natgillin/translations-raw huggingface dataset:
The half life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established.
Poluvijek amlodipina je produljeno i vrijednosti AUC-a su više u bolesnika s oštećenom funkcijom jetre; a preporuke za doziranje nisu utvrđene.
, hepatic enzymes increased (mostly consistent with cholestasis)
, povišeni jetreni enzimi (uglavnom upućuju na kolestazu)
Therefore, the potential exists for interactions between OATP inhibitors and aliskiren when administered concomitantly (see interaction with fruit juice).
Stoga postoji potencijal za interakcije između inhibitora OATP-a i aliskirena kada se primjenjuju istodobno (vidjeti interakciju s voćnim sokom).
Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25 and 2.5 mg/kg/day showed no evidence of carcinogenicity.
Štakori i miševi koji su dvije godine liječeni amlodipiomn u ishrani pri koncentracijama koje su prema izračunu osiguravale razine dnevnih doza od 0,5, 1,25 i 2,5 mg/kg/dan nisu pokazali dokaz karcinogenosti.
Patients should be informed to report to the physician any signs suggestive of allergic reactions, in particular difficulties in breathing or swallowing, swelling of face, extremities, eyes, lips or tongue.
Bolesnici trebaju biti obaviješteni da prijave liječniku bilo koje znakove koji upućuju na alergijske reakcije, osobito teškoće pri disanju ili gutanju, oticanje lica, ekstremiteta, očiju, usnica ili jezika.
Increases in AUC and elimination half-life in patients with congestive heart failure were as expected for the patient age group in this study (see section 4.4).
Povišenja AUC-a i poluvijeka eliminacije u bolesnika s kongestivnim zatajenjem srca bila su očekivana za bolesnike te dobne skupine u ovom ispitivanju (vidjeti dio 4.4).
• palpitations (awareness of your heart beat)
• palpitacije (svjesnost otkucaja srca).
Gender, weight and ethnicity have no clinically relevant influence on aliskiren pharmacokinetics.
Spol, tjelesna težina i etnička pripadnost nemaju klinički značajan utjecaj na farmakokinetiku aliskirena.
There is no data available regarding the effect of CYP3A4 inducers on amlodipine.
Nema dostupnih podataka o učinku induktora CYP3A4 na amlodipin.
These were statistically significant versus placebo and aliskiren for all doses.
Te su razlike bile statistički značajne naspram placeba i aliskirena u svim dozama.
The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
P-gp-a će vjerojatno ovisiti o stupnju inhibicije ovog transportera.
- Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone.
- Istodobna primjena višekratnih doza od 10 mg amlodipina s 80 mg simvastatina rezultirala je povećanjem izloženosti simvastatinu za 77% u usporedbi sa samim simvastatinom.
The combined action of aliskiren and amlodipine on these two central blood pressure-regulating factors (vasoconstriction and RAAS-mediated hypertensive effects) results in more effective antihypertensive effects than seen with monotherapy.
Kombinirano djelovanje aliskirena i amlodipina na ta dva ključna faktora regulacije krvnog tlaka (vazokonstrikcija i hipertenzivni učinci posredovani RAAS-om) razultiraju djelotvornijim antihipertenzivnim učincima nego viđenim s monoterapijom.
Rasilamlo must not be used in children from birth to less than 2 years of age.
Rasilamlo se ne smije primjenjivati u djece od rođenja do nenevršene 2 godine.
There was no effect on the fertility of rats treated with amlodipine (males for 64 days and females 14 days prior to mating) at doses up to 10 mg/kg/day (8 times* the maximum recommended human basis).
Nije bilo učinka na plodnost štakora liječeni amlodipinom (mužjaci 64 dana i ženke 14 dana prije parenja) pri dozama od 10 mg/kg/dan (8 puta više* od najviše preporučene doze za ljude od 10 mg
Fertility, pre-natal development and post-natal development were unaffected in rats at doses up to 250 mg/kg/day.
