natgillin/translations-raw huggingface dataset:
In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from 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).
In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function.
U tom će Vam slučaju Vaš liječnik možda raditi redovite pretrage krvi, posebno određivanje koncentracije kalija u krvi u slučaju oslabljene funkcije bubrega.
Teva Santé Tél: +33 155917800
Tél: +33 155917800
None of these increases were associated with identifiable clinical musculoskeletal events.
Niti jedan od tih slučajeva nije povezan s poremećajima mišićno-koštanog sustava koje je bilo moguće utvrditi.
At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
Pri vrlo visokim dozama (≥ 500 mg/kg/dan) irbesartan je izazvao degenerativne promjene na bubrezima (poput intersticijskog nefritisa, tubularne distenzije, bazofilnih tubula, povećane koncentracije ureje i kreatinina u plazmi) kod štakora i makaki majmuna, što se smatra sekundarnim učinkom, uz hipotenzivni učinak lijeka koji dovodi do smanjenja perfuzije bubrega.
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.
Popis nuspojava: 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.
Renal impairment and kidney transplantation
Oštećena funkcija bubrega i transplantacija bubrega
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of irbesartan 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.
How to take Irbesartan Teva
Kako uzimati Irbesartan Teva
In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-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).
U bolesnika u kojih vaskularni tonus i funkcija bubrega ovise najviše o aktivnosti renin-angiotenzinaldosteronskog 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 (vidjeti dio 4.5).
Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) i VA NEPHRON-D (eng. The Veterans Affairs Nephropathy in Diabetes)) ispitivala su primjenu kombinacije ACE inhibitora s blokatorom angiotenzin
14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 80 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets 100 film-coated tablets 50 x 1 film-coated tablets 56 x 1 film-coated tablets
7 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 56 filmom obloženih tableta 60 filmom obloženih tableta 80 filmom obloženih tableta 84 filmom obloženih tableta 90 filmom obloženih tableta 98 filmom obloženih tableta 100 filmom obloženih tableta
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan (see section 4.4).
Prethodno liječenje visokim dozama diuretika može dovesti do smanjenja volumena i rizika od pojave hipotenzije prilikom uvođenja terapije irbesartanom (vidjeti dio
Irbesartan Teva is used in adult patients to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
Irbesartan Teva primjenjuje se u odraslih bolesnika za liječenje visokog krvnog tlaka (esencijalne hipertenzije) zaštitu bubrega u bolesnika sa šećernom bolesti tipa 2 koji imaju povišeni krvni tlak i laboratorijski dokazanu oslabljenu bubrežnu funkciju.
Regression to normoalbuminuria (< 30 mg/day) was more frequent in the irbesartan 300 mg group (34 %) than in the placebo group (21 %).
30 mg/dan) bila je češća u skupini koja je primala irbesartan 300 mg (34%) nego u skupini koja je primala placebo (21%).
As with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with irbesartan, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Kao i kod ostalih lijekova koji djeluju na renin-angiotenzin-aldosteronski sustav, tijekom liječenja irbesartanom može se pojaviti hiperkalijemija, posebice ako je prisutna i oštećena bubrežna funkcija, izražena proteinurija zbog dijabetičke bubrežne bolesti i/ili zatajenje srca.
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
• Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, croscarmellose sodium, colloidal hydrated silica and magnesium stearate.
• Jezgra tablete: povidon, prethodno geliran kukuruzni škrob, poloksamer 188, mikrokristalična celuloza, umrežena karmelozanatrij, koloidni hidratizirani silicijev dioksid i magnezijev stearat.
What you need to know before you take Irbesartan Teva Do not take Irbesartan Teva
Što morate znati prije nego počnete uzimati Irbesartan Teva Kako uzimati Irbesartan Teva
and 5.1).
4.4, 4.5 i 5.1).
For therapeutic doses of irbesartan in humans, the hyperplasia/hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Nije izgledno da je, pri terapijskim dozama irbesartana u ljudi, hiperplazija/hipertrofija bubrežnih jukstaglomerularnih stanica od bilo kakve važnosti.
Not known (frequency cannot be estimated from the available data): feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis) and severe allergic reactions (anaphylactic shock).
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): vrtoglavica, glavobolja, promjene osjeta okusa, zvonjava u ušima, grčevi u mišićima, bol u zglobovima i mišićima, smanjen broj krvnih pločica, poremećaj funkcije jetre, povišena razina kalija u krvi, oslabljena funkcija bubrega, upala malih krvnih žila koja uglavnom zahvaća kožu (stanje poznato kao leukocitoklastični vaskulitis) i teške alergijske reakcije (anafilaktički šok).
Swensweg 5, Postbus 552 2003 RN Haarlem The Netherlands
Swensweg 5, Postbus 552
In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease.
U hipertenzivnih bolesnika sa šećernom bolesti tipa 2 liječenje treba započeti sa 150 mg irbesartana jedanput na dan i dozu titrirati do 300 mg jedanput na dan, što je doza održavanja koja se preporučuje za liječenje bubrežne bolesti.
Because no information is available regarding the use of irbersartan during breast-feeding, irbesartan 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 irbesartana tijekom dojenja, ne preporučuje se njegova primjena tijekom dojenja i prednost treba dati drugoj terapiji s boljim profilom sigurnosti primjene,
There is no clinical experience in patients with severe hepatic impairment.
Nema kliničkih iskustava s bolesnicima s teškim oštećenjem funkcije jetre.
Pack sizes of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98, 100 film-coated tablets in non-perforated blisters.
Pakiranja sa 7, 14, 28, 30, 56, 60, 80, 84, 90, 98 i 100 filmom obloženih tableta u neperforiranim blisterima.
