FrancophonIA/ELRC3.0 huggingface dataset:
English: In the frame of the referral under article 29(4), the Applicant was requested to respond to the following: “In the light of the available pharmacokinetic data showing a lower systemic exposure of the fluticasone propionate component of this fixed-dose combination product, there is concern that patients receiving this fixed-dose combination, whether for the 'substitution' indication or for the 'step-up' indication, may not experience the same level of efficacy in respect of long-term asthma control.
Danish: I rammerne af henvisningen i henhold til artikel 29, stk. 4, blev ansøgeren anmodet om at besvare følgende: “De foreliggende farmakokinetiske data viser lavere systemisk eksponering for fluticasonpropionat-komponenten i det faste kombinationsprodukt.
English: With regard to the “Step-up” indication, again the CHMP accepted the discussions presented by the Applicant and was of the view that the clinical effects of Iffeza in respect of asthma control are superior to the clinical effects of GSK fluticasone propionate administered alone.
Danish: For “optrapningsindikationen” accepterede CHMP ligeledes ansøgerens analyse og fandt, at Iffeza udviser superioritet med hensyn til astmakontrol i forhold til GSK fluticasonpropionat administreret alene.
English: The inclusion of a second, lower dose of Iffeza (100µg/10µg) in the PD study was also instructive.
Danish: Det var instruktivt, at den farmakodynamiske undersøgelse desuden omfattede en lavere dosis af Iffeza (100µg/10µg).
English: Literature data indicate that even if the PK data accurately reflect comparative pulmonary drug deposition for Iffeza versus GSK fluticasone propionate pMDI, such differences are not of clinical relevance.
Danish: Selv hvis de farmakokinetiske data for Iffeza nøjagtigt afspejler lægemidlets relative afsætning i lungerne i forhold til GSK fluticasonpropionat-inhalator, viser litteraturdata, at denne forskel ikke er klinisk relevant.
English: To further address the concerns raised regarding the duration of the Applicant's clinical studies and to supplement the exacerbations data and other clinical data, the Applicant reviewed the FEV1 data and their predictive value.
Danish: Ansøgeren gennemgik FEV1-data og disses prædiktive værdi for yderligere at imødekomme de rejste betænkeligheder vedrørende varigheden af de kliniske undersøgelser og supplere data om eksacerbationer og andre kliniske forhold.
English: Effects with the low dose of Iffeza (100µg/10µg) upon pre-dose FEV1 were similar to those with the high dose of GSK fluticasone propionate 500µg (alone or in combination with formoterol fumarate 24µg).
Danish: Iffeza i den lave dosis (100µg/10µg) havde samme virkning på FEV1 før dosering som den høje dosis af GSK fluticasonpropionat, 500µg (alene eller kombineret med formoterolfumarat, 24µg).
English: This comparison showed that despite a lower relative fluticasone propionate bioavailability, the effect upon pre-dose FEV1 (which was demonstrably mediated by fluticasone propionate alone in Study FLT3503) was numerically greater with Iffeza 500µg/20µg than with GSK fluticasone propionate 500µg (either alone or in conjunction with Novartis formoterol fumarate 24µg).
Danish: Denne sammenligning viste, at trods den mindre relative biotilgængelighed af fluticasonpropionat var virkningen på FEV1 før dosering (som påviseligt blev medieret af fluticasonpropionat alene i undersøgelse FLT3503) i absolutte tal større med Iffeza, 500µg/20µg, end med GSK fluticasonpropionat, 500µg (enten alene eller kombineret med Novartis formoterolfumarat, 24µg).
English: With regard to the “Switch” indication, the proportion of patients experiencing exacerbations in the pivotal “Switch” study (Study FLT3503) was similar in Iffeza and fluticasone propionate + formoterol fumarate treated patients (36.4% and 35.3%, respectively) although this analysis lacked discriminative capacity as the proportion of fluticasone propionate monotherapy-treated patients experiencing exacerbations was similar (37.4%).
Danish: For “substitutionsindikationen” var den andel af patienterne, der fik eksacerbationer i hovedundersøgelsen vedrørende “substitution” (undersøgelse FLT3503), den samme på Iffeza og fluticasonpropionat + formoterolfumarat (henholdsvis 36,4 % og 35,3 %).