Na plodnost, prenatalni razvoj i postnatalni razvoj nije bilo utjecaja u štakora pri dozama do 250 mg/kg/dan.
The safety and efficacy of amlodipine in hypertensive crisis have not been established.
Sigurnost i djelotvornost amlodipina u bolesnika u hipertenzivnoj krizi nisu utvrđene.
Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndrome a, toxic epidermal necrolysis (TEN)
Teške kožne nuspojave (SCAR) uključujući Stevens Johnsonov sindrom a, toksičnu epidermalnu nekrolizu (TEN)
Rasilamlo contains two active substances, called aliskiren and amlodipine.
Rasilamlo sadrži dvije djelatne tvari koje se zovu aliskiren i amlodipin.
Safety data for amlodipine are well established both clinically and non-clinically.
Amlodipin Podaci o sigurnosti amlodipina dobro su utvrđeni, klinički i neklinički.
• increased level of creatinine in the blood
• povišena razina kreatinina u krvi
Amlodipine has demonstrated beneficial clinical effects in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Amlodipin je pokazao korisne kliničke učinke u bolesnika s kroničnom stabilnom anginom pektoris, vazospastičnom anginom i angiografski dokumentiranom bolešću koronarnih arterija.
The concomitant use of CYP3A4 inducers (e.g. rifampicin, hypericum perforatum) may give a lower plasma concentration of amlodipine.
Istodobna primjena CYP3A4 induktora (npr. rifampicin, Hypericum perforatum) mogla bi imati za posljedicu nižu koncentraciju amlodipina u plazmi.
Clearance in rats aged 8 or 14 days was similar, but at these ages the clearance was only about 23% of clearance in rats aged 21 days and 16% of clearance in rats aged 28 days.
Klirens u štakora starih 8 ili 14 dana bio je sličan, ali u toj dobi klirens je bio samo oko 23% klirensa u štakora starih 21 dan te 16% klirensa u štakora starih 28 dana.
These studies indicate that excessive aliskiren exposure (>400-fold higher in 8-day old rats compared with adult rats) and high acute toxicity in juvenile rats are caused by immature MDR1, which suggests that in paediatric patients with immature MDR1, there is a potential for aliskiren overexposure (see sections 4.2, 4.3 and 5.2).
Ova ispitivanja upućuju na to da su prekomjerna izloženost aliskirenu (>400 puta viša u 8 dana starih štakora u usporedbi s odraslim štakorima) i visoka akutna toksičnost u mladih štakora uzrokovani nezrelim MDR1, što ukazuje na to da u pedijatrijskih bolesnika s nezrelim MDR1, postoji potencijal za prekomjernu izloženost aliskirenu (vidjeti dijelove 4.2, 4.3 i 5.2).
Preclinical safety studies have demonstrated that the combination of aliskiren and amlodipine was well tolerated in rats.
Pretklinička ispitivanja sigurnosti pokazala su da se kombinacija aliskirena i amlodipina dobro podnosila u štakora.
Exposure to aliskiren increased more than in proportion to the increase in dose.
Izloženost aliskirenu povećala se više nego razmjerno povećanju doze.
The usual dose of Rasilamlo is one tablet a day.
Uobičajena doza lijeka Rasilamlo je jedna tableta na dan.
As with any antihypertensive medicinal product, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Kao i kod svakog drugog antihipertenzivnog lijeka pretjerano sniženje krvnog tlaka u bolesnika s ishemijskom kardiopatijom ili ishemijskom kardiovaskularnom bolešću može rezultirati infarktom miokarda ili moždanim udarom.
There were no new adverse reactions which occurred specifically with Rasilamlo in addition to those known to be associated with the individual monotherapies.
Nije bilo pojave novih nuspojava, specifičnih za Rasilamlo, osim onih za koje je već poznato da su povezane s monoterapijama pojedinačnim komponentama.
