FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma accumulation of active substance was not apparent when mitoxantrone was administered either daily for five days or as a single dose every three weeks.
Croatian: Nakupljanje djelatne tvari u plazmi nije bilo očito kada se mitoksantron primijenio bilo dnevno tijekom pet dana ili kao jednokratna doza svaka tri tjedna.
English: Detailed information on this medicinal product is available on the website of {name of MS/Agency}
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici {naziv nadležnog tijela države članice/agencije}
English: Patients who receive immunosuppressive agents like mitoxantrone have a reduced immunological response to infection.
Croatian: Infekcije Bolesnici koji primaju imunosupresive poput mitoksantrona, imaju smanjeni imunološki odgovor na infekciju.
English: The medicinal product must also not be given by intrathecal injection.
Croatian: Ovaj lijek također se ne smije davati intratekalnom injekcijom.
English: It is recommended that frequent peripheral blood cell counts are performed on all patients receiving mitoxantrone in order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection.
Croatian: Preporučuje se često određivanje broja stanica u perifernoj krvi u svih bolesnika koji primaju mitoksantron kako bi se pratila pojava supresije koštane srži, prvenstveno neutropenije, koja može biti teška i rezultirati infekcijom.
English: - Hair loss.
Croatian: - Gubitak kose.
English: Haematological toxicity is difficult to evaluate in acute leukaemia because traditional parameters of bone marrow depression such as white blood cell and platelet counts are confounded by marrow replacement with leukemic cells.
Croatian: Hematološka toksičnost teško se procjenjuje u akutnoj leukemiji, jer su tradicionalni parametri depresije koštane srži poput broja bijelih krvnih stanica i krvnih pločica ometani (engl. confounded) nadomještanjem srži leukemijskim stanicama.
English: Fatal cases of Acute Myeloid Leukaemia (AML) have been reported (see section 4.4).
Croatian: Prijavljeni su smrtni slučajevi akutne mijeloične leukemije (AML) (vidjeti dio 4.4).
English: Amongst the 80 enrolled patients the median values for the lowest white blood cell count and platelet count were 400/μl (WHO grade 4), and 9.500/μl (WHO grade 4),
Croatian: Između 80 uključenih bolesnika vrijednosti medijana za najniže brojeve bijelih krvnih stanica i krvnih pločica iznosile su 400/μl (stupanj 4 prema SZO) odnosno 9 500/μl (stupanj 4 prema SZO).
English: The maximum lifetime cumulative dose should not exceed 72 mg/m2 (see section 5.1).
Croatian: Maksimalna doživotna kumulativna doza ne smije premašiti 72 mg/m2 (vidjeti dio 5.1).
English: Levels of uric acid, electrolytes and urea should be monitored.
Croatian: Potrebno je pratiti razine mokraćne kiseline, elektrolita i uree.
English: Discolouration of urine and other tissues
Croatian: Diskoloracija mokraće i drugih tkiva
English: Vaccinations and immunisation (protection against the vaccination substances) may not work during treatment with Novantrone and for three months after the end of treatment.
Croatian: Cijepljenja i imunizacije (zaštita protiv tvari u cjepivu) možda neće djelovati tijekom liječenja Novantronom i tijekom tri mjeseca nakon završetka liječenja.
English: Four patients receiving 140 to 180 mg/m2 as a single bolus injection died as a result of severe leukopenia with infection.
Croatian: Četvero bolesnika koji su primili 140 do 180 mg/m2 kao jednokratnu bolus injekciju preminuli su kao rezultat teške leukopenije s infekcijom.
English: The treatment must not be initiated in patients who have been previously treated with mitoxantrone.
Croatian: Liječenje se ne smije započeti u bolesnika koji su prethodno bili liječeni mitoksantronom.
English: Mitoxantrone causes myelosuppression as an extension of its pharmacological action.
Croatian: Mitoksantron uzrokuje mijelosupresiju kao proširenje njegova farmakološkog djelovanja.
English: Mitoxantrone is considered a potential human teratogen because of its mechanism of action and the developmental effects demonstrated by related agents.
