FrancophonIA/ELRC3.0 huggingface dataset:
English: Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis),and severe allergic reactions (anaphylactic shock).
Icelandic: Aukaverkanir þar sem tíðni er ekki þekkt eru: svimi, höfuðverkur, bragðtruflanir, suð fyrir eyrum, vöðvakrampar, verkur í liðum og vöðvum, fækkun blóðflagna, truflanir á lifrarstarfsemi, hækkuð kalíumgildi í blóði, skert nýrnastarfsemi, bólga í litlum æðum sem hefur aðallega áhrif á húð (sjúkdómur þekktur sem hvítkornasundrandi æðabólga) og veruleg ofnæmisviðbrögð (bráðaofnæmislost).
English: Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease.
Icelandic: Áhrif irbesartans, bæði á sjúklinga með nýrna- og hjarta- og æðasjúkdóma, voru ekki þau sömu hjá öllum undirhópum við greiningu sem gerð var í rannsókninni á sjúklingum með langt genginn nýrnasjúkdóm.
English: Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity.
Icelandic: Engin skaðleg áhrif komu fram hjá fullorðnum sem fengu skammta allt að 900 mg/sólarhring í 8 vikur.
English: Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows: 3.8 mmHg (low dose), 3.2 mmHg (medium dose), 5.6 mmHg (high dose).
Icelandic: 3,8 mmHg (lítill skammtur), 3,2 mmHg (meðalstór skammtur) og 5,6 mmHg (stór skammtur).
English: In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.
Icelandic: Hjá sjúklingum með háþrýsting og sykursýki af gerð 2 ásamt nýrnasjúkdómi var svimi þegar staðið er upp frá útafliggjandi eða sitjandi stöðu, lágþrýstingur þegar staðið er upp frá útafliggjandi eða sitjandi stöðu, verkir í liðum eða vöðvum og lækkuð gildi próteins í rauðum blóðkornum einnig gefið upp.
English: Each tablet contains: irbesartan 150 mg
Icelandic: Hver tafla inniheldur: irbesartan 150 mg
English: Hepatic impairment
Icelandic: bráðaofnæmislost
English: Each tablet contains: irbesartan 300 mg
Icelandic: Hver tafla inniheldur: irbesartan 300 mg
English: In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
Icelandic: Hjá sykursýkissjúklingum með langvinna nýrnabilun og verulega próteinmigu kom blóðkalíumhækkun (≥ 5,5 mEq/L) fram hjá 46,3% sjúklinga í irbesartanhópnum og 26,3% sjúklinga í lyfleysuhópnum.
English: Each tablet of Aprovel 150 mg contains 150 mg irbesartan.
Icelandic: Hver tafla af Aprovel 150 mg inniheldur 150 mg af irbesartani.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing Aprovel, amlodipine and placebo.
Icelandic: IDNT rannsóknin var tvíblind, lyfleysustýrð rannsókn á sjúkdómsástandi og dánartíðni þar sem borin voru saman Aprovel, amlódípín og lyfleysa.
English: Cardiac disorders:
Icelandic: Aldósterónheilkenni:
English: Patients with high blood pressure
Icelandic: Sjúklingar með háþrýsting
English: In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
Icelandic: Hjá sykursýkissjúklingum með háþrýsting sem höfðu öralbúmínmigu og eðlilega nýrnastarfsemi kom blóðkalíumhækkun (≥ 5,5 mEq/L) fram hjá 29,4% sjúklinga sem fengu 300 mg af irbesartani og 22% sjúklinga í lyfleysuhópnum.
English: Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Icelandic: Dýrarannsóknir með irbesartani sýndu skammvinn eituráhrif (aukin holmyndun í nýrnaskjóðum, þvagpípuþan eða húðbeðsbjúgur) hjá rottufóstrum en áhrif voru ekki merkjanleg eftir fæðingu.
English: Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.
Icelandic: Jafnvægi (steady-state) á plasmaþéttni næst innan 3 sólarhringa eftir að meðferð með einum skammti á sólarhring hefst.
English: There is no experience regarding the administration of Aprovel in patients with a recent kidney transplantation.
Icelandic: Engin reynsla er af notkun Aprovel hjá sjúklingum sem nýlega hafa gengist undir nýrnaígræðslu.
English: Aprovel 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 Aprovel einu sinni á sólarhring næst betri sólarhringsstjórn á blóðþrýstingi en með 75 mg skammti.
English: The efficacy of Aprovel is not influenced by age or gender.
Icelandic: Aldur og kyn hafa ekki áhrif á verkun Aprovel.
