natgillin/translations-raw huggingface dataset:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. 
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet.
No teratogenic effects were observed in the rat or rabbit. 
Nisu zabilježeni teratogeni učinci u štakora ni kunića.
Activated charcoal may be useful in the treatment of overdose. 
Za liječenje predoziranja može biti koristan aktivni ugljen.
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. 
Kao i kod bilo kojeg antihipertenziva, prekomjerni pad krvnog tlaka u bolesnika s ishemijskom kardiopatijom ili ishemijskom kardiovaskularnom bolešću može dovesti do infarkta miokarda ili moždanog udara.
Such conditions should be corrected before the administration of Aprovel. 
Takva stanja treba korigirati prije primjene lijeka Aprovel.
Rebound hypertension has not been observed. 
Nije zabilježena pojava veće (rebound) hipertenzije.
All of these changes were considered to be caused by the pharmacological action of irbesartan. 
Sve navedene promjene uzrokovane su farmakološkim djelovanjem irbesartana.
There is no clinically important effect on serum uric acid or urinary uric acid secretion. 
Nema klinički važnog učinka na mokraćnu kiselinu u serumu niti na urinarno izlučivanje mokraćne kiseline.
hyperkalaemia Nervous system disorders Common: 
hiperkalijemija Poremećaji živčanog sustava Često:
Aprovel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. 
Doza od 150 mg lijeka Aprovel jedanput na dan općenito osigurava bolju kontrolu krvnog tlaka u razdoblju od 24 sata nego doza od 75 mg.
No significant effects on the number of corpora lutea, implants, or live foetuses were observed. 
Nije zabilježen značajan utjecaj na broj žutih tijela, broj implantacija niti broj živih fetusa.
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. 
Kao i kod ostalih sličnih lijekova, zabilježeni su rijetki slučajevi alergijskih kožnih reakcija (osip, urtikarija), kao i lokalizirano oticanje lica, usnica i/ili jezika u bolesnika koji su uzimali irbesartan.
Irbesartan AUC and Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18-40 years). 
Vrijednosti AUC i Cmax irbesartana također su bile nešto veće u starijih ispitanika (≥ 65 godina) u usporedbi s mlađima (18-40 godina).
When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment. 
Prilikom upravljanja vozilima i strojevima potrebno je uzeti u obzir da se tijekom terapije mogu pojaviti omaglica i umor.
After withdrawal of therapy, blood pressure gradually returns toward baseline. 
Nakon prekida liječenja, krvni tlak se postupno vraća na početne vrijednosti.
Aprovel is unlikely to affect your ability to drive or use machines. 
Aprovel ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
14 tablets 28 tablets 30 tablets 56 tablets 56 x 1 tablets 84 tablets 90 tablets 98 tablets 
14 tableta 28 tableta 30 tableta 56 tableta 56 x 1 tableta 84 tableta 90 tableta 98 tableta
30 - 56 x 1 - 90 tablets: 
30 - 56 x 1 - 90 tableta:
The usual dose is 150 mg once a day. 
Uobičajena doza iznosi 150 mg jedanput na dan.
After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%. 
Nakon peroralne primjene irbesartan se dobro apsorbira: ispitivanja apsolutne bioraspoloživosti pokazala su vrijednosti od približno 60-80%.
No dosage adjustment is necessary in older people. 
Stoga nije potrebna prilagodba doze u starijih osoba.
Irbesartan had no effect upon fertility of treated rats and their offspring up to the dose levels inducing the first signs of parental toxicity (see section 5.3). 
Primjena irbesartana nije utjecala na plodnost ispitivanih štakora i njihovog potomstva, do doza koje su inducirale prve znakove parentalne toksičnosti (vidjeti dio 5.3).
arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps 
artralgija, mialgija (u nekim slučajevima povezana s povećanom koncentracijom kreatin kinaze u plazmi), grčevi mišića
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 
Možda ćete trebati obaviti pretrage krvi ako uzimate: nadomjeske kalija nadomjeske soli koji sadrže kalij lijekove koji čuvaju kalij (kao što su neki diuretici) lijekove koji sadrže litij
dizziness, orthostatic dizziness* 
omaglica, ortostatska omaglica*
The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment. 
Maksimalan učinak na sniženje krvnog tlaka trebao bi se postići za 4-6 tjedana nakon početka liječenja.
Fertility and reproductive performance were not affected in studies of male and female rats even at oral doses of irbesartan causing some parental toxicity (from 50 to 650 mg/kg/day), including mortality at the highest dose. 
Nije zabilježen utjecaj na plodnost i reproduktivnu učinkovitost u istraživanjima na mužjacima i ženkama štakora, čak ni pri oralnim dozama irbesartana koje su uzrokovale određenu parentalnu toksičnost (doze od 50 do 650 mg/kg/dnevno), uključujući mortalitet pri najvišim dozama.
