FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/14/918/001 (20 film-coated tablets) EU/1/14/918/002 (60 film-coated tablets) EU/1/14/918/003 (180 film-coated tablets)
Danish: EU/1/14/918/001 (20 filmovertrukne tabletter) EU/1/14/918/002 (60 filmovertrukne tabletter) EU/1/14/918/003 (180 filmovertrukne tabletter)
English: Patients (%) achieving HbA1c < 7% 45.5 Body weight
Danish: Patienter (%) der opnåede HbA1c
English: EU/1/14/918/004 (20 film-coated tablets) EU/1/14/918/005 (60 film-coated tablets) EU/1/14/918/006 (180 film-coated tablets)
Danish: EU/1/14/918/004 (20 filmovertrukne tabletter) EU/1/14/918/005 (60 filmovertrukne tabletter) EU/1/14/918/006 (180 filmovertrukne tabletter)
English: Patients with eGFR 45 mL/min/1.73 m 2 to < 60 mL/min/1.73 m In a pooled analysis of patients (N = 721) with a baseline eGFR 45 mL/min/1.73 m 2 to
Danish: Patienter med eGFR på 45 ml/min/1,73 m 2 til < 60 ml/min/1,73 m I en puljet analyse af patienter (N = 721) med eGFR 45 ml/min/1,73 m 2 til < 60 ml/min/1,73 m 2 ved baseline gav canagliflozin en klinisk betydningsfuld reduktion i HbA1c på -0,47 % for canagliflozin 100 mg og -0,52 % for canagliflozin 300 mg sammenlignet med placebo.
English: - 50 mg/1000 mg tablets: macrogol 3350, poly(vinylalcohol), talc, titanium dioxide (E171), iron oxide yellow (E172), and iron oxide red (E172).
Danish: - 50 mg/1.000 mg tabletter: macrogol 3350, poly(vinylalkohol), talcum, titandioxid
English: Patients with a baseline eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 treated with canagliflozin 100 mg and
Danish: Patienter med eGFR 45 ml/min/1,73 m 2 til < 60 ml/min/1,73 m 2 ved baseline, der blev behandlet med canagliflozin 100 mg eller 300 mg, udviste gennemsnitlige forbedringer i procentvis ændring i legemsvægt på hhv. -1,8 % og -2,0 % i forhold til placebo.
English: Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 1000 mg metformin hydrochloride.
Danish: Hver tablet indeholder canagliflozinhemihydrat svarende til 150 mg canagliflozin og 1.000 mg metforminhydrochlorid.
English: Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 1000 mg metformin hydrochloride.
Danish: Hver tablet indeholder canagliflozinhemihydrat svarende til 50 mg canagliflozin og 1.000 mg metforminhydrochlorid.
English: Cardiac failure
Danish: Indlæggelseskrævende hjertesvigt
English: Hepatic impairment
Danish: Ikkedødeligt slagtilfælde
English: - 150 mg/1000 mg tablets: macrogol 3350, poly(vinylalcohol), talc, titanium dioxide (E171), iron oxide red (E172) and iron oxide black (E172).
Danish: (E171) og gul jernoxid (E172) - 150 mg/1.000 mg tabletter: macrogol 3350, poly(vinylalkohol), talcum, titandioxid
English: Rash includes the terms rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, and rash vesicular.
Danish: Udslæt omfatter termerne erytematøst udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt, kløende udslæt, pustuløst udslæt og vesikuløst udslæt.
English: Avoid excessive alcohol intake while taking this medicine since this may increase the risk of lactic acidosis.
Danish: Du skal undgå at indtage store mængder alkohol, mens du er i behandling med Vokanamet, da det kan øge risikoen for laktatacidose (se afsnittet ”Advarsler og forsigtighedsregler”).
English: EU/1/19/1375/001 Grasustek
Danish: EU/1/19/1375/001
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe
Danish: 0,6 ml (10 mg/ml)
English: Solution for injection
Danish: 1 fyldt injektionssprøjte
English: Subcutaneous use pre-filled syringe (glass)
Danish: Fyldt injektionssprøjte (glas)
English: Further information on Udenyca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Udenyca findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Udenyca
Danish: Andre oplysninger om Udenyca
English: What is Udenyca and what is it used for?
