FrancophonIA/ELRC3.0 huggingface dataset:
English: A neutropenia can occur after each administration.
Slovenian: Nevtropenija se lahko pojavi po vsakem dajanju.
English: In the several studies in multiple sclerosis the effective cumulative dose ranged from 36 mg/m to 120 mg/m2.
Slovenian: V več raziskavah pri multipli sklerozi je bil učinkoviti kumulativni odmerek v razponu od 36 mg/m2 do 120 mg/m2.
English: Other medicines and Novantrone
Slovenian: Druga zdravila in zdravilo Novantrone
English: Cases of congestive heart failure with left-ventricular ejection fraction (LVEF) < 50 % have also been reported (see section 4.4).
Slovenian: Poročali so tudi o primerih kongestivnega srčnega popuščanja z iztisno frakcijo levega ventrikla (LVEF) < 50 % (glejte poglavje 4.4).
English: If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage.
Slovenian: Če je mogoče, se izogibajte žilam v sklepih ali okončinah z ogroženimi venami ali z limfno drenažo.
English: Therefore, live virus vaccines should not be administered during therapy.
Slovenian: Zato se živa cepiva med zdravljenjem ne smejo uporabljati.
English: - Changes to the colour of the whites of the eyes.
Slovenian: - izpuščaj, - spremembe v barvi beločnic,
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.
Slovenian: Ko se mitoksantron uporablja v visokih odmerkih (> 14 mg/m2/d x 3 dni), kot je indicirano za zdravljenje levkemije, se pojavi huda mielosupresija.
English: The recommended dose is based on your body surface area, which is calculated in square metres (m2) using your height and weight.
Slovenian: Priporočeni odmerek je odvisen od vaše telesne površine, ki se izračuna v kvadratnih metrih (m2) z uporabo vaše višine in telesne mase.
English: The active substance was carcinogenic in experimental animals at doses below the proposed clinical dose.
Slovenian: Zdravilna učinkovina je rakotvorna pri poskusnih živalih pri odmerkih, nižjih od predlaganih kliničnih odmerkov.
English: In comparative oncology trials, the overall cumulative probability rate of moderate or severe decreases in LVEF at this dose was 13%.
Slovenian: V primerjalnih onkoloških raziskavah je pri tem odmerku skupna kumulativna stopnja verjetnosti za zmerno ali resno zmanjšanje LVEF znašala 13 %.
English: There are very limited data on the use of mitoxantrone in pregnant women.
Slovenian: Nosečnost Podatkov o uporabi mitoksantrona pri nosečnicah je zelo malo.
English: The medicinal product must also not be given by intrathecal injection.
Slovenian: Zdravila se prav tako ne sme dajati z intratekalno injekcijo.
English: Mitoxantrone should be used with caution.
Slovenian: Mitoksantron je treba uporabljati zelo previdno.
English: This leaflet was last revised in {month YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne {mesec leto}.
English: A reversible thrombocytopenia can also be observed.
Slovenian: Opažena je tudi reverzibilna trombocitopenija.
English: Novantrone belongs to the group of medicines known as antineoplastic or anti-cancer medicines.
Slovenian: Zdravilo Novantrone spada v skupino zdravil, znanih kot antineoplastična zdravila ali zdravila proti raku.
English: It also belongs to the subgroup of anti-cancer medicines called anthracyclines.
Slovenian: Prav tako spada v podskupino zdravil proti raku, imenovanih antraciklini.
English: Oedema Extravasation* Dysgeusia
Slovenian: Ekstravazacija* Disgevzija
English: It must always be administered as an intravenous infusion (in a vein) and must always be diluted before.
Slovenian: Zdravilo mora biti vedno dano v obliki intravenske infuzije (v veno) in pred tem vedno razredčeno.
English: Its therapeutic efficacy has been reported in numerous malignancies.
Slovenian: O njegovih zdravilnih učinkih so poročali v primerih številnih malignih bolezni.
English: Distribution to tissues is extensive: steady-state volume of distribution exceeds 1,000 L/m2.
Slovenian: Porazdelitev Porazdelitev v tkiva je obsežna: porazdelitveni volumen v stanju ravnovesja presega 1.000 l/m2.
