FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequency groupings are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost pojavljivanja razvrstana je prema sljedećoj konvenciji: vrlo često (≥ 1/10), često ≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: What Temomedac is and what it is used for What you need to know before you take Temomedac How to take Temomedac
Croatian: Što je Temomedac i za što se koristi Što morate znati prije nego počnete uzimati Temomedac Kako uzimati Temomedac
English: In very rare cases, patients taking Temomedac and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
Croatian: U vrlo rijetkim slučajevima, bolesnici koji uzimaju Temomedac i slične lijekove mogu imati malen rizik od razvoja sekundarnih vrsta raka, uključujući leukemiju.
English: - if you develop fever or symptoms of an infection, contact your doctor immediately.
Croatian: • ako dobijete vrućicu ili simptome infekcije, odmah se javite svom liječniku.
English: There may be up to 6 treatment periods (cycles).
Croatian: Liječenje se može odvijati do ukupno 6 terapijskih razdoblja (ciklusa).
English: TMZ monotherapy n = 224
Croatian: TMZ u monoterapiji n = 224
English: Temomedac treatment can cause a reduction in certain kinds of blood cells.
Croatian: Liječenje lijekom Temomedac može izazvati smanjenje broja nekih vrsta krvnih stanica.
English: † Including cases with fatal outcome * Frequencies estimated based on relevant clinical trials.
Croatian: † uključujući slučajeve sa smrtnim ishodom * učestalost procijenjena na temelju relevantnih kliničkih ispitivanja
English: Paediatric patients had a higher AUC than adult patients; however, the maximum tolerated dose (MTD) was 1,000 mg/m² per cycle both in children and in adults.
Croatian: Pedijatrijski bolesnici imali su veći AUC nego odrasli bolesnici; međutim, maksimalna podnošljiva doza (MTD) iznosila je 1000 mg/m² po ciklusu kako u djece, tako i u odraslih bolesnika.
English: In some cases, it may be necessary to stop treatment with Temomedac.
Croatian: U nekim će slučajevima možda biti neophodno prekinuti liječenje lijekom Temomedac.
English: Temomedac is used in these tumours if they return or get worse after standard treatment.
Croatian: U ovom slučaju Temomedac se koristi ako se tumor ponovno pojavio ili se pogoršava nakon standardne terapije.
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: Te su nuspojave bile obično stupnja 1 ili 2 (0 - 5 epizoda povraćanja u 24 sata) i prestale bi same od sebe ili su se mogle lako kontrolirati standardnom terapijom antiemeticima.
English: 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.
Croatian: Rezultati ispitivanja nisu bili konzistentni u podskupini bolesnika s lošim izvedbenim statusom (SZO PS = 2, n = 70), za koje su ukupno preživljenje i vrijeme do progresije bolesti bili slični u obje ispitivane skupine.
English: Temomedac should not be administered to pregnant women.
Croatian: Temomedac se ne smije davati trudnicama.
English: What you need to know before you take Temomedac
Croatian: Što morate znati prije nego počnete uzimati Temomedac
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 January 2010
Croatian: Datum prvog odobrenja: 25. siječnja 2010.
English: - as you may have a small risk of other changes in blood cells, including leukaemia.
Croatian: • jer može postojati malen rizik od razvoja drugih promjena krvnih stanica, uključujući leukemiju.
English: TMZ dose levels are listed in Table 2.
Croatian: doze TMZ-a navedene su u Tablici 2.
English: Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and Day 28), and recovery was rapid, usually within 1 - 2 weeks.
Croatian: Mijelosupresija se mogla predvidjeti (obično se javljala u prvih nekoliko ciklusa liječenja, a bila je najizraženija između 21. i 28. dana), a oporavak je bio brz, obično u roku od 1- 2 tjedna.
English: The lowest recommended dose is 100 mg/m².
Croatian: Najniža preporučena doza iznosi 100 mg/m².
