FrancophonIA/ELRC3.0 huggingface dataset:
English: Entresto 24 mg/26 mg film-coated tablets Entresto 49 mg/51 mg film-coated tablets Entresto 97 mg/103 mg film-coated tablets sacubitril/valsartan
Maltese: Informazzjoni għall-pazjent Entresto 24 mg/26 mg pilloli miksija b'rita Entresto 49 mg/51 mg pilloli miksija b'rita Entresto 97 mg/103 mg pilloli miksija b'rita sacubitril/valsartan
English: In vitro metabolism studies indicate that potential for CYP 450-based drug interactions is low since there is limited metabolism of Entresto 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' Entresto permezz tal-enzimi CYP450.
English: No clinically relevant drug-drug interaction was observed when simvastatin and Entresto were coadministered.
Maltese: Ma ġiet osservata ebda interazzjoni klinikament relevanti meta simvastatin u Entresto ingħataw flimkien.
English: How to take Entresto
Maltese: X'fih Entresto
English: The safety of Entresto in patients with chronic heart failure was evaluated in the pivotal phase 3 study PARADIGM-HF, which compared patients treated twice daily with Entresto 97 mg/103 mg (n=4,203) or enalapril 10 mg (n=4,229).
Maltese: Is-sigurtà ta' Entresto f'pazjenti b'insuffiċjenza kronika tal-qalb ġiet evalwata fil-fażi pivotali 3 talistudju PARADIGM-HF, li qabbel il-pazjenti kkurati darbtejn kuljum b'Entresto 97 mg/103 mg (n=4,203) jew b'enalapril 10 mg (n=4,229).
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 Entresto 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'Entresto 100 mg darbtejn kuljum, li jiżdied għal 200 mg darbtejn kuljum (ara sezzjoni 4.8 għal twaqqif matul dan il-perjodu).
English: 14 film-coated tablets 20 film-coated tablets 28 film-coated tablets 56 film-coated tablets 168 film-coated tablets 196 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 168 pillola miksija b'rita 196 pillola miksija b'rita
English: In PARADIGM-HF, angioedema was reported in 0.5% of patients treated with Entresto, compared with 0.2% of patients treated with enalapril.
Maltese: F'PARADIGM-HF, anġjoedima ġiet irrapportata f'0.5% tal-pazjenti kkurati b'Entresto, imqabbla ma' 0.2% tal-pazjenti kkurati b'enalapril.
English: ACE inhibitor therapy must not be started until 36 hours after the last dose of Entresto (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' Entresto (ara sezzjonijiet 4.2 u 4.3).
English: Entresto 97 mg/103 mg tablets sacubitril/valsartan
Maltese: Entresto 97 mg/103 mg pilloli sacubitril/valsartan
English: If treatment with Entresto is stopped, ACE inhibitor therapy must not be initiated until 36 hours after the last dose of Entresto (see sections 4.2, 4.3 and 4.5).
Maltese: Jekk it-trattament b'Entresto jitwaqqaf, it-terapija b'inibitur ta' ACE m'għandhiex tinbeda sa 36 siegħa wara l-aħħar doża ta' Entresto (ara sezzjonijiet 4.2, 4.3 u 4.5).
English: Entresto 24 mg/26 mg tablets sacubitril/valsartan
Maltese: Entresto 24 mg/26 mg pilloli sacubitril/valsartan
English: Entresto 49 mg/51 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000
Maltese: Entresto 49 mg/51 mg pilloli miksija b'rita Ipromelloża, sostituzzjoni tat-tip 2910 (3 mPa·s) Diossidu tat-titanju (E171) Macrogol 4000
English: Entresto 97 mg/103 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000
Maltese: Entresto 97 mg/103 mg pilloli miksija b'rita Ipromelloża, sostituzzjoni tat-tip 2910 (3 mPa·s) Diossidu tat-titanju (E171) Macrogol 4000
English: Cases of symptomatic hypotension have been reported in patients treated with Entresto 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'Entresto matul l-istudji kliniċi (ara sezzjoni 4.8), speċjalment f'pazjenti ≥65 sena, pazjenti b'mard tal-kliewi u pazjenti b'SBP baxxa (<112 mmHg).
English: Sudden death accounted for 45% of cardiovascular deaths and was reduced by 20% in Entresto-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'Entresto, meta mqabbla mal-pazjenti kkurati b'enalapril (HR 0.80, p=0.0082).
English: Entresto 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: Entresto 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: The combination of Entresto with direct renin inhibitors such as aliskiren is not recommended (see section 4.4).
Maltese: Il-kombinazzjoni ta' Entresto flimkien ma' inibituri ta' renin diretti bħal aliskiren mhijiex rakkomandata (ara sezzjoni 4.4).
English: The adverse embryofoetal effects of Entresto are attributed to the angiotensin receptor antagonist activity (see section 4.6).
