FrancophonIA/ELRC3.0 huggingface dataset:
English: If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure.
Slovenian: e ga ne zdravimo, lahko poškoduje krvne žile v možganih, srcu in ledvicah, kar lahko povzro i možgansko kap, sr no popuš anje ali odpoved ledvic.
English: The primary benefit was a 27.5% (95% CI: 17 to 37%) reduction in risk for time to first heart failure hospitalisation (13.9% vs. 18.5%).
Slovenian: Primarna korist je bilo 27,5 % (95 % IZ: 17 do 37 %) manjše tveganje glede asa do prve hospitalizacije zaradi sr nega popuš anja (13,9 % v primerjavi z 18,5 %).
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded.
Slovenian: Epidemiološki podatki niso pokazali teratogenega u inka pri nose nicah, ki so bile v prvem trimese ju nose nosti izpostavljene zaviralcem ACE, vendar pa majhnega pove anja tveganja ni možno izklju iti.
English: Not all pack sizes may be marketed
Slovenian: Ni nujno, da so v prometu vsa navedena pakiranja.
English: • severely decreased kidney function (signs of acute renal failure)
Slovenian: • zelo zmanjšano delovanje ledvic (znak akutne ledvine odpovedi)
English: Abrupt withdrawal of Diovan has not been associated with rebound hypertension or other adverse clinical events.
Slovenian: Po nenadni prekinitvi jemanja zdravila Diovan ni prišlo do povratne hipertenzije ali drugih neželenih klini nih dogodkov.
English: Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 24 hours with tablets and 1-2 hours with solution formulation.
Slovenian: Po peroralni uporabi samo valsartana doseže ta najvišjo koncentracijo v plazmi v 2-4 urah po zaužitju tablet in v 1-2 urah po zaužitju raztopine.
English: In non-clinical safety studies, high doses of valsartan (200 to 600 mg/kg body weight) caused in rats a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit) and evidence of changes in renal haemodynamics (slightly raised plasma urea, and renal tubular hyperplasia and basophilia in males).
Slovenian: V neklini nih študijah varnosti so visoki odmerki valsartana (200 do 600 mg/kg telesne mase) pri podganah povzro ili zmanjšanje parametrov rde ih krvnih celic (ertirocitov, hemoglobina, hematokrita) in znake spremenjene ledvi ne hemodinamike (nekoliko zvišana se nina v plazmi in hiperplazija ledvi nih tubulov ter bazofilija pri samcih).
English: Valsartan is an orally active, potent, and specific angiotensin II (Ang II) receptor antagonist.
Slovenian: Valsartan je peroralno aktiven, mo an in specifi en antagonist receptorjev angiotenzina II.
English: Neurocognitive and developmental assessment of paediatric patients aged 6 to 16 years of age revealed no overall clinically relevant adverse impact after treatment with Diovan for up to one year.
Slovenian: Pri ocenjevanju nevrokognitivnih sposobnosti in razvoja pri pediatri nih bolnikih, starih od 6 do 16 let, po zdravljenju z zdravilom Diovan v obdobju do 1 leta niso opažali nobenega neugodnega vpliva, ki bi bil v celoti klini no pomemben.
English: • if you have liver disease.
Slovenian: • e imate bolezen jeter,
English: Mean absolute bioavailability is 23% and 39% with tablets and solution formulation, respectively.
Slovenian: Povpre na absolutna biološka uporabnost je 23 % po zaužitju tablet in 39 % po zaužitju raztopine.
English: Strength Pharmaceutical Form Route of administration
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe
English: Administration of Diovan to patients with hypertension results in reduction of blood pressure without affecting pulse rate.
Slovenian: Pri bolnikih s hipertenzijo zdravilo Diovan zniža krvni tlak, ne da bi vplivalo na sr no frekvenco.
English: Recent myocardial infarction
Slovenian: Nedavni miokardni infarkt
English: Like all medicines, Diovan can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Diovan neželene u inke, ki pa se ne pojavijo pri vseh bolnikih.
