FrancophonIA/ELRC3.0 huggingface dataset:
English: In the combined safety database with IMFINZI monotherapy, immune-mediated adrenal insufficiency occurred in 7 (0.4%) patients, including Grade 3 in 1 (< 0.1%) patient.
Danish: I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret adrenal insufficiens hos 7 (0,4 %) patienter inklusive Grad 3 hos 1 (< 0,1 %) patient.
English: In the combined safety database with IMFINZI monotherapy, immune-mediated hypopituitarism occurred in 1 (< 0.1%) patient (Grade 3).
Danish: I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret hypopituitarisme hos 1 (< 0,1 %) patient (Grad 3).
English: IMFINZI 50 mg/mL concentrate for solution for infusion
Danish: IMFINZI 50 mg/ml koncentrat til infusionsvæske, opløsning
English: Sixteen of the 31 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Danish: 16 ud af de 31 patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag).
English: Eleven of the 30 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Danish: 11 af de 30 patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag).
English: In the combined safety database with IMFINZI monotherapy, immune-mediated nephritis occurred in 3 (0.2%) patients, including Grade 3 in 1 (< 0.1%) patient.
Danish: I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret nefritis hos 3 (0,2 %) patienter, inklusive Grad 3 hos 1 (< 0,1 %) patient.
English: Thirteen of the 19 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Danish: 13 ud af 19 patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag).
English: HR (95% CI) 2-sided p-value OS at 24 months (%)
Danish: HR (95 % CI) 2-sidet p-værdi OS ved 24 måneder (%) (95 % CI) p-værdi PFS Antal hændelser (%) Median PFS (måneder) (95% CI) HR (95% CI) p-værdi p < 0,0001
English: Consider initial dose of 1 mg/kg/day to 4 mg/kg/day prednisone or equivalent followed by taper
Danish: Overvej initial dosis på 1-4 mg/kg/dag prednison eller tilsvarende, efterfulgt af nedtrapning
English: PFS at 12 months (%) (95% CI) PFS at 18 months (%) (95% CI) PFS2 Median PFS2
Danish: PFS ved 18 måneder (%) (95% CI)
English: Immune-mediated colitis or diarrhoea, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Danish: Immunmedieret colitis eller diarré, defineret som behandlingskrævende med systemiske kortikosteroider og uden klar alternativ ætiologi, forekom hos patienter, der fik IMFINZI (se pkt.
English: b (months)
Danish: Median PFS2 b (måneder)
English: • underactive thyroid gland that can cause tiredness or weight gain
Danish: • nedsat funktion af skjoldbruskkirtlen, der kan forårsage træthed eller vægtøgning
English: Preparation of solution
Danish: Fremstilling af opløsning
English: Immune-mediated hepatitis, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Danish: Immunmedieret hepatitis, defineret som behandlingskrævende med systemiske kortikosteroider og uden klar alternativ ætiologi, forekom hos patienter, der fik IMFINZI (se pkt.
English: Initiate 2 to 4 mg/kg/day prednisone or equivalent followed by a taper
Danish: Initiér 2-4 mg/kg/dag prednison eller tilsvarende, efterfulgt af nedtrapning
English: AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00
Danish: AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100
English: Immune-mediated nephritis, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Danish: Immunmedieret nefritis, defineret som behandlingskrævende med systemiske kortikosteroider og uden klar alternativ ætiologi, forekom hos patienter, der fik IMFINZI (se pkt.
English: Initiate 1 to 2 mg/kg/day prednisone or equivalent followed by a taper
Danish: Initiér 1-2 mg/kg/dag prednison eller tilsvarende, efterfulgt af nedtrapning
English: • night sweats
Danish: • nattesved
English: AstraZeneca Pharmaceuticals (Ireland) DAC
Danish: España AstraZeneca Farmacéutica Spain, S.A.
English: Initiate 1 to 4 mg/kg/day prednisone or equivalent followed by a taper
Danish: Initiér 1-4 mg/kg/dag prednison eller tilsvarende, efterfulgt af nedtrapning
English: Immune-mediated nephritis
Danish: Immunmedieret nefritis
English: Immune-mediated rash or dermatitis, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Danish: Immunmedieret udslæt eller dermatit, defineret som behandlingskrævende med systemiske kortikosteroider og uden klar alternativ ætiologi, forekom hos patienter, der fik IMFINZI (se pkt.