English: The objecting Member State stated that proof of similar control of inflammation by fluticasone in this new fixed-dose combination product compared with fluticasone as monotherapy or in combination with other long-acting β2 agonists has not been established either in pharmacokinetic studies or in clinical studies.
Danish: Den indsigende medlemsstat anførte, at hverken farmakokinetiske eller kliniske undersøgelser påviser, at det nye faste kombinationspræparat giver samme inflammationskontrol gennem fluticason, som når fluticason gives som monoterapi eller kombineret med andre langtidsvirkende β2-agonister.
English: In addition, the comparison of these PK data with PD data, Study FLT3503, shows that despite the lower relative bioavailability of fluticasone propionate in this new fixed-dose combination product the effect upon predose FEV1 (which was demonstrably mediated by fluticasone propionate alone in Study FLT3503) was numerically greater with Iffeza 500µg/20µg than with GSK fluticasone propionate 500µg (either administered alone or administered together with Novartis formoterol fumarate 24µg).
Danish: Ved sammenholdelse af disse farmakokinetiske data med de farmakodynamiske data fra undersøgelse FLT3503 ses, at uanset at biotilgængeligheden af fluticasonpropionat i det nye faste kombinationsprodukt var relativt mindre, var virkningen på FEV1 inden dosering (påviseligt medieret af fluticasonpropionat alene i undersøgelse FLT3503) numerisk større med Iffeza, 500µg/20µg, end med GSK fluticasonpropionat, 500µg (hvad enten dette blev administreret alene eller sammen med Novartis formoterolfumarat, 24µg).
English: Assessment of the pre-dose FEV1 data in the three specified studies demonstrated that in two of the three studies formoterol fumarate has no effect upon pre-dose FEV1 whilst in the third study there was some residual formoterol effect upon pre-dose FEV1 but it was insufficient to explain the magnitude of the predose FEV1 treatment effect difference between Iffeza and fluticasone propionate pMDI.
Danish: I den tredje undersøgelse havde formoterol nogen resterende virkning på FEV1-værdierne før dosering, dog ikke tilstrækkelig til at forklare forskellen mellem Iffeza og fluticasonpropionatinhalator hvad angår behandlingseffekten på FEV1-værdierne før dosering.
English: The data presented in respect of exacerbations demonstrate an increased protective benefit of Iffeza compared with GSK fluticasone propionate administered alone - the odds of any exacerbation occurring were 33% higher and the annual exacerbation rate was 49% higher in patients receiving GSK fluticasone propionate than in patients receiving Iffeza, p=0.019 and p=0.004, respectively.
Danish: Odds for forekomst af enhver eksacerbation var således 33 % højere og den årlige eksacerbationsrate 49 % højere for patienter på GSK fluticasonpropionat end på Iffeza (p= henholdsvis 0,019 og 0,004).
English: Turning to the data in the Applicant's clinical studies: For the “Step-up” indication both pre-dose and post-dose FEV1 effects at 8 to 12 weeks were significantly greater with Iffeza than with fluticasone propionate; for the “Switch” indication both pre-dose and post-dose FEV1 effects numerically favoured Iffeza over fluticasone propionate + formoterol fumarate (in both Per Protocol and Intention-to-Treat population comparisons).
Danish: For “substitutionsindikationen” var virkningerne på FEV1 både før og efter dosering i absolutte tal gunstigere med Iffeza end med fluticasonpropionat + formoterolfumarat (både for Per Protocol- og Intention-to-Treat-populationen).
English: Formoterol fumarate is used via the orally inhaled route in the management of patients with reversible airways obstruction.
Danish: Formoterolfumarat anvendes som inhalationspræparat til behandling af reversibel luftvejsobstruktion.
English: Hemlibra received a marketing authorisation valid throughout the EU on 23 February 2018.
Danish: Hemlibra fik en markedsføringstilladelse med gyldighed i hele EU den 23. februar 2018.
English: Further information on Hemlibra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/hemlibra.
Danish: Yderligere information om Hemlibra findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/hemlibra.
English: Other information about Hemlibra
Danish: Andre oplysninger om Hemlibra
English: The dose of Hemlibra depends on the patient's bodyweight.
Danish: Dosen af Hemlibra afhænger af patientens legemsvægt.
English: The recommended dose is 3 mg per kg of bodyweight once every week for the first 4 weeks.
