FrancophonIA/ELRC3.0 huggingface dataset:
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet presented by the European Medicines Agency
Danish: Videnskabelige konklusioner og begrundelse for ændringen af produktresuméet, etiketteringen og indlægssedlen, fremlagt af Det Europæiske Lægemiddelagentur
English: The CHMP also considered information on the treatment duration with tamoxifen to be justified, based on studies in which letrozole was administered after 5 years of adjuvant tamoxifen.
Danish: CHMP anså endvidere oplysningerne om behandlingsvarigheden med tamoxifen for at være berettiget, baseret på undersøgelser, hvor letrozol blev administreret efter fem år med adjuverende tamoxifen.
English: Women with a history of fractures and/or osteoporosis experienced higher rates of bone fractures than women without such a history, irrespective of treatment.
Danish: Hos kvinder med frakturer og /eller osteoporose i anamnesen var frekvensen af frakturer højere end hos kvinder uden en sådan anamnese, uanset behandlingen.
English: Regarding duration of treatment, the CHMP considered that studies show that Femara treatment should be continued until further progression of disease becomes evident.
Danish: Vedrørende behandlingsvarigheden var det CHMP's opfattelse, at undersøgelserne viser, at behandlingen med Femara bør fortsætte, indtil der er tegn på yderligere progression af sygdommen.
English: Finally, the CHMP inserted a statement advising against the co-administration of Femara with tamoxifen, other anti-oestrogens or oestrogens.
Danish: Endelig indsatte CHMP en anbefaling om at undgå koadministration af Femara med tamoxifen, andre antiøstrogener eller østrogener.
English: The CHMP considered the term “hormone-dependent” to be justified, as letrozole has no efficacy in hormone receptor negative breast cancer.
Danish: CHMP anså betegnelsen “hormonafhængig” for berettiget, da letrozol er uden virkning på hormonreceptornegativ mammacancer.
English: No studies have been performed in DCIS or LCIS on the use of extended adjuvant aromatase inhibitors after tamoxifen and there is no reason to suggest a different mechanism of action in the extended adjuvant setting compared with the adjuvant setting.
Danish: Der er ikke udført undersøgelser ved DCIS eller LCIS af forlænget adjuverende behandling med aromatasehæmmere efter tamoxifen, og der er ikke grund til at antage, at virkningsmekanismen ved forlænget adjuverende behandling er anderledes end ved adjuverende behandling.
English: The CHMP therefore concluded that the current data, including long-term follow-up information, is sufficient to support the neoadjuvant (pre-operative) treatment indication for Femara, in particular with the aim to down-size hormone receptor-positive tumours to allow BCS or to allow inoperable tumours to become operable.
Danish: CHMP konkluderede derfor, at de foreliggende data, herunder oplysninger om langtidsopfølgning, er tilstrækkelige til at underbygge indikationen neoadjuverende (præoperativ) behandling for Femara, navnlig med henblik på mindskelse af størrelsen af hormonreceptorpositive tumorer for at muliggøre brystbevarende operation eller gøre inoperable tumorer operable.
English: For the remaining sections, the CHMP adopted a harmonised wording in line with the nationally approved SmPCs, although minor revisions were made.
Danish: For de resterende punkter i produktresuméet vedtog CHMP en harmoniseret ordlyd i overensstemmelse med de nationalt godkendte produktresuméer, dog med mindre ændringer.
English: Regarding the description of selected adverse reactions, the CHMP agreed to separate the metastatic, adjuvant and extended adjuvant indications.
Danish: I beskrivelsen af udvalgte bivirkninger valgte CHMP at adskille dem efter indikationerne metastatisk, adjuverende og forlænget adjuverende.
English: A statement recommending against the use of Femara for patients with problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption was also added.
Danish: Desuden tilføjedes en anbefaling om at undgå anvendelse af Femara til patienter med galaktoseintolerans, svær laktasemangel eller glukose-galaktose-malabsorption.
English: Regarding renal impairment, the CHMP noted the available pharmacokinetics report and observed that letrozole is mainly cleared by the hepatic metabolism, with renal clearance reported to be less than 5%.
