FrancophonIA/ELRC3.0 huggingface dataset:
English: The starting dose of Exjade depends on the patient's body weight, on which form of the medicine is being taken, what the medicine is used for, and on the level of iron overload.
Danish: Startdosen af Exjade er baseret på patientens kropsvægt, hvilken form af lægemidlet der tages, hvad lægemidlet tages for og omfanget af jernophobning.
English: The company that markets Exjade must issue an education pack to healthcare professionals.
Danish: Virksomheden, der markedsfører Exjade, skal udsende informationsmateriale til sundhedspersoner.
English: The main measure of effectiveness was the change in iron levels in the liver after 12 months of treatment.
Danish: Det primære mål for virkningen var ændringen i jernniveauet i leveren efter 12 måneders behandling.
English: The granules are sprinkled on soft food such as yogurt or apple sauce that the patient can eat.
Danish: Granulatet drysses på en blød madvare som f.eks. yoghurt eller æblemos, som patienten spiser.
English: In patients treated with Exjade, liver iron levels decreased on average by 3.8 mg per gram of liver compared with an average increase of 0.4 mg per gram of liver in patients treated with placebo.
Danish: Hos patienter, der fik Exjade, faldt jernniveauet i leveren gennemsnitligt med 3,8 mg pr. gram lever sammenholdt med en gennemsnitlig stigning på 0,4 mg pr. gram lever hos patienter, der fik placebo.
English: Exjade is a medicine used to treat chronic iron overload (an excess of iron in the body) in:
Danish: Exjade er et lægemiddel til behandling af kronisk jernophobning (overskud af jern i kroppen) hos:
English: The body cannot remove iron effectively and excess iron can cause damage.
Danish: Kroppen kan ikke fjerne jern i tilstrækkelig grad, og et overskud af jern kan medføre skade.
English: It attaches to excess iron in the body to form a compound called a ‘chelate' that can be removed by the body, mainly in the stool.
Danish: Det binder til det overskydende jern i kroppen og danner derved en forbindelse ved navn "chelat", som kroppen kan fjerne, hovedsagelig gennem afføringen.
English: This helps to correct the iron overload and prevent damage to organs such as the heart or liver from excess iron.
Danish: Dette medvirker til at afhjælpe jernophobningen og forebygge skader på organer som f.eks. hjertet eller leveren på grund af overskud af jern.
English: Exjade contains the active substance deferasirox.
Danish: Exjade indeholder det aktive stof deferasirox.
English: Other common side effects (in up to 1 patient in 10) include nausea (feeling sick), vomiting, diarrhoea, indigestion, abdominal (belly) pain, constipation, headache, rash, itching, blood tests showing raised transaminases (which may suggest liver damage) and protein in urine.
Danish: Andre almindelige bivirkninger (som kan forekomme hos op til 1 ud af 10 personer) er kvalme, opkastning, diarré, fordøjelsesbesvær, mavesmerter, forstoppelse, hovedpine, udslæt, kløe, forhøjede transaminaser i blodtest (som kan indikere leverskade) og protein i urinen.
English: Kidney and liver tests should be done before starting treatment and at regular intervals during treatment with Exjade.
Danish: Der bør foretages nyre- og leverprøver, før behandlingen med Exjade indledes, og med jævne mellemrum i løbet af behandlingen.
English: The iron level was reduced satisfactorily in 53% of the patients receiving Exjade, compared with 66% of the patients receiving deferoxamine.
Danish: Jernniveauet blev reduceret i tilfredsstillende grad hos 53 % af de patienter, der blev behandlet med Exjade, sammenholdt med 66 % af de patienter, der fik deferoxamin.
English: It is available as film-coated tablets, dispersible tablets and granules.
Danish: Det fås som filmovertrukne tabletter, dispergible tabletter og granulat.
English: Another study involved 184 patients who could not be treated with deferoxamine, including patients with beta thalassaemia major and with other types of anaemia.
Danish: I et andet studie deltog 184 patienter, der ikke kunne behandles med deferoxamin, herunder patienter med svær beta-thalassæmi og med andre former for anæmi.
English: The company will also perform the following studies: a study on the long-term effects of the filmcoated tablets and dispersible tablets in children aged over 10 years with non-transfusion-dependent thalassaemia; and a study to assess the safety of the film-coated tablets (particularly when they are crushed) in children.
