natgillin/translations-raw huggingface dataset:
Frequency groupings are defined according to the following convention: very common (≥ 1/10); 
Skupine pogostnosti so opredeljene skladno s konvencijo: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10),
The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine. 
Menijo, da je citotoksičnost MTIK predvsem posledica alkilacije DNA, predvsem gvanina na položajih O6 in N7.
Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days. 
Odrasli in pediatrični bolniki, stari 3 leta ali več, s ponavljajočim se ali napredujočim malignim gliomom: Posamezen cikel zdravljenja traja 28 dni.
Your doctor will check your blood to make sure you have enough of these cells before you begin treatment. 
Pred zdravljenjem bo zdravnik preveril vašo kri, da bi se prepričal, ali imate dovolj teh celic.
Do not open, crush or chew the capsules, swallow whole. 
Kapsule ne odpirajte, drobite ali žvečite; pogoltnite celo.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). 
Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
Convulsions, consciousness 
konvulzije, motnje zavesti,
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). 
Če ste na novo diagnosticiran bolnik, bo zdravljenje potekalo v dveh fazah: - najprej zdravljenje skupaj z obsevanjem (faza sočasnega zdravljenja) - pozneje samo zdravljenje z zdravilom Temozolomid SUN (faza monoterapije).
If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose. 
Če se kapsula poškoduje, se izogibajte stiku praška z vašo kožo, očmi ali nosom .
Temozolomide SUN should only be prescribed by physicians experienced in the oncological treatment of brain tumours. 
Zdravilo Temozolomid SUN smejo predpisati le zdravniki, ki imajo izkušnje z zdravljenjem možganskih tumorjev.
If you accidentally take more Temozolomide SUN capsules than you were told to, contact your doctor, pharmacist or nurse immediately. 
Če ste vzeli večji odmerek zdravila Temozolomid SUN, kot bi smeli Če po nesreči vzamete več kapsul zdravila Temozolomid SUN, se takoj posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
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). 
V randomiziranem, z učinkovino nadzorovanem preskušanju je bil PFS po 6 mesecih statistično značilno daljši pri TMZ kot pri prokarbazinu (21 % v primerjavi z 8 %, hi-kvadrat, p = 0,008), z mediano vrednostjo PFS 2,89 meseca za temozolomid in 1,88 meseca za prokarbazin (test log.
Patients should be advised to keep capsules out of the sight and reach of children, preferably in a locked cupboard. 
Bolnikom svetujte, naj hranijo kapsule nedosegljive otrokom, najbolje v zaklenjeni omarici.
Temozolomide SUN monotherapy in recurrent or progressive glioma 
Monoterapija z zdravilom Temozolomid SUN pri ponavljajočem se ali napredujočem gliomu
TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC). 
TMZ spontano hidrolizira pri fiziološki vrednosti pH predvsem do aktivnih presnovkov, 3-metil(triazen-1-il)imidazol-4-karboksamida (MTIK).
This is based on your size (height and weight) and whether you have a recurrent tumour and have had chemotherapy treatment in the past. 
(višino in maso) in glede na to, ali imate ponavljajoče tumorje ter ali ste se v preteklosti zdravili s kemoterapijo.
Temozolomide SUN may cause permanent infertility. 
Zdravilo Temozolomid SUN lahko povzroči trajno neplodnost.
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. 
MTIK pa spontano hidrolizira do 5-amino-imidazol-4karboksamida (AIK), znanega intermediata v biosintezi purinov in nukleinskih kislin, ter metilhidrazina, za katerega menijo, da je aktivni alkilirajoči presnovek.
If you vomit after taking your dose, do not take a second dose on the same day. 
Če po zaužitju odmerka bruha, ne sme še isti dan vzeti drugega odmerka.
cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, sepsis† 
okužba s citomegalovirusom, reaktivacija okužb, kot sta okužbi s citomegalovirusom, z virusom hepatitisa B†, herpetični meningoencefalitis†, sepsa†
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. 
