FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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).
English: It is a multidimensional concept incorporating symptoms, night time awakenings, use of rescue medication, lung function and activity limitation.
Danish: Det er et multidimensionalt begreb, der indbefatter symptomer, natlige opvågninger,
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Several endpoints which reflect these different facets of asthma control are modulated by long-acting β-agonists.
Danish: Langtidsvirkende β-agonister virker modulerende på flere endepunkter, der afspejler disse forskellige facetter af astmakontrol.
English: The relative bioavailability of fluticasone propionate at steady state was 67% following Flutiform administration compared with GSK fluticasone propionate pMDI.
Danish: Den relative steady state-biotilgængelighed af fluticasonpropionat efter administration af Flutiform var 67 % af biotilgængeligheden ved brug af GSK fluticasonpropionat-inhalator.
English: 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).
Danish: • 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).
English: Data submitted by the Applicant demonstrated that asthma control with Flutiform is superior to that with fluticasone propionate pMDI alone and that asthma control with Flutiform is similar to that with fluticasone propionate pMDI + formoterol fumarate pMDI.
Danish: Dataene fra ansøgeren viser, at der opnås bedre astmakontrol med Flutiform end med fluticasonpropionatinhalator alene, og at der opnås samme astmakontrol med Flutiform som med fluticasonpropionatinhalator + formoterolfumarat-inhalator.
English: These PK and PD studies both included the same strengths/doses of Flutiform, GSK fluticasone propionate pMDI and Novartis formoterol fumarate pMDI, and all products in both studies were administered via the same spacing device, so allowing a valid comparison of PK and PD data.
Danish: Disse farmakokinetiske og farmakodynamiske undersøgelser omfattede begge de samme styrker og doseringer af Flutiform, GSK fluticasonpropionatinhalator og Novartis formoterolfumarat-inhalator, og der blev anvendt samme afstandsstykke til alle produkter i de to undersøgelser.
English: However, an analysis of annualised exacerbation rates in this study was able to differentiate the effects of high dose ICS-LABA (inhaled corticosteroid - long-acting β2 agonist) treatments (Flutiform 500µg/20µg and fluticasone propionate 500µg + formoterol fumarate 24µg) from low dose ICS-LABA treatment (fluticasone propionate 100µg/10µg) and fluticasone propionate 500µg monotherapy.
Danish: En analyse af den årlige eksacerbationsrate i denne undersøgelse gjorde det imidlertid muligt at differentiere virkningerne af højdosis-ICS-LABA - (inhaleret kortikosteroid + langtidsvirkende β2-agonist) (Flutiform 500µg/20µg og fluticasonpropionat 500µg + formoterolfumarat 24µg) - fra lavdosis-ICS-LABA (fluticasonpropionat 100µg/10µg) og fra fluticasonpropionat 500µg som monoterapi.
English: Approximately 20 subjects in each arm of this parallel group study were administered Flutiform 500/20 (fluticasone propionate 500µg and formoterol fumarate 20µg) or GSK fluticasone propionate 500µg pMDI + Novartis formoterol fumarate 24µg pMDI.
Danish: Ca. 20 personer i hver arm af dette parallelgruppeforsøg fik enten Flutiform, 500/20 (fluticasonpropionat 500µg og formoterolfumarat 20µg) eller GSK fluticasonpropionat-inhalator, 500µg, + Novartis formoterolfumarat-inhalator, 24µg.
English: Turning to the available data in the Applicant's studies, for the “Step-up” comparison the odds of “any” exacerbation were 33% higher in fluticasone propionate- than Flutiform-treated patients (p=0.019) whilst the annual exacerbation rate was 49% higher in fluticasone propionate- than Flutiform-treated patients (p=0.004).
Danish: Ansøgerens undersøgelser viser, at med henblik på “optrapning” var odds for “enhver” eksacerbation 33 % højere på fluticasonpropionat end på Flutiform (p=0,019), og den årlige eksacerbationsrate 49 % højere på fluticasonpropionat end på Flutiform (p=0,004).
