natgillin/translations-raw huggingface dataset:
If this happens, your doctor may reduce the dose of any other medicine you are taking, temporarily reduce your Entresto dose, or stop your Entresto treatment completely.
Ako se to dogodi, Vaš liječnik može smanjiti dozu bilo kojeg drugog lijeka kojeg uzimate, privremeno smanjiti Vašu dozu Entresta ili u potpunosti prekinuti liječenje Entrestom.
A decision should be made whether to abstain from breast-feeding or to discontinue Entresto while breast-feeding, taking into account the importance of Entresto to the mother.
Potrebno je odlučiti treba li se suzdržati od dojenja ili prekinuti primjenu Entresta tijekom dojenja, uzimajući u obzir važnost Entresta za majku.
Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Entresto.
Liječnik će Vas u pravilu savjetovati da prekinete uzimati ovaj lijek prije trudnoće ili čim saznate da ste trudni te će Vas savjetovati da uzmete drugi lijek umjesto Entresta.
Do not use any Entresto pack that is damaged or shows signs of tampering.
Nemojte koristiti niti jedno pakiranje Entresta koje je oštećeno ili na kojem su vidljivi znakovi otvaranja.
As they may be at higher risk for angioedema, caution is recommended if Entresto is used in these patients.
Budući da oni mogu biti izloženi povećanom riziku od angioedema, preporučuje se oprez ako se Entresto koristi u tih bolesnika.
Your doctor may check the amount of potassium in your blood at regular intervals during Entresto treatment.
Vaš liječnik Vam može provjeriti količinu kalija u krvi u redovitim intervalima tijekom liječenja Entrestom.
• Stop taking Entresto and seek immediate medical attention if you notice any swelling of the face, lips, tongue and/or throat, which may cause difficulties in breathing or swallowing.
• Prestanite uzimati Entresto i odmah zatražite liječničku pozornost ako primijetite bilo što od navedenoga u nastavku: oticanje lica, usana, jezika i/ili grla, što može uzrokovati poteškoće s disanjem ili gutanjem.
• if you have ever had angioedema (see “Do not take Entresto” and section 4 “Possible side effects”).
• ako ste ikada imali angioedem (vidjeti „Nemojte uzimati Entresto“ i dio 4 „Moguće nuspojave“).
Entresto is used to treat a type of long-term heart failure in adults.
Entresto se koristi za liječenje jedne vrste dugotrajnog zatajenja srca u odraslih.
What Entresto is and what it is used for What you need to know before you take Entresto How to take Entresto
Što je Entresto i za što se koristi Što morate znati prije nego počnete uzimati Entresto Kako uzimati Entresto
There are no available data on the effect of Entresto on human fertility.
Nema dostupnih podataka o učinku Entresta na ljudsku plodnost.
What you need to know before you take Entresto
Što morate znati prije nego počnete uzimati Entresto
Entresto does not induce or inhibit CYP450 enzymes.
Entresto ne inducira niti inhibira CYP450 enzime.
When initiating therapy or during dose titration with Entresto, blood pressure should be monitored routinely.
Kada se započinje terapija ili tijekom titracije doze Entresta, potrebno je rutinski pratiti krvni tlak.
Entresto has a minor influence on the ability to drive and use machines.
Entresto malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Interactions between Entresto and lithium have not been investigated.
Interakcije između Entresta i litija nisu bile ispitivane.
Patients randomised to the Entresto group received treatment for a median duration of exposure of 24 months; 3,271 patients were treated for more than one year.
Bolesnici randomizirani u Entresto skupinu primali su terapiju uz medijan trajanja izloženosti od 24 mjeseca; 3271 bolesnik bio je liječen više od jedne godine.
Entresto may be administered with or without food (see section 5.2).
Entresto se može primjenjivati uz obrok ili bez njega (vidjeti dio 5.2).
Caution should be exercised when initiating Entresto in patients with NYHA functional classification IV due to limited clinical experience in this population.
