natgillin/translations-raw huggingface dataset:
In view of the above, the Committee concluded that the benefit-risk balance of Novantrone and associated names remains favourable, subject to the agreed condition to the marketing authorisations set out in Annex IV, and taking into account the agreed amendments to the product information and other risk minimisation measures. 
Glede na navedeno je odbor zaključil, da je razmerje med tveganji in koristmi zdravila Novantrone in povezanih imen še naprej ugodno, ob upoštevanju dogovorjenega pogoja za dovoljenja za promet z zdravilom, opredeljenega v Prilogi IV, in ob upoštevanju dogovorjenih sprememb informacij o zdravilu in drugih dejavnosti za zmanjševanje tveganja.
The MAH proposed that only the administration via intravenous infusion should be retained, which was accepted. 
Imetnik dovoljenja za promet z zdravilom je predlagal, da se ohrani le dajanje z intravensko infuzijo, kar je bilo sprejeto.
Considering the risks of cardiotoxicity and leukaemia, the CHMP was of the view that mitoxantrone use should be limited to the population in which the benefits would outweigh these serious risks. 
Ob upoštevanju tveganja za kardiotoksičnost in levkemijo je odbor CHMP menil, da mora biti uporaba mitoksantrona omejena na populacije, pri katerih bi koristi odtehtale ta resna tveganja.
In some member states, additional information was included on absence of interactions or pharmacokinetic and pharmacodynamic interactions without clinical relevance, this was not considered relevant to be included in the harmonised PI. 
Za v nekaterih državah članicah vključene dodatne podatke o odsotnosti interakcij ali farmakokinetičnih in farmakodinamičnih interakcijah brez kliničnega pomena je bilo ocenjeno, da jih v usklajene informacije o zdravilu ni smiselno vključiti.
As the harmonised indication is in the treatment of metastatic breast cancer, a warning in section 4.4 informing of the small risk of leukaemia and of the paucity of efficacy data in the adjuvant treatment of breast cancer was considered sufficient. 
Ker je zdravljenje metastatskega raka dojke usklajena indikacija, se je opozorilo v poglavju 4.4 o majhnem tveganju za levkemijo in pomanjkanju podatkov o učinkovitosti pri adjuvantnem zdravljenju raka dojke štelo za zadostno.
The studies presented included in majority patients with metastatic breast cancer, this patient population was therefore considered acceptable for the harmonised indication. 
Predstavljene študije so v glavnem vključevale bolnike z metastatskim rakom dojke, zato je bila ta populacija bolnikov ocenjena kot sprejemljiva za usklajeno indikacijo.
Novantrone and associated names are approved for marketing as a 2mg/ml concentrate for solution for infusion for intravenous use in most European Union (EU) Member States (MS). 
Zdravilo Novantrone in povezana imena so kot 2 mg/ml koncentrat za raztopino za infundiranje za intravensko uporabo odobrena v večini držav članic Evropske unije (EU).
The CMHP followed this advice and considered that given their importance for the safe use of the product, the RMP and educational materials should be imposed as a condition to the MA while the study should be included in the RMP as a category 3. 
Odbor CHMP je temu nasvetu sledil in presodil, da morata biti zaradi svojega pomena za varno uporabo zdravila RMP in izobraževalno gradivo pogoj za imetnika dovoljenja za promet z zdravilom, študijo pa je treba v RMP vključiti kot kategorijo 3.
Current guidelines for treatment of AML recommend an induction therapy with regimens containing an anthracycline (such as mitoxantrone) administered for 3 days and cytarabine administered for 7 days. 
Trenutne smernice za zdravljenje AML priporočajo indukcijsko zdravljenje s shemami, pri katerih se antraciklin (npr. mitoksantron) daje tri dni in citarabin sedem dni.
Dilution recommendation and guidance for the choice of veins as well as warning regarding extravasation, were considered adequate. 
Priporočilo o redčenju in navodilo za izbiro ven ter opozorilo o ekstravazaciji so bili ocenjeni kot primerni.
