FrancophonIA/ELRC3.0 huggingface dataset:
English: The effects of candesartan cilexetil 8-16 mg (mean dose 12 mg), once daily, on cardiovascular morbidity and mortality were evaluated in a randomised clinical trial with 4,937 elderly patients (aged 70-89 years; 21% aged 80 or above) with mild to moderate hypertension followed for a mean of 3.7 years (Study on COgnition and Prognosis in the Elderly).
Slovenian: Učinke odmerkov od 8 do 16 mg cileksetilkandesartanata (povprečni odmerek 12 mg) enkrat na dan na kardiovaskularno obolevnost in umrljivost so ocenili v randomiziranem kliničnem preskušanju pri 4.937 starejših bolnikih (starih od 70 do 89 let, 21 % starih 80 let ali več) z blago do zmerno hipertenzijo; bolnike so spremljali povprečno 3,7 leta (študija SCOPE; Study on COgnition and Prognosis in the Elderly).
English: Medicinal products that block the renin-angiotensin-aldosterone system have less pronounced antihypertensive effect in black patients (usually a low-renin population) than in non-black patients.
Slovenian: Zdravila, ki blokirajo sistem renin-angiotenzin-aldosteron, imajo pri bolnikih-črncih manj izrazit antihipertenzivni učinek (po navadi gre za populacijo z nizkim reninom) kot pri bolnikih-nečrncih.
English: The CHMP also agreed with the inclusion of a contraindication in patients with hypersensitivity to candersartan or to any of its excipients and in patients with severe hepatic impairment and/or cholestasis.
Slovenian: CHMP se je tudi strinjal z vključitvijo kontraindikacije pri bolnikih s preobčutljivostjo za kandesartan ali katero koli pomožno snov ter pri bolnikih s hudo jetrno okvaro ali holestazo ali obojim.
English: Very rare Nausea
Slovenian: Zelo redki navzea
English: Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels
Slovenian: Luksemburg NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels
English: If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Atacand.
Slovenian: Če niste prepričani, ali kaj od tega velja za vas, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete zdravilo Atacand.
English: • Headache.
Slovenian: • Glavobol.
English: The antihypertensive effect of candesartan may be enhanced by other medicinal products with blood pressure lowering properties, whether prescribed as an antihypertensive or prescribed for other indications.
Slovenian: Antihipertenziven učinek kandesartana lahko povečajo zdravila, ki znižujejo krvni tlak, bodisi da so predpisana za zniževanje krvnega tlaka ali za druge indikacije.
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Slovenian: Razen, če je nadaljevanje z AIIRA nujno, morajo bolnice, ki načrtujejo nosečnost, preiti na antihipertenzivno zdravljenje, ki ima dokazan varnostni profil za uporabo med nosečnostjo.
English: The absolute bioavailability of candesartan is approximately 40% after an oral solution of candesartan cilexetil.
Slovenian: Absolutna biološka uporabnost kandesartana je po uporabi peroralne raztopine cileksetilkandesartanata približno 40 %.
English: In a 3-month clinical study in hypertensive patients with type 2 diabetes mellitus and microalbuminuria, antihypertensive treatment with candesartan cilexetil reduced urinary albumin excretion (albumin/creatinine ratio, mean 30%, 95%CI 15-42%).
Slovenian: V 3-mesečni klinični študiji pri hipertenzivnih bolnikih s sladkorno boleznijo tipa 2 in mikroalbuminurijo je antihipertenzivno zdravljenje s cileksetilkandesartanatom zmanjšalo izločanje albumina v urinu (razmerje albumin/kreatinin, povprečje 30 %, 95 % IZ: od 15 do 42 %).
English: The renal elimination of candesartan is both by glomerular filtration and active tubular secretion.
Slovenian: V ledvicah se kandesartan izloča z glomerularno filtracijo in aktivno tubularno sekrecijo.
English: Sections on use in special populations, such as elderly, patients with intravascular volume depletion, patients with impaired renal and hepatic function and patients of black ethnicity were also harmonised.
