natgillin/translations-raw huggingface dataset:
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. 
Podaci o kliničkoj djelotvornosti u bolesnika s multiformnim glioblastomom (Karnofski izvedbenog statusa [KPS] ≥ 70) koji napreduje ili je recidivirao nakon kirurškog zahvata i radioterapije temelje se na dva klinička ispitivanja peroralno primijenjenog TMZ-a.
The body is imprinted with “180”. 
Na tijelu je otisnuta oznaka „180“.
GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT. 
GT-a, povišene vrijednosti AST-a *Jedan bolesnik koji je bio randomiziran u skupinu koja je primala samo RT, primio je TMZ + RT.
If you have not been previously treated with chemotherapy, your first dose of Temozolomide Sandoz will be 200 mg/m2 once daily for the first 5 days. 
Ako niste prethodno liječeni kemoterapijom, prva doza Temozolomida Sandoz biti će 200 mg/m2 jedanput na dan tijekom prvih 5 dana.
The body is imprinted with “250”. 
Na tijelu je otisnuta oznaka „250“.
Shellac 
Šelak
Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use. 
Analiza populacijske farmakokinetike temozolomida otkrila je da klirens TMZ-a iz plazme ne ovisi o dobi, funkciji bubrega ni primjeni duhana.
If a capsule becomes damaged, contact of the powder contents with skin or mucous membrane must be avoided. 
Ako se kapsula ošteti, mora se izbjegavati kontakt kože i sluznica s praškastim sadržajem kapsule.
The safety of TMZ in children under the age of 3 years has not been established. 
Sigurnost primjene TMZ-a u djece u dobi do 3 godine nije ustanovljena.
• dry mouth 
suhoća usta
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. 
U šestociklusnom istraživanju na štakorima opažene su razne vrste neoplazmi, uključujući karcinome dojke, keratoakantom kože i adenom bazalnih stanica, dok u istraživanjima na psima nisu primijećeni nikakvi tumori niti preneoplastične promjene.
≥ 10 and < 100 x 109/l 
≥ 10 i < 100 x 109/l
Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare 
Vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥1/10 000 i
Headache 
Glavobolja
The body is imprinted with “140”. 
Na tijelu je otisnuta oznaka „140“.
The body is imprinted with “20”. 
Na tijelu je otisnuta oznaka „20“.
Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4 % and 23 %, respectively. 
TMZ-a izloženost MTIC-u iznosi ~2,4 %, a izloženost AIC-u 23 %.
Women of childbearing potential 
Žene u reproduktivnoj dobi
Dermatitis, dry skin, erythema, pruritus 
Dermatitis, suha koža, eritem, pruritus
Palpitation 
Palpitacije
OTHER SPECIAL WARNING, IF NECESSARY Cytotoxic 
DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO
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. 
< 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.
Bottle 
Bočica
≥ 0.5 and < 1.5 x 109/l 
≥ 0,5 i < 1,5 x 109/l
Laboratory results 
Laboratorijski nalazi
The dose should be reduced or administration discontinued according to Table 3. 
Dozu treba smanjiti ili prekinuti davanje lijeka sukladno napucima u Tablici 3.
Printing ink 
Tinta za označavanje
TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ 
Privremen ili trajan prekid primjene TMZ-a tijekom faze istodobnog liječenja radioterapijom i TMZ-om
• abnormal liver function tests. 
46. odstupanja od normalnih vrijednosti testova funkcije jetre.
Hepatic enzymes increased, Gamma 
Povišene vrijednosti jetrenih enzima, povišene vrijednosti gama
Reduction for prior toxicity Dose during Cycle 1 
Doza tijekom 1. ciklusa
Temozolomide Sandoz contains lactose 
Temozolomid Sandoz sadrži laktozu
• Periodic Safety Update Reports 
Periodička izvješća o neškodljivosti
Cases of brain infections caused by herpes virus (meningoencephalitis herpetic), including fatal cases, have been uncommonly reported. 
Manje često se prijavljuju slučajevi infekcija mozga izazvani virusom herpesa (herpesni meningoencefalitis), uključujući slučajeve sa smrtnim ishodom.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
DODATAK II A. PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
Cerebral haemorrhage, hypertension Embolism pulmonary, oedema, oedema peripheral 
Cerebralno krvarenje, hipertenzija Plućna embolija, edem, periferni edem
Then you will have 23 days without Temozolomide Sandoz. 
