FrancophonIA/ELRC3.0 huggingface dataset:
English: These reports have included seizures leading to coma and severe neurologic sequelae, and paralysis with bowel and bladder dysfunction.
Slovenian: Ta poročila obsegajo epileptične napade, ki vodijo v komo, in hude nevrološke posledice ter paralizo z disfunkcijo črevesja in sečnega mehurja.
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).
Slovenian: Pri moških ni na voljo nobenih podatkov, vendar sta bila pri živalih ugotovljena tubularna atrofija testisov in manjše število spermijev (glejte poglavje 5.3).
English: Amenorrhoea * Amenorrhea may be prolonged and may be consistent with premature menopause General disorders and administration site conditions Common
Slovenian: Amenoreja * Amenoreja je lahko dolgotrajna in povezana s prezgodnjo menopavzo.
English: In a pharmacokinetic study in children with de novo acute myeloid leukaemia, ciclosporin co-medication resulted in a 42% decreased clearance of mitoxantrone.
Slovenian: V farmakokinetični študiji pri otrocih z de novo akutno mieloično levkemijo je sočasna uporaba ciklosporina povzročila za 42 % manjši očistek mitoksantrona.
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.
Slovenian: Miokardna toksičnost, ki se v najhujši obliki kaže z morebitno nepopravljivim in smrtnim kongestivnim srčnim popuščanjem, se lahko pojavi bodisi med zdravljenjem z mitoksantronom ali več mesecev ali let po koncu zdravljenja.
English: Amenorrhoea*
Slovenian: Amenoreja*
English: The most serious side effects are damage to the heart (myocardial toxicity) and myelosuppression (reduced activity of the bone marrow).
Slovenian: Najresnejši neželeni neželeni učinki so poškodbe srca (miokardna toksičnost) in mielosupresija (zmanjšana aktivnost kostnega mozga).
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.
Slovenian: Priporočeni začetni odmerek zdravila Novantrone je 14 mg/m2 telesne površine, dan v enkratnem intravenskem odmerku, ki se lahko ponovi v 21-dnevnih presledkih, če so se vaše krvne vrednosti vrnile na sprejemljivo raven.
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.
Slovenian: Če mitoksantron dajemo večkrat, je treba dajanje po obsegu in trajanju prilagajati glede na zmanjšanje števila belih in rdečih krvnih celic ter krvnih ploščic.
English: Mitoxantrone was not teratogenic in animal studies at doses below human exposure, but caused reproductive toxicity (see section 5.3).
Slovenian: Mitoksantron ni bil teratogen pri raziskavah na živalih pri odmerkih, nižjih od tistih, ki so jim izpostavljeni ljudje, vendar je škodljivo vplival na sposobnost razmnoževanja (glejte poglavje 5.3).
English: There is no known specific antidote for mitoxantrone.
Slovenian: Za mitoksantron ni znan specifičen antidot.
English: The maximum lifetime cumulative dose should not exceed 72 mg/m2 (see section 5.1).
Slovenian: Najvišji kumulativni odmerek v celem življenju ne sme preseči 72 mg/m2 (glejte poglavje 5.1).
English: - Abnormal electrocardiogram.
Slovenian: - nenormalen elektrokardiogram,
English: Therefore you should avoid becoming pregnant.
Slovenian: Zato se morate izogniti zanositvi.
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).
Slovenian: Mitoksantron in njegovi presnovki se izločajo z žolčem in urinom, vendar ni znano, ali lahko na poti presnove in izločanja pride do nasičenja oziroma ali sta poti zavrti ali inducirani, ter ali mitoksantron in njegovi presnovki vstopajo v enterohepatični obtok (glejte poglavje 5.2).
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.
Slovenian: Zaradi morebitnih nevarnih posledic za srce pri bolnikih, predhodno zdravljenih z daunorubicinom ali doksorubicinom, je treba razmerje med koristmi in tveganostjo zdravljenja z mitoksantronom pri takšnih bolnikih določiti pred začetkom zdravljenja.
English: Neoplasms benign and malignant (including cysts and polyps) Uncommon
Slovenian: Benigne in maligne neoplazme (vključno s cistami in polipi) Občasni
English: When used for treatment in other indications mitoxantrone should not be administered during pregnancy in particular during the first trimester of pregnancy.
Slovenian: Pri zdravljenju drugih indikacij naj se mitoksantron ne uporablja med nosečnostjo, zlasti v prvem trimesečju.