English: The pre-dose FEV1 data in this study which were again a demonstrably inhaled corticosteroid-mediated effect provided no evidence of a lesser inhaled corticosteroid effect with Flutiform than seen with fluticasone propionate + formoterol fumarate.
Danish: Denne undersøgelses FEV1-data før dosering var igen bestemt af en påviseligt inhalationskortikosteroid-medieret virkning og gav ikke holdepunkt for, at Flutiform skulle resultere i ringere inhalationskortikosteroid-virkning end fluticasonpropionat + formoterolfumarat.
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 Flutiform 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 Flutiform udviser superioritet med hensyn til astmakontrol i forhold til GSK fluticasonpropionat administreret alene.
English: The clinical findings suggest that fluticasone propionate in Flutiform is non-inferior in respect of clinical effects to GSK fluticasone propionate.
Danish: De kliniske resultater indikerer non-inferioritet af den kliniske virkning af fluticasonpropionat i Flutiform i forhold til GSK fluticasonpropionat.
English: Literature data indicate that even if the PK data accurately reflect comparative pulmonary drug deposition for Flutiform versus GSK fluticasone propionate pMDI, such differences are not of clinical relevance.
Danish: Selv hvis de farmakokinetiske data for Flutiform nøjagtigt afspejler lægemidlets relative afsætning i lungerne i forhold til GSK fluticasonpropionat-inhalator, viser litteraturdata, at denne forskel ikke er klinisk relevant.
English: Effects with the low dose of Flutiform (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: Flutiform 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 Flutiform 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 Flutiform, 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 Flutiform 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 Flutiform og fluticasonpropionat + formoterolfumarat (henholdsvis 36,4 % og 35,3 %).
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 Flutiform 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 Flutiform, 500µg/20µg, end med GSK fluticasonpropionat, 500µg (hvad enten dette blev administreret alene eller sammen med Novartis formoterolfumarat, 24µg).
English: The inclusion of a second, lower dose of Flutiform (100µg/10µg) in the PD study was also instructive.
Danish: Det var instruktivt, at den farmakodynamiske undersøgelse desuden omfattede en lavere dosis af Flutiform (100µg/10µg).
English: The data presented in respect of exacerbations demonstrate an increased protective benefit of Flutiform 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 Flutiform, 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 Flutiform (p= henholdsvis 0,019 og 0,004).
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 Flutiform 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 Flutiform og fluticasonpropionatinhalator hvad angår behandlingseffekten på FEV1-værdierne før dosering.
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 Flutiform than with fluticasone propionate; for the “Switch” indication both pre-dose and post-dose FEV1 effects numerically favoured Flutiform 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 Flutiform end med fluticasonpropionat + formoterolfumarat (både for Per Protocol- og Intention-toTreat-populationen).
English: The effect should gradually disappear within a few days in most cases.
Danish: Virkningen bør aftage gradvist inden for nogle få dage i de fleste tilfælde.
English: CEA and PSA were defined as follows:
Danish: CEA og PSA blev defineret som følger:
English: See also section 2 under ‘Warnings and precautions'.
Danish: Se også afsnit 2 under 'Advarsler og forholdsregler'.
English: Children aged less than 2 years.
Danish: Børn under 2 år.
English: In some cases, symptoms may extend beyond the treatment area.
Danish: I nogle tilfælde kan symptomerne strække sig ud over det behandlede område.
English: Mirvaso may also cause the following other side effects:
Danish: Mirvaso kan også give følgende andre bivirkninger:
English: This is because its effects on your unborn baby are unknown.
Danish: Det skyldes, at medicinens virkning på dit ufødte barn ikke kendes.
English: If your symptoms remain the same or improve only slightly, you may then gradually increase the amount of gel.
Danish: Hvis dine symptomer forbliver de samme eller bedres lidt, kan du gradvist øge mængden af gel.
English: A potential consequence of stopping the treatment before finishing the course of treatment is the disease to come back to its initial state.
Danish: En potentiel konsekvens ved at stoppe behandlingen inden afslutningen af behandlingsforløbet er, at sygdommen kommer tilbage til sin oprindelige tilstand.
