FrancophonIA/ELRC3.0 huggingface dataset:
English: TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57 %) in the RT alone arm, and 62 patients of the 277 (22 %) in the TMZ + RT arm.
Croatian: TMZ se primjenjivao kao "salvage" (terapija spašavanja) pokušaj liječenja tijekom razdoblja praćenja u 161 od 282 bolesnika (57 %) u skupini u kojoj se primijenila samo RT te u 62 od 277 bolesnika (22 %) u skupini koja je uz RT primala i TMZ.
English: Uncommon (may affect up to 1 in 100 people): reduced blood cell counts (pancytopenia, anaemia, leukopenia).
Croatian: Manje česte (mogu se javiti u do 1 na 100 osoba): smanjen broj krvnih stanica (pancitopenija, anemija, leukopenija).
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 (60 Gy primijenjenih u 30 frakcija).
English: Temomedac is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Croatian: Temomedac se najprije koristi zajedno sa zračenjem (faza istodobnog liječenja), a zatim kao jedini lijek (faza monoterapije).
English: Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption, allergic reactions.
Croatian: Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba): crvenilo kože, urtikarija (koprivnjača), kožni osip, alergijska reakcija.
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ.
Croatian: Poremećaji broja trombocita stupnja 3 ili 4, uključujući trombocitopeniju, opaženi su u 14 % bolesnika koji su primili TMZ.
English: Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of TMZ.
Croatian: U Tablici 5 obuhvaćene su nuspojave prijavljene tijekom kliničkih ispitivanja recidivirajućeg ili progresivnog malignog glioma te nakon stavljanja u promet lijeka TMZ.
English: If you take more Temomedac than you should If you accidentally take more Temomedac capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Croatian: Ako uzmete više Temomedac kapsula nego što ste trebali, odmah se javite liječniku, ljekarniku ili medicinskoj sestri.
English: A total of 573 patients were randomised to receive either TMZ + RT (n = 287) or RT alone (n = 286).
Croatian: Randomizirano je ukupno 573 bolesnika u dvije skupine, jednu koja je primala TMZ + RT (n = 287) te drugu u kojoj se primijenila samo RT (n = 286).
English: Temomedac contains lactose (a kind of sugar).
Croatian: Temomedac tvrde kapsule sadrže laktozu (vrstu šećera).
English: < 1.0 x 109/l
Croatian: < 1,0 x 10
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: Nakon 6 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: Temomedac is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Croatian: Temomedac se primjenjuje u kombinaciji s radioterapijom (faza istodobnog liječenja), nakon čega slijedi do 6 ciklusa monoterapije temozolomidom (TMZ) (faza monoterapije).
English: Doses of 500, 750, 1,000, and 1,250 mg/m² (total dose per cycle over 5 days) have been evaluated clinically in patients.
Croatian: U bolesnika su klinički ocijenjene doze od 500, 750, 1000 i 1250 mg/m² (ukupna doza po ciklusu tijekom 5 dana).
English: Infection, herpes simplex, wound infection, pharyngitis, candidiasis oral
Croatian: infekcija, herpes simplex, infekcija rane, faringitis, oralna kandidijaza infekcija, oralna kandidijaza
English: How to store Temomedac
Croatian: Kako čuvati Temomedac
English: Hypokalaemia, alkaline phosphatase increased, weight increased
Croatian: hipokalijemija, povišene vrijednosti alkalne fosfataze, povećanje tjelesne težine hiperglikemija, povećanje tjelesne težine
English: prolonged pancytopenia, aplastic anaemia Neoplasm benign, malignant and unspecified Very rare:
Croatian: dugotrajna pancitopenija, aplastična anemija† Dobroćudne, zloćudne i nespecificirane novotvorine Vrlo rijetko:
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: < 50 x 109/l
Croatian: < 50 x 10
English: Hyperglycaemia, weight decreased Weight decreased
Croatian: hiperglikemija, smanjenje tjelesne težine smanjenje tjelesne težine
English: - 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.
