FrancophonIA/ELRC3.0 huggingface dataset:
English: Atazanavir/ritonavir (300 mg/100 mg orally, q.d.)
Danish: Atazanavir/ritonavir (300 mg/100 mg oralt, en gang dagligt)
English: ↔ Cmin 1.18 (1.13, 1.23) Rilpivirine ↔ Cmax 0.93 (0.87, 0.99)
Danish: ↔ Cmin 1,18 (1,13; 1,23) Rilpivirin ↔ Cmax 0,93 (0,87; 0,99)
English: The EC50 (50% effective concentration) values for tenofovir alafenamide ranged from 34.7 to 134.4 nM, with an overall mean EC50 of 86.6 nM.
Danish: Den antivirale aktivitet af tenofoviralafenamid blev vurderet i HepG2-celler mod et panel af kliniske isolater af HBV, som repræsenterede genotyperne A-H. EC50 (50 % effektiv koncentration) for tenofoviralafenamid lå i intervallet 34,7 til 134,4 nM med en samlet middel-EC50 på 86,6 nM. CC50 (50 % cytotoksicitetskoncentration) i HepG2-celler var > 44.400 nM.
English: Sofosbuvir/velpatasvir (400 mg/100 mg orally, q.d.)
Danish: Sofosbuvir/velpatasvir (400 mg/100 mg oralt, en gang dagligt)
English: Tenofovir alafenamide ↑ Cmax 1.80 (1.48, 2.18)
Danish: Tenofoviralafenamid ↑ Cmax 1,80 (1,48; 2,18)
English: HIV ANTIRETROVIRAL AGENTS - INTEGRASE INHIBITORS Dolutegravir (50 mg orally, q.d.)
Danish: ANTIRETROVIRALE MIDLER MOD HIV - INTEGRASEHÆMMERE Dolutegravir (50 mg oralt, en gang dagligt)
English: • Take care not to pass on your hepatitis B to other people.
Danish: • Vær forsigtig, så du ikke smitter andre med hepatitis B. Du kan stadig smitte andre, selv om du tager dette lægemiddel.
English: Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/ 100 mg + 100 mgi orally, q.d.)
Danish: Sofosbuvir/velpatasvir/voxilaprevir (400 mg/100 mg/ 100 mg + 100 mgi oralt, en gang dagligt) Tenofoviralafenamidf (25 mg oralt, en gang dagligt)
English: HBV DNA < 29 IU/mL Baseline HBV DNA < 7 log10 IU/mL ≥ 7 log10 IU/mL
Danish: HBV DNA < 29 IE/ml HBV DNA ved baseline < 7 log10 IE/ml ≥ 7 log10 IE/ml
English: No dose adjustment of Vemlidy or efavirenz is required.
Danish: Dosisjustering af Vemlidy eller efavirenz er ikke nødvendig.
English: Each Vemlidy film-coated tablet contains tenofovir alafenamide fumarate, equivalent to 25 mg of tenofovir alafenamide.
Danish: Hver Vemlidy filmovertrukket tablet indeholder tenofoviralafenamid-fumarat svarende til 25 mg tenofoviralafenamid.
English: Tenofovir alafenamide ↑ Cmax 1.24 (0.88, 1.74)
Danish: Tenofoviralafenamid ↑ Cmax 1,24 (0,88; 1,74)
English: Rilpivirine (25 mg orally, q.d.)
Danish: Rilpivirin (25 mg oralt, en gang dagligt)
English: HBV DNA ≥ 29 IU/mL Baseline HBV DNA < 7 log10 IU/mL ≥ 7 log10 IU/mL
Danish: HBV-DNA ≥ 29 IE/ml HBV-DNA ved baseline < 7 log10 IE/ml ≥ 7 log10 IE/ml
English: No dose adjustment of Vemlidy or raltegravir is required.
Danish: Dosisjustering af Vemlidy eller raltegravir er ikke nødvendig.
English: No dose adjustment of Vemlidy or sertraline is required.
Danish: Dosisjustering af Vemlidy eller sertralin er ikke nødvendig.
English: No dose adjustment of Vemlidy is required in patients with hepatic impairment (see sections 4.4 and 5.2).
Danish: Dosisjustering af Vemlidy er ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
English: No dose adjustment of Vemlidy or rilpivirine is required.
Danish: Dosisjustering af Vemlidy eller rilpivirin er ikke nødvendig.
