FrancophonIA/ELRC3.0 huggingface dataset:
English: Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.
Maltese: Telf ta' effikaċja jista' jseħħ, speċjalment meta prodotti mediċinali b'doża baxxa u indiċi terapewtiku dejjaq (eż. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), jingħataw flimkien ma' Eluxadoline.
English: Single supratherapeutic oral doses of eluxadoline up to 1,000 mg and single intranasal doses up to 200 mg were associated with a higher incidence of adverse events than a 100 mg single dose, especially gastrointestinal and central nervous system events.
Maltese: Dożi supraterapewtiċi waħdiet li jingħataw mill-ħalq ta' eluxadoline sa 1,000 mg u dożi intranażali b'waħdiet sa 200 mg kienu assoċjati ma' inċidenza ogħla ta' avvenimenti avversi milli doża waħda ta' 100 mg, speċjalment avvenimenti gastro-intestinali u tas-sistema nervuża ċentrali.
English: 80% (8/10) of sphincter of Oddi spasm events presented within the first week of treatment.
Maltese: 80% (8/10) tal-avvenimenti ta' spażmu tal-isfinkter ta' Oddi ippreżentaw ruħhom fl-ewwel ġimgħa tal-kura.
English: 1% of patients receiving 75 mg and 2% of patients receiving 100 mg discontinued treatment or temporarily suspended dosing secondary to constipation, respectively, compared to <1% of patients treated with placebo.
Maltese: 1 % tal-pazjenti li jirċievu 75 mg u 2 % ta' pazjenti li jirċievu 100 mg waqqfu l-kura jew waqqfu ddoża b'mod temporanju minħabba stitikezza, rispettivament, meta mqabbla ma' <1% tal-pazjenti kkurati bi plaċebo.
English: Therefore, eluxadoline is contraindicated in this population as well as in those with previous biliary tract problems (see sections 4.2, 4.3 and 4.4).
Maltese: Għaldaqstant, eluxadoline huwa kontraindikat f'din il-popolazzjoni kif ukoll f'dawk bi problemi preċedenti bil-passaġġ biljari (ara sezzjonijiet 4.2, 4.3, 4.4).
English: Take special care if you are 65 years of age or older, as there is a higher risk that you may have certain side effects (see section 4).
Maltese: Oqgħod attent/a jekk għandek 65 sena jew iktar, minħabba li hemm riskju ogħla li jista' jkollok ċerti effetti sekondarji (ara sezzjoni 4).
English: 3 “Sphincter of Oddi spasm” term includes: manifestation as pancreatitis (terms include alcoholic pancreatitis, pancreatitis, and pancreatitis acute) and hepatic enzyme elevations with abdominal pain (terms include abdominal pain, abdominal pain upper, dyspepsia, and sphincter of Oddi dysfunction).
Maltese: 3It-terminu “spażmu tal-isfinkter ta' Oddi” jinkludi: manifestazzjoni bħala pankreatite (it-terminu jinkludi pankreatite alkoħolika, pankreatite, u pankreatite akuta) u żieda fl-enzimi tal-fwied b'uġigħ addominali (it-terminu jinkludi uġigħ addominali, uġigħ fil-parti ta' fuq tal-addome, dispepsja, u disfunzjoni tal-isfinkter ta' Oddi).
English: There was an overall increased frequency of adverse events in the older population compared to patients <65 years which was comparable across all treatment groups, including placebo.
Maltese: Kien hemm frekwenza miżjuda b'mod ġenerali ta' avvenimenti avversi fl-ixjeħ popolazzjoni meta mqabbla ma' pazjenti <65 sena li kienu komparabbli fil-gruppi ta' kura kollha, inkluż il-plaċebo.
English: Eluxadoline is a substrate of the hepatic efflux transporter MRP2.
Maltese: Inibituri MRP2 Eluxadoline huwa sottostrat tat-trasportatur MRP2 tal-effluss tal-fwied.
English: A total of 1,282 patients in Study 1 (IBS-3001) and 1,146 patients in Study 2 (IBS-3002) were enrolled and received treatment with Truberzi 75 mg, Truberzi 100 mg or placebo twice daily.