Although mitoxantrone is not one of the most frequently used chemotherapy regimens in NHL, the CHMP acknowledged that it could represent an alternative treatment option and considered the proposed harmonised wording acceptable. 
Čeprav mitoksantron ni med najpogosteje uporabljanimi kemoterapevtskimi shemami za zdravljenje NHL, je odbor CHMP menil, da bi lahko bil alternativna možnost zdravljenja, in je predlagano usklajeno besedilo ocenil kot sprejemljivo.
The CMHP considered that mitoxantrone should be contraindicated in breastfeeding mothers as it is a potential human teratogen. 
Odbor CHMP je presodil, da mora biti mitoksantron kontraindiciran pri doječih materah, saj je potencialni humani teratogen.
General dose lowering for other serious toxicity, including recommendation to discontinue treatment in case of WHO grade 4 toxicity, were also accepted. 
Sprejeto je bilo tudi splošno znižanje odmerka pri drugi resni toksičnosti, vključno s priporočilom, da se zdravljenje v primeru toksičnosti 4. stopnje po lestvici SZO prekine.
This indication is currently authorised in only two MSs and current clinical practice guidelines do not support the use of mitoxantrone in ALL. 
Ta indikacija je trenutno odobrena le v dveh državah članicah, uporabe mitoksantrona pri ALL pa tudi ne podpirajo trenutne smernice za klinično prakso.
The CHMP as a consequence, recommends the variation to the terms of the marketing authorisations for Novantrone and associated names (see Annex I). 
Odbor CHMP zato priporoča spremembo pogojev dovoljenj za promet z zdravilom Novantrone in povezanimi imeni (glejte Prilogo I).
Contraindications against the incorrect routes of administration, due to the risk of extravasation and other contraindications in place in a few member states were also considered more adequately addressed by wording in other sections of the PI. 
Tudi za kontraindikacijo za nepravilne poti uporabe zaradi tveganja ekstravazacije in za druge kontraindikacije v nekaterih državah članicah je bilo ocenjeno, da jih je primerneje obravnavati v drugih poglavjih informacij o zdravilu.
Changes introduced in the SmPC were consistently reflected in the labelling, however most sections were left to be completed nationally. 
Spremembe, ki so jih uvedli v povzetek glavnih značilnosti zdravila, so bile dosledno vključene v označevanje, vendar je treba večino poglavij dopolniti na nacionalni ravni.
The CHMP considered that the efficacy of mitoxantrone has been demonstrated in these studies. 
Odbor CHMP je presodil, da je bila s temi študijami dokazana učinkovitost mitoksantrona.
The MAH's proposal including the fatal cases reported with overdosage was accepted with the addition of the types of toxicities observed and general recommended actions. 
Predlog imetnika dovoljenja za promet z zdravilom, vključno s poročili o primerih smrti pri prevelikem odmerjanju, je bil sprejet, pri čemer so bili dodani opažene vrste toksičnosti in splošni priporočeni ukrepi.
• The Committee considered the identified divergences for Novantrone and associated names, for the indications, posology, contraindications, special warnings and precaution for use, as well as the remaining sections of the SmPC, labelling and package leaflet. 
• odbor je upošteval ugotovljene razlike za zdravilo Novantrone in povezana imena za indikacije, odmerjanje, kontraindikacije, posebna opozorila in previdnostne ukrepe ter preostala poglavja povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
The standard contraindication in case of hypersensitivity to the active substance or any of the excipients (including sulphite, as already mentioned in some member states) was kept in the harmonised text. 
V usklajenem besedilu je ostala standardna kontraindikacija pri preobčutljivosti na zdravilno učinkovino ali katero koli pomožno snov (tudi sulfit, kot je bilo v nekaterih državah članicah že omenjeno).
Information on the need for contraception in men was added to that already included for women and both were adjusted considering mitoxantrone half-life and respective gamete cycles length in men and women. 
Poleg informacije, da je potrebna kontracepcija pri ženskah, je bila dodana tudi informacija o potrebi po kontracepciji pri moških, obe pa sta bili posodobljeni na podlagi podatkov o razpolovni dobi mitoksantrona in dolžinah gametnega ciklusa pri moških in ženskah.
