natgillin/translations-raw huggingface dataset:
Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Irbesartan Zentiva 300 mg group (34%) than in the placebo group (21%). 
V skupini s 300 mg zdravila Irbesartan Zentiva je bila pogostejša (34%) regresija na normoalbuminurijo (<30 mg/dan), kot v placebo skupini (21%).
Patients were titrated from 75 mg to a maintenance dose of 300 mg Irbesartan Zentiva, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated. 
Bolnikom so postopoma povečevali odmerek zdravila Irbesartan Zentiva od 75 mg do vzdrževalnega odmerka 300 mg, odmerek amlodipina od 2,5 do 10 mg, oziroma placeba, kot so ga prenesli.
Such conditions should be corrected before the administration of Irbesartan Zentiva. 
Ta stanja se mora korigirati, preden se uporabi zdravilo Irbesartan Zentiva.
Irbesartan Zentiva prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. 
Zdravilo Irbesartan Zentiva preprečuje vezavo angiotenzina-II na te receptorje in tako sprošča krvne žile ter znižuje krvni tlak.
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Irbesartan Zentiva has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics. 
Diuretiki in drugi antihipertenzivi: drugi antihipertenzivi lahko povečajo hipotenzivni učinek irbesartana; vendar pa so zdravilo Irbesartan Zentiva varno uporabljali z drugimi antihipertenzivi, kot so zaviralci adrenergičnih receptorjev beta, zaviralci kalcijevih kanalčkov z dolgotrajnim delovanjem in tiazidnimi diuretiki.
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan Zentiva, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. 
Hiperkaliemija: kot pri drugih zdravilih, ki vplivajo na sistem renin-angiotenzin-aldosteron, se lahko tudi med zdravljenjem z zdravilom Irbesartan Zentiva pojavi hiperkaliemija, zlasti ob prisotnosti ledvične okvare, izrazite proteinurije zaradi diabetične ledvične bolezni in/ali odpovedi srca.
For N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance: 
N-nitrozodietilamin (NDEA) uvesti naslednje specifikacije za učinkovino:
Therefore, the use of Irbesartan Zentiva is not recommended. 
Zato uporaba zdravila Irbesartan Zentiva ni priporočljiva.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan Zentiva, amlodipine and placebo. 
IDNT je bilo dvojno slepo, kontrolirano preskušanje vpliva zdravila Irbesartan Zentiva na obolevnost in smrtnost v primerjavi z amlodipinom in placebom.
If you forget to take Irbesartan Zentiva 
Če ste pozabili vzeti zdravilo Irbesartan Zentiva
Other medicines and Irbesartan Zentiva 
Druga zdravila in zdravilo Irbesartan Zentiva
Lithium: the combination of lithium and Irbesartan Zentiva is not recommended (see section 4.5). 
Litij: sočasna uporaba zdravila Irbesartan Zentiva in litija ni priporočljiva (glejte poglavje 4.5).
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). 
Neželeni učinki, katerih pogostnost ni znana, so: vrtoglavica, glavobol, motnje okušanja, zvonjenje v ušesih, mišični krči, bolečine v sklepih in mišicah, zmanjšano število trombocitov, nenormalno delovanje jeter, zvišane vrednosti kalija v krvi, okvara delovanja ledvic, vnetje malih krvnih žil, predvsem kože (bolezen, znana kot levkocitoklastični vaskulitis) in hude alergijske reakcije
o aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. 
Zdravnik vam bo morda v rednih presledkih kontroliral delovanje ledvic, krvni tlak in količino elektrolitov (npr. kalija) v krvi.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan Zentiva (see section 4.5). 
In sicer, se je pri dodatni uvedbi diuretika, kot je hidroklorotiazid, pokazal sinergistični učinek z zdravilom Irbesartan Zentiva (glejte poglavje 4.5).
arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps Renal and urinary disorders Not known: 
artralgija, mialgija (v nekaterih primerih sta bili povezani z zvišanjem ravni kreatin kinaze v plazmi), mišični krči
No dosage adjustment is necessary in older people. 
običajno pri starejših prilagajanje odmerka ni potrebno.
(It is also better to avoid Irbesartan Zentiva in early pregnancy - see pregnancy section) if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. 
(Jemanju zdravila Irbesartan Zentiva se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti) če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
Irbesartan Zentiva is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. 
