FrancophonIA/ELRC3.0 huggingface dataset:
English: These reactions were usually Grade 1 or 2 (0-5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Croatian: (0-5 epizoda povraćanja u 24 sata) i prestale bi same od sebe ili su se mogle lako kontrolirati standardnim antiemeticima.
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l
Croatian: - apsolutni broj neutrofila (ABN) ≥ 1,5 x 109/l
English: Terapia S.A. Str. Fabricii nr 124
Croatian: Fabricii nr 124
English: You will take Temozolomide SUN only once daily for the first 5 days.
Croatian: Uzimat ćete samo Temozolomid SUN jedanput na dan prvih 5 dana.
English: Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide SUN on your blood cells.
Croatian: Tijekom liječenja će se često provoditi krvne pretrage radi praćenja nuspojava Temozolomid SUN-a na krvne stanice.
English: 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
Croatian: U bolesnika koji su prethodno liječeni kemoterapijom početna doza iznosi 150 mg/m2 jedanput na dan, a u drugom ciklusu se povećava na 200 mg/m2 jedanput na dan tijekom 5 dana ako nema znakova hematološke toksičnosti (vidjeti dio 4.4).
English: Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of Temozolomide SUN.
Croatian: U Tablici 5 obuhvaćene su nuspojave prijavljene tijekom kliničkih ispitivanja recidivirajućeg ili progresivnog malignog glioma te nakon stavljanja u promet lijeka Temozolomid SUN-a.
English: Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
Croatian: povišene vrijednosti AST-a *Jedan bolesnik koji je bio randomiziran u skupinu koja je primala samo RT, primio je TMZ + RT.
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Croatian: a: Istodobno liječenje temozolomidom može se nastaviti kada su zadovoljeni svi sljedeći uvjeti: apsolutni broj neutrofila ≥ 1,5 x 109/l; broj trombocita ≥ 100 x 109/l; nehematološka toksičnost prema CTC ≤ stupnju 1 (osim alopecije, mučnine i povraćanja).
English: 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.
Croatian: Karnofsky performance status, KPS] ≥ 70) koji napreduje ili je recidivirao nakon kirurškog zahvata i radioterapije temelje se na dva klinička ispitivanja peroralno primijenjenog
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 % indicating complete absorption.
Croatian: Nakon peroralne primjene temozolomida označenog radioizotopom 14C, u fecesu je tijekom 7 dana nakon primjene doze izlučeno prosječno 0,8% radioizotopa 14C, što ukazuje na potpunu apsorpciju.
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide SUN (see also “Male fertility” below).
Croatian: I bolesnice i bolesnici koji uzimaju Temozolomid SUN moraju primjenjivati učinkovite mjere kontracepcije (pogledajte i dio "Plodnost muškaraca" u daljnjem tekstu).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: nedostatka Lapp laktaze ili malapsorpcije glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
English: 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.
Croatian: U slučajevima nakon stavljanja lijeka u promet, herpesni meningoencefalitis (uključujući slučajeve sa smrtnim ishodom) opažen je kod bolesnika koji primaju terapiju TMZ-om u kombinaciji s radioterapijom, uključujući slučajeve istodobne primjene steroida.
English: Hyde Park, Hayes 3
Croatian: Millington Road 11 Hyde Park, Hayes 3 5th Floor
English: If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus.
Croatian: Ako je nužno razmatrati mogućnost primjene Temozolomid SUN-a tijekom trudnoće, bolesnicu se mora upoznati s potencijalnim rizikom za plod.
English: 929 & 140 mg
Croatian: 929 i 140 mg
English: 5x1 hard capsule 20x1 hard capsule
Croatian: 20x1 tvrdih kapsula
English: 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.
Croatian: U bolesnika koji uzimaju TMZ za liječenje novodijagnosticiranog multiformnog glioblastoma, bilo u kombinaciji s RT-om ili u monoterapiji nakon RT-a te u bolesnika koji uzimaju TMZ u monoterapiji za liječenje recidivirajućeg ili progresivnog malignog glioma prijavljene su slične vrlo česte nuspojave: mučnina, povraćanje, konstipacija, anoreksija, glavobolja i umor.
English: In the noncomparative trial, the PFS at 6 months was 19 %, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
Croatian: 19%, medijan preživljenja bez progresije bolesti bio je 2,1 mjesec, a medijan ukupnog preživljenja 5,4 mjeseca.
English: 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.
Croatian: Nakon toga slijedila je monoterapija TMZ-om (150-200 mg/m2) od 1. do 5. dana svakog ciklusa od 28 dana.
