FrancophonIA/ELRC3.0 huggingface dataset:
English: The occurrence of an event in a single patient is defined as uncommon in view of the number of patients treated.
Slovenian: Glede na število zdravljenih bolnikov je pojav določenega neželenega pojava že pri enem samem bolniku opredeljen kot občasen.
English: NAME OF THE MEDICINAL PRODUCT Replagal 1 mg/ml concentrate for solution for infusion.
Slovenian: IME ZDRAVILA Replagal 1 mg/ml koncentrat za raztopino za infundiranje
English: Caution should be exercised when prescribing to breast-feeding women.
Slovenian: Pri predpisovanju zdravila doječim ženskam je potrebna previdnost.
English: Dilute the total volume of Replagal concentrate required in 100 ml 9 mg/ml sodium chloride solution for infusion (0.9%w/v).
Slovenian: Vso potrebno količino koncentrata zdravila Replagal razredčite s 100 ml raztopine natrijevega klorida za intravensko infundiranje 9 mg/ml (0,9-% m/v).
English: Your medicine is available in vials containing 3.5 mg/ 3.5 ml of agalsidase alfa.
Slovenian: Zdravilo je na voljo v vialah po 3,5 mg/3,5 ml agalzidaze alfa.
English: Pack sizes of 1, 4 or 10 vials.
Slovenian: 4 ali 10 vial.
English: The pharmacokinetic properties were essentially unaffected by the dose of the enzyme.
Slovenian: Odmerek encima ni bistveno vplival na farmakokinetične lastnosti.
English: The most common infusion related reactions were mild and include rigors, pyrexia, flushing, headache, nausea, dyspnea, tremor and pruritus.
Slovenian: Najpogostejše so bile blage reakcije, povezane z infundiranjem, ki so vključevale mrzlico, pireksijo, pordevanje, glavobol, navzeo, dispnejo, tremor in pruritus.
English: How to store Replagal
Slovenian: Kako se daje zdravilo Replagal
English: Infusion related reactions reported in the postmarketing setting (also see section 4.4) may include cardiac events such as cardiac arrhythmias (atrial fibrillation, ventricular extrasystoles, tachyarrhythmia), myocardial ischemia, and heart failure in patients with Fabry disease involving the heart structures.
Slovenian: Reakcije, povezane z infundiranjem, o katerih so poročali v obdobju trženja (glejte tudi poglavje 4.4), lahko vključujejo srčne dogodke, kot so srčne aritmije (atrijska fibrilacija, prekatne ekstrasistole,
English: Each vial of 3.5 ml of concentrate contains 3.5 mg of agalsidase alfa.
Slovenian: Ena viala s 3,5 ml koncentrata vsebuje 3,5 mg agalzidaze alfa.
English: (LVH) threshold throughout the 6.5 years of treatment.
Slovenian: ostala stabilna na ravni pod pragom hipertrofije levega prekata v celotnem 6,5-letnem obdobju zdravljenja.
English: Talk to your doctor or pharmacist before Replagal is used.
Slovenian: Pred začetkom uporabe zdravila Replagal se posvetujte z zdravnikom ali farmacevtom.
English: Fertility No effects on male fertility were seen in reproductive studies in male rats.
Slovenian: V študijah o vplivu na sposobnost razmnoževanja, opravljenih na podganjih samcih, niso opazili vpliva na plodnost samcev.
English: • Dilute the total volume of Replagal concentrate required in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion.
Slovenian: • Vso potrebno količino koncentrata zdravila Replagal razredčite s 100 ml raztopine natrijevega klorida za intravensko infundiranje 9 mg/ml (0,9-% m/v).
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Replagal 1 mg/ml sterile concentrate agalsidase alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Replagal 1 mg/ml sterilni koncentrat agalzidaza alfa intravenska uporaba
English: Infusion of Replagal at home may be considered for patients who are tolerating their infusions well.
Slovenian: Pri bolnikih, ki dobro prenašajo infundiranje, se lahko pretehta možnost infundiranja zdravila Replagal doma.
English: If severe hypersensitivity or anaphylactic reactions occur, the administration of Replagal should be discontinued immediately and appropriate treatment initiated.
