natgillin/translations-raw huggingface dataset:
You should stop breast-feeding while receiving treatment with Temozolomide SUN. 
Morate prekinuti dojenje dok se liječite Temozolomid SUN-om.
Men being treated with TMZ should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment (see section 4.6). 
Muškarcima koji se liječe TMZ-om treba savjetovati da ne začinju dijete do 6 mjeseci nakon primanja posljednje doze lijeka te da se prije početka liječenja posavjetuju oko kriokonzerviranja sperme zamrzavanjem (vidjeti dio 4.6).
Pack size: blisters are packed in cartons containing 5 or 20 hard capsules. 
Veličina pakovanja: blisteri su dostupni u kutijama koje sadrže 5 ili 20 tvrdih kapsula.
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, multiorgan failure and death. 
10 000 mg (ukupna doza tijekom 5 dana u jednom ciklusu), a prijavljene nuspojave bile su pancitopenija, pireksija, višeorgansko zatajenje i smrt.
During the concomitant phase, your doctor will start Temozolomide SUN at a dose of 75 mg/m2 (usual dose). 
U fazi istodobnog liječenja liječnik će započeti primjenu Temozolomid SUN-a u dozi od 75 mg/m2 (uobičajena doza).
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). 
U zasebnom ispitivanju faze I primjena TMZ-a s ranitidinom nije izazvala promjene u opsegu apsorpcije temozolomida niti u izloženosti njegovu aktivnom metabolitu monometil-triazenoimidazol karboksamidu (MTIC).
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. 
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),
You will again receive Temozolomide SUN once daily for 5 days, followed by 23 days without Temozolomide SUN. 
Ponovno ćete uzimati Temozolomid SUN jedanput na dan tijekom 5 dana, nakon čega slijede 23 dana bez Temozolomid SUN-a.
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). 
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).
Aluminium/aluminium unit dose blisters, consisting of an OPA [Oriented Poly Amide] / Aluminium / PVC [Polyvinyl chloride] forming film and peelable Aluminium lidding foil with heat seal laquer. 
Aluminij/aluminij blisterima djeljivima na jedinične doze, koji se sastoje od OPA [orijentirani poliamida] / aluminij / PVC [polivinil klorid] filma i toplinski zalijepljene odvojive aluminijske zaštitne folije.
- if you have liver or kidney problems, your dose of Temozolomide SUN may need to be adjusted. 
- ako imate problema s jetrom ili bubrezima, možda će biti potrebno prilagoditi dozu Temozolomid SUN-a.
Stearic acid 
tartaratna kiselina stearatna kiselina
Tell your doctor immediately if this occurs. 
Dogodi li se to, odmah obavijestite liječnika.
Temozolomide SUN contains lactose 
Temozolomid SUN sadrži laktozu
MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species. 
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.
In some cases, your Temozolomide SUN dose will be reduced or treatment stopped. 
U nekim će slučajevima smanjiti dozu Temozolomid SUN-a ili prekinuti liječenje ovim lijekom.
- if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC). 
- ako ste imali alergijsku reakciju na dakarbazin (antitumorski lijek).
The estimated probability of surviving 2 years or more (26 % vs 10 %) is higher for the RT + TMZ arm. 
Procijenjena vjerojatnost preživljenja od 2 godine ili dulje veća je za skupinu koja je primala RT + TMZ (26%
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. 
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 kriokonzerviranja sperme zamrzavanjem, jer postoji mogućnost da terapija TMZ-om dovede do trajne neplodnosti.
If you are a newly-diagnosed patient, treatment will occur in two phases: - treatment together with radiotherapy (concomitant phase) first - followed by treatment with Temozolomide SUN only (monotherapy phase). 
Ako ste novodijagnosticirani bolesnik, liječenje će se odvijati u dvije faze: - prvo liječenje zajedno sa zračenjem (faza istodobnog liječenja) - zatim liječenje samo Temozolomid SUN-om (faza monoterapije).
Herpes simplex, herpes zoster, influenza-like symptoms 
Herpes simplex, herpes zoster,
cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, sepsis† 
infekcija citomegalovirusom, reaktivacija infekcija poput infekcije citomegalovirusom, virusom hepatitisa B†, herpesni meningoencefalitis†, sepsa†
You will take your new dose of Temozolomide SUN once daily for the first 5 days (“dosing days”) of each cycle. 