Although the level of evidence is limited, the CHMP recognised that in selected cases and at the discretion of the treating physician the addition of mitoxantrone to combination regimens could be of benefit to this patient population, and accepted the indication. 
Čeprav je stopnja dokazov nizka, je odbor CHMP ugotovil, da bi v izbranih primerih in po presoji lečečega zdravnika dodatek mitoksantrona h kombiniranim shemam tej populaciji bolnikov lahko koristil, in sprejel indikacijo.
Treatment of metastatic breast cancer 
Zdravljenje metastatskega raka dojke
In the studies presented, albeit, limited in number and in heterogeneous populations, mitoxantrone demonstrated a consistent effect on relapses as well as disability. 
V predloženih študijah, ki so bile po številu in heterogenosti populacij sicer omejene, se je mitoksantron dosledno izkazal kot učinkovit za zdravljenje relapsov in zmanjševanje invalidnosti.
Pain relief in patients with advanced, castrate-resistant prostate cancer, in combination with corticosteroids 
Lajšanje bolečine pri bolnikih z napredovalim, proti kastraciji odpornim rakom prostate, v kombinaciji s kortikosteroidi
In multiple sclerosis a flexible dosing schedule was agreed in order to reflect those used in clinical trials and practices in the different member states. 
Pri multipli sklerozi je bil zaradi upoštevanja shem odmerjanja v kliničnih preizkušanjih in praks v različnih državah članicah sprejet dogovor o fleksibilni shemi odmerjanja.
The CHMP considered the level of evidence currently available insufficient to support the use of mitoxantrone in hepatocellular carcinoma, which the MAH accepted and therefore withdrew this indication from the proposed harmonised PI. 
Odbor CHMP je stopnjo trenutno razpoložljivih dokazov ocenil kot nezadostno, da bi bilo mogoče podpreti uporabo mitoksantrona pri hepatocelularnem karcinomu, kar je imetnik dovoljenja za promet z zdravilom sprejel in je zato to indikacijo umaknil iz predlaganih usklajenih informacij o zdravilu.
The CMHP followed the advice of the SAG and agreed on an operational definition for the indication in the harmonised product information. 
Odbor CHMP je upošteval nasvet znanstvene svetovalne skupine in podal soglasje k operativni opredelitvi za to indikacijo v usklajenih informacijah o zdravilu.
The CMHP was of the view that overall the evidence provided was insufficient, in particular considering the large heterogeneity among acute leukaemia patients. 
Po mnenju odbora CHMP v celoti gledano predloženi dokazi, zlasti ob upoštevanju velike heterogenosti bolnikov z akutno levkemijo, niso bili zadostni.
It is also authorised in a few EU MS as 2mg/ml concentrate for solution for injection or solution for intrapleural or intraperitoneal use and as concentrate for solution for injection/infusion. 
V nekaterih državah članicah EU je zdravilo Novantrone odobreno tudi kot 2 mg/ml koncentrat za raztopino za injiciranje za intraplevralno ali intraperitonealno uporabo in kot koncentrat za raztopino za injiciranje/infundiranje.
It is recognised that mitoxantrone is currently given in clinical practice to patients with CRPC to achieve palliation after exhaustion of other available treatment options. 
Znano je, da se mitoksantron v trenutni klinični praksi daje bolnikom s KORP z namenom lajšanja simptomov po izčrpanju drugih razpoložljivih možnosti zdravljenja.
Novantrone contains mitoxantrone, a synthetic anthracenedione antineoplastic agent that has a cytocidal effect on both proliferating and non-proliferating cultured human cells, suggesting activity against rapidly proliferating and slow-growing neoplasms. 
Zdravilo Novantrone vsebuje mitoksantron, sintetično antracendionsko antineoplastično snov, ki citocidno učinkuje na proliferacijske in neproliferacijske gojene človeške celice, kar kaže na delovanje proti hitro proliferacijskim in počasi rastočim novotvorbam.
