natgillin/translations-raw huggingface dataset:
I en samlet analyse af to identiske 1-års studier med moderate til svære KOL-patienter (forventede middelværdi for post-bronkodilatator screening FEV1 på 45 %, standardafvigelse (SD) 13 %), som havde haft en eksacerbation i det foregående år (n=3.255) var antallet af pneumonitilfælde pr. 1.000 patientår 97,9 for gruppen behandlet med FF/VI 184/22; 85,7 i FF/VI 92/22-gruppen og 42,3 i VI 22-gruppen.
In an integrated analysis of the two replicate one year studies in moderate to severe COPD (mean predicted post-bronchodilator screening FEV1 of 45%, standard deviation (SD) 13%) with an exacerbation in the preceding year (n = 3255), the number of pneumonia events per 1000 patient years was 97.9 with FF/VI 184/22, 85.7 in the FF/VI 92/22 and 42.3 in the VI 22 group.
Der var ingen evidens for, at køn, vægt eller BMI påvirker farmakokinetikken af vilanterol, baseret på en populationsfarmakokinetisk analyse med 856 patienter med astma (500 kvinder).
There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females).
Der var ingen evidens for, at køn, vægt eller BMI påvirker farmakokinetikken af vilanterol, baseret på en populationsfarmakokinetisk analyse med 856 patienter med astma (500 kvinder) og 1.091 patienter med KOL (340 kvinder).
There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females) and 1091 subjects with COPD (340 females).
• bihulebetændelse eller halsbetændelse
• infection of the nose sinuses or throat
I et 24-ugers studie (HZA113091) med voksne og unge patienter med ukontrolleret persisterende astma blev der påvist forbedringer i lungefunktionen i forhold til baseline med både fluticasonfuroat/vilanterol 92/22 mikrogram indgivet en gang daglig om aftenen og salmeterol/FP 50/250 mikrogram indgivet to gange daglig.
In a 24 week study (HZA113091) in adult and adolescent patients with uncontrolled persistent asthma both fluticasone furoate/vilanterol 92/22 micrograms given once daily in the evening and salmeterol/FP 50/250 micrograms given twice daily demonstrated improvements from baseline in lung function.
Den sædvanlige dosis til behandling af KOL er en inhalation (92 mikrogram fluticasonfuroat og 22 mikrogram vilanterol) én gang dagligt på samme tidspunkt hver dag.
The recommended dose to treat COPD is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily at the same time each day.
Er du i tvivl, så spørg lægen, sundhedspersonalet eller på apoteket.
- If you have any further questions, ask your doctor, pharmacist or nurse.
konfidensinterval) Absolut forskel i antal pr. år versus VI (95 % konfidensinterval) Tid til første eksacerbation:
Absolute difference in number per year vs VI (95% CI)
Det er ikke nødvendigt at kontrollere, om Ellipta-inhalatoren virker korrekt, før du bruger den første gang, ligesom det heller ikke er nødvendigt på anden måde at klargøre den til brug.
When you first use the Ellipta inhaler you do not need to check that it is working properly, and you do not need to prepare it for use in any special way.
Relvar Ellipta findes i to forskellige styrker: 92 mikrogram fluticasonfuroat og 22 mikrogram vilanterol eller 184 mikrogram fluticasonfuroat og 22 mikrogram vilanterol.
Two different strengths of Relvar Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.
Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
You can also report side effects directly via the national reporting system listed in Appendix V .
Den orale biotilgængelighed for både fluticasonfuroat og vilanterol var lav, i gennemsnit henholdsvis.
The oral bioavailability of both fluticasone furoate and vilanterol was low, on average 1.26% and <2%, respectively.
I en samlet analyse af begge studier blev der set klinisk relevante forbedringer af lungefunktionen med fluticasonfuroat/vilanterol 92/22 mikrogram.
In an integrated analysis of both studies, fluticasone furoate/vilanterol 92/22 micrograms showed clinically meaningful improvements in lung function.
Interaktion med betablokkere
Interaction with beta-blockers
Der var ingen evidens for, at køn, vægt eller BMI (body mass index) påvirker farmakokinetikken af fluticasonfuroat, baseret på en populationsfarmakokinetisk analyse af fase III-data med 1.213 patienter med astma (712 kvinder).
There was no evidence for gender, weight or BMI (body mass index) to influence the pharmacokinetics of fluticasone furoate based on a population pharmacokinetic analysis of phase III data in 1213 subjects with asthma (712 females).
Dette svarer til en afdelt dosis på 200 mikrogram fluticasonfuroat og 25 mikrogram vilanterol (som trifenatat).
