FrancophonIA/ELRC3.0 huggingface dataset:
English: The proposal of the MAH for this section was accepted with minor amendments in line with the rest of the SmPC and rearrangement of the information taking into account the QRD requirements.
Danish: Markedsføringstilladelsesindehaverens forslag til dette punkt blev godkendt med mindre ændringer på linje med resten af produktresuméet og med tilpasning af oplysningerne under hensyntagen til QRDkravene.
English: 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.
Danish: I den harmoniserede tekst opretholdtes de sædvanlige kontraindikationer ved hypersensitivitet over for det aktive stof eller nogen af hjælpestofferne (herunder sulfit, som allerede nævnes i nogle medlemsstater).
English: Based on the data provided, the MAH was asked to add dysgeusia in the table listing the ARDs reported in oncology.
Danish: På grundlag af de forelagte data blev indehaveren af markedsføringstilladelsen anmodet om at tilføje dysgeusi til listen over bivirkninger, der beskrives i onkologien.
English: 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).
Danish: Novantrone og relaterede navne er godkendt til markedsføring som et koncentrat til infusionsvæske, 2 mg/ml, opløsning til intravenøst brug, i de fleste EU-medlemsstater.
English: The CMHP was of the view that overall the evidence provided was insufficient, in particular considering the large heterogeneity among acute leukaemia patients.
Danish: CHMP fandt den samlede forelagte evidens utilstrækkelig, navnlig i betragtning af den store heterogenicitet af patienterne med akut leukæmi.
English: 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.
Danish: Den kardiovaskulære risiko og risikoen for leukæmi fandtes afgørende for benefit/riskforholdet ved indikationen multipel sklerose og blev gennemgået detaljeret, hvilket ligeledes gælder de foreslåede risikominimeringsforanstaltninger til at håndtere disse risici.
English: 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.
Danish: For effektivt at minimere disse risici fandt CHMP, at der hos patienter med multipel sklerose ud over vurdering af venstre ventrikels uddrivningsfraktion før hver dosis af mitoxantron som foreslået af markedsføringstilladelsesindehaveren også bør foretages årlig kontrol indtil 5 år efter afslutning af behandlingen, og at den maksimale kumulative dosis ikke bør overskrides.
English: Therefore the CHMP agreed to the proposed indication in CRPC intended specifically for palliation.
Danish: CHMP godkendte derfor den foreslåede indikation ved CRPC med palliativ virkning som specifikt formål.
English: 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.
Danish: Indehaveren af markedsføringstilladelsen foreslog harmoniserede dosisanbefalinger baseret på de doser, der er anvendt i de kliniske undersøgelser, og en generel anbefaling om at overvåge kardiotoksicitet hos kræftpatienter.
English: 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.
Danish: Der blev foreslået fælles dosisanbefalinger for metastatisk brystkræft og non-Hodgkins lymfom, herunder anvisninger for dosisreduktion ved kombinationsbehandling og i tilfælde af knoglemarvsdepression.
English: • 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.
Danish: • udvalget behandlede de konstaterede divergenser for Novantrone og relaterede navne hvad angår indikationer, dosering, kontraindikationer, særlige advarsler og forsigtighedsregler vedrørende brugen samt de øvrige punkter i produktresuméet, etiketteringen og indlægssedlen,
English: Further, as the potential additive risks of mitoxantrone in patients with long term exposure also to other immunosuppressants are not known, the CHMP was of the view that it should be mentioned that the safety and efficacy of mitoxantrone have not been demonstrated after other multiple sclerosis treatments approved more recently.
Danish: Eftersom man ikke kender de potentielle yderligere risici ved mitoxantron for patienter, der langtidseksponeres for andre immunsuppressiva, fandt CHMP, at det bør nævnes, at sikkerheden og virkningen af mitoxantron ikke er godtgjort siden den efterfølgende godkendelse af andre midler mod multipel sklerose.
English: General dose lowering for other serious toxicity, including recommendation to discontinue treatment in case of WHO grade 4 toxicity, were also accepted.
Danish: Ligeledes godkendtes en generel dosisnedsættelse ved anden alvorlig toksicitet, herunder en anbefaling om at seponere behandlingen ved WHO-toksicitet grad 4.
English: In some MS Novantrone was contraindicated for use as an adjuvant treatment for breast cancer, in relation to the possible risk of leukaemia.
Danish: I nogle medlemsstater var Novantrone kontraindiceret til anvendelse som adjuverende behandling ved brystkræft på grund af den mulige risiko for leukæmi.
English: These studies demonstrate the efficacy of mitoxantrone, in combination therapy, in the treatment of NHL.
Danish: Disse undersøgelser godtgør virkningen af mitoxantron ved kombinationsbehandling af NHL.
