natgillin/translations-raw huggingface dataset:
Mitoxantrone was found to be mutagenic in bacterial and mammalian test systems, as well as in vivo in rats.
Za mitoksantron je ugotovljeno, da je mutagen v testnih sistemih bakterij in sesalcev, kot tudi in vivo pri podganah.
• if your heart is not working well;
• če imate težave z delovanjem srca,
Tubular atrophy of the testes and decreased sperm counts were observed.
Ugotovljena je bila tubularna atrofija testisov in manjše število spermijev.
Accidental overdoses have been reported.
Poročali so o nezgodnih prevelikih odmerkih.
- Congestive heart failure (severe condition where the heart cannot anymore pump enough blood).
- kongestivno srčno popuščanje (resno stanje, ko srce ne more več črpati dovolj krvi), - srčni napad,
Novantrone might increase the risk for transient or persistent absence of menstruation (amenorrhoea) in women of childbearing age.
Zdravilo Novantrone lahko poveča tveganje za začasno ali trajno odsotnost menstruacije (amenoreja) pri ženskah v rodni dobi.
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.
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.
The most serious side effects with mitoxantrone are myocardial toxicity and myelosuppression.
Najresnejša neželena stranska učinka mitoksantrona sta miokardna toksičnost in mielosupresija.
Mitoxantrone does not cross the blood-brain barrier.
Mitoksantron ne prehaja skozi krvno-možgansko pregrado.
The pharmacokinetics of mitoxantrone in patients following single-dose intravenous administration can be characterised by a three-compartment model.
Farmakokinetiko mitoksantrona pri bolnikih po intravenskem enkratnem odmerku lahko opišemo po tridelnem modelu.
Men must use an effective method of contraception during the treatment and for at least 6 months after discontinuing the treatment.
Moški morajo uporabljati učinkovito metodo kontracepcije med zdravljenjem in še vsaj 6 mesecev po koncu zdravljenja.
How to use Novantrone
Kako uporabljati zdravilo Novantrone
Medicines which may increase the risk of side effects with Novantrone:
Zdravila, ki lahko skupaj z zdravilom Novantrone povečajo tveganje za pojav neželenih učinkov:
The fraction bound is independent of concentration and is not affected by the presence of phenytoin, doxorubicin, methotrexate, prednisone, prednisolone, heparin, or aspirin.
Vezava ni odvisna od koncentracije in nanjo ne vpliva prisotnost fenitoina, doksorubicina, metotreksata, prednizona, prednizolona, heparina ali acetilsalicilne kisline.
Haematological support and antimicrobial therapy may be required during prolonged periods of severe myelosuppression.
V daljših obdobjih hude mielosupresije sta lahko potrebna hematološka podpora in protimikrobno zdravljenje.
Weight fluctuations * Acute T and B lymphoblastic leukaemia and non-Hodgkin lymphomas (NHL) are most commonly associated with TLS
Anoreksija Nihanja v telesni masi * Akutna limfoblastna levkemija T in B ter ne-Hodgkinovi limfomi so najpogosteje povezani s sindromom tumorske lize.
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.
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.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva poročanje o katerem koli domnevnem neželenem učinku zdravila, in sicer nacionalnemu centru za poročanje,
Mitoxantrone pharmacokinetics in the paediatric population is unknown.
Farmakokinetika mitoksantrona pri pediatrični populaciji ni znana.
Acute congestive heart failure may occasionally occur in patients treated with mitoxantrone for acute myeloid leukaemia.
Akutno kongestivno srčno popuščanje se lahko občasno pojavi pri bolnikih, zdravljenih z mitoksantronom zaradi akutne mieloične levkemije.
Myelosuppression can be more pronounced and longer-lasting in patients who have previously received chemotherapy or radiotherapy.
Mielosupresija je lahko izrazitejša in dolgotrajnejša pri bolnikih, ki so bili predhodno zdravljeni s kemoterapijo ali radioterapijo.
However, cardiotoxicity increases with cumulative doses.
Vendar se tveganje za kardiotoksičnost povečuje s kumulativnim odmerkom.
Phlebitis has also been reported at the site of infusion.
Opažen je bil tudi flebitis na mestu infuzije.
In a clinical trial with acute leukaemia patients, significant myelosuppression occurred in all patients who were given mitoxantrone therapy.