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),
Slovenian: Med 80 vključenimi bolniki so mediane vrednosti za najnižje število belih krvnih celic in trombocitov znašale 400/μl (4. stopnja po SZO) oz. 9,500/μl (4. stopnja po SZO).
English: This risk increases with cumulative dose.
Slovenian: Tveganje se povečuje s kumulativnim odmerkom.
English: The effect of gender, race, and renal impairment on mitoxantrone pharmacokinetics is unknown.
Slovenian: Učinek spola, rase in okvare ledvic na farmakokinetiko mitoksantrona ni znan.
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.
Slovenian: Zaradi pomanjkanja zadostnih podatkov o učinkovitosti pri adjuvantnem zdravljenju raka dojke in povečanega tveganja za levkemijo se sme mitoksantron uporabljati samo v primeru metastatskega raka dojke.
English: These medicines should be used with care or may need to be avoided during your treatment with Novantrone.
Slovenian: Ta zdravila je treba uporabljati previdno ali se jim izogniti med zdravljenjem z zdravilom Novantrone.
English: A lower initial dosage
Slovenian: Nižji začetni odmerek
English: - Reduction of the volume of blood that the left ventrical can pump, with no symptoms.
Slovenian: - zmanjšanje obsega krvi, ki ga lahko črpa levi prekat, brez simptomov,
English: If used with other agents against cancer:
Slovenian: Pri uporabi z drugimi zdravili proti raku:
English: Inhibitors of the BCRP transporter (e.g. eltrombopag, gefitinib) could result in an increased bioavailability.
Slovenian: Zaviralci prenašalca BCRP (npr. eltrombopag, gefitinib) lahko povzročijo povečano biološko uporabnost.
English: There have been reports of neuropathy and neurotoxicity, both central and peripheral, following intrathecal injection.
Slovenian: Obstajajo poročila o nevropatiji in nevrotoksičnosti, tako centralni kot periferni, zaradi intratekalnega injiciranja.
English: The infusion liquid can leak out of the vein into the tissue (extravasation).
Slovenian: Tekočina infuzije lahko uhaja iz vene v tkivo (ekstravazacija).
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.
Slovenian: V naslednjih ciklih se predhodni odmerek običajno lahko ponovi, če se je število belih krvnih celic in trombocitov po 21 dneh vrnilo na normalno raven.
English: Haematopoietic, gastrointestinal, hepatic or renal toxicity may be seen, depending on the dosage given and the physical condition of the patient.
Slovenian: Lahko se pojavijo hematopoetska, gastrointestinalna, jetrna ali ledvična toksičnost, odvisno od odmerka in fizičnega stanja bolnika.
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.
Slovenian: Priporočljivo je pogosto spremljanje periferne krvne slike pri vseh bolnikih, ki prejemajo mitoksantron, z namenom nadzorovanja pojava supresije kostnega mozga, predvsem nevtropenije, ki je lahko huda in povzroči okužbo.
English: The tubing should be inserted preferably into a large vein.
Slovenian: Cevko je treba po možnosti vstaviti v veliko veno.
English: Levels of uric acid, electrolytes and urea should be monitored.
Slovenian: Spremljati je treba raven sečne kisline, elektrolitov in sečnine.
English: - Heavy bleeding.
Slovenian: - močne krvavitve,
English: Adjustments of the anticoagulant dose may be necessary in order to maintain the desired level of anticoagulation.
Slovenian: Za ohranitev želene ravni antikoagulantov bo morda treba prilagoditi odmerek antikoagulantov .
English: For this reason, patients should be monitored for evidence of cardiac toxicity and questioned about symptoms of heart failure prior to the initiation of and during treatment.
Slovenian: Zato je treba biti pri bolnikih pozoren na znake srčne toksičnosti in jih spraševati o simptomih srčnega popuščanja pred začetkom zdravljenja in med njim.
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.
Slovenian: Zdravilo Novantrone se prav tako ne sme injicirati v prostor pod možgani ali v hrbtenjačo (intratekalno injiciranje), saj to lahko povzroči hude poškodbe s trajnimi okvarami.
English: What Novantrone is and what it is used for
Slovenian: Kaj je zdravilo Novantrone in za kaj ga uporabljamo
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.
