FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro studies have shown that aclidinium bromide or the metabolites of aclidinium bromide at the therapeutic dose are not expected to cause interactions with active substances that are substrates of Pglycoprotein (P-gp) or active substances metabolised by cytochrome P450 (CYP450) enzymes and esterases (see section 5.2).
Danish: glykoprotein (P-gp) eller aktive stoffer, der metaboliseres af cytochrom P450 (CYP450)-enzymer og-esteraser (se pkt.
English: Hepatic impairment No dose adjustments are required for patients with hepatic impairment (see section 5.2).
Danish: Nedsat leverfunktion Det er ikke nødvendigt at justere dosis hos patienter med nedsat leverfunktion (se pkt.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Bretaris Genuair Fortæl det altid til lægen eller på apotekspersonalet, hvis du bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
English: What Bretaris Genuair is and what it is used for What you need to know before you use Bretaris Genuair How to use Bretaris Genuair Possible side effects
Danish: Det skal du vide, før du begynder at bruge Bretaris Genuair Sådan skal du bruge Bretaris Genuair Bivirkninger
English: Hepatically-impaired patients
Danish: Patienter med nedsat nyrefunktion
English: Method of administration For inhalation use.
Danish: Administration Til inhalationsbrug.
English: If you use more Bretaris Genuair than you should If you think you may have used more Bretaris Genuair than you should, contact your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet, hvis du mener, at du har brugt mere Bretaris Genuair, end du burde.
English: If you stop using Bretaris Genuair
Danish: Hvis du har brugt for meget Bretaris Genuair
English: Bretaris Genuair 322 micrograms inhalation powder aclidinium (aclidinium bromide)
Danish: Bretaris Genuair 322 mikrogram inhalationspulver aclidinium (aclidiniumbromid)
English: How to use Bretaris Genuair
Danish: Sådan skal du bruge Bretaris Genuair
English: Renal impairment No dose adjustments are required for patients with renal impairment (see section 5.2).
Danish: Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion (se pkt.
English: This medicine is for long-term use.
Danish: KOL er en langvarig sygdom.
English: Laboratori Guidotti S.p.A. Tel: +39- 050 971011
Danish: Tel: +39- 050 971011
English: Bretaris Genuair 322 mcg inhalation powder aclidinium (aclidinium bromide) Inhalation use
Danish: Bretaris Genuair 322 µg inhalationspulver aclidinium (aclidiniumbromid) Inhalationsbrug
English: What Bretaris Genuair contains - The active substance is aclidinium bromide.
Danish: - Aktivt stof: aclidiniumbromid.
English: For Instructions for Use, see section 6.6.
Danish: Brugsanvisning, se pkt.
English: Do not tilt.
Danish: Se i pkt.
English: How to store Bretaris Genuair Contents of the pack and other information Instructions for Use
Danish: Pakningsstørrelser og yderligere oplysninger Brugsanvisning
English: 1 inhaler containing 30 doses 1 inhaler containing 60 doses 3 inhalers each containing 60 doses
Danish: 3 inhalatorer, der hver indeholder 60 doser
English: If you have any questions about how to use your inhaler, please ask your doctor, pharmacist or nurse for assistance.
Danish: Spørg din læge, apotekspersonalet eller sygeplejersken om hjælp, hvis du har nogle spørgsmål om, hvordan du skal bruge din inhalator.
English: What Bretaris Genuair is
Danish: Bretaris Genuair
English: Protective Cap
Danish: Beskyttelseshætte
English: Tabulated summary of adverse reactions
Danish: Bivirkningsoversigt i tabelform
English: Bottle (HDPE)
Danish: Oral anvendelse Beholder (HDPE)
English: The Marketing Authorisation was granted by the European Commission on 1 July 2013 for the following indications in adult patients:
Danish: Markedsføringstilladelsen blev udstedt af Europa-Kommissionen den 1. juli 2013 for følgende indikationer hos voksne patienter:
English: Nevertheless the Committee agreed that it is important to reflect these data in the product information.
Danish: Udvalget fandt dog, at det er vigtigt, at disse data afspejles i produktinformationen
English: Therefore the European Commission triggered a procedure under Article 20 of Regulation (EC) No 726/2004 on 27 November 2013.
Danish: Den 27. november 2013 indledte Europa-Kommissionen derfor en procedure i medfør af artikel 20 i forordning (EF) nr. 726/2004.
English: Risk minimisation measures
Danish: Risikominimeringsforanstaltninger
English: The incidence of arterial thrombotic events (per 100 patient years) remains relatively constant.
