FrancophonIA/ELRC3.0 huggingface dataset:
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of aliskiren.
Croatian: U kontroliranim kliničkim ispitivanjima su klinički značajne promjene standardnih laboratorijskih parametara bile manje često povezane s primjenom aliskirena.
English: There were no new toxicities or increased severity of the toxicities which were associated with either
Croatian: Nije bilo novih toksičnosti ili pogoršanja težine toksičnosti koja bi bila povezana s ijednom od komponenti.
English: Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with aliskiren alone.
Croatian: Prekomjerna hipotenzija je manje često (0,1%) viđena u bolesnika s nekompliciranom hipertenzijom liječenih samo aliskirenom.
English: The safety of amlodipine in human pregnancy has not been established.
Croatian: Sigurnost amlodipina u trudnoći u ljudi nije utvrđena.
English: Fainting and/or light-headedness linked to low blood pressure could occur at the beginning of treatment with Rasilamlo.
Croatian: Nesvjestica i/ili ošamućenost povezana sa sniženim krvnim tlakom može se javiti na početku liječenja Rasilamlom.
English: The time to reach peak plasma concentrations of amlodipine is similar in elderly and younger subjects.
Croatian: Vrijeme do postizanja vršnih koncentracija amlodipina u plazmi slična je u starijih i mlađih bolesnika.
English: The incidence of adverse events did not show any association with gender, age, body mass index, race or ethnicity.
Croatian: Incidencija štetnih događaja nije pokazala nikakvu vezu sa spolom, dobi, indeksom tjelesne mase, rasnom ili etničkom pripadnošću.
English: However, since aliskiren has been shown to be a substrate for the organic anion-transporting polypeptide 1A2 (OATP1A2) (see interaction with organic anion transporting polypeptide (OATP) inhibitors), there is a potential for aliskiren to reduce plasma torasemide exposure by an interference with the absorption process.
Croatian: Međutim, budući da se pokazalo da je aliskiren supstrat za polipeptidni prijenosnik organskih aniona 1A2 (OATP1A2) (vidjeti interakciju s inhibitorima polipeptidnih prijenosnika organskih aniona (OATP)), postoji mogućnost da će aliskiren smanjiti izloženost torasemidu u plazmi ometanjem procesa apsorpcije.
English: When clinically appropriate and in line with the above-mentioned posology, direct change from monotherapy to the fixed combination may be considered.
Croatian: Kada je klinički opravdano i u skladu s gore navedenim doziranjem, može se uzeti u obzir direktni prijelaz s monoterapije na fiksnu kombinaciju.
English: Renin inhibitors suppress the enzymatic activity of renin, and thereby block the formation of Angiotensin II, the major effector molecule of the renin-angiotensin-aldosterone system (RAAS).
Croatian: Inhibitori renina suzbijaju enzimatsku aktivnost renina i tako blokiraju stvaranje angiotenzina II, glavne efektorske molekule reninangiotenzin-aldosteron sustava (RAAS).
English: Oral co-administration of aliskiren and furosemide had no effect on the pharmacokinetics of aliskiren but reduced exposure to furosemide by 20-30% (the effect of aliskiren on furosemide administered intramuscularly or intravenously has not been investigated).
Croatian: Istodobna peroralna primjena aliskirena i furosemida nije imala učinak na farmakokinetiku aliskirena, ali je smanjila izloženost furosemidu za 20-30% (učinak aliskirena na furosemid primijenjenog intramuskularno ili intravenski nije bio ispitivan).
English: ***Including one case of “liver failure fulminant” reported in the post-marketing experience, for which a causal relationship with aliskiren cannot be excluded.
Croatian: *** Uključujući jedan slučaj ‘fulminantnog zatajenja jetre' prijavljen nakon stavljanja lijeka u promet, za kojeg se uzročno-posljedična veza s aliskirenom ne može isključiti.
