FrancophonIA/ELRC3.0 huggingface dataset:
English: Irbesartan Zentiva is used in adult patients to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
Icelandic: Irbesartan Zentiva er notað handa fullorðnum sjúklingum ▪ til meðferðar á of háum blóðþrýstingi (háþrýstingi) ▪ til að hlífa nýrum hjá sjúklingum með háþrýsting, sykursýki af gerð 2 og þegar niðurstöður rannsókna gefa vísbendingu um skerta nýrnastarfsemi.
English: vertigo, headache Ear and labyrinth disorder Not known:
Icelandic: Eyru og völundarhús Tíðni ekki þekkt:
English: Irbesartan Zentiva 75 mg film-coated tablets irbesartan
Icelandic: Irbesartan Zentiva 75 mg filmuhúðaðar töflur irbesartan
English: The concomitant use of Irbesartan Zentiva with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73m2) (see sections 4.5 and 5.1).
Icelandic: Ekki má nota Irbesartan Zentiva samhliða lyfjum sem innihalda aliskiren hjá sjúklingum með sykursýki eða skerta nýrnastarfsemi (gaukulsíunarhraði (GFR) <60 ml/mín/1,73 m2) (sjá kafla 4.5 og
English: hypersensitivity reactions such as angioedema, rash, urticaria, anaphylactic reaction, anaphylactic shock
Icelandic: Ofnæmisviðbrögð eins og ofsabjúgur, útbrot, ofsakláði, bráðaofnæmisviðbrögð,
English: leukocytoclastic vasculitis Musculoskeletal and connective tissue disorders Common:
Icelandic: Hvítkornasundrandi æðabólga (leukocytoclastic vasculitis)
English: Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3000
Icelandic: Laktósa einhýdrat Hýprómellósa Títantvíoxíð Makrógól 3000 Karnaubavax.
English: 14 tablets 28 tablets 30 tablets 56 tablets 56 x 1 tablets 84 tablets 90 tablets 98 tablets
Icelandic: 14 töflur 28 töflur 56 töflur 56 x
English: Irbesartan Zentiva at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Icelandic: Með því að gefa 150 mg skammt af Irbesartan Zentiva einu sinni á sólarhring næst betri sólarhringsstjórn á blóðþrýstingi en með 75 mg skammti.
English: Irbesartan Zentiva 300 mg film-coated tablets irbesartan
Icelandic: Irbesartan Zentiva 300 mg filmuhúðaðar töflur irbesartan
English: There is no clinical experience in patients with severe hepatic impairment.
Icelandic: Engin klínísk reynsla er af notkun lyfsins hjá sjúklingum með alvarlega skerta.
English: The efficacy of Irbesartan Zentiva is not influenced by age or gender.
Icelandic: Aldur og kyn hafa ekki áhrif á verkun Irbesartan Zentiva.
English: Warning and precautions Talk to your doctor before taking Irbesartan Zentiva and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Irbesartan Zentiva for diabetic kidney disease.
Icelandic: ▪ ef þú færð mikil uppköst eða niðurgang ▪ ef þú ert með nýrnasjúkdóm ▪ ef þú ert með hjartasjúkdóm ▪ ef þú færð Irbesartan Zentiva við nýrnasjúkdómi af völdum sykursýki.
English: Irbesartan Zentiva 150 mg film-coated tablets irbesartan
Icelandic: Irbesartan Zentiva 150 mg filmuhúðaðar töflur irbesartan
English: Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme).
Icelandic: ▪ Algengar(geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum): svimi, ógleði/uppköst, þreyta og hækkuð blóðgildi ensíms, sem mælir starfsemi vöðva og hjarta (kreatínkínasaensím).
English: In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of Irbesartan Zentiva on the progression of renal disease and all-cause mortality were examined.
