FrancophonIA/ELRC3.0 huggingface dataset:
English: LVEF evaluation is recommended at regular intervals and/or if signs or symptoms of congestive heart failure develop.
Croatian: Preporučuje se procjena LVEF-a u redovitim intervalima i/ili pri pojavi znakova ili simptoma kongestivnog zatajenja srca.
English: - Abnormal electrocardiogram.
Croatian: - Abnormalan elektrokardiogram.
English: Extravasation*
Croatian: Ekstravazacija*
English: This risk increases with cumulative dose.
Croatian: Ovaj se rizik povećava s kumulativnom dozom.
English: There does not seem to be relevant differences in pharmacokinetics of mitoxantrone between elderly and young adult patients.
Croatian: Čini se da ne postoje relevantne razlike u farmakokinetici mitoksantrona između starijih i mladih odraslih bolesnika.
English: Oedema Extravasation* Dysgeusia
Croatian: Ekstravazacija* Disgeuzija
English: This is in general a transient neutropenia with the lowest count of leucocytes at day 10 after the infusion and recovered around day 20.
Croatian: Općenito je to prolazna neutropenija s najnižim brojem leukocita na 10. dan nakon infuzije i oporavkom broja oko 20. dana.
English: - Inflammation of the mouth and lips.
Croatian: - Upala usta ili usnica.
English: The medicine also suppresses the immune system and is used because of this effect to treat a specific form of multiple sclerosis when there are no alternative treatment options.
Croatian: Ovaj lijek također suprimira imunološki sustav te se zbog tog učinka primjenjuje za liječenje specifičnog oblika multiple skleroze kada ne postoje alternativne opcije liječenja.
English: Skin discolouration Tissue necrosis (after extravasation)
Croatian: Diskoloracija kože Nekroza tkiva (nakon ekstravazacije)
English: {MM/YYYY} {DD/MM/YYYY} {DD month YYYY}
Croatian: {Naziv i adresa} {tel} {fax} {e-mail}
English: What Novantrone looks like and contents of the pack
Croatian: Kako Novantrone izgleda i sadržaj pakiranja
English: - Reduction of the volume of blood that the left ventrical can pump, with no symptoms.
Croatian: - Smanjenje volumena krvi kojeg lijeva klijetka može istisnuti, bez simptoma.
English: This dosage is given in 21 day-cycles, for induction therapy in AML during three consecutive days, for consolidation therapy during two days.
Croatian: Doziranje se daje u ciklusima od 21 dana, za indukcijsku terapiju u AML-u tijekom tri uzastopna dana, za konsolidacijsku terapiju tijekom dva dana.
English: Haematological parameters should be regularly monitored (see section 4.4).
Croatian: Potrebno je redovito pratiti hematološke parametre (vidjeti dio 4.4).
English: The active substance was carcinogenic in experimental animals at doses below the proposed clinical dose.
Croatian: Djelatna tvar je kancerogena u eksperimentalnim životinjama pri dozama nižim od predložene kliničke doze.
English: Mitoxantrone should be used with caution.
Croatian: Mitoksantron je potrebno koristiti s oprezom.
English: Most complete remissions will occur following the initial course of induction therapy.
Croatian: Najpotpunije remisije pojavit će se nakon početnog ciklusa indukcijske terapije.
English: Your doctor will decide exactly what dosage you need.
Croatian: Vaš će liječnik odlučiti koje točno doziranje trebate.
English: The recommended dose is based on your body surface area, which is calculated in square metres (m2) using your height and weight.
Croatian: Preporučena doza temelji se na površini Vašeg tijela, koja se izračuna u kvadratnim metrima (m2) pomoću Vaše visine i težine.
English: It must always be administered as an intravenous infusion (in a vein) and must always be diluted before.
Croatian: Lijek se uvijek mora primijeniti kao intravenska infuzija (u venu) i mora se uvijek prije toga razrijediti.