Danish: Den anbefalede dosis er 3 mg pr. kg legemsvægt én gang om ugen i de første 4 uger.
English: As for all medicines, data on the use of Hemlibra is continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Hemlibra løbende overvåget.
English: What is Hemlibra and what is it used for?
Danish: Hvad er Hemlibra, og hvad anvendes det til?
English: Hemlibra contains the active substance emicizumab.
Danish: Hemlibra indeholder det aktive stof emicizumab.
English: Hemlibra reduces bleeding episodes in these patients and increases their quality of life.
Danish: Hemlibra reducerer blødningshændelser hos disse patienter og øger deres livskvalitet.
English: What measures are being taken to ensure the safe and effective use of Hemlibra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Hemlibra?
English: The European Medicines Agency therefore decided that Hemlibra's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Hemlibra opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Patients can then continue with either 1.5 mg/kg once every week, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks.
Danish: Derefter kan patienterne fortsætte med enten 1,5 mg pr. kg legemsvægt én gang om ugen, 3 mg pr. kg legemsvægt hver 2. uge eller 6 mg pr. kg legemsvægt hver 4. uge.
English: Why is Hemlibra authorised in the EU?
Danish: Hvorfor blev Hemlibra godkendt i EU?
English: Materials will include product information, guides, and a patient alert card.
Danish: Materialet omfatter produktinformation, vejledning og et patientadvarselskort.
English: An overview of Hemlibra and why it is authorised in the EU
Danish: En oversigt over Hemlibra, og hvorfor det er godkendt i EU
English: Side effects reported with Hemlibra are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Hemlibra vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Hemlibra is intended for longterm use.
Danish: Hemlibra er beregnet til langtidsbehandling.
English: Patients or their carers may be able to inject Hemlibra at home once they have been trained appropriately.
Danish: Patienten selv eller dennes omsorgsperson kan injicere Hemlibra i hjemmet efter at have fået passende oplæring.
English: For more information about using Hemlibra, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Hemlibra, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Patients receiving Hemlibra also had better quality of life scores than those who were not given Hemlibra.
Danish: Patienter, der fik Hemlibra, havde også bedre livskvalitet-scorer end dem, der ikke fik Hemlibra.
English: What are the risks associated with Hemlibra?
Danish: Hvilke risici er der forbundet med Hemlibra?
English: The study also enrolled patients who were already taking preventive treatment with medicines known as bypassing agents.
Danish: Undersøgelsen omfattede også patienter, der allerede fik forebyggende behandling med lægemidler med bypassing aktivitet.
English: The active substance in Hemlibra, emicizumab, is a monoclonal antibody which has been designed to do the work that factor VIII normally does - bringing together 2 clotting factors (IXa and X) as part of a chain of reactions needed for blood to clot.
Danish: Det aktive stof i Hemlibra, emicizumab, er et monoklonalt antistof, der er opbygget til at gøre det, som faktor VIII normalt gør, nemlig at sammenføre 2 størkningsfaktorer (IXa og X) som led i en kædereaktion, der er nødvendig for, at blodet kan størkne.
English: The most serious side effect is thrombotic microangiopathy (clots in small blood vessels, which may affect up to 1 in 100 people).
Danish: De mest alvorlige bivirkninger er trombotisk mikroangiopati (propper i små blodkar, der forekommer hos mellem 1 ud af 100 personer).
English: The side effects with Hemlibra are tolerable and information on how to manage the risks of serious side effects is in the prescribing information and educational materials.
Danish: Bivirkningerne ved Hemlibra er tålelige, og der er oplysninger om håndtering af risikoen for alvorlige bivirkninger i ordinationsoplysningerne og informationsmaterialet.
English: The company that markets Hemlibra will issue educational materials for healthcare professionals, patients, carers and laboratory professionals about abnormal clotting side effects, the risk of taking Hemlibra at the same time as bypassing agents and how laboratory tests should be carried out for these patients.
Danish: Den virksomhed, der markedsfører Hemlibra, skal udarbejde informationsmateriale til sundhedspersoner, patienter, omsorgsgivere og laboratoriepersonale om bivirkningerne ved unormal blodstørkning og risikoen ved at tage Hemlibra samtidig med bypassing-midler samt om, hvordan laboratorietest skal foretages for disse patienter.
English: Hemlibra can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia or bleeding disorders.
Danish: Hemlibra udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hæmofili eller blødningsforstyrrelser.
