FrancophonIA/ELRC3.0 huggingface dataset:
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform the medical staff looking after you.
Croatian: Ako primjetite bilo koju nuspojavu potrebno je obavijestiti liječnika ili druge zdravstvene djelatnike koji su uključeni u liječenje.
English: Package leaflet: Information for the user DepoCyte 50 mg suspension for injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA DepoCyte 50 mg suspenzija za injekciju citarabin
English: Tel: +34 91 3821870 infomed@mundipharma.es
Croatian: Mundipharma Pharmaceuticals, S.L. Tel: +34 91 3821870 infomed@mundipharma.es
English: Mundipharma Pharmaceuticals Srl Tel: + 39.02.318288216
Croatian: Mundipharma Pharmaceuticals Srl Tel: + 39.02. 318288216 Italy.InfoMedica@mundipharma.it
English: Organizační složka ČR
Croatian: KLINIČKI PODACI
English: Mundipharma Pharmaceuticals B.V. Tel: +31 (0) 33 450 8270 info@mundipharma.nl
Croatian: Tel: +31 (0) 33 450 8270 info@mundipharma.nl
English: Common: back pain, neck pain, neck stiffness Common: back pain, neck pain Uncommon: neck stiffness Common: back pain, neck pain, neck stiffness
Croatian: Često: bol u leđima, bol u vratu Manje često: zakočenost vrata
English: Common: deafness Common: deafness
Croatian: Manje često: meningizam
English: Common: impaired bowel control
Croatian: Često: poremećaj kontrole analnih sfinktera
English: INFORMATION IN BRAILLE
Croatian: Prijavljivanje nuspojava
English: Contents of the pack and other information What DepoCyte contains
Croatian: Što DepoCyte sadrži
English: VIAL LABEL
Croatian: OZNAČAVANJE
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Croatian: DODATAK III OZNAČAVANJE I UPUTA O LIJEKU
English: • Fatigue
Croatian: • Omaglica
English: Tel : +420 222 318 221 office@mundipharma.cz
Croatian: Česká republika Mundipharma Ges.m.b.H. Austria Organizační složka ČR Tel : +420 222 318 221 office@mundipharma.cz
English: Concomitant administration of DepoCyte with other antineoplastic agents administered by the intrathecal route has not been studied.
Croatian: Nisu provedena ispitivanja istovremene intratekalne primjene DepoCytea i drugih antineoplastičkih lijekova.
English: • if you have an active infection.
Croatian: • ako imate aktivnu infekciju.
English: Some of these side effects may be serious.
Croatian: Neke od tih nuspojava mogu biti ozbiljne.
English: • allergic reaction
Croatian: • alergijska reakcija
English: Additionally, the side effects that happened more often in adolescents and children include:
Croatian: Dodatno, nuspojave koje su se češće dogodile u adolescenata i djece uključuju:
English: Do not try to restart your pump.
Croatian: Ne pokušavajte ponovno upaliti svoju pumpu.
English: (see section 5.1).
Croatian: (vidjeti dio 5.1).
English: Currently available data in children are described in section 4.8 and 5.1.
Croatian: Trenutno dostupni podaci u djece opisani su u dijelu 4.8 i 5.1.
English: BSA = body surface area
Croatian: BSA = površina tijela
English: • if you think you may need any vaccinations in the near future, including those needed to travel to other countries.
Croatian: • ako mislite da biste u bliskoj budućnosti mogli trebati bilo kakvo cijepljenje, uključujući i cjepiva potrebna za putovanje u druge zemlje.
English: • Do not open the package.
Croatian: • Ne otvarajte pakiranje.
English: You may also be given medicines to reduce fever.
Croatian: Možda ćete dobiti i lijekove za sniženje vrućice.
English: BLINCYTO may not be suitable for you:
Croatian: BLINCYTO možda nije primjeren za Vas:
English: There are no data for children < 7 months of age.
Croatian: Nema podataka za djecu u dobi < 7 mjeseci.
English: You will then have a 2-week break where you will not be given the infusion.
Croatian: Nakon toga ćete imati period prekida od 2 tjedna, u kojem nećete dobivati infuziju.
English: See table 6 for the efficacy results.
Croatian: Vidjeti tablicu 6 za rezultate djelotvornosti.
English: These supplies are also required, but not included in the package
Croatian: Ovaj pribor je također potreban, ali nije uključen u pakiranje
English: N = total number of patients in the specified subgroup.
Croatian: N = ukupni broj bolesnika u specificiranoj podskupini.
