natgillin/translations-raw huggingface dataset:
Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Unutar svake skupine učestalosti, nuspojave su navedene redom od najozbiljnijih prema manje ozbiljnima.
• some types of antibiotics (rifamycin group), ciclosporin (used to prevent rejection of transplanted organs) or antivirals such as ritonavir (used to treat HIV/AIDS).
• neke vrste antibiotika (skupina rifamicina), ciklosporin (koristi se za sprječavanje odbacivanja presađenih organa) ili antivirusnih lijekova poput ritonavira (koristi se za liječenje
There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh B classification) or with AST/ALT values more than twice the upper limit of the normal range.
Postoji ograničeno kliničko iskustvo u bolesnika s umjerenim oštećenjem jetre (Child-Pugh stupanj B) ili s AST/ALT vrijednostima višim od dvostruke vrijednosti gornje granice normalnog raspona.
• dizziness when switching from sitting to standing position
• omaglica kod promjene položaja iz sjedećeg u stajaći
Patients with SBP <100 mmHg were not studied (see section 5.1).
Bolesnici sa SKT <100 mmHg nisu bili ispitivani (vidjeti dio 5.1).
Where there is involvement of the tongue, glottis or larynx likely to cause airway obstruction, appropriate therapy, e.g. adrenaline solution 1 mg/1 ml (0.3-0.5 ml), and/or measures necessary to ensure a patent airway, should be promptly administered.
Ako je uključen jezik, glotis ili larinks, što može uzrokovati opstrukciju dišnih puteva, potrebno je odmah primijeniti odgovarajuću terapiju, npr. otopinu adrenalina 1 mg/1 ml (0,3-0,5 ml) i/ili mjere potrebne da bi se osigurao otvoreni dišni put.
Sacubitril
Sakubitril
Caution is required in patients with renal artery stenosis and monitoring of renal function is recommended.
Potreban je oprez u bolesnika sa stenozom bubrežne arterije i preporučuje se praćenje bubrežne funkcije.
Talk to your doctor, pharmacist or nurse before taking Neparvis
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Neparvis
Sacubitril is further metabolised to the active metabolite LBQ657.
Sakubitril se dalje metabolizira u aktivni metabolit LBQ657.
A slight generalised delay in ossification was observed at doses of >50 mg/kg/day.
Blago generalizirana odgoda osifikacije bila je uočena u dozama >50 mg/kg/dan.
LBQ657 and valsartan exposure are increased in subjects over 65 years of age by 42% and 30%, respectively, compared to younger subjects.
Izloženost LBQ657 i valsartanu povećava se u ispitanika starijih od 65 godina za 42%, odnosno 30% u usporedbi s mlađim ispitanicima.
There is no experience in patients with end-stage renal disease and use of Neparvis is not recommended.
Ne postoji iskustvo u bolesnika sa završnim stadijem bolesti bubrega te se primjena Neparvisa ne preporučuje.
Down-titration should be considered in patients who develop a clinically significant decrease in renal function.
Postupno sniženje doze treba razmotriti u bolesnika u kojih se razvije klinički značajno smanjenje bubrežne funkcije.
The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.
Najčešći simptomi zatajenja srca su nedostatak zraka, umor, zamor i oticanje gležnjeva.
Neparvis may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis.
Neparvis može povećati razine ureje u krvi i kreatinina u serumu u bolesnika s obostranom ili jednostranom stenozom bubrežne arterije.
Should exposure to ARBs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Ako je do izloženosti ARB-ovima došlo od drugog tromjesečja trudnoće nadalje, preporučuje se ultrazvučni pregled funkcije bubrega i lubanje.
• if you are taking another type of medicine called an angiotensin converting enzyme (ACE) inhibitor (for example enalapril, lisinopril or ramipril).
• ako uzimate drugu vrstu lijeka koji se zove inhibitor angiotenzin konvertirajućeg enzima (ACE) (primjerice enalapril, lizinopril ili ramipril).
Increases in CSF Aβ1-40 and 1-42 were not observed in a two-week healthy volunteer study in humans (see section 5.1).
Povećanja Aβ1-40 i 1-42 u cerebrospinalnoj tekućini nisu bila uočena u dvotjednom ispitivanju na zdravim dobrovoljcima (vidjeti dio 5.1).
Sacubitril, LBQ657 and valsartan are eliminated from plasma with a mean elimination half-life (T½) of approximately 1.43 hours, 11.48 hours, and 9.90 hours, respectively.
Sakubitril, LBQ657 i valsartan eliminiraju se iz plazme sa srednjim vremenom polueliminacije (T½) od otprilike 1,43 sata, 11,48 sati, odnosno 9,90 sati.