The usual dose is 150 mg once a day (two tablets a day). 
Uobičajena doza iznosi 150 mg jedanput na dan (dvije tablete na dan).
Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists. 
Aprovel pripada skupini lijekova koja se naziva antagonisti receptora angiotenzina II.
While this is not documented with Aprovel, a similar effect should be anticipated with angiotensin-II receptor antagonists. 
Iako to još nije potvrđeno za Aprovel, sličan učinak može se očekivati s antagonistima receptora angiotenzina II.
hypersensitivity reactions such as angioedema, rash, urticaria, anaphylactic reaction, anaphylactic shock Metabolism and nutrition disorders Not known: 
reakcije preosjetljivosti kao što su angioedem, osip, urtikarija, anafilaktička reakcija, anafilaktički šok Poremećaji metabolizma i prehrane Nepoznato:
Concomitant food intake does not significantly influence the bioavailability of irbesartan. 
Istodobno uzimanje s hranom ne utječe značajno na bioraspoloživost irbesartana.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Aprovel, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated. 
Bolesnici su titrirani od 75 mg do doze održavanja od 300 mg lijeka Aprovel, od 2,5 mg do 10 mg amlodipina ili placeba do granice podnošljivosti.
Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. 
Angiotenzin II je tvar koja se stvara u tijelu i koja se veže na receptore u krvnim žilama te uzrokuje njihovo sužavanje.
Renal impairment and kidney transplantation: when Aprovel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. 
Oštećena funkcija bubrega i transplantacija bubrega: kad Aprovel uzimaju bolesnici s oštećenom funkcijom bubrega, preporučuje se periodički kontrolirati serumske razine kalija i kreatinina.
It is unknown whether irbesartan or its metabolites are excreted in human milk. 
Nije poznato izlučuju li se irbesartan ili njegovi metaboliti u majčino mlijeko u ljudi.
In patients insufficiently controlled with 150 mg once daily, the dose of Aprovel can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1). 
U bolesnika u kojih se bolest ne može dostatno kontrolirati dozom od 150 mg jedanput na dan, doza lijeka Aprovel može se povećati na 300 mg ili se mogu dodati drugi antihipertenzivi (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Aprovel (see section 4.5). 
Pokazalo se da dodavanje diuretika poput hidroklorotiazida ostvaruje aditivan učinak s lijekom Aprovel (vidjeti dio 4.5).
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. 
Budući da nema dostupnih podataka o upotrebi lijeka Aprovel tijekom dojenja, ne preporučuje se njegova primjena tijekom dojenja i prednost treba dati drugoj terapiji s ustanovljenim boljim profilom sigurnosti primjene, osobito kada se doji novorođenče ili nedonošče.
In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect. 
In vitro ispitivanja upućuju da se irbesartan primarno oksidira pomoću enzima CYP2C9 citokroma P450, dok izoenzim CYP3A4 ima neznatan učinak.
Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Aprovel 300 mg group (34%) than in the placebo group (21%). 
Regresija do normoalbuminurije (< 30 mg/dan) bila je češća u skupini koja je primala lijek Aprovel u dozi od 300 mg (34%) nego u skupini koja je primala placebo (21%).
How to take Aprovel 
Kako uzimati Aprovel
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. 
Epidemiološki podaci koji se odnose na rizik od teratogenog učinka nakon izloženosti ACE inhibitorima tijekom prvog tromjesečja nisu bili dostatni za donošenje zaključaka.
Aprovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. 
Aprovel sprječava vezanje angiotenzina II na te receptore uzrokujući opuštanje krvnih žila i sniženje krvnog tlaka.
Aprovel is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. 
Aprovel se ne preporučuje u ranoj trudnoći te se ne smije uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi Vašem djetetu ako ga uzimate u tom razdoblju.
The following table presents the adverse drug reactions that were reported in placebo-controlled trials in which 1,965 hypertensive patients received irbesartan. 
Sljedeća tablica prikazuje nuspojave prijavljene u placebom kontroliranim ispitivanjima, u kojima je 1965 hipertenzivnih bolesnika primalo irbesartan.
Based on its pharmacodynamic properties, irbesartan is unlikely to affect the ability to drive and use machines. 
Na temelju farmakodinamičkih svojstava, irbesartan ne bi trebao utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
Close monitoring of serum potassium in patients at risk is recommended (see section 4.5). 
Preporučuje se česta kontrola serumskog kalija u rizičnih bolesnika (vidjeti dio 4.5).
Additional information on irbesartan interactions: in clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide. 
Dodatne informacije o interakcijama irbesartana: u kliničkim ispitivanjima hidroklorotiazid nije utjecao na farmakokinetiku irbesartana.
In a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse reactions occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%). 