Croatian: Mitoksantron se smatra potencijalnim teratogenom u ljudi zbog svog mehanizma djelovanja i učinaka na razvoj koje su pokazali slični lijekovi.
English: Novantrone prevents cancer cells from growing, as a result of which they eventually die.
Croatian: Novantrone sprječava rast stanica raka što u konačnici rezultira njihovom smrću.
English: The pathways leading to the metabolism of mitoxantrone have not been elucidated.
Croatian: Putovi koji dovode do metaboliziranja mitoksantrona nisu razjašnjeni.
English: Novantrone must not be used during pregnancy for treatment of multiple sclerosis (specifically in the first three months of the pregnancy).
Croatian: Novantrone se tijekom trudnoće ne smije primjenjivati za liječenje multiple skleroze (posebno u prvom tromjesečju trudnoće).
English: However, cardiotoxicity increases with cumulative doses.
Croatian: kardiotoksičnost se povećava s kumulativnim dozama.
English: Recovery ≤ 21 days
Croatian: Oporavak ≤ 21 dan
English: Carcinogenic effects were seen in rat and in male mice.
Croatian: Kancerogeni učinci vidjeli su se na štakorima i mužjacima miševa.
English: The recommended initial dosage of Novantrone is 14 mg/m2 of body surface area, given as a single intravenous dose, which may be repeated at 21-day intervals, if your blood values have returned to acceptable levels.
Croatian: Preporučeno početno doziranje Novantrona iznosi 14 mg/m2 površine tijela, a daje se kao jednokratna doza u venu, koja se može ponoviti u intervalima od 21 dana, ako su se Vaše krvne vrijednosti vratile na prihvatljive razine.
English: In cases of overdosage patients should be monitored closely.
Croatian: U slučaju predoziranja potrebno je strogo praćenje bolesnika.
English: In case of non-haematological toxicities WHO grade 2 to 3 the following dose should be adjusted to 10 mg/m2, in case of non-haematological toxicity grade 4 the treatment should be discontinued.
Croatian: U slučaju nehematoloških toksičnosti stupnja 2 do 3 prema SZO potrebno je prilagoditi sljedeću dozu na 10 mg/m², u slučaju nehematološke toksičnosti stupnja 4 potrebno je prekinuti liječenje.
English: Mitoxantrone is 78 % bound to plasma proteins.
Croatian: Za proteine u plazmi vezano je 78% mitoksantrona.
English: Medicines that can damage your heart (e.g. anthracyclines).
Croatian: - lijekovi koji mogu oštetiti Vaše srce (npr. antraciklini)
English: Mitoxantrone is genotoxic and is considered a potential human teratogen.
Croatian: Mitoksantron je genotoksičan te se smatra potencijalnim teratogenom za ljude.
English: If mitoxantrone is administered repeatedly, dosing adjustments should be guided by extent and duration of the reduction in the number of white and red blood cells as well as platelets in your blood.
Croatian: Ako se mitoksantron primjenjuje u više navrata, potrebno je prilagoditi doziranje prema opsegu i trajanju smanjenja broja bijelih i crvenih krvnih stanica kao i krvnih pločica u Vašoj krvi.
English: In the event of an incomplete antileukaemic response, a second induction course may be given with mitoxantrone given for 2 days and cytarabine for 5 days, using the same daily dosage levels.
Croatian: U slučaju nepotpunog antileukemijskog odgovora smije se primijeniti drugi postupak indukcije s mitoksantronom, danog tijekom2 dana i citarabinom tijekom 5 dana, primjenjujući iste razine dnevnih doziranja.
English: The pharmacokinetics of mitoxantrone in patients following single-dose intravenous administration can be characterised by a three-compartment model.
Croatian: Farmakokinetika mitoksantrona u bolesnika nakon intravenske primjene jednokratne doze može se karakterizirati kao model s tri odjeljka.
English: Novantrone has also been used in various combinations for non-Hodgkin's lymphoma; however, data are presently limited and specific regimens cannot be recommended.
