FrancophonIA/ELRC3.0 huggingface dataset:
English: • 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).
Maltese: • Il-kisjiet tal-pilloli ta' 24 mg/26 mg u ta' 97 mg/103 mg fihom hypromellose, dijossidu tattitanju (E171), Macrogol 4000,talc, ossidu tal-ħadid aħmar (E172) u ossidu tal-ħadid iswed (E172).
English: 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).
Maltese: Il-livell bla effett ħażin osservat (NOAEL) embrijufetali għal sacubitril kien mill-inqas 750 mg/kg/jum fil-firien u 200 mg/kg/jum fil-fniek (2.2 darbiet aktar mill-MRHD abbażi ta' LBQ657 AUC).
English: Neparvis 49 mg/51 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000
Maltese: Neparvis 49 mg/51 mg pilloli miksija b'rita Ipromelloża, sostituzzjoni tat-tip 2910 (3 mPa·s) Diossidu tat-titanju (E171) Macrogol 4000
English: Approximate tablet dimensions 13.1 mm x 5.2 mm Neparvis 97 mg/103 mg film-coated tablets are light pink oval tablets with “NVR” on one side and “L11” on the other side.
Maltese: Il-pilloli miksija b'rita Neparvis 97 mg/103 mg huma pilloli ovali ta' lewn roża ċar b'“NVR” fuq naħa waħda u “L11” fuq in-naħa l-oħra.
English: The combination of Neparvis with direct renin inhibitors such as aliskiren is not recommended (see section 4.4).
Maltese: Il-kombinazzjoni ta' Neparvis flimkien ma' inibituri ta' renin diretti bħal aliskiren mhijiex rakkomandata (ara sezzjoni 4.4).
English: The adverse embryofoetal effects of Neparvis are attributed to the angiotensin receptor antagonist activity (see section 4.6).
Maltese: L-effetti embrijufetali avversi ta' Neparvis huma attribwiti għall-attività tal-antagonist tar-riċettur talanġjotensina (ara sezzjoni 4.6).
English: Each 97 mg/103 mg tablet contains 97.2 mg sacubitril and 102.8 mg valsartan (as sacubitril valsartan sodium salt complex).
Maltese: Kull pillola ta' 97 mg/103 mg fiha 97.2 mg sacubitril u 102.8 mg valsartan (bħala kumpless ta' melħ tas-sodju ta' sacubitril valsartan).
English: Neparvis 97 mg/103 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000
Maltese: Neparvis 97 mg/103 mg pilloli miksija b'rita Ipromelloża, sostituzzjoni tat-tip 2910 (3 mPa·s) Diossidu tat-titanju (E171) Macrogol 4000
English: 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.
Maltese: L-effetti ta' Neparvis fuq il-konċentrazzjonijiet tal-amilojde-β fis-CSF u t-tessut tal-moħħ kienu evalwati f'xadini cynomolgus żgħar (fl-età ta' 2-4 snin) ikkurati b' Neparvis (24 mg sacubitril/26 mg valsartan/kg/jum) għal ġimgħatejn.
English: • Severe hepatic impairment, biliary cirrhosis and cholestasis (see section 4.2).
Maltese: • Indeboliment tal-fwied, ċirrożi biljari u kolestażi gravi (ara sezzjoni 4.2).
English: 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).
Maltese: L-imwiet għall-għarrieda kienu jammontaw għal 45% tal-imwiet kardjovaskulari u tnaqqsu b'20% fil-pazjenti kkurati b' Neparvis, meta mqabbla mal-pazjenti kkurati b'enalapril (HR 0.80, p=0.0082).
English: ACE inhibitor therapy must not be started until 36 hours after the last dose of Neparvis (see sections 4.2 and 4.3).
Maltese: It-terapija b'inibitur ta' ACE m'għandhiex tinbeda sa 36 siegħa wara l-aħħar doża ta' Neparvis (ara sezzjonijiet 4.2 u 4.3).
English: No evidence of embryo-foetal toxicity or teratogenicity was observed in rats treated with sacubitril.
Maltese: Ma ġiet osservata ebda evidenza ta' tossiċità embrijufetali jew teratoġeniċità f'firien ikkurati b'sacubitril.
English: Treatment should not be initiated in patients with serum potassium level >5.4 mmol/l or with SBP <100 mmHg (see section 4.4).
Maltese: It-trattament m'għandux jinbeda f'pazjenti b'livell ta' potassju fis-serum ta' >5.4 mmol/l jew b'SBP ta' <100 mmHg (ara sezzjoni 4.4).
