FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Kovaltry 2000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Danish: Kovaltry 2000 IE pulver og solvens til injektionsvæske, opløsning rekombinant human koagulationsfaktor VIII (octocog alfa)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1076/024 - 30 x (Kovaltry 3000 IE - solvens (5 ml); fyldt injektionssprøjte (5 ml)) 13.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 500 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) Kovaltry 500 IE pulver til injektionsvæske, opløsning rekombinant human koagulationsfaktor VIII (octocog alfa) Intravenøs anvendelse.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 3000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) Kovaltry 3000 IE pulver til injektionsvæske, opløsning rekombinant human koagulationsfaktor VIII (octocog alfa) Intravenøs anvendelse.
English: NAME OF THE MEDICINAL PRODUCT Kovaltry 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Danish: Kovaltry 3000 IE pulver og solvens til injektionsvæske, opløsning rekombinant human koagulationsfaktor VIII (octocog alfa)
English: EU/1/15/1076/017 - 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/018 - 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Danish: EU/1/15/1076/017 - 30 x (Kovaltry 250 IE - solvens (2,5 ml); fyldt injektionssprøjte (3 ml)) EU/1/15/1076/018 - 30 x (Kovaltry 250 IE - solvens (2,5 ml); fyldt injektionssprøjte (5 ml))
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 2000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) Kovaltry 2000 IE pulver til injektionsvæske, opløsning rekombinant human koagulationsfaktor VIII (octocog alfa) Intravenøs anvendelse.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1076/023 - 30 x (Kovaltry 2000 IE - solvens (5 ml); fyldt injektionssprøjte (5 ml)) 13.
English: NAME OF THE MEDICINAL PRODUCT Kovaltry 1000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Danish: Kovaltry 1000 IE pulver og solvens til injektionsvæske, opløsning rekombinant human koagulationsfaktor VIII (octocog alfa)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/010 - 1 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1076/010 - 1 x (Kovaltry 3000 IE - solvens (5 ml); fyldt injektionssprøjte (5 ml)) 13.
English: Urticaria uncommon
Danish: • urticaria (kløende udslæt)
English: EU/1/15/1076/021 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/022 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Danish: EU/1/15/1076/021 - 30 x (Kovaltry 1000 IE - solvens (2,5 ml); fyldt injektionssprøjte (3 ml)) EU/1/15/1076/022 - 30 x (Kovaltry 1000 IE - solvens (2,5 ml); fyldt injektionssprøjte (5 ml))
English: EU/1/15/1076/006 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Danish: EU/1/15/1076/006 - 1 x (Kovaltry 1000 IE - solvens (2,5 ml); fyldt injektionssprøjte (3 ml)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 IE - solvens (2,5 ml); fyldt injektionssprøjte (5 ml))
English: EU/1/15/1076/002 - 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/012 - 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Danish: EU/1/15/1076/002 - 1 x (Kovaltry 250 IE - solvens (2,5 ml); fyldt injektionssprøjte (3 ml)) EU/1/15/1076/012 - 1 x (Kovaltry 250 IE - solvens (2,5 ml); fyldt injektionssprøjte (5 ml))
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 1000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) Kovaltry 1000 IE pulver til injektionsvæske, opløsning rekombinant human koagulationsfaktor VIII (octocog alfa) Intravenøs anvendelse.
English: EU/1/15/1076/019 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/020 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Danish: EU/1/15/1076/019 - 30 x (Kovaltry 500 IE - solvens (2,5 ml); fyldt injektionssprøjte (3 ml)) EU/1/15/1076/020 - 30 x (Kovaltry 500 IE - solvens (2,5 ml); fyldt injektionssprøjte (5 ml))
English: EU/1/15/1076/004 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/014 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Danish: EU/1/15/1076/004 - 1 x (Kovaltry 500 IE - solvens (2,5 ml); fyldt injektionssprøjte (3 ml)) EU/1/15/1076/014 - 1 x (Kovaltry 500 IE - solvens (2,5 ml); fyldt injektionssprøjte (5 ml))
English: Sodium chloride
Danish: Mave-tarm-kanalen
English: Oral use bottle (HDPE)
Danish: Oral opløsning Oral anvendelse Flaske (HDPE) 150 ml
English: Oral solution
Danish: Styrke
English: These recommendations were considered appropriate.
Danish: Disse anbefalinger blev fundet passende.
English: This section was restructured according to guidelines.
Danish: Dette punkt blev omstruktureret i henhold til retningslinjerne.
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC.
Danish: • udvalget behandlede indbringelsen i henhold til artikel 30 i direktiv 2001/83/EF,
English: These should be included in a risk management plan.