Uzimat ćete novu dozu Temozolomid SUN-a jedanput na dan prvih 5 dana svakog ciklusa ("dani doziranja").
Temozolomide SUN is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme. 
Temozolomid SUN se koristi za liječenje određenih vrsta tumora mozga: - u odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom.
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. 
(0-5 epizoda povraćanja u 24 sata) i prestale bi same od sebe ili su se mogle lako kontrolirati standardnim antiemeticima.
- absolute neutrophil count (ANC) ≥ 1.5 x 109/l 
- apsolutni broj neutrofila (ABN) ≥ 1,5 x 109/l
Terapia S.A. Str. Fabricii nr 124 
Fabricii nr 124
You will take Temozolomide SUN only once daily for the first 5 days. 
Uzimat ćete samo Temozolomid SUN jedanput na dan prvih 5 dana.
Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide SUN on your blood cells. 
Tijekom liječenja će se često provoditi krvne pretrage radi praćenja nuspojava Temozolomid SUN-a na krvne stanice.
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 
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).
Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of Temozolomide SUN. 
U Tablici 5 obuhvaćene su nuspojave prijavljene tijekom kliničkih ispitivanja recidivirajućeg ili progresivnog malignog glioma te nakon stavljanja u promet lijeka Temozolomid SUN-a.
Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT. 
povišene vrijednosti AST-a *Jedan bolesnik koji je bio randomiziran u skupinu koja je primala samo RT, primio je TMZ + RT.
a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting). 
a: Istodobno liječenje temozolomidom može se nastaviti kada su zadovoljeni svi sljedeći uvjeti: apsolutni broj neutrofila ≥ 1,5 x 109/l; broj trombocita ≥ 100 x 109/l; nehematološka toksičnost prema CTC ≤ stupnju 1 (osim alopecije, mučnine i povraćanja).
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. 
Karnofsky performance status, KPS] ≥ 70) koji napreduje ili je recidivirao nakon kirurškog zahvata i radioterapije temelje se na dva klinička ispitivanja peroralno primijenjenog
After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 % indicating complete absorption. 
Nakon peroralne primjene temozolomida označenog radioizotopom 14C, u fecesu je tijekom 7 dana nakon primjene doze izlučeno prosječno 0,8% radioizotopa 14C, što ukazuje na potpunu apsorpciju.
Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide SUN (see also “Male fertility” below). 
I bolesnice i bolesnici koji uzimaju Temozolomid SUN moraju primjenjivati učinkovite mjere kontracepcije (pogledajte i dio "Plodnost muškaraca" u daljnjem tekstu).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
nedostatka Lapp laktaze ili malapsorpcije glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
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. 
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.
Hyde Park, Hayes 3 
Millington Road 11 Hyde Park, Hayes 3 5th Floor
If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus. 
Ako je nužno razmatrati mogućnost primjene Temozolomid SUN-a tijekom trudnoće, bolesnicu se mora upoznati s potencijalnim rizikom za plod.
929 & 140 mg 
929 i 140 mg
5x1 hard capsule 20x1 hard capsule 
20x1 tvrdih kapsula
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. 
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.
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. 
19%, medijan preživljenja bez progresije bolesti bio je 2,1 mjesec, a medijan ukupnog preživljenja 5,4 mjeseca.
This was followed by monotherapy TMZ (150-200 mg/m2) on Days 1-5 of every 28-day cycle for up to 6 cycles, starting 4 weeks after the end of RT. 
Nakon toga slijedila je monoterapija TMZ-om (150-200 mg/m2) od 1. do 5. dana svakog ciklusa od 28 dana.
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). 
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).
What you need to know before you take Temozolomide SUN Do not take Temozolomide SUN 
Što morate znati prije nego počnete uzimati Temozolomid SUN
Temozolomide SUN is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. 
Temozolomid SUN je indiciran za liječenje: - odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom, istodobno s radioterapijom (RT), a zatim kao monoterapija.
Temozolomide SUN is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase). 
