FrancophonIA/ELRC3.0 huggingface dataset:
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, azotemia, oliguria, or rarely acute renal failure (see Section 4.5).
Icelandic: Hjá sjúklingum þar sem æðaþan (vascular tone) og nýrnastarfsemi er aðallega háð virkni renín-angíótensín-aldósterón kerfisins (t.d. sjúklingar með alvarlega hjartabilun eða undirliggjandi nýrnasjúkdóm, þar með talin nýrnaslagæðarþrengsli), hefur meðferð með ACE-hemlum eða angíótensín-II blokkum sem hafa áhrif á þetta kerfi verið tengd bráðri blóðþrýstingslækkun, aukningu köfnunarefnis í blóði, þvagþurrð og í örfáum tilvikum bráðri nýrnabilun (sjá kafla 4.5).
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3350, red, yellow and black ferric oxides, pregelatinized starch, carnauba wax.
Icelandic: ▪ Önnur innihaldsefni eru laktósamónóhýdrat, örkristallaður sellulósi, kroskarmellósanatríum, hýprómellósa, sílikontvíoxíð, magnesíumsterat, títantvíoxíð, macrogol 3350, rautt, gult og svart járnoxíð, forgelatíneruð sterkja, karnaubavax.
English: Please see section 2 “Irbesartan Hydrochlorothiazide Zentiva contains lactose”.
Icelandic: 2 „Irbesartan Hydrochlorothiazide Zentiva inniheldur laktósa“.
English: Potassium-sparing diuretics, potassium supplements or potassiumcontaining salts substitutes should be co-administered cautiously with Irbesartan Hydrochlorothiazide Zentiva (see section 4.5).
Icelandic: Gæta skal varúðar við samtímis notkun kalíumsparandi þvagræsilyfja, kalíumuppbótar eða saltuppbótar sem inniheldur kalíum og Irbesartan Hydrochlorothiazide Zentiva (sjá kafla 4.5).
English: Irbesartan Hydrochlorothiazide Zentiva can be taken once daily, with or without food.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva má taka einu sinni á sólarhring, með eða án fæðu.
English: Common side effects ( may affect up to 1 in 10 people): nausea/vomiting abnormal urination fatigue dizziness (including when getting up from a lying or sitting position) blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
Icelandic: Algengar aukaverkanir (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum): ógleði/uppköst óeðlileg þvaglát þreyta svimi (þar með talið þegar risið er upp úr liggjandi eða sitjandi stöðu) blóðrannsóknir geta sýnt aukið magn ensíms (kreatínkínasa), sem er mælikvarði á vöðva- og hjartastarfsemi eða aukið magn efna (blóðnitur og kreatínín í blóði) sem eru mælikvarði á starfsemi nýrna.
English: Because no information is available regarding the use of Irbesartan Hydrochlorothiazide Zentiva during breast-feeding, Irbesartan Hydrochlorothiazide Zentiva is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Icelandic: Þar sem engar upplýsingar liggja fyrir um notkun Irbesartan Hydrochlorothiazide Zentiva meðan á brjóstagjöf stendur er ekki mælt með notkun Irbesartan Hydrochlorothiazide Zentiva hjá konum sem hafa barn á brjósti.
English: In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock) and decrease in te number of platelets (a blood cell essential for the clotting of the blood) have also been reported.
Icelandic: Aukaverkanir sem tengjast irbesartani einu og sér Auk framangreindra aukaverkana hefur einnig verið tilkynnt um verk fyrir brjósti, veruleg ofnæmisviðbrögð (bráðaofnæmislost) og fækkun blóðflagna (blóðfrumur sem eru bráðnauðsynlegar fyrir storknun blóðs).
English: Renal impairment and kidney transplantation: when Irbesartan Hydrochlorothiazide Zentiva is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Icelandic: Þegar Irbesartan Hydrochlorothiazide Zentiva er gefið sjúklingum með skerta nýrnastarfsemi er mælt með reglulegri mælingu á gildum kalíums, kreatíníns og þvagsýru í sermi.
English: If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.