V kliničnih raziskavah z bolniki z akutno levkemijo se je pomembna mielosupresija pojavila pri vseh osebah, zdravljenih z mitoksantronom.
Mitoxantrone causes myelosuppression as an extension of its pharmacological action.
Mitoksantron povzroča mielosupresijo kot posledico njegovega farmakološkega delovanja.
How to store Novantrone
Kako shranjevati zdravilo Novantrone
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.
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.
Novantrone must not be administered under the skin (subcutaneous), in a muscle (intramuscular), or into the artery (intra-arterial).
Zdravilo Novantrone se ne sme dajati pod kožo (subkutano), v mišico (intramuskularno) ali v arterijo (intraarterijsko).
In metastatic breast cancer, combinations of mitoxantrone with other cytotoxic agents including cyclophosphamide and 5-fluorouracil or methotrexate and mitomycin C have been shown to be effective.
Pri metastatskem raku dojke so se kombinacije mitoksantrona z drugimi citotoksičnimi učinkovinami, vključno s ciklofosfamidom in 5-fluorouracilom ali metotreksatom in mitomicinom C, izkazale za učinkovite.
Inducers of the BCRP transporter could potentially decrease mitoxantrone exposure.
BCRP lahko zmanjšajo izpostavljenost mitoksantronu.
For patients with hepatic impairment dose adjustment may be necessary as mitoxantrone clearance is reduced by hepatic impairment.
Pri bolnikih z okvaro jeter je morda potrebna prilagoditev odmerka, saj je očistek mitoksantrona manjši zaradi okvare jeter.
This also has been reported for MS patients treated with mitoxantrone.
O tem so poročali tudi pri bolnikih z multiplo sklerozo, zdravljenih z mitoksantronom.
Mitoxantrone is active when given alone or in combination with other anticancer agents or corticosteroids.
Mitoksantron deluje samostojno ali v kombinaciji z drugimi zdravili proti raku ali kortikosteroidi.
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.
Mitoksantron in vitro zavira celice B in T ter proliferacijo makrofagov ter poslabša sposobnost antigenske prezentacije kot tudi izločanje interferona gama, tumorskega nekroznega faktorja alfa in interlevkina-2.
- Low number of special white blood cells (neutrophils).
- nizko število posebnih belih krvnih celic (nevtrofilcev),
Mitoxantrone is indicated in the treatment of non-Hodgkin's lymphoma.
Mitoksantron je indiciran za zdravljenje ne-Hodgkinovega limfoma.
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.
Mitoksantrona praviloma ne smejo prejemati bolniki z multiplo sklerozo, ki imajo bodisi LVEF < 50 % ali klinično pomembno zmanjšanje LVEF.
Do not use Novantrone: if you are allergic to mitoxantrone or any of the other ingredients of this medicine (see section 6); if you are allergic to sulphite; if you have a form of asthma (bronchial asthma) with sulphite allergy; if you are breast-feeding (see section “pregnancy and breast-feeding”).
- če ste alergični na sulfit, - če imate obliko astme (bronhialna astma) z alergijo na sulfite, - če dojite (glejte poglavje Nosečnost in dojenje).
UNIQUE IDENTIFIER - 2D BARCODE <Not applicable>
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Navedba smiselno ni potrebna.>
4.4 Special warnings and precautions for use
4.4 Posebna opozorila in varnostni ukrepi Previdnostni ukrepi so nujni pred ravnanjem z zdravilom in dajanjem zdravila
Mitoxantrone is indicated in the treatment of metastatic breast cancer.
Mitoksantron je indiciran za zdravljenje metastatskega raka dojke.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: {dan mesec leto}
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.
Dajanje zdravila brejim podganam v obdobju organogeneze je pokazalo zaostajanje rasti ploda pri odmerkih > 0,01-kratnika priporočenega odmerka za človeka na osnovi mg/m2.
Sinus bradycardia Electrocardiogram abnormal Left ventricular ejection fraction decreased
Sinusna bradikardija Nenormalen elektrokardiogram Zmanjšanje iztisne frakcije levega ventrikla
Topoisomerase II inhibitors, including mitoxantrone, when used concomitantly with other antineoplastic agents and/or radiotherapy, have been associated with the development of Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS) (see section 4.8).
Zaviralci topoizomeraze II, vključno z mitoksantronom, so v primeru sočasne uporabe z drugimi antineoplastiki in/ali obsevanjem povezani z razvojem akutne mieloične levkemije ali mielodisplastičnega sindroma (glejte poglavje 4.8).
