FrancophonIA/ELRC3.0 huggingface dataset:
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 ispitivanjima faze II, istodobna primjena s deksametazonom, proklorperazinom, fenitoinom, karbamazepinom, ondansetronom, antagonistima H2-receptora te fenobarbitalom nije promijenila klirens TMZ-a.
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: Sachets are composed of linear low density polyethylene (innermost layer), aluminium and polyethylene terephthalate.
Croatian: Vrećice su napravljene od linearnog polietilena niske gustoće (unutarnji sloj), aluminija i polietilentereftalata.
English: The first dose will be 150 mg/m2.
Croatian: Prva doza iznosit će 150 mg/m2.
English: Temodal is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme.
Croatian: Temodal se koristi za liječenje određenih vrsta tumora mozga: - u odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom.
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: Jedan je bolesnik uzeo preveliku dozu od 10 000 mg (ukupna doza tijekom pet dana u jednom ciklusu), a prijavljene nuspojave bile su pancitopenija, pireksija, višeorgansko zatajenje i smrt.
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: Your doctor may decide to reduce the dose, interrupt, stop or change your treatment.
Croatian: Vaš liječnik će možda odlučiti smanjiti dozu, privremeno odnosno trajno prekinuti liječenje ili promijeniti Vaše liječenje.
English: Adverse reactions reported during the two studies with the intravenous formulation (n=35) but not in studies using hard capsules, were infusion site reactions: pain, irritation, pruritus, warmth, swelling, and erythema, as well as haematoma.
Croatian: Nuspojave prijavljene tijekom dva klinička ispitivanja formulacije za intravensku primjenu (n = 35), a koje nisu prijavljene u ispitivanjima s tvrdim kapsulama, bile su reakcije na mjestu infuzije: bol, nadraženost, svrbež, toplina, oteklina i eritem, kao i hematom.
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), - vrućicu, - zimicu, - jaku glavobolju koja ne prestaje.
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 šest 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: 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: If you are a newly-diagnosed patient, treatment will occur in two phases: - treatment together with radiotherapy (concomitant phase) first - followed by treatment with only Temodal (monotherapy phase).
Croatian: Ako ste novodijagnosticirani bolesnik, liječenje će se odvijati u dvije faze: - prvo liječenje zajedno sa zračenjem (faza istodobnog liječenja) - zatim liječenje samo lijekom Temodal (faza monoterapije).
English: †, interstitial pneumonitis/pneumonitis, pulmonary fibrosis, nasal congestion
Croatian: †, intersticijski pneumonitis/pneumonitis, plućna fibroza, kongestija nosa
English: Behaviour disorder, emotional lability, hallucination, apathy
Croatian: poremećaj ponašanja, emocionalna labilnost, halucinacije, apatija
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: 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 Pneumocystis jirovecii pneumonije, bez obzira na režim doziranja.
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Croatian: Liječnik će detaljno pregledati bolesnike prije početka liječenja kako bi se utvrdilo postoje li znakovi ove infekcije.
English: Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
Croatian: Znakovi alergijske reakcije obuhvaćaju osjećaj svrbeža, nedostatak daha ili piskanje pri disanju, oticanje lica, usana, jezika ili grla.
English: Following oral administration, approximately 5 % to 10 % of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4-carboxamide (AIC) or unidentified polar metabolites.
Croatian: Nakon peroralne primjene se približno 5 do 10% doze nalazi u mokraći u nepromijenjenom obliku tijekom 24 sata, dok se ostatak izlučuje u obliku temozolomidske kiseline, 5-aminoimidazol-4-karboksamida ili neidentificiranih polarnih metabolita.
English: Prolonged pancytopenia, aplastic anaemia pancytopenia, petechiae
Croatian: dugotrajna pancitopenija, aplastična anemija pancitopenija, petehije
English: Visual acuity reduced, eyes dry
Croatian: smanjena oštrina vida, suhoća oka
English: - if you have nausea (feeling sick in your stomach) and/or vomiting which are very common side effects of Temodal (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.
Croatian: - ako imate mučninu i/ili povraćanje što su vrlo česte nuspojave lijeka Temodal (pogledajte dio 4.) Vaš liječnik Vam može propisati lijek koji sprječava povraćanje (antiemetik).
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: Once your medicine is prepared for infusion (reconstituted), the solution may be stored at room temperature (25°C) for up to 14 hours, including infusion time.
Croatian: Nakon što je lijek pripremljen za infuziju, otopina se može čuvati na sobnoj temperaturi (25°C) najdulje 14 sati, uključujući i vrijeme trajanja infuzije.
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: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temodal for 42 days in combination with radiotherapy.
Croatian: Ako ste bolesnik s novodijagnosticiranim multiformnim glioblastomom, uzimat ćete Temodal u kombinaciji sa zračenjem tijekom 42 dana.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, erythema multiforme, erythroderma, skin exfoliation, photosensitivity reaction, urticaria, exanthema, dermatitis, sweating increased, pigmentation abnormal
Croatian: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom, angioedem, multiformni eritem, eritrodermija, eksfolijacija kože, reakcija fotoosjetljivosti, urtikarija, egzantem, dermatitis, pojačano znojenje, poremećaj pigmentacije
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: During the concomitant phase, your doctor will start Temodal at a dose of 75 mg/m2 (usual dose).