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.
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.
Irbesartan Teva 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.
Irbesartan Teva ne preporučuje se u ranoj trudnoći te se ne smije uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi Vašem djetetu uzimate li ga u tom razdoblju.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/L) occurred in 29.4 % of the patients in the irbesartan 300 mg group and 22 % of the patients in the placebo group.
U bolesnika sa šećernom bolesti i hipertenzijom, mikroalbuminurijom i normalnom bubrežnom funkcijom, hiperkalijemija (≥ 5,5 mEq/L) se razvila kod 29,4% bolesnika koji su primali 300 mg irbesartana i kod 22% bolesnika u placebo skupini.
Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows: 3.8 mm Hg (low dose), 3.2 mm Hg (medium dose), 5.6 mm Hg (high dose).
Prilagođena srednja vrijednost promjene dijastoličkog krvnog tlaka u sjedećem položaju u „najnižoj točki djelovanja“ (engl. seated diastolic blood pressure, SeDBP) bila je sljedeća: 3,8 mmHg (niska doza), 3,2 mmHg (srednja doza) i 5,6 mmHg (visoka doza).
How to store Irbesartan Teva
Kako čuvati Irbesartan Teva
Potassium supplements and potassium-sparing diuretics Based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Na temelju iskustva s ostalim lijekovima koji utječu na renin-angiotenzinski sustav, istodobno uzimanje diuretika koji štede kalij, nadomjestaka kalija, nadomjestaka soli koji sadrže kalij ili ostalih lijekova koji mogu povećati serumsku razinu kalija (npr. heparin) može izazvati porast serumskog kalija te se, stoga, ne preporučuje (vidjeti dio 4.4.).
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.
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.
In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function if you are going to have an operation (surgery) or be given anaesthetics if you are taking any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems - aliskiren
U tom će Vam slučaju Vaš liječnik možda raditi redovite pretrage krvi, posebno određivanje koncentracije kalija u krvi u slučaju oslabljene funkcije bubrega ako trebate ići na operaciju (kirurški zahvat) ili trebate primiti anestetike ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog krvnog tlaka: - blokator angiotenzin II receptora (ARB) (nazivaju se i sartanima - primjerice valsartan, telmisartan, irbesartan), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću
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.
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)].
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)].
Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Zabilježen je neproporcionalan porast u oralnoj apsorpciji pri dozama većima od 600 mg (doza dvostruko veća od maksimalne preporučene doze): mehanizam za ovo je nepoznat.
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
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
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).
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)
In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
U kliničkim ispitivanjima hidroklorotiazid nije utjecao na farmakokinetiku irbesartana.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU
No dose adjustment is necessary in patients with impaired renal function.
Nije potrebna prilagodba doze u bolesnika s oštećenom funkcijom bubrega.
If you are more than 3 months pregnant (It is also better to avoid Irbesartan Teva in early pregnancy - see pregnancy section).
ako ste trudni više od 3 mjeseca (također se preporučuje izbjegavati Irbesartan Teva i u ranoj trudnoći - vidjeti dio o trudnoći).
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
II te treba, ako je to primjereno, započeti s alternativnom terapijom (vidjeti dijelove 4.3. i 4.6.).
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 mm Hg (low dose), 9.3 mm Hg (medium dose), 13.2 mm Hg (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 (engl. seated systolic blood pressure, SeSBP), iznosila je 11,7 mmHg (niska doza), 9,3 mmHg (srednja doza) i 13,2 mmHg (visoka doza).
Teva Pharma Belgium N.V./S.A/AG Tél/Tel: +32 38207373
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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 group.
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.
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).
mg/kg/dan u štakora i ≥ 100 mg/kg/dan u makaki majmuna) uzrokovale su smanjenje parametara crvenih krvnih stanica (eritrocita, hemoglobina, hematokrita).
Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
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if you are more than 3 months pregnant (it is also better to avoid Irbesartan Teva in early pregnancy - see pregnancy section).
ako ste trudni više od 3 mjeseca (preporučuje se, također, izbjegavati Irbesartan Teva i u ranoj trudnoći - vidjeti dio o trudnoći).
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.
selektivnim inhibitorima COX2, acetilsalicilatnom kiselinom (> 3 g/dan) i neselektivnim NSAIL) moguć je oslabljeni antihipertenzivni učinak.
In patients insufficiently controlled with 150 mg once daily, the dose of irbesartan can be increased to 300 mg, or other anti-hypertensive 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 irbesartana može se povećati na 300 mg ili se mogu dodati drugi antihipertenzivi (vidjeti dijelove 4.3,
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.
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.
Microcrystalline cellulose Croscarmellose sodium Silica, colloidal hydrated Magnesium stearate
celuloza, mikrokristalična karmelozanatrij, umrežena silicijev dioksid, koloidni, hidratizirani magnezijev stearat
No dose adjustment is necessary in patients with mild to moderate hepatic impairment.
Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
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 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.
vertigo, headache Ear and labyrinth disorder Not known:
Nepoznato: vrtoglavica, glavobolja Poremećaji uha i labirinta Nepoznato:
Irbesartan Teva slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Teva usporava slabljenje bubrežne funkcije u bolesnika koji imaju povišen krvni tlak i boluju od šećerne bolesti tipa 2.
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.
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.
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.
No dosage adjustment is necessary in female patients.
Stoga, nije potrebna prilagodba doziranja u žena.
Common (may affect up to 1in 10 people): 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 (mogu se javiti u manje od 1 na 10 osoba): omaglica, mučnina/povraćanje, umor i krvne pretrage mogu pokazati povišenu razinu enzima specifičnog za mišićnu i srčanu funkciju (enzim kreatinin kinaza).