English: If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea, the ability to react may
Croatian: Ako bolesnici koji uzimaju amlodipin pate od omaglice, glavobolje, umora ili mučnine, njihova sposobnost reagiranja mogla bi biti narušena.
English: One colonic adenoma and one caecal adenocarcinoma recorded in rats at the dose of 1,500 mg/kg/day were not statistically significant.
Croatian: Jedan adenom kolona i jedan adenokarcinom cekuma, koji su zabilježeni u štakora pri dozi od 1500 mg/kg/dan, nisu bili statistički značajni.
English: The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.
Croatian: Kontraktilni procesi srčanog mišića i glatkog mišića krvnih žila ovise o kretanju izvanstaničnih kalcijevih iona u ove stanice kroz specifične ionske kanale.
English: Whereas other medicinal products that inhibit the RAAS (ACEI and angiotensin II receptor blockers (ARB)) cause a compensatory rise in plasma renin activity (PRA), treatment with aliskiren decreases PRA in hypertensive patients by approximately 50 to 80%.
Croatian: Dok drugi lijekovi koji inhibiraju RAAS (ACE-I i blokatori receptora angiotenzina II (ARB)), uzrokuju kompenzatorni porast aktivnosti renina u plazmi (ARP), liječenje aliskirenom snižava ARP u hipertenzivnih bolesnika za približno 50 do 80%.
English: Lowering the blood pressure to a normal level reduces the risk
Croatian: Snižavanjem krvnoga tlaka na normalnu razinu smanjuje se rizik od razvoja tih poremećaja.
English: If symptomatic hypotension should occur with Rasilamlo, supportive treatment should be initiated.
Croatian: Ako se pojavi simptomatska hipotenzija s Rasilamlo, treba započeti potporno liječenje.
English: The effects of Rasilamlo on all cause and cardiovascular mortality and on cardiovascular morbidity and target organ damage are currently unknown.
Croatian: Učinci lijeka Rasilamlo na smrtnost od svih uzroka i kardiovaskularnu smrtnost te na kardiovaskularni pobol i oštećenje ciljanih organa trenutačno nisu poznati.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Rasilamlo in all subsets of the paediatric population in essential hypertension (see section 4.2 for
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Rasilamlo u svim podskupinama pedijatrijske populacije s esencijalnom hipertenzijom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Adverse reaction observed with Rasilamlo;
Croatian: Nuspojave opažene s Rasilamlom;
English: The change in plasma levels of aliskiren in the presence of ketoconazole or verapamil is expected to be within the range that would be achieved if the dose of aliskiren were doubled; aliskiren doses of up to 600 mg, or twice the highest recommended therapeutic dose, have been found to be well tolerated in controlled clinical trials.
Croatian: Očekuje se da bi promjena u razinama aliskirena u plazmi u prisutnosti ketokonazola ili verapamila bila unutar raspona koji bi se postigao kada bi se doza aliskirena udvostručila; u kontroliranim kliničkim ispitivanjima je otkriveno da se doze aliskirena do 600 mg, ili dvostruko više od najviše preporučene terapijske doze, dobro podnose.
English: Limited safety data are available from a pharmacokinetic study of aliskiren treatment in 39 hypertensive children aged 6 to less than 18 years (see sections 4.8 and 5.2).
Croatian: Ograničeni podaci o sigurnosti primjene dostupni su iz farmakokinetičkog ispitivanja liječenja aliskirenom u 39 hipertenzivne djece u dobi od 6 do nenavršenih 18 godina (vidjeti dijelove 4.8 i 5.2).
English: Aliskiren is an orally active, non-peptide, potent and selective direct inhibitor of human renin.
Croatian: Aliskiren Aliskiren je peroralno aktivan, nepeptidni, potentni i selektivni direktni inhibitor renina u ljudi.
English: The effect on blood pressure is seen within 1 week and maximum effect is reached at around 4 weeks.
Croatian: Učinak na krvni tlak vidljiv je unutar 1 tjedna, dok se maksimalni učinak postiže nakon otprilike 4 tjedna.