English: For the full list of side effects and restrictions with Hemlibra, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Hemlibra fremgår af indlægssedlen.
English: It is also used in patients without factor VIII inhibitors if their haemophilia A is severe.
Danish: Det anvendes også hos patienter uden faktor VIII-inhibitorer, hvis deres hæmofili A er alvorlig.
English: Because emicizumab has a different structure to factor VIII, it is not affected by factor VIII inhibitors.
Danish: Emicizumab har en anden struktur and faktor VIII og påvirkes ikke af faktor VIII-hæmmere.
English: How is Hemlibra used?
Danish: Hvordan anvendes Hemlibra?
English: When these patients were switched to Hemlibra, the number of treated bleeds per patient fell from the equivalent of around 16 bleeds per year before the switch to the equivalent of around 3 bleeds per year afterwards.
Danish: Når disse patienter skiftede til Hemlibra, faldt antallet af behandlede blødninger pr. patient fra ca. 16 blødninger pr. år til ca. 3 blødninger pr. år.
English: Hemlibra is available as a solution for injection under the skin in the belly, thigh or upper arm.
Danish: Hemlibra fås som en opløsning til injektion under huden i maven, låret eller overarmen.
English: The arm injection should only be given by a caregiver or healthcare professional.
Danish: Når lægemidlet skal injiceres i overarmen, bør dette kun foretages af en omsorgsperson eller sundhedspersonale.
English: Abnormal clotting, affecting between 1 and 10 in 1,000 people, may also occur and includes cavernous sinus thrombosis (clotting at the base of the brain) and superficial vein thrombosis (clotting in veins under the skin, usually in the arms or legs) with skin damage.
Danish: Unormal blodstørkning, der optræder hos mellem 1 og 10 ud af 1.000 patienter, kan også forekomme og omfatter kavernøs sinustrombose (blodprop i hjernens underside) og overfladisk venetrombose (blodprop i årerne under huden, typisk i armene eller benene) med beskadigelse af huden.
English: The medicine is used in patients who have developed factor VIII inhibitors, which are antibodies in the blood that act against factor VIII medicines and prevent them from working properly.
Danish: Lægemidlet anvendes hos patienter, der har udviklet faktor VIII-hæmmere, som er antistoffer i blodet, der virker mod faktor VIII-lægemidler, og forhindrer dem i at virke ordentligt.
English: The most common side effects with Hemlibra (which may affect 1 in 10 people or more) are redness, itching or pain at the place where it is injected, headache and joint pain.
Danish: De hyppigste bivirkninger ved Hemlibra (som kan forekomme hos mere end 1 ud af 10 patienter) er rødme, kløe eller ømhed på injektionsstedet, hovedpine og ledsmerter.
English: The day before starting Hemlibra treatment, patients should stop treatment with bypassing agents (medicines used to prevent bleeding in patients with factor VIII inhibitors, such as activated prothrombin complex concentrate or recombinant factor VIIa).
Danish: Dagen før påbegyndelse af behandling med Hemlibra bør patienterne stoppe behandling med bypassing-midler (dvs. lægemidler, der forhindrer blødning hos patienter med faktor VIII-hæmmere, f.eks. aktiveret protrombinkompleks-koncentrat eller rekombinant faktor VIIa).
English: Hemlibra is a medicine used to prevent or reduce bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Danish: Hemlibra er et lægemiddel, der anvendes til at forebygge eller mindske blødning hos patienter med hæmofili A (en arvelig blødningsforstyrrelse, som skyldes mangel på faktor VIII).
English: What benefits of Hemlibra have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Hemlibra?
English: Patients with haemophilia A lack factor VIII, a substance in the body that helps the blood to clot.
Danish: Patienter med hæmofili A mangler faktor VIII, der er et stof i kroppen, som hjælper blodet med at størkne.
English: How does Hemlibra work?
Danish: Hvordan virker Hemlibra?
English: Only a few medicines, called bypassing agents, are suitable for patients with haemophilia A who have developed factor VIII inhibitors.
Danish: Der findes kun få lægemidler (de såkaldte bypassing-midler), som er egnede til patienter med hæmofili A, som har udviklet faktor VIII-hæmmere.
English: Hemlibra also reduces bleeding in patients with severe haemophilia A without factor VIII inhibitors.