Following oral administration, 52-68% of sacubitril (primarily as LBQ657) and ~13% of valsartan and its metabolites are excreted in urine; 37-48% of sacubitril (primarily as LBQ657) and 86% of valsartan and its metabolites are excreted in faeces.
Nakon peroralne primjene, 52-68% sakubitrila (prvenstveno kao LBQ657) i ~13% valsartana i njegovih metabolita izlučuje se mokraćom; 37-48% sakubitrila (prvenstveno kao LBQ657) i 86% valsartana i njegovih metabolita izlučuje se stolicom.
The usual recommended target dose is 97 mg/103 mg twice a day (one tablet in the morning and one tablet in the evening).
Uobičajena preporučena ciljna doza je 97 mg/103 mg dvaput na dan (jedna tableta ujutro i jedna tableta uvečer).
Approximate tablet dimensions 15.1 mm x 6.0 mm.
Približne dimenzije tablete 15,1 mm x 6,0 mm.
• nitroglycerine, a medicine used to treat angina.
• nitroglicerin, lijek koji se koristi za liječenje angine.
In juvenile rats treated with sacubitril (postnatal days 7 to 70), there was a reduction in age-related bone mass development and bone elongation.
U juvenilnih štakora liječenih sakubitrilom (postnatalni dani od 7. do 70.), došlo je do smanjenja razvoja koštane mase i produljenja kosti povezanih s dobi.
No impairment of fertility was demonstrated in studies with it in male and female rats (see section 5.3).
Nije dokazano narušavanje plodnosti u ispitivanjima s njim u mužjaka i ženki štakora (vidjeti dio 5.3).
Sacubitril, LBQ657 and valsartan are highly bound to plasma proteins (94-97%).
Sakubitril, LBQ657 i valsartan se u velikoj mjeri vežu za proteine u plazmi (94-97%).
They were then randomised to the double-blind period of the study, during which they received either Neparvis 200 mg or enalapril 10 mg twice daily [Neparvis (n=4,209); enalapril (n=4,233)].
Zatim su bili randomizirani u dvostruko slijepo razdoblje ispitivanja tijekom kojeg su primali ili Neparvis 200 mg ili enalapril 10 mg dvaput na dan [Neparvis (n=4209); enalapril (n=4233)].
Sacubitril is readily converted to LBQ657 by carboxylesterases 1b and 1c; LBQ657 is not further metabolised to a significant extent.
Sakubitril lako prelazi u LBQ657 pomoću karboksilesteraza 1b i 1c; LBQ657 se dalje ne metabolizira u značajnom opsegu.
Neparvis has a minor influence on the ability to drive and use machines.
Neparvis malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
A higher incidence of angioedema was observed in Black patients treated with Neparvis (2.4%) and enalapril (0.5%) (see section 4.4).
Viša incidencija angioedema bila je uočena u bolesnika crne rase liječenih Neparvisom (2,4%) i enalaprilom (0,5%) (vidjeti dio 4.4).
• Hereditary or idiopathic angioedema (see section 4.4).
• Nasljedni ili idiopatski angioedem (vidjeti dio 4.4).
First heart failure hospitalisation
Prva hospitalizacija zbog zatajenja srca
Co-administration of Neparvis and furosemide had no effect on the pharmacokinetics of Neparvis but reduced Cmax and AUC of furosemide by 50% and 28%, respectively.
Istodobna primjena Neparvisa i furosemida nije imala učinka na farmakokinetiku Neparvisa, ali smanjila je Cmax furosemida za 50% i AUC za 28%.
Therefore, monitoring of renal function is recommended when initiating or modifying treatment in patients on Neparvis who are taking NSAIDs concomitantly (see section 4.4).
Stoga se preporučuje praćenje bubrežne funkcije kada se započinje ili modificira liječenje u bolesnika na Neparvisu koji istodobno uzimaju NSAID-e (vidjeti dio 4.4).
It dissociates into two active substances, sacubitril and valsartan.
On se razdvaja u dvije djelatne tvari, sakubitril i valsartan.
Neparvis does not induce or inhibit CYP450 enzymes.
Neparvis ne inducira niti inhibira CYP450 enzime.
The valsartan contained within Neparvis is more bioavailable than the valsartan in other marketed tablet formulations; 26 mg, 51 mg, and 103 mg of valsartan in Neparvis is equivalent to 40 mg, 80 mg and 160 mg of valsartan in other marketed tablet formulations, respectively.