PVC/polychlorotrifluoroethylene (PCTFE) - Alu blisters:
PVC/poliklorotrifloroetilen (PCTFE) - Al blisteri:
When given to patients whose blood pressure was not adequately controlled by either aliskiren or amlodipine, Rasilamlo results in greater blood pressure reductions after one week of treatment than the component monotherapies and a near-maximal effect is achieved after four weeks of therapy.
Kad se daje bolesnicima u kojih ni aliskirenom niti amlodipinom krvni tlak nije odgovarajuće kontroliran, Rasilamlo nakon tjedan dana liječenja rezultira većim sniženjima krvnog tlaka nego monoterapije komponentama, dok se nakon četiri tjedna terapije postiže gotovo maksimalan učinak.
The results showed that developmental changes of aliskiren exposure correlated with the ontogeny of transporter maturation in jejunum, liver, kidney and brain.
Rezultati su pokazali da su promjene izloženosti aliskirenu tijekom rezvoja u korelaciji s ontogenezom sazrijevanja prijenosnika u jejunumu, jetri, bubrezima i mozgu.
After oral administration of therapeutic doses of amlodipine alone, peak plasma concentrations of amlodipine are reached in 6-12 hours.
Nakon peroralne primjene terapijskih doza samo amlodipina, vršne koncentracije amlodipina u plazmi postižu se 6-12 sati.
Based on the limited amount of safety data available from a pharmacokinetic study of aliskiren treatment in 39 hypertensive children 6-17 years of age, the frequency, type and severity of adverse reactions in children are expected to be similar to that seen in hypertensive adults.
Na temelju ograničene količine podataka o sigurnosti dostupnih iz farmakokinetičkog ispitivanja liječenja aliskirenom u 39 hipertenzivne djece u dobi od 6-17 godina, očekuje se da će učestalost, vrsta i težina nuspojava u djece biti slična onima viđenim u hipertenzivnih odraslih osoba.
Clinically significant hypotension due to amlodipine overdosage calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output.
Klinički značajna hipotenzija zbog predoziranja amlodipinom zahtijeva aktivnu kardiovaskularnu potporu, uključujući često praćenje srčane i respiratorne funkcije, podizanje ekstremiteta, uz praćenje volumena cirkulirajuće tekućine i mokrenja.
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem) may give rise to significant increase in amlodipine exposure.
Istodobna primjena amlodipina sa snažnim ili umjerenim inhibitorima CYP3A4 (inhibitori proteaze, azolni protugljivični lijekovi, makrolidi poput eritromicina ili klaritromicina, verapamil ili diltiazem) mogu izazvati značajno povećanje izloženosti amlodipinu.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza Rok valjanosti/EXP.
Effects of amlodipine on other medicinal products - The blood pressure lowering effects of amlodipine adds to the blood pressure-lowering effects of other antihypertensive medicinal products.
Učinci amlodipina na druge lijekove - Učinci amlodipina na sniženje krvnog tlaka pojačavaju učinke drugih antihipertenzivnih lijekova .
• severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin,
• teške kožne reakcije (toksična epidermalna nekroliza i/ili reakcije oralne sluznice - crvena koža,
In patients treated with both aliskiren and oral furosemide or torasemide, it is therefore recommended that the effects of furosemide or torasemide be monitored when initiating and adjusting furosemide, torasemide or aliskiren therapy to avoid changes in extracellular fluid volume and possible situations of volume overload (see section 4.4).
U bolesnika liječenih s ooje, aliskirenom i peroralnim furosemidom ili torasemidom preporučuje se pratiti učinke furosemida ili torasemida kada se započinje i prilagođava terapija furosemidom, torasemidom ili aliskirenom kako bi se izbjegle promjene u volumenu izvanstanične tekućine i moguća preopterećenja volumena (vidjeti dio 4.4).
