natgillin/translations-raw huggingface dataset:
Therefore caution should be exercised in these patients.
Stoga je nužan oprez u tih bolesnika.
However, as with other medicinal products acting on the renin-angiotensin-aldosterone system, there is an increased risk of renal insufficiency, including acute renal failure, when patients with renal artery stenosis are treated with aliskiren.
Međutim, kao i s drugim lijekovima koji djeluju na renin-angiotenzin-aldosteron sustav, postoji povećan rizik od insuficijencije bubrega, uključujući akutno zatajenje bubrega, kada se bolesnici sa stenozom bubrežne arterije liječe aliskirenom.
In one rat study, adverse effects were found on male fertility (see section 5.3).
U jednom ispitivanju sa štakorima nađene su nuspojave na mušku plodnost (vidjeti dio 5.3).
Therefore, particular caution should be exercised in these patients.
Stoga je nužan osobit oprez u ovih bolesnika.
The results from a food effect study using a standard high fat meal with the 300 mg/10 mg fixed combination tablet showed that food reduced the rate and extent of absorption of aliskiren in the fixed combination tablet with a similar magnitude of effect as for aliskiren monotherapy.
Rezultati ispitivanja učinka hrane uz uzimanje standardnoga punomasnog obroka s tabletom s fiksnom kombinacijom doza od 300 mg/10 mg, pokazali su da hrana smanjuje stopu i opseg apsorpcije aliskirena u tableti s fiksnom kombinacijom sa sličnom magnitudom učinka kao i u monoterapiji aliskirenom.
The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle, causing reductions in peripheral vascular resistance and in blood pressure.
Mehanizam antihipertenzivnog djelovanja amlodipina temelji se na direktnom relaksirajućem učinku na glatki mišić krvnih žila što uzrokuje smanjenje periferne rezistencije u krvnim žilama i krvnog tlaka.
Taking into account the PRAC Assessment Report on the PSUR for aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide, the scientific conclusions of CHMP are as follows:
Uzimajući u obzir PRAC-ovo Izvješće o ocjeni periodičkih izvješća o neškodljivosti (PSUR) za aliskiren / aliskiren, amlodipin / aliskiren, hidroklorotiazid, znanstveni zaključci CHMP-a su sljedeći:
Plasma aliskiren exposure in rats aged 14 days was between 85- and 387fold higher than that in adult rats aged 64 days.
Izloženost aliskirenu u plazmi u štakora u dobi od 14 dana bila je od 85 do 387 puta veća nego u odraslih štakora starih 64 dana.
Patients with history of angioedema may be at increased risk of experiencing angioedema during treatment with aliskiren (see sections 4.3 and 4.8).
Bolesnici s angioedemom u anamnezi mogli bi imati povećani rizik pojave angioedema tijekom liječenja aliskirenom (vidjeti dijelove 4.3 i 4.8).
The clinical implications of the differences in effect on PRA are not known at the present time.
Trenutno nisu poznate kliničke implikacije razlika u učinku na APR.
In another rat study in which male rats were treated with amlodipine besilate for 30 days at a dose comparable with the human dose based on mg/kg, decreased plasma follicle-stimulating hormone and testosterone were found as well as decreases in sperm density and in the number of mature spermatids and Sertoli cells.
U drugom ispitivanju sa štakorima u kojem su mužjaci 30 dana bili liječeni izražene u mg/m amlodipin bezilatom u dozi usporedivoj s dozom za ljude izraženoj u mg/kg, nađeni su sniženi folikulostimulirajući hormon i testosteron u plazmi, kao i smanjena gustoća sperme i smanjeni broj zrelih spermija i Sertolijevih stanica.
Adverse reaction observed with monotherapy with aliskiren;
Nuspojave opažene u monoterapiji s aliskirenom;
If co-medication with an agent affecting the level of serum potassium is considered necessary, caution is advisable.
Ako se istodobna primjena s lijekom koji utječe na razinu kalija u serumu smatra nužnom, savjetuje se oprez.
Rasilamlo was studied in a number of active and placebo-controlled trials and long-term trials which included a total of 5,570 hypertensive patients with mild to moderate hypertension (diastolic blood pressure between 90 mmHg and 109 mmHg).
Rasilamlo je ispitivan u većem broju aktivnih i placebom kontroliranih ispitivanja te dugotrajnih ispitivanja koja su uključivala ukupno 5570 hipertenzivnih bolesnika s blagom do umjerenom hipertenzijom (dijastolički krvni tlak između 90 mmHg i 109 mmHg).
Steady-state plasma levels are reached after continuous administration for 7-8 days.