Danish: Hvad er Udenyca, og hvad anvendes det til?
English: The reference medicine for Udenyca is Neulasta.
Danish: Referencelægemidlet for Udenyca er Neulasta.
English: Udenyca is a ‘biosimilar medicine'.
Danish: Udenyca er et "biosimilært lægemiddel".
English: This means that Udenyca is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Udenyca i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: As for all medicines, data on the use of Udenyca are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Udenyca løbende overvåget.
English: An overview of Udenyca and why it is authorised in the EU
Danish: En oversigt over Udenyca, og hvorfor det er godkendt i EU
English: Side effects reported with Udenyca are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Udenyca vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: What measures are being taken to ensure the safe and effective use of Udenyca?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Udenyca?
English: The most common side effect with Udenyca (which may affect more than 1 in 10 people) is pain in the bones.
Danish: Den hyppigste bivirkning ved Udenyca (der kan forekomme hos mere end 1 ud af 10 patienter) er knoglesmerter.
English: Why is Udenyca authorised in the EU?
Danish: Hvorfor blev Udenyca godkendt i EU?
English: For more information about using Udenyca, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Udenyca, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Udenyca can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Danish: Udenyca udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kræft eller blodforstyrrelser.
English: What are the risks associated with Udenyca?
Danish: Hvilke risici er der forbundet med Udenyca?
English: Udenyca is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Danish: Udenyca gives som en enkeltdosis på 6 mg, der injiceres under huden mindst 24 timer efter afslutningen af hver behandlingsserie med kemoterapi (behandling med kræftlægemidler).
English: Because Udenyca is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Udenyca.
Danish: Da Udenyca er et biosimilært lægemiddel, behøver de studier af pegfilgrastims virkning og sikkerhed, der er udført for Neulasta, ikke at blive gentaget for Udenyca.
English: The active substance in Udenyca, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Danish: Det aktive stof i Udenyca, pegfilgrastim, består af filgrastim, der minder meget om det menneskelige protein granulocyt-kolonistimulerende faktor (G-CSF).
English: Studies have also shown that giving Udenyca produces similar levels of the active substance in the body to giving Neulasta.
Danish: Studier har også vist, at indgivelse af Udenyca giver samme niveau af det aktive stof i kroppen som indgivelse af Neulasta.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Udenyca has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Udenyca har en struktur, renhed og biologisk aktivitet, der svarer til Neulastas, og at det fordeles i kroppen på samme måde.
English: Therefore, the Agency's view was that, as for Neulasta, the benefit of Udenyca outweighs the identified risk and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Udenyca opvejer de identificerede risici som for Neulasta, og at det kan godkendes til anvendelse i EU.
English: All these data were considered sufficient to conclude that Udenyca will behave in the same way as Neulasta in terms of effectiveness and safety in its approved uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Udenyca vil have de samme egenskaber som Neulasta, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever).
Danish: Udenyca gives specifikt for at reducere varigheden af neutropeni og forebygge såkaldt febril neutropeni, dvs. neutropeni ledsaget af feber.
English: Udenyca is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in large numbers of abnormal blood cells are produced, , which can develop into leukaemia).
Danish: Udenyca er ikke beregnet til brug hos patienter med blodkræfttypen kronisk myeloid leukæmi eller myelodysplastisk syndrom (tilstand, hvor der produceres et stort antal unormale blodlegemer, som kan udvikle sig til leukæmi).
English: For the full list of side effects and restrictions with Udenyca, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Udenyca fremgår af indlægssedlen.
English: Laboratory studies comparing Udenyca with Neulasta have shown that the active substance in Udenyca is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, der sammenligner Udenyca med Neulasta, har vist, at det aktive stof i Udenyca svarer til det aktive stof i Neulasta, hvad angår struktur, renhed og biologisk aktivitet.
English: In Udenyca, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: I Udenyca er filgrastim blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglykol).
English: What benefits of Udenyca have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Udenyca?
English: It is available as a prefilled syringe containing a solution for injection under the skin.
Danish: Udenyca fås som en fyldt pen med injektionsvæske til indsprøjtning under huden.
