FrancophonIA/ELRC3.0 huggingface dataset:
English: The following protective recommendations are given due to the toxic nature of this substance:
Croatian: Preporučuju se sljedeće mjere zaštite zbog toksičnih svojstava ove tvari:
English: Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
Croatian: Vaš će liječnik s Vama razgovarati o nuspojavama i objasniti Vam potencijalne rizike i koristi liječenja.
English: Your doctor will check for these symptoms regularly.
Croatian: Vaš će Vas liječnik redovito pregledavati radi otkrivanja ovim simptoma.
English: Read all of this leaflet carefully before you receive this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primati lijek jer sadrži Vama važne podatke.
English: Therefore monitoring of the haemopoietic system is advised.
Croatian: Preporučuje se stoga praćenje hematopoetskog sustava.
English: • a designated area should be defined for preparation (preferably under a laminar flow system).
Croatian: • potrebno je odrediti posebno mjesto za pripremu (poželjno pod sustavom laminarnog protoka).
English: Side effects may occur after each injection, usually within the first five days.
Croatian: Nuspojave se mogu pojaviti nakon svake injekcije, obično unutar prvih 5 dana.
English: • Persistent or extreme sleepiness
Croatian: • Trajna ili ekstremna pospanost
English: • personnel must wear protective clothing: goggles, gowns, disposable gloves and masks;
Croatian: • osoblje mora nositi zaštitnu odjeću: zaštitne naočale, ogrtače, jednokratne rukavice i maske;
English: After first opening: from a microbiological point of view, the product should be used immediately.
Croatian: Nakon prvog otvaranja: s mikrobiološke točke gledišta, lijek treba odmah primijeniti.
English: Adults and the elderly
Croatian: Odrasli i bolesnici starije dobi
English: The mechanism of action is not completely understood, but it appears that araCTP acts primarily through inhibition of DNA synthesis.
Croatian: Mehanizam djelovanja nije još potpuno jasan, ali izgleda da araCTP prvenstveno djeluje inhibicijom sinteze DNA.
English: More than 90% of cytarabine was excreted by day 4 and an additional 2.7% by 21 days.
Croatian: Više od 90% citarabina izlučilo se do 4. dana i dodatnih 2,7% do 21. dana.
English: Teratology studies in animals have not been conducted with DepoCyte and there are no adequate and well controlled studies in pregnant women.
Croatian: Studije teratogenosti s DepoCyteom na životinjama nisu provedene i nema odgovarajućih i dobro kontroliranih ispitivanja u trudnica.
English: Date of first authorisation: 11 July 2001 Date of latest renewal: 11 July 2011
Croatian: Datum prvog odobrenja: 11. srpnja 2001.
English: In the majority of patients such treatment will be part of symptomatic palliation of the disease.
Croatian: Kod većine pacijenata ovo liječenje će biti dio palijativnog liječenja simptoma bolesti.
English: The suspension must not be diluted.
Croatian: Suspenzija se ne smije razrjeđivati.
English: − If you have further questions, ask your doctor.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku.
English: What DepoCyte looks like and contents of the pack
Croatian: Kako DepoCyte izgleda i sadržaj pakovanja
English: Patients who did not respond discontinued protocol treatment after 4 weeks.
Croatian: Bolesnici koji nisu odgovorili na terapiju prekinuli su protokol liječenja nakon 4 tjedna.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje u promet gotovog lijeka.
English: Women of childbearing potential/Contraception in males and females
Croatian: Žene reproduktivne dobi/Kontracepcija u muškaraca i žena
English: Management of overdose should be directed at maintaining vital functions.
Croatian: Liječenje predoziranja treba biti usmjereno održavanju vitalnih funkcija.
English: DepoCyte should not be diluted or mixed with any other medicinal products, as any change in concentration or pH may affect the stability of the microparticles.
Croatian: DepoCyte ne treba razrjeđivati ili miješati s ostalim lijekovima, jer svaka promjena koncentracije ili pH može utjecati na stabilnost njegovih mikročestica.