English: The combination of captopril and valsartan has shown no additional clinical benefit, instead the risk for adverse events increased compared to treatment with the respective therapies (see sections 4.2 and 5.1).
Slovenian: Uporaba kombinacije kaptoprila in valsartana ni pokazala dodatnih klini nih koristi, pove alo pa se je tveganje za neželene u inke v primerjavi z uporabo posameznih zdravil (glejte poglavji 4.2 in 5.1).
English: Results appearing to favour placebo (composite mortality and morbidity was 21.9% in placebo vs. 25.4% in valsartan group) were observed for those patients receiving the triple combination of an ACE inhibitor, a beta blocker and valsartan.
Slovenian: Opazili so rezultate v korist placeba (sestavljena umrljivost in obolevnost je bila 21,9 % pri placebu v primerjavi s 25,4 % v skupini z valsartanom) pri bolnikih, ki so prejemali trojno kombinacijo zaviralca ACE, antagonista adrenergi nih receptorjev beta in valsartana.
English: • if you are treated after a heart attack or for heart failure, your doctor may check your kidney function.
Slovenian: • e se zdravite po sr nem napadu ali zaradi sr nega popuš anja, bo morda zdravnik preveril delovanje vaših ledvic,
English: A long term study in the younger age group (1 to 5 years old).
Slovenian: Zaklju no poro ilo o študiji mora biti predloženo najpozneje do zadnjega etrtletja leta 2010, dolgoro no študijo v mlajši starostni skupini (starost otrok od 1 do 5 let).
English: Consistent results were observed for diastolic blood pressure with reductions of 9.1 mmHg and 8.5 mmHg with valsartan and enalapril, respectively.
Slovenian: S tem so se ujemali tudi rezultati meritev diastoli nega tlaka, ki ga je valsartan znižal za 9,1 mmHg, enalapril pa za 8,5 mmHg.
English: If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down.
Slovenian: e ste vzeli ve ji odmerek zdravila Diovan, kot bi smeli e ob utite hudo omoti nost in/ali omedlevico, se takoj povežite s svojim zdravnikom in se ulezite.
English: In patients who continued to receive the medium and high doses of valsartan, systolic blood pressure at trough was -4 and -7 mm Hg lower than patients who received the placebo treatment.
Slovenian: Pri bolnikih, ki so nadaljevali zdravljenje s srednje visokimi in z visokimi odmerki valsartana, je bila najnižja vrednost sistoli nega krvnega tlaka nižja za 4 oziroma 7 mmHg od vrednosti pri bolnikih, ki so prejemali placebo.
English: If you stop taking Diovan
Slovenian: e prenehate jemati zdravilo Diovan
English: Whilst there is no controlled epidemiological data on the risk with AIIRAs, similar risks may exist for this class of drugs.
Slovenian: eprav ni na voljo podatkov glede tveganja pri uporabi antagonistov angiotenzina II iz kontroliranih epidemioloških študij, lahko podobno tveganje obstaja tudi za to skupino zdravil.
English: All-cause mortality was similar in the valsartan (19.9%), captopril (19.5%), and valsartan + captopril (19.3%) groups.
Slovenian: Umrljivost iz vseh vzrokov je bila podobna v skupini z valsartanom (19,9 %), s kaptoprilom (19,5 %) in v skupini s kombinacijo valsartana in kaptoprila (19,3 %).
English: Daily oral dosing of neonatal/juvenile rats (from a postnatal day 7 to postnatal day 70) with valsartan at doses as low as 1 mg/kg/day (about 10-35% of the maximum recommended paediatric dose of 4 mg/kg/day on systemic exposure basis) produced persistent, irreversible kidney damage.
Slovenian: Vsakodnevno peroralno odmerjanje valsartana novorojenim/mladim podganam (od 7. do 70. dne po porodu) v višini samo 1 mg/kg/dan (kar je približno 10-35 % najvišjega priporo enega pediatri nega odmerka 4 mg/kg/dan glede na sistemsko izpostavljenost zdravilu) je povzro ilo persistentno neozdravljivo okvaro ledvic.
