natgillin/translations-raw huggingface dataset:
(E171) og gul jernoxid (E172) - 150 mg/1.000 mg tabletter: macrogol 3350, poly(vinylalkohol), talcum, titandioxid 
- 150 mg/1000 mg tablets: macrogol 3350, poly(vinylalcohol), talc, titanium dioxide (E171), iron oxide red (E172) and iron oxide black (E172).
Udslæt omfatter termerne erytematøst udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt, kløende udslæt, pustuløst udslæt og vesikuløst udslæt. 
Rash includes the terms rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, and rash vesicular.
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”). 
Avoid excessive alcohol intake while taking this medicine since this may increase the risk of lactic acidosis.
EU/1/19/1375/001 
EU/1/19/1375/001 Grasustek
1 fyldt injektionssprøjte 
Solution for injection
Fyldt injektionssprøjte (glas) 
Subcutaneous use pre-filled syringe (glass)
Yderligere information om Udenyca findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Further information on Udenyca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Andre oplysninger om Udenyca 
Other information about Udenyca
Hvad er Udenyca, og hvad anvendes det til? 
What is Udenyca and what is it used for?
Referencelægemidlet for Udenyca er Neulasta. 
The reference medicine for Udenyca is Neulasta.
Udenyca er et "biosimilært lægemiddel". 
Udenyca is a ‘biosimilar medicine'.
Det betyder, at Udenyca i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU. 
This means that Udenyca is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Som for alle lægemidler bliver data vedrørende brug af Udenyca løbende overvåget. 
As for all medicines, data on the use of Udenyca are continuously monitored.
En oversigt over Udenyca, og hvorfor det er godkendt i EU 
An overview of Udenyca and why it is authorised in the EU
Bivirkninger rapporteret for Udenyca vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Udenyca are carefully evaluated and any necessary action taken to protect patients.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Udenyca? 
What measures are being taken to ensure the safe and effective use of Udenyca?
Den hyppigste bivirkning ved Udenyca (der kan forekomme hos mere end 1 ud af 10 patienter) er knoglesmerter. 
The most common side effect with Udenyca (which may affect more than 1 in 10 people) is pain in the bones.
Hvorfor blev Udenyca godkendt i EU? 
Why is Udenyca authorised in the EU?
For mere information om brug af Udenyca, se indlægssedlen eller kontakt lægen eller apotekspersonalet. 
For more information about using Udenyca, see the package leaflet or contact your doctor or pharmacist.
Udenyca udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kræft eller blodforstyrrelser. 
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.
Hvilke risici er der forbundet med Udenyca? 
What are the risks associated with Udenyca?
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). 
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).
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. 
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.
Det aktive stof i Udenyca, pegfilgrastim, består af filgrastim, der minder meget om det menneskelige protein granulocyt-kolonistimulerende faktor (G-CSF). 
The active substance in Udenyca, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Studier har også vist, at indgivelse af Udenyca giver samme niveau af det aktive stof i kroppen som indgivelse af Neulasta. 
Studies have also shown that giving Udenyca produces similar levels of the active substance in the body to giving Neulasta.
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. 
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.
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. 
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.
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. 
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.
Udenyca gives specifikt for at reducere varigheden af neutropeni og forebygge såkaldt febril neutropeni, dvs. neutropeni ledsaget af feber. 
It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever).
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). 
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).
Den fuldstændige liste over bivirkninger og begrænsninger ved Udenyca fremgår af indlægssedlen. 
For the full list of side effects and restrictions with Udenyca, see the package leaflet.
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. 
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.
I Udenyca er filgrastim blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglykol). 
In Udenyca, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Hvilke fordele viser studierne, at der er ved Udenyca? 
What benefits of Udenyca have been shown in studies?
Udenyca fås som en fyldt pen med injektionsvæske til indsprøjtning under huden. 
It is available as a prefilled syringe containing a solution for injection under the skin.
Hvordan virker Udenyca? 
How does Udenyca work?
Filgrastim får knoglemarven til at danne flere hvide blodlegemer, og stigningen i hvide blodlegemer modvirker neutropeni. 
bone marrow to produce more white blood cells, increasing white blood cell counts and so treating neutropenia.
Hvordan anvendes Udenyca? 
How is Udenyca used?
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. 
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.
Udenyca er et lægemiddel, der anvendes hos kræftpatienter til behandling af neutropeni (lavt antal neutrofiler, en type hvide blodlegemer). 
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.
Samlet resumé af den videnskabelige vurdering af Flutiform og relaterede navne (se bilag I) 
Overall summary of the scientific evaluation of Flutiform and associated names (see Annex I)
De fem fase III-hovedundersøgelser med Flutiform omfattede ca. 2 500 patienter, og sikkerhedsdatabasen omfatter over 1 900 patienter behandlet med Flutiform. 
The five pivotal Flutiform Phase III studies included approximately 2500 patients and the safety database includes over 1900 Flutiform-treated patients.
Formålet med det kliniske udviklingsprogram for Flutiform var at vurdere virkningen og sikkerheden i den tilsigtede patientpopulation. 
The clinical development programme for Flutiform was set up to evaluate efficacy and safety in the intended patient population.
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. 