English: Your doctor will carry out blood tests more often, in which he will in particular monitor the number of white blood cells (neutrophilic leucocytes) in the blood:
Croatian: Vaš će liječnik češće provesti krvne pretrage u kojima će naročito pratiti broj bijelih krvnih stanica (neutrofilnih leukocita) u krvi:
English: The remaining 35 % was composed of monocarboxylic and dicarboxylic acid derivatives and their glucuronide conjugates.
Croatian: Preostalih 35% sastojalo se od derivata monokarboksilatne i dikarboksilatne kiseline i njihovih glukuronidnih konjugata.
English: The haematopoietic system was the primary target organ of toxicity showing myelosuppression.
Croatian: Hematopoetski sustav je bio primarni ciljni organ za toksičnost koji je pokazivao mijelosupresiju.
English: This is caused by possible side effects, such as confusion or feeling tired (see section 4).
Croatian: To je uzrokovano mogućim nuspojavama poput smetenosti ili osjećaja umora (vidjeti dio 4).
English: If Novantrone is used alone:
Croatian: Ako se Novantrone primjenjuje samostalno:
English: You should avoid becoming pregnant.
Croatian: Trebate izbjegavati trudnoću.
English: - Abnormal absence of menstruation (amenorrhoea).
Croatian: - Abnormalna odsutnost menstruacije (amenoreja).
English: There have been reports of neuropathy and neurotoxicity, both central and peripheral, following intrathecal injection.
Croatian: Prijavljeni su slučajevi neuropatije i neurotoksičnosti, kako centralne tako i periferne, nakon intratekalne injekcije.
English: Novantrone must also not be injected into the space under the brain or spinal cord (intrathecal injection) as this can result in severe injury with permanent impairment.
Croatian: Novantrone se također ne smije injicirati u prostor ispod mozga ili leđne moždine (intratekalna injekcija), jer to može rezultirati teškom ozljedom s trajnim oštećenjem.
English: In patients administered 15-90 mg/m2, there is a linear relationship between dose and the area under the concentration curve (AUC).
Croatian: U bolesnika u kojih je primijenjeno 15-90 mg/m2 postoji linearan odnos između doze i površine ispod krivulje koncentracije (AUC).
English: Therefore, mitoxantrone has the potential to be carcinogenic in humans.
Croatian: Stoga mitoksantron ima potencijal biti kancerogen u ljudi.
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Croatian: Ovaj sažetak opisa svojstava lijeka, označivanje i uputa o lijeku ishod su arbitražnog postupka na koji se odnosi ova odluka Komisije.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, including sulphites that may be produced during the manufacturing of mitoxantrone.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1, uključujući sulfite koji mogu nastati tijekom proizvodnje mitoksantrona.
English: This treatment should be used only after assessment of the benefit-risk, particularly concerning the haematological and cardiac risks (see section 4.4).
Croatian: Liječenje se smije primijeniti samo nakon procjene omjera koristi i rizika, naročito u pogledu hematoloških i srčanih rizika (vidjeti dio 4.4).
English: A cumulative dose of 72 mg/m² is still effective and associated with less cardiotoxicity than higher cumulative doses.
Croatian: Kumulativna doza od 72 mg/m2 još uvijek je učinkovita i povezana s manjom kardiotoksičnošću od većih kumulativnih doza.
English: For use as treatment of multiple sclerosis:
Croatian: Za primjenu kao liječenje multiple skleroze:
English: There is no known specific antidote for mitoxantrone.
Croatian: Ne postoji poznati specifičan antidot za mitoksantron.
English: Therefore you should avoid becoming pregnant.
Croatian: Stoga je nužno da izbjegavate trudnoću.
English: You should avoid contact with Novantrone, especially with the skin, mucous membranes (moist body surfaces, such as the lining of the mouth) and eyes.
Croatian: Potrebno je izbjegavati kontakt s Novantronom, naročito s kožom, sluznicama (vlažne površine tijela poput sluznice usta) i očima.
English: If any signs or symptoms of extravasation have occurred, including burning, pain, pruritus, erythema, swelling, blue discolouration, or ulceration, the administration should be stopped immediately (see section 4.4).