English: 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).
Croatian: mjeseci je udio bolesnika koji su preživjeli bio značajno veći u skupini bolesnika koji su primali TMZ (60%) nego u skupini bolesnika koji su primali prokarbazin (44%) (hi-kvadrat p = 0,019).
English: What you need to know before you take Temozolomide SUN Do not take Temozolomide SUN
Croatian: Što morate znati prije nego počnete uzimati Temozolomid SUN
English: Temozolomide SUN is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Croatian: Temozolomid SUN je indiciran za liječenje: - odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom, istodobno s radioterapijom (RT), a zatim kao monoterapija.
English: Temozolomide SUN is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Croatian: Temozolomid SUN se primjenjuje u kombinaciji s radioterapijom (faza istodobnog liječenja), nakon čega slijedi do 6 ciklusa monoterapije temozolomidom (TMZ) (faza monoterapije).
English: Temozolomide SUN contains a medicine called temozolomide.
Croatian: Temozolomid SUN sadrži lijek pod nazivom temozolomid.
English: The median survival was 7.34 and 5.66 months for TMZ and procarbazine, respectively (log rank p=0.33).
Croatian: Medijan preživljenja bio je 7,34 mjeseca u skupini koja je primala TMZ, odnosno 5,66 mjeseci u skupini koja je primala prokarbazin (log-rang p = 0,33).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BLISTER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BLISTER
English: Your doctor may decide to reduce the dose, interrupt, stop or change your treatment.
Croatian: Liječnik će možda odlučiti smanjiti dozu, ili privremeno odnosno trajno prekinuti liječenje.
English: prolonged pancytopenia, aplastic anaemia†
Croatian: dugotrajna pancitopenija, aplastična anemija†
English: Sodium starch glycolate (Type B) Tartaric acid
Croatian: laktoza natrijev škroboglikolat (vrste B) tartaratna kiselina stearatna kiselina
English: In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening.
Croatian: U oba je ispitivanja primarna mjera ishoda bilo vrijeme preživljenja bez progresije bolesti (engl. progression-free survival, PFS), određeno nalazom magnetske rezonancije
English: Temozolomide SUN may cause permanent infertility.
Croatian: Temozolomid može uzrokovati trajnu neplodnost.
English: - in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma.
Croatian: - u djece u dobi od 3 godine i starije te u odraslih bolesnika s malignim gliomom, kao što je multiformni glioblastom ili anaplastični astrocitom.
English: Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC).
Croatian: Temozolomid je triazen koji se pri fiziološkom pH brzo kemijski pretvara u aktivni spoj monometil triazenoimidazol-karboksamid (MTIC).
English: 930 & 180 mg
Croatian: 930 i 180 mg
English: Somnolence, dizziness, paresthesia
Croatian: somnolencija, omaglica, parestezija
English: Temozolomide SUN contains lactose (a kind of sugar).
Croatian: Temozolomid SUN tvrde kapsule sadrže laktozu (vrstu šećera).
English: This adds up to a 28-day treatment cycle.
Croatian: Ciklus liječenja traje 28 dana.
English: Temozolomide SUN in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Croatian: Temozolomid SUN u kombinaciji sa zračenjem u liječenju novodijagnosticiranog multiformnog glioblastoma
English: TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ Toxicity
Croatian: Privremen ili trajan prekid primjene TMZ-a tijekom faze istodobnog liječenja radioterapijom i TMZ-om
English: This is based on your size (height and weight) and whether you have a recurrent tumour and have had chemotherapy treatment in the past.
Croatian: Ona ovisi o Vašoj veličini (visini i težini) te o tome je li se tumor ponovno pojavio i jeste li ranije već primali kemoterapiju.
English: The cap is imprinted with ‘929'.
Croatian: Na kapici je otisnuta oznaka '929'.
English: Your doctor will work out your dose of Temozolomide SUN.
Croatian: Vaš liječnik će izračunati dozu Temozolomid SUN-a primjerenu za Vas.
English: Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption,
Croatian: Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba): crvenilo kože, urtikarija (koprivnjača), kožni osip, alergijska reakcija.
English: See package leaflet for further information.
Croatian: Sadržaj pakiranja druge informacije
English: - as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
Croatian: - jer će Vas se morati pomno nadzirati zbog moguće pojave teškog oblika upale pluća uzrokovane s Pneumocystis jirovecii.
English: The cap is imprinted with ‘930'.
Croatian: Na kapici je otisnuta oznaka '930'.
English: 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.
