FrancophonIA/ELRC3.0 huggingface dataset:
English: However, since aliskiren has been shown to be a substrate for the organic anion-transporting polypeptide 1A2 (OATP1A2) (see section ‘Organic anion transporting polypeptide (OATP' below) 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 dio „Inhibitori polipeptidnih prijenosnika organskih aniona (OATP)“ u nastavku), postoji mogućnost da će aliskiren smanjiti izloženost torasemidu u plazmi ometanjem procesa apsorpcije.
English: Not all pack sizes or strengths may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakiranja ili jačina.
English: The mean weight of patients concomitantly treated with furosemide and 300 mg aliskiren (84.6 kg) was higher than the weight of patients treated with furosemide alone (83.4 kg).
Croatian: Srednja vrijednost tjelesne težine bolesnika istodobno liječenih furosemidom i aliskirenom 300 mg (84,6 kg) bila je viša od težine bolesnika liječenih samo furosemidom (83,4 kg).
English: 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.
Croatian: 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 dodanim osnovnoj terapiji.
English: Safety pharmacology studies with aliskiren did not reveal any adverse effects on central nervous, respiratory or cardiovascular function.
Croatian: Ispitivanje sigurnosne farmakologije aliskirena nisu otkrila nikakve nuspojave na središnju živčanu, respiratornu ili kardiovaskularnu funkciju.
English: The primary endpoint was a composite of cardiovascular and renal complications.
Croatian: Primarni ishod bio je kompozit kardiovaskularnih i bubrežnih komplikacija.
English: Rasilez HCT should be taken once a day, always with or always without food, preferably at the same time each day.
Croatian: Rasilez HCT treba uzimati jednom na dan, uvijek s hranom ili uvijek bez hrane, po mogućnosti svaki dan u isto vrijeme.
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 oboje, 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: − History of angioedema with aliskiren.
Croatian: − Anamneza angioedema s aliskirenom.
English: Rasilez HCT contains lactose.
Croatian: Rasilez HCT sadrži laktozu.
English: Upon withdrawal of the aliskiren treatment (aliskiren with or without hydrochlorothiazide add-on), the return of blood pressure towards baseline was gradual (3-4 weeks) with no evidence of the rebound effect.
Croatian: Nakon prekida liječenja aliskirenom (aliskiren sa ili bez dodanog hidroklorotiazida), povratak krvnog tlaka prema početnim vrijednostima je bio postepen (3-4 tjedna) bez znakova povratnog učinka.
English: • Patients with marked volume depletion or patients with salt depletion (e.g. those receiving high doses of diuretics) or
Croatian: • U bolesnika sa izrazito smanjenim volumenom tekućine ili bolesnika sa sniženom razinom natrija (npr. u onih koji primaju visoke doze diuretika) ili
English: Hydrochlorothiazide increases urine output, which also lowers blood pressure.
Croatian: Hidroklorotiazid povećava izlučivanje mokraće što također snižava krvni tlak.
English: Adverse reactions previously reported with one of the individual components may occur with Rasilez HCT even if not observed in clinical study.
Croatian: Nuspojave ranije prijavljene s nekom od pojedinačnih komponenti mogu se pojaviti s Rasilez HCTom čak i ako nisu bile opažene u kliničkim ispitivanjima.
English: Increases in cholesterol and triglyceridesh
Croatian: Povišenje kolesterola i trigliceridah
English: No clinically relevant differences in efficacy or safety results were observed in the subpopulation of elderly patients with a history of hypertension and chronic heart failure Class I-II compared to the overall study population.
Croatian: Nisu zapažene klinički relevantne razlike u rezultatima za djelotvornost ili sigurnost u subpopulaciji starijih bolesnika koji u anamnezi imaju hipertenziju i kronično srčano zatajivanje klase I-II u usporedbi s ukupnom populacijom u ispitivanju.
English: Rasilez HCT is contraindicated in children from birth to less than 2 years.
Croatian: Rasilez HCT kontraindiciran je u djece mlađe od 2 godine.
English: Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics.
Croatian: Hidroklorotiazid pripada skupini lijekova koji se zovu tiazidni diuretici.