English: How does Udenyca work?
Danish: Hvordan virker Udenyca?
English: bone marrow to produce more white blood cells, increasing white blood cell counts and so treating neutropenia.
Danish: Filgrastim får knoglemarven til at danne flere hvide blodlegemer, og stigningen i hvide blodlegemer modvirker neutropeni.
English: How is Udenyca used?
Danish: Hvordan anvendes Udenyca?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Udenyca have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Udenyca.
English: Udenyca is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Danish: Udenyca er et lægemiddel, der anvendes hos kræftpatienter til behandling af neutropeni (lavt antal neutrofiler, en type hvide blodlegemer).
English: Overall summary of the scientific evaluation of Flutiform and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Flutiform og relaterede navne (se bilag I)
English: The five pivotal Flutiform Phase III studies included approximately 2500 patients and the safety database includes over 1900 Flutiform-treated patients.
Danish: De fem fase III-hovedundersøgelser med Flutiform omfattede ca. 2 500 patienter, og sikkerhedsdatabasen omfatter over 1 900 patienter behandlet med Flutiform.
English: The clinical development programme for Flutiform was set up to evaluate efficacy and safety in the intended patient population.
Danish: Formålet med det kliniske udviklingsprogram for Flutiform var at vurdere virkningen og sikkerheden i den tilsigtede patientpopulation.
English: Published sources indicate that these treatment differences would at worst remain static and at best improve in favour of Flutiform over the longer-term.
Danish: Publicerede kilder viser, at disse behandlingsbetingede forskelle på længere sigt i værste tilfælde vil være uændrede, og i bedste tilfælde vil ændres til fordel for Flutiform.
English: Across a broad range of endpoints such as discontinuation due to lack of efficacy, symptom-free days and nights and the amount of rescue medication, the size of effect seen is clinically important.
Danish: For et bredt udsnit af endepunkter såsom seponering pga. manglende virkning, symptomfrie dage og nætter samt forbrug af PNmedicin er virkningen klinisk væsentlig.
English: This provides further support for the clinical relevance of the effects seen with Flutiform.
Danish: Dette støtter yderligere den kliniske relevans af de fundne virkninger af Flutiform.
English: In both claimed indications the previously used inhaled corticosteroid (ICS) is replaced by the inhaled corticosteroid in Flutiform for which such proof is required.
Danish: Til begge de ansøgte indikationer er det tidligere anvendte inhalationskortikosteroid (ICS) erstattet med inhalationskortikosteroidet i Flutiform, og dette nødvendiggør en sådan påvisning.
English: Supportive studies compared the efficacy and safety of Flutiform with other combination therapies.
Danish: I de støttende undersøgelser blev virkningen og sikkerheden af Flutiform sammenlignet med andre kombinationsbehandlinger.
English: The pivotal clinical studies were designed to compare the efficacy and safety of Flutiform with its individual components administered separately and with its individual components administered together but inhaled from separate inhalers.
Danish: De kliniske hovedundersøgelser havde til formål at sammenligne virkningen og sikkerheden af Flutiform dels når dets enkelte komponenter blev administreret hver for sig, dels når dets enkelte komponenter blev administreret hver for sig, men inhaleret fra separate inhalatorer.
English: The development programme also assessed the efficacy and safety of Flutiform administered either with or without a spacing device and investigated the efficacy and safety of Flutiform across relevant subgroups.
Danish: I udviklingsprogrammet vurderedes endvidere virkningen og sikkerheden af Flutiform administreret med og uden afstandsstykke samt virkningen og sikkerheden af Flutiform i relevante undergrupper.
English: Flutiform 50/5, 125/5 and 250/10 microgram pressurised inhalation, suspension is a new fixed-dose combination of two well-known active drug substances fluticasone propionate and formoterol fumarate.
Danish: Flutiform, inhalationsspray, suspension, 50/5, 125/5 og 250/10 µg, er en ny fast kombination af to velkendte aktive lægemiddelstoffer, fluticasonpropionat og formoterolfumarat.
English: The CHMP was of the opinion that these findings suggest that the PK data from study FLT1501 do not reflect pulmonary deposition accurately and therefore in this study are not a valid surrogate for clinical efficacy of Flutiform.
