FrancophonIA/ELRC3.0 huggingface dataset:
English: The product does not contain a preservative, and the reconstituted product should be used immediately, or within 3 hours after reconstitution or removal of the grey tip cap. Other in-use storage times and conditions are the responsibility of the user.
Slovenian: Pripravljeno zdravilo morate porabiti takoj, najpozneje pa v 3 urah po rekonstituciji ali odstranitvi sivega pokrovčka.
English: 1 pre-filled syringe: 250 IU moroctocog alfa (approx. 62.5 IU/ml after reconstitution).
Slovenian: 1 napolnjena injekcijska brizga: 250 i.e. moroktokoga alfa (pribl.
English: Package size perforated unit dose blister (PVC/Alu) 5 x 2 tablets l t o r
Slovenian: Peroralno Perforiran pretisni omot za enkratni odmerek (PVC/Alu)
English: (See section 5.3).
Slovenian: (glejte poglavje 5.1).
English: Date of first authorisation: 27 August 1997 Date of latest renewal: 27 August 2007
Slovenian: Datum pridobitve dovoljenja za promet: 27. avgust 1997 Datum zadnjega podaljšanja dovoljenja: 27. avgust 2007
English: This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.
Slovenian: Tega zdravila se ne sme uporabljati pri otrocih in mladostnikih, ker varnost in učinkovitost še nista bili popolnoma ugotovljeni.
English: Patients with high blood pressure
Slovenian: Bolniki z visokim krvnim tlakom
English: However, no proper explanation for these findings in women has been identified.
Slovenian: Za te ugotovitve pri ženskah niso našli ustrezne razlage.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Slovenian: Bolnika se mora skrbno nadzorovati, zdravljenje pa mora biti simptomatsko in podporno.
English: None of these increases were associated with identifiable clinical musculoskeletal events.
Slovenian: Nobeno od teh povečanj ni bilo povezano s prepoznavnimi kliničnimi mišičnoskeletnimi pojavi.
English: Similar effects have been very rarely reported with irbesartan so far.
Slovenian: O podobnih učinkih do sedaj poročajo pri irbesartanu zelo redko.
English: The volume of distribution is 53-93 litres.
Slovenian: Volumen porazdelitve je 53-93 litrov.
English: These adverse reactions are derived from spontaneous reports.
Slovenian: Ti neželeni učinki izhajajo iz spontanih poročil.
English: Therefore, this combination is not recommended (see section 4.4).
Slovenian: Zato se takšne kombinacije ne priporoča (glejte poglavje 4.4).
English: The safety and efficacy of Aprovel in children aged 0 to 18 has not been established.
Slovenian: Varnost in učinkovitost zdravila Aprovel pri otrocih, starih od 0 do 18 let, nista bili dokazani.
English: Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity.
Slovenian: Izkušnje pri odraslih, ki so bili 8 tednov izpostavljeni odmerkom do 900 mg/dan, niso odkrile toksičnosti.
English: Plasma protein binding is approximately 96%, with negligible binding to cellular blood components.
Slovenian: Vezava na plazemske beljakovine je približno 96%, z zanemarljivo vezavo na krvne celice.
English: Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults (twelve children over 12 years, nine children between 6 and 12 years).
Slovenian: Od teh 23 otrok je bilo pri 21-ih farmakokinetiko možno primerjati s farmakokinetiko pri odraslih (dvanajst otrok starejših od 12 let, devet otrok starih od 6 do 12 let).
English: Activated charcoal may be useful in the treatment of overdose.
Slovenian: Aktivno oglje je lahko koristno pri zdravljenju prevelikega odmerjanja.
English: The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period.
Slovenian: Upočasnitev napredovanja v klinično proteinurijo je bila vidna že v prvih treh mesecih in se je nadaljevala preko dveletnega obdobja.
English: The antihypertensive effects are maintained during long term therapy.
Slovenian: Antihipertenzivni učinek se vzdržuje z dolgotrajno terapijo.
