FrancophonIA/ELRC3.0 huggingface dataset:
English: Interaction with CYP1A2 substrates with narrow therapeutic index Obeticholic acid may increase the exposure to concomitant medicinal products that are CYP1A2 substrates.
Maltese: Interazzjoni ma' substrati ta' CYP1A2 b'indiċi terapewtiku dejjaq Obeticholic acid jista' jżid l-esponiment għal prodotti mediċinali fl-istess ħin li huma substrati ta' CYP1A2.
English: In PBC patients who received OCALIVA 25 mg once daily (2.5 times the highest recommended dosage) or 50 mg once daily (5 times the highest recommended dosage), a dose-dependent increase in the incidence of liver-related adverse reactions (e.g., ascites, primary biliary cholangitis flare, new onset jaundice), and transaminase and bilirubin elevations (up to greater than 3-times upper limit of normal [ULN]) were reported.
Maltese: F'pazjenti b'PBC li rċivew OCALIVA 25 mg darba kuljum (2.5 darbiet l-ogħla dożaġġ rakkomandat) jew 50 mg darba kuljum (5 darbiet l-ogħla dożaġġ rakkomandat), żieda dipendenti fuq id-doża fl-inċidenza ta' reazzjonijiet avversi relatati mal-fwied (eż. axxite, fawra ta' kolanġite biljari primarja, suffejra ġdida li titfaċċa), u żidiet fit-transaminase u l-bilirubin (sa iktar minn 3 darbiet l-ogħla limitu tan-normal [ULN - upper limit of normal]) kienu rrapurtati.
English: ALP less than 1.67-times ULN, n (%)
Maltese: Bilirubin totali inqas minn jew daqs 1-darba l-ULNf, n (%)
English: Table 1: Dosage Regimen by PBC Patient Population Staging/Classification Non-Cirrhotic or
Maltese: Tabella 1: Programm ta' Dożaġġ skont il-Popolazzjoni ta' Pazjenti b'PBC Stadju/Klassifikazzjoni Pazjenti Mhux b'Ċirrożi jew b'Child-Pugh Klassi A
English: At month 3, 9 (38%) OCALIVA-treated patients achieved a response to the composite endpoint, compared to 1 (4%) placebo-treated patient.
Maltese: Fix-Xahar 3, 9 (38%) pazjenti trattati b'OCALIVA laħqu rispons għall-punt aħħari kompost, meta mqabbla ma' pazjent 1 (4%) ittrattat bi plaċebo.
English: Management strategies include the addition of bile acid binding resins or antihistamines, dose reduction, reduced dosing frequency, and/or temporary dose interruption (see sections 4.2 and 4.8).
Maltese: Strateġiji ta' immaniġjar jinkludu ż-żieda ta' reżini li jintrabtu ma' aċidu tal-bili jew antihistamines, tnaqqis fid-doża, tnaqqis fil-frekwenza tad-dożaġġ, u/jew twaqqif temporanju tad-doża (ara sezzjoni 4.2 u 4.8).
English: Intercept Pharma International Ltd. Ιρλανδία
Maltese: Intercept Pharma International Ltd.
English: Rationale: to investigate the effect of obeticholic acid on clinical outcomes in subjects with PBC
Maltese: Raġunament: sabiex jiġi investigat l-effett ta' obeticholic acid fuq eżiti kliniċi f'pazjenti b'PBC
English: Obeticholic acid is a selective and potent agonist for the farnesoid X receptor (FXR), a nuclear receptor expressed at high levels in the liver and intestine.
Maltese: Obeticholic acid huwa agonist selettiv u b'saħħtu għar-riċettur ta' farnesoid X (FXR), riċettur nukleari espress f'livelli għoljin fil-fwied u l-imsaren.
English: Following multiple-dose administration of 5, 10, and 25 mg once daily for 14 days, systemic exposures of obeticholic acid increase dose proportionally.
Maltese: Wara l-għoti ta' dożi multipli ta' 5, 10 u 25 mg darba kuljum għal 14-il jum, esponiment sistemiku ta' obethicolic acid iżidu d-doża b'mod proporzjonali.
English: Urinary excretion is less than 3%.
Maltese: L-eliminazzjon fl-awrina hija inqas minn 3%.
English: Mean baseline total bilirubin values ranged from 10 μmol/L to 12 μmol/L across treatment arms, with 92% of patients within normal range.