Zatim slijede 23 dana bez uzimanja Temozolomida Sandoz.
What you need to know before you take Temozolomide Sandoz Do not take Temozolomide Sandoz 
Što morate znati prije nego počnete uzimati Temozolomid Sandoz
TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen-1-yl)imidazole-4-carboxamide (MTIC). 
TMZ spontano se hidrolizira pri fiziološkom pH prvenstveno u aktivni spoj 3-metil-(triazen1-il)imidazol-4-karboksamid (MTIC).
Tell your doctor if you notice any of these symptoms. 
Primijetite li neki od tih simptoma, obavijestite svog liječnika.
Each capsule is approximately 15.8 mm in length. 
Svaka je kapsula dugačka približno 15,8 mm.
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). 
Pneumonija uzrokovana s Pneumocystis jirovecii 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 s Pneumocystis jirovecii.
Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat. 
Znakovi alergijske reakcije obuhvaćaju svrbež, nedostatak daha ili piskanje pri disanju, oticanje lica,
Febrile neutropenia, anaemia 
Febrilna neutropenija, anemija
If you have been previously treated with chemotherapy, your first dose of Temozolomide Sandoz will be 150 mg/m2 once daily for the first 
Ako ste prethodno liječeni kemoterapijom, prva doza Temozolomida Sandoz biti će 150 mg/m2 jedanput na dan tijekom prvih 5 dana.
Your doctor will work out your dose of Temozolomide Sandoz. 
Vaš liječnik će izračunati točnu dozu Temozolomida Sandoz koja Vam je potrebna.
TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see section 4.8). 
TMZ malo utječe na sposobnost upravljanja vozilima i rada sa strojevima zbog umora i somnolencije
Strength 
Jačina
Following oral administration, approximately 5 % to 10 % of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4-carboxamide (AIC) or unidentified polar metabolites. 
Nakon peroralne primjene se približno 5 % do 10 % doze nalazi u mokraći u nepromijenjenom obliku tijekom 24 sata, dok se ostatak izlučuje u obliku temozolomidske kiseline,
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 pohrane sperme zamrzavanjem
Lek Pharmaceuticals d.d. 
Lek Pharmaceuticals d.d. Verovškova 57
Endocrine disorders Uncommon: 
Endokrini poremećaji* Manje često:
Ear and labyrinth disorders Common: 
Poremećaji uha i labirinta Često:
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. 
Šestomjesečno preživljenje bez znakova bolesti u ITT populaciji iznosilo je 44 %, uz medijan preživljenja bez znakova bolesti od
Temozolomide Sandoz may make you feel tired or sleepy. 
Temozolomid Sandoz može uzrokovati umor ili pospanost.
Keep the desiccant pouch in the bottle. 
Ne vadite vrećicu sa sredstvom za sušenje iz bočice.
Hepatotoxicity 
Hepatotoksičnost
Type III amber glass bottle with polypropylene child-resistant closure containing 5 or 20 hard capsules. 
Bočica Bočica od smeđeg stakla tipa III, s polipropilenskim sigurnosnim zatvaračem za djecu, koja sadrži 5
Tell your doctor immediately if this occurs 
Ako se to dogodi, odmah obavijestite svog liječnika.
(≥1/10,000 to <1/1,000); Very rare (<1/10,000)), Not known: frequency cannot be estimated from the available data. 
<1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Anxiety, depression, emotional lability, insomnia 
Anksioznost, depresija, emocionalna labilnost, nesanica
Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain 
Vaginalno krvarenje, menoragija, amenoreja, vaginitis, bol u dojkama
hyperbilirubinemia, cholestasis, hepatitis, hepatic injury, hepatic failure† 
hiperbilirubinemija, kolestaza, hepatitis oštećenje jetre, zatajenje jetre†
Patients in the TMZ + RT arm received concomitant TMZ (75 mg/m2) once daily, starting the first day of RT until the last day of RT, for 42 days (with a maximum of 49 days). 
Bolesnici u skupini TMZ + RT su od prvog do zadnjeg dana radioterapije tijekom 42 dana (najdulje 49 dana) jedanput na dan primali i TMZ (75 mg/m2).
Neutropenia, thrombocytopenia, lymphopenia, leukopenia 
Neutropenija, trombocitopenija, limfopenija, leukopenija
Your doctor will check your blood to make sure you have enough of these cells before you begin treatment. 