English: Information on Rasilez HCT interactions
Croatian: Informacije o interakcijama Rasilez HCT-a
English: • Increased liver enzymes
Croatian: • povišeni jetreni enzimi
English: Where there is involvement of the tongue, glottis or larynx, adrenaline should be administered.
Croatian: Ako su zahvaćeni jezik, glotis ili grkljan, mora se primijeniti adrenalin.
English: It has been shown that there is a high-affinity receptor in the renal cortex as the primary binding site for the thiazide diuretic action and inhibition of NaCl transport in the distal convoluted tubule.
Croatian: Pokazalo se da receptor visokog afiniteta u kori bubrega kao primarno mjesto vezanja za djelovanje tiazidnih diuretika i inhibiciju transporta NaCl-a u distalnom zavijenom tubulu.
English: When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Croatian: Kada je klinički primjereno, može se razmotriti direktni prijelaz s monoterapije na fiksnu kombinaciju.
English: What Rasilez HCT is and what is it used for
Croatian: Što je Rasilez HCT i za što se koristi
English: The study showed no benefit of aliskiren when administered on top of standard therapy for acute heart failure and an increased risk of cardiovascular events in patients with diabetes mellitus.
Croatian: Ispitivanje nije pokazalo korist aliskirena kad se primjenjuje uz standardnu terapiju kod akutnog zatajenja srca, a pokazalo je povećani rizik od kardiovaskularnih događaja u pacijenata sa šećernom bolesti.
English: In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of iodine products.
Croatian: U slučaju dehidracije izazvane diuretikom postoji povećan rizik od akutnog zatajenja bubrega, posebno kod primjene visokih doza sredstava s jodom.
English: At steady state meals with low fat content reduce Cmax by 76% and AUC0tau by 67% in hypertensive patients.
Croatian: U stanju dinamičke ravnoteže obroci s niskim sadržajem masti smanjuju Cmax za 76% i AUC0-tau za 67% u hipertenzivnih bolesnika.
English: NSAIDs may reduce the anti-hypertensive effect of aliskiren.
Croatian: NSAIL-i mogu smanjiti antihipertenzivni učinak aliskirena.
English: In experimental animals, it has been shown that P-gp is a major determinant of aliskiren bioavailability.
Croatian: U eksperimentalnih se životinja pokazalo da je P-gp glavna odrednica bioraspoloživosti aliskirena.
English: The findings observed in the 2-week and 13-week toxicity studies were consistent with those observed previously with aliskiren or hydrochlorothiazide monotherapies.
Croatian: Nalazi opaženi u 2-tjednom i 13-tjednom ispitivanju toksičnosti bili su u skladu s onim prethodno opaženim za monoterapiju aliskirenom ili hidroklorotiazidom.
English: The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.
Croatian: Primarno liječenje je što je moguće brži prekid primjene hidroklorotiazida.
English: Steady-state-plasma concentrations are reached within 5-7 days following once-daily administration and steady-state levels are approximately 2-fold greater than with the initial dose.
Croatian: 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.
English: Rasilez HCT should not be used in children aged 2 to less than 6 years because of safety concerns due to potential aliskiren overexposure (see sections 4.3, 4.4, 5.2, and 5.3).
Croatian: Rasilez HCT se ne bi smio koristiti u djece u dobi od 2 godine do 6 godina zbog sigurnosnih rizika povezanih s potencijalnom prekomjernom izloženošću aliskirenu (vidjeti dijelove 4.3, 4.4, 5.2 i 5.3).
English: Following oral administration of Rasilez HCT tablets, the median peak plasma concentration time is within 1 hour for aliskiren and 2.5 hours for hydrochlorothiazide.
Croatian: Nakon peroralne primjene Rasilez HCT tableta, medijan vremena vršne koncentracije u plazmi je unutar 1 sata za aliskiren i 2,5 sati za hidroklorotiazid.
English: This medicine must not be used in babies from birth to less than 2 years of age.
Croatian: Ovaj se lijek ne smije primjenjivati u djece mlađe od 2 godine.
English: The safety and efficacy of aliskiren in children aged 6 to 17 years have not yet been established.
Croatian: Sigurnost i djelotvornost aliskirena u djece u dobi od 6 do 17 godina nisu još ustanovljene.