English: Treatment may include a bag change by a nurse.
Croatian: Liječenje može uključivati promjenu vrećice od strane medicinske sestre.
English: b MedDRA high level group terms (MedDRA version 18.1).
Croatian: b MedDRA HLGT klasifikacija (od eng. high level group terms) (MedDRA verzija 18.1).
English: This is particularly important when using an ambulatory infusion pump.
Croatian: Ovo je posebno važno kada se koristi ambulantna infuzijska pumpa.
English: Because the health-related quality of life results are based on a post-hoc sensitivity analysis, the results should be interpreted with caution.
Croatian: Budući da se rezultati kvalitete života uvjetovane zdravljem temelje na post-hoc analizi osjetljivosti, rezultati bi se trebali tumačiti s oprezom.
English: Elastomeric pumps should not be used.
Croatian: Elastomerne pumpe se ne smiju koristiti.
English: 6.1 months
Croatian: 6,1 mjeseci
English: The infusion rate may be faster or slower depending on how often the bag is changed.
Croatian: Brzina infuzije može biti brža ili sporija ovisno o tome koliko se često mijenja vrećica.
English: Additional information is provided in “Description of selected adverse reactions”.
Croatian: Dodatne informacije nalaze se u dijelu „Opis odabranih nuspojava”.
English: There is a possibility of a higher risk of neurologic events in this population.
Croatian: Postoji mogućnost većeg rizika od neuroloških događaja u ovoj populaciji.
English: If you are still suffering from active neurological problems or conditions, tell your doctor.
Croatian: Ako i dalje patite od aktivnih neuroloških problema ili stanja, obavijestite svog liječnika.
English: Below lower limit of quantification Unknown
Croatian: Ispod donje granice kvantifikacije
English: Your doctor will discuss with you if you can continue treatment at home after your initial hospital stay.
Croatian: Vaš liječnik će s Vama raspraviti možete li nastaviti liječenje kod kuće nakon početnog boravka u bolnici.
English: Aseptic preparation
Croatian: Aseptička priprema
English: The clinical significance of these imaging changes is unknown.
Croatian: Klinička značajnost ovih promjena u nalazima nije poznata.
English: based on local site evaluations.
Croatian: na temelju procjene lokalnih laboratorija.
English: BLINCYTO should not be used in children below 1 year of age.
Croatian: BLINCYTO se ne smije primjenjivati u djece mlađe od 1 godine.
English: These changes reversed after cessation of treatment.
Croatian: Ove promjene bile su reverzibilne nakon prekida liječenja.
English: If you have a catheter for infusion, it is very important to keep the area around the catheter clean; otherwise you could get an infection.
Croatian: Ako imate kateter za infuziju, vrlo je važno održavati područje oko katetera čistim; u suprotnom ćete dobiti infekciju.
English: Talk to your doctor or nurse about suitable methods of contraception.
Croatian: Razgovarajte sa svojim liječnikom ili medicinskom sestrom o odgovarajućim metodama kontracepcije.
English: Your doctor will determine when your BLINCYTO infusion bag will be changed, which may range from every day to every 4 days.
Croatian: Vaš liječnik će odrediti kada će se mijenjati Vaša BLINCYTO infuzijska vrećica, što može biti u rasponu od svakog dana do svaka 4 dana.
English: Do not adjust the settings on the pump, even if there is a problem or the pump alarm sounds.
Croatian: Ne mijenjajte postavke na pumpi, čak i ako postoji problem ili se upali alarm na pumpi.
English: Headache Tremor
Croatian: Glavobolja Tremor
English: If you respond to this treatment, your doctor may decide to give you up to 3 additional cycles of treatment.
Croatian: Ako odgovorite na ovo liječenje, Vaš liječnik može odlučiti primijeniti do najviše 3 dodatna ciklusa liječenja.
English: Dose adjustment was possible in case of adverse events.
Croatian: Prilagodba doze bila je moguća u slučaju štetnih događaja.
English: • increased bilirubin in the blood
Croatian: • povišen bilirubin u krvi
English: • high levels of some enzymes including blood enzymes
Croatian: • visoke razine nekih enzima, uključujući krvne enzime
English: High-dose steroid therapy may have contributed, in some cases, to the pancreatitis.
Croatian: Terapija visokim dozama steroida je, u nekim slučajevima, mogla doprinijeti pankreatitisu.
English: Number of subjects at Risk
Croatian: Broj ispitanika izloženih riziku
English: Final interpretation of MRD results followed EuroMRD Consortium guidelines.
