natgillin/translations-raw huggingface dataset:
• other medicines used to treat heart failure or lower blood pressure, such as angiotensin receptor blockers or aliskiren (see “Do not take Neparvis”).
• 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 Neparvis“).
Film-coated tablet (tablet)
Filmom obložena tableta (tableta)
Angioedema was reported in patients treated with Neparvis (see description of selected adverse reactions).
Angioedem je prijavljen u bolesnika liječenih Neparvisom (vidjeti opis odabranih nuspojava).
• painkillers of the type called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 (Cox-2) inhibitors.
• vrsta analgetika koji se zovu nesteroidni protuupalni lijekovi (NSAID) ili selektivni inhibitori ciklooksigenaze-2 (Cox-2).
A single dose of Neparvis 583 mg sacubitril/617 mg valsartan and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) were studied in healthy volunteers and were well tolerated.
Jednokratna doza Neparvisa od 583 mg sakubitrila/617 mg valsartana i višestruke doze od 437 mg sakubitrila/463 mg valsartana (14 dana) bile su ispitivane u zdravih dobrovoljaca i dobro su se podnosile.
In the enalapril group, 75% of patients remained on the target dose of 10 mg twice daily at the end of the study (mean daily dose of 18.9 mg).
U skupini koja je primala enalapril, 75% bolesnika ostalo je na ciljnoj dozi od 10 mg dvaput na dan na kraju ispitivanja (srednja dnevna doza od 18,9 mg).
The oral absolute bioavailability of sacubitril and valsartan is estimated to be more than 60% and 23%, respectively.
Procjenjuje se da je apsolutna bioraspoloživost nakon peroralne primjene sakubitrila i valsartana više od 60%, odnosno 23%.
These include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines and heparin.
Oni uključuju dodatke kalija, nadomjestke soli koji sadrže kalij, lijekove koji štede kalij i heparin.
Angioedema*
Angioedem*
Tell your doctor if you are breastfeeding or about to start breastfeeding.
Obavijestite svog liječnika ako dojite ili ćete početi dojiti.
Approximate tablet dimensions 13.1 mm x 5.2 mm.
Približne dimenzije tablete 13,1 mm x 5,2 mm.
• weakness
• slabost
At steady state, sacubitril and valsartan do not accumulate significantly, while LBQ657 accumulates 1.6-fold.
U stanju dinamičke ravnoteže, sakubitril i valsartan ne akumuliraju se značajno, dok se LBQ657 akumulira 1,6 puta.
Neparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1).
Neparvis je indiciran u odraslih bolesnika za liječenje simptomatskog kroničnog zatajenja srca sa smanjenom ejekcijskom frakcijom (vidjeti dio 5.1).
Neparvis is a medicine known as an angiotensin receptor neprilysin inhibitor.
Neparvis je lijek poznat kao inhibitor angiotenzinskog receptora i neprilizina.
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava Anemija
PARADIGM-HF was a multinational, randomised, double-blind study of 8,442 patients comparing Neparvis 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 Neparvis 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.
Sudden death accounted for 45% of cardiovascular deaths and was reduced by 20% in Neparvis-treated patients compared to enalapril-treated patients (HR 0.80, p=0.0082).
Iznenadna smrt predstavljala je 45% kardiovaskularnih smrti i bila je smanjena za 20% u bolesnika liječenih Neparvisom u usporedbi s bolesnicima liječenim enalaprilom (HR 0,80, p=0,0082).
Co-administration of nitroglycerin and Neparvis was associated with a treatment difference of 5 bpm in heart rate compared to the administration of nitroglycerine alone.
Istodobna primjena nitroglicerina i Neparvisa bila je povezana s terapijskom razlikom od 5 otkucaja u srčanoj frekvenciji u usporedbi s primjenom samog nitroglicerina.
The pharmacokinetics of Neparvis (sacubitril, LBQ657 and valsartan) are similar between male and female subjects.
Farmakokinetika Neparvisa (sakubitrila, LBQ657 i valsartana) slična je između muških i ženskih ispitanika.
If hypotension occurs, temporary down-titration or discontinuation of Neparvis is recommended (see section 4.2).