Croatian: Ako se pojave bilo kakvi znakovi ekstravazacije, uključujući pečenje, bol, pruritus, eritem, oticanje, plave diskoloracije ili ulceraciju,potrebno je odmah prekinuti primjenu (vidjeti dio 4.4).
English: Its presumed mechanism of action in MS is immunosuppression.
Croatian: Njegov pretpostavljeni mehanizam djelovanja u MS-u je imunosupresija.
English: given as a single intravenous dose, which may be repeated at 21-day intervals.
Croatian: a daje se kao jednokratna intravenska doza, koja se može ponoviti u intervalima od 21 dana.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: Mitoxantrone does not cross the blood-brain barrier.
Croatian: Mitoksantron ne prelazi krvno-moždanu barijeru.
English: The tubing should be inserted preferably into a large vein.
Croatian: Cijev je potrebno uvesti prvenstveno u veliku venu.
English: Inducers of the BCRP transporter could potentially decrease mitoxantrone exposure.
Croatian: Induktori prijenosnika BCRP mogli bi potencijalno smanjiti izloženost mitoksantronu.
English: It also belongs to the subgroup of anti-cancer medicines called anthracyclines.
Croatian: On također spada u podskupinu lijekova protiv raka nazvanih antraciklini.
English: Heart, kidney, gastrointestinal tract, and testes were additional targets.
Croatian: Srce, bubreg, probavni sustav i testisi bili su dodatni ciljevi.
English: The infusion liquid can leak out of the vein into the tissue (extravasation).
Croatian: Infuzijska tekućina može iscuriti iz vene u tkivo (ekstravazacija).
English: Accidental overdoses have been reported.
Croatian: Prijavljeno je slučajno predoziranje.
English: Mitoxantrone was not teratogenic in animal studies at doses below human exposure, but caused reproductive toxicity (see section 5.3).
Croatian: Mitoksantron nije bio teratogen u ispitivanjima na životinjama pri dozama nižim od izloženosti u ljudi, ali je uzrokovao reproduktivnu toksičnost (vidjeti dio 5.3).
English: The table below is based on safety data derived from clinical trials and spontaneous reporting in oncological indications and from clinical trials, post authorisation safety studies and spontaneous reporting for patients treated for multiple sclerosis.
Croatian: Tablica u nastavku temelji se na podacima o sigurnosti primjene proisteklim iz kliničkih ispitivanja i spontanih prijava u onkološkim indikacijama te iz kliničkih ispitivanja, ispitivanja sigurnosti lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet i spontanih prijava za bolesnike liječene od multiple skleroze.
English: You should stop breast-feeding before taking Novantrone.
Croatian: Trebate prestati dojiti prije uzimanja Novantrona.
English: If you become pregnant during the treatment with Novantrone, you must tell your doctor immediately and stop treatment with Novantrone.
Croatian: Ako zatrudnite tijekom liječenja Novantronom, odmah morate obavijestiti svog liječnika i prekinuti liječenje
English: Novantrone belongs to the group of medicines known as antineoplastic or anti-cancer medicines.
Croatian: Novantrone spada u skupinu lijekova poznatih kao antineoplastici ili lijekovi protiv raka.
English: In the several studies in multiple sclerosis the effective cumulative dose ranged from 36 mg/m to 120 mg/m2.
Croatian: U nekoliko ispitivanja multiple skleroze učinkovita kumulativna doza kretala se u rasponu od 36 mg/m2 do 120 mg/m2.
English: Medicines which may increase the risk of side effects with Novantrone:
Croatian: Lijekovi koji mogu povećati rizik od nuspojava pri primjeni Novantrona:
English: If used with other agents against cancer:
Croatian: Ako se primjenjuje s drugim lijekovima protiv raka:
English: - Congestive heart failure (severe condition where the heart cannot anymore pump enough blood).
Croatian: - Kongestivno zatajenje srca (teško stanje u kojem srce više ne može istiskivati dovoljno krvi).
