FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/25 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Icelandic: HEITI LYFS CoAprovel 300 mg/25 mg töflur irbesartan/hýdróklórtíazíð NAFN MARKAÐSLEYFISHAFA sanofi-aventis groupe FYRNINGARDAGSETNING FYRNIST LOTUNÚMER
English: NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Icelandic: HEITI LYFS CoAprovel 300 mg/12,5 mg töflur irbesartan/hýdróklórtíazíð NAFN MARKAÐSLEYFISHAFA sanofi-aventis groupe FYRNINGARDAGSETNING FYRNIST LOTUNÚMER
English: In patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Icelandic: Hjá sjúklingum með væga eða meðalvæga skorpulifur breytast lyfjahvarfastuðlar irbesartans óverulega.
English: CoAprovel 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Icelandic: CoAprovel 150 mg/12,5 mg töflur eru í þynnupökkum með 14, 28, 56 eða 98 töflum.
English: Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 12.5 mg
Icelandic: Hver tafla inniheldur: irbesartan 300 mg og hýdróklórtíazíð 12,5 mg
English: Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Icelandic: Lyf við of háum blóðþrýstingi sem verka með því að bæla renínangíótensín kerfið verka að öllu jöfnu ekki á sjúklinga með frumkomið aldósterónheilkenni.
English: CoAprovel 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: CoAprovel 300 mg/25 mg filmuhúðaðar töflur fást í þynnupökkum með 14, 28, 30, 56, 84, 90 eða 98 filmuhúðuðum töflum.
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, hjartavöðvakvilli með útstreymishindrun (obstructive hypertrophic cardiomyopathy):
English: Nervous system disorders:
Icelandic: Frumkomið aldósterónheilkenni:
English: if you are taking any of the following medicines used to treat high blood pressure: an ACE-inhibitor ( for example enalapril, lisinopril, ramipril) in particular if you have diabetes-related kidney problems.
Icelandic: o ACE hemil (til dæmis enalapríl, lisinopríl, ramipríl) sérstaklega ef þú ert með nýrnakvilla sem tengjast sykursýki.
English: Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur 150 mg af irbesartani og 12,5 mg af hýdróklórtíazíði.
English: Do not take CoAprovel 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: ef þú ert með ofnæmi fyrir hýdróklórtíazíði eða fyrir einhverjum öðrum lyfjum sem eru súlfonamíðafleiður ef þú ert gengin með meira en 3 mánuði á meðgöngu.
English: anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria
Icelandic: bráðaofnæmi, drep í húðþekju, æðabólga með drepi (æðabólga, æðabólga í húð), húðviðbrögð sem líkjast rauðum úlfum, endurvakning rauðra úlfa, ljósnæmi, útbrot, ofsakláði
English: Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mm Hg in patients with mild-to-moderate hypertension.
Icelandic: Við gjöf 150 mg af irbesartani og 12,5 mg af hýdróklórtíazíði einu sinni á sólarhring hjá sjúklingum með vægan eða miðlungi mikinn háþrýsting varð lækkun á slagbils-/þanbilsþrýstingi við lágmarksáhrif lyfsins (24 klst. eftir gjöf) sem nam að meðaltali 12,9/6,9 mm
English: Pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Icelandic: Bleik, kúpt, sporöskjulaga með upphleyptri mynd af hjarta á annarri hliðinni og númerið 2788 greypt í hina hliðina.
English: CoAprovel 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Icelandic: CoAprovel 300 mg/12,5 mg töflur eru í þynnupökkum með 14, 28, 56 eða 98 töflum.
English: CoAprovel 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:  CoAprovel 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: dizziness
Icelandic: Skammtar
English: The trough to peak effects measured by cuff during office visits were 68% and 76% for CoAprovel 150 mg/12.5 mg and CoAprovel 300 mg/12.5 mg, respectively.
Icelandic: Hlutfall lágmarksáhrifa/hámarksáhrifa (trough to peak) var 68% eftir gjöf CoAprovel 150 mg/12,5 mg þegar blóðþrýstingur var mældur með manséttumæli hjá sjúklingum við komu á læknastofu, en 76% eftir gjöf CoAprovel 300 mg/12,5 mg.