English: 1 to 4 mg/kg/day prednisone or equivalent followed by a taper
Danish: 1-4 mg/kg/dag prednison eller tilsvarende, efterfulgt af nedtrapning
English: n includes rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, erythema, eczema and rash.
Danish: n omfatter erytematøst udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papulært udslæt, pruritisk udslæt, pustuløst udlæst, erythem, eksem og udslæt.
English: Nephritis
Danish: Myocarditis
English: Name and address of the manufacturers responsible for batch release AstraZeneca AB
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse
English: Common Musculoskeletal and connective tissue disorders Myalgia
Danish: Knogler, led, muskler og bindevæv Myalgi
English: The review of Lartruvo was initiated on 31 January 2019 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Danish: Gennemgangen af Lartruvo blev indledt den 31. januar 2019 på anmodning af Europa-Kommissionen i medfør af artikel 20 i forordning (EF) nr. 726/2004.
English: Lartruvo was granted a ‘conditional approval'.
Danish: Lartruvo fik en "betinget godkendelse".
English: More information about the medicine can be found on the EMA website: ema.europa.eu/medicines/human/EPAR/lartruvo.
Danish: Yderligere information om lægemidlet findes på EMA's websted under: ema.europa.eu/medicines/human/EPAR/lartruvo.
English: Regarding safety, the data did not show any new safety concerns.
Danish: Hvad sikkerheden angår, gav dataene ikke anledning til nye betænkeligheder.
English: The Agency is therefore recommending that the marketing authorisation of the medicine be revoked.
Danish: Agenturet anbefaler derfor, at markedsføringstilladelsen for lægemidlet tilbagekaldes.
English: It was approved on condition that the company carried out a study to confirm its benefits.
Danish: Det blev godkendt på betingelse af, at virksomheden gennemførte et studie for at bekræfte dets fordele.
English: In addition, the Agency is preparing a scientific publication on this first revocation of a conditional marketing authorisation.
Danish: Agenturet er desuden ved at udarbejde en videnskabelig publikation om denne første tilbagekaldelse af en markedsføringstilladelse på særlige vilkår.
English: In January 2019, when preliminary results of the ANNOUNCE study became available, the Agency recommended that no new patients should start treatment with the medicine.
Danish: Da de foreløbige resultater af ANNOUNCE-studiet blev tilgængelige i januar 2019, anbefalede agenturet, at ingen nye patienter behandles med lægemidlet.
English: • There are no new safety concerns with the medicine.
Danish: • Der er ingen sikkerhedsmæssige problemer forbundet med lægemidlet.
English: 26 April 2019 EMA/237662/2019 Rev.11
Danish: 19. juli 2019 EMA/423345/2019
English: The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
Danish: CHMP's udtalelse blev fremsendt til Europa-Kommissionen, som traf en endelig juridisk bindende afgørelse med gyldighed i alle EU's medlemsstater den 19. juli 2019.
English: Having now assessed the full data from the study, the Agency has concluded that the benefit of Lartruvo in combination with doxorubicin is not confirmed.
Danish: Efter at have vurderet de fuldstændige data fra studiet har agenturet konkluderet, at fordelene ved Lartruvo anvendt i kombination med doxorubicin ikke er bekræftet.
English: • For patients already on treatment with Lartruvo, doctors should consider the available treatment options.
Danish: • For patienter, der allerede er i behandling med Lartruvo, bør lægerne overveje de tilgængelige behandlingsmuligheder.
English: • If you are already being treated with Lartruvo, your doctor will consider the most appropriate treatment for you.
Danish: • Hvis du allerede er i behandling med Lartruvo, vil din læge overveje, hvilken behandling er bedst for dig.
English: Lartruvo is a cancer medicine that was authorised in the EU on 9 November 2016 to treat adults with advanced soft tissue sarcoma, a type of cancer that affects tissues of the body such as muscles, blood vessels and fat tissue.
Danish: Lartruvo er et kræftlægemiddel tilladt i EU siden den 9. november 2016 til at behandle voksne med fremskredent bløddelssarkom, en type kræft, som rammer menneskeligt organmateriale såsom muskler, blodkar og fedtvæv.
English: • Additionally, no benefit was shown in terms of prolonging progression-free survival in the overall population (HR: 1.23; median 5.4 months for Lartruvo plus doxorubicin versus 6.8 months for placebo plus doxorubicin), which was one of the secondary objectives of the study.