Danish: Virksomheden skal også gennemføre følgende studier: et studie af den langvarige virkning af filmovertrukne tabletter og dispergible tabletter hos børn over 10 år med ikketransfusionskrævende thalassæmi og et studie af sikkerheden ved de filmovertrukne tabletter (især når de knuses) hos børn.
English: The active substance in Exjade, deferasirox, is an ‘iron chelator'.
Danish: Det aktive stof i Exjade, deferasirox, er et såkaldt jernchelerende stof.
English: Exjade can only be obtained with a prescription and treatment should be started and supervised by a doctor who is experienced in the treatment of chronic iron overload.
Danish: Exjade udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kronisk jernophobning.
English: In a further main study involving 166 patients from 10 years of age (including 21 patients aged 10 to 18 years) with non-transfusion-dependent thalassaemia syndromes and iron overload, Exjade was more effective than placebo (a dummy treatment).
Danish: I et andet hovedstudie med 166 patienter i alderen 10 år og opefter (herunder 21 patienter i alderen 10-18 år) med ikketransfusionskrævende thalassæmisyndromer og jernophobning var Exjade mere effektivt end placebo (en uvirksom behandling).
English: The dispersible tablets should be taken on an empty stomach (at least 30 minutes before food), and the film-coated tablets and granules can be taken on an empty stomach or with a light meal.
Danish: Mens de dispergible tabletter bør tages på tom mave (mindst 30 minutter før et måltid), kan de filmovertrukne tabletter og granulatet tages på tom mave eller sammen med et let måltid.
English: The most common side effect with Exjade (which may affect more than 1 in 10 people) is increased blood creatinine (a marker of kidney problems).
Danish: Den hyppigste bivirkning ved Exjade (som optræder hos mere end 1 ud af 10 patienter) er øget blodkreatinin (en markør for nyreproblemer).
English: In chronic iron overload due to blood transfusions, one main study compared Exjade with deferoxamine in 591 patients with beta thalassaemia major.
Danish: I forbindelse med kronisk jernophobning som følge af blodtransfusioner blev Exjade sammenlignet med deferoxamin i ét hovedstudie hos 591 patienter med svær beta-thalassæmi.
English: The film-coated tablets are to be swallowed with water while the dispersible tablets are to be mixed with a liquid to make up a suspension that the patient can drink.
Danish: De filmovertrukne tabletter synkes med vand, mens de dispergible tabletter blandes med en væske for at få en opløsning, som patienten kan drikke.
English: Effectiveness was determined by the level of iron in the liver before and after one year of treatment.
Danish: Virkningen blev målt ved at undersøge jernindholdet i leveren før og efter et års behandling.
English: Non-transfusion-dependent thalassaemia syndromes are blood disorders similar to beta thalassaemia major but which do not require blood transfusions.
Danish: Ikketransfusionskrævende thalassæmisyndromer er blodsygdomme, der ligner svær beta-thalassæmi, men hvor der ikke er behov for blodtransfusioner.
English: Cases of metabolic acidosis (when the body produces more acid than it gets rid of) have been reported with Exjade, mostly in patients with kidney impairment.
Danish: Der er i forbindelse med Exjade indberettet tilfælde af metabolisk acidose (når kroppen producerer mere syre, end den udskiller), hovedsageligt hos patienter med nedsat nyrefunktion.
English: How is Exjade used?
Danish: Hvordan anvendes Exjade?
English: This pack aims to inform them about the treatment recommendations with Exjade, including choosing the right dose, that the doses are different for dispersible tablets compared to film-coated tablets or granules, and the need to monitor the patient's health, especially kidney function.
Danish: Materialet skal indeholde anbefalinger og instruktioner i forbindelse med Exjade-behandling, herunder valg af den rigtige dosis, forskellig dosis for filmovertrukne tabletter og dispergible tabletter og behovet for at overvåge patientens helbred, især nyrefunktionen.
English: However, in the 381 patients who had particularly high levels of iron at the beginning of the study and who received comparable amounts of Exjade and deferoxamine, the two medicines were as effective as each other.
Danish: De to lægemidler var dog lige effektive hos de 381 patienter, der havde særligt højt jernindhold ved studiets begyndelse, og som havde fået Exjade eller deferoxamin i doser svarende til hinanden.
