natgillin/translations-raw huggingface dataset:
Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system. 
Renovaskularna hipertenzija: povećan je rizik od teške hipotenzije i insuficijencije bubrega u bolesnika koji se liječe lijekovima koji utječu na renin-angiotenzinski sustav, a imaju obostranu stenozu bubrežnih arterija ili stenozu arterije u jedinom funkcionalnom bubregu.
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. 
Litij: tijekom istodobne primjene litija i inhibitora angiotenzin konvertirajućeg enzima prijavljen je reverzibilan porast koncentracije serumskog litija i njegove toksičnosti.
No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. 
Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response. 
Doza se kasnije može povećati na 300 mg (četiri tablete na dan) jedanput na dan, ovisno o vrijednostima krvnog tlaka.
The efficacy of Aprovel is not influenced by age or gender. 
Dob i spol ne utječu na djelotvornost lijeka Aprovel.
The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg. Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i.e. 24 hours after dosing) by an average of 8-13/5-8 mm Hg (systolic/diastolic) greater than those associated with placebo. 
Doze od 150-300 mg jedanput na dan smanjuju krvni tlak u ležećem ili sjedećem položaju u vrijeme najniže koncentracije u krvi (to jest 24 sata nakon uzimanja doze) i to u prosjeku za 8-13/5-8 mmHg (sistolički/dijastolički) više od placeba.
At the end of the three weeks the mean reduction from baseline in the primary efficacy variable, trough seated systolic blood pressure (SeSBP) was 11.7 mmHg (low dose), 9.3 mmHg (medium dose), 13.2 mmHg (high dose). 
Nakon tri tjedna srednja vrijednost smanjenja krvnog tlaka u odnosu na početne vrijednosti za primarnu varijablu djelotvornosti, sistolički krvni tlak u sjedećem položaju kod najniže koncentracije u krvi (SjSKT), iznosila je 11,7 mmHg (niska doza), 9,3 mmHg
Aprovel is for oral use. 
Aprovel je namijenjen za primjenu kroz usta.
Each tablet of Aprovel 75 mg contains 75 mg irbesartan. 
Jedna Aprovel 75 mg tableta sadrži 75 mg irbesartana.
The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response. 
Doza se kasnije može povećati na 300 mg (dvije tablete na dan) jedanput na dan, ovisno o vrijednostima krvnog tlaka.
The most likely manifestations of overdose are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. 
Najčešće očekivane manifestacije predoziranja su hipotenzija i tahikardija.
Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3000 
Film-ovojnica: laktoza hidrat hipromeloza titanijev dioksid makrogol 3000 karnauba vosak
Each tablet of Aprovel 150 mg contains 150 mg irbesartan. 
Jedna Aprovel 150 mg tableta sadrži 150 mg irbesartana.
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. 
Osim ako se nastavak terapije antagonistima receptora angiotenzina II ne smatra neophodnim, bolesnice koje planiraju trudnoću trebaju prijeći na alternativnu antihipertenzivnu terapiju s utvrđenom sigurnošću primjene u trudnoći.
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. 
Manje često (mogu se javiti u manje od 1 na 100 osoba): ubrzan srčani ritam, crvenilo praćeno osjećajem vrućine, kašalj, proljev, probavni poremećaji/žgaravica, problemi sa seksualnom funkcijom, bol u prsištu.
While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose. 
Dok je sličan krvni tlak postignut u svim ispitivanim skupinama, manje bolesnika u skupini koja je primala 300 mg irbesartana (5,2%) dostiglo je mjeru ishoda manifestne proteinurije u odnosu na skupinu koja je primala placebo (14,9%)
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. 
Za sekundarnu mjeru ishoda ispitivanja, fatalne i nefatalne kardiovaskularne događaje, u sveukupnoj ispitivanoj populaciji nije bilo razlika između tri skupine, iako je zabilježena povećana incidencija nefatalnog infarkta miokarda u žena i smanjena incidencija nefatalnog infarkta miokarda u muškaraca u skupini koja je primala irbesartan u odnosu na onu koja je primala placebo.
Each tablet of Aprovel 300 mg contains 300 mg irbesartan. 
Jedna Aprovel 300 mg tableta sadrži 300 mg irbesartana.
hepatitis, abnormal liver function Skin and subcutaneous tissue disorders Not known: 
Poremećaji kože i potkožnog tkiva Nepoznato:
NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 300 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate. 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA NAZIV LIJEKA Aprovel 300 mg tablete irbesartan NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 300 mg irbesartana POPIS POMOĆNIH TVARI Pomoćne tvari: također sadrži laktozu hidrat.