This corresponds to a pre-dispensed dose of 200 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
Bivirkning(er)
Adverse reaction(s)
Hvis du har moderat eller alvorlig leversygdom, vil lægen muligvis ændre din dosis til den laveste styrke af Relvar Ellipta
If you have moderate or severe liver disease, your doctor will limit your dose to the lower strength of Relvar Ellipta (92/22 micrograms once daily).
• Hold inhalatoren væk fra munden og foretag den dybeste udånding, du finder behagelig.
• While holding the inhaler away from your mouth, breathe out as far as is comfortable.
Glaxo Operations UK Limited (handler som Glaxo Wellcome Operations), Harmire Road,
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Harmire Road,
Fluticasonfuroat/vilanterol 92/22 mikrogram udviste konsekvent forbedringer på 83 ml til 95 ml i trough-FEV1 ved uge 12, 36 og 52 og endepunktet sammenlignet med FF 92 mikrogram (p< 0,001; 95 % konfidensinterval 52;126 ml ved endepunktet).
Fluticasone furoate/vilanterol 92 /22 micrograms consistently demonstrated 83 mL to 95 mL improvements in trough FEV1 at weeks 12, 36 and 52 and Endpoint compared with FF 92 micrograms (p<0.001 95% CI 52, 126 mL at Endpoint).
Bakken indeholder en pose med tørremiddel for at beskytte mod fugt i pakningen.
The tray contains a desiccant sachet, to reduce moisture in the packaging.
Fluticasonfuroat
Fluticasone furoate
Dette svarer til en afdelt dosis på 100 mikrogram fluticasonfuroat og 25 mikrogram vilanterol (som trifenatat).
This corresponds to a pre-dispensed dose of 100 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
Der var ingen evidens for, at køn, vægt eller BMI (body mass index) påvirker farmakokinetikken af fluticasonfuroat, baseret på en populationsfarmakokinetisk analyse af fase III-data med 1.213 patienter med astma (712 kvinder) og 1.225 patienter med KOL (392 kvinder).
There was no evidence for gender, weight or BMI (body mass index) to influence the pharmacokinetics of fluticasone furoate based on a population pharmacokinetic analysis of phase III data in 1213 subjects with asthma (712 females) and 1225 subjects with COPD (392 females).
Multipakninger indeholder 3 inhalatorer med hver 30 doser.
Multipacks contain 3 x 30 dose inhalers.
Metabolitterne blev næsten udelukkende udskilt med fæces, og < 1 % af den genfundne radioaktive dosis blev udskilt via urinen.
Following oral administration, fluticasone furoate was eliminated in humans mainly by metabolism with metabolites being excreted almost exclusively in faeces, with <1% of the recovered radioactive dose eliminated in the urine.
Inhalatoren vil være i ”lukket” position, når den tages ud af den forseglede bakke.
When the inhaler is taken out of its tray, it will be in the ‘closed' position.
HZA106829 var et 24 ugers studie, der vurderede effekten af fluticasonfuroat/vilanterol 184/22 mikrogram [n=197] og FF 184 mikrogram [n=194], begge administreret en gang daglig, versus FP 500 mikrogram to gange daglig [n=195].
HZA106829 was 24 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 184/22 micrograms [n=197] and FF 184 micrograms [n=194]) both administered once daily compared with FP 500 micrograms twice daily [n=195].
Ændring i forhold til baseline i ekspiratorisk peak flow om morgenen Behandlingsforskel
Change from Baseline in PM Peak Expiratory Flow Treatment difference
I HZC112207 blev effekten af fluticasonfuroat/vilanterol 92/22 mikrogram [n=204] og fluticasonfuroat/vilanterol 184/22 mikrogram [n=205] sammenlignet med FF 92 mikrogram [n=204], FF 184 mikrogram [n=203], vilanterol 22 mikrogram [n=203] og placebo [n=205], alle administreret en gang daglig.
HZC112207 evaluated the efficacy of fluticasone furoate/vilanterol 92/22 micrograms [n=204] and fluticasone furoate/vilanterol 184/22 micrograms [n=205] compared with FF 92 micrograms [n=204], FF 184 micrograms [n=203] and vilanterol 22 micrograms [n=203] and placebo [n = 205], all administered once daily.
Fluticasonfuroat/vilanterol 92/22 mikrogram øgede den justerede gennemsnitligt vægtet FEV1 i de første 4 timer med 148 ml sammenlignet med FF alene (95 % konfidensinterval 112; 184 ml; p < 0,001).