Ako dođe do hipotenzije, preporučuje se privremeno postupno sniženje doze ili prekid primjene Neparvisa (vidjeti dio 4.2).
If patients experience clinically significant hyperkalaemia adjustment of concomitant medicinal products, or temporary down-titration or discontinuation is recommended.
Ako se u bolesnika javi klinički značajna hiperkalijemija, preporučuje se prilagođavanje lijekova koji se istodobno primjenjuju, ili privremeno postupno sniženje doze ili trajni prekid primjene.
Discontinuation of therapy due to an adverse reaction in the double-blind period of the PARADIGM-HF study occurred in 450 Neparvis-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 Neparvisom (10,7%) i 516 bolesnika liječenih enalaprilom (12,2%).
TITRATION was a 12-week safety and tolerability study in 538 patients with chronic heart failure (NYHA class II-IV) and systolic dysfunction (left ventricular ejection fraction ≤35%) naïve to ACE inhibitor or ARB therapy or on varying doses of ACE inhibitors or ARBs prior to study entry.
TITRATION je bilo 12-tjedno ispitivanje sigurnosti i podnošljivosti u 538 bolesnika s kroničnim zatajenjem srca (NYHA klasa II-IV) i sistoličkom disfunkcijom (ejekcijska frakcija lijevog ventrikula ≤35%) koji nisu nikada primali terapiju ACE inhibitorom ili ARB-om ili na različitim dozama ACE inhibitora ili ARB-a prije ulaska u ispitivanje.
A starting dose of 24 mg/26 mg twice daily should be considered for patients with SBP ≥100 to 110 mmHg.
Početna doza od 24 mg/26 mg dvaput na dan se treba razmotriti u bolesnika sa SKT-om ≥100 do 110 mmHg.
During the Neparvis run-in period, 10.4% of patients permanently discontinued, 5.9% because of an adverse reaction, most commonly renal dysfunction (1.8%), hypotension (1.7%) and hyperkalemia (1.3%).
Tijekom ulaznog razdoblja s Neparvisom, 10,4% bolesnika trajno je prekinulo sudjelovanje, 5,9% zbog nuspojave, najčešće bubrežne disfunkcije (1,8%), hipotenzije (1,7%) i hiperkalijemije (1,3%).
Concomitant use of potassium-sparing diuretics (triamterene, amiloride), mineralocorticoid antagonists (e.g. spironolactone, eplerenone), potassium supplements, salt substitutes containing potassium or other agents (such as heparin) may lead to increases in serum potassium, and to increases in serum creatinine.
Istodobna primjena diuretika koji štede kalij (triamteren, amilorid), mineralokortikoidnih antagonista (npr. spironolakton, eplerenon), nadomjestaka kalija, zamjena za sol koje sadrže kalij ili drugih tvari (kao što je heparin) može dovesti do povišenja kalija u serumu, te do povišenja serumskog kreatinina.
Black patients have an increased susceptibility to develop angioedema (see section 4.8).
Bolesnici crne rase imaju veću osjetljivost na razvoj angioedema (vidjeti dio 4.8).
• Neparvis contains valsartan, and therefore should not be co-administered with another ARB containing product (see sections 4.2 and 4.5).
• Neparvis sadrži valsartan i stoga se ne smije primjenjivati zajedno s drugim lijekom koji sadrži ARB (vidjeti dijelove 4.2 i 4.5).
Pre- and postnatal development studies in rats conducted with sacubitril at high doses up to 750 mg/kg/day (2.2-fold the MRHD on the basis of AUC) and valsartan at doses up to 600 mg/kg/day (0.86-fold the MRHD on the basis of AUC) indicate that treatment with Neparvis during organogenesis, gestation and lactation may affect pup development and survival.
Ispitivanja pred- i postnatalnog razvoja u štakora provedena sa sakubitrilom u visokim dozama do 750 mg/kg/dan (2,2 puta MRHD-a na temelju AUC-a) i valsartanom u dozama do 600 mg/kg/dan (0,86 puta MRHD-a na temelju AUC-a) ukazuju na to da liječenje Neparvisom tijekom organogeneze, gestacije i laktacije može utjecati na razvoj i preživljenje mladunčadi.