Potreban je oprez kada se započinje terapija Entrestom u bolesnika sa stupnjem IV prema NYHA funkcionalnoj klasifikaciji zbog ograničenog kliničkog iskustva u toj populaciji.
If you think you may be allergic to any component of this medicine, talk to your doctor before taking Entresto.
Ako mislite da biste mogli biti alergični na bilo koji sastojak ovog lijeka, obratite se svom liječniku prije nego uzmete Entresto.
Non-clinical data (including studies with sacubitril and valsartan components and/or Entresto) reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and fertility.
Neklinički podaci (uključujući ispitivanja s komponentama sakubitrilom i valsartanom i/ili Entrestom) ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala i plodnosti.
Stopping your treatment with Entresto may cause your condition to get worse.
Ako prekinete liječenje Entrestom, stanje bi Vam se moglo pogoršati.
Sodium and/or volume depletion should be corrected before starting treatment with Entresto, however, such corrective action must be carefully weighed against the risk of volume overload.
Snižena razina natrija i/ili smanjeni volumen tekućine treba korigirati prije početka liječenja Entrestom, međutim, takve korektivne mjere potrebno je pažljivo odvagnuti u odnosu na rizik od preopterećenja volumenom.
Entresto improved survival with a significant reduction in all-cause mortality of 2.8% (Entresto, 17%, enalapril, 19.8%).
Entresto je poboljšao preživljenje uz značajno smanjenje smrtnosti od svih uzroka od 2,8% (Entresto, 17%, enalapril, 19,8%).
The use of Entresto is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Primjena Entresta se ne preporučuje tijekom prvog tromjesečja trudnoće te je kontraindiciran tijekom drugog i trećeg tromjesečja trudnoće (vidjeti dio 4.3).
Do not take Entresto with ACE inhibitors.
Ne uzimajte Entresto s ACE inhibitorima.
Other medicines and Entresto Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Hypotension is the most likely symptom of overdose due to the blood pressure lowering effects of Entresto.
Hipotenzija je najvjerojatniji simptom predoziranja zbog učinaka Entresta na smanjenje krvnog tlaka.
N-nitrosodimethylamine (NDMA)
N-nitrozodimetilamin (NDMA)
If angioedema occurs, Entresto should be immediately discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred.
Ako se pojavi angioedem, primjenu Entresta treba odmah prekinuti te pružiti odgovarajuću terapiju i praćenje dok se znakovi i simptomi u potpunosti i trajno ne povuku.
A similar effect on the heart rate may occur when Entresto is co-administered with sublingual, oral or transdermal nitrates.
Sličan učinak na srčanu frekvenciju može se javiti kada se Entresto istodobno primjenjuje sa sublingualnim, oralnim ili transdermalnim nitratima.
The average daily dose of furosemide was unchanged from baseline until the end of the PARADIGM-HF study in patients treated with Entresto.
Prosječna dnevna doza furosemida bila je nepromijenjena u odnosu na početnu do kraja ispitivanja PARADIGM-HF u bolesnika liječenih Entrestom.
The components of Entresto, sacubitril and valsartan, were excreted in the milk of lactating rats (see section 5.3).
Sastojci Entresta, sakubitril i valsartan, izlučivali su se u mlijeko štakora u laktaciji (vidjeti dio 5.3).
The European Medicines Agency has deferred the obligation to submit the results of studies with Entresto in one or more subsets of the paediatric population in the treatment of heart failure (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Entresto u jednoj ili više podskupina pedijatrijske populacije u liječenju zatajenja srca (vidjeti dio 4.2. za informacije o pedijatrijskoj primjeni).
No. at risk Entresto
Br. izloženih riziku Entresto
The recommended starting dose of Entresto is one tablet of 49 mg/51 mg twice daily, except in the situations described below.
Preporučena početna doza Entresta je jedna tableta od 49 mg/51 mg dvaput na dan, osim u niže opisanim situacijama.
There is no experience in patients with end-stage renal disease and use of Entresto is not recommended.
Ne postoji iskustvo u bolesnika sa završnim stadijem bolesti bubrega te se primjena Entresta ne preporučuje.
