FrancophonIA/ELRC3.0 huggingface dataset:
English: • palpitations (abnormal heart beats)
Croatian: • palpitacije (neuobičajeno lupanje srca)
English: Take your prescribed dose of Temozolomide Accord once a day.
Croatian: Uzmite propisanu dozu lijeka Temozolomid Accord jedanput na dan.
English: In some cases, your temozolomide dose will be reduced or discontinued.
Croatian: U nekim slučajevima će Vaša doza temozolomida biti smanjena ili ukinuta.
English: - Be sure you know exactly which days are your dosing days.
Croatian: - Budite sigurni da točno znate koji dani su Vaši dani za uzimanje lijeka.
English: Temozolomide treatment can cause a reduction in certain kinds of blood cells.
Croatian: Liječenje temozolomidom može izazvati smanjenje broja nekih vrsta krvnih stanica.
English: These blood cells are important for fighting infection and for proper blood clotting.
Croatian: Te su krvne stanice važne za borbu protiv infekcije te za pravilno zgrušavanje krvi.
English: Middlesex, HA1 4HF, United Kingdom
Croatian: Middlesex, HA1 4HF, Ujedinjeno Kraljevstvo
English: The reduction of blood cells is usually temporary, but in some cases may be for longer and may lead to a very severe form of anaemia (aplastic anaemia).
Croatian: Smanjenje broja krvnih stanica obično je kratkotrajno, ali u nekim slučajevima može biti dugotrajno te dovesti do vrlo teškog oblika anemije (aplastična anemija).
English: Opportunistic infections, including PCP
Croatian: oportunističke infekcije, uključujući PCP
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjena sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: • dose level -1 (100 mg/m2 ) still results in unacceptable toxicity
Croatian: • ako razina doze -1 (100 mg/m2) i dalje dovodi do neprihvatljivih toksičnih učinaka
English: In some cases, it may be necessary to stop treatment with temozolomide.
Croatian: U nekim će slučajevima možda biti neophodno prekinuti liječenje temozolomidom.
English: Ask your doctor for advice before taking any medicine.
Croatian: Upitajte liječnika za savijet prije uzimanja bilo kojeg lijeka.
English: Dosage and duration of treatment
Croatian: Doziranje i trajanje liječenja
English: Experience in these children is very limited (see sections 4.4 and 5.1).
Croatian: Iskustvo u ove djece je vrlo ograničeno (vidjeti dijelove 4.4 i 5.1).
English: Temozolomide is an anti-cancer medicine.
Croatian: Temozolomid Accord je lijek protiv raka.
English: - you may have a small risk of other changes in blood cells, including leukaemia.
Croatian: - možete imati malen rizik od drugih promjena krvnih stanica, uključujući leukemiju.
English: If you are pregnant or, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: Temozolomide comes in different strength capsules (shown on the outer label in mg).
Croatian: Temozolomid dolazi u kapsulama različitih jačina (prikazano na vanjskom označavanju u mg).
English: The capsules contain lactose (a kind of sugar).
Croatian: Kapsule sadrže laktozu (vrstu šećera).
English: Your doctor may need to reduce the dose of your medicine or interrupt your treatment, or you may need other treatment.
Croatian: Liječnik će možda smanjiti dozu, prekinuti liječenje ili će Vam biti potrebna druga terapija.
English: - Be sure you understand exactly how many capsules you need to take of each strength.
Croatian: - Budite sigurni da ste u potpunosti razumjeli koliko kapsula pojedine jačine morate uzeti.
English: Your blood will be tested regularly to monitor your condition.
Croatian: Redovito će se provoditi krvne pretrage radi praćenja Vašeg stanja.
English: If a full day has gone by, check with your doctor.
Croatian: Ako je prošao cijeli dan, provjerite s liječnikom što da učinite.
English: What Temozolomide Accord is and what it is used for What you need to know before you take Temozolomide Accord How to take Temozolomide Accord Possible side effects
Croatian: Što je Temozolomid Accord i za što se koristi Što morate znati prije nego počnete uzimati Temozolomid Accord Kako uzimati Temozolomid Accord Moguće nuspojave
English: If Temozolomide Accord comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Croatian: Ako Temozolomid Accord dođe u kontakt s kožom ili sluznicom, to područje treba odmah temeljito isprati sapunom i vodom.
English: However, because the doses implicated in retinal degeneration were in the lethal dose range, and no comparable effect has been observed in clinical studies, this finding was not considered to have clinical relevance.
