FrancophonIA/ELRC3.0 huggingface dataset:
English: You will take Temozolomide Sandoz alone once daily for the first 5 days.
Croatian: Uzimat ćete samo Temozolomid Sandoz jedanput na dan prvih 5 dana.
English: Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.
Croatian: Bolesnici s recidivirajućim ili progresivnim malignim gliomom Bolesnicima koji su jako povraćali (stupanj 3 ili 4) tijekom prethodnog ciklusa liječenja možda će biti potrebno dati antiemetik.
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide Sandoz (see also “Male fertility” below).
Croatian: I bolesnice i bolesnici koji uzimaju Temozolomid Sandoz moraju primjenjivati učinkovite mjere kontracepcije (pogledajte i dio „Plodnost muškaraca“ u daljnjem tekstu).
English: This medicine is an antitumour agent.
Croatian: To je lijek protiv tumora.
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: Medijan vremena do progresije bolesti prema ovim mjerama ishoda bio je za 0,7 do 2,1 mjeseca dulji u skupini koja je primala TMZ nego u skupini koja je primala prokarbazin (lograng p = < 0,01 do 0,03).
English: Severe myelosuppression (see section 4.4).
Croatian: Teška mijelosupresija (vidjeti dio 4.4).
English: There may be up to 6 treatment periods (cycles).
Croatian: terapijskih razdoblja (ciklusa).
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 bijelih krvnih stanica ili trombocita.
English: Temozolomide Sandoz is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Croatian: Temozolomid Sandoz se najprije koristi zajedno sa zračenjem (faza istodobnog liječenja), a zatim kao jedini lijek (faza monoterapije).
English: IE-Bantry Co. Cork Tel: +353 27 50077
Croatian: Cork Tel: +353 27 50077
English: Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide Sandoz on your blood cells.
Croatian: Tijekom liječenja će se često provoditi krvne pretrage radi praćenja nuspojava Temozolomida Sandoz na krvne stanice.
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide Sandoz only
Croatian: Bolesnici s tumorom koji se ponovno pojavio ili pogoršao (malignim gliomom, poput multiformnog glioblastoma ili anaplastičnog astrocitoma) koji uzimaju samo Temozolomid Sandoz Ciklus liječenja Temozolomidom Sandoz traje 28 dana.
English: Other side effects:
Croatian: Ostale nuspojave:
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, srednja vrijednost izlučena u fecesu je tijekom 7 dana nakon primjene doze bila je 0,8 % radioizotopa 14C, što ukazuje na potpunu apsorpciju.
English: 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.
Croatian: Kad su se objedinila odstupanja laboratorijskih nalaza i štetni događaji faze istodobnog liječenja i faze monoterapije, poremećaji broja neutrofila stupnja 3 ili 4, uključujući neutropeniju, zabilježeni su u 8 % bolesnika.
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: 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 fokalnu radioterapiju (60 Gy primijenjenih u 30 frakcija).
English: Concomitant phase
Croatian: Istodobna primjena
English: Single-cycle (5-day dosing, 23 days non-treatment), 3- and 6-cycle toxicity studies were conducted in rats and dogs.
Croatian: Na štakorima i psima provedena su ispitivanja toksičnosti jednog ciklusa (5 dana doziranja, 23 dana bez terapije), 3 ciklusa i 6 ciklusa.
English: Data on time to worsening of neurological status favoured TMZ over procarbazine as did data on time to worsening of performance status (decrease to a KPS of < 70 or a decrease by at least 30 points).
Croatian: Podaci o vremenu do pogoršanja neurološkog statusa kao i o vremenu do pogoršanja izvedbenog statusa (KPS smanjen na < 70 bodova ili za najmanje 30 bodova) bolji su za TMZ u odnosu na prokarbazin.
English: • in children 3 years and older and adult patients with malignant glioma , such as glioblastoma multiforme or anaplastic astrocytoma.
Croatian: 2. 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: The body is imprinted with “5”.
Croatian: Na tijelu je otisnuto oznaka „5“.
English: Post-Marketing experience
Croatian: Iskustvo nakon stavljanja lijeka u promet
English: 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).
Croatian: U randomiziranom ispitivanju s aktivnom kontrolom je PFS nakon 6 mjeseci bio značajno veći u skupini koja je primala TMZ nego u skupini koja je primala prokarbazin (21 % naspram 8 %; hikvadrat p = 0,008), uz medijan PFS-a od 2,89 mjeseci u prvoj odnosno 1,88 mjeseci u drugoj skupini (log-rang p = 0,0063).
