natgillin/translations-raw huggingface dataset:
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.
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.