English: Elevated aspartate aminotransferase levels
Slovenian: Povišane vrednosti aspartat aminotransferaze
English: This medicine might increase the risk for transitory or persistent absence of menstruation (amenorrhoea) in women of childbearing age.
Slovenian: To zdravilo lahko poveča tveganje za začasno ali trajno odsotnost menstruacije (amenoreja) pri ženskah v rodni dobi.
English: Extravasation can result in tissue necrosis with resultant need for debridement and skin grafting.
Slovenian: Ekstravazacija lahko povzroči nekrozo tkiva s posledično potrebo po odstranitvi odmrlega tkiva in presaditvi kože.
English: Skin discolouration Tissue necrosis (after extravasation)
Slovenian: Obarvanje kože Nekroza tkiva (po ekstravazaciji)
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.
Slovenian: Akumulacije učinkovine v plazmi niso opazili, ko so mitoksantron dajali ali vsakodnevno pet dni ali v enkratnem odmerku vsake tri tedne.
English: However, in male animals, damage to the testes and decreased sperm counts were observed.
Slovenian: Vendar sta bila pri samcih živali ugotovljena poškodba testisov in manjše število spermijev.
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.
Slovenian: Mitoksantron se uporablja tudi v različnih kombinacijah za ne-Hodgkinov limfom; vendar so podatki trenutno omejeni, zato posebnega režima ni mogoče priporočiti.
English: Cardiac toxicity with mitoxantrone may occur at lower cumulative doses whether or not cardiac risk factors are present.
Slovenian: Srčna toksičnost z mitoksantronom se lahko pojavi pri nižjih kumulativnih odmerkih ne glede na to, ali so prisotni dejavniki tveganja.
English: Blood tests prior and during treatment with Novantrone Novantrone may affect your blood cell counts.
Slovenian: Krvni testi pred in med zdravljenjem z zdravilom Novantrone Zdravilo Novantrone lahko vpliva na število krvnih celic.
English: In patients receiving oral anticoagulant therapy, the prothrombin time ratio or INR should be closely monitored with the addition and withdrawal of treatment with mitoxantrone and should be reassessed more frequently during concurrent therapy.
Slovenian: Pri bolnikih, ki se zdravijo s peroralnimi antikoagulanti, je treba skrbno spremljati protrombinski čas ali mednarodno normalizirano razmerje (INR) ob dodajanju in prekinitvi zdravljenja z mitoksantronom ter ga med sočasnim zdravljenjem pogosteje ponovno oceniti.
English: - Low level of platelets - which may cause bleeding or bruising.
Slovenian: - nizko število krvnih ploščic - kar lahko povzroči krvavitve ali modrice,
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.
Slovenian: Zdravilo Novantrone se uporablja tudi v različnih kombinacijah za ne-Hodgkinov limfom; vendar so podatki trenutno omejeni, zato posebnega režima ni mogoče priporočiti.
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.
Slovenian: Če se to zdravilo uporablja med nosečnostjo ali če bolnica zanosi med jemanjem mitoksantrona, jo je treba obvestiti o možnem tveganju za plod in ji zagotoviti genetsko svetovanje.
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.
Slovenian: Za ženske, ki se zdravijo z mitoksantronom, velja povečano tveganje za prehodno ali trajno amenorejo, zato naj pred zdravljenjem razmislijo o shranitvi spolnih celic.
English: (approximately 5 to 15 minutes) intravenous infusion that may be repeated every 1-3 months.
Slovenian: do 15 minut) intravenske infuzije, ki se lahko ponovi vsakih 1 do 3 mesece.
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.
Slovenian: Starejši bolniki Starejši bolniki morajo prejemati odmerek pri spodnji meji razpona odmerkov zaradi morebitnega zmanjšanja delovanja jeter, ledvic ali srčne funkcije ter morebitnih bolezni ali zdravljenj z drugimi zdravili.
English: [To be completed nationally] SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
English: Mitoxantrone must not be used in treatment of multiple sclerosis in pregnant women (see sections 4.4 and
Slovenian: Mitoksantron se ne sme uporabljati pri zdravljenju multiple skleroze pri nosečnicah (glejte poglavji 4.4 in
English: In patients administered 15-90 mg/m2, there is a linear relationship between dose and the area under the concentration curve (AUC).
Slovenian: Pri bolnikih, ki so prejeli odmerek 15 do 90 mg/m2, obstaja linearno razmerje med odmerkom in površino pod krivuljo koncentracije.