Danish: Disse bør indgå i risikostyringsplanen.
English: Overall summary of the scientific evaluation of Novantrone and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Novantrone og relaterede navne (jf. bilag I)
English: Other sections have only been partially harmonised as it is considered that these should be adapted nationally.
Danish: Andre punkter er kun delvis harmoniseret, da de bør tilpasses nationalt.
English: Information of lesser relevance was removed in order to focus on the main information.
Danish: Mindre relevante oplysninger blev slettet for at fokusere på de vigtigste oplysninger.
English: However, no benefit in overall survival or other clinically relevant endpoints has been reported.
Danish: Der er dog ikke beskrevet nogen fordel i total overlevelse eller andre klinisk relevante endepunkter.
English: Relevant information available on risks of infertility was also harmonised.
Danish: Også relevante oplysninger om risiciene for infertilitet blev harmoniseret.
English: Further it was considered that the interaction with immunosuppressive medicines should be mentioned.
Danish: Derudover blev det fundet, at interaktionen med immunsuppressive lægemidler bør nævnes.
English: In most studies no comparator was used or, when a comparator was used it appeared to be more effective.
Danish: I størstedelen af undersøgelserne er der intet sammenligningspræparat, og når et sådant er anvendt, syntes det at være mere effektivt.
English: In addition, a complete blood count should be obtained before each dose of mitoxantrone and 10 days following each administration.
Danish: Desuden bør der foretages en komplet blodtælling før hver dosis af mitoxantron og 10 dage efter hver administration.
English: Patients should be advised to seek medical attendance if signs or symptoms develop, including over five years after end of treatment.
Danish: Patienterne bør instrueres om at søge lægehjælp ved opståen af tegn eller symptomer, også ud over fem år efter behandlingens afslutning.
English: Treatment of multiple sclerosis (MS)
Danish: Behandling af multipel sklerose (MS)
English: No significant differences between the national SmPCs were present in this section.
Danish: Der blev ikke fundet væsentlige forskelle mellem de nationale produktresuméer i dette punkt.
English: The CHMP was of the view that the scientific basis for this recommendation was weak and that information regarding vaccination schedule should rather be included in section 4.4 and 4.5, in line with clinical practice guidelines recommendations.
Danish: CHMP fandt, at det videnskabelige grundlag for denne anbefaling var svagt, og at oplysninger om vaccinationsplan snarere bør indgå i punkt 4.4 og 4.5 på linje med anbefalingerne i retningslinjerne for klinisk praksis.
English: Most of the existing statements on interactions across the MSs were supported.
Danish: De fleste af de eksisterende angivelser vedrørende interaktioner i medlemsstaterne fik tilslutning.
English: Sections related to the unique identifier were added in line with the current QRD template (dated February 2016).
Danish: Der blev tilføjet afsnit vedrørende den unikke identifikator på linje med den gældende QRD-skabelon (dateret februar 2016).
English: Treatment of non-Hodgkin's lymphoma (NHL)
Danish: Behandling af non-Hodgkin's lymfom (NHL)
English: Section 5 - Pharmacological properties
Danish: Punkt 5 - Farmakologiske egenskaber
English: In conclusion, the CHMP considered that the indication was not acceptable.
Danish: Som konklusion anså CHMP indikationen for uacceptabel.
English: The restrictions regarding the use of mitoxantrone in pregnant women was harmonised to reflect the information available.
Danish: Begrænsningerne for anvendelsen af mitoxantron hos gravide kvinder blev harmoniseret for at afspejle de foreliggende oplysninger.
English: In addition, due to the dose dependent risk of cardiotoxicity, the maximum lifetime cumulative dose was limited to 72 mg/m2.
Danish: På grund af den dosisafhængige risiko for kardiotoksicitet blev den maksimale kumulative livstidsdosis desuden begrænset til 72 mg/m2.
English: The MAH proposed that only the administration via intravenous infusion should be retained, which was accepted.
Danish: Indehaveren af markedsføringstilladelsen foreslog, at kun administration ved intravenøs infusion skulle bibeholdes, hvilket blev godkendt.
English: Changes introduced in the SmPC were consistently reflected in the labelling, however most sections were left to be completed nationally.
Danish: De foretagne ændringer af produktresuméet blev konsekvent afspejlet i etiketteringen, dog blev de fleste afsnit overladt til national udarbejdelse.
English: The use of mitoxantrone for the treatment of breast cancer is included in current hospital guidelines.
Danish: Anvendelsen af mitoxantron til behandling af brystkræft indgår i gældende hospitalsretningslinjer.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: In addition, the committee considered the advice of the Scientific Advisory Group Neurology and of the Pharmacovigilance Risk Assessment Committee.