Maltese: Il-valuri medji tal-bilirubin totali fil-linja bażi kienu fil-medda ta' 10 μmol/L sa 12 μmol/L fost il-partijiet ta' trattament tal-istudju, b'92% talpazjenti fil-medda normali.
English: After daily administration of obeticholic acid, there was accumulation of the glycine and taurine conjugates of obeticholic acid which have in vitro pharmacological activities similar to the parent drug.
Maltese: Wara għoti kuljum ta' obethicolic acid, kien hemm akkumulazzjoni ta' konġugati ta' glycine u taurine ta' obethicolic acid li għandhom attività farmakoloġika in vitro simili għall-parent drug.
English: Relative to patients who started on 10 mg once daily in the OCALIVA 10 mg arm, patients in the OCALIVA titration arm had a lower incidence of pruritus (70% and 56% respectively) and a lower discontinuation rate due to pruritus (10% and 1%, respectively).
Maltese: Mqabbla ma' pazjenti li bdew fuq 10 mg darba kuljum fil-parti tal-istudju b'OCALIVA 10 mg, pazjenti fil-parti tal-istudju b'titrazzjoni ta' OCALIVA kellhom inċidenza iktar baxxa ta' ħakk (70% u 56% rispettivament) u rata iktar baxxa ta' twaqqif minħabba ħakk (10% u 1%, rispettivament).
English: Child-Pugh Class A
Maltese: Għal pazjenti Mhux b'Ċirrożi jew Child-Pugh Klassi A:
English: Oedema peripheral, Pyrexia
Maltese: Edema periferali, Deni
English: Pack size: 30 or 100 film-coated tablets.
Maltese: Daqs tal-pakkett: 30 jew 100 pillola miksija b'rita.
English: Population pharmacokinetic analysis, developed using data from patients up to 65 years old, indicated that age is not expected to significantly influence obeticholic acid clearance from the circulation.
Maltese: Analiżi farmakokinetika tal-popolazzjoni, zviluppata minn dejta dwar pazjenti sa 65 sena, indikat li l-età mhux mistennija tinfluwenza b'mod sinifikanti t-tneħħija ta' obeticholic acid miċ-ċirkulazzjoni.
English: P-values are obtained using the Cochran-Mantel-Haenszel General Association test stratified by intolerance to UDCA and pretreatment ALP greater than 3-times ULN and/or AST greater than 2-times ULN and/or total bilirubin greater than ULN.
Maltese: Valuri-P huma ottenuti bl-użu ta' test ta' Cochran-Mantel-Haenszel General Association stratifikat skont intolleranza għal UDCA u ALP qabel ittrattament ikbar minn 3 darbiet ULN u/jew AST ikbar minn darbtejn ULN u/jew bilirubin totali ikbar minn ULN.
English: The volume of distribution of obeticholic acid is 618 L. The volume of distributions of glyco- and tauro-obeticholic acid has not been determined.
Maltese: Il-volum ta' distribuzzjoni ta' obeticholic acid huwa 618 L.
English: How to take OCALIVA
Maltese: Tiħux OCALIVA:
English: The median time to onset of severe pruritus was 11, 158, and 75 days for patients in the OCALIVA 10 mg, OCALIVA titration, and placebo arms, respectively.
Maltese: Il-ħin medjan għall-bidu ta' ħakk sever kien ta' 11, 158, u 75 jum għal pazjenti fil-partijiet tal-istudju dwar OCALIVA 10 mg, titrazjoni ta' OCALIVA, u plaċebo, rispettivament.
English: Intercept Pharma International Ltd. Ireland
Maltese: Intercept Pharma UK & Ireland Ltd.
English: Decrease in ALP of at least 15%, n (%) Total bilirubin less than or equal to 1-times ULNf, n a Percentage of subjects achieving a response, defined as an ALP less than 1.67-times the ULN, total bilirubin within the normal range, and an ALP decrease of at least 15%.
Maltese: a Perċentwal ta' pazjenti li rċivew rispons, definit bħala ALP anqas minn 1.67-drabi ULN, bilirubin totali fil medda normali, u tnaqqis fl-ALP tal-anqas 15%.
English: Tablet coating
Maltese: Kisi tal-pillola
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-flixkun wara “EXP”.
English: The percentages of patients who required interventions (i.e, dosage adjustments, treatment interruptions, or initiation of antihistamines or bile acid binding resins) were 41% in the OCALIVA 10 mg arm, 34% in the OCALIVA titration group, and 19% in the placebo group.