, dysgeusia
, disgeuzija
However, compounds potentially inhibiting organic anion transporting polypeptide-mediated uptake of aliskiren are widely present in fruits, vegetables, and many other plant products.
Međutim, spojevi koji mogu inhibirati pohranu aliskirena posredovanu polipeptidnim prijenosnicima organskih aniona vrlo su rasprostanjeni u voću, povrću, i mnogim drugim biljnim proizvodima.
In the majority of patients aged 65 years or older, the 300 mg dose of aliskiren shows no additional benefit in reducing blood pressure compared to the 150 mg dose.
U većine bolesnika u dobi od 65 godina ili starijih, doza aliskiren od 300 mg ne pokazuje nikakvu dodatnu korist u snižavanju krvnog tlaka u usporedbi s dozom od 150 mg.
The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose basis) was close to the maximum tolerated dose for mice but not for rats.
Najviša doza (za miševe slična, a za štakore dvostruka* od najviše preporučene kliničke doze od 10 mg izraženoj u mg/m2) bila je blizu najviše podnošljive doze za miševe, ali ne i za štakore.
Aliskiren induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide.
Aliskiren je izazvao dodatni učinak na snižavanje krvnoga tlaka, kada je dodan hidroklorotiazidu.
Among secondary endpoints, the incidence of heart failure (component of a composite combined cardiovascular endpoint) was significantly higher in the amlodipine group as compared to the chlorthalidone group (10.2% vs 7.7%, RR 1.38, 95% CI [1.25-1.52] p<0.001).
Među sekundarnim ishodima incidencija zatajenja srca (komponenta kompozita kombiniranog kardiovaskularnog ishoda) bila je značajno viša u skupini na amlodipinu u usporedbi sa skupinom na klortalidonu (10,2% naspram 7,7%, OR 1,38, 95% CI [1,25-1,52] p<0,001).
Amlodipine clearance tends to be decreased with resulting increases in AUC and elimination half-life in elderly patients.
Klirens amlodipina obično je smanjen uz posljedična povećanja AUC-a i poluvijeka eliminacije u starijih bolesnika.
Not all pack sizes or strengths may be available in your country.
Na tržištu u Vašoj zemlji se ne moraju nalaziti sve veličine pakiranja ili jačina.
Visual disturbance (including diplopia)
Poremećaji vida (uključujući diplopiju)
There is no experience of overdose with Rasilamlo.
Ne postoji iskustvo s predoziranjem lijekom Rasilamlo.
In a 36-week study involving 820 patients with ischaemic left ventricular dysfunction, no changes in ventricular remodelling as assessed by left ventricular end systolic volume were detected with aliskiren compared to placebo on top of background therapy.
U 36-tjednom ispitivanju u koje je bilo uključeno 820 bolesnika s ishemijskom disfunkcijom lijevog ventrikula nisu otkrivene nikakve promjene u ventrikularnom remodeliranju prema volumenu lijevog ventrikula na kraju sistole s aliskirenom u usporedbi s placebom dodanom osnovnoj terapiji.
• disturbed sense of taste
• poremećaji osjeta okusa
The recommended dose of Rasilamlo is one tablet per day.
Doziranje Preporučena doza lijeka Rasilamlo je jedna tableta na dan.
The safety profile of Rasilamlo presented below is based on clinical studies performed with Rasilamlo and the known safety profile of the individual components aliskiren and amlodipine.
Sigurnosni profil lijeka Rasilamlo opisan u nastavku temelji se na kliničkim ispitivanjima provedenim s Rasilamlom i poznatim sigurnosnim profilima pojedinačnih komponenti aliskirena i amlodipina.
The amlodipine component of Rasilamlo inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Amlodipinska komponenta lijeka Rasilamlo inhibira transmembranski ulaz kalcijevih iona u srčani mišić i glatki mišić krvnih žila.
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.
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 angiotenzina.
Reproductive studies in rats have shown no toxicity except for delayed date of delivery and prolonged duration of labour at dosages 50 times greater than the maximum recommended dosage for humans (see section 5.3).