English: MARKETING AUTHORISATION NUMBER [To be completed nationally]
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET [Izpolni država lanica]
English: • elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can trigger yellow skin and eyes in severe cases)
Slovenian: • zvišane vrednosti jetrnih testov (kar lahko kaže na poškodbo jeter), vklju no z zvišano koncentracijo bilirubina v krvi (ki lahko v hudih primerih povzro i porumenelost kože in o i)
English: • to treat symptomatic heart failure in adult patients.
Slovenian: • Za zdravljenje simptomatskega sr nega popuš anja pri odraslih bolnikih.
English: The antihypertensive effect of valsartan have been evaluated in four randomized, double-blind clinical studies in 561 paediatric patients from 6 to 18 years of age and 165 paediatric patients 1 to 6 years of age.
Slovenian: Antihipertenzivno delovanje valsartana so ocenjevali v štirih randomiziranih, dvojno slepih klini nih študijah s 561 pediatri nimi bolniki v starosti od 6 do 18 let in s 165 pediatri nimi bolniki v starosti od 1 leta do 6 let.
English: In controlled clinical studies in adult patients with hypertension, the overall incidence of adverse reactions (ADRs) was comparable with placebo and is consistent with the pharmacology of valsartan.
Slovenian: V kontroliranih klini nih študijah pri odraslih bolnikih s hipertenzijo je bila pogostnost vseh neželenih u inkov primerljiva s tisto pri placebu in v skladu s farmakologijo valsartana.
English: • If you have any further questions, ask your doctor or pharmacist.
Slovenian: e imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: This combination apparently increases the risk for adverse events and is therefore not recommended.
Slovenian: Kaže, da ta kombinacija pove uje tveganje za neželene u inke, zato ni priporo ena.
English: Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours-10 days) myocardial infarction (see sections 4.4 and 5.1).
Slovenian: Zdravljenje klini no stabilnih odraslih bolnikov s simptomatskim sr nim popuš anjem ali asimptomatsko sistoli no disfunkcijo levega prekata po nedavnem miokardnem infarktu (12 ur10 dni) (glejte poglavji 4.4 in 5.1).
English: In a study of 26 paediatric hypertensive patients (aged 1 to 16 years) given a single dose of a suspension of valsartan (mean: 0.9 to 2 mg/kg, with a maximum dose of 80 mg), the clearance (litres/h/kg) of valsartan was comparable across the age range of 1 to 16 years and similar to that of adults receiving the same formulation.
Slovenian: V študiji s 26 pediatri nimi hipertenzivnimi bolniki (v starosti od 1 leta do 16 let), ki so prejeli en sam odmerek valsartana v obliki suspenzije (povpre no 0,9 do 2 mg/kg, pri emer je bil najvišji odmerek 80 mg), je bilo izlo anje valsartana (v litrih na uro na kilogram) primerljivo pri vseh starostih od 1 leta do 16 let, in podobno izlo anju pri odraslih, ki uporabljajo isto obliko zdravila.
English: With the exception of isolated gastrointestinal disorders (like abdominal pain, nausea, vomiting) and dizziness, no relevant differences in terms of type, frequency and severity of adverse reactions were identified between the safety profile for paediatric patients aged 6 to 18 years and that previously reported for adult patients.
Slovenian: Razen posameznih prebavnih motenj (kot so bole ine v trebuhu, navzea, bruhanje) in omoti nosti, med varnostnimi lastnostmi zdravila pri pediatri nih bolnikih, starih 6 do 18 let, in že opisanimi varnostnimi lastnostmi pri odraslih, niso ugotovili bistvenih razlik glede vrste, pogostnosti ali izraženosti neželenih u inkov.
English: In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced cough compared to 68.5% of those treated with an ACE inhibitor (p<0.05).
Slovenian: V klini nem preskušanju pri bolnikih, ki so imeli v anamnezi suh kašelj v asu zdravljenja z zaviralcem ACE, je do kašlja prišlo pri 19,5 % preiskovancev, ki so dobivali valsartan, pri 19,0 % tistih, ki so prejemali tiazidni diuretik, in pri 68,5 % preiskovancev, ki so dobivali zaviralec ACE (p < 0,05).
