FrancophonIA/ELRC3.0 huggingface dataset:
English: Azilsartan is not removed by dialysis.
Slovenian: Z dializo se azilsartan ne odstrani.
English: Activated renin-angiotensin-aldosterone system (RAAS) In patients whose vascular tone and renal function depend predominantly on the activity of the RAAS (e.g. patients with congestive heart failure, severe renal impairment or renal artery stenosis), treatment with medicinal products that affect this system, such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists, has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure.
Slovenian: Aktiviran sistem renin-angiotenzin-aldosteron (RAAS) Pri bolnikih, pri katerih sta žilni tonus in delovanje ledvic odvisna predvsem od delovanja sistema RAAS (npr. pri bolnikih s kongestivnim srčnim popuščanjem, hudo ledvično okvaro ali stenozo ledvične arterije) je bilo zdravljenje z zdravili, ki vplivajo na ta sistem, kot so zaviralci angiotenzinske konvertaze (ACE) ali antagonisti angiotenzina II, povezano z akutno hipotenzijo, azotemijo, oligurijo ali redkeje, z akutno odpovedjo ledvic.
English: Uncommon side effects (may affect up to 1 in 100 people): - Low blood pressure, which may make you feel faint or dizzy - Feeling tired - Swelling of the hands, ankles or feet (peripheral oedema) - Skin rash and itching - Nausea - Muscle spasms - Increased serum creatinine in the blood (an indicator of kidney function) - Increased uric acid in the blood.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): - nizek krvni tlak, zaradi katerega se lahko pojavi omedlevica ali omotica - utrujenost - zatekanje rok, gležnjev ali nog (periferni edem) - kožni izpuščaj in srbenje - siljenje na bruhanje - mišični krči - zvišanje vrednosti serumskega kreatinina v krvi (pokazatelj delovanja ledvic) - zvišanje vrednosti sečne kisline v krvi.
English: Monitoring of serum potassium should be undertaken as appropriate (see section 4.4).
Slovenian: Potrebno je stalno spremljanje koncentracije kalija v serumu (glejte poglavje 4.4).
English: The incidence of elevations in serum creatinine following treatment with Edarbi was similar to placebo in the randomised placebo-controlled monotherapy studies.
Slovenian: Pogostnost zvišanih koncentracij serumskega kreatinina po zdravljenju z zdravilom Edarbi je bila v randomizirani, s placebom kontrolirani študiji monoterapije podobna kot pri placebu.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of lithium and angiotensin-converting enzyme inhibitors.
Slovenian: Poročajo o reverzibilnem povečanju serumske koncentracije in toksičnosti litija med sočasno uporabo litija in zaviralcev angiotenzinske konvertaze.
English: Intravascular volume depletion
Slovenian: Zmanjšan intravaskularni volumen
English: Pharmacokinetics of azilsartan do not differ significantly between males and females.
Slovenian: Farmakokinetika azilsartana se med moškimi in ženskami ni pomembno razlikovala.
English: The antihypertensive effect of azilsartan medoxomil occurred within the first 2 weeks of dosing with the full effect achieved by 4 weeks.
Slovenian: Antihipertenzivni učinek medoksomilazilsartanata se je pokazal v prvih dveh tednih zdravljenja, poln učinek pa je bil dosežen v štirih tednih.
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Slovenian: Uporaba antagonistov angiotenzina II je kontraindicirana v drugem in tretjem trimesečju nosečnosti (glejte poglavji 4.3 in 4.4).
English: Elimination Following an oral dose of
Slovenian: Izločanje Po peroralnem odmerku s
English: Kidney transplantation
Slovenian: Presaditev ledvic
English: As with other angiotensin II receptor antagonists the combination of lithium and Edarbi is not recommended (see section 4.5).
Slovenian: Kot pri vseh drugih antagonistih angiotenzina II, kombinacije litija in zdravila Edarbi ne priporočamo (glejte poglavje 4.5).