Croatian: U fazi istodobnog liječenja liječnik će započeti primjenu Temodala u dozi od 75 mg/m2 (uobičajena doza).
English: Diabetes insipidus
Croatian: dijabetes insipidus
English: Women of childbearing potential should be advised to use effective contraception to avoid pregnancy while they are receiving TMZ.
Croatian: Ženama u generativnoj dobi treba savjetovati da koriste pouzdanu kontracepciju kako bi izbjegle trudnoću za vrijeme liječenja temozolomidom.
English: Reconstituted product must be used within 14 hours, including infusion time.
Croatian: Pripremljen lijek mora se upotrijebiti u roku od 14 sati, uključujući i vrijeme trajanja infuzije.
English: In some cases, your Temodal dose will be reduced or treatment stopped.
Croatian: U nekim će slučajevima smanjiti dozu lijeka Temodal ili prekinuti liječenje ovim lijekom.
English: If Temodal comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Croatian: Ako Temodal dođe u kontakt s kožom ili sluznicom, to područje treba odmah temeljito isprati sapunom i vodom.
English: Temodal contains a medicine called temozolomide.
Croatian: Temodal sadrži lijek pod nazivom temozolomid.
English: †, hepatic injury, hepatitis, cholestasis, hyperbilirubinemia
Croatian: †, oštećenje jetre, hepatitis, kolestaza, hiperbilirubinemija
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 (prosječno vrijeme između 0,5 i 1,5 sati).
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 dvije godine ili dulje veća je za skupinu koja je primala RT + TMZ (26% naspram 10%).
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 ispitivanju istodobno primali TMZ i RT prema produljenom 42-dnevnom režimu liječenja bili su izloženi osobitom riziku od razvoja pneumonije uzrokovane s Pneumocystis jirovecii.
English: Reconstituted solution: after reconstitution the chemical and physical in-use stability has been demonstrated for 14 hours at 25C, including infusion time.
Croatian: Pripremljena otopina: nakon pripreme je dokazana kemijska i fizikalna stabilnost tijekom 14 sati na temperaturi od 25°C, uključujući i vrijeme trajanja infuzije.
English:  10 and < 100 x 10
Croatian:  10 i < 100 x 10
English: In preclinical studies in rats and rabbits receiving 150 mg/m 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/m pokazalo se da lijek ima teratogen i/ili fetotoksičan učinak (vidjeti dio 5.3).
English: The active substance is temozolomide.
Croatian: Djelatna tvar je temozolomid.
English: A volume up to 40 ml reconstituted solution should be withdrawn, according to the total prescribed dose and transferred into an empty 250 ml infusion bag (PVC or polyolefin).
Croatian: Sukladno ukupnoj propisanoj dozi, iz bočice treba izvući najviše 40 ml pripremljene otopine i prebaciti je u praznu 250-mililitarsku infuzijsku vrećicu (PVC ili poliolefinsku).
English: In a study of 288 subjects with newlydiagnosed 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: The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O
Croatian: Smatra se da je citotoksičnost MTIC-a prvenstveno posljedica alkilacije DNK većinom na položajima gvanina
English: Temodal 2.5 mg/ml powder for solution for infusion may be administered in the same IV line with 0.9% Sodium Chloride injection.
Croatian: Temodal 2,5 mg/ml prašak za otopinu za infuziju može se primijeniti u istoj infuzijskoj liniji s injekcijom 0,9%-tnog natrijevog klorida.
English: C over 7 days post-dose was 0.8 %
Croatian: C, u fecesu je tijekom 7 dana nakon primjene doze izlučeno prosječno 0,8% radioizotopa
English: The vials should be gently swirled and not shaken.
Croatian: Bočicu treba nježno vrtjeti, a ne tresti.
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 "salvage" (terapija spašavanja) pokušaj liječenja 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: Very Common side effects (may affect more than 1 in 10 people) are: - loss of appetite, difficulty speaking, headache - vomiting, nausea, diarrhoea, constipation - rash, hair loss - tiredness
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) su: - gubitak teka, otežan govor, glavobolja - povraćanje, mučnina, proljev, zatvor - osip, gubitak kose - umor
English: The hard capsules (capsules) for oral use are individually sealed in sachets and dispensed in cartons containing 5 or 20 hard capsules.
Croatian: Tvrde kapsule (kapsule) za primjenu kroz usta su pojedinačno zatvorene u vrećice i dostupne su u pakiranjima koja sadrže 5 ili 20 tvrdih kapsula.
English: It is incompatible with dextrose solutions.
Croatian: Ovaj lijek nije kompatibilan s otopinama dekstroze.
English: The pump tubing should be attached to the bag, the tubing purged and then capped.
Croatian: Cijevi infuzijske pumpe treba pričvrstiti na vrećicu, pročistiti ih a zatim zatvoriti kapicom.
