FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of tenofovir disoproxil in HIV-1 infected children under 2 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' tenofovir disoproxil fi tfal infettati bl-HIV-1 li għandhom inqas minn sentejn ma ġewx determinati.
English: Subjects must have been naïve to tenofovir disoproxil, but could have received interferon based regimens (> 6 months prior to screening) or any other non-tenofovir disoproxil containing oral anti-HBV nucleoside/nucleotide therapy (> 16 weeks prior to screening).
Maltese: L-individwi li ħadu sehem kellhom fil-passat qatt ma ngħataw tenofovir disoproxil, iżda setgħu irċievew korsijiet ta' kura bbażati fuq interferon (> 6 xhur qabel liscreening) jew kwalunkwe terapija oħra li ma fihiex tenofovir disoproxil li fiha terapija anti-HBV nucleoside/nucleotide orali (> 16-il ġimgħa qabel l-iscreening).
English: Simulations suggest that the prolonged dose interval using tenofovir disoproxil 245 mg film-coated tablets is not optimal and could result in increased toxicity and possibly inadequate response.
Maltese: Simulazzjonijiet jissuġġerixxu li intervall tad-doża mtawwal bl-użu ta' tenofovir disoproxil 245 mg pilloli miksija b'rita mhuwiex l-aħjar għażla, u jista' jirriżulta f'żieda fit-tossiċità u possibbilment f'rispons inadegwat.
English: Renal function should be closely monitored (see section 4.4).
Maltese: Il-funzjoni renali għandha tkun immonitorjata mill-qrib (ara sezzjoni 4.4).
English: 1, muscular weakness
Maltese: 1, dgħjufija fil-muskoli
English: In study GS-US-104-0352, 97 treatment-experienced patients 2 to < 12 years of age with stable, virologic suppression on stavudine- or zidovudine-containing regimens were randomised to either replace stavudine or zidovudine with tenofovir disoproxil (n = 48) or continue on their original regimen (n = 49) for 48 weeks.
Maltese: Fi studju GS-US-104-0352, 97 pazjent li kienu diġà rċivew il-kura fil-passat, li kellhom minn sentejn sa < 12-il sena bi trażżin viroloġiku stabbli u li kienu fuq korsijiet li kien fihom stavudine jew zidovudine, intgħażlu b'mod każwali biex jew jissostitwixxu stavudine jew zidovudine ma' tenofovir disoproxil (n = 48) jew ikomplu fuq il-kors oriġinali tagħhom (n = 49) għal 48 ġimgħa.
English: 48 weeks of double-blind adefovir dipivoxil followed by up to 192 weeks open-label tenofovir disoproxil.
Maltese: d 48 ġimgħa ta' adefovir dipivoxil double-blind segwiti minn sa 192 ġimgħa ta' tenofovir disoproxil open-label.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: Dejta ġenotipika minn iżolati
English: Baseline demographics were similar between the two treatment arms: At baseline, 52.5% of subjects were HBeAg negative, 47.5% were HBeAg positive, mean HBV DNA level was 6.5 log10 copies/ml, and mean ALT was 79 U/l, respectively.
Maltese: 5% kienu HbeAg pożittivi, il-medja tal-livell ta' DNA tal-HBV kienet ta' 6.5 log10 kopja/ml, u l-medja tal-ALT kienet 79 U/l, rispettivament.
English: Pharmacokinetic studies have not been performed with tenofovir disoproxil 245 mg tablets in children under 12 years or with renal impairment.
Maltese: Studji fuq il-farmakokinetika ma' sarux b'tenofovir disoproxil 245 mg pilloli fi tfal li kellhom inqas minn 12-il sena jew li kellhom indeboliment renali.
English: Co-administration of tenofovir disoproxil and didanosine is not recommended as this may result in an increased risk of adverse reactions (see section 4.5).
Maltese: L-għoti ta' tenofovir disoproxil flimkien ma' didanosine mhuwiex rakkomandat għax jista' jirriżulta f'żieda fir-riskju ta' reazzjonijiet avversi (ara sezzjoni 4.5).
English: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage in HIV patients when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once-daily regimen.
Maltese: Kien hemm rapporti ta' rata għolja ta' ħsara viroloġika, u ta' reżistenza li titfaċċa, li seħħew it-tnejn li huma fi stadju bikri f'pazjenti bl-HIV, meta tenofovir disoproxil ngħata flimkien ma' lamivudine u abacavir, kif ukoll ma' lamivudine u didanosine bħala kors ta' għoti ta' darba kuljum.