English: The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
Icelandic: Tíðni aukaverkana var óháð skömmtum (á ráðlögðu skammtabili), kyni, aldri, kynstofni eða meðferðarlengd.
English: Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Aprovel, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Icelandic: Eins og önnur lyf sem hafa áhrif á renín-angíótensín-aldósterónkerfið getur blóðkalíumhækkun komið fram við notkun Aprovel, sérstaklega ef skert nýrnastarfsemi, veruleg próteinmiga vegna nýrnasjúkdóms af völdum sykursýki og/eða hjartabilun er til staðar.
English: Aprovel 75 mg film-coated tablets irbesartan
Icelandic: Aprovel 75 mg filmuhúðaðar töflur irbesartan
English: Hypertension and type 2 diabetes with renal disease
Icelandic: Háþrýstingur og sykursýki af gerð 2 með nýrnasjúkdómi
English: Excipients: also contains lactose monohydrate.
Icelandic: Inniheldur einnig laktósa einhýdrat.
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Icelandic: Engin faraldsfræðileg gögn eru til um áhættu við notkun angíótensín II blokka en búast má við að hún sé svipuð fyrir þennan lyfjaflokk.
English: If a child swallows some tablets, contact your doctor immediately.
Icelandic: Hafðu samstundis samband við lækni ef barn gleypir töflur.
English: Peak plasma concentrations are attained at 1.5 - 2 hours after oral administration.
Icelandic: Hámarksþéttni í plasma næst 1,5-2 klst. eftir inntöku.
English: When irbesartan is administered concomitantly with a low dose of hydrochlorothiazide (e.g. 12.5 mg daily), the antihypertensive response in black patients approaches that of white patients.
Icelandic: Þegar irbesartan er gefið samtímis litlum skammti hýdróklórtíazíðs (t.d. 12,5 mg á sólarhring), nálgast blóðþrýstingslækkandi svörun sjúklinga af svörtum kynstofni þeirra sem eru hvítir.
English: The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
Icelandic: Blóðþrýstingslækkandi áhrif irbesartans og þvagræsilyfja af tíazíð gerð eru samleggjandi.
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 lifrarstarfsemi.
English: Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).
Icelandic: Hjá sjúklingum sem fengu lyfleysu jókst slagbilsþrýstingur í sitjandi stöðu um 2,4 mmHg og þanþrýstingur um 2,0 mmHg samanborið við +0,1 mmHg og -0,3 mmHg hjá þeim sem fengu irbesartan í öllum skömmtum (sjá kafla 4.2).
English: Because no information is available regarding the use of Aprovel during breast-feeding, Aprovel 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 Aprovel meðan á brjóstagjöf stendur er ekki mælt með notkun Aprovel hjá konum sem hafa barn á brjósti.
English: Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
Icelandic: Angíótensín-II er efni sem framleitt er í líkamanum, það binst viðtökum í æðum og veldur þrengingu þeirra.
English: Do not take Aprovel  if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)  if you are more than 3 months pregnant.
Icelandic:  ef um er að ræða ofnæmi fyrir irbesartani eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6) eftir þriðja mánuð meðgöngu.
English: At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
Icelandic: Við mjög stóra skammta (≥ 500 mg/kg/sólarhring) hafði irbesartan hvetjandi áhrif á hrörnun í nýrum (svo sem nýrna- og skjóðubólgu, þan í píplum, lútsækni í píplum (basophilic tubules), aukið magn þvagefnis og kreatíníns í plasma) í rottum og makakíöpum sem, auk blóðþrýstingslækkandi áhrifa lyfsins, leiddi til minna gegnflæðis um nýrun.
English: Aprovel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Icelandic: Ekki er mælt með notkun Aprovel snemma á meðgöngu og það má ekki taka þegar liðnir eru meira en 3 mánuðir af meðgöngunni þar sem notkun lyfsins á þeim tíma getur haft alvarlegar afleiðingar fyrir barnið (sjá kaflann um meðgöngu).
English: Based on its pharmacodynamic properties, irbesartan is unlikely to affect the ability to drive and use machines.
Icelandic: Miðað við lyfhrif irbesartans er talið ólíklegt að það hafi áhrif á hæfni til akstur og notkunar véla.
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Aprovel 300 mg group (34%) than in the placebo group (21%).
Icelandic: Algengara var að albúmín í þvagi kæmist aftur í eðlilegt horf (< 30 mg/sólarhring) hjá hópnum sem fékk 300 mg af Aprovel (34%) en þeim sem fengu lyfleysu
English: In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease.