Croatian: Konačno tumačenje rezultata MRB bilo je u skladu sa smjernicama konzorcija EuroMRD.
English: Other instructions
Croatian: Druge upute
English: Body surface area, gender and age
Croatian: Površina tijela, spol i dob
English: Pancreatitis a
Croatian: Pankreatitis a
English: From a microbiological point of view, unless the method of reconstituting precludes the risks of microbial contamination, the reconstituted solution should be diluted immediately.
Croatian: S mikrobiološkog gledišta, osim ako metoda rekonstitucije ne otklanja rizik mikrobiološke kontaminacije, rekonstituirana otopina treba se odmah razrijediti.
English: 5 years (2°C - 8°C)
Croatian: 5 godina (2°C - 8°C).
English: This medicine works by enabling your immune system to attack and destroy these abnormal white blood cancer cells.
Croatian: Ovaj lijek djeluje tako što omogućuje Vašem imunološkom sustavu da napada i uništava te abnormalne tumorske bijele krvne stanice.
English: • increased levels of liver enzymes (ALT, AST, GGT)
Croatian: • povišene razine jetrenih enzima (ALT, AST, GGT)
English: The type and frequency of adverse events were similar across different paediatric sub-groups (gender, age, geographic region).
Croatian: Vrsta i učestalost štetnih događaja bile su slične u različitim pedijatrijskim pod-skupinama (spol, dob, geografska regija).
English: (stabiliser).
Croatian: (stabilizatorom).
English: Other medicines and BLINCYTO
Croatian: Drugi lijekovi i BLINCYTO
English: The mean (SD) half-life was 2.11 (1.42) hours.
Croatian: Srednja vrijednost (SD) poluvijeka bila je 2,11 (1,42) sati.
English: You should not use BLINCYTO during pregnancy, unless your doctor thinks that it is the best medicine for you.
Croatian: Ne smijete primjenjivati BLINCYTO tijekom trudnoće, osim ako Vaš liječnik ne smatra da je to najbolji lijek za Vas.
English: Date of first authorisation: 23 November 2015 Date of last renewal: 19 April 2018
Croatian: Datum posljednje obnove odobrenja: 19. travnja 2018.
English: Kaplan-Meier curve of overall survival
Croatian: Slika 1. Kaplan-Meierova krivulja ukupnog preživljenja
English: The median time to onset was 7.5 days.
Croatian: Medijan vremena do nastupa bio je 7,5 dana.
English: Leukoencephalopathy including progressive multifocal leukoencephalopathy
Croatian: Leukoencefalopatija, uključujući progresivnu multifokalnu leukoencefalopatiju
English: ≥50% to <75%
Croatian: ≥50% do <75% ≥75% do <90%
English: In the event of overdose, the infusion should be temporarily interrupted and patients should be monitored.
Croatian: U slučaju predoziranja, infuziju treba privremeno obustaviti, a bolesnika treba pratiti.
English: Your doctor or nurse will monitor you for signs and symptoms of these reactions.
Croatian: Vaš liječnik ili medicinska sestra će Vas pratiti radi znakova i simptoma ovih reakcija.
English: From a microbiological point of view, the prepared infusion bags should be used immediately.
Croatian: S mikrobiološkog gledišta, pripremljene infuzijske vrećice trebaju se odmah primijeniti.
English: The safety and efficacy of BLINCYTO in children < 1 year of age have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka BLINCYTO u djece u dobi < 1 godine nisu još ustanovljene.
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 izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Medication errors
Croatian: Medikacijske pogreške
English: • confusion, disorientation
Croatian: • smetenost, dezorijentacija
English: * Centrally assessed in an assay with minimum sensitivity of 10-4
Croatian: * Centralno procijenjeno u testu uz minimalnu osjetljivost od 10
English: For all subsequent cycle starts and reinitiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalisation is recommended.
Croatian: Prilikom početka svakog sljedećeg ciklusa i ponovnog započinjanja liječenja (npr. ako se liječenje privremeno prekine na 4 ili više sati) preporučuje se nadzor od strane zdravstvenog radnika ili hospitalizacija.
English: Generally, safety was similar between elderly patients (≥ 65 years of age) and patients less than 65 years of age treated with BLINCYTO.
Croatian: Općenito, sigurnost je bila slična između starijih bolesnika (≥ 65 godina) i bolesnika mlađih od 65 godina liječenih lijekom BLINCYTO.