Croatian: • djece od navršene tri godine starosti, adolescenata i odraslih bolesnika s malignim gliomom, kao što je multiformni glioblastom ili anaplastični astrocitom, koji je recidivirao ili napreduje nakon standardne terapije.
English: At the start of Cycle 2, the dose is escalated to 200 mg/m² if the CTC non-haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/l, and the thrombocyte count is ≥ 100 x 109/l.
Croatian: Na početku drugog ciklusa doza se povećava na 200 mg/m² ako je CTC stupanj nehematološke toksičnosti za prvi ciklus bio ≤ 2 (osim za alopeciju, mučninu i povraćanje) te ako je apsolutni broj neutrofila (ABN) ≥ 1,5 x 10
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 jedanput na dan tijekom 5 dana svakih 28 dana.
English: In patients previously untreated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m² once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
Croatian: U bolesnika koji prethodno nisu liječeni kemoterapijom, TMZ se primjenjuje peroralno u dozi od 200 mg/m² jedanput na dan tijekom prvih 5 dana, nakon čega slijede 23 dana bez liječenja (ukupno 28 dana).
English: Additional information for Temomedac 20 mg hard capsules The excipient sunset yellow FCF (E110) included in the capsules shell may cause allergic reactions.
Croatian: Pomoćna tvar sunset yellow FCF (E110) sadržana u ovojnici kapsule može uzrokovati alergijske reakcije.
English: You should make sure you fully understand and remember the following: - how many capsules you need to take every dosing day.
Croatian: • koliko kapsula morate uzeti svakoga dana.
English: Each hard capsule contains 72 mg of anhydrous lactose and sunset yellow FCF (E110).
Croatian: Jedna tvrda kapsula sadrži 72 mg bezvodne laktoze i boju sunset yellow FCF (E110).
English: Tell your doctor if you notice any of these symptoms.
Croatian: Odmah se obratite liječniku ako imate neki od sljedećih simptoma:
English: Anxiety, emotional lability, insomnia Anxiety, depression, emotional lability, insomnia
Croatian: anksioznost, emocionalna labilnost, nesanica anksioznost, depresija, emocionalna labilnost, nesanica
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: Prema podacima za 400 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: ≥ 0.5 and < 1.5 x 109/l < 0.5 x 109/l
Croatian: ≥ 0,5 i < 1,5 x 10
English: How to take Temomedac
Croatian: Kako uzimati Temomedac
English: TMZ is spontaneously hydrolysed at physiologic pH primarily to the active species, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC).
Croatian: TMZ se spontano hidrolizira pri fiziološkom pH prvenstveno u aktivni spoj 3-metil-(triazen1-il)imidazol-4-karboksamid (MTIC).
English: If you have been previously treated with chemotherapy, your first dose of Temomedac will be 150 mg/m² once daily for the first 5 days.
Croatian: Ako ste ranije već liječeni kemoterapijom, prva doza lijeka Temomedac bit će 150 mg/m² jedanput na dan tijekom prvih 5 dana.
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: Temomedac may make you feel tired or sleepy.
Croatian: Temomedac može uzrokovati umor ili pospanost.
English: Temomedac 5 mg hard capsules Temomedac 20 mg hard capsules Temomedac 100 mg hard capsules Temomedac 140 mg hard capsules Temomedac 180 mg hard capsules Temomedac 250 mg hard capsules temozolomide
Croatian: Temomedac 5 mg tvrde kapsule Temomedac 20 mg tvrde kapsule Temomedac 100 mg tvrde kapsule Temomedac 140 mg tvrde kapsule Temomedac 180 mg tvrde kapsule Temomedac 250 mg tvrde kapsule
English: - The other ingredients are: capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid (see section 2 “Temomedac contains lactose”).