Slovenian: Če se pojavijo hude preobčutljivostne ali anafilaktične reakcije, takoj prekinite dajanje zdravila Replagal in uvedite ustrezno zdravljenje.
English: The presence of extensive renal damage may limit the renal response to enzyme replacement therapy, possibly due to underlying irreversible pathological changes.
Slovenian: Obstoječa obsežna poškodba ledvic lahko zmanjša odziv ledvic na encimsko nadomestno zdravljenje,
English: After 6 months of therapy Replagal significantly reduced pain in patients when compared to placebo (dummy) treated patients.
Slovenian: Zdravilo Replagal je po 6 mesecih zdravljenja pomembno zmanjšalo bolečino pri bolnikih v primerjavi s tistimi, ki so dobivali placebo (zdravilo brez zdravilne učinkovine).
English: Very common: may affect more than 1 in 10 people - general pain or discomfort.
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: In this study, only one patient had LVH at baseline and remained stable over time.
Slovenian: Ob izhodišču te študije je samo en bolnik imel hipertrofijo levega prekata, ki se s časom ni spremenila.
English: Do not infuse Replagal concomitantly in the same intravenous line with other agents.
Slovenian: Skozi isti intravenski kanal ne smete infundirati hkrati zdravila Replagal in drugih zdravil.
English: These effects include chills, headache, nausea, fever, facial flushing (redness), tiredness, low blood pressure, unsteadiness, sweating, difficulty breathing, itching, shaking, cough and vomiting.
Slovenian: utrujenost, nizek krvni tlak, nestabilnost, znojenje, težave pri dihanju, srbenje, tresenje, kašelj in bruhanje.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 1 mg of agalsidase alfa*.
Slovenian: 1 ml koncentrata za raztopino za infundiranje vsebuje 1 mg agalzidaze alfa*.
English: Replagal 1 mg/ml concentrate for solution for infusion Agalsidase alfa
Slovenian: Replagal 1 mg/ml koncentrat za raztopino za infundiranje agalzidaza alfa
English: After 6 months of therapy there was a significant reduction in pain in the Replagal treated patients compared with placebo (p=0.021), as measured by the Brief Pain Inventory (a validated pain measurement scale).
Slovenian: Kot so izmerili s kratko lestvico za oceno bolečine (Brief Pain Inventory, validirana lestvica za merjenje bolečine), se je po 6 mesecih zdravljenja pri bolnikih, zdravljenih z zdravilom Replagal, pomembno zmanjšala bolečina v primerjavi s tistimi, ki so prejemali placebo (p = 0,021).
English: Replagal is a concentrate for solution for infusion.
Slovenian: Zdravilo Replagal je koncentrat za raztopino za infundiranje.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Slovenian: PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: - The active substance is agalsidase alfa.
Slovenian: - Zdravilna učinkovina je agalzidaza alfa.
English: In male paediatric patients ≥ 7 years of age, heart rate variability was abnormal at baseline and improved after 6 months of Replagal therapy in 15 boys and the improvement was sustained through 6.5 years of Replagal 0.2 mg/kg therapy in an open-label long-term extension study in 9 boys.
Slovenian: Pri moških pediatričnih bolnikih, starih ≥ 7 let, je bila variabilnost srčnega utripa na izhodišču abnormalna in se je pri 15 dečkih izboljšala po 6 mesecih zdravljenja z zdravilom Replagal.
English: • The solution should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: • Raztopino pred uporabo preglejte, da ugotovite prisotnost delcev ali obarvanje.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje Bistra in brezbarvna raztopina.
English: Gastrointestinal disorders nausea diarrhoea , vomiting, abdominal pain/discomfort
Slovenian: Bolezni prebavil navzea driska, bruhanje, trebušne bolečine/nelagodje
English: Three of 8 (37.5%) paediatric patients <7 years of age experienced at least one infusion related reaction over a mean observation time of 4.2 years.
Slovenian: Trije od 8 (37,5 %) pediatričnih bolnikov, mlajših od 7
English: What Replagal is and what it is used for The active substance in Replagal is agalsidase alfa (1mg/ml).
Slovenian: Zdravilna učinkovina v zdravilu Replagal je agalzidaza alfa (1 mg/ml).
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products - Enzymes.ATC code: A16AB03.
Slovenian: Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove - encimi.