English: Other medicines and DepoCyte
Croatian: Drugi lijekovi i DepoCyte
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 webportal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: Staff who are pregnant or trying to conceive (male and female) should not work with DepoCyte.
Croatian: Zdravstvene djelatnice koje su trudne ili djelatnici koji namjeravaju začeti (muškarci i žene) ne bi trebali raditi s DepoCyteom.
English: • all items used during administration or cleaning should be placed in high risk, waste-disposal bags for high temperature incineration;
Croatian: • sve predmete korištene prilikom primjene i čišćenja treba odlagati u vreće za odlaganje visoko rizičnog otpada koji se spaljuje na visokim temperaturama;
English: Very common (experienced in more than 1 in 10 patients)
Croatian: Vrlo često (pojavljuje se u više od 1 od 10 bolesnika)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA
English: Proper precautions should be taken for the handling and administration of a cytotoxic drug (proper handling technique, use of a suitable designated area, protective clothing, procedures to address risk of contamination).
Croatian: Treba poduzeti odgovarajuće mjere opreza prilikom rukovanja citotoksičnim lijekom (rukovati na odgovarajući način, koristiti prikladni prostor za pripremu, nositi zaštitnu odjeću, provoditi postupke koji će spriječiti rizik od kontaminacije).
English: The work surface should be protected by disposable, plastic backed, absorbent paper;
Croatian: Radna površina treba biti zaštićena jednokratnim apsorbirajućim papirom s plastičnom zaštitnom podlogom;
English: • Partial paralysis
Croatian: • Parcijalna paraliza
English: DepoCyte should be injected slowly over a period of 1-5 minutes.
Croatian: DepoCyte se treba injicirati polako, kroz 1-5 minuta.
English: If neurotoxicity develops, the dose should be reduced to 25 mg.
Croatian: Ako nastupe znakovi neurotoksičnosti, dozu treba smanjiti na 25 mg.
English: • personnel should be trained in good technique for handling anticancer agents;
Croatian: • osoblje treba obučiti kako ispravno rukovati agensima za liječenje neoplazmi;
English: • Nausea and/or vomiting
Croatian: • Mučnina i/ili povraćanje
English: There is no antidote for DepoCyte.
Croatian: Ne postoji antidot za DepoCyte.
English: Injections are given slowly over 1-5 minutes and you may be asked to lie flat for one hour afterwards.
Croatian: Injekcija se daje sporo kroz 1-5 minuta, i od Vas može biti zatraženo da nakon toga ostanete ležati još sat vremena.
English: Because toxic effects can occur at any time during therapy (although they are most likely within 5 days of administration), patients receiving DepoCyte therapy should be monitored continuously for the development of neurotoxicity.
Croatian: Budući da toksični učinci mogu nastupiti bilo kada tijekom terapije (iako su češći u prvih 5 dana nakon primjene) bolesnike koji primaju terapiju DepoCyteom trebalo bi trajno nadzirati u smislu razvoja neurotoksičnosti.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICA LIJEKA
English: Store in a refrigerator (2°C - 8°C).
Croatian: Čuvati u hladnjaku (2 °C - 8 °C).
English: DepoCyte must be used as supplied without further dilution.
Croatian: DepoCyte treba koristiti kakav je isporučen, bez dodatnog razrjeđivanja.
English: Table 3 below lists these reactions for patients treated DepoCyte, and for patients treated with methotrexate and cytarabine as well.
Croatian: Tablica 3, dolje, navodi ove reakcije za pacijente koji su liječeni DepoCyteom i za pacijente liječene metotreksatom, kao i citarabinom.
English: DepoCyte must not be mixed with any other medicinal products (see section 6.2).
Croatian: DepoCyte se ne smije miješati s niti jednim drugim lijekom (vidjeti dio 6.2).