English: Both children were reported to have made a full recovery within 24 hours.
Danish: Der blev rapporteret om fuldstændig remission hos begge børn i løbet af 24 timer.
English: Should any gel get onto these areas, wash them immediately with plenty of water.
Danish: Hvis du får gel på disse områder, skal du straks vaske dem med rigelige mængder vand.
English: This is particularly important in children under the age of 2 years (see ‘Do not use Mirvaso').
Danish: Dette er særligt vigtigt, når det gælder børn under 2 år (se 'Brug ikke Mirvaso').
English: Bradycardia and hypotension
Danish: Bradykardi og hypotension
English: - you have problems with your heart or your blood circulation.
Danish: - du har problemer med hjerte eller kredsløb eller din blodcirkulation.
English: Pack size of 1 tube or 1 pump.
Danish: Pakningsstørrelse: 1 tube eller 1 pumpe.
English: There are no or limited amount of data from the use of brimonidine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af brimonidin til gravide kvinder.
English: Do not use a double dose to make up for a forgotten dose and continue your treatment as prescribed.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis og fortsæt din behandling som foreskrevet.
English: Mirvaso should not be used in children or adolescents aged 2 to 18 years.
Danish: Mirvaso bør ikke anvendes til børn eller unge i alderen 2-18 år.
English: The amount of gel can then be increased gradually based on tolerability and patient response.
Danish: Mængden af gel kan derefter øges gradvist på basis af tolerabiliteten og patientens reaktion.
English: Then pull the cap off.
Danish: Træk dernæst hætten af.
English: You should not use this medicine during breast-feeding, as it is unknown whether this medicine passes into the breast milk.
Danish: Du bør ikke anvende dette lægemiddel under amning, da det ikke er kendt, om dette lægemiddel passerer ind i modermælken.
English: No meaningful differences in the safety profiles were observed between the elderly subject population and subjects 18 to 65 years of age.
Danish: Der blev ikke observeret nogen meningsfulde forskelle i sikkerhedsprofilerne mellem den ældre patientgruppe og patienter fra 18 til 65 år.
English: Study 1 + Study 2
Danish: Studie 1 + Studie 2
English: Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy has not been established for this age group.
Danish: Giv ikke dette lægemiddel til børn og unge under 18 år, da sikkerhed og virkning hos denne aldersgruppe ikke er klarlagt.
English: Distribution The protein binding of brimonidine has not been studied.
Danish: Fordeling Brimonidins proteinbinding er ikke undersøgt.
English: - in children below 2 years of age, as they may be at greater risk of side effects from any of the medicine absorbed through the skin.
Danish: - til børn under 2 år, som de kan have en øget risiko for bivirkninger af det lægemiddel, der optages gennem huden.
English: The pump is child-resistant again.
Danish: Pumpen er igen børnesikret.
English: Generally, it resolves spontaneously after treatment is stopped.
Danish: Almindeligvis falder den til ro af sig selv, efter at behandlingen er stoppet.
English: The requirements for submission of periodic safety reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequently updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Please contact your doctor, who will advise you on what action to take.
Danish: Kontakt lægen, som kan rådgive dig om, hvad du skal gøre.
English: Any increase in the daily amount applied above 5 pea sized amounts and/or increase in frequency of daily application of the medicinal product should be avoided, since the safety of higher daily doses or repeated daily application has not been assessed.
Danish: Enhver øgning af den daglige påførte mængde ud over 5 mængder på størrelse med en ært og/eller øgning af hyppigheden af den daglige applikation af lægemidlet skal undgås, eftersom sikkerheden ved højere daglige doser eller gentagne daglige applikationer ikke er undersøgt.
English: Do not use Mirvaso: - if you are allergic to brimonidine or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Mirvaso: - hvis du er allergisk over for brimonidin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Mirvaso works on a daily basis, starting with the first day of treatment.
Danish: Mirvaso virker på et dagligt grundlag allerede fra den første behandlingsdag.
English: Take the medicine pack with you, so the doctor knows what was swallowed.
Danish: Tag medicinpakningen med dig, så lægen ved, hvilken medicin det drejer sig om.