English: Respiratory, thoracic and mediastinal disorders cough, hoarseness, throat tightness, dyspnoea, nasopharyngitis, pharyngitis, throat secretion increased, rhinorrhoea oxygen saturation decreased
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, hripavost, stiskanje v žrelu, dispneja, nazofaringitis,
English: Skin and subcutaneous tissue disorders acne, erythema, pruritus, rash, livedo reticularis angioneurotic oedema,
Slovenian: livedo reticularis angionevrotičn i edem, urtikarija hiperhidroza
English: In paediatric patients <7 yrs of age, 0/7 male patients tested positive for IgG anti-agalsidase alfa antibodies.
Slovenian: moških bolnikov pozitivnih za protitelesa IgG proti agalzidazi alfa.
English: The most common symptoms have been rigors, headache, nausea, pyrexia, flushing and fatigue.
Slovenian: Najpogostejši simptomi so okorelost, glavobol, navzeja, zvišana telesna temperatura, pordelost obraza in utrujenost.
English: This will usually be in your arm.
Slovenian: Po redčenju boste prejeli zdravilo Replagal v veno, običajno na roki.
English: Tell your doctor if you experience any side effects whilst having the infusion.
Slovenian: Če imate med infuzijo kakršne koli neželene učinke, o tem obvestite zdravnika.
English: - The other ingredients are: Sodium phosphate monobasic, monohydrate Polysorbate 20
Slovenian: - Druge sestavine zdravila so: natrijev dihidrogenfosfat monohidrat, polisorbat 20, natrijev klorid, natrijev hidroksid, voda za injekcije.
English: (p=0.030).
Slovenian: Oznaka ATC: A16AB03.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sodium phosphate monobasic, monohydrate Polysorbate 20
Slovenian: 6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat monohidrat, polisorbat 20, natrijev klorid, natrijev hidroksid, voda za injekcije.
English: Nervous system disorders headache dizziness, dysgeusia, neuropathic pain, tremor, hypersomnia, hypoesthesia, paraesthesia parosmia
Slovenian: Bolezni živčevja glavobol omotica, disgevzija,
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 3.5 mg of agalsidase alfa
Slovenian: Ena viala vsebuje 3,5 mg agalzidaze alfa.
English: Agalsidase alfa is unlikely to be a candidate for drug-drug interactions.
Slovenian: Verjetnost, da bi agalzidaza alfa medsebojno delovala z drugimi zdravili, je majhna.
English: Reduction in their hypernormal eGFRs was observed within 6 months of initiating Replagal therapy.
Slovenian: 6 mesecih po začetku zdravljenja z zdravilom Replagal.
English: The following adverse reactions have been identified for agalsidase alfa:
Slovenian: Pri agalzidazi alfa so ugotovili naslednje neželene reakcije: Preglednica 1
English: Anaphylactic reaction, hypersensitivity
Slovenian: hipersomnija, hipestezija, parestezije parozmija
English: Idiosyncratic infusion related reactions
Slovenian: Bolezni imunskega sistema anafilaktična reakcija,
English: Musculoskeletal, connective tissue and bone disorders musculoskeletal discomfort, myalgia, back pain, limb pain, peripheral swelling, arthralgia, joint swelling sensation of heaviness
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva nelagodje v mišicah in sklepih, mialgija,
English: The solution should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: Raztopino pred uporabo preglejte, da ugotovite prisotnost delcev ali obarvanje.
English: Sodium hydroxide
Slovenian: rinoreja zmanjšana nasičenost s kisikom
English: The safety and efficacy of Entresto in children and adolescents aged below 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Entresto pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
English: Entresto may be administered with or without food (see section 5.2).
Slovenian: Entresto je mogoče jemati skupaj s hrano ali brez nje (glejte poglavje 5.2).
English: What Entresto is and what it is used for
Slovenian: Kaj je zdravilo Entresto in za kaj ga uporabljamo
English: Do not take Entresto:
Slovenian: Ne jemljite zdravila Entresto:
English: • 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.
Slovenian: • Prenehajte jemati zdravilo Entresto in takoj poiščite zdravniško pomoč, če opazite otekanje obraza, ustnic, jezika in/ali grla oziroma žrela, kar lahko oteži dihanje ali požiranje.
