FrancophonIA/ELRC3.0 huggingface dataset:
English: Different treatment effects of aliskiren were reported for overall mortality within 12 months dependent on diabetes mellitus status.
Slovenian: Vplivi zdravljenja na celokupno umrljivost v 12 mesecih se po poročilih razlikujejo glede na status sladkorne bolezni.
English: The findings observed in the 2-week and 13-week toxicity studies were consistent with those observed previously with aliskiren or hydrochlorothiazide monotherapies.
Slovenian: Rezultati, ki so jih opažali v dveh študijah toksičnosti, 2-tedenski in 13-tedenski, so se ujemali s predhodnimi rezultati, ki so jih opažali pri uporabi aliskirena ali hidroklorotiazida v monoterapiji.
English: The safety and efficacy of Rasilez HCT in children below 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Rasilez HCT pri otrocih, starih manj kot 18 let, nista bili dokazani.
English: No clinically relevant differences in efficacy or safety results were observed in the subpopulation of elderly patients with a history of hypertension and chronic heart failure Class I-II compared to the overall study population.
Slovenian: Pri rezultatih glede učinkovitosti in varnosti niso opažali klinično pomembnih razlik pri podskupini starejših bolnikov z anamnezo hipertenzije in kroničnega srčnega popuščanja razredov I/II v primerjavi s celotno študijsko populacijo.
English: If blood pressure remains uncontrolled after 2-4 weeks of therapy, the dose may be titrated up to a maximum of Rasilez HCT 300 mg/25 mg daily.
Slovenian: Če po 2-4 tednih zdravljenja krvni tlak še vedno ni urejen, je odmerek mogoče zvišati do največ 300 mg/25 mg zdravila Rasilez HCT dnevno.
English: Therefore, drinks containing plant extracts, including herbal teas, should not be taken together with Rasilez HCT.
Slovenian: Iz tega razloga se napitkov, ki vsebujejo rastlinske izvlečke, vključno z zeliščnimi čaji, ne sme uživati skupaj z zdravilom Rasilez HCT.
English: A cumulative doseresponse relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Slovenian: Razmerje med kumulativnim odmerkom in odzivom so dokazali s tem, da se je prilagojeni OR z 2,1 (95-odstotni IZ: 1,7-2,6), zvišal na 3,9 (3,04,9) pri velikih odmerkih (~ 25.000 mg) in celo na 7,7 (5,7-10,5) pri največjih kumulativnih odmerkih (~ 100.000 mg) (glejte tudi poglavje 4.4).
English: In the event of severe and perisistent diarrhoea, Rasilez HCT therapy should be stopped (see section 4.8).
Slovenian: V primeru hude ali persistentne driske je treba zdravljenje z zdravilom Rasilez HCT prekiniti (glejte poglavje 4.8).
English: It has been shown that there is a high-affinity receptor in the renal cortex as the primary binding site for the thiazide diuretic action and inhibition of NaCl transport in the distal convoluted tubule.
Slovenian: Dokazali so da v ledvični skorji obstaja receptor z veliko afiniteto, ki je glavno vezavno mesto za delovanje tiazidnih diuretikov in zaviranje transporta NaCl v distalnem zvitem tubulu.
English: Rasilez HCT combines two antihypertensive active substances to control blood pressure in patients with essential hypertension: Aliskiren belongs to the class of direct renin inhibitors and hydrochlorothiazide to the class of thiazide diuretics.
Slovenian: Zdravilo Rasilez HCT združuje dve antihipertenzivni učinkovini za uravnavanje krvnega tlaka pri bolnikih z esencialno hipertenzijo: aliskiren sodi v skupino neposrednih zaviralcev renina, hidroklorotiazid pa v skupino tiazidnih diuretikov.
English: − Hyponatraemia, hypercalcaemia, symptomatic hyperuricaemia and refractory hypokalaemia.
Slovenian: − hiponatriemija, hiperkalciemija, simptomatska hiperurikemija in neodzivna hipokaliemija;
English: In controlled clinical study, the incidence of diarrhoea in Rasilez HCT-treated patients was 1.3% compared to 1.4% for aliskiren- or 1.9% for hydrochlorothiazide-treated patients.