English: It is unknown whether brimonidine/metabolites are excreted in human milk.
Danish: Det er ukendt, om brimonidin/metabolitter udskilles i human mælk.
English: 92927 La Défense Cedex France
Danish: 92927 La Défense Cedex Frankrig
English: Success day 29
Danish: Forbedring dag 29
English: In case of severe irritation or contact allergy, the treatment with the medicinal product should be discontinued.
Danish: I tilfælde af svær irritation eller kontaktallergi skal behandlingen med lægemidlet seponeres.
English: Note: when the cap is removed, the pump is not child-resistant.
Danish: Bemærk: Når hætten er taget af, er pumpen ikke børnesikret.
English: METHOD OF ADMINISTRATION Do not swallow.
Danish: ADMINISTRATIONSMETODE Må ikke sluges.
English: If this occurs, you should discard the excess gel so as not to apply more than the recommended dose.
Danish: Hvis dette sker, skal du kassere den overskydende gel, så du ikke påfører mere end den anbefalede dosis.
English: Treatment should be initiated with a smaller amount of gel (less than the maximum) for at least one week.
Danish: Behandlingen skal indledes med en mindre mængde gel (mindre end den maksimale mængde) i mindst en uge.
English: If anyone, especially a child, accidentally swallows Mirvaso, they may have serious side effects and need to be treated in a hospital.
Danish: Hvis andre, særligt et barn, ved et uheld sluger Mirvaso, kan de få alvorlige bivirkninger og skulle have hospitalsbehandling.
English: Important: Mirvaso is intended for adults and only for use on the skin of the face.
Danish: Vigtigt: Mirvaso er kun beregnet til voksne og kun til anvendelse på huden i ansigtet.
English: Across all clinical studies, 16% of patients receiving Mirvaso experienced an event of symptom exacerbation.
Danish: I alle kliniske studier set under ét oplevede 16 % af de patienter, der fik Mirvaso, en hændelse med symptomforværring.
English: Mirvaso is contraindicated in children aged less than 2 years because of serious systemic safety risk (see section 4.3).
Danish: Mirvaso er kontraindiceret til børn under 2 år på grund af en alvorlig systemisk sikkerhedsrisiko (se pkt.
English: If you do not experience worsening of redness or burning, continue with the usual treatment (see section 3).
Danish: Hvis du ikke oplever en forværring af rødmen eller brænden, fortsætter du med den sædvanlige behandling (se punkt 3).
English: Repeated doses within the same 24 hour period could result in side effects, such as low blood pressure, drowsiness or sleepiness.
Danish: Gentagne doser i løbet af den samme 24-timers periode kan resultere i bivirkninger, f.eks. lavt blodtryk, søvnighed eller døsighed.
English: You must avoid the eyes, eyelids, lips, mouth, and the inside of the nose.
Danish: Du skal undgå øjne, øjenlåg, læber, mund og indersiden af næsen.
English: The children experienced symptoms consistent with previously reported oral overdoses of alpha2-agonist in young children.
Danish: Børnene fik symptomer, der var overensstemmende med tidligere indberettede orale overdoseringer af α2-agonister hos små børn.
English: Of these, 539 completed 29 days of treatment and had data available to be included in the efficacy analysis at Day 29, with the majority being Caucasians between 18 and 65 years of age.
Danish: Af disse gennemførte 539 forsøgspersoner 29 døgns behandling og frembragte data til inklusion i virkningsanalysen på dag 29, og de fleste var hvide i alderen 18-65 år.
English: Brimonidine may cause clinically insignificant decreases in blood pressure in some patients.
Danish: Brimonidin kan forårsage klinisk insignifikante blodtryksfald hos nogle patienter.
English: You should wash your hands immediately after applying this medicine.
Danish: Du skal vaske dine hænder straks efter anvendelse af denne medicin.
English: Such worsening of redness usually develops within the first 2 weeks of treatment with Mirvaso.
Danish: En sådan forværring af rødme udvikles sædvanligvis inden for de første 2 uger med behandling med Mirvaso.