Danish: Udvalget tog desuden rådgivningen fra den videnskabelige rådgivende gruppe vedrørende neurologi og Udvalget for Risikovurdering inden for Lægemiddelvurdering i betragtning,
English: 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.
Danish: Oplysninger om udskillelsen af mitoxantron i brystmælk og nødvendigheden af at afbryde amning før initiering af behandlingen var samstemmende afspejlet i medlemsstaterne.
English: 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.
Danish: 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.
English: • 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.
Danish: • udvalget fandt, at det var behov for supplerende risikominimeringsforanstaltninger i form af oplysningsmateriale til anvendelse af Novantrone og relaterede navne ved multipel sklerose.
English: Treatment of metastatic breast cancer
Danish: Behandling af metastatisk brystkræft
English: 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.
Danish: 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.
English: Further, mitoxantrone is not recommended in any treatment guidelines for hepatocellular carcinoma.
Danish: Desuden anbefales mitoxantron ikke i nogen behandlingsretningslinjer til hepatocellulært karcinom.
English: The studies presented included in majority patients with metastatic breast cancer, this patient population was therefore considered acceptable for the harmonised indication.
Danish: De forelagte undersøgelser omfattede for størstedelen patienter med metastatisk brystkræft; denne patientgruppe anses derfor for acceptabel til den harmoniserede indikation.
English: Separate dosing recommendations were also proposed for treatment of blast crisis and prostate cancer.
Danish: Der blev ligeledes foreslået særskilte dosisanbefalinger til behandling af blastkrise og prostatakræft.
English: 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.
Danish: 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.
English: The CHMP considered that the efficacy of mitoxantrone has been demonstrated in these studies.
Danish: CHMP fandt virkningen af mitoxantron påvist i disse undersøgelser.
English: 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.
Danish: 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.
English: In addition, as multiple sclerosis is not a life threatening disease, mitoxantrone should be contraindicated in the treatment of multiple sclerosis in pregnant women.
Danish: Da multipel sklerose ikke er en livstruende sygdom, bør mitoxantron desuden være kontraindiceret til behandling af multipel sklerose hos gravide kvinder.
English: 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.
Danish: 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.
English: The CMHP followed the advice of the SAG and agreed on an operational definition for the indication in the harmonised product information.
Danish: CHMP fulgte rådet fra den videnskabelige rådgivende gruppe og vedtog en operationel definition af indikationen til den harmoniserede produktinformation.
English: 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.
Danish: 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.
English: Dilution recommendation and guidance for the choice of veins as well as warning regarding extravasation, were considered adequate.
Danish: Anbefalingen om fortynding og vejledningen i valg af vener samt advarslen om ekstravasation blev anset for hensigtsmæssige.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: • 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.
Danish: • 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The CHMP concluded that the level of evidence provided is limited.
Danish: CHMP konkluderede, at den forelagte evidens er begrænset.
English: 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.
Danish: 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.
English: The results suggested a dose-response effect which forms supporting evidence of biological activity of mitoxantrone in multiple sclerosis.
Danish: Resultaterne tydede på en dosis-responsvirkning, som er støttende evidens for den biologiske aktivitet af mitoxantron ved multipel sklerose.
English: Palliation of non-resectable primary hepatocellular carcinoma
Danish: Palliativ behandling af ikke-resektabelt primært hepatocellulært karcinom
English: 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.
Danish: På grund af risikoen for at udvikle sekundære maligniteter bør risk/benefit-forholdet for behandling med mitoxantron desuden bestemmes før initiering af behandlingen.
English: 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.
Danish: CHMP fandt den kliniske fordel ved mitoxantron godtgjort hos voksne, og anbefalede anvendelse af betegnelsen akut myeloid leukæmi frem for akut ikke-lymfatisk leukæmi.
English: Remission-induction treatment of blast crisis in chronic myeloid leukaemia, in combination regimen
Danish: Remissionsinduktion til behandling af blastkrise ved kronisk myeloid leukæmi, i kombinationsregimer
English: 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.
Danish: 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.
English: 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.
Danish: I nogle medlemsstater indgik der desuden oplysninger om manglende interaktioner eller farmakokinetiske og farmakodynamiske interaktioner uden klinisk relevans.
English: In addition, the CMHP requested the advice of the SAG and of the PRAC regarding the need for additional risk minimisation measures.
Danish: CHMP konsulterede derudover den videnskabelige rådgivende gruppe og PRAC vedrørende behovet for supplerende risikominimeringsforanstaltninger.