If you take more Aprovel than you should If you accidentally take too many tablets, contact your doctor immediately. 
Ako slučajno uzmete previše tableta, odmah se obratite svom liječniku.
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). 
Poznato je da u ljudi terapija antagonistima receptora angiotenzina II tijekom drugog i trećeg tromjesečja izaziva fetotoksičnost (smanjena bubrežna funkcija, oligohidramnion, usporavanje okoštavanja lubanje) i neonatalnu toksičnost (zatajenje bubrega, hipotenzija, hiperkalijemija) (vidjeti dio 5.3).
The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4). 
Uzimanje antagonista receptora angiotenzina II ne preporučuje se tijekom prvog tromjesečja trudnoće (vidjeti dio 4.4), a kontraindicirano je tijekom drugog i trećeg tromjesečja (vidjeti dijelove 4.3 i 4.4).
Less than 2% of the dose is excreted in the urine as unchanged irbesartan. 
doze izlučuje se u obliku nepromijenjenog irbesartana.
thrombocytopenia Immune system disorders Not known: 
Poremećaji imunološkog sustava Nepoznato:
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. 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA NAZIV LIJEKA Aprovel 150 mg tablete irbesartan NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 150 mg irbesartana POPIS POMOĆNIH TVARI Pomoćne tvari: također sadrži laktozu hidrat.
Aprovel 75 mg film-coated tablets irbesartan 
Aprovel 75 mg filmom obložene tablete irbesartan
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. 
Aprovel se, međutim, pokazao sigurnim za primjenu s ostalim antihipertenzivnim lijekovima poput beta blokatora, dugodjelujućih blokatora kalcijevih kanala i tiazida.
Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. 
Iskustvo je pokazalo da nije bilo toksičnog djelovanja irbesartana u odraslih ljudi koji su bili izloženi dozama do 900 mg/dan tijekom 8 tjedana.
Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available. 
Dostupna su i pakiranja s 56 x 1 tabletom u blisterima djeljivim na jedinične doze za primjenu u bolnicama.
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. 
Nemojte uzimati Aprovel ako ste alergični na irbesartan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) ako ste trudni više od 3 mjeseca (također se preporučuje izbjegavati Aprovel i u ranoj trudnoći - vidjeti dio o trudnoći) ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje krvnog tlaka koji sadrži aliskiren
Studies have not been performed in patients with severe hepatic impairment. 
Nisu provedena ispitivanja u bolesnika s teškim oštećenjem funkcije jetre.
In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed. 
Smanjenje razine hemoglobina*, koje nije bilo klinički značajno, zabilježeno je u 1,7% hipertenzivnih bolesnika s uznapredovalom dijabetičkom bubrežnom bolešću koji su primali irbesartan.
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). 
Lijekovi koji sadrže aliskiren ili ACE inhibitori: podaci iz kliničkih ispitivanja pokazali su da je dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS) kombiniranom primjenom ACE inhibitora, blokatora angiotenzin II receptora ili aliskirena povezana s većom učestalošću štetnih događaja kao što su hipotenzija, hiperkalemija i smanjena bubrežna funkcija (uključujući akutno zatajenje bubrega) u usporedbi s primjenom samo jednog lijeka koji djeluje na RAAS (vidjeti dijelove 4.3, 4.4 i 5.1).
Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available. 
Dostupna su i pakiranja s 56 x 1 filmom obloženom tabletom u blisterima djeljivim na jedinične doze za primjenu u bolnicama.
Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses. 
Pri preporučenim dozama irbesartan ne utječe značajno na razinu serumskog kalija.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started. 
Ako se utvrdi trudnoća, mora se odmah prekinuti terapija antagonistima receptora angiotenzina II te, ako je to primjereno, uvesti drugu terapiju.
Uncommon: diarrhoea, dyspepsia/heartburn Not known: 
Manje često: proljev, dispepsija/žgaravica Nepoznato:
 The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188. 
Drugi sastojci su mikrokristalična celuloza, umrežena karmelozanatrij, laktoza hidrat, magnezijev stearat, koloidni hidratizirani silicijev dioksid, prethodno geliran kukuruzni škrob i poloksamer 188. Vidjeti dio 2., „Aprovel sadrži laktozu”
Valsartan 
KUTIJA
However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. 
