natgillin/translations-raw huggingface dataset:
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 s većom učestalosti nego kod placeba.
The concomitant use of Sabervel with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1). 
Istodobna primjena Sabervel s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
Sabervel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. 
Sabervel usporava slabljenje bubrežne funkcije u bolesnika koji imaju povišen krvni tlak i boluju od šećerne bolesti tipa 2.
In 1,715 
Doze od 150
HOW TO TAKE SABERVEL 
Kako uzimati Sabervel
See leaflet for further information 
Dodatne informacije
Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing. 
Ograničena akumulacija irbesartana (< 20%) zabilježena je u plazmi nakon primjene opetovanih doza jedanput na dan.
If you forget to take Sabervel: 
Ako ste zaboravili uzeti Sabervel
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Sabervel (see section 4.4). 
Prethodno liječenje visokim dozama diuretika može dovesti do smanjenja volumena i rizika od pojave hipotenzije prilikom uvođenja terapije Sabervelom (vidjeti dio 4.4).
• Very common : if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium. 
• Vrlo često: ako imate povišen krvni tlak i šećernu bolest tipa 2 te bolest bubrega, krvne pretrage mogu pokazati povišene vrijednosti kalija.
(≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). 
do < 1/10); manje često (≥ 1/1.000 do < 1/100); rijetko (≥ 1/10.000 do < 1/1.000); vrlo rijetko (< 1/10.000).
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. 
Kao i s ACE inhibitorima, istodobna primjena antagonista angiotenzina II i nesteroidnih protuupalnih lijekova može povećati rizik od pogoršanja bubrežne funkcije, uključujući moguće akutno zatajenje bubrega i porast serumskog kalija, posebice u bolesnika s već postojećom slabom funkcijom bubrega.
15351 Pallini, Attiki, Greece 
15351 Pallini, Attiki, Grčka
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 
nedostatkom Lapp-laktaze ili malapsorpcijom glukoze-galaktoze ne smiju uzimati ovaj lijek.
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).
What Sabervel contains 
DODATNE INFORMACIJE Što Sabervel sadrži
The blood pressure lowering effect of irbesartan is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy. 
Učinak irbesartana na snižavanje krvnog tlaka vidljiv je unutar 1-2 tjedna, s maksimalnim učinkom za 46 tjedana od početka terapije.
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 jednodnevnog doziranja.
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 bila je placebom kontrolirana, dvostruko-slijepa studija morbiditeta u 590 bolesnika sa šećernom bolesti 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).
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%). 
318 djece i adolescenata s hipertenzijom u dobi od 6 do 16 godina pojavile su se sljedeći štetni događaji povezani s primjenom lijeka: glavobolja (7,9%), hipotenzija (2,2%), omaglica (1,9%), kašalj (0,9%).
There is no clinical experience in patients with severe hepatic impairment. 
Nema kliničkih iskustava u bolesnika s teškim oštećenjem funkcije jetre.
Unite d Kingdom Aspire Pharma Limited Tel: +44(0)1730 234527 
United Kingdom Aspire Pharma Limited Tel: +44(0)1730 234527
• Common : dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). 
• Često: omaglica, mučnina/povraćanje, umor a krvne pretrage mogu pokazati povišenu razinu enzima specifičnog za mišićnu i srčanu funkciju (enzim kreatinin kinaza).
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Sabervel, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. 
Hiperkalijemija: kao i kod ostalih lijekova koji djeluju na renin-angiotenzin-aldosteronski sustav, tijekom liječenja Sabervelom može se pojaviti hiperkalijemija, posebice ako je prisutna i oštećena bubrežna funkcija, izražena proteinurija zbog dijabetičke bubrežne bolesti i/ili zatajenje srca.
Ös te rreich Pharmathen S.A. 
Ös te rre ich Pharmathen S.A.
Pregnancy: Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. 
Trudnoća: tijekom trudnoće ne smiju se uvoditi antagonisti receptora angiotenzina II.
For oral use. 
Za peroralnu primjenu
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4). 
Dojenčad čije su majke uzimale antagoniste receptora angiotenzina II treba pažljivo pratiti zbog moguće hipotenzije (također vidjeti dijelove 4.3 i 4.4).
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. 
Smanjenje krvnog tlaka ispitivano je tijekom tri tjedna pri primjeni ciljanih titriranih doza od 0,5 mg/kg (niska doza), 1,5 mg/kg (srednja doza) i 4,5 mg/kg (visoka doza) irbesartana u 318 djece i adolescenata s hipertenzijom ili s rizikom od hipertenzije (šećerna bolest, hipertenzija u povijesti bolesti obitelji) u dobi od 6 do 16 godina.
Some side effects have been reported since marketing of Irbesartan Side 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, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis). 
Prijavljene su sljedeće nuspojave: glavobolja, poremećaji okusa, zvonjenje u ušima, grčevi u mišićima, bol u zglobovima i mišićima, poremećaj funkcije jetre, povišena razina kalija u krvi, oslabljena funkcija bubrega te upala malih krvnih žila koja uglavnom zahvaća kožu (stanje poznato kao leukocitoklastični vaskulitis).