- Irregular heart beat or slowed heart beat.
- občutek odrevenelosti, - nereden ali upočasnjen srčni utrip,
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte s svojim zdravnikom ali medicinsko sestro.
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.
Običajno je treba odmerek za starejše bolnike določiti pri spodnji meji zaradi pogostejšega zmanjšanja delovanja jeter, ledvic ali srčne funkcije ter sočasnih bolezni ali zdravljenj z drugimi zdravili.
• if you had previous therapies with anthracyclines or anthracenediones, such as daunorubicin or doxorubicin.
• če že uporabljate druga zdravila, ki vplivajo na srce, • če ste se že prej zdravili z antraciklini ali antracenedioni, kot sta daunorubicin ali doksorubicin.
The maximum lifetime cumulative dose should not exceed 72 mg/m2.
Največji kumulativni odmerek (v celem življanju) ne sme preseči 72 mg/m2.
- Skin discolouration.
- obarvanje kože,
Mitoxantrone may cause a blue-green colouration to the urine for 24 hours after administration.
Obarvanje urina in drugih tkiv Mitoksantron lahko povzroči modro-zeleno obarvanost urina 24 ur po dajanju.
- Low number of red blood cells which can cause a feeling of tiredness and shortness of breath
- nizko število rdečih krvnih celic, ki lahko povzroči občutek utrujenosti in zadihanosti (anemija).
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.
Odmerek se lahko prilagodi, če: - kombinacija zdravil zmanjšuje nastajanje belih in rdečih krvnih celic ter krvnih ploščic v kostnem mozgu bolj kot samostojna uporaba zdravila Novantrone,
Mitoxantrone alone or in combination with other cytostatic medicinal products shows objective response in patients with several types of NHL.
Mitoksantron sam ali v kombinaciji z drugimi citostatičnimi zdravili kaže objektivni odziv pri bolnikih z več vrstami ne-Hodgkinovih limfomov.
Topoisomerase II inhibitors (a groups of anticancer medicines including mitoxantrone) in combination with other chemotherapy and/or radiotherapy.
- zaviralci topoizomeraze II (skupina zdravil proti raku, vključno z mitoksantronom) v kombinaciji z drugo kemoterapijo in/ali obsevanjem.
Fatal cases of Acute Myeloid Leukaemia (AML) have been reported (see section 4.4).
Poročali so o smrtnih primerih zaradi akutne mieloične levkemije (glejte poglavje 4.4).
Novantrone is used in combination with other medicinal products in this indication; pain caused by prostate cancer at an advanced stage of prostate cancer in combination with corticosteroids; highly active relapsing multiple sclerosis associated with rapidly evolving disability where no alternative therapeutic options exist (see sections 2 and 3).
- bolečin zaradi raka prostate v poznejši fazi raka, v kombinaciji s kortikosteroidi, - zelo aktivne recidivne multiple skleroze, povezane s hitro razvijajočo se invalidnostjo, ko ni drugih možnosti zdravljenja (glejte poglavji 2 in 3).
Mitoxantrone has been detected in breast-milk for up to one month after the last administration.
Dojenje Mitoksantron je bil zaznan v materinem mleku še en mesec po zadnjem odmerku.
o Burning feeling and/or discolouration of the skin.
o bolečina, o pekoč občutek in/ali razbarvanje kože,
Hence, patients with multiple sclerosis should not receive a lifetime cumulative dose greater than 72 mg/m².
Tako običajno bolniki z multiplo sklerozo v celem življenju ne smejo prejeti kumulativnega odmerka, večjega od 72 mg/m2.
Decrease by 2 mg/m2 from prior dose, after recovery.
Predhodni odmerek zmanjšajte za 2 mg/m2, po izboljšanju.
Mitoxantrone is excreted in breast-milk and has been detected in breast-milk for up to one month after the last administration.
Mitoksantron se izloča v materino mleko je bil v njem zaznan še en mesec po zadnjem odmerku.
• if you had prior treatment of the chest with radiation;
• če ste bili pred tem na obsevanju predela prsnega koša,
Decrease by 4 mg/m from prior dose, after recovery.
Predhodni odmerek zmanjšajte za 4 mg/m2, po izboljšanju.