English: Risk factors for developing acute angle-closure glaucoma may include a history of sulphonamide or penicillin allergy.
Croatian: Faktori rizika za razvoj akutnoga glaukoma zatvorenog kuta mogu uključivati i alergiju na sulfonamide ili penicilin u anamnezi.
English: - if you are taking 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) or quinidine (a medicine used to correct heart rhythm).
Croatian: - ako uzimate 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) ili kinidin (lijek koji se koristi za korekciju srčanog ritma).
English: The greater blood pressure reductions with these combination doses were also significantly greater than the respective doses of aliskiren and hydrochlorothiazide when used alone.
Croatian: Najveća sniženja krvnog tlaka s ovim kombiniranim dozama bila su također značajno veća od sniženja s istim dozama aliskirena i hidroklorotiazida kada su primjenjivani zasebno.
English: − Hyponatraemia, hypercalcaemia, symptomatic hyperuricaemia and refractory hypokalaemia.
Croatian: − Hiponatrijemija, hiperkalcijemija, simptomatska hiperuricemija i refrakterna hipokalijemija.
English: • Nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes (signs of liver disorder) (frequency not known: frequency cannot be estimated from the available data).
Croatian: • Mučnina, gubitak apetita, tamno obojani urin ili žuto obojana koža i oči (znakovi poremećaja jetre) (učestalost nepoznata: učestalost se ne može procijeniti iz dostupnih podataka).
English: If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Croatian: Ako se terapija dvostrukom blokadom RASS-a smatra apsolutno nužnom, smije se samo provoditi pod nadzorom specijalista i uz učestalo pažljivo praćenje bubrežne funkcije, elektrolita i krvnog tlaka.
English: Treatment effects were similar in patients with diabetes and with renal insufficiency.
Croatian: Učinci liječenja bili su slični u bolesnika s dijabetesom i bubrežnom insuficijencijom.
English: Urticaria and other forms of rasha,h
Croatian: Urtikarija i druge vrste osipaa,h
English: - cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide.
Croatian: - citotoksični lijekovi (koriste se za liječenje raka), kao što su metotreksat ili ciklofosfamid.
English: Concomitant administration of thiazide diuretics with subtances that also have a blood pressure lowering effect (e.g. by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic hypotension.
Croatian: Istodobna primjena tiazidnih diuretika s lijekovima koji također imaju učinak na sniženje krvnog tlaka (npr. smanjenjem aktivnosti simpatičkoga središnjeg živčanog sustava ili direktnom vazodilatacijom) može dovesti do ortostatske hipotenzije.
English: Dose adjustment of the antidiabetic medicinal product may be necessary (see section 4.4).
Croatian: Možda će biti potrebna prilagodba doze antidijabetičkih lijekova (vidjeti dio 4.4).
English: Based on the pharmacological mechanism of action of hydrochlorothiazide, its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Croatian: Temeljeno na farmakološkom mehanizmu djelovanja hidroklorotiazida njegova primjena tijekom drugog i trećeg tromjesečja može ugroziti feto-placentnu perfuziju te može uzrokovati fetalne i neonatalne učinke poput žutice, poremećaja ravnoteže elektrolita i trombocitopenije.
English: Anaphylactic reactions and angioedema
Croatian: Anafilaktičke reakcije i angioedem
English: NSAIDs may also weaken the diuretic and antihypertensive activity of hydrochlorothiazide.
Croatian: NSAIL-i također mogu oslabiti diuretičku i antihipertenzivnu aktivnost hidroklorotiazida.
English: In a pooled analysis of efficacy and safety data from clinical study up to 12 months duration, there was no statistically significant difference in blood pressure reduction between aliskiren 300 mg and aliskiren 150 mg in elderly patients (≥ 65 years).
Croatian: U skupnoj analizi podataka o djelotvornosti i sigurnosti iz kliničkog ispitivanja trajanja do 12 mjeseci, nije bilo statistički značajne razlike u smanjenju krvnog tlaka između aliskirena 300 mg i aliskirena 150 mg u starijih bolesnika (≥ 65 godina).
