FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Replagal 1 mg/ml sterile concentrate agalsidase alfa
Maltese: U MNEJN GĦANDU JINGĦATA Replagal 1 mg/ml konċentrat sterili
English: The experience in children 0-6 years old is limited and therefore no dose can be recommended for this age group.
Maltese: L-esperjenza fi tfal ta' bejn 0 u 6 snin hija limitata u għaldaqstant ebda doża ma tista' tkun rakkomandata għal dan il-grupp ta' età.
English: Infusion related reactions reported in the postmarketing setting (also see section 4.4) may include cardiac events such as cardiac arrhythmias (atrial fibrillation, ventricular extrasystoles, tachyarrhythmia), myocardial ischemia, and heart failure in patients with Fabry disease involving the heart structures.
Maltese: Reazzjonijiet relatati ma' infużjonijiet irrapportati fl-ambjent ta' wara t-tqegħid fis-suq (ara wkoll issezzjoni 4.4) jistgħu jinkludu avvenimenti kardijaċi bħal arritmiji kardijaċi (fibrillazzjoni atrijali,
English: These changes were associated with the development of low titre antibodies to agalsidase alfa but no clinically significant effects on safety or efficacy were observed in the patients studied.
Maltese: antikorpi kontra agalidase alfa f'titru baxx iżda l-ebda effetti klinikament sinifikanti fuq sigurtà jew effikaċja ma kienu osservati fil-pazjenti mistħarrġa.
English: Agalsidase alfa has been produced in a human cell line to provide for a human glycosylation profile that can influence uptake by mannose-6-phosphate receptors on the surface of target cells.
Maltese: Agalsidase alfa ġie magħmul f'razza ta' ċelloli umani biex jipprovdi għal profil ta' glajkosilizzazzjoni umana li tista' tinfluwenza t-teħid minn riċettaturi mannose-6-phoshate fil-wiċċ taċ-ċelloli bersalljati.
English: NAME OF THE MEDICINAL PRODUCT Replagal 1 mg/ml concentrate for solution for infusion agalsidase alfa
Maltese: Informazzjoni għall-utent Replagal 1 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: The most commonly reported adverse reactions were infusion associated reactions, which occurred in 13.7% of adult patients treated with Replagal in clinical trials.
Maltese: L-aktar reazzjonijiet avversi rapportati b'mod komuni kienu reazzjonijiet assoċjati ma' l-infużjoni, li fi provi kliniċi seħħew fi 13.7% ta' pazjenti adulti ttrattati b'Replagal.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 3.5 mg of agalsidase alfa
Maltese: Kull kunjett fih 3.5 mg ta' agalsidase alfa
English: In subsequent studies, in male paediatric patients above the age of 7, a reduction in pain was observed after 9 and 12 months of Replagal therapy compared to pretreatment baseline.
Maltese: f'pazjenti pedjatriċi maskili ta' aktar minn 7 snin, tnaqqis fl-uġigħ kien osservat wara 9 sa 12-il xahar ta' terapija b'Replagal ikkomparat fil-linja bażi ta' riferiment ma' trattament ta' qabel.
English: This pain reduction persisted through 4 years of Replagal therapy in 9 patients (in patients 7 - 18 years of age).
Maltese: Dan it-tnaqqis fl-uġigħ baqa' persistenti matul l-4 snin ta' kura b'Replagal f'9 pazjenti (f' pazjenti 7 - 18 snin).
English: The adverse reactions categorized as incidence “not known (cannot be estimated from the available data)” are derived from post-marketing spontaneous reports.
Maltese: Ir-reazzjonijiet avversi kklassifikati bħala inċidenza “mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli)” huma miksubin minn rapporti spontanji ta' wara t-tqegħid fis-suq.
English: Respiratory, thoracic and mediastinal disorders cough, hoarseness, throat tightness, dyspnoea, nasopharyngitis, pharyngitis, throat secretion increased, rhinorrhoea oxygen saturation decreased
Maltese: toraċiċi u medjastinali sogħla, ħanqa, issikar fil-griżmejn, dispnea, nasofarinġite, faringite, żieda fil katarru mill griżmejn, rinorrea tnaqqis fissaturazzjoni tal-ossiġenu
English: These IgG antibodies appeared to develop following approximately 3-12 months of treatment.
Maltese: IgG dehru li żviluppaw bejn wieħed u ieħor bejn 3-12-il xahar wara t-trattament.
English: The reductions in LV mass observed by echocardiography in both male and female Fabry patients over 24 to 36 months of Replagal treatment were associated with meaningful symptom improvement as measured using the NYHA and CCS in Fabry patients with severe heart failure or anginal symptoms at baseline.