U stanju dinamičke ravnoteže razine u plazmi postižu se nakon kontinuirane primjene tijekom 7-8 dana.
Therefore, drinks containing plant extracts, including herbal teas, should not be taken together with Rasilamlo.
Stoga se napitci koji sadrže biljne ekstrakte, uključujući biljne čajeve, ne smiju uzimati zajedno s lijekom Rasilamlo.
These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine
Ova sniženja krvnog tlaka nisu praćena značajnom promjenom srčane frekvencije ili razina katekolamina u plazmi kod kroničnog predoziranja.
Therefore the combination of aliskiren with an NSAID requires caution, especially in
Stoga primjena aliskirena s NSAIL-ima zahtijeva oprez, posebno u starijih bolesnika.
Where there is involvement of the tongue, glottis or larynx adrenaline should be administered.
Ako su zahvaćeni jezik, glotis ili grkljan mora se primijeniti adrenalin.
Symptomatic hypotension could occur after initiation of treatment with Rasilamlo in the following
Simptomatska hipotenzija se može pojaviti na početku liječenja lijekom Rasilamlo u sljedećim slučajevima:
In addition, measures necessary to maintain patent airways should be provided.
Osim toga, potrebno je omogućiti mjere neophodne za održavanje dišnih puteva bolesnika.
Therefore, Rasilamlo is contraindicated in children from birth to less than 2 years and should not be used in children aged 2 to less than 6 years.
Stoga je Rasilamlo kontraindiciran u djece od rođenja do nenavršene 2 godine i ne bi se smio koristiti u djece u dobi od 2 do nenavršenih 6 godina.
Use in patients with heart failure
Primjena u bolesnika sa zatajenjem srca
Tolerability was comparable in both treatment arms, however cough was more often reported with the ramipril regimen than the aliskiren regimen (14.2% vs. 4.4%), whilst diarrhoea was more common with the aliskiren regimen than for the ramipril regimen (6.6% vs. 5.0%).
Podnošljivost je bila usporediva u obje liječene skupine, no kašalj je bio češće prijavljivan tijekom liječenja ramiprilom nego tijekom liječenja aliskirenom (14,2% naspram 4,4%), dok je proljev bio češći tijekom liječenja aliskirenom nego tijekom liječenja ramiprilom (6,6% naspram 5,0%).
The clearance of aliskiren increased in an age-dependent manner.
Klirens aliskirena povećavao se ovisno o dobi.
General In the event of severe and persistent diarrhoea, Rasilamlo therapy should be stopped (see section 4.8).
U slučaju teškog i ustrajnog proljeva potrebno je prekinuti terapiju lijekom Rasilamlo (vidjeti dio 4.8).
In clinical studies in hypertensive patients, aliskiren had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
U kliničkim ispitivanjima hipertenzivnih bolesnika aliskiren nije imao klinički značajnih učinaka na ukupni kolesterol, HDLkolesterol (HDL-C), trigliceride natašte, glukozu natašte ili mokraćnu kiselinu.
Reproductive studies in rats and mice have shown delayed date of delivery, prolonged duration of labour and decreased pup survival at dosages approximately 50 times greater than the maximum recommended dosage for humans based on mg/kg.
Ispitivanja na reprodukciju štakora i miševa pokazala su odgodu datumaokota, produljeno trajanje okota i smanjeno preživljavanje mladunčadi pri dozama koje su otprilike 50 puta veće od najviše preporučene doze za ljude izražene u mg/kg.
The combination at a dose of 300 mg/5 mg also showed statistically significantly greater blood pressure reduction than aliskiren 300 mg monotherapy.
Primjenom kombinirane doze 300 mg/5 mg također je pokazano statistički značajno veće sniženje krvnog tlaka nego monoterapijom aliskirenom 300 mg.
Amlodipine, one of the active substances in Rasilamlo, may make you feel dizzy and drowsy.
Od amlodipina, jedne od djelatnih tvari lijeka Rasilamlo, mogli biste osjetiti omaglicu ili omamljenost.
The most frequent adverse reactions for Rasilamlo are hypotension and peripheral oedema.
Najčešće nuspojave lijeka Rasilamlo su hipotenzija i periferni edem.
Exceptional cases of extrapyramidal syndrome have been reported.
Amlodipin Prijavljeni su iznimni slučajevi ekstrapiramidalnog sindroma.
In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow without change in filtration fraction or proteinuria.
U hipertenzivnih bolesnika s normalnom funkcijom bubrega, terapijske doze amlodipina rezultiraju smanjenjem bubrežne vaskularne rezistencije i povećanjem brzine glomerularne filtracije te učinkovitim protokom plazme kroz bubrege, bez promjene u filtracijskom udjelu ili proteinurije.