Danish: Vedrørende nedsat nyrefunktion tog CHMP den foreliggende farmakokinetiske rapport til efterretning og konstaterede, at letrozol hovedsagelig elimineres ved hepatisk metabolisering, og at den renale clearance er rapporteret at være under 5 %.
English: Regarding male breast cancer, the CHMP noted the absence of clinical trials or specific systematic investigation on the use of Femara in male breast cancer.
Danish: Hvad angår brystkræft hos mænd bemærkede CHMP, at der ikke findes kliniske undersøgelser eller specifikke systematiske undersøgelser af anvendelse af Femara ved brystkræft hos mænd.
English: The CHMP noted that while elimination of metabolites is expected to be slower in patients with renal impairment, the available data show that this did not affect the safety profile and did not alter pharmacokinetics in patients with severe renal impairment.
Danish: CHMP bemærkede, at elimineringen af metabolitter må forventes at ske langsommere hos patienter med nedsat nyrefunktion, men at de foreliggende data viser, at dette ikke medførte forringet sikkerhedsprofil eller ændret farmakokinetik hos patienter med svært nedsat nyrefunktion.
English: The CHMP concluded that no specific warnings or dose adjustments recommendations are needed for patients with CrCl  10 ml/min.
Danish: CHMP konkluderede, at der for patienter med CrCl  10 ml/min ikke er behov for særlige advarsler eller anbefalinger om dosisjustering.
English: Regarding hepatic impairment, the CHMP considered that a strict contraindication is not appropriate for letrozole, which is a potentially life-saving treatment with a relatively benign safety profile.
Danish: Vedrørende nedsat leverfunktion fandt CHMP det uhensigtsmæssigt med en streng kontraindikation af letrozol, som er en potentielt livsreddende behandling med en forholdsvis godartet sikkerhedsprofil.
English: As a result, efficacy was suboptimal and high rates of menopausal symptoms such as hot flushes occurred, as their perimenopausal status was insufficient to suppress the feedback loop of oestrogen synthesis.
Danish: Dette har medført suboptimal virkning og høj forekomst af menopausale symptomer såsom hedeture, fordi den perimenopausale status har været utilstrækkelig til at undertrykke tilbagekoblingssløjfen for østrogensyntesen.
English: Letrozole inhibits the enzyme involved in the synthesis of oestrogens, which are required for proper embryo and foetal development.
Danish: Letrozol hæmmer det enzym, der medvirker ved syntese af østrogener, som er nødvendige for den embryo-føtale udvikling.
English: The adverse drug reactions table was structured according to the SmPC guideline and several ADRs were relocated under more appropriate system organ class.
Danish: Tabellen over bivirkninger blev opstillet i overensstemmelse med vejledningen for produktresuméer, og flere bivirkninger blev flyttet til en mere passende systemorganklasse.
English: The CHMP reviewed all available data and considered that letrozole has shown significant superiority to tamoxifen in clinical response rate, mammographic response rate, breast ultrasound response rate and rate of breast-conserving surgery (BCS).
Danish: CHMP gennemgik alle foreliggende data og tog i betragtning, at letrozol har vist sig signifikant overlegent over for tamoxifen med hensyn til klinisk responsrate, mammografisk responsrate, responsrate ved ultralydsskanning af mammae og andel af brystbevarende kirurgiske indgreb (BCS).
English: Regarding use in elderly, the CHMP did not consider dose adjustment to be required, based on analyses of efficacy and safety conducted for all pivotal studies with Femara.
Danish: Vedrørende behandling af ældre fandt CHMP ikke, at der er behov for dosisjustering, baseret på analyser af virkning og sikkerhed i alle hovedundersøgelser med Femara.
English: Regarding bone effects, the CHMP reviewed data from studies showing that long-term use of Femara is associated with a significantly higher rate of osteoporosis and a significantly higher rate of bone fractures than tamoxifen (adjuvant setting) or placebo (extended adjuvant setting).
Danish: Vedrørende effekter på knoglerne gennemgik CHMP undersøgelser, der viser, at langvarig anvendelse af Femara er forbundet med signifikant højere forekomst af osteoporose og signifikant højere forekomst af frakturer end med tamoxifen (som adjuverende behandling) eller med placebo (som forlænget adjuverende behandling).
English: The CHMP introduced a warning regarding postmenopausal endocrine status, as studies have shown sub-optimal efficacy and increased frequency and severity of adverse events in women with perimenopausal status.
