FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: F'PARADIGM-HF, iperkalimja u konċentrazzjonijiet ta' potassju fis-serum ta' >5.4 mmol/l kienu rrappurtati fi 11.6% u 19.7% tal-pazjenti trattati b' Neparvis u f'14.0% u 21.1% tal-pazjenti trattati b'enalapril, rispettivament.
English: 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.
Maltese: Il-farmakokinetiċi ta' sacubitril, LBQ657 u valsartan kienu approssivament lineari fuq medda tad-doża ta' Neparvis ta' 24 mg sacubitril/26 mg valsartan sa 97 mg sacubitril/103 mg valsartan.
English: Syncope
Maltese: Sinkope
English: 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.
Maltese: Wara għoti mill-ħalq, 52-68% ta' sacubitril (primarjament bħala LBQ657) u ~13% ta' valsartan u lmetaboliti tiegħu jitneħħew fl-awrina; 37-48% ta' sacubitril (primarjament bħala LBQ657) u 86% ta' valsartan u l-metaboliti tiegħu jitneħħew fl-ippurgar.
English: Full analysis set
Maltese: Informazzjoni għall-pazjent
English: • lithium, a medicine used to treat some types of psychiatric illness.
Maltese: • lithium, mediċina li tintuża għall-kura ta' xi tipi ta' mard psikjatriku.
English: 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.
Maltese: Fi studju kkontrollat bil-valsartan mifrux fuq 7 ijiem f'pazjenti bi frazzjoni mnaqqsa ta' tfigħ 'il barra (HFrEF), l-għoti ta' Neparvis rriżulta f'żieda inizjali f'natrijureżi, żieda fl-awrina cGMP u livelli mnaqqsa fil-plażma ta' mid-regional pro-atrial natriuretic peptide (MR-proANP) u N-terminal prohormone brain natriuretic peptide (NT-proBNP), meta mqabbel ma' valsartan.
English: Adverse reactions are ranked by System organ class and then by frequency with the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont is-Sistema tal-klassifika tal-organi u mbagħad skont il-frekwenza, bl-aktar frekwenti jiġu l-ewwel, billi tintuża l-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000).
English: 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.
Maltese: F'PARADIGM-HF, pressjoni baxxa u pressjoni sistolika baxxa klinikament rilevanti (<90 mmHg u tnaqqis mil-linja bażi ta' >20 mmHg) ġew irrappurtati fi 17.6% u 4.76% tal-pazjenti trattati b' Neparvis meta mqabbel ma' 11.9% u 2.67% tal-pazjenti trattati b'enalapril, rispettivament.
English: Immune system disorders
Maltese: Disturbi fis-sistema immunitarja Ipersensittività
English: ≥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).
Maltese: 72 darba mid-doża massima rrakkomandata għallbniedem [MRHD] fuq il-bażi tal-AUC) u fil-fniek f'dożi ≥4.9 mg sacubitril/5.1 mg valsartan/kg/jum (2 darbiet u 0.03 darbiet mid-MRHD fuq il-bażi tal-AUC ta' valsartan u LBQ657, rispettivament).
English: 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%).
Maltese: 4% tal-pazjenti waqfu b'mod permanenti, 5.9% minħabba reazzjoni avvera, l-aktar komuni disfunzjoni renali (1.8%), pressjoni baxxa (1.7%) u iperkalemija (1.3%).
English: Patients with renal artery stenosis
Maltese: Pazjenti bi stenożi tal-arterja renali
English: Interactions resulting in a contraindication
Maltese: Interazzjonijiet li jirriżultaw f'kontraindikazzjoni
English: 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.
Maltese: PARADIGM-HF kien studju double-blind, randomizzat u multinazzjonali ta' 8,442 pazjent li qabbel lNeparvis mal-enalapril, it-tnejn mogħtija lil pazjenti adulti b'insuffiċjenza kronika tal-qalb, NYHA tal-kategorija II-IV u frazzjoni mnaqqsa ta' tfigħ 'il barra (frazzjoni ventrikulari tax-xellug ta' tfigħ 'il barra [LVEF] ≤40%, aktar tard emendata għal ≤35%) minbarra terapija oħra għal insuffiċjenza talqalb.
English: 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.
Maltese: Il qawwiet ta' 24 mg/26 mg, 49 mg/51 mg u 97 mg/103 mg f'xi publikazzjonijiet saret referenza għalihom bħala 50, 100 jew 200 mg.
English: 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).
