FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/08/470/001 14 film-coated tablets EU/1/08/470/002 56 film-coated tablets EU/1/08/470/003 168 film-coated tablets EU/1/08/470/020 56 x 1 film-coated tablet EU/1/08/470/024 14 x 1 film-coated tablet EU/1/08/470/025 28 film-coated tablets EU/1/08/470/032 60 film-coated tablets
Danish: EU/1/08/470/001 14 filmovertrukne tabletter EU/1/08/470/002 56 filmovertrukne tabletter EU/1/08/470/003 168 filmovertrukne tabletter EU/1/08/470/020 56 x 1 filmovertrukket tablet EU/1/08/470/024 14 x 1 filmovertrukket tablet EU/1/08/470/025 28 filmovertrukne tabletter EU/1/08/470/032 60 filmovertrukne tabletter
English: Vimpat 100 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Danish: Vimpat 100 mg <Fritaget fra krav om brailleskrift> 56 x 1 og 14 x 1 filmovertrukket tablet
English: Vimpat 50 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Danish: Vimpat 50 mg <Fritaget fra krav om brailleskrift> 56 x 1 og 14 x 1 filmovertrukket tablet
English: Adjunctive therapy doses to be taken twice daily for children from 4 years of age weighing less than 20 kg(1):
Danish: Tillægsbehandlingsdoser, der skal tages to gange dagligt for børn fra 4 år, der vejer under 20 kg Vægt
English: To be taken twice daily for children and adolescents from 4 years of age weighing 30 kg to under
Danish: Skal tages to gange dagligt for børn og unge fra 4 år, der vejer 20 kg til under 30 kg: Vægt
English: Tabulated list of adverse reactions
Danish: Gangforstyrrelse Asteni reaktioner på administrationsstede t
English: 21 ml To be taken twice daily for children and adolescents from 4 years of age weighing 40 kg to under
Danish: Monoterapidoser, der skal tages to gange daglig, for børn og unge fra 4 år, der vejer 40 kg til under 50 kg
English: To be used twice daily for children and adolescents from 4 years of age weighing 20 kg to under
Danish: Skal bruges to gange dagligt for børn og unge fra 4 år, der vejer 20 kg til under 30 kg: Vægt
English: The maximum recommended dose is 6 mg (0.6 ml) for each kg of body weight, twice a day, for children weighing under 40 kg.
Danish: Den maksimale anbefalede dosis for børn, der vejer under 40 kg, er 6 mg (0,6 ml) for hvert kg kropsvægt, to gange dagligt.
English: Talk to your doctor before taking Vimpat if: you have thoughts of harming or killing yourself.
Danish: Kontakt lægen før De tager Vimpat hvis:
English: Common: may affect up to 1 in 10 people Injection site pain or discomfort or irritation.
Danish: • Smerte, ubehag eller irritation på injektionsstedet.
English: To be used twice daily for children and adolescents from 4 years of age weighing 30 kg to under
Danish: Skal bruges to gange dagligt for børn og unge fra 4 år, der vejer 30 kg til under 50 kg: Vægt
English: If you take more Vimpat than you should
Danish: Hvis De har taget for meget Vimpat
English: Vimpat with alcohol
Danish: Polyvinylalkohol
English: NN:
Danish: Fortyndere:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: Uncommon
Danish: Meget almindelig
English: UCB Pharma S.A. Tél: + 33 / (0)1 47 29 44 35
Danish: Tél: + 33/(0)1 47 29 44 35
English: Pharmasud Ltd. Tel: + 356 / 21 37 64 36
Danish: Tel: + 356/21 37 64 36
English: Non-clinical data
Danish: Ikke-kliniske data
English: An unusual fracture in a healthy woman on long term alendronate.
Danish: An unusual fracture in a healthy woman on longterm alendronate.