English: Take your prescribed dose of Temomedac once a day, preferably at the same time each day.
Croatian: Uzmite propisanu dozu lijeka Temomedac jedanput na dan, po mogućnosti svakoga dana u isto vrijeme.
English: TMZ demonstrates low protein binding (10 % to 20 %), and thus it is not expected to interact with highly protein-bound substances.
Croatian: TMZ se slabo veže za proteine (10 do 20 %) pa se stoga ne očekuje da ulazi u interakcije s tvarima koje imaju visok afinitet vezanja za proteine.
English: It is recommended to seek advice on conservation of sperm prior to treatment.
Croatian: Preporučuje se da potraže savjet oko kriokonzervacije sperme prije početka liječenja.
English: - if you have low counts of red blood cells (anaemia), white blood cells and platelets, or blood clotting problems before starting the treatment, or if you develop them during treatment.
Croatian: • ako imate smanjen broj crvenih krvnih stanica (anemiju), bijelih krvnih stanica i trombocita ili problema sa zgrušavanjem krvi prije početka liječenja, ili se ti poremećaji razviju tijekom liječenja.
English: For patients on a 42-day treatment cycle liver function tests should be repeated midway during this cycle.
Croatian: U bolesnika na 42-dnevnom terapijskom ciklusu, pretrage funkcije jetre potrebno je ponoviti sredinom tog ciklusa.
English: Most haematologic adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5); the frequency of Grade 3 - 4 laboratory findings is presented after each table.
Croatian: Većina hematoloških nuspojava prijavljena je često ili vrlo često u obje indikacije (Tablice 4 i 5); iza svake tablice navedena je učestalost poremećaja laboratorijskih nalaza stupnja 3 - 4.
English: This is because Temomedac could cause hepatitis B to become active again, which can be fatal in some cases.
Croatian: Ovo je zato što Temomedac može uzrokovati ponovnu aktivaciju hepatitisa B, što u nekim slučajevima može imati smrtni ishod.
English: - if you have nausea (feeling sick in your stomach) and/or vomiting which are very common side effects of Temomedac (see section 4), your doctor may prescribe you a medicine (an antiemetic) to help prevent vomiting.
Croatian: • ako imate mučninu i/ili povraćanje što su vrlo česte nuspojave lijeka Temomedac (pogledajte dio 4) liječnik Vam može propisati lijek koji sprečava povraćanje (antiemetik).
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: U nekomparativnom ispitivanju je PFS nakon šest mjeseci iznosio 19 %, medijan preživljenja bez progresije bolesti bio je 2,1 mjesec, a medijan ukupnog preživljenja 5,4 mjeseca.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Temomedac,
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Temomedac,
English: the next cycle should be reduced one dose level (see section 4.2).
Croatian: 9/l, u sljedećem se ciklusu doza mora sniziti za jednu razinu (vidjeti dio 4.2).
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temomedac to prevent or control nausea and vomiting.
Croatian: Liječnik Vam može dati i neke druge lijekove (antiemetike) koje ćete uzimati prije i/ili nakon što uzmete lijek Temomedac radi izbjegavanja ili kontrole mučnine i povraćanja.
English: Herpes simplex, herpes zoster, influenza-like symptoms
Croatian: herpes simplex, herpes zoster, simptomi nalik gripi
English: TMZ dose (mg/m²/day)
Croatian: Razina doze Doza TMZ-a (mg/m²/dan)
English: Dose during Cycles 2 - 6 in absence of toxicity
Croatian: Doza tijekom 2. - 6. ciklusa ako nema toksičnih učinaka Tablica
English: *A patient who was randomised to the RT arm only, received TMZ + RT.
Croatian: *Jedan bolesnik koji je bio randomiziran u skupinu koja je primala samo RT, primio je TMZ + RT.
English: If you forget to take Temomedac
Croatian: Ako ste zaboravili uzeti Temomedac
English: Before each new treatment cycle, your blood will be tested to see if the Temomedac dose needs to be adjusted.
