FrancophonIA/ELRC3.0 huggingface dataset:
English: Lowering the amount of angiotensin II allows the blood vessels to relax; this lowers blood pressure.
Croatian: Smanjenjujući količinu angiotenzina II omogućava opuštanje krvnih žila, što dovodi do sniženja krvnog tlaka.
English: There is limited experience with Rasilamlo, in particular in patients aged 75 years or older.
Croatian: Iskustva s primjenom lijeka Rasilamlo, osobito u bolesnika u dobi od 75 godina ili starijih, ograničena su.
English: 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
Croatian: 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
English: At steady state the non-linearity may be more pronounced.
Croatian: U stanju dinamičke ravnoteže nelinearnost može biti izraženija.
English: 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
Croatian: 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.
English: Angiotensin II causes blood vessels to tighten, which raises blood pressure.
Croatian: Angiotenzin II uzrokuje suženje krvnih žila, što dovodi do povišenja krvnog tlaka.
English: A mechanistic study was conducted to investigate the relationship between age, aliskiren exposure and MDR1 and OATP2 expression maturation in rats.
Croatian: Ispitivanje mehanizma provedeno je da bi se istražio odnos između dobi, izloženosti aliskirenu te sazrijevanja ekspresije MDR1 i OATP2 u štakora.
English: 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).
Croatian: 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).
English: , back pain
Croatian: • bol u leđima
English: Combination therapy studies are available for aliskiren added to the diuretic hydrochlorothiazide and the beta blocker atenolol.
Croatian: Dostupna su klinička ispitivanja kombinirane terapije aliskirena dodanog diuretiku hidroklorotiazidu i blokatoru kalcijevih kanala atenololu.
English: Individual dose titration with each of the two components may be recommended before changing to the fixed combination.
Croatian: Prije prelaska na fiksnu kombinaciju doza preporučuje se individualno titriranje doze sa svakom od dvije komponente.
English: The findings from the 2- and 13-week oral toxicity studies in rats were consistent with those of aliskiren and amlodipine when both active substances are administered alone.
Croatian: Nalazi 2-tjednoga i 13-tjednoga ispitivanja toksičnosti peroralne primjene lijeka u štakora bili su dosljedni onima s aliskirenom i amlodipinom kad su obje djelatne tvari bile primjenjivane zasebno.
English: Over the 12 week period, aliskiren monotherapy lowered systolic/diastolic blood pressure by 14.0/5.1 mmHg, compared to 11.6/3.6 mmHg for ramipril, consistent with aliskiren being non-inferior to ramipril at the dosages chosen and the differences in systolic and diastolic blood pressure were statistically significant.
Croatian: Tijekom razdoblja od 12 tjedana monoterapija aliskirenom snizila je sistolički/dijastolički krvni tlak za 14,0/5,1 mmHg, u usporedbi s 11,6/3,6 mmHg za ramipril, što dosljedno ukazuje da aliskiren nije inferioran ramiprilu u izabranim dozama te da su razlike u sistoličkom i dijastoličkom krvnom tlaku bile statistički značajne.
English: If you take more Rasilamlo than you should If you have accidentally taken too many Rasilamlo tablets, talk to a doctor immediately.
Croatian: Ako ste slučajno uzeli previše Rasilamlo tableta, odmah se obratite svom liječniku.
English: Haemodynamically unstable heart failure after acute myocardial infarction.
Croatian: Hemodinamski nestabilno zatajenje srca nakon akutnog infarkta miokarda.
English: Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilatation resulting in a reduction of supine and standing blood pressures.
Croatian: Nakon primjene terapijskih doza bolesnicima s hipertenzijom, amlodipin dovodi do vazodilatacije što rezultira sniženjem krvnog tlaka u ležećem i stojećem položaju.
English: 280 tablets (20x14, PA/Alu/PVC blisters)
Croatian: 280 tableta (20x14, PA/Al/PVC blisteri)
English: The pharmacokinetics of aliskiren were evaluated in patients with varying degrees of renal insufficiency.
Croatian: Farmakokinetika aliskirena ispitivana je u bolesnika s različitim stupnjevima insuficijencije bubrega.
English: In hypertensive patients, once-daily administration of aliskiren at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Croatian: U hipertenzivnih bolesnika, primjena aliskirena jedanput dnevno u dozama od 150 mg i 300 mg osigurala je sniženje sistoličkog i dijastoličkog krvnog tlaka ovisno o dozi, koje je održavano tijekom čitavog 24-satnog doznog intervala (održavajući korist u ranim jutarnjim satima) sa srednjom vrijednošću omjera najviše i najniže vrijednosti za dijastolički odgovor do 98% pri dozi od 300 mg.