Slovenian: Usklajena so bila tudi poglavja o uporabi pri posebnih populacijah, kot so starostniki, bolniki z zmanjšanim intravaskularnim volumnom, bolniki z motnjami v delovanju ledvic in jeter ter bolniki črne rase.
English: No gender related differences in the pharmacokinetics of candesartan have been observed.
Slovenian: V farmakokinetiki kandesartana niso ugotovili s spolom povezanih razlik.
English: Fourteen patients needed to be treated for the duration of the study to prevent one patient from dying of a cardiovascular event or being hospitalised for treatment of heart failure.
Slovenian: Med trajanjem študije je bilo treba zdraviti 14 bolnikov, da bi preprečili smrt enega bolnika zaradi kardiovaskularnega dogodka ali hospitalizacijo za zdravljenje srčnega popuščanja.
English: • Lithium (a medicine for mental health problems).
Slovenian: • litij (zdravilo za duševne motnje).
English: The combination of an ACE inhibitor, a potassium-sparing diuretic (e.g. spironolactone) and Atacand is not recommended and should be considered only after careful evaluation of the potential benefits and risks (see sections 4.4, 4.8 and 5.1).
Slovenian: Kombinacija zaviralca ACE, diuretika, ki varčuje s kalijem (npr. spironolaktona) in zdravila Atacand ni priporočljiva in pride v poštev šele po natančni oceni možnih koristi in tveganj (glejte poglavja 4.4, 4.8 in 5.1).
English: Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Slovenian: Če je prišlo do izpostavljenosti AIIRA v drugem trimesečju nosečnosti, je priporočljivo ultrazvočno pregledati delovanje ledvic in lobanjo.
English: An increased antihypertensive effect is also seen when candesartan cilexetil is combined with amlodipine or felodipine.
Slovenian: Večji antihipertenzivni učinek je opazen tudi med uporabo cileksetilkandesartanata v kombinaciji z amlodipinom ali felodipinom.
English: Atacand can be administered with other heart failure treatment, including ACE inhibitors, beta-blockers, diuretics and digitalis or a combination of these medicinal products.
Slovenian: Atacand se lahko uporablja skupaj z drugimi zdravili za srčno popuščanje, vključno z zaviralci ACE, zaviralci adrenergičnih receptorjev beta, diuretiki in digitalisom ali kombinacijo teh zdravil.
English: In general, there were no clinically important influences of Atacand on routine laboratory variables.
Slovenian: Na splošno Atacand ni klinično pomembno vplival na običajne laboratorijske vrednosti.
English: Candesartan was effective also in patients taking both beta-blockers and ACE inhibitors at the same time, and the benefit was obtained whether or not patients were taking ACE inhibitors at the target dose recommended by treatment guidelines.
Slovenian: Kandesartan je bil učinkovit tudi pri bolnikih, ki so hkrati prejemali zaviralce adrenergičnih receptorjev beta in zaviralce ACE, koristni učinki pa so bili neodisni od tega, ali so bolniki zaviralce ACE jemali v ciljnih odmerkih, priporočenih v smernicah za zdravljenje.
English: The SPC in one MS mentioned the addition of a calcium channel blocker (CCB) as an additional alternative strategy.
Slovenian: V povzetku glavnih značilnosti zdravila v eni državi članici se kot dodatna alternativna strategija omenja dodatek zaviralca kalcijevih kanalčkov.
English: Elderly population No initial dose adjustment is necessary in elderly patients.
Slovenian: Starejša populacija Starejšim bolnikom začetnega odmerka ni treba prilagoditi.
English: Treatment with candesartan cilexetil reduces mortality, reduces hospitalisation due to heart failure, and improves symptoms in patients with left ventricular systolic dysfunction as shown in the Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity (CHARM) programme.
Slovenian: Zdravljenje s cileksetilkandesartanatom zmanjša umrljivost, zmanjša hospitalizacije zaradi srčnega popuščanja in izboljša simptome pri bolnikih z blago do zmerno sistolično disfunkcijo levega prekata, kot je pokazal program CHARM (Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity).