Icelandic: ≥ 900 mg/sólarhring og kreatínín í sermi á bilinu 1,0-3,0 mg/dl voru rannsökuð langtímaáhrif (að meðaltali 2,6 ár)
English: Gastrointestinal disorders Common:
Icelandic: Aldósterónheilkenni:
English: Uncommon: diarrhoea, dyspepsia/heartburn Not known:
Icelandic: Niðurgangur, meltingartruflanir/brjóstsviði Tíðni ekki þekkt:
English: Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Icelandic: Rannsókn á áhrifum irbesartans á öralbúmínmigu hjá háþrýstingssjúklingum með sykursýki af gerð 2 (Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus, IRMA 2) sýndi að 300 mg af irbesartani hægja á framrás í verulega próteinmigu hjá sjúklingum með öralbúmínmigu.
English: Irbesartan Zentiva is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Icelandic: Irbesartan Zentiva snemma á meðgöngu og það má alls ekki taka þegar liðnir eru meira en 3 mánuðir af meðgöngunni þar sem notkun lyfsins á þeim tíma getur haft alvarlegar afleiðingar fyrir barnið.
English: Renal impairment and kidney transplantation: when Irbesartan Zentiva is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Icelandic: Mælt er með að mæla kalíum- og kreatíníngildi í sermi reglulega, þegar Irbesartan Zentiva er notað hjá sjúklingum með skerta nýrnastarfsemi.
English: Hypertension and type 2 diabetes with renal disease
Icelandic: Háþrýstingssjúklingar með sykursýki af gerð 2 og nýrnasjúkdóm:
English: Other medicines and Irbesartan Zentiva
Icelandic: Irbesartan Zentiva og pakkningastærðir
English: In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan Zentiva can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1).
Icelandic: Irbesartan Zentiva í 300 mg eða gefa að auki annað blóðþrýstingslækkandi lyf (sjá kafla 4.3, 4.4, 4.5 og 5.1).
English: Therefore, the use of Irbesartan Zentiva is not recommended.
Icelandic: Irbesartan Zentiva ekki ráðlögð.
English: impaired renal function including cases of renal failure in patients at risk (see section 4.4) Reproductive system and breast disorders Uncommon: sexual dysfunction
Icelandic: Skert nýrnastarfsemi, þar með talin tilvik nýrnabilunar hjá sjúklingum í áhættu (sjá kafla 4.4)
English: The demonstration of renal benefit of Irbesartan Zentiva in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1).
Icelandic: Þetta byggist á rannsóknum þar sem irbesartan var notað með öðrum háþrýstingslyfjum eftir þörfum til þess að ná markblóðþrýstingi (sjá kafla 4.3, 4.4, 4.5 og 5.1).
English: arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps Renal and urinary disorders Not known:
Icelandic: Liðverkir, vöðvaverkir (í sumum tilvikum tengt aukningu á plasmaþéttni kreatínkínasa), vöðvakrampar
English: Clinical efficacy:
Icelandic: Blóðkalíumhækkun:
English: EU/1/06/376/038-039
Icelandic: EU/1/06/376/028-033 EU/1/06/376/038-039
English: o aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
Icelandic: Hugsanlegt er að læknirinn rannsaki nýrnastarfsemi, mæli blóðþrýsting og magn blóðsalta (t.d. kalíums) með reglulegu millibili.
English: What Irbesartan Zentiva contains  The active substance is irbesartan.
Icelandic: Virka innihaldsefnið er irbesartan.
English: Irbesartan Zentiva 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Icelandic: Irbesartan Zentiva 300 mg filmuhúðaðar töflur fást með 14, 28, 30, 56, 84, 90 eða 98 filmuhúðuðum töflum í þynnupakkningu.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 75 mg film-coated tablets.
Icelandic: Irbesartan Zentiva 75 mg filmuhúðaðar töflur.
English: EU/1/06/376/034-035
Icelandic: EU/1/06/376/016-021 EU/1/06/376/034-035
English: Irbesartan Zentiva contains lactose.
Icelandic: Irbesartan Zentiva inniheldur laktósa.
English: Irbesartan Zentiva 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Icelandic: Irbesartan Zentiva 75 mg filmuhúðaðar töflur fást með 14, 28, 30, 56, 84, 90 eða 98 filmuhúðuðum töflum í þynnupakkningu.