Valsartan sadržan u Neparvisu više je bioraspoloživ nego valsartan u drugim formulacijama tableta koje se nalaze na tržištu; 26 mg, 51 mg i 103 mg valsartana u Neparvisu ekvivalentno je 40 mg, 80 mg, odnosno 160 mg valsartana u drugim formulacijama tableta na tržištu.
Patients taking Neparvis 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.
Neparvis mogu razviti niski krvni tlak (omaglicu, ošamućenost), visoku razinu kalija u krvi (koja bi se otkrila prilikom provođenja krvnih pretraga) ili smanjenu funkciju bubrega.
• lithium, a medicine used to treat some types of psychiatric illness.
• litij, lijek koji se koristi za liječenje nekih vrsta psihijatrijskih bolesti.
Co-administration of Neparvis with metformin reduced both Cmax and AUC of metformin by 23%.
Istodobna primjena Neparvisa s metforminom smanjila je i Cmax i AUC metformina za 23%.
No studies have been performed in patients undergoing dialysis.
Nisu provedena ispitivanja u bolesnika koji su na dijalizi.
The valsartan contained within Neparvis is more bioavailable than the valsartan in other marketed tablet formulations (see section 5.2).
Valsartan sadržan u Neparvisu više je bioraspoloživ nego valsartan u drugim formulacijama tableta koje se nalaze na tržištu (vidjeti dio 5.2).
The relative risk reduction was 16% compared with enalapril (see Table 2).
Relativno smanjenje rizika bilo je 16% u usporedbi s enalaprilom (vidjeti Tablicu 2).
• if you are being treated with an angiotensin receptor blocker (ARB) or aliskiren (see “Do not take Neparvis”).
• ako se liječite blokatorom angiotenzinskog receptora (ARB) ili aliskirenom (vidjeti „Nemojte uzimati Neparvis“).
Addition of a single dose of sildenafil to Neparvis at steady state in patients with hypertension was associated with a significantly greater blood pressure reduction compared to administration of Neparvis alone.
Dodavanje jednokratne doze sildenafila Neparvisu u stanju dinamičke ravnoteže u bolesnika s hipertenzijom bilo je povezano sa značajno većim smanjenjem krvnog tlaka u usporedbi s primjenom samog Neparvisa.
• The combination of Neparvis with an ACE inhibitor is contraindicated due to the increased risk of angioedema (see section 4.3).
• Kombinacija Neparvisa s ACE inhibitorom kontraindicirana je zbog povećanog rizika od angioedema (vidjeti dio 4.3).
Evaluation of patients with heart failure should always include assessment of renal function.
Procjena bolesnika sa zatajenjem srca uvijek treba uključivati procjenu bubrežne funkcije.
The concomitant use of Neparvis with ACE inhibitors is contraindicated, as the concomitant inhibition of neprilysin (NEP) and ACE may increase the risk of angioedema.
Istodobna primjena Neparvisa s ACE inhibitorima je kontraindicirana, jer istodobna inhibicija neprilizina (NEP) i ACE-a može povećati rizik od angioedema.
• low blood pressure (dizziness, light-headedness) when switching from sitting or lying to standing position
• niski krvni tlak (omaglica, ošamućenost) kod promjene položaja iz sjedećeg ili ležećeg u stajaći
You will usually start by taking 24 mg/26 mg or 49 mg/51 mg twice a day (one tablet in the morning and one tablet in the evening).
Obično ćete početi liječenje uzimajući 24 mg/26 mg ili 49 mg/51 mg dvaput na dan (jednu tabletu ujutro i jednu tabletu navečer).
In vitro data indicate that sacubitril inhibits OATP1B1 and OATP1B3 transporters.
In vitro podaci upućuju na to da sakubitril inhibira OATP1B1 i OATP1B3 prijenosnike.
• Concomitant use with ACE inhibitors (see sections 4.4 and 4.5).
• Istodobna primjena s ACE inhibitorima (vidjeti dijelove 4.4 i 4.5).
How to take Neparvis
Kako uzimati Neparvis
Administration with food has no clinically significant impact on the systemic exposures of sacubitril, LBQ657 and valsartan.
Primjena s hranom nema klinički značajan utjecaj na sistemske izloženosti sakubitrila, LBQ657 i valsartana.
Hypotension is the most likely symptom of overdose due to the blood pressure lowering effects of Neparvis.
Hipotenzija je najvjerojatniji simptom predoziranja zbog učinaka
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors or angiotensin II receptor antagonists.
Prijavljena su reverzibilna povećanja koncentracija litija u serumu i toksičnost tijekom istodobne primjene litija s ACE inhibitorima ili antagonistima receptora angiotenzina II.