English: Common (experienced in less than 1 in 10 but more than 1 in 100 patients)
Croatian: Često (pojavljuje se kod manje od 1 na 10, ali više od 1 na 100 bolesnika)
English: Do not operate any tools or machines during treatment.
Croatian: Za vrijeme liječenja nemojte koristiti alate niti strojeve.
English: One patient at the 125 mg dose level died of encephalopathy 36 hours after receiving DepoCyte intraventricularly.
Croatian: Jedan je bolesnik s dozom od 125 mg umro od encefalopatije 36 sati nakon intraventrikularne primjene DepoCytea.
English: Make sure you take as directed any dexamethasone tablets that you may have been prescribed, as they reduce the risk of unwanted effects caused by DepoCyte.
Croatian: Pazite da redovito uzimate tablete deksametazon prema uputama ako su Vam propisane, jer one smanjuju rizik neželjenih učinaka uzrokovanih DepoCyteom.
English: For the treatment of lymphomatous meningitis, DepoCyte is given according to the following schedules:
Croatian: Za liječenje limfomatoznog meningitisa DepoCyte se primjenjuje prema sljedećem rasporedu:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Podrobnije informacije o ovom lijeku dostupne su na web stranicama Europske agencije za lijekove http://www.ema.europa.eu.
English: If left untreated, chemical arachnoiditis may be fatal.
Croatian: Ako se ne liječi, kemijski uzrokovan arahnoiditis može biti smrtonosan.
English: There have been no reports explicitly relating to effects of DepoCyte treatment on the ability to drive or use machines.
Croatian: Nema izvješća koji jasno povezuju utjecaj liječenja DepoCyteom sa sposobnošću upravljanja vozilima ili rada na strojevima.
English: Suspension for injection.
Croatian: OBLIK Suspenzija za injekciju.
English: Pharmacotherapeutic group: Antimetabolites, pyrimidine analogues, ATC code: L01BC01
Croatian: Farmakoterapijska skupina: Antimetaboliti, analozi pirimidina, ATK oznaka: L01BC01
English: Mouse, rat and dog studies have shown that free cytarabine is highly toxic for the haemopoietic system.
Croatian: Ispitivanja provedena na miševima, štakorima i psima pokazala su da je slobodni citarabin visoko toksičan za hematopoetski sustav.
English: No statistically significant differences were noted in secondary endpoints such as duration of response, progression-free survival, neurological signs and symptoms, Karnofsky performance status, quality of life and overall survival.
Croatian: Nije zabilježena statistički značajna razlika u sekundarnim mjerama ishoda, kao što su trajanje odgovora na terapiju, vrijeme preživljenja bez progresije bolesti, neurološki znakovi i simptomi, Kamofsky izvedbeni status, kvaliteta života i ukupno preživljenje.
English: Because these reactions are reported from a population of uncertain size, it is not possible to reliably estimate their frequency.
Croatian: Budući da su ove nuspojave primijećene na populaciji neodređene veličine, nije moguće pouzdano utvrditi njihovu učestalost.
English: DepoCyte should be used as soon as possible after first opening, and should normally be used within 4 hours (stored at 18-22ºC).
Croatian: DepoCyte treba primijeniti što prije nakon prvog otvaranja, i treba se iskoristiti unutar 4 sata (čuvati na temperaturi 18-22ºC).
English: Toxic effects may be related to a single dose or to cumulative doses.
Croatian: Toksični učinak može biti posljedica pojedinačne ili kumulativne doze.
English: In addition, compared with free cytarabine, the formulation increases the biological half-life by a factor of 27 to 71 depending upon the route of administration and the compartment sampled.
Croatian: Nadalje, u usporedbi sa slobodnim citarabinom, ovaj pripravak produžava biološki poluvijek za faktor umnoška od 27 do 71, ovisno o putu primjene, odnosno odjeljka iz kojeg je uzorak dobiven.