English: For the full list of side effects of Exjade, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Exjade fremgår af indlægssedlen.
English: What benefits of Exjade have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Exjade?
English: Cases of kidney and liver failure have been reported with Exjade.
Danish: Der er i forbindelse med Exjade indberettet tilfælde af nyre- og leversvigt.
English: Interruption of treatment with Exjade should be considered in patients who develop this condition.
Danish: Hos patienter, som udvikler denne tilstand, bør det overvejes at afbryde behandlingen med Exjade.
English: How does Exjade work?
Danish: Hvordan virker Exjade?
English: • patients from 6 years of age who have beta thalassaemia major (an inherited blood disorder in which patients do not have enough normal haemoglobin in the blood) and who receive frequent blood transfusions;
Danish: • patienter fra seksårsalderen, der har svær beta-thalassæmi (en arvelig blodsygdom, hvor patienterne ikke har nok hæmoglobin i blodet), og som hyppigt får blodtransfusioner
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Exjade have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Exjade.
English: • patients from 10 years of age with non-transfusion-dependent thalassaemia syndromes, when deferoxamine cannot be used or is inadequate.
Danish: • patienter fra 10-årsalderen med ikketransfusionskrævende thalassæmisyndromer, når deferoxamin ikke kan anvendes eller ikke virker.
English: • patients from 2 years of age who suffer from other types of anaemia (low levels of haemoglobin in the blood) and who receive blood transfusions, when deferoxamine cannot be used or is inadequate;
Danish: • patienter fra toårsalderen, der lider af forskellige former for anæmi (lavt hæmoglobinindhold i blodet), og som får blodtransfusioner, når deferoxamin ikke kan anvendes eller ikke virker
English: • children aged 2 to 5 years with beta thalassaemia major who receive frequent blood transfusions, when deferoxamine (another medicine used to treat iron overload) cannot be used or is inadequate;
Danish: • børn i alderen to til fem år med svær beta-thalassæmi, som hyppigt får blodtransfusioner, når deferoxamin (et andet lægemiddel til behandling af jernophobning) ikke kan anvendes eller ikke virker
English: • patients from 2 years of age with beta thalassaemia major who receive infrequent blood transfusions, when deferoxamine cannot be used or is inadequate;
Danish: • patienter fra toårsalderen med svær beta-thalassæmi, som sjældent får blodtransfusioner, når deferoxamin ikke kan anvendes eller ikke virker
English: Novantrone is marketed in the following EU member states: Cyprus, Finland, France, Germany, Greece, Italy, Romania, Slovenia, Spain and Sweden, as well as Iceland and Norway.
Danish: Novantrone markedsføres i følgende EU-medlemsstater: Cypern, Finland, Frankrig, Tyskland, Grækenland, Italien, Rumænien, Slovenien, Spanien og Sverige samt Island og Norge.
English: What is Novantrone?
Danish: Hvad er Novantrone?
English: It is also available in the EU under the trade names Elsep and Ralenova.
Danish: Det fås også i EU under handelsnavnene Elsep og Ralenova.
English: Novantrone has been authorised in the EU via national procedures.
Danish: Novantrone blev godkendt i EU via nationale procedurer.
English: The company that markets these medicines is MEDA.
Danish: Disse lægemidler markedsføres af virksomheden MEDA.
English: The European Commission issued a decision on this opinion on 24/06/2016.
Danish: Europa-Kommissionen traf en afgørelse på grundlag af denne udtalelse den 24. juni 2016.
English: On 28 April 2016, the European Medicines Agency completed a review of Novantrone.
Danish: Den 28. april 2016 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Novantrone.
English: A risk management plan will be developed to ensure that Novantrone is used as safely as possible.
Danish: Der vil blive udarbejdet en risikostyringsplan for at sikre, at Novantrone anvendes så sikkert som muligt.
English: Why was Novantrone reviewed?
Danish: Hvorfor blev Novantrone vurderet igen?
English: The Committee also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use), 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), 4.8 (side effects) and 5.1 (pharmacodynamic properties).
Danish: CHMP harmoniserede også andre afsnit i produktresuméet, herunder punkt 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen), 4.5 (interaktioner), 4.6 (fertilitet, graviditet og amning), 4.7 (virkning på evnen til at føre motorkøretøj og betjene maskiner), 4.8 (bivirkninger) og 5.1 (farmakodynamiske egenskaber).