Since CYP450-enzyme-mediated metabolism of sacubitril and valsartan is minimal, co-administration with medicinal products that impact CYP450 enzymes is not expected to impact the pharmacokinetics.
Budući da je metabolizam sakubitrila i valsartana posredovan CYP450 enzimima minimalan, ne očekuje se da će istodobna primjena lijekova koji utječu na CYP450 enzime utjecati na farmakokinetiku.
OUTER CARTON OF UNIT PACK
VANJSKA KUTIJA JEDINIČNOG PAKIRANJA
This risk reduction was consistently observed across subgroups including: gender, age, race, geography, NYHA class (II/III), ejection fraction, renal function, history of diabetes or hypertension, prior heart failure therapy, and atrial fibrillation.
Ovo smanjenje rizika bilo je dosljedno uočavano u podskupinama koje su uključivale: spol, dob, rasu, geografiju, NYHA klasu (II/III), ejekcijsku frakciju, bubrežnu funkciju, šećernu bolest ili hipertenziju u anamnezi, prijašnju terapiju za zatajenje srca i fibrilaciju atrija.
You must tell your doctor if you think that you are (or might become) pregnant.
Morate obavijestiti svog liječnika ako mislite da ste (ili biste mogli postati) trudni.
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 Neparvis 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 Neparvisa (vidjeti dio 4.4).
• 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 Neparvis”).
• 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 Neparvis“).
In this study CSF Aβ clearance in cynomolgus monkeys was reduced, increasing CSF Aβ1-40, 1-42 and 1-38 levels; there was no corresponding increase in Aβ levels in the brain.
U ovom ispitivanju klirens Aβ-a u cerebrospinalnoj tekućini u cynomolgus majmuna bio je smanjen, povećavajući razine Aβ1-40, 1-42 i 1-38 u cerebrospinalnoj tekućini; nije bilo odgovarajućeg povećanja razina Aβ-a u mozgu.
The 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg strengths are in some publications referred to as 50, 100 or 200 mg.
Doze od 24 mg/26 mg, 49 mg/51 mg i 97 mg/103 mg se u nekim publikacijama nazivaju 50, 100 ili 200 mg.
Cases of symptomatic hypotension have been reported in patients treated with Neparvis 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 Neparvisom 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).
However, LBQ657 and valsartan are highly bound to plasma protein and therefore unlikely to be effectively removed by dialysis.
Međutim, LBQ657 i valsartan u velikoj se mjeri vežu za protein u plazmi i stoga je malo vjerojatno da će se ukloniti dijalizom.
Valsartan inhibits detrimental cardiovascular and renal effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.
Valsartan inhibira štetne kardiovaskularne i renalne učinke angiotenzina II tako što selektivno blokira AT1 receptor te također inhibira otpuštanje aldosterona ovisno o angiotenzinu II.
Administration of Neparvis 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 Neparvisa 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.
The absolute risk reductions were 4.7% for the composite of the CV death or HF hospitalisation, 3.1% for CV death alone, and 2.8% for first HF hospitalisation alone.
Apsolutna smanjenja rizika bila su 4,7% za kompozitni ishod KV smrti ili hospitalizacije zbog zatajenja srca, 3,1% samo za KV smrt te 2,8% samo za prvu hospitalizaciju zbog zatajenja srca.
The recommended starting dose of Neparvis is one tablet of 49 mg/51 mg twice daily, except in the situations described below.
Neparvisa je jedna tableta od 49 mg/51 mg dvaput na dan, osim u niže opisanim situacijama.
There are no data from the use of sacubitril in pregnant women.
Ne postoje podaci o primjeni sakubitrila u trudnica.
If serum potassium level is >5.4 mmol/l discontinuation should be considered.
Ako je razina kalija u serumu >5,4 mmol/l, potrebno je razmotriti prekid primjene Neparvisa.
Monitoring of serum potassium is recommended, especially in patients who have risk factors such as renal impairment, diabetes mellitus or hypoaldosteronism or who are on a high potassium diet or on mineralocorticoid antagonists (see section 4.2).
Preporučuje se praćenje kalija u serumu, osobito u bolesnika koji imaju rizične čimbenike kao što su oštećenje bubrega, šećerna bolest ili hipoaldosteronizam ili koji su na prehrani s visokim udjelom kalija ili koji uzimaju mineralokortikoidne antagoniste (vidjeti dio 4.2).
A correlation was observed between renal function and systemic exposure to LBQ657 in patients with mild to severe renal impairment.
Uočena je korelacija između bubrežne funkcije i sistemske izloženosti LBQ657 u bolesnika s blagim do teškim oštećenjem bubrega.