Danish: • Desuden sås der ikke nogen fordel med hensyn til forlængelse af den progressionsfrie overlevelse i den samlede population (HR: 1,23; median 5,4 måneder for Lartruvo plus doxorubicin versus 6,8 måneder for placebo plus doxorubicin), en af studiets sekundære målsætninger.
English: • The study did not meet its primary objective to prolong survival in the overall population (stratified hazard ratio [HR]: 1.05; median 20.4 for Lartruvo plus doxorubicin versus 19.8 months for placebo plus doxorubicin) or in the leiomyosarcoma sub-population (HR: 0.95; median 21.6 months for Lartruvo plus doxorubicin versus 21.9 months for placebo plus doxorubicin).
Danish: • Studiet opfyldte ikke den primære målsætning om at forlænge overlevelsen i den samlede population (stratificeret hazard ratio [HR]: 1,05; median 20,4 for Lartruvo plus doxorubicin versus 19,8 måneder for placebo plus doxorubicin) eller i delpopulationen med leiomyosarkom (HR: 0,95; median 21,6 måneder for Lartruvo plus doxorubicin versus 21,9 måneder for placebo plus doxorubicin).
English: At time of its approval, data on the effects of Lartruvo were limited because of the small number of patients included in the main study which supported authorisation.
Danish: På tidspunktet for godkendelsen forelå der kun begrænsede data om virkningerne af Lartruvo på grund af det lave antal deltagere i det hovedstudie, der lå til grund for tilladelsen.
English: Lartruvo was to be given in combination with doxorubicin for up to 8 cycles of treatment, followed by Lartruvo alone in patients whose disease has not got worse.
Danish: Lartruvo skulle gives i kombination med doxorubicin i op til 8 behandlingscyklusser, hvorefter det skulle anvendes alene hos patienter, hvis sygdom ikke var forværret.
English: • The phase 3 study ANNOUNCE of Lartruvo in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma did not confirm the clinical benefit of Lartruvo.
Danish: • ANNOUNCE-fase 3-studiet af Lartruvo anvendt i kombination med doxorubicin hos patienter med fremskredent eller metastatisk bløddelssarkom bekræftede ikke den kliniske fordel ved Lartruvo.
English: The medicine was therefore granted a conditional marketing authorisation on condition that the company provided additional data from the ANNOUNCE study.
Danish: Lægemidlet fik derfor en markedsføringstilladelse på særlige vilkår under forudsætning af, at virksomheden fremlagde supplerende data fra ANNOUNCE-studiet.
English: The medicine was therefore granted a marketing authorisation on condition that the company provided additional data from the ANNOUNCE study in order to confirm the benefits and safety of the medicine.
Danish: Lægemidlet fik derfor en markedsføringstilladelse under forudsætning af, at virksomheden fremlagde supplerende data fra ANNOUNCE-studiet for at bekræfte lægemidlets fordele og sikkerhed.
English: • Lartruvo was approved to treat a rare type of cancer called soft tissue sarcoma.
Danish: • Lartruvo blev godkendt som behandling for en sjælden type kræft kaldet bløddelssarkom.
English: • As a consequence, the marketing authorisation of Lartruvo will be revoked and no new patients will be able to receive Lartruvo.
Danish: • Markedsføringstilladelsen for Lartruvo vil derfor blive tilbagekaldt, og ingen nye patienter vil kunne modtage Lartruvo.
English: Lartruvo was for use together with doxorubicin (another cancer medicine) in patients who could not undergo surgery or radiotherapy (treatment with radiation) and who had not been previously treated with doxorubicin.
Danish: Lartruvo skulle anvendes sammen med doxorubicin (et andet kræftlægemiddel) hos patienter, der ikke kunne gennemgå operation eller strålebehandling, og som ikke tidligere var behandlet med doxorubicin.
English: • The marketing authorisation of Lartruvo will therefore be withdrawn and no new patients will be treated with the medicine.
Danish: • Markedsføringstilladelsen for Lartruvo vil derfor blive kaldt tilbage, og ingen nye patienter vil blive behandlet med lægemidlet.
English: • However, that study showed that Lartruvo with doxorubicin is no better than doxorubicin alone at prolonging patients' lives.
Danish: • Af studiet fremgik det imidlertid, at Lartruvo anvendt i kombination med doxorubicin ikke er bedre end doxorubicin anvendt alene til at forlænge patienternes levetid.
English: Lartruvo was authorised in November 2016 to treat advanced soft tissue sarcoma, a condition for which there is paucity of suitable medicines.