English: Additionally, Novantrone must not be used for the treatment of multiple sclerosis in pregnant women.
Danish: Derudover må Novantrone ikke anvendes til behandling af multipel sklerose hos gravide kvinder.
English: Therefore, to avoid potential serious side effects in breastfed infants, breastfeeding must be discontinued before starting treatment with Novantrone.
Danish: For at undgå potentielt alvorlige bivirkninger hos diende børn skal amning derfor ophøre, før behandling med Novantrone påbegyndes.
English: As part of this plan, the company will provide educational materials about the use of Novantrone in patients with multiple sclerosis.
Danish: Som en del af denne plan vil virksomheden udarbejde oplysningsmateriale om anvendelsen af Novantrone hos patienter med multipel sklerose.
English: Daily doses vary from 6 to 14 mg per square metre of body surface area (calculated using the patient's height and weight).
Danish: Den anbefalede daglige dosis varierer fra 6-14 mg pr. kvadratmeter kropsoverflade (beregnet ud fra patientens højde og vægt).
English: • Metastatic breast cancer (breast cancer that has spread to other parts of the body);
Danish: • Metastatisk brystkræft (kræft, der har bredt sig til andre dele af kroppen)
English: The CHMP also harmonised the recommendations on how to use Novantrone for the different indications.
Danish: CHMP harmoniserede også anbefalingerne for brug af Novantrone i de forskellige indikationer.
English: It is also used to treat patients with worsening multiple sclerosis when no alternative treatments are available.
Danish: Det anvendes også til behandling af patienter med forværring af multipel sklerose, når der ikke er andre behandlingsmuligheder.
English: On 1 October 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Novantrone in the EU.
Danish: Den 1. oktober 2014 indbragte Europa-Kommissionen sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Novantrone i EU.
English: The recommended dose of Novantrone and the duration of treatment depend on the disease it is used for, whether it is used in combination with other medicines, on the height and weight of the patient, and on the response to treatment.
Danish: Den anbefalede dosis Novantrone og behandlingsvarigheden afhænger af, hvilken sygdom der er tale om, hvorvidt lægemidlet bruges i kombination med andre lægemidler, patientens højde og vægt samt patientens reaktion på behandlingen.
English: The CHMP agreed that Novantrone can be used for the treatment of the following conditions:
Danish: CHMP vedtog, at Novantrone kan anvendes til følgende lidelser:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Novantrone in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for at harmonisere ordineringsoplysningerne for Novantrone i Den Europæiske Union (EU).
English: Novantrone should only be given by infusion into a vein.
Danish: Novantrone må kun gives ved infusion i en vene.
English: • Non-Hodgkin's lymphoma;
Danish: • Non-Hodgkins lymfom
English: Patients will receive a guide to the risks and an alert card describing the signs and symptoms to watch out for.
Danish: Patienterne vil få udleveret en folder om disse risici samt et patientkort med angivelse af, hvilke tegn og symptomer de skal være opmærksomme på.
English: Novantrone is a medicine that is used in the treatment of cancers including breast cancer, non-Hodgkin's lymphoma (a cancer of the lymphatic system, which is part of the immune system) and certain types of blood cancer, as well as pain caused by prostate cancer.
Danish: Novantrone er et lægemiddel, der anvendes til behandling af kræft, herunder brystkræft, non-Hodgkins lymfom (kræft i lymfesystemet, der er en del af immunforsvaret) og visse typer blodkræft samt smerter forårsaget af prostatakræft.
English: • Highly active relapsing multiple sclerosis associated with rapidly evolving disability, in patients for whom no alternative treatments are available.
Danish: • Højaktiv tilbagevendende multipel sklerose i forbindelse med hastigt tiltagende invaliditet hos patienter, hvor der ikke er andre behandlingsmuligheder.
English: The educational materials will include a guide and checklist for healthcare professionals informing of the risks of cardiotoxicity (harm to the heart) and leukaemia with the medicine, and how patients should be monitored.
Danish: Oplysningsmaterialet vil omfatte en folder og en tjekliste til sundhedspersoner vedrørende de risici for kardiotoksicitet (hjerteskade) og leukæmi, der er forbundet med lægemidlet, med vejledning i, hvordan patienterne skal overvåges.
