FrancophonIA/ELRC3.0 huggingface dataset:
English: Mitoxantrone alone or in combination with other cytostatic medicinal products shows objective response in patients with several types of NHL.
Croatian: Mitoksantron u monoterapiji ili u kombinaciji s drugim citostatskim lijekovima pokazuje objektivan odgovor u bolesnika s nekoliko tipova NHL-a.
English: A lower initial dosage (12 mg/m2 or less) is recommended in patients with low bone marrow reserves e.g. due to prior chemotherapy or poor general condition.
Croatian: Niže početno doziranje (12 mg/m2 ili manje) preporučuje se u bolesnika s niskim rezervama koštane srži, npr. zbog prijašnje kemoterapije ili slabog općeg stanja.
English: If severe or life-threatening non haematological toxicity is observed during the first induction course, the second induction course shouldbe withheld until toxicity resolves.
Croatian: Ako se tijekom prvog postupka indukcije uoči teška ili po život opasna hematološka toksičnost, potrebno je obustaviti drugi postupak indukcije dok se ne razriješi toksičnost.
English: - Bleeding in your stomach or bowels, this may include blood in vomit, bleeding when emptying the bowels or black tarry stool.
Croatian: - Krvarenje u želucu ili crijevima, to može uključivati povraćanje krvi, krvarenje pri pražnjenju crijeva ili crnu stolicu.
English: Men must use an effective method of contraception during the treatment and for at least 6 months after discontinuing the treatment.
Croatian: Muškarci moraju primjenjivati učinkovitu metodu kontracepcije tijekom liječenja i najmanje 6 mjeseci nakon prekida liječenja.
English: ** The casual relationship to mitoxantrone administration is uncertain.
Croatian: ** Uzročna povezanost s primjenom mitoksantrona nije sigurna.
English: Blood and lymphatic system disorders Very common
Croatian: Poremećaji krvi i limfnog sustava Vrlo često
English: Vaccinations and immunisations may not work during treatment with Novantrone and for 3 months after the end of treatment; if you are pregnant or if you and your partner are trying to become pregnant; if you are breast-feeding.
Croatian: - ako planirate cijepljenje ili imunizaciju tijekom liječenja; Cijepljenja i imunizacije možda neće djelovati tijekom liječenja Novantronom i tijekom 3 mjeseca nakon završetka liječenja; - ako ste trudni ili Vi i Vaš partner radite na trudnoći;
English: Mitoxantrone in combination with cytarabine as initial induction treatment is at least as effective for inducing remission as daunorubicin combinations in adult patients with previously untreated AML.
Croatian: Mitoksantron u kombiniranoj terapiji s citarabinom kao početnim indukcijskim liječenjem učinkovit je u induciranju remisije barem kao i kombinacije s daunorubicinom u odraslih bolesnika s prethodno neliječenim AML-om.
English: The most serious side effects are damage to the heart (myocardial toxicity) and myelosuppression (reduced activity of the bone marrow).
Croatian: Najozbiljnije nuspojave su oštećenje srca (miokardijalna toksičnost) i mijelosupresija (smanjena aktivnost koštane srži).
English: Myelosuppression can be more pronounced and longer-lasting in patients who have previously received chemotherapy or radiotherapy.
Croatian: Mijelosupresija može biti izraženija i dugotrajnija u bolesnika koji su prethodno primili kemoterapiju ili radioterapiju.
English: Functional cardiac changes may occur in patients with multiple sclerosis treated with mitoxantrone.
Croatian: Funkcijske promjene srca mogu se pojaviti u bolesnika s multiplom sklerozom koji se liječe mitoksantronom.
English: Myelosuppression may be more severe and prolonged in patients with poor general condition, or prior chemotherapy and/or radiotherapy.
Croatian: Mijelosupresija može biti teška i prolongirana u bolesnika s lošim općim stanjem ili prije kemoterapije i/ili radioterapije.
English: Mitoxantrone is active when given alone or in combination with other anticancer agents or corticosteroids.
Croatian: Mitoksantron je aktivan kada se daje u monoterapiji ili u kombinaciji s drugim lijekovima protiv raka ili kortikosteroidima.