Danish: CHMP fandt, at disse resultater tyder på, at de farmakokinetiske data fra undersøgelse FLT1501 ikke nøjagtigt afspejler afsætningen i lungerne og derfor i denne undersøgelse ikke er et validt surrogat for den kliniske virkning af Flutiform.
English: Of the five pivotal studies submitted with this Marketing Authorisation Application three studies were designed such that they facilitate a rigorous, internally validated examination as to whether the long-acting β2 agonist formoterol fumarate “masks” deficient corticosteroid effects of Flutiform upon pre-dose FEV1.
Danish: Af de fem hovedundersøgelser, der blev forelagt sammen med denne ansøgning om markedsføringstilladelse, var de tre udformet, så de tillader en stringent, internt valideret fastlæggelse af, om den langtidsvirkende β2-agonist formoterolfumarat “maskerer” manglende kortikosteroid virkning af Flutiform på FEV1 før dosering.
English: The question posed by CHMP implied that the 67% relative bioavailability of the fluticasone propionate component of Flutiform compared with GSK fluticasone propionate pMDI may translate to a lesser inhaled corticosteroid effect and that this lesser effect would be best evaluated in a 6- to 12-month exacerbations study.
Danish: Spørgsmålet fra CHMP forudsatte, at den relative biotilgængelighed af fluticasonpropionatkomponenten af Flutiform på 67 % i forhold til GSK fluticasonpropionat-inhalator muligvis skal oversættes til en ringere inhalationskortikosteroid-virkning, og at dette bedst kan vurderes med en 6-12-måneders undersøgelse vedrørende eksacerbationer.
English: The PK study (Study FLT1501) which has given rise to concerns was conducted to evaluate the comparative safety of Flutiform when compared with the marketed monoproduct pMDIs.
Danish: Den PK-undersøgelse, der giver anledning til bekymring (undersøgelse FLT1501), blev udført til vurdering af den relative sikkerhed af Flutiform i forhold til de markedsførte monokomponentinhalationsprodukter.
English: • In the pharmacokinetic data presented systemic exposure of fluticasone was lower (67%) following Flutiform inhalation than following the concurrent inhalation of fluticasone and formoterol from monoproduct pMDIs.
Danish: • de forelagte farmakokinetiske data viser, at den systemiske eksponering for fluticason var lavere (67 %) efter inhalation af Flutiform end efter samtidig inhalation af fluticason og formoterol fra inhalationspræparater af monokomponenttypen.
English: These data were generated from the five pivotal 8- to 12-week studies and demonstrate the protective benefit of Flutiform against exacerbations compared with fluticasone propionate monotherapy.
Danish: Disse data, der er uddraget af de fem 8-12-ugers hovedundersøgelser, viser den beskyttende virkning af Flutiform mod eksacerbationer sammenlignet med fluticasonpropionat-monoterapi.
English: These endpoints were demonstrably inhaled cortocosteroid-driven and/or inhaled corticosteroid dose-responsive and all provided rigorous statistical evidence that the inhaled corticosteroid effects of Flutiform were not less than those of fluticasone propionate + formoterol fumarate.
Danish: Disse endepunkter blev påviseligt drevet af inhalationskortikosteroid og/eller udviste dosisrespons for inhalationskortikosteroid, og de gav alle klart statistisk bevis for, at de inhalationskortikosteroid-betingede virkninger af Flutiform ikke var mindre end de tilsvarende virkninger af fluticasonpropionat + formoterolfumarat.
English: The products are orally inhaled products and the combined therapy of an inhaled glucocorticosteroid and a selective long-acting ß2 adrenergic agonist is well established for use in the regular treatment of adults and children with asthma where the use of such a combination is deemed appropriate.
Danish: Kombinationen af et inhalationsglukokortikosteroid med en langtidsvirkende, selektiv adrenerg ß2-agonist er anerkendt til regelmæssig behandling af voksne og børn med astma, hvor denne kombination er hensigtsmæssig.