English: Renal failure (renal failure, acute renal failure)
Maltese: Indeboliment tal-kliewi* Komuni ħafna Insuffiċjenza renali (insuffiċjenza renali, insuffiċjenza renali akuta)
English: • allergic reaction with rash and itching
Maltese: • reazzjoni allerġika b'raxx jew ħakk
English: 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.
Maltese: Neparvis juri l-mekkaniżu ta' azzjoni ta' inibitur ta' neprilysin tar-riċettur tal-anġjotensina billi jinibixxi n-neprilysin b'mod simultanju (endopeptidase newtrali; NEP) permezz ta' LBQ657, ilmetabolita attiva tal-promediċina sacubitril, u billi jimblokka r-riċettur tal-anġjotensina
English: Neparvis 24 mg/26 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000
Maltese: Neparvis 24 mg/26 mg pilloli miksija b'rita Ipromelloża, sostituzzjoni tat-tip 2910 (3 mPa·s) Diossidu tat-titanju (E171) Macrogol 4000
English: 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).
Maltese: Neparvis m'għandux jingħata flimkien ma' inibitur ta' ACE jew ma' ARB. Minħabba r-riskju potenzjali ta' anġjoedima meta jintuża fl-istess ħin ma' inibitur ta' ACE, m'għandux jinbeda għal millinqas 36 siegħa wara li titwaqqaf it-terapija b'inibitur ta' ACE (ara sezzjonijiet 4.3, 4.4 u 4.5).
English: 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).
Maltese: Kombinazzjoni ta' Neparvis ma' aliskiren hija potenzjalment assoċjata ma' frekwenza ogħla ta' avvenimenti avversi bħal pressjoni baxxa, iperkalimja u tnaqqis filfunzjoni renali (li jinkludi insuffiċjenza akuta tal-kliewi) (ara sezzjonijiet 4.3 u 4.4).
English: 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).
Maltese: Fil-grupp ta' enalapril, 75% tal-pazjenti baqgħu jieħdu d-doża fil-mira ta' 10 mg darbtejn kuljum fi tmiem l-istudju (doża medja ta' kuljum ta' 18.9 mg).
English: • metformin, a medicine used to treat diabetes.
Maltese: • metformin, mediċina li tintuża għall-kura tad-dijabete.
English: ≤ 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
Maltese: <30 ml/min/1.73 m2) kien 1.4 darbiet u 2.2 darbiet ogħla meta mqabbel ma' pazjenti b'indeboliment renali ħafif (60 ml/min/1.73 m
English: • dizziness
Maltese: • dijarrea
English: A correlation was observed between renal function and systemic exposure to LBQ657 in patients with mild to severe renal impairment.
Maltese: Ġiet osservata korrelazzjoni bejn il-funzjoni renali u l-espożizzjoni sistemika għal LBQ657 f'pazjenti b'indeboliment renali minn ħafif sa gravi
English: Animal studies with Neparvis have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali urew effett tossiku fuq issistema riproduttiva (ara sezzjoni 5.3).
English: 56 film-coated tablets
Maltese: 56 pillola miksija b'rita
English: The relative risk reduction was 16% compared with enalapril (see Table 2).
Maltese: It-tnaqqis tar-riskju relattiv kien ta' 16% meta mqabbel ma' enalapril (ara Tabella 2).
English: LBQ657 and valsartan exposure are increased in subjects over 65 years of age by 42% and 30%, respectively, compared to younger subjects.
Maltese: L-espożizzjoni għal LBQ657 u l-espożizzjoni għal valsartan huma miżjuda f'individwi ta' 'l fuq minn 65 sena bi 42% u 30%, rispettivament, imqabbla ma' individwi iżgħar.
English: 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).
Maltese: Fil-grupp ta' Neparvis, 76% tal-pazjenti baqgħu jieħdu d-doża fil-mira ta' 200 mg darbtejn kuljum fi tmiem l-istudju (doża medja ta' kuljum ta' 375 mg).
English: 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.
Maltese: It-tnaqqis tar-riskju assolut kien ta' 4.7% għall-aggregat tal-mewt CV jew tal-ospitalizzazzjoni ta' pazjenti b'HF, 3.1% għall-mewt CV waħdu u 2.8% għall-ewwel ospitalizzazzjoni ta' pazjenti b'HF weħidha.
English: In PARADIGM-HF, angioedema was reported in 0.5% of patients treated with Neparvis, compared with 0.2% of patients treated with enalapril.
Maltese: F'PARADIGM-HF, anġjoedima ġiet irrapportata f'0.5% tal-pazjenti kkurati b' Neparvis, imqabbla ma' 0.2% tal-pazjenti kkurati b'enalapril.
