FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the CHMP considered that this is an acceptable indication.
Slovenian: Posledično je CHMP menil, da je ta indikacija sprejemljiva.
English: Blood pressure may also be lowered by one of the following drugs/ class of drugs: tricyclic antidepressants, antipsychotics, baclofene, amifostine,
Slovenian: Krvni tlak vam lahko zniža tudi katero od naslednjih zdravil/skupin zdravil: triciklični antidepresivi, antipsihotiki, baklofen, amifostin.
English: WEEK 2 (Day 8-14)
Slovenian: TEDEN (8.-14. dan)
English: • dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position,
Slovenian: • od odmerka odvisni ortostatski učinki, kot je padec krvnega tlaka, ko vstanete iz ležečega ali sedečega položaja
English: The results showed that the active metabolite is formed from losartan in all age groups.
Slovenian: Rezultati so pokazali, da se iz losartana tvori aktivni presnovek v vseh starostnih skupinah.
English: Like other substances that directly affect the renin-angiotensin system, losartan has been shown to induce adverse effects on the late foetal development, resulting in foetal death and malformations.
Slovenian: Tako kot druge snovi, ki neposredno vplivajo na sistem renin-angiotenzin, ima tudi losartan neželene učinke na pozni razvoj ploda, kar povzroči smrt ploda in malformacije.
English: RENAAL-Study
Slovenian: Študija RENAAL
English: • elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.
Slovenian: • zvečana količina alaninaminotransferaze (ALT) v krvi, ki se po prekinitvi zdravljenja običajno popravi
English: • if you are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently,
Slovenian: • če veste, da imate zožanje ali zaprtje krvnih žil, ki vodijo do ledvic, ali če so vam pred kratkim presadili ledvico,
English: Lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor.
Slovenian: • Zdravila, ki vsebujejo litij, se v kombinaciji z losartanom brez natančnega nadzora zdravnika ne smejo uporabljati.
English: The lowest doses studied, 2.5 mg and 5 mg, corresponding to an average daily dose of 0.07 mg/ kg, did not appear to offer consistent antihypertensive efficacy.
Slovenian: Pri najmanjših preučevanih odmerkih, 2,5 mg in 5 mg, ustrezajočih povprečnemu dnevnemu odmerku 0,07 mg/ kg, ni kazalo, da bi zagotavljala konsistentno antihipertenzivno učinkovitost.
English: Cozaar is unlikely to affect your ability to drive or use machines.
Slovenian: Zelo malo verjetno je, da bi zdravilo Cozaar vplivalo na sposobnost vožnje in upravljanja s stroji.
English: The pharmacokinetic parameters for the metabolite differed to a greater extent between the age groups.
Slovenian: Farmakokinetični parametri za presnovek so se med starostnimi skupinami razlikovali v večji meri.
English: Importantly, an ongoing study (HEAAL) comparing 50mg with 150mg losartan in patients with heart failure, may give relevant information on the dosing issue and address other open issues such as the negative results observed in patients on beta-blockers and losartan.
Slovenian: Pomembno je omeniti, da utegne potekajoča študija (HEAAL), primerjajoča 50 mg s 150 mg losartana pri bolnikih s srčnim popuščanjem, posredovati relevantne informacije v zvezi s problematiko odmerjanja ter odgovoriti na odprta vprašanja, kot so negativni rezultati, ugotovljeni pri bolnikih, prejemajočih zaviralce beta in losartan.
English: Therefore, the proposed indication was considered approvable after a majority vote by the CHMP plenum and is supported with the following wording: “reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy, documented by ECG”.
Slovenian: Posledično je bila predlagana indikacija z večino glasov na plenarnem zasedanju CHMP ocenjena za sprejemljivo ter je podprta z naslednjim besedilom: „zmanjšanje tveganja kapi pri hipertenzivnih bolnikih s hipertrofijo levega prekata, dokazano z EKG-jem“.
