natgillin/translations-raw huggingface dataset:
Begrænsningerne for anvendelsen af mitoxantron hos gravide kvinder blev harmoniseret for at afspejle de foreliggende oplysninger.
The restrictions regarding the use of mitoxantrone in pregnant women was harmonised to reflect the information available.
På grund af den dosisafhængige risiko for kardiotoksicitet blev den maksimale kumulative livstidsdosis desuden begrænset til 72 mg/m2.
In addition, due to the dose dependent risk of cardiotoxicity, the maximum lifetime cumulative dose was limited to 72 mg/m2.
Indehaveren af markedsføringstilladelsen foreslog, at kun administration ved intravenøs infusion skulle bibeholdes, hvilket blev godkendt.
The MAH proposed that only the administration via intravenous infusion should be retained, which was accepted.
De foretagne ændringer af produktresuméet blev konsekvent afspejlet i etiketteringen, dog blev de fleste afsnit overladt til national udarbejdelse.
Changes introduced in the SmPC were consistently reflected in the labelling, however most sections were left to be completed nationally.
Anvendelsen af mitoxantron til behandling af brystkræft indgår i gældende hospitalsretningslinjer.
The use of mitoxantrone for the treatment of breast cancer is included in current hospital guidelines.
På grund af de divergerende nationale afgørelser, der er truffet af medlemsstaterne ved godkendelsen af ovenstående produkt (og relaterede navne), anmeldte Europa-Kommissionen en officiel indbringelse til Det Europæiske Lægemiddelagentur i medfør af artikel 30 i direktiv 2001/83/EF med henblik på at få ophævet divergenserne mellem de nationalt godkendte produktinformationer og dermed få produktinformationerne harmoniseret i EU.
Due to the divergent national decisions taken by MSs concerning the authorisation of the abovementioned product (and its associated names), the European Commission notified the European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised Product Information (PI) and thus to harmonise the PI across the EU.
I de nuværende retningslinjer for behandling af AML anbefales induktionsbehandling med regimer, der indeholder et antracyclin (såsom mitoxantron) administreret i tre dage, og cytarabin administreret i 7 dage.
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.
Udvalget tog desuden rådgivningen fra den videnskabelige rådgivende gruppe vedrørende neurologi og Udvalget for Risikovurdering inden for Lægemiddelvurdering i betragtning,
In addition, the committee considered the advice of the Scientific Advisory Group Neurology and of the Pharmacovigilance Risk Assessment Committee.
Oplysninger om udskillelsen af mitoxantron i brystmælk og nødvendigheden af at afbryde amning før initiering af behandlingen var samstemmende afspejlet i medlemsstaterne.
Information on the excretion of mitoxantrone in breast milk and the need to interrupt breastfeeding prior to treatment initiation was consistently reflected across member states.
Til multipel sklerose godkendtes en fleksibel dosisplan for at afspejle dem, der er anvendt i de kliniske undersøgelser og den kliniske praksis i de forskellige medlemsstater.
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.
• udvalget fandt, at det var behov for supplerende risikominimeringsforanstaltninger i form af oplysningsmateriale til anvendelse af Novantrone og relaterede navne ved multipel sklerose.
• 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.
Behandling af metastatisk brystkræft
Treatment of metastatic breast cancer
Oplysninger om behovet for antikonception hos mænd blev tilføjet til dem, der i forvejen var medtaget for kvinder, og begge blev justeret i henhold til halveringstiden af mitoxantron og den respektive længde af gametogenesen hos mænd og kvinder.
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.
Desuden anbefales mitoxantron ikke i nogen behandlingsretningslinjer til hepatocellulært karcinom.
Further, mitoxantrone is not recommended in any treatment guidelines for hepatocellular carcinoma.
De forelagte undersøgelser omfattede for størstedelen patienter med metastatisk brystkræft; denne patientgruppe anses derfor for acceptabel til den harmoniserede indikation.
The studies presented included in majority patients with metastatic breast cancer, this patient population was therefore considered acceptable for the harmonised indication.
Der blev ligeledes foreslået særskilte dosisanbefalinger til behandling af blastkrise og prostatakræft.
Separate dosing recommendations were also proposed for treatment of blast crisis and prostate cancer.
Da den harmoniserede indikation er behandling af metastatisk brystkræft, fandtes det tilstrækkeligt med en advarsel i punkt 4.4 om den lille risiko for leukæmi og de sparsomme data vedrørende virkning ved adjuverende behandling af brystkræft.