English: 56 x 1 tablets:
Slovenian: 56 x 1 tableta:
English: The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
Slovenian: Pogostost neželenih dogodkov ni bila povezana z velikostjo odmerka (v mejah priporočenega odmerjanja), s spolom, starostjo, raso ali trajanjem zdravljenja.
English: Biotransformatin
Slovenian: Biotransformacija
English: No significant difference was apparent between these doses.
Slovenian: Razlike med temi odmerki niso bile značilne.
English: The terminal elimination half-life of irbesartan is 11-15 hours.
Slovenian: Končni razpolovni eliminacijski čas irbesartana je 11-15 ur.
English: It is important that you continue to take Aprovel until your doctor tells you otherwise.
Slovenian: Pomembno je, da zdravilo Aprovel jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
English: Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavju 4.8, 5.1 in 5.2 vendar priporočil o odmerjanju ni mogoče dati.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V vsaki skupini pogostnosti so neželeni učinki navedeni v zaporedju padajoče resnosti.
English: The usual recommended initial and maintenance dose is 150 mg once daily, with or without food.
Slovenian: Običajni priporočeni začetni in vzdrževalni odmerek je 150 mg enkrat na dan, s hrano ali brez.
English: The predefined blood pressure goal was ≤ 135/85 mmHg.
Slovenian: Ciljni krvni tlak je bil ≤135/85 mmHg.
English: The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Slovenian: Glavni metabolit v obtoku je irbesartan glukuronid (približno 6%).
English: If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje (laktozo), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: Pred začetkom jemanja natančno preberete navodilo, ker vsebuje za vas pomembne podatke!
English: musculoskeletal pain*
Slovenian: mišičnoskeletna bolečina*
English: However, there was no difference in the half-life and accumulation of irbesartan.
Slovenian: Vendar pa ni bilo nobene razlike v razpolovnem času in kopičenju irbesartana.
English: Results showed that Cmax, AUC and clearance rates were comparable to those observed in adult patients receiving 150 mg irbesartan daily.
Slovenian: Rezultati so pokazali, da so bili Cmax, AUC in očistek primerljivi tistim pri odraslih, ki so dobivali 150 mg irbesartana na dan.
English: See also information under the heading “Do not take Aprovel”.
Slovenian: Glejte tudi informacije pod naslovom “Ne jemljite zdravila Aprovel”.
English: In particular, they appeared less favourable in women and non-white subjects (see section 5.1).
Slovenian: In sicer, so bili videti manj ugodni pri ženskah in pri ne-belcih (glejte poglavje 5.1).
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Slovenian: Če je takšna kombinacija nedvoumno potrebna, se priporoča skrbno nadzorovanje serumske ravni litija.
English: The combination should be administered with caution, especially in the elderly.
Slovenian: Kombinacijo je predvsem pri starejših bolnikih treba uporabljati previdno.
English: Therefore, the use of Aprovel is not recommended.
Slovenian: Zato uporaba zdravila Aprovel ni priporočljiva.
English: You can take Aprovel with or without food.
Slovenian: Zdravilo Aprovel lahko jemljete s hrano ali brez nje.
English: At 24 hours the reduction of blood pressure was 60-70% of the corresponding peak diastolic and systolic responses at the recommended doses.
Slovenian: Po 24 urah je bilo zmanjšanje krvnega tlaka 60-70% ustreznega največjega diastoličnega in sistoličnega odziva na priporočeni odmerek.
English: When the individual components of the primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Slovenian: Pri podrobnem proučevanju posameznih komponent primarnega izida, niso opazili učinka na celokupno smrtnost, pač pa pozitivno tendenco pri zniževanju ESRD in pomembno zmanjšanje podvojitve serumskega kreatinina.
English: Concomitant food intake does not significantly influence the bioavailability of irbesartan.
Slovenian: Sočasen vnos hrane ne vpliva pomembno na biološko razpoložljivost irbesartana.
English: All of these changes were considered to be caused by the pharmacological action of irbesartan.