Slovenian: Hematološko toksičnost je pri akutni levkemiji težko oceniti, ker so tradicionalni parametri depresije kostnega mozga, kot je število belih krvnih celic in trombocitov, zamegljeni zaradi zamenjave mozga z levkemičnimi celicami.
English: Patients who receive immunosuppressive agents like mitoxantrone have a reduced immunological response to infection.
Slovenian: Bolniki, ki prejemajo imunosupresivna zdravila, kot je mitoksantron, beležijo zmanjšan imunski odziv na okužbo.
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.
Slovenian: Zaradi možnosti resnih neželenih učinkov pri dojenčkih zaradi mitoksantrona je dojenje kontraindicirano (glejte poglavje 4.3) in ga je treba prekiniti pred začetkom zdravljenja.
English: What Novantrone is and what it is used for What you need to know before you use Novantrone How to use Novantrone
Slovenian: Kaj vsebujejo ta navodila Kaj je zdravilo Novantrone in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Novantrone Kako uporabljati zdravilo Novantrone
English: Your doctor will do heart function tests before you start Novantrone and at regular intervals during therapy.
Slovenian: Vaš zdravnik bo opravljal teste delovanja srca preden se začnete zdraviti z zdravilom Novantrone in v rednih časovnih presledkih med zdravljenjem.
English: The treatment must not be initiated in patients who have been previously treated with mitoxantrone.
Slovenian: Zdravljenja se ne sme začeti pri bolnikih, ki so bili predhodno zdravljeni z mitoksantronom.
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
Slovenian: V teh študijah ni bilo opaziti teratogenih učinkov, vendar so bili največji preizkušeni odmerki nižji od priporočenega odmerka za človeka (0,02- in 0,05-kratnik pri podganah in kuncih oziroma na osnovi mg/m2).
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.
Slovenian: Testi srčne funkcije pred in med zdravljenjem z zdravilom Novantrone Zdravilo Novantrone lahko poškoduje vaše srce in povzroči poslabšanje vaše srčne funkcije ter v hujših primerih srčno popuščanje.
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.
Slovenian: Cepljenje in imunizacija (zaščita pred cepilnimi snovmi) morda ne bosta učinkovita med zdravljenjem z zdravilom Novantrone in še 3 mesece po koncu zdravljenja.
English: Mutagenicity and carcinogenicity
Slovenian: Mutagenost in rakotvornost
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.
Slovenian: V primeru nehematološke toksičnosti 2. do 3. stopnje po SZOje treba naslednji odmerek prilagoditi na 10 mg/m2, v primeru nehematološke toksičnosti 4. stopnje pa je treba zdravljenje prekiniti.
English: Dosage modification and the timing of subsequent dosing should be determined by clinical judgment depending on the degree and duration of myelosuppression.
Slovenian: Prilagajanje odmerjanja in čas nadaljnjega odmerka je treba določiti na podlagi klinične ocene, odvisno od stopnje in trajanja mielosupresije.
English: If you become pregnant during the treatment with Novantrone, you must tell your doctor immediately and stop treatment with Novantrone.
Slovenian: Če zanosite med zdravljenjem z zdravilom Novantrone, morate o tem nemudoma obvestiti svojega zdravnika in prekiniti zdravljenje z zdravilom Novantrone.
English: It has a cytocidal effect on both proliferating and non-proliferating cultured human cells, suggesting lack of cell cycle phase specificity and activity against rapidly proliferating and slow-growing neoplasms.
Slovenian: Ima citocidno delovanje na deleče in nedeleče se človeške celice v kulturi, kar kaže na pomanjkanje specifičnosti za fazo celičnega cikla in na aktivnost tako proti hitro delečim se kot počasi rastočim novotvorbam.
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.
Slovenian: Zdravljenje z 12 mg/m² mitoksantrona vsake tri mesece je bilo boljše od 5 mg/m² in placeba v eni klinični študiji z visoko aktivno vnetno MS.
English: Before you start Novantrone and during treatment, your doctor will do a blood test to count the number of your blood cells.
Slovenian: Preden začnete jemati zdravilo Novantrone in med zdravljenjem bo zdravnik opravil krvne teste, da bi preveril število krvnih celic.