Icelandic: Ef óþol fyrir sykrum (t.d. laktóas) hefur verið staðfest skal hafa samband við lækni áður en lyfið er tekið inn.
English: Due to the hydrochlorothiazide component, Irbesartan Hydrochlorothiazide Zentiva is not recommended for patients with severe renal dysfunction (creatinine clearance <30 ml/min).
Icelandic: Irbesartan Hydrochlorothiazide Zentiva á ekki að nota handa sjúklingum með verulega skerta nýrnastarfsemi (kreatínín úthreinsun < 30 ml/mín.)
English: No dosage adjustment is necessary inolder people.
Icelandic: Ekki þarf að breyta skömmtum hjá öldruðum.
English: Lithium: the combination of lithium and Irbesartan Hydrochlorothiazide Zentiva is not recommended (see section 4.5).
Icelandic: Ekki er mælt með samtímis meðferð með litíum og Irbesartan Hydrochlorothiazide Zentiva (sjá kafla 4.5).
English: No dosage adjustment is necessary in patients with renal impairment whose creatinine clearance is ≥30 ml/min.
Icelandic: Ekki þarf að breyta skömmtum hjá sjúklingum með skerta nýrnastarfsemi ef kreatínín úthreinsun er ≥ 30 ml/mín.
English: Risk Management Plan (RMP)
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Pregelatinised starch Silicon dioxide Magnesium stearate Red and yellow ferric oxides
Icelandic: Forgelatíneruð sterkja Sílikon tvíoxíð Magnesíumsterat Rautt og gult járnoxíð
English: Each film-coated tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla af Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg inniheldur 300 mg af irbesartani og 25 mg af hýdróklórtíazíði.
English: If you take more Irbesartan Hydrochlorothiazide Zentiva than you should If you accidentally take too many tablets, contact your doctor immediately.
Icelandic: Ef þú tekur of margar töflur fyrir slysni skaltu tafarlaust hafa samband við lækninn.
English: Other antihypertensive agents: the antihypertensive effect of Irbesartan Hydrochlorothiazide Zentiva may be increased with the concomitant use of other antihypertensive agents.
Icelandic: Blóðþrýstingslækkandi áhrif Irbesartan Hydrochlorothiazide Zentiva geta aukist við samtímis notkun annarra blóðþrýstingslækkandi lyfja.
English: Irbesartan/hydrochlorothiazide
Icelandic: Irbesartan Hydrochlorothiazide Zentiva
English: No dosage adjustment of Irbesartan Hydrochlorothiazide Zentiva is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Icelandic: Irbesartan Hydrochlorothiazide Zentiva hjá sjúklingum með væga eða miðlungs skerta lifrarstarfsemi (sjá kafla 4.3).
English: Irbesartan Hydrochlorothiazide Zentiva contains lactose.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva hjá öldruðum.
English: Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (>3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Icelandic: II blokkar eru gefnir samtímis bólgueyðandi gigtarlyfjum (t.d. sértækum COX-2 hemlum, asetýlsalisýlsýru (> 3 g/sólarhring) og ósértækum bólgueyðandi gigtarlyfjum) getur dregið úr blóðþrýstingslækkandi áhrifum.
English: What Irbesartan Hydrochlorothiazide Zentiva contains The active substances are irbesartan and hydrochlorothiazide.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva inniheldur ▪ Virku innihaldsefnin eru irbesartan og hýdróklórtíazíð.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmuhúðaðar töflur.
English: Do not take Irbesartan Hydrochlorothiazide Zentiva if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines if you are more than 3 months pregnant.
Icelandic: Ekki má nota Irbesartan Hydrochlorothiazide Zentiva ▪ ef um er að ræða ofnæmi fyrir irbesartani eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6).
English: Immune system disorders:
Icelandic: Frumkomið aldósterónheilkenni:
English: Side effects reported since the launch of Irbesartan Hydrochlorothiazide Zentiva Some undesirable effects have been reported since marketing of Irbesartan Hydrochlorothiazide Zentiva.
Icelandic: Eftir markaðssetningu hefur verið greint frá nokkrum aukaverkunum Irbesartan Hydrochlorothiazide Zentiva.