Maltese: It-tnaqqis fil-massa LV osservata permezz ta' l-ekokardjografija kemm f'pazjenti Fabry irġiel u kemm nisa fuq trattament ta' 24 sa 36 xhar b'Replagal kien assocjat ma'titjib sinifikanti fis sintomi kif imkejjel bil-NHYA u CCS f'pazjenti Fabry b'falliment tal-qalb severu jew sintomi anġinali fil-linja bażi ta' riferiment.
English: An analysis showed that serious adverse events were reported in 39.4% of those patients who switched from agalsidase beta compared to 31.0% in those who were naïve to therapy prior to study entry.
Maltese: Analiżi uriet li episodji avversi serji ġew irrapportati fi 39.4% ta' dawk il-pazjenti li qelbu minn agalsidase beta meta mqabbla ma' 31.0% f'dawk li qatt ma' ħadu l-kura qabel daħlu għall-istudju.
English: Nervous system disorders headache dizziness, dysgeusia, neuropathic pain, tremor, hypersomnia, hypoesthesia, paraesthesia parosmia
Maltese: disgewsja, uġigħ newropatiku, tertir, ipersomnija, ipoestesja, paraestesja parosmija
English: Sodium chloride Sodium hydroxide Water for injections
Maltese: soluzzjoni ta' sodium chloride għall-infużjoni.
English: After dilution Replagal is given in a vein.
Maltese: Wara li jiġi dilwit Replagal għandu jingħata ġol-vina.
English: After 12 to 54 months of therapy, 17% of Replagal treated patients were still antibody positive whereas 7% showed evidence for the development of immunologic tolerance, based on the disappearance of IgG antibodies over time.
Maltese: Wara 12 sa 54 xahar ta' terapija, 17% ta' pazjenti ttrattati b'Repagal kienu għadhom pożittivi għal antikorpi filwaqt li ma wrew l-ebda evidenza ta' żvilupp ta' tolleranza immunoloġika, ibbażat fuq l-għejbin ta' antikorpi
English: Four of 17 (23.5%) paediatric patients ≥7 years of age enrolled in clinical trials experienced at least one infusion reaction over a period of 4.5 years of treatment (mean duration of approx. 4 years).
Maltese: Erba' pazjenti pedjatriċi minn 17 (23.5%) ≥7 snin irreġistrati fi provi kliniċi esperjenzaw mill-inqas reazzjoni waħda marbuta ma' infużjoni fuq perjodu ta' 4.5 snin ta' kura (tul medju ta' madwar 4 snin).
English: In male paediatric Fabry patients plasma Gb3 decreased 40-50% after 6 months of Replagal therapy 0.2 mg/kg and this reduction persisted after a total 4 years of treatment in 11 patients.
Maltese: terapija b'Replagal 0.2 mg/kg u dan it-tnaqqis ippersista wara total ta' 12-il xahar total ta' 4 snin ta' kura fi 11-il pazjent.
English: Gastrointestinal disorders nausea diarrhoea , vomiting, abdominal pain/discomfort
Maltese: Disturbi gastrointestinali dardir dijarrea, remettar,
English: The safety and efficacy of Replagal in children aged 0-6 years has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Replagal fit-tfal minn età 0 u 6 snin ma ġewx determinati s'issa.
English: Each ml of Replagal contains 1 mg of agalsidase alfa.
Maltese: 1 ml ta' konċentrat għal soluzzjoni għall-infużjoni fih 1 mg ta' agalsidase alfa*.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products - Enzymes.ATC code: A16AB03.
Maltese: It-tabib tiegħek jista' jikkura wkoll is-sintomi b'mediċini oħrajn (antiħistamini jew kortikosterojdi).
English: Skin and subcutaneous tissue disorders acne, erythema, pruritus, rash, livedo reticularis angioneurotic oedema,
Maltese: Sintomi relatati mal-infużjoni jistgħu jinkludu wkoll sturdament, iperidrożi, pressjoni baxxa, sogħla, rimettar u għejja.
English: As metabolism is expected to occur by peptide hydrolysis, impaired liver function is not expected to affect the pharmacokinetics of agalsidase alfa in a clinically significant manner.
Maltese: Minħabba li l-metaboliżmu huwa mistenni li jseħħ permezz ta' idroliżi tal-peptide, funzjoni epatika imxekkla mhix mistennija li teffettwa l-farmakokinetiċi ta' agalsidase alfa f'manjiera klinikament sinifikattiva.