English: When used for treatment in other indications mitoxantrone should not be administered during pregnancy in particular during the first trimester of pregnancy.
Croatian: Kada se primjenjuje za liječenje u drugim indikacijama mitoksantron se ne bi smio primjenjivati tijekom trudnoće naročito tijekom prvog tromjesečja trudnoće.
English: This dose might be adjusted if: - The combination of medicines reduces the production of white and red blood cells as well as platelets in your bone marrow more than Novantrone used alone; - If you have serious liver or kidney problems.
Croatian: Doza se može prilagoditi ako: - Kombinacija lijekova smanjuje proizvodnju bijelih i crvenih krvnih stanica kao i krvnih pločica u Vašoj koštanoj srži više od primjene Novantrona samostalno; - Ako imate ozbiljnih problema s jetrom ili bubrezima.
English: A reduction of neurologic disability worsening and frequency of clinical relapses was observed.
Croatian: Opaženo je smanjenje pogoršanja neurološkog invaliditeta i učestalosti kliničkih relapsa.
English: Any duration
Croatian: Bilo koje vrijeme
English: Single and repeat toxicity studies were conducted in mouse, rat, dog, rabbits, and monkey.
Croatian: Ispitivanja toksičnosti jednokratnih i ponovljenih doza provedene su na miševima, štakorima, kunićima i majmunima.
English: Combination therapy (if used with other agents)
Croatian: Kombinirana terapija (primjena s drugim lijekovima)
English: o Death of tissue cells which can lead to the need to remove dead cells and skin transplantation.
Croatian: o Odumiranje tkivnih stanica što može dovesti do potrebe za uklanjanjem mrtvih stanica i transplantacije kože.
English: Novantrone is secreted into breast milk and may cause serious adverse reactions in your baby.
Croatian: Novantrone se izlučuje u majčino mlijeko i može uzrokovati ozbiljne nuspojave u Vašeg djeteta.
English: When mitoxantrone is used in high doses (> 14 mg/m2/d x 3 days) such as indicated for the treatment of leukaemia, severe myelosuppression will occur.
Croatian: Kada se mitoksantron primjenjuje u velikim dozama (>14 mg/m2/d x 3 dana), kao što je indicirano za liječenje leukemije, pojavit će se teška mijelosupresija.
English: • if you had previous therapies with anthracyclines or anthracenediones, such as daunorubicin or doxorubicin.
Croatian: • ako ste primali prethodne terapije antraciklinima ili antracendionima poput daunorubicina ili doksorubicina.
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojave
English: Cases of congestive heart failure with left-ventricular ejection fraction (LVEF) < 50 % have also been reported (see section 4.4).
Croatian: Također su prijavljeni slučajevi kongestivnog zatajenja srca s istisnom frakcijom lijeve klijetke (LVEF) <50% (vidjeti dio 4.4).
English: Systemic infections should be treated concomitantly with or just prior to commencing therapy with mitoxantrone.
Croatian: Sistemske infekcije je potrebno liječiti istodobno s ili neposredno prije započinjanja terapije mitoksantronom.
English: Mitoxantrone blocks the cell cycle in G2-phase leading to an increase of cellular RNA and polyploidy.
Croatian: Mitoksantron blokira stanični ciklus u G2-fazi dovodeći do povećanja stanične RNK i poliploidije.
English: For patients being treated for cancer:
Croatian: Za bolesnike koji se liječe protiv raka:
English: to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: manje često (≥1/1000 do <1/100), rijetko (≥1/10 000 do <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Amenorrhoea * Amenorrhea may be prolonged and may be consistent with premature menopause General disorders and administration site conditions Common
Croatian: Amenoreja * Amenoreja može biti produljena i može biti konzistentna s preuranjenom menopauzom
English: In the absence of sufficient efficacy data in the adjuvant treatment of breast cancer and accounting for the increased risk of leukaemia, mitoxantrone should only be used for metastatic breast cancer.