English: Change of infusion bag
Croatian: Promjena infuzijske vrećice
English: Survival Probability
Croatian: Vjerojatnost preživljenja
English: Therefore, the potential benefit and risks associated with continued therapy in patients who do not show haematological and/or clinical improvement after 1 treatment cycle should be assessed by the treating physician.
Croatian: Stoga potencijalnu korist i rizike povezane s nastavkom terapije u bolesnika koji ne pokažu hematološko i/ili kliničko poboljšanje nakon 1 ciklusa liječenja treba procijeniti nadležni liječnik.
English: The demographics and baseline characteristics were well-balanced between the two arms (see table 1).
Croatian: Demografske i početne karakteristike bile su ujednačene između dviju skupina (vidjeti tablicu 1).
English: • Water for injections
Croatian: • Voda za injekcije
English: Neurologic events including events with a fatal outcome have been observed.
Croatian: Opaženi su neurološki događaji, uključujući i događaje sa smrtnim ishodom.
English: Always use this medicine exactly as your doctor, pharmacist or nurse have told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik, ljekarnik ili medicinska sestra.
English: Your doctor will assess your nervous system and conduct tests before deciding if you should receive BLINCYTO.
Croatian: Vaš će liječnik procijeniti Vaš živčani sustav i provesti pretrage prije nego se odluči trebate li primiti BLINCYTO.
English: Contact your doctor or nurse immediately if:
Croatian: Odmah kontaktirajte svog liječnika ili medicinsku sestru ako:
English: - When refrigerated, the infusion bags must be used within 10 days of preparation.
Croatian: - Kada se čuvaju u hladnjaku, infuzijske vrećice moraju se primijeniti unutar 10 dana od pripreme.
English: Complete remission (CR)
Croatian: Potpuna remisija (CR)
English: The infusion reactions were generally rapid, occurring within 48 hours after initiating infusion.
Croatian: Reakcije povezane s infuzijom općenito su bile brze, pojavljujući se unutar 48 sati nakon započinjanja infuzije.
English: Your first cycle
Croatian: Vaš prvi ciklus
English: • there is a problem with the pump or the pump alarm sounds
Croatian: • postoji problem s pumpom ili se upali alarm na pumpi
English: Clinical testing of MRD, regardless of the choice of technique, should be performed by a qualified laboratory familiar with the technique, following well established technical guidelines.
Croatian: Kliničko ispitivanje MRB-a, bez obzira na tehniku, treba obaviti kvalificirani laboratorij koji je upoznat s tehnikom, prateći dobro utvrđene tehničke smjernice.
English: The majority of patients who respond to blinatumomab achieve a response after 1 cycle (see section 5.1).
Croatian: Većina bolesnika koji reagiraju na blinatumomab postižu odgovor nakon 1 ciklusa (vidjeti dio 5.1).
English: The dose of the concomitant medicinal product should be adjusted as needed.
Croatian: Dozu istodobno primjenjivanog lijeka treba prilagoditi prema potrebi.
English: Less than 45 kg (BSA-based dose)
Croatian: Manja od 45 kg (doza se temelji na BSA)
English: If not diluted immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se ne razrijedi odmah, vrijeme i uvjeti čuvanja pripremljene otopine odgovornost su korisnika.
English: Health related quality of life
Croatian: Kvaliteta života uvjetovana zdravljem
English: Neurologic events
Croatian: Neurološki događaji
English: • Management of neurotoxicity (including dose adjustment and dose interruption)
Croatian: • Zbrinjavanje neurotoksičnosti (uključujući prilagodbu doze i privremeni prekid doziranja).
English: Your doctor or nurse will advise you on how to manage your daily activities around your infusion pump.
Croatian: Vaš liječnik ili medicinska sestra će Vas savjetovati o tome kako da obavljate svoje svakodnevne aktivnosti uz svoju infuzijsku pumpu.
English: If you are pregnant, are breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili medicinskoj sestri za savjet prije nego uzmete ovaj lijek.
English: Store and transport refrigerated.
Croatian: Čuvati i prevoziti u hladnjaku.
English: Special instructions to support accurate preparation
Croatian: Posebne upute za pravilnu pripremu
English: Due to the potential for progressive multifocal leukoencephalopathy (PML), patients should be monitored for signs and symptoms.
Croatian: Zbog mogućnosti razvoja progresivne multifokalne leukoencefalopatije (PML), bolesnike treba pratiti radi znakova i simptoma.
English: * The study protocol needs to be developed and presented for PRAC review within 2 months after the EU Commission Decision.
Croatian: * Protokol ispitivanja mora se izraditi i predstaviti na pregled PRAC-u unutar 2 mjeseca nakon odluke EU komisije.