English: In clinical trials doses up to 0.4 mg/kg weekly were used, and their safety profile was not different from the recommended dose of 0.2 mg/kg biweekly.
Maltese: Fi provi kliniċi, intużaw dożi sa 0.4 mg/kg fil-ġimgħa, u l-profil tas-sigurtà tagħhom ma kienx differenti mid-doża rrakkomandata ta' 0.2 mg/kg ġimgħa iva u ġimgħa le.
English: Adverse drug reactions reported in patients with history of end stage renal disease were similar to those reported in the general patient population.
Maltese: Reazzjonijiet avversi għal mediċina kienu rrapportati f'pazjenti bi storja ta' mard renali fl-istadju finali li kienu simili għal dawk irrapportati fil-popolazzjoni tal-pazjenti ġenerali.
English: Study in patients switching from agalsidase beta to Replagal (agalsidase alfa) 100 patients [(naïve (n=29); or previously treated with agalsidase beta who switched to Replagal (n=71)) were treated for up to 30 months in an open label, uncontrolled study.
Maltese: Studju f'pazjenti li jaqilbu minn agalsidase beta għal Replagal (agalsidase alfa) 100 pazjenti [li qatt ma ħadu l-kura qabel (n=29) jew li ġew ikkurati qabel b'agalsidase beta li qelbu għal Replagal (n=71)] ġew ikkurati għal mhux aktar minn 30 xahar fi studju mhux ikkontrollat b'tikketta mikxufa.
English: It is produced by switching on the gene for α-galactosidase A in cells.
Maltese: Hija prodotta billi jiġi stimulat il-ġene għal α-galactosidase A fiċ-ċelloli.
English: Replagal should not be co-administered with chloroquine, amiodarone, benoquin or gentamicin since these substances have the potential to inhibit intra-cellular α-galactosidase activity.
Maltese: Replagal m'għandux jingħata flimkien ma' chloroquine, amiodarone, benoquin jew gentamicin peress li dawn il-mediċini għandhom potenzjal li jinibixxu l-attività ta' α-galactosidase intra-ċellolari.
English: In male paediatric patients ≥ 7 years of age, heart rate variability was abnormal at baseline and improved after 6 months of Replagal therapy in 15 boys and the improvement was sustained through 6.5 years of Replagal 0.2 mg/kg therapy in an open-label long-term extension study in 9 boys.
Maltese: F'pazjenti pedjatriċi maskili ≥ 7 snin, il-varjabilità tar-rata tat-taħbit tal-qalb kienet abnormali fil-linja bażi u tjiebet wara 6 xhur ta' kura b'Replagal fi 15-il tifel u t-titjib kien sostnut matul 6.5 snin ta' terapija b'Replagal 0.2 mg/kg fi studju ta' estensjoni b'tikketta miftuħa u fuq perjodu ta' żmien twil fuq 9 subien.
English: Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency).
Maltese: Replagal huwa intiż għal terapija ta' sostituzzjoni ta' enżimi fuq żmien twil f'pazjenti li huma konfermati bil-Marda ta' Fabry (defiċjenza ta' α-galactosidase A).
English: A review of cardiac events showed that infusion reactions may be associated with hemodynamic stress triggering cardiac events in patients with pre-existing cardiac manifestations of Fabry disease.
Maltese: Reviżjoni tal-episodji kardijaċi uriet li r-reazzjonijiet għall-infużjoni jistgħu jkunu assoċjati ma' stress emodinamiku li jagħti bidu għal episodji kardijaċi f'pazjenti b'manifestazzjonijiet kardijaċi pre-eżistenti tal-marda ta'
English: Two patients with right bundle branch block in the studies conducted reverted to normal following therapy with Replagal.
Maltese: Fl-istudji magħmulin żewġ pazjenti b'right bundle branch block reġgħu lura għan-normal wara terapija b'Replagal.
English: Adverse drug reactions reported in the paediatric population (children and adolescents) were, in general, similar to those reported in adults.
Maltese: Reazzjonijiet avversi tal-mediċina rrapportati fil-popolazzjoni pedjatrika (tfal u adolexxenti) kienu, b'mod ġenerali, simili għal dawk irrapportati fl-adulti.
English: Hepatic impairment
Maltese: Pożittività ta' antikorpi
English: Mild and transient effects may not require medical treatment or discontinuation of the infusion.
Maltese: Effetti ħfief jew transitorji jistgħu ma jeħteġux trattament mediku jew tittwaqqif ta' l-infużjoni.
English: Replagal is used to treat adult patients, as well as adolescents and children from the age of 7, with confirmed diagnosis of Fabry Disease.