English: Epidemiological studies
Danish: Epidemiologiske undersøgelser
English: Post-marketing reports
Danish: Indberetninger efter markedsføring
English: Overall summary of the scientific evaluation of Bisphosphonate-containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler indeholdende bisfosfonat (se bilag I)
English: Concomitant treatment with other anti-resorptive drugs such as hormone replacement therapy and raloxifene have also been proposed as possible risk factors.
Danish: Samtidig behandling med andre anti-resorptive lægemidler som hormonel substitutionsterapi og raloxifene er også foreslået som mulige risikofaktorer.
English: • The Committee considered the referral made under Article 31 of Directive 2001/83/EC, as amended for biphosphonates containing medicines;
Danish: • Udvalget behandlede indbringelsen i henhold til artikel 31 i Rådets direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende bisfosfonater.
English: The main postulated mechanism is the suppression of bone turnover leading indirectly to ageing bone and the delay or prevention of repair of naturally occurring stress fractures although the evidence is not conclusive.
Danish: Den primære postulerede mekanisme er undertrykkelse af knogleomsætning, som indirekte fører til aldrende knogler og forsinkelse eller forhindring af reparation af naturligt forekommende stressfrakturer, selvom dokumentationen ikke er fyldestgørende.
English: The CHMP concluded that the findings of this review do not change the overall balance of risks and benefits of individual bisphosphonates in their authorised indications.
Danish: CHMP konkluderede, at resultaterne af denne vurdering ikke ændrer det overordnede benefit/riskforhold for individuelle bisfosfonater ved deres godkendte indikationer.
English: The potential risk of atypical fractures at sites other than the femur will be kept under review.
Danish: Den potentielle risiko for atypiske frakturer andre steder end femur vil blive overvåget.
English: There is currently no robust evidence regarding the value of interrupting treatment with bisphosphonates.
Danish: Der foreligger i øjeblikket ingen fyldestgørende dokumentation vedrørende betydningen af at afbryde behandlingen med bisfosfonater.
English: The CHMP reviewed the available data from non-clinical and histological studies, relevant clinical trials, epidemiological studies, post-marketing reports and published literature.
Danish: CHMP har vurderet de tilgængelige data fra ikke-kliniske og histologiske undersøgelser, relevante kliniske undersøgelser, epidemiologiske undersøgelser, indberetninger efter markedsføringen og publiceret litteratur.
English: However these studies do not specifically relate to atypical fracture of the femur as they do not contain information about radiographic fracture pattern.
Danish: Disse undersøgelser er imidlertid ikke specifikt relateret til atypiske femurfrakturer, da de ikke indeholder information om radiografisk frakturmønster.
English: This issue was considered again by the PhVWP in April 2010, as cases had been reported in association with other bisphosphonates, supporting the view that atypical stress fractures are a class effect of bisphosphonates.
Danish: Dette spørgsmål blev igen overvejet af PhVWP i april 2010, da der havde været indberetninger i forbindelse med andre bisfosfonater, som understøttede det synspunkt, at atypiske stressfrakturer er en bivirkning ved bisfosfonat-klassen.
English: In view of the above, the CHMP has recommended the variation to the terms of the Marketing Authorisations for Bisphosphonate-containing medicinal products (see Annex I), for which the relevant sections of the Summary of Product Characteristics and Package Leaflets are set out in Annex III and subject to the conditions set out in Annex IV of this Opinion.
Danish: I lyset af ovenstående anbefalede CHMP ændringen af betingelserne for markedsføringstilladelser for lægemidler indeholdende bisfosfonat (se bilag I), for hvilke de relevante afsnit i produktresuméerne og indlægssedlerne er anført i bilag III og i overensstemmelse med betingelserne i bilag IV i denne udtalelse.
English: Definition of atypical fracture of the femur
Danish: Definition af atypisk femurfraktur
English: • Addition of a warning in section 4.4 of the SmPC (Special warnings and precautions for use) to reflect this risk , the main features of these fractures and the potential need for discontinuation of treatment in case a fracture is suspected.