English: CoAprovel 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: CoAprovel 150 mg/12,5 mg filmuhúðaðar töflur fást í þynnupökkum með 14, 28, 30, 56, 84, 90 eða 98 filmuhúðuðum töflum.
English: NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/12.5 mg film-coated tablets.
Icelandic: HEITI LYFS CoAprovel 300 mg/12,5 mg filmuhúðaðar töflur.
English: EU/1/98/086/008 - 14 tablets EU/1/98/086/004 - 28 tablets EU/1/98/086/005 - 56 tablets EU/1/98/086/010 - 56 x 1 tablets EU/1/98/086/006 - 98 tablets
Icelandic: EU/1/98/086/008 - 14 töflur EU/1/98/086/004 - 28 töflur EU/1/98/086/005 - 56 töflur EU/1/98/086/010 - 56 x 1 töflur EU/1/98/086/006 - 98 töflur
English: tinnitus
Icelandic: Litíum:
English: Cartons of 56 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 56 filmuhúðuðum töflum í PVC/PVDC/álþynnum.
English: Cartons of 56 tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 56 töflum í PVC/PVDC/álþynnum.
English: Each tablet of CoAprovel 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Icelandic: Hver CoAprovel 150 mg/12,5 mg tafla inniheldur 150 mg af irbesartani og 12,5 mg af hýdróklórtíazíði.
English: CoAprovel 150 mg/12.5 mg film-coated tablets.
Icelandic: HEITI LYFS CoAprovel 150 mg/12,5 mg filmuhúðaðar töflur.
English: What CoAprovel looks like and contents of the pack CoAprovel 300 mg/25 mg film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Icelandic: CoAprovel 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.
English: The frequency of the side effects listed below is defined using the following convention: Common: may affect up to 1 in 10 people
Icelandic: Tíðni aukaverkana sem taldar eru upp hér fyrir neðan er skilgreind á eftirfarandi hátt:
English: Thu
Icelandic: Mið
English: Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
Icelandic: Sanofi Bulgaria EOOD Тел.: +359 (0)2 970 53 00
English: 14 tablets 28 tablets 30 tablets 56 tablets 56 x 1 tablets 84 tablets 90 tablets 98 tablets
Icelandic: 84 töflur 90 töflur 98 töflur
English: Calcium salts: thiazide diuretics may increase serum calcium levels due to decreased excretion.
Icelandic: Tíazíð þvagræsilyf geta aukið kalsíumþéttni í sermi vegna minni útskilnaðar.
English: Cartons of 30 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 30 filmuhúðuðum töflum í PVC/PVDC/álþynnum.
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 verið skýrt frá afturkræfri hækkun á litíumþéttni í sermi og eiturverkunum.
English: Efficacy and safety of CoAprovel as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomized, double-blind, active-controlled, 8-week, parallel-arm study.
Icelandic: ≥ 110 mmHg) voru metin í 8 vikna fjölsetra, slembiraðaðri, tvíblindri, samanburðarrannsókn með virku lyfi hjá samhliða hópum.
English: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
Icelandic: truflun á saltajafnvægi (þ.m.t. lækkun á kalíum í blóði og lækkun á natríum í blóði, sjá kafla 4.4), þvagsýrudreyri, sykurmiga, blóðsykurshækkun, hækkun á kólesteróli og þríglýseríðum
English: CoAprovel 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg.
Icelandic: CoAprovel 300 mg/12,5 mg má gefa sjúklingum ef 300 mg af irbesartani eða CoAprovel 150 mg/12,5 mg reynist ekki nægjanlegt til að ná stjórn á blóðþrýstingi.
English: EU/1/98/086/007 - 14 tablets EU/1/98/086/001 - 28 tablets EU/1/98/086/002 - 56 tablets EU/1/98/086/009 - 56 x 1 tablets EU/1/98/086/003 - 98 tablets
Icelandic: EU/1/98/086/007 - 14 töflur EU/1/98/086/001 - 28 töflur EU/1/98/086/002 - 56 töflur EU/1/98/086/009 - 56 x 1 töflur EU/1/98/086/003 - 98 töflur
English: Cartons of 90 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 90 filmuhúðuðum töflum í PVC/PVDC/álþynnum.