U trotjednoj dvostruko slijepoj fazi randomiziranog kliničkog ispitivanja u koju je bilo uključeno 318 djece i adolescenata s hipertenzijom u dobi od 6 do 16 godina pojavile su se sljedeće nuspojave: glavobolja (7,9%), hipotenzija (2,2%), omaglica (1,9%), kašalj (0,9%).
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Aprovel (see section 4.4). 
Prethodno liječenje visokim dozama diuretika može dovesti do smanjenja volumena i rizika od pojave hipotenzije prilikom uvođenja terapije lijekom Aprovel (vidjeti dio 4.4).
Some undesirable effects have been reported since marketing of Aprovel. 
Neke nuspojave prijavljene su otkad je Aprovel na tržištu.
As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1). 
Kao što je zapaženo kod inhibitora angiotenzin konvertirajućeg enzima, irbesartan i ostali antagonisti angiotenzina očigledno su manje učinkoviti u snižavanju krvnog tlaka u bolesnika crne rase nego u drugih rasa, vjerojatno zbog veće prevalencije stanja niskog renina u populaciji hipertoničara crne rase (vidjeti dio 5.1).
In rabbits, abortion or early resorption were noted at doses causing significant maternal toxicity, including mortality. 
Pobačaj ili rana resorpcija opaženi su u kunića pri dozama koje su uzrokovale značajnu toksičnost kod majke, uključujući i smrtnost.
The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration. 
Selektivni antagonizam receptora angiotenzina II (AT1) za ishod ima povećanje razine renina u plazmi i razine angiotenzina II te snižavanje koncentracije aldosterona u plazmi.
musculoskeletal pain* 
mišićno-koštana bol*
The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. 
Nisu ispitivani učinci induktora CYP2C9 poput rifampicina na farmakokinetiku irbesartana.
Available pharmacodynamic/toxicological data in rats have shown excretion of irbesartan or its metabolites in milk (for details see 5.3). 
Dostupni farmakodinamički/toksikološki podaci iz ispitivanja na štakorima pokazali su da se irbesartan ili njegovi metaboliti izlučuju u mlijeko (za detalje vidjeti dio 5.3).
In a study, somewhat higher plasma concentrations of irbesartan were observed in female hypertensive patients. 
U ispitivanju su zabilježene nešto veće koncentracije irbesartana u plazmi u hipertenzivnih bolesnica.
In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/kg/day in rats and ≥ 100 mg/kg/day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit). 
U nekliničkim ispitivanjima sigurnosti primjene, velike doze irbesartana (≥ 250 mg/kg/dan u štakora i ≥ 100 mg/kg/dan u makaki majmuna) uzrokovale su smanjenje parametara crvenih krvnih stanica (eritrocita, hemoglobina, hematokrita).
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. 
Farmakokinetika irbesartana proučavana je tijekom 4 tjedna u 23 djece s hipertenzijom, nakon primjene jednokratne i višekratnih dnevnih doza (2 mg/kg) do maksimalne dnevne doze od 150 mg irbesartana.
The blood pressure lowering effect of Aprovel is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy. 
Učinak lijeka Aprovel na snižavanje krvnog tlaka vidljiv je unutar 1-2 tjedna, s maksimalnim učinkom nakon 4-6 tjedana od početka terapije.
There is no experience regarding the administration of Aprovel in patients with a recent kidney transplantation. 
Nema iskustava s primjenom lijeka Aprovel u bolesnika kojima je nedavno transplantiran bubreg.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported. 
Prijavljeni su i manje česti slučajevi žutice (žuta boja kože i/ili bjeloočnica).
Furthermore, irbesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/kg/day, in macaques at ≥ 10 mg/kg/day). 
Nadalje, irbesartan je izazivao hiperplaziju/hipertrofiju jukstaglomerularnih stanica (u štakora pri dozi od ≥ 90 mg/kg/dan, u makaki majmuna pri dozi od ≥ 10 mg/kg/dan).
As is the case with other medicinal products that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy. 
Kao što je to slučaj s ostalim lijekovima koji utječu na renin-angiotenzinski sustav, hipertenzivni bolesnici crne rase slabije reagiraju na monoterapiju irbesartanom.
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. 
Nesteroidni protuupalni lijekovi: kad se antagonisti angiotenzina II primjenjuju istodobno s nesteroidnim protuupalnim lijekovima (tj. selektivnim inhibitorima COX-2, acetilsalicilatnom kiselinom (> 3 g/dan) i neselektivnim NSAIL) moguć je oslabljeni antihipertenzivni učinak.
Side effects reported in clinical studies for patients treated with Aprovel were: 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. 