Ispitivanja reprodukcije u štakora nisu pokazala toksičnost, osim odgode datuma okota i produljnoeg trajanja okota pri dozama 50 puta većim od najviše preporučene doze za ljude (vidjeti dio 5.3).
Treatment with Rasilamlo at doses up to 300 mg/10 mg had an overall incidence of adverse experiences similar to the component monotherapies.
Liječenje Rasilamlom u dozama do 300 mg/10 mg imalo je ukupnu incidenciju štetnih događaja sličnu onoj tijekom monoterapije komponentama.
The pharmacokinetics of aliskiren was evaluated in rats aged from 8 to 28 days after intravenous administration of aliskiren 3 mg/kg.
Farmakokinetika aliskirena ocjenjivana je u štakora starih od 8 do 28 dana nakon intravenske primjene aliskirena od 3 mg/kg.
BLISTERS (PVC/PCTFE OR PA/Alu/PVC) CALENDAR BLISTERS ONLY
BLISTERI (PVC/PCTFE ILI PA/Al/PVC) SAMO KALENDARSKI BLISTERI
In controlled clinical trials, angioedema and hypersensitivity reactions occurred rarely during treatment with aliskiren with rates comparable to treatment with placebo or comparators.
U kontroliranim kliničkim ispitivanjima angioedem i reakcije preosjetljivost javljali su se rijetko tijekom liječenja aliskirenom uz stope koje se mogu usporediti s liječenjem placebom ili komparatorima.
Adverse reaction observed with monotherapy with amlodipine; * Peripheral oedema is a known, dose-dependent adverse reaction of amlodipine and has also been reported with aliskiren therapy in post-marketing experience.
Nuspojave opažene u monoterapiji s amlodipinom; * Periferni edem je poznata nuspojava amlodipina ovisna o dozi, koja je također bila prijavljena i s terapijom aliskirenom nakon stavljanja tog lijeka u promet.
- 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.
- Istodobna primjena aliskirena bilo s metforminom (↓28%), amlodipinom (↑29%) ili cimetidinom (↑19%) rezultirala je promjenom Cmax ili AUC-u aliskirena između 20% i 30%.
Rasilamlo is available in packs containing 14, 28, 56 or 98 tablets (in calendar blisters), 30 or 90 tablets (in normal blisters) and 56x1 tablet (as perforated unit dose blisters).
Rasilamlo je dostupan u pakiranjima od 14, 28, 56 ili 98 tableta (u kalendarskim blisterima), 30 ili 90 tableta (u normalnim blisterima) i 56x1 tableta (u perforiranim blisterima djeljivim na jedinične doze).
The plasma exposure was approximately 100-fold higher in rats aged 14 days and 3-fold higher in rats aged 21 days compared to adult rats.
Izloženost u plazmi bila je otprilike 100 puta veća u štakora starih 14 dana te 3 puta veća u štakora starih 21 dan u usporedbi s odraslim štakorima.
Via Provinciale Schito 131 IT-80058 Torre Annunziata Italy
Novartis Farma S.p.A. Via Provinciale Schito 131 IT-80058 Torre Annunziata Italija
Although aliskiren has known 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.
Iako aliskiren ima poznat 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 karcinogenosti u štakora.
A population pharmacokinetic study has been conducted in 74 hypertensive children aged from 1 to 17 years (with 34 patients aged 6 to 12 years and 28 patients aged 13 to 17 years) receiving amlodipine between 1.25 and 20 mg given either once or twice daily.
Ispitivanje populacijske farmakokinetike provedeno je u 74 hipertenzivne djece u dobi od 1-17 godina (s 34 bolesnika u dobi 6-12 godina, a 28 bolesnika u dobi 13-17 godina) koji su primali amlodipin u dozama od 1,25 mg do 20 mg bilo jednom ili dvaput dnevno.