Pretisnih omotih aluminij/aluminij, sestavljenih iz filma iz orientiranega poliamida (OPA)/aluminija/polivinilklorida (PVC ) in toplotno zavarjene odstranljive aluminijaste prekrivne folije.
TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ Toxicity 
Prekinitev jemanja ali ukinitev TMZ med sočasno radioterapijo in zdravljenjem s TMZ
The median survival was 7.34 and 5.66 months for TMZ and procarbazine, respectively (log rank p=0.33). 
Mediana vrednost časa preživetja je bila 7,34 mesecev za TMZ in 5,66 mesecev za prokarbazin (test log.
Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy. 
Bolniki s ponavljajočim se ali napredujočim malignim gliomom Pri bolnikih, ki so močno bruhali (stopnja 3 ali 4) v prejšnjih ciklih zdravljenja je potrebno antiemetično zdravljenje.
You will again receive Temozolomide SUN once daily for 5 days, followed by 23 days without Temozolomide SUN. 
Zdravilo Temozolomid SUN boste spet jemali pet dni enkrat dnevno, temu pa bo sledilo 23 dni brez jemanja zdravila.
TMZ dose levels for monotherapy treatment Dose level 
Ravni odmerkov TMZ za monoterapijo
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. 
Analiza populacijske farmakokinetike v preskušanjih druge faze je pokazala, da sočasna uporaba deksametazona, proklorperazina, fenitoina, karbamazepina, ondansetrona, antagonistov receptorjev H2 ali fenobarbitala ne spremeni očistka TMZ.
Opportunistic infections and reactivation of infections Opportunistic infections (such as Pneumocystis jirovecii pneumonia) and reactivation of infections (such as HBV, CMV) have been observed during the treatment with TMZ (see section 4.8). 
Med zdravljenjem s TMZ so opazili oportunistične okužbe (kot je pljučnica, ki jo povzroča Pneumocystis jirovecii) in reaktivacijo okužb (kot sta HBV, CMV) (glejte poglavje 4.8).
Propylene glycol 
Šelak Propilenglikol
Dry skin, pruritus 
pruritus suha koža, pruritus
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 
Pri bolnikih, ki so že bili zdravljeni s kemoterapijo, je začetni odmerek 150 mg/m2 enkrat na dan, v drugem ciklu pa se poveča na 200 mg/m2 enkrat na dan 5 dni, če ni bilo hematoloških toksičnih učinkov (glejte poglavje 4.4).
At the start of Cycle 2, the dose is escalated to 200 mg/m2 if the CTC non-haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/l, and the thrombocyte count is ≥ 100 x 109/l. 
Na začetku 2. cikla odmerek povečajte na 200 mg/m2, če je SMT za nehematološko toksičnost za 1. cikel stopnje ≤ 2 (z izjemo alopecije, slabosti in bruhanja), absolutno število nevtrofilcev (ANC) ≥ 1,5 x 109/l in število trombocitov ≥ 100 x 109/l.
Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment. 
V 1. ciklu (monoterapija) je odmerek zdravila 150 mg/m2 enkrat na dan 5 dni, temu pa naj sledi 23 dni brez terapije.
Adverse reactions in patients with recurrent or progressive malignant glioma Infections and infestations 
Neželeni učinki pri bolnikih s ponavljajočim se ali napredujočim malignim gliomom Infekcijske in parazitske bolezni
Temozolomide SUN contains lactose 
Zdravilo Temozolomid SUN vsebuje laktozo
Temozolomide SUN is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase). 
Zdravilo Temozolomid SUN se uporablja v kombinaciji z žariščno radioterapijo (faza sočasne terapije), temu pa sledi do 6 ciklov monoterapije (monoterapijska faza) s temozolomidom (TMZ).
A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286). 
Skupaj 573 bolnikov so randomizirali v dve skupini, od katerih je ena prejemala TMZ in RT (n=287), druga pa samo RT (n=286).
Patients usually present with shortness of breath and cough. 
Pri bolnikih se ponavadi pojavi zasoplost in kašelj.