English: CoAprovel 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: CoAprovel 300 mg/12,5 mg filmuhúðaðar töflur fást í þynnupökkum með 14, 28, 30, 56, 84, 90 eða 98 filmuhúðuðum töflum.
English: Each film-coated tablet of CoAprovel 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla af CoAprovel 150 mg/12,5 mg inniheldur 150 mg af irbesartani og 12,5 mg af hýdróklórtíazíði.
English: Lactose monohydrate Hypromellose
Icelandic: Laktósa mónóhýdrat Örkristallaður sellulósi Kroskarmellósanatríum
English: pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
Icelandic: brisbólga, lystarleysi, niðurgangur, hægðatregða, magaerting, munnvatnskirtlabólga, minnkuð matarlyst
English: Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine): the effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide;
Icelandic: Vöðvaslakandi lyf sem ekki eru afskautandi (t.d. túbókúrarín): verkun vöðvaslakandi lyfja sem ekki eru afskautandi getur aukist við samtímis notkun hýdróklórtíazíðs;
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate
Icelandic: Hýprómellósi Sílikon tvíoxíð Magnesíumsterat
English: NAME OF THE MEDICINAL PRODUCT CoAprovel 150 mg/12.5 mg tablets.
Icelandic: HEITI LYFS CoAprovel 150 mg/12,5 mg töflur.
English: Each film-coated tablet of CoAprovel 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla af CoAprovel 300 mg/12,5 mg inniheldur 300 mg af irbesartani og 12,5 mg af hýdróklórtíazíði.
English: Each tablet of CoAprovel 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Icelandic: Hver CoAprovel 300 mg/12,5 mg tafla inniheldur 300 mg af irbesartani og 12,5 mg af hýdróklórtíazíði.
English: Cartons of 84 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 84 filmuhúðuðum töflum í PVC/PVDC/álþynnum.
English: Irbesartan is not removed by haemodialysis.
Icelandic: Irbesartan skilst ekki út með blóðskilun.
English: Talk to your doctor before taking CoAprovel and if any of the following apply to you: 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 o 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 mikil uppköst eða niðurgang ef þú ert með nýrnasjúkdóm eða ert með ígrætt nýra ef þú ert með hjartasjúkdóm ef þú ert með lifrarsjúkdóm 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 þú notar eitthvert af eftirtöldum lyfjum sem notuð eru til að meðhöndla háan blóðþrýsting:
English: CoAprovel 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Icelandic: CoAprovel 300 mg/12,5 mg töflur irbesartan/hýdróklórtíazíð
English: Cartons of 28 tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 28 töflum í PVC/PVDC/álþynnum.
English: Conditions to the MA
Icelandic: Upplýsingar fyrir notandalyfsins
English: EU/1/98/086/023 - 14 tablets EU/1/98/086/024 - 28 tablets EU/1/98/086/031 - 30 tablets EU/1/98/086/025 - 56 tablets EU/1/98/086/028 - 56 x 1 tablets EU/1/98/086/026 - 84 tablets EU/1/98/086/034 - 90 tablets EU/1/98/086/027 - 98 tablets
Icelandic: EU/1/98/086/023 - 14 töflur EU/1/98/086/024 - 28 töflur EU/1/98/086/031 - 30 töflur EU/1/98/086/025 - 56 töflur EU/1/98/086/028 - 56 x 1 töflur EU/1/98/086/026 - 84 töflur EU/1/98/086/034 - 90 töflur EU/1/98/086/027 - 98 töflur
English: Cartons of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 14 filmuhúðuðum töflum í PVC/PVDC/álþynnum.