English: General disorders and administration site conditions Common:
Icelandic: Stoðkerfi og stoðvefur Algengar:
English: Irbesartan Zentiva 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Icelandic: Irbesartan Zentiva 75 mg töflur fást með 14, 28, 56 eða 98 töflum í þynnupakkningu.
English: Irbesartan Zentiva 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Icelandic: Irbesartan Zentiva 150 mg filmuhúðaðar töflur fást með 14, 28, 30, 56, 84, 90 eða 98 filmuhúðuðum töflum í þynnupakkningu.
English: EU/1/06/376/011 - 14 tablets EU/1/06/376/012 - 28 tablets EU/1/06/376/013 - 56 tablets EU/1/06/376/014 - 56 x 1 tablets EU/1/06/376/015 - 98 tablets
Icelandic: EU/1/06/376/011 - 14 töflur EU/1/06/376/012 - 28 töflur EU/1/06/376/013 - 56 töflur EU/1/06/376/014 - 56 x 1 töflur EU/1/06/376/015 - 98 töflur
English: Irbesartan Zentiva 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Icelandic: Irbesartan Zentiva 300 mg töflur fást með 14, 28, 56 eða 98 töflum í þynnupakkningu.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 300 mg tablets.
Icelandic: Irbesartan Zentiva 300 mg töflur.
English: Investigations:
Icelandic: Rannsóknaniðurstöður
English: Irbesartan Zentiva 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Icelandic: Irbesartan Zentiva 150 mg töflur fást með 14, 28, 56 eða 98 töflum í þynnupakkningu.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 75 mg tablets.
Icelandic: Irbesartan Zentiva 75 mg töflur.
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Icelandic: Irbesartan Zentiva 75 mg filmuhúðuð tafla er hvít eða beinhvít, tvíkúpt og sporöskjulaga með inngreyptri mynd af hjarta á annarri hliðinni og númerið 2871 greypt á hinni hliðinni.
English: EU/1/06/376/022 - 14 tablets EU/1/06/376/023 - 28 tablets EU/1/06/376/036 - 30 tablets EU/1/06/376/024 - 56 tablets EU/1/06/376/025 - 56 x 1 tablets EU/1/06/376/026 - 84 tablets EU/1/06/376/037 - 90 tablets EU/1/06/376/027 - 98 tablets
Icelandic: EU/1/06/376/022 - 14 töflur EU/1/06/376/023 - 28 töflur EU/1/06/376/036 - 30 töflur EU/1/06/376/024 - 56 töflur EU/1/06/376/025 - 56 x 1 töflur EU/1/06/376/026 - 84 töflur EU/1/06/376/037 - 90 töflur EU/1/06/376/027 - 98 töflur
English: EU/1/06/376/036-037
Icelandic: EU/1/06/376/022-027 EU/1/06/376/036-037
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Icelandic: Irbesartan Zentiva 75 mg töflur eru hvítar eða beinhvítar, tvíkúptar og sporöskjulaga með ígreyptri mynd af hjarta á annarri hliðinni og númerið 2771 greypt á hinni hliðinni.
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Icelandic: Irbesartan Zentiva 300 mg filmuhúðuð tafla er hvít eða beinhvít, tvíkúpt og sporöskjulaga með inngreyptri mynd af hjarta á annarri hliðinni og númerið 2873 greypt á hinni hliðinni.
English: EU/1/06/376/006 - 14 tablets EU/1/06/376/007 - 28 tablets EU/1/06/376/008 - 56 tablets EU/1/06/376/009 - 56 x 1 tablets EU/1/06/376/010 - 98 tablets
Icelandic: EU/1/06/376/006 - 14 töflur EU/1/06/376/007 - 28 töflur EU/1/06/376/008 - 56 töflur EU/1/06/376/009 - 56 x 1 töflur EU/1/06/376/010 - 98 töflur
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 300 mg film-coated tablets.
Icelandic: Irbesartan Zentiva 300 mg filmuhúðaðar töflur.