Slovenian: V kontrolirani klinični študiji je bila incidenca driske pri uporabi zdravila Rasilez HCT 1,3 % v primerjavi z 1,4 % pri uporabi samo aliskirena oziroma z 1,9 % pri uporabi samo hidroklorotiazida.
English: The study showed no benefit of aliskiren when administered on top of standard therapy for acute heart failure and an increased risk of cardiovascular events in patients with diabetes mellitus.
Slovenian: Rezultati študije niso pokazali nobene koristi dodajanja aliskirena standardnemu zdravljenju akutnega srčnega popuščanja, hkrati pa so pokazali povečano tveganje za kardiovaskularne dogodke pri bolnikih s sladkorno boleznijo.
English: • Skin and lip cancer (Non-melanoma skin cancer)
Slovenian: • kožni rak in rak ustnice (nemelanomski kožni rak),
English: The use of Rasilez HCT during breast-feeding is not recommended.
Slovenian: Uporaba zdravila Rasilez HCT med dojenjem ni priporočena.
English: It is not known whether aliskiren is excreted in human milk.
Slovenian: Dojenje Ni znano, ali se aliskiren izloča v materino mleko.
English: See leaflet for further information.
Slovenian: Za več podatkov glejte priložena navodila.
English: In controlled clinical study, angioedema and hypersensitivity reactions occurred rarely during treatment with aliskiren with rates comparable to treatment with placebo or comparators.
Slovenian: V kontrolirani klinični študiji je med zdravljenjem z aliskirenom redko prišlo do angioedema in preobčutljivostnih reakcij in sicer s pogostnostjo, ki je bila primerljiva z zdravljenjem s placebom ali primerjalnimi zdravili.
English: • Low level of blood platelets (sometimes with bleeding or bruising underneath the skin)
Slovenian: • nizka raven trombocitov v krvi (včasih s krvavitvami ali s podkožnimi podplutbami),
English: − Severe renal impairment (GFR < 30 ml/min/1.73 m2).
Slovenian: − huda okvara ledvic (hitrost glomerulne filtracije < 30 ml/min/1,73 m2);
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 14 filmsko obloženih tablet.
English: Other medicines and Rasilez HCT
Slovenian: Druga zdravila in zdravilo Rasilez HCT
English: When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Slovenian: Kadar je to klinično primerno, velja razmisliti tudi o neposrednem prehodu z monoterapije na že pripravljeno kombinacijo zdravila.
English: The clinical implications of the effects on PRA are not known at the present time.
Slovenian: Klinični pomen učinka na delovanje renina v plazmi zaenkrat ni znan.
English: What Rasilez HCT is and what it is used for What you need to know before you take Rasilez HCT How to take Rasilez HCT
Slovenian: Kaj je zdravilo Rasilez HCT in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Rasilez HCT Kako jemati zdravilo Rasilez HCT Možni neželeni učinki
English: The mode of action of thiazides is through inhibition of the Na+Cl- symporter by competing for the Cl- site, thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly by this diuretic action reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Slovenian: Tiazidi delujejo tako, da tekmujejo za vezavno mesto za Cl- ione na skupnem prenašalcu Na+ in Cl- ionov in ga na ta način zavirajo, s tem pa vplivajo na mehanizme reabsorpcije elektrolitov: neposredno povečajo izločanje natrija in klorida v približno enaki meri, posredno pa s takim diuretičnim delovanjem zmanjšajo volumen plazme, s tem povzročijo zvišanje delovanja renina v plazmi, izločanje aldosterona in izgubljanje kalija z urinom ter znižano koncentracijo kalija v serumu.
English: Aliskiren is mainly eliminated as unchanged compound in the faeces (oral radioactive dose recovery = 91%).
Slovenian: Aliskiren se večinoma izloča z blatom v nespremenjeni obliki (po peroralnem radioaktivnem odmerku je mogoče iz blata prestreči 91 % odmerka).
English: The volume or salt depletion should be corrected prior to administration of Rasilez HCT, or the treatment should start under close medical supervision.
Slovenian: Hipovolemijo ali primanjkljaj natrija je treba odpraviti pred dajanjem zdravila Rasilez HCT ali pa je treba zdravljenje uvajati pod strogim zdravniškim nadzorom.