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.
CHMP fandt virkningen af mitoxantron påvist i disse undersøgelser.
The CHMP considered that the efficacy of mitoxantrone has been demonstrated in these studies.
I betragtning af risiciene for kardiotoksicitet og leukæmi fandt CHMP, at anvendelsen af mitoxantron bør begrænses til den population, hos hvilken fordelene overstiger disse alvorlige risici.
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.
Da multipel sklerose ikke er en livstruende sygdom, bør mitoxantron desuden være kontraindiceret til behandling af multipel sklerose hos gravide kvinder.
In addition, as multiple sclerosis is not a life threatening disease, mitoxantrone should be contraindicated in the treatment of multiple sclerosis in pregnant women.
Disse krav bør indgå i en risikostyringsplan med særligt fokus på anvendelsen ved multipel sklerose for at sikre en ensartet minimumstandard for håndtering af risiciene i medlemsstaterne.
These should be included in a risk management plan (RMP) with a particular focus on the use in multiple sclerosis to ensure a consistent minimum standard of management of the risks across MSs.
CHMP fulgte rådet fra den videnskabelige rådgivende gruppe og vedtog en operationel definition af indikationen til den harmoniserede produktinformation.
The CMHP followed the advice of the SAG and agreed on an operational definition for the indication in the harmonised product information.
CHMP søgte rådgivning hos den videnskabelige rådgivende gruppe vedrørende neurologi for at få indblik i den nuværende kliniske anvendelse af mitoxantron og klart definere den patientgruppe, der kan have fordel af behandlingen.
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.
Anbefalingen om fortynding og vejledningen i valg af vener samt advarslen om ekstravasation blev anset for hensigtsmæssige.
Dilution recommendation and guidance for the choice of veins as well as warning regarding extravasation, were considered adequate.
Disse foranstaltninger blev anset for hensigtsmæssige af den videnskabelige rådgivende gruppe og af PRAC, som desuden fandt, at der i betragtning af de talrige krav og deres betydning for sikker anvendelse af produktet ved multipel sklerose bør udarbejdes informationsmateriale og foretages en undersøgelse for at sikre, at kravene overholdes.
These measures were considered adequate by the SAG and the PRAC, who further considered the numerous requirement and their importance for the safe use of the product in multiple sclerosis, educational material should be developed and a study should be conducted to ensure they are adhered to.
Af samme grund blev det specificeret, at initiering af behandling med Novantrone ved multipel sklerose ikke bør finde sted hos patienter, der i forvejen er behandlet med det. I den harmoniserede tekst bibeholdtes en dosisjusteringsvejledning baseret på knoglemarvsdepression for at minimere risikoen for leukæmi.
For this reason also, it was specified that Novantrone should not be initiated for treatment of multiple sclerosis in patients who have already been treated with it. A dosing adjustment guide, based on bone marrow suppression was kept in the harmonised text in order to minimise the risk of leukaemia.
• udvalget gennemgik de af markedsføringstilladelsesindehaveren forelagte data til underbygning af den foreslåede harmonisering af produktinformationen, herunder kliniske undersøgelser, åbne undersøgelser, publicerede undersøgelser, oversigtsartikler samt evidens- og konsensusbaserede retningslinjer.
• 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.
Skønt mitoxantron ikke hører til de oftest anvendte kemoterapeutika ved NHL, anerkendte CHMP, at det kan udgøre en alternativ behandlingsmulighed, og fandt den foreslåede harmoniserede ordlyd acceptabel.
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.
Kontraindikationerne vedrørende ukorrekte administrationsveje, der er begrundet i risikoen for ekstravasation, og andre kontraindikationer, der er gældende i enkelte medlemsstater, blev ligeledes anset for at være bedre omhandlet i andre punkter af produktinformationen.
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.
CHMP konkluderede, at den forelagte evidens er begrænset.
The CHMP concluded that the level of evidence provided is limited.
Novantrone indeholder mitoxantron, et syntetisk antineoplastisk anthracenedion, der har cytocid virkning på både prolifererende og ikke-prolifererende kulturer af humane celler som tegn på aktivitet mod hurtigt prolifererende og langsomtvoksende neoplasmer.
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.
Resultaterne tydede på en dosis-responsvirkning, som er støttende evidens for den biologiske aktivitet af mitoxantron ved multipel sklerose.
The results suggested a dose-response effect which forms supporting evidence of biological activity of mitoxantrone in multiple sclerosis.