Maltese: L-effetti embrijufetali avversi ta' Entresto huma attribwiti għall-attività tal-antagonist tar-riċettur talanġjotensina (ara sezzjoni 4.6).
English: Entresto 49 mg/51 mg tablets sacubitril/valsartan
Maltese: Entresto 49 mg/51 mg pilloli sacubitril/valsartan
English: Approximate tablet dimensions 13.1 mm x 5.2 mm Entresto 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 Entresto 97 mg/103 mg huma pilloli ovali ta' lewn roża ċar b'“NVR” fuq naħa waħda u “L11” fuq in-naħa l-oħra.
English: Entresto 24 mg/26 mg film-coated tablets Entresto 49 mg/51 mg film-coated tablets Entresto 97 mg/103 mg film-coated tablets
Maltese: Entresto 24 mg/26 mg pilloli miksija b'rita Entresto 49 mg/51 mg pilloli miksija b'rita Entresto 97 mg/103 mg pilloli miksija b'rita
English: Combination of Entresto 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' Entresto 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: Entresto 24 mg/26 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000
Maltese: Entresto 24 mg/26 mg pilloli miksija b'rita Ipromelloża, sostituzzjoni tat-tip 2910 (3 mPa·s) Diossidu tat-titanju (E171) Macrogol 4000
English: Entresto 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: Entresto 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: The effects of Entresto on amyloid-β concentrations in CSF and brain tissue were assessed in young (2-4 years old) cynomolgus monkeys treated with Entresto (24 mg sacubitril/26 mg valsartan/kg/day) for two weeks.
Maltese: L-effetti ta' Entresto 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'Entresto (24 mg sacubitril/26 mg valsartan/kg/jum) għal ġimgħatejn.
English: Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1).
Maltese: Entresto 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: Discontinuation of therapy due to an adverse reaction in the double-blind period of the PARADIGM-HF study occurred in 450 Entresto-treated patients (10.7%) and 516 enalapril-treated patients (12.2%).
Maltese: It-twaqqif tat-terapija minħabba reazzjoni avversa fil-perjodu double-blind tal-istudju PARADIGM-HF seħħ f'450 pazjent ikkurati b'Entresto (10.7%) u f'516-il pazjent ikkurati b'enalapril
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 Entresto 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' Entresto 200 mg meta kienu titrati 'l fuq għal 6 ġimgħat (84.8%) versus 3 ġimgħat (73.6%).
English: If hypotension occurs, temporary down-titration or discontinuation of Entresto is recommended (see section 4.2).
Maltese: Jekk ikun hemm pressjoni baxxa, huma rrakkomandati titrazzjoni 'l isfel temporanja jew twaqqif ta' Entresto (ara sezzjoni 4.2).
English: Animal studies with Entresto have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali urew effett tossiku fuq issistema riproduttiva (ara sezzjoni 5.3).
English: The combination of Entresto 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' Entresto 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: • 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 Entresto”).
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 Entresto”).
English: Pack sizes: 14, 20, 28, 56 or 196 film-coated tablets and multipacks containing 196 (7x28) film-coated tablets.
Maltese: Daqsijiet tal-pakkett: 14, 20, 28, 56 jew 196 pillola miksija b'rita u pakketti b'ħafna li fihom 196 (7x28) pillola miksija b'rita.
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 Entresto 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'Entresto matul l-organoġenesi, il-ġestazzjoni u t-treddigħ jista' jaffettwa l-iżvilupp u s-sopravivenza tal-frieħ.
English: In the Entresto 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' Entresto, 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 valsartan contained within Entresto is more bioavailable than the valsartan in other marketed tablet formulations (see section 5.2).
Maltese: Il-valsartan li jinsab f'Entresto huwa aktar bijodisponibbli mill-valsartan fil-formulazzjonijiet ta' pilloli oħra li qedgħin fis-suq (ara sezzjoni 5.2).
English: The concomitant use of Entresto with ACE inhibitors is contraindicated, as the concomitant inhibition of neprilysin (NEP) and ACE may increase the risk of angioedema.
Maltese: L-użu konkomitanti ta' Entresto ma' inibituri ta' ACE huwa kontraindikat, billi l-inibizzjoni konkomitanti ta' neprilysin (NEP) u ACE tista' żżid ir-riskju ta' anġjoedima.
English: • The combination of Entresto with an ACE inhibitor is contraindicated due to the increased risk of angioedema (see section 4.3).
Maltese: • Il-kombinazzjoni ta' Entresto flimkien ma' inibitur ta' ACE huwa kontraindikat minħabba rriskju miżjud ta' anġjoedima (ara sezzjoni 4.3).
English: How to store Entresto
Maltese: “Tiħux Entresto”).