English: The maximum lifetime cumulative dose should not exceed 72 mg/m2.
Croatian: Maksimalna doživotna kumulativna doza ne bi smjela premašiti 72 mg/m2.
English: Mitoxantrone is indicated in combination with corticosteroids for palliation (e.g. pain relief) related to advanced castrate resistant prostate cancer.
Croatian: Mitoksantron je indiciran u kombiniranoj terapiji s kortikosteroidima za palijaciju (npr. ublažavanje boli) povezanu s uznapredovalim rakom prostate rezistentnim na kastraciju.
English: Bluish discolouration of the sclera, skin and nails may also occur.
Croatian: Također se može pojaviti plavkasta diskoloracija bjeloočnice, kože i noktiju.
English: As a guide, when Novantrone is used in combination chemotherapy, the initial dose of Novantrone should be reduced by 2-4 mg/m2 below the doses recommended when Novantrone is used alone.
Croatian: Kao smjernica, kada se Novantrone primjenjuje u kombiniranoj kemoterapiji, potrebno je smanjiti početnu dozu Novantrona za 2-4 mg/m2 ispod doza preporučenih za primjenu Novantrona samostalno.
English: Method of administration Novantrone concentrate should be given by intravenous infusion only.
Croatian: Novantrone koncentrat je potrebno davati samo intravenskom infuzijom.
English: Extravasation can result in tissue necrosis with resultant need for debridement and skin grafting.
Croatian: Ekstravazacija može rezultirati nekrozom tkiva s rezultirajućom potrebom za debridmanom i presađivanjem kože.
English: If this medicinal product is used during pregnancy or if the patient becomes pregnant while taking mitoxantrone, the patient should be informed of the potential risk to the foetus and genetic counselling should be provided.
Croatian: Ako se lijek primjenjuje tijekom trudnoće ili ako bolesnica zatrudni tijekom uzimanja mitoksantrona, bolesnicu je potrebno informirati o potencijalnom riziku za fetus te joj omogućiti genetičko savjetovanje.
English: The most serious side effects with mitoxantrone are myocardial toxicity and myelosuppression.
Croatian: Najozbiljnije nuspojave mitoksantrona su miokardijalna toksičnost i mijelosupresija.
English: - Low level of platelets - which may cause bleeding or bruising.
Croatian: - Niska razina krvnih pločica - može uzrokovati krvarenje ili nastanak modrica.
English: Therefore, live virus vaccines should not be administered during therapy.
Croatian: Stoga se tijekom terapije ne smiju primjenjivati cjepiva sa živim virusom.
English: Paediatric population Safety and efficacy in paediatric patients have not been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost u pedijatrijskih bolesnika nije ustanovljena.
English: Mitoxantrone may cause a blue-green colouration to the urine for 24 hours after administration.
Croatian: Mitoksantron može uzrokovati promjenu boje mokraće u plavo-zelenu tijekom 24 sata nakon primjene.
English: Acute congestive heart failure may occasionally occur in patients treated with mitoxantrone for acute myeloid leukaemia.
Croatian: Akutno kongestivno zatajenje srca može se povremeno pojaviti u bolesnika liječenih mitoksantronom protiv akutne mijeloične leukemije.
English: Hence, patients with multiple sclerosis should not receive a lifetime cumulative dose greater than 72 mg/m².
Croatian: Stoga, bolesnici s multiplom sklerozom ne smiju primiti doživotnu kumulativnu dozu veću od 72 mg/m².
English: - Fever.
Croatian: - Vrućica.
English: - Leakage of fluid into surrounding tissue (extravasation):
Croatian: - Istjecanje tekućine u okolno tkivo (ekstravazacija):
English: - Nail abnormalities (e.g. detachment of the nail fro the nail bed, changes in nail texture and structure).
Croatian: - Abnormalnosti noktiju (npr. odvajanje nokta od podloge, promjene u teksturi i strukturi nokta).