Maltese: Total ta' 1,282 pazjent fi Studju 1 (IBS-3001) u 1,146 pazjent fi Studju 2 (IBS-3002) iddaħħlu u rċevew kura bi
English: Pack sizes of 28, 56 and a multipack containing 168 (3 packs of 56) film-coated tablets.
Maltese: Daqs tal-pakkett ta' 28, 56 u pakketti multipli li fihom 168-il pillola miksija b'rita (3 pakkett ta' 56) .
English: Following a 1,000 mg oral dose in healthy male volunteers, M11 was detected in urine but not in systemic circulation.
Maltese: Wara doża ta' 1,000 mg li ngħatat mill-ħalq lil voluntiera rġiel f'saħħithom, M11 kien osservat fl-awrina iżda mhux fiċ-ċirkolazzjoni sistemika.
English: Eluxadoline has demonstrated efficacy in normalizing GI transit and defecation in several models of stress induced or post GI inflammation-altered GI function in animals.
Maltese: Eluxadoline wera effikaċja fin-normalizzazzjoni tat tranżitu GI u ppurgar f'diversi mudelli ta' funzjoni GI fl-annimali ikkaġunati mill-istress jew wara li nbidlu mill-infjammazzjoni GI.
English: Each tablet contains 75 mg of eluxadoline.
Maltese: Kull pillola fiha 75 mg eluxadoline.
English: The administration of eluxadoline with a high fat meal significantly decreased both Cmax (50%) and AUC (60%) without any effect on Tmax.
Maltese: ikla b'kontenut għoli ta' xaħam naqqas b'mod sinifikanti kemm Cmax (50%) kif ukoll l-AUC (60%)
English: There is a potential for increased risk of somnolence and sedation when taking eluxadoline (see section 4.8) in patients who may experience increased plasma levels, such as in patients with a genetic predisposition for poor function of OATP1B1 transporter.
Maltese: Hemm potenzjal għal riskju ogħla ta' somnolenza u sedazzjoni meta tieħu eluxadoline (ara sezzjoni 4.8) f'pazjenti li jistgħu jesperjenzaw livelli miżjuda ta' plażma, bħal f'pazjenti bi predispożizzjoni ġenetika għal funzjoni dgħajfa tat-trasportatur OATP1B1.
English: Truberzi is contraindicated in patients without a gallbladder and other conditions that increase the risk of developing pancreatitis (see section 4.3).
Maltese: Truberzi huwa kontraindikat f'pazjenti mingħajr marrara u kundizzjonijiet oħrajn li jżidu r-riskju li tiżviluppa pankreatite (ara sezzjoni 4.3).
English: Cmax and AUC for the metabolite 1hydroxy-midazolam increased by ~14% and 7% respectively, suggesting that eluxadoline may be a mild inducer of CYP3A4 and may decrease the exposure of concomitantly administered CYP3A4 substrates.
Maltese: Is-Cmax u l-AUC għall-metabolit 1-hydroxy-midazolam żdiedu b'~14% u 7% rispettivament, u dan jissuġġerixxi li eluxadoline jista' jkun induttur ħafif ta' CYP3A4 u jista' jnaqqas l-esponiment għal sottostrati ta' CYP3A4 mogħtija fl-istess ħin (ara sezzjoni 4.5).
English: Given eluxadoline's local action in the GI tract, low Foral and lack of metabolism, prospective clinical studies regarding differences in age, body mass index (BMI), ethnicity, and gender were deemed unnecessary.
Maltese: Minħabba l-azzjoni lokali ta' eluxadoline fl-apparat GI, Forali baxx u nuqqas ta' metaboliżmu, studji kliniċi prospettivi rigward id-differenzi fl-età, indiċi tal-massa tal-ġisem (BMI), etniċità, u sess ma kinux meqjusa meħtieġa.
English: Eluxadoline is not an inducer/inhibitor of major CYP enzymes, however, eluxadoline has some potential for the metabolism based inactivation of CYP3A4.