Fluticasone furoate/vilanterol 92/22 micrograms increased adjusted mean weighted mean FEV1 over 0-4 hours by 148 ml compared to FF alone (95% CI: 112, 184 mL, p< 0.001).
Alle patienter skulle have en rygeanamnese på mindst 10 pakkeår, en FEV1/FVC-ratio efter salbutamol under eller lig med 0,70, et FEV1 efter salbutamol under eller lig med 70 % af forventet værdi og en dyspnøscore ≥ 2 på Modified Medical Research Council (mMRC) dyspnea scale (skala 0-4) ved screening.
All patients were required to have a smoking history of at least 10 pack years; a post-salbutamol FEV1/FVC ratio less than or equal to 0.70; post-salbutamol FEV1 less than or equal to 70% predicted and have a
I HZC112206 blev effekten af fluticasonfuroat/vilanterol 46/22 mikrogram [n=206] og fluticasonfuroat/vilanterol 92/22 mikrogram [n=206] sammenlignet med FF 92 mikrogram [n=206], vilanterol 22 mikrogram [n=205] og placebo [n=207], alle administreret en gang daglig.
HZC112206 evaluated the efficacy of fluticasone furoate/vilanterol 46 /22 micrograms [n=206] and fluticasone furoate/vilanterol 92/22 micrograms [n=206] compared with FF 92 micrograms [n=206], vilanterol 22 micrograms [n=205] and placebo [n = 207], all administered once daily.
Sådan skal du tage Relvar Ellipta
How to use Relvar Ellipta
Sikkerheden og virkningen af FF 92 mikrogram en gang daglig [n=114] og FP 250 mikrogram to gange daglig [n=114] versus placebo [n=115] hos voksne og unge patienter med persisterende astma er blevet undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret studie af 24 ugers varighed (FFA112059).
A 24 week randomised, double-blind placebo controlled study (FFA112059) evaluated the safety and efficacy of FF 92 micrograms once daily [n= 114] and FP 250 micrograms twice daily [n=114] versus placebo [n=115] in adult and adolescent patients with persistent asthma.
Indlægsseddel: Information til brugeren Relvar Ellipta 92 mikrogram/22 mikrogram inhalationspulver, afdelt Relvar Ellipta 184 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/vilanterol
Package leaflet: Information for the user Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Hos patienter med leverinsufficiens (Child-Pugh A, B eller C) blev der efter gentagen dosering af fluticasonfuroat/vilanterol i 7 dage set en stigning i systemisk eksponering af fluticasonfuroat (op til 3 gange større målt ved AUC(0-24)) sammenlignet med raske personer.
Following repeat dosing of fluticasone furoate/vilanterol for 7 days, there was an increase in fluticasone furoate systemic exposure (up to three-fold as measured by AUC(0-24)) in subjects with hepatic impairment (Child-Pugh A, B or C) compared with healthy subjects.
Hvis inhalatoren opbevares på køl, skal den ligge ved stuetemperatur i mindst en time før brug.
If stored in a refrigerator, the inhaler should be allowed to return to room temperature for at least an hour before use.
HZA106827 var et 12 ugers studie, der vurderede effekten af fluticasonfuroat/vilanterol 92/22 mikrogram [n=201] og FF 92 mikrogram [n=205] versus placebo [n=203], alle administreret en gang daglig.
HZA106827 was 12 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 92/22 micrograms [n=201] and FF 92 micrograms [n=205]) compared with placebo [n=203], all administered once daily.
Sjældne bivirkninger Kan forekomme hos op til 1 ud af 1.000 personer:
These may affect up to 1 in 1,000 people:
Sikkerheden og virkningen af fluticasonfuroat/vilanterol hos voksne og unge patienter med persisterende astma er blevet vurderet i tre randomiserede, dobbeltblindede fase III-studier af forskellig varighed (HZA106827, HZA106829 og HZA106837).
Three phase III randomised, double-blind studies (HZA106827, HZA106829 and HZA106837) of different durations evaluated the safety and efficacy of fluticasone furoate/vilanterol in adult and adolescent patients with persistent asthma.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (ENKELTPAKNINGER) 92/22 mikrogram
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 92/22 micrograms
- 184/22 mikrogram dosis: Hver enkelt inhalation afgiver en leveret dosis (den dosis, der afgives fra mundstykket) på 184 mikrogram fluticasonfuroat og 22 mikrogram vilanterol (som trifenatat).
- For the 184/22 dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Monoterapi med fluticasonfuroat
Fluticasone furoate monotherapy
- 92/22 mikrogram dosis: Hver enkelt inhalation afgiver en leveret dosis (den dosis, der afgives fra mundstykket) på 92 mikrogram fluticasonfuroat og 22 mikrogram vilanterol (som trifenatat).