Croatian: Novantrone se također primijenio u različitim kombinacijama za ne-Hodgkinov limfom; međutim, ti su podaci trenutno ograničeni te se specifični režimi ne mogu preporučiti.
English: Laboratory measurement cannot predict clearance of the active substance and dose adjustments (see section 5.2).
Croatian: Laboratorijska mjerenja ne mogu predvidjeti klirens djelatne tvari i prilagodbe doze (vidjeti dio 5.2).
English: Amenorrhoea*
Croatian: Amenoreja*
English: Elderly patient should receive doses at the low end of the dosing range due to possible reduced liver, kidney or heart function and of possible illness or treatment with other medicines.
Croatian: Stariji bolesnici trebaju primiti doze u nižem dijelu raspona doziranja zbog moguće smanjene funkcije jetre, bubrega ili srca te moguće bolesti ili liječenja drugim lijekovima.
English: Combining mitoxantrone with potentially cardiotoxic active substances (e.g. anthracyclines) increases the risk of cardiac toxicity.
Croatian: Kombiniranje mitoksantrona s potencijalno kardiotoksičnim djelatnim tvarima (npr. antraciklinima) povećava rizik kardiotoksičnosti.
English: Elevated aspartate aminotransferase levels
Croatian: Povišene razine aspartat aminotransferaze
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.Naročito je važno da spomenete svaki od sljedećih lijekova.
English: Myocardial toxicity, manifested in its most severe form by potentially irreversible and fatal congestive heart failure (CHF), may occur either during therapy with mitoxantrone or months to years after termination of therapy.
Croatian: Miokardijalna toksičnost koja se očituje u svojem najtežem obliku kao potencijalno ireverzibilno kongestivno zatajenje srca sa smrtnim ishodom može se pojaviti ili tijekom terapije mitoksantronom ili mjesecima do godinama nakon završetka terapije.
English: Decrease by 4 mg/m from prior dose, after recovery.
Croatian: Smanjiti za 4 mg/m od prijašnje doze, nakon oporavka.
English: Mitoxantrone also interferes with ribonucleic acid (RNA) and is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling and repairing damaged DNA.
Croatian: Mitoksantron također interferira s ribonukleinskom kiselinom (RNK) te je potentan inhibitor topoizomeraze II, enzima odgovornog za odmotavanje i popravak oštećene DNK.
English: To date, only isolated cases of severe local reactions (necroses) have been described due to extravasation.
Croatian: Dosad su opisani samo izolirani slučajevi teških lokalnih reakcija
English: Medicines that suppress your immune system (immunosuppressive agents).
Croatian: - lijekovi koji potiskuju imunološki sustav (imunosupresivni lijekovi)
English: - Abnormal number of white blood cells.
Croatian: - Abnormalan broj bijelih krvnih stanica.
English: Mitoxantrone is indicated for treatment of patients with highly active relapsing multiple sclerosis associated with rapidly evolving disability where no alternative therapeutic options exist (see sections 4.2, 4.4 and 5.1).
Croatian: Mitoksantron je indiciran za liječenje bolesnika s jako aktivnom relapsirajućom multiplom sklerozom povezanom s brzo razvijajućim invaliditetom kada ne postoje alternativne terapijske mogućnosti (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic medicinal products may increase the risk of cardiac toxicity.
Croatian: Aktivna ili latentna kardiovaskularna bolest, ranija ili istodobna radioterapija na medijastinalnom/perikardijalnom predjelu, prethodna terapija s drugim antraciklinima ili antracendionima ili istodobna primjena drugih kardiotoksičnih lijekova može povećati rizik od kardiotoksičnosti.
English: Severe local tissue damage may occur if there is extravasation during administration.
Croatian: Teška lokalna oštećenja tkiva mogu se pojaviti u slučaju ekstravazacije tijekom primjene.
English: The combination of mitoxantrone with other immunosuppressive agents may increase the risk of excessive immunodepression and lymphoproliferative syndrome.
Croatian: Kombinacija mitoksantrona s drugim imunosupresivnim lijekovima može povećati rizik od izražene imunodepresije i limfoproliferativnog sindroma.