English: Cardiovascular death and stroke were both numerically more frequent in the aliskiren group that in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.
Icelandic: Dauðsfall vegna hjarta- og æðasjúkdóms og heilablóðfall voru algengari hjá hópnum sem fékk aliskiren en hjá hópnum sem fékk lyfleysu og oftar var tilkynnt um aukaverkanir og þær alvarlegu aukaverkanir sem sérstaklega var fylgst með (blóðkalíumhækkun, lágþrýstingur og vanstarfsemi nýrna) hjá hópnum sem fékk aliskiren en hjá hópnum sem fékk lyfleysu.
English: The recommended dose of Irbesartan Hydrochlorothiazide Zentiva is one tablet a day.
Icelandic: Ráðlagður skammtur af Irbesartan Hydrochlorothiazide Zentiva er ein tafla á sólarhring.
English: Irbesartan Hydrochlorothiazide Zentiva is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva inniheldur blöndu af angíótensín-II blokka, irbesartani, og tíazíð þvagræsilyfi, hýdróklórtíazíði.
English: When measured by ambulatory blood pressure monitoring, the trough to peak effects of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg were 100%.
Icelandic: Þegar mældur var blóðþrýstingur hjá sjúklingum með fótavist eftir gjöf 150 mg/12,5 mg skammts af Irbesartan Hydrochlorothiazide Zentiva var munur á lágmarksáhrifum að hámarksáhrifum 100%.
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg töflur eru í þynnupökkum með 14, 28, 56 eða 98 töflum.
English: postural hypotension
Icelandic: Hýdróklórtíazíð
English: Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate).
Icelandic: Hver tafla inniheldur 38,5 mg af laktósa (sem laktósa einhýdrat).
English: Tables 2 and 3 below detail the adverse reactions reported with the individual components of Irbesartan Hydrochlorothiazide Zentiva.
Icelandic: Í töflu 2 og 3 eru aukaverkanir taldar upp sem greint hefur verið frá vegna einstakra innihaldsefna
English: Irbesartan Hydrochlorothiazide Zentiva with food and drink Irbesartan Hydrochlorothiazide Zentiva can be taken with or without food.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva má taka með eða án matar.
English: Based on its pharmacodynamic properties, Irbesartan Hydrochlorothiazide Zentiva is unlikely to affect the ability to drive and use machines.
Icelandic: Ólíklegt er talið að Irbesartan Hydrochlorothiazide Zentiva hafi áhrif á hæfni til aksturs eða stjórnunar véla.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg töflur eru í þynnupökkum með 14, 28, 56 eða 98 töflum.
English: After either oral or intravenous administration of 14C irbesartan, about 20% of the radioactivity is recovered in the urine,
Icelandic: C-irbesartani eða gjöf í bláæð, kemur um 20% af geislamerktu efni fram í þvagi, en afgangurinn í hægðum.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmuhúðaðar töflur fást í þynnupökkum með 14, 28, 30, 56, 84, 90 eða 98 filmuhúðuðum töflum.
English: • decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan.
Icelandic: Þessar vefjaskemmdir komu ekki fram hjá makakíöpum; ▪ lækkun á kalíum í sermi vegna áhrifa hýdróklórtíazíðs, sem að hluta til var komið í veg fyrir þegar hýdróklórtíazíð var gefið ásamt irbesartani.
English: How to take Irbesartan Hydrochlorothiazide Zentiva
Icelandic: Ef gleymist að taka Irbesartan Hydrochlorothiazide Zentiva:
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmuhúðaðar töflur fást í þynnupökkum með 14, 28, 30, 56, 84, 90 eða 98 filmuhúðuðum töflum.
English: Each tablet of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Icelandic: Hver Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tafla inniheldur 150 mg af irbesartani og 12,5 mg af hýdróklórtíazíði.