English: Weight fluctuations * Acute T and B lymphoblastic leukaemia and non-Hodgkin lymphomas (NHL) are most commonly associated with TLS
Croatian: * Akutna T i B limfoblastična leukemija i ne-Hodgkinovi limfomi (NHL) najčešće su povezani sa sindromom lize tumora.
English: Mitoxantrone, a synthetic anthracenedione derivative, is an established cytotoxic, antineoplastic agent.
Croatian: Mitoksantron, sintetski derivat antracendiona, ustanovljen je citotoksični, antineoplastični lijek.
English: Treatment with mitoxantrone 12 to 14 mg/m² was effective in the treatment of various cancers.
Croatian: Klinička djelotvornost i sigurnost Liječenje mitoksantronom 12 do 14 mg/m² bilo je učinkovito u liječenju različitih rakova.
English: In a clinical trial with acute leukaemia patients, significant myelosuppression occurred in all patients who were given mitoxantrone therapy.
Croatian: U kliničkom ispitivanju bolesnika s akutnom leukemijom pojavila se značajna mijelosupresija u svih bolesnika kojima je dana terapija mitoksantronom.
English: In comparative oncology trials, the overall cumulative probability rate of moderate or severe decreases in LVEF at this dose was 13%.
Croatian: komparativnim onkološkim ispitivanjima ukupna kumulativna stopa vjerojatnosti za umjerena do teška smanjenja istisne frakcije lijeve klijetke (eng. left-ventricular ejection fraction, LVEF) pri ovoj dozi iznosila je 13%.
English: Mitoxantrone is excreted in breast-milk and has been detected in breast-milk for up to one month after the last administration.
Croatian: Dojenje Mitoksantron se izlučuje u mlijeko i detektiran je u izdojenom mlijeku u razdoblju do jednog mjesecu nakon posljednje primjene.
English: Mitoxantrone in combination regimens is indicated in the remission-induction treatment of blast crisis in chronic myeloid leukaemia.
Croatian: Mitoksantron u kombiniranim režimima terapije je indiciran za indukciju remisije u liječenju blastične krize kod kronične mijeloične leukemije.
English: Because of the risk of development of secondary malignancies, the benefit-to-risk ratio of mitoxantrone therapy should be determined before starting therapy.
Croatian: Zbog rizika od razvoja sekundarnih zloćudnih bolesti potrebno je prije započinjanja terapije odrediti omjer koristi i rizika za terapiju mitoksantronom.
English: Rare (may affect up to 1 in 1,000 people) None.
Croatian: Rijetko (može se javiti u do 1 na 1000 osoba) Nema.
English: In general, dose selection for an elderly patient should be initiated at the low end of the dosing range, reflecting the greater frequency of decreasing hepatic, renal, or cardiac function, and of concomitant disease or treatment with other medicinal products.
Croatian: Općenito, u starijeg bolesnika potrebno je započeti s dozom u nižem dijelu raspona doziranja, odražavajući veću učestalost smanjene funkcije jetre, bubrega i srca, te istodobne bolesti ili liječenja drugim lijekovima.
English: Safety and efficacy in paediatric patients have not been established.
Croatian: Sigurnost i djelotvornost u pedijatrijskih bolesnika nije ustanovljena.
English: It is advised to use live virus vaccines with caution after stopping chemotherapy, and vaccinate not sooner than 3 months after the last dose of chemotherapy (see section
Croatian: Preporučuje se oprezna primjena cjepiva sa živim virusom nakon prekida kemoterapije i cijepljenje tek 3 mjeseca nakon posljednje doze kemoterapije (vidjeti dio 4.5).
English: Anaemia Neutropenia Leukopenia
Croatian: Anemija Neutropenija Leukopenija
English: - Abnormal results of blood tests to check liver function (raised aspartate aminotransferase levels).
Croatian: - Abnormalni rezultati krvnih pretraga za provjeru jetrene funkcije (povećane razine aspartat aminotransferaze).
English: Because of the possible danger of cardiac effects in patients previously treated with daunorubicin or doxorubicin, the benefit-to-risk ratio of mitoxantrone therapy in such patients should be determined before starting therapy.