Danish: CHMP indsatte en advarsel om postmenopausal endokrin status, da undersøgelserne har vist, at virkningen er suboptimal og bivirkningerne hyppigere og sværere hos kvinder med perimenopausal status.
English: Femara was included in the list of products for Summary of Product Characteristics (SmPC) harmonisation, due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product.
Danish: Femara blev sat på listen over produkter, som skal have opdateret produktresuméet, fordi medlemsstaterne har truffet divergerende afgørelser vedrørende godkendelse af produktet.
English: The CHMP concluded that there are significant safety concerns warranting a contraindication in premenopausal women, specifically in women of premenopausal endocrine status.
Danish: CHMP konkluderede, at der er væsentlige sikkerhedsmæssige betænkeligheder, som giver belæg for en kontraindikation hos præmenopausale kvinder, specielt kvinder med præmenopausal endokrin status.
English: The CHMP defined the target patient population as women of established postmenopausal status and patients with ER-positive tumours, patients whose tumours are HER-2 (Human Epidermal Growth Factor Receptor 2) negative and patients who are unable to tolerate or who refuse to take neoadjuvant chemotherapy as well as patient for whom immediate surgery is not an option.
Danish: CHMP definerede målpopulationen som patienter med manifest postmenopausal status og patienter med ER-positiv tumor, patienter, hvis tumor at HER-2- (human epidermal vækstfaktor receptor 2) negativ, patienter, der ikke tåler eller ikke ønsker neoadjuverende kemoterapi, samt patienter, der ikke er egnede til øjeblikkelig operation.
English: Regarding renal impairment, the CHMP noted that there is very limited information about patients whose creatinine clearance is below 10 ml/min and therefore agreed on a precaution for these patients.
Danish: Vedrørende nedsat nyrefunktion konstaterede CHMP, at der kun foreligger meget begrænsede oplysninger om patienter med kreatininclearance under 10 ml/min., og indsatte derfor en forsigtighedsregel fra sådanne patienter.
English: The CHMP noted the absence of adequate clinical trials in pregnant women and that isolated cases of birth defects have been reported in pregnant women exposed to Femara, while nonclinical studies have shown that letrozole is embryotoxic and foetotoxic.
Danish: CHMP bemærkede, at der ikke findes fyldestgørende kliniske undersøgelser hos gravide kvinder, at der er indberettet enkeltstående tilfælde af fødselsdefekter hos gravide kvinder eksponeret for Femara, og at de ikke-kliniske undersøgelser har vist, at letrozol er embryotoksisk og føtotoksisk.
English: In the absence of clinical trials, the CHMP therefore concluded that the safety and efficacy of Femara in this population is not established.
Danish: I mangel af kliniske undersøgelser konkluderede CHMP derfor, at der ikke er dokumenteret sikkerhed og virkning af Femara hos denne patientgruppe.
English: The CHMP also clarified the contraindications for pregnancy and breast-feeding, making the information more visible and included a contraindication for known hypersensitivity to letrozole or to any of the excipients.
Danish: CHMP præciserede desuden kontraindikationerne ved graviditet og amning, således at oplysningerne blev mere synlige, og indsatte som kontraindikation kendt overfølsomhed for letrozol eller et eller flere af hjælpestofferne.
English: Regarding premenopausal endocrine status, the CHMP noted that although no clinical trials testing the safety or efficacy of Femara in premenopausal women have been conducted, there are safety reasons for not treating premenopausal or even perimenopausal women with letrozole.
Danish: Vedrørende præmenopausal endokrin status bemærkede CHMP, at der ikke er udført kliniske undersøgelser af sikkerheden eller virkningen af Femara hos præmenopausale kvinder, men at det af sikkerhedsmæssige grunde bør undgås at behandle præmenopausale eller endog perimenopausale kvinder med letrozol.
English: The CHMP also noted the limitations of the pregnancy prevention tools and therefore considered that postmenopausal status must be fully established before initiation of and during treatment of Femara and that Femara should not be used in women when postmenopausal status is not fully established.
Danish: CHMP bemærkede endvidere, at svangerskabsforebyggende midler har begrænsninger, og fandt derfor, at den postmenopausale status skal være fastslået med sikkerhed før og under behandlingen med Femara, og at Femara ikke bør anvendes, medmindre dette er tilfældet.