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 temeljenom na ramiprilu u 9-mjesečnom ispitivanju neinferiornosti u kojem je sudjelovao 901 stariji bolesnik (≥65 godina) s esencijalnom sistoličkom hipertenzijom.
English: Single-packs containing 7, 14, 28, 30, 50 or 56 tablets.
Croatian: Pojedinačna pakiranja sadrže 7, 14, 28, 30, 50 ili 56 tableta.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not known
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Nepoznata
English: Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide.
Croatian: Metformin treba primjenjivati s oprezom zbog rizika od laktacidoze izazvane mogućim funkcionalnim zatajenjem bubrega povezanim s hidroklorotiazidom.
English: Diarrhoeac,a,h, decreased appetiteh, nausea and vomitinga,h
Croatian: Proljevc,a,h, smanjen apetith, mučnina i povraćanjea,h
English: The combination of aliskiren and hydrochlorothiazide neutralised the reactive increase of PRA caused by hydrochlorothiazide.
Croatian: Kombinacija aliskirena i hidroklorotiazida neutralizirala je reaktivno povećanje ARP uzrokovano hidroklorotiazidom.
English: Special caution is necessary in patients with a hypersensitivity predisposition.
Croatian: Potreban je poseban oprez u bolesnika sa sklonošću preosjetljivosti.
English: The antihypertensive effect of Rasilez HCT may be increased with the concomitant use of other antihypertensive agents.
Croatian: Antihipertenzivni učinak Rasilez HCT-a može se povećati istodobnom primjenom drugih antihipertenzivnih lijekova.
English: - medicines to increase blood pressure, such as noradrenaline or adrenaline.
Croatian: Rasilez HCT“ i „Upozorenja i mjere opreza“). - lijekove koji povisuju krvni tlak kao što su noradrenalin ili adrenalin.
English: Aliskiren plasma protein binding is moderate (47-51%) and independent of the concentration.
Croatian: Aliskiren se umjereno veže na proteine plazme (47-51%) i vezanje ne ovisi o koncentraciji.
English: Conversely, it is anticipated that prokinetic substances such as cisapride may decrease the bioavailability of thiazide-type diuretics.
Croatian: Nasuprot tome, predviđa se da prokinetički lijekovi kao što je cisaprid mogu smanjiti bioraspoloživost tiazidnih diuretika.
English: Caution should therefore be exercised when prescribing aliskiren to patients with a history of angioedema, and such patients should be closely monitored during treatment (see section 4.8) especially at the beginning of the treatment.
Croatian: Stoga je nužan oprez pri propisivanju aliskirena bolesnicima s angioedemom u anamnezi i te bolesnike je potrebno vrlo pozorno pratiti tijekom liječenja (vidjeti dio 4.8), a osobito na početku liječenja.
English: Psychiatric disorders Rare
Croatian: Psihijatrijski poremećaji Rijetko
English: If this combination proves essential, careful monitoring of serum lithium level is recommended during concomitant use.
Croatian: Ako je ova kombinacija neophodna, preporučuje se pažljivo praćenje razine litija u serumu tijekom istodobne primjene.
English: Single-packs containing 7, 14, 28, 30, 50, 56, 90 or 98 tablets.
Croatian: Pojedinačna pakiranja sadrže 7, 14, 28, 30, 50, 56, 90 ili 98 tableta.
English: However, in patients receiving aliskiren there was a significantly higher rate of hyperkalaemia, hypotension and kidney dysfunction when compared to the placebo group.
Croatian: Međutim, u bolesnika koji su primali aliskiren stopa hiperkalijemije, hipotenzije i disfunkcije bubrega bila je značajno viša u usporedbi s placebo skupinom.
English: Other medicines and Rasilez HCT
Croatian: Drugi lijekovi i Rasilez HCT
English: In controlled clinical study, angioedema and hypersensitivity reactions occurred rarely during treatment with aliskiren with rates comparable to treatment with placebo or comparators.
Croatian: U kontroliranim kliničkim ispitivanjima angioedem i reakcije preosjetljivosti javljali su se rijetko tijekom liječenja aliskirenom uz stope koje se mogu usporediti s liječenjem placebom ili komparatorima.