English: If you forget to take Irbesartan Zentiva:
Icelandic: Ekki má nota Irbesartan Zentiva:
English: EU/1/06/376/016 - 14 tablets EU/1/06/376/017 - 28 tablets EU/1/06/376/034 - 30 tablets EU/1/06/376/018 - 56 tablets EU/1/06/376/019 - 56 x 1 tablets EU/1/06/376/020 - 84 tablets EU/1/06/376/035 - 90 tablets EU/1/06/376/021 - 98 tablets
Icelandic: EU/1/06/376/016 - 14 töflur EU/1/06/376/017 - 28 töflur EU/1/06/376/034 - 30 töflur EU/1/06/376/018 - 56 töflur EU/1/06/376/019 - 56 x 1 töflur EU/1/06/376/020 - 84 töflur EU/1/06/376/035 - 90 töflur EU/1/06/376/021 - 98 töflur
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Icelandic: Irbesartan Zentiva 300 mg töflur eru hvítar eða beinhvítar, tvíkúptar og sporöskjulaga með ígreyptri mynd af hjarta á annarri hliðinni og númerið 2773 greypt á hinni hliðinni.
English: dysgeusia
Icelandic: Taugakerfi
English: EU/1/06/376/028 - 14 tablets EU/1/06/376/029 - 28 tablets EU/1/06/376/038 - 30 tablets EU/1/06/376/030 - 56 tablets EU/1/06/376/031 - 56 x 1 tablets EU/1/06/376/032 - 84 tablets EU/1/06/376/039 - 90 tablets EU/1/06/376/033 - 98 tablets
Icelandic: EU/1/06/376/028 - 14 töflur EU/1/06/376/029 - 28 töflur EU/1/06/376/038 - 30 töflur EU/1/06/376/030 - 56 töflur EU/1/06/376/031 - 56 x 1 töflur EU/1/06/376/032 - 84 töflur EU/1/06/376/039 - 90 töflur EU/1/06/376/033 - 98 töflur
English: EU/1/06/376/001 - 14 tablets EU/1/06/376/002 - 28 tablets EU/1/06/376/003 - 56 tablets EU/1/06/376/004 - 56 x 1 tablets EU/1/06/376/005 - 98 tablets
Icelandic: EU/1/06/376/001 - 14 töflur EU/1/06/376/002 - 28 töflur EU/1/06/376/003 - 56 töflur EU/1/06/376/004 - 56 x 1 töflur EU/1/06/376/005 - 98 töflur
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 150 mg film-coated tablets.
Icelandic: Irbesartan Zentiva 150 mg filmuhúðaðar töflur.
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Icelandic: Irbesartan Zentiva 150 mg filmuhúðuð tafla er hvít eða beinhvít, tvíkúpt og sporöskjulaga með inngreyptri mynd af hjarta á annarri hliðinni og númerið 2872 greypt á hinni hliðinni.
English: How to store Irbesartan Zentiva
Icelandic: Áður en byrjað er að nota Irbesartan Zentiva
English: In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.
Icelandic: Hækkuð gildi kreatíníns (6,5%) og hækkuð gildi kreatínkínasa (CK)hjá 2% barna sem fengu lyfið.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 150 mg tablets.
Icelandic: Irbesartan Zentiva 150 mg töflur.
English: Wed
Icelandic: Notkun
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Icelandic: Irbesartan Zentiva 150 mg töflur eru hvítar eða beinhvítar, tvíkúptar og sporöskjulaga með ígreyptri mynd af hjarta á annarri hliðinni og númerið 2772 greypt á hinni hliðinni.
English: No dosage adjustment is necessary in older people.
Icelandic: Ekki þarf að breyta skömmtum hjá öldruðum .
English: Blood and lymphatic system disorders Not known:
Icelandic: Húð og undirhúð Tíðni ekki þekkt:
English: Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Icelandic: ▪ Algengar (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum): svimi, ógleði/uppköst, þreyta og hækkuð blóðgildi ensíms, sem mælir starfsemi vöðva og hjarta (kreatínkínasaensím).