Maltese: It-trattament b'Sacubitril matul l-organoġenesi rriżulta f'letalità embrijufetali u tossiċità embrijufetali (tnaqqis fil-piżijiet tal-ġisem tal-fetu u malformazzjonijiet skeletali) fil-fniek f'dożi assoċjati mattossiċità materna (500 mg/kg/jum; 5.7 darbiet aktar mill-MRHD abbażi ta' LBQ657 AUC).
English: Increases in CSF Aβ1-40 and 1-42 were not observed in a two-week healthy volunteer study in humans (see section 5.1).
Maltese: Aβ1-40 u 1-42 fi studju fuq voluntiera umani f'saħħithom mifrux fuq ġimgħatejn (ara sezzjoni 5.1).
English: 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.
Maltese: Doża waħda ta' Neparvis 583 mg sacubitril/617 mg valsartan u dożi multipli ta' 437 mg sacubitril/463 mg valsartan (14-il jum) ġew studjati fuq voluntiera f'saħħithom u kienu ttollerati tajjeb.
English: 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).
Maltese: [SBP - systolic blood pressure] ≤95 mmHg, pressjoni baxxa sintomatika, iperkalimja, disfunzjoni tal-kliewi), huwa rakkomandat aġġustament ta' prodotti mediċinali li jittieħdu fl-istess waqt, titrazzjoni 'l isfel temporanja jew twaqqif ta' Neparvis (ara sezzjoni 4.4).
English: Neparvis is contraindicated in patients with severe hepatic impairment, biliary cirrhosis or cholestasis (Child-Pugh C classification) (see section 4.3).
Maltese: Neparvis huwa kontraindikat f'pazjenti b'indeboliment tal-fwied, ċirrożi biljari jew kolestażi gravi (klassifikazzjoni Child-Pugh C) (ara sezzjoni 4.3).
English: In PARADIGM-HF, renal impairment was reported in 10.1% of Neparvis-treated patients and 11.5% of enalapril-treated patients.
Maltese: F'PARADIGM-HF, indeboliment renali kien irrappurtat f'10.1% tal-pazjenti trattati b' Neparvis u fi 11.5% tal-pazjenti trattati b'enalapril.
English: A slight generalised delay in ossification was observed at doses of >50 mg/kg/day.
Maltese: Ittardjar ġeneralizzat ħafif fl-ossifikazzjoni kien osservat b'dożi ta' >50 mg/kg/jum.
English: • some types of antibiotics (rifamycin group), ciclosporin (used to prevent rejection of transplanted organs) or antivirals such as ritonavir (used to treat HIV/AIDS).
Maltese: • xi tipi ta' antibijotiċi (grupp ta' rifamycin), ciclosporin (li tintuża sabiex tipprevjeni r-rifjut mill ġisem tal-organi trapjantati) jew antivirali bħal ritonavir (li tintuża għall-kura tal-HIV/AIDS).
English: 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.
Maltese: Fi studju kliniku QTc imwettaq bir-reqqa f'individwi maskili f'saħħithom, dożi waħdiet ta' Neparvis 194 mg sacubitril/206 mg valsartan u 583 mg sacubitril/617 mg valsartan ma kellhom ebda effett fuq ir-ripolarizzazzjoni kardijaka.
English: 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).
Maltese: Il-ħsara filpompa kienet tammonta għal 26% tal-imwiet kardjovaskulari u tnaqqset b'21% fil-pazjenti kkurati b' Neparvis, meta mqabbla mal-pazjenti kkurati b'enalapril (HR 0.79, p=0.0338).
English: 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.
Maltese: Dan it-tnaqqis tar-riskju kien osservat konsistentement fis-sottogruppi, inklużi: is-sess, l-età, ir-razza, il-ġeografija, il-kategorija ta' NYHA (II/III), il-frazzjoni ta' tfigħ 'il barra, il-funzjoni tal-kliewi, listorja tad-dijabete jew il-pressjoni għolja, it-terapija preċedenti għal insuffiċjenza tal-qalb u lfibrillazzjoni atrijali.
English: 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.
Maltese: L-għoti ta' Neparvis flimkien ma' furosemide ma kellu ebda effett fuq il-farmakokinetika ta' Neparvis, iżda naqqas Cmax u AUC ta' furosemide b'50% u 28%, rispettivament.
English: 168 film-coated tablets
Maltese: 168 pillola miksija b'rita
English: • The active substances are sacubitril and valsartan.
Maltese: • Is-sustanzi attivi huma sacubitril u valsartan.
English: • The other ingredients in the tablet core are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, magnesium stearate, talc and silica colloidal anhydrous.
Maltese: • Is-sustanzi l-oħra fil-qalba tal-pillola huma ċelluloża mikrokristallina, hydroxypropylcellulose b'sostituzzjoni baxxa, crospovidone, stearate tal-manjeżju (oriġini veġetali), talc u anidru kollojdali silika.
English: Neparvis does not induce or inhibit CYP450 enzymes.
Maltese: Neparvis la jinduċi u lanqas jinibixxi enzimi CYP450.
English: The oral absolute bioavailability of sacubitril and valsartan is estimated to be more than 60% and 23%, respectively.
Maltese: Il-bijodisponibbiltà orali assoluta ta' sacubitril u valsartan hija stmata li hija ta' aktar minn 60% u 23%, rispettivament.
English: *See description of selected adverse reactions.
Maltese: *Ara deskrizzjoni ta' reazzjonijiet avversi magħżula.
English: • gastritis (stomach pain, nausea)
Maltese: • gastrite (uġigħ fl-istonku, dardir)
English: ≤ eGFR <90 ml/min/1.73 m2), the largest group of patients enrolled in
Maltese: ≤ eGFR <90 ml/min/1.73 m2), l-akbar grupp ta' pazjenti rreġistrati f'PARADIGM-HF).
English: No clinically relevant drug-drug interaction was observed when simvastatin and Neparvis were coadministered.
Maltese: Ma ġiet osservata ebda interazzjoni klinikament relevanti meta simvastatin u Neparvis ingħataw flimkien.
English: Potassium
Maltese: Potassju
English: 28 film-coated tablets.
Maltese: 28 pillola miksija b'rita.
English: Neparvis may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis.
Maltese: Neparvis jista' jżid l-urea fid-demm u l-livelli tal-kreatinina fis-serum f'pazjenti bi stenożi bilaterali jew unilaterali fl-arterja renali.
English: Table 2 Treatment effect for the primary composite endpoint, its components and all-cause mortality over a median follow-up of 27 months
Maltese: Tabella 2 L-effett tat-trattament għall-endpoint kompost primarju, il-komponenti tiegħu u lmortalità minn kull kawża fuq perjodu ta' segwitu medju ta' 27 xahar
English: • The combination of Neparvis with direct renin inhibitors such as aliskiren is not recommended (see section 4.5).
Maltese: • Il-kombinazzjoni ta' Neparvis ma' inibituri ta' renin diretti bħal aliskiren mhijiex rakkomandata (ara sezzjoni 4.5).
English: Based on the comparison of plasma and CSF exposures, LBQ657 crosses the blood brain barrier to a limited extent (0.28%).
Maltese: Abbażi talparagun tal-espożizzjonijiet fil-plażma u fis-CSF, LBQ657 jaqsam il-barriera ematoenċefalika sa ċertu punt limitat (0.28%).
English: 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).
Maltese: Fi studju PARADIGM-HF, Neparvis ingħata flimkien ma' terapiji oħra għal insuffiċjenza tal-qalb, minflok inibitur ta' ACE jew imblokkatur tar-riċetturi ta' angiotensin II (ARB - angiotensin receptor blocker) ieħor (ara sezzjoni 5.1).
English: 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.
Maltese: Il-pazjenti b'SBP <100 mmHg, indeboliment tal-kliewi gravi (eGFR <30 ml/min/1.73 m2) u indeboliment tal-fwied gravi ġew esklużi fl-iskrinjar u, għalhekk, ma ġewx studjati b'mod prospettiv.
English: • Known history of angioedema related to previous ACE inhibitor or ARB therapy (see section 4.4).
Maltese: • Storja magħrufa ta' anġjoedima relatata ma' inibitur ta' ACE jew terapija ARB preċedenti (ara sezzjoni 4.4).
English: Neparvis 24 mg/26 mg film-coated tablets Neparvis 49 mg/51 mg film-coated tablets Neparvis 97 mg/103 mg film-coated tablets sacubitril/valsartan
Maltese: Neparvis 24 mg/26 mg pilloli miksija b'rita Neparvis 49 mg/51 mg pilloli miksija b'rita Neparvis 97 mg/103 mg pilloli miksija b'rita sacubitril/valsartan
English: • painkillers of the type called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 (Cox-2) inhibitors.
Maltese: • mediċini li jtaffu l-uġigħ tat-tip imsejħa mediċini anti-infjammatorji nonsterojdali (NSAIDs) jew inibituri selettivi ta' cyclooxygenase-2 (Cox-2).
English: Impaired renal function
Maltese: Funzjoni renali indebolita
English: • nitroglycerine, a medicine used to treat angina.
Maltese: • nitrogliċerina, mediċina li tintuża għall-kura ta' anġina.
English: 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).
Maltese: Anormalitajiet kardjovaskulari (il-biċċa l-kbira kardjomegalija) kienu osservati filfeti tal-fniek b'doża mhux tossika għall-omm (1.46 mg sacubitril/1.54 mg valsartan/kg/jum).
English: 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.
Maltese: F'pazjenti b'indeboliment tal-fwied minn ħafif sa moderat, l-espożizzjonijiet ta' sacubitril żdiedu b'1.5- u 3.4 darbiet, ta' LBQ657 żdiedu b'1.5- u 1.9 darbiet u ta' valsartan żdiedu b'1.2 u 2.1 darbiet, rispettivament, imqabbla ma' dawk f'individwi f'saħħithom.
English: 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).
Maltese: Is-sigurtà ta' Neparvis f'pazjenti b'insuffiċjenza kronika tal-qalb ġiet evalwata fil-fażi pivotali 3 talistudju PARADIGM-HF, li qabbel il-pazjenti kkurati darbtejn kuljum b' Neparvis 97 mg/103 mg (n=4,203) jew b'enalapril 10 mg (n=4,229).
English: 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.
Maltese: Aβ fix-xadini cynomolgus naqset, billi żied il-livelli Aβ1-40, 1-42 u 1-38 tas-CSF; ma kien hemm ebda żieda korrispondenti fillivelli Aβ fil-moħħ.
English: Very common Orthostatic hypotension Common
Maltese: Komuni ħafna Pressjoni baxxa ortostatika Komuni
English: Therefore, co-administration of Neparvis with inhibitors of OATP1B1, OATP1B3, OAT3 (e.g. rifampicin, ciclosporin), OAT1 (e.g. tenofovir,
Maltese: Għalhekk, it-teħid ta' Neparvis flimkien ma' inibituri ta' OATP1B1, OATP1B3, OAT3 (eż. rifampicin, ciclosporin), OAT1 (eż. tenofovir, cidofovir) jew MRP2 (eż. ritonavir) jista' jżid l-espożizzjoni sistemika għal LBQ657 jew valsartan.
English: 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).
Maltese: Jekk it-trattament b' Neparvis jitwaqqaf, it-terapija b'inibitur ta' ACE m'għandhiex tinbeda sa 36 siegħa wara l-aħħar doża ta' Neparvis (ara sezzjonijiet 4.2, 4.3 u 4.5).
English: Multipack: 168 (3 packs of 56) film-coated tablets Multipack: 196 (7 packs of 28) film-coated tablets
Maltese: Pakkett b'ħafna: 168 (3 pakketti ta' 56) pilloli miksija b'rita Pakkett b'ħħħafna: 196 (7 pakketti ta' 28) pilloli miksija b'rita
English: • The 49 mg/51 mg tablet coating contains hypromellose, titanium dioxide (E171), Macrogol 4000, talc, iron oxide red (E172) and iron oxide yellow (E172).
Maltese: • Il-kisja tal-pillola ta' 49 mg/51 mg fiha hypromellose, dijossidu tat-titanju (E171), Macrogol 4000, talc, ossidu tal-ħadid aħmar (E172) u ossidu tal-ħadid isfar (E172).
English: 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.
Maltese: Studji tal-metaboliżmu in vitro jindikaw li l-potenzjal għal interazzjonijiet b'mediċini bbażati fuq CYP450 huwa baxx minħabba li hemm metaboliżmu limitat ta' Neparvis permezz tal-enzimi CYP450.
English: Unless continued ARB therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Maltese: Sakemm terapija kontinwa b'ARB ma tkunx meqjusa essenzjali, pazjenti li qed jippjanaw tqala għandhom jinqalbu għal trattamenti alternattivi kontra l-pressjoni li għandhom profil ta' sigurtà stabbilit għall-użu fit-tqala.
English: The 49 mg/51 mg and 97 mg/103 mg tablets are also supplied in multipacks of 168 tablets (3 packs of 56 tablets).
Maltese: Il-pilloli ta' 49 mg/51 mg u ta' 97 mg/103 mg jiġu wkoll f'pakketti b'ħafna ta' 168 pillola (3 pakketti ta' 56 pillola).
English: 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.
Maltese: L-NPs jeżerċitaw l-effetti tagħhom billi jattivaw ir-riċetturi akkoppjati minn guanylyl cyclase marbuta b'membrana, li jirriżultaw f'konċentrazzjonijiet akbar tattieni monofosfat gwanożina ċikliku (cGMP) messaġġier, li jistgħu jirriżultaw f'vażodilazzjoni, innatrijureżi u d-dijureżi, żieda fir-rata tal-filtrazzjoni glomerulari u l-fluss tad-demm renali, inibizzjoni tar-rilaxx tar-renin u tal-aldosterone, tnaqqis tal-attività simpatetika u l-effetti anti-ipertrofiċi u anti-fibrotiċi.
English: Neparvis 49 mg/51 mg tablets sacubitril/valsartan
Maltese: Neparvis 49 mg/51 mg pilloli sacubitril/valsartan
English: 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).
Maltese: Il-pazjenti ntalbu jwaqqfu t-terapija eżistenti tagħhom b'inibitur ta' ACE jew ARB u jidħlu f'perjodu inizjali single-blind sekwenzjali, li matulu rċevew trattament b'enalapril 10 mg darbtejn kuljum, segwit minn trattament single-blind b' Neparvis 100 mg darbtejn kuljum, li jiżdied għal 200 mg darbtejn kuljum (ara sezzjoni 4.8 għal twaqqif matul dan il-perjodu).
English: Impaired hepatic function
Maltese: Funzjoni epatika indebolita
English: 14 film-coated tablets 20 film-coated tablets 28 film-coated tablets 56 film-coated tablets
Maltese: 14-il pillola miksija b'rita 20 pillola miksija b'rita 28 pillola miksija b'rita 56 pillola miksija b'rita
English: Primary composite endpoint of CV death and heart failure hospitalisations*
Maltese: Endpoint kompost primarju ta' mewt CV u ospitalizzazzjonijiet ta' pazjenti b'insuffiċjenza talqalb *
English: Tabulated list of adverse reactions
Maltese: Lista ttabulata tar-reazzjonijiet avversi
English: Neparvis 24 mg/26 mg tablets sacubitril/valsartan
Maltese: Neparvis 24 mg/26 mg pilloli sacubitril/valsartan
English: Neparvis 97 mg/103 mg tablets sacubitril/valsartan
Maltese: Neparvis 97 mg/103 mg pilloli sacubitril/valsartan
English: Pack sizes: 14, 20, 28 or 56 film-coated tablets and multipacks containing 168 (3x56) or 196 (7x28) film-coated tablets.
Maltese: Daqsijiet tal-pakkett: 14, 20, 28 jew 56 pillola miksija b'rita u pakketti b'ħafna li fihom 168 (3x56) jew 196 (7x28) pillola miksija b'rita.
English: 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%).
Maltese: 5%) waqfu b'mod permanenti mill-istudju, 5.6% minħabba reazzjoni avversa, l-aktar komuni disfunzjoni renali (1.7%), iperkalemija (1.7%) u pressjoni baxxa (1.4%).
English: Neparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1).
Maltese: Neparvis huwa indikat f'pazjenti adulti għall-kura ta' insuffiċjenza sintomatika kronika tal-qalb bi frazzjoni mnaqqsa ta' tfigħ 'il barra (ara sezzjoni 5.1).
English: Hyperkalaemia*
Maltese: Iperkalemija*
English: • Concomitant use with ACE inhibitors (see sections 4.4 and 4.5).
Maltese: • Użu fl-istess ħin ma' inibituri ta' ACE (ara sezzjonijiet 4.4 u 4.5).
English: 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.
Maltese: TITRAZZJONI kien studju tas-sigurtà u t-tollerabbiltà mifrux fuq 12-il ġimgħa f'538 pazjent b'insuffiċjenza kronika tal-qalb (NYHA tal-kategorija II-IV) u disfunzjoni sistolika (frazzjoni ventrikulari tax-xellug ta' tfigħ 'il barra ≤35%) naivi għat-terapija b'inibitur ta' ACE jew ARB jew fuq dożi li jvarjaw ta' inibituri ta' ACE jew ARBs qabel id-dħul fl-istudju.
English: Co-administration of Neparvis with metformin reduced both Cmax and AUC of metformin by 23%.
Maltese: L-għoti ta' Neparvis flimkien ma' metformin naqqas Cmax u AUC ta' metformin bi 23%.
English: Neparvis 24 mg/26 mg film-coated tablets Neparvis 49 mg/51 mg film-coated tablets Neparvis 97 mg/103 mg film-coated tablets
Maltese: Neparvis 24 mg/26 mg pilloli miksija b'rita Neparvis 49 mg/51 mg pilloli miksija b'rita Neparvis 97 mg/103 mg pilloli miksija b'rita