Maltese: Eluxadoline mhuwiex induċitur/inibitur tal-enzimi tas-CYP ewlenin, madankollu, eluxadoline għandu xi potenzjal għall inattivazzjoni bbażata fuq il-metaboliżmu ta' CYP3A4.
English: EU/1/16/1126/003 56 film-coated tablets EU/1/16/1126/004 28 film-coated tablets
Maltese: EU/1/16/1126/003 56 pillola miksijin b'rita EU/1/16/1126/004 28 pillola miksijin b'rita
English: The safety and efficacy of eluxadoline in children aged 0 to18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' eluxadoline fit-tfal tal-età 0 sa 18-il sena għadhom ma ġewx stabbiliti.
English: In vitro studies indicated that eluxadoline is a substrate and an inhibitor of the hepatic uptake transporter OATP1B1; a substrate for the hepatic efflux transporter MRP2 and is not a substrate or inhibitor of the P-gp and BCRP transporters.
Maltese: Studji in vitro indikaw li eluxadoline huwa sottostrat u inibitur tat-trasportatur OATP1B1 talassorbiment tal-fwied; sottostrat tat-trasportatur MRP2 tal-effluss tal-fwied u mhuwiex sottostrat jew inibitur tat-trasportaturi P-gp u BCRP.
English: How to store Truberzi
Maltese: X'fih Truberzi
English: EU/1/16/1126/001 56 film-coated tablets EU/1/16/1126/002 28 film-coated tablets
Maltese: EU/1/16/1126/001 56 pillola miksijin b'rita EU/1/16/1126/002 28 pillola miksijin b'rita
English: Considering the short half-life of naloxone, repeated administration may be necessary.
Maltese: Meta wieħed iqis il-half-life qasira ta' naloxone, jista' jkun meħtieġ għoti ripetut.
English: The recommended dose is 200 mg daily (one 100 mg tablet, twice daily).
Maltese: Id-doża rakkomandata hija ta' 200 mg ta' kuljum (pillola waħda ta' 100 mg, meħuda darbtejn kuljum).
English: Film-coated tablets 56 tablets.
Maltese: 56 pillola.
English: It is a substrate and an inhibitor of the hepatic uptake transporter OATP1B1; and a substrate for the hepatic efflux transporter MRP2.
Maltese: OATP1B1 tal-assorbiment tal-fwied; u sottostrat tat-trasportatur MRP2 tal-effluss tal-fwied.
English: All pancreatic events resolved with lipase normalization upon discontinuation of eluxadoline, with 80% (4/5) resolving within 1 week of treatment discontinuation (see section 4.4).
Maltese: L-avvenimenti pankreatiċi kollha ssolvew bin normalizzazzjoni ta' lipase malli twaqqaf eluxadoline, bi 80% (4/5) jissolvew fi żmien ġimgħa mittwaqqif tal-kura (ara sezzjoni 4.4).
English: Eluxadoline has a low potential for drug-drug interactions based on limited in vitro CYP inhibition/induction and given that eluxadoline is not a substrate for CYPs at clinically meaningful concentrations.
Maltese: Eluxadoline għandu potenzjal baxx għal interazzjonijiet mediċinali abbażi tal-inibizzjoni/induzzjoni tas-CYP in vitro u minħabba li eluxadoline mhuwiex sottostrat għas-CYPs f'konċentrazzjonijiet klinikament sinifikanti.
English: Following a single oral dose of 300 mg [14C] eluxadoline in healthy male subjects, 82.2% of the total [14C] eluxadoline was recovered in faeces in 336 hours and less than 1% was recovered in urine in 192 hours.
Maltese: Wara doża waħda mogħtija mill-ħalq ta' 300 mg [14C] eluxadoline f'individwi rġiel f'saħħithom, 82.2% tat-total[14C] ta' eluxadoline ġie rkuprat fl-ippurgar fi 336 siegħa u anqas minn 1% ġie rkuprat fl-awrina f'192 siegħa.
English: It is used to treat irritable bowel syndrome (‘IBS') with diarrhoea (IBS-D) in adults.
Maltese: Dan jintuża sabiex jikkura s-sindrome tal-imsaren irritabbli (‘IBS') bid-dijarea (‘IBS-D') fl-adulti.
English: Abdominal pain2
Maltese: Nefħa addominali
English: In vitro studies in human liver microsomes showed that eluxadoline is not a direct inhibitor of CYP3A4 at clinically relevant concentrations [IC50 =450 µM] but in human intestinal microsomes, eluxadoline was a metabolism dependent inhibitor of CYP3A4 with kinact of 0.1 min-1 and K-I of 450 µM (256 µg/mL).
Maltese: eluxadoline kien inibitur dipendenti fuq il-metaboliżmu ta' CYP3A4 b'kinact ta' 0.1 min-1 u K-I ta'
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (WITHOUT BLUE BOX - MULTIPACK ONLY) - 75 mg
Maltese: KARTUNA TAN-NOFS (MINGĦAJR IL-KAXXA L-BLU PAKKETT MULTIPLU BISS)75 mg
English: Increased ALT Increased AST 1“Somnolence” term includes: somnolence and sedation.
Maltese: 1It-terminu “somnolenza” jinkludi: somnolenza u sedazzjoni
English: The European Medicines Agency has deferred the obligation to submit the results of clinical studies with Truberzi in one or more subsets of the paediatric population in IBS-D (see section 4.2 for information on paediatric use).
Maltese: Truberzi f'subsett wieħed jew aktar tal-popolazzjoni pedjatrika b'IBS-D (ara t-taqsima 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: In vitro studies demonstrated that eluxadoline was stable in human hepatocytes, liver and intestinal microsomes, and that the only minor and inactive metabolite of eluxadoline detected was the acyl glucuronide metabolite (M11) formed through glucuronidation of the methoxybenzoic acid moiety.
Maltese: Studji in vitro urew li eluxadoline kien stabbli f'epatoċiti, mikrosomi tal-fwied u tal-imsaren talbniedem, u li l-unika metabolit minuri u inattiv ta' eluxadoline osservat kien il-metabolit acyl glucuronide (M11) ifformat permezz tal-glucuronidation tal-frazzjoni tal-aċidu methoxybenzoic.
English: 4 “Gastrooesophageal reflux disease” term includes gastrooesophageal reflux disease, dyspepsia and gastritis.
Maltese: 4It-terminu “marda ta' rifluss gastro-esofagali” jinkludi l-marda ta' rifluss gastro-esofagali, dispepsja u gastrite.
English: - midazolam (a medicine to sedate you when you e.g.undergo endoscopic procedures); - nifedipine (used to treat high blood pressure); - alfentanil, fentanyl (opioid analgesic used to treat pain); - dihydroergotamine, ergotamine (used to treat migraine); - pimozide (used to treat mental disorders); - quinidine (used to treat heart diseases); - sirolimus, tacrolimus (immunosuppressant used for the control of body's immune response).
Maltese: - nifedipine (użat biex jikkura pressjoni għolja tad-demm); - alfentanil, fentanyl )analġesiku opjojd użati sabiex jikkura l-uġigħ); - dihydroergotamine, ergotamine (użati sabiex jikkuraw il-migranja); - pimozide (użat sabiex jikkura d-disturbi mentali); - quinidine (użat sabiex jikkura l-mard tal-qalb);
English: Gastric lavage or charcoal administration should be considered.
Maltese: Ħasil gastriku u amministrazzjoni ta' charcoal għandhom jiġu kkunsidrati.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX - MULTIPACK ONLY) - 100 mg
Maltese: KARTUNA TAN-NOFS (MINGĦAJR IL-KAXXA L-BLU PAKKETT MULTIPLU BISS)100 mg
English: In a population pharmacokinetic analysis, the estimated apparent volume of distribution of eluxadoline was 27,100 L. In healthy subjects, eluxadoline was moderately (81%) bound to plasma proteins.