- Leakage of fluid into surrounding tissue (extravasation):
- uhajanje tekočine v okoliško tkivo (ekstravazacija),
Myelosuppression is a dose-limiting undesirable effect of mitoxantrone.
Mielosupresija je neželen učinek mitoksantronoma, ki omejuje odmerek.
Confusion and fatigue may occur following administration of mitoxantrone (see section 4.8).
Po prejemu odmerka mitoksantrona se lahko pojavita zmedenost in utrujenost (glejte poglavje 4.8).
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.
Za indukcijo je priporočeni odmerek 12 mg/m2 mitoksantrona na dan od 1. do 3. dne v obliki intravenske infuzije in 100 mg/m2 citarabina 7 dni v obliki stalne 24-urne infuzije od 1. do 7. dne.
Method of administration Novantrone concentrate should be given by intravenous infusion only.
Koncentrat zdravila Novantrone je treba dajati le v obliki intravenske infuzije.
Mitoxantrone is 78 % bound to plasma proteins.
Mitoksantron v 78 %
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.
Nenadna smrt** * Opažene so bile ekstravazacije na mestu infuzije, ki lahko povzročijo eritem, otekline, bolečine,
A single course of mitoxantrone 6 mg/m2 intravenous (IV) bolus, etoposide 80 mg/m2 intravenous for a period of 1 hour, and cytarabine (Ara-C) 1 g/m2 intravenous for a period of 6 hours daily for 6 days
bolusom, z 80 mg/m2 etopozida intravensko za obdobje 1 ure in z 1 g/m2 citarabina (Ara-C) intravensko za obdobje 6 ur na dan 6 dni (MEC)
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).
eritemom, oteklino, modro obarvanostjo ali razjedo, je treba dajanje takoj prekiniti (glejte poglavje 4.4).
UNIQUE IDENTIFIER - HUMAN READABLE DATA <Not applicable>
EDINSTVENA OZNAKA -V BERLJIVI OBLIKI < Navedba smiselno ni potrebna.>
Mitoxantrone clearance may be reduced by hepatic impairment.
Očistek mitoksantrona je lahko manjši zaradi okvare jeter.
Contusion Haemorrhage Hypotension
Kontuzija Krvavitev Hipotenzija
Secondary acute myeloid leukaemia and myelodysplastic syndrome Topoisomerase II inhibitors, including mitoxantrone, when used as monotherapy or especially concomitantly with other antineoplastic agents and/or radiotherapy, have been associated with the development of Acute Myeloid Leukaemia or Myelodysplastic Syndrome.
Sekundarna akutna mieloična levkemija in mielodisplastični sindrom Zaviralci topoizomeraze II, vključno z mitoksantronom, so v primeru monoterapije ali sočasne uporabe z drugimi antineoplastiki in/ali obsevanjem povezane z razvojem akutne mieloične levkemije ali mielodisplastičnega sindroma.
- Bleeding in your stomach or bowels, this may include blood in vomit, bleeding when emptying the bowels or black tarry stool.
- bolečine v trebuhu, - krvavitev v želodcu ali črevesju, kar lahko vključuje kri v bruhanju, krvavitve pri praznjenju črevesja ali črno blato,
Mitoxantrone has been demonstrated to be a substrate for the BCRP transporter protein in vitro.
Mitoksantron je dokazano substrat za prenašalca proteina odpornosti pri raku dojke (BCRP - breast cancer resistance protein) in vitro.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Če opazite kateri koli stranski učinek, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v teh navodilih.O neželenih učinkih lahko poročate tudi neposredno nacionalnemu centru za poročanje, ki je naveden v Prilogi V. S poročanjem o neželenih učinkih prispevate k zagotovitvi več informacij o varnosti tega zdravila.
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.
Kot vodilo naj velja: ko se zdravilo Novantrone uporablja v kombinirani kemoterapiji, je treba začetni odmerek zdravila Novantrone zmanjšati za 2 do 4 mg/m2 pod priporočeni odmerek za uporabo zdravila kot samostojne učinkovine.
Anaemia Neutropenia Leukopenia
Anemija Nevtropenija Levkopenija
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
Diferencialna krvna slika v 21 dneh po infuziji mitoksantrona Znaki in simptomi okužbe ter diferencialna krvna slika skladno s 3. stopnjo po SZO: naslednji odmerek 10 mg/m²
Your bone marrow can be more depressed or be depressed for a longer period if you have had chemotherpy or radiotherapy.