English: Sat
Icelandic: Fyrnist
English: Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
Icelandic: ef þú ert með háþrýsting og sykursýki af gerð 2 með nýrnasjúkdómi, geta blóðsýni mælst með of hátt kalíumgildi.
English: PV-Greece@zentiva.com
Icelandic: PV-Norway@zentiva.com
English: contact your doctor as soon as possible.
Icelandic: hafðu samband við lækninn eins fljótt og hægt er.
English: Read this before you start
Icelandic: Lesið þetta áður en byrjað er
English: If your symptoms do not improve
Icelandic: Ef einkenni batna ekki
English: Hold this breath for as long as possible (at least 3-4 seconds).
Icelandic: Haltu niðri í þér andanum eins lengi og þú getur (a.m.k. 3-4 sekúndur).
English: Component of a multipack, can't be sold separately.
Icelandic: Hluti af fjölpakkningu, má ekki selja einan sér.
English: How much to use
Icelandic: Hve mikið skal nota
English: Do not block the air-vents with your fingers.
Icelandic: Ekki teppa loftopin með fingrunum.
English: You do not need to prepare Relvar Ellipta in any special way, not even the first time you use it.
Icelandic: Þú þarft ekki að undirbúa Relvar Ellipta á neinn sérstakan hátt, ekki einu sinni þegar þú notar það í fyrsta sinn.
English: This dose is also used once daily at the same time each day.
Icelandic: Þessi skammtur er einnig notaður einu sinni á dag, á sama tíma dag hvern.
English: if you have ever been told you have diabetes or high blood sugar.
Icelandic: - ef þér hefur einhvern tíma verið sagt að þú sért með sykursýki eða hafir háan blóðsykur.
English: This leaflet was last revised in <{MM/YYYY}>
Icelandic: Þessi fylgiseðill var síðast uppfærður <{MM/ÁÁÁÁ}>
English: Results for the primary and key secondary endpoints in these studies are described in Table 1.
Icelandic: Niðurstöður fyrir aðal- og aðra lykilendapunkta í þessum rannsóknum eru kynntar í töflu 1.
English: Interaction with beta-blockers
Icelandic: Milliverkanir við beta-blokka
English: If a dose is missed the next dose should be taken at the usual time the next day.
Icelandic: Ef gleymist að taka skammt skal taka næsta skammt á venjulegum tíma næsta dag.
English: This helps to open the airways and makes it easier for air to get in and out of the lungs.
Icelandic: Þetta hjálpar til við að opna loftrásir og auðvelda lofti að komast inn og út úr lungunum.
English: Elderly patients (> 65 years old)
Icelandic: Aldraðir sjúklingar (> 65 ára)
English: Elderly patients (>65 years)
Icelandic: Aldraðir sjúklingar (>65 ára)
English: • suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness)
Icelandic: • skyndilegt máttleysi eða aðsvif (sem getur leitt til losts eða meðvitundarleysis)
English: When you take these two active substances together regularly, they will help to control your breathing difficulties more than either medicine alone.
Icelandic: Þegar þú tekur þessi tvö virku efni saman reglulega, hjálpa þau til við að ná stjórn á öndunarvandamálunum meira en annað lyfið eitt og sér.
English: This will help to keep you free of symptoms throughout the day and night.
Icelandic: Þetta stuðlar að því að þú sért einkennalaus allan daginn og nóttina.
English: No risk factors were identified.
Icelandic: Engir áhættuþættir greindust.
English: Six month studies
Icelandic: Sex mánaða rannsóknir
English: Do not use this medicine after the expiry date which is stated on the pack after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á umbúðunum á eftir EXP.
English: In HZA106837 the primary endpoint was the time to first severe asthma exacerbation.
Icelandic: Í HZA106837 var aðalendapunkturinn tími að fyrstu alvarlegu versnun astma.
English: Multipack: 90 (3 packs of 30) doses
Icelandic: 90 skammtar (3 pakkningar með 30)
English: After inhalation, patients should rinse their mouth with water without swallowing.