English: TITRATION
Maltese: TITRAZZJONI
English: Each 49 mg/51 mg tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex).
Maltese: Kull pillola ta' 49 mg/51 mg fiha 48.6 mg sacubitril u 51.4 mg valsartan (bħala kumpless ta' melħ tassodju ta' sacubitril valsartan).
English: Following twice daily dosing of Neparvis, steady-state levels of sacubitril, LBQ657 and valsartan are reached in three days.
Maltese: Wara dożaġġ darbtejn kuljum ta' Neparvis, il-livelli fi stat stabbli ta' sacubitril, LBQ657 u valsartan jintlaħqu fi tlett ijiem.
English: More patients who were naïve to previous ACE inhibitor or ARB therapy or on low-dose therapy (equivalent to <10 mg enalapril/day) were able to achieve and maintain Neparvis 200 mg when up-titrated over 6 weeks (84.8%) versus 3 weeks (73.6%).
Maltese: Aktar pazjenti li kienu naivi għat-terapija preċedenti b'inibitur ta' ACE jew ARB jew fuq terapija b'doża baxxa (ekwivalenti għal <10 mg enalapril/jum) setgħu jilħqu u jżommu d-doża ta' Neparvis 200 mg meta kienu titrati 'l fuq għal 6 ġimgħat (84.8%) versus 3 ġimgħat (73.6%).
English: • diarrhoea
Maltese: • debbulizza
English: 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).
Maltese: Il-kombinazzjoni ta' Neparvis ma' prodotti li fihom aliskiren huwa kontraindikat f'pazjenti b'dijabete mellitus jew f'pazjenti b'indeboliment tal-kliewi (eGFR <60 ml/min/1.73 m2) (ara sezzjonijiet 4.3 u 4.5).
English: 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.
Maltese: L-użu fl-istess ħin ta' dijuretiċi li ma jneħħux il-potassju (triamterene, amiloride), antagonisti mineralokortikojdi (eż. spironolactone, eplerenone), supplimenti tal-potassju, sostituti tal-melħ li jkun fihom il-potassju jew aġenti oħrajn (bħal eparina) jista' jwassal għal żidiet tal-potassju fis-serum u għal żidiet tal-kreatinina fis-serum.
English: • 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).
Maltese: • Użu fl-istess ħin ma' prodotti mediċinali li fihom aliskiren f'pazjenti b'dijabete mellitus jew f'pazjenti b'indeboliment tal-kliewi (eGFR <60 ml/min/1.73 m2) (ara sezzjonijiet 4.4 u 4.5).
English: 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.
Maltese: Żieda żgħira f'żewġ varjazzjonijiet skeletriċi tal-fetu (sternebra sfurmata, ossifikazzjoni bilaterali talisternebra) kienet osservata fil-fniek b'doża ta' Neparvis ta' 4.9 mg sacubitril/5.1 mg valsartan/kg/jum.
English: The risk may be further increased by dehydration or concomitant use of non-steroidal anti-inflammatory agents (NSAIDs) (see section 4.5).
Maltese: Ir-riskju jista' jkompli jiżdied permezz ta' deidrazzjoni jew l-użu fl-istess ħin ta' aġenti anti-infjammatorji nonsterojdali (NSAIDs) (ara sezzjoni 4.5).
English: 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.
Maltese: Neparvis kien superjuri għal enalapril, billi naqqas ir-riskju ta' mewt kardjovaskulari jew lospitalizzazzjonijiet ta' pazjenti b'insuffiċjenza tal-qalb għal 21.8% meta mqabbel ma' 26.
English: • furosemide, a medicine belonging to the type known as diuretics, which are used to increase the amount of urine you produce.
Maltese: • furosemide, mediċina li tappartjeni għat-tip magħruf bħala dijuretiċi, li jintużaw sabiex iżidu l ammont ta' awrina li tipproduċi.
English: Component of a multipack.
Maltese: Komponent ta' pakkett b'ħafna.
English: If serum potassium level is >5.4 mmol/l discontinuation should be considered.
Maltese: Jekk il-livell tal-potassju fis-serum ikun >5.4 mmol/l, għandu jiġi kkunsidrat twaqqif.
English: 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.
Maltese: F'firien żgħar ikkurati b'valsartan (minn 7 ijiem sa 70 jum wara t-twelid), dożi baxxi daqs 1 mg/kg/jum ipproduċew bidliet persistenti u irriversibbli fil-kliewi li jikkonsistu f'nefropatija tubulari (xi drabi akkumpanjata minn nekrożi epiteljali tubulari) u twessigħ tal-pelvi.
English: 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.
Maltese: L-istudji tal-iżvilupp prenatali u postnatali fil-firien, li twettqu b'sacubitril f'dożi għoljin sa 750 mg/kg/jum (2.2 darbiet aktar mill-MRHD fuq il-bażi tal-AUC) u b'valsartan f'dożi sa 600 mg/kg/jum (0.86 darba mill-MRHD fuq il-bażi tal-AUC), jindikaw li t-trattament b' Neparvis matul l-organoġenesi, il-ġestazzjoni u t-treddigħ jista' jaffettwa l-iżvilupp u s-sopravivenza tal-frieħ.
English: 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.
Maltese: Madankollu f'pazjenti b'indeboliment tal-fwied minn ħafif sa moderat, l-espożizzjonijiet tal-konċentrazzjonijiet ħielsa ta' LBQ657 żdiedu b'1.47 u 3.08 darbiet, rispettivament, u l-espożizzjonijiet tal-konċentrazzjonijiet ħielsa ta' valsartan żdiedu b'1.09 darbiet u 2.20 darba, rispettivament, imqabbla ma' dawk f'individwi f'saħħithom.
English: PVC/PVDC/Aluminium blisters.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-PVC/PVDC/Aluminju.
English: 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.
Maltese: Minħabba li l-metaboliżmu medjat b'enzima CYP450 ta' sacubitril u valsartan huwa minimu, l-għoti flimkien ma' prodotti mediċinali li jħallu impatt fuq l-enzimi CYP450 mhux mistenni li jħalli impatt fuq il-farmakokinetiċi.
English: • 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”).
Maltese: • jekk għandek id-dijabete jew funzjoni indebolita tal-kliewi u qed tingħata kura b'mediċina li tbaxxi l-pressjoni tad-demm li fiha aliskiren (ara “Mediċini oħra u Neparvis”).
English: o Each 97 mg/103 mg film-coated tablet contains 97.2 mg sacubitril and 102.8 mg valsartan (as sacubitril valsartan sodium salt complex).
Maltese: o Kull pillola miksija b'rita ta' 97 mg/103 mg fiha 97.2 mg sacubitril u 102.8 mg valsartan (bħala kumpless ta' melħ tas-sodju ta' sacubitril valsartan).
English: 28 film-coated tablets
Maltese: 28 pillola miksija b'rita
English: The primary endpoint was the composite of cardiovascular (CV) death or hospitalisation for heart failure (HF).
Maltese: L-endpoint primarju kien l-aggregat ta' mewta kardjovaskulari (CV) jew l-ospitalizzazzjoni għal insuffiċjenza tal-qalb (HF).
English: Neparvis 97 mg/103 mg film-coated tablets
Maltese: Neparvis 97 mg/103 mg pilloli miksija b'rita
English: 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.
Maltese: Hemm esperjenza klinika limitata f'pazjenti b'indeboliment moderat tal-fwied (klassifikazzjoni Child-Pugh B) jew b'valuri ta' AST/ALT ta' aktar minn darbtejn l-ogħla limitu tal-firxa normali.
English: Pack sizes: 14, 20, 28 or 56 film-coated tablets and multipacks containing 196 (7x28) film-coated tablets.
Maltese: Daqsijiet tal-pakkett: 14, 20, 28 jew 56 pillola miksija b'rita u pakketti b'ħafna li fihom 196 (7x28) pillola miksija b'rita.
English: A starting dose of 24 mg/26 mg twice daily should be considered for patients with SBP ≥100 to 110 mmHg.
Maltese: Doża tal-bidu ta' 24 mg/26 mg darbtejn kuljum għandha tiġi kkunsidrata għall-pazjenti b'SBP ta' ≥100 sa 110 mmHg.
English: Hypokalaemia
Maltese: Ipokalemija
English: The valsartan contained within Neparvis is more bioavailable than the valsartan in other marketed tablet formulations (see section 5.2).
Maltese: Il-valsartan li jinsab f'Neparvis huwa aktar bijodisponibbli mill-valsartan fil-formulazzjonijiet ta' pilloli oħra li qedgħin fis-suq (ara sezzjoni 5.2).
English: 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).
Maltese: Neparvis huwa kontraindikat f'pazjenti bi storja magħrufa ta' anġjoedima relatata ma' inibitur ta' ACE jew terapija b'ARB preċedenti jew b'anġjoedima ereditarja jew idjopatika (ara sezzjoni 4.3).
English: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Neparvis is a medicine known as an angiotensin receptor neprilysin inhibitor.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: o Each 49 mg/51 mg film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex).
Maltese: o Kull pillola miksija b'rita ta' 49 mg/51 mg fiha 48.6 mg sacubitril u 51.4 mg valsartan (bħala kumpless ta' melħ tas-sodju ta' sacubitril valsartan).