Croatian: Međutim, s obzirom da su doze koje su izazvale degeneraciju mrežnice bile u rasponu letalnih doza, a sličan učinak nije opažen u kliničkim ispitivanjima, ovaj se nalaz ne smatra klinički značajnim.
English: Experience in older children and adolescents is very limited (see sections 4.2 and 5.1).
Croatian: Iskustvo u starije djece i adolescenata je vrlo ograničeno (vidjeti dijelove 4.2 i 5.1).
English: TMZ is more toxic to the rat and dog than to humans, and the clinical dose approximates the minimum lethal dose in rats and dogs.
Croatian: TMZ je toksičniji za štakore i pse nego za čovjeka, a klinička je doza vrlo blizu najniže letalne doze za štakore i pse.
English: • increased sugar in the blood, loss of weight
Croatian: • povišena razina šećera u krvi, gubitak težine
English: What Temozolomide Accord is and what it is used for
Croatian: Što je Temozolomid Accord i za što se koristi
English: Store in the original bottle.
Croatian: Čuvati u originalnoj bočici.
English: You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Croatian: Tu ćete dozu uzimati svakodnevno tijekom 42 dana (najdulje 49 dana) u kombinaciji sa zračenjem.
English: • hair loss
Croatian: • gubitak kose
English: Each carton contains 5 or 20 sachets.
Croatian: Svaka kutija sadrži 5 ili 20 vrećica.
English: * Frequencies estimated based on relevant clinical trials.
Croatian: *Učestalost se temelji na ključnim kliničkim istraživanjima.
English: Depending on your blood test results, your doctor may adjust your dose for the next cycle.
Croatian: S obzirom na rezultate krvnih pretraga, Vaš liječnik može prilagoditi dozu lijeka za sljedeći ciklus.
English: Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population)
Croatian: Slika 1. Kaplan-Meierove krivulje ukupnog preživljenja (populacija koju se namjeravalo liječiti)
English: Each carton contains 1 bottle.
Croatian: Svaka kutija sadrži 1 bočicu.
English: If you vomit frequently before or during treatment, ask your doctor about medicines to help prevent vomiting or control the vomiting and the best time to take temozolomide until the vomiting is under control.
Croatian: Ako često povraćate prije ili za vrijeme liječenja, upitajte svog liječnika o lijekovima koji sprečavaju povraćanje ili kontroliraju povraćanje i kada je najbolje uzimati temozolomid dok povraćanje ne bude pod kontrolom.
English: It is recommended to seek advice on conservation of sperm prior to treatment.
Croatian: Preporučuje se da potraže savjet o pohrani sperme prije početka liječenja.
English: This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and/or a reduced resistance to infections.
Croatian: To može uzrokovati povećanu sklonost modricama ili krvarenju, anemiju (nedostatak crvenih krvnih stanica), vrućicu i/ili smanjenu otpornost na infekcije.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Temozolomide Accord,
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Temozolomid Accord,
English: Each time you start a new treatment cycle, be sure you understand exactly how many capsules of each strength you need to take each day and how many days you will receive this dose.
Croatian: Prije početka svakog novog terapijskog ciklusa budite sigurni da ispravno razumijete koliko točno kapsula koje jačine trebate uzimati svakog dana i koliko dana trebate uzimati određenu dozu.
English: Your doctor will decide the correct dose of temozolomide for you to take, based on your size (height and weight) and whether you have had chemotherapy treatment.
Croatian: Vaš liječnik će odlučiti o ispravnoj dozi temozolomida za Vas na temelju Vaše veličine (visine i težine) te o tome jeste li već primali kemoterapiju.
English: Opportunistic infections and reactivation of infections
Croatian: Oportunističke infekcije i reaktivacija infekcija
English: Temozolomide Accord may cause permanent infertility.
Croatian: Temozolomid Accord može uzrokovati trajnu neplodnost.
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 standardnim antiemeticima.
English: Each strength has a different colour cap.
Croatian: Svaka jačina kapsule ima kapicu druge boje.
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: 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).
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).
English: However, since TMZ does not undergo hepatic metabolism and exhibits low protein binding, it is unlikely that it would affect the pharmacokinetics of other medicinal products (see section 5.2).
Croatian: Međutim, budući da se TMZ ne metabolizira u jetri i da se slabo veže za proteine, nije vjerojatno da bi utjecao na farmakokinetiku drugih lijekova (vidjeti dio 5.2).
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, ispitivanje funkcije jetre potrebno je ponoviti sredinom ovog ciklusa.
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: Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.