Croatian: Na temelju rezultata analize populacijske farmakokinetike u kliničkim ispitivanjima faze II, istodobna primjena s deksametazonom, proklorperazinom, fenitoinom, karbamazepinom, ondansetronom,
English: 890 & 5 mg
Croatian: 890 i 5 mg
English: 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.
Croatian: Ako ste ranije već liječeni kemoterapijom, prva doza Temozolomid SUN-a bit će 150 mg/m2 jedanput na dan tijekom prvih 5 dana.
English: 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).
Croatian: Bolesnici koji su u pilot istraživanju istodobno primali TMZ i RT prema produljenom 42-dnevnom režimu liječenja bili su izloženi osobitom riziku od razvoja pneumonije uzrokovane Pneumocystis jirovecii.
English: 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.
Croatian: ispitivanju s 288 ispitanika s novodijagnosticiranim multiformnim glioblastomom neutropenija stupnja 4 nastupila je u 3% žena naspram 0% muškaraca, a trombocitopenija stupnja 4 u 1% žena naspram 0%
English: 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.
Croatian: Ako niste prethodno liječeni kemoterapijom, prva doza Temozolomid SUN-a bit će 200 mg/m2 jedanput na dan tijekom prvih 5 dana.
English: 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
Croatian: CTC stupanj 4b a: doze TMZ-a navedene su u Tablici 2. b: TMZ se mora prekinuti:
English: - thrombocyte count ≥ 100 x 109/l
Croatian: - broj trombocita ≥ 100 x 109/l
English: 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.
Croatian: U prvom ciklusu terapije učestalost neutropenije (ABN < 0,5 x 109/l) i trombocitopenije (< 20 x 109/l) stupnja 4 bila je viša u žena nego u muškaraca: 12% naspram 5% kod neutropenije i 9% naspram 3% kod trombocitopenije.
English: Temozolomide SUN should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Croatian: 4.2 Doziranje i način primjene Temozolomid SUN smiju propisivati samo liječnici s iskustvom u onkološkom liječenju tumora mozga.
English: SUN Pharma logo
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET SUN Pharma logo
English: Excipient with known effect Each hard capsule contains 163.441 mg of lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 163,441 mg laktoze.
English: 893 & 250 mg
Croatian: 893 i 250 mg
English: Excipient with known effect Each hard capsule contains 127.121 mg of lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 127,121 mg laktoze.
English: Sun Pharmaceutical Industries Europe B.V.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sun Pharmaceutical Industries Europe B.V.
English: - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Croatian: - nehematološka toksičnost prema općim kriterijima toksičnosti (engl. common toxicity criteria, CTC) ≤ stupnju 1 (osim alopecije, mučnine i povraćanja).
English: hyperbilirubinemia, cholestasis, hepatitis hepatic injury, hepatic failure†
Croatian: hiperbilirubinemija, kolestaza, hepatitis oštećenje jetre, zatajenje jetre†
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Kako uzimati Temozolomid SUN Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik.
English: 892 & 100 mg
Croatian: 892 i 100 mg
English: How to take Temozolomide SUN
Croatian: Kako uzimati Temozolomid SUN
English: 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).
Croatian: 2,1 mjeseca dulji u skupini koja je primala TMZ nego u skupini koja je primala prokarbazin (log-rang p = < 0,01 do 0,03).
English: 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.
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba): smanjen broj krvnih stanica (neutropenija ili limfopenija, trombocitopenija), gubitak teka, glavobolja, povraćanje, mučnina (osjećaj mučnine), zatvor (otežano pražnjenje crijeva), umor.
English: Erythema multiforme, erythroderma, urticaria, exanthema
Croatian: multiformni eritem, eritrodermija, urtikarija, egzantem
English: 891 & 20 mg
Croatian: 891 i 20 mg
English: How to store Temozolomide SUN
Croatian: Kako čuvati Temozolomid SUN
English: The hazard ratio (HR) for overall survival was 1.59 (95 % CI for HR=1.33-1.91) with a log-rank p < 0.0001 in favour of the TMZ arm.
Croatian: HR = 1,33-1,91), uz log-rang p < 0,0001 u korist skupine koja je primala TMZ.
English: Excipient with known effect Each hard capsule contains 90.801 mg of lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 90,801 mg laktoze.