Croatian: Prije svakog novog terapijskog ciklusa napravit će Vam se krvne pretrage kako bi se utvrdilo treba li prilagoditi dozu lijeka Temomedac.
English: The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60 % to 100 % of rats and dogs tested, degeneration of the retina occurred.
Croatian: Toksični učinci primarno su zahvaćali koštanu srž, limforetikularni sustav, testise i gastrointestinalni trakt, a pri većim dozama koje su bile letalne za 60 % do 100 % ispitanih štakora i pasa razvila se degeneracija mrežnice.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA BOCE
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 4,6 mjeseci, što je slično rezultatima za preživljenje bez progresije bolesti.
English: Patients receiving Temomedac in combination with radiotherapy may experience different side effects than patients taking Temomedac alone.
Croatian: Bolesnici koji uzimaju Temomedac u kombinaciji sa zračenjem mogu imati drugačije nuspojave od bolesnika koji uzimaju samo Temomedac.
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-4carboxamide (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, 5-aminoimidazol-4-karboksamida ili neidentificiranih polarnih metabolita.
English: Temomedac should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Croatian: Temomedac smiju propisivati samo liječnici s iskustvom u onkološkom liječenju tumora mozga.
English: Pancytopenia, anaemia (Grade 3 - 4), leukopenia
Croatian: pancitopenija, anemija (stupanj 3 - 4), leukopenija
English: You will take Temomedac alone once daily for the first 5 days.
Croatian: Uzimat ćete samo Temomedac jedanput na dan prvih 5 dana.
English: Colour/marking
Croatian: Boja/oznaka kapice
English: What Temomedac contains
Croatian: Što Temomedac sadrži
English: Do not take Temomedac - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na temozolomid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Temomedac may cause permanent infertility.
Croatian: Temomedac može uzrokovati trajnu neplodnost.
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: Omjer hazarda (engl. hazard ratio, HR) za ukupno preživljenje iznosio je 1,59 (95 % CI za HR = 1,33 - 1,91), uz log-rang p < 0,0001 u korist skupine koja je primala TMZ.
English: MTIC is spontaneously hydrolysed to 5-amino-imidazole-4carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Croatian: MTIC se spontano hidrolizira u 5-amino-imidazol-4karboksamid (AIC), poznati međuspoj u biosintezi purina i nukleinskih kiselina te u metilhidrazin, za koji se vjeruje da je aktivan alkilirajući spoj.
English: If lymphopenia occurs, they are to continue the prophylaxis until recovery of lymphopenia to Grade ≤ 1.
Croatian: Ako se razvije limfopenija, bolesnici moraju nastaviti s profilaksom sve do poboljšanja limfopenije do stupnja ≤ 1.
English: Based on a population pharmacokinetic analysis in patients 19 - 78 years of age, clearance of TMZ is not affected by age.
Croatian: Na temelju farmakokinetičke analize populacije bolesnika u dobi od 19 do 78 godina, dob ne utječe na klirens TMZ-a.
English: Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01A X03 Mechanism of action
Croatian: Farmakoterapijska skupina: Antineoplastici - ostali alkilirajući pripravci, ATK oznaka: L01A X03.
English: PHARMACEUTICAL FORM Hard capsule (capsule).
Croatian: Tvrda kapsula (kapsula).
English: You should stop breast-feeding while receiving treatment with Temomedac.
Croatian: Morate prekinuti dojenje dok se liječite lijekom Temomedac.
English: You will take your new dose of Temomedac alone once daily for the first 5 days (“dosing days”) of each cycle.
Croatian: Uzimat ćete novu dozu lijeka Temomedac jedanput na dan prvih 5 dana svakog ciklusa ("dani doziranja").
English: A treatment cycle with Temomedac lasts 28 days.
Croatian: Ciklus liječenja lijekom Temomedac traje 28 dana.