English: Novartis Farma S.p.A. Largo Umberto Boccioni 1
Slovenian: Largo Umberto Boccioni 1
English: In patients receiving the low dose of valsartan, systolic blood pressure at trough was similar to that of patients who received the placebo treatment.
Slovenian: Pri bolnikih, ki so prejemali nizke odmerke valsartana, je bila najnižja vrednost sistoli nega krvnega tlaka podobna vrednosti pri bolnikih, ki so prejemali placebo.
English: However, other agents that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with unilateral renal artery stenosis, therefore monitoring of renal function is recommended when patients are treated with valsartan.
Slovenian: Vendar pa lahko druga zdravila, ki vplivajo na renin-angiotenzinski sistem, pove ajo vrednosti dušika se nine v krvi in kreatinina v serumu pri bolnikih z enostransko stenozo ledvi ne arterije, zato je med zdravljenjem bolnikov z valsartanom priporo eno spremljanje ledvi ne funkcije.
English: Side effects include:
Slovenian: Navodilo vsebuje:
English: The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4).
Slovenian: Uporaba antagonistov angiotenzina II v prvem trimese ju nose nosti ni priporo ljiva (glejte poglavje 4.4).
English: As valsartan is an angiotensin II antagonist, it cannot be excluded that the use of Diovan may be associated with impairment of the renal function.
Slovenian: Ker je valsartan antagonist angiotenzina II, ni mogo e izklju iti, da je uporaba zdravila Diovan lahko povezana z okvaro delovanja ledvic.
English: The ADRs reported from clinical studies, post-marketing experience and laboratory findings are listed below according to system organ class.
Slovenian: Neželeni u inki, o katerih so poro ali v klini nih študijah, na podlagi izkušenj po za etku trženja zdravila in laboratorijskih izvidov, so po organskih sistemih našteti v spodnji preglednici.
English: • if you have severe kidney disease or if you are undergoing dialysis.
Slovenian: • e imate hude težave z ledvicami ali e se zdravite z dializo,
English: In another clinical study involving 300 hypertensive paediatric patients 6 to 18 years of age, eligible patients were randomized to receive valsartan or enalapril tablets for 12 weeks.
Slovenian: V drugi klini ni študiji, v katero je bilo vklju enih 300 hipertenzivnih pediatri nih bolnikov v starosti od 6 do 18 let, so bolnike, ki so bili primerni za vklju itev, randomizirali tako, da so 12 tednov prejemali tablete z bodisi valsartanom ali enalaprilom.
English: The combination with ACE inhibitors is not recommended (see sections 4.4 and 5.1).
Slovenian: Kombinacija z zaviralci ACE ni priporo ljiva (glejte poglavji 4.4 in 5.1).
English: • breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure)
Slovenian: • zadihanost, težave z dihanjem v ležeem položaju, oteklina stopal in nog (znaki srnega popušanja)
English: In this subgroup all-cause mortality was significantly reduced with valsartan compared to placebo by 33% (95% CI: -6% to 58%) (17.3% valsartan vs. 27.1% placebo) and the composite mortality and morbidity risk was significantly reduced by 44% (24.9% valsartan vs. 42.5% placebo).
Slovenian: V tej podskupini je bila umrljivost iz vseh vzrokov z valsartanom statisti no zna ilno manjša za 33 % v primerjavi s placebom (95 % IZ: -6 % do 58 %) (17,3 % pri valsartanu v primerjavi s 27,1 % pri placebu), tveganje glede sestavljene umrljivosti in obolevnosti pa je bilo statisti no zna ilno manjše za 44 % (24,9 % pri valsartanu v primerjavi z 42,5 % pri placebu).
English: Paediatric heart failure and recent myocardial infarction Diovan is not recommended for the treatment of heart failure or recent myocardial infarction in children and adolescents below the age of 18 years due to the lack of data on safety and efficacy.