Rasilamlo combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: aliskiren belongs to the class of direct renin inhibitors and amlodipine belongs to the calcium antagonist class.
Rasilamlo je kombinacija dva antihipertenzivna lijeka s komplementarnim mehanizmima kontrole krvnog tlaka u bolesnika s esencijalnom hipertenzijom: aliskiren pripada skupini direktnih inhibitora renina, dok amlodipin pripada skupini antagonista kalcija.
• swelling, including swelling of hands, ankles or feet (peripheral oedema)
• oticanje, ukjlučujući oticanje ruku, gležnjeva ili stopala (periferni edem)
Safety information for Rasilamlo in patients aged 75 years and older is limited.
Informacije o sigurnosti lijeka Rasilamlo u bolesnika u dobi od 75 godina i starijih su ograničeni.
Anaphylactic reactions a, hypersensitivity reactions a
Anafilaktičke reakcije a, reakcije preosjetljivosti a
The adverse reactions observed with Rasilamlo or with monotherapy with one or both of the two components are included in the table below.
Nuspojave opažene s Rasilamlom ili u monoterapiji s jednom ili svakom od dvije komponente uključene su u tablici u nastavku.
The assays included in vitro assays in bacterial and mammalian cells and in vivo assessments in rats.
Testovi su uključivali in vitro određivanja na stanicama bakterija i sisavaca, te in vivo ispitivanja na štakorima.
Aliskiren monotherapy studies have shown blood-pressure-lowering effects comparable to other classes of antihypertensive medicinal products including selected ACEI and ARB.
Ispitivanja monoterapije aliskirenom pokazala su učinke snižavanja krvnoga tlaka koji se mogu usporediti s drugim skupinama antihipertenzivnih lijekova, uključujući izabrane ACEI-e i ARB-ove.
In children 6 to 12 years and in adolescents 13-17 years of age the typical oral clearance (CL/F) was 22.5 and 27.4 l/hr respectively in males and 16.4 and 21.3 l/hr respectively in females.
U djece u dobi 6-12 godina i adolescenata u dobi 13-17 godina tipičan peroralni klirens (CL/F) bio je 22,5 odnosno 27,4 l/h u muških te 16,4 odnosno 21,3 l/h u ženskih ispitanika.
The patients had at least one additional coronary heart disease risk factor, including: previous myocardial infarction or stroke (>6 months prior to enrollment) or documentation of other atherosclerotic cardiovascular disease (overall 51.5%), type 2 diabetes (36.1%), high density lipoprotein - cholesterol <35 mg/dl or <0.906 mmol/l (11.6%), left ventricular hypertrophy diagnosed by electrocardiogram or echocardiography (20.9%), current cigarette smoking (21.9%).
Bolesnici su imali najmanje jedan dodatni faktor rizika za koronarnu bolest srca, uključujući prethodni infarkt miokarda ili moždani udar (>6 mjeseci prije uključivanja u ispitivanje) ili dokumentaciju o drugoj aterosklerotskoj kardiovaskularnoj bolesti (ukupno 51,5%), šećernu bolest tip 2 (36,1%), lipoprotein visoke gustoće - kolesterol <35 mg/dl ili <0,906 mmol/l (11,6%), hipertrofiju lijevog ventrikula dijagnosticiranu elektrokardiogramom ili ehokardiografijom (20,9%), aktivni status pušača (21,9%).
- Organic anion transporting polypeptide (OATP) inhibitors Preclinical studies indicate that aliskiren might be a substrate of organic anion transporting polypeptides.
- Inhibitori polipeptidnih transportera organskih aniona (OATP) Pretklinička ispitivanja pokazuju da bi aliskiren mogao biti supstrat polipeptidnih transportera organskih aniona.
Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome, have been reported with amlodipine.
Prijavljena je izražena i vjerojatno produljena hipotenzija uključujući šok sa smrtnim ishodom s amlodipinom.