natgillin/translations-raw huggingface dataset:
Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle. 
Pred vsakim novim ciklom zdravljenja pri zdravniku znova preverite velikost odmerka; ta morda ne bo enaka kot v prejšnjem ciklu.
The median survival was 7.34 and 5.66 months for TMZ and procarbazine, respectively (log rank p = 0.33). 
Srednje preživetje je bilo pri TMZ 7,34 meseca in pri prokarbazinu 5,66 meseca (vrednost p testa log rank = 0,33).
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. 
Ponavljajoč se ali napredujoč maligni gliom Podatki o klinični učinkovitosti pri bolnikih z multiformnim glioblastomom (indeks telesne zmogljivosti Karnofsky ≥ 70), ki se je po operaciji in obsevanju ponovil ali napredoval, temeljijo na dveh kliničnih preskušanjih s peroralnimi odmerki TMZ.
During the concomitant phase, your doctor will start Temozolomide Teva at a dose of 75 mg/m² (usual dose). 
V obdobju sočasnega zdravljenja boste začeli jemati odmerek zdravila Temozolomide Teva 75 mg/m² (običajni odmerek).
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). 
Ko so samemu obsevanju dodali sočasno zdravljenje s TMZ, ki mu je v zdravljenju bolnikov z na novo diagnosticiranim multiformnim glioblastomom sledila samostojna terapija s TMZ, so dosegli statistično pomembno izboljšanje skupnega preživetja v primerjavi s samim obsevanjem (Slika 1).
Contents of the pack and other information What Temozolomide Teva contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Temozolomide Teva
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 šestih mesecih je bila frakcija preživelih bolnikov znatno večja v kraku s TMZ (60 %) kot v kraku s prokarbazinom (44 %) (vrednost p testa hi-kvadrat = 0,019).
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. 
S kombiniranjem nenormalnih rezultatov laboratorijskih preiskav in neželenih učinkov iz obdobij sočasnega in samostojnega zdravljenja so pri 8 % bolnikov opazili nepravilnosti nevtrofilcev stopnje 3 ali 4, vključno z nevtropeničnimi dogodki.
Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat. 
DTIC): med znaki alergijske reakcije so lahko srbenje, zasoplost ali oteženo dihanje, otekanje obraza, ustnic, jezika ali grla;
PET studies in humans and preclinical data suggest that TMZ crosses the blood-brain barrier rapidly and is present in the CSF. 
Študije s pozitronsko emisijsko tomografijo pri ljudeh in predklinični podatki kažejo, da TMZ hitro prehaja skozi krvno-možgansko pregrado in da je prisoten v cerebrospinalni tekočini.
Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4% and 23%, respectively. 
Glede na vrednost AUC TMZ je izpostavljenost MTIC približno 2,4-odstotna, izpostavljenost AIC pa 23-odstotna.
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 podlagi populacijske farmakokinetične analize v preskušanjih faze II sočasna uporaba deksametazona, proklorperazina, fenitoina, karbamazepina, ondansetrona, antagonistov receptorjev H2
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA citotoksična snov
† Including cases with fatal outcome *Frequencies estimated based on relevant clinical trials 
* Pogostnosti so ocenjene na podlagi ustreznih kliničnih raziskav.
Experience in these children is very limited (see sections 4.4 and 5.1). 
Izkušenj pri tehotrocih je malo (glejte poglavji 4.4 in 5.1).
Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported. 
Občasno so poročali o povišanih vrednostih bilirubina, težavah s pretokom žolča (holestazi), hepatitisu in poškodbi jeter, vključno z odpovedjo jeter s smrtnim izidom.
Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed. 
Opazili so mielosupresijo (nevtropenija in trombocitopenija), znan toksični učinek, ki omejuje odmerke večine citotoksičnih učinkovin, vključno s TMZ.
Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC). 
Mehanizem delovanja Temozolomid je triazen, ki se pri fiziološki vrednosti pH hitro kemijsko pretvori v aktivni monometiltriazenoimidazolkarboksamid (MTIC).
Dose reductions and discontinuations during the monotherapy phase should be applied according to Tables 2 and 3. 
Zmanjšanje odmerka ali opustitev zdravljenja v obdobju samostojne uporabe mora ustrezati priporočilom v razpredelnicah 2 in 3.