English: The CHMP also considered that in the table of ADR in multiple sclerosis the footnote specifying that the events amenorrhea may be consistent with premature menopause and that the causal relationship between the cases of sudden death and mitoxantrone administration is uncertain should be left in the harmonised PI.
Danish: CHMP fandt desuden, at der i tabellen over bivirkninger ved multipel sklerose fortsat bør være en fodnote om, at hændelser med amenoré kan være ensbetydende med præmatur menopause, og at det harmoniserede produktresumé fortsat bør nævne, at der er usikkerhed om årsagssammenhængen mellem tilfældene af pludseligt dødsfald og administration af mitoxantron.
English: 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.
Danish: Skønt der er tale om begrænset evidens, anerkendte CHMP, at mitoxantron i udvalgte tilfælde og efter den behandlende læges afgørelse kan tilføjes kombinationsregimer og være til fordel for denne patientgruppe, og accepterede indikationen.
English: The MAH also proposed to harmonise a contraindication present in a MS against the immunisation with a live attenuated vaccine.
Danish: Indehaveren af markedsføringstilladelsen foreslog desuden at harmonisere kontraindikationen, der findes i én medlemsstat, ved immunisering med levende, svækket vaccine.
English: 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).
Danish: Der er på nuværende tidspunkt tre hovedindikationer, som er godkendt i alle de medlemsstater, hvor Novantrone har markedsføringstilladelse, dog med divergenser i den eksakte ordlyd: behandling af metastatisk brystkræft, behandling af non-Hodgkins lymfom og behandling af akut myeloid leukæmi (akut ikke-lymfatisk leukæmi).
English: Novantrone is indicated in adults in a number of malignancies, including breast carcinoma, acute leukaemia and non-Hodgkin's lymphoma.
Danish: Novantrone er indiceret hos voksne med en række maligniteter, herunder brystkræft, akut leukæmi og non-Hodgkins lymfom.
English: This indication is currently authorised in only two MSs and current clinical practice guidelines do not support the use of mitoxantrone in ALL.
Danish: Denne indikation er aktuelt kun godkendt i to medlemsstater, og de nuværende retningslinjer for klinisk praksis støtter ikke anvendelse af mitoxantron ved akut lymfatisk leukæmi.
English: 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.
Danish: Ud over ovennævnte advarsler blev advarslerne om ukorrekt administrationsvej, kardiale risici, risikoen for leukæmi og anbefalingerne for overvågning af knoglemarv/hæmatologi, nedsat immunreaktion på infektion, sekundær akut myeloid leukæmi og myelodysplastisk syndrom anset for acceptable med visse ændringer.
English: The MAH was asked to discuss the relevance of including four ADRs, which have been reported and are listed in the PI of other mitoxantrone-containing products.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at drøfte relevansen af at medtage fire bivirkninger, som er beskrevet og opført i produktinformationen for andre produkter, der indeholder mitoxantron.
English: 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.
Danish: Den videnskabelige rådgivende gruppe fandt, at mitoxantron kan tænkes anvendt til behandling af inflammatorisk aktiv multipel sklerose forbundet med tiltagende invaliditet, når ingen anden behandlingsmulighed foreligger.
English: The CMHP considered that mitoxantrone should be contraindicated in breastfeeding mothers as it is a potential human teratogen.
Danish: CHMP fandt, at mitoxantron bør kontraindiceres hos kvinder, der ammer, da det er potentielt teratogent for mennesker.
English: 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.
Danish: I enkelte EU-medlemsstater er det desuden godkendt som koncentrat, 2 mg/ml, til injektionsvæske, opløsning, eller injektionsvæske til intrapleural eller intraperitoneal anvendelse, og som koncentrat til injektionsvæske/infusionsvæske, opløsning.
English: 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.
Danish: Det anvendes desuden til smertelindring ved prostatakræft i kombination med kortikosteroider, og mitoxantrons immunsuppressive og immunmodulerende egenskaber giver grundlag for dets anvendelse ved højaktiv multipel sklerose.
English: In the studies presented, albeit, limited in number and in heterogeneous populations, mitoxantrone demonstrated a consistent effect on relapses as well as disability.
Danish: De forelagte undersøgelser var begrænsede i antal og omfattede heterogene populationer, men viste samstemmende virkning af mitoxantron på recidiver og på udviklingen af invaliditet.
English: 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.
Danish: Det anerkendes, at mitoxantron på nuværende tidspunkt gives i klinisk praksis ved CRPC, når andre foreliggende behandlingsmuligheder er udtømt.
English: Pain relief in patients with advanced, castrate-resistant prostate cancer, in combination with corticosteroids
Danish: Smertelindring ved fremskreden kastrationsresistent prostatakræft, i kombination med kortikosteroider
English: 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.
