with a poor performance status (WHO PS=2, n=70), where overall survival and time to progression were similar in both arms.
Croatian: Slika 1. Kaplan-Meierove krivulje ukupnog preživljenja (populacija koju se namjeravalo liječiti) Rezultati ispitivanja nisu bili konzistentni u podskupini bolesnika s lošim izvedbenim statusom (SZO PS = 2, n = 70), za koje su ukupno preživljenje i vrijeme do progresije bolesti bili slični u obje ispitivane skupine.
English: - The active substance is temozolomide.
Croatian: - Djelatna tvar je temozolomid.
English: Thus, prophylaxis against PCP is required for all patients receiving concomitant TMZ and RT for the 42 day regimen (with a maximum of 49 days) regardless of lymphocyte count.
Croatian: Stoga je potrebno primijeniti profilaksu protiv PCP-a u svih bolesnika koji istodobno primaju TMZ i RT prema protokolu liječenja od 42 dana (najdulje 49 dana), bez obzira na broj limfocita.
English: Baseline liver function tests should be performed prior to treatment initiation.
Croatian: Ispitivanje funkcije jetre potrebno je provesti prije započinjanja liječenja.
English: After day 28, the next cycle will begin, in which you will again take this medicine once daily for five days followed by 23 days without temozolomide.
Croatian: Nakon 28. dana započinje sljedeći ciklus u kojem ćete ponovno uzimati ovaj lijek jedanput na dan tijekom 5 dana, nakon čega slijede 23 dana bez temozolomida.
English: Cases of elevations of liver enzymes have been commonly reported.
Croatian: Često su zabilježeni slučajevi povišenja jetrenih enzima.
English: Allergic reactions, including anaphylaxis, angioedema
Croatian: alergijske reakcije uključujući anafilaksiju, angioedem
English: Marketing Authorisation Holder Accord Healthcare S.L.U.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Accord Healthcare S.L.U.
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: Polyester/aluminium/polyethylene (PET/alu/PE) sachet.
Croatian: Vrećica od poliestera/aluminija/polietilena (PET/alu/PE vrećica).
English: Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
Croatian: Znakovi alergijske reakcje uključuju osjećaj svrbeži, nedostatak zraka ili piskanje pri disanju, oticanje lica, usana, jezika ili grla.
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide Accord (see also “Male fertility” below).
Croatian: I bolesnice i bolesnici koji uzimaju Temozolomid Accord moraju primjenjivati učinkovite mjere kontracepcije (vidjeti također „Plodnost muškaraca“ u daljnjem tekstu).
English: TMZ dose (mg/m2 /day)
Croatian: Razina doze Doza TMZ-a (mg/m2/dan)
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 reactions 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: If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x109/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
Croatian: Ako tijekom bilo kojeg ciklusa ABN padne na < 1,0 x 109/l ili je broj trombocita < 50 x 109/l, u sljedećem se ciklusu doza mora sniziti za jednu razinu (vidjeti dio 4.2).
English: The objective response rate (ORR) based on MRI scans was 8%.
Croatian: Objektivna stopa odgovora na liječenje (engl. objective response rate, ORR) na temelju MR nalaza iznosila je 8%.
English: Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
Croatian: neutropenija ili limfopenija (stupanj 3-4), trombocitopenija (stupanj 3-4)
English: For patients with significant liver function abnormalities, physicians should assess the benefit/risk of continuing treatment.
Croatian: U bolesnika sa značajnim odstupanjem od normalnih vrijednosti funkcije jetre, liječnici trebaju pažljivo procijeniti koristi i rizike nastavka liječenja.
English: Skin redness, an itchy rash with raised yellow or white lumps that are surrounded by red inflammation, skin eruption, allergic reactions.
Croatian: crvenilo kože, osip koji svrbi, s uzdignutim žutim ili bijelim kvržicama okruženim crvenom upaljenom kožom, izbijanje promjena po koži, alergijske reakcije.
English: Date of first authorisation:15 March 2010 Date of latest renewal: 12 January 2015
Croatian: Datum posljednje obnove: 12. siječnja 2015.
English: Dose during Cycles 2-6 in absence of toxicity Table 3.
Croatian: Doza tijekom 2.-6. ciklusa ako nema toksičnih učinaka
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: Erythema multiforme, erythroderma, urticaria, exanthema General disorders and administration site conditions Very common:
Croatian: multiformni eritem, eritrodermija, urtikarija, egzantem Opći poremećaji i reakcije na mjestu primjene Vrlo često:
English: In preclinical studies in rats and rabbits receiving 150 mg/m2, 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: children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Croatian: - djece od navršene tri godine starosti, adolescenata i odraslih bolesnika s malignim gliomom, kao što je multiformni glioblastom ili anaplastični astrocitom, koji je recidivirao ili napreduje nakon standardne terapije.
English: 20 hard capsules
Croatian: 20 tvrdih kapsula
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 hard capsule
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1 kapsula
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 temozolomida, odnosno 1,8 sati.
English: Male patients should use effective contraception and not father a child for up to 6 months after stopping treatment.
Croatian: Bolesnici muškog spola moraju primjenjivati učinkovite mjere kontracepcije te ne smiju pokušavati začeti dijete do 6 mjeseci nakon prestanka liječenja.