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): pordelost kože, urtikarija (koprivnica), kožni izpuščaji, alergijske reakcije.
During treatment a complete blood count should be obtained on Day 22 (21 days after the first dose of TMZ). 
22. dan zdravljenja (21 dni po prvem odmerku TMZ) je treba narediti celotno krvno sliko.
Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8). 
Zelo redko so poročali tudi o primerih mielodisplastičnega sindroma in sekundarnih malignomov, vključno z mieloidno levkemijo (glejte poglavje 4.8).
No data are available on the administration of TMZ in patients with severe hepatic impairment (Child's Class C) or with renal impairment. 
O uporabi TMZ pri bolnikih s hudo okvaro jeter (razred C po Childu) ali okvaro ledvic ni podatkov.
Depending on your blood test results, your doctor may adjust your dose for the next cycle. 
Glede na rezultate krvnih preiskav vam bo morda za naslednji cikel zdravljenja predpisal drugačen odmerek.
However, because the doses implicated in retinal degeneration were in the lethal dose range, and no comparable effect has been observed in clinical studies, this finding was not considered to have clinical relevance. 
Vendar to odkritje ne velja za klinično pomembno, ker so bili odmerki, ki so povzročili degeneracijo mrežnice, v razponu smrtnih odmerkov, in ker v kliničnih študijah niso opazili nobenega primerljivega učinka.
Then, you will start the monotherapy phase. 
Nato boste začeli obdobje samostojnega zdravljenja.
Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral 
okužba, herpes simplex, okužba rane, faringitis, oralna kandidoza okužba, oralna kandidoza
Themedian 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). 
Srednja časa do napredovanja bolezni sta bila v teh primarnih točkah ocene učinkovitosti pri TMZ od 0,7 do 2,1 meseca daljša kot pri prokarbazinu (vrednost p testa log rank = < 0,01 do 0,03).
No dose reductionsare recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non-haematological toxicity criteria. 
Zmanjšanje odmerkov se ne priporoča, vendar je treba na podlagi meril hematološke in nehematološke toksičnosti vsak teden razmisliti o odložitvi ali ukinitvi zdravljenja s
Patients in the control arm received RT only. 
Bolniki v kontrolnem kraku so se zdravili samo z obsevanjem.
Absolute Neutrophil Count 
absolutno število nevtrofilcev
In patients with prior chemotherapy a benefit was indicated in those with a KPS ≥ 80. 
Pri bolnikih, ki so se že prej zdravili s kemoterapijo, se je korist zdravljenja pokazala pri tistih z indeksom telesne zmogljivosti po Karnofskyju ≥ 80.
Single-cycle (5-day dosing, 23 days non-treatment), 3- and 6-cycle toxicity studies were conducted in rats and dogs. 
Pri podganah in psih so opravili študije toksičnosti z enim (pet dni odmerjanja, 23 dni brez zdravljenja), tremi in šestimi cikli zdravljenja.
Temozolomide Teva may cause permanent infertility. 
Zdravilo Temozolomide Teva lahko povzroči trajno neplodnost.
Patients with recurrent or progressive malignant glioma Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy. 
Bolniki, ki so imeli v prejšnjih ciklih zdravljenja težave s hudim bruhanjem (stopnja 3 ali 4), bodo verjetno potrebovali antiemetično terapijo.
Temozolomide Teva monotherapy in recurrent or progressive glioma The following side effects may occur, and may require medical attention. 
Samostojno zdravljenje ponavljajočega se ali napredujočega glioma z zdravilom Temozolomide Teva Lahko se pojavijo naslednji neželeni učinki, zaradi katerih boste morda potrebovali zdravniško pomoč.
The estimated probability of surviving 2 years or more (26% vs 10%) is higher for the RT + TMZ arm. 
Ocenjena verjetnost dveletnega ali daljšega preživetja je večja v kraku z obsevanjem in TMZ (26 % v primerjavi z 10 %).
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 krvno sliko, da bi se prepričal, ali imate dovolj teh celic.
hyperbilirubinemia, cholestasis, hepatitis, hepatic injury, hepatic failure† 
hiperbilirubinemija, holestaza, hepatitis jetrna poškodba, jetrna odpoved †
If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose. 