Icelandic: Eftir innöndun skulu sjúklingar skola munninn með vatni án þess að kyngja.
English: Treatment Dose of FF/VI*(micrograms)
Icelandic: Meðferðarskammtur af FF/VI*(míkróg)
English: if you have heart problems or high blood pressure.
Icelandic: - ef um er að ræða hjartavandamál eða háan blóðþrýsting.
English: Interaction with CYP3A4 inhibitors
Icelandic: Milliverkanir við CYP3A4-hemla
English: Adults aged 18 years and over
Icelandic: Fullorðnir 18 ára og eldri
English: Always use this medicine exactly as your doctor has told you to.
Icelandic: Notið lyfið alltaf eins og læknirinn hefur sagt til um.
English: No dose adjustment is required in this population (see section 5.2).
Icelandic: Ekki þarf að breyta skömmtum hjá þessum hópi (sjá kafla 5.2).
English: Date of latest renewal: 26 July 2018
Icelandic: 26. júlí 2018
English: Just follow these step-by-step instructions.
Icelandic: Aðeins skal fylgja þessum leiðbeiningum, skref-fyrir-skref.
English: See section 4 for information on symptoms to look out for while you are using this medicine.
Icelandic: Sjá upplýsingar í kafla 4 varðandi einkenni sem fylgjast skal með meðan lyfið er notað.
English: **Fractures
Icelandic: **Beinbrot
English: After this date the inhaler should no longer be used.
Icelandic: Eftir það skal lyfið ekki lengur notað.
English: 12 month studies
Icelandic: 12 mánaða rannsóknir
English: It should be administered at the same time of the day, each day.
Icelandic: Það skal gefa á sama tíma dags, dag hvern.
English: In an integrated analysis of 11 studies in asthma (7,034 patients), the incidence of fractures was <1%, and usually associated with trauma.
Icelandic: Í heildargreiningu á 11 rannsóknum á astma (7.034 sjúklingar) var tíðni brota <1% og brotin yfirleitt tengd áverkum.
English: ritonavir or cobicistat, to treat HIV infections.
Icelandic: - rítónavír eða cobicistat gegn HIV-sýkingum.
English: Children aged under 12 years
Icelandic: Börn yngri en 12 ára:
English: Just take your next dose at the usual time.
Icelandic: Taka skal næsta skammt á venjulegum tíma.
English: When the inhaler is used for the first time, there is no need to check that it is working properly, and to prepare it for use in any special way.
Icelandic: Þegar innöndunartækið er notað í fyrsta sinn þarf ekki að athuga hvort það virki rétt eða undirbúa það fyrir notkun á neinn sérstakan hátt.
English: There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.
Icelandic: Nokkrar vísbendingar hafa komið fram um aukna áhættu við stækkandi skammta stera en ekki hefur ótvírætt verið sýnt fram á það í öllum rannsóknum.
English: • swelling, sometimes of the face or mouth (angioedema)
Icelandic: • þrota, stundum í andliti eða munni (ofnæmisbjúg)
English: This is because larger doses of Relvar Ellipta may reduce the amount of steroid hormones produced naturally by your body.
Icelandic: Það er vegna þess að stórir skammtar af Relvar Ellipta geta minnkað magn sterahormóna sem eru framleidd náttúrulega í líkamanum.
English: Administration of fluticasone furoate/vilanterol to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Icelandic: Gjöf flútíkasónfúróats/vílanteróls hjá barnshafandi konum skal aðeins íhuga ef áætlaður ávinningur fyrir móðurina er meiri en hugsanleg áhætta fyrir fóstrið.
English: Pneumonia in patients with asthma
Icelandic: Lungnabólga hjá sjúklingum með astma
English: Check with your doctor before you use this medicine if you think any of these applies to you.
Icelandic: Leitaðu ráða hjá lækninum áður en þú notar lyfið ef þú heldur að eitthvað af þessu eigi við um þig.
English: How to prepare a dose
Icelandic: Hvernig á að undirbúa skammt