FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacologic effects of beta2-adrenergic agonists, including vilanterol, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP).
Icelandic: örvunar adenýlatcýklasa innan frumna, ensímsins sem hvetur umbreytingu adenósínþrífosfats (ATP) yfir í hringlaga-3', 5'-adenósíneinfosfat (hringlaga AMP).
English: In nonclinical studies with umeclidinium and vilanterol, alone and in combination, findings were those typically associated with the primary pharmacology of either muscarinic receptor antagonists or beta2-adrenergic agonists respectively and/or local irritancy.
Icelandic: Í forklínískum rannsóknum með umeclidinium og vílanteróli, einum sér og saman, voru niðurstöður sem komu fram í samræmi við helstu lyfjafræðilega eiginleika annaðhvort múskarínviðtakablokka eða beta2-adrenvirkra örva og/eða staðbundin erting.
English: - if you have thyroid gland problems
Icelandic: - ef þú ert með skjaldkirtilsvandamál
English: If stored in a refrigerator allow the inhaler to return to room temperature for at least an hour before use.
Icelandic: Ef innöndunartækið er geymt í kæli skal leyfa því að ná stofuhita í a.m.k. eina klukkustund fyrir notkun.
English: How to use ANORO ELLIPTA
Icelandic: Hvernig nota á ANORO ELLIPTA
English: In the other two active-comparator studies, a similar proportion of patients achieved at least the MCID with ANORO ELLIPTA and tiotropium; 49% and 54% for ANORO ELLIPTA 55/22 micrograms and 52% and 55% for tiotropium.
Icelandic: MCID með ANORO ELLIPTA og tíótrópíum; 49% og 54% fyrir ANORO ELLIPTA 55/22 míkróg og 52% og 55% fyrir tíótrópíum.
English: There are no data on the effects of umeclidinium/vilanterol on human fertility.
Icelandic: Engar upplýsingar liggja fyrir um áhrif umeclidinium/vílanteróls á frjósemi hjá mönnum.
English: Other medicines and ANORO ELLIPTA
Icelandic: Notkun annarra lyfja samhliða ANORO ELLIPTA
English: The maximum mean difference in prolongations of QT interval (corrected using the Fridericia method, QTcF) from placebo after baseline-correction was 4.3 (90% CI=2.2 to 6.4) milliseconds seen 10 minutes after administration with umeclidinium/vilanterol 113/22 micrograms and 8.2 (90% CI=6.2 to 10.2) milliseconds seen 30 minutes after administration with umeclidinium/vilanterol 500/100 micrograms.
Icelandic: QT bils (leiðréttu samkvæmt aðferð Fridericia, QTcF) miðað við lyfleysu eftir leiðréttingu miðað við grunngildi var 4,3 (90% CI=2,2 til 6,4) millisekúndur sem kom fram 10 mínútum eftir gjöf umeclidiniums/vílanteróls 113/22 míkróg og 8,2 (90% CI=6,2 til 10,2) millisekúndur sem kom fram 30 mínútum eftir gjöf umeclidiniums/vílanteróls 500/100 míkróg.
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol is co-administered with P-gp inhibitors.
Icelandic: Miðað við stærðargráðu þessara breytinga er ekki búist við neinum lyfjahvarfamilliverkunum af klínískri þýðingu við gjöf umeclidiniums/vílanteróls samhliða P-gp-hemlum.
English: Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control.
Icelandic: Aukin notkun skjótvirkra berkjuvíkkandi lyfja gegn einkennum bendir til verri sjúkdómsstjórnunar.
English: • taste disturbance
Icelandic: truflanir á bragðskyni
English: Not applicable.
Icelandic: ekki metið
English: In the event of deterioration of COPD during treatment with umeclidinium/vilanterol, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Icelandic: Ef langvinn lungnateppa versnar meðan á meðferð með umeclidiniumi/vílanteróli stendur skal endurmeta sjúklinginn og meðferðaráætlunina gegn langvinnu lungnateppunni.
English: ANORO ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Icelandic: ANORO ELLIPTA er ætlað til notkunar sem berkjuvíkkandi viðhaldsmeðferð gegn einkennum hjá fullorðnum sjúklingum með langvinna lungnateppu.