English: Weight decrease
Croatian: smanjenje tjelesne težine
English: • frequent urination, difficulty with holding your urine or urine leakage
Croatian: • učestalo mokrenje, poteškoće sa zadržavanjem urina ili nevoljno istjecanje urina
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: 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: The following additional serious adverse reactions have been identified during post-marketing exposure:
Croatian: Sljedeće ozbiljne nuspojave su prepoznate nakon stavljanja lijeka u promet;
English: Patients will be carefully checked by their doctor for signs of this infection before treatment.
Croatian: Liječnik će detaljno pregledati bolesnike prije početka liječenja kako bi se utvrdilo postoje li znakovi ove infekcije.
English: Anorexia
Croatian: anoreksija
English: Tell your doctor immediately if this occurs.
Croatian: Dogodi li se to, odmah obavijestite svog liječnika.
English: Convulsions, headache
Croatian: glavobolja konvulzije, glavobolja
English: Symptoms of diabetes insipidus include passing a lot of urine and feeling thirsty.
Croatian: Simptomi dijabetes insipidusa uključuju obilno mokrenje te osjećaj žeđi.
English: • bleeding within the brain, high blood pressure, blood clot in the lung, swelling
Croatian: • krvarenje u mozgu, visok krvni tlak, krvni ugrušak u plućima, oticanje
English: Temozolomide Accord is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Croatian: Temozolomid Accord se primjenjuje u kombinaciji s fokalnom radioterapijom (faza istodobnog liječenja), nakon čega slijedi do 6 ciklusa monoterapije temozolomidom (TMZ) (faza monoterapije).
English: TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57%) in the RT alone arm, and 62 patients of the 277 (22%) in the TMZ + RT arm.
Croatian: TMZ se primjenjivao kao „terapija spasa“ (engl. salvage therapy) tijekom razdoblja praćenja u 161 od 282 bolesnika (57%) u skupini u kojoj se primijenila samo RT te u 62 od 277 bolesnika (22%) u skupini koja je uz RT primala i TMZ.
English: 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 pneumonija uzrokovana Pneumocystis jirovecii) i reaktivacija infekcija (kao što su HBV, CMV) primijećene su tijekom liječenja TMZ-om (vidjeti dio 4.8).
English: diabetes insipidus
Croatian: dijabetes insipidus
English: If you take more Temozolomide Accord than you should If you accidentally take more capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Croatian: Ako zabunom uzmete više kapsula nego što ste trebali, odmah se javite liječniku, ljekarniku ili medicinskoj sestri.
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 temozolomidom.
English: The following side effects may occur if you are a newly diagnosed patient taking Temozolomide Accord for a specific brain tumour (glioblastoma multiforme) in combination treatment with radiotherapy and then later taking temozolomide on its own.
Croatian: Slijedeće nuspojave mogu se pojaviti ako ste novodijagnosticirani bolesnik koji uzima Temozolomid Accord zbog specifičnog tumora mozga (glioblastoma multiforme) u kombiniranom liječenju sa zračenjem nakon čega slijedi uzimanje samo temozolomida.
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: 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).
English: Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Croatian: Analiza populacijske farmakokinetike temozolomida otkrila je da klirens TMZ-a iz plazme ne ovisi o dobi, funkciji bubrega ni pušenju.
English: Accidental ingestion can be lethal for children.
Croatian: Nehotično gutanje može biti smrtonosno za djecu.
English: Very rare cases of lung side effects have been observed with temozolomide.
Croatian: Vrlo rijetko su primijećene nuspojave na plućima s temozolomidom.
English: Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS] ≥70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral TMZ.
Croatian: Karnofsky performance status, KPS] ≥ 70) koji napreduje ili je recidivirao nakon kirurškog zahvata i radioterapije temelje se na dva klinička ispitivanja peroralno primijenjenog TMZ-a.
English: interstitial pneumonitis/pneumonitis, pulmonary fibrosis, respiratory failure†
Croatian: intersticijalni pneumonitis/pneumonitis, plućna fibroza, respiratorno zatajenje†
English: • anxiety, depression, changing emotions, inability to fall asleep or stay asleep,
Croatian: • tjeskoba, depresija, promjena emocija, nemogućnost usnivanja ili dužeg spavanja.
English: - Be sure you review the dose with your health care provider each time you start a new cycle.
Croatian: - Budite sigurni da, svaki puta kada započinjete novi ciklus, provjerite s Vašim liječnikom dozu lijeka.
English: Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC).
Croatian: Temozolomid je triazen koji se pri fiziološkom pH brzo kemijski pretvara u aktivni spoj monometiltriazenoimidazol-karboksamid (MTIC).
English: Cases of fatal respiratory failure have been reported in patients using TMZ, in particular in combination with dexamethasone or other steroids.
Croatian: Prijavljeni su slučajevi zatajenja dišnog sustava sa smrtnim ishodom u bolesnika koji koriste TMZ, a posebno u kombinaciji sa deksametazonom ili nekim drugim steroidom.
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma:
Croatian: Odrasli bolesnici i pedijatrijski bolesnici u dobi od 3 godine ili stariji s recidivirajućim ili progresivnim malignim gliomom:
English: • changes in blood cells,
Croatian: • promjene krvnih stanica
English: Four weeks after completing the TMZ + RT phase, TMZ is administered for up to 6 cycles of monotherapy treatment.
Croatian: Četiri tjedna nakon završetka faze istodobnog liječenja TMZ-om i RT-om, TMZ se primjenjuje kao monoterapija u najviše 6 ciklusa.
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 Prilog I: Sažetak opisa svojstava lijeka, dio 4.2).