English: • male and female staff who are trying to conceive and female staff who are pregnant should be excluded from working with the substance;
Croatian: • muške i ženske članove osoblja koji namjeravaju začeti, te ženske članice osoblja koje su trudne treba isključiti iz postupaka rukovanja ovom tvari;
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 4 hours at 18 to 22°C.
Croatian: Ne primijeni li se lijek odmah, za vrijeme i uvjete čuvanja lijeka prije primjene odgovoran je korisnik, i ne bi trebali biti duži od 4 sata na temperaturi od 18 do 22 °C.
English: Symptoms have included effects on the nervous system (e.g. convulsions, pain, numbness or tingling, blindness or visual disturbances).
Croatian: Simptomi su uključivali učinke na živčani sustav (npr. konvulzije, bol, utrnutost i mravinjanje, sljepoću ili smetnje vida).
English: You will also be given dexamethasone, usually as tablets but possibly by intravenous injection for 5 days after you receive each DepoCyte dose to help reduce any side effects which might occur.
Croatian: Dobivat ćete i deksametazon, obično u tabletama, ali moguće i kao intravensku injekciju, kroz 5 dana nakon davanja svake doze DepoCytea, kako bi se time pomoglo smanjiti rizik nastanka nuspojava.
English: However, on the basis of reported adverse reactions, patients should be advised against driving or using machines during treatment.
Croatian: Ipak, na temelju prijavljenih nuspojava, bolesnicima se tijekom liječenja ne savjetuje upravljati vozilima niti rad na strojevima.
English: Given that cytarabine has a mutagenic potential which could induce chromosomal damage in the human spermatozoa, males undergoing DepoCyte treatment and their partner should be advised to use a reliable contraceptive method.
Croatian: Budući da citarabin ima mutageni potencijal koji može uzrokovati oštećenje kromosoma spermatozoida u ljudi, muškarcima koji će biti podvrgnuti terapiji DepoCyteom i njihovim partnericama treba preporučiti primjenu učinkovite metode kontracepcije.
English: In an early uncontrolled study without dexamethasone prophylaxis, single doses up to 125 mg were administered.
Croatian: U jednom ranom nekontroliranom ispitivanju bez profilakse deksametazonom primjenjivane su pojedinačne doze do 125 mg.
English: Similar changes (generally described as minimal to slight) were also observed in some animals receiving DepoFoam alone (DepoCyte vesicles without cytarabine) but not in sodium chloride solution control animals.
Croatian: Slične promjene (općenito opisane kao minimalne do blage) primijećene su i u nekih životinja koje su primile samo DepoFoam (vezikule DepoCytea bez citarabina), ali ne i životinje kontrolne skupine koje su primile otopinu natrijeva klorida.
English: These changes were believed to be consistent with the toxic effects of other intrathecal agents such as unencapsulated cytarabine.
Croatian: Vjeruje se da su ove toksične promjene svojstvene i drugim intratekalnim agensima, poput neinkapsuliranog citarabina.
English: Common: somnolence Common: somnolence
Croatian: Često: somnolencija Često: somnolencija
English: In vitro studies, examining more than 60 cell lines, demonstrated that the median cytarabine concentration resulting in 50% growth inhibition (IC50) was approximately 10 µM (2.4 µg/ml) for two days of exposure and 0.1 µM (0.024 µg/ml) for 6 days of exposure.
Croatian: Ispitivanja in vitro na više od 60 staničnih linija, pokazala su da medijan koncentracije citarabina koji izaziva inhibiciju rasta od 50% (IC50) iznosi oko 10 µM (2,4 µg/ml) za dva dana ekspozicije i 0,1 µM (0,024 µg/ml) za 6 dana ekspozicije.
English: Patients should be informed about the expected adverse reactions of headache, nausea, vomiting and fever, and about the early signs and symptoms of neurotoxicity.
Croatian: Pacijente treba informirati o očekivanim nuspojavama, poput glavobolje, mučnine, povraćanja i vrućice kao i o ranim znacima i simptomima neurotoksičnosti.