Icelandic: Við háþrýsting hjá sjúklingum með sykursýki af gerð 2 á að hefja meðferð með 150 mg af irbesartani einu sinni á sólarhring og hækka hana upp í 300 mg einu sinni á sólarhring sem æskilegan viðhaldsskammt við meðferð á nýrnasjúkdómi.
English: As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Icelandic: Eins og gildir um ACE-hemla getur samhliða notkun angíótensín-II blokka og bólgueyðandi gigtarlyfja leitt til aukinnar hættu á skerðingu nýrnastarfsemi, þ.á m. mögulegrar bráðrar nýrnabilunar, og aukningar á kalíum í sermi, sérstaklega hjá sjúklingum sem hafa lélega nýrnastarfsemi fyrir.
English: vertigo, headache Ear and labyrinth disorder Not known:
Icelandic: Niðurgangur, meltingartruflanir/brjóstsviði Tíðni ekki þekkt:
English: Aprovel 300 mg film-coated tablets irbesartan
Icelandic: Aprovel 300 mg filmuhúðaðar töflur irbesartan
English: Aprovel 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: Aprovel 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: The study examined the long-term effects (2 years) of Aprovel on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
Icelandic: Í rannsókninni voru athuguð langtímaáhrif (2 ár) Aprovel á framrás í klíníska (verulega) próteinmigu (útskilnaðarhraði albúmíns í þvagi > 300 mg/sólarhring og aukning um a.m.k.
English: The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
Icelandic: Lyfjahvörf dígoxíns breyttust ekki við samtímis gjöf irbesartans.
English: In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%).
Icelandic: Í samanburðarrannsókn með lyfleysu hjá sjúklingum með of háan blóðþrýsting var heildartíðni aukaverkana sambærileg hjá þeim sem fengu irbesartan (56,2%) og hjá þeim sem fengu lyfleysu (56,5%).
English: Aprovel 150 mg film-coated tablets irbesartan
Icelandic: Aprovel 150 mg filmuhúðaðar töflur irbesartan
English: Patients in all treatment groups typically received between 2 and 4 antihypertensive agents (e.g., diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg.
Icelandic: Dæmigert fyrir sjúklinga í öllum meðferðarhópum var að þeir fengu á bilinu 2 til 4 gerðir háþrýstingslyfja (t.d. þvagræsilyf, beta-blokka, alfa-blokka) til þess að ná fyrirfram skilgreindu blóðþrýstingsmarkmiði sem nam ≤ 135/85 mm
English: Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
Icelandic: Stjörnumerktar aukaverkanir (*) vísa til aukaverkana, sem komu að auki fram, hjá >2% sykursýkisjúklinga með langvinna nýrnabilun og verulega próteinmigu og oftar en hjá þeim sem fengu lyfleysu.
English: Reduction of blood pressure with 0.5 mg/kg (low), 1.5 mg/kg (medium) and 4.5 mg/kg (high) target titrated doses of irbesartan was evaluated in 318 hypertensive or at risk (diabetic, family history of hypertension) children and adolescents aged 6 to 16 years over a three week period.
Icelandic: Blóðþrýstingslækkun var metin hjá 318 börnum og unglingum á aldrinum 6-16 ára með háþrýsting eða áhættuþætti (sykursýki, fjölskyldusögu um háþrýsting) sem fengu 0,5 mg/kg (lítinn), 1,5 mg/kg (meðalstóran) eða 4,5 mg/kg (stóran) títraðan markskammt af irbesartani í 3 vikur.
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 Aprovel 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) Aprovel á framrás nýrnasjúkdóms og dánartíðni af hvaða ástæðu sem er.
English: Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Icelandic: Í tveimur stórum slembiröðuðum samanburðarrannsóknum, ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) og VA NEPHRON-D
English: The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/kg) up to a maximum daily dose of 150 mg for four weeks.
Icelandic: Lyfjahvörf irbesartans voru metin hjá 23 börnum með háþrýsting eftir gjöf staks skammts eða eftir fleiri sólarhringsskammta irbesartans (2 mg/kg) allt að 150 mg á sólarhring að hámarki í fjórar vikur.
English: For therapeutic doses of irbesartan in humans, the hyperplasia/ hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Icelandic: Við meðferðarskammta af irbesartani fyrir menn virðist stækkun frumna nærliggjandi gaukulfrumum ekki hafa neina þýðingu.
English: Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Aprovel has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Icelandic: Önnur blóðþrýstingslækkandi lyf geta aukið blóðþrýstingslækkandi áhrif irbesartans; þó hefur samtímis gjöf Aprovel og annarra blóðþrýstingslækkandi lyfja eins og beta-blokka, langverkandi kalsíumgangaloka og tíazíð þvagræsilyfja reynst örugg.