Effects of aliskiren on mortality and cardiovascular morbidity are currently unknown.
Trenutno nisu poznati učinci aliskirena na smrtnost i kardiovaskularni pobol.
In 3 additional cases where severe hyponatremia was associated with neurological symptoms such as brain oedema or major confusion and cerebral oedema,
U 3 dodatna slučaja gdje je teška hiponatrijemija bila povezana s neurološkim simptomima, kao što su edem mozga ili jaka konfuzija i cerebralni edem, uzročno-posljedična veza također se nije mogla isključiti.
The safety and efficacy of Rasilamlo in children below age 18 have not been established.
Sigurnost i djelotvornost lijeka Rasilamlo u djece u dobi do nenavršenih 18 godina nije ustanovljena.
In a double-blind, randomised placebocontrolled study in 1,688 patients with mild or moderate hypertension, discontinuation of therapy due to a clinical adverse event occurred in 1.7% of patients treated with Rasilamlo versus 1.5% of
U dvostruko slijepom, randomiziranom, placebom kontroliranom ispitivanju u kojem je sudjelovalo 1688 bolesnika s blagom do umjerenom hipertenzijom do prekida terapije zbog štetnog kliničkoga događaja došlo je u 1,7% bolesnika liječenih Rasilamlom naspram 1,5% bolesnika kojima je davan placebo.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Stenoza aortnog i mitralnog zaliska, opstruktivna hipertrofična kardiomiopatija Kao i s drugim vazodilatatorima, nužan je poseban oprez u bolesnika sa aortalnom ili mitralnom stenozom, ili opstruktivnom hipertrofičnom kardiomiopatijom.
Therefore, in view of available data regarding aliskiren/ aliskiren,amlodipine / aliskiren, hydrochlorothiazide, the PRAC considered that changes to the product information were warranted.
Stoga, s obzirom na dostupne podatke o aliskirenu/ aliskirenu, amlodipinu / aliskirenu, hidroklorotiazidu, PRAC smatra da su izmjene informacija o lijeku opravdane.
With aliskiren, the most likely manifestation of overdose would be hypotension, related to the antihypertensive effect of aliskiren.
Najvjerojatnije manifestacije predoziranja aliskirenom bila bi hipotenzija, koja je povezana s antihipertenzivnim učinkom aliskirena.
If you experience these, tell your doctor immediately.
Ako osjetite takve simptome, odmah obavijestite svog liječnika.
• Severe allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue,
• Teška alergijska reakcija sa simptomima poput osipa, svrbeža, oticanje lica ili usnica ili jezika,
Due to risk of hyperkalaemia, it is recommended that the co-administration of calcium channel blockers such as amlodipine be avoided in patients susceptible to malignant hyperthermia and in the management of
Zbog rizika od hiperkalijemije preporučuje se izbjegavati istodobnu primjenu blokatora kalcijevih kanala kao što je amlodipin u bolesnika podložnih pojavi maligne hipertermije i u liječenju maligne hipertermije.
Steady-state-plasma concentrations are reached within 5-7 days following once-daily administration and steady-state levels are approximately 2-fold greater than
Koncentracije u plazmi u stanju dinamičke ravnoteže postižu se unutar 5-7 dana nakon primjene jednom dnevno, a razine u stanju dinamičke ravnoteže su približno 2 puta veće nego s početnom dozom.
A single dose drug interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold.
Ispitivanje interakcije lijekova uz primjenu jednokratne doze lijeka u zdravih ispitanika pokazalo je da ciklosporin (200 i 600 mg) povećava Cmax aliskirena u dozi od 75 mg otprilike 2,5 puta, a AUC otprilike 5 puta.
, mood changes (including anxiety)
, promjene raspoloženja (uključujući anksioznost)
PERFORATED UNIT DOSE BLISTER (PCTFE)
PERFORIRANI BLISTER DJELJIV NA JEDINIČNE DOZE (PCTFE)
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.
Povećana incidencija hiperkalijemije (20,9% naspram 17,5%), oštećenje/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.
The fertility of rats was unaffected at doses of up to aliskiren 250 mg/kg/day (see section 5.3).
Aliskiren nije imao utjecaja na plodnost štakora pri dozi od 250 mg/kg/dan (vidjeti dio 5.3).
Very limited clinical data are available regarding amlodipine administration in patients with hepatic impairment.
Dostupni su vrlo ograničeni klinički podaci o primjeni amlodipina u bolesnika s oštećenjem jetrene funkcije.
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.