English: The efficacy and safety of aliskiren-based therapy were compared to ramipril-based therapy in a 9month non-inferiority study in 901 elderly patients (≥65 years) with essential systolic hypertension.
Croatian: Djelotvornost i sigurnost terapije temeljene na aliskirenu uspoređivana je s terapijom temeljenoj na ramiprilu u 9-mjesečnom ispitivanju neinferiornosti u kojem je sudjelovao 901 stariji bolesnik (≥65 godina) s esencijalnom sistoličkom hipertenzijom.
English: The half life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established.
Croatian: Poluvijek amlodipina je produljeno i vrijednosti AUC-a su više u bolesnika s oštećenom funkcijom jetre; a preporuke za doziranje nisu utvrđene.
English: , hepatic enzymes increased (mostly consistent with cholestasis)
Croatian: , povišeni jetreni enzimi (uglavnom upućuju na kolestazu)
English: Therefore, the potential exists for interactions between OATP inhibitors and aliskiren when administered concomitantly (see interaction with fruit juice).
Croatian: Stoga postoji potencijal za interakcije između inhibitora OATP-a i aliskirena kada se primjenjuju istodobno (vidjeti interakciju s voćnim sokom).
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: • palpitations (awareness of your heart beat)
Croatian: • palpitacije (svjesnost otkucaja srca).
English: Gender, weight and ethnicity have no clinically relevant influence on aliskiren pharmacokinetics.
Croatian: Spol, tjelesna težina i etnička pripadnost nemaju klinički značajan utjecaj na farmakokinetiku aliskirena.
English: There is no data available regarding the effect of CYP3A4 inducers on amlodipine.
Croatian: Nema dostupnih podataka o učinku induktora CYP3A4 na amlodipin.
English: These were statistically significant versus placebo and aliskiren for all doses.
Croatian: Te su razlike bile statistički značajne naspram placeba i aliskirena u svim dozama.
English: The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
Croatian: P-gp-a će vjerojatno ovisiti o stupnju inhibicije ovog transportera.
English: - 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.
Croatian: - Istodobna primjena višekratnih doza od 10 mg amlodipina s 80 mg simvastatina rezultirala je povećanjem izloženosti simvastatinu za 77% u usporedbi sa samim simvastatinom.
English: 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.
Croatian: 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.
English: Rasilamlo must not be used in children from birth to less than 2 years of age.
Croatian: Rasilamlo se ne smije primjenjivati u djece od rođenja do nenevršene 2 godine.
English: 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).
Croatian: 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
English: Fertility, pre-natal development and post-natal development were unaffected in rats at doses up to 250 mg/kg/day.
Croatian: Na plodnost, prenatalni razvoj i postnatalni razvoj nije bilo utjecaja u štakora pri dozama do 250 mg/kg/dan.
English: The safety and efficacy of amlodipine in hypertensive crisis have not been established.
Croatian: Sigurnost i djelotvornost amlodipina u bolesnika u hipertenzivnoj krizi nisu utvrđene.
English: Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndrome a, toxic epidermal necrolysis (TEN)
Croatian: Teške kožne nuspojave (SCAR) uključujući Stevens Johnsonov sindrom a, toksičnu epidermalnu nekrolizu (TEN)
English: Rasilamlo contains two active substances, called aliskiren and amlodipine.
Croatian: Rasilamlo sadrži dvije djelatne tvari koje se zovu aliskiren i amlodipin.
English: Safety data for amlodipine are well established both clinically and non-clinically.
Croatian: Amlodipin Podaci o sigurnosti amlodipina dobro su utvrđeni, klinički i neklinički.
English: • increased level of creatinine in the blood
Croatian: • povišena razina kreatinina u krvi
English: Amlodipine has demonstrated beneficial clinical effects in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Croatian: Amlodipin je pokazao korisne kliničke učinke u bolesnika s kroničnom stabilnom anginom pektoris, vazospastičnom anginom i angiografski dokumentiranom bolešću koronarnih arterija.