English: PET studies in humans and preclinical data suggest that TMZ crosses the blood-brain barrier rapidly and is present in the CSF.
Croatian: Ispitivanja u ljudi primjenom PET-a kao i neklinički podaci ukazuju na to da TMZ brzo prelazi krvnomoždanu barijeru i da je prisutan u cerebrospinalnom likvoru.
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 je slijedila monoterapija TMZ-om (150-200 mg/m2) od 1. do 5. dana svakog ciklusa od 28 dana.
English: Pneumonia, sinusitis, upper respiratory infection, bronchitis
Croatian: Upala pluća, sinusitis, infekcija gornjih dišnih putova, bronhitis
English: Temozolomide Sandoz contains a medicine called temozolomide.
Croatian: Temozolomid Sandoz sadrži lijek pod nazivom temozolomid.
English: Thus, prophylaxis against PCP is required for all patients receiving concomitant TMZ and RT for the 42-day regimen (with a maximum of 49 days) regardless of lymphocyte count.
Croatian: Stoga je potrebno primijeniti profilaksu protiv Pneumocystis jirovecii pneumonije u svih bolesnika koji istodobno primaju TMZ i RT prema režimu 42-dnevnog liječenja (najdulje 49 dana), bez obzira na broj limfocita.
English: During the concomitant phase, your doctor will start Temozolomide Sandoz at a dose of 75 mg/m2
Croatian: U fazi istodobnog liječenja liječnik će započeti primjenu Temozolomida Sandoz u dozi od 75 mg/m2 (uobičajena doza).
English: Erythema, pigmentation abnormal, sweating increased
Croatian: Eritem, poremećaj pigmentacije, pojačano znojenje
English: Name and address of the manufacturers responsible for batch release
Croatian: Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
English: Each carton contains 5 or 20 hard capsules.
Croatian: Svaka kutija sadrži 5 ili 20 tvrdih kapsula.
English: Opportunistic infections, including PCP
Croatian: Oportunističke infekcije, uključujući
English: In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma.
Croatian: U bolesnika u dobi od 3 ili više godina TMZ se smije primjenjivati samo u liječenju recidivirajućeg ili progresivnog malignog glioma.
English: Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC).
Croatian: Mehanizam djelovanja Temozolomid je triazen koji se pri fiziološkom pH brzo kemijski pretvara u aktivni spoj monometil triazenoimidazol-karboksamid (MTIC).
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Croatian: - apsolutni broj neutrofila (ABN) ≥ 1,5 x 109/l - broj trombocita ≥ 100 x 109/l - nehematološka toksičnost prema općim kriterijima toksičnosti (engl. common toxicity criteria, CTC) ≤ stupnja 1 (osim alopecije, mučnine i povraćanja).
English: Colour of the cap
Croatian: Boja kapice
English: • constipation (difficulty passing stools)
Croatian: konstipacija (otežano pražnjenje crijeva) umor.
English: Temozolomide Sandoz should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Croatian: 4.2 Doziranje i način primjene Temozolomid Sandoz smiju propisivati samo liječnici s iskustvom u onkološkom liječenju tumora mozga.
English: Weight decrease
Croatian: Smanjenje tjelesne težine
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: 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: - If you have any further questions, ask your doctor, pharmacist or nurse.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain
Croatian: Hemianopija, smanjena oštrina vida, poremećaj vida, ispad vidnog polja, bol u oku
English: diabetes insipidus
Croatian: insipidni dijabetes
English: You will again receive Temozolomide Sandoz once daily for 5 days, followed by 23 days without Temozolomide Sandoz.
Croatian: Ponovno ćete uzimati Temozolomid Sandoz jedanput na dan tijekom 5 dana, nakon čega slijede 23 dana bez Temozolomida Sandoz.
English: Patients in the control arm received RT only.
Croatian: Bolesnici u kontrolnoj skupini liječeni su samo radioterapijom.
English: 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).
Croatian: Istodobna primjena TMZ-a i RT-a na koju se nastavila monoterapija TMZ-om u liječenju bolesnika s novodijagnosticiranim multiformnim glioblastomom dovela je do statistički značajnog poboljšanja ukupnog preživljenja (OS) u usporedbi s primjenom samo RT-a (Slika 1).
English: In a separate pharmacokinetic study, plasma pharmacokinetic profiles in patients with mild to moderate hepatic impairment were similar to those observed in patients with normal hepatic function.