English: Tenofovir alafenamide ↓ Cmax 0.78 (0.58, 1.05)
Danish: Tenofoviralafenamid ↓ Cmax 0,78 (0,58; 1,05)
English: TDF = tenofovir disoproxil fumarate a Missing = failure analysis b Treatment-naïve subjects received < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue including tenofovir disoproxil fumarate or tenofovir alafenamide.
Danish: b. Behandlingsnaive patienter fik < 12 ugers oral antiviral behandling med en hvilken som helst nukleosid- eller nukleotidanalog, herunder tenofovirdisoproxilfumarat eller tenofoviralafenamid.
English: Each film-coated tablet contains tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Danish: Hver filmovertrukket tablet indeholder tenofoviralafenamidfumarat svarende til 25 mg tenofoviralafenamid.
English: Hepatitis B and HIV co-infection
Danish: Samtidig infektion med HBV og hiv
English: Ledipasvir/sofosbuvir (90 mg/400 mg orally, q.d.)
Danish: Ledipasvir/sofosbuvir (90 mg/400 mg oralt, en gang dagligt)
English: Tenofovir alafenamide ↔ Cmax 1.01 (0.84, 1.22)
Danish: Tenofoviralafenamid ↔ Cmax 1,01 (0,84; 1,22)
English: Tenofovir alafenamide ↔ Cmax 0.93 (0.72, 1.21)
Danish: Tenofoviralafenamid ↔ Cmax 0,93 (0,72; 1,21)
English: 1,000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity associated with the use of tenofovir disoproxil fumarate.
Danish: Evaluering af et stort antal graviditeter (mere end 1000), hvor der er forekommet eksponering for tenofovirdisoproxilfumarat, indikerer imidlertid ingen misdannelser eller føtal/neonatal toksicitet i forbindelse hermed.
English: Tenofovir alafenamide ↔ Cmax 1.00 (0.86, 1.16)
Danish: Tenofoviralafenamid ↔ Cmax 1,00 (0,86; 1,16)
English: Flares on treatment
Danish: Opblussen under behandling
English: Lopinavir/ritonavir (800 mg/200 mg orally, q.d.)
Danish: Lopinavir/ritonavir (800 mg/200 mg oralt, en gang dagligt)
English: ↔ Cmin 1.10 (1.07, 1.12) Tenofovir alafenamide ↔ Cmax 1.03 (0.94, 1.14)
Danish: ↔ Cmin 1,10 (1,07; 1,12) Tenofoviralafenamid ↔ Cmax 1,03 (0,94; 1,14)
English: No dose adjustment of Vemlidy or sofosbuvir/velpatasvir/voxilaprevir is required.
Danish: Dosisjustering af Vemlidy eller sofosbuvir/velpatasvir/voxilaprevir er ikke nødvendig.
English: Each film-coated tablet contains tenofovir alafenamide fumarate (equivalent to 25 mg of tenofovir alafenamide).
Danish: Hver filmovertrukket tablet indeholder tenofoviralafenamidfumarat (svarende til 25 mg tenofoviralafenamid).
English: GS-331007g ↔ Cmax 1.02 (0.98, 1.06)
Danish: GS-331007g ↔ Cmax 1,02 (0,98; 1,06) ↔ AUC 1,04 (1,01; 1,06)
English: No dose adjustment of Vemlidy or nevirapine is required.
Danish: Dosisjustering af Vemlidy eller nevirapin er ikke nødvendig.
English: Darunavir/ritonavir (800 mg/100 mg orally, q.d.)
Danish: Darunavir/ritonavir (800 mg/100 mg oralt, en gang dagligt)
English: If you take more Vemlidy than you should
Danish: Hvis du har taget for mange Vemlidy
English: HBeAg loss / seroconversione
Danish: HBeAg-tab/serokonversion
English: Tenofovir alafenamide ↑ Cmax 2.19 (1.72, 2.79)
Danish: Tenofoviralafenamid ↑ Cmax 2,19 (1,72; 2,79)
English: Discontinued study drug due to lack of efficacy Discontinued study drug due to AE or death Discontinued study drug due to other reasonsd
Danish: Nukleosid-erfaren Ingen virologiske data i uge 48 Seponerede studielægemidlet på grund af manglende virkning Seponerede studielægemidlet på grund af bivirkninger eller død
English: No dose adjustment of Vemlidy or ledipasvir/sofosbuvir is required.
Danish: Dosisjustering af Vemlidy eller ledipasvir/sofosbuvir er ikke nødvendig.