English: The concomitant use of CYP3A4 inducers (e.g. rifampicin, hypericum perforatum) may give a lower plasma concentration of amlodipine.
Croatian: Istodobna primjena CYP3A4 induktora (npr. rifampicin, Hypericum perforatum) mogla bi imati za posljedicu nižu koncentraciju amlodipina u plazmi.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: Preclinical safety studies have demonstrated that the combination of aliskiren and amlodipine was well tolerated in rats.
Croatian: Pretklinička ispitivanja sigurnosti pokazala su da se kombinacija aliskirena i amlodipina dobro podnosila u štakora.
English: Exposure to aliskiren increased more than in proportion to the increase in dose.
Croatian: Izloženost aliskirenu povećala se više nego razmjerno povećanju doze.
English: The usual dose of Rasilamlo is one tablet a day.
Croatian: Uobičajena doza lijeka Rasilamlo je jedna tableta na dan.
English: 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.
Croatian: 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.
English: There were no new adverse reactions which occurred specifically with Rasilamlo in addition to those known to be associated with the individual monotherapies.
Croatian: Nije bilo pojave novih nuspojava, specifičnih za Rasilamlo, osim onih za koje je već poznato da su povezane s monoterapijama pojedinačnim komponentama.
English: PVC/polychlorotrifluoroethylene (PCTFE) - Alu blisters:
Croatian: PVC/poliklorotrifloroetilen (PCTFE) - Al blisteri:
English: 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.
Croatian: 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.
English: The results showed that developmental changes of aliskiren exposure correlated with the ontogeny of transporter maturation in jejunum, liver, kidney and brain.
Croatian: Rezultati su pokazali da su promjene izloženosti aliskirenu tijekom rezvoja u korelaciji s ontogenezom sazrijevanja prijenosnika u jejunumu, jetri, bubrezima i mozgu.
English: After oral administration of therapeutic doses of amlodipine alone, peak plasma concentrations of amlodipine are reached in 6-12 hours.
Croatian: Nakon peroralne primjene terapijskih doza samo amlodipina, vršne koncentracije amlodipina u plazmi postižu se 6-12 sati.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza Rok valjanosti/EXP.
English: 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.
Croatian: Učinci amlodipina na druge lijekove - Učinci amlodipina na sniženje krvnog tlaka pojačavaju učinke drugih antihipertenzivnih lijekova .
English: • severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin,
Croatian: • teške kožne reakcije (toksična epidermalna nekroliza i/ili reakcije oralne sluznice - crvena koža,
English: 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).
Croatian: 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).
English: , dysgeusia
Croatian: , disgeuzija
English: However, compounds potentially inhibiting organic anion transporting polypeptide-mediated uptake of aliskiren are widely present in fruits, vegetables, and many other plant products.
Croatian: Međutim, spojevi koji mogu inhibirati pohranu aliskirena posredovanu polipeptidnim prijenosnicima organskih aniona vrlo su rasprostanjeni u voću, povrću, i mnogim drugim biljnim proizvodima.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Aliskiren induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide.
Croatian: Aliskiren je izazvao dodatni učinak na snižavanje krvnoga tlaka, kada je dodan hidroklorotiazidu.
English: 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).
Croatian: 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).
English: Amlodipine clearance tends to be decreased with resulting increases in AUC and elimination half-life in elderly patients.
Croatian: Klirens amlodipina obično je smanjen uz posljedična povećanja AUC-a i poluvijeka eliminacije u starijih bolesnika.
English: Not all pack sizes or strengths may be available in your country.
Croatian: Na tržištu u Vašoj zemlji se ne moraju nalaziti sve veličine pakiranja ili jačina.
English: Visual disturbance (including diplopia)
Croatian: Poremećaji vida (uključujući diplopiju)
English: There is no experience of overdose with Rasilamlo.
Croatian: Ne postoji iskustvo s predoziranjem lijekom Rasilamlo.
English: Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
Croatian: Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200