English: - if you have liver or kidney problems, your dose of Temomedac may need to be adjusted.
Croatian: • ako imate problema s jetrom ili bubrezima, možda će biti potrebno prilagoditi dozu lijeka
English: Temomedac contains lactose
Croatian: Temomedac sadrži laktozu
English: The first dose will be 150 mg/m².
Croatian: Prva doza iznosit će 150 mg/m².
English: During the concomitant phase, your doctor will start Temomedac at a dose of 75 mg/m² (usual dose).
Croatian: U fazi istodobnog liječenja liječnik će započeti primjenu lijeka Temomedac u dozi od 75 mg/m² (uobičajena doza).
English: Once escalated, the dose remains at 200 mg/m² per day for the first 5 days of each subsequent cycle except if toxicity occurs.
Croatian: Kad se jednom poveća, doza ostaje na razini od 200 mg/m² na dan tijekom prvih 5 dana svakog sljedećeg ciklusa, osim u slučaju pojave toksičnih učinaka.
English: Temomedac contains a medicine called temozolomide.
Croatian: Temomedac sadrži lijek pod nazivom temozolomid.
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temomedac for 42 days in combination with radiotherapy.
Croatian: Ako ste bolesnik s novodijagnosticiranim multiformnim glioblastomom, uzimat ćete Temomedac u kombinaciji sa zračenjem tijekom 42 dana.
English: Neutropenia or lymphopenia (Grade 3 - 4), thrombocytopenia (Grade 3 - 4)
Croatian: neutropenija ili limfopenija (stupanj 3 - 4), trombocitopenija (stupanj 3 - 4)
English: Opportunistic infections and reactivation of infections Opportunistic infections (such as Pneumocystis jirovecii pneumonia) and reactivation of infections (such as HBV, CMV) have been observed during the treatment with TMZ (see section 4.8).
Croatian: Oportunističke infekcije (kao što su pneumocystis jirovecii penumonija) i reaktivacija infekcija (kao što su HBV, CMV) primijećene su tijekom liječenja TMZ-om (vidjeti dio 4.8).
English: The Temomedac dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Croatian: Uzimanje lijeka Temomedac može se odgoditi ili prekinuti ovisno o broju Vaših krvnih stanica i o tome kako podnosite lijek tijekom faze istodobnog liječenja.
English: The objective response rate (ORR) based on MRI scans was 8 %.
Croatian: Objektivna stopa odgovora na liječenje (engl. objective response rate, ORR) na temelju MR nalaza iznosila je 8 %.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 hard capsules
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 5 tvrdih kapsula
English: - if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC).
Croatian: • ako ste imali alergijsku reakciju na dakarbazin (antitumorski lijek).
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C.
Croatian: POSEBNE MJERE ČUVANJA Nemojte čuvati na temperaturi iznad 30°C.
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 kriokonzervacije sperme zamrzavanjem (vidjeti dio 4.6).
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 Temomedaca tijekom trudnoće, bolesnicu se mora upoznati s potencijalnim rizikom za plod.
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temomedac only
Croatian: Bolesnici s tumorom koji se ponovno pojavio ili pogoršao (malignim gliomom, poput multiformnog glioblastoma ili anaplastičnog astrocitoma) koji uzimaju samo Temomedac:
English: In some cases, your Temomedac dose will be reduced or treatment stopped.
Croatian: U nekim će slučajevima smanjiti dozu lijeka Temomedac ili prekinuti liječenje ovim lijekom.
English: Amber glass bottle with white polypropylene child-resistant closure equipped with an induction seal of polyethylene containing 5 or 20 capsules.
Croatian: Smeđa staklena boca s bijelim polipropilenskim sigurnosnim zatvaračem za djecu te sa zalijepljenim polietilenskim zaštitnim poklopcem, koja sadrži 5 ili 20 tvrdih kapsula.