Međutim, u bolesnika na hemodijalizi i u bolesnika starijih od 75 godina može se razmotriti započinjanje terapije dozom od 75 mg.
Cartons of 56 x 1 tablet in PVC/PVDC/Aluminium perforated unit dose blisters. 
Kutija s 56 x 1 tabletom u PVC/PVDC/aluminij perforiranim blisterima djeljivim na jedinične doze.
Cardiac disorders Uncommon: tachycardia Vascular disorders Common: 
Srčani poremećaji Manje često: tahikardija Krvožilni poremećaji Često:
Sun 
NED
Aprovel 150 mg film-coated tablets irbesartan 
Aprovel 150 mg filmom obložene tablete irbesartan
Aprovel 300 mg film-coated tablets irbesartan 
Aprovel 300 mg filmom obložene tablete irbesartan
Warning and precautions Talk to your doctor before taking Aprovel 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 Aprovel for diabetic kidney disease. 
ako Vas muči prekomjerno povraćanje ili proljev ako imate problema s bubrezima ako imate srčanih problema ako uzimate Aprovel zbog dijabetičke bolesti bubrega.
Cartons of 56 x 1 film-coated tablet in PVC/PVDC/Aluminium perforated unit dose blisters. 
Kutija s 56 x 1 filmom obloženom tabletom u PVC/PVDC/aluminij perforiranim blisterima djeljivim na jedinične doze.
CHINOIN PRIVATE CO. LTD. Lévai u.5. 
Lévai u.5.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate. 
Jezgra tablete: laktoza hidrat celuloza, mikrokristalična karmelozanatrij, umrežena hipromeloza silicijev dioksid magnezijev stearat
Tablet core: 
Mehanizam djelovanja:
Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect. 
Za učinak liječenja ocjenjivane su podskupine prema spolu, rasi, dobi, trajanju šećerne bolesti, početnom krvnom tlaku, serumskom kreatininu i brzini izlučivanja albumina.U podskupinama žena i pripadnika crne rase, koji su činili 32% odnosno 26% ukupne populacije u ispitivanju, nisu bili vidljivi povoljni učinci na bubrege, premda to intervali pouzdanosti nisu isključivali.
Excipient with known effect: 30.75 mg of lactose monohydrate per tablet. 
Pomoćna tvar s poznatim učinkom: 30,75 mg laktoze hidrata po tableti.
Excipient with known effect: 61.50 mg of lactose monohydrate per tablet. 
Pomoćna tvar s poznatim učinkom: 61,50 mg laktoze hidrata po tableti.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5). 
Općenito: u bolesnika u kojih vaskularni tonus i funkcija bubrega ovise najviše o aktivnosti reninangiotenzin-aldosteronskog sustava (npr. bolesnici s teškim kongestivnim zatajenjem srca ili postojećom bolešću bubrega, uključujući stenozu bubrežne arterije) liječenje inhibitorima angiotenzin konvertirajućeg enzima ili antagonistima receptora angiotenzina II, koji utječu na taj sustav, povezano je s pojavom akutne hipotenzije, azotemije, oligurije i rijetko, akutnim zatajenjem bubrega(vidjeti dio 4.5).
Excipient with known effect: 25.50 mg of lactose monohydrate per film-coated tablet. 
Pomoćna tvar s poznatim učinkom: 25,50 mg laktoze hidrata po filmom obloženoj tableti.
Excipient with known effect: 15.37 mg of lactose monohydrate per tablet. 
Pomoćna tvar s poznatim učinkom: 15,37 mg laktoze hidrata po tableti.
Excipient with known effect: 102.00 mg of lactose monohydrate per film-coated tablet. 
Pomoćna tvar s poznatim učinkom: 102,00 mg laktoze hidrata po filmom obloženoj tableti.
Package leaflet: Information for the user Aprovel 75 mg tablets irbesartan 
Uputa o lijeku: Informacija za korisnika Aprovel 75 mg tablete irbesartan
Aprovel 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets. 
Aprovel 75 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84, 90 ili 98 filmom obloženih tableta.
Aprovel 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Aprovel 75 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
Package leaflet: Information for the user Aprovel 75 mg film-coated tablets irbesartan 
Uputa o lijeku: Informacija za korisnika Aprovel 75 mg filmom obložene tablete irbesartan
Excipient with known effect: 51.00 mg of lactose monohydrate per film-coated tablet. 
Pomoćna tvar s poznatim učinkom: 51,00 mg laktoze hidrata po filmom obloženoj tableti.