English: • rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever
Croatian: • osip, crvena koža, stvaranje mjehurića na usnicama, očima ili ustima, ljuštenje kože, vrućica
English: 56x1 tablet (PVC/PCTFE single-unit-dose blisters)
Croatian: 56x1 tableta (PVC/PCTFE blisteri djeljivi na jedinične doze)
English: Talk to your doctor before taking Rasilamlo: - if you are suffering from vomiting or diarrhoea or if you are taking a diuretic (a medicine to increase the amount of urine you produce) - if you have already experienced angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Rasilamlo: - ako Vas muče povraćanje ili proljev ili ako uzimate diuretik (lijek kojim se povećava količina mokraće koju stvarate) - ako ste već imali angioedem (teškoće pri disanju ili gutanju, ili oticanje lica, ruku i nogu, očiju, usnica i/ili jezika).
English: The concomitant use of Rasilamlo with an ACEI or an ARB is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Croatian: Istodobna primjena lijeka Rasilamlo s ACEI-ima ili ARB-ima kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR <60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
English: , syncope
Croatian: , sinkopa
English: , gingival hyperplasia
Croatian: , hiperplazija gingive
English: - Medicinal products affecting serum potassium levels Concomitant use of other agents affecting the RAAS, of NSAIDs or of agents that increase serum potassium levels (e.g. potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, heparin) may lead to increases in serum potassium.
Croatian: - Lijekovi koji utječu na razine kalija u serumu Istodobna primjena drugih lijekova koji utječu na RAAS, NSAIL-ova ili lijekova koji povisuju razine kalija u serumu (npr. diuretici koji štede kalij, nadomjesci kalija, nadomjesne soli koje sadrže kalij, heparin) mogu dovesti do povišenja kalija u serumu.
English: A number of these patients had a history of angioedema or symptoms suggestive of angioedema which in some cases was associated with the administration of other medicinal products known to cause angioedema, including RAAS blockers (ACEIs or ARBs).
Croatian: Određeni broj tih bolesnika imao je u anamnezi angioedem ili simptome koji upućuju na angioedem, čija je pojava u nekim slučajevima bila povezana s primjenom drugih lijekova za koje je poznato da uzokuju pojavu angioedema, uključujući blokatore RAAS-a (ACEI-eve ili ARB-ove).
English: At steady state meals with low fat content reduce Cmax by 76% and AUC 0-tau by 67% in hypertensive patients.
Croatian: U stanju dinamičke ravnoteže u hipertenzivnih bolesnika obroci s niskim sadžajem masti smanjuju Cmax za 76% i AUC 0-tau za 67%.
English: No adjustment of the initial dose is required for patients with mild to moderate renal impairment (GFR 89-60 ml/min/1.73 m and 59-30 ml/min/1.73 m 2, respectively, see sections 4.4 and 5.2).
Croatian: U bolesnika s blagim do teškim oštećenjem bubrežne funkcije nije potrebna prilagodba početne doze (GFR 89-60 ml/min/1,73 m i 59-30 ml/min/1,73 m2, vidjeti dijelove 4.4 i 5.2).
English: Coadministration of grapefruit juice with aliskiren 150 mg resulted in a 61% decrease in aliskiren AUC and co-administration with aliskiren 300 mg resulted in a 38% decrease in aliskiren AUC.
Croatian: Istodobna primjena soka od grejpa s aliskirenom 150 mg rezultirala je smanjenjem AUC-a aliskirena za 61%, dok je istodobna primjena s aliskirenom 300 mg rezultirala smanjenjem AUC-a aliskirena za 38%.
English: The increased incidence of stroke was greater in patients with renal
Croatian: Povećana incidencija moždanog udara bila je veća u bolesnika s insuficijencijom bubrega.
English: Aliskiren has been studied in 1,864 patients aged 65 years or older, and in
Croatian: Aliskiren je ispitivan u 1864 bolesnika u dobi od 65 godina ili starijih te u 426 bolesnika u dobi od 75 godina ili starijih.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or
Croatian: Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili drugih derivata dihidropiridina.