Maltese: Il-perċentwal ta' pazjenti li kienu jeħtieġu interventi (i.e, aġġustamenti tad-dożaġġ, twaqqif tattrattament, jew bidu ta' antihistamines jew reżini li jintrabti mal-aċidu tal-bili) kienu 41% fil-parti talistudju b'OCALIVA 10 mg, 34% fil-grupp ta' titrazzjoni ta' OCALIVA, u 19% fil-grupp bil-plaċebo.
English: Description: In order to confirm the efficacy and safety of OCALIVA, the MAH should conduct and submit the results of study 747-401, a double-blind, randomised, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of OCALIVA in patients with PBC and moderate to severe hepatic impairment.
Maltese: Sabiex jiġu kkonfermati l-effikaċja u s-sigurtà ta' OCALIVA, l-MAH għandu jwettaq u jippreżenta r-riżultati ta' studju 747-401, studju double-blind, każwali, ikkontrollat bi placebo u multiċentriku li jinvestiga l-effikaċja, is-sigurtà u l-farmakokinetika ta' OCALIVA f'pazjenti b'PBC u b'indeboliment tal-fwied minn moderat sa sever.
English: Medicinal products that affect obeticholic acid
Maltese: Obeticholic acid
English: Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce efficacy of obeticholic acid.
Maltese: Reżina li tintrabat ma' aċidu tal-bili bħal cholestyramine, colestipol, jew colesevelam jadsorbu u jnaqqsu l-assorbiment ta' aċidi tal-bili u jistgħu jnaqqsu l-effikaċja ta' obeticholic acid.
English: The systemic exposure of obeticholic acid, its active conjugates, and endogenous bile acids is increased in patients with moderate and severe hepatic impairment (Child-Pugh Class B and C, respectively) when compared to healthy controls.
Maltese: L-esponiment sistemiku għal obeticholic acid, il-konġugati attivi tiegħu, u l-aċidi tal-bili endoġeni jiżdied f'pazjenti b'indeboliment tal-fwied minn moderat sa sever (Child-Pugh Klassi B u Ċ, rispettivament), meta mqabbla ma' kontrolli b'saħħithom.
English: OCALIVA 5 mg film-coated tablets Yellow, 8 mm round tablet debossed with ‘INT' on one side and ‘5' on the other side.
Maltese: Pillola safra, tonda 8 mm mnaqqxa b'‘INT' fuq naħa waħda u ‘5' fuq in-naħa l-oħra.
English: A phase III, randomised, double-blind, placebo-controlled, parallel-group, 12-month study (POISE) evaluated the safety and efficacy of OCALIVA in 216 patients with PBC who were taking UDCA for at least 12 months (stable dose for ≥ 3 months) or who were unable to tolerate UDCA and did not receive UDCA for ≥3 months.
Maltese: III, double-blind, bi plaċebo bħala kontroll, bi grupp paralleli, ta' 12-il xahar (POISE) evalwa s-sigurtà u l-effikaċja ta' OCALIVA f'216-il pazjent bi PBC li kienu qed jieħdu UDCA għal tal-anqas 12-il xahar (doża stabbli għal ≥3 xhur) jew li ma setgħux jittoleraw UDCA u ma rċivewx UDCA għal ≥3 xhur.
English: Description: In order to confirm the efficacy and safety of OCALIVA, the MAH should conduct and submit the results of study 747-302, a confirmatory doubleblind, randomised, placebo-controlled multicentre study investigating the clinical benefit associated with OCALIVA treatment in patients with PBC who are either unresponsive or intolerant to UDCA treatment based on clinical endpoints.
Maltese: Sabiex jiġu kkonfermati l-effikaċja u s-sigurtà ta' OCALIVA, l-MAH għandu jwettaq u jippreżenta r-riżultati ta' studju 747-302, studju konfermatorju double-blind, każwali, ikkontrollat bi placebo u multiċentriku li jinvestiga lbenefiċċju kliniku assoċjat ma' trattament ta' OCALIVA f'pazjnti b'PBC li ma jirrispondux jew ma jittollerawx trattament ta' UDCA bbażat fuq punti aħħarin kliniċi.