U kliničkim ispitivanjima s bolesnicima liječenima lijekom Aprovel prijavljene su sljedeće nuspojave: Vrlo često (mogu se javiti u više od 1 na 10 osoba): ako imate povišen krvni tlak i šećernu bolest tipa 2 te bolest bubrega, krvne pretrage mogu pokazati povišene vrijednosti kalija.
sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France 
sanofi-aventis groupe 54, rue La Boétie F-75008 Pariz - Francuska
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. 
U bolesnika s povišenim krvnim tlakom, šećernom bolešću tipa 2 i bubrežnom bolešću također su prijavljeni omaglica i nizak krvni tlak nakon ustajanja iz sjedećeg ili ležećeg položaja, bol u zglobovima ili mišićima i smanjene razine proteina u crvenim krvnim stanicama (hemoglobina).
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. 
Pojmovi označeni zvjezdicom (*) odnose se na nuspojave koje su dodatno prijavljene u više od 2% dijabetičkih hipertenzivnih bolesnika s kroničnom insuficijencijom bubrega i manifestnom proteinurijom i to češće nego kod placeba.
Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites. 
Irbesartan ne inhibira ACE (kininazu II), enzim koji stvara angiotenzin-II te degradira bradikinin u neaktivne metabolite.
 If you have any further questions, ask your doctor or pharmacist. 
Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a medicinal product metabolised by CYP2C9. 
Nisu zabilježene značajne farmakokinetičke ni farmakodinamičke interakcije kod istodobne primjene irbesartana i varfarina, lijeka koji se metabolizira pomoću CYP2C9.
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. 
Dodatni antihipertenzivi (isključujući ACE inhibitore, antagoniste receptora angiotenzina II i dihidropiridinske blokatore kalcijevih kanala) dodavani su prema potrebi kako bi se postigao ciljni krvni tlak.
A limited accumulation of irbesartan (18%) in plasma was observed upon repeated once daily dosing. 
Ograničeno nakupljanje irbesartana u plazmi (18%) opaženo je nakon ponovljenog doziranja jedanput dnevno.
Approximately 33% of patients in the irbesartan group reached the primary renal composite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20% relative risk reduction versus placebo (p = 0.024) and 23% relative risk reduction compared to amlodipine (p = 0.006)]. 
Približno 33% bolesnika u irbesartan skupini dostiglo je primarnu složenu mjeru ishoda ispitivanja za bubrežnu bolest, u usporedbi sa 39% u placebo i 41% u amlodipin skupini [smanjenje relativnog rizika za 20% u odnosu na placebo (p=0,024) i smanjenje relativnog rizika za 23% u usporedbi s amplodipinom (p=0,006)].
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). 
IRMA 2 bilo je placebom kontrolirano, dvostruko slijepo ispitivanje morbiditeta u 590 bolesnika sa šećernom bolešću tipa 2, mikroalbuminurijom (30-300 mg/dan) i normalnom bubrežnom funkcijom (serumski kreatinin ≤ 1,5 mg/dl u muškaraca i < 1,1 mg/dl u žena).
Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. 
Smanjenje intravaskularnog volumena: simptomatska hipotenzija, posebice nakon prve doze, može se pojaviti u bolesnika sa hipovolemijom i/ili hiponatrijemijom zbog snažne diuretske terapije, restrikcijske dijete sa smanjenim unosom soli, proljeva ili povraćanja.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake “EXP“.
PHARMACEUTICAL FORM AND CONTENTS 14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use. 
OBLIK I SADRŽAJ 14 tableta 28 tableta 56 tableta 56 x 1 tableta 98 tableta NAČIN I PUT(EVI) PRIMJENE LIJEKA Primjena kroz usta.
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. 
Bolesnici u svim liječenim skupinama obično su uzimali između 2 i 4 antihipertenzivna lijeka (npr. diuretike, beta blokatore, alfa blokatore) kako bi postigli unaprijed definirani krvni tlak od ≤ 135/85 mmHg ili smanjenje sistoličkog tlaka za 10 mmHg ako je početna vrijednost bila > 160 mmHg.
Peak plasma concentrations are attained at 1.5-2 hours after oral administration. 
Vršne koncentracije u plazmi postižu se 1,5 do 2 sata nakon peroralne primjene.
Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan-treated patients (3.3%) than for placebo-treated patients (4.5%). 
Prekid terapije zbog određenih kliničkih ili laboratorijskih štetnih događaja bio je manje čest u bolesnika liječenih irbesartanom (3,3%) nego u skupini bolesnika koji su primali placebo (4,5%).
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. 
Hipertenzivni bolesnici sa šećernom bolešću tipa 2 i bubrežnom bolešću: učinak irbesartana na događaje povezane s bubrezima i kardiovaskularnim sustavom nije bio ujednačen u svim podskupinama u analizi rezultata ispitivanja bolesnika s uznapredovalom bubrežnom bolešću.
Hypertension and type 2 diabetes with renal disease 
Hipertenzija i šećerna bolest tipa 2 s bubrežnom bolešću