English: The combination of mitoxantrone with other immunosuppressive agents may increase the risk of excessive immunodepression and lymphoproliferative syndrome.
Slovenian: Kombinacija mitoksantrona in drugih imunosupresivnih zdravil lahko poveča tveganje za prekomerno imunosupresijo in limfoproliferativni sindrom.
English: Mitoxantrone blocks the cell cycle in G2-phase leading to an increase of cellular RNA and polyploidy.
Slovenian: Mitoksantron zavira cikel celic v fazi G2, kar vodi v povečanje količine celične RNA
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).
Slovenian: Mitoksantron je indiciran za zdravljenje bolnikov z zelo aktivno recidivno multiplo sklerozo, povezano s hitro razvijajočo se invalidnostjo, ko ni drugih možnosti zdravljenja (glejte poglavja 4.2, 4.4 in 5.1).
English: Cardiotoxicity can occur at any time during mitoxantrone therapy, and the risk increases with cumulative dose.
Slovenian: Kardiotoksičnost lahko pojavi kadar koli med zdravljenjem z mitoksantronom, tveganje pa se povečuje s kumulativnim odmerkom.
English: Novantrone is secreted into breast milk and may cause serious adverse reactions in your baby.
Slovenian: Zdravilo Novantrone se izloča v materino mleko in lahko povzroči resne neželene učinke pri vašem otroku.
English: Anaphylaxis/anaphylactoid reactions (including shock)
Slovenian: Anafilaksija/anafilaktoidne reakcije (vključno s šokom)
English: Four patients receiving 140 to 180 mg/m2 as a single bolus injection died as a result of severe leukopenia with infection.
Slovenian: Štirje bolniki, ki so prejeli 140 do 180 mg/m2 v obliki enkratne bolusne injekcije, so umrli zaradi hude levkopenije z okužbo.
English: Novantrone prevents cancer cells from growing, as a result of which they eventually die.
Slovenian: Zdravilo Novantrone rakavim celicam preprečuje rast, zaradi česar na koncu umrejo.
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.
Slovenian: Aktivna ali mirujoča kardiovaskularna bolezen, predhodno ali sočasno obsevanje mediastinalnega/perikardnega območja, predhodno zdravljenje z drugimi antraciklini ali antracendioni ali sočasna uporaba drugih kardiotoksičnih zdravil lahko povečajo tveganje toksičnosti za srce.
English: Combining mitoxantrone with potentially cardiotoxic active substances (e.g. anthracyclines) increases the risk of cardiac toxicity.
Slovenian: Kombiniranje mitoksantrona s potencialno kardiotoksičnimi zdravilnimi učinkovinami (npr. antraciklini) poveča tveganje za srčno toksičnost.
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.
Slovenian: Če jemljete zdravilo Novantrone za zdravljenje multiple skleroze, bo vaš zdravnik opravljal teste delovanja srca pred začetkom zdravljenja, pred vsakim nadaljnjim odmerkom in vsako leto do 5 let po koncu zdravljenja.
English: Treatment with mitoxantrone 12 to 14 mg/m² was effective in the treatment of various cancers.
Slovenian: Klinična učinkovitost in varnost Zdravljenje z 12 do 14 mg/m² mitoksantrona je bilo učinkovito pri zdravljenju različnih vrst raka.
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.
Slovenian: Razen za zdravljenje akutne mieloične levkemije se mitoksantrona praviloma ne sme dajati bolnikom z izhodiščnim številom nevtrofilcev manj kot 1.500 celic/mm3.
English: There have been reports of local/regional neuropathy, some irreversible, following intra-arterial injection.
Slovenian: Obstajajo poročila o lokalni/regionalni nevropatiji, tudi z nepovratnimi posledicami, zaradi intraarterijskega injiciranja.
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).
Slovenian: Spodnja tabela vsebuje predloge kot smernice prilagajanja odmerkov pri zdravljenju metastatskega raka dojke in ne-Hodgkinovega limfoma glede na hematološko najnižjo raven (ki se običajno pojavi približno 10 dni po dajanju).
English: Carcinogenic effects were seen in rat and in male mice.
Slovenian: Rakotvorni učinki so bili opaženi pri podganah in mišjih samcih.
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.