Danish: • Tilføjelse af en advarsel i produktresuméets punkt 4.4 (Særlige advarsler og forsigtighedsregler vedrørende brugen) for at afspejle denne risiko, de væsentligste karakteristika ved disse frakturer og et potentielt behov for seponering af behandlingen ved mistanke om en fraktur.
English: Mechanism of atypical fractures
Danish: Atypiske frakturers mekanisme
English: However not all preclinical studies have found adverse effects of alendronic acid on bone (Burr et al2).
Danish: Det er imidlertid ikke alle prækliniske undersøgelser, som har fundet bivirkninger af alendronsyre i knogler (Burr et al2).
English: Annex II Scientific conclusions and grounds for amendment of the summaries of product characteristics and package leaflets presented by the EMA
Danish: Bilag II Videnskabelige konklusioner og begrundelser for ændring af produktresuméer og indlægssedler fremlagt af EMA
English: At the present time there is little evidence from literature and spontaneous reports to support an association between bisphosphonates and atypical fracture at sites other than the femur.
Danish: På nuværende tidspunkt er der kun ringe dokumentation fra litteraturen og spontane indberetninger, som understøtter en forbindelse mellem bisfosfonater og atypiske frakturer andre steder end femur.
English: However, the optimal duration of use of bisphosphonates for osteoporosis is not known.
Danish: Den optimale varighed af brug af bisfosfonater til behandling af osteoporose kendes imidlertid ikke.
English: The CHMP also concluded that main risk factor associated with these fractures appears to be long-term bisphosphonate treatment.
Danish: Udvalget konkluderede også, at den væsentligste risikofaktor forbundet med disse frakturer ser ud til at være langvarig behandling med bisfosfonater.
English: Bisphosphonates are medicinal products that are used to treat and prevent bone disorders including hypercalcaemia and the prevention of bone problems in patients with cancer, the treatment of osteoporosis and Paget's disease.
Danish: Bisfosfonater er lægemidler, som anvendes til behandling og forebyggelse af knoglelidelser, herunder hypercalcæmi, samt forebyggelse af knogleproblemer hos patienter med cancer, behandling af osteoporose og Pagets sygdom.
English: The long-term use of bisphosphonates is thought to be the main risk factor for atypical femoral fractures.
Danish: Man mener, at langvarig brug af bisfosfonater er den væsentligste risikofaktor for atypiske femurfrakturer.
English: The number of post-marketing reports of possible atypical femur fracture suspected to be associated with bisphosphonates has increased since the 2008 PhVWP review.
Danish: Antallet af indberetninger efter markedsføringen om atypiske femurfrakturer, som mistænkes for at have forbindelse med bisfosfonater, er steget siden vurderingen af PhVWP i 2008.
English: The Committee also concluded that information should be added to section 4.2. of the product information for bisphosphonates authorised for osteoporosis, about the need to periodically evaluate the need for continuing bisphosphonate treatment, particularly after 5 years of treatment, on an individual patient basis.
Danish: Udvalget konkluderede også, at der skal tilføjes information i punkt 4.2. for bisfosfonater, som er godkendt til behandling af osteoporose, om nødvendigheden af regelmæssigt at evaluere behovet for fortsat behandling med bisfosfonater, særligt efter 5 års behandling, på en individuel patientbasis.
English: Grounds for amendment of the summaries of product characteristics and package leaflets
Danish: Begrundelser for ændring af produktresuméer og indlægssedler
English: Further to the PhVWP discussions and the emerging data from published literature and post-marketing reports that suggest that atypical stress fractures may be a class effect of bisphosphonates, the UK asked the CHMP in September 2010, to provide an opinion under Article 31 of directive 2001/83 EEC, as amended on whether the Marketing Authorisations for medicinal products containing bisphosphonates should be maintained, varied, suspended or withdrawn.