English: Angiotensin II causes blood vessels to tighten, which makes blood pressure higher.
Slovenian: Angiotenzin II povzroči, da se krvne žile stisnejo, kar zviša krvni tlak.
English: Rasilez HCT contains lactose.
Slovenian: Zdravilo Rasilez HCT vsebuje laktozo.
English: For the combination of aliskiren and enalapril there were statistically significant differences in the rate of angina unstable compared to enalapril.
Slovenian: Pri uporabi kombinacije aliskirena in enalaprila je prišlo do statistično značilnih razlik pri pogostnosti pojavljanja nestabilne angine pektoris v primerjavi z uporabo enalaprila.
English: Rasilez HCT is contraindicated in children from birth to less than 2 years.
Slovenian: Zdravilo Rasilez HCT je kontraindicirano pri otrocih, starih do 2 let.
English: What Rasilez HCT is and what is it used for
Slovenian: Kaj je zdravilo Rasilez HCT in za kaj ga uporabljamo
English: At the end of this extension study, changes in msSBP from baseline were similar with aliskiren compared to enalapril (-7.63 mmHg vs. -7.94 mmHg) in the full analysis set.
Slovenian: Po koncu podaljšane študije so bile spremembe povprečnega sistoličnega krvnega tlaka sede v primerjavi z vrednostjo na začetku pri aliskirenu podobne kot pri enalaprilu (-7,63 mmHg v primerjavi z -7,94 mmHg) pri kompletni analizi.
English: Due to the hydrochlorothiazide component, Rasilez HCT is contraindicated for use in patients with anuria and in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min/1.73 m2).
Slovenian: Zaradi vsebnosti hidroklorotiazida je zdravilo Rasilez HCT kontraindicirano za uporabo pri bolnikih z anurijo in pri bolnikih s hudo okvaro ledvic (s hitrostjo glomerulne filtracije (GFR) < 30 ml/min/1,73 m2).
English: The blood-pressure-lowering effect was sustained during long-term treatment (12 months), and was independent of age, gender, body mass index and ethnicity.
Slovenian: Učinek zniževanja krvnega tlaka se je ohranjal pri dolgotrajnem zdravljenju (12 mesecev) in je bil neodvisen od starosti, spola, indeksa telesne mase in etnične pripadnosti.
English: • Swelling of hands, ankles or feet (peripheral oedema)
Slovenian: • otekanje rok, gležnjev ali stopal (periferni edemi),
English: Warfarin The effects of aliskiren on warfarin pharmacokinetics have not been evaluated.
Slovenian: Varfarin Učinkov aliskirena na farmakokinetične lastnosti varfarina niso ocenjevali.
English: Ion exchange resins
Slovenian: Ionske izmenjevalne smole
English: Results from an in vitro MDR1 human tissue study suggested an age and tissue dependent pattern of MDR1 (P-gp) transporter maturation.
Slovenian: Rezultati in vitro študije prenašalca MDR1 v človeških tkivih kažejo, da je vzorec dozorevanja prenašalcev MDR1 (P-gp) odvisen od starosti in vrste tkiva.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS (PVC/PCTFE OR PA/ALU/PVC) BLISTER (CALENDAR) (PVC/PCTFE OR PA/ALU/PVC)
Slovenian: PRETISNI OMOT (PVC/PCTFE ALI PA/ALU/PVC) PRETISNI OMOT (KOLEDARSKO PAKIRANJE) (PVC/PCTFE ALI PA/ALU/PVC)
English: This study was extended with a 52-week double-blind, randomised study to evaluate the safety, tolerability and efficacy of aliskiren compared to enalapril in 208 paediatric hypertensive patients aged 6 to 17 years (at baseline in the previous study).
Slovenian: Ta študija je bila podaljšana s 52-tedensko, randomizirano, dvojno slepo študijo za oceno varnosti, prenašanja in učinkovitosti aliskirena v primerjavi z enalaprilom pri 208 pediatričnih bolnikih s hipertenzijo, starih od 6 do 17 let (z izhodiščem v prejšnji študiji).
English: Rasilez HCT should be taken once a day, always with or always without food, preferably at the same time each day.