Slovenian: Sr no popuš anje in nedavni miokardni infarkt pri pediatri nih bolnikih Zaradi pomanjkanja podatkov o varnosti in u inkovitosti uporaba zdravila Diovan ni priporo ljiva za zdravljenje sr nega popuš anja ali nedavnega miokardnega infarkta pri otrocih in mladostnikih, ki so mlajši od 18 let.
English: Discontinuations due to various types of renal dysfunction occurred in 1.1% of valsartan-treated patients, 1.3% in valsartan+captopril patients, and 0.8% of captopril patients.
Slovenian: Do prekinitve zdravljenja zaradi razli nih vrst ledvi ne disfunkcije je prišlo pri 1,1 % bolnikov, ki so se zdravili z valsartanom, pri 1,3 % bolnikov, ki so se zdravili s kombinacijo valsartana in kaptoprila, in pri 0,8 % bolnikov, ki so se zdravili s kaptoprilom.
English: For maximum doses studied in clinical trials please refer to the table below.
Slovenian: Najvišji odmerki, ki so jih prou evali v klini nih preskušanjih, so navedeni v spodnji preglednici.
English: In the second study, higher doses of valsartan were associated with greater BP reductions, but the dose response trend did not achieve statistical significance and the treatment difference compared to placebo was not significant.
Slovenian: V drugi študiji se je pokazala povezava med višjimi odmerki in ve jim znižanjem krvnega tlaka, vendar trend odvisnosti odziva od odmerka ni dosegel statisti ne zna ilnosti, pa tudi razlika zaradi zdravljenja v primerjavi s placebom ni bila statisti no zna ilna.
English: If this applies to you, the use of Diovan is not recommended.
Slovenian: e pride do tega pri vas, uporaba zdravila Diovan ni priporo ena,
English: - Hypersensitivity to the active substance or to any of the excipients.
Slovenian: - Preob utljivost za zdravilno u inkovino ali katerokoli pomožno snov.
English: At 24 weeks, UAE was reduced (p <0.001) by 42% (-24.2 µg/min; 95% CI: -40.4 to -19.1) with valsartan and approximately 3% (-1.7 µg/min; 95% CI: -5.6 to 14.9) with amlodipine despite similar rates of blood pressure reduction in both groups.
Slovenian: Po 24 tednih se je izlo anje albumina z urinom zmanjšalo (p < 0,001) za 42 % (-24,2 µg/min; 95 % IZ: -40,4 do -19,1) z valsartanom in približno za 3 % (-1,7 µg/min; 95 % IZ: -5,6 do 14,9) z amlodipinom kljub podobnemu obsegu zmanjšanja krvnega tlaka pri obeh skupinah.
English: Because of these inconsistencies, valsartan is not recommended in this age group (see section 4.8).
Slovenian: Zaradi navedenih neskladnosti v rezultatih uporaba valsartana ni priporo ena za to starostno skupino (glejte poglavje
English: No children below the age of 1 year were enrolled in these studies.
Slovenian: V ti dve študiji niso vklju evali otrok, ki bi bili mlajši od 1 leta.
English: Use in children under 6 years of age.
Slovenian: Klini ne izkušnje pri otrocih, mlajših od 6 let
English: • Restart the cycle of PSUR submission for Diovan as follows: o Six-monthly PSURs until two full years of experience with the paediatric indication in the EU has been gained o Yearly PSURs for the following two years o Thereafter submission at 3-yearly intervals The PSURs should focus on the use in the paediatric population.
Slovenian: • ponovno za el cikel rednega predlaganja posodobljenih poro il o varnosti zdravila Diovan, kot sledi: o enkrat na 6 mesecev je treba predložiti posodobljena poro ila o varnosti zdravila, dokler ne bodo na voljo izkušnje s pediatri no indikacijo v EU za obdobje dveh celih let,
English: Dose adjustment is therefore not required in patients with renal impairment (creatinine clearance >10 ml/min).
Slovenian: Zato pri bolnikih z okvarjenim delovanjem ledvic odmerka ni treba prilagajati (o istek kreatinina > 10 ml/min).