If a dose is missed, the patient should take the next dose at the scheduled time.
Ako bolesnik propusti dozu Neparvisa, sljedeću dozu treba uzeti prema rasporedu.
Time to first occurrence of CV death or heart failure hospitalisations in PARADIGM-HF
Vrijeme do prve pojave KV smrti ili hospitalizacije zbog zatajenja srca u PARADIGM-HF-u
In PARADIGM-HF study, Neparvis was administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin II receptor blocker (ARB) (see section 5.1).
U PARADIGM-HF ispitivanju, Neparvis je primijenjen zajedno s drugim terapijama za liječenje zatajenja srca, umjesto ACE inhibitora ili drugog blokatora receptora angiotenzina II (ARB) (vidjeti dio 5.1).
Patients were required to discontinue their existing ACE inhibitor or ARB therapy and enter a sequential single-blind run-in period during which they received treatment with enalapril 10 mg twice daily, followed by single-blind treatment with Neparvis 100 mg twice daily, increasing to 200 mg twice daily (see section 4.8 for discontinuations during this period).
Bolesnici su trebali prekinuti postojeću terapiju ACE inhibitorom ili ARB-om te ući u uzastopno jednostruko slijepo ulazno razdoblje tijekom kojeg su primali terapiju enalaprilom 10 mg dvaput na dan, nakon čega je slijedilo jednostruko slijepo liječenje Neparvisom 100 mg dvaput na dan, povećano na 200 mg dvaput na dan (vidjeti dio 4.8 za prekide tijekom tog razdoblja).
In vitro metabolism studies indicate that potential for CYP 450-based drug interactions is low since there is limited metabolism of Neparvis 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
Exposure to ARBs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Poznato je da izloženost terapiji ARB-ovima tijekom drugog i trećeg tromjesečja u ljudi izaziva fetotoksičnost (smanjenu funkciju bubrega, oligohidramnion, retardaciju okoštavanja lubanje) i neonatalnu toksičnost (zatajenje bubrega, hipotenziju, hiperkalijemiju).
Neparvis should be used with caution in these patients and the recommended starting dose is 24 mg/26 mg twice daily (see sections 4.4 and 5.2).
Neparvis treba primjenjivati s oprezom u tih bolesnika te se preporučuje početna doza od 24 mg/26 mg dvaput na dan (vidjeti dijelove 4.4 i 5.2).
NPs exert their effects by activating membrane-bound guanylyl cyclase-coupled receptors, resulting in increased concentrations of the second messenger cyclic guanosine monophosphate (cGMP), which could result in vasodilation, natriuresis and diuresis, increased glomerular filtration rate and renal blood flow, inhibition of renin and aldosterone release, reduction of sympathetic activity, and anti-hypertrophic and anti-fibrotic effects.
NP-i ostvaruju svoje učinke aktiviranjem za membranu vezanih receptora sparenih s guanilil ciklazom, što rezultira povišenim koncentracijama drugog glasnika cikličkog guanozin monofosfata (cGMP), što bi moglo rezultirati vazodilatacijom, natriurezom i diurezom, povećanjem glomerularne filtracije i protoka krvi kroz bubrege, inhibicijom otpuštanja renina i aldosterona, smanjenjem simpatičke aktivnosti te antihipertrofičnim i antifibrotičkim učincima.
Neparvis may therefore increase the systemic exposure of OATP1B1 and OATP1B3 substrates such as statins.
Neparvis stoga može povećati sistemsku izloženost supstratima OATP1B1 i OATP1B3 kao što su statini.
As there is very limited clinical experience in patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) (see section 5.1) Neparvis should be used with caution and a starting dose of 24 mg/26 mg twice daily is recommended.
Budući da postoji vrlo ograničeno kliničko iskustvo u bolesnika s teškim oštećenjem bubrega (eGFR <30 ml/min/1,73 m2) (vidjeti dio 5.1) Neparvis treba primjenjivati s oprezom te se preporučuje početna doza od 24 mg/26 mg dvaput na dan.
A hydroxyl metabolite of valsartan has been identified in plasma at low concentrations (<10%).