English: You will again receive Temomedac once daily for 5 days, followed by 23 days without Temomedac.
Croatian: Ponovno ćete uzimati Temomedac jedanput na dan tijekom 5 dana, nakon čega slijede 23 dana bez lijeka Temomedac.
English: Response rate, based on the central reviewer assessment, was 35 % (13 CR and 43 PR) for the intent-to-treat population (ITT) n = 162.
Croatian: Stopa odgovora na liječenje prema procjeni glavnog recenzenta iznosila je 35 % (13 potpunih odgovora i 43 djelomična odgovora) populacije koju se namjeravalo liječiti (engl. intent-to-treat, ITT) n = 162.
English: In preclinical studies in rats and rabbits receiving 150 mg/m² TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Croatian: U pretkliničkim istraživanjima na štakorima i kunićima koji su primali TMZ u dozi od 150 mg/m² pokazalo se da lijek ima teratogen i/ili fetotoksičan učinak (vidjeti dio 5.3).
English: PHARMACEUTICAL FORM AND CONTENTS 5 hard capsules
Croatian: OBLIK I SADRŽAJ 5 tvrdih kapsula
English: Your blood will be tested frequently during treatment to monitor the side effects of Temomedac on your blood cells.
Croatian: Tijekom liječenja će se često provoditi krvne pretrage radi praćenja nuspojava lijeka Temomedac na krvne stanice.
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 %; hi-kvadrat 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: A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC > 1.5 x 109/l and platelet count > 100 x 109 /l.
Croatian: Kompletna krvna slika mora se napraviti 22. dana (21 dan nakon prve doze) ili unutar 48 sati od tog dana, a zatim jednom tjedno sve dok ABN ne bude > 1,5 x 10
English: Women of childbearing potential should be advised to use effective contraception to avoid pregnancy while they are receiving TMZ.
Croatian: Žene reproduktivne dobi treba savjetovati da koriste pouzdanu kontracepciju kako bi izbjegle trudnoću za vrijeme liječenja temozolomidom.
English: Therefore, men being treated with it 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, because of the possibility of irreversible infertility due to therapy with TMZ.
Croatian: Stoga, muškarcima koji se liječe ovim lijekom treba savjetovati da ne začinju dijete do 6 mjeseci nakon primanja posljednje doze lijeka te da se prije početka liječenja posavjetuju oko kriokonzervacije sperme zamrzavanjem, jer postoji mogućnost da terapija TMZ-om dovede do trajne neplodnosti.
English: Marketing Authorisation Holder and Manufacturer medac
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač medac
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).
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: Your doctor will work out your dose of Temomedac.
Croatian: Vaš liječnik će izračunati dozu lijeka Temomedac primjerenu za Vas.
English: Dose levels include 100 mg/m², 150 mg/m², and 200 mg/m².
Croatian: Razine doza su 100 mg/m², 150 mg/m² i 200 mg/m².
English: TMZ is to be discontinued if: dose level -1 (100 mg/m²) still results in unacceptable toxicity the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Croatian: TMZ se mora prekinuti: ako razina doze -1 (100 mg/m²) i dalje stvara neprihvatljive toksične učinke ako se nakon smanjenja doze ponovno jave isti nehematološki toksični učinci stupnja 3 (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 TMZ-a.
English: LIST OF EXCIPIENTS Contains lactose, sunset yellow FCF (E110).
Croatian: POPIS POMOĆNIH TVARI Sadrži laktozu, sunset yellow FCF (E110).
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temomedac (see also “Male fertility” below).
Croatian: I bolesnice i bolesnici koji uzimaju Temomedac moraju primjenjivati učinkovite mjere kontracepcije (pogledajte i dio "Plodnost muškaraca" u daljnjem tekstu).
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma
Croatian: Odrasli bolesnici i pedijatrijski bolesnici u dobi od 3 godine ili stariji s recidivirajućim ili progresivnim malignim gliomom