English: • if you have ever had angioedema (see “Do not take Entresto” and section 4 “Possible side effects”).
Slovenian: • če ste že kadarkoli imeli angioedem (glejte pod naslovom "Ne jemljite zdravila Entresto" in poglavje 4 "Možni neželeni učinki").
English: Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Entresto affects you.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Preden začnete voziti, uporabljati orodje, upravljati stroje ali izvajati druge dejavnosti, ki zahtevajo zbranost, morate zagotovo vedeti, kako zdravilo Entresto deluje na vas.
English: Other medicines and Entresto Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Entresto Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: 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.
Slovenian: Bolniki, ki so jih randomizirali v skupino z zdravilom Entresto, so zdravilo prejemali z medianim trajanjem izpostavljenosti zdravilu 24 mesecev, pri tem pa je 3.271 bolnikov prejemalo zdravilo več kot eno leto.
English: 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.
Slovenian: Če pride do navedenega, vam zdravnik lahko zniža odmerek katerega od drugih zdravil, ki jih jemljete, začasno zniža odmerek zdravila Entresto ali pa vam dokončno ukine zdravljenje z zdravilom Entresto.
English: 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).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Entresto za eno ali več podskupin pediatrične populacije za zdravljenje srčnega popuščanja (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Use of Entresto may be associated with decreased renal function.
Slovenian: Uporaba zdravila Entresto je lahko povezana z zmanjšanim delovanjem ledvic.
English: The recommended starting dose of Entresto is one tablet of 49 mg/51 mg twice daily, except in the situations described below.
Slovenian: Priporočeni začetni odmerek zdravila Entresto je ena tableta 49 mg/51 mg dvakrat na dan, razen v spodaj opisanih primerih.
English: Entresto does not induce or inhibit CYP450 enzymes.
Slovenian: Zdravilo Entresto niti ne inducira niti ne zavira encimov CYP450.
English: When initiating therapy or during dose titration with Entresto, blood pressure should be monitored routinely.
Slovenian: Ob začetku zdravljenja oziroma med titriranjem odmerka zdravila Entresto je treba rutinsko spremljati krvni tlak.
English: 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.
Slovenian: Če pride do angioedema, je treba zdravljenje z zdravilom Entresto takoj prekiniti in poskrbeti za ustrezno zdravljenje in spremljanje bolnika, dokler znaki in simptomi angioedema niso v celoti in trajno odpravljeni.
English: KM estimate of cumulative failure rate (%)
Slovenian: KaplanMeierjevaocena kumulativne stopnje neuspeha(%)
English: 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.
Slovenian: Zdravnik vam bo načeloma svetoval, da prenehate jemati to zdravilo, prede zanosite ali takoj, ko ugotovite, da ste noseči.
English: 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.
Slovenian: Pomanjkanje natrija in/ali hipovolemijo je treba odpraviti pred začetkom zdravljenja z zdravilom Entresto, vendar je pri izvajanju takšnih korektivnih ukrepov potreben skrben razmislek zaradi tveganja za volumsko preobremenitev.
English: It is not known whether Entresto is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Entresto izloča v materino mleko.
English: If you have accidentally taken too many Entresto tablets, or if someone else has taken your tablets, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Entresto, kot bi smeli Če ste pomotoma vzeli preveč tablet zdravila Entresto ali če je vaše tablete zaužil kdo drug, takoj obvestite zdravnika.
English: 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.
Slovenian: Skupno je 76 % bolnikov doseglo in vztrajalo pri prejemanju ciljnega odmerka 200 mg zdravila Entresto dvakrat na dan brez prekinitve odmerjanja ali zniževanja odmerka v obdobju 12 tednov.
English: There was no drug-drug interaction between Entresto and intravenously administered nitroglycerin with regard to blood pressure reduction.
Slovenian: Med zdravilom Entresto in intravensko apliciranim nitroglicerinom ni bilo nobenih interakcij, povezanih z znižanjem krvnega tlaka.
English: What you need to know before you take Entresto
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Entresto
English: There are no available data on the effect of Entresto on human fertility.
Slovenian: O vplivu zdravila Entresto na plodnost pri ljudeh ni na voljo nobenih podatkov.
English: Entresto is not recommended for mothers who are breastfeeding.
Slovenian: Uporaba zdravila Entresto ni priporočljiva za doječe matere.