Danish: I fortsættelse af drøftelserne i PhVWP og de nye data fra publiceret litteratur og rapporter efter markedsføringen, som tyder på, at atypiske stressfrakturer kan være en bivirkning ved bisfosfonatklassen, bad Det Forenede Kongerige i september 2010 CHMP om at afgive udtalelse i henhold til artikel 31 i Rådets direktiv 2001/83/EF, med senere ændringer, om, hvorvidt markedsføringsgodkendelserne for lægemidler indeholdende bisfosfonater skulle opretholdes, ændres, suspenderes eller trækkes tilbage.
English: Other than osteoporosis the most prevalent co-morbid conditions in patients with atypical femur fracture were found to be chronic obstructive pulmonary disease or asthma, rheumatoid arthritis and diabetes.
Danish: Ud over osteoporose blev det påvist, at de hyppigst forekommende komorbide tilstande hos patienter med atypisk femurfraktur var kronisk obstruktiv lungesygdom eller astma, reumatoid arthritis og diabetes.
English: • The Committee considered all the available data submitted (pre-clinical, clinical, epidemiological studies, post-marketing reports, published literature) in relation to the risk of atypical femoral fractures with biphosphonates.
Danish: • Udvalget vurderede alle de tilgængelige, fremlagte data (prækliniske, kliniske, epidemiologiske undersøgelser, indberetninger efter markedsføringen, publiceret litteratur) i forhold til risikoen for atypiske femurfrakturer med bisfosfonater.
English: Following a Pharmacovigilance Working Party (PhVWP) review in 2008, it was concluded that a warning about atypical stress fractures of the proximal femoral shaft would be added to the product information for alendronic acid containing medicinal products across Europe.
Danish: Efter en vurdering i arbejdsgruppen vedrørende lægemiddelovervågning (PhVWP) i 2008 blev det besluttet, at der skulle tilføjes en advarsel om atypiske stressfrakturer i proksimal femurdiafyse til produktinformationen for lægemidler, som indeholder alendronsyre, i hele Europa.
English: The lack of reports with the remaining bisphosphonates, clodronic acid, neridronic acid and tiludronic acid may be related to the lower exposure of these medicinal products compared with other bisphosphonates and a lack of an association can not be excluded.
Danish: Det faktum, at der ikke er nogen indberetninger om de resterende bisfosfonater, clodronsyre, neridronsyre og tiludronsyre, kan hænge sammen med den lavere eksponering for disse lægemidler sammenlignet med andre bisfosfonater, og det kan ikke udelukkes, at der ikke er nogen sammenhæng.
English: The lack of evidence may be due to a lack of recognition and reporting of atypical fractures at sites other than the femur with bisphosphonate use or it is possible that the unique characteristics of the femur as the major weight bearing bone in the body mean that atypical fractures only occur at this site.
Danish: Den manglende dokumentation kan skyldes, at atypiske frakturer andre steder end femur sammen med brug af bisfosfonater ikke er anerkendt og indberettet, eller det er muligt, at femurs unikke egenskab som kroppens største, vægtbærende knogle betyder, at atypiske frakturer kun forekommer på dette sted.
English: Glucocorticoids and proton pumps inhibitor (PPI) have been identified as possible important risk factors for atypical femur fracture.
Danish: Glukokortikoider og protonpumpehæmmere (PPI) er identificeret som mulige, væsentlige risikofaktorer for atypisk femurfraktur.
English: Taking into account all the available evidence, the CHMP concluded that use of biphosphonates can be associated with the risk of atypical femoral fractures and therefore recommended that the following information is included in the Product Information of all biphosphonates:
Danish: CHMP konkluderede på baggrund af al den foreliggende dokumentation, at anvendelse af bisfosfonater kan være forbundet med risiko for atypiske femurfrakturer, og anbefalede derfor, at følgende information medtages i produktinformationen for alle bisfosfonater:
English: • On the basis of the available evidence, mainly from epidemiological studies and post-marketing reports, the Committee concluded that use of bisphosphonates may be associated with the risk of atypical femoral fractures.