Danish: CHMP fandt, at der på nuværende tidspunkt var utilstrækkelig evidens som grundlag for anvendelse af mitoxantron ved hepatocellulært karcinom, hvilket indehaveren af markedsføringstilladelsen accepterede og derfor slettede denne indikation fra den foreslåede harmoniserede produktinformation.
English: 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.
Danish: Endelig blev nogle medlemsstaters advarsler om mutagent potentiale, potentiel misfarvning af urin og andre væv og om risikoen for tumorlysesyndrom, anbefalinger om antikonception samt advarsel om risikoen for forbigående eller blivende amenoré fundet relevante.
English: The MAH provided a phase III study and several uncontrolled phase II studies in induction therapy as well as studies of mitoxantrone in combination regimens in relapsed/refractory ALL (including a study in children).
Danish: Indehaveren af markedsføringstilladelsen fremlagde en fase III-undersøgelse og flere ukontrollerede fase II-undersøgelser ved induktionsterapi samt undersøgelser af mitoxantron i kombinationsregimer ved recidiverende/refraktær akut lymfatisk leukæmi (herunder en undersøgelse hos børn).
English: • The Committee agreed the harmonisation of the summary of product characteristic, labelling and package leaflet.
Danish: • udvalget vedtog harmoniseringen af produktresuméet, etiketteringen og indlægssedlen,
English: Grounds for the variation to the terms of the marketing authorisations
Danish: Begrundelse for ændringen af betingelserne for markedsføringstilladelserne Eftersom:
English: The MAH presented an overview of studies of mitoxantrone, mainly in patients with relapsing remitting and secondary progressive multiple sclerosis.
Danish: Indehaveren af markedsføringstilladelsen fremlagde en oversigt over undersøgelser af mitoxantron, hovedsagelig hos patienter med recidiverende/remitterende og sekundær progressiv multipel sklerose.
English: Treatment of acute myeloid leukaemia
Danish: Behandling af akut myeloid leukæmi
English: 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.
Danish: konkluderede udvalget, at benefit/risk-forholdet for lægemidler, der indeholder Novantrone og relaterede navne fortsat er positivt under forudsætning af gennemførelsen af de vedtagne betingelser for markedsføringstilladelserne, der fremgår af bilag IV, og under hensyntagen til de vedtagne ændringer af produktinformationen samt øvrige risikominimeringsforanstaltninger, anbefalede CHMP ændringen af betingelserne for markedsføringstilladelserne for Novantrone og relaterede navne (se bilag I).
English: 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).
Danish: Dataene godtgør en virkning af mitoxantron i kombination med kortikosteroider til palliativ behandling af fremskreden kastrationsresistent prostatacancer (CRPC).
English: Treatment of acute lymphocytic leukaemia
Danish: Behandling af akut lymfatisk leukæmi
English: The MAH provided several phase III studies and a phase II study investigating the effect of mitoxantrone in combination with corticosteroids on pain relief and on overall survival.
Danish: Indehaveren af markedsføringstilladelsen forelagde flere fase III-undersøgelser og en fase IIundersøgelse af virkningen af mitoxantron i kombination med kortikosteroider på smertelindring og samlet overlevelse.
English: 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.
Danish: Indehaveren af markedsføringstilladelsen har indsendt en oversigt over undersøgelser udført ved denne indikation, herunder undersøgelser med monoterapi og store, randomiserede, sammenlignende undersøgelser, hvor mitoxantron er anvendt i kombination med andre midler og sammenlignet med andre behandlingsregimer.
English: The MAH presented four studies of mitoxantrone administered in combination with other cytostatic agents in the treatment of a blast crisis in chronic myeloid leukaemia.
Danish: Indehaveren af markedsføringstilladelsen forelagde fire undersøgelser af mitoxantron administreret i kombination med andre cytostatika til behandling af blastkrise ved kronisk myeloid leukæmi.
English: 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.
Danish: CHMP fulgte dette råd og fandt, at markedsføringstilladelsen skulle gøres betinget af risikostyringsplanen og informationsmaterialet på grund af betydningen heraf for sikker anvendelse af produktet, og at undersøgelsen skulle indgå i risikostyringsplanen som kategori 3.
English: The MAH presented an overview of studies performed with mitoxantrone as single agent or in combination regimens for the treatment of patients with specific subgroups of NHL, pre-treated or treatment naïve.
Danish: Indehaveren af markedsføringstilladelsen forelagde en oversigt over undersøgelser udført med mitoxantron som monoterapi eller i kombinationsregimer til behandling af bestemte undergrupper af NHL hos tidligere behandlede eller behandlingsnaive patienter.
English: 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.