English: AUC: ↑ 22% Cmin: ↑ 37%
Maltese: AUC: ↑ 22%
English: Fifty-four patients (including 2 patients with lamivudine resistance mutations at baseline) initially received blinded placebo treatment for 72 weeks, and 52/54 patients followed with tenofovir disoproxil (PLB-tenofovir disoproxil group).
Maltese: Erbgħa u ħamsin pazjent (inkluż 2 pazjenti b'mutazzjonijiet ta' reżistenza għal lamivudine fil-linja bażi) fil-bidu rċivew kura bi plaċebo blinded għal 72 ġimgħa, u 52/54 pazjent segwew b'tenofovir disoproxil (il-grupp PLB-tenofovir disoproxil).
English: Administration of tenofovir disoproxil 33 mg/g granules to provide a reduced daily dose of tenofovir disoproxil is recommended for adult patients with creatinine clearance < 50 ml/min, including haemodialysis patients.
Maltese: L-għoti ta' tenofovir disoproxil 33 mg/g granijiet biex jtipprovdi doża mnaqqsa ta' kuljum ta' tenofovir disoproxil hu rakkomandat għal pazjenti adulti bi tneħħija tal-krejatinina ta' < 50 ml/min, li jinkludu pazjenti fuq id-dijaliżi tad-demm.
English: A. Martins & Fernandes, S.A.
Maltese: Martins & Fernandes, S.A.
English: Ge Healthcare Bio-Sciences, S.A.U.
Maltese: GE Healthcare Bio-Sciences, S.
English: Bulgaria дотарем
Maltese: Il-Bulgarija дотарем
English: Netherlands Guerbet Nederland Bv
Maltese: Guerbet Nederland BV
English: Ge Healthcare Buchler Gmbh & Co. Kg
Maltese: GE Healthcare Buchler GmbH & Co.
English: Gadoteric Acid 27.932g/100 Ml
Maltese: Dotarem Gadoteric Acid 27.932g/100 Ml
English: Luxembourg Guerbet
Maltese: Il-Lussemburgu Guerbet
English: Belgium Ge Healthcare Bvba
Maltese: GE Healthcare Bvba
English: Jenapharm Gmbh & Co Kg
Maltese: Jenapharm GmbH & Co
English: Magnevision B.E.
Maltese: B.E.
English: Meglumine Gadoterate 376.4mg/Ml
Maltese: Dotarem Meglumine Gadoterate 376.4mg/Ml
English: Belgium Bayer Sa Nv
Maltese: Bayer SA NV
English: Gadodiamide 5.74mol/15 Ml
Maltese: Gadodiamide 5.74mol/15
English: Luxembourg Bayer Sa Nv
Maltese: Il-Lussemburgu Bayer SA NV
English: Ge Healthcare Handels Gmbh
Maltese: GE Healthcare Handels GmbH Omniscan
English: Luxembourg Medithek Gmbh
Maltese: Il-Lussemburgu Medithek GmbH
English: Meglumine Gadoterate 377mg/Ml
Maltese: Dotarem Meglumine Gadoterate 377mg/Ml
English: Netherlands Bayer Bv
Maltese: Bayer BV
English: Luxembourg Ge Healthcare Bvba
Maltese: Il-Lussemburgu GE Healthcare Bvba
English: Gadodiamide 4.305g/15 Ml
Maltese: Gadodiamide 4.305g/15
English: Gadodiamide 4.31g/15 Ml
Maltese: Gadodiamide 4.31g/15
English: Intraarticular use
Maltese: użu intraartikulari
English: Netherlands Ge Healthcare B.V.
Maltese: GE Healthcare B.V.
English: Conpharm Gmbh
Maltese: M.C.S. Conpharm GmbH
English: Meglumine Gadoterate 0.5mmol/Ml
Maltese: Dotarem Meglumine Gadoterate 0.5mmol/Ml
English: Bracco Imaging Deutschland Gmbh
Maltese: Bracco Imaging Deutschland GmbH Multihance
English: 30 ml
Maltese: 32mg/Ml
English: Ενεσιμο διαλυμα Intravenous use
Maltese: Magnegita soluzzjoni għallinjezzjoni/infużjoni
English: Gadoteric Acid 0.5 Milli Molar / Ml Solution for injection Intravenous use
Maltese: Gadoteric Acid 0.5mmol/Ml soluzzjoni għallinjezzjoni
English: Gadobenic Acid 0.5 Molar / Ml
Maltese: Gadobenic Acid 0.5
English: Luxembourg Bracco Imaging Deutschland Gmbh
Maltese: Il-Lussemburgu Bracco Imaging Deutschland GmbH Prohance
English: Bayer Spa
Maltese: Bayer S.p.A.