English: Mitoxantrone was mutagenic and clastogenic in all in vitro test systems and in rats in vivo.
Slovenian: Mitoksantron je bil mutagen in klastogen v vseh testnih sistemih in vitro ter pri podganah in vivo.
English: - Reduced activity of the bone marrow.
Slovenian: - zmanjšana aktivnost kostnega mozga.
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.
Slovenian: V primeru nepopolnega antilevkemičnega odziva se lahko da drugi indukcijski krog zdravljenja z mitoksantronom, dajanim 2 dni, in citarabinom, dajani 5 dni, in sicer v enakih dnevnih odmerkih.
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.
Slovenian: Če se to zdravilo jemlje med nosečnostjo ali če zanosite med jemanjem tega zdravila, obvestite svojega zdravnika, saj je zdravilo lahko nevarno za plod.
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.
Slovenian: Če je v prvem indukcijskem krogu zdravljenja opaziti hudo ali smrtno nevarno nehematološko toksičnost, je treba z drugim krogom indukcijskega zdravljenja počakati, dokler toksičnost ne mine.
English: A bluish disolouration of the whites of your eyes, skin and nails may also occur.
Slovenian: Lahko se pojavi tudi modrikasta obarvanost oči, kože in nohtov.
English: For this reason, the use of mitoxantrone to treat MS is contraindicated for pregnant women (see section 4.3).
Slovenian: Zato je uporaba mitoksantrona pri zdravljenju MS kontraindicirana za nosečnice (glejte poglavje 4.3).
English: Heart, kidney, gastrointestinal tract, and testes were additional targets.
Slovenian: Srce, ledvice, prebavila in moda so bili dodatne tarče.
English: Bluish discolouration of the sclera, skin and nails may also occur.
Slovenian: Lahko se pojavi tudi modrikasta obarvanost beločnice, kože in nohtov.
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.
Slovenian: Mitoksantron v kombinaciji s kortikosteroidi izboljšuje nadzor bolečine in kakovost življenja pri bolnikih z napredovalim rakom prostate, ki se ni odzval na kastracijo, brez kakršnih koli izboljšav v preživetju.
English: For use as treatment of multiple sclerosis:
Slovenian: Za zdravljenje multiple skleroze:
English: Single doses ranged from 5 to 12 mg/m2, dose intervals from once per month to once per 3 months.
Slovenian: Posamični odmerki so se gibali od 5 do 12 mg/m2, intervali dajanj pa od 1-krat na mesec do 1-krat na 3 mesece.
English: Because of the risk of development of secondary malignancies, the benefit-to-risk ratio of mitoxantrone therapy should be determined before starting therapy.
Slovenian: Zaradi tveganja za razvoj sekundarnih malignomov je treba razmerje med koristmi in tveganostjo zdravljenja z mitoksantronom določiti pred začetkom zdravljenja.
English: Mitoxantrone is contraindicated in women who are breast-feeding (see sections 4.4 and 4.6).
Slovenian: Mitoksantron je kontraindiciran pri doječih ženskah (glejte poglavji 4.4 in 4.6).
English: Mitoxantrone is indicated for the treatment of acute myeloid leukaemia (AML) in adults.
Slovenian: Mitoksantron je indiciran za zdravljenje akutne mieloične levkemije (AML) pri odraslih.
English: Cardiac function
Slovenian: Srčna funkcija
English: Myelosuppresion can be increased when it is used in combination chemotherapy with another myelosuppressive agent such as for treatment of breast cancer.
Slovenian: Mielosupresija se lahko poveča pri uporabi v kombinaciji s kemoterapijo z drugo mielosupresivno učinkovino, kot v primeru zdravljenja raka dojke.
English: Mitoxantrone, a DNA-reactive agent that intercalates into deoxyribonucleic acid (DNA) through hydrogen bonding, causes crosslinks and strand breaks.
Slovenian: Mitoksantron, učinkovina, ki reagira z DNK, tako da se vrine v deoksiribonukleinsko kislino (DNK) prek vodikovih vezi, povzroča navzkrižne povezave in prelome verig.
English: Mitoxantrone, a synthetic anthracenedione derivative, is an established cytotoxic, antineoplastic agent.
Slovenian: Mitoksantron, sintetični derivat antracena, je uveljavljeno citotoksično, antineoplastično sredstvo.