Croatian: U odvojenom farmakokinetičkom ispitivanju, farmakokinetička svojstva u plazmi bolesnika s blagim do umjerenim oštećenjem funkcije jetre bila su slična onima u bolesnika s normalnom funkcijom jetre.
English: interstitial pneumonitis/pneumonitis, pulmonary fibrosis, respiratory failure†
Croatian: intersiticijski pneumonitis/pneumonitis, plućna fibroza, zatajenje dišnog sustava†
English: Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.
Croatian: Manje često su prijavljeni slučajevi povišenja razine bilirubina, poteškoća s protokom žući (kolestaza), hepatitisa i oštećenja jetre, uključujući i zatajenje jetre sa smrtnim ishodom.
English: • double vision
Croatian: 19. dvostruke slike
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 pacijenta (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: 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 109/l i broj trombocita ≥ 100 x 109/l.
English: If vomiting occurs after the dose is administered, a second dose should not be administered that day.
Croatian: Ako nakon primjene doze dođe do povraćanja, druga doza lijeka ne smije se dati istoga dana.
English: Hepatic injury, including fatal hepatic failure, has been reported in patients treated with TMZ (see section 4.8).
Croatian: Oštećenje jetre, uključujući zatajenje jetre sa smrtnim ishodom, prijavljeno je u bolesnika liječenih TMZ-om (vidjeti dio 4.8).
English: Somnolence, dizziness, paresthesia
Croatian: Somnolencija, omaglica, parestezije
English: Dose level
Croatian: Razina doze
English: CTC non-haematological Toxicity (except for alopecia, nausea, vomiting)
Croatian: CTC stupanj nehematološke toksičnosti (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: 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.
English: The body is imprinted with “180”.
Croatian: Na tijelu je otisnuta oznaka „180“.
English: GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
Croatian: GT-a, povišene vrijednosti AST-a *Jedan bolesnik koji je bio randomiziran u skupinu koja je primala samo RT, primio je TMZ + RT.
English: 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.
Croatian: Ako niste prethodno liječeni kemoterapijom, prva doza Temozolomida Sandoz biti će 200 mg/m2 jedanput na dan tijekom prvih 5 dana.
English: The body is imprinted with “250”.
Croatian: Na tijelu je otisnuta oznaka „250“.
English: Shellac
Croatian: Šelak
English: Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Croatian: Analiza populacijske farmakokinetike temozolomida otkrila je da klirens TMZ-a iz plazme ne ovisi o dobi, funkciji bubrega ni primjeni duhana.
English: If a capsule becomes damaged, contact of the powder contents with skin or mucous membrane must be avoided.
Croatian: Ako se kapsula ošteti, mora se izbjegavati kontakt kože i sluznica s praškastim sadržajem kapsule.
English: The safety of TMZ in children under the age of 3 years has not been established.
Croatian: Sigurnost primjene TMZ-a u djece u dobi do 3 godine nije ustanovljena.
English: • dry mouth
Croatian: suhoća usta
English: 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.
Croatian: 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.
English: ≥ 10 and < 100 x 109/l
Croatian: ≥ 10 i < 100 x 109/l
English: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare
Croatian: Vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥1/10 000 i
English: Headache
Croatian: Glavobolja
English: The body is imprinted with “140”.
Croatian: Na tijelu je otisnuta oznaka „140“.
English: The body is imprinted with “20”.
Croatian: Na tijelu je otisnuta oznaka „20“.
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4 % and 23 %, respectively.
Croatian: TMZ-a izloženost MTIC-u iznosi ~2,4 %, a izloženost AIC-u 23 %.
English: Women of childbearing potential
Croatian: Žene u reproduktivnoj dobi
English: Dermatitis, dry skin, erythema, pruritus
Croatian: Dermatitis, suha koža, eritem, pruritus
English: Palpitation
Croatian: Palpitacije
English: OTHER SPECIAL WARNING, IF NECESSARY Cytotoxic
Croatian: DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO
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: < 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: Bottle
Croatian: Bočica
English: ≥ 0.5 and < 1.5 x 109/l
Croatian: ≥ 0,5 i < 1,5 x 109/l
English: Laboratory results
Croatian: Laboratorijski nalazi
English: The dose should be reduced or administration discontinued according to Table 3.
Croatian: Dozu treba smanjiti ili prekinuti davanje lijeka sukladno napucima u Tablici 3.
English: Printing ink
Croatian: Tinta za označavanje
English: TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Croatian: Privremen ili trajan prekid primjene TMZ-a tijekom faze istodobnog liječenja radioterapijom i TMZ-om
English: • abnormal liver function tests.