Published sources indicate that these treatment differences would at worst remain static and at best improve in favour of Flutiform over the longer-term.
For et bredt udsnit af endepunkter såsom seponering pga. manglende virkning, symptomfrie dage og nætter samt forbrug af PNmedicin er virkningen klinisk væsentlig. 
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.
Dette støtter yderligere den kliniske relevans af de fundne virkninger af Flutiform. 
This provides further support for the clinical relevance of the effects seen with Flutiform.
Til begge de ansøgte indikationer er det tidligere anvendte inhalationskortikosteroid (ICS) erstattet med inhalationskortikosteroidet i Flutiform, og dette nødvendiggør en sådan påvisning. 
In both claimed indications the previously used inhaled corticosteroid (ICS) is replaced by the inhaled corticosteroid in Flutiform for which such proof is required.
I de støttende undersøgelser blev virkningen og sikkerheden af Flutiform sammenlignet med andre kombinationsbehandlinger. 
Supportive studies compared the efficacy and safety of Flutiform with other combination therapies.
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. 
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.
I udviklingsprogrammet vurderedes endvidere virkningen og sikkerheden af Flutiform administreret med og uden afstandsstykke samt virkningen og sikkerheden af Flutiform i relevante undergrupper. 
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.
Flutiform, inhalationsspray, suspension, 50/5, 125/5 og 250/10 µg, er en ny fast kombination af to velkendte aktive lægemiddelstoffer, fluticasonpropionat og formoterolfumarat. 
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.
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. 
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.
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. 
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.
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. 
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.
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. 
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.
• 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. 
• 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.
Disse data, der er uddraget af de fem 8-12-ugers hovedundersøgelser, viser den beskyttende virkning af Flutiform mod eksacerbationer sammenlignet med fluticasonpropionat-monoterapi. 
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.
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. 
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.
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. 
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.
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. 
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.
Den klart lavere systemiske tilgængelighed af fluticasonpropionat i Flutiform end i GSK fluticasonpropionat-inhalatoren synes ikke at medføre ringere klinisk virkning. 
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.
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. 
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.
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. 
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.
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”). 
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).
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. 
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.
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. 
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.
CHMP bemærkede, at forskellen i biotilgængelighed mellem Flutiform og GSK fluticasonpropionat i undersøgelse FLT1501 (67 % relativ biotilgængelighed) ligger inden for den variation, der iagttages for samme patient (fra inhalation til inhalation) mellem forskellige batcher af samme produkt og mellem forskellige inhalatorer indeholdende samme aktive stof(fer). 
The CHMP noted that the differences of the magnitude observed between Flutiform and GSK fluticasone propionate in Study FLT1501 (67% relative bioavailability) are within the same range of variance as observed within patients (from inhalation to inhalation), between different batches of the same product and between different inhalers containing the same or more than one of the same active substances and are without adverse clinical consequences, and therefore are likely to be clinically irrelevant.
Det er et multidimensionalt begreb, der indbefatter symptomer, natlige opvågninger, 
It is a multidimensional concept incorporating symptoms, night time awakenings, use of rescue medication, lung function and activity limitation.
Desuden tyder uoverensstemmelsen mellem de farmakokinetiske og farmakodynamiske data for Flutiform på, at de farmakokinetiske data ikke afspejler den relative afsætning i lungerne nøjagtigt og ikke er et gyldigt surrogat for klinisk virkning. 
Furthermore, the discordance between the PK and PD data for Flutiform suggests that the PK data do not accurately reflect comparative pulmonary deposition and are not a valid surrogate for clinical effect.
Hvad angår “substitutionsbehandling” accepterede CHMP den af ansøgeren fremlagte analyse og var af den opfattelse, at de kliniske virkninger af Flutiform på astmakontrol og eksacerbationsrisiko er sammenlignelige eller identiske med de kliniske virkninger af GSK fluticasonpropionat og Novartis formoterolfumarat givet samtidigt. 
With regard to the “Switch” therapy, the CHMP accepted the discussions presented by the Applicant and was of the view that the clinical effects of Flutiform in respect of asthma control and exacerbation risk are comparable with/similar to the clinical effects of GSK fluticasone propionate and Novartis formoterol fumarate given concomitantly.
Langtidsvirkende β-agonister virker modulerende på flere endepunkter, der afspejler disse forskellige facetter af astmakontrol. 
Several endpoints which reflect these different facets of asthma control are modulated by long-acting β-agonists.
Den relative steady state-biotilgængelighed af fluticasonpropionat efter administration af Flutiform var 67 % af biotilgængeligheden ved brug af GSK fluticasonpropionat-inhalator. 
The relative bioavailability of fluticasone propionate at steady state was 67% following Flutiform administration compared with GSK fluticasone propionate pMDI.
• Udvalget konkluderede derfor, at benefit/risk-forholdet for Flutiform til de ansøgte indikationer er gunstigt anbefalede CHMP udstedelse af markedsføringstilladelse, for hvilken produktresuméet, etiketteringen og indlægssedlen er uændrede svarende til endelige version, der er fastlagt ved behandlingen i koordinationsgruppen som anført i bilag III for Flutiform og relaterede navne (se bilag I). 
the CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Flutiform and associated names (see Annex I).