English: Regarding hepatic impairment, the CHMP noted that no signal was raised regarding the safety of Femara in patients with severe impairment of hepatic function.
Danish: Hvad angår nedsat leverfunktion konstaterede bemærkede CHMP, at der ikke har været signaler om sikkerheden af Femara hos patienter med svært nedsat leverfunktion.
English: Having considered the data submitted by the Marketing Authorisation Holder, the rapporteur and co-rapporteur assessment reports and the scientific discussions within the Committee, the CHMP was of the opinion that the benefit-risk ratio of Femara and associated names is favourable.
Danish: Grundlaget for indbringelsen var harmonisering af produktresuméet, etiketteringen og indlægssedlen På grundlag af den dokumentation, der er forelagt af indehaveren af markedsføringstilladelsen, vurderingsrapporterne fra rapportøren og co-rapportøren samt de faglige drøftelser i udvalget anså CHMP benefit/risk-forholdet for Femara og relaterede navne for positivt.
English: Femara was first approved in the European Union (EU) in 1996 and is available as a 2.5 mg film-coated tablet.
Danish: Femara blev først gang godkendt i EU i 1996 og dispenseres som en filmovertrukken tablet i styrken 2,5 mg. Femara er godkendt til en række indikationer i tilknytning til behandling af brystkræft hos postmenopausale kvinder med progression af sygdommen.
English: The CHMP considered the indication to be well-established and that confirmation of postmenopausal endocrine status of women before initiation of treatment is justified for both efficacy and safety reasons, as studies have shown that women with induced menopausal status may not be of postmenopausal endocrine status.
Danish: CHMP anså indikationen for at være almindeligt anerkendt og fandt det af hensyn til både virkning og sikkerhed berettiget, at patientens postmenopausale endokrine status bekræftes før initiering af behandlingen, da undersøgelser har vist, at kvinder med artificiel menopausal status ikke nødvendigvis har postmenopausal endokrin status.
English: The CHMP was also of the opinion that there is a concern of reduced efficacy of letrozole in premenopausal or perimenopausal women.
Danish: CHMP var desuden af den opfattelse, at virkningen af letrozol må formodes at være ringere hos kvinder, der er præmenopausale eller perimenopausale.
English: “Section 4.1 - Therapeutic indications
Danish: ”Punkt 4.1 - Terapeutiske indikationer
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Femara and associated names (see Annex I).
Danish: • Det produktresumé og den etikettering og indlægsseddel, der er foreslået af indehaveren af markedsføringstilladelsen, blev vurderet på grundlag af den forelagte dokumentation og de videnskabelige drøftelser i udvalget anbefalede CHMP ændring af markedsføringstilladelserne.
English: Regarding neoadjuvant treatment, recent studies investigating duration of therapy show higher response rates and more patients becoming suitable for BCS at 4-8 months, with very little incremental benefit beyond that and that the minimum duration is 4-6 months.
Danish: Vedrørende neoadjuverende behandling viser nylige undersøgelser af behandlingsvarigheden, at der efter 4-8 måneder opnås højere responsrate, og at et øget antal patienter bliver egnede til brystbevarende operation.
English: 4) Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens.
Danish: 4) Fremskreden mammacancer efter recidiv eller progression af sygdommen hos kvinder, der har naturlig eller artificiel postmenopausal endokrin status og tidligere er blevet behandlet med antiøstrogener.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Danish: • Indbringelsen vedrørte harmoniseringen af produktresuméet, etiketteringen og indlægssedlen.
English: The CHMP considered this indication to be well-established and noted that the wording was consistent with the wording in the nationally approved SmPCs.
Danish: CHMP anså indikationen for at være almindeligt anerkendt og konstaterede, at ordlyden var i overensstemmelse med ordlyden i de fleste nationalt godkendte produktresuméer.
English: 2) Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
Danish: 2) Forlænget adjuverende behandling af hormonafhængig, invasiv mammacancer hos postmenopausale kvinder, som forud har modtaget adjuverende standardbehandling med tamoxifen i fem år.
English: Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with antioestrogens.