Prije nego započnete s liječenjem, liječnik će Vam provjeriti krvnu sliku kako bi se uvjerio da imate dovoljno tih stanica.
Very rare (may affect up to 1 in 10,000 people): 
Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba):
Newly-diagnosed glioblastoma multiforme 
Novodijagnosticirani multiformni glioblastom
Blood and lymphatic system disorders Very common: 
Poremećaji krvi i limfnog sustava Vrlo često:
Rare (may affect up to 1 in 1,000 people): 
Rijetke (mogu se javiti u do 1 na 1000 osoba):
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. 
Smatra se da je za citotoksičnost MTIC-a primarno odgovorna alkilacija na položaju O6 gvanina, uz dodatnu alkilaciju na položaju N7. U nastanak citotoksičnih lezija vjerojatno je uključen poremećaj mehanizma za popravak metilne skupine.
The body is imprinted with “100”. 
Na tijelu je otisnuta oznaka „100“.
Constipation, nausea, vomiting Constipation, nausea, vomiting 
Konstipacija, mučnina, povraćanje Konstipacija, mučnina, povraćanje
Very common (may affect more than 1 in 10 people): 
Vrlo česte (mogu se javiti u više od 1 na 10 osoba):
Cases of fatal respiratory failure have been reported in patients using TMZ, in particular in combination with dexamethasone or other steroids. 
U bolesnika koji su primali TMZ, osobito u kombinaciji s deksametazonom ili drugim steroidima,
Eye disorders Common: 
Poremećaji oka Često:
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
. Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
Skin and subcutaneous tissue disorders Very common: 
Poremećaji kože i potkožnog tkiva Vrlo često:
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. 
PS = 2, n = 70), za koje su ukupno preživljenje i vrijeme do progresije bolesti bili slični u obje ispitivane skupine.
Vomiting, nausea, constipation 
Povraćanje, mučnina, konstipacija
The cap is imprinted with “TMZ”. 
Na kapici je otisnuta oznaka „TMZ“.
Remarks Reduction for prior toxicity Dose during Cycle 1 Dose during Cycles 2-6 in absence of toxicity Table 3. 
Doza tijekom 1. ciklusa Doza tijekom 2.-6. ciklusa ako nema toksičnih učinaka
Allergic reaction, fever, radiation injury, pain, taste perversion 
Alergijska reakcija, vrućica, ozljeda zbog zračenja, bol, promjena osjeta okusa
Table 4.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
Bottle Do not store above 25 °C. 
POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25 °C.
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 
Recidivirajući ili progresivni maligni gliom Podaci o kliničkoj djelotvornosti u bolesnika s multiformnim glioblastomom (Karnofski izvedbenog statusa [KPS] ≥ 70) koji napreduje ili je recidivirao nakon kirurškog zahvata i radioterapije temelje se na dva klinička ispitivanja peroralno primijenjenog TMZ-a.
• muscle damage 
20. oštećenje sluha
Meningoencephalitis herpetic 
Herpesni meningoencefalitis
Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment. 
U Tablici 4 navedeni su štetni događaji koji su se pojavili tijekom liječenja u bolesnika s novodijagnosticiranim multiformnim glioblastomom u fazi istodobnog liječenja i fazi monoterapije.
Erythema multiforme, erythroderma, urticaria, exanthema 
Multiformni eritem, eritrodermija, urtikarija, egzantem
Each hard capsule contains 73 mg of anhydrous lactose. 
Jedna tvrda kapsula sadrži 73 mg bezvodne laktoze.
In the tables undesirable effects are classified according to System Organ Class and frequency. 
U tablicama su nuspojave razvrstane prema organskim sustavima i učestalosti pojavljivanja.
How to take Temozolomide Sandoz 
Kako uzimati Temozolomid Sandoz
• blood clot in the legs 
23. krvni ugrušak u nogama
Oral use Read the package leaflet before use. 
Prije uporabe pročitajte Uputu o lijeku.
Latvia brunch 
Sandoz d.d. Latvia brunch
Visual acuity reduced, eye pain, eyes dry 
Smanjena oštrina vida, bol u oku, suhoća oka
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING SACHETS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
Each hard capsule contains 131.4 mg of anhydrous lactose. 
Jedna tvrda kapsula sadrži 131,4 mg bezvodne laktoze.
Febrile neutropenia, thrombocytopenia, anaemia, leukopenia 
Febrilna neutropenija, trombocitopenija, anemija, leukopenija
Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ. 
