FrancophonIA/ELRC3.0 huggingface dataset:
English: The tablets must always be taken after the patient has not eaten anything for at least six hours overnight and at least 30 minutes before the first food or drink of the day.
Danish: Tabletterne skal altid tages, efter at patienten ikke har spist noget i mindst seks timer natten over, og mindst 30 minutter inden dagens første måltid eller drikkevarer indtages.
English: What are the benefits and risks of Iasibon?
Danish: Hvilke fordele og risici er der ved Iasibon?
English: They must be taken with a full glass of plain water (in areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content should be used).
Danish: Tabletterne skal indtages sammen med et helt glas almindeligt vand (i områder med hårdt vand, hvor postevandet indeholder en del opløst calcium, kan flaskevand med lavt mineralindhold anvendes).
English: For more information about treatment with Iasibon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Iasibon, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: By preventing the breakdown of bones, Iasibon also helps to reduce the amount of calcium released into the blood.
Danish: Ved at forebygge nedbrydningen af knoglerne er Iasibon også med til at reducere den mængde calcium, der frigives til blodet.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Iasibon.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Iasibon skal anvendes.
English: Iasibon is a ‘generic medicine'.
Danish: Iasibon er et "generisk lægemiddel".
English: • as an infusion to treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
Danish: • som en infusion til behandling af hypercalcæmi (højt calciumniveau i blodet), der skyldes tumorer.
English: It is available as a concentrate that is made up into a solution for infusion (drip into a vein) and as tablets (50 mg).
Danish: Det fås som et koncentrat, der blandes til en opløsning til infusion (drop) i en vene, og som tabletter (50 mg).
English: This means that Iasibon is similar to a ‘reference medicine' already authorised in the European Union (EU) called Bondronat.
Danish: Det betyder, at Iasibon ligner et "referencelægemiddel", som allerede er godkendt i EU, i dette tilfælde Bondronat.
English: What measures are being taken to ensure the safe and effective use of Iasibon?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af BeneFIX?
English: The Committee recommended that Iasibon be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Iasibon.
English: Patients with moderate or severe kidney problems should receive Iasibon infusions at a lower dose over an hour, or the tablets every two days or every week.
Danish: Patienter med moderate eller svære nyreproblemer skal have infusioner af en lavere dosis Iasibon, som varer en time, eller skal tage tabletterne hver anden dag eller hver uge.
English: Because Iasibon is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Eftersom Iasibon er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som referencelægemidlets.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Iasibon, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Iasibon, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Iasibon is a medicine that contains the active substance ibandronic acid.
Danish: Iasibon er et lægemiddel, der indeholder det aktive stof ibandronsyre.
English: The active substance in Iasibon, ibandronic acid, is a bisphosphonate.
Danish: Det aktive stof i Iasibon, ibandronsyre, er et bifosfonat.
English: In the prevention of skeletal events, Iasibon is either given as a 6-mg infusion lasting at least 15 minutes every three to four weeks, or as one tablet once a day.
Danish: Til forebyggelse af knoglerelaterede hændelser gives Iasibon enten som en 6 mg infusion, der varer mindst 15 minutter, hver 3.-4. uge, eller som én tablet en gang dagligt.
English: Because Iasibon is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Bondronat.
Danish: Eftersom Iasibon er et generisk lægemiddel, har undersøgelserne hos patienter været begrænset til test for at fastslå, at det er bioækvivalent med referencelægemidlet Bondronat.
English: Therefore, the CHMP's view was that, as for Bondronat, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Bondronat.
English: Why has Iasibon been approved?
Danish: Hvorfor blev Iasibon godkendt?
English: The CHMP concluded that, in accordance with EU requirements, Iasibon has been shown to have comparable quality and to be bioequivalent to Bondronat.
Danish: CHMP konkluderede, at det i overensstemmelse med EU-kravene er påvist, at Iasibons kvalitet svarer til Bondronats, og at Iasibon er bioækvivalent med Bondronat.
English: Iasibon ibandronic acid
Danish: Iasibon ibandronsyre
English: What is Iasibon?
Danish: Hvad er Iasibon?
English: In the treatment of hypercalcaemia caused by tumours, Iasibon is given over 2 hours as an infusion of either 2 or 4 mg, depending on how severe the hypercalcaemia is.