Temozolomid SUN se primjenjuje u kombinaciji s radioterapijom (faza istodobnog liječenja), nakon čega slijedi do 6 ciklusa monoterapije temozolomidom (TMZ) (faza monoterapije).
Temozolomide SUN contains a medicine called temozolomide. 
Temozolomid SUN sadrži lijek pod nazivom temozolomid.
The median survival was 7.34 and 5.66 months for TMZ and procarbazine, respectively (log rank p=0.33). 
Medijan preživljenja bio je 7,34 mjeseca u skupini koja je primala TMZ, odnosno 5,66 mjeseci u skupini koja je primala prokarbazin (log-rang p = 0,33).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BLISTER 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BLISTER
Your doctor may decide to reduce the dose, interrupt, stop or change your treatment. 
Liječnik će možda odlučiti smanjiti dozu, ili privremeno odnosno trajno prekinuti liječenje.
prolonged pancytopenia, aplastic anaemia† 
dugotrajna pancitopenija, aplastična anemija†
Sodium starch glycolate (Type B) Tartaric acid 
laktoza natrijev škroboglikolat (vrste B) tartaratna kiselina stearatna kiselina
In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening. 
U oba je ispitivanja primarna mjera ishoda bilo vrijeme preživljenja bez progresije bolesti (engl. progression-free survival, PFS), određeno nalazom magnetske rezonancije
Temozolomide SUN may cause permanent infertility. 
Temozolomid može uzrokovati trajnu neplodnost.
- in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. 
- u djece u dobi od 3 godine i starije te u odraslih bolesnika s malignim gliomom, kao što je multiformni glioblastom ili anaplastični astrocitom.
Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC). 
Temozolomid je triazen koji se pri fiziološkom pH brzo kemijski pretvara u aktivni spoj monometil triazenoimidazol-karboksamid (MTIC).
930 & 180 mg 
930 i 180 mg
Somnolence, dizziness, paresthesia 
somnolencija, omaglica, parestezija
Temozolomide SUN contains lactose (a kind of sugar). 
Temozolomid SUN tvrde kapsule sadrže laktozu (vrstu šećera).
This adds up to a 28-day treatment cycle. 
Ciklus liječenja traje 28 dana.
Temozolomide SUN in combination treatment with radiotherapy in newly-diagnosed glioblastoma 
Temozolomid SUN u kombinaciji sa zračenjem u liječenju novodijagnosticiranog multiformnog glioblastoma
TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ Toxicity 
Privremen ili trajan prekid primjene TMZ-a tijekom faze istodobnog liječenja radioterapijom i TMZ-om
This is based on your size (height and weight) and whether you have a recurrent tumour and have had chemotherapy treatment in the past. 
Ona ovisi o Vašoj veličini (visini i težini) te o tome je li se tumor ponovno pojavio i jeste li ranije već primali kemoterapiju.
The cap is imprinted with ‘929'. 
Na kapici je otisnuta oznaka '929'.
Your doctor will work out your dose of Temozolomide SUN. 
Vaš liječnik će izračunati dozu Temozolomid SUN-a primjerenu za Vas.
Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption, 
Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba): crvenilo kože, urtikarija (koprivnjača), kožni osip, alergijska reakcija.
See package leaflet for further information. 
Sadržaj pakiranja druge informacije
- as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP). 
- jer će Vas se morati pomno nadzirati zbog moguće pojave teškog oblika upale pluća uzrokovane s Pneumocystis jirovecii.
The cap is imprinted with ‘930'. 
Na kapici je otisnuta oznaka '930'.
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. 
Na temelju rezultata analize populacijske farmakokinetike u kliničkim ispitivanjima faze II, istodobna primjena s deksametazonom, proklorperazinom, fenitoinom, karbamazepinom, ondansetronom,
890 & 5 mg 
890 i 5 mg
If you have been previously treated with chemotherapy, your first dose of Temozolomide SUN will be 150 mg/m2 once daily for the first 5 days. 
Ako ste ranije već liječeni kemoterapijom, prva doza Temozolomid SUN-a bit će 150 mg/m2 jedanput na dan tijekom prvih 5 dana.
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). 
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 Pneumocystis jirovecii.
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. 
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%
If you have not been previously treated with chemotherapy, your first dose of Temozolomide SUN will be 200 mg/m2 once daily for the first 5 days. 