Poremećaji broja trombocita stupnja 3 ili 4, uključujući trombocitopeniju, opaženi su u 14 %
Temozolomide monotherapy in recurrent or progressive glioma 
Monoterapija temozolomidom kod ponovne pojave ili pogoršanja glioma
Diarrhoea, abdominal pain, dyspepsia 
Proljev, bolovi u abdomenu, dispepsija
Patients with hepatic or renal impairment 
Bolesnici s oštećenjem funkcije jetre ili bubrega
Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids 
Abdominalna distenzija, inkontinencija stolice, nespecificirani gastrointestinalni poremećaj, gastroenteritis, hemoroidi
Anxiety, emotional lability, insomnia 
Anksioznost, emocionalna labilnost, nesanica
Each capsule is approximately 11.4 mm in length. 
Svaka je kapsula dugačka približno 11,4 mm.
Titanium dioxide (E 171) Water 
Titanijev dioksid (E171) Voda
Pneumonia, upper respiratory infection, nasal congestion 
Upala pluća, infekcija gornjih dišnih putova, kongestija nosa
PHARMACEUTICAL PARTICULARS 6.1 List of excipients 
6.1 Popis pomoćnih tvari
Hyperglycaemia, weight increased 
Hiperglikemija, povećanje tjelesne težine
23 %, respectively. 
nalaza iznosila je 8 %.
Muscle weakness, arthralgia 
Mišićna slabost, artralgija
Reproductive system and breast disorders Uncommon: 
Poremećaji reproduktivnog sustava i dojki Manje često:
• the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) 
• ako se nakon smanjenja doze ponovno jave isti nehematološki toksični učinci stupnja 3 (osim alopecije, mučnine i povraćanja).
Hyperglycaemia, weight decreased 
Hiperglikemija, smanjenje tjelesne težine
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). 
nego u skupini bolesnika koji su primali prokarbazin (44 %) (hi-kvadrat p = 0,019).
Oral TMZ has been studied in paediatric patients (age 3-18 years) with recurrent brainstem glioma or recurrent high grade astrocytoma, in a regimen administered daily for 5 days every 28 days. 
Peroralno primijenjen TMZ ispitivan je u pedijatrijskih bolesnika (u dobi od 3 do 18 godina) s recidivirajućim gliomom moždanog debla ili recidivirajućim astrocitomom visokog stupnja, prema režimu doziranja jednom na dan tijekom 5 dana, svakih 28 dana.
Each capsule is approximately 21.4 mm in length. 
Svaka je kapsula dugačka približno 21,4 mm.
Each hard capsule contains 14.6 mg of anhydrous lactose. 
Jedna tvrda kapsula sadrži 14,6 mg bezvodne laktoze.
Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion 
Alergijska reakcija, vrućica, ozljeda zbog zračenja, edem lica, bol,
Discontinue TMZ 
Prekinuti primjenu TMZ-a
Convulsions were reported very commonly in the newly-diagnosed 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. 
Osip je zabilježen vrlo često u bolesnika s novodijagnosticiranim multiformnim glioblastomom koji primaju TMZ bilo u kombinaciji s RT-om ili u monoterapiji, a često u bolesnika s recidivirajućim malignim gliomom.
Baseline liver function tests should be performed prior to treatment initiation. 
Prije započinjanja liječenja potrebno je provesti pretrage funkcije jetre.
Each hard capsule contains 168 mg of anhydrous lactose. 
Jedna tvrda kapsula sadrži 168 mg bezvodne laktoze.
Temozolomide Sandoz is indicated for the treatment of: adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment, 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. 
odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom, istodobno s radioterapijom (RT), a zatim kao monoterapija, djece od navršene tri godine starosti, adolescenata i odraslih bolesnika s malignim gliomom,
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
Each capsule is approximately 19.3 mm in length. 
Svaka je kapsula dugačka približno 19,3 mm.
During the monotherapy phase, the dose and way you take Temozolomide Sandoz will be different. 
Doza i način uzimanja Temozolomida Sandoz u fazi monoterapije razlikovat će se od prethodne faze.
Male patients 
Zloćudne bolesti
The first dose will be 150 mg/m2. 
150 mg/m2.
The bottles also contain a desiccant pouch. 
Bočice sadrže i vrećicu sa sredstvom za sušenje.