Slovenian: Za vse te spremembe se domneva, da so posledica farmakološkega delovanja irbesartana.
English: If you forget to take Aprovel
Slovenian: Če ste pozabili vzeti zdravilo Aprovel
English: The following table presents the adverse drug reactions that were reported in placebo-controlled trials in which 1,965 hypertensive patients received irbesartan.
Slovenian: Sledeča tabela predstavlja neželene učinke zdravila o katerih so poročali v s placebom kontroliranih preskušanjih, v katerih je sodelovalo 1.965 bolnikov z visokim krvnim tlakom, ki so prejemali irbesartan.
English: However the terminal half-life was not significantly altered.
Slovenian: Vendar pa ni bilo pomembnih sprememb končnega razpolovnega časa.
English: Irbesartan does not require metabolic activation for its activity.
Slovenian: Za svojo učinkovitost irbesartan ne potrebuje metabolične aktivacije.
English: (It is also better to avoid Aprovel in early pregnancy - see pregnancy section) if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
Slovenian: (Jemanju zdravila Aprovel se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti) če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Slovenian: Pogostnost spodaj naštetih neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000).
English: Other medicines and Aprovel
Slovenian: Druga zdravila in zdravilo Aprovel
English: Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for older people.
Slovenian: Čeprav je treba pretehtati možnost uporabe začetnega odmerka 75 mg pri bolnikih starejših od 75 let, običajno pri starejših prilagajanje odmerka ni potrebno.
English: There was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Slovenian: O mutagenosti, klastogenosti ali karcinogenosti ni nobenih dokazov.
English: After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Slovenian: Irbesartan se po peroralni uporabi dobro absorbira: študije absolutne biološke razpoložljivosti so dale vrednosti približno 60-80%.
English: After withdrawal of therapy, blood pressure gradually returns toward baseline.
Slovenian: Po ukinitvi terapije se krvni tlak postopno vrne na začetno vrednost.
English: Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or allcause mortality.
Slovenian: Irbesartan je pomembno znižal tveganje za primarno povezan izid podvojitve serumskega kreatinina, zadnje faze ledvične bolezni (ESRD) in celokupne smrtnosti.
English: Hypertension and type 2 diabetes with renal disease
Slovenian: Hipertenzija in sladkorna bolezen tipa 2 z ledvično boleznijo
English: In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.
Slovenian: Med 26-tedenskim odprtim obdobjem tega preskušanja so bila najpogostejša laboratorijska odstopanja zvišanje kreatinina (6,5%) in zvišanje vrednosti kreatinin-kinaze (CK) pri 2% otrok.
English: When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment.
Slovenian: Pri upravljanju z vozili ali stroji se mora upoštevati, da se med zdravljenjem lahko pojavita omotica ali utrujenost.
English: No specific information is available on the treatment of overdose with Aprovel.
Slovenian: Specifični podatki o zdravljenju prevelikega odmerjanja z zdravilom Aprovel niso na voljo.
English: Aprovel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Slovenian: Na splošno zagotavlja odmerek 150 mg zdravila Aprovel enkrat na dan boljši 24 urni nadzor krvnega tlaka kot 75 mg.
English: You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium
Slovenian: Morda bodo potrebne krvne preiskave, če jemljete: dodatke kalija nadomestke soli, ki vsebujejo kalij zdravila, ki varčujejo s kalijem (kot so nekateri diuretiki) zdravila, ki vsebujejo litij
English: Aprovel with food and drink Aprovel can be taken with or without food.
Slovenian: Zdravilo Aprovel skupaj s hrano in pijačo Zdravilo Aprovel lahko jemljete s hrano ali brez nje.
English: The usual dose is 150 mg once a day (two tablets a day).
Slovenian: Običajen odmerek je 150 mg enkrat na dan (dve tableti).
English: Irbesartan lowers blood pressure with minimal change in heart rate.
Slovenian: Irbesartan znižuje krvni tlak z minimalno spremembo srčnega utripa.
English: 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%).