Danish: Hyppigheden af arterielle trombotiske hændelser (pr. 100 patientår) er relativt konstant.
English: Serious cardiac failure events have occurred in a total of 23 patients (5.1%).
Danish: Hændelser med alvorligt hjertesvigt er forekommet hos i alt 23 patienter (5,1 %).
English: It is therefore appropriate to reinforce existing recommendations for the cardiovascular status of the patient to be assessed before initiating treatment.
Danish: Det er derfor hensigtsmæssigt at skærpe de eksisterende anbefalinger om, at den kardiovaskulære status bør vurderes før initiering af behandlingen.
English: A total of 81 (18%) patients on the phase 2 study (n=449) have experienced serious vascular occlusive events and overall, a total of 101 patients (23%) have experienced vascular occlusive events (serious and non-serious).
Danish: I alt 81 (18 %) af patienterne i fase 2-undersøgelsen (n=449) har haft alvorlige vaskulære okklusive hændelser, og i alt 101 patienter (23 %) har haft vaskulære okklusive hændelser (alvorlige og ikke-alvorlige).
English: However these data include a relatively small number of patients, most of which had been dose reduced due to adverse events, and follow-up time is limited.
Danish: Disse data omfatter imidlertid et relativt lille antal patienter, hvoraf størstedelen havde fået reduceret deres dosis pga. bivirkninger, og opfølgningstiden er begrænset.
English: Non-clinical issues
Danish: Ikke-kliniske spørgsmål
English: In October 2013, the EMA was informed that the rate of vascular occlusive events was higher than observed in the clinical trials that supported the initial marketing authorisation.
Danish: I oktober 2013 blev EMA underrettet om, at forekomsten af vaskulære okklusive hændelser var højere end iagttaget i de kliniske undersøgelser, der lå til grund for den oprindelige markedsføringstilladelse.
English: • Updated information on adverse reactions.
Danish: • ajourførte oplysninger om bivirkninger.
English: • Updated recommendations to assess cardiovascular status and consider alternative treatments where appropriate.
Danish: • ajourførte anbefalinger om at vurdere kardiovaskulær status og overveje andre behandlingsmuligheder, når det er hensigtsmæssigt
English: A type II variation was submitted and additional risk minimisation measures such as updates to the product information were put in place.
Danish: Der blev indsendt en type II-ændringsansøgning og truffet supplerende risikominimeringsforanstaltninger, såsom ajourføring af produktinformationen.
English: In view of the high risk for vascular occlusive events, the PRAC considered that it should be made clear in the product information that ponatinib should be discontinued in patients who do not respond to treatment (no haematologic response by 3 months).
Danish: I betragtning af den høje risiko for vaskulære okklusive hændelser fandt PRAC, at det af produktinformationen klart bør fremgå, at ponatinib skal seponeres hos patienter, der ikke responderer på behandlingen (ingen hæmatologisk respons i løbet af 3 måneder).
English: • Discontinuation of treatment if haematologic response has not occurred by 3 months.
Danish: • behandlingsophør, hvis hæmatologisk respons ikke er opnået efter tre måneder
English: The PRAC has therefore recommended the variation to the terms of the marketing authorisation for Iclusig.
Danish: PRAC anbefalede derfor ændring af betingelserne for markedsføringstilladelsen for Iclusig.
English: This study is considered key to the benefit-risk of ponatinib and has been imposed as a condition to the marketing authorisation.
Danish: Denne undersøgelse anses for at være nøglen til benefit/risk-forholdet for ponatinib og er påbudt som en betingelse for markedsføringstilladelsen.
English: The CHMP, having considered the PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and is of the opinion that the marketing authorisation for Iclusig should be varied.
Danish: Efter gennemgang af PRAC's anbefaling tilsluttede CHMP sig PRAC's overordnede videnskabelige konklusioner og er af den opfattelse, at markedsføringstilladelsen for Iclusig bør ændres.
English: However, there were a number of outstanding issues which could not be resolved within the expedited variation procedure and which required a further review of the benefit-risk balance of Iclusig.
Danish: En række tilbagestående spørgsmål kunne imidlertid ikke afklares inden for rammerne af den fremskyndede ændringsprocedure, men krævede nærmere gennemgang af benefit/risk-forholdet for Iclusig.
English: The overall safety profile for ponatinib is generally consistent with that considered at the time of marketing authorisation, with the notable addition of the risk of vascular occlusive events.