English: There are no data from the use of azilsartan medoxomil in pregnant women.
Slovenian: Ni podatkov o uporabi a medoksomilazilsartanata pri nosečnicah.
English: No increase (+5%) was observed in end-stage renal disease patients who were dialysed.
Slovenian: Pri bolnikih na dializi v zaključni fazi bolezni ledvic povečanje ni bilo opaženo (+5 %).
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately and, if appropriate, alternative therapy should be started.
Slovenian: Ob potrjeni nosečnosti je treba zdravljenje z antagonisti angiotenzina II takoj prekiniti in, če je primerno, uvesti alternativno zdravljenje.
English: Dose dependent adverse events including dizziness, hypotension and serum creatinine elevations were more frequent with diuretic coadministration compared with Edarbi alone, while hypokalemia was less frequent compared with diuretic alone.
Slovenian: Od odmerka odvisni neželeni učinki, kot so omotica, hipotenzija in zvišana serumska koncentracija kreatinina, so bili pogostejši pri sočasnem dajanju diuretika kot pri zdravljenju samo z zdravilom Edarbi, medtem ko je bila hipokaliemija manj pogosta kot pri zdravljenju samo z diuretikom.
English: The tablets are white round debossed with “ASL” on one side and either “20”, “40” or “80” on the other.
Slovenian: Tablete so bele, okrogle, z vtisnjeno oznako “ASL” na eni in številko “20”, “40” ali “80” na drugi strani.
English: In addition, plasma esterases are involved in the hydrolysis of azilsartan medoxomil to azilsartan.
Slovenian: Poleg tega pri hidrolizi medoksomilazilsartanata v azilsartan sodelujejo tudi plazemske esteraze.
English: However, there is no clinical experience in patients with severe renal impairment or end stage renal disease (see section 4.2).
Slovenian: Kliničnih izkušenj pri bolnikih s hudo ledvično okvaro ali s končno stopnjo ledvične bolezni ni (glejte poglavje 4.2).
English: Hypovolemia should be corrected prior to administration of Edarbi, or the treatment should start under close medical supervision, and consideration can be given to a starting dose of 20 mg.
Slovenian: Hipovolemijo je potrebno pred dajanjem zdravila Edarbi odpraviti, ali pa je treba zdravljenje uvesti pod skrbnim zdravniškim nadzorom.
English: Clinic SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) (LOCF) Study 1
Slovenian: Klinični SKT: Povprečna sprememba NK od izhodišča do 6. tedna (mm Hg) (ZOPN) Študija 1
English: Serum creatinine
Slovenian: Koncentracija kreatinina v serumu
English: Edarbi contains an active substance called azilsartan medoxomil and belongs to a class of medicines called angiotensin II receptor antagonists (AIIRAs).
Slovenian: Zdravilo Edarbi vsebuje zdravilno učinkovino medoksomilazilsartanat in sodi v razred zdravil, ki se imenujejo antagonisti angiotenzina II.
English: Hypotension in volume- and /or salt-depleted patients In patients with marked volume- and/or salt-depletion (e.g. patients with vomiting, diarrhoea or taking high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Edarbi.
Slovenian: Hipotenzija in bolniki z zmanjšanim volumnom in/ali izgubo soli Pri bolnikih z izrazitim zmanjšanim volumnom ali z izgubo soli (npr. pri bolnikih, ki bruhajo, imajo drisko ali jemljejo visoke odmerke diuretikov) lahko po začetku zdravljenja z zdravilom Edarbi pride do pojava simptomatične hipotenzije.
English: Because no information is available regarding the use of azilsartan medoxomil during breastfeeding, Edarbi is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while breast-feeding a newborn or preterm infant.