English: Entresto 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: Entresto 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: Entresto 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: Entresto 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: Entresto is a medicine known as an angiotensin receptor neprilysin inhibitor.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Following twice daily dosing of Entresto, steady-state levels of sacubitril, LBQ657 and valsartan are reached in three days.
Maltese: Wara dożaġġ darbtejn kuljum ta' Entresto, il-livelli fi stat stabbli ta' sacubitril, LBQ657 u valsartan jintlaħqu fi tlett ijiem.
English: If you have been taking an ACE inhibitor, wait 36 hours after taking the last dose of the ACE inhibitor before starting to take Entresto (see “Do not take Entresto”).
Maltese: Jekk kont qed tieħu inibitur ta' ACE, stenna 36 siegħa wara li tieħu l-aħħar doża tal-inibitur ta' ACE qabel tibda tieħu Entresto (ara “Tiħux Entresto”).
English: 14 film-coated tablets 20 film-coated tablets 28 film-coated tablets 56 film-coated tablets 196 film-coated tablets
Maltese: Pillola miksija b'rita 14-il pillola miksija b'rita 20 pillola miksija b'rita 28 pillola miksija b'rita 56 pillola miksija b'rita 196 pillola miksija b'rita
English: Entresto 97 mg/103 mg film-coated tablets
Maltese: Entresto 97 mg/103 mg pilloli miksija b'rita
English: Entresto 49 mg/51 mg film-coated tablets
Maltese: Entresto 49 mg/51 mg pilloli miksija b'rita
English: In elderly patients, volume-depleted patients (including those on diuretic therapy), or patients with compromised renal function, concomitant use of Entresto 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' Entresto u NSAIDs jista' jwassal għal żieda fir-riskju ta' funzjoni renali li tmur għall-agħar.
English: The concomitant use of Entresto 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' Entresto 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: Entresto 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 Entresto 49 mg/51 mg huma pilloli ovali ta' lewn isfar pallidu b'“NVR” fuq naħa waħda u “L1” fuq in-naħa l-oħra.
English: In the PARADIGM-HF study, subjects were previously treated with ACE inhibitors and/or ARBs and also had to successfully complete sequential enalapril and Entresto run-in periods (median drug exposure of 15 and 29 days, respectively) prior to the randomised double-blind period.
Maltese: Fl-istudju PARADIGM-HF, l-individwi kienu ttrattati minn qabel b'inibituri ta' ACE u/jew ARBs u wkoll kellhom jikkompletaw b'suċċess il-perjodi inizjali sekwenzjali ta' enalapril u Entresto (tul medju ta' espożizzjoni għall-mediċina ta' 15-il jum u 29 jum, rispettivament) qabel il-perjodu doubleblind magħżul b'mod każwali.
English: Use of Entresto may be associated with an increased risk of hyperkalaemia, although hypokalaemia may also occur (see section 4.8).
Maltese: L-użu ta' Entresto jista' jiġi assoċjat ma' żieda fir-riskju ta' iperkalemija, għalkemm jista' jkun hemm ukoll ipokalemija (ara sezzjoni 4.8).
English: Entresto 24 mg/26 mg film-coated tablets
Maltese: Entresto 24 mg/26 mg pilloli miksija b'rita
English: It is teratogenic based on a low incidence of foetal hydrocephaly, associated with maternally toxic doses, which was observed in rabbits at an Entresto dose of ≥4.9 mg sacubitril/5.1 mg valsartan/kg/day.
Maltese: Huwa teratoġeniku bbażat fuq inċidenza baxxa ta' idroċefalija tal-fetu, assoċjata ma' dożi tossiċi għall-omm, li kienet osservata fil-fniek f'doża ta' Entresto ta' ≥4.9 mg sacubitril/5.1 mg valsartan/kg/jum.
English: The pharmacodynamic effects of Entresto 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' Entresto 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: What Entresto looks like and contents of the pack Entresto 24 mg/26 mg film-coated tablets are violet-white oval tablets with “NVR” on one side and “LZ” on the other side.
Maltese: Il-pilloli miksija b'rita Entresto 24 mg/26 mg huma pilloli ovali ta' lewn vjola u abjad b'“NVR” fuq naħa waħda u “LZ” fuq in-naħa l-oħra.
English: If you have been taking an ACE inhibitor, wait for 36 hours after taking the last dose before you start to take Entresto (see “Other medicines and Entresto”).
Maltese: Jekk kont qed tieħu inibitur ta' ACE, stenna 36 siegħa wara li tieħu l-aħħar doża qabel ma tibda tieħu Entresto (ara “Mediċini oħra u Entresto”).
English: Angioedema was reported in patients treated with Entresto (see description of selected adverse reactions).