Danish: • På baggrund af den foreliggende dokumentation, primært fra epidemiologiske undersøgelser og indberetninger efter markedsføringen, konkluderede udvalget, at brugen af bisfosfonater kan være forbundet med risiko for atypiske femurfrakturer.
English: The effects of high-dose, long-term alendronate treatment on microarchitecture and bone mineral density of compact and trabecular bone in the proximal femur of adult male rabbits.
Danish: Hofstaetter JG et al. The effects of high-dose, long-term alendronate treatment on microarchitecture and bone mineral density of compact and trabecular bone in the proximal femur of adult male rabbits.
English: Evidence from studies that do provide specific information about atypical femoral fractures identified from radiographs suggests that these fractures may be causally related to bisphosphonate use.
Danish: Dokumentation fra undersøgelser, som indeholder specifik information om atypiske femurfrakturer identificeret af radiografer, tyder på, at disse frakturer kan have en årsagsmæssig sammenhæng med brug af bisfosfonater.
English: Although the highest number of possible atypical femoral fracture continue to be reported in association with alendronic acid for osteoporosis, post-marketing reports have also been reported for other bisphosphonates for osteoporosis (etidronic acid, ibandronic acid, risedronic acid and zoledronate), and also for Paget's disease (zoledronate) and oncology indications (ibandronic acid, pamidronic acid and zoledronate), suggesting that these fractures may be a class effect of bisphosphonates.
Danish: Selvom det højeste antal mulige atypiske femurfrakturer fortsat indberettes i forbindelse med alendronsyre til behandling af osteoporose, har der også været indberetninger efter markedsføringen for andre bisfosfonater til behandling af osteoporose (etidronsyre, ibandronsyre, risedronsyre og zoledronat) og også ved Pagets sygdom (zoledronat) og onkologiske indikationer (ibandronsyre, pamidronsyre og zoledronat), hvilket tyder på, at disse frakturer kan være en bivirkning ved bisfosfonatklassen.
English: The mechanism(s) for the development of atypical fractures in patients taking bisphosphonates is not known.
Danish: Mekanismen/mekanismerne ved udvikling af atypiske frakturer hos patienter, som tager bisfosfonater, kendes ikke.
English: While some epidemiology studies suggest that subtrochanteric and femoral shaft fractures may be normal osteoporotic fractures (Abrahamsen et al, 20096, Abrahamsen, 20107, Vestergaard et al, 20108) other studies suggest that long-term bisphosphonate use may increase the risk of subtrochanteric and femoral shaft fractures (Park-Wyllie et al, 20119, Wang & Bhattacharyya, 201110).
Danish: Mens nogle epidemiologiske undersøgelser tyder på, at subtrochantære frakturer og femurfrakturer kan være normale osteoporotiske fakturer (Abrahamsen et al, 20096, Abrahamsen, 20107, Vestergaard et al, 20108), tyder andre undersøgelser på, at langvarig brug af bisfosfonater kan øge risikoen for subtrochantære frakturer og femurfrakturer (Park-Wyllie et al, 20119, Wang & Bhattacharyya, 201110).
English: Based on the small number of spontaneous reports of comminuted atypical femoral fracture in association with bisphosphonates, one published case report (Schneider, 20064), as well as preliminary data presented at the October meeting of the ASBMR (Nitche et al, 20105), the CHMP for the purpose of its assessment agreed on a modified case definition that lists ‘noncomminuted' as a minor feature rather than a major feature of atypical femur femoral fracture.
Danish: På baggrund af det ringe antal spontane rapporter om komminutte atypiske femurfrakturer i forbindelse med bisfosfonater, en offentliggjort indberetning (Schneider, 20064) samt præliminære data fremlagt ved ASBMR's møde i oktober (Nitche et al, 20105) blev CHMP for så vidt angår vurderingen enige om en ændret definition, som angiver “ikke-komminut” som et mindre væsentligt karakteristika ved atypisk femurfraktur.