If you stop taking Entresto
Ako prestanete uzimati Entresto
Therefore, caution should be exercised when sildenafil or another PDE5 inhibitor is initiated in patients treated with Entresto.
Stoga je potreban oprez kada se započinje liječenje sildenafilom ili drugim PDE5 inhibitorom u bolesnika liječenih Entrestom.
There was no drug-drug interaction between Entresto and intravenously administered nitroglycerin with regard to blood pressure reduction.
Nije bilo interakcije između Entresta i intravenski primijenjenog nitroglicerina s obzirom na smanjenje krvnog tlaka.
Entresto can be administered with or without food.
Entresto se može primjenjivati uz hranu ili bez nje.
You can take Entresto with or without food.
Možete uzimati Entresto uz hranu ili bez nje.
Talk to your doctor, pharmacist or nurse before taking Entresto
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Entresto
Entresto may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis.
Entresto može povećati razine ureje u krvi i kreatinina u serumu u bolesnika s obostranom ili jednostranom stenozom bubrežne arterije.
Overall, 76% of patients achieved and maintained the target dose of Entresto 200 mg twice daily without any dose interruption or down-titration over 12 weeks.
Ukupno je 76% bolesnika postiglo i održalo ciljnu dozu Entresta 200 mg dvaput na dan bez ikakvog prekida u doziranju ili postupno sniženje doze tijekom 12 tjedana.
Therefore, monitoring of renal function is recommended when initiating or modifying treatment in patients on Entresto who are taking NSAIDs concomitantly (see section 4.4).
Stoga se preporučuje praćenje bubrežne funkcije kada se započinje ili modificira liječenje u bolesnika na Entrestu koji istodobno uzimaju NSAID-e (vidjeti dio 4.4).
Caution should be exercised when co-administering Entresto with statins.
Potreban je oprez kada se Entresto primjenjuje istodobno sa statinima.
Patients taking Entresto can develop low blood pressure (dizziness, light-headedness), a high level of potassium in the blood (which would be detected when your doctor performed a blood test) or decreased kidney function.
Bolesnici koji uzimaju Entresto mogu razviti niski krvni tlak (omaglicu, ošamućenost), visoku razinu kalija u krvi (koja bi se otkrila prilikom provođenja krvnih pretraga) ili smanjenu funkciju bubrega.
There are no data from the use of Entresto in pregnant women.
Ne postoje podaci o primjeni Entresta u trudnica.
In vitro metabolism studies indicate that potential for CYP 450-based drug interactions is low since there is limited metabolism of Entresto via CYP450 enzymes.
In vitro ispitivanja metabolizma upućuju na to da je potencijal za interakcije s lijekovima na temelju CYP 450 nizak budući da je metabolizam Entresta putem CYP450 enzima ograničen.
Co-administration of Entresto and furosemide had no effect on the pharmacokinetics of Entresto but reduced Cmax and AUC of furosemide by 50% and 28%, respectively.
Istodobna primjena Entresta i furosemida nije imala učinka na farmakokinetiku Entresta, ali smanjila je Cmax furosemida za 50% i AUC za 28%.
Co-administration of Entresto with metformin reduced both Cmax and AUC of metformin by 23%.
Istodobna primjena Entresta s metforminom smanjila je i Cmax i AUC metformina za 23%.
The valsartan contained within Entresto is more bioavailable than the valsartan in other marketed tablet formulations; 26 mg, 51 mg, and 103 mg of valsartan in Entresto is equivalent to 40 mg, 80 mg and 160 mg of valsartan in other marketed tablet formulations, respectively.
Valsartan sadržan u Entrestu više je bioraspoloživ nego valsartan u drugim formulacijama tableta koje se nalaze na tržištu; 26 mg, 51 mg i 103 mg valsartana u Entrestu ekvivalentno je 40 mg, 80 mg, odnosno 160 mg valsartana u drugim formulacijama tableta na tržištu.
The valsartan contained within Entresto is more bioavailable than the valsartan in other marketed tablet formulations (see section 5.2).