English: You will receive this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Croatian: Tu ćete dozu primati svakodnevno tijekom 42 dana (najdulje 49 dana) u kombinaciji sa zračenjem.
English: Temodal is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Croatian: Temodal je indiciran za liječenje: - odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom, istodobno s radioterapijom (RT), a zatim kao monoterapija.
English: It is therefore unlikely that you will receive more Temodal than you should.
Croatian: Stoga nije vjerojatno da ćete primiti više lijeka Temodal nego što ste trebali.
English: You will take your new dose of Temodal alone once daily for the first 5 days (“dosing days”) of each cycle.
Croatian: Uzimat ćete novu dozu lijeka Temodal jedanput na dan prvih 5 dana svakog ciklusa ("dani doziranja").
English: MTIC is spontaneously hydrolyzed to 5-aminoimidazole-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-4karboksamid (AIC), poznati međuspoj u biosintezi purina i nukleinskih kiselina, te u metilhidrazin, za koji se vjeruje da je aktivan alkilirajući spoj.
English: capsule shell:
Croatian: Ovojnica kapsule:
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 tvari, uključujući TMZ-a.
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: Mean AUC (0  ) values for TMZ and MTIC were 25 µg•h/ml and 1,004 ng•h/ml, respectively.
Croatian: Prosječan AUC (0  ) TMZ-a bio je 25 µg•h/ml, a MTIC-a 1,004 ng•h/ml.
English: Convulsions, hemiparesis, aphasia/dysphasia, headache
Croatian: konvulzije, hemipareza, afazija/disfazija, glavobolja
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4 % and 23 %, respectively.
Croatian: U odnosu na AUC temozolomida izloženost MTIC-u iznosi ~2,4%, a izloženost AIC-u 23%.
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: Temodal 2.5 mg/ml must be administered by intravenous infusion only over a period of 90 minutes.
Croatian: Temodal 2,5 mg/ml mora se primijeniti isključivo intravenskom infuzijom u trajanju od 90 minuta.
English: In patients treated with TMZ in clinical trials, the most common adverse reactions were nausea, vomiting, constipation, anorexia, headache, fatigue, convulsions, and rash.
Croatian: U bolesnika koji su primali TMZ u kliničkim ispitivanjima najčešće nuspojave bile su mučnina, povraćanje, konstipacija, anoreksija, glavobolja, umor, konvulzije i osip.
English: In patients previously treated with chemotherapy, the initial dose is 150 mg/m 2 once daily, to be increased in the second cycle to 200 mg/m 2 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/m 2 jedanput na dan, a u drugom ciklusu se povećava na 200 mg/m 2 jedanput na dan tijekom 5 dana ako nema znakova hematološke toksičnosti (vidjeti dio 4.4).
English: Temodal 2.5 mg/ml powder for solution for infusion, given as an intravenous infusion over 90 minutes, is bioequivalent to the hard capsule formulation (see section 5.2).
Croatian: Temodal 2,5 mg/ml prašak za otopinu za infuziju primijenjen u obliku intravenske infuzije tijekom 90 minuta bioekvivalentan je tvrdim kapsulama (vidjeti dio 5.2).
English: Skin and subcutaneous tissue disorders Very Common:
Croatian: Poremećaji kože i potkožnog tkiva Vrlo često:
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: Ataxia, balance impaired, cognition impaired, concentration impaired, consciousness decreased, dizziness, hypoesthesia, memory impaired, neurologic disorder, neuropathy d, paraesthesia, somnolence, speech disorder, taste perversion, tremor
Croatian: ataksija, poremećaj ravnoteže, narušene kognitivne funkcije, narušena koncentracija, smanjena razina svijesti, omaglica, hipoestezija, narušeno pamćenje, neurološki poremećaj, neuropatija d, parestezija, somnolencija, poremećaj govora, promjena osjeta okusa, tremor
English: If you use more Temodal than you should
Croatian: Ako uzmete više Temodal kapsula nego što ste trebali
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 šest 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: Pneumonia, dyspnoea, sinusitis, bronchitis, coughing, upper respiratory infection
Croatian: pneumonija, dispneja, sinusitis, bronhitis, kašalj, infekcija gornjih dišnih puteva
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temodal 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 primite Temodal radi izbjegavanja ili kontrole mučnine i povraćanja.
English: Powder for solution for infusion 100 mg
Croatian: Prašak za otopinu za infuziju 100 mg
English:  0.5 and < 1.5 x 10
Croatian:  0,5 i < 1,5 x 10
English: Adverse reactions in patients treated with temozolomide Infections and infestations
Croatian: Tablica 4. Nuspojave u bolesnika liječenih temozolomidom Infekcije i infestacije
English: Temodal is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Croatian: Temodal se primjenjuje u kombinaciji s radioterapijom (faza istodobnog liječenja), nakon čega slijedi do 6 ciklusa monoterapije temozolomidom (TMZ) (faza monoterapije).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: Pripremljeni lijek ne bi se smio čuvati dulje od 24 sata na temperaturi od 2°C do 8°C, osim ako se priprema nije odvijala u kontroliranim i validiranim aseptičkim uvjetima.