English: B. PACKAGE LEAFLET
Maltese: Ιρλανδία
English: Oropharyngeal pain
Maltese: Popolazzjoni pedjatrika
English: Adverse reactions leading to discontinuation were 1% in the OCALIVA titration arm and 11% in the OCALIVA 10 mg arm.
Maltese: Reazzjonijiet avversi illi wasslu għat-twaqqif tal-kura kienu 1% fil-parti tal-istudju b'titrazzjoni ta' OCALIVA u 11% fil-parti tal-istudju b'OCALIVA 10 mg.
English: 5 mg once daily
Maltese: 5 mg darba kuljum
English: The levels of some medicines such as theophylline (a medicine to help breathing) or tizanidine (a medicine to relieve the stiffness and restriction of muscles) may be increased and need to be monitored by your doctor while taking OCALIVA.
Maltese: Il-livelli ta' xi mediċini bħal theophylline (mediċina li tgħin in-nifs) jew tizanidine (mediċina li sserraħ mill-ebusija u r-restrizzjoni tal-muskoli) jistgħu jiżdiedu u għandhom jiġu mmonitorjati mit-tabib tiegħek waqt li qed tieħu OCALIVA.
English: Severe pruritus was reported in 23% of patients treated with OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of patients in the placebo arms.
Maltese: Ħakk sever ġie rrappurtat fi 23% tal-pazjenti fil-parti tal-istudju bi trattament b'OCALIVA 10 mg kuljum, 19% tal-pazjenti fil-parti tal-istudju b'titrazzjoni ta' OCALIVA, u 7% tal-pazjenti fil-partijiet tal-istudju bi plaċebo.
English: Obeticholic acid is metabolised in the liver and intestines.
Maltese: Obeticholic acid huwa metabolizzat fil-fwied u fl-imsaren.
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14(7) tarRegolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li gejjin:
English: Population pharmacokinetic analysis indicated that gender does not influence obeticholic acid pharmacokinetics.
Maltese: Analiżi farmakokinetika fil-popolazzjoni indikat li s-sess ma jinfluwenzax il-farmakokinetika ta' obeticholic acid.
English: OCALIVA is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Maltese: Din il-mediċina hija użata sabiex tittratta pazjenti adulti b'tip ta' mard tal-fwied bl-isem ta' kolanġite biljari primarja (magħrufa wkoll bħala ċirrosi biljari primarja), kemm waħedha kif ukoll flimkien ma' mediċina oħra, ursodeoxycholic acid.
English: Patients were included in the trial if the alkaline phosphatase (ALP) was greater than or equal to 1.67 times upper limit of normal (ULN) and/or if total bilirubin was greater than 1 x ULN but less 2 x ULN.
Maltese: Pazjenti ġew inklużi fl-istudji jekk l-alkaline phosphatase (ALP) kien ogħla minn jew daqs 1.67 drabi l-limitu ta' fuq tan-normal (ULN) u/jew jekk il-bilirubin totali kien ikbar minn 1 x ULN imma inqas minn 2 x ULN.
English: Abdominal pain and discomfort
Maltese: Uġigħ addominali u skonfort
English: The majority (93%) of patients received treatment in combination with UDCA and a small number of patients (7%) unable to tolerate UDCA received placebo, OCALIVA (10 mg) or OCALIVA titration (5 mg to 10 mg) as monotherapy.
Maltese: Il-maġġoranza (93%) tal-pazjenti rċivew trattament fl-istess ħin ma' UDCA u numru żgħir ta' pazjenti (7%) ma setgħux jittolleraw UDCA rċivew plaċebo, OCALIVA (10 mg) jew titrazzjoni ta' OCALIVA
English: Fifty-one PBC patients with baseline ALP 1.67-times ULN or greater and/or total bilirubin greater than ULN were evaluated for a biochemical response to OCALIVA as monotherapy (24 patients received OCALIVA 10 mg once daily and 27 patients received placebo) in a pooled analysis of data from the phase III randomised, double-blind, placebo-controlled 12 month study (POISE) and from a randomised, double-blind, placebo-controlled, 3- month study.
Maltese: Wieħed u ħamsin pazjent b'PBC bil-linja bażi ta' ALP 1.67-drabi ULN jew aktar u/jew bilirubin totali ogħla mill-ULN kienu evalwati għal rispons bijokimiku għal OCALIVA bħala monoterapija (24 pazjent rċivew OCALIVA 10 mg darba kuljum u 27 pazjent rċivew plaċebo) f'analiżi miġbura ta' dejta mill-istudju ta' fażi
English: Very common
Maltese: Ħakk sever
English: The adverse reactions reported with OCALIVA in the phase III clinical study are listed in the table below by MedDRA system organ class and by frequency.
