FrancophonIA/ELRC3.0 huggingface dataset:
English: In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i.e., uncommon) but in excess of placebo.
Icelandic: Hjá 0,5% sykursýkissjúklinga með háþrýsting og öralbúmínmigu og eðlilega nýrnastarfsemi var greint frá réttstöðusundli og réttstöðuþrýstingsfalli (þ.e. sjaldgæft) en fleirum en þeim sem fengu lyfleysu.
English: Additional information on irbesartan interactions: in clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Icelandic: Viðbótarupplýsingar um milliverkanir irbesartans: Í klínískum rannsóknum breyttust lyfjahvörf irbesartans ekki við samtímis gjöf hýdróklórtíazíðs.
English: Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Icelandic: Við skammta yfir 600 mg (tvöfaldan ráðlagðan hámarksskammt) eykst frásog minna en hlutfallslega; skýring á þessu er ekki þekkt.
English: The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg. Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i.e. 24 hours after dosing) by an average of 8-13/5-8 mm Hg (systolic/diastolic) greater than those associated with placebo.
Icelandic: 150-300 mg skammtar gefnir einu sinni á sólarhring lækka blóðþrýsting bæði í útafliggjandi og sitjandi stöðu við lægsta blóðgildi (þ.e. 24 klst. eftir skömmtun) að meðaltali um 8-13/5-8 mm
English: NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 75 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Icelandic: HEITI LYFS Aprovel 75 mg töflur irbesartan VIRK(T) EFNI Hver tafla inniheldur: irbesartan 75 mg HJÁLPAREFNI Hjálparefni:
English: nausea/vomiting
Icelandic: Blóð og eitlar
English: Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice daily dosing on the same total dose.
Icelandic: 150 mg skammtur einu sinni á sólarhring olli svipaðri meðaltals- og lágmarkssvörun á 24 klst. og ef sama heildarmagn var gefið í tveimur skömmtum á sólarhring.
English: Very common: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Icelandic: Blóðkalíumhækkun* kom oftar fram hjá sykursýkissjúklingum sem meðhöndlaðir voru með irbesartani en hjá þeim sem fengu lyfleysu.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets.
Icelandic: HEITI LYFS Aprovel 300 mg töflur.
English: Aliskiren-containing products or ACE-inhibitors: clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Icelandic: Upplýsingar úr klínískri rannsókn hafa sýnt að tvöföld hömlun á renín-angíótensín-aldósterónkerfinu með samsettri meðferð með ACE-hemlum, angíótensín II viðtakablokkum eða aliskireni tengist hærri tíðni aukaverkana eins og blóðþrýstingslækkun, blóðkalíumhækkun og skerðingu á nýrnastarfsemi (þ.m.t. bráðri nýrnabilun) samanborið við notkun á einu lyfi sem hamlar renín-angíótensín-aldósterónkerfinu (sjá kafla 4.3, 4.4 og 5.1).
English: Cartons of 56 x 1 film-coated tablet in PVC/PVDC/Aluminium perforated unit dose blisters.
Icelandic: Öskjur með 56 x 1 filmuhúðaðri töflu í PVC/PVDC/ál rifgötuðum stakskammtaþynnum.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 300 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Icelandic: HEITI LYFS Aprovel 300 mg töflur irbesartan VIRK(T) EFNI Hver tafla inniheldur: irbesartan 300 mg HJÁLPAREFNI Hjálparefni:
English: Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Icelandic: Aukin áhætta alvarlegs lágþrýstings og nýrnabilunar er hjá sjúklingum með tvíhliða nýrnaslagæðaþrengsli eða þrengsli í nýrnaslagæð, þegar einungis annað nýra þeirra er starfhæft og þeir eru á meðferð með lyfjum sem verka á renín-angíótensín-aldósterón kerfið.
English: Fri
Icelandic: Skammtar
English: Excipient with known effect: 102.00 mg of lactose monohydrate per film-coated tablet.
Icelandic: 102,00 mg af laktósa einhýdrati í hverri filmuhúðaðri töflu.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg tablets.
Icelandic: HEITI LYFS Aprovel 150 mg töflur.
English: In patients not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at trough of 7-10/3-6 mm Hg (systolic/diastolic).
Icelandic: Hjá sjúklingum, þar sem ekki tekst að stjórna blóðþrýstingi á viðeigandi hátt með irbesartani eingöngu, verður frekari blóðþrýstingslækkun um 7-10/3-6 mm Hg (slagbils/þanbils) ef litlum skammti af hýdróklórtíazíði (12,5 mg) er bætt við gjöf af irbesartani einu sinni á sólarhring.
English: The demonstration of renal benefit of Aprovel 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: NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg film-coated tablets.
Icelandic: HEITI LYFS Aprovel 300 mg filmuhúðaðar töflur.