Croatian: Bolesnicima koji su jako povraćali (stupanj 3 ili 4) tijekom prethodnog ciklusa liječenja možda će biti potrebno dati antiemetik.
English: What you need to know before you take Temozolomide Accord
Croatian: Što morate znati prije nego počnete uzimati Temozolomid Accord
English: Most of the toxicity showed evidence of reversibility, except for adverse reactions on the male reproductive system and retinal degeneration.
Croatian: Veći dio toksičnih učinaka bio je reverzibilan, osim nuspojava na reproduktivni sustav mužjaka i degeneracije mrežnice.
English: Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.
Croatian: Liječnik će provjeriti Vašu krvnu sliku kako bi ustanovio imate li dovoljan broj tih stanica prije početka liječenja.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim problemima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcije glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
English: Before each new treatment cycle, your blood will be tested to see if the temozolomide dose needs to be adjusted.
Croatian: Prije svakog novog ciklusa, napravit će Vam krvne pretrage kako bi se utvrdilo treba li prilagoditi dozu temozolomida.
English: A treatment cycle comprises 28 days.
Croatian: Ciklus liječenja traje 28 dana.
English: If you are taking Temozolomide Accord capsules alone (without radiotherapy):
Croatian: Ako uzimate Temozolomid Accord kapsule same (bez zračenja):
English: Use of TMZ in combination with other myelosuppressive agents may increase the likelihood of myelosuppression.
Croatian: Uporaba TMZ-a u kombinaciji s drugim mijelosupresivima može povećati vjerojatnost razvoja mijelosupresije.
English: This is because Temozolomide Accord could cause hepatitis B to become active again, which can be fatal in some cases.
Croatian: Ovo je zato što Temozolamid Accord može uzrokovati ponovnu aktivaciju hepatitisa B, što u nekim slučajevima može imati smrtni ishod.
English: Pack-size of 5 or 20 hard capsules individually sealed in sachets.
Croatian: Pakiranje od 5 ili 20 tvrdih kapsula pojedinačno zapakiranih u vrećice.
English: If you are taking Temozolomide Accord in combination with radiotherapy (newly diagnosed patients):
Croatian: Ako uzimate Temozolomid Accord u kombinaciji sa zračenjem (novodijagnosticirani bolesnici):
English: CTC Grade 4b a : TMZ dose levels are listed in Table 2. b : TMZ is to be discontinued if:
Croatian: CTC stupanj 4b a: doze TMZ-a navedene su u Tablici 2. b: TMZ se mora prekinuti:
English: Very rarely, patients taking temozolomide and medicines like it may have a small risk of other changes in blood cells, including leukaemia.
Croatian: U vrlo rijetkim slučajevima, bolesnici koji uzimaju temozolomid i slične lijekove mogu imati malen rizik od drugih promjena u krvnim stanicama, uključujući leukemiju.
English: Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.
Croatian: Istodobna primjena s valproičnom kiselinom bila je povezana s malim, no statistički značajnim smanjenjem klirensa TMZ-a.
English: • partial loss of vision, dry or painful eyes
Croatian: • djelomičan gubitak vida, suhe ili bolne oči
English: In the non-comparative 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 6 mjeseci iznosio 19%, medijan preživljenja bez progresije bolesti bio je 2,1 mjesec, a medijan ukupnog preživljenja 5,4 mjeseca.
English: Temozolomide Accord contains lactose
Croatian: Temozolomid Accord sadrži laktozu
English: In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43%) and vomiting (36%).
Croatian: U kliničkim su ispitivanjima najčešće nuspojave povezane s liječenjem bile poremećaji probavnog sustava, preciznije mučnina (43%) i povraćanje (36%).
English: • peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating
Croatian: • ljuštenje kože, povećana osjetljivost kože na sunčevu svjetlost, promjena boje kože, pojačano znojenje
English: How to store Temozolomide Accord Contents of the pack and other information
Croatian: Kako čuvati Temozolomid Accord Sadržaj pakiranja i druge informacije
English: The following side effects may occur if you are taking only temozolomide (patients treated for brain tumours that have come back or that have spread)
Croatian: Slijedeće nuspojave mogu se pojaviti ako uzimate samo temozolomid (bolesnici liječeni zbog tumora mozga koji se ponovno pojavio ili se proširio)
English: Depending on the dose of temozolomide that your doctor prescribes, you may have to take several capsules on each dosing day of the treatment cycle.
Croatian: Ovisno o dozi temozolomida koju Vam je liječnik propisao, možda ćete morati uzimati nekoliko kapsula u istom danu terapijskog ciklusa.