Maltese: III huma mniżżla fit-tabella t'hawn taħt u kklassifikati skont is-sistema ta' MedDRA tal-klassi tal-organi u skont il-frewkenza.
English: Consider discontinuing treatment with obeticholic acid for patients who continue to experience persistent, intolerable pruritus.
Maltese: Ikkunsidra li jitwaqqaf t-trattament b'obeticholic acid għal pazjenti li jkomplu jesperjenzaw ħakk intollerabli u persistenti.
English: * Adverse reactions are defined as events occurring at a rate of greater than or equal to 5% of patients on obeticholic acid treatment arm and at an incidence greater than or equal to 1% higher than in the placebo treatment arm.
Maltese: * Reazzjonijiet avversi huma definiti bħala eventi li jseħħu b'rata ta' daqs jew iktar minn 5% tal-pazjenti fil-parti tal-istudju b'obeticholic acid u b'inċidenza daqs jew iktar minn 1% ogħla mill-parti tal-istudju bil-plaċebo.
English: Paediatric population No pharmacokinetic studies were performed with obeticholic acid in patients less than 18 years of age.
Maltese: Ma sar l-ebda studju farmakokinetiku b'obeticholic acid f'pazjenti inqas min 18-il sena.
English: What OCALIVA looks like and contents of the pack - OCALIVA 5 mg is a yellow, round film-coated tablet with ‘INT' on one side and ‘5' on the other side of the film-coated tablet.
Maltese: Kif jidher OCALIVA u l-kontenut tal-pakkett - OCALVIA 5 mg hija pillola safra, tonda u miksija b'rita, b'‘INT' fuq naħa waħda u ‘5' fuq in naħa l-oħra tal-pillola miksija b'rita.
English: See table 1 for dose recommendations.
Maltese: Ara tabella 1 għal rakkomandazzjonijiet dwar id-doża.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji illi saru fuq l-annimali ma jindikawx effetti ta' ħsara diretta jew indiretta ta' tossiċità riproduttiva (ara sezzjoni 5.3).
English: As a precautionary measure, it is preferable to avoid the use of obeticholic acid during pregnancy.
Maltese: Bħala prekawzjoni, huwa preferibbli li jiġi evitat l-użu ta' obeticholic acid matul it-tqala.
English: Child-Pugh Class B or C or Decompensated Cirrhotic
Maltese: Pazjenti b'Child-Pugh Klassi B jew Ċ jew b'Ċirrożi Dikumpensata
English: ALP and total bilirubin were assessed as categorical variables in the primary composite endpoint, as well as continuous variables over time.
Maltese: ALP u bilirubin totali ġew evalwati bħala varjabbli kategoriċi fil-punt aħħari primarju kompost, kif ukoll bħala varjabbli kontinwi fuq tul ta' żmien.
English: • Risk Management Plan (RMP) The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Obeticholic acid is absorbed with peak plasma concentrations (Cmax) occurring at a median time (tmax) of approximately 2 hours.
Maltese: Obeticholic acid huwa assorbit bl-ogħla konċetrazzjonijiet fil-plażma (Cmax) jseħħu f'ħin medjan (tmax) ta' madwar sagħtejn.
English: For patients who have not achieved an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin after 6 months of treatment and the patient is tolerating obeticholic acid, titrate up to 10 mg once daily
Maltese: Għal pazjenti li ma kisbux tnaqqis xieraq fl-alkaline phosphatase (ALP) u/jew bilirubina totali wara 6 xhur ta' trattament u l-pazjent qed jittolera obeticholic acid, ittitra sa 10 mg darba kuljum
English: Animal studies do not indicate any direct or indirect effects on fertility or reproduction (see section 5.3).
Maltese: Studji fl-annimali ma jindikawx effetti diretti jew indiretti fuq il-fertilità jew ir-riproduzzjoni (ara sezzjoni 5.3).
English: Pharmacotherapeutic group: Bile and liver therapy, Bile acid preparations.