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Poloxamer 188 
6.1 Popis pomoćnih tvari celuloza, mikrokristalična karmelozanatrij, umrežena laktoza hidrat magnezijev stearat silicijev dioksid, koloidni, hidratizirani kukuruzni škrob, prethodno geliran poloksamer 188
Aprovel 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Aprovel 300 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
Aprovel 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Aprovel 150 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
Package leaflet: Information for the user Aprovel 150 mg tablets irbesartan 
Uputa o lijeku: Informacija za korisnika Aprovel 150 mg tablete irbesartan
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA Aprovel 150 mg tablete irbesartan NAZIV NOSITELJA
Package leaflet: Information for the user Aprovel 300 mg tablets irbesartan 
Uputa o lijeku: Informacija za korisnika Aprovel 300 mg tablete irbesartan
What Aprovel looks like and contents of the pack Aprovel 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side. 
Aprovel 75 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2771 na drugoj strani.
Thu 
ČET
What Aprovel looks like and contents of the pack Aprovel 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side. 
Aprovel 75 mg filmom obložene tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2871 na drugoj strani.
Package leaflet: Information for the user Aprovel 150 mg film-coated tablets irbesartan 
Uputa o lijeku: Informacija za korisnika Aprovel 150 mg filmom obložene tablete irbesartan
Marketing Authorisation Holder: sanofi-aventis groupe 54, rue La Boétie 
Nositelj odobrenja za stavljanje lijeka u promet: sanofi-aventis groupe
Musculoskeletal and connective tissue disorders 
Poremećaji bubrega i mokraćnog sustava
Drug substance* 
ortostatska hipotenzija*
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of irbesartan. 
Jedna filmom obložena tableta sadrži 75 mg irbesartana.
NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET sanofi-aventis groupe ROK VALJANOSTI
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. 
U bolesnika koji imaju visoki krvni tlak i boluju od šećerne bolesti tipa 2 preporučena doza održavanja za liječenje pridružene bolesti bubrega iznosi 300 mg (dvije tablete na dan) jedanput na dan.
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease. 
U bolesnika koji imaju visoki krvni tlak i boluju od šećerne bolesti tipa 2 preporučena doza održavanja za liječenje pridružene bolesti bubrega iznosi 300 mg (četiri tablete na dan) jedanput na dan.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan. 
Jedna filmom obložena tableta sadrži 150 mg irbesartana.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA Aprovel 75 mg tablete irbesartan NAZIV NOSITELJA
What Aprovel looks like and contents of the pack Aprovel 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side. 
Aprovel 300 mg filmom obložene tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2873 na drugoj strani.
Cartons of 98 tablets in PVC/PVDC/Aluminium blisters. 
Kutijas 98 tableta u PVC/PVDC/aluminij blisterima.
fatigue Uncommon: chest pain 
umor Manje često: bol u prsištu Pretrage
NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 75 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate. 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA NAZIV LIJEKA Aprovel 75 mg tablete irbesartan NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 75 mg irbesartana POPIS POMOĆNIH TVARI
Package leaflet: Information for the user Aprovel 300 mg film-coated tablets irbesartan 
Uputa o lijeku: Informacija za korisnika Aprovel 300 mg filmom obložene tablete irbesartan
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA Aprovel 300 mg tablete irbesartan NAZIV NOSITELJA
Aprovel 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets. 
Aprovel 150 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84 i 98 filmom obloženih tableta.
NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg film-coated tablets. 
Aprovel 75 mg filmom obložene tablete
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease. 
U bolesnika koji imaju visoki krvni tlak i boluju od šećerne bolesti tipa 2 preporučena doza održavanja za liječenje pridružene bolesti bubrega iznosi 300 mg jedanput na dan.
EU/1/97/046/011 - 14 tablets EU/1/97/046/004 - 28 tablets EU/1/97/046/005 - 56 tablets EU/1/97/046/014 - 56 x 1 tablets EU/1/97/046/006 - 98 tablets 
EU/1/97/046/011 - 14 tableta EU/1/97/046/004 - 28 tableta EU/1/97/046/005 - 56 tableta EU/1/97/046/014 - 56 x 1 tableta EU/1/97/046/006 - 98 tableta
Each tablet contains: irbesartan 75 mg 
Jedna tableta sadrži 75 mg irbesartana
Aprovel 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets. 
Aprovel 300 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84 i 98 filmom obloženih tableta.