Utvrđen je hidroksilni metabolit valsartana u plazmi pri niskim koncentracijama
Treatment should not be initiated in patients with serum potassium level >5.4 mmol/l or with SBP <100 mmHg (see section 4.4).
Liječenje se ne smije započeti u bolesnika s razinom kalija u serumu >5,4 mmol/l ili sa SKT-om <100 mmHg (vidjeti dio 4.4).
Patients with mild and moderate renal impairment are more at risk of developing hypotension (see section 4.2).
Bolesnici s blagim i umjerenim oštećenjem bubrega izloženi su većem riziku od razvoja hipotenzije (vidjeti dio 4.2).
• The other ingredients in the tablet core are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, magnesium stearate, talc and silica colloidal anhydrous.
• Drugi sastojci u jezgri tablete su mikrokristalična celuloza, niskosupstituirana hidroksipropilceluloza, krospovidon, magnezijev stearat, talk i silicijev dioksid koloidni bezvodni.
You can take Neparvis with or without food.
Neparvis uz hranu ili bez nje.
• low blood pressure (dizziness, light-headedness)
• niski krvni tlak (omaglica, ošamućenost)
Combination of Neparvis with aliskiren is potentially associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) (see sections 4.3 and 4.4).
Kombinacija Neparvisa s aliskirenom je potencijalno povezana s višom učestalošću nuspojava kao što su hipotenzija, hiperkalijemija i smanjena funkcija bubrega (uključujući akutno zatajenje bubrega) (vidjeti dijelove 4.3 i 4.4).
No dose adjustment is required when administering Neparvis to patients with mild hepatic impairment (Child-Pugh A classification).
Nije potrebno prilagođavanje doze kada se Neparvis primjenjuje u bolesnika s blagim oštećenjem jetre (stupanj A prema Child-Pugh klasifikaciji).
There is very limited clinical experience in patients with severe renal impairment (estimated GFR <30 ml/min/1.73m2) and these patients may be at greatest risk of hypotension (see section 4.2).
Postoji vrlo ograničeno iskustvo s bolesnicima s teškim oštećenjem bubrega (procijenjeni GFR <30 ml/min/1,73m2) te bi ti bolesnici mogli biti izloženi najvećem riziku od hipotenzije (vidjeti dio 4.2).
Neparvis 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.
Neparvis 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.
The effects of Neparvis on amyloid-β concentrations in CSF and brain tissue were assessed in young (2-4 years old) cynomolgus monkeys treated with Neparvis (24 mg sacubitril/26 mg valsartan/kg/day) for two weeks.
Neparvisa na koncentracije amiloida-β u cerebrospinalnoj tekućini i moždanom tkivu ocijenjeni su u mladih (2-4 godine starosti) cynomolgus majmuna liječenih Neparvisom (24 mg sakubitrila/26 mg valsartana/kg/dan) tijekom dva tjedna.
In a thorough QTc clinical study in healthy male subjects, single doses of Neparvis 194 mg sacubitril/206 mg valsartan and 583 mg sacubitril/617 mg valsartan had no effect on cardiac repolarisation.
U temeljitom kliničkom ispitivanju QTc intervala u zdravih muških ispitanika, jednokratne doze Neparvisa od 194 mg sakubitrila/206 mg valsartana te 583 mg sakubitrila/617 mg valsartana nisu imale učinak na srčanu repolarizaciju.
In the Neparvis group, 76% of patients remained on the target dose of 200 mg twice daily at the end of the study (mean daily dose of 375 mg).
U skupini koja je primala Neparvis, 76% bolesnika ostalo je na ciljnoj dozi od 200 mg dvaput na dan na kraju ispitivanja (srednja dnevna doza od 375 mg).
In juvenile rats treated with valsartan (postnatal days 7 to 70), doses as low as 1 mg/kg/day produced persistent irreversible kidney changes consisting of tubular nephropathy (sometimes accompanied by tubular epithelial necrosis) and pelvic dilatation.