Danish: Den overordnede sikkerhedsprofil for ponatinib er generelt overensstemmende med den, der var grundlag for markedsføringstilladelsen, men med tilføjelse af risikoen for vaskulære okklusive hændelser.
English: Ponatinib is a tyrosine kinase inhibitor (TKI), designed with the purpose of inhibiting the kinase activity of native BCR-ABL, and all mutant variants, including ‘gatekeeper' T315I.
Danish: Ponatinib er en tyrosinkinasehæmmer, der er udformet med det formål at hæmme kinaseaktiviteten af det naturlige BCR-ABL og alle muterede varianter heraf, herunder “portvagten” T315I.
English: While these data can be useful for physicians considering dose reduction, it is currently considered insufficient to adopt a formal recommendation for dose reduction in patients who have not experienced an adverse event.
Danish: Sådanne data kan være nyttige for lægerne ved overvejelse af dosisreduktion, men anses på nuværende tidspunkt for utilstrækkelige til at fremsætte en formel anbefaling om dosisreduktion hos patienter, der ikke har haft en bivirkning.
English: It is therefore unclear whether the maintenance of response observed in this particular group of patients can be generalised to the CP-CML population.
Danish: Det er derfor uklart, om opretholdelsen af respons hos denne særlige patientgruppe kan generaliseres til patientgruppen med kronisk myeloid leukæmi i kronisk fase.
English: The majority of cases of cardiac failure occurred in patients at known risk from underlying disease, cardiovascular risk factors and prior treatment with cardiotoxic medications including other TKIs.
Danish: De fleste tilfælde af hjertesvigt optrådte hos patienter med kendt risiko som følge af underliggende sygdom, kardiovaskulære risikofaktorer og tidligere behandling med kardiotoksiske lægemidler, herunder andre tyrosinkinasehæmmere.
English: A number of plausible molecular mechanism exists that may contribute to vascular occlusive events.
Danish: En række plausible molekylære mekanismer kan tænkes at bidrage til vaskulære okklusive hændelser.
English: • The PRAC took note of the serious risk of vascular occlusive events associated with Iclusig, which is likely to be dose-related.
Danish: • PRAC tog i betragtning den alvorlige risiko for vaskulære okklusive hændelser, der er forbundet med Iclusig, og som antages at være dosisrelaterede
English: There is also an association between vascular occlusive events and a risk of cardiac failure as a secondary event.
Danish: Der er desuden sammenhæng mellem vaskulære okklusive hændelser og risiko for hjertesvigt som sekundær hændelse.
English: • The PRAC reviewed all data presented by the MAH on the safety and efficacy of Iclusig, as well as the views expressed by the oncology scientific advisory group.
Danish: • PRAC gennemgik alle oplysninger fra indehaveren af markedsføringstilladelsen om sikkerheden og virkningen af Iclusig samt synspunkterne hos den videnskabelige rådgivende gruppe vedrørende onkologi
English: • Additional warnings about hypertension, cardiac failure and risk of bleeding with anti-clotting agents.
Danish: • supplerende advarsler om hypertension, hjerteinsufficiens og blødningsrisiko ved brug af antitrombotiske lægemidler
English: These included further consideration of the PK-PD profile of ponatinib to determine the optimal dosing in all patient populations and indications (including recommendations for initial dose and dose reductions), further assessment of the nature, severity and frequency of all treatment-emergent vascular occlusive adverse events (and possible sequelae), and heart failure, exploration of the potential mechanisms of action leading to vascular occlusive events and consideration of the possibilities for further risk minimisation measures.
Danish: Disse punkter var en yderligere gennemgang af den farmakokinetisk-farmakodynamiske profil for ponatinib til fastlæggelse af optimal dosering for alle patientgrupper og indikationer (med anbefalinger for initialdosis og dosisreduktion), yderligere vurdering af art, sværhed og hyppighed af alle behandlingsbetingede vaskulære okklusive bivirkninger (og mulige sequelae) og hjertesvigt, undersøgelser af de potentielle virkningsmekanismer, der medfører vaskulære okklusive hændelser, samt stillingtagen til eventuelle yderligere risikominimeringsforanstaltninger.
English: Clinical issues
Danish: Kliniske spørgsmål
English: Further non-clinical studies will be conducted with the aim to further characterise the potential mechanisms for vascular occlusive events with ponatinib treatment.
Danish: Der vil blive udført yderligere ikke-kliniske undersøgelser til nærmere karakterisering af de potentielle mekanismer bag vaskulære okklusive hændelser ved behandling med ponatinib.