English: The reason for this broader indication is that the LIFE study was not a placebo-controlled study, studying the effect on stroke only compared to placebo, but an actively controlled study, comparing a losartan based with an atenolol based antihypertensive treatment using a primary composite endpoint of CV death, stroke and MI.
Slovenian: Razlog za to širšo indikacijo je dejstvo, da študija LIFE ni bila s placebom kontrolirana študija, ki bi preučevala le učinek na kap v primerjavi s placebom, temveč aktivno kontrolirana raziskava, ki je primerjala antihipertenzivno zdravljenje na podlagi losartana z zdravljenjem na podlagi atenolola ob uporabi sestavljene primarne končne točke - srčnožilne smrti, kapi in miokardnega infarkta.
English: • if you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a reduced blood circulation in the brain),
Slovenian: • če imate koronarno srčno bolezen (zaradi zmanjšanega krvnega obtoka v srčnih žilah) ali možganskožilno bolezen (zaradi zmanjšanega krvnega obtoka v možganih).
English: Measurements of blood pressure 24 hours post-dose relative to 5 - 6 hours post-dose demonstrated blood pressure reduction over 24 hours; the natural diurnal rhythm was retained.
Slovenian: Meritve krvnega tlaka 24 ur po odmerku so v primerjavi z meritvami 5 - 6 ur po odmerku pokazale 24 urno znižanje krvnega tlaka; ohranjen je bil naravni vsakodnevni ritem.
English: 2 tablets = 25 mg once daily
Slovenian: 2 tableti = 25 mg enkrat dnevno
English: Via G. Fabbroni 6, 00191 Rome, Italy
Slovenian: Via G. Fabbroni 6, 00191 Rim, Italija
English: • very rapid and irregular heartbeat (artrial fibrillation) brain attack (stroke),
Slovenian: • zelo hitro in neredno bitje srca (atrijska fibrilacija), možganska kap
English: See leaflet for further information.
Slovenian: Za nadaljnje informacije glejte Navodilo za uporabo.
English: If you take more Cozaar than you should
Slovenian: Če ste vzeli večji odmerek zdravila Cozaar, kot bi smeli
English: The combination of losartan with a beta-blocker should be used with caution”.
Slovenian: Kombinacijo losartana in zaviralca beta je treba uporabljati previdno.“
English: Symptoms of intoxication
Slovenian: Simptomi zastrupitve
English: Cozaar 12.5 mg, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively.
Slovenian: Cozaar 12,5 mg, 25 mg, 50 mg oz. 100 mg tablete vsebujejo kalij v naslednjih količinah: 1,06 mg (0,027 mEq), 2,12 mg (0,054 mEq), 4,24 mg (0,108 mEq) oz. 8,48 mg (0,216 mEq).
English: BATCH NUMBER
Slovenian: ŠTEVILKA SERIJE Batch:
English: Losartan is equally effective in males and females, and in younger (below the age of 65 years) and older hypertensive patients.
Slovenian: Losartan je enako učinkovit pri zdravljenju bolnikov s hipertenzijo moškega in ženskega spola, tako mlajših (mlajših od 65 let) kot starejših.
English: Take particular care if you are taking the following medicines while under treatment with Cozaar:
Slovenian: Še posebej pozorni bodite, če med zdravljenjem z zdravilom Cozaar jemljete katero od naslednjih zdravil:
English: The observation of the ELITE I Study, that, compared with captopril, Losartan reduced the mortality risk, was not confirmed in the subsequent ELITE II Study, which is described in the following.
Slovenian: Opažanje iz študije ELITE, da je losartan v primerjavi s kaptoprilom zmanjšal tveganje za smrt, v naslednji študiji ELITE II, ki je opisana v nadaljevanju, ni bilo potrjeno.
English: This composite endpoint can be considered as representative for CV morbidity and mortality, and has translated into this indication in many medicinal products that have been discussed in the CHMP (e.g. statins).