English: - Abnormal results of blood tests to check liver function (raised aspartate aminotransferase levels).
Slovenian: - v primeru nenormalnih rezultatov krvnih preiskav potreba po preverjanju funkcij jeter (povišane vrednosti aspartat aminotransferaz).
English: Myelosuppression may be more severe and prolonged in patients with poor general condition, or prior chemotherapy and/or radiotherapy.
Slovenian: Mielosupresija je lahko hujša in dolgotrajnejša pri bolnikih v slabem splošnem stanju ali pred kemoterapijo in/ali radioterapijo.
English: Metastatic breast cancer, non-Hodgkin's lymphoma
Slovenian: Metastatski rak dojke, ne-Hodgkinov limfom
English: What Novantrone looks like and contents of the pack
Slovenian: Izgled zdravila Novantrone in vsebina pakiranja
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.
Slovenian: Nosečnost, dojenje in plodnost Če ste noseči ali dojite, če menite, da ste noseči, ali če načrtujete nosečnost, se pred uporabo tega zdravila posvetujte s svojim zdravnikom ali farmacevtom.
English: Paediatric population Safety and efficacy in paediatric patients have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost pri pediatričnih bolnikih nista bili dokazani.
English: Cases of ECG anomalies have been reported.
Slovenian: Srčna toksičnost Poročali so o primerih nepravilnosti na EKG.
English: Systemic infections should be treated concomitantly with or just prior to commencing therapy with mitoxantrone.
Slovenian: Sistemske okužbe je treba zdraviti sočasno z začetkom zdravljenja z mitoksantronom ali tik pred njim.
English: Functional cardiac changes may occur in patients with multiple sclerosis treated with mitoxantrone.
Slovenian: Funkcionalne spremembe na srcu se lahko pojavijo pri bolnikih z multiplo sklerozo, zdravljenih z mitoksantronom.
English: Mitoxantrone in combination regimens is indicated in the remission-induction treatment of blast crisis in chronic myeloid leukaemia.
Slovenian: Mitoksantron je v kombiniranih režimih indiciran za zdravljenje z indukcijo remisije blastne krize pri kronični mieloični levkemiji.
English: Mitoxantrone was found to be mutagenic in bacterial and mammalian test systems, as well as in vivo in rats.
Slovenian: Za mitoksantron je ugotovljeno, da je mutagen v testnih sistemih bakterij in sesalcev, kot tudi in vivo pri podganah.
English: • if your heart is not working well;
Slovenian: • če imate težave z delovanjem srca,
English: Tubular atrophy of the testes and decreased sperm counts were observed.
Slovenian: Ugotovljena je bila tubularna atrofija testisov in manjše število spermijev.
English: Accidental overdoses have been reported.
Slovenian: Poročali so o nezgodnih prevelikih odmerkih.
English: - Congestive heart failure (severe condition where the heart cannot anymore pump enough blood).
Slovenian: - kongestivno srčno popuščanje (resno stanje, ko srce ne more več črpati dovolj krvi), - srčni napad,
English: Novantrone might increase the risk for transient or persistent absence of menstruation (amenorrhoea) in women of childbearing age.
Slovenian: Zdravilo Novantrone lahko poveča tveganje za začasno ali trajno odsotnost menstruacije (amenoreja) pri ženskah v rodni dobi.
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.
Slovenian: V študijah pri ljudeh so v 5-dnevnem obdobju po dajanju zdravila našli le 10 % odmerka v urinu in 18 % v blatu, bodisi v obliki zdravilne učinkovine ali presnovkov.
English: The most serious side effects with mitoxantrone are myocardial toxicity and myelosuppression.
Slovenian: Najresnejša neželena stranska učinka mitoksantrona sta miokardna toksičnost in mielosupresija.
English: Mitoxantrone does not cross the blood-brain barrier.
Slovenian: Mitoksantron ne prehaja skozi krvno-možgansko pregrado.
English: The pharmacokinetics of mitoxantrone in patients following single-dose intravenous administration can be characterised by a three-compartment model.
Slovenian: Farmakokinetiko mitoksantrona pri bolnikih po intravenskem enkratnem odmerku lahko opišemo po tridelnem modelu.
English: Men must use an effective method of contraception during the treatment and for at least 6 months after discontinuing the treatment.
Slovenian: Moški morajo uporabljati učinkovito metodo kontracepcije med zdravljenjem in še vsaj 6 mesecev po koncu zdravljenja.