U juvenilnih štakora liječenih valsartanom (postnatalni dani od 7. do 70.), doze već od 1 mg/kg/dan proizvele su trajne ireverzibilne promjene na bubrezima koje su odgovarale tubularnoj nefropatiji (ponekad popraćene nekrozom tubularnog epitela) i dilataciju zdjelice.
Pump failure accounted for 26% of cardiovascular deaths and was reduced by 21% in Neparvis-treated patients compared to enalapril-treated patients (HR 0.79, p=0.0338).
Zatajenje srca kao pumpe predstavljalo je 26% kardiovaskularnih smrti i bilo je smanjeno za 21% u bolesnika liječenih Neparvisom u usporedbi s bolesnicima liječenima enalaprilom (HR 0,79, p=0,0338).
In PARADIGM-HF, angioedema was reported in 0.5% of patients treated with Neparvis, compared with 0.2% of patients treated with enalapril.
U ispitivanju PARADIGM-HF, angioedem je bio zabilježen u 0,5% bolesnika liječenih Neparvisom, u usporedbi s 0,2% bolesnika liječenih enalaprilom.
Non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors
Nesteroidni protuupalni lijekovi (NSAID), uključujući selektivne inhibitore ciklooksigenaze-2 (COX-2)
Patients with a prior history of angioedema were not studied.
Bolesnici s angioedemom u anamnezi nisu bili ispitivani.
The risk may be further increased by dehydration or concomitant use of non-steroidal anti-inflammatory agents (NSAIDs) (see section 4.5).
Ovaj se rizik može dodatno povećati dehidracijom ili istodobnom primjenom nesteroidnih protuupalnih lijekova (NSAID) (vidjeti dio 4.5).
Use of Neparvis may be associated with decreased renal function.
Primjena Neparvisa može biti povezana sa smanjenom bubrežnom funkcijom.
The most commonly reported adverse reactions during treatment with Neparvis were hypotension, hyperkalaemia and renal impairment (see section 4.4).
Najčešće prijavljene nuspojave tijekom liječenja Neparvisom bile su hipotenzija, hiperkalijemija i oštećenje bubrega (vidjeti dio 4.4).
The primary endpoint was the composite of cardiovascular (CV) death or hospitalisation for heart failure (HF).
Primarni kompozitni ishod obuhvatio je kardiovaskularnu (KV) smrt ili hospitalizaciju zbog zatajenja srca.
The complementary cardiovascular benefits of Neparvis in heart failure patients are attributed to the enhancement of peptides that are degraded by neprilysin, such as natriuretic peptides (NP), by LBQ657 and the simultaneous inhibition of the effects of angiotensin II by valsartan.
Komplementarne kardiovaskularne koristi Neparvisa u bolesnika sa zatajenjem srca pripisuju se povećanju količine peptida koje neprilizin razgrađuje, kao što su natriuretski peptidi (NP), pomoću LBQ657 i istodobnoj inhibiciji učinaka angiotenzina II od strane valsartana.
BNP is not a suitable biomarker of heart failure in patients treated with Neparvis because BNP is a neprilysin substrate (see section 4.4).
BNP nije prikladan biomarker zatajenja srca u bolesnika liječenih Neparvisom zato što je BNP supstrat neprilizina (vidjeti dio 4.4).
The embryo-foetal no-observed adverse effect level (NOAEL) for sacubitril was at least 750 mg/kg/day in rats and 200 mg/kg/day in rabbits (2.2-fold the MRHD on the basis of LBQ657 AUC).
Embriofetalna razina bez opaženih štetnih učinaka (NOAEL) za sakubitril bila je najmanje 750 mg/kg/dan u štakora i 200 mg/kg/dan u zečeva (2,2 puta MRHD-a na temelju AUC-a LBQ657).
Patients with SBP <100 mmHg, severe renal impairment (eGFR <30 ml/min/1.73 m2) and severe hepatic impairment were excluded at screening and therefore not prospectively studied.
Bolesnici koji su imali SKT <100 mmHg, teško oštećenje bubrega (eGFR <30 ml/min/1,73 m2) i teško oštećenje jetre bili su isključeni kod probira i stoga nisu bili prospektivno ispitivani.
