natgillin/translations-raw huggingface dataset:
• if you are going to have an operation (surgery) or be given anaesthetics.
• Ako trebate ići na bilo kakav kirurški zahvat ili trebate primiti anestetike.
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)].
Oko 33% bolesnika u irbesartan skupini dostiglo je primarni složeni studijski ishod za bubrežnu bolest, u usporedbi sa 39% u placebo i 41% u amlodipin skupini [20% smanjenje relativnog rizika u odnosu na placebo (p=0,024) i 23% smanjenje relativnog rizika u usporedbi s amplodipinom (p=0,006)].
Studies in animals indicate that the radiolabeled irbesartan is detected in rat and rabbit fetuses.
Ispitivanja na životinjama pokazuju da je radioaktivno označeni ibesartan otkriven u štakora i fetusa kunića.
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 bolesti tipa 2 i bubrežnom bolešću također su prijavljeni omaglica i nizak krvni tlak nakon podizanja iz sjedećeg ili ležećeg položaja, bol u zglobovima i mišićima i smanjene razine proteina u crvenim krvnim stanicama (hemoglobina).
Because no information is available regarding the use of Sabervel during breast-feeding, Sabervel is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Budući da nema dostupnih podataka o upotrebi Sabervela tijekom dojenja, ne preporučuje se njegova primjena tijekom dojenja i prednost treba dati drugoj terapiji s boljim profilom sigurnosti primjene, osobito kada se doji novorođenče ili nedonošče.
No studies on the effects on the ability to drive and use machines have been performed.
Nisu provedena ispitivanja o utjecaju na sposobnost upravljanja vozilima i rada na strojevima.
• if you get excessive vomiting or diarrhoea
• Ako Vas muči prekomjerno povraćanje ili proljev.
In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%).
U placebom kontroliranim ispitivanjima, koja su provedena na bolesnicima s hipertenzijom, ukupna incidencija štetnih događaja nije se razlikovala između skupine koja je uzimala irbesartan (56,2%) i placebo skupine (56,5%).
Sabervel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Sabervel sprječava vezanje angiotenzina II na te receptore, uzrokujući opuštanje krvnih žila i sniženje krvnog tlaka.
The total body and renal clearance are 157 - 176 and 3 - 3.5 ml/min, respectively.
Ukupni tjelesni klirens iznosi 157-176, a bubrežni klirens 3-3,5 ml/min.
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 bilo utjecaja na plodnost i reprodukcijsku sposobnost u ispitivanjima na mužjacima i ženkama štakora, čak i pri oralnim dozama irbesartana koje katkad uzrokuju roditeljsku toksičnost (od 50 do 650 mg/kg/dan), uključujući i smrtnost pri najvišoj dozi.
Hypersensitivity to the active substance, or to any of the excipients (see section 6.1).
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari (vidjeti dio 6.1).
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 COX2, acetilsalicilnom kiselinom (> 3 g/dan) i neselektivnim NSAIL) moguć je oslabljeni antihipertenzivni učinak.
Irbesartan is excreted in the milk of lactating rats.
Irbesartan se izlučuje u mlijeku kod štakorica.
In patients insufficiently controlled with 150 mg once daily, the dose of Sabervel 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 Sabervela može se povećati na 300 mg ili se mogu dodati drugi antihipertenzivi (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
UVJETI ILI OGRANIČENJA VEZANA UZ SIGURNU I UČINKOVITU PRIMJENU
28 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets
28 filmom obloženih tableta 56 filmom obloženih tableta 90 filmom obloženih tableta 98 filmom obloženih tableta
• medicines containing lithium
• lijekove koji sadrže litij
Sabervel 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.
Sabervel se ne preporučuje u ranoj trudnoći te se ne smije uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi
Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).
Tijekom sljedeća dva tjedna kada su bolesnici ponovo randomizirani ili na lijek ili na placebo, bolesnici na placebu imali su porast od 2,4 i 2,0 mmHg za sjSKT i sjDKT, u usporedbi s promjenom od +0,1 i -0,3 mmHg za bolesnike na svim dozama irbesartana (vidjeti dio 4.2.).
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however irbesartan has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Diuretici i drugi antihipertenzivni lijekovi: drugi antihipertenzivi mogu pojačati hipotenzivni učinak irbesartana; irbesartan se, međutim, pokazao sigurnim za primjenu s ostalim antihipertenzivnim lijekovima poput beta blokatora, dugodjelujućih blokatora kalcijevih kanala i tiazida.
• salt substitutes containing potassium
• nadomjeske soli koji sadrže kalij
Lithium: the combination of lithium and Sabervel is not recommended (see section 4.5).
Litij: ne preporučuje se kombinacija litija i Sabervela (vidjeti dio 4.5).
6, Dervenakion str., 15351 Pallini Attiki, Greece Tel.: +30 210 66 65 067
6, Dervenakion str., 15351 Pallini Attiki, Grčka Tel.: +30 210 66 65 067
hypersensitivity reactions such as angioedema, rash, urticaria
Reakcije preosjetljivosti kao što su angioedem, osip, urtikarija
While this is not documented with Sabervel, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Iako to još nije potvrđeno za Sabervel, sličan učinak može se očekivati s antagonistima receptora angiotenzina II.
C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
irbesartana, oko 20% radioaktivnosti pojavilo se u mokraći, a ostatak u stolici.
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.