Maltese: Replagal jiġi użat biex jittratta pazjenti adulti, kif ukoll adolexxenti u tfal minn età ta' 7 snin,
English: Do not take Entresto:
Maltese: Tiħux Entresto:
English: Entresto improved survival with a significant reduction in all-cause mortality of 2.8% (Entresto, 17%, enalapril, 19.8%).
Maltese: Entresto tejjeb is-sopravivenza bi tnaqqis sinjifikanti fil-mortalità minn kull kawża ta' 2.8% (Entresto, 17%, enalapril, 19.8%).
English: The pharmacokinetics of Entresto (sacubitril, LBQ657 and valsartan) are similar between male and female subjects.
Maltese: Il-farmakokinetiċi ta' Entresto (sacubitril, LBQ657 u valsartan) huma simili bejn individwi maskili u femminili.
English: No clinically meaningful drug-drug interaction was observed when Entresto was co-administered with digoxin, warfarin, hydrochlorothiazide, amlodipine, omeprazole, carvedilol or a combination of levonorgestrel/ethinyl estradiol.
Maltese: Ma ġiet osservata ebda interazzjoni klinikament sinjifikanti bejn mediċina u oħra meta Entresto ngħata flimkien ma' digoxin, warfarin, hydrochlorothiazide, amlodipine, omeprazole, carvedilol jew kombinazzjoni ta' levonorgestrel/ethinyl estradiol.
English: Therefore, co-administration of Entresto with inhibitors of OATP1B1, OATP1B3, OAT3 (e.g. rifampicin, ciclosporin), OAT1 (e.g. tenofovir,
Maltese: Għalhekk, it-teħid ta' Entresto flimkien ma' inibituri ta' OATP1B1, OATP1B3, OAT3 (eż. rifampicin, ciclosporin), OAT1 (eż. tenofovir,
English: Interactions between Entresto and lithium have not been investigated.
Maltese: L-interazzjonijiet bejn Entresto u lithium ma ġewx investigati.
English: A higher incidence of angioedema was observed in Black patients treated with Entresto (2.4%) and enalapril (0.5%) (see section 4.4).
Maltese: Ġiet osservata inċidenza ogħla ta' anġjoedima f'pazjenti suwed ikkurati b'Entresto (2.4%) u b'enalapril (0.5%) (ara sezzjoni 4.4).
English: The tablets are supplied in PVC/PVDC/Aluminium blister packs of 14, 20, 28, 56, 168 or 196 tablets and in multipacks of 196 tablets (7 packs of 28 tablets).
Maltese: Il-pilloli jiġu f'pakketti ta' folji tal-PVC/PVDC/Aluminju ta' 14, 20, 28, 56, 168 jew 196 pillola u f'pakketti b'ħafna ta' 196 (7 pakketti ta' 28 pillola).
English: The valsartan contained within Entresto is more bioavailable than the valsartan in other marketed tablet formulations; 26 mg, 51 mg, and 103 mg of valsartan in Entresto is equivalent to 40 mg, 80 mg and 160 mg of valsartan in other marketed tablet formulations, respectively.
Maltese: Il-valsartan li hemm f'Entresto huwa aktar bijodisponibbli mill-valsartan f'formulazzjonijiet ta' pilloli kummerċjalizzati oħrajn; 26 mg, 51 mg u 103 mg ta' valsartan f'Entresto huwa ekwivalenti għal 40 mg, 80 mg u 160 mg ta' valsartan f'formulazzjonijiet ta' pilloli kummerċjalizzati oħrajn, rispettivament.
English: • if you have ever had angioedema (see “Do not take Entresto” and section 4 “Possible side effects”).
Maltese: • jekk qatt xi darba kellek anġjoedima (ara “Tiħux Entresto” u sezzjoni 4 “Effetti sekondarji possibbli”).
English: They were then randomised to the double-blind period of the study, during which they received either Entresto 200 mg or enalapril 10 mg twice daily [Entresto (n=4,209); enalapril (n=4,233)].
Maltese: Imbagħad huma ġew randomizzati fil-perjodu double-blind tal-istudju, li matulu rċevew Entresto 200 mg jew enalapril 10 mg darbtejn kuljum [Entresto (n=4,209); enalapril (n=4,233)].
English: In PARADIGM-HF, hyperkalaemia and serum potassium concentrations >5.4 mmol/l were reported in 11.6% and 19.7% of Entresto-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'Entresto 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 Entresto 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' Entresto ta' 24 mg sacubitril/26 mg valsartan sa 97 mg sacubitril/103 mg valsartan.