English: Adverse reaction Nervous system disorders Very common Headache Common
Danish: Systemorganklasse Hyppighed Bivirkning Nervesystemet
English: No dose adjustment of Vemlidy or sofosbuvir is required.
Danish: Dosisjustering af Vemlidy eller sofosbuvir er ikke nødvendig.
English: Tenofovir alafenamide ↓ Cmax 0.43 (0.36, 0.51) ↓ AUC 0.45 (0.40, 0.51)
Danish: Tenofoviralafenamid ↓ Cmax 0,43 (0,36; 0,51)
English: In the open-label phase, the median change in eGFR from Week 96 to Week 120 was -0.6 mL/min in patients who remained on Vemlidy, compared to +1.8 mL/min in patients who switched from tenofovir disoproxil fumarate to Vemlidy at Week 96.
Danish: som forblev på Vemlidy, sammenlignet med +1,8 ml/min hos patienter, som skiftede fra tenofovirdisoproxilfumarat til Vemlidy i uge 96.
English: h Study conducted with tenofovir alafenamide 40 mg and emtricitabine 200 mg. i Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV infected patients.
Danish: a. Alle interaktionsstudier er udført med raske frivillige b. Alle nuleffekt-grænser er 70 % - 143 % c. Studie udført med emtricitabin/tenofoviralafenamid som fastdosis-kombinationstablet d. Et sensitivt CYP3A4-substrat e. Studie udført med elvitegravir/cobicistat/emtricitabin/tenofoviralafenamid som fastdosis-kombinationstablet f. Studie udført med emtricitabin/rilpivirin/tenofoviralafenamid som fastdosis-kombinationstablet g. Sofosbuvirs dominerende cirkulerende nukleosid-metabolit h. Studie udført med tenofoviralafenamid 40 mg og emtricitabin 200 mg i. Studie udført med yderligere 100 mg voxilaprevir for at opnå de voxilaprevir-eksponeringer, der forventes hos HCVinficerede patienter.
English: Midazolam ↔ Cmax 1.02 (0.92, 1.13) ↔ AUC 1.13 (1.04, 1.23)
Danish: Midazolam ↔ Cmax 1,02 (0,92; 1,13)
English: No dose adjustment of Vemlidy or sofosbuvir/velpatasvir is required.
Danish: Dosisjustering af Vemlidy eller sofosbuvir/velpatasvir er ikke nødvendig.
English: Changes in measures of bone mineral density In both studies tenofovir alafenamide was associated with smaller mean percentage decreases in bone mineral density (BMD; as measured by hip and lumbar spine dual energy X ray absorptiometry
Danish: I begge studier var tenofoviralafenamid efter 96 ugers behandling forbundet med mindre gennemsnitlige procentvise reduktioner i knoglemineraltæthed (BMD, målt ved DXA-scanning af hofte og lænderyg), sammenlignet med tenofovirdisoproxilfumarat.
English: No dose adjustment of Vemlidy or dolutegravir is required.
Danish: Dosisjustering af Vemlidy eller dolutegravir er ikke nødvendig.
English: What Vemlidy is and what it is used for What you need to know before you take Vemlidy How to take Vemlidy
Danish: Det skal du vide, før du begynder at tage Vemlidy Sådan skal du tage Vemlidy Bivirkninger
English: Darunavir ↔ Cmax 0.99 (0.91, 1.08) ↔ AUC 1.01 (0.96, 1.06) ↔ Cmin 1.13 (0.95, 1.34)
Danish: Velpatasvir ↔ Cmax 1,05 (0,96; 1,16) ↔ AUC 1,01 (0,94; 1,07) ↔ Cmin 1,01 (0,95; 1,09)
English: ↔ GS-331007 ↔ Velpatasvir
Danish: Forventet: ↔ Sofosbuvir ↔ GS-331007
English: Tenofovir alafenamideh (40 mg orally, q.d.)
Danish: Tenofoviralafenamidh (40 mg oralt, en gang dagligt)
English: • antibiotics used to treat bacterial infections including tuberculosis, containing:
Danish: • antibiotika, der anvendes til behandling af bakterieinfektioner, herunder tuberkulose, og som indeholder: rifabutin, rifampicin eller rifapentin
English: Tenofovir alafenamidec (10 mg orally, s.d.)