Danish: Ved behandling af hypercalcæmi forårsaget af svulster gives Bondronat over en periode på to timer som en infusion på enten 2 eller 4 mg afhængigt af, hvor alvorlig hypercalcæmien er. Infusionen vil som regel bringe blodets calciumindhold ned på et normalt niveau i løbet af en uge.
English: What is Iasibon used for?
Danish: Hvad anvendes Iasibon til?
English: • as an infusion or as a tablet to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone);
Danish: eller knoglekomplikationer, der kræver behandling) hos patienter med brystkræft og knoglemetastaser (når kræften har spredt sig til knoglerne);
English: How has Iasibon been studied?
Danish: Hvordan blev Iasibon undersøgt?
English: How is Iasibon used?
Danish: Hvordan anvendes Iasibon?
English: How does Iasibon work?
Danish: Hvordan virker Iasibon?
English: The concerned Member States (CMS) are: CZ, DE, ES, IT, NL, PL and UK.
Danish: De berørte medlemsstater er: CZ, DE, ES, IT, NL, PL og UK.
English: in their Risk Management Plan as appropriate.
Danish: på passende måde afspejles i risikostyringsplanen.
English: This usually occurs during treatment or within the first years post treatment.
Danish: Dette indtræffer sædvanligvis i løbet af behandlingen eller inden for de første år efter behandlingen.
English: • The Committee considered the referral under Article 13 of Regulation (EC) No 1234/2008.
Danish: • udvalget behandlede indbringelsen i henhold til artikel 13 i forordning (EF) nr. 1234/2008
English: The reference Member State (RMS) is: FR
Danish: Referencemedlemsstaten er: FR
English: The mutual recognition procedure FR/H/0283/001/II/27G started on 28/11/2015.
Danish: Den gensidige anerkendelsesprocedure (FR/V/0283/001/II/002) blev indledt 28.11.2015.
English: The CMDh 60 day procedure was initiated on 02/12/2016.
Danish: CMDh's 60-dages procedure blev indledt 2.12.2016.
English: • removal of the contraindication in children and adolescents
Danish: • sletning af kontraindikationen for børn og unge
English: • widening of the indication from “advanced and/or metastatic adult breast cancer patients” to “cancer patients”.
Danish: • udvidelse af indikationen fra "voksne patienter med fremskreden og/eller metastatisk brystkræft" til "kræftpatienter"
English: The primary changes requested in the variation were:
Danish: I ændringsansøgningen blev der primært søgt om:
English: In this context and considering
Danish: Ud fra følgende betragtninger:
English: Delayed effects usually manifest as congestive heart failure which can occur up to 20 years post treatment.
Danish: Forsinkede virkninger manifesterer sig sædvanligvis som venstresidig hjerteinsufficiens, der kan opstå op til 20 år efter behandling.
English: UK did not concur with the RMS assessment related to the removal of the contra-indication for a certain subset of the paediatric population.
Danish: Det Forenede Kongerige var ikke enig i referencemedlemsstatens vurdering vedrørende sletning af kontraindikationen for en bestemt undergruppe af den pædiatriske population.
English: A type II grouping of variations application was submitted under the mutual recognition procedure for Cardioxane 500 mg powder for solution for infusion.
Danish: Der er indgivet en gruppe af type II-ændringsansøgninger i henhold til den gensidige anerkendelsesprocedure for Cardioxane, 500 mg pulver til infusionsvæske, opløsning.
English: It is acknowledged that DRZ may increase the risk of myelosuppression and infections; however these risks can be minimised by appropriate measures currently in place in standard paediatric treatment protocols.
Danish: Det er anerkendt, at dexrazoxan kan øge risikoen for myelosuppression og infektioner, en risiko, der dog kan minimeres gennem passende foranstaltninger, som nu indgår i standardprotokoller for pædiatrisk behandling.
English: In view of the potential serious risk to public health raised by UK, the procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), under Article 13(1) of Regulation (EC) No 1234/2008 by France on 04/11/2016.
Danish: På baggrund af den potentielle alvorlige risiko for folkesundheden, der var taget op af Det Forenede Kongerige, indbragte Frankrig 4.11.2016 proceduren for Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh), i henhold til artikel 13, stk. 1, i forordning (EF) nr. 1234/2008.
English: There is therefore no robust long term efficacy data that demonstrate that the use of DRZ prevents the chronic or long term cardiotoxic effects of anthracyclines in the paediatric population.