If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x 109/l during any cycle, the next cycle should be reduced one dose level (see section 4.2). 
pade na < 1,0 x 109/l ali število trombocitov na < 50 x 109/l, morate odmerek zdravila v naslednjem ciklu zmanjšati za eno odmerno stopnjo (glejte poglavje 4.2).
PHARMACEUTICAL PARTICULARS 6.1 List of excipients 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Vsebina kapsule
- common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting). 
- skupna merila toksičnosti (SMT) za nehematološko toksičnost ≤ 1. stopnje (z izjemo alopecije, slabosti in bruhanja).
Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption, 
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): pordečelost kože, urtikarija (koprivnica), kožni izpuščaj, alergijske reakcije.
Pneumocystis jiroveciipneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy. 
Med RT sta bili potrebni profilaksa proti pljučnici zaradi okužbe s Pneumocystis jirovecii (PCP) in kombinirana terapija s TMZ.
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). 
Mediana vrednost časa do napredovanja bolezni za naštete končne točke je bila za 0,7 do 2,1 meseca daljša za TMZ kot za prokarbazin (test log.
The major route of 14C elimination is renal. 
Zdravilo 14C se izloča predvsem preko ledvic.
How to store Temozolomide SUN Contents of the pack and other information 
Možni neželeni učinki Shranjevanje zdravila Temozolomid SUN Vsebina pakiranja in dodatne informacije
If a capsule is damaged, avoid contact with your skin, eyes or nose. 
Če je kapsula poškodovana, ne sme priti v stik s kožo, očmi ali nosom.
Reduce TMZ by 1 dose levela 
Zmanjšajte odmerek TMZ
Titanium dioxide (E171) 
Želatina Titanov dioksid (E171)
Titanium dioxide (E171) Sodium laurilsulfate 
Titanov dioksid (E171) Natrijev lavrilsulfat
What Temozolomide SUN looks like and contents of the pack 
Izgled zdravila Temozolomid SUN in vsebina pakiranja
Dermatitis, dry skin, erythema, pruritus 
dermatitis, suha koža, eritem,
- in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. 
- pri otrocih, starih 3 leta ali več, in pri odraslih bolnikih z malignega glioma, na primer multiformnega glioblastoma ali anaplastičnega astrocitoma.
The objective response rate (ORR) based on MRI scans was 8 %. 
Objektivno ugotovljena stopnja odzivanja bolnikov na zdravljenje določena na podlagi NMR posnetkov, je bila 8 %.
TMZ dose reduction or discontinuation during monotherapy treatment Toxicity 
Zmanjšanje odmerka ali ukinitev zdravila TMZ med monoterapijoToksičnost Toksičnost
The cap is imprinted with ‘929'. 
Na pokrovčku je odtisnjena oznaka »929«.
5x1 hard capsule 20x1 hard capsule 
20x1 trdih kapsul
Agitation, apathy, behaviour 
vznemirjenost, apatija, vedenjske motnje,
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 - the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction. 
SMT stopnja 4b a: Ravni odmerkov TMZ so podane v preglednici 2. b: TMZ morate ukiniti, če: raven odmerka -1 (100 mg/m2) še vedno povzroči nesprejemljivo toksičnost po zmanjšanju odmerka ponovno nastopi ista nehematološka toksičnost 3. stopnje (z izjemo alopecije, slabosti in bruhanja).
- The active substance is temozolomide. 
- Zdravilna učinkovina je temozolomid.
The cap is imprinted with ‘930'. 
Na pokrovčku je odtisnjena oznaka »930«.
Convulsions were reported very commonly in the newlydiagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very commonly in newly-diagnosed glioblastoma multiforme patients receiving TMZ concurrent with RT and also as monotherapy, and commonly in recurrent glioma. 
Pri bolnikih z novo diagnosticiranim multiformnim glioblastomom na monoterapiji so zelo pogosto poročali o konvulzijah, medtem ko je bil izpuščaj opisan zelo pogosto pri bolnikih z novo diagnosticiranim multiformnim glioblastomom, ki so prejemali TMZ sočasno z RT, ter pri tistih, ki so zdravilo prejemali v obliki monoterapije, pogosto pa pri tistih s ponavljajočim se gliomom.