English: Hepatic enzymes increased,
Croatian: povišene vrijednosti jetrenih enzima,
English: Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Croatian: abdominalna distenzija, inkontinencija stolice, nespecificirani gastrointestinalni poremećaj, gastroenteritis, hemoroidi
English: Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme System organ class
Croatian: Tablica 4. Štetni događaji koji su se pojavili tijekom faze istodobnog liječenja i faze monoterapije u bolesnika s novodijagnosticiranim multiformnim glioblastomom Organski sustav
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion
Croatian: alergijska reakcija, vrućica, ozljeda zbog zračenja, edem lica, bol,
English: Excipient with known effect Each hard capsule contains 18.16 mg of lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 18,16 mg laktoze.
English: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Croatian: Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
English: Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain
Croatian: hemianopija, smanjena oštrina vida, poremećaj vida, ispad vidnog polja,
English: Frequency not known:
Croatian: Učestalost nepoznata:
English: Adverse reactions in patients with recurrent or progressive malignant glioma Infections and infestations
Croatian: Tablica 5. Nuspojave u bolesnika s recidivirajućim ili progresivnim malignim gliomom Infekcije i infestacije
English: Convulsions, consciousness
Croatian: konvulzije, smanjena razina svijesti,
English: Newly-diagnosed glioblastoma multiforme
Croatian: Novo dijagnosticirani multiformni glioblastom
English: 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).
Croatian: TMZ se primjenjuje peroralno u dozi od 75 mg/m2 na dan tijekom 42 dana uz istodobnu radioterapiju
English: Side effects from clinical studies
Croatian: Nuspojave iz kliničkih ispitivanja:
English: 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.
Croatian: 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 pet dana, svakih 28 dana.
English: Excipient with known effect Each hard capsule contains 227.001 mg of lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 227,001 mg laktoze.
English: In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8 % of female vs 4 % of male subjects and Grade 4 thrombocytopenia in 8 % of female vs 3 % of male subjects in the first cycle of therapy.
Croatian: ispitanika s recidivirajućim gliomom, neutropenija stupnja 4 se u prvom ciklusu terapije razvila u 8% žena naspram 4% muškaraca, a trombocitopenija stupnja 4 u 8% žena naspram 3% muškaraca.
English: Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
Croatian: neutropenija ili limfopenija (stupanj 3-4),
English: 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 jiroveciipneumonia (PCP).
Croatian: 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 Pneumocystis jirovecii.
English: Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Croatian: impotencija vaginalno krvarenje, menoragija, amenoreja, vaginitis, bol u dojkama
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Temozolomide SUN 20 mg
Croatian: Temozolomid SUN 20 mg
English: Temozolomide SUN 5 mg
Croatian: Temozolomid SUN 5 mg
English: Cytotoxic.
Croatian: TMZ-a.
English: Common (may affect up to 1 in 10 people): loss of weight, sleepiness, dizziness, tingling sensation, shortness of breath, diarrhoea, abdominal pain, upset stomach, rash, itching, hair loss, fever, weakness, shivering, feeling unwell, pain, change in taste.
Croatian: Česte (mogu se javiti u do 1 na 10 osoba): gubitak tjelesne težine, pospanost, omaglica, trnci, nedostatak zraka, proljev, bol u trbuhu, želučane tegobe, osip, svrbež, gubitak kose, vrućica, slabost, drhtavica, loše osjećanje, bol, promjene osjeta okusa.
English: Temozolomide SUN 250 mg
Croatian: Temozolomid SUN 250 mg
English: of female vs 4 % of male subjects and Grade 4 thrombocytopenia in 8 % of female vs 3 % of male subjects in the first cycle of therapy.
Croatian: žena naspram 4% muškaraca, a trombocitopenija stupnja 4 u 8% žena naspram 3% muškaraca.
English: Allergic reaction, fever, radiation injury, pain, taste perversion
Croatian: promjena osjeta okusa alergijska reakcija, vrućica, ozljeda zbog zračenja, bol, promjena osjeta okusa
English: Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
Croatian: Laboratorijski nalazi Trombocitopenija stupnja 3 ili 4 razvila se u 19%, a neutropenija stupnja 3 ili 4 u 17% bolesnika liječenih zbog malignog glioma, što je dovelo do hospitalizacije i/ili obustave liječenja TMZ-om u 8% odnosno 4% bolesnika.
English: Stomatitis, diarrhoea, abdominal pain, dyspepsia, dysphagia
Croatian: stomatitis, proljev, bolovi u abdomenu, dispepsija, disfagija stomatitis, proljev, dispepsija,
English: Temozolomide SUN is at first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Croatian: se najprije koristi zajedno sa zračenjem (faza istodobnog liječenja), a zatim kao jedini lijek (faza monoterapije).