Danish: Der er derfor ingen robuste langtidsdata om virkning, der viser, at anvendelsen af dexrazoxan forhindrer de kroniske eller langsigtede kardiotoksiske virkninger af antracycliner hos den pædiatriske population.
English: However there are still remaining uncertainties with regard to long term effects for DRZ in children.
Danish: Der tilbagestår dog fortsat usikkerheder vedrørende langsigtede virkninger for dexrazoxan hos børn.
English: This is due either to a low rate of clinical cardiac events in patients in the included RCTs or to the small numbers of patients who were treated with lower cumulative doses of anthracyclines and the relatively short duration of follow-up of these patients.
Danish: Dette skyldes enten en lav andel af kardiale kliniske hændelser hos patienter i de omfattede randomiserede kontrollerede undersøgelser eller det ringe antal patienter behandlet med lavere kumulative doser antracycliner og den relativt korte opfølgningsvarighed for disse patienter.
English: However, there is currently no established correlation between the used cardiac markers and the long term cardioprotective effects of DRZ as data are unavailable due to the length of follow-up needed.
Danish: På nuværende tidspunkt er korrelationen mellem de anvendte kardiale markører og de langsigtede kardioprotektive virkninger af dexrazoxan imidlertid ikke fastlagt, da der ikke foreligger data på grund af den nødvendige opfølgningsvarighed.
English: With higher cumulative doses of anthracyclines, studies (including several RCTS and non-randomised studies) have showed that DRZ could improve the surrogate cardiac markers and therefore reduce subclinical acute cardiotoxicity.
Danish: Ved højere kumulative antracyclindoser har undersøgelser (herunder flere randomiserede kontrollerede undersøgelser og ikkerandomiserede undersøgelser) vist, at dexrazoxan kunne forbedre de kardiale surrogatmarkører og derfor reducere den subkliniske akutte kardiotoksicitet.
English: High cumulative doses of anthracycline are rarely used in the paediatric population; however, they are requested for the treatment of some pathologies such as sarcomas and relapsed acute myeloid leukaemia.
Danish: Høje kumulative doser antracyclin anvendes sjældent hos den pædiatriske population, men efterspørges til behandling af visse sygdomme såsom sarkomer og recidiverende akut myeloid leukæmi.
English: The studies may not have been sufficiently powered to observe a statistically confirmed increase of SPM.
Danish: Undersøgelsernes styrke har muligvis ikke været tilstrækkelig til, at der kan iagttages en statistisk bekræftet stigning i sekundære primære maligniteter.
English: Although the cardiac markers used in the original studies may not be as robust as those used currently, they provide some evidence of DRZ acute cardioprotective effect.
Danish: Skønt de kardiale markører i de oprindelige undersøgelser ikke nødvendigvis er så robuste som de, der anvendes nu, giver de nogen evidens for dexrazoxans akut kardioprotektive virkning.
English: Moreover, there is evidence that there is no delay to chemotherapy treatment as a result of a potential DRZ myelosuppression effect.
Danish: Der er desuden evidens for, at kemoterapi ikke forsinkes som følge af en potentiel myelosuppressiv virkning af dexrazoxan.
English: Anthracycline related cardiac damage can be acute, manifesting as acute heart failure, reduction in the shortening fraction or changes to the ventricular wall thickening.
Danish: Antracyclinrelateret hjerteskade kan være akut og manifestere sig som akut hjertesvigt, reduktion i forkortningsfraktionen eller ændringer i ventriklens vægtykkelse.
English: Day 60 of the CMDh procedure was on 30/01/2017 and as no agreement could be reached, the procedure and the objections raised by the UK to the lifting of the contraindication for a subset of anthracycline treated paediatric population were referred to the CHMP on 31/01/2017 by the RMS.
Danish: Dag 60 i CMDh-proceduren var 30.1.2017, og da der ikke kunne opnås enighed, foretog referencemedlemsstaten 31.1.2017 en indbringelse for CHMP af proceduren og Det Forenede Kongeriges indsigelser over for ophævelsen af kontraindikationen for en undergruppe af den pædiatriske population, der blev behandlet med antracycliner.
English: The evaluation of the data submitted as part of this procedure have allowed a better characterisation of the risk of the short term effects on SPM, myelosuppression and infections, following treatment with DRZ in children undergoing chemotherapy with anthracycline based regimens.