Pregnancy and breast-feeding 
Trudnoća i dojenje Trudnoća
It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1). 
Takoder je indiciran za liječenje bubrežne bolesti u bolesnika s hipertenzijom i šećernom bolesti tipa 2 u sklopu antihipertenzivne terapije (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
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. 
Kada je ibesartan primijenjen istodobno s niskom dozom hidroklorotiazida (npr. 12,5 mg jedanput na dan), antihipertenzivni odgovor u bolesnika crne rase se približio onome u bolesnika bijele rase.
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 on the progression of renal disease and all-cause mortality were examined. 
U 1715 hipertenzivnih bolesnika sa šećernom bolesti tipa 2, proteinurijom ≥900 mg/dan i serumskim kreatininom u rasponu od 1,0 do 3,0 mg/dl ispitivan je dugotrajan učinak irbesartana (prosječno 2,6 godina) na progresiju bubrežne bolesti i svih uzroka mortaliteta.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
C OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
Sixty per cent (60%) of patients in the placebo group reached this target blood pressure whereas this figure was 76% and 78% in the irbesartan and amlodipine groups respectively. 
skupini koja je primala placebo 60% bolesnika postiglo je ciljni krvni tlak dok je ta vrijednost bila 76% u skupini koja je primala irbesartan, odnosno 78% u skupini koja je primala amlodipin.
Marketing Authorisation Holder: Pharmathen S.A, 
Nositelj odobrenja za stavljanje u promet gotovog lijeka: Pharmathen S.A,
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. 
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 bolesti 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.
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.
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 bolesti tipa 2 i bubrežnom bolesti: učinak irbesartana na događaje povezane s bubrezima i kardiovaskularnim sustavom nije bio ujednačen u svim podskupinama u analizi rezultata kliničkih ispitivanja bolesnika s uznapredovalom bubrežnom bolesti.
Do not use Sabervel after the expiry date which is stated on the carton and on the blister after EXP. 
Sabervel se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili blisteru.
However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. 
75 mg, posebice u hemodijaliziranih bolesnika i u bolesnika starijih od 75 godina.
In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i.e., uncommon) but in excess of placebo. 
U bolesnika koji boluju od hipertenzije i šećerne bolesti s mikroalbuminurijom, uz normalnu bubrežnu funkciju, prijavljene su ortostatska omaglica i ortostatska hipotenzija kod njih 0,5%, dakle manje često, ali s većom učestalošću nego kod placeba.
Sabervel 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). 
Ne smijete ga uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi Vašem djetetu ako ga uzimate u tom stadiju (vidjeti dio o trudnoći).
The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients 
vrlo često: pojavljuje se u najmanje 1 na 10 bolesnika ili više od toga često: najmanje 1 na 100, a manje od 1 na 10 bolesnika manje često: najmanje 1 na 1000, a manje od 1 na 100 bolesnika.
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 
U bolesnika sa šećernom bolesti koji su imali povišeni krvni tlak, kroničnu bubrežnu insuficijenciju i manifestnu proteinuriju, hiperkalijemija (≥ 5,5 mEq/L) se razvila u 46,3% bolesnika koji su primali irbesartan te u 26,3% bolesnika u placebo skupini.
significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects. 
zabilježen je značajan porast kreatin kinaze u plazmi u 1,7% bolesnika koji su uzimali irbesartan.
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality. 
Irbesartan značajno snižava relativni rizik u primarnoj kombiniranoj mjeri ishoda udvostručenog serumskog kreatinina,
Metabolism and nutrition disorders: Not known: 
Poremećaji metabolizma i prehrane:
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 s hipovolemijom i/ili hiponatrijemijom zbog snažne diuretske terapije, restrikcijske dijete sa smanjenim unosom soli, proljeva ili povraćanja.
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. 
urtikarija), kao i lokalizirano oticanje lica, usnica i/ili jezika kod bolesnika koji su uzimali irbesartan.
Renal impairment: no dosage adjustment is necessary in patients with impaired renal function. 
Oštećenje funkcije bubrega: nije potrebna prilagodba doze u bolesnika s oštećenom funkcijom bubrega.
Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered. 
Oštećena funkcija bubrega: u bolesnika s oštećenom bubrežnom funkcijom ili u bolesnika na hemodijalizi, farmakokinetički parametri irbesartana nisu bitno promijenjeni.
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). 
Prilagođena srednja vrijednost dijastoličkog krvnog tlaka u sjedećem položaju (sjDKT) u «najnižoj točki djelovanja» bila je sljedeća: 3,8 mmHg (niska doza), 3,2 mmHg (srednja doza) i 5,6 mmHg (visoka doza).
Each tablet of Sabervel 75 mg contains 75 mg irbesartan. 
• Jedna Sabervel 75 mg tableta sadrži 75 mg irbesartana.
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). 