Slovenian: Med randomiziranim preskušanjem pri 318 hipertenzivnih otrocih in mladostnikih, starih od 6 do 16 let, so se med 3-tedensko dvojno slepo fazo pojavili naslednji neželeni učinki: glavobol (7,9%), hipotenzija (2,2%), omotica (1,9%), kašelj (0,9%).
English: arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps
Slovenian: artralgija, mialgija (v nekaterih primerih sta bili povezani z zvišanjem ravni kreatinkinaze v plazmi), mišični krči
English: The most likely manifestations of overdose are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
Slovenian: Kot manifestacijo prevelikega odmerjanja je najverjetneje pričakovati hipotenzijo in tahikardijo; zaradi prevelikega odmerka se lahko pojavi tudi bradikarija.
English: PHARMACEUTICAL FORM AND CONTENTS 14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 14 tablet 28 tablet 56 tablet 56 x 1 tableta 98 tablet POSTOPEK IN POT(I) UPORABE ZDRAVILA Peroralna uporaba.
English: In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Slovenian: Pri 1,7% bolnikov z visokim krvnim tlakom z napredovalo diabetično ledvično boleznijo, ki so jih zdravili z irbesartanom, so opazili znižanje hemoglobina*, ki ni bilo klinično pomembno.
English: In rabbits, abortion or early resorption were noted at doses causing significant maternal toxicity, including mortality.
Slovenian: Pri zajčjih samicah so opazili splav ali zgodnjo resorpcijo pri odmerkih, pomembno toksičnih za samico, vključno s smrtjo.
English: Based on its pharmacodynamic properties, irbesartan is unlikely to affect the ability to drive and use machines.
Slovenian: Na podlagi farmakodinamičnih lastnosti ni verjetno, da bi irbesartan poslabšal sposobnost vožnje in upravljanja s stroji.
English: The study examined the long-term effects (2 years) of Aprovel on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
Slovenian: V raziskavi so proučevali dolgotrajne učinke (2 leti) zdravila Aprovel na napredovanje v klinično proteinurijo (hitrost izločanja albuminov z urinom -“urinary albumin excretion rate”-UAER >300 mg/dan in povečanje UAER-a najmanj za 30% začetne vrednosti).
English: What you need to know before you take Aprovel
Slovenian: Kaj morate vedeti preden boste vzeli zdravilo Aprovel
English: Please see section 2 “Aprovel contains lactose”.
Slovenian: Prosimo, glejte tudi poglavje 2 »Zdravilo Aprovel vsebuje laktozo«.
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Aprovel (see section 4.4).
Slovenian: Predhodno zdravljenje z visokimi odmerki diuretikov lahko povzroči zmanjšanje volumna in tveganje za hipotenzijo ob uvedbi zdravljenja z zdravilom Aprovel (glejte poglavje 4.4).
English: The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/kg) up to a maximum daily dose of 150 mg for four weeks.
Slovenian: Farmakokinetiko irbesartana so ocenili pri 23 hipertenzivnih otrocih po uporabi posamičnega in večkratnih dnevnih odmerkov irbesartana (2 mg/kg) do največjega dnevnega odmerka 150 mg štiri tedne.
English: Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Slovenian: Irbesartan ne zavira ACE (kininaze-II), to je encima, ki tvori angiotenzin II in tudi razgrajuje bradikinin v neučinkovite metabolite.
English: Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Slovenian: Primarni aldosteronizem: bolniki s primarnim aldosteronizmom se na splošno ne odzivajo na antihipertenzive, ki delujejo preko inhibicije sistema renin-angiotenzin.
English: 30 - 56 x 1 - 90 tablets:
Slovenian: 30 - 56 x 1 - 90 tablet:
English: Irbesartan AUC and Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18-40 years).
Slovenian: Vrednosti AUC in Cmax irbesartana so bile pri starejših osebah (≥65 let) nekoliko večje kot pri mlajših (18-40 let).
English: Paediatric population: irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2).