Valsartan sadržan u Entrestu više je bioraspoloživ nego valsartan u drugim formulacijama tableta koje se nalaze na tržištu (vidjeti dio 5.2).
A higher incidence of angioedema was observed in Black patients treated with Entresto (2.4%) and enalapril (0.5%) (see section 4.4).
Viša incidencija angioedema bila je uočena u bolesnika crne rase liječenih Entrestom (2,4%) i enalaprilom (0,5%) (vidjeti dio 4.4).
Angioedema was reported in patients treated with Entresto (see description of selected adverse reactions).
Angioedem je prijavljen u bolesnika liječenih Entrestom (vidjeti opis odabranih nuspojava).
If any of the above applies to you, do not take Entresto and talk to your doctor.
Ako se bilo što od navedenoga odnosi na Vas, nemojte uzeti Entresto i obratite se svom liječniku.
Following oral administration, Entresto dissociates into valsartan and the prodrug sacubitril.
Nakon oralne primjene, Entresto se disocira u valsartan i prolijek sakubitril.
The concomitant use of Entresto with ACE inhibitors is contraindicated, as the concomitant inhibition of neprilysin (NEP) and ACE may increase the risk of angioedema.
Istodobna primjena Entresta s ACE inhibitorima je kontraindicirana, jer istodobna inhibicija neprilizina (NEP) i ACE-a može povećati rizik od angioedema.
Addition of a single dose of sildenafil to Entresto at steady state in patients with hypertension was associated with a significantly greater blood pressure reduction compared to administration of Entresto alone.
Dodavanje jednokratne doze sildenafila Entrestu u stanju dinamičke ravnoteže u bolesnika s hipertenzijom bilo je povezano sa značajno većim smanjenjem krvnog tlaka u usporedbi s primjenom samog Entresta.
• if you are being treated with an angiotensin receptor blocker (ARB) or aliskiren (see “Do not take Entresto”).
• ako se liječite blokatorom angiotenzinskog receptora (ARB) ili aliskirenom (vidjeti „Nemojte uzimati Entresto“).
• if you have diabetes or impaired kidney function and you are being treated with a blood pressure lowering medicine containing aliskiren (see “Other medicines and Entresto”).
• ako imate šećernu bolest ili oštećenu bubrežnu funkciju i pri tome se liječite lijekom za snižavanje krvnog tlaka koji sadrži aliskiren (vidjeti „Drugi lijekovi i Entresto“).
They were then randomised to the double-blind period of the study, during which they received either Entresto 200 mg or enalapril 10 mg twice daily [Entresto (n=4,209); enalapril (n=4,233)].
Zatim su bili randomizirani u dvostruko slijepo razdoblje ispitivanja tijekom kojeg su primali ili Entresto 200 mg ili enalapril 10 mg dvaput na dan [Entresto (n=4209); enalapril (n=4233)].
• The combination of Entresto with an ACE inhibitor is contraindicated due to the increased risk of angioedema (see section 4.3).
• Kombinacija Entresta s ACE inhibitorom kontraindicirana je zbog povećanog rizika od angioedema (vidjeti dio 4.3).
If patients experience tolerability issues (systolic blood pressure [SBP] ≤95 mmHg, symptomatic hypotension, hyperkalaemia, renal dysfunction), adjustment of concomitant medicinal products, temporary down-titration or discontinuation of Entresto is recommended (see section 4.4).
Ako bolesnici osjete probleme s podnošljivosti (sistolički krvni tlak [SKT] ≤95 mmHg, simptomatsku hipotenziju, hiperkalijemiju, disfunkciju bubrega) preporučuje se prilagođavanje istodobno primijenjenih lijekova, privremeno postupno sniženje doze ili prekid primjene Entresta (vidjeti dio 4.4).
The pharmacokinetics of Entresto (sacubitril, LBQ657 and valsartan) are similar between male and female subjects.
Farmakokinetika Entresta (sakubitrila, LBQ657 i valsartana) slična je između muških i ženskih ispitanika.