English: In particular, updates on the potential dose increase up to 32 mg, increased antihypertensive effect when candesartan is combined with other medicinal products, including hydrochlorothiazide and CCB such as amlodipine or felodipine were considered.
Slovenian: Podrobneje so bile obravnavane posodobitve glede možnega povečanja odmerka do 32 mg in povečanega antihipertenzivnega učinka pri kombiniranju kandesartana z drugimi zdravili, vključno s hidroklorotiazidom in zaviralcem kalcijevih kanalčkov, kot sta amlodipin in felodipin.
English: It is acknowledged that there is limited data in this population, however, analysis of the primary composite endpoint, cardiovascular death or hospitalisation due to heart failure by NYHA class subgroups in the low EF trials (CHARMAlternative and CHARM-Added pooled, part of the CHARM programme), revealed Hazard Ratios (HR) below 1.0 in favour of candesartan compared to placebo in each of the NYHA subgroups.
Slovenian: Strinja se, da obstaja malo podatkov v tej populaciji, vendar je analiza sestavljenega primarnega cilja, kardiovaskularne smrti ali hospitalizacije zaradi srčnega popuščanja, razdeljenih po razredih NYHA, v preskušanjih z nizkim iztisnim deležem (združeni podatki študij CHARMAlternative in CHARM-Added, delov programa CHARM), v vsaki podskupino po NYHA pokazala razmerja ogroženosti (HR) pod 1,0 v prid kandesartana v primerjavi s placebom.
English: In patients with impaired hepatic function, the initial starting dose was changed from 2 mg to 4 mg.
Slovenian: Priporočljiv začetni odmerek pri bolnikih z jetrno okvaro so spremenili iz 2 mg na 4 mg.
English: In the elderly (over 65 years) Cmax and AUC of candesartan are increased by approximately 50% and 80%, respectively in comparison to young subjects.
Slovenian: Pri starejših osebah (nad 65 let) se Cmax v primerjavi z mladimi osebami poveča za približno 50 %, AUC pa za približno 80 %.
English: In these patients Atacand should be carefully titrated with thorough monitoring of blood pressure.
Slovenian: Tem bolnikom je treba odmerek Atacanda skrbno prilagajati in jim ob tem natančno kontrolirati krvni tlak.
English: Regarding concomitant therapy, according to the ESC heart failure guidelines (ESC HF, 2008), the current standard of care in patients is an adequate dose of a beta-blocker and an ACE inhibitor.
Slovenian: Glede sočasne uporabe drugih zdravil je po priporočilih ESC za srčno popuščanje (ESC HF, 2008) trenutni standard oskrbe bolnikov zadosten odmerek zaviralca beta in zaviralca ACE.
English: Package leaflet and labelling
Slovenian: Navodilo za uporabo in označevanje
English: In an open label clinical experience trial in 5,156 patients with diastolic hypertension, the blood pressure reduction during candesartan treatment was significantly less in black than non-black patients (14.4/10.3 mmHg vs 19.0/12.7 mmHg, p<0.0001/p<0.0001).
Slovenian: V odprtem kliničnem preskušanju pri 5.156 bolnikih z diastolično hipertenzijo je bilo znižanje krvnega tlaka med zdravljenjem s kandesartanom značilno manjše med bolniki-črnci kot nečrnci (14,4/10,3 mmHg v primerjavi z 19,0/12,7 mmHg, p < 0,0001/p < 0,0001).
English: [See Annex I - to be completed nationally]
Slovenian: [Glejte Dodatek I - Izpolni država članica]
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Slovenian: Če se kombinacija izkaže kot potrebna, je priporočljivo natančno kontrolirati koncentracijo litija v serumu.
English: Norway AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo , Norway
Slovenian: AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo , Norway
English: Norway AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo, Norway
Slovenian: AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo, Norway
English: This is because Atacand, when combined with some anaesthetics, may cause a drop in blood pressure.
Slovenian: Zdravilo Atacand lahko namreč v kombinaciji z nekaterimi anestetiki povzroči padec krvnega tlaka.
English: The most commonly reported adverse reactions were hyperkalaemia, hypotension and renal impairment.