English: Common (may affect up to 1 in 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: Thu
Icelandic: Þri
English: Aprovel 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: Ekki er mælt með notkun Aprovel 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: NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg film-coated tablets.
Icelandic: HEITI LYFS Aprovel 150 mg filmuhúðaðar töflur.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Icelandic: HEITI LYFS Aprovel 300 mg töflur irbesartan NAFN MARKAÐSLEYFISHAFA sanofi-aventis groupe FYRNINGARDAGSETNING Fyrnist LOTUNÚMER
English: Excipient with known effect: 61.50 mg of lactose monohydrate per tablet.
Icelandic: 61,50 mg af laktósa einhýdrati í hverri töflu.
English: Renal impairment and kidney transplantation: when Aprovel 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 Aprovel er notað hjá sjúklingum með skerta nýrnastarfsemi.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Icelandic: HEITI LYFS Aprovel 75 mg töflur irbesartan NAFN MARKAÐSLEYFISHAFA sanofi-aventis groupe FYRNINGARDAGSETNING Fyrnist LOTUNÚMER
English: The frequency of the side effects listed below is defined using the following convention: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people
Icelandic: Mjög algengar (geta komið fyrir hjá fleiri en 1 af hverjum 10 einstaklingum):
English: In a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse reactions occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
Icelandic: Höfuðverkur (7,9%), lágþrýstingur (2,2%), sundl (1,9%), hósti (0,9%).
English: Excipient with known effect: 51.00 mg of lactose monohydrate per film-coated tablet.
Icelandic: 51,00 mg af laktósa einhýdrati í hverri filmuhúðaðri töflu.
English: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Poloxamer 188
Icelandic: Pregelatíneruð maíssterkja Póloxamer 188
English: Excipient with known effect: 15.37 mg of lactose monohydrate per tablet.
Icelandic: 15,37 mg af laktósa einhýdrati í hverri töflu.
English: No dosage adjustment is necessary in patients with mild to moderate hepatic impairment.
Icelandic: Ekki er nauðsynlegt að breyta skömmtum hjá sjúklingum með væga eða meðallagi skerta á lifrarstarfsemi.
English: Excipient with known effect: 30.75 mg of lactose monohydrate per tablet.
Icelandic: 30,75 mg af laktósa einhýdrati í hverri töflu.
English: In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Icelandic: Lækkun hemóglóbíns*, sem ekki skipti máli klínískt, kom fram hjá 1,7% sjúklinga með háþrýsting sem voru með langt gengna sykursýki með nýrnasjúkdómi og voru á irbesartan meðferð.
English: Aprovel 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Icelandic: Aprovel 150 mg filmuhúðaðar töflur fást með 14, 28, 30, 56, 84, 90 eða 98 filmuhúðuðum töflum í þynnupakkningu.
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Icelandic: Vitað er að notkun angíótensín-II blokka á öðrum og þriðja þriðjungi meðgöngu hefur skaðleg áhrif á fóstur (skert starfsemi nýrna, legvatnsbrestur, skert beinmyndun höfuðkúpu) og skaðleg áhrif á nýbura (nýrnabilun, lágþrýstingur, blóðkalíumhækkun).
English: Aprovel 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Icelandic: Aprovel 75 mg filmuhúðaðar töflur fást með 14, 28, 30, 56, 84, 90 eða 98 filmuhúðuðum töflum í þynnupakkningu.
English: Aprovel 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Icelandic: Aprovel 300 mg filmuhúðaðar töflur fást með 14, 28, 30, 56, 84, 90 eða 98 filmuhúðuðum töflum í þynnupakkningu.
English: Package leaflet: Information for the user Aprovel 75 mg tablets irbesartan
Icelandic: Upplýsingar fyrir notanda lyfsins Aprovel 75 mg töflur irbesartan
English: General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.
Icelandic: Hjá sjúklingum, þar sem æðaþan (vascular tone) og nýrnastarfsemi eru aðallega háð virkni renín-angíótensín-aldósterónkerfisins (t.d. sjúklingum með alvarlega hjartabilun eða undirliggjandi nýrnasjúkdóm, þar með töldum nýrnaslagæðarþrengslum), hefur meðferð með ACE-hemlum eða angíótensín-II blokkum sem hafa áhrif á þetta kerfi verið tengd bráðum lágþrýstingi, aukningu köfnunarefnis í blóði, þvagþurrð og í örfáum tilvikum bráðri nýrnabilun.
English: 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: Hypertension
Icelandic: Taugakerfi
English: The antihypertensive effects are maintained during long term therapy.
Icelandic: Blóðþrýstingslækkandi verkun helst við langtímameðferð.