Croatian: • Drugi sastojci su: sadržaj kapsule: bezvodna laktoza, koloidni, bezvodni silicijev dioksid, natrijev škroboglikolat vrste A, tartaratna kiselina, stearatna kiselina (pogledajte dio 2 „Temomedac sadrži laktozu”). ovojnica kapsule (uključujući i tintu za označavanje):
English: If you have not been previously treated with chemotherapy, your first dose of Temomedac will be 200 mg/m² once daily for the first 5 days.
Croatian: Ako niste prethodno liječeni kemoterapijom, prva doza lijeka Temomedac bit će 200 mg/m² jedanput na dan tijekom prvih 5 dana.
English: Temomedac in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Croatian: Temomedac u kombinaciji sa zračenjem u liječenju novodijagnosticiranog multiformnog glioblastoma
English: Table 4: Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme
Croatian: Tablica 4. Nuspojave koje su se pojavile tijekom faze istodobnog liječenja i faze monoterapije u bolesnika s novodijagnosticiranim multiformnim glioblastomom
English: hyperbilirubinemia, cholestasis, hepatitis, hepatic injury, hepatic failure†
Croatian: hiperbilirubinemija, kolestaza, hepatitis, oštećenje jetre, zatajenje jetre†
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: Capsule shell gelatin, titanium dioxide (E171)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171)
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 %
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: Dose in Cycle 1 (monotherapy) is 150 mg/m² once daily for 5 days followed by 23 days without treatment.
Croatian: U prvom ciklusu monoterapije TMZ se daje u dozi od 150 mg/m² jedanput na dan tijekom 5 dana, nakon čega slijede 23 dana bez terapije.
English: ≥ 10 and < 100 x 109/l < 10 x 109/l
Croatian: ≥ 10 i < 100 x 10
English: Temomedac hard capsules should be administered in the fasting state.
Croatian: Temomedac tvrde kapsule moraju se uzimati natašte.
English: Cerebral haemorrhage, hypertension Embolism pulmonary, oedema, oedema peripheral
Croatian: cerebralno krvarenje, hipertenzija plućna embolija, edem, periferni edem
English: Temomedac 140 mg hard capsules shellac, propylene glycol, indigo carmine (E132) aluminium lake
Croatian: Temomedac 140 mg tvrde kapsule šelak propilenglikol indigo carmine (E132), aluminium lake
English: Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Croatian: Odrasli bolesnici s novodijagnosticiranim multiformnim glioblastomom Preporučuje se primjena antiemetičke profilakse prije početne doze temozolomida u fazi istodobnog liječenja, a izrazito se preporučuje u fazi monoterapije.
English: - if certain kinds of blood cells are severely reduced (myelosuppression), such as your white blood cell count and platelet count.
Croatian: • ako imate jako smanjen broj određenih vrsta krvnih stanica (mijelosupresiju), primjerice leukocita ili trombocita.
English: During the monotherapy phase, the dose and way you take Temomedac will be different.
Croatian: Doza i način uzimanja lijeka Temomedac u fazi monoterapije razlikovat će se od prethodne faze.
English: 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).
Croatian: 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).
English: If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x 109/l during any cycle,
Croatian: Ako tijekom bilo kojeg ciklusa ABN padne na < 1,0 x 10
English: Uncommon (may affect up to 1 in 100 people): flu-like symptoms, red spots under the skin, low potassium level in the blood, weight gain, mood swings, hallucination and memory impairment, partial paralysis, impaired coordination, impaired sensations, partial loss of vision, dry or painful eyes, deafness, infection of the middle ear, ringing in the ears, earache, palpitations (when you can feel your heart beat), blood clot in the lung, high blood pressure, pneumonia, inflammation of your sinuses, bronchitis, a cold or the flu, swollen stomach, difficulty controlling your bowel movements, haemorrhoids, peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating, muscle damage, back pain, difficulty in urinating, vaginal bleeding, sexual impotence, absent or heavy menstrual periods, vaginal irritation, breast pain, hot flushes, shivering, discolouration of your tongue, change in your sense of smell, thirst, tooth disorder.