English: Rare Rare Rare
Icelandic: Sjaldgæfar Mjög sjaldgæfar
English: The maximum mean difference in heart rate from placebo after baseline-correction was 8.4 (90% CI=7.0 to 9.8) beats/minute and 20.3 (90% CI=18.9 to 21.7) beats/minute seen 10 minutes after administration of umeclidinium/vilanterol 113/22 micrograms and 500/100 micrograms respectively.
Icelandic: Meðalmunur á hjartsláttartíðni miðað við lyfleysu þegar leiðrétt hafði verið miðað við grunngildi, var að hámarki 8,4 (90% CI=7,0 - 9,8) slög/mínútu 10 mínútum eftir gjöf umeclidiniums/vílanteróls 113/22 míkróg og 20,3 (90% CI=18,9 - 21,7) 10 mínútum eftir gjöf umeclidiniums/vílanteróls 500/100 míkróg.
English: The absolute bioavailability of inhaled umeclidinium was on average 13% of the dose, with negligible contribution from oral absorption.
Icelandic: Heildaraðgengi umeclidiniums við innöndun var að meðaltali 13% af skammtinum, en frásog frá meltingarvegi var hverfandi.
English: Following intravenous administration to healthy volunteers, the mean volume of distribution at steady state was 165 litres.
Icelandic: Eftir gjöf á bláæð hjá heilbrigðum sjálfboðaliðum var dreifingarrúmmál að meðaltali 165 lítrar.
English: Mean peak improvements in FEV1 within the first 6 hours following dosing relative to placebo was 224 ml (p<0.001∗) at Week 24.
Icelandic: eftir gjöf skammts miðað við lyfleysu var að meðaltali 224 ml (p<0,001) í viku
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 55 micrograms/22 micrograms
Icelandic: YTRI UMBÚÐUM ÁLETRUN (MEÐ BLUE BOX) Á FJÖLPAKKNINGAR 55 míkróg/22 míkróg
English: ANORO ELLIPTA is for inhalation use only.
Icelandic: ANORO ELLIPTA er aðeins til innöndunar.
English: Placebo (N = 280) ANORO ELLIPTA (N =
Icelandic: ANORO ELLIPTA (N = 413 miðað við lyfleysu (N = 280)
English: No clinically relevant effects on plasma glucose were observed in clinical studies with umeclidinium/vilanterol at the recommended therapeutic dose.
Icelandic: Engin áhrif af klínískri þýðingu á glúkósa í plasma komu fram í klínískum rannsóknum á umeclidiniumi/vílanteróli við notkun ráðlagðra skammta.
English: If you stop using ANORO ELLIPTA
Icelandic: Ef hætt er að nota ANORO ELLIPTA
English: Patients with severe renal impairment showed no evidence of an increase in systemic exposure to either umeclidinium or vilanterol (Cmax and AUC) following administration of umeclidinium/vilanterol with umeclidinium at twice the recommended dose and vilanterol at the recommended dose and no evidence of altered protein binding between patients with severe renal impairment and healthy volunteers.
Icelandic: Engar vísbendingar komu fram um aukna altæka útsetningu hjá sjúklingum með alvarlega skerðingu á nýrnastarfsemi, hvorki fyrir umeclidiniumi né vílanteróli (Cmax og AUC) eftir gjöf umeclidiniums/vílateróls í skammti sem var tvöfaldur ráðlagður skammtur af umeclidiniumi og ráðlagður skammtur af vílanteróli og engar vísbendingar um breytingar í próteinbindingu milli sjúklinga með alvarlega skerðingu á nýrnastarfsemi og heilbrigðra sjálfboðaliða.
English: What ANORO ELLIPTA is and what it is used for What you need to know before you use ANORO ELLIPTA How to use ANORO ELLIPTA Possible side effects
Icelandic: Upplýsingar um ANORO ELLIPTA og við hverju það er notað Áður en byrjað er að nota ANORO ELLIPTA
English: ANORO ELLIPTA also demonstrated a greater increase from baseline in the proportion of days when no rescue medication was needed in all three studies (average within the range 17.6% to 21.5%) compared with tiotropium (average within the range 11.7% to 13.4%).
Icelandic: Hlutfall daga þar sem ekki var þörf fyrir bráðalyf (að meðaltali á bilinu 17,6% til 21,5%) jókst meira frá upphafsgildi við notkun ANORO ELLIPTA samanborið við tíótrópíum (að meðaltali á bilinu 11,7% til 13,4%) í öllum rannsóknunum þremur.