Danish: Tenofoviralafenamidc (10 mg oralt, enkeltdosis)
English: Sertraline ↔ Cmax 1.14 (0.94, 1.38) ↔ AUC 0.93 (0.77, 1.13)
Danish: Sertralin ↔ Cmax 1,14 (0,94; 1,38)
English: Ethinylestradiol ↔ Cmax 1.22 (1.15, 1.29) ↔ AUC 1.11 (1.07, 1.16) ↔ Cmin 1.02 (0.93, 1.12)
Danish: Voxilaprevir ↔ Cmax 0,96 (0,84; 1,11) ↔ AUC 0,94 (0,84; 1,05) ↔ Cmin 1,02 (0,92; 1,12)
English: Sofosbuvir ↔ Cmax 0.95 (0.86, 1.05)
Danish: Sofosbuvir ↔ Cmax 0,95 (0,86; 1,05) ↔ AUC 1,01 (0,97; 1,06)
English: Norelgestromin ↔ Cmax 1.17 (1.07, 1.26) ↔ AUC 1.12 (1.07, 1.17) ↔ Cmin 1.16 (1.08, 1.24)
Danish: Norelgestromin ↔ Cmax 1,17 (1,07; 1,26)
English: Norgestrel ↔ Cmax 1.10 (1.02, 1.18) ↔ AUC 1.09 (1.01, 1.18) ↔ Cmin 1.11 (1.03, 1.20)
Danish: ↔ Cmin 1,16 (1,08; 1,24) Norgestrel ↔ Cmax 1,10 (1,02; 1,18)
English: • Periodic Safety Update reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Tenofovir alafenamidef (25 mg orally, q.d.)
Danish: Tenofoviralafenamidf (25 mg oralt, en gang dagligt)
English: Tenofovir alafenamidec (10 mg orally, q.d.)
Danish: Tenofoviralafenamidc (10 mg oralt, en gang dagligt)
English: Tenofovir ↓ Cmax 0.75 (0.67, 0.86)
Danish: Tenofovir ↓ Cmax 0,75 (0,67; 0,86) ↔ AUC 0,80 (0,73; 0,87) ↔ Cmin 0,82 (0,75; 0,89)
English: Tenofovir alafenamidec (25 mg orally, q.d.)
Danish: Tenofoviralafenamidc (25 mg oralt, en gang dagligt)
English: ↓ Tenofovir alafenamide
Danish: ↓ Tenofoviralafenamid
English: ANTICONVULSANTS Carbamazepine (300 mg orally, b.i.d.)
Danish: ANTIKONVULSIVA Carbamazepin (300 mg oralt, to gange dagligt) Tenofoviralafenamidc (25 mg oralt, enkeltdosis)
English: Gastrointestinal disorders Common
Danish: Mave-tarm-kanalen Almindelig
English: Hold this breath in for as long as possible (at least 3-4 seconds).
Danish: Hold vejret så længe som muligt (mindst 3-4 sekunder).
English: It is very important that you use Elebrato Ellipta every day, as instructed by your doctor.
Danish: Det er meget vigtigt, at du bruger Elebrato Ellipta hver dag i henhold til lægens anvisninger.
English: Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Elebrato Ellipta.
Danish: Lægen vil muligvis overvåge dig omhyggeligt, hvis du tager nogen af disse lægemidler, da de kan øge bivirkningerne fra Elebrato Ellipta.
English: Administration of Elebrato Ellipta to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.
Danish: Administration af Elebrato Ellipta til gravide kvinder bør kun overvejes, hvis den forventede fordel for moderen opvejer enhver mulig risiko for fostret.
English: There is no relevant use of Elebrato Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
Danish: Det er ikke relevant at anvende Elebrato Ellipta hos den pædiatriske population (under 18 år) til indikationen KOL.
English: Elebrato Ellipta should not be used in patients with asthma since it has not been studied in this patient population.
Danish: Elebrato Ellipta må ikke bruges til patienter med astma, fordi det ikke er blevet undersøgt hos denne patientpopulation.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Elebrato Ellipta and to contact their doctor immediately should any of these signs or symptoms develop.
Danish: Patienterne skal informeres om tegn og symptomer på akut snævervinklet glaukom og om, at de skal stoppe med at bruge Elebrato Ellipta og omgående kontakte deres læge, hvis nogen af disse tegn eller symptomer opstår.
English: There is no specific treatment for an overdose with Elebrato Ellipta.
Danish: Der findes ingen specifik behandling af overdosering med Elebrato Ellipta.
English: Elebrato Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD.
Danish: Elebrato Ellipta skal bruges hver dag og ikke kun, når du har problemer med vejrtrækningen eller andre symptomer på KOL.