English: Before your treatment with BLINCYTO, you will be given other medicines (pre-medication) to help reduce infusion reactions and other possible side effects.
Croatian: Prije Vašeg liječenja lijekom BLINCYTO, dobit ćete druge lijekove (premedikacija) koji će pomoći u smanjenju reakcija na infuziju i drugih mogućih nuspojava.
English: Your doctor will check if you should have the vaccination.
Croatian: Vaš liječnik će provjeriti jeste li trebali biti cijepljeni.
English: The type of adverse events observed in infants were similar to those observed in the overall paediatric population.
Croatian: Vrste štetnih događaja opažene u dojenčadi bile su slične onima opaženim u sveukupnoj pedijatrijskoj populaciji.
English: Patients received up to 4 cycles of treatment.
Croatian: Bolesnici su primili do 4 ciklusa liječenja.
English: What BLINCYTO is and what it is used for
Croatian: Što je BLINCYTO i za što se koristi
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 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijene odmah, vrijeme i uvjeti čuvanja pripremljenih vrećica prije primjene odgovornost su korisnika i ne smiju, u normalnim uvjetima, biti dulji od 24 sata na temperaturi od 2°C - 8°C, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: Subgroup
Croatian: Podskupina
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates 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) predviđenim člankom 107. c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenim na europskom internetskom portalu za lijekove.
English: • When preparing an infusion bag, remove all air from infusion bag.
Croatian: • Prilikom pripreme infuzijske vrećice, uklonite sav zrak iz infuzijske vrećice.
English: Refractory status - n (%)
Croatian: Refraktorni status - n (%)
English: A population pharmacokinetic analysis was performed to evaluate the effects of demographic characteristics on blinatumomab pharmacokinetics.
Croatian: Provedena je populacijska analiza farmakokinetike kako bi se procijenili učinci demografskih karakteristika na farmakokinetiku blinatumomaba.
English: • Pump specifications: The infusion pump to administer BLINCYTO solution for infusion should be programmable, lockable and have an alarm.
Croatian: • Specifikacije pumpe: infuzijska pumpa za primjenu BLINCYTO otopine za infuziju treba imati mogućnost programiranja, zaključavanja i mora imati alarm.
English: • Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: • Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: If your leukaemia has spread to your brain and/or spinal cord, your doctor may have to treat this first before you can start treatment with BLINCYTO.
Croatian: Ako se Vaša leukemija proširila na Vaš mozak i/ili leđnu moždinu, Vaš liječnik će možda morati liječiti to stanje prije nego što ćete moći započeti liječenje lijekom BLINCYTO.
English: Excipients with known effect
Croatian: Pomoćne tvari s poznatim učinkom
English: Blinatumomab should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
Croatian: Blinatumomab se ne smije primjenjivati u trudnoći, osim ako potencijalna korist nadilazi potencijalan rizik za fetus.
English: * The study protocol needs to be developed and presented for PRAC review within 3 months after the EU Commission Decision.
Croatian: * Protokol ispitivanja mora se izraditi i predstaviti na pregled PRAC-u unutar 3 mjeseca nakon odluke EU komisije.
English: Prior to launch of BLINCYTO in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka BLINCYTO u promet u svakoj državi članici, nositelj odobrenja mora dogovoriti s Nacionalnim nadležnim tijelom sadržaj i format edukacijskog programa, uključujući komunikacijske medije, načine distribucije i sve ostale aspekte programa.
English: BLINCYTO infusion bags should be prepared to infuse over 24 hours, 48 hours, 72 hours, or 96 hours.
Croatian: Infuzijske vrećice lijeka BLINCYTO trebaju se pripremiti za infuziju u trajanju od 24 sata, 48 sati, 72 sata ili 96 sati.
English: - Do not freeze.
Croatian: - Ne zamrzavati.
English: Do not use BLINCYTO: - if you are allergic to blinatumomab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati BLINCYTO: - ako ste alergični na blinatumomab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako dojite.
English: Caution should be exercised as cases of late occurrence of first neurological events have been observed.
Croatian: Potreban je oprez jer su opaženi slučajevi kasne pojave prvih neuroloških događaja.
English: Common (≥ 1/100 to < 1/10)
Croatian: Često (≥ 1/100 do < 1/10)
English: Body surface area (0.37 to 2.70 m2) influences the pharmacokinetics of blinatumomab.
Croatian: Površina tijela (0,37 do 2,70 m2) utječe na farmakokinetiku blinatumomaba.