Slovenian: Najpogosteje opisani neželeni učinki so bili hiperkaliemija, hipotenzija in okvara ledvic.
English: Twenty-three patients needed to be treated for the duration of the study to prevent one patient from dying of a cardiovascular event or being hospitalised for treatment of heart failure.
Slovenian: Med trajanjem študije je bilo treba zdraviti 23 bolnikov, da bi preprečili smrt enega bolnika zaradi kardiovaskularnega dogodka ali hospitalizacijo za zdravljenje srčnega popuščanja.
English: If you stop taking Atacand
Slovenian: Če ste prenehali jemati zdravilo Atacand
English: What Atacand looks like and contents of the pack
Slovenian: Izgled zdravila Atacand in vsebina pakiranja
English: • Swelling of the face, lips, tongue and/or throat.
Slovenian: • Oteklost obraza, ustnic, jezika in/ali žrela.
English: The posology for patients with heart failure was the same in all MSs.
Slovenian: Odmerjanje za bolnike s srčnim popuščanjem je bilo enako v vseh državah članicah.
English: Severe hepatic impairment and/or cholestasis.
Slovenian: Huda okvara jeter in/ali holestaza.
English: Up-titration to the target dose of 32 mg once daily (maximum dose) or the highest tolerated dose is done by doubling the dose at intervals of at least 2 weeks (see section 4.4).
Slovenian: Povečevanje do ciljnega odmerka 32 mg enkrat na dan (največji odmerek) ali največjega odmerka, ki ga bolnik prenese, je treba opraviti s podvajanjem odmerka v presledkih najmanj 2 tedna (glejte poglavje 4.4).
English: You may notice tiredness, yellowing of your skin and the whites of your eyes and flu like symptoms.
Slovenian: porumenelost kože in očesnih beločnic ter gripi podobni simptomi.
English: Evaluation of patients with heart failure should always comprise assessment of renal function including monitoring of serum creatinine and potassium.
Slovenian: Ocena bolnikov s srčnim popuščanjem mora vedno obsegati oceno delovanja ledvic, vključno s kontroliranjem kreatinina in kalija v serumu.
English: • swelling of the face, lips, tongue and/or throat, which may cause difficulties in swallowing
Slovenian: • otekanje obraza, ustnic, jezika in/ali žrela, ki lahko povzroči težave pri požiranju.
English: Black patients
Slovenian: Bolniki-črnci
English: Results from the CHARM programme showed clear benefits with regard to cardiovascular (CV) mortality and morbidity for patients with heart failure on candesartan and concomitant medication.
Slovenian: Rezultati programa CHARM so pokazali jasne koristne učinke z ozirom na smrtnost in obolevnost zaradi srčno-žilnih dogodkov pri bolnikih s srčnim popuščanjem, ki so jemali kandesartan in sočasno uporabljana zdravila.
English: Candesartan does not inhibit ACE, which converts angiotensin I to angiotensin II and degrades bradykinin.
Slovenian: Kandesartan ne zavira ACE, ki pretvarja angiotenzin I v angiotenzin II in razgrajuje bradikinin.
English: - the scope of the referral was the harmonisation of the Summary of Products Characteristics, labelling and package leaflet.
Slovenian: - Obseg napotitve je bil uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo.
English: Exposure to AIIRA 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 zdravljenju z AIIRA v drugem in tretjem trimesečju lahko povzroči fetotoksičnost (zmanjšano ledvično funkcijo, oligohidramnij, zapoznelo osifikacijo lobanje) in neonatalno toksičnost (odpoved ledvic, hipotenzija, hiperkaliemija) (glejte poglavje 5.3).
English: The trough blood pressure reduction (systolic/diastolic) was 13.1/10.5 mmHg with candesartan cilexetil 32 mg once daily and 10.0/8.7 mmHg with losartan potassium 100 mg once daily (difference in blood pressure reduction 3.1/1.8 mmHg, p<0.0001/p<0.0001).