English: In an 8-week randomised, double-blind, placebo-controlled, parallel group factorial study in 1,688 randomised patients with mild to moderate hypertension, treatment with Rasilamlo at doses from 150 mg/5 mg to 300 mg/10 mg produced dose-dependent clinically meaningful mean blood pressure reductions (systolic/diastolic) ranging between 20.6/14.0 mmHg and 23.9/16.5 mmHg, respectively, compared to 15.4/10.2 mmHg for aliskiren 300 mg, 21.0/13.8 mmHg for amlodipine 10 mg and 6.8/5.4 mmHg with placebo in a population of patients with mean baseline blood pressure of 157.3/99.7 mmHg.
Croatian: U 8-tjednom randomiziranom, dvostruko slijepom, placebom kontroliranom faktorijelnom ispitivanju paralelnih skupina u kojem je sudjelovalo 1688 randomiziranih bolesnika s blagom do umjerenom hipertenzijom, liječenje Rasilamlom u dozama od 150 mg/5 mg do 300 mg/10 mg dovelo je do klinički značajnih, o dozi ovisnih, sniženja srednje vrijednosti krvnog tlaka (sistoličkog/dijastoličkog) u rasponu između 20,6 mmHg odnosno 14,0 mmHg i 23,9 mmHg odnosno 16,5 mmHg, u usporedbi sa sniženjem od 15,4 mmHg odnosno 10,2 mmHg s aliskirenom 300 mg, 21,0 mmHg odnosno 13,8 mmHg s amlodipinom 10 mg te 6,8 mmHg odnosno 5,4 mmHg s placebom, u populaciji bolesnika s početnom srednjom vrijednošću krvnog tlaka od 157,3 mmHg odnosno 99,7 mmHg.
English: Component of a multipack comprising 2 packs, each containing 49x1 tablet.
Croatian: Sastavni dio višestrukog pakiranja koje sadrži 2 pakiranja, od kojih svako sadrži 49x1 tabletu.
English: There are no clinical data on fertility with the use of Rasilamlo.
Croatian: Plodnost Nema kliničkih podataka o plodnosti s primjenoml lijeka Rasilamlom.
English: The results of this study did not suggest that age, body weight or gender have any significant effect on aliskiren
Croatian: Rezultati ovog ispitivanja nisu upućivali na to da dob, tjelesna težina ili spol imaju bilo kakav značajan učinak na sistemsku izloženost aliskirenu (vidjeti dio 4.2).
English: Mutagenicity studies revealed no effects related to the medicinal product at either the gene or
Croatian: Ispitivanja mutagenosti nisu otkrila nikakeo učinke povezane s lijekom na razini gena ili na razini kromosoma.
English: , hypotension c,a,am
Croatian: , hipotenzija c,a,am
English: , dyspepsia
Croatian: , dispepsija
English: In a study in 545 randomised patients not adequately responsive to 5 mg amlodipine, the combination of aliskiren 150 mg/amlodipine 5 mg resulted in greater blood pressure reduction than those patients
Croatian: U ispitivanju 545 randomiziranih bolesnika s neodgovarajućim odgovorom na amlodipin 5 mg, primjena kombinacije aliskiren 150 mg/ amlodipin 5 mg rezultirala je većim sniženjem krvnog tlaka nego u onih bolesnika koji su ostali na amlodipinu 5 mg.
English: A number of these patients had a history of angioedema or symptoms suggestive of angioedema, which in some cases followed use of other medicinal products that can cause angioedema, including RAAS blockers (angiotensin converting enzyme inhibitors or angiotensin receptor blockers) (see
Croatian: Određeni broj tih bolesnika imao je u anamnezi angioedem ili simptome koji upućuju na angioedem, čija je pojava u nekim slučajevima nastupila nakon primjene drugih lijekova koji mogu uzrokovati angioedem, uključujući blokatore RAAS-a (inhibitori angiotenzin - konvertirajućeg enzima ili blokatori receptora angiotenzina) (vidjeti dio 4.8).
English: Aliskiren is an effective once-a-day antihypertensive treatment in adult patients, regardless of gender,
Croatian: Aliskiren je učinkovita antihipertenzivna terapija koja se uzima jedanput na dan u odraslih bolesnika, bez obzira na spol, dob, indeks tjelesne mase i etničku pripadnost.