Če je kapsula poškodovana, pazite, da prašek ne pride v stik s kožo, očmi ali nosom.
Patients with hepatic or renal impairment 
Bolniki z okvaro ledvic ali jeter
Temozolomide Teva is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment). 
Zdravilo Temozolomide Teva se najprej uporablja skupaj z obsevanjem (obdobje sočasnega zdravljenja), nato pa še samostojno (obdobje samostojnega zdravljenja);
You will take Temozolomide Teva alone once daily for the first 5 days. 
Prvih pet dni boste jemali samo Temozolomide Teva enkrat dnevno.
Experts in liver disease should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease). 
Pred začetkom zdravljenja bolnikov s pozitivno serologijo na hepatitis B
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 bilo preživetje brez napredovanja bolezni po šestih mesecih pomembno večje v skupini s TMZ kot v tisti s prokarbazinom (21 % v primerjavi z 8 %, vrednost p testa hi-kvadrat = 0,008), s srednjim preživetjem brez napredovanja bolezni 2,89 v primerjavi z 1,88 meseca (vrednost p testa log rank = 0,0063).
TMZ dose levels for monotherapy treatment 
Ravni odmerkov TMZ za samostojno zdravljenje raven odmerka odmerek
Prior to dosing, the following laboratory parameters must be met: ANC ≥ 1.5 x 109/l and platelet count ≥ 100 x 109/l. 
Pred odmerjanjem morata biti izpolnjena naslednja pogoja laboratorijskih parametrov: absolutno število nevtrofilcev ≥ 1,5 x 109/l in število trombocitov ≥ 100 x 109/l.
This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections. 
Zato boste morda imeli pogostejše podplutbe ali krvavitve, anemijo (pomanjkanje rdečih krvnih celic),
Agitation, apathy, behaviour disorder, depression, hallucination 
agitacija, apatija, vedenjska motnja, depresija, halucinacija halucinacija, amnezija
Red iron oxide (E172) 
rdeči železov oksid (E172),
Newly-diagnosed glioblastoma multiforme 
Na novo diagnosticiran multiformni glioblastom
Table 4: Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme System organ class 
Razpredelnica 4: dogodki, nastali med zdravljenjem v obdobjih sočasnega in samostojnega zdravljenja pri bolnikih z novo diagnosticiranim multiformnim glioblastomom
Table 5. 
Razpredelnica 5.
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. 
Rezultati preskušanja niso bili dosledni v podskupini bolnikov s slabo telesno zmogljivostjo (TZ po merilih Svetovne zdravstvene organizacije = 2, n = 70), kjer sta bila skupno preživetje in čas do napredovanja bolezni podobna v obeh krakih.
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, nemudoma obvestite zdravnika: - huda alergijska (preobčutljivostna) reakcija (izpuščaji; sopenje ali druge težave z dihanjem),
In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma. 
Pri bolnikih, starih tri leta in več, se sme TMZ uporabljati pri ponavljajočem se ali napredujočem malignem gliomu.
A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286). 
Na novo diagnosticirani multiformni glioblastom 573 bolnikov so naključno razvrstili v krak kombiniranega zdravljenja s temolozomidom in obsevanjem (n = 287) ali v krak s samim obsevanjem (n = 286).
Your doctor will work out your dose of Temozolomide Teva. 
Zdravnik bo izračunal, kako velik odmerek zdravila Temozolomide Teva vam ustreza.
- 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 malignim gliomom, na primer multiformnega glioblastoma ali anaplastičnega astrocitoma.
*A patient who was randomised to the RT arm only, received TMZ + RT. 
*Bolnik, ki je bil naključno razvrščen v krak s samim obsevanjem, se je zdravil s TMZ in obsevanjem.
Temozolomide Teva hard capsules should be administered in the fasting state. 
Temozolomide Teva trde kapsule se jemljejo na tešče.
Contains lactose, sunset yellow FCF (E110). 
Vsebuje laktozo in sončno rumeno FCF (E110).
Always take Temozolomide Teva exactly as your doctor has told you. 
Pri jemanju zdravila Temozolomide Teva vedno natančno upoštevajte navodila zdravnika.