Slovenian: Ker o uporabi medoksomilazilsartanata med dojenjem ni podatkov, ga ne priporočajo, zato je treba med dojenjem, še zlasti med dojenjem novorojenčkov ali prezgodaj rojenih dojenčkov, dati prednost alternativnim zdravilom z uveljavljenim varnostnim profilom za uporabo med dojenjem.
English: Clinical trial data has shown that dual blockade of the 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).
Slovenian: Podatki kliničnih preskušanj so pokazali, da je dvojna blokada RAAS s hkratno uporabo zaviralcev ACE, blokatorjev receptorjev angiotenzina II ali aliskirena povezana z večjo pogostnostjo neželenih učinkov, npr. hipotenzije, hiperkaliemije in zmanjšanega delovanja ledvic (vključno z akutno odpovedjo ledvic) kot uporaba enega samega zdravila, ki deluje na RAAS (glejte poglavja 4.3, 4.4. in 5.1).
English: Exposure to angiotensin II receptor antagonist 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) (see section 5.3).
Slovenian: Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (ledvična odpoved, hipotenzija, hiperkaliemija) (glejte poglavje 5.3).
English: Common side effects (may affect up to 1 in 10 people): - Dizziness - Diarrhoea - Increased blood creatine phosphokinase (an indicator of muscle damage).
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - omotica - driska - zvišanje vrednosti kreatin-fosfokinaze (pokazatelj poškodbe mišic).
English: Therefore, adequate hydration and monitoring of renal function at the beginning of the treatment are recommended.
Slovenian: Zato je na začetku zdravljenja priporočljiv nadzor delovanje ledvic, potrebna pa je tudi ustrezna hidracija bolnika.
English: Edarbi is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Slovenian: Če boste želeli dojiti, bo zdravnik za vas izbral drugo zdravilo, še zlasti, če je vaš otrok novorojenček ali se je prezgodaj rodil.
English: Azilsartan medoxomil is rapidly hydrolysed to the active moiety azilsartan by esterases in the gastrointestinal tract and/or during drug absorption (see section 5.2).
Slovenian: Medoksomilazilsartanat se hitro hidrolizira v aktivno obliko azilsartan, s pomočjo esteraz v prebavnem traktu in/ali med absorpcijo zdravila (glejte poglavje 5.2).
English: When Edarbi is taken with chlortalidone (a water tablet), higher levels of certain chemicals in the blood (such as creatinine), which are indicators of kidney function, have been seen commonly (in less than 1 in 10 users), and low blood pressure is also common.
Slovenian: Če se jemlje zdravilo Edarbi sočasno s klortalidonom (zdravilo za odvajanje vode), so bile pogosto (pri manj kot 1 od 10 bolnikov) opažene višje vrednosti nekaterih kemičnih snovi v krvi (npr. kreatinina), ki so pokazatelji delovanja ledvic.
English: Edarbi 20 mg: Each tablet contains 20 mg azilsartan medoxomil (as potassium) Edarbi 40 mg: Each tablet contains 40 mg azilsartan medoxomil (as potassium) Edarbi 80 mg: Each tablet contains 80 mg azilsartan medoxomil (as potassium)
Slovenian: Edarbi 20 mg: Ena tableta vsebuje 20 mg medoksomilazilsartanata (v obliki kalijeve soli) Edarbi 40 mg: Ena tableta vsebuje 40 mg medoksomilazilsartanata (v obliki kalijeve soli) Edarbi 80 mg: Ena tableta vsebuje 80 mg medoksomilazilsartanata (v obliki kalijeve soli)
English: Caution should be exercised in hypertensive patients with severe renal impairment, congestive heart failure or renal artery stenosis, as there is no experience of use of Edarbi in these patients (see sections 4.2 and 5.2).
Slovenian: Pri hipertenzivnih bolnikih s hudo ledvično okvaro, kongestivnim srčnim popuščanjem ali stenozo ledvične arterije je potrebna previdnost, ker ni izkušenj z uporabo zdravila Edarbi pri teh bolnikih (glejte poglavji 4.2 in 5.2).