English: This has led to divergences across Member States in the medicine's authorised uses, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets.
Danish: Dette har ført til afvigelser mellem medlemsstaterne med hensyn til lægemidlets godkendte anvendelser, således som det fremgår af forskellene mellem produktresuméer, etikettering og indlægssedler i de forskellige EU-lande.
English: The company will prepare a survey for healthcare professionals to check how well these materials work.
Danish: Virksomheden vil udarbejde et spørgeskema til sundhedspersoner for at kontrollere, om oplysningsmaterialet fungerer efter hensigten.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, considered that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På grundlag af de forelagte data og den videnskabelige drøftelse i udvalget fandt CHMP, at produktresuméer, etikettering og indlægssedler skulle harmoniseres i EU.
English: The CHMP also agreed that Novantrone should no longer be approved for the treatment of acute lymphocytic leukaemia (a cancer of a different type of white blood cells) and liver cancer.
Danish: CHMP har også vurderet, at Novantrone ikke længere bør være godkendt til behandling af akut lymfocytær leukæmi (en anden type kræft i de hvide blodlegemer) og leverkræft.
English: • Relief of pain in patients with advanced prostate cancer;
Danish: • Fremskreden prostatakræft hos patienter, der har brug for smertelindring
English: Novantrone contains the active substance mitoxantrone and it is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Danish: Novantrone indeholder det aktive stof mitoxantron og leveres som et koncentrat, der blandes til en infusionsvæske, opløsning, (drop) til indgift i en vene.
English: • ‘Blast crisis' in chronic myeloid leukaemia (the final, rapidly progressive stage of another type of cancer of white blood cells);
Danish: • Såkaldt blastkrise ved kronisk myeloid leukæmi (det sidste, hurtigt fremadskridende stadie af en anden type kræft i de hvide blodlegemer)
English: • Acute myeloid leukaemia (cancer of a type of white blood cell called myeloid cells);
Danish: • Akut myeloid leukæmi (kræft i myelomcellerne, en type hvide blodlegemer)
English: Novantrone was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) fandt det nødvendigt at harmonisere Novantrone.
English: Mitoxantrone, the active substance in Novantrone, passes into breast milk and has been detected in breast milk for up to one month after the medicine was discontinued.
Danish: Mitoxantron, det aktive stof i Novantrone, udskilles i modermælk.
English: Pharmaceutical Form
Danish: Lægemidlet s navn
English: Immediate Packaging
Danish: Lægemiddelform Indgivelsesmåde Indre emballage
English: MA (EU) number
Danish: Markedsføringstill adelsesnummer (numre)
English: If necessary your doctor may tell you to take a different dose.
Danish: Om nødvendigt kan din læge give dig besked på at tage en anden dosis.
English: Nederland Focus Care Pharmaceuticals B.V.
Danish: Focus Care Pharmaceuticals B.V.
English: - if you have or ever had bladder cancer.
Danish: - hvis du har eller nogensinde har haft blærekræft.
English: - This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.
Danish: - Dette uddannelsesmateriale har til hensigt at styrke opmærksomheden om betydningsfulde identificerede risici for blærecancer og hjertesvigt og de samlede anbefalinger beregnet på at optimere marginen for fordele og ulemper på patientniveau.
English: The Prescriber Guide should highlight the following: - Patient selection criteria including that Pioglitazone should not be used as first line therapy and emphasising the need for regular review of treatment benefit.
Danish: Ordinationsvejledningen skal belyse følgende: - Kriterier for udvælgelse af patienter, herunder at pioglitazon ikke bør anvendes som førstevalgsbehandling og understregning af behovet for regelmæssig kontrol af behandlingens gavn.
English: Pioglitazone Krka helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Danish: Pioglitazone Krka hjælper med at kontrollere sukkerniveauet i dit blod, hvis du har type 2-diabetes, ved at hjælpe din krop til bedre at udnytte den insulin, kroppen producerer.
English: 14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 98 tablets
Danish: 14 tabletter 28 tabletter 30 tabletter 56 tabletter 60 tabletter 90 tabletter 98 tabletter
English: Environmental Risk Assessment (ERA): no environmental impact is anticipated from the clinical use of pioglitazone.
Danish: Miljørisikovurdering: Der forventes ingen virkninger på miljøet fra klinisk anvendelse af pioglitazon.