English: • Liver disorders which can occur together with yellow skin and eyes
Croatian: • poremećaj jetre koji može biti popraćen žutilom kože i očiju
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 oznake „Rok valjanosti” i „EXP”.
English: - if the level of calcium in your blood is too high.
Croatian: - ako je razina kalcija u Vašoj krvi previsoka.
English: The mode of action of thiazides is through inhibition of the Na+Cl- symporter by competing for the Cl- site, thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly by this diuretic action reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Croatian: Način djelovanja tiazida je kroz inhibiciju Na+Cl- simportera nadmetanjem za mjesto vezanja Cl-, čime se utječe na mehanizme reapsorpcije elektrolita: direktno povećanjem izlučivanja natrija i klorida u otprilike jednakoj mjeri, a indirektno smanjenjem volumena plazme putem ovog diuretskog djelovanja, s posljedičnim povećanjima aktivnosti renina u plazmi, izlučivanja aldosterona i gubitka kalija mokraćom te sniženja kalija u serumu.
English: Rasilez HCT combines two antihypertensive active substances to control blood pressure in patients with essential hypertension: Aliskiren belongs to the class of direct renin inhibitors and hydrochlorothiazide to the class of thiazide diuretics.
Croatian: Rasilez HCT je kombinacija dvaju antihipertenzivnih djelatnih tvari za kontrolu krvnog tlaka u bolesnika s esencijalnom hipertenzijom: aliskiren pripada skupini direktnih inhibitora renina, a hidroklorotiazid skupini tiazidnih diuretika.
English: Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected (see other P-gp references in section 4.5).
Croatian: Stoga se može očekivati povećana izloženost aliskirenu tijekom istodobne primjene s CYP3A4 inhibitorima koji također inhibiraju P-gp (vidjeti ostale reference za P-gp u dijelu 4.5).
English: PVC/polychlorotrifluoroethylene (PCTFE) - Alu blisters:
Croatian: PVC/poliklorotrifluoroetilen (PCTFE) - Al blisteri:
English: Fertility, pre-natal development and post-natal development were unaffected in rats at doses up to 250 mg/kg/day.
Croatian: prenatalni razvoj i postnatalni razvoj nije bilo utjecaja u štakora pri dozama do 250 mg/kg/dan.
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 unos aliskirena posredovan polipeptidnim prijenosnikom organskih aniona vrlo su rasprostanjeni u voću, povrću, i mnogim drugim biljnim proizvodima.
English: However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, corticosteroids, laxatives, adrenocorticotropic hormone (ACTH), amphotericin, carbenoxolone, penicillin G, salicylic acid derivatives).
Croatian: Međutim, može se očekivati da ovaj učinak hidroklorotiazida na kalij u serumu bude pojačan drugim lijekovima povezanim s gubitkom kalija i hipokalijemijom (npr. drugi diuretici koji pojačavaju izlučivanje kalija mokraćom, kortikosteroidi, laksativi, adrenokortikotropni hormon (ACTH), amfotericin, karbenoksolon, penicilin G, derivati salicilatne kiseline).
English: • Itchy rash (urticarial)
Croatian: • osip praćen svrbežom (urtikarija)
English: The study also evaluated the combination of aliskiren and enalapril.
Croatian: Ispitivanje je također procjenjivalo kombinaciju aliskirena i enalaprila.
English: In a post-authorisation observational study, the co-administration of aliskiren with ACEIs or ARBs has been associated with an increased risk of angioedema.
Croatian: U opservacijskom ispitivanju nakon davanja odobrenja, istodobna primjena aliskirena s ACEI-ima ili ARB-ima bila je povezana s povećanim rizikom od angioedema.
English: The volume or salt depletion should be corrected prior to administration of Rasilez HCT, or the treatment should start under close medical supervision.
Croatian: Volumen tekućine ili razina natrija se treba ispraviti prije primjene Rasilez HCT, ili liječenje treba započeti uz pomni nadzor liječnika.
English: Rasilez HCT has been shown to be effective as a once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Croatian: Rasilez HCT se pokazao učinkovitom antihipertenzivnom terapijom koja se uzima jedanput na dan u odraslih bolesnika, bez obzira na spol, dob, indeks tjelesne mase i etničku pripadnost.
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 prijenosnika.