U bolesnika koji nisu prikladno kontrolirani samo s irbesartanom, dodatak niske doze hidroklorotiazida (12,5 mg) irbesartanu jedanput na dan rezultira dodatnim placebo prilagođenim sniženjem krvnog tlaka za 7-10/3-6 mm Hg (sistolički/dijastolički).
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 izlučivanju albumina.
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 ishod manifestne proteinurije u odnosu na skupinu koja je primala placebo (14,9%) ili na skupinu koja je primala 150 mg irbesartana
Side effects reported in clinical studies for patients treated with Irbesartan were: 
U kliničkim ispitivanjima na bolesnicima liječenima irbesartanom prijavljene su sljedeće nuspojave:
Rebound hypertension has not been observed. 
(rebound) hipertenzije.
B e lgië/Belgique/Belgien Pharmathen S.A. 
B e lgië /B e lgique /B e lgie n Pharmathen S.A.
INFORMATION IN BRAILLE Sabervel 75 mg 
16. PODACI NA BRAILLEOVOM PISMU Sabervel 75 mg
very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare 
Učestalost nuspojava u nastavku teksta definira se na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1.000 do < 1/100); rijetko (≥ 1/10.000 do < 1/1.000); vrlo rijetko (<
Pharmacotherapeutic group: Angiotensin-II antagonists, plain. 
5.1 Farmakodinamička svojstva Farmakoterapijska skupina: antagonisti angiotenzina II, čisti.
• potassium supplements 
• nadomjeske kalija
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems. 
• ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog krvnog tlaka: - ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću.
• Patients with high blood pressure and type 2 diabetes with kidney disease 
Bolesnici s visokim krvnim tlakom i šećernom bolešću tipa 2 te bolešću bubrega
Exposure to AIIRA therapy during the second and third trimesters is known to induce human fetotoxicity (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
Reproductive system and breast disorders: Uncommon: 
Poremećaji reproduktivnog sustava i dojki: Manje često:
Each tablet of Sabervel 150 mg contains 150 mg irbesartan. 
• Jedna Sabervel 150 mg tableta sadrži 150 mg irbesartana.
Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered. 
Oštećena funkcija jetre: u bolesnika s blagom do umjerenom cirozom farmakokinetički parametri irbesartana nisu bitno promijenjeni.
Titanium dioxide (E171) 
Film-ovojnica: titanijev dioksid (E171) hipromeloza makrogol 400
Following oral or intravenous administration of 
Nakon oralne ili intravenske primjene 14
Each tablet of Sabervel 300 mg contains 300 mg irbesartan. 
• Jedna Sabervel 300 mg tableta sadrži 300 mg irbesartana.
INFORMATION IN BRAILLE Sabervel 300 mg 
16. PODACI NA BRAILLEOVOM PISMU Sabervel 300 mg
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 zabilježen je reverzibilan porast koncentracije serumskog litija i njegove toksičnosti.
The demonstration of renal benefit of Sabervel 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). 
Dokaz koristi Sabervela na bubrežnu funkciju u hipertenzivnih bolesnika sa šećernom bolesti tipa 2 zasniva se na ispitivanjima u kojima se irbesartan prema potrebi uzimao kao dopuna ostalim antihipertenzivnim lijekovima za postizanje ciljnog krvnog tlaka (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section 
U bolesnika na hemodijalizi treba razmotriti započinjanje liječenja nižom početnom dozom (75 mg)
Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria. 
Klinička studija «Učinak irbesartana na mikroalbuminuriju u hipertenzivnih bolesnika sa šećernom bolesti tipa 2 (IRMA 2)» pokazuje da 300 mg irbesartana odgađa progresiju izražene proteinurije u bolesnika s mikroalbuminurijom.
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Sabervel” and “Warnings and precautions”). 
<primjenjivati> Sabervel” i “Upozorenja i mjere opreza”).
mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group. 
se razvila kod 29,4% bolesnika koji su primali 300 mg irbesartana i kod 22% bolesnika u placebo skupini.
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovoga lijeka, obratite se svom liječniku ili ljekarniku.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 
mikroalbuminurijom i normalnom bubrežnom funkcijom, hiperkalijemija (≥ 5,5 mEq/L)
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 (sjSKT) kod najniže koncentracije u krvi, iznosila je 11,7 mmHg (niska doza), 9,3 mmHg (srednja doza) i 13,2 mmHg
Sabervel is for oral use. 
Način primjene Sabervel je namijenjen za primjenu kroz usta.
INFORMATION IN BRAILLE Sabervel 150 mg 
16. PODACI NA BRAILLEOVOM PISMU Sabervel 150 mg
Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment. 
Oštećenje funkcije jetre: nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
What Sabervel looks like and contents of the pack Sabervel 300 mg film-coated tablets are white, concave, round, film-coated tablets with 11 mm diameter. 
Kako Sabervel izgleda i sadržaj pakovanja Sabervel 300 mg filmom obložene tablete su bijele, konkavne, okrugle filmom obložene tablete promjera 11 mm .