Take the missed dose as soon as possible during the same day. 
drugega odmerka ne vzemite istega dne.
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. 
Če ste se že zdravili s kemoterapijo, bo prvih pet dni vaš odmerek zdravila Temozolomid SUN 150 mg/m2 enkrat dnevno.
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. 
V študiji pri 288 preiskovancih z novo diagnosticiranim multiformnim glioblastomom se je v prvem ciklu terapije nevtropenija 4. stopnje pojavila pri 3 % žensk in 0 % moških,
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. 
TMZ ima lahko genotoksične učinke, zato morate moškim, ki se zdravijo z njim, svetovati, naj ne zaplodijo otroka še šest mesecev po zadnjem vzetem odmerku in naj se zaradi možnosti ireverzibilne neplodnosti zaradi zdravljenja s TMZ pred zdravljenjem posvetujejo o možnostih shranjevanja zamrznjene sperme.
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. 
Če se še nikoli niste zdravili s kemoterapijo, bo prvih pet dni vaš odmerek zdravila Temozolomid SUN 200 mg/m2 enkrat dnevno.
For the 20 capsules packs, 4 blisters of 5 capsules will be included in a carton. 
Pakiranje z 20 kapsulami je pakirano v škatlo s 4 pretisnimi omoti po 5 kapsul.
In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr. 
In vivo je bila razpolovna doba t1/2 za MTIK podobna razpolovni dobi temozolomida, t.j.
Propylene glycol Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) 
Rdeči železov oksid (E172) Rumeni železov oksid (E172) Titanov dioksid (E171)
- 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. 
- otrok, starih 3 leta in več, mladostnikov in odraslih bolnikov z malignim gliomom, na primer multiformnim glioblastomom ali anaplastičnim astrocitomom, ki se po standardnem zdravljenju ponovi ali napreduje.
Tell your pharmacist if you notice any change in the appearance of the capsules. 
Če opazite kakršnokoli spremembo v videzu kapsul, obvestite farmacevta.
Otitis media, tinnitus, hyperacusis, earache 
otitis media, tinitus,
Excipient with known effect Each hard capsule contains 18.16 mg of lactose. 
Pomožna snov z znanim učinkom Ena trda kapsula vsebuje 18,16 mg laktoze.
Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT. 
AST *Bolnik, ki je bil randomiziran v skupino, ki je prejemala samo RT, je prejemal TMZ in RT.
Excipient with known effect Each hard capsule contains 90.801 mg of lactose. 
Pomožna snov z znanim učinkom Ena trda kapsula vsebuje 90,801 mg laktoze.
Blood and lymphatic system disorders Very common: 
Bolezni krvi in limfatičnega sistema Pogosti:
This medicine is an antitumour agent. 
To je protitumorsko zdravilo.
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. 
Pri ženskah so ugotovili 12 % pogostnost nevtropenije 4. stopnje (absolutno število nevtrofilcev (ANC) < 0,5 x 109/l), v primerjavi s 5 % pri moških, medtem ko je pogostnost trombocitopenije (< 20 x 109/l) pri ženskah znašala 9 %, v primerjavi s 3 % pri moških, torej so bile v prvem ciklu terapije pri ženskah te pogostnosti večje kot pri moških.
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. 
Če imate kateregakoli od naslednjih znakov, se nemudoma obrnite na zdravnika: - huda alergijska (preobčutljivostna) reakcija (koprivnica, hropenje ali druge težave z dihanjem)
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu 
Podrobne informacije o izdelku so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro .
In some cases, it may be necessary to stop treatment with Temozolomide SUN. - as you may have a small risk of other changes in blood cells, including leukaemia. 
- ker morda obstaja manjše tveganje za druge spremembe krvnih celic, vključno z levkemijoče.
What you need to know before you take Temozolomide SUN Do not take Temozolomide SUN 
Kaj morate vedeti, preden boste vzeli zdravilo Temozolomid SUN
Muscle weakness, arthralgia Muscle weakness, arthralgia, musculoskeletal pain, myalgia 
mišična šibkost, artralgija mišična šibkost, artralgija, mišičnoskeletne bolečine, mialgija
You will take Temozolomide SUN only once daily for the first 5 days. 