Slovenian: Zdravilo Rasilez HCT je treba jemati enkrat na dan, vedno s hrano ali vedno brez, najbolje vsak dan ob istem času.
English: The increased aliskiren exposure in juvenile rats appears to be attributed mainly to lack of maturation of P-gp in the gastrointestinal tract.
Slovenian: Kot kaže, je povečano izpostavljenost aliskirenu pri podganjih mladičih mogoče pripisati manjši zrelosti prenašalca P-gp v gastrointestinalnem traktu.
English: − The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent
Slovenian: − sočasna uporaba aliskirena s ciklosporinom in itrakonazolom, ki sta zelo močna zaviralca P
English: In a pharmacokinetic study of aliskiren treatment in 39 paediatric hypertensive patients aged 6 to 17 years given daily doses of 2 mg/kg or 6 mg/kg aliskiren administered as granules (3.125 mg/tablet), pharmacokinetic parameters were similar to those in adults.
Slovenian: V farmakokinetični študiji z aliskirenom pri zdravljenju 39 pediatričnih bolnikov, ki so imeli hipertenzijo in so bili stari od 6 do 17 let, prejemali pa so dnevne odmerke aliskirena 2 mg/kg oziroma 6 mg/kg v obliki zrnc (3,125 mg/tableto), so bili farmakokinetični parametri podobni kot pri odraslih.
English: Excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Slovenian: Prekomerno znižanje krvnega tlaka lahko pri bolnikih z ishemično boleznijo srca ali ishemično kardiovaskularno boleznijo povzroči miokardni infarkt ali možgansko kap.
English: In the subgroup of patients with diabetes mellitus the hazard ratio was 1.64 in favour of placebo (95% Confidence Interval: 1.15-2.33), whereas the hazard ratio in the subgroup of patients without diabetes was 0.69 in favour of aliskiren (95% Confidence Interval: 0.50-0.94); p-value for interaction = 0.0003.
Slovenian: V podskupini bolnikov s sladkorno boleznijo je bilo razmerje ogroženosti 1,64 v korist placeba (95-odstotni interval zaupanja: 1,15-2,33), medtem ko je bilo razmerje ogroženosti v podskupini bolnikov brez sladkorne bolezni 0,69 v korist aliskirena (95-odstotni interval zaupanja: 0,50-0,94); vrednost p za interakcije = 0,0003.
English: Therefore, because of the risk of therapeutic failure, fruit juice should not be taken together with Rasilez HCT.
Slovenian: Ker bi torej lahko prišlo do zmanjšanja terapevtskega učinka, se sadnega soka ne sme uživati skupaj z zdravilom Rasilez HCT.
English: Aliskiren is a P-glycoprotein (P-gp) substrate, and there is a potential for aliskiren overexposure in children with an immature P-gp drug transporter system.
Slovenian: Aliskiren je substrat P-glikoproteina (P-gp) in pri otrocih z nezrelim prenašalnim sistemom P-gp lahko pride do prevelike izpostavljenosti aliskirenu.
English: Hypotension and related adverse events were uncommon with the combination treatment, with no increased incidence in elderly patients.
Slovenian: Pri uporabi kombiniranega zdravila je do hipotenzije in z njo povezanih dogodkov prišlo le občasno, pri tem ni prišlo do povečane incidence pri starejših bolnikih.
English: • Worsening of the diabetic metabolic state
Slovenian: • poslabšanje presnovnega stanja pri sladkorni bolezni,
English: The rate and extent of absorption of Rasilez HCT are equivalent to the bioavailability of aliskiren and hydrochlorothiazide when administered as individual monotherapies.
Slovenian: Hitrost in obseg absorpcije zdravila Rasilez HCT ustrezata biološki uporabnosti aliskirena in hidroklorotizida pri uporabi posameznih monoterapij.
English: NSAIDs may also weaken the diuretic and antihypertensive activity of hydrochlorothiazide.
Slovenian: NSAID lahko oslabijo diuretično in antihipertenzivno delovanje hidroklorotiazida.
English: You should avoid taking this medicine together with fruit juice and/or drinks containing plant extracts (including herbal teas), as it could cause a decrease in the effectiveness of this medicine
Slovenian: Izogibati se morate jemanju tega zdravila skupaj s sadnim sokom in/ali z napitki, ki vsebujejo rastlinske izvlečke (kar vključuje tudi zeliščne čaje), saj bi lahko zmanjšali učinkovitost tega zdravila.