Slovenian: Ta sestavljeno primarno končno točko je mogoče smatrati za reprezentativno za srčnožilno obolevnost in smrtnost, na tej osnovi pa je bila oblikovana navedena indikacija pri številnih zdravilih, obravnavanih v okviru CHMP (npr. statinih).
English: Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar
Slovenian: MSD Chibropharm GmbH Postfach 1202 D-85530 Haar, Nemčija
English: The combination of losartan with a beta-blocker should be used with caution (see section 5.1).
Slovenian: Kombinacijo losartana in beta zaviralca je treba previdno uporabljati (glejte poglavje 5.1).
English: Losartan may also delay progression of diabetic nephropathy and is also indicated for the reduction of renal disease progression in patients with type 2 diabetes, hypertension and microalbuminuria (>30 mg/24 hours) or proteinuria (>900 mg/24 hours).
Slovenian: Losartan lahko tudi odloži napredovanje diabetične nefropatije ter je indiciran tudi za upočasnitev napredovanja ledvične bolezni pri bolniki s sladkorno boleznijo tipa 2, hipertenzijo in mikroalbuminurijo (>30 mg/24 ur) ali proteinurijo (>900 mg/24 ur).
English: In the treatment of heart failure, losartan is usually combined with a diuretic (medicine that increases the amount of water that you pass out through your kidneys) and/or digitalis (medicine that helps to make the heart stronger and more efficient) and/or a beta-blocker .
Slovenian: Pri zdravljenju srčnega popuščanje se losartan običajno kombinira z diuretikom (zdravilo, ki poveča količino vode, ki se izloči skozi ledvice) in/ali digitalisom (zdravilo, ki pripomore, da je srce močnejše in učinkovitejše) in/ali beta zaviralcem.
English: At the time of the study, beta-blockade alone, or in combination with diuretics had shown to reduce rates of many CV events by 15-45%.
Slovenian: V času študije je bilo dokazano, da blokada receptorjev beta sama ali v kombinaciji z diuretiki zmanjša pogostost številnih srčnožilnih dogodkov za 15 do 45 %.
English: Despite these increases, antihypertensive activity and suppression of plasma aldosterone concentration are maintained, indicating effective angiotensin II receptor blockade.
Slovenian: Kljub temu povečanju pa se ohranjata antihipertenzivna aktivnost in zmanjševanje koncentracije aldosterona v plazmi, kar kaže na učinkovito blokado receptorjev za angiotenzin II.
English: During oncedaily dosing with 100 mg, neither losartan nor its active metabolite accumulates significantly in plasma.
Slovenian: Pri enkrat dnevnem odmerjanju 100 mg se niti losartan niti njegov aktivni presnovek v plazmi ne kopičita pomembno.
English: When pregnancy is diagnosed, treatment with losartan should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Slovenian: Ko se ugotovi nosečnost, je treba zdravljenje z losartanom takoj prekiniti in, če je primerno, začeti alternativno zdravljenje (glejte poglavji 4.3 in 4.6).
English: Some patients may receive an additional benefit by increasing the dose to 100 mg once daily (in the morning).
Slovenian: Pri nekaterih bolnikih lahko dodatno korist dosežemo s povečanjem odmerka na 100 mg enkrat na dan (zjutraj).
English: - Renal protection in patients with Type-2 diabetes and proteinuria The CHMP considered the benefit/risk ratio of this indication is positive.
Slovenian: - Zaščita ledvic pri bolnikih s sladkorno boleznijo tipa 2 in proteinurijo CHMP je bil mnenja, da je razmerje med tveganji in koristmi za to indikacijo pozitivno.
English: The rise in trough diastolic blood pressure was the same in patients receiving placebo and in those continuing losartan at the lowest dose in each group, again suggesting that the lowest dose in each group did not have significant antihypertensive effect.
Slovenian: Povečanje diastoličneg krvnega tlaka ob izteku učinka je bilo pri bolnikih, ki so prejemali placebo, in pri tistih, ki so nadaljevali z uporabo losartana v najnižjem odmerku, enako v vseh skupinah, kar ponovno nakazuje, da najnižji odmerek v vsaki skupini ni imel pomembnega antihipertenzivnega učinka.