Vaš kostni mozeg lahko prizadane impresija tudi za daljše obdobje, če ste podvrženi kemoterapiji ali radioterapiji,
Rare (may affect up to 1 in 1,000 people) None.
Redki (lahko se pojavijo pri 1 od 1 000 bolnikov): jih ni.
Mitoxantrone must not be given subcutaneously, intramuscularly, or intra-arterially.
Mitoksantrona se ne sme dajati subkutano, intramuskularno ali intraarterijsko.
Mitoxantrone must not be given by intrathecal injection.
Mitoksantrona se prav tako ne sme dajati z intratekalnim injiciranjem.
If used alone for recurrence (return of the cancer)
V primeru samostojne uporabe pri ponovitvah raka
Signs and symptoms of infection and differential blood count with WHO grade 3 to 4: discontinuation of therapy
Znaki in simptomi okužbe ter diferencialna krvna slika skladno s 3. do 4. stopnjo po SZO: prekinitev zdravljenja
The most common side effects with mitoxantrone (seen in more than 1 patient in 10) are anaemia, leucopenia, neutropenia, infections, amenorrhoea, alopecia, nausea and vomiting.
Najpogostejši neželeni učinki mitoksantrona (opaženi pri več kot 1 bolniku od 10) so anemija, levkopenija,
Acute myeloid leukaemia:
Akutna mieloična levkemija:
Novantrone contains the active substance mitoxantrone.
Zdravilo Novantrone vsebuje zdravilno učinkovino mitoksantron.
Acute myeloid leukaemia
akutna levkemija
Detailed information on this medicine is available on the website of {MS/Agency}
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/ in na spletni strani {ime agencije v državi članici (povezava)}.
Congestive heart failure Myocardial infarction (including fatal events)
Kongestivno srčno popuščanje Miokardni infarkt (vključno s
The recommended dosage of mitoxantrone is usually 12 mg/m2 body surface area given as a short
Priporočeni odmerek mitoksantrona je običajno 12 mg/m2 telesne površine, dan v obliki kratke (približno 5
Cancer patients who received cumulative doses of 140 mg/m2 either alone or in combination with other chemotherapeutic agents had a cumulative 2.6% probability of clinical congestive heart failure.
Rakavi bolniki, ki so prejeli kumulativne odmerke 140 mg/m2 bodisi samostojno bodisi v kombinaciji z drugimi kemoterapevtiki, so beležili 2,6 % kumulativne verjetnosti klinično kongestivnega srčnega popuščanja.
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.
Napredovali rak prostate, ki se ni odzval na kastracijo Na podlagi podatkov iz dveh primerjalnih raziskav mitoksantrona plus kortikosteroidov v primerjavi s samimi kortikosteroidi znaša priporočeni odmerek mitoksantrona 12 do 14 mg/m2 v obliki kratke intravenske infuzije vsakih 21 dni, v kombinaciji z nizkimi peroralnimi odmerki kortikosteroidov.
The safety of mitoxantrone in patients with renal impairment is not established.
Varnost mitoksantrona pri bolnikih z okvaro ledvic ni ugotovljena.
Detailed information on this medicinal product is available on the website of {name of MS/Agency}
Drugi viri informacij Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu in na spletni strani {ime agencije v državi članici (povezava)}.
• cancer of white blood cells (acute myeloid leukaemia, AML)
• rak belih krvnih celic (akutna mieloidna levkemija; AML),
Novantrone concentrate must not be given subcutaneously, intramuscularly, or intra-arterially.
Koncentrata zdravila Novantrone se ne sme dajati subkutano, intramuskularno ali intraarterijsko.
Pharmacotherapeutic group: Antineoplastic agents, Anthracyclines and related substances ATC-Code: L01DB07
Oznaka ATC: L01DB07
** The casual relationship to mitoxantrone administration is uncertain.
** Vzročna povezanost z dajanjem mitoksantrona ni gotova.
Contents of the pack and other information
Shranjevanje zdravila Novantrone Vsebina pakiranja in dodatne informacije
Mitoxantrone may cause a blue-green colouration to the urine for 24 hours after administration, and patients should be advised to expect this during therapy.
Obarvanje urina in drugih tkiv Mitoksantron lahko povzroči modro-zeleno obarvanost urina 24 ur po dajanju in bolnike je treba opozoriti,