English: How to use Novantrone
Slovenian: Kako uporabljati zdravilo Novantrone
English: Medicines which may increase the risk of side effects with Novantrone:
Slovenian: Zdravila, ki lahko skupaj z zdravilom Novantrone povečajo tveganje za pojav neželenih učinkov:
English: The fraction bound is independent of concentration and is not affected by the presence of phenytoin, doxorubicin, methotrexate, prednisone, prednisolone, heparin, or aspirin.
Slovenian: Vezava ni odvisna od koncentracije in nanjo ne vpliva prisotnost fenitoina, doksorubicina, metotreksata, prednizona, prednizolona, heparina ali acetilsalicilne kisline.
English: Haematological support and antimicrobial therapy may be required during prolonged periods of severe myelosuppression.
Slovenian: V daljših obdobjih hude mielosupresije sta lahko potrebna hematološka podpora in protimikrobno zdravljenje.
English: Weight fluctuations * Acute T and B lymphoblastic leukaemia and non-Hodgkin lymphomas (NHL) are most commonly associated with TLS
Slovenian: Anoreksija Nihanja v telesni masi * Akutna limfoblastna levkemija T in B ter ne-Hodgkinovi limfomi so najpogosteje povezani s sindromom tumorske lize.
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.
Slovenian: Mitoksantron je v kombinaciji z drugimi citostatičnimi zdravilnimi učinkovinami učinkovit pri zdravljenju metastatskega raka dojke, tudi pri bolnikih, pri katerih adjuvantno zdravljenje z antraciklinskim režimom ni bilo uspešno.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva poročanje o katerem koli domnevnem neželenem učinku zdravila, in sicer nacionalnemu centru za poročanje,
English: Mitoxantrone pharmacokinetics in the paediatric population is unknown.
Slovenian: Farmakokinetika mitoksantrona pri pediatrični populaciji ni znana.
English: Acute congestive heart failure may occasionally occur in patients treated with mitoxantrone for acute myeloid leukaemia.
Slovenian: Akutno kongestivno srčno popuščanje se lahko občasno pojavi pri bolnikih, zdravljenih z mitoksantronom zaradi akutne mieloične levkemije.
English: Myelosuppression can be more pronounced and longer-lasting in patients who have previously received chemotherapy or radiotherapy.
Slovenian: Mielosupresija je lahko izrazitejša in dolgotrajnejša pri bolnikih, ki so bili predhodno zdravljeni s kemoterapijo ali radioterapijo.
English: However, cardiotoxicity increases with cumulative doses.
Slovenian: Vendar se tveganje za kardiotoksičnost povečuje s kumulativnim odmerkom.
English: Phlebitis has also been reported at the site of infusion.
Slovenian: Opažen je bil tudi flebitis na mestu infuzije.
English: In a clinical trial with acute leukaemia patients, significant myelosuppression occurred in all patients who were given mitoxantrone therapy.
Slovenian: V kliničnih raziskavah z bolniki z akutno levkemijo se je pomembna mielosupresija pojavila pri vseh osebah, zdravljenih z mitoksantronom.
English: Mitoxantrone causes myelosuppression as an extension of its pharmacological action.
Slovenian: Mitoksantron povzroča mielosupresijo kot posledico njegovega farmakološkega delovanja.
English: How to store Novantrone
Slovenian: Kako shranjevati zdravilo Novantrone
English: As a guide, when mitoxantrone is used in combination chemotherapy with another myelosuppressive agent, the initial dose of mitoxantrone should be reduced by 2 to 4 mg/m2 below the doses recommended for single agent usage; subsequent dosing, as outlined in the table above, depends on the degree and duration of myelosuppression.
Slovenian: Kot vodilo naj velja: ko se mitoksantron uporablja v kombinirani kemoterapiji z drugim mielosupresivnim sredstvom, je treba začetni odmerek mitoksantrona zmanjšati za 2 do 4 mg/m2 pod priporočeni odmerek za uporabo samo ene učinkovine; naknadno dajanje, kot je prikazano v zgornji tabeli, je odvisno od stopnje in trajanja mielosupresije.
English: Novantrone must not be administered under the skin (subcutaneous), in a muscle (intramuscular), or into the artery (intra-arterial).
Slovenian: Zdravilo Novantrone se ne sme dajati pod kožo (subkutano), v mišico (intramuskularno) ali v arterijo (intraarterijsko).