Maltese: Terapija tal-Fwied u tal-Bili, preparazzjonijiet ta' Aċidu tal-Bili, Kodiċi ATC:
English: For patients who have not achieved an adequate reduction in ALP and/or total bilirubin after 3 months of treatment and the patient is tolerating obeticholic acid, titrate up to 5 mg twice weekly (at least 3 days apart) and subsequently to 10 mg twice weekly (at least 3 days apart) based on response and tolerability
Maltese: Għal pazjenti li ma kisbux tnaqqis xieraq fl-ALP u/jew bilirubina totali wara 3 xhur ta' trattament u l-pazjent qed jittolera obeticholic acid, ittitra sa 5 mg darbtejn fil-ġimgħa (talanqas f'intervall ta' 3 ijiem) u sussegwentement sa 10 mg darbtejn fil-ġimgħa (tal-anqas f'intervall ta' 3 ijiem) skont ir-rispons u t-tollerabilità
English: OCALIVA 5 mg film-coated tablets OCALIVA 10 mg film-coated tablets obeticholic acid
Maltese: OCALIVA 10 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 10 mg obeticholic acid.
English: The most commonly reported adverse reactions were pruritus (63%) and fatigue (22%).
Maltese: L-iktar reazzjonijiet avversi komuni li ġew irrapurtati kienu ħakk (63%) u għeja (22%).
English: For Child-Pugh Class B or C or Decompensated Cirrhotic patients:
Maltese: Għal pazjenti b'Child-Plugh Klassi B jew Ċ jew Ċirrożi dikumpensata:
English: Population pharmacokinetic analysis indicated that race is not expected to influence obeticholic acid pharmacokinetics.
Maltese: Analiżi farmakokinetika fil-popolazzjoni indikat li r-razza mhux mistennija tinfluwenza l-farmakokinetika ta' obeticholic acid.
English: Based on population pharmacokinetic analysis, renal function did not have a meaningful effect on the pharmacokinetics of obeticholic acid.
Maltese: Skont analiżi farmakokinetika fil-popolazzjoni, il-funzjoni tal-kliewi ma kelliex effett sinifikanti fuq il-farmakokinetika ta' obeticholic acid.
English: Oral administration of obeticholic acid above the NOAEL to mice, rats, and dogs in pivotal, repeat dose toxicity studies resulted primarily in effects on the hepatobiliary system.
Maltese: Għoti mill-ħalq ta' obeticholic acid 'il fuq minn NOAEL lil ġrieden, firien, u klieb fi studji ewlenin ta' tossiċità, u ta' doża ripetuta, irriżultaw primarjament f'effetti fuq is-sistema epatobiljari.
English: If you experience itching that is difficult to tolerate, talk to your doctor.
Maltese: Jekk tesperjenza ħakk li jkun diffiċli tissaportih, kellem lit-tabib tiegħek.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to fertility, reproduction and development.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, u effett tossiku fuq il-fertilità, is-sistema riproduttiva u l-iżvilupp, ma juri l-ebda periklu speċjali għall-bnedmin.
English: Hepatic impairment
Maltese: Mhux appplikabbli.
English: Treatment with OCALIVA 10 mg or OCALIVA titration (5 mg to 10 mg) resulted in clinically and statistically significant increases (p < 0.0001) relative to placebo in the number of patients achieving the primary composite endpoint at all study time points (see Table 3).
Maltese: (5 mg sa 10 mg) irriżultat f'żidiet klinikament u statistikament sinifikanti (p <0.
English: The conjugates can be deconjugated in the ileum and colon by intestinal microbiota, leading to the conversion to obeticholic acid that can be reabsorbed or excreted in faeces, the principal route of elimination.
Maltese: Il-konġugati jistgħu jiġu dikonġugati fl-ileju u l-kolon mill-mikrobijota intestinali, li jwasslu għall-konverżjoni ta' obethicholic acid li jista' jiġi assorbit mill-ġdid jew imneħħi fl-ippurgar, ir-rotta prinċipali ta' tneħħija.
English: Dosage Titration
Maltese: Titrazzjoni Dożali
English: Percentage of PBC patients achieving the primary composite endpointa at month 6 and month 12 with or without UDCAb OCALIVA 10 mgc (N = 73)
Maltese: Tabella 3. Perċentwali ta' pazjenti b'PBC li laħqu l-punt aħħari primarju komposta f'Xahar 6 u Xahar 12 bi jew mingħajr UDCAb
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1139/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1139/001
English: OCALIVA 10 mg film-coated tablets
Maltese: OCALIVA 10 mg pilloli miksija b'rita