English: Although patients with severe renal failure have not been studied, mitoxantrone is extensively tissue bound and it is unlikely that the therapeutic effect or toxicity would be mitigated by peritoneal or haemodialysis.
Croatian: Iako bolesnici s teškim zatajenjem bubrega nisu ispitavani, mitoksantron se opsežno veže za tkivo te nije vjerojatno da će se terapijski učinak ili toksičnost ublažiti peritonealnom dijalizom ili hemodijalizom.
English: - Tiredness, feeling weak and having no energy.
Croatian: - Umor, osjećaj slabosti i nedostatak energije.
English: Mitoxantrone is excreted slowly in urine and faeces as either unchanged active substance or as inactive metabolites.
Croatian: Mitoksantron se sporo izlučuje putem mokraće i fecesa bilo kao nepromijenjena djelatna tvar ili kao neaktivni metaboliti.
English: Mitoxantrone may cause a blue-green colouration to the urine for 24 hours after administration, and patients should be advised to expect this during therapy.
Croatian: Mitoksantron može uzrokovati plavo-zelenu diskoloraciju mokraće tijekom 24 sata nakon primjene, a bolesnike je potrebno uputiti da to očekuju tijekom terapije.
English: The most common side effects with mitoxantrone (seen in more than 1 patient in 10) are anaemia, leucopenia, neutropenia, infections, amenorrhoea, alopecia, nausea and vomiting.
Croatian: Najčešće nuspojave mitoksantrona (opažene u više od 1 na 10 bolesnika) su anemija, leukopenija, neutropenija, infekcije,
English: Antivitamin K, in particular if you are taking Novantrone because you have cancer.
Croatian: - antivitamin K, naročito ako uzimate
English: - Reduced activity of the bone marrow.
Croatian: - Smanjena aktivnost koštane srži.
English: Your doctor will do heart function tests before you start Novantrone and at regular intervals during therapy.
Croatian: Vaš će liječnik napraviti pretrage srčanih funkcija prije nego započnete terapiju Novantronom i u pravilnim vremanskim razmacima tijekom terapije.
English: If this medicine is used during pregnancy or if you become pregnant while taking this medicine, inform your doctor as there may be risks to the foetus.
Croatian: Ako se ovaj lijek primjenjuje tijekom trudnoće ili zatrudnite tijekom uzimanja lijeka, obavijestite svog liječnika, jer mogu postojati rizici za fetus.
English: Treatment with mitoxantrone 12 mg/m² administered every three months was superior to 5 mg/m² and placebo in one clinical study with highly active inflammatory active MS disease.
Croatian: Liječenje mitoksantronom 12 mg/m² primijenjenim svaka tri mjeseca bilo je superiorno naspram 5 mg/m² i placeba u jednom kliničkom ispitivanju s visoko aktivnom upalnom bolesti MS.
English: Anaphylaxis/anaphylactoid reactions (including shock)
Croatian: Anafilaksija/anafilaktička reakcija (uključujući šok)
English: Cardiac function for cancer patients should be carefully monitored during treatment.
Croatian: Tijekom liječenja potrebno je pažljivo pratiti funkciju srca u bolesnika oboljelih od raka.
English: - Heart attack.
Croatian: - Srčani udar.
English: In a pharmacokinetic study in children with de novo acute myeloid leukaemia, ciclosporin co-medication resulted in a 42% decreased clearance of mitoxantrone.
Croatian: U farmakokinetičkom ispitivanju u djece s de novo akutnom mijeloičnom leukemijom istodobna primjena ciklosporina rezultirala je 42%-tnim smanjenjem klirensa mitoksantrona.
English: This medicine might increase the risk for transitory or persistent absence of menstruation (amenorrhoea) in women of childbearing age.
Croatian: Ovaj lijek može povećati rizik od prolaznog ili trajnog izostanka menstruacije (amenoreja) u žena u reproduktivnoj dobi.
English: Novantrone might increase the risk for transient or persistent absence of menstruation (amenorrhoea) in women of childbearing age.