Danish: Hemlibra mindsker også blødningen hos patienter med svær hæmofili A uden faktor VIII-hæmmere.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hemlibra have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Hemlibra.
English: A study in 109 patients showed that Hemlibra is effective at preventing bleeding in patients with haemophilia A of any severity who have factor VIII inhibitors: patients given Hemlibra for prevention had fewer bleeds that needed to be treated (equivalent to 3 per year) than patients who received no preventive treatment (equivalent to 23 per year).
Danish: Patienter, der fik Hemlibra som forebyggende behandling, havde færre blødninger, som det var nødvendigt at behandle (ca. 3 pr. år), end patienter, der ikke fik forebyggende behandling (ca. 23 pr. år).
English: A study in 152 patients showed that Hemlibra is also effective at preventing bleeding in patients with severe haemophilia A without factor VIII inhibitors: patients given Hemlibra for prevention had around 1 bleed per year that needed to be treated, compared with 38 bleeds per year in patients who received no preventive treatment.
Danish: Patienter, der fik Hemlibra til forebyggelse, havde ca. 1 blødning pr. år, som skulle behandles, sammenlignet med 38 blødninger pr. år hos patienter, der ikke fik nogen forebyggende behandling.
English: [relevant text]
Danish: [relevant tekst]
English: Additional considerations
Danish: Yderligere overvejelser
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres efter behov af de relevante myndigheder i medlemsstaten i samarbejde med referencemedlemsstaten i henhold til de procedurer, der er fastsat i afsnit III, kapitel 4 i direktiv 2001/83/EC
English: [other monocomponent]
Danish: [andet enkeltstof]
English: If no adequate strength of [product name] is available, individual monocomponents should be used instead of the fixed dose combination.
Danish: Hvis der ikke findes en passende styrke af [Produktnavn], bør enkeltstofferne anvendes enkeltvist i stedet for fastdosis-kombinationen.
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Danish: Den eksisterende produktinformation skal ændres (indsættelse, udskiftning eller sletning af tekst, hvor det er relevant) for at afspejle den aftalte ordlyd, som er gengivet nedenfor.
English: If you have severely reduced kidney function.
Danish: • Hvis du har alvorligt nedsat nyrefunktion.
English: - The text: “(to be divided into 2-3 daily doses)” should be omitted.]
Danish: - Teksten: “(skal fordeles på 2-3 daglige doser)” skal udelades.]
English: During treatment with <Product name>, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Danish: Under behandlingen med <Præparatnavn> vil lægen kontrollere din nyrefunktion mindst en gang om året eller hyppigere, hvis du er ældre, og/eller hvis din nyrefunktion bliver dårligere.
English: [The dosing table above should be adapted for extended-release products containing metformin as single agent as follows: - The total maximum daily dose for patients with GFR 60-89 mL/min should be the same as the currently approved dose in adults with normal renal function.
Danish: [Doseringstabellen ovenfor skal tilpasses for depotpræparater, der indeholder metformin som enkeltstof, på følgende måde: - Den totale maksimale daglige dosis til patienter med GFR 60-89 ml/min skal være den samme som den i øjeblikket godkendte dosis til voksne med normal nyrefunktion.
English: These amendments to the relevant sections of the Product Information are the outcome of the referral procedure.
Danish: Ændringerne til de relevante afsnit i produktresumeet og indlægssedlen er resultatet af referralproceduren.
English: <Product name> with alcohol
Danish: Brug af <Præparatnavn> sammen med alkohol
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (>5 mmol/L) and an increased anion gap and lactate/pyruvate ratio.
Danish: Diagnostiske laboratoriefund er nedsat pH i blodet (< 7,35), forhøjet laktatniveau i blodet (> 5 mmol/l) samt øget anion-gap og laktat/pyruvat-ratio.
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking <Product name> before or at the time of the injection.
Danish: Hvis du skal have sprøjtet et kontrastmiddel, som indeholder jod, ind i dit blod, for eksempel i forbindelse med en røntgenundersøgelse eller scanning, skal du stoppe med at tage <Præparatnavn> forud for eller på tidspunktet for injektionen.
English: If you need to have major surgery you must stop taking <Product name> during and for some time after the procedure.
Danish: Hvis du skal have en større operation, skal du stoppe med at tage <Præparatnavn> under indgrebet og i nogen tid herefter.