- For the 92/22mcg dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INTERMEDIÆR YDRE KARTON (UDEN BLUE BOX - KUN MULTIPAKNING) 184/22 mikrogram
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 184/22 micrograms
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INTERMEDIÆR YDRE KARTON (UDEN BLUE BOX - KUN MULTIPAKNING) 92/22 mikrogram
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 92/22 micrograms
I SUMMIT studiet var hyppigheden af alle hændelser for fraktur med FF/VI, FF, VI og placebo 2 % i hver arm; frakturer almindeligvis forbundet med brug af ICS var mindre end 1 % i hver arm. Forekomst justeret for eksponering (pr. 1000 behandlingsår) for alle hændelser med frakturer var henholdsvis 13,6, 12,8, 13,2, 11,5; frakturer almindeligvis forbundet med brug af ICS var henholdsvis 3,4, 3,9, 2,4, 2,1.
The exposureadjusted rates (per 1000 treatment years) for all fracture events were 13.6, 12.8, 13.2, 11.5 respectively; fractures commonly associated with ICS use were 3.4, 3.9, 2.4, 2.1 respectively.
Kontakt lægen, før du tager denne medicin, hvis din læge har fortalt dig, at du ikke tåler visse sukkerarter eller mælkeprotein.
If you have been told by your doctor that you have an intolerance to some sugars, or to milk protein, contact your doctor before using this medicine.
Holdbarhed efter anbrud: 6 uger Kasseres senest:
In use shelf-life: 6 weeks Discard by:
KOL
Cough
Hvis du opbevarer inhalatoren på køl, skal den ligge ved stuetemperatur i mindst én time før brug.
If you store in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use.
Holdbarhed efter anbrud af bakken: 6 uger.
In-use shelf-life after opening the tray: 6 weeks.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERETIKET (MED BLUE BOX - MULTIPAKNING) 92/22 mikrogram
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 92/22 micrograms
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERETIKET (MED BLUE BOX - MULTIPAKNING) 184/22 mikrogram
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 184/22 micrograms
Også i denne undergruppe blev der set forbedringer i justeret gennemsnitligt trough-FEV1 (44 ml, 95 % konfidensinterval 15-73 ml; p=0,003) ved uge 52, når fluticasonfuroat/vilanterol 92/22 mikrogram blev sammenlignet med vilanterol 22 mikrogram.
Improvements were also seen in this subgroup at week 52 when comparing the fluticasone furoate/vilanterol 92/22 micrograms vs. vilanterol 22 micrograms in adjusted mean trough FEV1 (44 mL 95% CI: 15, 73mL, (p=0.003)).
• Efter brug af inhalatoren skylles munden med vand uden at synke det.
• Rinse your mouth with water after you have used the inhaler, do not swallow.
På dag 169 blev der set en stigning i den justerede gennemsnitlige trough-FEV1 på 129 ml (95 % konfidensinterval 91;167 ml; p < 0,001) med fluticasonfuroat/vilanterol 92/22 mikrogram og på 83 ml (95 % konfidensinterval 46;121 ml; p < 0,001) med vilanterol sammenlignet med placebo.
At Day 169 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean trough FEV1 by 129 mL (95% CI: 91, 167 mL, p<0.001) and 83 mL (95% CI: 46, 121mL, p<0.001) respectively compared to placebo.
På grund af de lave plasmakoncentrationer, der opnås efter inhalation, anses det for usandsynligt, at kliniske doser af fluticasonfuroat/vilanterol vil medføre klinisk signifikante lægemiddelinteraktioner.
Clinically significant drug interactions mediated by fluticasone furoate/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
LÆGEMIDLETS NAVN Relvar Ellipta 92 mikrogram/22 mikrogram inhalationspulver, afdelt.
NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed
Hver enkelt inhalation leverer en afgivet dosis (den dosis, der forlader mundstykket) på 184 mikrogram fluticasonfuroat (FF) og 22 mikrogram vilanterol (VI) (som trifenatat).
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
LÆGEMIDLETS NAVN Relvar Ellipta 184 mikrogram/22 mikrogram inhalationspulver, afdelt.
NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Hvis du har glemt at tage Relvar Ellipta
While you're using Relvar Ellipta
Multipakning med 3 inhalatorer med hver 30 doser.
Multipack of 3 x 30 dose Inhalers.
1 inhalator med 14 doser
1 inhaler of 14 doses 1 inhaler of 30 doses
Ellipta-inhalatoren er en lysegrå inhalator med en gul beskyttelseshætte over mundstykket og en dosistæller.