Maltese: Anġjoedima kienet irrappurtata f'pazjenti trattati b'Entresto (ara deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: Iron oxide yellow (E172)
Maltese: Ossidu tal-ħadid aħmar (E172) Ossidu tal-ħadid iswed (E172)
English: Based on the comparison of plasma and CSF exposures, LBQ657 crosses the blood brain barrier to a limited extent
Maltese: Abbażi talparagun tal-espożizzjonijiet fil-plażma u fis-CSF, LBQ657 jaqsam il-barriera ematoenċefalika sa ċertu punt limitat (0.28%).
English: Time to occurrence of CV death in PARADIGM-HF
Maltese: Fl-istudju PARADIGM-HF, Entresto naqqas il-plażma
English: BNP is not a suitable biomarker of heart failure in patients treated with Entresto because BNP is a neprilysin substrate (see section 4.4).
Maltese: BNP mhuwiex bijomarkatur adegwat ta' insuffiċjenza tal-qalb f'pazjenti kkurati b'Entresto minħabba li BNP huwa sottostrat tan-neprilysin (ara sezzjoni 4.4).
English: 196 film-coated tablets
Maltese: 196 pillola miksija b'rita
English: If you stop taking Entresto
Maltese: Interazzjonijiet li jeħtieġu prekawzjonijiet
English: Patients received a starting dose of Entresto of 50 mg twice daily and were up-titrated to 100 mg twice daily, then to the target dose of 200 mg twice daily, with either a 3-week or a 6-week regimen.
Maltese: Il-pazjenti rċevew doża inizjali ta' Entresto ta' 50 mg darbtejn kuljum u kienu titrati 'l fuq għal 100 mg darbtejn kuljum, imbagħad għad-doża fil-mira ta' 200 mg darbtejn kuljum, b'reġimen ta' 3 ġimgħat jew ta' 6 ġimgħat.
English: Non-clinical data (including studies with sacubitril and valsartan components and/or Entresto) reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and fertility.
Maltese: Tagħrif mhux kliniku (inklużi studji b'komponenti ta' sacubitril u valsartan u/jew Entresto) ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer u l-fertilità, ma juri l-ebda periklu speċjali għall-bnedmin.
English: Entresto must not be started until 36 hours after taking the last dose of ACE inhibitor therapy.
Maltese: Entresto m'għandux jinbeda sa 36 siegħa wara li tittieħed l-aħħar doża ta' terapija b'inibitur ta' ACE.
English: The most commonly reported adverse reactions during treatment with Entresto were hypotension, hyperkalaemia and renal impairment (see section 4.4).
Maltese: Ir-reazzjonijiet avversi rappurtati bl-aktar mod komuni matul trattament b'Entresto kienu pressjoni baxxa, iperkalimja u indeboliment tal-kliewi (ara sezzjoni 4.4).
English: Each 24 mg/26 mg tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium salt complex).
Maltese: Kull pillola ta' 24 mg/26 mg fiha 24.3 mg sacubitril u 25.
English: Co-administration of Entresto increased the Cmax of atorvastatin and its metabolites by up to 2-fold and AUC by up to 1.3-fold.
Maltese: It-teħid flimkien ta' Entresto żied is-Cmax ta' atorvastatin u l-metaboliti tiegħu b'sa darbtejn u l-AUC b'sa 1.3 darbiet.
English: In vitro data indicate that sacubitril inhibits OATP1B1 and OATP1B3 transporters.
Maltese: Id-dejta in vitro tindika li sacubitril jinibixxi t-trasportaturi OATP1B1 u OATP1B3. Għalhekk, Entresto jista' jżid l-espożizzjoni sistemika ta' sottostrati OATP1B1 u OATP1B3 bħal statini.
English: Administration of Entresto 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.
Maltese: L-għoti ta' Entresto 194 mg sacubitril/206 mg valsartan darba kuljum għal ġimgħatejn lil individwi f'saħħithom kien assoċjat ma' żieda fis-CSF Aβ1-38 meta mqabbel mal-plaċebo; ma kien hemm ebda bidla fil-konċentrazzjonijiet tas-CSF
English: In the PARADIGM-HF study, Entresto decreased plasma NT-proBNP and increased plasma BNP and urine cGMP compared with enalapril.
Maltese: NT-proBNP u żied il-plażma BNP u l-awrina cGMP, meta mqabbel ma' enalapril.
English: The full EPAR for Ibandronic acid Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Ibandronic acid Accord jinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ibandronic acid Accord is available as a solution for injection (3 mg) in a pre-filled syringe and as a concentrate (2 mg and 6 mg) to be made up into a solution for infusion (drip) into a vein.
Maltese: Ibandronic acid Accord jiġi bħala soluzzjoni għall-injezzjoni (3 mg) f'siringa mimlija lesta u bħala konċentrat (2 mg u 6 mg) biex isir f'soluzzjoni għall-infużjoni (dripp) fil-vina.