Croatian: Novantrone može povećati rizik od prolaznog ili trajnog izostanka menstruacije (amenoreja) u žena u reproduktivnoj dobi.
English: - Irregular heart beat or slowed heart beat.
Croatian: Nepravilni otkucaji srca ili usporeni otkucaji srca.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of the vial contains 2 mg mitoxantrone (as hydrochloride).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica od 1 ml sadrži 2 mg mitoksantrona (u obliku mitoksantronklorida).
English: Mitoxantrone was mutagenic and clastogenic in all in vitro test systems and in rats in vivo.
Croatian: Mitoksantron je bio mutagen i klastogen u svim in vitro testnim sustavima te u štakora in vivo.
English: Mitoxantrone in combination with corticosteroids improves pain control, and quality of life in patients with advanced castrate resistant prostate cancer, without any improvement in overall survival.
Croatian: Mitoksantron u kombiniranoj terapiji s kortikosteroidima poboljšava kontrolu boli i kvalitetu života u bolesnika s uznapredovalim rakom prostate rezistentnim na kastraciju bez poboljšanja u ukupnom preživljenju.
English: No teratogenic effects were observed in these studies, but the maximum doses tested were well below the recommended human dose (0.02 and 0.05 times in rats and rabbits, respectively, on an mg/m2
Croatian: Teratogeni učinci nisu se opazili u ovim ispitivanjima, ali maksimalne doze su bile znatno niže od preporučene doze u ljudi (0,02 odnosno 0,05 puta u štakora odnosno kunića na temelju mg/m2).
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju
English: (approximately 5 to 15 minutes) intravenous infusion that may be repeated every 1 to 3 months.
Croatian: (približno 5 do 15 minuta) infuzija u venu, koja se može ponoviti svakih 1 do 3 mjeseca.
English: These reports have included seizures leading to coma and severe neurologic sequelae, and paralysis with bowel and bladder dysfunction.
Croatian: Ovi izvještaji su uključivali napadaje koji dovode do kome i teške neurološke posljedice te paralizu s poremećenom funkcijom crijeva i mokraćnog mjehura.
English: There are very limited data on the use of mitoxantrone in pregnant women.
Croatian: Trudnoća Podaci o primjeni mitoksantrona u trudnica su vrlo ograničeni.
English: Mitoxantrone is indicated for the treatment of acute myeloid leukaemia (AML) in adults.
Croatian: Mitoksantron je indiciran za liječenje akutne mijeloične leukemije (AML) u odraslih.
English: Evaluation of the left-ventricular ejection fraction (LVEF) by echocardiogram or MUGA is recommended prior to administration of the initial dose of mitoxantrone and prior to each dose in multiple sclerosis patients and yearly for up to 5 years after the end of therapy.
Croatian: Procjena istisne frakcije lijeve klijetke (LVEF) pomoću ehokardiograma ili MUGA preporučuje se prije primjene početne doze mitoksantrona i prije svake doze u bolesnika oboljelih od multiple skleroze te svake godine u trajanju do 5 godina po završetku terapije.
English: Confusion and fatigue may occur following administration of mitoxantrone (see section 4.8).
Croatian: Konfuzija i umor mogu se javiti tijekom primjene mitoksantrona (vidjeti dio 4.8).
English: - Damage to the kidneys, causing swelling and weakness (nephropathy).
Croatian: - Oštećenje bubrega koje uzrokuje oticanje i slabost (nefropatija).
English: Mitoxantrone is contraindicated in women who are breast-feeding (see sections 4.4 and 4.6).
Croatian: Mitoksantron je kontraindiciran u žena koje doje (vidjeti dijelove 4.4 i 4.6).
English: Novantrone contains the active substance mitoxantrone.
Croatian: Novantrone sadrži djelatnu tvar mitoksantron.
English: Mitoxantrone has been demonstrated to be a substrate for the BCRP transporter protein in vitro.
Croatian: Pokazano je da je mitoksantron supstrat za prijenosni protein BCRP in vitro.
English: (approximately 5 to 15 minutes) intravenous infusion that may be repeated every 1-3 months.