Croatian: Zbog moguće opasnosti od učinaka na srce u bolesnika koji su prethodno liječeni daunorubicinom ili doksorubicinom, potrebno je prije započinjanja terapije odrediti omjer koristi i rizika za terapiju mitoksantronom u takvih bolesnika.
English: - Metabolic disturbances (tumour lysis syndrome).
Croatian: - Metabolički poremećaji (sindrom lize tumora).
English: Very Common (may affect more than 1 in 10 people)
Croatian: Vrlo često (može se javiti u više od 1 na 10 osoba)
English: Decrease by 2 mg/m2 from prior dose, after recovery.
Croatian: Smanjiti za 2 mg/m od prijašnje doze, nakon oporavka.
English: Mitoxantrone administered at any dose can cause myelosuppression.
Croatian: Mitoksantron primijenjen u svakoj dozi može uzrokovati mijelosupresiju.
English: Based on data from two comparative trials of mitoxantrone plus corticosteroids versus corticosteroids alone, the recommended dosage of mitoxantrone is 12 to 14 mg/m2 given as a short intravenous infusion every 21 days, in combination with low oral doses of corticosteroids.
Croatian: Na temelju podataka iz dvaju komparativnih ispitivanja mitoksantrona plus kortikosteroidi naspram kortikosteroida u monoterapiji preporučeno doziranje mitoksantrona iznosi 12 do 14 mg/m2 danih kao kratka intravenska infuzija svakih 21 dan u kombinaciji s niskim oralnim dozama kortikosteroida.
English: Mitoxantrone pharmacokinetics in the paediatric population is unknown.
Croatian: Farmakokinetika mitoksantrona u pedijatrijskoj populaciji nije poznata.
English: Neoplasms benign and malignant (including cysts and polyps) Uncommon
Croatian: Dobroćudne i zloćudne novotvorine (uključujući ciste i polipe) Manje često
English: Mitoxantrone has been shown in vitro to inhibit B cell, T cell, and macrophage proliferation and impair antigen presentation, as well as the secretion of interferon gamma, tumour necrosis factor alpha, and interleukin-2.
Croatian: Za mitoksantron je pokazano kako u in vitro uvjetima inhibira proliferaciju B stanica, T stanica i makrofaga te narušava predočavanje antigena, kao i lučenje interferona gama, faktora nekroze tumora alfa i interleukina-2.
English: For this reason, the use of mitoxantrone to treat MS is contraindicated for pregnant women (see section 4.3).
Croatian: Iz tog je razloga primjena mitoksantrona za liječenje MS-a kontraindicirana u trudnica (vidjeti dio 4.3).
English: Your bone marrow can be more depressed or be depressed for a longer period if you have had chemotherpy or radiotherapy.
Croatian: Vaša koštana srž može biti više potisnuta ili potisnuta tijekom duljeg razdoblja ako ste primili kemoterapiju ili terapiju zračenjem.
English: - Unsual bruising or bleeding, such as coughing up blood, blood in your vomit or urine, or black stools (potential sign of platelet reduction).
Croatian: - neuobičajena pojava modrica ili krvarenja, poput iskašljavanja krvi, pojava krvi u povraćenom sadržaju ili mokraći, ili crna stolica (mogući znak smanjenja broja krvnih pločica);
English: Mitoxantrone in combination with other cytostatic active substances is effective in the treatment of metastatic breast cancer, also in patients who failed adjuvant therapy with an anthracycline-containing regimen.
Croatian: Mitoksantron u kombinaciji s drugim citostatskim djelatnim tvarima učinkovit je u liječenju metastatskog raka dojke, također u bolesnika u kojih je adjuvantna terapija s režimom koji se sastojao od antraciklin bila neuspješna.
English: Subsequent dosing
Croatian: Naknadno doziranje
English: Novantrone has been given as part of combination therapy.
Croatian: Novantrone se davao kao dio kombinirane terapije.
English: Heart function tests prior and during treatment with Novantrone Novantrone may damage your heart and cause a deterioration of your heart function or in more severe cases heart failure.
Croatian: Novantrone može oštetiti Vaše srce i uzrokovati propadanje srčane funkcije ili u težim slučajevima zatajenje srca.