Zdravila Irbesartan Zentiva ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo po tretjem mesecu nosečnosti resno škoduje vašemu otroku.
The demonstration of renal benefit of Irbesartan Zentiva in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1). 
Koristi zdravljenja z zdravilom Irbesartan Zentiva za ledvice pri bolnikih z visokim krvnim tlakom z diabetesom tipa 2 so pokazale študije, kjer so irbesartan uporabljali dodatno z drugimi antihipertenzivi, potrebnimi za doseganje ciljnega krvnega tlaka (glejte poglavja 4.3, 4.4, 4.5 in 5.1).
hypersensitivity reactions such as angioedema, rash, urticaria, anaphylactic reaction, anaphylactic shock 
preobčutljivostne reakcije, kot so angioedem, izpuščaj, koprivnica, anafilaktična reakcija, anafilaktični šok
Side effects reported in clinical studies for patients treated with Irbesartan Zentiva were: 
V kliničnih preskušanjih so pri bolnikih, ki so se zdravili z zdravilom Irbesartan Zentiva, poročali o naslednjih neželenih učinkih:
(It is also better to avoid Irbesartan Zentiva in early pregnancy - see pregnancy section) if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.. 
(Jemanju zdravila Irbesartan Zentiva se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti) če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren
Your doctor will normally advise you to stop taking Irbesartan Zentiva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Zentiva. 
Zdravnik vam bo praviloma svetoval, da zdravljenje z zdravilom Irbesartan Zentiva prekinete, še preden zanosite ali takoj, ko se izkaže, da ste zanosili, in vam predpisal zdravljenje z drugim zdravilom.
Adverse reactions additionally reported from post-marketing experience are also listed. 
Prav tako so navedeni dodatni neželeni učinki, o katerih so poročali po pridobitvi dovoljenja za promet.
There is no experience regarding the administration of Irbesartan Zentiva in patients with a recent kidney transplantation. 
Glede uporabe zdravila Irbesartan Zentiva pri bolnikih po nedavni presaditvi ledvic ni nobenih izkušenj.
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). 
Pri bolnikih, ki niso zadostno kontrolirani s samim irbesartanom, se z dodatno uvedbo nizkega odmerka hidroklorotiazida (12,5 mg) enkrat dnevno, poleg enkrat dnevnega odmerka irbesartana, doseže nadaljnje s placebom-uravnano znižanje krvnega tlaka v celoti za 7-10/3-6 mmHg (sistolični/
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium. 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): če imate visok krvni tlak in sladkorno bolezen tipa 2 z boleznijo ledvic, lahko krvne preiskave pokažejo zvišanje vrednosti kalija v krvi.
In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan Zentiva can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1). 
Pri bolnikih, kjer enkratni dnevni odmerek 150 mg zdravila Irbesartan Zentiva ne zadošča za nadzor krvnega tlaka, se lahko odmerek poveča na 300 mg ali uvede dodatni antihipertenziv (glejte poglavja 4.3, 4.4, 4.5 in 5.1).
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain. 
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): hitro utripanje srca, rdečica, kašelj, driska, motnje prebave/zgaga, motnje pri spolnih aktivnostih, bolečina v prsnem košu.
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. 
Nesteroidna protivnetna zdravila: kadar sočasno jemljemo antagoniste angiotenzina II in nesteroidna protivnetna zdravila (NSAID) (npr. selektivne COX-2 zaviralce, acetilsalicilno kislino (> 3 g dnevno)
How to take Irbesartan Zentiva 
Kako jemati zdravilo Irbesartan Zentiva
Irbesartan Zentiva should not be given to children under 18 years of age. 
Otroci in mladostniki, mlajši od 18 let, zdravila Irbesartan Zentiva ne smejo jemati.
Olmesartan 40 Irbesartan 300 Candesartan 32 
v ppm v učinkovini valsartan 320 losartan olmesartan 40 irbesartan 300 kandesartan 32
You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium 
dodatke kalija nadomestke soli, ki vsebujejo kalij zdravila, ki varčujejo s kalijem (kot so nekateri diuretiki) zdravila, ki vsebujejo litij
How to store Irbesartan Zentiva Contents of the pack and other information 
Shranjevanje zdravila Irbesartan Zentiva Vsebina pakiranja in dodatne informacije
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). 
Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (odpoved ledvic, hipotenzija,
Hypertension and type 2 diabetes with renal disease 
Študija ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease
Do not take Irbesartan Zentiva  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. 