What Relvar Ellipta looks like and contents of the pack The Ellipta device itself is a light grey inhaler with a yellow mouthpiece cover and a dose counter.
På dag 168 blev der set en stigning i den justerede gennemsnitlig vægtet FEV1 over de første 4 timer på 193 ml (95 % konfidensinterval 156; 230 ml; p < 0,001) med fluticasonfuroat/vilanterol 92/22 mikrogram og 145 ml (95 % konfidensinterval 108; 181 ml; p < 0,001) med vilanterol sammenlignet med placebo.
At Day 168 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean weighted mean FEV1 over 0-4 hours by 193mL (95% CI: 156, 230 mL, p<0.001) and 145 mL (95% CI: 108, 181 mL, p<0.001) respectively compared to placebo.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Relvar Ellipta 92 mikrogram/22 mikrogram inhalationspulver fluticasonfuroat/vilanterol
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Relvar Ellipta 92 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Relvar Ellipta 184 mikrogram/22 mikrogram inhalationspulver fluticasonfuroat/vilanterol
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Relvar Ellipta 184 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
Glaxo Operations UK Ltd (handler som Glaxo Wellcome Operations), Priory Street,
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Priory Street,
HZC102970 og HZC102871 var randomiserede, dobbeltblindede, parallelgruppe-studier af 52 ugers varighed, der sammenlignede effekten af fluticasonfuroat/vilanterol 184/22 mikrogram, fluticasonfuroat/vilanterol 92/22 mikrogram, fluticasonfuroat/vilanterol 46/22 mikrogram med vilanterol 22 mikrogram, alle blev administreret en gang daglig.
Studies HZC102970 and HZC102871 were 52 week randomised, double-blind, parallel-group, studies comparing the effect of fluticasone furoate/vilanterol 184/22 micrograms, fluticasone furoate/vilanterol 92/22 micrograms, fluticasone furoate/vilanterol 46/22 micrograms with vilanterol 22 micrograms, all administered once daily, on the annual rate of moderate/severe exacerbations in subjects with COPD with a smoking history of at least 10 pack years and a post-salbutamol FEV1/FVC ratio less than or equal to 0.70 and post-salbutamol FEV1 less than or equal to 70% predicted and documented history of ≥ 1 COPD exacerbation that required antibiotics and/or oral corticosteroids or hospitalisation in the 12 months prior to visit 1.
Den er pakket i en bakke af laminatfolie, der indeholder en silica-gel tørrepose.
The inhaler consists of a light grey body, a yellow mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet.
Ved begge behandlinger blev der set en forbedret lungefunktion over 24 timer målt ved 24 timers justeret gennemsnitlig stigning i vægtet gennemsnitligt FEV1 på 130 ml (fluticasonfuroat/vilanterol) og 108 ml (salmeterol/FP) i forhold til baseline.
Adjusted mean treatment increases from baseline in weighted mean 0-24 hours FEV1 of 130 mL (fluticasone furoate/vilanterol) and 108 mL (salmeterol/FP) demonstrated an overall improvement in lung function over 24 hours for both treatments.
Den justerede gennemsnitlige ændring i trough-FEV1 på dag 85 i forhold til baseline var 111 ml i fluticasonfuroat/vilanterol-gruppen og 88 ml i salmeterol/FP-gruppen.
The adjusted mean change from baseline in trough FEV1 on Day 85 was 111 mL in the fluticasone furoate/vilanterol group and 88 mL in the salmeterol/FP group; the 23 mL (95% CI: -20, 66) difference between the treatment groups was not clinically meaningful or statistically significant (p=0.294).
• ledsmerter
• tremor
Hvis du har taget for meget Relvar Ellipta
If patients are inadequately controlled on Relvar Ellipta
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver afgivet dosis indeholder 184 mikrogram fluticasonfuroat og 22 mikrogram vilanterol (som trifenatat).
Each delivered dose contains 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Metabolisme og ernæring Hyperglykæmi
Metabolism and nutrition disorders
Skriv dato for ”Kasseres senest” i det felt, der er angivet på inhalatorens etiket.
When the tray is opened, write the “Discard by” date on the inhaler label in the space provided.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver afgivet dosis indeholder 92 mikrogram fluticasonfuroat og 22 mikrogram vilanterol (som trifenatat).
Each delivered dose contains 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
• udslæt (nældefeber) eller rødme
• skin rash (hives) or redness
Relvar Ellipta 92 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/vilanterol
NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate /vilanterol
Brug af anden medicin sammen med Relvar Ellipta Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.