Maltese: F'individwi f'saħħithom, eluxadoline kien marbut b'mod moderat (81%) mal-proteini tal-plażma.
English: • Patients on treatment with potent inhibitors of OATP1B1 (e.g. cyclosporine)
Maltese: • Pazjenti li jkunu għaddejjin fuq kura b'inibituri qawwijin ta' OATP1B1 (eż. cyclosporine)
English: EU/1/16/1126/005 168 film-coated tablets (3 packs of 56)
Maltese: EU/1/16/1126/005 168-il pillola miksijin b'rita (3 pakketti ta' 56)
English: Eluxadoline is primarily excreted in the feces, either as unabsorbed active substance or via the biliary system with the kidney playing a minimal role in elimination.
Maltese: Eluxadoline huwa primarjament ippurgat fl-ipprugar, jew bħala sustanza attiva mhux assorbita jew permezz tas-sistema biljari bil-kliewi jkollhom irwol minimu fl-eliminazzjoni.
English: EU/1/16/1126/006 168 film-coated tablets (3 packs of 56)
Maltese: EU/1/16/1126/006 168-il pillola miksijin b'rita (3 pakketti ta' 56)
English: Truberzi 75 mg film-coated tablets Each film-coated tablet contains 75 mg of eluxadoline.
Maltese: Truberzi 75 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 75 mg ta' eluxadoline.
English: Eluxadoline is primarily cleared as such via the biliary system with the kidney playing a minimal role in elimination.
Maltese: Eluxadoline huwa primarjament eliminat kif inhu permezz tas-sistema biljari bil-kliewi jkollhom irwol minimu fl-eliminazzjoni.
English: Eluxadoline is a locally acting, mixed mu opioid receptor (μOR) agonist and delta opioid receptor
Maltese: Eluxadoline huwa agonista tar-riċettur imħallat tal-mu opjojde (μOR) u antagonist tar-riċettur delta opjojde (δOR) li jaħdem lokalment.
English: Truberzi is contraindicated in patients without a gallbladder.
Maltese: Truberzi huwa kontraindikat f'pazjenti mingħajr marrara.
English: Pharmacokinetic data for healthy volunteers pooled across Phase 1 studies (using the 100 mg single oral dose) and analyzed for potential differences based on sex, age, race, and BMI demonstrated no significant differences.
Maltese: Data farmakokinetika dwar voluntiera f'saħħithom miġbura fost l-istudju talFażi 1 (bl-użu ta' doża ta' 100 mg waħda mogħtija mill-ħalq) u analizzata għal differenzi potenzjali abbażi tas-sess, tal-età, razza, u BMI ma wriet l-ebda differenza sinifikanti.
English: 6”Hypersensitivity” term includes: anaphylaxis, angioedema, (e.g. swollen face and/or throat), dyspnea, throat tightness and chest pain/tightness - spontaneously reported in the post-marketing period.
Maltese: 6It-terminu “sensittività eċċessiva” jinkludi: anafilassi, anġjoedima, (eż. wiċċ u/jew ġerżuma minfuħa), qtugħ ta' nifs, tagħfis fil-griżmejn u uġigħ/tagħfis fis-sider - irrappurtati b'mod spontanju fil-perjodu ta' wara t-tqegħid fis-suq.
English: Patients receiving eluxadoline reported significant increases in urgency-free days both for ≥50% urgency-free days as well as ≥75% urgency free days.
Maltese: Il-pazjenti li jirċievu eluxadoline irrapportaw żidiet sinifikanti f'jiem mingħajr urġenza għal ≤50% tal-jiem mingħajr urġenza kif ukoll ≤75% tal jiem mingħajr urġenza.
English: Eluxadoline has very low oral bioavailability and exerts no detectable central nervous system (CNS)-mediated effects when administered orally to animals at effective doses.
Maltese: Eluxadoline għandu bijodisponibilità orali baxxa ħafna u ma jeżerċitax effetti medjati mis-sistema nervuża ċentrali (CNS) meta mogħti mill-ħalq lill-annimali f'dożi effettivi.