Croatian: U odsutnosti dostatnih podataka o djelotvornosti u adjuvantnom liječenju raka dojke i uzimajući u obzir povećani rizik od leukemije, mitoksantron se smije primjenjivati samo za metastatski rak dojke.
English: The following table is suggested as a guide to dosage adjustment, in the treatment of metastatic breast cancer and non-Hodgkin's lymphoma according to haematological nadir (which usually occurs about 10 days after dosing).
Croatian: Sljedeća tablica preporučuje se kao smjernica za prilagodbu doziranja u liječenju metastatskog raka dojke i ne-Hodgkinovog limfoma prema hematološkoj najnižoj vrijednosti (koja se obično javlja oko 10 dana nakon doziranja).
English: The effect of gender, race, and renal impairment on mitoxantrone pharmacokinetics is unknown.
Croatian: Učinak spola, rase i oštećenja bubrega na farmakokinetiku mitoksantrona nije poznata.
English: Safety and efficacy have not been established.
Croatian: Sigurnost i djelotvornost primjene nije ustanovljena.
English: Tell your doctor or pharmacist or nurse immediately if you get any of the following signs or symptoms during treatment with Novantrone: - fever, infections, unexplained bleeding or bruising, weakness and easy fatigability; - breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the ankles or legs , heart fluttering (irregular heart beat).
Croatian: Odmah obavijestite svog liječnika ili ljekarnika ili medicinsku sestru ako primijetite bilo koji od sljedećih znakova ili simptoma tijekom liječenja Novantronom: - vrućicu, infekcije, neobjašnjeno krvarenje ili nastanak modrica, slabost i lako umaranje; - nedostatak zraka (uključujući nedostatak zraka noću), kašalj, zadržavanje tekućine (oticanje) u gležnjevima ili nogama, treperenje srca (nepravilni otkucaji srca).
English: What you need to know before you use Novantrone
Croatian: Što morate znati prije nego počnete primjenjivati Novantrone
English: Because of the potential for serious adverse reactions in infants from mitoxantrone, breast-feeding is contraindicated (see section 4.3) and must be discontinued before starting treatment.
Croatian: Zbog mogućih ozbiljnih nuspojava od mitoksantrona u dojenčadi, dojenje je kontraindicirano (vidjeti dio 4.3) i mora se prekinuti prije započinjanja liječenja.
English: Immunisation with live virus vaccines (e.g. yellow fever vaccination) increases the risk of infection and other adverse reactions such as vaccinia gangrenosa and generalized vaccinia, in patients with reduced immunocompetence, such as during treatment with mitoxantrone.
Croatian: Imunizacija cjepivima sa živim virusom (npr. cijepljenje protiv žute groznice) povećava rizik od infekcije i drugih nuspojava poput progresivne vakcinije i generalizirane vakcinije u bolesnika sa smanjenom imunokompetencijom kao što je slučaj tijekom liječenja mitoksantronom.
English: Women treated with Mitoxantrone have an increased risk of transitory or persistent amenorrhoea and therefore preservation of gametes should be considered prior to therapy.
Croatian: Žene liječene mitoksantronom imaju povećani rizik od prolazne ili trajne amenoreje i stoga je potrebno razmotriti čuvanje gameta prije terapije.
English: The long-term usefulness of mitoxantrone is limited by emerging cancer resistance which ultimately may result in fatal outcome when used as last-line therapy.
Croatian: Dugoročna korisnost mitoksantrona ograničena je pojavom rezistencije raka koja u konačnosti može rezultirati smrtnim ishodom kada se lijek koristi kao zadnja terapija.
English: - Severe condition where the heart cannot anymore pump enough blood (congestive heart failure).
Croatian: - Teško stanje u kojem srce više ne može potiskivati dovoljno krvi (kongestivno zatajenje srca).
English: Distribution to tissues is extensive: steady-state volume of distribution exceeds 1,000 L/m2.
Croatian: Distribucija u tkivima je opsežna: volumen distribucije u stanju dinamičke ravnoteže premašuje 1000 l/m2.