English: The MAH shall provide relevant healthcare professionals with educational material highlighting important medical risks for which monitoring and/or dose adjustment are recommended, instructions on management of adverse events based on monitoring and dose modifications or treatment withdrawal and available data on the relationship between dose and risk of vascular occlusive events.
Danish: Indehaveren af markedsføringstilladelsen skal til de relevante sundhedspersoner udlevere oplysningsmateriale med fremhævelse af de vigtige risici, for hvilke der anbefales overvågning og/eller dosisjustering, anvisninger for behandling af bivirkninger baseret på overvågning og dosisændring eller seponering, samt foreliggende data om forholdet mellem dosis og risiko for vaskulære okklusive hændelser.
English: • The PRAC also considered the currently available data on dose-efficacy and dose-toxicity relationship, and concluded that it was too limited to allow for a formal recommendation for dose reduction as a risk minimisation measure in patients who have not experienced toxicity.
Danish: • PRAC tog også de aktuelt foreliggende data om dosis/virkning og dosis/toksicitet i betragtning og konkluderede, at de var for begrænsede til at fremsætte en formel anbefaling om dosisreduktion som risikominimeringsforanstaltning for patienter, som ikke har haft toksisk virkning.
English: Therefore no formal recommendation can be issued regarding concomitant the use of these agents and the potential risks of haemorrhage with anti-platelet and anticoagulant agents in ponatinib treated patients need to be considered.
Danish: Der kan derfor ikke fremsættes en formel anbefaling om samtidig brug af disse midler, hvorfor man må være opmærksom på risikoen for blødning ved anvendelse af antitrombocytmidler og antikoagulantia hos patienter i behandling med ponatinib.
English: This raises the question of whether similar outcomes in terms of efficacy could be achieved with lower (starting and/or maintenance) doses, which are expected to reduce the risk of vascular occlusive events.
Danish: Dette giver anledning til at spørge, om der kan opnås tilsvarende virkning med lavere initialdosis og/eller vedligeholdelsesdosis, som forventes at mindske risikoen for vaskulære okklusive hændelser.
English: The PRAC considered whether a recommendation for dose reduction (in the absence of an adverse event) in patients with chronic phase CML who have achieved major cytogenetic response was appropriate.
Danish: PRAC overvejede, om det var hensigtsmæssigt at anbefale dosisreduktion (i fravær af en bivirkning) hos patienter med kronisk myeloid leukæmi i kronisk fase, som har opnået en betydningsfuld cytogenetisk respons.
English: An additional risk minimisation activity was required by the PRAC.
Danish: PRAC stillede krav om endnu et tiltag til risikominimering.
English: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation and
Danish: • kronisk myeloid leukæmi, som er i kronisk fase, accelereret fase eller blastfase og resistent over for dasatinib eller nilotinib, hvor masitinib eller nilotinib ikke tåles, og efterfølgende behandling med imatinib ikke er klinisk hensigtsmæssig, eller hvor patienten har T315Imutationen
English: The risk of vascular occlusive events is likely to be dose related and therefore a dose reduction would be expected to reduce the risk of vascular occlusive events.
Danish: Risikoen for vaskulære okklusive hændelser må antages at være dosisrelateret, hvorfor dosisreduktion må forventes at mindske risikoen for vaskulære okklusive hændelser.
English: Based on the totality of the data assessed during the procedure and on the advice from the Scientific Advisory Group for oncology, the PRAC concluded that the benefit-risk balance of Iclusig remains favourable taking into account the product information amendments and subject to the risk minimisation measures and additional pharmacovigilance activities agreed.
Danish: På grundlag af samtlige ved proceduren gennemgåede data og rådgivning fra den videnskabelige rådgivende gruppe vedrørende onkologi konkluderede PRAC, at benefit/risk-forholdet for Iclusig fortsat er gunstigt under forudsætning af de vedtagne ændringer i produktinformationen og de vedtagne risikominimeringsforanstaltninger og supplerende lægemiddelovervågningsaktiviteter.
English: The Product Information for Iclusig was revised to include the following:
Danish: Produktinformationen for Iclusig blev revideret med
English: As part of the assessment of potential causes that may lead to an increased occurrence of vascular occlusive events in ponatinib treated patients, molecular mechanisms based on on-target and offtarget effects were discussed.
Danish: Med henblik på at vurdere de mulige årsager til øget forekomst af vaskulære okklusive hændelser ved behandling med ponatinib drøftedes molekylære mekanismer baseret på farmakologiske og ikke-farmakologiske virkninger.