English: CoAprovel 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Icelandic: CoAprovel 150 mg/12,5 mg töflur irbesartan/hýdróklórtíazíð
English: EU/1/98/086/011 - 14 tablets EU/1/98/086/012 - 28 tablets EU/1/98/086/029 - 30 tablets EU/1/98/086/013 - 56 tablets EU/1/98/086/014 - 56 x 1 tablets EU/1/98/086/021 - 84 tablets EU/1/98/086/032 - 90 tablets EU/1/98/086/015 - 98 tablets
Icelandic: EU/1/98/086/011 - 14 töflur EU/1/98/086/012 - 28 töflur EU/1/98/086/029 - 30 töflur EU/1/98/086/013 - 56 töflur EU/1/98/086/014 - 56 x 1 töflur EU/1/98/086/021 - 84 töflur EU/1/98/086/032 - 90 töflur EU/1/98/086/015 - 98 töflur
English: Cartons of 28 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 28 filmuhúðuðum töflum í PVC/PVDC/álþynnum.
English: Corticosteroids, ACTH: electrolyte depletion, particularly hypokalaemia, may be increased; Digitalis glycosides: thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Icelandic: Kalíumskortur í blóði vegna tíazíðs eða magnesíumskortur geta komið af stað hjartsláttaróreglu af völdum dígitalisnotkunar (sjá kafla 4.4);
English: EU/1/98/086/016 - 14 tablets EU/1/98/086/017 - 28 tablets EU/1/98/086/030 - 30 tablets EU/1/98/086/018 - 56 tablets EU/1/98/086/019 - 56 x 1 tablets EU/1/98/086/022 - 84 tablets EU/1/98/086/033 - 90 tablets EU/1/98/086/020 - 98 tablets
Icelandic: EU/1/98/086/016 - 14 töflur EU/1/98/086/017 - 28 töflur EU/1/98/086/030 - 30 töflur EU/1/98/086/018 - 56 töflur EU/1/98/086/019 - 56 x 1 töflur EU/1/98/086/022 - 84 töflur EU/1/98/086/033 - 90 töflur EU/1/98/086/020 - 98 töflur
English: What CoAprovel looks like and contents of the pack CoAprovel 300 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Icelandic: CoAprovel 300 mg/12,5 mg filmuhúðaðar töflur eru ferskjulituð, kúptar, sporöskjulaga með upphleyptri mynd af hjarta á annarri hliðinni og númerið 2876 greypt í hina hliðina.
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 CoAprovel 300 mg/12.5 mg tablets.
Icelandic: HEITI LYFS CoAprovel 300 mg/12,5 mg töflur.
English: Cartons of 14 tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 14 töflum í PVC/PVDC/álþynnum.
English: CoAprovel 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Icelandic: CoAprovel 300 mg/12,5 mg filmuhúðaðar töflur irbesartan/hýdróklórtíazíð
English: CoAprovel 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Icelandic: CoAprovel 150 mg/12,5 mg filmuhúðaðar töflur irbesartan/hýdróklórtíazíð
English: What CoAprovel looks like and contents of the pack CoAprovel 150 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Icelandic: CoAprovel 150 mg/12,5 mg filmuhúðaðar töflur eru ferskjulituð, kúptar, sporöskjulaga með upphleyptri mynd af hjarta á annarri hliðinni og númerið 2875 greypt í hina hliðina.
English: Cartons of 98 film-coated tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 98 filmuhúðuðum töflum í PVC/PVDC/álþynnum.
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Icelandic: Ferskjulituð, kúpt, sporöskjulaga með upphleyptri mynd af hjarta á annarri hliðinni og númerið 2876 greypt í hina hliðina.
English: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Red and yellow ferric oxides (E172)
Icelandic: Forgelatíneruð maíssterkja Rautt og gult járnoxíð (E172)
English: What CoAprovel looks like and contents of the pack CoAprovel 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: CoAprovel 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: Anti-doping test: hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test.
Icelandic: Vegna hýdróklórtíazíð innihalds lyfsins geta niðurstöður úr lyfjaprófum orðið ranglega jákvæðar.
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Icelandic: Ferskjulituð, kúpt, sporöskjulaga með upphleyptri mynd af hjarta á annarri hliðinni og númerið 2776 greypt í hina hliðina.
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Icelandic: Ferskjulituð, kúpt, sporöskjulaga með upphleyptri mynd af hjarta á annarri hliðinni og númerið 2875 greypt í hina hliðina.