Cases of symptomatic hypotension have been reported in patients treated with Entresto during clinical studies (see section 4.8), especially in patients ≥65 years old, patients with renal disease and patients with low SBP (<112 mmHg).
Slučajevi simptomatske hipotenzije zabilježeni su u bolesnika liječenih Entrestom tijekom kliničkih ispitivanja (vidjeti dio 4.8), osobito u bolesnika u dobi od ≥65 godina, bolesnika s bolesti bubrega i bolesnika s niskim SKT-om (<112 mmHg).
Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1).
Entresto je indiciran u odraslih bolesnika za liječenje simptomatskog kroničnog zatajenja srca sa smanjenom ejekcijskom frakcijom (vidjeti dio 5.1).
In elderly patients, volume-depleted patients (including those on diuretic therapy), or patients with compromised renal function, concomitant use of Entresto and NSAIDs may lead to an increased risk of worsening of renal function.
U starijih bolesnika, bolesnika sa smanjenim volumenom tekućine (uključujući one na terapiji diureticima), ili bolesnika s oštećenom bubrežnom funkcijom, istodobna primjena Entresta i NSAID-a može dovesti do povećanog rizika od pogoršanja bubrežne funkcije.
If a dose is missed, the patient should take the next dose at the scheduled time.
Ako bolesnik propusti dozu Entresta, sljedeću dozu treba uzeti prema rasporedu.
The adverse embryofoetal effects of Entresto are attributed to the angiotensin receptor antagonist activity (see section 4.6).
Štetni embriofetalni učinci Entresta pripisuju se antagonističkoj aktivnosti prema angiotenzinskom receptoru (vidjeti dio 4.6).
The pharmacodynamic effects of Entresto were evaluated after single and multiple dose administrations in healthy subjects and in patients with heart failure, and are consistent with simultaneous neprilysin inhibition and RAAS blockade.
Farmakodinamički učinci Entresta ocjenjivani su nakon primjene jednokratne i višekratnih doza u zdravih ispitanika i u bolesnika sa zatajenjem srca, te su u skladu s istodobnom inhibicijom neprilizina i blokadom RAAS-a.
Administration of Entresto 194 mg sacubitril/206 mg valsartan once daily for two weeks to healthy subjects was associated with an increase in CSF Aβ1-38 compared to placebo; there were no changes in concentrations of CSF Aβ1-40 and 1-42.
Primjena Entresta 194 mg sakubitrila/206 mg valsartana jedanput na dan tijekom dva tjedna u zdravih ispitanika bila je povezana s povećanjem Aβ1-38 u cerebrospinalnoj tekućini u usporedbi s placebom; nije bilo promjena u koncentracijama Aβ1-40 i 1-42 u cerebrospinalnoj tekućini.
Use of Entresto may be associated with an increased risk of hyperkalaemia, although hypokalaemia may also occur (see section 4.8).
Primjena Entresta može biti povezana s povećanim rizikom od hiperkalijemije, iako može doći i do hipokalijemije (vidjeti dio 4.8).
How to store Entresto
Kako čuvati Entresto
If you forget to take Entresto
Ako ste zaboravili uzeti Entresto
Patients received a starting dose of Entresto of 50 mg twice daily and were up-titrated to 100 mg twice daily, then to the target dose of 200 mg twice daily, with either a 3-week or a 6-week regimen.
Bolesnici su primali početnu dozu Entresta od 50 mg dvaput na dan te bili titrirani na 100 mg dvaput na dan, zatim na ciljnu dozu od 200 mg dvaput na dan, s režimom doziranja od 3 tjedna ili od 6 tjedana.
Entresto was superior to enalapril, reducing the risk of cardiovascular death or heart failure hospitalisations to 21.8% compared to 26.5% for enalapril treated patients.
Entresto je bio superioran u odnosu na enalapril, smanjujući rizik od kardiovaskularne smrti ili hospitalizacija zbog zatajenja srca na 21,8% u usporedbi s 26,5% kod bolesnika liječenih enalaprilom.
In the PARADIGM-HF study, subjects were previously treated with ACE inhibitors and/or ARBs and also had to successfully complete sequential enalapril and Entresto run-in periods (median drug exposure of 15 and 29 days, respectively) prior to the randomised double-blind period.