Danish: • Fremskreden mammacancer efter recidiv eller progression af sygdommen hos kvinder, som har naturlig eller artificiel postmenopausal endokrin status og tidligere er blevet behandlet med antiøstrogener.
English: 5) Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.
Danish: 5) Neoadjuverende behandling af hormonreceptorpositiv, HER-2-negativ mammacancer hos postmenopausale kvinder, hvor kemoterapi ikke er hensigtsmæssig og øjeblikkelig operation ikke er indiceret.
English: Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.
Danish: • Neoadjuverende behandling af hormonreceptorpositiv, HER-2-negativ mammacancer hos postmenopausale kvinder, hvor kemoterapi ikke er hensigtsmæssig og øjeblikkelig operation ikke er indiceret.
English: Section 4.2 - Posology and Method of Administration
Danish: Punkt 4.2 - Dosering og indgivelsesmåde
English: The CHMP also noted that the wording was consistent with the wording in most nationally approved SmPCs.
Danish: CHMP bemærkede endvidere, at ordlyden var i overensstemmelse med ordlyden i de fleste nationalt godkendte produktresuméer.
English: The CHMP also noted that the wording was largely consistent with the nationally approved SmPCs.
Danish: CHMP konstaterede endvidere, at ordlyden i det væsentlige var i overensstemmelse med de nationalt godkendte produktresuméer.
English: Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
Danish: • Forlænget adjuverende behandling af hormonafhængig, invasiv mammacancer hos postmenopausale kvinder, som har fået adjuverende standardbehandling med tamoxifen i fem år.
English: 1) Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.
Danish: 1) Adjuverende behandling af hormonreceptorpositiv, invasiv mammacancer i tidligt stadium hos postmenopausale kvinder.
English: 3) First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.
Danish: 3) Førstevalgsbehandling af hormonafhængig, fremskreden mammacancer hos postmenopausale kvinder.
English: Regarding hepatic impairment, the CHMP noted that studies have shown that Femara is safe in mild to moderate hepatic insufficiency but that there is limited experience of use in patients with severely impaired hepatic function, non-cancer patients with liver cirrhosis and/or Child-Pugh stage C liver insufficiency.
Danish: Hvad angår nedsat leverfunktion bemærkede CHMP, at undersøgelserne har vist, at Femara kan anvendes uden risiko ved let til moderat leverinsufficiens, men at der er begrænsede erfaringer ved svært nedsat leverfunktion og hos non-cancer patienter med levercirrose og/eller leverinsufficiens af Child-Pugh klasse C. Da fordobling af eksponeringen for det aktive stof ikke medfører sikkerhedsmæssige betænkeligheder, og da undereksponering bør undgås fordi virkningen er vist at være dosisafhængig, konkluderede CHMP, at dosisjustering ikke er nødvendig for patienter med svært nedsat leverfunktion, men at der bør indsættes en advarsel herom i punkt 4.4.
English: First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.
Danish: • Førstevalgsbehandling af hormonafhængig, fremskreden mammacancer hos postmenopausale kvinder.
English: Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.
Danish: • Adjuverende behandling af hormonreceptorpositiv, invasiv mammacancer i tidligt stadium hos postmenopausale kvinder.
English: The company that applied for authorisation is Laboratoires SMB s.a.
Danish: Den virksomhed, der ansøgte om tilladelse, er Laboratoires SMB s.a.
English: What is Labazenit?
Danish: Hvad er Labazenit?
English: The effects of Labazenit were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Labazenit blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The two active substances in Labazenit are well known and are present in several medicines used to treat asthma, either alone or in combination with other medicines.
Danish: De to aktive stoffer i Labazenit er velkendte og findes i flere lægemidler, der anvendes til astmabehandling, enten alene eller i kombination med andre lægemidler.
English: What was Labazenit expected to be used for?
Danish: Hvad forventedes Labazenit anvendt til?
English: FEV1 is the maximum volume of air a person can breathe out in one second, while PEF is the maximum speed at which a person can expel air from their lungs.
Danish: FEV1 er det maksimale rumfang luft, som en person kan udånde på 1 sekund, mens PEF er den maksimale hastighed, som en person kan udånde luften med.
English: It was to be available as capsules containing powder for inhalation.
Danish: Det var hensigten, at det skulle leveres som kapsler med inhalationspulver.