English: Gadoteric Acid 0.0025mmol/Ml
Maltese: Dotarem Gadoteric Acid 0.0025mmol/Ml użu intraartikulari
English: Netherlands Bracco Imaging Deutschland Gmbh
Maltese: Il-Lussemburgu Bracco Imaging Deutschland GmbH Multihance
English: Gender, age, ethnicity
Maltese: Sess, età, etniċità
English: Study 2 (IBS 3002)
Maltese: Studju 2 (IBS 3002)
English: BSS <5 Response
Maltese: BSS <5 rispons
English: Warner Chilcott Deutschland GmbH Dr.-Otto-Roehm-Strasse 2-4, 64331 Weiterstadt, Germany
Maltese: Warner Chilcott Deutschland GmbH Dr.-Otto-Roehm-Strasse 2-4, 64331 Weiterstadt,
English: Global Symptom Response
Maltese: Rispons tas-sintomi globali
English: Crospovidone, type B (E1202);
Maltese: Crospovidone, tip B (E1202);
English: Rash5
Maltese: Raxx5
English: Placebo n=427
Maltese: Plaċebo n=427
English: (see sections 4.2 and 4.4).
Maltese: (ara sezzjoni 4.2).
English: Film-coating: polyvinyl alcohol (E1203); titanium dioxide (E171); macrogol 3350 (E1521); talc (E553b); iron oxide yellow (E172) and iron oxide red (E172).
Maltese: Kisja b'rita: polyvinyl alcohol (E1203); titanium dioxide (E171); macrogol 3350 (E1521); talc (E553b); iron oxide yellow (E172) u iron oxide red (E172).
English: Gastrointestinal disorders
Maltese: disturbi gastrointestinali.
English: Hypersensitivity6
Maltese: Sensittività eċċessiva6
English: Reporting of suspected adverse reactions
Maltese: Rapportar ta' effetti avversi suspettati
English: Allergan Norden AB Tlf/Puh/Tel: + 4580884560 (DK); + 47 80 01 04 97 (NO); + 358 800 115 003 (FI); + 46 8 594 100 00 (SE)
Maltese: Tlf/Puh/Tel: + 4580884560 (DK); + 47 80 01 04 97 (NO); + 358 800 115 003 (FI); + 46 8 594 100 00 (SE)
English: - The active substance is eluxadoline.
Maltese: - Is-sustanza attiva hija eluxadoline.
English: Date of first authorisation: 19 September 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Settembru 2016
English: Core tablet: silicified microcrystalline cellulose (E460); colloidal anhydrous silica (E551); crospovidone, type B (E1202); mannitol (E421) and magnesium stearate (E572).
Maltese: Qalba tal-pillola: silicified microcrystalline cellulose (E460); colloidal anhydrous silica (E551); crospovidone, tip B (E1202); mannitol (E421) u magnesium stearate (E572).
English: In vitro studies indicate that eluxadoline is neither an inducer of CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4, nor an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2C8 and CYP2D6 at clinically relevant concentrations.
Maltese: Studji in vitro jindikaw li eluxadoline la huwa induttur ta' CYP1A2, CYP2B6, CYP2C9, CYP2C19, u CYP3A4, u lanqas inibitur ta' CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2C8 u
English: Pharmacotherapeutic group: antipropulsives, ATC code: A07DA06 Mechanism of action
Maltese: Kategorija farmakoterapewtika: antipropulsivi, kodiċi ATC:
English: 5 “Rash" term includes: dermatitis, dermatitis allergic, rash, rash generalized, rash macula-papular, rash papular, rash pruritic, urticaria, and idiopathic urticarial.
Maltese: 5It-terminu “raxx” jinkludi: dermatite, dermatite allerġika, raxx, raxx ġeneralizzat, raxx makulo papulari, raxx papulari, raxx pruritiku, urtikarja, u urtikarja idjopatika.