English: The estimated absolute oral bioavailability of azilsartan medoxomil based on plasma levels of azilsartan is approximately 60%.
Slovenian: Na osnovi koncentracij azilsartana v plazmi je izračunana peroralna biološka uporabnost medoksomilazilsartanata približno 60 %.
English: (haemoglobin).
Slovenian: irbesartan).
English: (medicines to relieve pain and inflammation) - Acetylsalicyclic acid if taking more than 3 g per day (medicine to relieve pain and inflammation) - Medicines that increase the amount of potassium in your blood; these include potassium supplements, potassium-sparing medicines (certain ‘water tablets') or salt substitutes containing potassium - Heparin (a medicine for thinning the blood) - Diuretics (water tablets) - Aliskiren or other medicines to lower your blood pressure (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker, such as enalapril, lisinopril, ramipril or valsartan,
Slovenian: Še posebej ne pozabite povedati svojemu zdravniku, če jemljete katero od naslednjih zdravil: - litij (zdravilo za težave z mentalnim zdravjem), - nesteroidna protivnetna zdravila, kot so ibuprofen, diklofenak ali celekoksib (zdravila za lajšanje bolečine in vnetja), - acetilsalicilna kislina, če jemljete več kot 3 grame na dan (zdravilo za lajšanje bolečine in vnetja), - zdravila, ki povečujejo količino kalija v krvi, vključno z dodatki kalija, zdravili, ki zadržujejo kalij (nekatera “zdravila za odvajanje vode”) ali nadomestki soli, ki vsebujejo kalij, - heparin (zdravilo za redčenje krvi), - diuretike (zdravila za odvajanje vode), - aliskiren ali druga zdravila za nižanje krvnega tlaka (zaviralci angiotenzinske konvertaze ali antagonisti angiotenzina II, kot so enalapril, lizinopril, ramipril ali valsartan, telmisartan,
English: Azilsartan and M-II showed no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Slovenian: V in vitro študijah azilsartana in M-II niso odkrili znakov mutagenosti ali pomembne klastogene aktivnosti.
English: In the repeated-dose toxicity studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters, changes in the kidney and renal haemodynamics,
Slovenian: V študijah toksičnosti pri ponovljenih odmerkih so odmerki, ki so povzročili izpostavljenost, primerljivo s tisto v kliničnem terapevtskem območju, povzročili zmanjšanje parametrov rdečih krvničk, spremembe v ledvicah in hemodinamike ledvic, kakor tudi povečanje koncentracije kalija v serumu pri živalih z normalnim krvnim tlakom.
English: Based on experience with the use of other medicinal products that affect the RAAS, concomitant use of Edarbi with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (e.g. heparin) may lead to increases in serum potassium in hypertensive patients (see section 4.5).
Slovenian: Na osnovi izkušenj pri uporabi drugih zdravil, ki vplivajo na RAAS, lahko pri bolnikih s povišanim krvnim tlakom sočasno dajanje zdravila Edarbi z diuretiki, ki zadržujejo kalij, z dodatki kalija, z nadomestki soli, ki vsebujejo kalij, ali z drugimi učinkovinami, ki lahko povečujejo koncentracijo kalija (npr. heparin), vodi k povečani serumski koncentraciji kalija (glejte poglavje 4.5).
English: What Edarbi contains
Slovenian: Kaj vsebuje zdravilo Edarbi
English: Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Slovenian: Diuretiki, ki varčujejo s kalijem, dodatki kalija, nadomestki soli, ki vsebujejo kalij, in druge snovi, ki lahko povečajo koncentracijo kalija
English: Nonclinical studies demonstrated that azilsartan did not appear to affect male or female fertility in the rat (see section 5.3).
Slovenian: Podatkov o vplivu medoksomilazilsartanata na plodnost pri ljudeh ni. Ne-klinične študije o vplivu azilsartana na moško ali žensko plodnost pri podganah vpliva niso pokazale (glejte poglavje 5.3).