Palliativ behandling af ikke-resektabelt primært hepatocellulært karcinom
Palliation of non-resectable primary hepatocellular carcinoma
På grund af risikoen for at udvikle sekundære maligniteter bør risk/benefit-forholdet for behandling med mitoxantron desuden bestemmes før initiering af behandlingen.
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.
CHMP fandt den kliniske fordel ved mitoxantron godtgjort hos voksne, og anbefalede anvendelse af betegnelsen akut myeloid leukæmi frem for akut ikke-lymfatisk leukæmi.
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.
Remissionsinduktion til behandling af blastkrise ved kronisk myeloid leukæmi, i kombinationsregimer
Remission-induction treatment of blast crisis in chronic myeloid leukaemia, in combination regimen
Markedsføringstilladelsesindehaverens forslag om at medtage de fatale tilfælde, der er indberettet ved overdosering, blev godkendt med tilføjelse af de iagttagne former for toksicitet og de anbefalede generelle tiltag.
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.
I nogle medlemsstater indgik der desuden oplysninger om manglende interaktioner eller farmakokinetiske og farmakodynamiske interaktioner uden klinisk relevans.
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.
CHMP konsulterede derudover den videnskabelige rådgivende gruppe og PRAC vedrørende behovet for supplerende risikominimeringsforanstaltninger.
In addition, the CMHP requested the advice of the SAG and of the PRAC regarding the need for additional risk minimisation measures.
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.
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.
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).
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.
På grundlag af de forelagte data blev indehaveren af markedsføringstilladelsen anmodet om at tilføje dysgeusi til listen over bivirkninger, der beskrives i onkologien.
Based on the data provided, the MAH was asked to add dysgeusia in the table listing the ARDs reported in oncology.
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.
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).
CHMP fandt den samlede forelagte evidens utilstrækkelig, navnlig i betragtning af den store heterogenicitet af patienterne med akut leukæmi.
The CMHP was of the view that overall the evidence provided was insufficient, in particular considering the large heterogeneity among acute leukaemia patients.
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.
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.
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.
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.
CHMP godkendte derfor den foreslåede indikation ved CRPC med palliativ virkning som specifikt formål.
Therefore the CHMP agreed to the proposed indication in CRPC intended specifically for palliation.
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.
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.
Der blev foreslået fælles dosisanbefalinger for metastatisk brystkræft og non-Hodgkins lymfom, herunder anvisninger for dosisreduktion ved kombinationsbehandling og i tilfælde af knoglemarvsdepression.
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.
• 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,
• 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.
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.
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.
Ligeledes godkendtes en generel dosisnedsættelse ved anden alvorlig toksicitet, herunder en anbefaling om at seponere behandlingen ved WHO-toksicitet grad 4.
General dose lowering for other serious toxicity, including recommendation to discontinue treatment in case of WHO grade 4 toxicity, were also accepted.
I nogle medlemsstater var Novantrone kontraindiceret til anvendelse som adjuverende behandling ved brystkræft på grund af den mulige risiko for leukæmi.
In some MS Novantrone was contraindicated for use as an adjuvant treatment for breast cancer, in relation to the possible risk of leukaemia.
Disse undersøgelser godtgør virkningen af mitoxantron ved kombinationsbehandling af NHL.
These studies demonstrate the efficacy of mitoxantrone, in combination therapy, in the treatment of NHL.
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.
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.
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.
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.
Indehaveren af markedsføringstilladelsen foreslog desuden at harmonisere kontraindikationen, der findes i én medlemsstat, ved immunisering med levende, svækket vaccine.
The MAH also proposed to harmonise a contraindication present in a MS against the immunisation with a live attenuated vaccine.
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).
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).
Novantrone er indiceret hos voksne med en række maligniteter, herunder brystkræft, akut leukæmi og non-Hodgkins lymfom.
Novantrone is indicated in adults in a number of malignancies, including breast carcinoma, acute leukaemia and non-Hodgkin's lymphoma.
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.
This indication is currently authorised in only two MSs and current clinical practice guidelines do not support the use of mitoxantrone in ALL.
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.
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.
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.
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.
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.
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.
CHMP fandt, at mitoxantron bør kontraindiceres hos kvinder, der ammer, da det er potentielt teratogent for mennesker.
The CMHP considered that mitoxantrone should be contraindicated in breastfeeding mothers as it is a potential human teratogen.
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.
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.