Muscle weakness, arthralgia, musculoskeletal pain, myalgia 
Mišićna slabost, artralgija, bol u mišićima i kostima, mialgija
Each hard capsule contains 182.5 mg of anhydrous lactose. 
Jedna tvrda kapsula sadrži 182,5 mg bezvodne laktoze.
Myopathy, back pain, musculoskeletal pain, myalgia 
Miopatija, bol u leđima, bol u mišićima i kostima, mialgija
The objective response rate (ORR) based on MRI scans was 8 %. 
Objektivna stopa odgovora na liječenje (ORR) na temelju MR
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time. 
Plana (RMP), dokumenti mogu biti podneseni istodobno.
Very rare cases of lung side effects have been observed with temozolomide. 
Pri primjeni temozolomida vrlo rijetko su primijećene nuspojave na plućima.
Infections and infestations Common: 
Infekcije i infestacije
Asthenia, face oedema, pain, condition aggravated, rigors, tooth disorder 
Astenija, edem lica, bol, pogoršanje stanja, tresavica, promjene na zubima
Each hard capsule contains 102.2 mg of anhydrous lactose. 
Jedna tvrda kapsula sadrži 102,2 mg bezvodne laktoze.
Temozolomide Sandoz 5 mg 
Temozolomid Sandoz 5 mg
Urinary incontinence 
Inkontinencija mokraće
Temozolomide Sandoz is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase). 
Odrasli bolesnici s novodijagnosticiranim multiformnim glioblastomom Temozolomid Sandoz se primjenjuje u kombinaciji s fokalnom radioterapijom (faza istodobnog liječenja), nakon čega slijedi do 6 ciklusa monoterapije temozolomidom (TMZ) (faza monoterapije).
The bottles contain a desiccant pouch. 
Bočice sadrže vrećicu sa sredstvom za sušenje.
Patients with newly-diagnosed glioblastoma multiforme 
Bolesnici s novodijagnosticiranim multiformnim glioblastomom
Black iron oxide (E 172) Potassium hydroxide 
Željezov oksid, crni (E172) Kalijev hidroksid
Printing ink: contains shellac, black iron oxide (E 172), potassium hydroxide. 
Tinta za označavanje: sadrži šelak, crni željezov oksid (E 172), kalijev hidroksid.
Adult patients with newly-diagnosed glioblastoma multiforme 
Odrasli bolesnici s novodijagnosticiranim multiformnim glioblastomom
• dizziness 
Dispneja
Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days. 
Odrasli bolesnici i pedijatrijski bolesnici u dobi od 3 godine ili stariji s recidivirajućim ili progresivnim malignim gliomom
There is limited information in patients over 3 years of age who have taken Temozolomide Sandoz. 
Informacije o primjeni Temozolomida Sandoz u djece starije od 3 godine su ograničene.
Temozolomide Sandoz 5 mg hard capsules Each capsule contains 5 mg temozolomide. 
Temozolomid Sandoz 5 mg tvrde kapsule Jedna kapsula sadrži 5 mg temozolomida.
Table 4. 
44. bol
Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor 
Hemipareza, afazija, poremećaj ravnoteže, somnolencija, konfuzija, omaglica, narušeno pamćenje, narušena koncentracija, disfazija, nespecificirani neurološki poremećaj, neuropatija,
Temozolomide Sandoz 20 mg 
Temozolomid Sandoz 20 mg
Keep this medicine out of the sight and reach of children, preferably in a locked cupboard. 
Kako čuvati Temozolomid Sandoz Ovaj lijek čuvajte izvan pogleda i dohvata djece, najbolje u zaključanom ormariću.
Table 2.TMZ dose levels for monotherapy treatment 
Tablica 2. Razine doze TMZ-a u fazi monoterapije
• in adults with newly-diagnosed glioblastoma multiforme. 
1. u odraslih s novodijagnosticiranim multiformnim glioblastomom.
Capsule shell: gelatine, titanium dioxide (E 171), indigo carmine (E 132), water. 
Ovojnica kapsule: želatina, titanijev dioksid (E 171), indigo karmin (E 132), voda.
Temozolomide Sandoz 250 mg 
Temozolomid Sandoz 250 mg
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
Temozolomide Sandoz 250 mg hard capsules Each capsule contains 250 mg temozolomide. 
Temozolomid Sandoz 250 mg tvrde kapsule Jedna kapsula sadrži 250 mg temozolomida.