English: If you vomit after your dose, do not take a second dose on the same day.
Croatian: Ako povratite nakon uzimanja doze, nemojte uzeti sljedeću dozu istoga dana.
English: - if you have a reduced number of blood cells, such as your white blood cell count and platelet count.
Croatian: - ako imate smanjen broj krvnih stanica, kao što su bijele krvne stanice i krvne pločice.
English: How to open sachet Open the sachet by folding and tearing along the fold line with the notch in the corner of the sachet.
Croatian: Kako se otvara vrećica Vrećicu otvorite tako što ćete je saviti i otrgnuti duž preklopne linije s urezom u kutu vrećice.
English: In a multicentre, prospective phase II trial evaluating the safety and efficacy of oral TMZ in the treatment of patients with anaplastic astrocytoma at first relapse, the 6 month PFS was 46%.
Croatian: U multicentričnom, prospektivnom ispitivanju faze II u kojemu se procjenjivala sigurnost i djelotvornost peroralno primijenjenog TMZ-a u liječenju bolesnika s prvim relapsom anaplastičnog astrocitoma, šestomjesečni PFS iznosio je 46%.
English: - Once you take the medicine home, if you are confused or unsure about how to take your dose, call for re-instruction before beginning the treatment cycle.
Croatian: Ako se zbunite ili niste sigurni kako uzimati svoju dozu nakon što donesete lijek doma, nazovite radi ponovnog dobivanja uputa prije početka terapijskog ciklusa.
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 primjenu tijekom trudnoće, bolesnicu se mora upoznati s potencijalnim rizikom za plod.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Croatian: Nepoznata reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS)
English: Based on your blood counts and how you tolerate temozolomide during each treatment cycle, the dose may be adjusted, delayed or stopped.
Croatian: Ovisno o broju Vaših krvnih stanica i o tome kako podnosite temozolomid u svakom terapijskom ciklusu, doza se može prilagoditi, odgoditi ili prekinuti.
English: Other medicines and Temozolomide Accord Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out 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 periodička izvješćih o neškodljivosti za ovaj lijek definirani su u referentnom popisom datum 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: 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: • loss of hearing, ringing noise in the ear
Croatian: • gubitak sluha, buka poput zvonjave u ušima
English: MTIC is spontaneously hydrolyzed 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: • change in your sense of smell
Croatian: • promjena osjeta mirisa
English: However, caution should be exercised when TMZ is administered in these patients.
Croatian: Ipak, potreban je oprez kad se TMZ primjenjuje u ovih bolesnika.
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
English: myelodysplastic syndrome (MDS), secondary malignancies, including myeloid leukaemia
Croatian: mijelodisplastični sindrom (MDS), sekundarni malignitet, uključujući mijeloičnu leukemiju
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: - if you have liver or kidney problems as your dose of temozolomide may need to be adjusted.
Croatian: - ako imate problema s jetrom ili bubrezima jer će možda biti potrebno prilagoditi Vašu dozu.
English: - if you develop fever or symptoms of an infection, contact your doctor immediately.
Croatian: - ako razvijete vrućicu ili simptome infekcije, odmah se obratite svom liječniku.
English: Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01A X03
Croatian: Farmakoterapijska skupina: Antineoplastici - ostali alkilirajući pripravci, ATK oznaka: L01A X03.
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: 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 probavni sustav, a pri većim dozama koje su bile letalne za 60% do 100% ispitanih štakora i pasa razvila se degeneracija mrežnice.
English: - as you should be observed closely for the development of a serious form of chest infectioncalled Pneumocystis jirovecii pneumonia (PCP).
Croatian: jer Vas se mora pažljivo nadgledati zbog mogućeg razvoja teškog oblika infekcije koja se naziva upala pluća uzrokovana s Pneumocystis jirovecii (PCP).
English: Liver toxicity may occur several weeks or more after the last treatment with temozolomide.
Croatian: Toksičnost jetre može se pojaviti i više tjedana nakon prestanka liječenja temozolomidom.
English: Older patients are more prone to infections, increased bruising or bleeding.
Croatian: Stariji bolesnici su skloniji infekcijama, stvaranju modrica ili krvarenju.
English: Special populations Paediatric population
Croatian: Posebne populacije Pedijatrijska populacija
English: The carton contains one bottle.
Croatian: U kutiji se nalazi jedna bočica.
English: Do not give this medicine to children under the age of 3 years because it has not been studied.
Croatian: Ovaj lijek nije ispitivan u djece mlađe do 3 godine te im ga stoga nemojte davati.