English: Dosage modification and the timing of subsequent dosing should be determined by clinical judgment depending on the degree and duration of myelosuppression.
Croatian: Modifikaciju doze i vrijeme primjene naknadnih doza potrebno je odrediti prema kliničkoj procjeni ovisno o stupnju i trajanju mijelosupresije.
English: Except for the treatment of acute myeloid leukaemia, mitoxantrone therapy generally should not be given to patients with baseline neutrophil counts of less than 1,500 cells/mm3.
Croatian: Osim za liječenje akutne mijeloične leukemije, terapija mitoksantronom općenito se ne smije davati bolesnicima s početnim brojem neutrofila manjim od 1500 stanica/mm3.
English: The individual dose of Novantrone is calculated by your doctor.
Croatian: Vaš liječnik će izračunati individualnu dozu Novantrona.
English: Blood tests prior and during treatment with Novantrone Novantrone may affect your blood cell counts.
Croatian: Krvne pretrage prije i tijekom liječenja Novantronom Novantrone može utjecati na Vaše brojeve krvnih stanica.
English: For subsequent courses, the prior dose can usually be repeated if white blood cell and platelet counts have returned to normal levels after 21 days.
Croatian: Za naknadne cikluse obično se može ponoviti prijašnja doza ako su se brojevi bijelih krvnih stanica i krvnih pločica vratili na normalne razine nakon 21 dana.
English: However, in male animals, damage to the testes and decreased sperm counts were observed.
Croatian: Međutim, u mužjaka životinja opažena su oštećenja testisa i smanjeni broj spermija.
English: Cardiotoxicity can occur at any time during mitoxantrone therapy, and the risk increases with cumulative dose.
Croatian: Kardiotoksičnost se može pojaviti bilo kad tijekom terapije mitoksantronom, a rizik se povećava s kumulativnom dozom.
English: Mitoxantrone and its metabolites are excreted in bile and urine, but it is not known whether the metabolic or excretory pathways are saturable, may be inhibited or induced, or if mitoxantrone and its metabolites undergo enterohepatic circulation (see section 5.2).
Croatian: Mitoksantron i njegovi metaboliti izlučuju se putem žuči i mokraće, ali nije poznato jesu li metabolički ili ekskretorni putovi zasićeni, mogu li biti inhibirani ili inducirani ili pak da li mitoksantron i njegovi metaboliti prolaze kroz enterohepatičnu cirkulaciju (vidjeti dio 5.2).
English: In men, no data are available, but tubular atrophy of the testes and reduced sperm counts were observed in animals (see section 5.3).
Croatian: U muškaraca nisu dostupni podaci, ali opaženi su tubularna atrofija testisa i smanjeni broj spermija u životinja (vidjeti dio 5.3).
English: Novantrone has a minor effect on your ability to drive and use machines.
Croatian: Novantrone malo utječe na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: Haematopoietic, gastrointestinal, hepatic or renal toxicity may be seen, depending on the dosage given and the physical condition of the patient.
Croatian: Može se uočiti hematopoetska, gastrointestinalna, jetrena ili bubrežna toksičnost ovisno o danom doziranju i fizičkom stanju bolesnika.
English: In clinical studies with a dosage of 12 mg/m2 daily for 5 days, patients who achieved a complete remission did so as a result of the first induction course.
Croatian: U kliničkim ispitivanjima s doziranjem od 12 mg/m2 dnevno tijekom 5 dana, bolesnici koji su postigli potpunu remisiju, uspjeli su to kao rezultat prvog ciklusa indukcije.
English: Before you start Novantrone and during treatment, your doctor will do a blood test to count the number of your blood cells.
Croatian: Prije nego započnete te tijekom liječenja Novantronom, Vaš će liječnik napraviti krvne pretrage kako bi odredio broj Vaših krvnih stanica.
English: - Changes to the colour of the whites of the eyes.
Croatian: - Promjene boje bjeloočnice.