What Temozolomide Teva looks like and contents of the pack 
Izgled zdravila Temozolomide Teva in vsebina pakiranja
Pneumonia, sinusitis, upper respiratory infection, bronchitis 
zamašen nos pljučnica, sinuzitis, okužba zgornjih dihal, bronhitis
Nausea and vomiting are very commonly associated with TMZ. 
Z uporabo TMZ sta zelo pogosto povezana navzeja in bruhanje.
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. 
Zato je treba moškim, ki se zdravijo s TMZ, svetovati, naj ne zaplodijo otroka še do šest mesecev po zadnjem odmerku ter da se pred zdravljenjem pozanimajo o možnostih kriokonzervacije sperme.
Dose-limiting toxicity was haematological and was reported with any dose but is expected to be more severe at higher doses. 
O njej so poročali pri vsakem odmerku, vendar je pričakovati, da bo bolj izrazita pri večjih odmerkih.
The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O6 position of guanine with additional alkylation also occurring at the N7 position. 
alkilacija na položaju gvanina O6 z dodatno alkilacijo, ki se tudi zgodi na položaju N7.
If vomiting occurs after the dose is administered, a second dose should not be administered that day. 
Če po odmerku zdravila bolnik bruha, tistega dne ne sme vzeti drugega odmerka.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
Datum prve odobritve:
- 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 tri leta in več, mladostnikov in odraslih z malignim gliomom, na primer multiformnim glioblastomom ali anaplastičnim astrocitomom, ki se je po standardnem zdravljenju ponovil ali napredoval.
Patients receiving Temozolomide Teva in combination with radiotherapy may experience different side effects than patients taking Temozolomide Teva alone. 
Temozolomide Teva v zdravljenju na novo diagnosticiranega glioblastoma v kombinaciji z obsevanjem Bolniki, ki se zdravijo z zdravilom Temozolomide Teva v kombinaciji z obsevanjem, lahko doživijo drugačne neželene učinke kot tisti, ki jemljejo samo Temozolomide Teva.
After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8% 
Po peroralnem vnosu 14C-označenega TMZ se je v sedmih dneh po vnosu z blatom izločilo povprečno 0,8 % odmerka, kar kaže na popolno absorpcijo.
How to take Temozolomide Teva 
Kako jemati zdravilo Temozolomide Teva
The excipient sunset yellow FCF (E110) included in the capsules shell may cause allergic reactions. 
Sončno rumeno FCF (E110) Ovoj kapsul vsebuje pomožno snov sončno rumeno FCF (E110), ki lahko povzroči alergijske reakcije.
Temozolomide Teva 5 mg hard capsules Temozolomide Teva 20 mg hard capsules Temozolomide Teva 100 mg hard capsules Temozolomide Teva 140 mg hard capsules Temozolomide Teva 180 mg hard capsules Temozolomide Teva 250 mg hard capsules 
Temozolomide Teva 5 mg trde kapsule Temozolomide Teva 20 mg trde kapsule Temozolomide Teva 100 mg trde kapsule Temozolomide Teva 140 mg trde kapsule Temozolomide Teva 180 mg trde kapsule Temozolomide Teva 250 mg trde kapsule
TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met: 
Uporaba TMZ se lahko nadaljuje skozi celotno 42 dnevno obdobje sočasnega zdravljenja (do 49
The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60% to 100% of rats and dogs tested, degeneration of the retina occurred. 
Med glavnimi tarčnimi tkivi toksičnega delovanja so bili kostni mozeg, limforetikularni sistem, testisi in prebavila, večji odmerki, ki so bili smrtni za 60 do
During the monotherapy phase, the dose and way you take Temozolomide Teva will be different. 
V obdobju samostojnega zdravljenja boste jemali zdravilo Temozolomide Teva drugače in v drugačnem odmerku.
Do not open, crush or chew the capsules. 
Kapsul ne smete odpreti, drobiti ali žvečiti.
Cerebral haemorrhage, hypertension Embolism pulmonary, oedema, oedema peripheral 
možganska krvavitev, hipertenzija pljučna embolija, edem, periferni edem
Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy. 