Croatian: Manje česte (mogu se javiti u do 1 na 100 osoba): simptomi nalik gripi, crvene potkožne mrlje, niska razina kalija u krvi, povećanje tjelesne težine, promjene raspoloženja, halucinacije i poremećaj pamćenja, djelomična paraliza, poremećaj koordinacije, poremećaj osjeta, djelomičan gubitak vida, suhe ili bolne oči, gluhoća, infekcija srednjeg uha, zvonjava u ušima, bol u uhu, palpitacije (osjećaj lupanja srca), krvni ugrušak u plućima, visok krvni tlak, upala pluća, upala sinusa, bronhitis, prehlada ili gripa, oticanje trbuha, poteškoće s kontroliranjem stolice, hemoroidi, ljuštenje kože, povećana osjetljivost kože na sunčevu svjetlost, promjena boje kože, pojačano znojenje, oštećenje mišića, bol u leđima, poteškoće s mokrenjem, vaginalno krvarenje, impotencija, izostanak ili obilne menstruacije, nadraženost rodnice, bol u dojkama, navale vrućine, drhtanje, promjena boje jezika, promjena osjeta mirisa, žeđ, promjene na zubima.
English: Common (may affect up to 1 in 10 people): oral infections, wound infection, reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia), increased sugar in the blood, loss of weight, change in mental status or alertness, anxiety/depression, sleepiness, difficulty speaking, impaired balance, dizziness, confusion, forgetfulness, difficulty concentrating, inability to fall asleep or stay asleep, tingling sensation, bruising, shaking, abnormal or blurry vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid retention, swollen legs, diarrhoea, stomach or abdominal pain, heartburn, upset stomach, difficulty swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, painful joints, muscle aches and pains, frequent urination, difficulty with holding your urine, allergic reaction, fever, radiation injury, face swelling, pain, abnormal taste, abnormal liver function tests.
Croatian: Česte (mogu se javiti u do 1 na 10 osoba): infekcije usne šupljine, infekcija rane, smanjen broj krvnih stanica (neutropenija, trombocitopenija, limfopenija, leukopenija), povišena razina šećera u krvi, gubitak tjelesne težine, promjena mentalnog stanja ili budnosti, tjeskoba/depresija, pospanost, otežan govor, poremećaj ravnoteže, omaglica, smetenost, zaboravljivost, poteškoće s koncentracijom, nemogućnost da bolesnik zaspi ili spava, trnci, stvaranje modrica, drhtanje, poremećen ili zamagljen vid, dvostruke slike, oštećenje sluha, nedostatak zraka, kašalj, krvni ugrušak u nogama, zadržavanje tekućine, otečene noge, proljev, bol u želucu ili trbuhu, žgaravica, nadražen želudac, otežano gutanje, suha usta, nadraženost ili crvenilo kože, suha koža, svrbež, mišićna slabost, bolni zglobovi, tupi bolovi i probadanja u mišićima, učestalo mokrenje, poteškoće sa zadržavanjem urina, alergijska reakcija, vrućica, ozljeda zbog zračenja, oticanje lica, bol, promjena osjeta okusa, odstupanja od normalnih vrijednosti testova funkcije jetre.
English: Prior to dosing, the following laboratory parameters must be met: ANC ≥ 1.5 x 109/l and platelet count ≥ 100 x 109/l.
Croatian: Prije primjene temozolomida moraju biti zadovoljeni sljedeći laboratorijski parametri: ABN ≥ 1,5 x 10
English: TMZ + concomitant RT n = 288*
Croatian: TMZ + istodobna RT
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 in your stomach), 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 (loše osjećanje u želucu), zatvor (otežano pražnjenje crijeva), umor.
English: Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Croatian: U Tablici 4 navedene su nuspojave koje su se pojavile tijekom liječenja u bolesnika s novodijagnosticiranim multiformnim glioblastomom u fazi istodobnog liječenja i fazi monoterapije.
English: Diarrhoea, abdominal pain, dyspepsia
Croatian: proljev, bol u abdomenu, dispepsija
English: Very common (may affect more than 1 in 10 people): loss of appetite, headache, constipation (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba): gubitak teka, glavobolja, zatvor (otežano pražnjenje crijeva), mučnina (loše osjećanje u želucu), povraćanje, osip, gubitak kose, umor.