English: When pregnancy is diagnosed, treatment with losartan should be stopped immediately and, if appropriate, alternative therapy should be started.
Slovenian: Ob potrjeni nosečnosti je treba zdravljenje z losartanom takoj prekiniti, in, če je primerno, začeti alternativno zdravljenje.
English: LIFE-Study
Slovenian: Študija LIFE
English: During the referral procedure, the MAH proposed amending the indication to substitute “cardiovascular morbidity and mortality” with “stroke”.
Slovenian: Med postopkom napotitve je imetnik dovoljenja za promet z zdravilom predlagal dopolnitev indikacije tako, da se „srčnožilna obolevnost in smrtnost“ nadomesti s „kapjo“.
English: The active metabolite is 10- to 40- times more active than Losartan on a weight for weight basis.
Slovenian: Aktivni presnovek je 10- do 40-krat bolj aktiven kot losartan (v isti količini).
English: The concomitant use of potassium sparing diuretics, potassium supplements and potassium containing salt substitutes with losartan is not recommended (see section 4.5).
Slovenian: Sočasne uporabe diuretikov, ki varčujejo kalij, kalijevih dodatkov in nadomestkov soli, ki vsebujejo kalij, ter losartana ne priporočamo (glejte poglavje 4.5).
English: - The use of losartan in paediatric patients should be included in sections 4.2, 4.4, 4.8, 5.1 and 5.2 of the SPC, and the relevant sections of the Package Leaflet.
Slovenian: - Uporabo losartana pri pediatričnih bolnikih je treba vključiti v poglavja 4.2, 4.4, 4.8, 5.1 in 5.2 SPC ter v ustrezna poglavja navodila za uporabo.
English: An increased mortality was observed in ELITE II in the small subgroup (22% of all HF patients) taking beta-blockers at baseline.
Slovenian: Povečano smrtnost so opazili v majhni podskupini bolnikov iz študije ELITE II (22 % vseh bolnikov s srčnim popuščanjem), ki so na začetku jemali beta zaviralce.
English: Compared to patients with normal renal function, the AUC for Losartan is about 2-times higher in haemodialysis dialysis patients.
Slovenian: V primerjavi z bolniki z normalno ledvično funkcijo je pri bolnikih na hemodializi AUC losartana približno 2-krat večja.
English: When losartan is administered orally, about 4% of the dose is excreted unchanged in the urine, and about 6% of the dose is excreted in the urine as active metabolite.
Slovenian: Po peroralnem odmerku losartana se približno 4 % zaužitega odmerka izloči v urin nespremenjenega, približno 6 % zaužitega odmerka pa v obliki aktivnega presnovka.
English: The results showed roughly similar pharmacokinetic parameters of losartan following oral administration in infants and toddlers, preschool children, school age children and adolescents.
Slovenian: Rezultati so pokazali približno podobne farmakokinetične parametre za losartan po peroralni uporabi pri dojenčkih in malčkih, predšolskih otrocih, šolarjih in mladostnikih.
English: There are limited data on the efficacy and safety of losartan in children and adolescents aged 6-16 years old for the treatment of hypertension (see 5.1: Pharmacodynamic properties).
Slovenian: Na voljo je le malo podatkov o učinkovitosti in varnosti losartana pri otrocih in mladostnikih, starih 6 do 16 let, pri uporabi za zdravljenje hipertenzije (glejte 5.1: Farmakodinamične lastnosti).
English: A recent review in the BMJ shows that specifically the preventive effect on stroke of atenolol is lower than for other antihypertensives; RR of 1.26 (95%CI: 1.15 to 1.38).
Slovenian: Nedavni pregled v BMJ kaže, da je preventivni učinek atenolola glede kapi manjši kot pri drugih antihipertenzivih; relativno tveganje (RR) 1,26 (95-odstotni interval zaupanja (CI): 1,15 do 1,38).