English: • Severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin, blistering of the lips, eyes or mouth, skin peeling, fever) (uncommon: may affect up to 1 in
Croatian: • Teške kožne reakcije (toksična epidermalna nekroliza i/ili reakcija oralne sluznice - crvena koža, stvaranje mjehurića na usnicama, očima ili ustima, guljenje kože, vrućica) (manje često:
English: Compared to a diuretic (hydrochlorothiazide, HCTZ), aliskiren 300 mg lowered systolic/diastolic blood pressure by 17.0/12.3 mmHg, compared to 14.4/10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Croatian: U usporedbi s diuretikom (hidroklorotiazid - HCTZ), aliskiren je u dozi od 300 mg snizio sistolički/dijastolički krvni tlak za 17,0/12,3 mmHg, u usporedbi s 14,4/10,5 mmHg za HCTZ u dozi od 25 mg nakon 12 tjedana liječenja.
English: Torasemide renal excretion is known to be mediated by organic anion transporters (OATs).
Croatian: Poznato je da izlučivanjem torasemida putem bubrega posreduju prijenosnici organskih aniona (OAT).
English: Consistent with standard medical practice, periodic determination of renal function including serum electrolytes is advised if co-administration is considered necessary.
Croatian: U skladu sa standardnom medicinskom praksom, ako se istodobna primjena lijekova smatra nužno potrebnom, savjetuje se periodička provjera funkcije bubrega, uključujući elektrolite u serumu.
English: However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidonebased therapy RR 0.96 95% CI [0.89-1.02] p=0.20.
Croatian: Međutim, kad je riječ o smrtnosti od svih uzroka, između terapije temeljene na amlodipinu i terapije temeljene na klortalidonu nije bilo značajne razlike OR 0,96 95% CI [0,89-1,02] p=0,20.
English: Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.
Croatian: Rasilamlo je indiciran za liječenje esencijalne hipertenzije u odraslih osoba čiji krvni tlak nije odgovarajuće kontroliran primjenom aliskirena ili amlodipina zasebno.
English: - Non-steroidal anti-inflammatory drugs (NSAIDs) As with other medicinal products acting on the renin-angiotensin-aldosterone system, NSAIDs may reduce the anti-hypertensive effect of aliskiren.
Croatian: Kao i s drugim lijekovima koji djeluju na renin-angiotenzin -aldosteron sustav, i NSAIL-i mogu smanjiti antihipertenzivni učinak aliskirena.
English: It is therefore not recommended for women who are breast-feeding to use Rasilamlo.
Croatian: Dojiljama se stoga ne preporučuje da uzimaju Rasilamlo.
English: Another repeat-dose toxicity study was conducted in juvenile rats 14 days post-partum for 8 weeks with aliskiren dosing at 30, 100 or 300 mg/kg/day.
Croatian: Još jedno ispitivanje toksičnosti ponovljenih doza provedeno je u mladih štakora14 dana nakon okota tijekom 8 tjedana s dozom aliskirena od 30, 100 ili 300 mg/kg/dan.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: Rasilamlo is used to treat high blood pressure in adult patients whose blood pressure is not sufficiently controlled with aliskiren or amlodipine alone.
Croatian: Rasilamlo se koristi za liječenje povišenoga krvnog tlaka u odraslih bolesnika u kojih nije postignuta dostatna kontrola krvnog tlaka samo aliskirenom ili samo amlodipinom.
English: These observed changes, however, did not correlate with the severity of renal impairment.
Croatian: Ove opažene promjene nisu bile u korelaciji s težinom oštećenja bubrega.
English: , altered bowel habits (including diarrhoea and constipation)
Croatian: , promjene navike pražnjenja crijeva (uključujući proljev i konstipaciju)
English: The most likely manifestation of overdose for Rasilamlo would be hypotension, related to the antihypertensive effect of aliskiren and amlodipine.
Croatian: Rasilamlom bila bi hipotenzija povezana s antihipertenzivnim učinkom aliskirena i amlodipina.
English: Consistent with the monotherapy formulation, food had no effect on the pharmacokinetics of amlodipine in the
Croatian: Dosljedno formulaciji monoterapije, hrana nije imala učinak na farmakokinetiku amlodipina u tableti s fiksnom kombinacijom.
English: Increases in serum potassium have been observed with aliskiren in post-marketing experience and these may be exacerbated by concomitant use of other agents acting on the RAAS or by non-steroidal anti-inflammatory drugs (NSAIDs).
Croatian: Nakon stavljanja aliskirena u promet zabilježene su povišene vrijednosti kalija u serumu, što može biti dodatno potaknuto istodobnom uporabom drugih lijekova koji djeluju na RAAS ili nesteroidnih prouupalnih lijekova (NSAID-a).