English: ANORO ELLIPTA is an inhalation powder, pre-dispensed.
Icelandic: ANORO ELLIPTA er innöndunarduft, afmældir skammtar.
English: Lactose monohydrate Magnesium stearate
Icelandic: Laktósaeinhýdrat Magnesíumsterat
English: Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium/vilanterol.
Icelandic: Áhrif á hjarta og æðar, svo sem hjartsláttartruflanir t.d. gáttatif og hraðtaktur, geta komið fram eftir gjöf múskarínviðtakablokka og adrenvirkra lyfja þ.m.t. umeclidiniums/vílanteróls.
English: Patients with moderate hepatic impairment (Child-Pugh Class B) showed no evidence of an increase in systemic exposure to either umeclidinium or vilanterol (Cmax and AUC) following administration of umeclidinium/vilanterol with umeclidinium at twice the recommended dose and vilanterol at the recommended dose and no evidence of altered protein binding between patients with moderate hepatic impairment and healthy volunteers.
Icelandic: Hvorki komu fram vísbendingar um aukna altæka útsetningu hjá sjúklingum með miðlungsalvarlega (Child-Pugh stig B) skerðingu á lifrarstarfsemi, hvorki fyrir umeclidiniumi né vílanteróli (Cmax og AUC) eftir gjöf umeclidiniums/vílateróls í skammti sem var tvöfaldur ráðlagður skammtur af umeclidiniumi og ráðalgður skammtur af vílanteróli né vísbendingar um breytingar í próteinbindingu milli sjúklinga með miðlungsalvarlega skerðingu á lifrarstarfsemi og heilbrigðra sjálfboðaliða.
English: The clinical development programme included 2,354 patients who received umeclidinium/vilanterol once daily in the Phase III clinical studies of 24 weeks or more, of whom 1,296 patients received the recommended dose of 55/22 micrograms in 24-week studies, 832 patients received a higher dose of 113/22 micrograms in 24-week studies and 226 patients received 113/22 micrograms in a 12-month study.
Icelandic: 1.296 sjúklingar ráðlagðan skammt, 55/22 míkróg í 24 vikna rannsóknum, 832 sjúklingar fengu stærri skammt, 113/22 míkróg í 24 vikna rannsóknum og 226 sjúklingar fengu 113/22 míkróg í 12-mánaða rannsókn.
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 24 was greater for ANORO ELLIPTA (49%) compared with placebo (34%) and each monotherapy component (44% for umeclidinium and 48% for vilanterol).
Icelandic: 24 var hærra fyrir ANORO ELLIPTA (49%) samanborið við lyfleysu (34%) og hvort virka efnið um sig (44% fyrir umeclidinium og 48% fyrir vílanteról).
English: Step-by-step instructions What is the inhaler?
Icelandic: Leiðbeiningar, skref fyrir skref Upplýsingar um innöndunartækið
English: Not for acute use Umeclidinium/vilanterol is not indicated for the treatment of acute episodes of bronchospasm.
Icelandic: Ekki til notkunar í bráðatilvikum Umeclidinium/vílanteról er ekki ætlað til meðferðar við bráðum berkjukrampa.
English: The Ellipta inhaler consists of a light grey plastic body, a red mouthpiece cover and a dose counter.
Icelandic: Ellipta innöndunartækið samanstendur af ljósgráum meginhluta, rauðu loki yfir munnstykkið og skammtateljara.
English: The absolute bioavailability of inhaled vilanterol was 27%, with negligible contribution from oral absorption.
Icelandic: Heildaraðengi vílanteróls eftir innöndun var 27%, en frásog frá meltingarvegi var hverfandi.
English: ANORO ELLIPTA showed a statistically significant reduction in SGRQ total score compared with tiotropium in one of the three activecomparator studies (see Table 1).
Icelandic: Tölfræðilega marktæk lækkun á SGRQ heildarskori kom fram við notkun ANORO ELLIPTA samanborið við tíótrópíum í einni af rannsóknunum þremur með virkum samanburði (sjá töflu 1).
English: How to store ANORO ELLIPTA
Icelandic: Hvernig geyma á ANORO ELLIPTA
English: The active substances are umeclidinium bromide and vilanterol.
Icelandic: Virku innihaldsefnin eru umeclidiniumbrómíð og vílanteról.
English: ANORO ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Icelandic: ANORO ELLIPTA er notað til meðferðar við langvinnri lungnateppu hjá fullorðnum.