Slovenian: Dolgoročno uporabnost mitoksantrona omejuje pojav odpornosti raka, ki se lahko konča s smrtnim izidom, kadar se uporablja kot zdravilo zadnje izbire.
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.
Slovenian: V kliničnih študijah z odmerkom 12 mg/m2 vsak dan 5 dni je bila pri bolnikih, ki so dosegli popolno remisijo, ta rezultat prvega kroga indukcijskega zdravljenja.
English: Mitoxantrone is genotoxic and is considered a potential human teratogen.
Slovenian: Mitoksantron je genotoksičen in velja za potencialno teratogenega pri ljudeh.
English: Laboratory measurement cannot predict clearance of the active substance and dose adjustments (see section 5.2).
Slovenian: Na podlagi laboratorijskih meritev ni mogoče predvideti očistka zdravilne učinkovine in prilagajanja odmerkov (glejte poglavje 5.2).
English: Mitoxantrone is excreted slowly in urine and faeces as either unchanged active substance or as inactive metabolites.
Slovenian: Mitoksantron se izloča počasi z urinom in blatom bodisi kot nespremenjena zdravilna učinkovina bodisi kot neaktivni presnovki.
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.
Slovenian: Koncentrat zdravila Novantrone je treba počasi injicirati v prosto tekočo intravensko infuzijo izotonične fiziološke raztopine ali 5-odstotne raztopine glukoze v obdobju, ki ni krajše od 3 do 5 minut.
English: The combination of vitamin K antagonists and cytotoxic agents may result in an increased risk of bleeding.
Slovenian: Kombinacija antagonistov vitamina K in citotoksičnih zdravil lahko povzroči povečano tveganje za krvavitve.
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.
Slovenian: Cepljenje in imunizacija morda ne bosta učinkovita med zdravljenjem z zdravilom Novantrone in 3 mesece po koncu zdravljenja, - če ste noseči ali če s partnerjem poskušata zanositi,
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.
Slovenian: Čeprav niso preučevali bolnikov s hudo ledvično odpovedjo, se mitoksantron v veliki meri veže na tkivo in ni verjetno, da bi peritonealna dializa ali hemodializa ublažili učinek zdravljenja ali toksičnost.
English: (12 mg/m2 or less) is recommended in patients with inadequate bone marrow reserves e.g. due to prior chemotherapy or poor general condition.
Slovenian: (12 mg/m2 ali manj) se priporoča pri bolnikih s pomanjkljivimi rezervami kostnega mozga, npr. zaradi kemoterapije ali slabega splošnega stanja.
English: The haematopoietic system was the primary target organ of toxicity showing myelosuppression.
Slovenian: Hematopoetski sistem je bil primarni tarčni organ toksičnosti, kar se odraža z mielosupresijo.
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.
Slovenian: Mitoksantron je v kombinaciji s citarabinom v obliki začetnega indukcijskega zdravljenja vsaj tako učinkovit za indukcijo remisije kot kombinacije z daunorubicinom pri odraslih bolnikih s predhodno nezdravljeno
English: Novantrone has a minor effect on your ability to drive and use machines.
Slovenian: Zdravilo Novantrone ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
English: In combination regimens mitoxantrone, in starting doses ranging from 7 to 8 to 10 to 12 mg/m2, dependent on the combination and frequency used, has shown effectiveness.
Slovenian: Pri kombiniranem zdravljenju se je mitoksantron, v začetnem odmerku v razponu od 7 do 8 do 10 do 12 mg/m2 , odvisno od kombinacije in pogostosti uporabe, izkazal za učinkovitega.
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.
Slovenian: Mitoksantron posega tudi v ribonukleinsko kislino (RNK) in je močan zaviralec topoizomeraze II, encima, odgovornega za odvijanje in popravilo poškodovanega DNK.
English: A complete blood count, including platelets, should be obtained prior to administration of the initial dose of mitoxantrone, 10 days following the administration and prior to each subsequent infusion and in the event that signs and symptoms of infection develop.
Slovenian: Popolno krvno sliko, vključno s trombociti, je treba pridobiti pred dajanjem začetnega odmerka mitoksantrona, 10 dni po dajanju in pred vsako naslednjo infuzijo ter v primeru pojava znakov in simptomov okužbe.