Nervous system disorders
Poremećaji živčanog sustava Omaglica
Furosemide
Furosemid
168 film-coated tablets
168 filmom obloženih tableta
In PARADIGM-HF, hyperkalaemia and serum potassium concentrations >5.4 mmol/l were reported in 11.6% and 19.7% of Neparvis-treated patients and 14.0% and 21.1% of enalapril-treated patients, respectively.
U ispitivanju PARADIGM-HF, hiperkalijemija i koncentracije kalija u serumu >5.4 mmol/l bile su prijavljene u 11,6% i 19,7% bolesnika liječenih Neparvisom, odnosno u 14,0% i 21,1% bolesnika liječenih enalaprilom.
Animal studies with Neparvis have shown reproductive toxicity (see section 5.3).
Ispitivanja Neparvisa u životinja su pokazala reproduktivnu toksičnost (vidjeti dio 5.3).
Hypotension*
Hipotenzija*
This prevents sustained activation of the renin-angiotensin-aldosterone system that would result in vasoconstriction, renal sodium and fluid retention, activation of cellular growth and proliferation, and subsequent maladaptive cardiovascular remodelling.
To sprječava održanu aktivaciju renin-angiotenzin-aldosteronskog sustava koja bi rezultirala vazokonstrikcijom, zadržavanjem natrija i tekućine putem bubrega, aktivacijom staničnog rasta i proliferacije te naknadnim maladaptivnim kardiovaskularnim remodeliranjem.
The tablets are supplied in PVC/PVDC/Aluminium blister packs of 14, 20, 28 tablets or 56 tablets and in multipacks of 196 tablets (7 packs of 28 tablets).
Tablete se isporučuju u PVC/PVDC/aluminij blister pakiranjima od 14, 20, 28 ili 56 tableta i u višestrukim pakiranjima od 196 tableta (7 pakiranja od po 28 tableta).
However, in patients with mild to moderate hepatic impairment, the exposures of free concentrations of LBQ657 increased by 1.47- and 3.08-fold, respectively, and the exposures of free concentrations of valsartan increased by 1.09-fold and 2.20-fold, respectively, compared to matching healthy subjects.
Međutim, u bolesnika s blagim do umjerenim oštećenjem jetre izloženosti slobodnih koncentracija LBQ657 povećale su se za 1,47 odnosno 3,08 puta, a izloženosti slobodnih koncentracija valsartana povećale su se za 1,09 odnosno 2,20 puta, u usporedbi s odgovarajućim zdravim ispitanicima.
≤ eGFR <90 ml/min/1.73 m2), the largest group of patients enrolled in
≤ eGFR <90 ml/min/1,73 m2) koji su bili najveća skupina bolesnika uključena u PARADIGM-HF.
Co-administration of Neparvis increased the Cmax of atorvastatin and its metabolites by up to 2-fold and AUC by up to 1.3-fold.
Istodobna primjena Neparvisa povećala je Cmax atorvastatina i njegovih metabolita za do 2 puta te AUC za do 1,3 puta.
During the enalapril run-in period, 1,102 patients (10.5%) permanently discontinued from the study, 5.6% because of an adverse reaction, most commonly renal dysfunction (1.7%), hyperkalemia (1.7%) and hypotension (1.4%).
Tijekom ulaznog razdoblja s enalaprilom, 1102 bolesnika (10,5%) trajno je prekinulo sudjelovanje u ispitivanju, 5,6% zbog nuspojave, najčešće bubrežne disfunkcije (1,7%), hiperkalijemije (1,7%) i hipotenzije (1,4%).
• metformin, a medicine used to treat diabetes.
• metformin, lijek koji se koristi za liječenje šećerne bolesti.
Following twice daily dosing of Neparvis, steady-state levels of sacubitril, LBQ657 and valsartan are reached in three days.
Nakon doziranja Neparvisa dvaput na dan, razine sakubitrila, LBQ657 i valsartana u stanju dinamičke ravnoteže postižu se za tri dana.
Tablet core
Jezgra tablete
Hyperkalaemia and serum potassium
Hiperkalijemija i kalij u serumu
• The active substances are sacubitril and valsartan.
• Djelatne tvari su sakubitril i valsartan.