Slovenian: Pediatrična populacija: Irbesartan so raziskovali pri pediatričnih bolnikih, starih od 6 do 16 let, vendar trenutni podatki ne zadoščajo za podporo podaljšane uporabe pri otrocih, dokler ne bo na voljo dodatnih podatkov (glejte poglavja 4.8, 5.1 in 5.2).
English: Older people
Slovenian: Starejši bolniki
English: For therapeutic doses of irbesartan in humans, the hyperplasia/ hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Slovenian: Za terapevtske odmerke pri človeku kaže, da je hiperplazija/hipertrofija ledvičnih jukstaglomerulnih celic brez pomena.
English: For N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora za N-nitrozodimetilamin (NDMA) in N-nitrozodietilamin (NDEA) uvesti naslednje specifikacije za učinkovino:
English: Such conditions should be corrected before the administration of Aprovel.
Slovenian: Ta stanja se mora korigirati, preden se uporabi zdravilo Aprovel.
English: Renal impairment and kidney transplantation: when Aprovel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Slovenian: Ledvična okvara in presaditev ledvic: pri dajanju zdravila Aprovel bolnikom s prizadeto ledvično funkcijo se priporoča redno nadzorovanje ravni kalija in kreatinina v serumu.
English: However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.
Slovenian: Vendar pa je treba pretehtati možnost uvajanja zdravljenja s 75 mg, zlasti pri bolnikih na hemodializi in starejših od 75 let.
English: Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.
Slovenian: Ravnotežne koncentracije v plazmi so dosežene v 3 dneh po začetku enkrat-dnevnega režima odmerjanja.
English: Less than 2% of the dose is excreted in the urine as unchanged irbesartan.
Slovenian: Manj kot 2% odmerka irbesartana se izloči z urinom v nespremenjeni obliki.
English: Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Slovenian: Po peroralni ali intravenski uporabi 14C irbesartana, prispeva 80-85% radioaktivnosti v plazemskem obtoku nespremenjeni irbesartan.
English: Irbesartan is not removed by haemodialysis.
Slovenian: Irbesartan se s hemodializo ne odstranjuje.
English: Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists.
Slovenian: Zdravilo Aprovel spada v skupino zdravil, ki so znana kot antagonisti angiotenzina-II.
English: Aprovel is indicated in adults for the treatment of essential hypertension.
Slovenian: Zdravilo Aprovel je indicirano pri odraslih za zdravljenje esencialne hipertenzije.
English: What Aprovel is and what it is used for
Slovenian: Kaj je zdravilo Aprovel in za kaj ga uporablamo
English: Suggested measures include induction of emesis and/or gastric lavage.
Slovenian: Priporočeni ukrepi vključujejo sprožitev bruhanja in/ali izpiranje želodca.
English: 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)].
Slovenian: Približno 33% bolnikov v skupini z irbesartanom je doseglo primarno povezan ledvični izid v primerjavi s 39% pri placebu in 41% v skupini z amlodipinom [20% relativno zmanjšanje tveganja v primerjavi s placebom (p = 0,024) in 23% relativno zmanjšanje tveganja v primerjavi z amlodipinom (p = 0,006)].
English: It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II.
Slovenian: Pričakovani učinek je blokada vseh učinkov angiotenzina II, ki se prenašajo preko receptorja AT1, ne glede na izvor ali sintezno pot angiotenzina-II.
English: Patients were titrated from 75 mg to a maintenance dose of 300 mg Aprovel, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Slovenian: Bolnikom so postopoma povečevali odmerek zdravila Aprovel od 75 mg do vzdrževalnega odmerka 300 mg, odmerek amlodipina od 2,5 do 10 mg, oziroma placeba, kot so ga prenesli.
English: 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.
Slovenian: Učinki označeni z zvezdico (*) se nanašajo na neželene učinke o katerih so dodatno poročali pri > 2% diabetičnih bolnikov z visokim krvnim tlakom s kronično ledvično insuficienco in izraženo proteinurijo in večjim deležem kot pri placebu.