Danish: Vurderingen af de data, der er indsendt som led i denne procedure, har givet bedre mulighed for at karakterisere risikoen ved de kortsigtede virkninger på sekundære primære maligniteter, myelosuppression og infektioner efter behandling med dexrazoxan hos børn, der gennemgår kemoterapi med et antracyclinbaseret regime.
English: Unravelling confounders for the cause of SPM would be difficult and overall the long term risk of SPM remains unknown at present.
Danish: At udrede konfunderende faktorer i forbindelse med årsagen til sekundære primære maligniteter vil være vanskeligt, og den langsigtede risiko for sekundære primære maligniteter er på nuværende tidspunkt i det store hele ukendt.
English: • The Committee noted the reassuring safety data on the occurrence of secondary primary malignancies in particular acute myelogenous leukaemia and myelodysplastic syndrome in children and adolescents aged 0 to 18 years, the high risk for long term occurrence of severe cardiomyopathy when using high cumulated dose of anthracycline in children and adolescents and the medical need of high anthracycline dosing regimen for pathology such as sarcoma or acute myelogenous leukaemia relapses in children and adolescents
Danish: • udvalget noterede sig de betryggende sikkerhedsdata om forekomsten af sekundære primære maligniteter, navnlig akut myeloid leukæmi og myelodysplastisk syndrom, hos børn og unge i alderen 0 til 18 år, den høje risiko for langsigtet forekomst af svær kardiomyopati ved anvendelse af en høj kumuleret dosis antracyclin hos børn og unge, og det medicinske behov for et højdosisregime for antracyclin til sygdomme såsom sarkom eller recidiverende akut myeloid leukæmi hos børn og unge
English: The CHMP noted that the MAH will reflect the ongoing observational study (Effects of Dexrazoxane Hydrochloride on Biomarkers Associated with Cardiomyopathy and Heart Failure after Cancer Treatment, NCT01790152.)
Danish: CHMP noterede sig, at indehaveren af markedsføringstilladelsen sørger for, at det igangværende observationsstudie (virkningerne af dexrazoxanhydrochlorid på biomarkører for kardiomyopati og hjertesvigt efter kræftbehandling, NCT01790152.)
English: The CHMP was informed that the MAH will conduct a prospective safety study in children using existing cancer disease registries to collect data on dexrazoxane use in the paediatric population, the incidence of adverse events (e.g. secondary malignancies, myelosuppression and infections) and the long-term (>12 years) cardiac effects (including cardiac failure, left ventricular failure).
Danish: CHMP blev informeret om, at indehaveren af markedsføringstilladelsen vil gennemføre en prospektiv sikkerhedsundersøgelse hos børn ved hjælp af eksisterende kræftregistre, idet der indsamles data om anvendelse af dexrazoxan hos den pædiatriske population, forekomsten af uønskede hændelser (f.eks. sekundære maligniteter, myelosuppression og infektioner) og de langsigtede (> 12 år) kardiale virkninger (herunder hjertesvigt, svigt af venstre ventrikel).
English: Moreover, in the view of the presented data, the RMS considered not acceptable to fully remove the contra-indication in children, as requested by the MAH.
Danish: Referencemedlemsstaten vurderede desuden, at det på baggrund af de fremlagte data ikke var acceptabelt helt at slette kontraindikationen for børn som anmodet af indehaveren af markedsføringstilladelsen.
English: • The Committee considered the data submitted by the MAH in relation to the objections raised on the lifting of the contraindication for Cardioxane in children and adolescents receiving high cumulative doses of anthracycline.
Danish: • udvalget behandlede de af indehaveren af markedsføringstilladelsen forelagte oplysninger i forbindelse med indsigelserne mod ophævelsen af kontraindikationen for Cardioxane hos børn og unge, som får en høj kumulativ dosis af antracyclin
English: • The Committee concluded that, in view of the above, it is justified to limit the contraindication for Cardioxane in children aged 0 to 18 years receiving low cumulative anthracycline doses (less than 300 mg/m2 of doxorubicin or equivalent)
Danish: • udvalget konkluderede, at det på baggrund af ovenstående er begrundet at begrænse kontraindikationen for Cardioxane hos børn i alderen 0 til 18 år, som får en lav kumulativ antracyclindosis (mindre end 300 mg/m2 doxorubicin eller ækvivalent dermed)
English: The assessment of this risk is confounded by concomitant chemotherapy treatments, small numbers of patients and the overall rarity of SPM events.