English: non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)
Icelandic: húðkrabbamein sem ekki er sortuæxli (grunnfrumukrabbamein og flöguþekjukrabbamein)
English: What CoAprovel looks like and contents of the pack CoAprovel 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: CoAprovel 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: Dual blockade of the renin-angiotensin-aldosterone system (RAAS): there is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Icelandic: Vísbendingar eru um að samhliðanotkun ACE hemla, angíótensín II viðtakablokka eða aliskirens auki hættu á blóðþrýstingslækkun, blóðkalíumhækkun og skerðingu á nýrnastarfsemi (þ.m.t. bráðri nýrnabilun).
English: swelling extremity
Icelandic: Ambarès & Lagrave
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 síðasta þriðjungi meðgöngu hefur skaðleg áhrif á fóstur (skert starfsemi nýrna, legvatnsbrestur, skert beinmyndun höfuðkúpu) og skaðleg áhrif á nýbura (nýrnabilun, lágþrýstingur, blóðkalíumhækkun) (sjá kafla 5.3).
English: Additional information on hydrochlorothiazide interactions: when administered concurrently, the following medicinal products may interact with thiazide diuretics:
Icelandic: Önnur rannsókn sýndi hugsanleg tengsl milli varakrabbameins (flöguþekjukrabbameins) og útsetningar fyrir hýdróklórtíazíði:
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Icelandic: Ferskjulituð, kúpt, sporöskjulaga með upphleyptri mynd af hjarta á annarri hliðinni og númerið 2775 greypt í hina hliðina.
English: Table 3: Adverse reactions reported with the use of hydrochlorothiazide alone
Icelandic: Aukaverkanir sem greint hefur verið frá við notkun hýdróklórótíazíðs eins sér
English: If possible, another class of diuretics should be used;
Icelandic: Ef þess er kostur á að nota þvagræsilyf úr öðrum lyfjaflokki.
English: Cartons of 98 tablets in PVC/PVDC/Aluminium blisters.
Icelandic: Öskjur með 98 töflum í PVC/PVDC/álþynnum.
English: Other antihypertensive agents: the antihypertensive effect of CoAprovel may be increased with the concomitant use of other antihypertensive agents.
Icelandic: Blóðþrýstingslækkandi áhrif CoAprovel geta aukist við samtímis notkun annarra blóðþrýstingslækkandi lyfja.
English: Vascular disorders:
Icelandic: Elektrólýtaröskun:
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Icelandic: Sjúklingar sem ráðgera að verða barnshafandi skulu skipta yfir í aðra blóðþrýstingslækkandi meðferð þar sem sýnt hefur verið fram á öryggi á meðgöngu, nema nauðsynlegt sé talið að halda áfram meðferð með angíótensín-II blokkum.
English: CoAprovel 300 mg/25 mg may be administered in patients insufficiently controlled by CoAprovel 300 mg/12.5 mg.
Icelandic: CoAprovel 300 mg/25 mg má gefa sjúklingum ef CoAprovel 300 mg/12,5 mg reynist ekki nægjanlegt til að ná stjórn á blóðþrýstingi.
English: No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).
Icelandic: Ekki má nota CoAprovel samhliða lyfjum sem innihalda aliskiren hjá sjúklingum með sykursýki eða skerta nýrnastarfsemi (gaukulsíunarhraði (GFR) <60 ml/mín/1,73 m2) (sjá kafla 4.4 og 5.1).
English: Pregnancy
Icelandic: hósti
English: interstitial nephritis, renal dysfunction
Icelandic: millivefsbólga í nýrum, vanstarfsemi nýrna
English: Valsartan
Icelandic: réttstöðusundl
English: arthralgia, myalgia
Icelandic: Lifur og gall:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur 300 mg af irbesartani og 25 mg af hýdróklórtíazíði.
English: Excipients: also contains lactose monohydrate.
Icelandic: Inniheldur einnig laktósamónóhýdrat.
English: Tue
Icelandic: LESIÐ
English: headache
Icelandic: sótthiti
English: Losartan
Icelandic: 13. LOTUNÚMER
English: Electrolyte imbalance: as for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Icelandic: Þegar sjúklingar nota þvagræsilyf á að mæla elektrólýta í sermi með reglulegu millibili.