English: ANORO ELLIPTA contains lactose
Icelandic: ANORO ELLIPTA inniheldur laktósa
English: When given subcutaneously there were no effects at 36-times the human clinical exposure of vilanterol 22 micrograms, based on AUC.
Icelandic: Við gjöf undir húð komu engin áhrif fram við útsetningu sem var 36 sinnum meiri en klínísk útsetning við notkun vílanteróls 22 míkróg, miðað við AUC.
English: What ANORO ELLIPTA is and what it is used for What ANORO ELLIPTA is
Icelandic: Upplýsingar um ANORO ELLIPTA og við hverju það er notað Upplýsingar um ANORO ELLIPTA
English: Common Uncommon Uncommon Not known
Icelandic: Algengar Sjaldgæfar Sjaldgæfar Tíðni ekki þekkt
English: ELLIPTA 55/22 mcg
Icelandic: Meðferð með ANORO ELLIPTA 55/22 míkróg
English: In addition, no clinically significant effects on cardiac rhythm were observed on 24-hour Holter monitoring in 53 patients with COPD who were treated with umeclidinium/vilanterol 55/22 micrograms once daily in
Icelandic: Holter sírita hjá 53 sjúklingum með langvinna lungnateppu sem fengu meðferð með umeclidiniumi/vílanteróli 55/22 míkróg einu
English: Consistent with its antimuscarinic activity, umeclidinium/vilanterol should be used with caution in patients with urinary retention or with narrow-angle glaucoma.
Icelandic: Vegna andmúskarínvirkni umeclidiniums/vílanteróls skal gæta varúðar við notkun hjá sjúklingum með þvagteppu eða þrönghornsgláku.
English: What ANORO ELLIPTA looks like and contents of the pack
Icelandic: Lýsing á útliti ANORO ELLIPTA og pakkningastærðir
English: If you become wheezy or breathless, use your quick-acting reliever inhaler (such as salbutamol), then seek medical advice.
Icelandic: Ef blísturshljóð við öndun eða mæði koma fram skalt þú nota innöndunartæki með skjótvirku lyfi (svo sem salbútamóli) og leita ráða hjá lækni.
English: ANORO ELLIPTA 55/22 micrograms improved exercise endurance time compared with placebo, as evaluated with the endurance shuttle walk test (ESWT), in one study but not the second and improved lung volume measures compared with placebo in both studies in adult COPD patients with hyperinflation (functional residual capacity [FRC] >120%).
Icelandic: ESWT (Endurance Shuttle Walk Test) í fyrri rannsókninni en ekki þeirri seinni og jók mælt rúmmál lungna samanborið við lyfleysu í báðum rannsóknum hjá fullorðnum sjúklingum með langvinna lungnateppu og ofurþan (hyperinflation) (slakmál, [FRC] >120%).
English: ANORO ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing.
Icelandic: ANORO ELLIPTA skal ekki nota við skyndilegri mæði eða blísturshljóðum við öndun.
English: SGRQ Total Score
Icelandic: SGRQ heildarskor Notkun bráðalyfs3
English: Summary of the safety profile The most frequently reported adverse reaction with umeclidinium/vilanterol was nasopharyngitis (9%).
Icelandic: Nefkoksbólga (9%) var algengasta aukaverkunin sem greint var frá við notkun umeclidiniums/vílanteróls.
English: If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention.
Icelandic: Ef notaður er stærri skammtur en mælt er fyrir um Ef þú notar af slysni of mikið af lyfinu skalt þú strax leita ráða hjá lækninum eða lyfjafræðingi.
English: Other antimuscarinics and sympathomimetics
Icelandic: Önnur andmúskarín- og adrenhermandi lyf
English: When umeclidinium and vilanterol were administered in combination by the inhaled route, the pharmacokinetics of each component was similar to those observed when each active substance was administered separately.
Icelandic: Þegar umeclidinium og vílanteról voru gefin saman til innöndunar, voru lyfjahvörf hvors þáttar um sig svipuð og komu fram við gjöf hvors virks efnis um sig.
English: Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms vilanterol (as trifenatate).
Icelandic: Hver skammtur gefur 55 míkróg af umeclidinium (sem jafngildir 65 míkróg af umeclidiniumbrómíði) og 22 míkróg af vílanteróli (sem trífenatat).