English: The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4).
Slovenian: Uporaba antagonistov angiotenzina II v prvem trimesečju ni priporočljiva (glejte poglavje 4.4).
English: How to take Edarbi
Slovenian: Kako jemati zdravilo Edarbi
English: Based on in vitro studies, carboxymethylenebutenolidase is involved in the hydrolysis in the intestine and liver.
Slovenian: Glede na in vitro študije pri hidrolizi v črevesu in jetrih sodeluje karboksimetilenebutenolidaza.
English: The placebo-corrected trough-to-peak ratios for SBP and DBP were approximately 80% or higher.
Slovenian: Za placebo popravljeno razmerje celodnevnega proti največjemu znižanju sistoličnega krvnega tlaka in diastoličnega krvnega tlaka je bilo približno 80 % ali višje.
English: 24 Hour Mean SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) Study 1
Slovenian: 24-urni srednji SKT: Povprečna sprememba NK od izhodišča do 6. tedna (mm Hg) Študija 1
English: The major metabolite in plasma is formed by Odealkylation, referred to as metabolite M-II, and the minor metabolite is formed by decarboxylation, referred to as metabolite M-I.
Slovenian: Glavni presnovek v plazmi, presnovek M-II, nastane z O-dealkilacijo, stranski presnovek M-I nastane z dekarboksilacijo.
English: Uncommon Fatigue Peripheral oedema
Slovenian: Občasni utrujenost periferni edem
English: Aluminum blisters integrated with desiccant.
Slovenian: Aluminijasti pretisni omoti z integriranim sušilnim sredstvom.
English: - For patients such as the very elderly (75 years and above) your doctor may recommend a lower starting dose of 20 mg once a day.
Slovenian: Pri zelo starih bolnikih (≥ 75 let), pri katerih obstaja nevarnost hipotenzije, lahko začnete z začetnim odmerkom 20 mg.
English: Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products (e.g. heparin) may increase potassium levels.
Slovenian: Sočasno dajanje diuretikov, ki varčujejo s kalijem, dodatkov kalija, nadomestkov soli, ki vsebujejo kalij, ali drugih učinkovin (npr. heparina) lahko poveča koncentracijo kalija.
English: Rebound hypertension was not observed following abrupt cessation of Edarbi therapy after 6 months of treatment.
Slovenian: Po nenadni prekinitvi 6 mesečnega zdravljenja z zdravilom Edarbi ni bil opažen povratni hipertenzivni učinek.
English: Diarrhoea Nausea
Slovenian: Žilne bolezni
English: If you forget to take Edarbi Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: After oral administration of azilsartan medoxomil, peak plasma concentrations (Cmax) of azilsartan are reached within 1.5 to 3 hours.
Slovenian: Najvišja koncentracija (Cmax) azilsartana v plazmi je dosežena 1,5 do 3 ure po peroralni uporabi medoksomilazilsartanata.
English: Caution should be exercised in hypertensive patients with severe renal impairment and end stage renal disease as there is no experience of use of Edarbi in these patients (see sections 4.4 and 5.2).
Slovenian: Pri hipertenzivnih bolnikih s hudo ledvično okvaro in končno stopnjo ledvične bolezni je potrebna previdnost, ker ni izkušenj z uporabo zdravila Edarbi pri teh bolnikih (glejte poglavji 4.4 in 5.2).
English: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 3 g/l and 1 volume percent, respectively) were observed in placebo-controlled monotherapy studies.
Slovenian: V s placebom kontroliranih študijah monoterapije so bila opažena manjša zmanjšanja vrednosti hemoglobina in hematokrita (srednje zmanjšanje približno 3 g/l oz. 1 volumski odstotek).