Kaj morate vedeti, preden boste vzeli zdravilo Irbesartan Zentiva Ne jemljite zdravila Irbesartan Zentiva če ste alergični na irbesartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6) če ste noseči dlje kot tri mesece.
Irbesartan and its metabolites are eliminated by both biliary and renal pathways. 
Izločanje Irbesartan in njegovi metaboliti se izločajo tako z žolčem kot preko ledvic.
Iif you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Zentiva” and “Warnings and precautions”). 
Zdravnik vam bo morda moral spremeniti odmerek in/ali uporabiti druge previdnostne ukrepe: Če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne jemljite zdravila Irbesartan Zentiva" in "Opozorila in previdnostni ukrepi").
Each tablet contains: irbesartan 150 mg 
Ena tableta vsebuje: irbesartan 150 mg
Each tablet of Irbesartan Zentiva 75 mg contains 75 mg irbesartan. 
Ena tableta zdravila Irbesartan Zentiva 75 mg vsebuje 75 mg irbesartana.
Each tablet of Irbesartan Zentiva 300 mg contains 300 mg irbesartan. 
Ena tableta zdravila Irbesartan Zentiva 300 mg vsebuje 300 mg irbesartana.
Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria. 
Preskušanje delovanja irbesartana na mikroalbuminurijo pri bolnikih z visokim krvnim tlakom z diabetesom melitusom tipa 2 (IRMA 2), je pokazalo, da pri bolnikih z mikroalbuminurijo, 300 mg irbesartana odloži napredovanje do izražene proteinurije.
Irbesartan Zentiva is unlikely to affect your ability to drive or use machines. 
Verjetnost, da bi zdravilo Irbesartan Zentiva vplivalo na sposobnost upravljanja vozil ali strojev, je majhna.
Warning and precautions Talk to your doctor before taking Irbesartan Zentiva and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Irbesartan Zentiva for diabetic kidney disease. 
Pred začetkom jemanja zdravila Irbesartan Zentiva se posvetujte z zdravnikom, če za vas velja karkoli od spodaj navedenega:: če začnete prekomerno bruhati ali dobite hudo drisko če imate težave z ledvicami če imate težave s srcem če zdravilo Irbesartan Zentiva jemljete zaradi diabetične bolezni ledvic.
Each tablet of Irbesartan Zentiva 150 mg contains 150 mg irbesartan. 
Ena tableta zdravila Irbesartan Zentiva 150 mg vsebuje 150 mg irbesartana.
The concomitant use of Irbesartan Zentiva with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73m2) (see sections 4.5 and 5.1). 
Sočasna uporaba zdravila Irbesartan Zentiva in zdravil, ki vsebujejo aliskiren, je kontraindicirana pri bolnikih s sladkorno boleznijo ali z okvaro ledvic (hitrost glomerularne filtracije < 60 ml/min/1,73 m2) (glejte poglavji 4.5 in 5.1).
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of Irbesartan Zentiva on the progression of renal disease and all-cause mortality were examined. 
Pri 1.715 bolnikih z visokim krvnim tlakom z diabetesom tipa 2, proteinurijo ≥900 mg/dan in serumskim kreatininom 1,0-3,0 mg/dl, so raziskovali dolgotrajne učinke zdravila Irbesartan Zentiva (povprečje 2,6 let) na napredovanje ledvične bolezni in na celokupno smrtnost.
If you take more Irbesartan Zentiva than you should If you accidentally take too many tablets, contact your doctor immediately. 
Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
Irbesartan Zentiva 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). 
Zdravila Irbesartan Zentiva ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo v tem obdobju resno škoduje vašemu otroku
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. 
V podskupinah z ženskami in temnopoltimi, ki so predstavljale 32% oziroma 26% celotne preiskovane populacije, ni bila dokazana koristnost irbesartana za ledvice, čeprav je meje zaupanja ne izključujejo.
Metabolism and nutrition disorders 
Bolezni krvi in limfatičnega sistema
Irbesartan Zentiva 75 mg film-coated tablets irbesartan 
Irbesartan Zentiva 75 mg filmsko obložene tablete irbesartan
Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). 
(npr. z enim kozarcem vode).
The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria. 
Hipertenzija in sladkorna bolezen tipa 2 z ledvično boleznijo Preskušanje irbesartana pri diabetični nefropatiji “Irbesartan Diabetic Nephropathy Trial" (IDNT) kaže, da irbesartan pri bolnikih s kronično ledvično insuficienco in izraženo proteinurijo zmanjša napredovanje ledvične bolezni.