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street
Icelandic: UK Limited (trading as Glaxo Wellcome operations) Priory Street
English: ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed umeclidinium/vilanterol
Icelandic: ANORO ELLIPTA 55 míkróg/ 22 míkróg innöndunarduft, afmældir skammtar umeclidinium/vilanterol
English: In the first study, ANORO ELLIPTA 55/22 micrograms demonstrated a statistically significant and clinically relevant improvement (based on a minimal clinically important difference (MCID) between 45 to 85 seconds) over placebo in exercise endurance time (EET) obtained 3 hours after dosing at Week 12 (69.4 seconds [p=0.003]).
Icelandic: Í fyrri rannsókninni með ANORO ELLIPTA 55/22 míkróg fékkst tölfræðilega marktæk og af klínískri þýðingu, lenging (miðað við mikilvægan lágmarksmun (MCID á milli 45 til 85 sekúndur) á áreynsluþolstíma (EET (Exercise Endurance Time)) samanborið við lyfleysu 3 klst.
English: Umeclidinium 55 mcg (N = 418)
Icelandic: ANORO ELLIPTA (N = 413) miðað við umeclidinium 55 míkróg (N = 418)
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Harmire Road
Icelandic: UK Limited (trading as Glaxo Wellcome Operations) Harmire Road
English: ANORO ELLIPTA demonstrated a statistically significant and clinically meaningful reduction in breathlessness as evaluated by an increase in TDI focal score at Week 24 (key secondary end-point) compared with placebo (see Table 1).
Icelandic: Áhrif ANORO ELLIPTA 55/22 míkróg gegn mæði reyndust tölfræðilega marktæk og af klínísku mikilvægi miðað við hækkun á TDI mælikvarðanum (focal score) í viku 24 (lykilaukaendapunktur) samanborið við lyfleysu (sjá töflu 1).
English: - if you have an eye problem called narrow-angle glaucoma
Icelandic: - ef þú ert með augnvandamál sem kallast þrönghornsgláka
English: Excipient with known effect Each delivered dose contains approximately 25 mg of lactose (as monohydrate).
Icelandic: Hver gefinn skammtur inniheldur u.þ.b. 25 mg af laktósa (sem einhýdrat).
English: ANORO ELLIPTA is for inhalation use.
Icelandic: ANORO ELLIPTA er til innöndunar.
English: Oropharyngeal pain Dysphonia
Icelandic: Notkun bráðalyfs
English: Eye problems during treatment with ANORO ELLIPTA
Icelandic: Augnvandamál meðan á meðferð með ANORO ELLIPTA stendur
English: Your ANORO ELLIPTA inhaler carton contains
Icelandic: Askjan með ANORO ELLIPTA innöndunartækinu inniheldur
English: Plasma metabolic profiles following oral administration of vilanterol in a human radiolabel study were consistent with high first-pass metabolism.
Icelandic: Umbrotaferlar í plasma eftir gjöf vílanteróls til inntöku í rannsókn með geislamerkingum hjá mönnum samræmdust miklum umbrotum við fyrstu umferð um lifur.
English: - if you suffer from epilepsy
Icelandic: - ef þú ert með flogaveiki
English: There is no relevant use of ANORO ELLIPTA in the paediatric population (under 18 years of age) for the indication of COPD.
Icelandic: Notkun ANORO ELLIPTA við ábendingunni langvinnri lungnateppu á ekki við hjá börnum (yngri en 18 ára).
English: In a 24-week placebo-controlled study in patients with symptomatic COPD, ANORO ELLIPTA reduced the risk of a moderate/severe COPD exacerbation by 50% compared with placebo (based on analysis of time to first exacerbation: Hazard Ratio (HR) 0.5; 95% CI: 0.3, 0.8; p=0.004*); by 20% compared with umeclidinium (HR 0.8; 95% CI: 0.5, 1.3; p=0.391); and by 30% compared with vilanterol (HR 0.7; 95% CI: 0.4, 1.1; p=0.121).
Icelandic: 0,3; 0,8; p=0,004*); um 20% miðað við umeclidinium (HR 0,8; 95% CI: 0,5; 1,3 p=0,391); og um 30% samanborið við vílanteról (HR 0,7; 95% CI: 0,4; 1,1; p=0,121).
English: Hyperglycaemia Beta2-adrenergic agonists may produce transient hyperglycemia in some patients.