English: Intrathecal administration of cytarabine may cause myelopathy (3%) and other neurologic toxicities sometimes leading to a permanent neurological deficit.
Croatian: Intratekalna primjena citarabina može uzrokovati mijelopatiju (3%) i druga neurotoksična oštećenja koja ponekad dovode do trajnog neurološkog deficita.
English: Patients who achieved a response (defined as clearing of the CSF of malignant cells in the absence of progression of neurological symptoms) went on to receive Consolidation and Maintenance therapy for up to 29 weeks.
Croatian: Bolesnici koji su imali odgovor na terapiju (definiran kao nestanak malignih stanica iz cerebrospinalne tekućine uz izostanak progresije neuroloških simptoma) nastavili su dobivati konsolidacijsku terapiju i terapiju održavanja do 29 tjedana.
English: DepoCyte is supplied in individual cartons each containing one single-dose vial.
Croatian: DepoCyte je dostupan u pojedinačnim kartonskim kutijama od kojih svaka sadrži jednu jednodoznu bočicu.
English: • Blindness and other visual disturbances
Croatian: • Sljepoća ili drugi poremećaji vida
English: • in the event of accidental contact with the skin, exposed areas should be washed immediately with soap and water;
Croatian: • u slučaju nehotičnog kontakta s kožom, izloženo područje treba smjesta oprati sapunom i vodom.
English: PC: {number} SN: {number} NN: {number}
Croatian: SN: {broj} [serijalizacijski broj]
English: The severity of adverse events of DepoCyte may be increased when DepoCyte is given in combination with other chemotherapeutic agents.
Croatian: Težina neželjenih učinaka DepoCytea može biti povećana kada se lijek daje zajedno s drugim kemoterapeuticima.
English: The proportion of patients alive at 12 months was 24% for DepoCyte versus 19% for unencapsulated cytarabine.
Croatian: Postotak preživjelih bolesnika nakon 12 mjeseci bio je 24% u skupini DepoCytea naspram 19% u skupini neinkapsuliranog citarabina.
English: DepoCyte has the potential of producing serious neurological toxicity.
Croatian: DepoCyte potencijalno može izazvati ozbiljna toksična neurološka oštećenja.
English: These peaks were followed by a biphasic elimination profile consisting of an initial sharp decline and subsequent slow decline with a terminal phase half-life of 100 to 263 hours over a dose-range of 12.5 mg to 75 mg.
Croatian: Nakon vršne razine slijedi bifazični profil eliminacije koji se sastoji od početnog oštrog pada, nakon čega slijedi spori pad s poluvijekom u terminalnoj fazi od 100 do 163 sati, pri rasponu doza od 12,5 do 75 mg.
English: This patient, however, was also receiving concomitant whole brain irradiation and had previously received intraventricular methotrexate.
Croatian: Ovom je bolesniku istovremeno zračen cijeli mozak, a ranije je intraventrikularno dobivao metotreksat.
English: Patients should be observed by the physician for immediate toxic reactions.
Croatian: Bolesnike treba opservirati liječnik radi neposrednih toksičnih reakcija.
English: There is no antidote for intrathecal DepoCyte or unencapsulated cytarabine released from DepoCyte.
Croatian: Nema antidota za intratekalno primjenjen DepoCyte ili neinkapsulirani citarabin otpušten iz DepoCytea.
English: Patients should be instructed to seek medical attention if signs or symptoms of neurotoxicity develop, or if oral dexamethasone is not well tolerated.
Croatian: Pacijente treba uputiti da potraže medicinsku pomoć ako se razviju znaci ili simptomi neurotoksičnosti, odnosno ako se peroralna primjena deksametazona dobro ne podnosi.
English: − if you are allergic to cytarabine or any of the other ingredients of this medicine (listed in − if you have a meningeal infection.