Conditions to the MA 
Meja za NDMA
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. 
(kot so intersticijski nefritis, razširitev tubulov, bazofilni tubuli, povečana plazemska koncentracija sečnine in kreatinina), za katere domnevajo, da so sekundarne hipotenzivnim učinkom zdravila, ki vodi do zmanjšanega pretoka v ledvicah.
leukocytoclastic vasculitis Musculoskeletal and connective tissue disorders Common: 
Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti:
Irbesartan Zentiva contains lactose. 
Zdravilo Irbesartan Zentiva vsebuje laktozo.
Irbesartan Zentiva 300 mg film-coated tablets irbesartan 
Irbesartan Zentiva 300 mg filmsko obložene tablete irbesartan
Because no information is available regarding the use of Irbesartan Zentiva during breast-feeding, Irbesartan 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. 
Podatkov o uporabi zdravila Irbesartan Zentiva med dojenjem ni na voljo, zato uporaba zdravila Irbesartan Zentiva med dojenjem ni priporočljiva.
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Zentiva ” and “Warnings and precautions”). 
Če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne jemljite zdravila
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Poloxamer 188 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi mikrokristalna celuloza premreženi natrijev karmelozat laktoza monohidrat magnezijev stearat koloidni hidratirani silicijev dioksid predgelirani koruzni škrob poloksamer 188
The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response. 
300 mg (štiri tablete) enkrat na dan, odvisno od odziva krvnega tlaka.
How to store Irbesartan Zentiva 
Shranjevanje zdravila Irbesartan Zentiva
Irbesartan Zentiva is for oral use. 
Irbesartan Zentiva ni priporočljivo.
In patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered. 
Ledvična okvara Farmakokinetični parametri irbesartana pri bolnikih z ledvično okvaro ali tistih na hemodializi, niso pomembno spremenjeni.
Irbesartan Zentiva 150 mg film-coated tablets irbesartan 
Irbesartan Zentiva 150 mg filmsko obložene tablete irbesartan
Lévai u.5. 
Po peroralnem ali i.v.
Rebound hypertension has not been observed. 
Ponovnega padca zvečanega krvnega tlaka niso opazili.
Irbesartan Zentiva is used in adult patients to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function. 
Zdravilo Irbesartan Zentiva uporabljamo pri odraslih bolnikih: za zdravljenje visokega krvnega tlaka (primarne hipertenzije).
Investigations: 
Preiskave Zelo pogosti:
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. 
Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg (dve tableti) enkrat na dan.
Irbesartan Zentiva 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Irbesartan Zentiva 75 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
 If you get any side effects, talk to your doctor or pharmacist. 
Če opazite kateri koli neželeni učinek, , se posvetujte z zdravnikom ali s farmacevtom.
The efficacy of Irbesartan Zentiva is not influenced by age or gender. 
Spol in starost ne vplivata na učinkovitost zdravila Irbesartan Zentiva.
Irbesartan Zentiva 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Irbesartan Zentiva 150 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Irbesartan Zentiva 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Irbesartan Zentiva 300 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 150 mg tablets irbesartan 
Navodilo za uporabo Irbesartan Zentiva 150 mg tablete irbesartan
Some undesirable effects have been reported since marketing of Irbesartan Zentiva. 
Po prihodu zdravila Irbesartan Zentiva na tržišče so poročali še o nekaterih drugih neželenih učinkih.
IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/day) and normal renal function (serum creatinine ≤ 1.5 mg/dl in males and < 1.1 mg/dl in females). 
(30-300 mg/dan) in normalno ledvično funkcijo (serumski kreatinin pri moških ≤1,5 mg/dl, pri ženskah <1,1 mg/dl).
Irbesartan Zentiva 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets. 
Irbesartan Zentiva 300 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Irbesartan Zentiva 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets. 
Irbesartan Zentiva 75 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
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). 
blokatorjev receptorjev angiotenzina II ali aliskirena povezana z večjo pogostnostjo neželenih učinkov, npr. hipotenzije, hiperkaliemije in zmanjšanega delovanja ledvic (vključno z akutno odpovedjo ledvic) kot uporaba enega samega zdravila, ki deluje na RAAS (glejte poglavja 4.3, 4.4. in