English: Temomedac 20 mg hard capsules shellac propylene glycol, titanium dioxide (E171) sunset yellow FCF (E110) aluminium lake
Croatian: Temomedac 20 mg tvrde kapsule šelak propilenglikol titanijev dioksid (E171) sunset yellow FCF aluminium lake (E110)
English: Skin and subcutaneous tissue disorders Very rare:
Croatian: Poremećaji kože i potkožnog tkiva Vrlo rijetko:
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, nadražen želudac, osip, svrbež, gubitak kose, vrućica, slabost, drhtanje, loše osjećanje, bol, promjene osjeta okusa.
English: Temomedac 5 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, indigo carmine (E 132) aluminium lake, yellow iron oxide (E 172) Temomedac 20 mg hard capsules: gelatine, titanium dioxide (E 171), shellac, propylene glycol, sunset yellow FCF aluminium Lake (E 110).
Croatian: Temomedac 5 mg tvrde kapsule: želatina, titanijev dioksid (E 171), šelak,propilenglikol, indigo carmine (E 132) aluminium lake, žuti željezov oksid (E 172) Temomedac 20 mg tvrde kapsule: želatina, titanijev dioksid (E 171), šelak,propilenglikol, sunset yellow FCF aluminium lake (E 110)
English: Your doctor will work out your exact dose.
Croatian: Liječnik će izračunati točnu dozu lijeka Temomedac koja Vam je potrebna.
English: - The active substance is temozolomide.
Croatian: • Djelatna tvar je temozolomid.
English: Name and address of the manufacturer responsible for batch release medac
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet medac
English: GT increased, AST increased
Croatian: povišene vrijednosti ALT-a povišene vrijednosti ALT-a
English: Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Croatian: mišićna slabost, artralgija mišićna slabost, artralgija, bol u mišićima i kostima, mialgija
English: Administration of TMZ with food resulted in a 33 % decrease in Cmax and a 9 % decrease in area under the curve (AUC).
Croatian: Primjena TMZ-a s hranom dovela je do smanjenja Cmax za 33 %, a površine ispod krivulje (AUC) za Budući da se ne može isključiti da je promjena Cmax klinički značajna, Temomedac treba uzimati bez hrane.
English: Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
Croatian: 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: INFORMATION IN BRAILLE Temomedac 5 mg
Croatian: Temomedac 5 mg
English: TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Croatian: Smanjenje doze ili prekid primjene TMZ-a u fazi monoterapije
English: Each hard capsule contains 209 mg of anhydrous lactose.
Croatian: Jedna tvrda kapsula sadrži 209 mg laktoze, bezvodne.
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion
Croatian: alergijska reakcija, vrućica, ozljeda zbog zračenja, edem lica, bol, promjena osjeta okusa alergijska reakcija, vrućica, ozljeda zbog zračenja, bol, promjena osjeta okusa
English: Temomedac 250 mg hard capsules: Each capsule contains 250 mg temozolomide.
Croatian: Temomedac 250 mg tvrde kapsule: jedna kapsula sadrži 250 mg temozolomida.
English: Each hard capsule contains 117 mg of anhydrous lactose.
Croatian: Jedna tvrda kapsula sadrži 117 mg laktoze, bezvodne.
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paraesthesia, speech disorder, tremor
Croatian: konvulzije, smanjena razina svijesti, somnolencija, afazija, poremećaj ravnoteže, omaglica, konfuzija, narušeno pamćenje, narušena koncentracija, neuropatija, parestezije, poremećaj govora, tremor hemipareza, afazija, poremećaj ravnoteže, somnolencija, konfuzija, omaglica, narušeno pamćenje, narušena koncentracija, disfazija, nespecificirani neurološki poremećaj, neuropatija, periferna neuropatija, parestezije, poremećaj govora, tremor