Croatian: 5 do 15 minuta) intravenska infuzija, koja se može ponoviti svaka 1-3 mjeseca.
English: If you receive Novantrone to treat multiple sclerosis your doctor will test your heart function before the start of therapy, prior to each subsequent dose and yearly for up to 5 years after the end of therapy.
Croatian: Ako primate Novantrone za liječenje multiple skleroze, Vaš će liječnik ispitati srčanu funkciju prije započinjanja terapije, prije svake naknadne doze i svake godine tijekom
English: Date of first authorisation: {DD month YYYY} Date of latest renewal: {DD month YYYY} [To be completed nationally]
Croatian: Datum posljednje obnove odobrenja: {DD mjesec GGGG}
English: The fraction bound is independent of concentration and is not affected by the presence of phenytoin, doxorubicin, methotrexate, prednisone, prednisolone, heparin, or aspirin.
Croatian: Vezani udio je neovisan o koncentraciji i na njega ne utječe prisutnost fenitoina, doksorubicina, metotreksata, prednizona, prednizolona, heparina ili aspirina.
English: Cardiac toxicity with mitoxantrone may occur at lower cumulative doses whether or not cardiac risk factors are present.
Croatian: Kardiotoksičnost pri terapiji mitoksantronom može se pojaviti pri nižim kumulativnim dozama bez obzira jesu li prisutni rizični faktori za srce.
English: Mitoxantrone has also been used in various combinations for non-Hodgkin's lymphoma; however, data are presently limited and specific regimens cannot be recommended.
Croatian: Mitoksantron se također primijenio u različitim kombinacijama za ne-Hodgkinov limfom; međutim, podaci su trenutno ograničeni te se specifični režimi terapije ne mogu preporučiti.
English: Novantrone concentrate should be slowly injected into a free flowing intravenous infusion of isotonic saline or 5% glucose solution over a period of not less than 3 to 5 minutes.
Croatian: Novantrone koncentrat potrebno je sporo injicirati u intravensku infuziju slobodnog protoka izotonične otopine natrijevog klorida ili 5%-tne otopine glukoze tijekom razdoblja od najmanje 3 do 5 minuta.
English: Therapy with mitoxantrone should be accompanied by close and frequent monitoring of haematological and chemical laboratory parameters, as well as frequent patient observation.
Croatian: Nužno je da se tijekom terapije mitoksantronom provodi pažljivo i često praćenje hematoloških i kemijskih laboratorijski parametara kao i često motrenje bolesnika.
English: Tubular atrophy of the testes and decreased sperm counts were observed.
Croatian: Opaženi su tubularna atrofija testisa i smanjeni broj spermija.
English: Single doses ranged from 5 to 12 mg/m2, dose intervals from once per month to once per 3 months.
Croatian: Jednokratne doze kretale su se u rasponu od 5 do 12 mg/m2, dozni intervali od jednom na mjesec do jednom u 3 mjeseca.
English: Common (may affect up to 1 in 10 people) - Low number of red blood cells which can cause a feeling of tiredness and shortness of breath
Croatian: Često (može se javiti u do 1 na 10 osoba) - Nizak broj crvenih krvnih stanica koji može uzrokovati osjećaj umora i nedostatka zraka (anemija).
English: Mitoxantrone must not be given by intrathecal injection.
Croatian: Mitoksantron se ne smije davati intratekalnom injekcijom.
English: Myelosuppresion can be increased when it is used in combination chemotherapy with another myelosuppressive agent such as for treatment of breast cancer.
Croatian: Mijelosupresija se može povećati kada se lijek primjenjuje u kombiniranoj kemoterapiji s drugim mijelosupresivnim lijekom kao što se primjenjuju u liječenju raka dojke.
English: In human studies, only 10 % and 18 % of the dose were recovered in urine and faeces respectively as either active substance or metabolite during the 5-day period following administration of the medicinal product.
Croatian: U ispitivanjima u ljudi samo 10% odnosno 18% doze nađeno je u mokraći odnosno fecesu bilo kao djelatna tvar ili metabolit tijekom razdoblja od 5 dana nakon primjene lijeka.