Slovenian: Največje znižanje tlaka (sistolični/diastolični) je bilo z 32 mg cileksetilkandesartanata enkrat na dan 13,1/10,5 mmHg in s 100 mg losartana enkrat na dan 10,0/8,7 mmHg (razlika v znižanju krvnega tlaka 3,1/1,8 mmHg, p < 0,0001/p < 0,0001).
English: The candesartan serum concentrations increase linearly with increasing doses in the therapeutic dose range.
Slovenian: Koncentracija kandesartana v serumu se v območju terapevtskih odmerkov s povečevanjem odmerka povečuje linearno.
English: There is limited experience in patients with very severe or end-stage renal impairment (Clcreatinine < 15 ml/min) (see section 4.4).
Slovenian: Malo je izkušenj pri bolnikih z zelo hudo ali končno odpovedjo ledvic (očistek kreatinina < 15 ml/min) (glejte poglavje 4.4).
English: Section 4.9 Overdose
Slovenian: Poglavje 4.9 Prekomerno odmerjanje
English: However, all-cause mortality was also assessed in pooled populations, CHARMAlternative and CHARM-Added, HR 0.88 (95%CI: 0.79 to 0.98, p=0.018) and all three studies, HR 0.91 (95%CI: 0.83 to 1.00, p=0.055).
Slovenian: Vendar pa so umrljivost zaradi vseh vzrokov ocenili tudi v skupni populaciji študij CHARM-Alternative in CHARM-Added, HR 0,88 (95 % IZ: od 0,79 do 0,98, p = 0,018) ter vseh treh študij, HR 0,91 (95 % IZ: od 0,83 do 1,00, p = 0,055).
English: • You can take Atacand with or without food.
Slovenian: • Zdravilo Atacand lahko vzamete s hrano ali brez nje.
English: There is limited experience in patients with very severe or end-stage renal impairment (Clcreatinine < 15 ml/min).
Slovenian: Malo je izkušenj pri bolnikih z zelo hudo ali končno odpovedjo ledvic (očistek kreatinina < 15 ml/min ).
English: The combination of an ACE inhibitor, a potassium-sparing diuretic (e.g. spironolactone) and Atacand is not recommended and should be considered only after careful evaluation of the potential benefits and risks.
Slovenian: Kombinacija zaviralca ACE, diuretika, ki varčuje s kalijem (npr. spironolaktona), in Atacanda ni priporočljiva in pride v poštev šele po natančni oceni možnih koristi in tveganj.
English: Patients received candesartan cilexetil or placebo with other antihypertensive treatment added as needed.
Slovenian: Bolniki so prejemali cileksetilkandesartanat ali placebo, ki so ju po potrebi kombinirali z drugimi antihipertenzivi.
English: Atacand is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Slovenian: Zdravila Atacand ne priporočamo v zgodnji nosečnosti in ga ne smete jemati, če ste noseči več kot 3 mesece, saj lahko resno poškoduje vašega otroka, če ga uporabljamo v tem obdobju.
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels
Slovenian: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels Belgium
English: The AUC of candesartan in patients undergoing haemodialysis was similar to that in patients with severe renal impairment.
Slovenian: AUC kandesartana je bil pri bolnikih na hemodializi podoben kot pri bolnikih s hudo okvaro ledvic.
English: The heart failure indication was approved in all MSs.
Slovenian: Indikacija srčnega popuščanja je bila odobrena v vseh državah članicah.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Slovenian: Ko je nosečnost potrjena, moramo zdravljenje z antagonisti receptorjev angiotenzina II takoj prekiniti in, če je primerno, začeti z nadomestnim zdravljenjem (glejte poglavji 4.3 in 4.6).
English: The antagonism of the angiotensin II (AT1) receptors results in dose related increases in plasma renin levels, angiotensin I and angiotensin II levels, and a decrease in plasma aldosterone concentration.
Slovenian: Posledica antagonizma na receptorjih angiotenzina II (AT1) je z odmerkom povezano povečanje plazemske ravni renina, angiotenzina I in angiotenzina II ter zmanjšanje plazemske koncentracije aldosterona.
English: In very rare cases, kidney failure may occur.