English: After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Icelandic: Rannsóknir á heildaraðgengi gáfu gildi um 60-80%.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
Icelandic: Laktósa einhýdrat Örkristallaður sellulósi Kroskarmellósnatríum Hýprómellósa Kísiltvíoxíð Magnesíumsterat.
English: Drug substance*
Icelandic: Stoðkerfisverkir*
English: The most likely manifestations of overdose are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
Icelandic: Líklegustu einkenni ofskömmtunar eru talin vera lágþrýstingur og hraðtaktur; hægur hjartsláttur getur einnig komið fram vegna ofskömmtunar.
English: Aprovel is for oral use.
Icelandic: Aprovel er til inntöku.
English: However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.
Icelandic: Þó skal hafa í huga að gefa má sjúklingum sem eru í blóðskilun og þeim sem eru eldri en 75 ára 75 mg upphafsskammt.
English: The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Icelandic: Rannsókn á irbesartani hjá sykursýkissjúklingum með nýrnakvilla (Irbesartan Diabetic Nephropathy Trial, IDNT) sýndi fram á að irbesartan hægir á framrás nýrnasjúkdóms hjá sjúklingum með langvarandi skerta nýrnastarfsemi og mikla próteinmigu.
English: Potassium supplements and potassium-sparing diuretics: based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Icelandic: Með hliðsjón af notkun annarra lyfja sem hafa áhrif á renín-angíótensín kerfið, getur samtímis notkun kalíumsparandi þvagræsilyfja, kalíumuppbótar, saltuppbótar sem inniheldur kalíum eða annarra lyfja sem auka kalíumgildi í sermi (t.d. heparín) valdið aukningu á kalíum í sermi og er því ekki ráðlögð (sjá kafla 4.4).
English: Additional antihypertensive agents (excluding ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Icelandic: Viðbótarháþrýstingslyfjum (nema ACE-hemlum, angíótensín-II blokkum og díhýdrópýrídín kalsíumgangalokum) var bætt við eftir þörfum til þess að stuðla að því að blóðþrýstingsmarkmiði yrði náð.
English: Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Icelandic: Irbesartan er öflugur sértækur angíótensín-II (gerð AT1) blokki, virkur í inntöku.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg film-coated tablets.
Icelandic: HEITI LYFS Aprovel 75 mg filmuhúðaðar töflur.
English: As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Icelandic: Eins og við á um önnur blóðþrýstingslækkandi lyf getur mikil blóðþrýstingslækkun hjá sjúklingum með kransæðasjúkdóma eða hjarta- og æðasjúkdóma með blóðþurrð valdið hjartadrepi (myocardial infarction) eða heilablóðfalli.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 150 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Icelandic: HEITI LYFS Aprovel 150 mg töflur irbesartan VIRK(T) EFNI Hver tafla inniheldur: irbesartan 150 mg HJÁLPAREFNI Hjálparefni:
English: Adverse reactions additionally reported from post-marketing experience are also listed.
Icelandic: Að auki hefur verið greint frá aukaverkunum eftir markaðssetningu lyfsins.
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, asetýlsalicýlsýru (> 3 g/sólarhring) og ósértækum bólgueyðandi gigtarlyfjum) getur dregið úr blóðþrýstingslækkandi áhrifum.
English: hypersensitivity reactions such as angioedema, rash, urticaria, anaphylactic reaction, anaphylactic shock Metabolism and nutrition disorders Not known:
Icelandic: Ofnæmisviðbrögð eins og ofsabjúgur, útbrot, ofsakláði, bráðaofnæmisviðbrögð,
English: In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it. As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased regimen.
Icelandic: Hjá konum og svörtum undirhópum sem voru 32% og 26% heildarþýðis í rannsókninni, hvor undirhópur um sig, var nýrnaávinningur ekki augljós þótt vikmörk útiloki hann ekki.
English: Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect.
Icelandic: Metin voru meðferðaráhrif á undirhópa út frá kyni, kynstofni, aldri, hversu lengi sykursýki hafði staðið, blóðþrýstingi við grunnlínu, kreatíníni í sermi og útskilnaðarhraða albúmíns.
English: Excipient with known effect: 25.50 mg of lactose monohydrate per film-coated tablet.
Icelandic: 25,50 mg af laktósa einhýdrati í hverri filmuhúðaðri töflu.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets.
Icelandic: HEITI LYFS Aprovel 75 mg töflur.