English: • Addition of atypical femoral fracture to section 4.8 (Undesirable effects) of the SmPC accompanied by a statement that this adverse effect is a class attribution of all bisphosphonates.
Danish: • Tilføjelse af atypisk femurfraktur i produktresuméets punkt 4.8 (Bivirkninger) sammen med en udtalelse om, at denne bivirkning kan tilskrives hele klassen af bisfosfonater.
English: Other studies with radiographic evidence have also reported an increased incidence of atypical femoral fractures in patients treated with bisphosphonates compared to non-exposed patients, which may increase with duration of bisphosphonate treatment (Dell et al, 201013, Schilcher et al, 200914).
Danish: Andre undersøgelser med radiografisk dokumentation har også rapporteret en øget forekomst af atypiske femurfrakturer hos patienter behandlet med bisfosfonater sammenlignet med ikkeeksponerede patienter, som kan stige med varigheden af bisfosfonatbehandlingen (Dell et al, 201013, Schilcher et al, 200914).
English: Acta Orthopaedica 2009; 80: 413-415
Danish: Orthopaedica 2009; 80: 413-415
English: A number of possible risk factors have been proposed for atypical femoral fractures in association with bisphosphonate use.
Danish: Flere mulige risikofaktorer er foreslået for atypiske femurfrakturer i forbindelse med brug af bisfosfonater.
English: Although pre-clinical studies have provided limited information on the risk of atypical fractures with bisphosphonates, some of them have demonstrated that suppression of bone turnover by bisphosphonates may increase microdamage accumulation and the accumulation of advanced glycation end-products resulting in changes in the biomechanical properties of bone (Brennan et al, 2011, Hofstaetter et al, 2010, Mashiba et al, 2000, O'Neal et al, Tang et al, 20091).
Danish: Selvom prækliniske undersøgelser har givet begrænset information om risikoen for atypiske frakturer ved bisfosfonater, har nogle af dem påvist, at bisfosfonaters hæmning af knogleomsætningen kan øge akkumulering af mikroskader og akkumulering af AGE-forbindelser (advanced glycation end-products), som resulterer i ændringer i knoglens biomekaniske egenskaber (Brennan et al, 2011, Hofstaetter et al, 2010, Mashiba et al, 2000, O'Neal et al, Tang et al, 20091).
English: Casecontrol studies have reported a significant association between atypical femur fracture pattern and bisphosphonate use (Lenart et al, 200911, Isaacs et al, 201012).
Danish: Case-kontrolundersøgelser har rapporteret en signifikant forbindelse mellem mønsteret for atypiske femurfrakturer og brug af bisfosfonater (Lenart et al, 200911, Isaacs et al, 201012).
English: • The Committee concluded that the Product Information of all bisphopshonates should include a warning in section 4.4 on the risk of atypical fractures of the femur and this adverse reaction should also be listed in section 4.8 of the SPCs.
Danish: • Udvalget konkluderede, at produktinformationen for alle bisfosfonater skal indeholde en advarsel i punkt 4.4 om risikoen for atypiske femurfrakturer.
English: However a number of possible mechanisms of atypical fracture in association with bisphosphonate use have been postulated.
Danish: Flere mulige mekanismer ved atypiske frakturer i forbindelse med bisfosfonater er imidlertid blevet foreslået.
English: The task force of the American Society for Bone and Mineral Research (ASBMR) on atypical subtrochanteric and diaphyseal femoral fractures have defined major and minor features of atypical femoral fracture (Shane et al, 20103) and recommend that for a case to be considered an atypical femoral fracture all major features need to be present, whereas the minor features have commonly been described in cases of atypical femoral fractures, but are not present in all patients.
Danish: Arbejdsgruppen under American Society for Bone and Mineral Research (ASBMR) om atypiske subtrochantære femurfrakturer og frakturer i femurdiafyse har defineret væsentlige og mindre væsentlige karakteristika ved atypiske femurfrakturer (Shane et al, 20103).