FrancophonIA/ELRC3.0 huggingface dataset:
English: • Combined use of aliskiren with other agents acting on the RAAS.
Croatian: • istodobna primjena aliskirena s drugim lijekovima koji djeluju na RAAS.
English: No pharmacokinetic data on Rasilez HCT are available in the paediatric population.
Croatian: Nisu dostupni farmakokinetički podaci za Rasilez HCT u pedijatrijskoj populaciji.
English: Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or pre-eclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease.
Croatian: Hidroklorotiazid se ne smije primjenjivati u liječenju gestacijskog edema, gestacijske hipertenzije ili preeklampsije zbog rizika od smanjenja volumena plazme i hipoperfuzije placente, bez korisnog učinka na tijek bolesti.
English: P-gp substrates or weak inhibitors
Croatian: P-gp supstrati ili slabi inhibitori
English: Therefore, drinks containing plant extracts, including herbal teas, should not be taken together with Rasilez HCT.
Croatian: Stoga se napitci koji sadrže biljne ekstrakte, uključujući biljne čajeve, ne smiju uzimati zajedno s Rasilez HCT-om.
English: Wheat starch in this medicine contains only very low levels of gluten and is very unlikely to cause problems if you have coeliac disease.
Croatian: Pšenični škrob u ovom lijeku sadrži samo vrlo nisku razinu glutena i malo je vjerojatno da će uzrokovati probleme ako imate celijakiju.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) Hypotension, syncope, stroke, hyperkalaemia, and decreased renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system (see section 5.1).
Croatian: Dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS) Hipotenzija, sinkopa, moždani udar, hiperkalijemija i smanjena bubrežna funkcija (uključujući akutno zatajenje bubrega) zabilježeni su u osjetljivih pojedinaca, osobito ako su se kombinirali lijekovi koji utječu na taj sustav (vidjeti dio 5.1).
English: Hypokalaemia may result in muscle spasms and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain antiarrhythmic medicinal products.
Croatian: Hipokalijemija može rezultirati spazmom mišića i/ili pojačati srčane aritmije povezane s istodobnom primjenom glikozida digitalisa ili određenih antiaritmijskih lijekova.
English: Hyperkalaemiaa, hyponatraemia c, a, h
Croatian: Hiperkalijemijaa, hiponatrijemija c, a, h
English: − Severe renal impairment (GFR < 30 ml/min/1.73 m2).
Croatian: Teško oštećenje bubrežne funkcije (GFR <30 ml/min/1,73 m2).
English: Therefore, caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors (clarithromycin, telithromycin, erythromycin, amiodarone).
Croatian: Stoga je nužan oprez kada se aliskiren primjenjuje s ketokonazolom, verapamilom ili drugim umjerenim P-gp inhibitorima (klaritromicin, telitromicin, eritromicin, amiodaron).
English: Caution required with concomitant use
Croatian: Istodobna primjena zahtijeva oprez
English: Anticholinergic agents and other medicinal products affecting gastric motility The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Croatian: Antikolinergički lijekovi i drugi lijekovi koji utječu na motilitet želuca Bioraspoloživost tiazidnih diuretika može se povećati antikolinergičkim lijekovima (npr. atropin, biperiden), vjerojatno zbog smanjenja gastrointestinalnog motiliteta i brzine pražnjenja želuca.
English: Due to the hydrochlorothiazide component, Rasilez HCT is contraindicated in symptomatic hyperuricaemia (see section 4.3).
Croatian: Zbog hidroklortiazidne komponente, Rasilez HCT je kontraindiciran u simptomatskoj hiperuricemiji (vidjeti dio 4.3).
English: In the event of any signs suggesting a hypersensitivity reaction/angioedema (in particular difficulties in breathing or swallowing, rash, itching, hives or swelling of the face, extremities, eyes, lips and/or tongue, dizziness) patients should discontinue treatment and contact the physician (see section 4.4).
