natgillin/translations-raw huggingface dataset:
What Temozolomide Sandoz is and what it is used for 
Kaj je zdravilo Temozolomid Sandoz in za kaj ga uporabljamo
MARKETING AUTHORISATION NUMBER(S) 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
What you need to know before you take Temozolomide Sandoz Do not take Temozolomide Sandoz 
Kaj morate vedeti, preden boste vzeli zdravilo Temozolomid Sandoz Ne uporabljajte zdravila Temozolomid Sandoz
TMZ discontinuation 
Ukinitev TMZ
Otitis media, tinnitus, hyperacusis, earache 
otitis media, tinitus, hiperakuzija,
Therefore, special care should be taken when TMZ is administered in elderly patients. 
Zato je pri uporabi zdravila TMZ pri starejših bolnikih potrebna posebna previdnost.
Based on the pharmacokinetic properties of TMZ, it is unlikely that dose reductions are required in patients with severe hepatic impairment or any degree of renal impairment. 
Na podlagi farmakokinetičnih lastnosti TMZ obstaja majhna verjetnost, da bo pri bolnikih s hudo jetrno okvaro ali ledvično okvaro katerekoli stopnje potrebno zmanjšanje odmerka zdravila.
5 x 1 hard capsule in sachet 20 x 1 hard capsule in sachet 
5 x 1 trda kapsula v vrečici 20 x 1 trda kapsula v vrečici
• flu-like symptoms 
• gripi podobni simptomi,
Cases of elevations of liver enzymes have been commonly reported. 
Pogosto so poročali o primerih povišanih vrednostih jetrnih encimov.
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.
• nausea (feeling sick in your stomach) 
• navzea (občutek slabosti v želodcu),
Temozolomide Sandoz should not be administered to pregnant women. 
Zdravilo Temozolomid Sandoz se ne sme dajati nosečnicam.
Other medicines and Temozolomide Sandoz 
Druga zdravila in Temozolomid Sandoz
The Temozolomide Sandoz dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle. 
Odmerek zdravila Temozolomid Sandoz lahko prilagodijo, prestavijo ali zdravljenje prekinejo glede na vašo krvno sliko in na to, kako dobro prenašate zdravilo med vsakim ciklom zdravljenja.
What Temozolomide Sandoz is and what it is used for What you need to know before you take Temozolomide Sandoz How to take Temozolomide Sandoz Possible side effects 
Kaj je zdravilo Temozolomid Sandoz in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Temozolomid Sandoz Kako jemati zdravilo Temozolomid Sandoz
You will again receive Temozolomide Sandoz once daily for 5 days, followed by 23 days without Temozolomide Sandoz. 
Znova boste 5 dni jemali zdravilo Temozolomid Sandoz enkrat na dan, nato pa bo sledilo 23 dni brez zdravila Temozolomid Sandoz.
Patients with hepatic or renal impairment 
Bolniki z jetrno ali ledvično okvaro
Rash, pruritus, alopecia 
izpuščaj, pruritus, alopecija
Laboratory results 
Laboratorijski izvidi
CTC Grade 3 
SMT 3. stopnja
- This medicine has been prescribed for you only. 
- Zdravilo je bilo predpisano samo vam osebno in ga ne smete dajati drugim.
Cases of sepsis (when bacteria and their toxins circulate in the blood and start to damage the organs) have been uncommonly reported. 
Občasno so poročali o primerih sepse (ko v krvnem obtoku krožijo bakterije in njihovi toksini ter začnejo okvarjati organe).
In preclinical studies in rats and rabbits receiving 150 mg/m2 TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3). 
Podatkov o nosečnicah ni. Predklinične študije na podganah in kuncih, ki so prejemali 150 mg/m2 TMZ, so pokazale teratogenost in/ali toksičnost za plod (glejte poglavje 5.3).
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 
Podatki o klinični učinkovitosti zdravila pri bolnikih z multiformnim glioblastomom (indeks kliničnega stanja po Karnofskyju [KPS - »Karnofsky performance status«] ≥ 70), ki napreduje ali se je ponovil po kirurškem posegu in RT, temeljijo na dveh kliničnih preskušanjih s peroralno uporabo
Four weeks after completing the TMZ + RT concomitant phase, TMZ is administered for up to 6 cycles of monotherapy treatment. 
Štiri tedne po zaključku faze sočasnega zdravljenja s TMZ in RT naj bolnik jemlje TMZ do 6 ciklov monoterapije.
Before each new treatment cycle, your blood will be tested to see if the Temozolomide dose needs to be adjusted. 
Pred vsakim novim ciklom zdravljenja se preveri vaša krvna slika, da se lahko prilagodi odmerek zdravila Temozolomid Sandoz.