Prvih pet dni boste jemali samo zdravilo Temozolomid SUN enkrat dnevno.
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. 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): zmanjšano število krvnih celic (nevtropenija ali limfopenija, trombocitopenija), izguba apetita, glavobol, bruhanje, slabost, zaprtje (težave pri odvajanju blata).
If you accidentally get some in your eyes or nose, flush the area with water. 
Če pride zdravilo Temozolomid SUN po nesreči v stik z očmi ali nosom, to področje sperite z vodo.
Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids 
inkontinenca blata, bolezni prebavil (NOS), gastroenteritis,
Erythema multiforme, erythroderma, urticaria, exanthema 
multiformni eritem, eritroderma, urtikarija,
Hypokalemia, alkaline phosphatase increased, weight increased 
hipokaliemija, zvišanje vrednosti alkalne fosfataze,
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BLISTER 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Temozolomide SUN is at first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment). 
Zdravilo Temozolomid SUN se najprej uporablja skupaj z obsevanjem (faza sočasnega zdravljenja), nato pa še samostojno (faza monoterapije).
Micturition frequency, urinary incontinence 
pogosto uriniranje, inkontinenca seča inkontinenca seča
Excipient with known effect Each hard capsule contains 127.121 mg of lactose. 
Ena trda kapsula vsebuje 127,121 mg laktoze.
Temozolomide SUN in combination treatment with radiotherapy in newly-diagnosed glioblastoma 
Zdravilo Temozolomid SUN pri zdravljenju na novo diagnosticiranega glioblastoma v kombianciji z obsevanjem
disorder, depression, hallucination 
halucinacije, amnezija depresija, halucinacije
Pneumonia, sinusitis, upper respiratory infection, bronchitis 
pljučnica, okužba zgornjih dihal, kongestija nosne sluznice pljučnica, sinusitis, okužba zgornjih dihal, bronhitis
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). 
Po 6 mesecih je bil delež preživelih bolnikov statistično značilno večji v skupini, ki je prejemala TMZ (60 %), kot v tisti, ki je prejemala prokarbazin (44 %)
- thrombocyte count ≥ 100 x 109/l 
- število trombocitov ≥ 100 x 109/l,
Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain 
impotenca vaginalne krvavitve, menoragija, amenoreja, vaginitis, bolečine v dojkah
Response rate, based on the central reviewer assessment, was 35 % (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162. 
Po ugotovitvi osrednjega ocenjevalca je bil delež odziva v populaciji, ki so jo želeli zdraviti (ITT, n=162) 35 % (13 popolno okrevanje in 43 delno okrevanje).
photosensitivity reaction, pigmentation abnormal abnormal, sweating increased 
preobčutljivostne reakcije na svetlobo, nenormalna pigmentacija eritem, nenormalna pigmentacija, povečano znojenje
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 
b: TMZ morate ukiniti, če: - raven odmerka -1 (100 mg/m2) še vedno povzroči nesprejemljivo toksičnost
(difficulty passing stools), nausea (feeling sick), vomiting, rash, hair loss, tiredness. 
(težave pri odvajanju blata), slabost, bruhanje, izpuščaj, izpadanje las, utrujenost.
Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/ 
België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/
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. 
V obdobju trženja so pri bolnikih, ki so prejemali TMZ v kombinaciji z radioterapijo, vključno s primeri sočasnega dajanja steroidov, opazili primere herpetičnega meningoencefalitisa (vključno s smrtnimi primeri).
Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme System organ class 
Neželeni učinki, ki so nastopili med zdravljenjem med fazo sočasne in monoterapije pri bolnikih z novo diagnosticiranim multiformnim glioblastomom
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). 
V ločeni študiji 1. faze sočasna uporaba zdravila TMZ in ranitidina ni povzročila spremembe obsega absorpcije temozolomida ali izpostavljenosti njegovemu aktivnemu presnovku,