Palliation of non-resectable primary hepatocellular carcinoma 
Lajšanje simptomov pri neresektabilnem primarnem hepatocelularnem karcinomu
The MAH proposed harmonised dosing recommendations based on the doses studied in clinical trials and a general recommendation to monitor cardiac toxicity in cancer patients. 
Imetnik dovoljenja za promet z zdravilom je predlagal usklajena priporočila za odmerjanje na osnovi odmerkov, ki so jih preučevali v kliničnih preizkušanjih, in splošno priporočilo o spremljanju kardiotoksičnosti pri bolnikih z rakom.
Common dosing recommendations were proposed for metastatic breast cancer and non-Hodgkin's lymphoma including dose reduction guidance for use in combination therapy and in case of myelosuppression. 
Predlagana so bila skupna priporočila o odmerjanju za metastatski rak dojke in ne-Hodgkinov limfom, vključno z navodili za zmanjševanje odmerka pri kombiniranem zdravljenju in ob mielosupresiji.
In addition, due to the risk of development of secondary malignancies, the benefit-to-risk ratio of mitoxantrone therapy should be determined before starting therapy. 
Poleg tega je treba zaradi tveganja za razvoj sekundarnih malignih bolezni pred začetkom zdravljenja z mitoksantronom določiti razmerje med tveganji in koristmi zdravljenja.
No significant differences between the national SmPCs were present in this section. 
V tem poglavju ni bilo večjih razlik med nacionalnimi povzetki glavnih značilnosti zdravila.
• The Committee considered that additional risk minimisation measures in the form of educational materials for the use of Novantrone and associated names in multiple sclerosis were necessary. 
• odbor je ocenil, da so za uporabo zdravila Novantrone in povezanih imen pri multipli sklerozi potrebne dodatne dejavnosti za zmanjševanje tveganja v obliki izobraževalnega gradiva.
Remission-induction treatment of blast crisis in chronic myeloid leukaemia, in combination regimen 
Indukcijsko zdravljenje blastne krize pri kronični mieloični levkemiji v kombinirani shemi
In order to effectively minimise these risk the CMHP considered that in addition to the MAH proposal to evaluate the LVEF prior to each dose of mitoxantrone in multiple sclerosis patients, it should also be monitored yearly for up to 5 years after the end of therapy and the maximum cumulative dose should not be exceeded. 
Da bi učinkovito zmanjšal ta tveganja, je odbor CHMP presodil, da je treba pri bolnikih z multiplo sklerozo LVEF meriti ne le pred vsakim odmerkom mitoksantrona, kot je predlagal imetnik dovoljenja za promet z zdravilom, ampak tudi vsako leto vsaj še pet let po končanem zdravljenju, poleg tega pa se ne sme preseči največji kumulativni odmerek.
The CHMP sought the advice of the SAG Neurology in order to gain insight into the current clinical use of mitoxantrone and clearly define the patient population which can benefit from this treatment. 
Odbor CHMP se je za nasvet obrnil na znanstveno svetovalno skupino za nevrologijo, da bi dobil vpogled v trenutno klinično uporabo mitoksantrona in jasno opredelil populacijo bolnikov, ki bi ji to zdravljenje lahko koristilo.
• The Committee agreed the harmonisation of the summary of product characteristic, labelling and package leaflet. 
• odbor je soglašal z uskladitvijo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
The SAG considered that mitoxantrone could be used in treatment of inflammatory active multiple sclerosis associated with accumulation of disability where no other treatment option is available. 
Znanstvena svetovalna skupina je presodila, da bi se mitoksantron lahko uporabljal pri vnetno aktivni multipli sklerozi, povezani z napredovanjem invalidnosti, pri kateri ni na voljo nobena druga možnost zdravljenja.
These studies demonstrate the efficacy of mitoxantrone, in combination therapy, in the treatment of NHL. 
Te študije so pokazale učinkovitost mitoksantrona pri zdravljenju NHL v kombiniranem zdravljenju.
In some MS Novantrone was contraindicated for use as an adjuvant treatment for breast cancer, in relation to the possible risk of leukaemia. 