Croatian: − ako ste alergični na citarabin ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: DepoCyte should be administered only under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
Croatian: DepoCyte treba primjenjivati samo pod nadzorom liječnika koji ima iskustva u primjeni kemoterapijskih lijekova u liječenju karcinoma.
English: Before DepoCyte is used the vial should be warmed to room temperature (18°C - 22°C) for at least 30 minutes.
Croatian: Prije davanja bočicu DepoCytea treba ugrijati na sobnoj temperaturi (18 °C - 22 °C) barem 30 minuta.
English: DepoCyte contains cytarabine, and should be disposed of in a manner consistent with local requirements.
Croatian: DepoCyte sadrži citarabin i treba ga odlagati na način sukladan lokalnim propisima.
English: A review of the toxicological data available for the constituent lipids (DOPC and DPPG) or similar phospholipids to those in DepoCyte indicates that such lipids are well tolerated in various animal species even when administered for prolonged periods at doses in the g/kg range.
Croatian: Pregled dostupnih toksikoloških podataka o pomoćnim lipidnim tvarima (DOPC i DPPG) i fosfolipidima sličnima onima koje sadrži DepoCyte ukazuje da se takvi lipidi dobro podnose u raznim životinjskim vrstama, čak i kad se primjenjuju kroz duže vremensko razdoblje u dozama koje se mjere u g/kg.
English: Cytarabine, the active ingredient in DepoCyte, can cause foetal harm when administered systemically during pregnancy, mainly during the first trimester.
Croatian: Citarabin, djelatna tvar DepoCytea, može uzrokovati oštećenje ploda ako se primijeni sistemski tijekom trudnoće, poglavito u prvom tromjesečju.
English: Despite the low apparent risk women of childbearing potential should not receive treatment until pregnancy is excluded and should be advised to use a reliable contraceptive method.
Croatian: Unatoč prividno niskom riziku, u žena reproduktivne dobi ne bi se trebao primjenjivati ovaj lijek dok se ne isključi mogućnost postojanja trudnoće i trebala bi im se preporučiti učinkovita metoda kontracepcije.
English: Just before withdrawing DepoCyte, the vial should be gently inverted to mix the particles evenly.
Croatian: Neposredno prije navlačenja DepoCytea iz bočice, bočicu treba pažljivo preokrenuti kako bi se čestice suspenzije jednakomjerno raspršile.
English: <2D barcode carrying the unique identifier included.>
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Sadrži 2D barkod s jedinstvenim identifikatorom.> <Nije primjenjivo.>
English: DepoCyte must be used as supplied; it must not be diluted (see section 6.2).
Croatian: DepoCyte se mora primjenjivati u obliku u kojem je isporučen; ne smije se razrjeđivati (vidjeti dio 6.2).
English: Arachnoiditis is a syndrome manifested primarily by nausea, vomiting, headache and fever.
Croatian: Arahnoiditis je sindrom koji se prvenstveno manifestira mučninom, povraćanjem, glavoboljom i vrućicom.
English: Intracellularly, cytarabine is converted into cytarabine-5'-triphosphate (ara-CTP), which is the active metabolite.
Croatian: Intracelularno on se konvertira u citarabin-5'-trifosfat (araCTP), koji je njegov aktivni metabolit.
English: Since it is a single use vial and does not contain any preservative, the medicinal product should be used within 4 hours of withdrawal from the vial.
Croatian: Budući da se radi o jednokratnoj dozi koja ne sadrži konzervans, lijek se treba primijeniti unutar 4 sata od izvlačenja iz bočice.
English: The studies also demonstrated susceptibility of many solid tumour cell lines to cytarabine, particularly after longer periods of exposure to cytarabine.
Croatian: Ispitivanja su također pokazala osjetljivost mnogih staničnih linija solidnih tumora na citarabin, poglavito nakon dužeg vremena izloženosti citarabinu.
English: Τηλ: +44 (0) 1628 530554
Croatian: Ηνωμένο Βασίλειο Τηλ: +44 (0) 1628 530554