Danish: Lartruvo blev tilladt i november 2016 som behandling for fremskredent bløddelssarkom, en tilstand, for hvilken der kun findes få egnede behandlinger.
English: EMA has completed its assessment of the results of the ANNOUNCE study2 and concluded that Lartruvo (olaratumab) with doxorubicin does not prolong the lives of patients with soft tissue cancer more than doxorubicin alone.
Danish: Den 26. april 2019 afsluttede EMA sin vurdering af resultaterne af ANNOUNCE-studiet1 og konkluderede, at Lartruvo (olaratumab) anvendt i kombination med doxorubicin ikke forlænger levetiden for patienter med bløddelskræft mere end doxorubicin anvendt alene.
English: • No new safety concerns were identified during the study.
Danish: • Studiet gav ikke anledning til nye betænkeligheder med hensyn til sikkerheden.
English: Once the European Commission has issued its decision, the Agency will publish on its website the assessment report, with details of the data assessed and the reasons for the revocation.
Danish: Vurderingsrapporten med nærmere oplysninger om de vurderede data og begrundelsen for tilbagekaldelsen findes på EMA's websted.
English: 18 October 2019
Danish: 18. oktober 2019
English: Re-examination confirms refusal
Danish: Revurdering bekræfter afslag
English: It had issued its initial opinion on 27 June 2019.
Danish: Det afgav sin første udtalelse den 27. juni 2019.
English: The Agency issued its opinion on 17 October 2019, after concluding the re-examination.
Danish: Agenturet afgav udtalelse den 17. oktober 2019 efter at have afsluttet revurderingen.
English: Further information on Translarna's current uses can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/translarna.
Danish: Yderligere information om de nuværende anvendelser af Translarna findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/translarna.
English: The refusal was confirmed after re-examination.
Danish: Afslaget blev bekræftet efter revurderingen.
English: If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.
Danish: Hvis du deltager i en klinisk undersøgelse og har behov for mere information om din behandling, kan du kontakte din læge.
English: What change had the company applied for?
Danish: Hvilken ændring havde virksomheden ansøgt om?
English: What were the main reasons for refusing the change to the marketing authorisation?
Danish: Hvad var hovedårsagerne til at afvise ændringen af markedsføringstilladelsen?
English: There are no consequences for the use of Translarna in its authorised indication.
Danish: Der er ingen konsekvenser for brugen af Translarna til de godkendte indikationer.
English: After re-examining its initial opinion, the European Medicines Agency has confirmed its recommendation to refuse a change to the marketing authorisation for the medicine Translarna (ataluren).
Danish: Efter revurdering af sin oprindelige udtalelse har Det Europæiske Lægemiddelagentur bekræftet sin anbefaling om at afvise en ændring af markedsføringstilladelsen for lægemidlet Translarna (ataluren).
English: The company that had applied for the change to Translarna's authorisation is PTC Therapeutics International Limited.
Danish: Den virksomhed, der havde ansøgt om ændringen af Translarnas tilladelse, er PTC Therapeutics International Limited.
English: This is because patients unable to walk are at a more advanced stage of the disease and have reduced muscle mass and therefore the benefits of treatment may be different.
Danish: Dette skyldes, at patienter, der ikke er i stand til at gå, befinder sig på et mere fremskredent stadium af sygdommen og har reduceret muskelmasse, og at fordelene ved behandling derfor kan være forskellige.
English: The additional data from the study could also not confirm the benefit of Translarna in patients no longer able to walk because there were problems with the way data from the CINRG database, which was used to indirectly compare the effects of Translarna, were selected and analysed.
Danish: De yderligere data fra undersøgelsen kunne heller ikke bekræfte fordelen ved Translarna hos patienter, der ikke længere er i stand til at gå, idet der var problemer med den måde, hvorpå data fra CINRG's database, som blev brugt til indirekte at sammenligne virkningerne af Translarna, blev udvalgt og analyseret.
English: The company then compared the results with historical data from patients with Duchenne muscular dystrophy recorded in the database of the CINRG (Cooperative International Neuromuscular Research Group).
Danish: Virksomheden sammenlignede derefter resultaterne med historiske data fra patienter med Duchennes muskeldystrofi, der er registreret i CINRG's database (Cooperative International Neuromutuous Research Group).
English: The company provided data to show that the body handles the medicine in a similar way in patients who are able to walk and those who cannot.