English: Package leaflet: Information for the user Aprovel 150 mg tablets irbesartan
Icelandic: Upplýsingar fyrir notanda lyfsins Aprovel 150 mg töflur irbesartan
English: Package leaflet: Information for the user Aprovel 300 mg tablets irbesartan
Icelandic: Upplýsingar fyrir notanda lyfsins Aprovel 300 mg töflur irbesartan
English: Similar effects have been very rarely reported with irbesartan so far.
Icelandic: Örsjaldan hefur verið greint frá svipuðum áhrifum með irbesartani.
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Icelandic: Ósæðar- og míturlokuþrengsli, ofvaxtarhjartavöðvakvilli með teppu (obstructive hypertrophic cardiomyopathy):
English: Biotransformatin
Icelandic: LYFJAFORM
English: Cartons of 56 tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 56 töflum í PVC/PVDC/álþynnu.
English: Aprovel 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Icelandic: Aprovel 75 mg töflur fást með 14, 28, 56 eða 98 töflum í þynnupakkningu.
English: Irbesartan and its metabolites are eliminated by both biliary and renal pathways.
Icelandic: Irbesartan og umbrotsefni þess skiljast út bæði með galli og í gegnum nýru.
English: Cartons of 56 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 56 filmuhúðuðum töflum í PVC/PVDC/álþynnu.
English: General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5).
Icelandic: Hjá sjúklingum, þar sem æðaþan (vascular tone) og nýrnastarfsemi eru aðallega háð virkni renín-angíótensín-aldósterónkerfisins (t.d. sjúklingum með alvarlega hjartabilun eða undirliggjandi nýrnasjúkdóm, þar með töldum nýrnaslagæðarþrengslum), hefur meðferð með ACE-hemlum eða angíótensín-II blokkum sem hafa áhrif á þetta kerfi verið tengd bráðum lágþrýstingi, aukningu köfnunarefnis í blóði, þvagþurrð og í örfáum tilvikum bráðri nýrnabilun (sjá kafla 4.5).
English: Pregnancy
Icelandic: Hósti
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Icelandic: HEITI LYFS Aprovel 150 mg töflur irbesartan NAFN MARKAÐSLEYFISHAFA sanofi-aventis groupe FYRNINGARDAGSETNING Fyrnist LOTUNÚMER
English: Cartons of 30 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 30 filmuhúðuðum töflum í PVC/PVDC/álþynnu.
English: What Aprovel looks like and contents of the pack Aprovel 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: Aprovel 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: Aprovel 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Icelandic: Aprovel 150 mg töflur fást með 14, 28, 56 eða 98 töflum í þynnupakkningu.
English: The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.
Icelandic: Skammtinn má síðan auka í 300 mg (fjórar töflur á dag) einu sinni á sólarhring, háð svörun blóðþrýstingsins.
English: Cartons of 90 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 90 filmuhúðuðum töflum í PVC/PVDC/álþynnu.
English: Aprovel 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Icelandic: Aprovel 300 mg töflur fást með 14, 28, 56 eða 98 töflum í þynnupakkningu.
English: Hepatobiliary disorders Uncommon: jaundice Not known:
Icelandic: Sundl, réttstöðusundl* Tíðni ekki þekkt:
English: Cartons of 28 tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 28 töflum í PVC/PVDC/álþynnu.
English: What Aprovel looks like and contents of the pack Aprovel 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: Aprovel 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: Cartons of 84 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 84 filmuhúðuðum töflum í PVC/PVDC/álþynnu.
English: Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Icelandic: Við samtímis gjöf litíums og ACE-hemla hefur orðið vart hækkunar á litíumgildum í sermi, sem gekk til baka og eiturverkana.
English: The dose may later be increased to 300 mg once daily depending on blood pressure response.
Icelandic: Skammtinn má síðan auka í 300 mg einu sinni á sólarhring, eftir svörun blóðþrýstingsins.
English: EU/1/97/046/016 - 14 tablets EU/1/97/046/017 - 28 tablets EU/1/97/046/034 - 30 tablets EU/1/97/046/018 - 56 tablets EU/1/97/046/019 - 56 x 1 tablets EU/1/97/046/031 - 84 tablets EU/1/97/046/037 - 90 tablets EU/1/97/046/020 - 98 tablets
Icelandic: EU/1/97/046/016 - 14 töflur EU/1/97/046/017 - 28 töflur EU/1/97/046/034 - 30 töflur EU/1/97/046/018 - 56 töflur EU/1/97/046/019 - 56 x 1 töflur EU/1/97/046/031 - 84 töflur EU/1/97/046/037 - 90 töflur EU/1/97/046/020 - 98 töflur
English: Posology
Icelandic: Skiladagur
English: musculoskeletal pain*
Icelandic: Blóðkalíumhækkun
English: Cartons of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 14 filmuhúðuðum töflum í PVC/PVDC/álþynnu.
English: What Aprovel looks like and contents of the pack Aprovel 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: Aprovel 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/1/97/046/021 - 14 tablets EU/1/97/046/022 - 28 tablets EU/1/97/046/035 - 30 tablets EU/1/97/046/023 - 56 tablets EU/1/97/046/024 - 56 x 1 tablets EU/1/97/046/032 - 84 tablets EU/1/97/046/038 - 90 tablets EU/1/97/046/025 - 98 tablets
Icelandic: EU/1/97/046/021 - 14 töflur EU/1/97/046/022 - 28 töflur EU/1/97/046/035 - 30 töflur EU/1/97/046/023 - 56 töflur EU/1/97/046/024 - 56 x 1 töflur EU/1/97/046/032 - 84 töflur EU/1/97/046/038 - 90 töflur EU/1/97/046/025 - 98 töflur
English: Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Icelandic: Sjúklingar með háþrýsting og sykursýki tegund 2 með nýrnasjúkdómi Hjá sjúklingum með háþrýsting og sykursýki af gerð 2 eru 300 mg (fjórar töflur á dag) einu sinni á sólarhring ráðlagður viðhaldsskammtur við meðferð á tengdum nýrnasjúkdómi.
English: Cartons of 28 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 28 filmuhúðuðum töflum í PVC/PVDC/álþynnu.
English: EU/1/97/046/026 - 14 tablets EU/1/97/046/027 - 28 tablets EU/1/97/046/036 - 30 tablets EU/1/97/046/028 - 56 tablets EU/1/97/046/029 - 56 x 1 tablets EU/1/97/046/033 - 84 tablets EU/1/97/046/039 - 90 tablets EU/1/97/046/030 - 98 tablets
Icelandic: EU/1/97/046/026 - 14 töflur EU/1/97/046/027 - 28 töflur EU/1/97/046/036 - 30 töflur EU/1/97/046/028 - 56 töflur EU/1/97/046/029 - 56 x 1 töflur EU/1/97/046/033 - 84 töflur EU/1/97/046/039 - 90 töflur EU/1/97/046/030 - 98 töflur
English: Cartons of 14 tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 14 töflum í PVC/PVDC/álþynnu.
English: What Aprovel looks like and contents of the pack Aprovel 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: Aprovel 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: No dosage adjustment is necessary in patients with impaired renal function.
Icelandic: Ekki er nauðsynlegt að breyta skömmtum hjá sjúklingum með skerta nýrnastarfsemi.
English: What Aprovel looks like and contents of the pack Aprovel 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: Aprovel 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: EU/1/97/046/011 - 14 tablets EU/1/97/046/004 - 28 tablets EU/1/97/046/005 - 56 tablets EU/1/97/046/014 - 56 x 1 tablets EU/1/97/046/006 - 98 tablets
Icelandic: EU/1/97/046/011 - 14 töflur EU/1/97/046/004 - 28 töflur EU/1/97/046/005 - 56 töflur EU/1/97/046/014 - 56 x
English: Cartons of 98 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 98 filmuhúðuðum töflum í PVC/PVDC/álþynnu.
English: Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Icelandic: Sjúklingar með háþrýsting og sykursýki tegund 2 með nýrnasjúkdómi Hjá sjúklingum með háþrýsting og sykursýki af gerð 2 eru 300 mg (tvær töflur á dag) einu sinni á sólarhring ráðlagður viðhaldsskammtur við meðferð á tengdum nýrnasjúkdómi.
English: EU/1/97/046/012 - 14 tablets EU/1/97/046/007 - 28 tablets EU/1/97/046/008 - 56 tablets EU/1/97/046/015 - 56 x 1 tablets EU/1/97/046/009 - 98 tablets
Icelandic: EU/1/97/046/012 - 14 töflur EU/1/97/046/007 - 28 töflur EU/1/97/046/008 - 56 töflur EU/1/97/046/015 - 56 x
English: Tablet core:
Icelandic: Blóðkalíumhækkun:
English: Package leaflet: Information for the user Aprovel 75 mg film-coated tablets irbesartan
Icelandic: Upplýsingar fyrir notanda lyfsins Aprovel 75 mg filmuhúðaðar töflur irbesartan
English: The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response.
Icelandic: Skammtinn má síðan auka í 300 mg (tvær töflur á dag) einu sinni á sólarhring, eftir svörun blóðþrýstingsins.
English: 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: Hvít eða beinhvít, tvíkúpt og sporöskjulaga með inngreyptri mynd af hjarta á annarri hliðinni og númerið 2871 greypt á hinni hliðinni.
English: 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: Hvít eða beinhvít, tvíkúpt og sporöskjulaga með inngreyptri mynd af hjarta á annarri hliðinni og númerið 2873 greypt á hinni hliðinni.