English: EU/1/06/377/017 - 14 tablets EU/1/06/377/018 - 28 tablets EU/1/06/377/031 - 30 tablets EU/1/06/377/019 - 56 tablets EU/1/06/377/020 - 56 x 1 tablets EU/1/06/377/021 - 84 tablets EU/1/06/377/032 - 90 tablets EU/1/06/377/022 - 98 tablets
Icelandic: EU/1/06/377/017 - 14 töflur EU/1/06/377/018 - 28 töflur EU/1/06/377/031 - 30 töflur EU/1/06/377/019 - 56 töflur EU/1/06/377/020 - 56 x 1 töflur EU/1/06/377/021 - 84 töflur EU/1/06/377/032 - 90 töflur EU/1/06/377/022 - 98 töflur
English: if you get excessive vomiting or diarrhoea if you suffer from kidney problems or have a kidney transplant if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
Icelandic: ▪ ef þú ert með sykursýki ▪ ef þú ert með rauða úlfa (einnig þekkt sem lúpus eða helluroði) ▪ ef þú ert með frumkomið aldósterónheilkenni (ástand sem tengist of mikilli framleiðslu aldósterónhormóns, sem veldur uppsöfnun natríums og þar af leiðandi hækkun blóðþrýstings)ef ▪ ef þú notar eitthvert af eftirtöldum lyfjum sem notuð eru til að meðhöndla háan blóðþrýsting:
English: EU/1/06/377/011 - 14 tablets EU/1/06/377/012 - 28 tablets EU/1/06/377/029 - 30 tablets EU/1/06/377/013 - 56 tablets EU/1/06/377/014 - 56 x 1 tablets EU/1/06/377/015 - 84 tablets EU/1/06/377/030 - 90 tablets EU/1/06/377/016 - 98 tablets
Icelandic: EU/1/06/377/011 - 14 töflur EU/1/06/377/012 - 28 töflur EU/1/06/377/029 - 30 töflur EU/1/06/377/013 - 56 töflur EU/1/06/377/014 - 56 x 1 töflur EU/1/06/377/015 - 84 töflur EU/1/06/377/030 - 90 töflur EU/1/06/377/016 - 98 töflur
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Icelandic: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmuhúðaðar töflur irbesartan/hýdróklórtíazíð
English: EU/1/06/377/006 - 14 tablets EU/1/06/377/007 - 28 tablets EU/1/06/377/008 - 56 tablets EU/1/06/377/009 - 56 x 1 tablets EU/1/06/377/010 - 98 tablets
Icelandic: EU/1/06/377/006 - 14 töflur EU/1/06/377/007 - 28 töflur EU/1/06/377/008 - 56 töflur EU/1/06/377/009 - 56 x 1 töflur EU/1/06/377/010 - 98 töflur
English: EU/1/06/377/023 - 14 tablets EU/1/06/377/024 - 28 tablets EU/1/06/377/033 - 30 tablets EU/1/06/377/025 - 56 tablets EU/1/06/377/026 - 56 x 1 tablets EU/1/06/377/027 - 84 tablets EU/1/06/377/034 - 90 tablets EU/1/06/377/028 - 98 tablets
Icelandic: EU/1/06/377/023 - 14 töflur EU/1/06/377/024 - 28 töflur EU/1/06/377/033 - 30 töflur EU/1/06/377/025 - 56 töflur EU/1/06/377/026 - 56 x 1 töflur EU/1/06/377/027 - 84 töflur EU/1/06/377/034 - 90 töflur EU/1/06/377/028 - 98 töflur
English: What you need to know before you take Irbesartan Hydrochlorothiazide Zentiva
Icelandic: Áður en byrjað er að nota Irbesartan Hydrochlorothiazide Zentiva
English: EU/1/06/377/001 - 14 tablets EU/1/06/377/002 - 28 tablets EU/1/06/377/003 - 56 tablets EU/1/06/377/004 - 56 x 1 tablets EU/1/06/377/005 - 98 tablets
Icelandic: EU/1/06/377/001 - 14 töflur EU/1/06/377/002 - 28 töflur EU/1/06/377/003 - 56 töflur EU/1/06/377/004 - 56 x 1 töflur EU/1/06/377/005 - 98 töflur
English: The trough to peak effects measured by cuff during office visits were 68% and 76% for Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg and Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg, respectively.