Ako niste prethodno liječeni kemoterapijom, prva doza Temozolomid SUN-a bit će 200 mg/m2 jedanput na dan tijekom prvih 5 dana.
CTC Grade 4b a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if: - dose level -1 (100 mg/m2) still results in unacceptable toxicity 
CTC stupanj 4b a: doze TMZ-a navedene su u Tablici 2. b: TMZ se mora prekinuti:
- thrombocyte count ≥ 100 x 109/l 
- broj trombocita ≥ 100 x 109/l
There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 109/l ), 9 % vs 3 %, in women vs men in the first cycle of therapy. 
U prvom ciklusu terapije učestalost neutropenije (ABN < 0,5 x 109/l) i trombocitopenije (< 20 x 109/l) stupnja 4 bila je viša u žena nego u muškaraca: 12% naspram 5% kod neutropenije i 9% naspram 3% kod trombocitopenije.
Temozolomide SUN should only be prescribed by physicians experienced in the oncological treatment of brain tumours. 
4.2 Doziranje i način primjene Temozolomid SUN smiju propisivati samo liječnici s iskustvom u onkološkom liječenju tumora mozga.
SUN Pharma logo 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET SUN Pharma logo
Excipient with known effect Each hard capsule contains 163.441 mg of lactose. 
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 163,441 mg laktoze.
893 & 250 mg 
893 i 250 mg
Excipient with known effect Each hard capsule contains 127.121 mg of lactose. 
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 127,121 mg laktoze.
Sun Pharmaceutical Industries Europe B.V. 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sun Pharmaceutical Industries Europe B.V.
- common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting). 
- nehematološka toksičnost prema općim kriterijima toksičnosti (engl. common toxicity criteria, CTC) ≤ stupnju 1 (osim alopecije, mučnine i povraćanja).
hyperbilirubinemia, cholestasis, hepatitis hepatic injury, hepatic failure† 
hiperbilirubinemija, kolestaza, hepatitis oštećenje jetre, zatajenje jetre†
Always take this medicine exactly as your doctor or pharmacist has told you. 
Kako uzimati Temozolomid SUN Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik.
892 & 100 mg 
892 i 100 mg
How to take Temozolomide SUN 
Kako uzimati Temozolomid SUN
The median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p=< 0.01 to 0.03). 
2,1 mjeseca dulji u skupini koja je primala TMZ nego u skupini koja je primala prokarbazin (log-rang p = < 0,01 do 0,03).
Very common (may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick), constipation (difficulty passing stools), tiredness. 
Vrlo česte (mogu se javiti u više od 1 na 10 osoba): smanjen broj krvnih stanica (neutropenija ili limfopenija, trombocitopenija), gubitak teka, glavobolja, povraćanje, mučnina (osjećaj mučnine), zatvor (otežano pražnjenje crijeva), umor.
Erythema multiforme, erythroderma, urticaria, exanthema 
multiformni eritem, eritrodermija, urtikarija, egzantem
891 & 20 mg 
891 i 20 mg
How to store Temozolomide SUN 
Kako čuvati Temozolomid SUN
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. 
HR = 1,33-1,91), uz log-rang p < 0,0001 u korist skupine koja je primala TMZ.
Excipient with known effect Each hard capsule contains 90.801 mg of lactose. 
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 90,801 mg laktoze.
Hepatic enzymes increased, 
povišene vrijednosti jetrenih enzima,
Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids 
abdominalna distenzija, inkontinencija stolice, nespecificirani gastrointestinalni poremećaj, gastroenteritis, hemoroidi
Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme System organ class 
Tablica 4. Štetni događaji koji su se pojavili tijekom faze istodobnog liječenja i faze monoterapije u bolesnika s novodijagnosticiranim multiformnim glioblastomom Organski sustav
Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion 
alergijska reakcija, vrućica, ozljeda zbog zračenja, edem lica, bol,
Excipient with known effect Each hard capsule contains 18.16 mg of lactose. 
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 18,16 mg laktoze.
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./ 
Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain 
hemianopija, smanjena oštrina vida, poremećaj vida, ispad vidnog polja,
Frequency not known: 
Učestalost nepoznata: