natgillin/translations-raw huggingface dataset:
Neparvis exhibits the mechanism of action of an angiotensin receptor neprilysin inhibitor by simultaneously inhibiting neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and by blocking the angiotensin II type-1 (AT1) receptor via valsartan.
Neparvis pokazuje mehanizam djelovanja inhibitora angiotenzinskog receptora i neprilizina tako što istodobno inhibira neprilizin (neutralna endopeptidaza; NEP) putem LBQ657, aktivnog metabolita prolijeka sakubitrila, te blokira receptor angiotenzina II tip 1 (AT1) putem valsartana.
There are no data from the use of Neparvis in pregnant women.
Ne postoje podaci o primjeni Neparvisa u trudnica.
Sacubitril treatment during organogenesis resulted in embryo-foetal lethality and embryo-foetal toxicity (decreased foetal body weights and skeletal malformations) in rabbits at doses associated with maternal toxicity (500 mg/kg/day; 5.7-fold the MRHD on the basis of LBQ657 AUC).
Liječenje sakubitrilom tijekom organogeneze rezultiralo je embriofetalnom smrtnošću i embriofetalnom toksičnošću (smanjena fetalna tjelesna težina i malformacije skeleta) u zečeva pri dozama povezanima s maternalnom toksičnošću (500 mg/kg/dan; 5,7 puta MRHD-a na temelju AUC-a LBQ657).
How to store Neparvis
Kako čuvati Neparvis
• if you have liver disease.
• ako imate bolest jetre.
Table 1 List of adverse reactions
Tablica 1 Popis nuspojava
The pharmacodynamic effects of Neparvis 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.
Neparvisa 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.
Cardiovascular abnormalities (mainly cardiomegaly) were observed in rabbit foetuses at a maternally non-toxic dose (1.46 mg sacubitril/1.54 mg valsartan/kg/day).
Kardiovaskularne abnormalnosti (uglavnom kardiomegalija) uočene su u fetusa zečeva pri dozama koje nisu toksične za majku (1,46 mg sakubitrila/1,54 mg valsartana/kg/dan).
• if you have low blood pressure or are taking any other medicines that reduce your blood pressure (for example, a diuretic) or are suffering from vomiting or diarrhoea, especially if you are aged 65 years or more, or if you have kidney disease and low blood pressure.
diuretik) ili ako patite od povraćanja ili proljeva, posebno ako imate 65 godina ili više, ili ako imate bolest bubrega i niski krvni tlak.
In PARADIGM-HF, hypotension and clinically relevant low systolic blood pressure (<90 mmHg and decrease from baseline of >20 mmHg) were reported in 17.6% and 4.76% of Neparvis-treated patients compared with 11.9% and 2.67% of enalapril-treated patients, respectively.
U ispitivanju PARADIGM-HF, hipotenzija i klinički značajan niski sistolički krvni tlak (<90 mmHg i smanjenje od početne vrijednosti >20 mmHg) bili su prijavljeni u 17,6% i 4,76% bolesnika liječenih Neparvisom, odnosno u 11,9% i 2,67% bolesnika liječenih enalaprilom.
A starting dose of 24 mg/26 mg twice daily should be considered in patients with moderate renal impairment (eGFR 30-60 ml/min/1.73 m2).
Početna doza od 24 mg/26 mg dvaput na dan se treba razmotriti u bolesnika s umjerenim oštećenjem bubrega (eGFR 30-60 ml/min/1,73 m2).
OATP1B1 and OATP1B3 substrates, e.g. statins
Supstrati OATP1B1 i OATP1B3, npr. statini
Microcrystalline cellulose Low-substituted hydroxypropylcellulose Crospovidone, type A Magnesium stearate
Celuloza, mikrokristalična Niskosupstituirana hidroksipropilceluloza Krospovidon, tip A
Symptomatic hypotension is more likely to occur if the patient has been volume-depleted, e.g. by diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Veća je vjerojatnost da će se pojaviti simptomatska hipotenzija u bolesnika sa smanjenim volumenom tekućine, npr. zbog liječenja diureticima, ograničenja unosa soli, proljeva ili povraćanja.
Neparvis is contraindicated in patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy or with hereditary or idiopathic angioedema (see section 4.3).
Neparvis je kontraindiciran u bolesnika s angioedemom u anamnezi povezanim s prethodnom terapijom ACE inhibitorom ili ARB-om ili s nasljednim ili idiopatskim angioedemom (vidjeti dio 4.3).
The combination of Neparvis with direct renin inhibitors such as aliskiren is not recommended (see section 4.4).
Kombinacija Neparvisa s izravnim inhibitorima renina kao što je aliskiren nije preporučena (vidjeti dio 4.4).
The relative risk reduction was 20% versus enalapril (see Table 2).
Relativno smanjenje rizika iznosilo je 20% u odnosu na enalapril (vidjeti Tablicu 2).
The adverse embryofoetal effects of Neparvis are attributed to the angiotensin receptor antagonist activity (see section 4.6).
Neparvisa pripisuju se antagonističkoj aktivnosti prema angiotenzinskom receptoru (vidjeti dio 4.6).
ACE inhibitor therapy must not be started until 36 hours after the last dose of Neparvis (see sections 4.2 and 4.3).
Terapija ACE inhibitorom ne smije se započinjati do 36 sati nakon zadnje doze Neparvisa (vidjeti dijelove 4.2 i 4.3).
Multipack: 168 (3 packs of 56) film-coated tablets Multipack: 196 (7 packs of 28) film-coated tablets
Višestruko pakiranje: 168 (3 pakiranja od 56) filmom obloženih tableta Višestruko pakiranje: 196 (7 pakiranja od 28) filmom obloženih tableta
BNP is not a suitable biomarker of heart failure in patients treated with Neparvis because it is a neprilysin substrate (see section 5.1).
BNP nije odgovarajući biomarker zatajenja srca u bolesnika liječenih Neparvisom zato što je supstrat neprilizina (vidjeti dio 5.1).
196 film-coated tablets
196 filmom obloženih tableta
Angioedema has been reported in patients treated with Neparvis.
Angioedem je prijavljen u bolesnika liječenih Neparvisom.
Hyperkalaemia*
Hiperkalijemija*
It is teratogenic based on a low incidence of foetal hydrocephaly, associated with maternally toxic doses, which was observed in rabbits at an Neparvis dose of ≥4.9 mg sacubitril/5.1 mg valsartan/kg/day.
On je teratogen na temelju niske incidencije fetalne hidrocefalije, povezano s toksičnim dozama za majku, što je bilo uočeno u zečeva uz dozu Neparvisa ≥4,9 mg sakubitrila/5,1 mg valsartana/kg/dan.
• The combination of Neparvis with direct renin inhibitors such as aliskiren is not recommended (see section 4.5).
• Kombinacija Neparvisa s direktnim inhibitorima renina kao što je aliskiren nije preporučljiva (vidjeti dio 4.5).
If any of the above applies to you, tell your doctor or pharmacist before you take Neparvis.
Ako se bilo što od navedenoga odnosi na Vas, obratite se svom liječniku ili ljekarniku prije uzimanja Neparvisa.
Neparvis is contraindicated in patients with severe hepatic impairment, biliary cirrhosis or cholestasis (Child-Pugh C classification) (see section 4.3).
Neparvis je kontraindiciran u bolesnika s teškim oštećenjem jetre, bilijarnom cirozom ili kolestazom (Child-Pugh stupanj C) (vidjeti dio 4.3).
Primary composite endpoint of CV death and heart failure hospitalisations*
Primarni kompozitni ishod KV smrti i hospitalizacija zbog zatajenja srca*
If treatment with Neparvis is stopped, ACE inhibitor therapy must not be initiated until 36 hours after the last dose of Neparvis (see sections 4.2, 4.3 and 4.5).
Ako se prekine liječenje Neparvisom, terapija ACE inhibitorom ne smije se započinjati do 36 sati nakon zadnje doze Neparvisa (vidjeti dijelove 4.2, 4.3 i 4.5).
• (acute) renal failure (severe kidney disorder)
• (akutno) zatajenje bubrega (teški poremećaj bubrega)
• Known history of angioedema related to previous ACE inhibitor or ARB therapy (see section 4.4).
• Angioedem u anamnezi povezan s prethodnom terapijom ACE inhibitorom ili ARB-om (vidjeti dio 4.4).
Monitoring of serum potassium is recommended if Neparvis is co-administered with these agents (see section 4.4).
Preporučuje se praćenje kalija u serumu ako se Neparvis primjenjuje istodobno s tim tvarima (vidjeti dio 4.4).
Multipack: 196 (7 packs of 28) film-coated tablets
Filmom obložena tableta Višestruko pakiranje: 196 (7 pakiranja od 28) filmom obloženih tableta
No clinically relevant drug-drug interaction was observed when simvastatin and Neparvis were coadministered.
Nije primjećena klinički značajna interakcija među lijekovima prilikom istodobne primjene simvastatina i Neparvisa.
In a 21-day study in HFrEF patients, Neparvis significantly increased urine ANP and cGMP and plasma cGMP, and decreased plasma NT-proBNP, aldosterone and endothelin-1 compared to baseline.
U 21-dnevnom ispitivanju u bolesnika s HFrEF-om, Neparvis je značajno povećao ANP i cGMP u mokraći te cGMP u plazmi, a smanjio NT-proBNP, aldosteron i endotelin-1 u plazmi u usporedbi s početnim vrijednostima.
In patients with mild to moderate hepatic impairment, the exposures of sacubitril increased by 1.5- and 3.4- fold, LBQ657 increased by 1.5- and 1.9-fold, and valsartan increased by 1.2-fold and 2.1-fold, respectively, compared to matching healthy subjects.
U bolesnika s blagim do umjerenim oštećenjem jetre, izloženosti sakubitrilu povećale su se za 1,5, odnosno 3,4 puta, LBQ657 za 1,5, odnosno 1,9 puta, a valsartanu za 1,2, odnosno 2,1 puta, u usporedbi s odgovarajućim zdravim ispitanicima.
A slight increase in two foetal skeletal variations (misshapen sternebra, sternebra bipartite ossification) was observed in rabbits at an Neparvis dose of 4.9 mg sacubitril/5.1 mg valsartan/kg/day.
Blago povećanje dviju varijacija fetusnog skeleta (deformirana sternebra, dvostrana osifikacija sternebre) bilo je uočeno u zečeva pri dozi Neparvisa od 4,9 mg sakubitrila/5,1 mg valsartana/kg/dan.
If any of the above applies to you, tell your doctor, pharmacist or nurse before you take Neparvis.
Ako se bilo što od navedenoga odnosi na Vas, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije uzimanja Neparvisa.
• spinning sensation
• osjećaj vrtnje
• Severe hepatic impairment, biliary cirrhosis and cholestasis (see section 4.2).
• Teško oštećenje jetre, bilijarna ciroza i kolestaza (vidjeti dio 4.2).
Neparvis 97 mg/103 mg film-coated tablets
Neparvis 97 mg/103 mg filmom obložene tablete
The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of N-nitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible.
Nnitrozamina te da se prema potrebi promijene kako bi se kontaminacija nitrozaminom svela na najmanju moguću mjeru.
• if you have severe liver disease.
• ako imate tešku bolest jetre
Iron oxide yellow (E172)
Željezov oksid, crveni (E172) Željezov oksid, žuti (E172)
Iron oxide black (E172)
Željezov oksid, crveni (E172) Željezov oksid, crni (E172)
Neparvis 24 mg/26 mg film-coated tablets
Neparvis 24 mg/26 mg filmom obložene tablete
Neparvis has not been studied in patients with severe hepatic impairment, biliary cirrhosis or cholestasis (see sections 4.3 and 4.4).
Neparvis nije bio ispitivan u bolesnika s teškim oštećenjem jetre, bilijarnom cirozom ili kolestazom (vidjeti dijelove 4.3 i 4.4).
If you have been taking an ACE inhibitor, wait for 36 hours after taking the last dose before you start to take Neparvis (see “Other medicines and Neparvis”).
Ako uzimate ACE inhibitor, pričekajte 36 sati nakon uzimanja posljednje doze prije nego počnete uzimati Neparvis (vidjeti „Drugi lijekovi i Neparvis“).
Treatment should not be initiated if the serum potassium level is >5.4 mmol/l.
Liječenje se ne smije započeti u bolesnika s razinom kalija u serumu >5,4 mmol/l.
20 film-coated tablets
20 filmom obloženih tableta
Neparvis 49 mg/51 mg film-coated tablets are pale yellow oval tablets with “NVR” on one side and “L1” on the other side.
Neparvis 49 mg/51 mg filmom obložene tablete su blijedo žute ovalne tablete s oznakom „NVR“ s jedne strane i „L1“ s druge strane.
In the PARADIGM-HF study, Neparvis decreased plasma NT-proBNP and increased plasma BNP and urine cGMP compared with enalapril.
U ispitivanju PARADIGM-HF, Neparvis je smanjio NT-proBNP u plazmi i povećao BNP u plazmi i cGMP u mokraći u usporedbi s enalaprilom.
• The 49 mg/51 mg tablet coating contains hypromellose, titanium dioxide (E171), Macrogol 4000, talc, iron oxide red (E172) and iron oxide yellow (E172).
• Ovojnica tablete od 49 mg/51 mg sadrži hipromelozu, titanijev dioksid (E171), makrogol 4000, talk, željezov oksid crveni (E172) i željezov oksid žuti (E172).
Neparvis 49 mg/51 mg film-coated tablets
Neparvis 49 mg/51 mg filmom obložene tablete
≥49 mg sacubitril/51 mg valsartan/kg/day (≤0.72-fold the maximum recommended human dose [MRHD] on the basis of AUC) and rabbits at doses ≥4.9 mg sacubitril/5.1 mg valsartan/kg/day (2-fold and 0.03-fold the MRHD on the basis of valsartan and LBQ657 AUC, respectively).
Liječenje Neparvisom tijekom organogeneze rezultiralo je povećanom embriofetalnom smrtnosti u štakora pri dozama ≥49 mg sakubitrila/51 mg valsartana/kg/dan (≤0,72 puta najveće preporučene doze za ljude [MRHD] na temelju AUC-a) i u zečeva pri dozama ≥4,9 mg sakubitrila/5,1 mg valsartana/kg/dan (2 odnosno 0,03 puta MRHD-a na temelju AUC-a valsartana, odnosno LBQ657).
At the time of Commission Decision
Odluke Komisije
Neparvis should not be co-administered with an ACE inhibitor or an ARB. Due to the potential risk of angioedema when used concomitantly with an ACE inhibitor, it must not be started for at least 36 hours after discontinuing ACE inhibitor therapy (see sections 4.3, 4.4 and 4.5).
Zbog potencijalnog rizika od angioedema kada se primjenjuje istodobno s ACE inhibitorom, on se ne smije uvesti u terapiju najmanje 36 sati nakon prekida terapije ACE inhibitorom (vidjeti dijelove 4.3, 4.4 i 4.5).
Hypokalaemia
Hipokalijemija
• The 24 mg/26 mg and the 97 mg/103 mg tablet coatings contain hypromellose, titanium dioxide (E171), Macrogol 4000,talc, iron oxide red (E172) and iron oxide black (E172).
• Ovojnica tableta od 24 mg/26 mg i 97 mg/103 mg sadrži hipromelozu, titanijev dioksid (E171), makrogol 4000, talk, željezov oksid crveni (E172) i željezov oksid crni (E172).
• if your kidney artery has narrowed.
• ako imate suženu bubrežnu arteriju.
In PARADIGM-HF, renal impairment was reported in 10.1% of Neparvis-treated patients and 11.5% of enalapril-treated patients.
U ispitivanju PARADIGM-HF, oštećenje bubrega je prijavljeno u 10,1% bolesnika liječenih Neparvisom te u 11,5% bolesnika liječenih enalaprilom.
Candesartan 32 * These limits are not applicable for batches where more than one of the above N-nitrosamines has been identified simultaneously; such batches should be rejected.
valsartan 320 losartan 150 olmesartan 40 irbesartan 300 kandesartan 32 * Te granične vrijednosti nisu primjenjive za serije gdje je utvrđeno istodobno postojanje više od jednog od prethodno navedenih N-nitrozamina; takve serije treba odbaciti.
• low level of red blood cells (shown in a blood test)
• niska razina crvenih krvnih stanica (vidljivo iz krvne pretrage)
56 film-coated tablets.
56 filmom obloženih tableta.
28 film-coated tablets
28 filmom obloženih tableta
If you have been taking an ACE inhibitor, wait 36 hours after taking the last dose of the ACE inhibitor before starting to take Neparvis (see “Do not take Neparvis”).
Ako uzimate ACE inhibitor, pričekajte 36 sati nakon uzimanja posljednje doze ACE inhibitora prije nego počnete uzimati Neparvis (vidjeti „Uzimanje drugih lijekova“).
28 film-coated tablets.
28 filmom obloženih tableta.
No dose adjustment is required in patients with mild (Estimated Glomerular Filtration Rate [eGFR] 60-90 ml/min/1.73 m2) renal impairment.
Estimated Glomerular Filtration Rate [eGFR] 60-90 ml/min/1,73 m2) oštećenjem bubrega.
• decreased renal function (renal impairment)
• smanjena bubrežna funkcija (oštećenje bubrega)
1) Limits for NDMA and NDEA outlined below should be implemented for a transitional period of 2 years:
U prijelaznom razdoblju od dvije godine potrebno je primjenjivati granične vrijednosti za tvari NDMA i NDEA navedene u nastavku:
Very common Orthostatic hypotension Common
Ortostatska hipotenzija
then to the target dose of 200 mg twice daily, with either a 3-week or a 6-week regimen.
Neparvisa 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.
Neparvis must not be administered until 36 hours after discontinuing ACE inhibitor therapy.
Neparvis se ne smije primjenjivati do 36 sati nakon prekida terapije ACE inhibitorom.
≤ eGFR <60 ml/min/1.73 m 2) and severe renal impairment (15 ml/min/1.73 m eGFR <30 ml/min/1.73 m2) was 1.4-fold and 2.2-fold higher compared to patients with mild renal impairment (60 ml/min/1.73 m
<30 ml/min/1,73 m2) bila je 1,4-puta odnosno 2,2-puta viša u usporedbi s bolesnicima s blagim oštećenjem bubrega (60 ml/min/1,73 m
Therefore, when initiating therapy with Neparvis in patients receiving metformin, the clinical status of the patient should be evaluated.
Stoga je potrebno ocijeniti klinički status bolesnika kada se započinje terapija Neparvisom u bolesnika koji primaju metformin.
• Concomitant use with aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2) (see sections 4.4 and 4.5).
• Istodobna primjena s lijekovima koji sadrže aliskiren u bolesnika sa šećernom bolesti ili u bolesnika s oštećenjem bubrega (eGFR <60 ml/min/1,73 m2) (vidjeti dijelove 4.4 i 4.5).
Syncope
Sinkopa
In a 7-day valsartan-controlled study in patients with reduced ejection fraction (HFrEF), administration of Neparvis resulted in an initial increase in natriuresis, increased urine cGMP, and decreased plasma levels of mid-regional pro-atrial natriuretic peptide (MR-proANP) and N-terminal prohormone brain natriuretic peptide (NT-proBNP) compared to valsartan.
povećanjem koncentracije cGMP-a u mokraći te smanjenim razinama u plazmi srednje-regionalnog proatrijalnog natriuretskog peptida (MR-proANP) i N-terminalnog prohormona moždanog natriuretskog peptida (NT-proBNP) u usporedbi s valsartanom.
Impaired hepatic function
Oštećena bubrežna funkcija
• low level of sugar in the blood (shown in a blood test)
• niska razina šećera u krvi (vidljivo iz krvne pretrage)
Neparvis contains valsartan, and therefore should not be co-administered with another ARB containing product (see section 4.4).
Interakcije koje rezultiraju time da se ne preporučuje istodobna primjena Neparvis sadrži valsartan pa se stoga ne smije primjenjivati zajedno s drugim lijekom koji sadrži ARB (vidjeti dio 4.4).
Secondary endpoint
Sekundarni ishod
Other possible side effects: If any of the side effects listed below becomes severe, tell your doctor or pharmacist.
Ako bilo koja od nuspojava navedenih u nastavku postane teška, obratite se svom liječniku ili ljekarniku.
What Neparvis looks like and contents of the pack Neparvis 24 mg/26 mg film-coated tablets are violet-white oval tablets with “NVR” on one side and “LZ” on the other side.
Neparvis 24 mg/26 mg filmom obložene tablete su ljubičasto bijele ovalne tablete s oznakom „NVR“ s jedne strane i „LZ“ s druge strane.
56 film-coated tablets
56 filmom obloženih tableta
Therefore, co-administration of Neparvis with inhibitors of OATP1B1, OATP1B3, OAT3 (e.g. rifampicin, ciclosporin), OAT1 (e.g. tenofovir,
Stoga istodobna primjena Neparvisa s inhibitorima OATP1B1, OATP1B3, OAT3 (npr. rifampicinom, ciklosporinom), OAT1 (npr. tenofovirom, cidofovirom) ili MRP2 (npr. ritonavirom) može povećati sistemsku izloženost LBQ657 ili valsartanu.
CLINICAL PARTICULARS
Ostali neklinički nalazi
Worsening renal function
Pogoršanje bubrežne funkcije
Neparvis must not be started until 36 hours after taking the last dose of ACE inhibitor therapy.
Neparvis se ne smije započinjati do 36 sati nakon uzimanja zadnje doze terapije ACE inhibitorom.
The exposure of LBQ657 in patients with moderate (30 ml/min/1.73 m
Izloženost LBQ657 u bolesnika s umjerenim (30 ml/min/1,73 m eGFR <60 ml/min/1,73 m2) i teškim oštećenjem bubrega (15 ml/min/1,73 m
Neparvis must not be initiated until 36 hours after taking the last dose of ACE inhibitor therapy.
Primjena Neparvisa ne smije se započinjati do 36 sati nakon uzimanja zadnje doze terapije ACE inhibitorom.
Neparvis 49 mg/51 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000
Neparvis 49 mg/51 mg filmom obložene tablete Hipromeloza, supstitucijski tip 2910 (3 mPa s) Titanijev dioksid (E171) Makrogol 4000
The pharmacokinetics of sacubitril, LBQ657 and valsartan were approximately linear over an Neparvis dose range of 24 mg sacubitril/26 mg valsartan to 97 mg sacubitril/103 mg valsartan.
Neparvisa od 24 mg sakubitrila/26 mg valsartana do 97 mg sakubitrila/103 mg valsartana.
The concomitant use of Neparvis with aliskiren-containing products is contraindicated in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2) (see section 4.3).
Istodobna primjena Neparvisa i lijekova koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolesti ili u bolesnika s oštećenjem bubrega (eGFR <60 ml/min/1,73 m2) (vidjeti dio 4.3).
The combination of Neparvis with aliskiren-containing products is contraindicated in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2) (see sections 4.3 and 4.5).
Kombinacija Neparvisa s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolesti ili u bolesnika s oštećenjem bubrega (eGFR <60 ml/min/1,73 m (vidjeti dijelove 4.3 i 4.5).
Neparvis 24 mg/26 mg tablets sacubitril/valsartan
Neparvis 24 mg/26 mg tablete sakubitril/valsartan
Pale yellow ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L1” on the other side.
Blijedo žuta ovaloidna bikonveksna filmom obložena tableta s kosim rubovima, bez zareza, s utisnutom oznakom „NVR“ s jedne strane i „L1“ s druge strane.
Pack sizes: 14, 20, 28 or 56 film-coated tablets and multipacks containing 168 (3x56) or 196 (7x28) film-coated tablets.
Neparvis 49 mg/51 mg filmom obložene tablete Veličine pakiranja: 14, 20, 28 ili 56 filmom obloženih tableta i višestruka pakiranja koja sadrže 168 (3x56) ili 196 (7x28) filmom obloženih tableta.
Neparvis 97 mg/103 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000
Neparvis 97 mg/103 mg filmom obložene tablete Hipromeloza, supstitucijski tip 2910 (3 mPa s) Titanijev dioksid (E171) Makrogol 4000
Light pink ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L11” on the other side.
Svijetlo ružičasta ovaloidna bikonveksna filmom obložena tableta s kosim rubovima, bez zareza, s utisnutom oznakom „NVR“ s jedne strane i „L11“ s druge strane.
Neparvis 49 mg/51 mg tablets sacubitril/valsartan
Neparvis 49 mg/51 mg tablete sakubitril/valsartan
Neparvis 97 mg/103 mg tablets sacubitril/valsartan
Neparvis 97 mg/103 mg tablete sakubitril/valsartan
Neparvis 24 mg/26 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000
Neparvis 24 mg/26 mg filmom obložene tablete Hipromeloza, supstitucijski tip 2910 (3 mPa s) Titanijev dioksid (E171) Makrogol 4000
Violet white ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “LZ” on the other side.
Ljubičasto bijela ovaloidna bikonveksna filmom obložena tableta s kosim rubovima, bez zareza, s utisnutom oznakom „NVR“ s jedne strane i „LZ“ s druge strane.
Neparvis 24 mg/26 mg film-coated tablets sacubitril/valsartan
Neparvis 24 mg/26 mg filmom obložene tablete sakubitril/valsartan
Immune system disorders
Poremećaji imunološkog sustava Preosjetljivost
Neparvis 97 mg/103 mg film-coated tablets sacubitril/valsartan
Neparvis 97 mg/103 mg filmom obložene tablete sakubitril/valsartan
• high level of potassium in the blood (shown in a blood test)
• visoka razina kalija u krvi (vidljivo iz krvne pretrage)
Each film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex).
Svaka filmom obložena tableta sadrži 48,6 mg sakubitrila i 51,4 mg valsartana (u obliku sakubitril valsartan kompleksa natrijeve soli).