Icelandic: Hlutfall lágmarksáhrifa/hámarksáhrifa (trough to peak) var 68% eftir gjöf Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg þegar blóðþrýstingur var mældur með manséttumæli hjá sjúklingum við komu á læknastofu, en 76% eftir gjöf Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg.
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva og pakkningastærðir Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg töflur eru ferskjulitaðar, kúptar, sporöskjulaga með upphleyptri mynd af hjarta á annarri hliðinni og númerið 2775 greypt í hina hliðina.
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva og pakkningastærðir Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg töflur eru ferskjulitaðar, kúptar, sporöskjulaga með upphleyptri mynd af hjarta á annarri hliðinni og númerið 2776 greypt í hina hliðina.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmuhúðaðar töflur fást í þynnupökkum með 14, 28, 30, 56, 84, 90 eða 98 filmuhúðuðum töflum.
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Icelandic: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg töflur irbesartan/hýdróklórtíazíð
English: Each film-coated tablet of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla af Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg inniheldur 150 mg af irbesartani og 12,5 mg af hýdróklórtíazíði.
English: • Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;
Icelandic: ▪ Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg má gefa sjúklingum ef hýdróklórtíazíð eða 150 mg skammtur af irbesartani einu sér reynist ekki nægjanlegt til að ná stjórn á blóðþrýstingi.
English: Lietuva Zentiva, k.s.
Icelandic: Sverige Zentiva, k.s.
English: Irbesartan/hydrochlorothiazide combination:
Icelandic: Samsetning með irbesartani/hýdróklórótíazíði:
English: Psychiatric disorders:
Icelandic: Hýdróklórtíazíð:
English: There is no clinical experience with Irbesartan Hydrochlorothiazide Zentiva in patients with hepatic impairment.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva hjá sjúklingum með skerta lifrarstarfsemi.
English: Side effects associated with irbesartan alone
Icelandic: örsjaldan verið greint frá svipuðum áhrifum af irbesartani.
English: Each film-coated tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla af Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg inniheldur 300 mg af irbesartani og 12,5 mg af hýdróklórtíazíði.
English: Each tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Icelandic: Hver Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tafla inniheldur 300 mg af irbesartani og 12,5 mg af hýdróklórtíazíði.
English: There is no experience regarding the administration of Irbesartan Hydrochlorothiazide Zentiva in patients with a recent kidney transplantation.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva hjá sjúklingum sem nýverið hafa gengist undir nýrnaígræðslu.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Icelandic: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg töflur irbesartan/hýdróklórtíazíð
English: However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min but <60 ml/min) this fixed dose combination should be administered with caution.
Icelandic: Hins vegar skal gæta varúðar við gjöf þessarar föstu samsetningu virkra efna hjá sjúklingum með væga til miðlungi skerta nýrnastarfsemi (kreatínín úthreinsun ≥ 30 ml/mín. en < 60 ml/mín.).
English: However, in patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min but <60 ml/min) this fixed dose combination should be administered with caution.
Icelandic: Hins vegar skal gæta varúðar við gjöf þessarar föstu samsetningu virkra efna hjá sjúklingum með væga til miðlungs skerta nýrnastarfsemi (kreatínín úthreinsun ≥ 30 ml/mín. en < 60 ml/mín.).
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmuhúðaðar töflur.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) Second and third trimesters of pregnancy (see sections 4.4 and 4.6) Severe renal impairment (creatinine clearance < 30 ml/min) Refractory hypokalaemia, hypercalcaemia
Icelandic: ▪ Ofnæmi fyrir virku efnunum eða einhverju hjálparefnanna sem talin eru upp í kafla 6.1 eða öðrum súlfónamíðafleiðum (hýdróklórtíazíð er súlfónamíðafleiða), ▪
English: • Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended.
Icelandic: ▪ Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg má gefa sjúklingum ef Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg reynist ekki nægjanlegt til að ná stjórn á blóðþrýstingi.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmuhúðaðar töflur.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Icelandic: OG SKILYRÐI MARKAÐSLEYFIS>
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets are pink, biconvex, ovalshaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Icelandic: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmuhúðaðar töflur eru bleik, kúptar, sporöskjulaga með upphleyptri mynd af hjarta á annarri hliðinni og númerið 2788 greypt í hina hliðina.