English: Committee was also of the opinion that the corticosteroid effects seen with Flutiform are no less than those seen with GSK fluticasone propionate pMDI and that formoterol fumarate does not appreciably “mask” any lesser corticosteroid effect.
Danish: Udvalget fandt desuden, at de konstaterede kortikosteroide virkninger af Flutiform ikke er mindre end af GSK fluticasonpropionatinhalatoren, og at formoterolfumarat ikke i nævneværdigt omfang ”maskerer” en eventuel nedsat kortikosteroid effekt.
English: The apparent lower systemic availability of fluticasone propionate in Flutiform compared with GSK fluticasone propionate pMDI would not appear to result in a lesser clinical effect.
Danish: Den klart lavere systemiske tilgængelighed af fluticasonpropionat i Flutiform end i GSK fluticasonpropionat-inhalatoren synes ikke at medføre ringere klinisk virkning.
English: These findings should be taken together with the results that show that the clinical effects of Flutiform are comparable with the clinical effects of GSK fluticasone propionate and Novartis formoterol fumarate given concomitantly.
Danish: Disse resultater må ses i sammenhæng med dem, der viser, at de kliniske virkninger af Flutiform er sammenlignelige med de kliniske virkninger af GSK fluticasonpropionat og Novartis formoterolfumarat indgivet samtidigt.
English: An annual exacerbation rate ratio of 0.98, i.e. very close to unity for the comparison of Flutiform 500µg/20µg versus fluticasone propionate 500µg + formoterol fumarate 24µg was therefore suggestive of non-inferiority but was not statistically definitive.
Danish: Forholdet mellem de årlige eksacerbationsrater var 0,98, dvs. meget tæt på 1, for Flutiform 500µg/20µg versus fluticasonpropionat 500µg + formoterolfumarat 24µg, hvilket således tyder på non-inferioritet, som dog ikke er statistisk sikker.
English: In conclusion, given the long-term predictive value of FEV1, given the static nature of FEV1 after 8 to 12 weeks of treatment, and given the pattern of the FEV1 data observed in the five pivotal studies, the CHMP considers there to be no reason to anticipate that the long-term exacerbation risk with Flutiform may exceed that with fluticasone propionate alone (the “Step-up” indication) or fluticasone propionate in combination with formoterol fumarate (the “Switch” indication).
Danish: På grundlag af den langsigtede prædiktive værdi af FEV1, de konstante FEV1-værdier efter 8-12-ugers behandling og det iagttagne mønster af FEV1-dataene i de fem hovedundersøgelser konkluderede CHMP, at der ikke er grund til at forvente, at den langsigtede eksacerbationsrisiko med Flutiform er større end med fluticasonpropionat alene (“optrapningsindikationen”) eller med fluticasonpropionat kombineret med formoterolfumarat “substitutionsindikationen”).
English: The Applicant presented some reasons which could potentially explain such discordance: this could be a function of the deviation of orally inhaled product (OIP) pulmonary PK from standard PK principles, i.e. unlike conventional PK analysis (e.g. for tablets) blood concentrations of OIPs are a “post-event” (rather than “pre-event”) surrogate for efficacy and standard PK analysis does not necessarily define drug residence at the pulmonary site of action.
Danish: Ansøgeren angav nogle eventuelle årsager til sådanne overensstemmelser: De kan være betinget af inhalationsprodukters særlige pulmonale farmakokinetik, idet blodkoncentrationen af inhalationsprodukter (modsat f.eks. tabletter) er et “post-event” (snarere end “preevent”) surrogat for virkning, og idet sædvanlig farmakokinetisk analyse ikke nødvendigvis beskriver lægemidlets tilstedeværelse på det pulmonale virkningssted.
English: The CHMP was of the view that clinical data generated over 6 to 12 months to further elucidate the level of asthma control and to further assess exacerbation rates seen with Flutiform compared with fluticasone propionate administered concomitantly with formoterol fumarate or administered alone, are not required.
Danish: CHMP fandt ikke, at der er behov for kliniske undersøgelser af 6-12 måneders varighed til yderligere belysning af graden af astmakontrol eller fastlæggelse af eksacerbationsraterne med Flutiform sammenlignet med fluticasonpropionat alene eller kombineret med formoterolfumarat.