Slovenian: Zelo redko se lahko pojavi odpoved ledvic.
English: Very rare Back pain, arthralgia, myalgia
Slovenian: Zelo redki bolečine v hrbtu, artralgija, mialgija
English: Warnings regarding renal impairment, concomitant therapy with an ACE inhibitor in heart failure, haemodialysis, renal artery stenosis, kidney transplantation, hypotension, anaesthesia and surgery, aortic and mitral valve stenosis, primary hyperaldosteronism and hyperkalaemia were harmonised.
Slovenian: Usklajena so bila opozorila v zvezi z ledvično okvaro, sočasnim zdravljenjem z zaviralcem ACE pri srčnem popuščanju, hemodializo, stenozo ledvične arterije, presaditvijo ledvic, hipotenzijo, anestezijo in kirurškim posegom, stenozo aortne in mitralne zaklopke, primarnim hiperaldosteronizmom in hiperkaliemijo.
English: Aortic and mitral valve stenosis (obstructive hypertrophic cardiomyopathy) As with other vasodilators, special caution is indicated in patients suffering from haemodynamically relevant aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.
Slovenian: Stenoza aortne ali mitralne zaklopke (obstruktivna hipertrofična kardiomiopatija) Tako kot pri drugih vazodilatatorjih je posebna previdnost potrebna pri bolnikih s hemodinamsko pomembno stenozo aortne ali mitralne zaklopke ali z obstruktivno hipertrofično kardiomiopatijo.
English: Very rare Angioedema, rash, urticaria, pruritus
Slovenian: Zelo redki angioedem, izpuščaj, urtikarija, srbenje
English: Medicinal products that affect the renin-angiotensin-aldosterone system, including angiotensin II receptor antagonists (AIIRAs), may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
Slovenian: Zdravila, ki vplivajo na sistem renin-angiotenzin-aldosteron, vključno z antagonisti receptorjev angiotenzina II (AIIRA), lahko pri bolnikih z bilateralno stenozo ledvične arterije ali stenozo arterije solitarne ledvice povečajo koncentracijo sečnine v krvi in kreatinina v serumu.
English: A full contraindication in all trimesters of pregnancy and in lactation was previously included in the SPC.
Slovenian: V povzetek glavnih značilnosti zdravila je bila prej vključena popolna kontraindikacija v vseh trimesečjih nosečnosti in v obdobju dojenja.
English: This placebo controlled, double-blind study programme in chronic heart failure (CHF) patients with NYHA functional class II to IV consisted of three separate studies: CHARM-Alternative (n=2,028) in patients with LVEF  40% not treated with an ACE inhibitor because of intolerance (mainly due to cough, 72%), CHARM-Added (n=2,548) in patients with LVEF  40% and treated with an ACE inhibitor, and CHARM-Preserved (n=3,023) in patients with LVEF > 40%.
Slovenian: Obsegal je tri ločene študije: CHARMAlternative (n = 2.028) pri bolnikih z LVEF  40 %, ki zaradi neprenašanja (v glavnem zaradi kašlja, 72 %) niso prejemali zaviralca ACE, CHARM-Added (n = 2.548) pri bolnikih z LVEF  40 %, zdravljenih z zaviralcem ACE, in CHARM-Preserved (n = 3.023) pri bolnikih z LVEF > 40 %.
English: Treatment with candesartan cilexetil resulted in improved NYHA functional class (p=0.008).
Slovenian: Zdravljenje s cileksetilkandesartanatom je povzročilo izboljšanje funkcijskega razreda po NYHA (p = 0,008).
English: Very rare Dizziness, headache
Slovenian: Zelo redki omotica, glavobol
English: In conclusion, based on the assessment of the MAH proposal and responses, and following the discussions of the committee, the CHMP adopted harmonised sets of PI documents for Atacand and associated names.
Slovenian: CHMP je na osnovi ocene predlogov in odgovorov imetnika dovoljenja za promet z zdravilom ter po razpravi znotraj Odbora sprejel usklajene komplete navodila za uporabo zdravila Atacand in z njim povezanih imen.