English: Single Agent Therapy in Relapse
Croatian: Terapija jednokratnom dozom u relapsu
English: Mitoxantrone was found to be mutagenic in bacterial and mammalian test systems, as well as in vivo in rats.
Croatian: Za mitoksantron je otkriveno da je mutagen u testnim sustavima na bakterijama i stanicama sisavaca, kao i in vivo na štakorima.
English: - Severe allergic reaction (anaphylactic reaction including anyphylactic shock) - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, and you may feel you are going to faint).
Croatian: - Teška alergijska reakcija (anafilaktička reakcija koja uključuje anafilaktički šok) - možete iskusiti iznenadni osip koji svrbi (koprivnjaču), oticanje ruku, stopala, gležnjeva, lica, usnica, usta ili grla, što može uzrokovati teškoće pri gutanju ili disanju te se možete osjećati kao da ćete se onesvijestiti).
English: Treatment with mitoxantrone is not recommended in the paediatric population.
Croatian: Liječenje mitoksantronom ne preporučuje se u pedijatrijskoj populaciji.
English: Metastatic breast cancer, non-Hodgkin's lymphoma
Croatian: Metastatski rak dojke, ne-Hodgkinov limfom
English: o Burning feeling and/or discolouration of the skin.
Croatian: o Osjećaj pečenja i/ili promjena boje kože.
English: Mitoxantrone should not ordinarily be not receive a lifetime cumulative dose greater than 72 mg/m administered to multiple sclerosis patients, with either LVEF of < 50% or a clinically-significant reduction in LVEF.
Croatian: Mitoksantron se obično ne smije primijeniti u bolesnika s multiplom sklerozom koji imaju LVEF <50% ili klinički značajno smanjenje LVEF-a.
English: Mitoxantrone has been detected in breast-milk for up to one month after the last administration.
Croatian: Mitoksantron je detektiran u mlijeku liječenih žena u razdoblju do mjesec dana nakon posljednje primjene.
English: For patients with hepatic impairment dose adjustment may be necessary as mitoxantrone clearance is reduced by hepatic impairment.
Croatian: Za bolesnike s oštećenjem jetre može biti neophodna prilagodba doze jer je klirens mitoksantrona smanjen uslijed oštećenja jetre.
English: Mitoxantrone is indicated in the treatment of non-Hodgkin's lymphoma.
Croatian: Mitoksantron je indiciran za liječenje ne-Hodgkinovog limfoma.
English: Treatment of pregnant rats during the organogenesis period of gestation was associated with foetal growth retardation at doses > 0.01 times the recommended human dose on an mg/m2 basis.
Croatian: Primjena lijeka na skotnim štakorima tijekom razdoblja organogeneze u gestaciji bila je povezana sa zaostalim fetalnim rastom pri dozama >0,01 puta preporučena doza u ljudi na temelju mg/m2.
English: Weight fluctuations Tumour lysis syndrome*
Croatian: Fluktuacije u težini Sindrom lize tumora*
English: Topoisomerase II inhibitors (a groups of anticancer medicines including mitoxantrone) in combination with other chemotherapy and/or radiotherapy.
Croatian: - inhibitori topoizomeraze II (skupina lijekova protiv raka uključujući mitoksantron) u kombinaciji s drugom kemoterapijom i/ili terapijom zračenjem.
English: Differential blood count within 21 days after mitoxantrone infusion Signs and symptoms of infection and differential blood count with WHO grade 3: following dose 10 mg/m²
Croatian: Diferencijalna krvna slika unutar 21 dana nakon infuzije mitoksantrona Znakovi i simptomi infekcije i diferencijalna krvna slika sa stupnjem 3 prema Svjetskoj zdravstvenoj organizaciji (SZO): nakon doze 10 mg/m²
English: Sudden death** * Extravasation at the infusion site has been reported, which may result in erythema, swelling, pain, burning and/or blue discolouration of the skin.