English: Table 2: Efficacy Results in Randomized Clinical Studies Study 1 (IBS 3001)
Maltese: Studju 1 (IBS 3001)
English: The binding affinity (Ki) of eluxadoline for human κOR has not been determined; however, the Ki for guinea pig cerebellum κOR is 55 nM.
Maltese: L-affinità tal-irbit (Ki) ta' eluxadoline κOR tal-bniedem ma ġietx iddeterminata;
English: Truberzi 100 mg film-coated tablets Each film-coated tablet contains 100 mg of eluxadoline.
Maltese: Truberzi 100 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 100 mg ta' eluxadoline.
English: Truberzi 75 mg film-coated tablets
Maltese: Truberzi 75 mg pilloli miksijin b'rita
English: However, such an increase is unlikely to be of clinical significance (see section 5.2).
Maltese: Madankollu, żieda bħal din mhux probabbli li tkun klinikament sinifikanti (ara sezzjoni 5.2).
English: Eluxadoline is an inhibitor of the hepatic uptake transporter OATP1B1.
Maltese: Sottostrati OATP1B1 Eluxadoline huwa inibitur tat-trasportatur OATP1B1 tal-assorbiment tal-fwied.
English: Truberzi is available in packs containing 28 or 56 film-coated tablets and in a multipack of 168 film-coated tablets comprising 3 cartons, each containing 56 film-coated tablets.
Maltese: Truberzi hu disponibbli f'pakketti li fihom 28 jew 56 pillola miksija b'rita u f'pakketti multipli ta' 168 pillola miksija b'rita li jikkonsistu minn 3 kaxxi tal-kartun, li kull waħda jkun fiha 56 pillola miksija b'rita.
English: Renal impairment
Maltese: Stitikezza Dardir
English: All events resolved upon discontinuation of Truberzi, with symptoms typically improved by the following day.
Maltese: L-avvenimenti kollha ssolvew bit-twaqqif ta' Truberzi, bis-sintomi normalment jitjiebu sal għada.
English: Truberzi may increase the level of some medicines in the blood.
Maltese: Truberzi jista' jnaqqas il-livell ta' xi mediċini fid-demm.
English: Truberzi 100 mg film-coated tablets
Maltese: Truberzi 100 mg pilloli miksijin b'rita
English: IBS is a common gut disorder.
Maltese: L-IBS hija disturb komuni tal-musrana.
English: The active substance has linear pharmacokinetics with no accumulation upon repeated twice daily dosing.
Maltese: Is-sustanza attiva għandha farmakokinetiċi lineari mingħajr akkumulazzjoni b'dożaġġ darbtejn kuljum ripetut.
English: Serious adverse reactions of pancreatitis (0.2% and 0.3% of patients receiving 75 mg and 100 mg respectively) and sphincter of Oddi spasm (0.2% of patients receiving 75 mg and 0.8% of patients receiving 100 mg) may also occur.
Maltese: Reazzjonijiet avversi serji ta' pankreatite (0.2% u 0.3% ta' pazjenti li jirċievu 75 mg u
English: Due to events of somnolence and sedation observed in clinical studies, caution should be exercised (see sections 4.4 and 4.5).
Maltese: Minħabba avvenimenti ta' somnolenza u sedazzjoni osservati fl-istudji kliniċi, għandha tintuża lkawtela (ara sezzjonijiet 4.4 u 4.5).
English: Effect of OATP1B1 transporter function variability on plasma levels The plasma levels in patients with a genetic predisposition for poor function of OATP1B1 transporter are increased, and in these patients a higher rate of adverse events, especially with regard to gastrointestinal events, as well as CNS effects might be expected (see section 5.2).
Maltese: Il-livelli fil-plażma f'pazjenti bi predispożizzjoni ġenetika għall-funzjoni ħażina tat-trasportatur OATP1B1 huma miżjuda, u f'dawn il-pazjenti tista' tkun mistennija rata ogħla ta' avvenimenti avversi, speċjalment fir-rigward ta' avvenimenti gastro-intestinali, kif ukoll effetti fuq is-sistema nervuża ċentrali (CNS) (ara sezzjoni 5.2).