V nekaterih državah članicah je bilo zdravilo Novantrone kontraindicirano pri adjuvantnem zdravljenju raka dojke zaradi potencialnega tveganja za levkemijo.
The results suggested a dose-response effect which forms supporting evidence of biological activity of mitoxantrone in multiple sclerosis. 
Rezultati so nakazali odziv (učinek) v odvisnosti od odmerka, kar je podkrepilo dokaze o biološkem delovanju mitoksantrona pri multipli sklerozi.
There are currently three main indications, approved in all member states where Novantrone has a marketing authorisation (MA), with however divergences in their exact wording: treatment of metastatic breast cancer, treatment of non-Hodgkin's lymphoma, treatment of acute myeloid leukaemia (acute non-lymphocytic leukaemia). 
Trenutno obstajajo tri glavne indikacije, ki so odobrene v vseh državah članicah, kjer ima zdravilo Novantrone dovoljenje za promet, pri čemer pa se njihovo besedilo nekoliko razlikuje: zdravljenje metastatskega raka dojke, zdravljenje ne-Hodgkinovega limfoma, zdravljenje akutne mieloične levkemije (akutne nelimfocitne levkemije).
It is also used to alleviate pain in prostate cancer in combination with corticosteroids and its immunosuppressant and immunomodulatory properties provide a rationale for use of mitoxantrone in highly active multiple sclerosis. 
V kombinaciji s kortikosteroidi se uporablja tudi za lajšanje bolečine pri raku prostate, imunosupresivne in imunomodularne lastnosti mitoksantrona pa so razlog za njegovo uporabo pri visoko aktivni multipli sklerozi.
In addition, the CMHP requested the advice of the SAG and of the PRAC regarding the need for additional risk minimisation measures. 
Poleg tega se je odbor CHMP za nasvet o potrebi po dodatnih dejavnostih za zmanjševanje tveganja obrnil na znanstveno svetovalno skupino in odbor PRAC.
The data indicate an effect of mitoxantrone, in combination with corticosteroids, for the palliation (e.g. pain relief) of patients with advanced castrate-resistant prostate cancer (CRPC). 
Podatki kažejo, da je mitoksantron v kombinaciji s kortikosteroidi učinkovit pri lajšanju simptomov (npr. lajšanju bolečine) pri bolnikih z napredovalim, proti kastraciji odpornim rakom prostate (KORP).
• The Committee reviewed the data submitted by the MAH in support of the proposed harmonisation of the Product Information, including clinical trials, open studies, published studies and reviews as well as evidence based and consensus guidelines. 
• odbor je pregledal podatke, ki jih je v podporo predlagani uskladitvi informacij o zdravilu predložil imetnik dovoljenja za promet z zdravilom, vključno s kliničnimi preizkušanji, odprtimi študijami,
The MAH has submitted an overview of studies performed in this indication including single agent studies and large randomised comparative studies using mitoxantrone in combination with other agents and comparing with other regimens. 
Imetnik dovoljenja za promet z zdravilom je predložil pregled za to indikacijo izvedenih študij, vključno s študijami z eno samo učinkovino in velikimi randomiziranimi primerjalnimi študijami, v katerih so mitoksantron uporabili v kombinaciji z drugimi učinkovinami in primerjali z drugimi shemami.
The CHMP considered the clinical benefit of mitoxantrone demonstrated in adults and recommended the use of the term acute myeloid leukaemia rather than acute non-lymphocytic leukaemia. 
Odbor CHMP je presodil, da so bile klinične koristi mitoksantrona pri odraslih dokazane, in namesto izraza „akutna nelimfocitna levkemija“ priporočil uporabo izraza „akutna mieloična levkemija“.
For acute myeloid leukaemia dosing recommendations were proposed as a single agent in relapses and in combination as induction, consolidation and salvage therapy. 
Za akutno mieloično levkemijo so bila predlagana priporočila o odmerjanju pri samostojni uporabi pri relapsih in v kombinaciji v indukcijskem, konsolidacijskem in rešilnem zdravljenju.