English: There are no clinical data to support the use of Elebrato Ellipta for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Danish: Der er ingen kliniske data, der understøtter brugen af Elebrato Ellipta til behandling af akutte tilfælde af bronkospasme eller akut eksacerbation af KOL (dvs. som nødbehandling).
English: Treatment with Elebrato Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
Danish: Behandling med Elebrato Ellipta skal stoppes omgående, hvis der opstår paradoks bronkospasme.
English: One fatal case of pneumonia was reported in a patient who received Elebrato Ellipta.
Danish: Der blev indberettet et tilfælde af dødelig pneumoni hos en patient, der fik Elebrato Ellipta.
English: Once the tray is opened Elebrato Ellipta is ready to use.
Danish: Når bakken er åbnet er Elebrato Ellipta klar til brug.
English: Upon initiation of treatment with Elebrato Ellipta, plasma glucose should be monitored more closely in diabetic patients.
Danish: Ved initiering af behandling med Elebrato Ellipta, bør plasmaglucose monitoreres tættere hos diabetespatienter.
English: Eye problems during treatment with Elebrato Ellipta If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images as well as red eyes during treatment with Elebrato Ellipta:
Danish: Øjenproblemer ved behandling med Elebrato Ellipta Hvis du oplever smerter eller ubehag i øjnene, midlertidigt sløret syn, synlige haloer eller farvede billeder såvel som røde øjne ved behandling med Elebrato Ellipta:
English: The other ingredients are lactose monohydrate (see section 2 under ‘Elebrato Ellipta contains lactose') and magnesium stearate.
Danish: De øvrige indholdsstoffer er lactosemonohydrat (se punkt 2 ”Elebrato Ellipta indeholder lactose”) og magnesiumstearat.
English: Don't use Elebrato Ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Elebrato Ellipta: - hvis du er allergisk over for fluticasonfuroat, umeclidinium, vilanterol eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: The most frequently reported adverse reactions with Elebrato Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Danish: De hyppigst indberettede bivirkninger ved brug af Elebrato Ellipta var nasopharyngitis (7 %), hovedpine (5 %) og infektion i de øvre luftveje (2 %).
English: Elebrato Ellipta is for inhalation use only.
Danish: Elebrato Ellipta er kun beregnet til inhalation.
English: Tabulated summary of adverse reactions The safety profile of Elebrato Ellipta is based on three phase III clinical studies.
Danish: Tabel over bivirkninger Sikkerhedsprofilen for Elebrato Ellipta er baseret på tre kliniske fase III-studier.
English: Rinsing your mouth out with water immediately after using Elebrato Ellipta may help prevent this side effect.
Danish: Hvis du skyller munden med vand og spytter vandet ud, umiddelbart efter at du har brugt Elebrato Ellipta, kan det være med til at forebygge denne bivirkning
English: Don't use Elebrato Ellipta if you already use these medicines.
Danish: Du må ikke bruge Elebrato Ellipta, hvis du allerede bruger et eller flere af disse lægemidler.
English: Pneumonia which required hospitalisation occurred in 1% of patients receiving Elebrato Ellipta and <1% of patients receiving budesonide/formoterol up to 24 weeks.
Danish: Der opstod pneumoni, som krævede hospitalsindlæggelse, hos 1 % af de patienter, der fik Elebrato Ellipta, og hos < 1 % af de patienter, der fik budesonid/formoterol op til 24 uger.
English: Elebrato Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Danish: Elebrato Ellipta bruges til at behandle kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: The fluticasone furoate/vilanterol component of Elebrato Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Danish: Fluticasonfuroat/vilanterol-komponenten i Elebrato Ellipta er blevet vurderet hos patienter med alle sværhedsgrader af nedsat leverfunktion (Child-Pugh A, B eller C).
English: Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while using Elebrato Ellipta - these could be symptoms of a lung infection:
Danish: Lungebetændelse (pneumoni) hos KOL-patienter (almindelig bivirkning) Kontakt lægen, hvis du får et eller flere af følgende symptomer, mens du bruger Elebrato Ellipta - det kan være symptomer på lungebetændelse:
English: In Study 200812, Elebrato Ellipta was non-inferior compared with FF/VI+UMEC, co-administered in two inhalers, in the improvement from baseline in trough FEV1 at week 24.
Danish: I studie 200812 var Elebrato Ellipta non-inferior sammenlignet med FF/VI + UMEC, som blev administreret samtidig i to inhalatorer, i forbedringen fra FEV1-baseline i uge 24.