English: If photosensitivity reaction occurs during treatment with Rasilez HCT, it is recommended to stop the treatment.
Slovenian: Če med zdravljenjem z zdravilom Rasilez HCT pride do fotosenzitivnostne reakcije, je priporočena prekinitev zdravljenja.
English: Rasilez HCT should not be used in children aged 2 to less than 6 years because of safety concerns due to potential aliskiren overexposure (see sections 4.3, 4.4, 5.2, and 5.3).
Slovenian: Zdravila Rasilez HTC se ne sme uporabljati pri otrocih po dopolnjenem 2. letu in pred dopolnjenim 6. letom starosti zaradi pomislekov glede varnosti v povezavi z možnostjo prevelike izpostavljenosti aliskirenu (glejte poglavja 4.3, 4.4, 5.2 in 5.3).
English: PHARMACEUTICAL FORM AND CONTENTS 280 film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 280 filmsko obloženih tablet.
English: The primary endpoint was a composite of cardiovascular death and first hospitalisation for heart failure.
Slovenian: Primarni cilj opazovanja je bil sestavljen iz kardiovaskularne smrti in ponovne hospitalizacije zaradi srčnega popuščanja.
English: Rasilez HCT has been shown to be effective as a once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Slovenian: Pokazalo se je, da je zdravilo Rasilez HCT učinkovito antihipertenzivno zdravljenje za enkrat dnevno odmerjanje pri odraslih bolnikih ne glede na spol, starost, indeks telesne mase in etnično pripadnost.
English: Aliskiren was evaluated for cardiovascular mortality and morbidity benefit in a double-blind active controlled randomised study in 7,064 patients with chronic heart failure and reduced left ventricular ejection fraction, of which 62% had a history of hypertension.
Slovenian: Koristne učinke aliskirena glede kardiovaskularne umrljivosti in obolevnosti so ovrednotili v dvojno slepi, aktivno kontrolirani, randomizirani študiji pri 7.064 bolnikih s kroničnim srčnim popuščanjem in zmanjšanim iztisnim deležem levega prekata, med katerimi jih je imelo 62 % v anamnezi hipertenzijo.
English: You should take this medicine once a day, always with or always without food, preferably at the same time each day.
Slovenian: To zdravilo je treba jemati enkrat na dan, vedno s hrano ali vedno brez nje, najbolje vsak dan ob istem času.
English: Similar food effect was observed for Rasilez HCT as for the individual monotherapies.
Slovenian: Pri zdravilu Rasilez HCT so opažali podoben vpliv hrane kot pri posameznih monoterapijah.
English: Fertility There are no clinical data on fertility.
Slovenian: Plodnost Kliničnih podatkov o vplivu na plodnost ni.
English: P-gp interactions
Slovenian: Interakcije povezane s P-gp
English: Optional titration of the respective study drug doses to the next highest weight-based dose level was available by doubling the dose with each of the two allowed dose titrations, up to 600 mg (highest studied dose in adults) for aliskiren and 40 mg for enalapril in the ≥80 to ≤150 kg weight group, if medically necessary to control the mean sitting systolic blood pressure (i.e. msSBP should be less than the 90th percentile for age, gender and height).
Slovenian: Neobvezno titriranje ustreznega odmerka proučevanega zdravila do naslednjega največjega odmerka glede na telesno maso je bilo mogoče s podvajanjem odmerka z vsako od dveh dovoljenih titracij odmerka do največ 600 mg (največji proučevani odmerek pri odraslih) za aliskiren in 40 mg za enalapril v skupini s telesno maso ≥ 80 do ≤ 150 kg, če je bilo to medicinsko potrebno za nadzorovanje povprečnega sistoličnega krvnega tlaka sede (msSBP - mean sitting systolic blood pressure) (t. j. msSBP mora biti manj kot 90. percentil za starost, spol in telesno maso).
English: Although aliskiren has known local (gastrointestinal tract) irritation potential, safety margins obtained in humans at the dose of 300 mg during a study in healthy volunteers were considered to be appropriate at 9-11-fold based on faecal concentrations or 6-fold based on mucosa concentrations in comparison with 250 mg/kg/day in the rat carcinogenicity study.