Croatian: U slučaju bilo kakvih znakova koji ukazuju na reakciju preosjetljivosti/angioedem (osobito teškoće pri disanju ili gutanju, osip, svrbež, koprivnjača ili oticanje lica, ekstremiteta, očiju, usnica i/ili jezika, omaglica), bolesnici trebaju prekinuti liječenje i obratiti se liječniku (vidjeti dio 4.4).
English: The rate and extent of absorption of Rasilez HCT are equivalent to the bioavailability of aliskiren and hydrochlorothiazide when administered as individual monotherapies.
Croatian: Brzina i opseg apsorpcije Rasilez HCT-a ekvivalentni su bioraspoloživosti aliskirena i hidroklorotiazida kada se primjenjuju kao individualne monoterapije.
English: Not all pack sizes or strengths may be available in your country.
Croatian: Na tržištu u Vašoj zemlji se ne moraju nalaziti sve veličine pakiranja ili jačine.
English: Combination therapy studies are available for aliskiren added to the diuretic hydrochlorothiazide, the calcium channel blocker amlodipine and the beta blocker atenolol.
Croatian: Dostupna su klinička ispitivanja kombinirane terapije aliskirena dodanog diuretiku hidroklorotiazidu, blokatoru kalcijevih kanala amlodipinu and beta-blokatoru atenololu.
English: Patients with a history of angioedema may be at increased risk of experiencing angioedema during treatment with aliskiren (see sections 4.3 and 4.8).
Croatian: Bolesnici s angioedemom u anamnezi mogli bi imati povećani rizik pojave angioedema tijekom liječenja aliskirenom (vidjeti dijelove 4.3 i 4.8).
English: The renal clearance is composed of passive filtration and active secretion into the renal tubule.
Croatian: Bubrežni klirens se odvija pasivnom filtracijom i aktivnom sekrecijom u bubrežne tubule.
English: Administration of a single oral dose of 300 mg aliskiren was associated with very minor changes in the pharmacokinetics of aliskiren (change in Cmax of less than 1.2 fold; increase in AUC of up to 1.6 fold) compared to matched healthy subjects.
Croatian: Peroralna primjena jednokratne doze aliskirena od 300 mg bila je povezana s vrlo malim promjenama u farmakokinetici aliskirena (promjena Cmax-a za manje od 1,2 puta, povećanje AUC-a do najviše 1,6 puta) u usporedbi s usporedivim zdravim ispitanicima.
English: All patients receiving thiazide diuretics should be periodically monitored for imbalances in electrolytes, particularly potassium, sodium and magnesium.
Croatian: Sve bolesnike koji primaju tiazidne diuretike potrebno je periodički pratiti radi neravnoteže elektrolita, osobito kalija, natrija i magnezija.
English: If Rasilez HCT is used during breast-feeding, doses should be kept as low as possible.
Croatian: Ako se Rasilez HCT primjenjuje tijekom dojenja, doze moraju biti najmanje moguće.
English: The safety and efficacy of Rasilez HCT in children below 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost Rasilez HCT-a u djece mlađe od 18 godina nije još ustanovljena.
English: • Skin and lip cancer (Non-melanoma skin cancer)
Croatian: • rak kože i usana (nemelanomski rak kože)
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.
Croatian: Iako aliskiren ima poznat lokalni (gastrointestinalni trakt) iritacijski potencijal, smatra se da sigurnosne granice, koje su tijekom ispitivanja na zdravim dobrovoljcima dobivene u ljudi pri dozi od 300 mg, odgovaraju 9-11 puta većoj dozi na temelju koncentracija u stolici, ili 6 puta većoj dozi na temelju koncentracija u sluznici, u usporedbi s 250 mg/kg/dan u ispitivanju kancerogenosti u štakora.
English: Organic anion transporting polypeptide (OATP) inhibitors Preclinical studies indicate that aliskiren might be a substrate of organic anion transporting polypeptides.
Croatian: Inhibitori polipeptidnih prijenosnika organskih aniona (OATP) Pretklinička ispitivanja pokazuju da bi aliskiren mogao biti supstrat polipeptidnih prijenosnika organskih aniona.
English: Therefore, the use of Rasilez HCT with an NSAID requires caution, especially in elderly patients.
Croatian: Stoga primjena Rasilez HCT-a s NSAIL-ovima zahtijeva oprez, posebno u starijih bolesnika.
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.
Croatian: U farmakokinetičkom ispitivanju liječenja aliskirenom u 39 pedijatrijskih hipertenzivnih bolesnika u dobi od 6 do 17 godina koji su dobivali dnevne doze od 2 mg/kg ili 6 mg/kg aliskirena primijenjenog u obliku granula (3,125 mg/tableta), farmakokinetički parametri bili su slični onima u odraslih osoba.
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).
Croatian: Povezanost odgovora i kumulativne doze dokazan je s prilagođenim OR 2,1 (95% CI: 1,7-2,6) s povećanjem na OR 3,9 (3,0-4,9) za veliku primjenu hidroklorotiazida (~25 000 mg) i OR 7,7 (5,7-10,5) za najvišu kumulativnu dozu (~100 000 mg) (vidjeti i dio 4.4).
English: Co-administration of aliskiren with either metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of aliskiren.
Croatian: Istodobna primjena aliskirena bilo s metforminom (↓28%), amlodipinom (↑29%) ili cimetidinom (↑19%) rezultirala je promjenom Cmax ili AUC-a aliskirena između 20% i 30%.
English: Rifampicin, which is an inducer of P-gp, reduced aliskiren bioavailability by approximately 50% in a clinical study.
Croatian: Rifampicin, induktor P-gp-a, u kliničkom je ispitivanju smanjio bioraspoloživost aliskirena za približno 50%.
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.
Croatian: Ako nakon 2-4 tjedna terapije krvni tlak i dalje nije kontroliran, doza se može titrirati do najviše 300 mg/25 mg Rasilez HCT-a dnevno.
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.
Croatian: Na kraju ovog produženog ispitivanja, promjene u srednjoj vrijednosti sistoličkog krvnog tlaka u sjedećem položaju u odnosu na početak bile su slične kod aliskirena i kod enalaprila (-7,63 mmHg u odnosu na -7,94 mmHg) u potpunom skupu podataka za analizu.
English: - if you have gout (uric acid crystals in the joints).
Croatian: - ako imate giht (kristali mokraćne kiseline u zglobovima).
English: In this study, aliskiren 300 mg was compared to placebo when added to standard of care which included either an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker.
Croatian: U ovom ispitivanju aliskiren 300 mg bio je uspoređivan s placebom kad su aliskiren odnosno placebo dodani standardnoj terapiji koja je uključivala ili neki inhibitor angiotenzin konvertirajućeg enzima ili blokator receptora angiotenzin.
English: The incidence of adverse events tended to be higher in patients with diabetes, or with GFR <60 ml/min/1.73 m², or with age ≥ 65 years; however, there was no difference between patients treated with aliskiren and those treated with enalapril.
Croatian: Incidencija štetnih događaja imala je tendenciju povećanja u bolesnika s dijabetesom ili s GFR <60 ml/min/1,73 m2 ili s dobi ≥ 65 godina; međutim, nije bilo razlike između bolesnika liječenih aliskirenom i onih liječenih enalaprilom.
English: If hypokalaemia develops during hydrochlorothiazide therapy Rasilez HCT should be discontinued until stable correction of the potassium balance.
Croatian: Ako se hipokalijemija razvije tijekom terapije hidroklorotiazidom, potrebno je prekinuti primjenu lijeka Rasilez HCT-a sve dok se postigne stabilna korekcija ravnoteže kalija.
English: The final study results indicated a hazard ratio for the primary endpoint of 1.097 in favour of placebo (95.4% Confidence Interval: 0.987, 1.218, 2-sided p=0.0787).
Croatian: Završni rezultati ispitivanja pokazali su omjer hazarda za primarni ishod od 1,097 u korist placeba (95,4% interval pouzdanosti: 0,987, 1,218, 2-strani p=0,0787).
English: Therefore, the combination of aliskiren with an NSAID requires caution, especially in elderly patients.
Croatian: Stoga primjena aliskirena s NSAIL-ima zahtijeva oprez, posebno u starijih bolesnika.
English: Medicinal products used in the treatment of gout
Croatian: Lijekovi koji se koriste za liječenje gihta
English: Co-administration of lithium and hydrochlorothiazide is not recommended.
Croatian: Ne preporučuje se istodobna primjena litija i hidroklorotiazida.
English: Hypersensitivity reactions to hydrochlorothiazide may occur in patients, but are more likely in patients with allergy and asthma.
Croatian: U bolesnika se mogu javiti reakcije preosjetljivosti na hidroklorotiazid, ali veća je vjerojatnost njihove pojave u bolesnika s alergijom i astmom.
English: - if you have serious liver or serious kidney problems.
Croatian: - ako imate ozbiljnih problema s jetrom ili bubrezima.
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.
Croatian: U podskupini bolesnika sa šećernom bolesti omjer hazarda bio je 1,64 u korist placeba (95% interval pouzdanosti: 1,15-2,33), dok je omjer hazarda u podskupini bolesnika bez šećerne bolesti bio 0,69 u korist aliskirena (95% interval pouzdanosti: 0,50-0,94); p-vrijednost za interakciju = 0,0003.
English: Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with aliskiren may reduce diuretic-induced hypokalaemia.
Croatian: Premda se hipokalijemija može razviti kada se uzimaju tiazidni diuretici, istodobna terapija aliskirenom može smanjiti hipokalijemiju izazvanu diuretikom.
English: • Sugar in the urine
Croatian: • šećer u mokraći
English: The increased incidence of stroke was greater in patients with renal insufficiency.
Croatian: Povećana incidencija moždanog udara bila je veća u bolesnika s insuficijencijom bubrega.
English: Concomitant intake with fruit juice and/or drinks containing plant extracts (including herbal teas) should be avoided (see section 4.5).
Croatian: Treba izbjegavati istodobno uzimanje voćnog soka i/ili napitaka koji sadrže biljne ekstrakte (uključujući biljne čajeve) (vidjeti dio 4.5).
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).
Croatian: Konačni rezultati ispitivanja nisu statistički pokazali da je aliskiren ne-inferioran u odnosu na enalapril u primarnoj mjeri ishoda, međutim u osnovi nije bilo razlike u zabilježenim stopama incidencije između aliskirena i enalaprila (omjer hazarda od 0,99; 95% interval pouzdanosti: 0,90-1,10).
English: Via Provinciale Schito 131 IT-80058 Torre Annunziata/NA Italy
Croatian: Novartis Farma S.p.A. Via Provinciale Schito 131 IT-80058 Torre Annunziata/NA
English: • Difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress including pneumonitis and pulmonary oedema)
Croatian: • teškoće pri disanju s vrućicom, kašljem, zviždanjem u plućima, nedostatkom zraka (respiratorni distres uključujući pneumonitis i plućni edem)
English: It is not known whether aliskiren is excreted in human milk.
Croatian: Nije poznato izlučuje li se aliskiren u majčino mlijeko.
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.
Croatian: U ovom ispitivanju aliskiren u ciljnoj dozi od 300 mg uspoređen je s enalaprilom u ciljnoj dozi od 20 mg kada se dodaju standardu skrbi koji uključuje beta-blokator (i antagonist mineralokortikoidnih receptora u 37% bolesnika) i diuretik po potrebi.
English: Pancreatitish
Croatian: Pankreatitish
English: - if the level of potassium in your blood is too low despite treatment.
Croatian: - ako je razina kalija u Vašoj krvi preniska unatoč liječenju.
English: Marked hypercalcaemia may be evidence of hidden hyperparathyroidism.
Croatian: Značajna hiperkalcijemija može biti dokaz prikrivenog hiperparatireoidizma.
English: Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndromea, toxic epidermal necrolysis (TEN)a, oral mucosal reactionsa, pruritusa
Croatian: Teške kožne nuspojave (SCAR) uključujući Stevens Johnsonov sindroma, toksičnu epidermalnu nekrolizu (TEN)a, reakcije oralne sluznicea, pruritusa
English: Posology The recommended dose of Rasilez HCT is one tablet per day.
Croatian: Doziranje Preporučena doza Rasilez HCT-a je jedna tableta na dan.
English: The adverse reactions observed with Rasilez HCT or with monotherapy with one or both of the two components are included in the table below.
Croatian: Nuspojave opažene s Rasilez HCT-om ili u monoterapiji s jednom ili svakom od dvije komponente uključene su u tablici u nastavku.
English: Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Croatian: Može biti potrebna prilagodba doze urikozuričnih lijekova budući da hidroklorotiazid može povisiti razinu mokraćne kiseline u serumu.
English: Small decreases in haemoglobin and haematocrit (mean decreases of approximately 0.05 mmol/l and 0.16 volume percent, respectively) were observed.
Croatian: Opažena su mala sniženja hemoglobina i hematokrita (srednja vrijednost sniženja od približno 0,05 mmol/l, odnosno 0,16 volumnog postotka.
English: Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis.
Croatian: Predoziranje hidroklorotiazidom je povezano sa smanjenjem razina elektrolita (hipokalijemija, hipokloremija, hiponatrijemija) i dehidracijom koja rezultira prekomjernom diurezom.
English: There were no statistically significant differences in the mean changes in weight, height, or BMI between the treatment groups from Baseline to LT Visit 18 (Week 104) (primary analysis).
Croatian: Nije bilo statistički značajnih razlika u promjenama srednjih vrijednosti težine, visine ili BMI-a između liječenih skupina od početnih vrijednosti do onih u 18. posjetu provedenom u sklopu procjene dugoročne sigurnosti (104. tjedan) (primarna analiza).
English: Aliskiren 150 mg or 300 mg per day or ramipril 5 mg or 10 mg per day were administered for 36 weeks with optional add-on therapy of hydrochlorothiazide (12.5 mg or 25 mg) at week 12, and amlodipine (5 mg or 10 mg) at week 22.
Croatian: Aliskiren 150 mg ili 300 mg na dan ili ramipril 5 mg ili 10 mg na dan primjenjivani su 36 tjedana s mogućom dodatnom terapijom hidroklortiazidom (12,5 mg ili 25 mg) u 12. tjednu i amlodipinom (5 mg ili 10 mg) u 22. tjednu.
English: Aliskiren 150 mg (increased to 300 mg if tolerated) added to conventional therapy was evaluated in a double-blind placebo-controlled randomised trial in 1,639 patients with reduced ejection fraction hospitalised for an episode of acute heart failure (NYHA Class III-IV) who were haemodynamically stable at baseline.
Croatian: Aliskiren 150 mg (povećan na 300 mg ako se podnosi) dodan konvencionalnoj terapiji, bio je ocijenjen u dvostruko slijepom, placebo kontroliranom randomiziranom ispitivanju provedenom na 1639 bolesnika sa smanjenom ejekcijskom frakcijom koji su bili hospitalizirani zbog epizode akutnog zatajenja srca (NYHA klasa III-IV), a koji su na početku bili hemodinamički stabilni.
English: In the event of severe and perisistent diarrhoea, Rasilez HCT therapy should be stopped (see section 4.8).
Croatian: Općenito U slučaju teškog i ustrajnog proljeva, potrebno je prekinuti terapiju Rasilez HCT-om (vidjeti dio 4.8).
English: Via Provinciale Schito 131 I-80058 Torre Annunziata/NA Italy
Croatian: Novartis Farma S.p.A. Via Provinciale Schito 131 I-80058 Torre Annunziata/NA
English: Aliskiren/hydrochlorothiazide
Croatian: Aliskiren/hidroklorotiazid
English: An increased incidence of hyperkalaemia (20.9% versus 17.5%), renal impairment/renal failure (16.6% versus 12.1%) and hypotension (17.1% versus 12.6%) was observed in the aliskiren group compared with placebo and was greater in patients with diabetes.
Croatian: Povećana incidencija hiperkalijemije (20,9% naspram 17,5%), oštećenje bubrežne funkcije/zatajenje bubrega (16,6% naspram 12,1%) i hipotenzija (17,1% naspram 12,6%) uočeni su u skupini koja je primala aliskiren u odnosu na onu koja je primala placebo i bili su veći u bolesnika sa šećernom bolesti.
English: Aliskiren should be used with caution in patients with heart failure treated with furosemide or torasemide (see section 4.5).
Croatian: Aliskiren treba oprezno primjenjivati u bolesnika sa zatajenjem srca koji se liječe furosemidom ili torasemidom (vidjeti dio 4.5).
English: The usual recommended starting dose of aliskiren in elderly patients aged 65 years or older is 150 mg.
Croatian: Uobičajena preporučena početna doza aliskirena u starijih bolesnika u dobi od 65 godina ili više iznosi 150 mg.
English: Statistically significantly higher incidences in the occurrence of cardiac failure and ischaemic stroke were also found for aliskiren compared to enalapril in patients with NYHA I/II with hypertension, and in the occurrence of chronic cardiac failure and ventricular extrasystole in patients with NYHA III/IV with hypertension.
Croatian: Također, statistički značajno veća incidencija nastanka srčanog zatajivanja i ishemijskog moždanog udara utvđena je za aliskiren u usporedbi s enalaprilom u bolesnika s NYHA I/II s hipertenzijom, te nastanka kroničnog zatajivanja srca i ventrikularnih ekstrasistola u bolesnika s NYHA III/IV s hipertenzijom.
English: Haemoglobin decreaseda, haematocrit decreaseda, blood creatinine increaseda, glycosuriah c Adverse reaction observed with Rasilez HCT a Adverse reaction observed with monotherapy with aliskiren h Adverse reaction observed with monotherapy with hydrochlorothiazide * Isolated cases of liver disorder with clinical symptoms and laboratory evidence of more marked hepatic dysfunction.
Croatian: Sniženi hemoglobina, sniženi hematokrita, povišeni kreatinin u krvia, glikozurijah c Nuspojave opažene s Rasilez HCT-om a Nuspojave opažene u monoterapiji s aliskirenom h Nuspojave opažene u monoterapiji s hidroklortiazidom *Izolirani slučajevi poremećaja jetre s kliničkim simptomima i laboratorijskim dokazom izraženije jetrene disfunkcije.
English: Aliskiren was evaluated for cardiovascular and/or renal benefit in a double-blind placebo controlled randomised trial in 8,606 patients with type 2 diabetes and chronic kidney disease (evidenced by proteinuria and/or GFR < 60 ml/min/1.73 m2) with or without cardiovascular disease.
Croatian: Aliskiren je ocjenjivan s obzirom na kardiovaskularnui/ili bubrežnu korist u dvostruko slijepom placebom kontroliranom randomiziranom ispitivanju u kojem je sudjelovalo 8606 bolesnika sa šećernom bolešću tip 2 i kroničnom bolešću bubrega (koja se dokazuje proteinurijom i/ili GFR-om <60 ml/min/1,73 m2) sa ili bez kardiovaskularne bolesti.