English: Diovan and associated names (see Annex I) 40 mg film-coated tablets Diovan and associated names (see Annex I) 80 mg film-coated tablets Diovan and associated names (see Annex I) 160 mg film-coated tablets Diovan and associated names (see Annex I) 320 mg film-coated tablets [See Annex I - To be completed nationally]
Slovenian: Diovan in sorodna imena (glejte Dodatek I) 40 mg filmsko obložene tablete Diovan in sorodna imena (glejte Dodatek I) 80 mg filmsko obložene tablete Diovan in sorodna imena (glejte Dodatek I) 160 mg filmsko obložene tablete Diovan in sorodna imena (glejte Dodatek I) 320 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država lanica]
English: In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with Diovan.
Slovenian: Bolniki s pomanjkanjem natrija in/ali hipovolemijo Pri bolnikih s hudim pomanjkanjem natrija in/ali hipovolemijo, ki prejemajo velike odmerke diuretikov, lahko v redkih primerih po za etku zdravljenja z zdravilom Diovan pride do simptomatske hipotenzije.
English: It was concluded that 160-320 mg of valsartan produced clinically relevant reductions in UAE in hypertensive patients with type 2 diabetes.
Slovenian: Zaklju ili so, da je 160-320 mg valsartana doseže klini no pomembno zmanjšanje izlo anja albumina z urinom pri hipertenzivnih bolnikih s sladkorno boleznijo tipa 2.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET [Izpolni država lanica]
English: See section 4.2 for information on paediatric use.
Slovenian: Za podatke o uporabi pri pediatri ni populaciji glejte poglavje 4.2.
English: Valsartan may be used in patients treated with other post-myocardial infarction therapies, e.g. thrombolytics, acetylsalicylic acid, beta blockers, statins, and diuretics.
Slovenian: Valsartan lahko uporabljajo bolniki, ki se zdravijo z drugimi zdravili po miokardnem infarktu, npr. s trombolitiki, z acetilsalicilno kislino, z antagonisti adrenergi nih receptorjev beta, s statini in z diuretiki.
English: Diovan and associated names (see Annex I) 40 mg film-coated tablets Diovan and associated names (see Annex I) 80 mg film-coated tablets Diovan and associated names (see Annex I) 160 mg film-coated tablets Diovan and associated names (see Annex I) 320 mg film-coated tablets [See Annex I -To be completed nationally] Valsartan
Slovenian: Diovan in sorodna imena (glejte Dodatek I) 40 mg filmsko obložene tablete Diovan in sorodna imena (glejte Dodatek I) 80 mg filmsko obložene tablete Diovan in sorodna imena (glejte Dodatek I) 160 mg filmsko obložene tablete Diovan in sorodna imena (glejte Dodatek I) 320 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država lanica] valsartan
English: He may also combine Diovan with an additional medicine (e.g. a diuretic).
Slovenian: Zdravilu Diovan lahko doda tudi druga zdravila (npr. diuretike).
English: • muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)
Slovenian: • mišini kri, nenormalen srni ritem (znaki hiperkaliemije)
English: Other conditions with stimulation of the renin-angiotensin system In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death.
Slovenian: Druge bolezni, pri katerih je stimuliran renin-angiotenzinski sistem Pri bolnikih, pri katerih je delovanje ledvic lahko odvisno od aktivnosti renin-angiotenzinskega sistema, (npr. pri bolnikih s hudim kongestivnim sr nim popuš anjem), je bilo zdravljenje z zaviralcem angiotenzinske konvertaze povezano z oligurijo in/ali s progresivno azotemijo, v redkih primerih tudi z akutno odpovedjo ledvic in/ali s smrtjo.
English: 5.2 Pharmacokinetic properties
Slovenian: 5.2 Farmakokineti ne lastnosti
English: Patients were randomised within 12 hours to 10 days after the onset of myocardial infarction symptoms to valsartan, captopril, or the combination of both.
Slovenian: Po nastopu simptomov miokardnega infarkta so bili bolniki v roku 12 ur do 10 dni randomizirani v skupino z valsartanom, s kaptoprilom ali s kombinacijo obeh.