English: • The combination of Neparvis with an ACE inhibitor is contraindicated due to the increased risk of angioedema (see section 4.3).
Maltese: • Il-kombinazzjoni ta' Neparvis flimkien ma' inibitur ta' ACE huwa kontraindikat minħabba rriskju miżjud ta' anġjoedima (ara sezzjoni 4.3).
English: 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.
Maltese: F'pazjenti anzjani, pazjenti li naqqsu mill-volum (inklużi dawk fuq terapija dijuretika), jew pazjenti b'funzjoni renali kompromessa, l-użu konkomitanti ta' Neparvis u NSAIDs jista' jwassal għal żieda fir-riskju ta' funzjoni renali li tmur għall-agħar.
English: Neprilysin is one of multiple enzymes involved in the clearance of amyloid-β (Aβ) from the brain and cerebrospinal fluid (CSF).
Maltese: In-neprilysin huwa waħda minn bosta enzimi involuti fit-tneħħija tal-amilojde-β (Aβ) mill-moħħ u mill-fluwidu ċerebrospinali (CSF).
English: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Maltese: F'kull grupp ta' frekwenza, ir-reazzjonijiet avversi jiġu kklassifikati fl-ordni tal-gravità dejjem tonqos.
English: 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.
Maltese: L-effetti farmakodinamiċi ta' Neparvis ġew evalwati wara l-għoti ta' doża waħda u dożi multipli f'individwi f'saħħithom u f'pazjenti b'insuffiċjenza tal-qalb, u huma konsistenti mal-inibizzjoni tanneprilysin simultanja u l-imblokk tal-RAAS.
English: 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).
Maltese: L-użu konkomitanti ta' Neparvis ma' prodotti li fihom aliskiren huwa kontraindikat f'pazjenti b'dijabete mellitus jew f'pazjenti b'indeboliment renali (eGFR <60 ml/min/1.73 m2) (ara sezzjoni 4.3).
English: If hypotension occurs, temporary down-titration or discontinuation of Neparvis is recommended (see section 4.2).
Maltese: Jekk ikun hemm pressjoni baxxa, huma rrakkomandati titrazzjoni 'l isfel temporanja jew twaqqif ta' Neparvis (ara sezzjoni 4.2).
English: Neparvis 49 mg/51 mg film-coated tablets
Maltese: Neparvis 49 mg/51 mg pilloli miksija b'rita
English: In juvenile rats treated with sacubitril (postnatal days 7 to 70), there was a reduction in age-related bone mass development and bone elongation.
Maltese: F'firien żgħar ikkurati b'sacubitril (minn 7 ijiem sa 70 jum wara t-twelid), kien hemm tnaqqis fliżvilupp tal-massa tal-għadam u fl-elongazzjoni tal-għadam b'rabta mal-età.
English: Vascular disorders
Maltese: Ebda interazzjoni sinjifikanti
English: 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).
Maltese: Ġew irrapportati każijiet ta' pressjoni baxxa sintomatika f'pazjenti kkurati b' Neparvis matul l-istudji kliniċi (ara sezzjoni 4.8), speċjalment f'pazjenti ≥65 sena,
English: • sildenafil, a medicine used to treat erectile dysfunction or lung hypertension.
Maltese: • sildenafil, mediċina li tintuża għall-kura ta' disfunzjoni erettili jew pressjoni għolja fil-pulmun.
English: There are no data from the use of sacubitril in pregnant women.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: Valsartan inhibits detrimental cardiovascular and renal effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.
Maltese: Valsartan jinibixxi l-effetti renali u kardjovaskulari detrimentali tal-anġjotensina
English: Neparvis 49 mg/51 mg film-coated tablets are pale yellow oval tablets with “NVR” on one side and “L1” on the other side.
Maltese: Il-pilloli miksija b'rita Neparvis 49 mg/51 mg huma pilloli ovali ta' lewn isfar pallidu b'“NVR” fuq naħa waħda u “L1” fuq in-naħa l-oħra.
English: Neparvis 24 mg/26 mg film-coated tablets
Maltese: Neparvis 24 mg/26 mg pilloli miksija b'rita
English: At randomisation, 70% of patients were NYHA class II, 24% were class III and 0.7% were class IV.
Maltese: L-età medja tal-popolazzjoni studjata kienet ta' 64 sena u 19% kellhom 75 sena jew aktar. Firrandomizzazzjoni, 70% tal-pazjenti kienu NYHA tal-kategorija II, 24% kienu tal-kategorija III u 0.7% kienu tal-kategorija IV.