U ispitivanju PARADIGM-HF ispitanici su bili prethodno liječeni ACE inhibitorima i/ili ARB-ovima te su morali uspješno dovršiti sekvencijalna ulazna razdoblja s enalaprilom i Entrestom (medijan trajanja izloženosti lijeku od 15 odnosno 29 dana) prije randomiziranog dvostruko slijepog razdoblja.
It is not known whether Entresto is excreted in human milk.
Nije poznato izlučuje li se Entresto u majčino mlijeko.
Additionally, in a toxicology study in cynomolgus monkeys treated with Entresto at 146 mg sacubitril/154 mg valsartan/kg/day for 39 weeks, there was no evidence for the presence of amyloid plaques in the brain.
Uz to, u toksikološkom ispitivanju u cynomolgus majmuna liječenih Entrestom u dozi od 146 mg sakubitrila/154 mg valsartana/kg/dan tijekom 39 tjedana, nije bilo dokaza prisutnosti amiloidnih plakova u mozgu.
Entresto is a medicine known as an angiotensin receptor neprilysin inhibitor.
Entresto je lijek poznat kao inhibitor angiotenzinskog receptora i neprilizina.
The safety of Entresto in patients with chronic heart failure was evaluated in the pivotal phase 3 study PARADIGM-HF, which compared patients treated twice daily with Entresto 97 mg/103 mg (n=4,203) or enalapril 10 mg (n=4,229).
Sigurnost Entresta u bolesnika s kroničnim zatajenjem srca ocjenjivala se u ključnom ispitivanju faze 3 PARADIGM-HF, u kojem su uspoređivani bolesnici liječeni dvaput na dan Entrestom 97 mg/103 mg (n=4203) ili enalaprilom 10 mg (n=4229).
No clinically meaningful drug-drug interaction was observed when Entresto was co-administered with digoxin, warfarin, hydrochlorothiazide, amlodipine, omeprazole, carvedilol or a combination of levonorgestrel/ethinyl estradiol.
Nije bila uočena klinički značajna interakcija između lijekova kada se Entresto primjenjivao istodobno s digoksinom, varfarinom, hidroklorotiazidom, amlodipinom, omeprazolom, karvedilolom ili kombinacijom levonorgestrel/etinil estradiol.
Discontinuation of therapy due to an adverse reaction in the double-blind period of the PARADIGM-HF study occurred in 450 Entresto-treated patients (10.7%) and 516 enalapril-treated patients (12.2%).
Do prekida terapije zbog nuspojave u dvostruko slijepom razdoblju ispitivanja PARADIGM-HF došlo je u 450 bolesnika liječenih Entrestom (10,7%) i 516 bolesnika liječenih enalaprilom (12,2%).
• other medicines used to treat heart failure or lower blood pressure, such as angiotensin receptor blockers or aliskiren (see “Do not take Entresto”).
• ostali lijekovi koji se koriste za liječenje zatajenje srca ili za sniženje krvnog tlaka, kao što je blokator angiotenzinskog receptora ili aliskiren (vidjeti „Nemojte uzimati Entresto“).
PARADIGM-HF was a multinational, randomised, double-blind study of 8,442 patients comparing Entresto to enalapril, both given to adult patients with chronic heart failure, NYHA class II-IV and reduced ejection fraction (left ventricular ejection fraction [LVEF] ≤40%, amended later to ≤35%) in addition to other heart failure therapy.
PARADIGM-HF je bilo multinacionalno, randomizirano, dvostruko slijepo ispitivanje u 8442 bolesnika u kojem se uspoređivao Entresto s enalaprilom, gdje su oba lijeka primjenjivana u odraslih bolesnika s kroničnim zatajenjem srca, NYHA klase II-IV i smanjenom ejekcijskom frakcijom (ejekcijska frakcija lijevog ventrikula [LVEF] ≤40%, kasnije izmijenjeno u ≤35%) uz druge terapije za zatajenje srca.