English: Truberzi 75 mg film-coated tablets.
Maltese: Truberzi 75 mg pilloli miksijin b'rita.
English: For patients who are unable to tolerate the 200 mg daily dose (one 100 mg tablet, twice daily), the dose can be lowered to 150 mg daily (one 75 mg tablet twice daily).
Maltese: Għal pazjenti li ma jistgħux jittolleraw id-doża ta' kuljum ta' 200 mg (pillola waħda ta' 100 mg, meħuda darbtejn kuljum), id-doża tista' titnaqqas għal 150 mg kuljum (pillola waħda ta' 75 mg darbtejn kuljum).
English: • Alcoholism, alcohol abuse, alcohol addiction or chronic or acute excessive alcohol use.
Maltese: • Alkoħoliżmu, abbuż mill-alkoħol, vizzju tal-alkoħol jew użu tal-alkoħol eċċessiv b'mod kroniku jew akut.
English: Truberzi acts on the surface of your gut to restore the normal function of your bowels and block the sensation of pain and discomfort in IBS-D patients.
Maltese: Truberzi jaġixxi fuq is-superfiċje ta' msarnek biex iġib lura l-funzjoni normali ta' msarnek, u jimblokka s-sensazzjoni ta' uġigħ u skumdità f'pazjenti b'IBS-D.
English: If patients develop severe constipation, they should be instructed to stop Truberzi and seek medical attention.
Maltese: Jekk il-pazjenti jiżviluppaw stitikezza severa, għandhom jingħataw istruzzjonijiet sabiex iwaqqfu Truberzi u jfittxu attenzjoni medika.
English: Given the mu opioid receptor agonism of eluxadoline, there is a potential for increased risk of sphincter of Oddi spasm, resulting in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain (eg, biliary-type pain) in patients taking eluxadoline, especially in patients without a gallbladder (see sections 4.3 and 4.8).
Maltese: Minħabba l-agoniżmu tar-riċettur mu opjojd ta' eluxadoline, hemm il-potenzjal ta' żieda fir-riskju ta' spażmu tal-isfinkter ta' Oddi, li jirriżulta f'pankreatite jew f'żieda tal-enzima tal-fwied assoċjati ma' uġigħ addominali akut (eż, uġigħ tat-tip biljarji) f'pazjenti li jieħdu eluxadoline, speċjalment f'pazjenti mingħajr marrara (ara sezzjonijiet 4.3 u 4.8).
English: The film-coated tablets are modified capsule-shaped, pale yellow to light-tan and debossed with ‘FX75' on one side.
Maltese: Il-pilloli miksijin b'rita huma f'għamla ta' kapsula modifikata, sofor ċari għal kannella ċar, u għandhom “FX75” imnaqqxa fuq naħa waħda.
English: Eluxadoline This medicine is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: In clinical studies, events of sphincter of Oddi spasm manifested as elevated hepatic enzymes associated with abdominal pain in 8 patients, pancreatitis in 1 patient and abdominal pain with lipase elevation less than 3 times the upper limit of normal in 1 patient.
Maltese: Fi studji kliniċi, avvenimenti tal-ispażmu tal-Isfinkier Oddi immanifestaw ruħhom bħala żieda talenzimi tal-fwied assoċjati ma' uġigħ addominali fi 8 pazjenti, pankreatite f'pazjent wieħed, u uġigħ addominali b'żieda fil-lipase anqas minn 3 darbiet il-limitu massimu tan-normal f'pazjent wieħed.
English: The absolute bioavailability of eluxadoline has not been determined but is estimated to be low due to limited absorption and first pass effects.
Maltese: Il-bijodisponibilità assoluta ta' eluxadoline ma ġietx iddeterminata iżda hija stmata li hija baxxa minħabba l-assorbiment limitat u effetti tal-ewwel passaġġ.
English: Adequate Relief Response
Maltese: MANIFATTUR RESPONSABBLI