Croatian: Iznenadna smrt** * Prijavljena je ekstravazacija na mjestu infuzije što može rezultirati eritemom, oticanjem, boli,
English: The recommended dosage of mitoxantrone is usually 12 mg/m2 body surface area given as a short
Croatian: Preporučeno doziranje mitoksantrona obično iznosi 12 mg/m2 tjelesne površine, a daje se kao kratka
English: Mitoxantrone, a DNA-reactive agent that intercalates into deoxyribonucleic acid (DNA) through hydrogen bonding, causes crosslinks and strand breaks.
Croatian: Mitoksantron, lijek koji reagira s DNK i umeće se u deoksiribonukleinsku kiselinu (DNK) vodikovim vezama uzrokujući unakrsna povezivanja i lomove lanaca.
English: - Skin inflammations (erythema).
Croatian: - Upale kože (eritem).
English: For induction, the recommended dosage is 12 mg/m2 of mitoxantrone daily on Days 1 to 3 given as an intravenous infusion, and 100 mg/m2 of cytarabine for 7 days given as a continuous 24-hour infusion on Days 1 to 7.
Croatian: Za indukciju preporučeno doziranje iznosi 12 mg/m2 mitoksantrona dnevno danog kao intravenska infuzija 1. do 3. dana i 100 mg/m2 citarabina tijekom 7 dana danog kao kontinuirana 24-satna infuzija 1. do 7. dana.
English: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000
Croatian: Učestalosti su definirane prema sljedećoj konvenciji: vrlo često (≥1/10), često (≥1/100 do <1/10),
English: Novantrone concentrate must not be given subcutaneously, intramuscularly, or intra-arterially.
Croatian: Novantrone koncentrat ne smije se davati supkutano, intramuskularno ili intraarterijski.
English: - Damages to the heart muscle preventing it from pumping properly (cardiomyopathy).
Croatian: - Oštećenja srčanog mišića koja sprječavaju njegov pravilan rad (kardiomiopatija).
English: For the full list of excipients, see section 6.1.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom: Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: Mitoxantrone must not be used in treatment of multiple sclerosis in pregnant women (see sections 4.4 and
Croatian: Mitoksantron se ne smije primjenjivati za liječenje multiple skleroze u trudnica (vidjeti dijelove 4.4 i 4.6).
English: Contusion Haemorrhage Hypotension
Croatian: Kontuzija Hemoragija Hipotenzija
English: The combination of vitamin K antagonists and cytotoxic agents may result in an increased risk of bleeding.
Croatian: K i citotoksičnim lijekovima može rezultirati povećanim rizikom od krvarenja.
English: Precautions to be taken before handling or administering the medicinal product Mitoxantrone should be given slowly into a freely flowing intravenous infusion.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Mitoksantron je potrebno davati sporo u intravensku infuziju slobodnog protoka.
English: - Irregular heart beat.
Croatian: - Nepravilni otkucaji srca.
English: Signs and symptoms of infection and differential blood count with WHO grade 4: following dose 8 mg/m²
Croatian: Znakovi i simptomi infekcije i diferencijalna krvna slika sa stupnjem 4 prema SZO: nakon doze 8 mg/m²
English: Infections and Infestations Very common
Croatian: Infekcije i infestacije
English: This also has been reported for MS patients treated with mitoxantrone.
Croatian: To je također prijavljeno za bolesnike liječene mitoksantronom protiv multiple skleroze (MS).
English: • if you had prior treatment of the chest with radiation;
Croatian: • ako Vaše srce ne radi dobro; • ako ste ranije primali terapiju prsišta zračenjem;
English: Mitoxantrone is indicated in the treatment of metastatic breast cancer.
Croatian: Mitoksantron je indiciran za liječenje metastatskog raka dojke.
English: Novantrone must not be administered under the skin (subcutaneous), in a muscle (intramuscular), or into the artery (intra-arterial).
Croatian: Novantrone se ne smije primjenjivati pod kožu (supkutano), u mišić (intramuskularno) ili u arteriju
English: [See Annex I - To be completed nationally] {Name and address} {tel} {fax} {e-mail}
Croatian: [Vidjeti Prilog I. - ispunjava država članica]
English: How to store Novantrone
Croatian: Kako čuvati Novantrone