• allergic reaction 
• alergijske reakcije,
Temozolomide Sandoz contains lactose (a kind of sugar). 
Zdravilo Temozolomid Sandoz vsebuje laktozo (vrsto sladkorja).
Dose levels include 100 mg/m2, 150 mg/m2, and 200 mg/m2. 
Stopnje odmerka so 100 mg/m2, 150 mg/m2 in
Temozolomide Sandoz is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment). 
Temozolomid Sandoz se najprej uporablja skupaj s terapijo z obsevanjem (sočasna faza zdravljenja), nato pa samostojno (faza zdravljenja z enim zdravilom).
The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine. 
MTIK predvsem posledica alkilacije DNA, predvsem gvanina na položajih O6 in N7.
Anti-emetic therapy may be administered prior to or following administration of TMZ. 
Antiemetično zdravljenje se lahko da pred uporabo TMZ ali po njej.
• 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, kot sta multiformni glioblastom ali anaplastični astrocitom.
A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC > 1.5 x 109/l and platelet count > 100 x 109/l. 
Na 22. dan (21 dni po prvem odmerku) ali v roku 48 ur od navedenega dne, morate pregledati celotno krvno sliko in jo nato spremljati vsak teden, dokler ni ANC > 1,5 x 109/l in število trombocitov > 100 x 109/l.
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. 
Ko so sešteli nenormalne laboratorijske izvide in neželene sopojave iz faze sočasne terapije in faze monoterapije, so pri 8 % bolnikov opažali anomalije nevtrofilcev 3. ali 4. stopnje, vključno z nevtropeničnimi sopojavi.
If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temozolomide Sandoz for 42 days in combination with radiotherapy. 
(multiformni glioblastom) ugotovili na novo, boste morda zdravilo Temozolomid Sandoz prejemali 42 dni v kombinaciji z radioterapijo.
Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4) 
nevtropenija ali limfopenija (3. do 4. stopnje), trombocitopenija (3. do 4. stopnje)
prolonged pancytopenia, aplastic anaemia† 
podaljšana pancitopenija, aplastična anemija†
interstitial pneumonitis/pneumonitis, pulmonary fibrosis, respiratory failure† 
intersticijski pnevmonitis/pnevmonitis, pljučna fibroza, odpoved dihalnega sistema†
Contents of the pack and other information What Temozolomide Sandoz contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Temozolomid Sandoz
In some cases, it may be necessary to stop treatment with Temozolomide Sandoz. 
V nekaterih primerih je treba zdravljenje z zdravilom Temozolomid Sandoz prekiniti.
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, trombocitopenija 4. stopnje pa pri 1 % žensk in 0 % moških.
The dose should be reduced or administration discontinued according to Table 3. 
Odmerek zmanjšajte ali zdravilo ukinite, kot je opisano v preglednici 3.
Dose reductions and discontinuations during the monotherapy phase should be applied according to Tables 2 and 3. 
Zmanjšanje odmerka in ukinitev zdravila med fazo monoterapije opravite, kot je opisano v preglednicah 2 in 3.
Patients should be advised to keep capsules out of the sight and reach of children, preferably in a locked cupboard. 
Bolnikom je treba svetovati, naj zdravilo shranjujejo nedosegljivo otrokom, po možnosti v zaklenjeni omari.
Do not open, crush or chew the capsules, swallow whole. 
Ne odpirajte, drobite ali žvečite kapsul, ampak jih pogoltnite cele.
Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC). 
Temozolomid je zdravilo iz skupine triazenov, ki se pri fiziološkem pH hitro kemično pretvori v aktivni monometil triazenoimidazol karboksamid (MTIC).
Temozolomide Sandoz is used for the treatment of specific forms of brain tumours: 
Zdravilo Temozolomid Sandoz se uporablja za zdravljenje določenih vrst možganskih tumorjev:
Laboratory parameters 
Laboratorijske vrednosti
• dry skin 
• suha koža,
Do not swallow it. 
Zavojčka ne pogoltnite.
Oral use Read the package leaflet before use. 
peroralna uporaba Pred uporabo preberite priloženaa navodila.
Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use. 
Analiza populacijske farmakokinetike TMZ je pokazala, da plazemski očistek TMZ ni odvisen od starosti, delovanja ledvic ali kajenja.
There may be up to 6 treatment periods (cycles). 
Morda bo treba opraviti do 6 obdobij
TMZ is administered orally at a dose of 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions). 
TMZ naj bolnik jemlje peroralno v odmerku 75 mg/m2 na dan 42 dni, sočasno z žariščno radioterapijo (60 Gy, danih v 30 delnih odmerkih).
nausea, vomiting). 
slabosti in bruhanja).
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). 