English: Do not use Cozaar after the expiry date which is stated on the carton after EXP.
Slovenian: Zdravila Cozaar ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake "Uporabno do".
English: Since then the beneficial effect of atenolol regarding CV morbidity and mortality has been questioned.
Slovenian: Od tedaj je ugoden učinek atenolola v zvezi s srčnožilno obolevnostjo in smrtnostjo pod vprašajem.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: As a consequence the observed 25% risk reduction with losartan versus atenolol brings the protective effect of losartan on stroke in the same range as for other antihypertensives.
Slovenian: Posledično ugotovljeno 25-odstotno zmanjšanje tveganja pri uporabi losartana v primerjavi z atenololom pomeni zaščitni učinek losartana glede kapi enakega reda velikosti, kot ga imajo drugi antihipertenzivi.
English: Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 6.1).
Slovenian: Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavji 4.4 in 6.1).
English: Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system.
Slovenian: Bolniki s primarnim hiperladosteronizmom se na zdravljenje z antihipertenzivi, ki zavirajo sistem renin-angiotenzin, večinoma ne odzovejo.
English: • low blood pressure,
Slovenian: • nizek krvni tlak
English: • back pain and urinary track infection.
Slovenian: • bolečine v hrbtu in okužba urinarnega trakta
English: The proposed indication is based on the results from the RENAAL study, where the effect of losartan was investigated on a composite primary endpoint of renal endpoints and mortality in patients with Type II diabetes mellitus with proteinuria.
Slovenian: Predlagana indikacija temelji na rezultatih študije RENAAL, v kateri so preučevali učinek losartana z ozirom na primarno končno točko, sestavljeno iz ledvičnih pokazateljev in smrtnosti, pri bolnikih s sladkorno boleznijo tipa 2 s proteinurijo.
English: In female hypertensive patients the plasma levels of losartan were up to twice as high as in male hypertensive patients, while the plasma levels of the active metabolite did not differ between men and women.
Slovenian: Pri ženskah s hipertenzijo so bile koncentracije losartana v plazmi do dvakrat višje kot pri moških s hipertenzijo, količine aktivnega presnovka v plazmi pa se med moškimi in ženskami niso razlikovale.
English: • if your liver function is impaired (see sections 2 "Do not take Losartan" and 3 ‘Dosage in special patient groups'),
Slovenian: • če imate okvaro jeter (glejte poglavje 2 "Ne jemljite zdravila Cozaar" in poglavje 3 "Odmerjanje pri posebnih skupinah bolnikov").
English: Doses above 1.4 mg/ kg (or in excess of 100 mg) daily have not been studied in pediatric patients.
Slovenian: Odmerkov nad 1,4 mg/ kg (ali nad 100 mg) dnevno pri pediatričnih bolnikih niso preučevali.
English: Losartan is predominantly metabolised by cytochrome P450 (CYP) 2C9 to the active carboxy-acid metabolite.
Slovenian: Losartan presnavlja predvsem citokrom P450 (CYP) 2C9 v aktivni karboksikislinski presnovek.
English: • too less sugar in the blood (hypoglycaemia),
Slovenian: • premalo sladkorja v krvi (hipoglikemija)
English: Losartan is an orally active angiotensin II (Ang- II) receptor antagonist acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade.
Slovenian: Losartan je peroralno aktivni antagonist receptorjev angiotenzina II (Ang- II), delujoč na receptorje podtipa AT1, ki na ta način blokira učinek Ang-II v kaskadi renin-angiotenzinskega sistema (RAS).
English: In a clinical trial it was found that fluconazole (inhibitor of CYP2C9) decreases the exposure to the active metabolite by approximately 50%.
Slovenian: V kliničnem preizkušanju so ugotovili, da flukonazol (zaviralec CYP2C9) zmanjšuje izpostavljenost aktivnemu presnovku za približno 50 %.