Med zdravljenjem z obsevanjem in TMZ je bila potrebna profilaksa proti pljučnici Pneumocystis jirovecii (PCP).
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. 
in obsevanjem v 42-dnevnem režimu (največ 49 dni), potrebna profilaksa proti PCP, ne glede na število limfocitov.
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). 
Pneumocystis jirovecii) in reaktivacijo okužb (kot sta HBV, CMV) (glejte poglavje 4.8).
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). 
≥ 1,5 x 109/l; število trombocitov ≥ 100 x 109/l; SMT za nehematološko toksičnost ≤ 1. stopnje (z izjemo alopecije, slabosti in bruhanja).
The dose should be reduced or administration discontinued according to Table 3. 
Zmanjšanje odmerka ali opustitev zdravljenja mora ustrezati priporočilom v razpredelnici 3.
The excipient sunset yellow FCF (E110) is also included in the capsule shell of Temozolomide Teva 20 mg hard capsules and may cause allergic reactions. 
Zdravilo Temozolomide Teva vsebuje sončno rumeno FCF (E110) Ovoj kapsul zdravila Temozolomide Teva 20 mg trde kapsule vsebuje tudi pomožno snov sončno rumeno FCF (E110), ki lahko povzroči alergijske reakcije.
Anxiety, emotional lability, insomnia Anxiety, depression, emotional lability, insomnia 
anksioznost, čustvena labilnost, nespečnost anksioznost, depresija, čustvena labilnost, nespečnost
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. 
TMZ (v odmerku od 150 do 200 mg/m²), ki se je začelo štiri tedne po koncu obsevanja.
Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain 
hemianopija, zmanjšana ostrina vida, motnja vida, nepravilnost vidnega polja, bolečina v očesu zmanjšana ostrina vida, bolečina v očesu, suhe oči
Temozolomide Teva 20 mg hard capsules Temozolomide Teva 100 mg hard capsules Temozolomide Teva 140 mg hard capsules Temozolomide Teva 180 mg hard capsules Temozolomide Teva 250 mg hard capsules temozolomide 
Temozolomide Teva 20 mg trde kapsule Temozolomide Teva 100 mg trde kapsule Temozolomide Teva 140 mg trde kapsule Temozolomide Teva 180 mg trde kapsule Temozolomide Teva 250 mg trde kapsule temozolomid
The active substance is temozolomide. 
Zdravilna učinkovina je temozolomid.
Adult patients with newly-diagnosed glioblastoma multiforme 
Odrasli bolniki z na novo diagnosticiranim multiformnim glioblastomom
This led to hospitalisation and/or discontinuation of TMZ in 8% and 4%, respectively. 
To je pri 8 % (trombocitopenija) oziroma 4 % (nevtropenija) bolnikov privedlo do hospitalizacije oziroma opustitve zdravljenja s TMZ.
At the start of Cycle 2, the dose is escalated to 200 mg/m² if the CTC nonhaematological 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 
Na začetku drugega cikla se odmerek poveča na 200 mg/m², če je nehematološka toksičnost po splošnih merilih toksičnosti za prvi cikel stopnja ≤ 2 (razen za alopecijo, navzejo in bruhanje) ter če je absolutno število nevtrofilcev
Haemorrhage, oedema, oedema leg Haemorrhage, deep venous thrombosis, oedema leg 
krvavitev, edem, edem noge krvavitev, globoka venska tromboza, edem noge
Hypokalemia, alkaline phosphatase increased, weight increased 
hipokaliemija, povišana raven alkalne fosfataze, povečanje telesne mase hiperglikemija, povečanje telesne mase
Hepatic injury, including fatal hepatic failure, has been reportedin patients treated with TMZ (see section 4.8). 
Pri bolnikih, zdravljenih s TMZ, so poročali o poškodbah jeter, vključno z odpovedjo jeter s smrtnim izidom (glejte poglavje 4.8).
Male fertility 
Moška plodnost
Patients with newly-diagnosed glioblastoma multiforme 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 Temozolomide Teva (monotherapy phase). 
Če ste na novo diagnosticiran bolnik, bo zdravljenje potekalo v dveh obdobjih: - najprej jemanje zdravila skupaj z obsevanjem (obdobje sočasnega zdravljenja),