Danish: Vurderingen af denne risiko konfunderes af samtidig kemoterapi, ringe patientantal og af, at sekundære primære maligniteter generelt er sjældne.
English: However, data assessed are still insufficient to provide reassurance concerning the occurrence of long-term risk of SPM particularly solid SPMs.
Danish: De vurderede data er dog stadig utilstrækkelige til at være betryggende, hvad angår den langsigtede risiko for sekundære primære maligniteter, navnlig massive tumorer.
English: The data assessed during the Art.31 referral procedure in 2011 regarded the carcinogenic potential of dexrazoxane due its cytotoxic activity and on the occurrence of second malignant neoplasms in the paediatric population; such data justified the introduction of a contraindication of the product in children aged 0 to 18 years.
Danish: De data, der blev vurderet i forbindelse med artikel 31-henvisningsproceduren i 2011, vedrørte det karcinogene potentiale af dexrazoxan betinget af dets cytotoksiske aktivitet samt forekomsten af sekundære maligne neoplasmer hos den pædiatriske population.
English: However, the RMS considered acceptable to alleviate the contra-indication in children and proposed limiting it to children receiving low cumulative anthracycline doses (less than 300mg/m2 of doxorubicin or equivalent).
Danish: Referencemedlemsstaten fandt det dog acceptabelt at lette kontraindikationen for børn og foreslog at begrænse den til børn, der modtager lave kumulative doser af antracycliner (mindre end 300 mg/m2 doxorubicin eller ækvivalent dermed).
English: DRZ efficacy as a cardioprotectant has not been demonstrated in children for cumulative anthracycline doses of less than 300 mg/m2.
Danish: Dexrazoxans virkning som kardioprotektivt middel er ikke godtgjort hos børn ved kumulative antracyclindoser på mindre end 300 mg/m2.
English: Data are reassuring as regard to occurrence of SPMs in children after being exposed to DRZ, up to 12 years post treatment.
Danish: Hos børn, der har været udsat for dexrazoxan, er dataene betryggende, hvad angår forekomsten af sekundære primære maligniteter, op til 12 år efter behandlingen.
English: The Committee, as a consequence, recommends the granting of the variation to the terms of the marketing authorisation for the medicinal products referred to in Annex I of the CHMP opinion subject to the amendments to the product information as set out in Annex III of the CHMP opinion and the amendments of the risk management plan as described above.
Danish: • udvalget var af den opfattelse, at der behøves ændringer af produktinformationen samt indførelse af rutinemæssige lægemiddelovervågningsaktiviteter i form af specifikke opfølgende spørgeskemaer til indsamling af oplysninger om sikkerheden og virkningen af lægemidlet hos børn anbefaler udvalget, at ændringen af betingelserne i markedsføringstilladelsen godkendes for de lægemidler, der er omhandlet i bilag I til CHMP's udtalelse, under forudsætning af gennemførelse af de ændringer af produktinformationen, som er anført i bilag III til CHMP's udtalelse og de ændringer af risikostyringsplanen, som er beskrevet ovenfo
English: Although studies suggest there is no safe dose of anthracycline, it is known that the risk of anthracycline induced cardiotoxicity increases with higher cumulative dosing; guidelines imply that above 250 mg/m2 there is sufficient cardiac risk to provide recommendations on lifelong surveillance1.
Danish: Af retningslinjer kan det udledes, at ved en dosis over 250 mg/m2 er den kardiale risiko tilstrækkelig til at anbefale livsvarig overvågning1.
English: Furthermore, in the short (up to 5 years post treatment) to medium term (up to 12 years post treatment) anthracycline's anti-tumour efficacy was not compromised by DRZ use.
Danish: Anvendelse af dexrazoxan modvirkede desuden ikke antracycliners antitumoreffekt hverken på kort sigt (op til 5 år efter behandling) eller på mellemlang sigt (op til 12 år efter behandling).
English: The RMS considered that none of the data presented by the Marketing Authorisation Holder (MAH) were sufficiently supportive to widen the indication in adults; therefore, the first requested change on the widening of the indication to “cancer patients” was rejected.
Danish: Den først ansøgte ændring om udvidelse af indikationen til "kræftpatienter" blev derfor afvist.