TMZ k radioterapiji, ki ji sledi monoterapija s TMZ, med zdravljenjem bolnikov z novo diagnosticiranim multiformnim glioblastomom so ugotovili statistično značilno izboljšanje skupnega preživetja (OS) v primerjavi s samo RT (Slika 1).
The 6-month event-free survival for the ITT population was 44 % with a median event-free survival of 4.6 months, which was similar to the results for the progression-free survival. 
Mediana vrednost preživetja brez sopojavov je bila 4,6 mesecev, kar je podobno izsledkom za preživetje brez napredovanja bolezni.
Not known drug reaction with eosinophilia and systemic symptoms (DRESS) 
reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS, drug reaction with eosinophilia and systemic symptoms)
Package leaflet: information for the user Temozolomide Sandoz 5 mg hard capsules Temozolomide Sandoz 20 mg hard capsules Temozolomide Sandoz 100 mg hard capsules Temozolomide Sandoz 140 mg hard capsules Temozolomide Sandoz 180 mg hard capsules Temozolomide Sandoz 250 mg hard capsules temozolomide 
Navodilo za uporabo Temozolomid Sandoz 5 mg trde kapsule Temozolomid Sandoz 20 mg trde kapsule Temozolomid Sandoz 100 mg trde kapsule Temozolomid Sandoz 140 mg trde kapsule Temozolomid Sandoz 180 mg trde kapsule Temozolomid Sandoz 250 mg trde kapsule temozolomid
TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen-1-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).
Doses of 500, 750, 1,000, and 1,250 mg/m2 (total dose per cycle over 5 days) have been evaluated clinically in patients. 
Pri bolnikih so klinično ovrednotili odmerke 500, 750, 1.000 in 1.250 mg/m2 (skupni odmerek na 5dnevni cikel).
PET studies in humans and preclinical data suggest that TMZ crosses the blood-brain barrier rapidly and is present in the CSF. 
Študije z uporabo PET pri človeku in predklinični podatki kažejo, da TMZ hitro prehaja hematoencefalno pregrado in da je prisoten v cerebrospinalni tekočini (CFS - »celebrospinal fluid«).
If you accidentally get some in your eyes or nose, flush the area with water. 
Če pride zdravilo po nesreči v stik s kožo, očmi ali nosom, to področje sperite z vodo.
Type III amber glass bottle with polypropylene child-resistant closure containing 5 or 20 hard capsules. 
Rjava steklenica tipa III z za otroke varno zaporko iz polipropilena vsebuje 5 ali 20 trdih kapsul.
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 študije niso skladni pri podskupini s slabim odzivom (WHO PS=2, n=70), čas skupnega preživetja in napredovanje bolezni pa je podobno v obeh primerih.
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 aktivnemu presnovku, monometiltriazenoimidazol karboksamidu (MTIC).
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). 
Pilotno preskušanje podaljšane 42-dnevne sheme zdravljenja je pokazalo, da pri bolnikih, ki so sočasno prejemali TMZ in RT, obstaja še posebej veliko tveganje za nastanek pljučnice zaradi okužbe s Pneumocystis jirovecii (PCP).
MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4-carboxamide (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-imidazol4- karboksamida (AIK), znanega intermediata v biosintezi purinov in nukleinskih kislin, ter metilhidrazina, za katerega menijo, da je aktivni alkilirajoči presnovek.
The safety of TMZ in children under the age of 3 years has not been established. 
Varnost TMZ pri otrocih, mlajših od 3 let, ni bila dokazana.
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). 
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).
Temozolomide Sandoz is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase). 
Zdravilo Temozolomid Sandoz se uporablja v kombinaciji z žariščno radioterapijo (faza sočasne terapije), temu pa sledi do 6 ciklov monoterapije (monoterapijska faza) s temozolomidom (TMZ).
5 capsules 20 capsules 
5 trdih kapsul 20 trdih kapsul
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.
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 poškodbah jeter, vključno z odpovedjo jeter s smrtnim izidom.
Fatigue 
utrujenost
• muscle damage 
• mišične poškodbe,
Neoplasm benign, malignant and unspecified 
Benigne, maligne in neopredeljene novotvorbe
reduced blood cell counts (pancytopenia, anaemia, leukopenia). 
zmanjšano število krvnih celic (pancitopenija, anemija, levkopenija).
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). 
Po peroralnem vnosu se pri odraslih zdravilo TMZ hitro absorbira in doseže največjo koncentracijo že v 20 minutah po zaužitju odmerka (srednja vrednost časa med 0,5 in 1,5 ure).
The body is imprinted with “5”. 
Na telesu pa je vtisnjen znak „5”.
Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response. 
(HPBL - »Human Peripheral Blood Lymphocyte«) so pokazali pozitiven mutageni odziv.
Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral 
okužba, Herpes simplex, okužba rane, faringitis, oralna kandidiaza okužba, oralna kandidiaza
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 malignostih, vključno z mieloidno levkemijo (glejte poglavje 4.8).
Baseline liver function tests should be performed prior to treatment initiation. 
Pred začetkom zdravljenja je treba opraviti teste jetrne funkcije.
Your doctor will work out your exact dose. 
Natančen odmerek bo določil zdravnik.
Reduce TMZ by 1 dose levela 
Zmanjšajte odmerek TMZ za eno ravena
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 enega cikla (5 dni jemanja zdravila, 23 dni brez zdravila), 3 ciklov in 6 ciklov.
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 %) (hi-kvadrat, p = 0,019).
Remarks 
Pripombe
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
A variety of neoplasms, including mammary carcinomas, keratocanthoma of the skin and basal cell adenoma were observed in the 6-cycle rat study while no tumours or pre-neoplastic changes were evident in dog studies. 
V študijah šestih ciklov pri podganah so opažali različne neoplazme, vključno s karcinomom dojk, keratoakantomom kože in bazalnoceličnim adenomom, v študijah pri psih pa niso opažali nobenih tumorjev ali preneoplastičnih sprememb.
Patients usually present with shortness of breath and cough. 
Pri bolnikih se običajno pojavljata zasoplost in kašelj.
• bronchitis 
• bronhitis,
• seizures (convulsions), 
• epileptični napadi (konvulzije).
Keep the desiccant pouch in the bottle. 
Zavojček sušilnega sredstva hranite v steklenici.
Each carton contains 5 or 20 hard capsules. 
Vsaka škatla vsebuje 5 ali 20 trdih kapsul.
In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma. 
Pri bolnikih starih 3 leta ali več, se TMZ uporablja samo za zdravljenje ponavljajočega se ali napredujočega malignega glioma.
Temozolomide Sandoz contains lactose 
Temozolomid Sandoz vsebuje laktozo
• difficulty in urinating 
• težave z uriniranjem,
Keep this medicine out of the sight and reach of children, preferably in a locked cupboard. 
Zdravilo shranjujte nedosegljivo otrokom, po možnosti v zaklenjeni omari.
Dermatitis, dry skin, erythema, pruritus Dry skin, pruritus 
dermatitis, suha koža, eritem, pruritus suha koža, pruritus
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING BOTTLE 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA, KI VSEBUJE STEKLENICO
How to store Temozolomide Sandoz Contents of the pack and other information 
Shranjevanje zdravila Temozolomid Sandoz Vsebina pakiranja in dodatne informacije
hyperbilirubinemia, cholestasis, hepatitis, hepatic injury, hepatic failure† 
hiperbilirubinemija, holestaza, hepatitis jetrna poškodba, jetrna odpoved†
The body is imprinted with “180”. 
Na telesu pa je vtisnjen znak „180”.
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 TMZ, tj. 1,8 ure.
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. 
Pri bolnikih, ki se zdravijo s TMZ v kombinaciji z RT ali monoterapijo po RT zaradi novo diagnosticiranega multiformnega glioblastoma ali z monoterapijo pri bolnikih s ponavljajočim se ali napredujočim gliomom, so bili zelo pogosti neželeni učinki podobni; slabost, bruhanje, zaprtje, neješčnost, glavobol in utrujenost.
Convulsions, headache 
glavobol konvulzije, glavobol
Tell your doctor if you notice any of these symptoms. 
Če opazite katerega od teh simptomov, povejte svojemu zdravniku.
The cap is imprinted with “TMZ”. 
Na kapici je vtisnjen znak „TMZ”.
Temozolomide in combination treatment with radiotherapy in newly-diagnosed glioblastoma 
Zdravilo Temozolomid Sandoz pri kombiniranem zdravljenju z radioterapijo pri novo diagnosticiranem glioblastomu
The body is imprinted with “20”. 
Na telesu pa je vtisnjen znak „20”.
The body is imprinted with “250”. 
Na telesu pa je vtisnjen znak „250”.
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.
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.
• abnormal liver function tests. 
• nenormalen okus, • nenormalni izvidi preiskav delovanja jeter.
Prior to dosing, the following laboratory parameters must be met: ANC ≥ 1.5 x 109/l and platelet count ≥ 100 x 109/l. 
Pred jemanjem zdravila morata biti izpolnjena naslednja pogoja za laboratorijske izvide: ANC ≥ 1,5 x 109/l in število trombocitov ≥ 100 x 109/l.
• partial paralysis 
• delna paraliza,
Pneumocystis jirovecii pneumonia (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.
Temozolomide Sandoz may cause permanent infertility. 
Zdravilo Temozolomid Sandoz lahko povzroči trajno neplodnost.