English: 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.
Slovenian: Sočasna uporaba zdravila Entresto in zaviralcev ACE je kontraindicirana, saj sočasno zaviranje neprilizina (NEP) in ACE lahko poveča tveganje za angioedem.
English: 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.
Slovenian: Odločiti se je treba med prenehanjem dojenja ali prenehanjem zdravljenja z zdravilom Entresto v času dojenja, pri čemer je treba pretehtati, kako pomembno je zdravilo Entresto za mater.
English: If you think you may be allergic to any component of this medicine, talk to your doctor before taking Entresto.
Slovenian: Če mislite, da bi lahko bili alergični na katero od sestavin tega zdravila, se posvetujte z zdravnikom, preden začnete jemati zdravilo Entresto.
English: If you forget to take Entresto
Slovenian: Če ste pozabili vzeti zdravilo Entresto
English: The components of Entresto, sacubitril and valsartan, were excreted in the milk of lactating rats (see section 5.3).
Slovenian: Sestavini zdravila Entresto - sakubitril in valsartan - sta se izločali v mleko doječih podgan (glejte poglavje 5.3).
English: There is no experience in patients with end-stage renal disease and use of Entresto is not recommended.
Slovenian: Pri bolnikih s končno ledvično odpovedjo ni na voljo nobenih izkušenj in uporaba zdravila Entresto pri teh bolnikih ni priporočena.
English: 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.
Slovenian: In vitro študije metabolizma kažejo, da je možnost za s CYP 450 povezane interakcije majhna, saj se zdravilo Entresto le v majhni meri presnavlja z encimi CYP450.
English: Stopping your treatment with Entresto may cause your condition to get worse.
Slovenian: Če prekinete zdravljenje z zdravilom Entresto, se vam lahko bolezen poslabša.
English: If you stop taking Entresto
Slovenian: Če ste prenehali jemati zdravilo Entresto
English: 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.
Slovenian: Bolniki so prejemali začetni odmerek 50 mg zdravila Entresto dvakrat na dan , nato pa so jim odmerek postopno zviševali najprej na 100 mg dvakrat na dan, nato pa na ciljni odmerek 200 mg dvakrat na dan v okviru bodisi 3-tedenskega ali 6-tedenskega režima.
English: Co-administration of Entresto with metformin reduced both Cmax and AUC of metformin by 23%.
Slovenian: Sočasna uporaba zdravila Entresto in metformina je zmanjšala vrednosti tako Cmax kot AUC metformina za 23 %.
English: Use of Entresto may be associated with an increased risk of hyperkalaemia, although hypokalaemia may also occur (see section 4.8).
Slovenian: Uporaba zdravila Entresto je lahko povezana s povečanjem tveganja za hiperkaliemijo, lahko pa pride tudi do hipokaliemije (glejte poglavje 4.8).
English: 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).
Slovenian: V prvem trimesečju nosečnosti uporaba zdravila Entresto ni priporočena, v drugem in tretjem trimesečju pa je kontraindicirana (glejte poglavje 4.3).
English: 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.
Slovenian: Sočasna uporaba zdravila Entresto in furosemida ni vplivala na farmakokinetiko zdravila Entresto, je pa znižala Cmax furosemida za 50 % in zmanjšala njegovo AUC za 28 %.
English: The pharmacokinetics of Entresto (sacubitril, LBQ657 and valsartan) are similar between male and female subjects.
Slovenian: Farmakokinetika zdravila Entresto (sakubitrila, substance LBQ657 in valsartana) je pri moških in ženskah približno enaka.
English: 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)].
Slovenian: Po tem obdobju so jih vključili v obdobje randomiziranega dvojno slepega zdravljenja, v katerem so prejemali bodisi zdravilo Entresto 200 mg ali enalapril 10 mg dvakrat na dan [Entresto (n=4.209); enalapril (n=4.233)].
English: Entresto improved survival with a significant reduction in all-cause mortality of 2.8% (Entresto, 17%, enalapril, 19.8%).
Slovenian: Zdravilo Entresto je izboljšalo preživetje s statistično značilnim zmanjšanjem umrljivosti iz kateregakoli vzroka za 2,8 % (Entresto 17 %, enalapril 19,8 %).