English: Patients should not stop therapy with Elebrato Ellipta without physician supervision since symptoms may recur after discontinuation.
Danish: Patienten bør ikke stoppe behandlingen med Elebrato Ellipta uden samråd med lægen, da symptomerne kan vende tilbage efter seponering.
English: Use Elebrato Ellipta regularly
Danish: Brug Elebrato Ellipta regelmæssigt
English: The recommended and maximum dose is one inhalation of Elebrato Ellipta 92/55/22 micrograms once daily, at the same time each day.
Danish: Den anbefalede og maksimale dosis er én inhalation med Elebrato Ellipta 92/55/22 mikrogram én gang dagligt på samme tidspunkt hver dag.
English: In the event of deterioration of COPD during treatment with Elebrato Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Danish: Hvis KOL-tilstanden forværres under behandling med Elebrato Ellipta, skal der foretages en ny vurdering af patienten og af KOL-behandlingsmetoden.
English: The efficacy of Elebrato Ellipta (92/55/22 micrograms), administered as a once-daily treatment, has been evaluated in patients with a clinical diagnosis of COPD in two, active-controlled studies and in a single, noninferiority study.
Danish: Virkningen af Elebrato Ellipta (92/55/22 mikrogram), der administreres én gang dagligt, er blevet evalueret hos patienter med en klinisk KOL-diagnose i to studier med aktiv kontrol og i et enkelt, noninferiorstudie.
English: In FULFIL, bronchodilatory effects with Elebrato Ellipta were evident on the first day of treatment and were maintained over the 24-week treatment period (mean changes from baseline in FEV1 were 90-222 mL on day 1 and 160-339 mL at week 24).
Danish: I FULFIL var de bronkodilatoriske virkninger med Elebrato Ellipta evidente på den første behandlingsdag og blev opretholdt i løbet af behandlingsperioden på 24 uger (ændringerne i forhold til baseline i FEV1 var 90-222 ml på dag 1 og 160-339 ml i uge 24).
English: For the 14-dose inhaler, the dose counter will also show half red when there are fewer than 10 doses left, and then will show half red with the number 0 after the last dose is used.
Danish: På inhalatoren med 14 doser vises halvdelen af dosistælleren i rødt, når der er under 10 doser tilbage, og vil når den sidste dose er brugt, vise halvdelen i rødt og tallet 0.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Elebrato Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Elebrato Ellipta i alle undergrupper af den pædiatriske population ved KOL (se pkt.
English: Talk to your doctor before using Elebrato Ellipta - if you have asthma (Don't use Elebrato Ellipta to treat asthma) - if you have heart problems or high blood pressure - if you have liver problems - if you have tuberculosis (TB) of the lung, or any long standing or untreated infections - if you have an eye problem called narrow-angle glaucoma - if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder - if you suffer from epilepsy - if you have thyroid gland problems - if you have low potassium in your blood - if you have a history of diabetes - if you experience blurred vision or other visual disturbances
Danish: Kontakt lægen, før du bruger Elebrato Ellipta - hvis du har astma (Elebrato Ellipta må ikke bruges til at behandle astma) - hvis du har hjerteproblemer eller højt blodtryk - hvis du har leverproblemer - hvis du har lungetuberkulose (TB) eller langvarige eller ubehandlede infektioner - hvis du har et problem med øjnene kaldet snævervinklet glaukom - hvis du har forstørret prostata, besvær med at tisse eller en blokering i blæren - hvis du lider af epilepsi - hvis du har problemer med skjoldbruskkirtlen - hvis du har lavt kaliumindhold i blodet - hvis du har diabetes - hvis du oplever sløret syn eller andre synsforstyrrelser.
English: In 113 East Asian subjects with COPD (Japanese and East Asian Heritage), who received FF/UMEC/VI from a single inhaler (27% subjects), fluticasone furoate AUC(ss) estimates were on average 30% higher compared with Caucasian subjects.
Danish: Hos 113 østasiatiske forsøgspersoner med KOL (japansk og østasiatisk herkomst), som fik FF/UMEC/VI fra en enkelt inhalator (27 % af forsøgspersonerne), lå estimaterne for fluticasonfuroat AUC(ss) i gennemsnit 30 % højere end hos kaukasiske forsøgspersoner..
English: INFORMATION IN BRAILLE elebrato ellipta
Danish: INFORMATION I BRAILLESKRIFT elebrato ellipta
English: Other medicines and Elebrato Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Elebrato Ellipta Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.