Icelandic: Beta2-adrenvirkir örvar geta valdið skammvinnri blóðsykurshækkun hjá sumum sjúklingum.
English: Skin and subcutaneous tissue disorders
Icelandic: Húð og undir húð
English: ANORO ELLIPTA 55/22 micrograms also showed statistically significant improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 in the first study (inspiratory capacity: 237 ml and 316 ml respectively, residual volume: -466 ml and -643 ml respectively and functional residual capacity: -351 ml and -522 ml respectively; all p<0.001).
Icelandic: 237 ml og 316 ml, loftleif (residual volume): -466 ml og -643 ml og FRC: -351 ml og -522 ml, p<0,001 í öllum tilvikum seinni rannsókninni ANORO ELLIPTA
English: In a pre- and post-natal study, subcutaneous administration of umeclidinium to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 80-times the human clinical exposure of umeclidinium 55 micrograms, based on AUC).
Icelandic: Í rannsóknum sem gerðar voru fyrir og eftir fæðingu með gjöf umeclidiniums undir húð hjá rottum, kom fram minni þyngdaraukning og minni neysla fæðu hjá mæðrum og svolítið minni þyngd unga áður en þeir voru vandir af spena hjá kvendýrum sem fengu 180 míkróg/kg/dag (u.þ.b.
English: Therefore, no clinically relevant pro-arrhythmic potential related to QT-interval prolongations was observed with umeclidinium/vilanterol 113/22 micrograms.
Icelandic: QT bils komu fram með umeclidiniumi/vílanteróli 113/22 míkróg.
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 65 micrograms umeclidinium bromide equivalent to 55 micrograms of umeclidinium and 22 micrograms of vilanterol (as trifenatate).
Icelandic: Hver stök innöndun gefur skammt (skammt sem fer í gegnum munnstykkið) sem er 65 míkróg af umeclidiniumbrómíði sem jafngildir 55 míkróg af umeclidiniumi og 22 míkróg af vílanteróli (sem trífenatat).
English: Once daily
Icelandic: eftir notkun skammts í viku
English: Open the cover when ready to inhale a dose.
Icelandic: Opnaðu lokið þegar anda á inn skammti.
English: Therefore, umeclidinium/vilanterol should be used with caution in patients with severe cardiovascular disease.
Icelandic: Því skal gæta varúðar við notkun umeclidiniums/vílanteróls hjá sjúklingum með alvarlega hjarta- og æðasjúkdóma.
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate)
Icelandic: Hver stök innöndun gefur skammt (skammt sem fer í gegnum munnstykkið) sem er 55 míkróg af umeclidiniumi (jafngildir 65 míkróg af umeclidiniumbrómíði) og 22 míkróg af vílanteróli (sem trífenatat).
English: Animal studies indicate no effects of umeclidinium or vilanterol on fertility.
Icelandic: Dýrarannsóknir benda hvorki til að umeclidinium né vílanteról hafi áhrif á frjósemi.
English: In the other two studies, the risk of a moderate/severe COPD exacerbation was increased by 20% and 90% (HR 1.2; 95% CI: 0.5, 2.6; p=0.709 and HR 1.9; 95% CI: 1.0, 3.6; p=0.062 respectively).
Icelandic: 0,5; 2,6; p=0,709) og hins vegar 90% (HR 1,9; 95% CI:
English: Lung function, symptomatic and health related quality of life outcomes at Week 24 Treatment comparisons with ANORO
Icelandic: Tafla 1. Niðurstöður hvað varðar lungnastarfsemi, einkenni og heilsutengd lífsgæði í viku 24 Meðferðarmunur1 (95% öryggisbil, p-gildi)
English: In the second study, ANORO ELLIPTA 55/22 micrograms showed improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 (inspiratory capacity: 198 ml and 238 ml respectively, residual volume: -295 ml and -351 ml respectively and functional residual capacity: -238 ml and -302 ml respectively); all p<0.001∗).
Icelandic: 12 (aðmál: 198 ml og 238 ml, loftleif: -295 ml og -351 ml og FRC: -238 ml og-302 ml, p<0,001∗
English: See section 4.
Icelandic: á 24 klst.
English: Treatment difference1 (95% confidence intervals, p-value) Trough FEV1 (ml)
Icelandic: Lággildi FEV1 (ml)
English: Use of rescue medication
Icelandic: LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR