natgillin/translations-raw huggingface dataset:
A patient who experiences dose limiting adverse reactions on either component alone may be switched to Rasilamlo containing a lower dose of that component to achieve similar blood pressure 
Bolesnik koji tijekom terapije jednom od komponenti osjeti nuspojave zbog kojih je potrebno ograničiti dozu te komponente, može se prebaciti na Rasilamlo, koji sadrži nižu dozu te komponente, i postići sličan učinak na sniženja krvnog tlaka.
In a study conducted in patients with end stage renal disease (ESRD) receiving haemodialysis, dialysis clearance of aliskiren was low (<2% of oral clearance). 
U ispitivanju provedenom na bolesnicima u završnom stadiju bubrežne bolesti (ESRD) na hemodijalizi klirens aliskirena dijalizom bio bi nizak (<2% peroralnog klirensa).
In a 8-week study in 754 hypertensive elderly (≥65 years) and very elderly patients (30% ≥75 years) aliskiren at doses of 75 mg, 150 mg and 300 mg provided statistically significant superior reduction in blood pressure (both systolic and diastolic) when compared to placebo. 
U 8-tjednom ispitivanju u kojem je sudjelovalo 754 hipertenzivnih starijih (≥65 godina) i vrlo starijih bolesnika (30% ≥75 godina) aliskiren u dozama od 75 mg, 150 mg i 300 mg dovodio je do statistički značajnog superiornog sniženja krvnog tlaka (sistoličkog i dijastoličkog) u usporedbi s placebom.
The volume or salt depletion should be corrected prior to administration of Rasilamlo, or the treatment should start under close medical supervision. 
Volumen tekućine ili razina natrija se treba ispraviti prije primjene lijeka Rasilamlo ili, liječenje treba započeti uz pomni nadzor liječnika.
In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed. 
U kliničkim ispitivanjima u kojima je amlodipin primjenjivan u kombinaciji s betablokatorima bolesnicima ili s hipertenzijom ili anginom pektoris, nisu opažene nuspojave vezane uz elektrokardiografske parametre.
Plasma aliskiren exposure (AUC) in rats aged 8 days was nearly 4-fold higher than that in rats aged 14 days at 100 mg/kg/day. 
Izloženost aliskirenu u plazmi (AUC) u štakora u dobi od 8 dana bila je skoro 4 puta veća od izloženosti u štakora u dobi od 14 dana uz 100 mg/kg/dan.
• allergic reactions (hypersensitivity) and angioedema (the symptoms of which can include difficulties in breathing or swallowing, rash, itching, hives or swelling of the face, hands and feet, eyes, lips and/or tongue, dizziness) 
• alergijske reakcije (preosjetljivost) i angioedem (čiji simptomi mogu uključivati teškoće pri disanju ili gutanju, osip, svrbež, koprivnjača ili oticanje lica, ruku i nogu, očiju, usnica i/ili jezika, omaglica)
Delayed mortality was observed at 300 mg/kg/day (8.5-fold the MRHD on mg/m2 basis assuming a 60 kg adult patient) with no cause of death 
Odgođeni mortalitet uočen je uz 300 mg/kg/dan (8,5 puta više od MRHD-a na temelju mg/m2 za odraslog bolesnika od 60 kg) pri čemu nije bio utvrđen uzrok smrti.
High acute mortality (within hours) and severe morbidity were observed at 100 and 300 mg/kg/day (2.3- and 6.8-fold the maximum recommended basis assuming a 60 kg adult patient) with no cause of death established and occurring without signs or prodromal symptoms. 
Visoki akutni mortalitet (u roku od nekoliko sati) i teški morbiditet uočeni su uz doze od 100 i 300 mg/kg/dan (2,3 i 6,8 puta više od najviše preporučene doze za ljude (eng. maximum recommended human dose, MRHD) na temelju mg/m za odraslog bolesnika od 60 kg) pri čemu uzrok smrti nije bio utvrđen, a smrt se javila bez znakova ili prodromalnih simptoma.
In some patients with compromised renal function (dehydrated patients or elderly patients) aliskiren given concomitantly with NSAIDs may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. 
(dehidrirani bolesnici ili stariji bolesnici) aliskiren dan istodobno s NSAIL-ovima mogu rezultirati daljnjim pogoršanjem funkcije bubrega, uključujući moguće akutno zatajenje bubrega, koje je obično reverzibilno.
As for other RAAS blockers, headache is a common adverse event in children treated with aliskiren. 
Kao što je slučaj i s drugim blokatorima RAAS-a, glavobolja je česta nuspojava u djece liječene aliskirenom.
• skin rash with flaking or peeling 
• kožni osip s perutanjem ili ljuštenjem
- Compounds that have been investigated in aliskiren clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide. 
Bez interakcija - Lijekovi koji su istraživani u ispitivanjima kliničke farmakokinetike aliskirena uključuju acenokumarol, atenolol, celekoksib, pioglitazon, alopurinol, izosorbid-5-mononitrat i hidroklorotiazid.
Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering 
Ne preporučuje se primjena amlodipina s grejpom ili sokom od grejpa jer bi u nekih bolesnika moglo doći do povećanja bioraspoloživosti, što rezultira pojačanim učincima na snižavanje krvnog tlaka.
In haemodynamic studies, amlodipine has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and humans, even when co-administered with beta blockers to humans. 
U hemodinamskim ispitivanjima, amlodipin nije bio povezan s negativnim inotropnim učinkom kada se primjenjivao u rasponu terapijskih doza intaktnim životinjama i ljudima, čak i kada se primjenjivao istodobno s betablokatorima u ljudi.
With amlodipine, available data suggest that gross overdose could result in excessive peripheral vasodilatation and possibly reflex tachycardia. 
Dostupni podaci upućuju na to da jako predoziranje amlodipinom može rezultirati izrazitom perifernom vazodilatacijom te moguće,, refleksnom tahikardijom.
• mood changes (including anxiety) 
• promjene raspoloženja (uključujući tjeskobu)
• Patients with marked volume depletion or patients with salt depletion (e.g. those receiving high 
• u bolesnika sa izrazito smanjenim volumenom tekućine ili bolesnika sa sniženom razinom natrija (npr. u onih koji primaju visoke doze diuretika) ili
On the basis of the scientific conclusions for aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide is favourable subject to the proposed changes to the product information. 
Na temelju znanstvenih zaključaka za aliskiren / aliskiren, amlodipin / aliskiren, hidroklorotiazid CHMP smatra da je omjer koristi i rizika lijeka/lijekova koji sadrži/sadrže djelatnu tvar/djelatne tvari aliskiren / aliskiren, amlodipin / aliskiren, hidroklorotiazid povoljan, uz predložene izmjene informacija o lijeku.
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. 
Aliskiren je supstrat P-glikoproteina (P-gp) pa u djece s nezrelim sustavom prijenosa lijekova P-gpom postoji potencijal za prekomjernu izloženost aliskirenu.
Following oral administration of Rasilamlo, the median peak plasma concentration time is within 3 hours for aliskiren and 8 hours for amlodipine. 
Nakon peroralne primjene lijeka Rasilamlo medijan vremena do vršne koncentracije u plazmi je unutar 3 sata s aliskirenom odnosno 8 sati s amlodipinom.
Preclinical studies indicate that aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion. 
Pretklinička ispitivanja pokazuju da istodobna primjena aliskirena i ketokonazola pojaćava gastrointestinalnu apsorpciju aliskirena i smanjuje njegovo izlučivanje putem žuči.
No controlled clinical data are available on the use of Rasilamlo in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney. 
Nisu dostupni kontrolirani klinički podaci o primjeni lijeka Rasilamlo u bolesnika s jednostranom ili obostranom stenozom bubrežne arterije, ili stenozom bubrežne arterije kod postojanja samo jednog bubrega.
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, renin inhibitors, ATC 
Farmakoterapijska skupina: lijekovi koji djeluju na sustav renin-angiotenzin; inhibitor renina, ATK oznaka: C09XA53
Do not stop taking this medicine, even if you are feeling well unless your doctor tells you to do so. People who have high blood pressure often do not notice any signs of the problem. 
Nemojte prekinuti uzimanje ovag lijeka, čak i ako se osjećate dobro osim ako Vam tako ne kaže liječnik.
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. 
Aliskiren je ocjenjivan s obzirom na kardiovaskularnu i/ili bubrežnu korist u dvostruko slijepom placebom kontroliranom randomiziranom ispitivanju u kojem je sudjelovalo 8606 bolesnika sa šećernom bolešću tipa 2 i kroničnom bolešću bubrega (koja se dokazuje proteinurijom i/ili GFR-om <60 ml/min/1,73 m2) sa ili bez kardiovaskularne bolesti.
In healthy subjects, itraconazole (100 mg) increases AUC and Cmax of aliskiren (150 mg) by 6.5-fold and 5.8-fold, respectively. 
U zdravih ispitanika itrakonazol (100 mg) povećava AUC aliskirena (150 mg) za 6,5 puta a Cmax za 5,8 puta.
**, liver failure a, 
**, zatajenje jetre a,
It is also available in multi-packs of 98 tablets (2 packs of 49) and 280 tablets (20 packs of 14) in calendar blisters and 98x1 tablet (2 packs of 49x1) as perforated unit dose blisters. 
Također je dostupan u višestrukim pakiranjima od 98 tableta (2 kutije od 49) i 280 tableta (20 kutija od 14) u kalendarskim blisterima i 98x1 tableta (2 kutije od 49x1) u perforiranim blisterima djeljivim na jedinične doze.
As with other medicinal products acting on the renin-angiotensinaldosterone system, angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have been reported in patients treated with aliskiren. 
Kao i s drugim lijekovima koji djeluju na renin-angiotenzin-aldosteron sustav, angioedem ili simptomi koji upućuju na angioedem (oticanje lica, usnica, grla i/ili jezika) prijavljeni su u bolesnika liječenih aliskirenom.
This decrease is likely due to an inhibition of organic anion transporting polypeptide-mediated uptake of aliskiren by components of fruit juice in the gastrointestinal tract. 
To je smanjenje vjerojatno zbog inhibicijskog djelovanja sastojaka voćnog soka na pohranu aliskirena posredovanu polipeptidnim prijenosnicima organskih aniona u gastrointestinalnom traktu.
The MAH submitted an analysis with 1407 cases of “dyspnoea”, in 13 of them there was positive dechallenge and three cases with positive rechallenge. 
Nositelj odobrenja je podnio analizu sa 1407 slučajeva “dispneje”, u 13 od njih nuspojave su nestale nakon prekida davanja lijeka i u tri slučaja ponovno su se javile nakon ponovnog davanja lijeka.
Calcium channel blockers act to prevent the influx of calcium into the vascular smooth muscle cells in the vessel wall, thereby preventing smooth muscle cell contraction and vasoconstriction. 
Blokatori kalcijevih kanala djeluju tako da sprečavaju ulaz kalcija u glatke mišićne stanice u stijenci krvnih žila sprečavajući tako kontrakciju i vazokonstrikciju glatkih mišićnih stanica.
blistering of the lips, eyes or mouth, skin peeling, fever) 
stvaranje mjehurića na usnicama, očima ili ustima, guljenje kože, vrućica)
Meals (low or high fat content) have been shown to reduce the absorption of aliskiren substantially 
Pokazalo se da obroci (s niskim ili visokim sadržajem masti) značajno smanjuju apsorpciju aliskirena (vidjeti dio 4.2).
In clinical studies aliskiren has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥150 μmol/l or 1.70 mg/dl in women and ≥177 μmol/l or 2.00 mg/dl in men and/or estimated GFR <30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension. 
U kliničkim ispitivanjima aliskiren nije ispitivan u hipertenzivnih bolesnika s teškim oštećenjem bubrežne funkcije (kreatinin u serumu ≥150 μmol/l ili 1,70 mg/dl u žena, te ≥177 μmol/l ili 2,00 mg/dl u muškaraca i/ili procijenjena brzina glomerularne filtracije (GFR) <30 ml/min/1,73 m2), dijalizom, nefrotskim sindromom ili renovaskularnom hipertenzijom u anamnezi.
blood creatinine increased a 
povišeni kreatinin u krvi a
• kidney problems including acute renal failure (severely decreased urine output) 
• problemi s bubrezima, uključujući akutno zatajenje bubrega (jako smanjeno izlučivanje mokraće)
As for other medicinal products acting on the renin-angiotensin-aldosterone system, caution should be exercised when Rasilamlo is given in the presence of conditions pre-disposing to kidney dysfunction such as hypovolaemia (e.g. due to blood loss, severe or prolonged diarrhoea, prolonged vomiting, etc.), heart disease, liver disease, diabetes mellitus or kidney disease. 
Kao i s drugim lijekovima koji djeluju na renin-angiotenzin -aldosteron sustav, nužan je oprez kada se Rasilamlo daje u stanjima s predispozicijom za disfunkciju bubrega kao što su hipovolemija (npr. zbog gubitka krvi, teškog ili produljenog proljeva, produljenog povraćanja, itd), bolest srca, bolest jetre, šećerna bolest ili bolest bubrega.
Multipack containing 280 (20 packs of 14) tablets. 
Višestruko pakiranje sadrži 280 (20 pakiranja od 14) tableta.
No long-term efficacy data for aliskiren in patients with heart failure are currently available. 
Podaci o dugotrajnoj djelotvornosti aliskirena u bolesnika sa zatajenjem srca trenutačno nisu dostupni.
Skin and subcutaneous tissue disorders Uncommon 
Poremećaji kože i potkožnog tkiva Manje često
Multipack containing 98 (2 packs of 49) tablets. 
Višestruko pakiranje sadrži 98 (2 pakiranja od 49) tableta.
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent Pglycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is 
Kontraindicirana je istodobna primjena aliskirena s ciklosporinom i itrakonazolom, dva visoko potentna inhibitora P-glikoproteina (P-gp), i drugim potentnim P-gp inhibitorima (npr. kinidin) (vidjeti dio 4.5).
After single dose administration in the dose range of 75 to 600 mg, a 2-fold increase in dose results in a ~2.3 and 2.6fold increase in AUC and Cmax, respectively. 
Nakon primjene jednokratne doze u rasponu doza od 75 do 600 mg, 2 puta povećanje doze rezultira ~2,3-, odnosno 2,6 puta povećanjem AUC-a, odnosno Cmax-a.
Children from birth to less than 2 years (see sections 4.2 and 5.3). 
Djeca od rođenja do nenavršene 2 godine (vidjeti dijelove 4.2 i 5.3).
It is unknown whether aliskiren and/or amlodipine are excreted in human milk. 
Dojenje Nije poznato izlučuju li se aliskiren i/ili amlodipin u majčino mlijeko.
Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality. 
Potreban je oprez prilikom primjene blokatora kalcijevih kanala, uključujući amlodipin, u bolesnika s kongestivnim zatajenjem srca, jer mogu povećati rizik od budućih kardiovaskularnih događaja i smrtnosti.
PVC/polychlorotrifluoroethylene (PCTFE) - Alu calendar blisters: Single pack containing 14, 28, 56, 98 tablets Multi-packs containing 280 tablets (20 packs of 14) 
PVC/poliklorotrifloroetilen (PCTFE) - Al kalendarski blisteri: Pojedinačno pakiranje sadrži 14, 28, 56, 98 tableta Višestruka pakiranja sadrže 280 tableta (20 pakiranja od 14)
The blood-pressure-lowering effect was sustained during long-term treatment, and was independent of age, gender, body mass index and ethnicity. 
Učinak sniženja krvnoga tlaka održavan je tijekom dugotrajnog liječenja, a nije ovisio o dobi, spolu, indeksu tjelesne mase ni etničkoj pripadnosti.
, hypoesthesia paraesthesia 
, hipoestezija parestezija
CARTON OF SINGLE PACK/CARTON OF UNIT PACK (perforated unit dose blister) 
KUTIJA POJEDINAČNOG PAKIRANJA/KUTIJA PAKIRANJA S JEDINIČNIM DOZAMA (perforirani blister djeljiv na jedinične doze)
- In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, 
Bez interakcija - U kliničkim ispitivanjima interakcija amlodipin nije utjecao na farmakokinetiku atorvastatina,
- Children from birth to less than 2 years (see sections 4.2 and 5.3). 
- Djeca od rođenja do nenavršene 2 godine (vidjeti dijelove 4.2 i 5.3).
A randomised double-blind morbidity-mortality study called the Antihypertensive and LipidLowering treatment to prevent Heart Attack Trial (ALLHAT) was performed to compare newer therapies: amlodipine 2.5-10 mg/day (calcium channel blocker) or lisinopril 10-40 mg/day (ACEinhibitor) as first-line therapies to that of the thiazide-diuretic, chlorthalidone 12.5-25 mg/day in mild 
Randomizirano dvostruko slijepo ispitivanje pobola smrtnosti pod nazivom Antihipertenzivno ispitivanje i liječenje snižavanja lipida a u cilju sprečavanja srčanog udara (ALLHAT) provedeno je da bi se usporedile novije terapije: amlodipin 2,5-10 mg/dan (blokator kalcijevih kanala) ili lizinopril 10-40 mg/dan (ACE-inhibitor ) kao terapije prve linije s terapijom tiazidnim diuretikom, klortalidonom 12,5-25 mg/dan u blagoj do umjerenoj hipertenziji.
Unit dose pack (perforated unit dose blister) containing 56x1 tablet Multi-packs of unit dose (perforated unit dose blister) containing 98x1 tablet (2 packs of 49x1) 
Pakiranje s jediničnim dozama (perforirani blister djeljiv na jedinične doze) sadrži 56x1 tabletu Višestruka pakiranja s jediničnim dozama (perforirani blister djeljiv na jedinične doze) sadrže 98x1 tabletu (2 pakiranja od 49x1)
Single pack containing 14, 28, 56 tablets Multi-packs containing 98 tablets (2 packs of 49) and 280 tablets (20 packs of 14) 
Pojedinačno pakiranje sadrži 14, 28, 56 tableta Višestruka pakiranja sadrže 98 tableta (2 pakiranja od 49) i 280 tableta (20 pakiranja od 14)
• Nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes (may be signs of 
• Mučnina, gubitak apetita, tamno obojani urin ili žuto obojana koža i oči (znakovi poremećaja jetre) (učestalost nepoznata).
Diarrhoea a, abdominal pain 
Proljev a, bol u abdomenu
Caution should be exercised when administering Rasilamlo to patients with hepatic impairment (see sections 4.2 and 5.2). 
Rasilamlo se mora primjenjivati s oprezom u bolesnika s oštećenjem jetrene funkcije (vidjeti dijelove 4.2 i 5.2).
Coadministration of aliskiren had no significant impact on atorvastatin, metformin or amlodipine pharmacokinetics. 
Istodobna primjena aliskirena nije imala značajan utjecaj na farmakokinetiku atorvastatina, metformina ili amlodipina.
After multiple doses of furosemide (60 mg/day) co-administered with aliskiren (300 mg/day) to patients with heart failure the urinary sodium excretion and the urine volume were reduced during the first 4 hours by 31% and 24%, respectively, as compared to furosemide alone. 
Nakon višekratnih doza furosemida (60 mg/dan) primijenjenih istodobno s aliskirenom (300 mg/dan) bolesnicima sa zatajanjem srca izlučivanje natrija mokraćom i volumen mokraće bili su smanjenji tijekom prva 4 sata za 31% odnosno za 24%, u usporedbi s bolesnicima koji su primali furosemid zasebno.
Liver disorder a, 
Poremećaji jetre a,
- Haemodynamically unstable heart failure after acute myocardial infarction. 
- Hemodinamski nestabilno zatajenje srca nakon akutnog infarkta miokarda.
The rate and extent of absorption of Rasilamlo are similar in fasting state to those of aliskiren and amlodipine when administered as individual monotherapies. 
Stopa i opseg apsorpcije lijeka Rasilamlo natašte slični su onima aliskirena i amlodipina primijenjenih kao zasebne monoterapije.
As a result no dose adjustment for aliskiren or these co-administered 
Kao rezultat toga, nije potrebna prilagodba doze aliskirena ili ovih istodobno primijenjenih lijekova.
The adverse reactions previously reported with one of the individual components of Rasilamlo (aliskiren and amlodipine) and included in the tabulated list of adverse reactions may occur with Rasilamlo. 
Nuspojave koje su ranije prijavljene s jednom od pojedinačnih komponenti lijeka Rasilamlo (aliskiren i amlodipin), te uključene u tablični popis nuspojava, mogu se pojaviti i s lijekom Rasilamlom.
Angioedema a, erythema a 
Angioedem a, eritem a
When administered with atorvastatin, steady-state aliskiren AUC and Cmax increased by 50%. 
Kada je primijenjen s atorvastatinom, u stanju dinamičke ravnoteže aliskirena AUC i Cmax povisili su se za 50%.
Hyperkalaemia a 
Hiperkalijemija a
A switch to a suitable alternative antihypertensive treatment should be carried out in advance of a planned pregnancy since Rasilamlo should not be used in 
Railamlo se mora unaprijed zamijeniti odgovarajućim alternativnim antihipertenzivnim liječenjem jer žene koje planiraju zatrudnjeti ne smiju uzimati Rasilamlo.
, peripheral oedema c,a,am 
, periferni edem c,a,am
No interaction studies with other medicinal products were performed with Rasilamlo. 
Nisu provedena ispitivanja interakcija lijeka Rasilamlo s drugim lijekovima.
You should avoid taking this medicine together with fruit juice and/or drinks containing plant extracts (including herbal teas). 
Izbjegavajte uzimanje ovog lijeka zajedno s voćnim sokom i/ili napitcima koji sadrže biljne ekstrakte (uključujući biljne čajeve).
Lowering the amount of angiotensin II allows the blood vessels to relax; this lowers blood pressure. 
Smanjenjujući količinu angiotenzina II omogućava opuštanje krvnih žila, što dovodi do sniženja krvnog tlaka.
There is limited experience with Rasilamlo, in particular in patients aged 75 years or older. 
Iskustva s primjenom lijeka Rasilamlo, osobito u bolesnika u dobi od 75 godina ili starijih, ograničena su.
Rasilamlo 150 mg/5 mg film-coated tablets Rasilamlo 150 mg/10 mg film-coated tablets Rasilamlo 300 mg/5 mg film-coated tablets Rasilamlo 300 mg/10 mg film-coated tablets Aliskiren/amlodipine 
Rasilamlo 150 mg/5 mg filmom obložene tablete Rasilamlo 150 mg/10 mg filmom obložene tablete Rasilamlo 300 mg/5 mg filmom obložene tablete Rasilamlo 300 mg/10 mg filmom obložene tablete aliskiren/amlodipin
At steady state the non-linearity may be more pronounced. 
U stanju dinamičke ravnoteže nelinearnost može biti izraženija.
Co-administration of aliskiren and amlodipine does not cause meaningful changes in the steady-state pharmacokinetic exposure (AUC) and the maximum concentration (Cmax) of either component in 
Istodobna primjena aliskirena i amlodipina u stanju dinamičke ravnoteže ne uzrokuje značajne promjene farmakokinetičke izloženosti (AUC) i maksimalne koncentracije (Cmax) nijedne komponente u zdravih dobrovoljaca.
Angiotensin II causes blood vessels to tighten, which raises blood pressure. 
Angiotenzin II uzrokuje suženje krvnih žila, što dovodi do povišenja krvnog tlaka.
A mechanistic study was conducted to investigate the relationship between age, aliskiren exposure and MDR1 and OATP2 expression maturation in rats. 
Ispitivanje mehanizma provedeno je da bi se istražio odnos između dobi, izloženosti aliskirenu te sazrijevanja ekspresije MDR1 i OATP2 u štakora.
Dual blockade of the RAAS with aliskiren, ARBs or ACEIs Clinical trial data has shown that dual blockade of the RAAS through the combined use of ACEIs, ARBs or aliskiren is associated with a higher frequency of adverse events such as hypotension, stroke, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1). 
Podaci iz kliničkih ispitivanja pokazali su da je dvostruka blokada RAAS-a kombiniranom primjenom ACEI-a, ARB-a ili aliskirena povezana s većom učestalošću štetnih događaja kao što su hipotenzija, moždani udar, hiperkalemija i smanjena bubrežna funkcija (uključujući akutno zatajenje bubrega) u usporedbi s primjenom samo jednog lijeka koji djeluje na RAAS (vidjeti dijelove 4.3, 4.4 i 5.1).
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