Slovenian: Čeprav je znano, da aliskiren lahko povzroča lokalno draženje (v gastrointestinalnem traktu), so v študiji z zdravimi prostovoljci, ki so prejemali odmerke 300 mg, ugotovili, da obsega okvir še varnih odmerkov 9 do 11-kratne vrednosti glede na koncentracije v blatu oziroma 6-kratne vrednosti glede na koncentracije v sluznici v primerjavi z odmerkom 250 mg/kg/dan v študiji karcinogenosti na podganah.
English: In another clinical studies, the efficacy and safety of Rasilez HCT were also assessed in 489 obese hypertensive patients who did not respond to hydrochlorothiazide 25 mg (baseline systolic/diastolic blood pressure 149.4/96.8 mmHg).
Slovenian: V drugih kliničnih študijah so učinkovitost in varnost zdravila Rasilez HCT ocenjevali tudi pri 489 debelih hipertenzivnih bolnikih, ki se niso ustrezno odzvali na zdravljenje s 25 mg hidroklorotiazida (s sistoličnim/diastoličnim krvnim tlakom ob izhodišču 149,4/96,8 mmHg).
English: PVC/polychlorotrifluoroethylene (PCTFE) - Alu blisters Single-packs containing 7, 14, 28, 30, 50, 56, 90 or 98 tablets.
Slovenian: Aluminijasti pretisni omoti - PVC/ poliklorotrifluoroetilen (PCTFE) Posamična pakiranja, ki vsebujejo 7, 14, 28, 30, 50, 56, 90 ali 98 tablet.
English: An additional 52 to 104 weeks non-interventional observational extension study in 106 patients (no study treatment administered) was conducted with the objective to evaluate the long-term safety in terms of growth and development of children 6-17 years of age with hypertension (primary or secondary) at baseline in the core study, previously treated with aliskiren.
Slovenian: Dodatna 52- do 104-tedenska neintervencijska opazovalna podaljšana študija s 106 bolniki (ki niso prejemali študijskega zdravila) je bil izvedena s ciljem oceniti dolgoročno varnost v smislu rasti in razvoja otrok, starih od 6 do17 let, s hipertenzijo (primarno ali sekundarno) ob izhodišču v osnovni študiji, ki so bili predhodno zdravljeni z aliskirenom.
English: The final results of the study did not demonstrate statistically that aliskiren was non-inferior to enalapril on the primary endpoint, however there was essentially no difference in the observed incidence rates between aliskiren and enalapril (hazard ratio of 0.99 with 95% Confidence Interval: 0.90-1.10).
Slovenian: Končni rezultati v tej študiji ne dokazujejo s statistično značilnostjo, da aliskiren ni slabši od enalaprila (da je neinferioren v primerjavi z enalaprilom) kar zadeva primarni cilj opazovanja, vendar med aliskirenom in enalaprilom praktično ni bilo bistvene razlike v pogostnostih opazovanih dogodkov (razmerje ogroženosti 0,99 s 95-odstotnim intervalom zaupanja: 0,90-1,10).
English: In this study, aliskiren at a target dose of 300 mg was compared to enalapril at a target dose of 20 mg when added to standard of care which included a beta blocker (and a mineralocorticoid receptor antagonist in 37% of patients) and a diuretic as needed.
Slovenian: V tej študiji so aliskiren s ciljnim odmerkom 300 mg primerjali z enalaprilom s ciljnim odmerkom 20 mg, pri čemer so enega ali drugega dodajali standardnemu zdravljenju, ki je vključevalo zaviralec adrenergičnih receptorjev beta (in antagonist mineralokortikoida pri 37 % bolnikov) ter diuretik po potrebi.
English: The incidence of adverse reactions showed no association with gender, age, body mass index, race or ethnicity.
Slovenian: Incidenca neželenih učinkov ni kazala nobene povezave s spolom, starostjo, z indeksom telesne mase ter z rasno ali etnično pripadnostjo.
English: Information on Rasilez HCT interactions
Slovenian: Informacije o interakcijah zdravila Rasilez HCT