Danish: Virksomheden fremlagde data for at vise, at kroppen håndterer lægemidlet på lignende måde hos patienter, der er i stand til at gå, og hos patienter, som ikke er i stand til det.
English: Although the main objective of the study was to assess the long-term safety of Translarna, the study also investigated the effectiveness of treatment in patients unable to walk, measuring changes in lung function.
Danish: Selv om det primære formål med studiet var at vurdere Translarnas sikkerhed på lang sigt, så studiet også nærmere på behandlingseffekten hos patienter, der ikke var i stand til at gå, ved at måle ændringer i lungefunktionen.
English: Therefore, the Agency was of the opinion that the balance of benefits and risks of Translarna in patients unable to walk could not be established and recommended refusing the change to the marketing authorisation.
Danish: Agenturet er derfor af den opfattelse, at benefit/risk-forholdet for Translarna hos patienter, der ikke er i stand til at gå, ikke er klarlagt, og anbefalede afslag på ansøgningen om ændring af markedsføringstilladelsen.
English: Does this refusal affect patients in clinical trials?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser?
English: The fact that Translarna is handled by the body in a similar way in patients who can walk and those who cannot was not enough to confirm the effectiveness of Translarna in these patients.
Danish: Det forhold, at Translarna håndteres på lignende måde af kroppen hos patienter, der er i stand til at gå, og patienter der ikke er, var ikke tilstrækkeligt til at bekræfte, at Translarna er effektivt hos disse patienter.
English: The company informed the Agency that there are no consequences for patients who are receiving Translarna in clinical trials.
Danish: Virksomheden har til agenturet oplyst, at beslutningen ikke vil få konsekvenser for patienter, der deltager i kliniske undersøgelser.
English: What did the company present to support its application?
Danish: Hvilken dokumentation fremlagde virksomheden i forbindelse med sin ansøgning?
English: In addition, the company presented the results of a study involving 94 patients with nonsense mutation Duchenne muscular dystrophy, 44 of whom were no longer able to walk.
Danish: Desuden fremlagde virksomheden resultaterne af et studie, der omfattede 94 patienter med nonsensmutation Duchennes muskeldystrofi, hvoraf 44 patienter ikke længere var i stand til at gå.
English: What is happening with Translarna for the treatment of patients with Duchenne muscular dystrophy who are able to walk?
Danish: Hvad sker der med Translarna for behandlingen af patienter med Duchennes muskeldystrofi, som er i stand til at gå?
English: Translarna is a medicine used to treat patients aged 2 years and older with Duchenne muscular dystrophy who are able to walk.
Danish: Translarna er et lægemiddel til behandling af patienter på 2 år og derover, der har Duchennes muskeldystrofi, og som er i stand til at gå.
English: Translarna is for use in patients whose disease is due to the presence of certain defects (called nonsense mutations) in the dystrophin gene that prematurely stop the production of dystrophin, leading to a shortened dystrophin protein that does not function properly.
Danish: Translarna er beregnet til patienter, hos hvem sygdommen er forårsaget af visse defekter (nonsensmutationer) i genet for dystrofin, som blokerer den normale opbygning af dystrofin, så proteinet bliver for kort og ikke fungerer, som det skal.
English: The change concerned an extension of indication to add the treatment of patients with Duchenne muscular dystrophy who are no longer able to walk.
Danish: Ændringen vedrørte en udvidelse af indikationen til at tilføje behandlingen af patienter med Duchennes muskeldystrofi, som ikke længere er i stand til at gå.
English: It contains the active substance ataluren and is available as granules to be taken by mouth.
Danish: Translarna har været godkendt i EU siden juli 2014.Det indeholder det aktive stof ataluren og fås som granulater til indtagelse gennem munden.
English: The company applied for an extension of indication to add the treatment of patients with Duchenne muscular dystrophy who can no longer walk.
Danish: Virksomheden ansøgte om at få udvidet indikationen til at omfatte behandling af patienter med Duchennes muskeldystrofi, som ikke længere er i stand til at gå.
English: This will be done by a nurse or doctor.
Danish: Dette gøres af sygeplejersken eller lægen.
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør lægemidlet anvendes straks.
English: A risk to the newborn/infants cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes.
English: The results of blood tests and your medical condition will also be taken into account.
Danish: Også resultaterne af blodprøverne og din sygdomstilstand vil blive taget i betragtning.
English: Reduce the dose by 20%.
Danish: Reducer dosis med 20 %