English: How to store Edarbi
Slovenian: Shranjevanje zdravila Edarbi
English: When Edarbi was coadministered with chlortalidone, the frequencies of blood creatinine increased and hypotension were increased from uncommon to common.
Slovenian: Pri sočasni uporabi zdravila Edarbi in klortalidona se je pogostnost zvišane koncentracije kreatinina v krvi in hipotenzije z občasne povečala na pogosto.
English: Tlf: + 47 6676 3030 infonorge@takeda.com
Slovenian: Takeda Nycomed AS Tlf: + 47 6676 3030 infonorge@takeda.com
English: Following discontinuation of treatment, the majority of the elevations that had not resolved during treatment were reversible, with the creatinine levels of most subjects returning to baseline or near-baseline values.
Slovenian: Po prenehanju terapije je bila večina dvigov, ki se niso uredili že med terapijo, reverzibilna.
English: Following oral administration, azilsartan medoxomil is rapidly hydrolyzed to the active moiety azilsartan in the gastrointestinal tract and/or during absorption.
Slovenian: Po peroralni uporabi se medoksomilazilsartanat v gastrointestinalnem traktu in/ali med absorpcijo hitro hidrolizira v aktivno obliko azilsartan.
English: Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day), and non-selective NSAIDs When angiotensin II receptor antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Slovenian: Če se antagonisti angiotenzina II dajejo sočasno z nesteroidnimi protivnetnimi zdravili (npr. selektivnimi zaviralci COX-2, acetilsalicilno kislino (> 3 g/dan) in neselektivnimi NSAID), se lahko njihov antihipertenzivni učinek zmanjša.
English: The incidence of adverse reactions with this treatment was not affected by gender, age, or race.
Slovenian: Spol, starost ali rasa niso vplivali na pogostnost neželenih učinkov pri tem zdravljenju.
English: White to nearly white round tablets, 7.6 mm in diameter, debossed “ASL” on one side and “40” on the other.
Slovenian: Bele do skoraj bele okrogle tablete, premera 7,6 mm, z vtisnjeno oznako “ASL” na eni in oznako “40” na drugi strani.
English: Edarbi 20 mg tablets Edarbi 40 mg tablets Edarbi 80 mg tablets
Slovenian: Edarbi 20 mg tablete Edarbi 40 mg tablete Edarbi 80 mg tablete
English: Takeda UK Ltd Tel: +44 (0) 1628 537 900
Slovenian: Takeda UK Limited Tel: +44 (0) 1628 537 900
English: Adverse reactions were reported at a similar frequency for the Edarbi 20 mg dose as with the 40 and 80 mg doses in one placebo controlled study.
Slovenian: V eni s placebom kontrolirani študiji z 20 mg odmerkom zdravila Edarbi so bili ugotovljeni neželeni učinki s podobno pogostnostjo, kot pri 40 in 80 mg odmerkih.
English: In these clinical studies, adverse reactions associated with treatment with Edarbi were mostly mild or moderate, with an overall incidence similar to placebo.
Slovenian: Te klinične študije so pokazale pretežno blage do srednje močne neželene učinke, povezane z dajanjem zdravila Edarbi, katerih skupna pogostnost je bila podobna pogostnosti pri placebu.
English: Monitoring of potassium should be undertaken as appropriate.
Slovenian: Potrebno je stalno spremljanje kalija.
English: Edarbi has not been studied in patients with severe hepatic impairment and therefore its use is not recommended in this patient group (see sections 4.2 and 5.2).
Slovenian: Uporabe zdravila Edarbi pri bolnikih s hudo jetrno okvaro niso preučevali, zato njegove uporabe pri tej skupini bolnikov ne priporočamo (glejte poglavji 4.2. in 5.2).
English: ACE inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients with diabetic nephropathy.
Slovenian: Zato se pri bolnikih z diabetično nefropatijo zaviralcev ACE in blokatorjev receptorjev angiotenzina II ne sme uporabljati sočasno.