English: As observed for angiotensin converting enzyme inhibitors, losartan 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.
Slovenian: Tako kot so opazili pri zaviralcih angiotenzinske konvertaze, so tudi losartan in drugi antagonisti angiotenzina pri črncih očitno manj učinkoviti za zniževanje krvnega tlaka kot pri drugih rasah, verjetno zaradi večje pojavnosti nizkih vrednosti renina pri črnski populaciji hipertonikov.
English: The primary endpoint of the study was a composite endpoint of doubling of the serum creatinine endstage renal failure (need for dialysis or transplantation) or death.
Slovenian: Primarni opazovani dogodek v študiji je bil sestavljeni opazovani dogodek podvojitve kreatinina v serumu, končne ledvične odpovedi (potreba po dializi ali presaditvi) ali smrt.
English: Both losartan and its active metabolite are ≥99% bound to plasma proteins, primarily albumin.
Slovenian: Tako losartan kot njegov aktivni presnovek sta v ≥ 99 % vezana na plazemske proteine, predvsem na albumin.
English: If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: Pregnancy and Lactation
Slovenian: Nosečnost in dojenje
English: Co-administration of lithium and losartan should be undertaken with caution.
Slovenian: Sočasne uporabe litija in losartana se je treba lotiti previdno.
English: If you forget to take Cozaar
Slovenian: Če ste pozabili vzeti zdravilo Cozaar
English: Dosage in special patient groups
Slovenian: Odmerjanje pri posebnih skupinah bolnikov
English: [To be implemented nationally]
Slovenian: [Izpolni država članica]
English: Concomitant use of angiotensin II antagonists or diuretics and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Slovenian: Sočasna uporaba antagonistov angiotenzina II ali diuretikov in NSAR-ov lahko poveča tveganje za poslabšanje ledvične funkcije, vključno z možno akutno ledvično odpovedjo, ter poveča količino kalija v serumu, še posebej pri bolnikih z že obstoječim slabim delovanjem ledvic.
English: For the following individual and combined components of the primary endpoint, the results showed a significant risk reduction in the group treated with Losartan: 25.3 % risk reduction for doubling of the serum creatinine (p = 0.006); 28.6 % risk reduction for end-stage renal failure (p = 0.002); 19.9 % risk reduction for end-stage renal failure or death (p = 0.009); 21.0 % risk reduction for doubling of serum creatinine or end-stage renal failure (p = 0.01).
Slovenian: V skupini, ki se je zdravila z losartanom, se je pomembno zmanjšalo tveganje za naslednje posamezne komponente primarnega opazovanega dogodka in njihove kombinacije: 25,3 % zmanjšanje tveganja za podvojitev kreatinina v serumu (p = 0,006); 28,6 % zmanjšanje tveganja za končno ledvično odpoved (p = 0,002), 19,9 % zmanjšanje tveganja za končno ledvično odpoved ali smrt (p = 0,009), 21,0 % zmanjšanje tveganja za podvojitev kreatinina v serumu ali končno ledvično odpoved (p = 0,010).
English: Cozaar has been studied in children.
Slovenian: Zdravilo Cozaar so preizkušali pri otrocih.
English: After a majority voting at the CHMP plenum, the CHMP recommended that the following wording be proposed to reflect the data from the ELITE I and II studies, within a second-line indication: “Treatment of chronic heart failure (in patients aged 60 or over), when treatment with ACE inhibitors is not considered suitable due to incompatibility or contraindications.
Slovenian: Na svojem plenarnem zasedanju je CHMP z večino glasov priporočil, da se predlaga naslednje besedilo, odražajoče podatke iz študij ELITE I in II, v okviru indikacije kot druga izbira: „Zdravljenje kroničnega srčnega popuščanja (pri bolnikih, starih 60 let ali več), ko je zdravljenje z zaviralci ACE ocenjeno kot neprimerno zaradi nezdružljivosti ali kontraindikacij.