Croatian: 46. odstupanja od normalnih vrijednosti testova funkcije jetre.
English: Hepatic enzymes increased, Gamma
Croatian: Povišene vrijednosti jetrenih enzima, povišene vrijednosti gama
English: Reduction for prior toxicity Dose during Cycle 1
Croatian: Doza tijekom 1. ciklusa
English: Temozolomide Sandoz contains lactose
Croatian: Temozolomid Sandoz sadrži laktozu
English: • Periodic Safety Update Reports
Croatian: Periodička izvješća o neškodljivosti
English: Cases of brain infections caused by herpes virus (meningoencephalitis herpetic), including fatal cases, have been uncommonly reported.
Croatian: Manje često se prijavljuju slučajevi infekcija mozga izazvani virusom herpesa (herpesni meningoencefalitis), uključujući slučajeve sa smrtnim ishodom.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: DODATAK II A. PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Cerebral haemorrhage, hypertension Embolism pulmonary, oedema, oedema peripheral
Croatian: Cerebralno krvarenje, hipertenzija Plućna embolija, edem, periferni edem
English: Then you will have 23 days without Temozolomide Sandoz.
Croatian: Zatim slijede 23 dana bez uzimanja Temozolomida Sandoz.
English: What you need to know before you take Temozolomide Sandoz Do not take Temozolomide Sandoz
Croatian: Što morate znati prije nego počnete uzimati Temozolomid Sandoz
English: TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen-1-yl)imidazole-4-carboxamide (MTIC).
Croatian: TMZ spontano se hidrolizira pri fiziološkom pH prvenstveno u aktivni spoj 3-metil-(triazen1-il)imidazol-4-karboksamid (MTIC).
English: Tell your doctor if you notice any of these symptoms.
Croatian: Primijetite li neki od tih simptoma, obavijestite svog liječnika.
English: Each capsule is approximately 15.8 mm in length.
Croatian: Svaka je kapsula dugačka približno 15,8 mm.
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: 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.
English: Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
Croatian: Znakovi alergijske reakcije obuhvaćaju svrbež, nedostatak daha ili piskanje pri disanju, oticanje lica,
English: Febrile neutropenia, anaemia
Croatian: Febrilna neutropenija, anemija
English: If you have been previously treated with chemotherapy, your first dose of Temozolomide Sandoz will be 150 mg/m2 once daily for the first
Croatian: Ako ste prethodno liječeni kemoterapijom, prva doza Temozolomida Sandoz biti će 150 mg/m2 jedanput na dan tijekom prvih 5 dana.
English: Your doctor will work out your dose of Temozolomide Sandoz.
Croatian: Vaš liječnik će izračunati točnu dozu Temozolomida Sandoz koja Vam je potrebna.
English: TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see section 4.8).
Croatian: TMZ malo utječe na sposobnost upravljanja vozilima i rada sa strojevima zbog umora i somnolencije
English: Strength
Croatian: Jačina
English: K.Valdemāra 33 - 30
Croatian: K.Valdemāra 33 - 30 LV-1010 Rīga
English: 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.
Croatian: 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,
English: 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).
Croatian: 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
English: Lek Pharmaceuticals d.d.
Croatian: Lek Pharmaceuticals d.d. Verovškova 57
English: Endocrine disorders Uncommon:
Croatian: Endokrini poremećaji* Manje često:
English: Ear and labyrinth disorders Common:
Croatian: Poremećaji uha i labirinta Često:
English: 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.
Croatian: Šestomjesečno preživljenje bez znakova bolesti u ITT populaciji iznosilo je 44 %, uz medijan preživljenja bez znakova bolesti od
English: Temozolomide Sandoz may make you feel tired or sleepy.
Croatian: Temozolomid Sandoz može uzrokovati umor ili pospanost.
English: Keep the desiccant pouch in the bottle.
Croatian: Ne vadite vrećicu sa sredstvom za sušenje iz bočice.
English: Hepatotoxicity
Croatian: Hepatotoksičnost
English: Type III amber glass bottle with polypropylene child-resistant closure containing 5 or 20 hard capsules.
Croatian: Bočica Bočica od smeđeg stakla tipa III, s polipropilenskim sigurnosnim zatvaračem za djecu, koja sadrži 5
English: Tell your doctor immediately if this occurs
Croatian: Ako se to dogodi, odmah obavijestite svog liječnika.
English: (≥1/10,000 to <1/1,000); Very rare (<1/10,000)), Not known: frequency cannot be estimated from the available data.
Croatian: <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).