Danish: I nogle af de medlemsstater, hvor Novantrone har markedsføringstilladelse, omfatter indikationerne desuden behandling af hepatom/hepatocellulært karcinom, smertelindring ved fremskreden hormonresistent prostatakræft (i kombination med kortikosteroider), reduktion af neurologisk funktionsnedsættelse og kliniske recidiver ved sekundær (kronisk) progressiv multipel sklerose, behandling af blastkrise ved (kronisk) myeloid leukæmi og behandling af akut lymfatisk leukæmi.
English: The MAH submitted an overview of studies performed with mitoxantrone as single agent or in combination regimens for the treatment of patients with advanced or metastatic breast cancer.
Danish: Indehaveren af markedsføringstilladelsen forelagde en oversigt over undersøgelser udført med mitoxantron alene eller i kombinationsregimer til behandling af fremskreden eller metastatisk brystkræft.
English: This was accepted by the MAH which therefore withdrew it from the proposed harmonised PI.
Danish: Dette blev accepteret af indehaveren af markedsføringstilladelsen, som derfor slettede indikationen fra den foreslåede harmoniserede produktinformation.
English: For acute myeloid leukaemia dosing recommendations were proposed as a single agent in relapses and in combination as induction, consolidation and salvage therapy.
Danish: Til akut myeloid leukæmi blev der foreslået dosisanbefalinger for monoterapi ved recidiver og kombinationsanvendelse til induktionsbehandling, konsoliderende behandling og redningsbehandling.
English: The MAH recalculated the frequencies as per the SmPC guideline and included details of the most important adverse reactions.
Danish: Indehaveren af markedsføringstilladelsen foretog en ny beregning af hyppighederne i henhold til retningslinjerne for produktresuméer og medtog detaljer om de vigtigste bivirkninger.
English: The CMHP was of the view that, in line with the SmPC guideline, as confusion and fatigue have been reported with mitoxantrone, it should be mentioned that the treatment has minor influence on those abilities.
Danish: CHMP fandt, at det i betragtning af beskrivelserne af konfusion og træthed med mitoxantron bør nævnes, at behandlingen kun har minimal indflydelse på denne evne, hvilket er i overensstemmelse med retningslinjerne for produktresuméer.
English: The MAH provided several phase II studies and case studies reported in the literature where mitoxantrone was given to patients with HCC.
Danish: Indehaveren af markedsføringstilladelsen forelagde flere fase II-undersøgelser og case-undersøgelser fra litteraturen, hvor mitoxantron blev administreret ved hepatocellulært karcinom.
English: In addition, the increased thrombotic or haemorrhage risk with concomitant Vitamin K antagonists with tumoural disease, widely described in the literature was considered relevant to be added by the CHMP.
Danish: CHMP fandt det desuden relevant at tilføje den fra litteraturen velkendte forhøjede risiko for trombose eller hæmoragi ved samtidig brug af vitamin K-antagonister ved tumorsygdomme.
English: The MAH considered relevant to list Tumour lysis syndrome.
Danish: Indehaveren af markedsføringstilladelsen fandt det relevant at opføre tumorlysesyndrom.
English: Other sections of the SmPC
Danish: Andre punkter i produktresuméet
English: Every 24 hours*
Danish: Hver 24. time *
English: This method is also known as “a drip”.
Danish: Denne metode kaldes også et “drop”.
English: * Beginning 24 hours after the loading dose
Danish: * Startende 24 timer efter loading-dosen
English: Some of the doses (maintenance doses) may be given by mouth.
Danish: Nogle af doserne (vedligeholdelsesdoserne) kan gives gennem munden.
English: The optimal duration of treatment has not been established.
Danish: Der er ikke påvist en optimal behandlingsvarighed.
English: Date of first authorisation: 02/07/2009 Date of latest renewal: 03/03/2014
Danish: Dato for første markedsføringstilladelse: 02/07/2009 Dato for seneste fornyelse: 03/03/2014
English: Peyona should be used with caution.
Danish: Peyona bør anvendes med forsigtighed.
English: Non invasive support
Danish: Ikke-invasiv støtte
English: It is advisable to measure baseline caffeine levels in:
Danish: Det er tilrådeligt at måle baseline caffeinniveauerne hos:
English: Each carton contains 10 ampoules.
Danish: Hver karton indeholder 10 ampuller.
English: No support
Danish: Ingen støtte
English: Treatment of caffeine overdose is primarily symptomatic and supportive.
Danish: Behandling af caffeinoverdosering er primært symptomatisk og understøttende.
English: These active substances should not be used concurrently.
Danish: Disse aktive stoffer bør ikke anvendes samtidig.
English: − very premature infants (< 28 weeks gestational age and/or body weight <1000 g) particularly when receiving parenteral nutrition
Danish: − meget præmature børn (gestationsalder <28 uger og/eller legemsvægt <1000 g), især ved parenteral ernæring