English: Amlodipine causes blood vessels to dilate and relax, thus blood pressure
Croatian: Amlodipin uzrokuje širenje i opuštanje krvnih žila što snizuje krvni tlak.
English: - if you are between three and nine months pregnant - if you are taking any of the following medicines ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis) itraconazole (a medicine used to treat fungal infections) quinidine (a medicine used to correct heart rhythm) - if you have diabetes or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan - if the patient is less than 2 years of age - if you have very low blood pressure - if you are suffering from shock, including cardiogenic shock - if you have a narrowing of the aortic heart valve (aortic stenosis) - if you have heart failure after an acute heart attack If any of the above applies to you, do not take Rasilamlo and talk to your doctor.
Croatian: - ako ste imali bilo koji od sljedećih oblika angioedema (teškoće pri disanju ili gutanju, ili oticanje lica, ruku i nogu, očiju, usnica i/ili jezik): angioedem tijekom uzimanja aliskirena nasljedni angioedem angioedem nepoznatog uzroka - ako ste trudni između tri i devet mjeseci - ako uzimate bilo koji od sljedećih lijekova ciklosporin (lijek koji se koristi u presađivanju radi sprječavanja odbacivanja organa ili za neka druga stanja, npr. reumatoidni artritis ili atopijski dermatitis) itrakonazol (lijek koji se koristi u liječenju gljivičnih infekcija) kinidin (lijek koji se koristi za korekciju srčanog ritma) - ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se bilo kojom od skupina lijekova navedenih u nastavku, koje se koriste za liječenje visokog krvnog tlaka: inhibitorom angiotenzin konvertirajućeg enzima kao što je enalapril, lizinopril, ramipril ili blokatorom angiotenzin II receptora kao što je valsartan, telmisartan, irbesartan - ako je bolesnik mlađi od 2 godine - ako imate vrlo nizak krvni tlak - ako bolujete od šoka, uključujući kardiogeni šok - ako imate suženje aortnog srčanog zaliska (stenoza aorte) - ako imate zatajivanje srca nakon akutnog srčanog udara
English: Keep your appointments with the doctor even if
Croatian: Ne propuštajte kontrole kod svojeg liječnika čak i ako se osjećate dobro.
English: The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment; therefore, caution should be exercised when administering Rasilamlo to patients with
Croatian: Farmakokinetika amlodipina nije ispitivana u bolesnika s teškim oštećenjem jetrene funkcije, stoga je nužan oprez kod primjene lijeka Rasilamlo bolesnicima s oštećenjem jetre.
English: , skin decolouration hyperhidrosis
Croatian: , promjena boje kože hiperhidroza
English: Grounds recommending the variation to the terms of the Marketing Authorisation
Croatian: Razlozi za preporuku izmjena uvjeta odobrenja za stavljanje lijeka u promet
English: Component of a multipack comprising 20 packs, each containing 14 tablets.
Croatian: Sastavni dio višestrukog pakiranja koje sadrži 20 pakiranja, od kojih svako sadrži 14 tableta.
English: Other inducers of P-gp (St. John's wort) might decrease the bioavailability of aliskiren.
Croatian: Ostali induktori P-gp-a (Gospina trava) mogu smanjiti bioraspoloživost aliskirena.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često
English: , rhinitis
Croatian: , rinitis
English: Aliskiren is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m
Croatian: Aliskiren se ne preporučuje bolesnicima s teškim oštećenjem bubrežne funkcije (brzina glomerularne filtracije (GFR) <30 ml/min/1,73 m
English: The adverse reactions previously reported with one or both of the two active substances (aliskiren and amlodipine) of Rasilamlo and listed below may occur with
Croatian: Nuspojave već prije prijavljene u bolesnika s jednom ili obje od dvije djelatne tvari (aliskiren i amlodipin) lijeka Rasilamlo niže su navedene i mogu se pojaviti s uzimanjem lijeka Rasilamlo.
English: The pharmacokinetics of aliskiren were not significantly affected in patients with mild to severe liver disease.
Croatian: Na farmakokinetiku aliskirena nije značajno utjecala blaga do teška bolest jetre bolesnika.
English: A repeat-dose toxicity study was conducted in juvenile rats 8 days post-partum for 4 weeks with aliskiren dosing at 30, 100 or 300 mg/kg/day.
Croatian: Ispitivanje toksičnosti ponovljenih doza provedeno je u mladih štakora 8 dana nakon okota tijekom 4 tjedna uz doze aliskirena od 30, 100 ili 300 mg/kg/dan.