Studies in animals have shown reproductive toxicity (see section 5.3).
Ispitivanja u životinja su pokazala reproduktivnu toksičnost (vidjeti dio 5.3).
Use of Neparvis may be associated with an increased risk of hyperkalaemia, although hypokalaemia may also occur (see section 4.8).
Primjena Neparvisa može biti povezana s povećanim rizikom od hiperkalijemije, iako može doći i do hipokalijemije (vidjeti dio 4.8).
In the PARADIGM-HF study, subjects were previously treated with ACE inhibitors and/or ARBs and also had to successfully complete sequential enalapril and Neparvis 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 Neparvisom (medijan trajanja izloženosti lijeku od 15 odnosno 29 dana) prije randomiziranog dvostruko slijepog razdoblja.
The 49 mg/51 mg and 97 mg/103 mg tablets are also supplied in multipacks of 168 tablets (3 packs of 56 tablets).
Tablete od 49 mg/51 mg i 97 mg/103 mg se također isporučuju u višestrukim pakiranjima od 168 tableta (3 pakiranja od po 56 tableta).
In elderly patients, volume-depleted patients (including those on diuretic therapy), or patients with compromised renal function, concomitant use of Neparvis 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 Neparvisa i NSAID-a može dovesti do povećanog rizika od pogoršanja bubrežne funkcije.
The active metabolite of sacubitril (LBQ657) and valsartan are OATP1B1, OATP1B3, OAT1 and OAT3 substrates; valsartan is also a MRP2 substrate.
Aktivni metaboliti sakubitrila (LBQ657) i valsartana su supstrati OATP1B1, OATP1B3, OAT1 i OAT3; valsartan je također supstrat MRP2.
No. at risk
Br. izloženih riziku
14 film-coated tablets 20 film-coated tablets 28 film-coated tablets 56 film-coated tablets
Filmom obložena tableta 14 filmom obloženih tableta 20 filmom obloženih tableta 28 filmom obloženih tableta 56 filmom obloženih tableta
The safety of Neparvis in patients with chronic heart failure was evaluated in the pivotal phase 3 study PARADIGM-HF, which compared patients treated twice daily with Neparvis 97 mg/103 mg (n=4,203) or enalapril 10 mg (n=4,229).
Sigurnost Neparvisa u bolesnika s kroničnim zatajenjem srca ocjenjivala se u ključnom ispitivanju faze 3 PARADIGM-HF, u kojem su uspoređivani bolesnici liječeni dvaput na dan Neparvisom 97 mg/103 mg (n=4203) ili enalaprilom 10 mg (n=4229).
Following oral administration, Neparvis dissociates into valsartan and the prodrug sacubitril.
Nakon oralne primjene, Neparvis se disocira u valsartan i prolijek sakubitril.
Caution should be exercised when co-administering Neparvis with statins.
Potreban je oprez kada se Neparvis primjenjuje istodobno sa statinima.
No clinically meaningful drug-drug interaction was observed when Neparvis 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 Neparvis primjenjivao istodobno s digoksinom, varfarinom, hidroklorotiazidom, amlodipinom, omeprazolom, karvedilolom ili kombinacijom levonorgestrel/etinil estradiol.
It is not known whether Neparvis is excreted in human milk.
Nije poznato izlučuje li se Neparvis u majčino mlijeko.
Additionally, in a toxicology study in cynomolgus monkeys treated with Neparvis 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 Neparvisom u dozi od 146 mg sakubitrila/154 mg valsartana/kg/dan tijekom 39 tjedana, nije bilo dokaza prisutnosti amiloidnih plakova u mozgu.
There is limited experience in patients not currently taking an ACE inhibitor or an ARB or taking low doses of these medicinal products, therefore a starting dose of 24 mg/26 mg twice daily and slow dose titration (doubling every 3-4 weeks) are recommended in these patients (see “Titration” in section 5.1).
Postoji ograničeno iskustvo s bolesnicima koji trenutno ne uzimaju ACE inhibitor ili ARB ili koji uzimaju niske doze tih lijekova, stoga se preporučuje početna doza od 24 mg/26 mg dvaput na dan i polagana titracija doze (udvostručavanje svaka 3-4 tjedna) u tih bolesnika (vidjeti „Titration“ u dijelu 5.1).
The dose should be doubled at 2-4 weeks to the target dose of one tablet of 97 mg/103 mg twice daily, as tolerated by the patient (see section 5.1).
Dozu treba udvostručiti u 2.-4. tjednu do ciljane doze od jedne tablete od 97 mg/103 mg dvaput na dan, ovisno o tome kako je bolesnik podnosi (vidjeti dio 5.1).