English: cidofovir) or MRP2 (e.g. ritonavir) may increase the systemic exposure of LBQ657 or valsartan.
Maltese: cidofovir) jew MRP2 (eż. ritonavir) jista' jżid l-espożizzjoni sistemika għal LBQ657 jew valsartan.
English: In a 7-day valsartan-controlled study in patients with reduced ejection fraction (HFrEF), administration of Entresto 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' Entresto 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: 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 Entresto-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'Entresto meta mqabbel ma' 11.9% u 2.67% tal-pazjenti trattati b'enalapril, rispettivament.
English: PARADIGM-HF was a multinational, randomised, double-blind study of 8,442 patients comparing Entresto 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 lEntresto mal-enalapril, it-tnejn mogħtija lil pazjenti adulti b'insuffiċjenza kronika tal-qalb, NYHA talkategorija 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: During the Entresto 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% talpazjenti 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: In PARADIGM-HF, renal impairment was reported in 10.1% of Entresto-treated patients and 11.5% of enalapril-treated patients.
Maltese: F'PARADIGM-HF, indeboliment renali kien irrappurtat f'10.1% tal-pazjenti trattati b'Entresto u fi 11.5% tal-pazjenti trattati b'enalapril.
English: 19 November 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI 19 Novembru 2015
English: A single dose of Entresto 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' Entresto 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: Pump failure accounted for 26% of cardiovascular deaths and was reduced by 21% in Entresto-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'Entresto, meta mqabbla mal-pazjenti kkurati b'enalapril (HR 0.79, p=0.0338).
English: Entresto is contraindicated in patients with severe hepatic impairment, biliary cirrhosis or cholestasis (Child-Pugh C classification) (see section 4.3).
Maltese: Entresto huwa kontraindikat f'pazjenti b'indeboliment tal-fwied, ċirrożi biljari jew kolestażi gravi (klassifikazzjoni Child-Pugh C) (ara sezzjoni 4.3).
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 Entresto 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' Entresto (ara sezzjoni 4.4).
English: Co-administration of Entresto and furosemide had no effect on the pharmacokinetics of Entresto but reduced Cmax and AUC of furosemide by 50% and 28%, respectively.
Maltese: L-għoti ta' Entresto flimkien ma' furosemide ma kellu ebda effett fuq il-farmakokinetika ta' Entresto, iżda naqqas Cmax u AUC ta' furosemide b'50% u 28%, rispettivament.
English: In a thorough QTc clinical study in healthy male subjects, single doses of Entresto 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' Entresto 194 mg sacubitril/206 mg valsartan u 583 mg sacubitril/617 mg valsartan ma kellhom ebda effett fuq ir-ripolarizzazzjoni kardijaka.
English: Entresto does not induce or inhibit CYP450 enzymes.
Maltese: Entresto la jinduċi u lanqas jinibixxi enzimi CYP450.
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: Ma ġewx osservati żidiet fis-CSF Aβ1-40 u 1-42 fi studju fuq voluntiera umani f'saħħithom mifrux fuq ġimgħatejn (ara sezzjoni 5.1).
English: There are no available data on the effect of Entresto on human fertility.
Maltese: Ma hemm ebda dejta disponibbli dwar l-effett ta' Entresto fuq il-fertilità umana.
English: No. at risk Entresto
Maltese: Nru. f'riskju Entresto
English: • The combination of Entresto with direct renin inhibitors such as aliskiren is not recommended (see section 4.5).
Maltese: • Il-kombinazzjoni ta' Entresto ma' inibituri ta' renin diretti bħal aliskiren mhijiex rakkomandata (ara sezzjoni 4.5).
English: Entresto may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis.
Maltese: Entresto jista' jżid l-urea fid-demm u l-livelli tal-kreatinina fis-serum f'pazjenti bi stenożi bilaterali jew unilaterali fl-arterja renali.
English: Co-administration of Entresto with metformin reduced both Cmax and AUC of metformin by 23%.
Maltese: L-għoti ta' Entresto flimkien ma' metformin naqqas Cmax u AUC ta' metformin bi 23%.
English: Pack sizes: 14, 20, 28, 56, 168 or 196 film-coated tablets and multipacks containing 168 (3x56) or 196 (7x28) film-coated tablets.
Maltese: Daqsijiet tal-pakkett: 14, 20, 28, 56, 168 jew 196 pillola miksija b'rita u pakketti b'ħafna li fihom 168 (3x56) jew 196 (7x28) pillola miksija b'rita.
English: In PARADIGM-HF study, Entresto 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, Entresto 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).