English: • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
Danish: • philadelphiakromosompositiv akut lymfoblastær leukæmi (Ph+ ALL) ved resistens eller manglende tolerance over for dasatinib, hvor videre behandling med imatinib ikke er klinisk hensigtsmæssig, eller hvor patienten har T315I-mutationen.
English: The possible role of anti-platelet, anti-coagulant or lipid lowering drugs in reducing the risk of vascular occlusive events remains uncertain.
Danish: Der er fortsat usikkerhed om den eventuelle rolle af antitrombocytmidler, antikoagulantia og lipidsænkende lægemidler i reduktion af risikoen for vaskulære okklusive hændelser.
English: Conducting further studies aimed at clarifying the dose-efficacy relationship of ponatinib is considered key to allow exploration of dose reduction in the context of risk minimisation, which could ultimately lead to improving the benefit-risk balance of the product.
Danish: Der behøves yderligere undersøgelser af dosis/virkningsforholdet for ponatinib med henblik på at undersøge dosisreduktion i forbindelse med risikominimering, hvilket i sidste instans kan tænkes at resultere i et bedre benefit/riskforhold for lægemidlet.
English: The PRAC also recommended that a dose-ranging study be conducted in patients with CP-CML in order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving major cytogenetic response.
Danish: PRAC anbefalede desuden, at der gennemføres en dosisfastlæggelsesundersøgelse hos patienter med kronisk myeloid leukæmi i kronisk fase til bestemmelse af den optimale initialdosis af Iclusig og til karakterisering af sikkerheden og virkningen af Iclusig ved dosisreduktion efter opnåelse af væsentlig cytogenetisk respons.
English: Efficacy data in relation to dose reduction indicates that patients who have been dose reduced maintained response (MCyR and MMR) for the duration of the currently available follow-up.
Danish: Data vedrørende virkning i relation til dosisreduktion viser, at patienter, der fik reduceret deres dosis, fortsat responderede (med væsentlig cytogenetisk og molekylær respons) i hele den foreliggende opfølgningsperiode.
English: A dose-ranging study will be conducted in patients with CP-CML in order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving MCyR.
Danish: Der vil blive udført en dosisfastlæggelsesundersøgelse hos patienter med kronisk myeloid leukæmi i kronisk fase til fastlæggelse af den optimale initialdosis af Iclusig og til karakterisering af Iclusigs sikkerhed og virkning ved dosisreduktion efter opnåelse af væsentlig cytogenetisk respons.
English: • The PRAC considered Iclusig (ponatinib) in the procedure under Article 20 of Regulation (EC) No
Danish: • PRAC behandlede den procedure, som var indledt af Europa-Kommissionen i henhold til artikel
English: • The PRAC also noted that, although limited, the data in chronic phase CML is indicative of maintenance of response in patients who are dose reduced and therefore it was considered important to generate further data on the dose-efficacy relationship to potentially inform future risk minimisation measures.
Danish: • PRAC bemærkede desuden, at skønt dataene om kronisk myeloid leukæmi i kronisk fase er begrænsede, tyder de på fortsat respons hos patienter, som får reduceret deres dosis.
English: The PRAC is therefore of the opinion that the benefit-risk balance of Iclusig remains favourable taking into account the product information amendments and subject to the risk minimisation measures and additional pharmacovigilance activities agreed.
Danish: Det blev derfor anset for vigtigt at generere yderligere data om dosis/virkningsforholdet som muligt grundlag for fremtidige risikominimeringsforanstaltninger er PRAC af den opfattelse, at benefit/risk-forholdet for Iclusig fortsat er positivt i betragtning af ændringerne i produktinformationen og under forudsætning af de vedtagne risikominimeringsforanstaltninger og supplerende lægemiddelovervågningsaktiviteter.
English: • Inclusion of safety and efficacy data following dose reduction in CP-CML patients who have achieved MCyR to inform physicians of the currently available data on dose reduction.
Danish: • information til lægerne om de foreliggende data vedrørende sikkerhed og virkning ved dosisreduktion efter væsentlig cytogenetisk respons hos patienter med kronisk myeloid leukæmi i kronisk fase
English: The European Commission issued a decision on 26 August 2010.
Danish: Europa-Kommissionen traf en afgørelse den 26. august 2010.
English: In addition, evidence in support of the proposed dose was insufficient.
Danish: Desuden var dokumentationen til støtte for den foreslåede dosering utilstrækkelig.