The MAH presented an overview of studies of mitoxantrone, mainly in patients with relapsing remitting and secondary progressive multiple sclerosis. 
Imetnik dovoljenja za promet z zdravilom je predložil pregled študij mitoksantrona, predvsem pri bolnikih z relapsno-remitentno in sekundarno progresivno multiplo sklerozo.
Therefore the CHMP agreed to the proposed indication in CRPC intended specifically for palliation. 
Odbor CHMP je zato soglašal s predlagano indikacijo za lajšanje simptomov pri KORP.
Novantrone is indicated in adults in a number of malignancies, including breast carcinoma, acute leukaemia and non-Hodgkin's lymphoma. 
Zdravilo Novantrone je indicirano pri odraslih za zdravljenje številnih vrst malignih bolezni, med drugim karcinoma dojke, akutne levkemije in neHodgkinovega limfoma.
In addition, indications in treatment of hepatoma/hepatocellular carcinoma, pain relief in patients with advanced, hormone-resistant prostate cancer (in combination with corticosteroids), reduction of neurologic disability and clinical relapses in secondary (chronic) progressive multiple sclerosis, treatment of blast crisis in (chronic) myeloid leukaemia and treatment of acute lymphocytic leukaemia are included in some of the MSs where Novantrone has a MA. 
Poleg tega so v nekaterih državah članicah, kjer ima zdravilo Novantrone dovoljenje za promet, med indikacije vključeni tudi zdravljenje hepatoma/hepatocelularnega karcinoma, lajšanje bolečine pri bolnikih z napredovalim hormonsko odpornim rakom prostate (v kombinaciji s kortikosteroidi), zmanjševanje nevrološke invalidnosti in števila kliničnih relapsov pri sekundarni (kronični) progresivni multipli sklerozi, zdravljenje blastne krize pri (kronični) mieloični levkemiji in zdravljenje akutne limfocitne levkemije.
The cardiovascular and leukaemia risks were considered key to the benefit-risk balance in the multiple sclerosis indication and were reviewed in details as well as risk minimisation measures proposed to manage those. 
Kot ključna za razmerje med tveganji in koristmi pri indikaciji za multiplo sklerozo so bila prepoznana in natančno pregledana kardiovaskularna tveganja in tveganja za levkemijo, pri čemer so bile za njihovo obvladovanje predlagane tudi dejavnosti za zmanjševanje tveganja.
The MAH also proposed to harmonise a contraindication present in a MS against the immunisation with a live attenuated vaccine. 
Imetnik dovoljenja za promet z zdravilom je predlagal tudi uskladitev kontraindikacije pri imunizaciji z živim oslabljenim cepivom v eni od držav članic.
In addition to those described above, warnings related to incorrect route of administration, to cardiac risks, risk of leukaemia and bone marrow/haematological monitoring recommendations, reduced immunological response to infection, secondary AML and MDS were considered acceptable with some amendments. 
Poleg opisanih opozoril so bila z nekaterimi spremembami kot sprejemljiva ocenjena opozorila v zvezi z nepravilno potjo uporabe, tveganji za srce, tveganjem za levkemijo, priporočila o spremljanju kostnega mozga/hematološkem spremljanju, zmanjšanem imunskem odzivu na okužbo, sekundarnih AML in MDS.
Finally, warnings relative to the mutagenic potential, to the potential discoloration of urine and other tissues, to the risk of tumour lysis syndrome and contraception recommendations, risk of transient or persistent amenorrhea, present in some members states were considered relevant. 
Kot ustrezna so bila ocenjena v nekaterih državah članicah uporabljana opozorila o mutagenem potencialu, potencialnem obarvanju urina in tkiv, tveganju za sindrom tumorske lize in priporočila o kontracepciji ter tveganju za prehodno ali trajno amenorejo.
The MAH recalculated the frequencies as per the SmPC guideline and included details of the most important adverse reactions. 
Imetnik dovoljenja za promet z zdravilom je ponovno izračunal pogostnosti po smernici o povzetku glavnih značilnosti zdravila in vključil podrobnosti o najpomembnejših neželenih učinkih.