English: The following adverse reactions considered related to eluxadoline treatment from clinical trials and spontaneous reporting are presented according to the MedDRA System Organ Classification and frequency convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi li ġejjin li huma kkunsidrati relatati ma' trattament b'eluxadoline mill-provi kliniċi u rappurtar spontanju huma ppreżentati skont is-Sistem tal-Klassifika tal-Organi u l konvenzjoni ta' frekwenza MedDRA: komuni ħafna (≤ 1/10); komuni (≤1/100 sa <1/10); mhux komuni (≤1/1,000 sa <1/100); rari (≤1/10,000 sa <1/1,000); rari ħafna (<1/10,000); u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Other substrates potentially affected include e.g. sartans (valsartan, olmesaran).
Maltese: Sottostrati oħrajn li huma potenzjalment affetwati jinkludu eż: sartans (valsartan, olmesaran).
English: Film-coated tablets Multipack: 168 (3 packs of 56) tablets.
Maltese: Pilloli miksijin b'rita Pakkett multiplu: 168 (3 pakketti ta' 56) pillola
English: Following single oral 100 mg dose in subjects with varying degrees of liver impairment and healthy subjects, eluxadoline plasma levels were on average 6-fold, 4-fold, and 16-fold elevated in mild, moderate, and severe hepaticimpaired subjects (Child Pugh Class A, B, C), respectively, while half-life increased 3-5 fold (see sections 4.3 and 4.4).
Maltese: Wara doża ta' 100 mg waħda li tingħata mill-ħalq f'individwi bi gradi differenti ta' indeboliment tal-fwied u individwi f'saħħithom, il-livelli tal-plażma ta' eluxadoline kienu bħala medja elevati 6 darbiet, 4 darbiet u 16-il darba f'individwi b'indeboliment ħafif, moderat u sever tal-fwied (Child Pugh Klassi A, B, C), rispettivament, filwaqt li l-half-life żdiedet bi 3-5 darbiet (ara sezzjonijiet 4.3 u 4.4).
English: Eluxadoline is also an agonist at the kappa opioid receptor (κOR).
Maltese: Eluxadoline huwa wkoll agonist fir-riċettur kappa opjojde (κOR).
English: Allergan Baltics UAB Tel: + 371 676 60 831 (LT); + 37 052 072 777 (LV); + 37 2634 6109 (ET)
Maltese: Tel: + 371 676 60 831 (LT); + 37 052 072 777 (LV); + 37 2634 6109 (ET)
English: Co-administration of OATP1B1 inhibitors (cyclosporine, gemfibrozil, antiretrovirals [atazanavir, lopinavir, ritonavir, saquinavir, tipranavir], rifampin) with eluxadoline may increase exposure to eluxadoline (see section 5.2).
Maltese: L-għoti flimkien ta' inibituri OATP1B1 (cyclosporine, gemfibrozil, antiretrovirali (atazanavir, lopinavir, ritonavir, saquinavir, tipranavir), rifampin) ma' eluxadoline jista' jżid l-esponiment għal eluxadoline (ara sezzjoni 5.2).
English: Component of a multipack, can't be sold separately
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament.
English: Abdominal distention Gastroesophageal reflux disease4
Maltese: Marda ta' rifluss gastroesofagali4
English: • an average global symptom score >2.0 on a 0-4 scale (0 corresponds to no symptoms, 1 corresponds to mild symptoms, 2 corresponds to moderate symptoms, 3 corresponds to severe symptoms and 4 corresponds to very severe symptoms) over the week prior to randomization
Maltese: • punteġġ ta' sintomu ġenerali medju >2.0 fuq skala minn 0 sa 4 (0 jikkorrispondi għal ebda sintomu, 1 jikkorrispondi għal sintomi ħfief, 2 jikkorrispondi għal sintomi moderati, 3 jikkorrispondi għal sintomi severi u 4 jikkorrispondi għal sintomi severi ħafna) matul il-ġimgħa qabel ir randomizzazzjoni.
English: As a precautionary measure, it is preferable to avoid the use of Truberzi during pregnancy.
Maltese: Bћala prekawzjoni huwa preferribli li ma jintużax Truberzi waqt it-tqala.
English: Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D).
Maltese: Truberzi huwa indikat fl-adulti għall-kura tas-sindrome tal-imsaren irritabbli bid-dijarea (irritable bowel syndrome with diarrhoea, IBS-D).
English: Co-administration of eluxadoline with cyclosporine (an OATP1B1 inhibitor) increased eluxadoline exposure by approximately 5-fold (see sections 4.3 and 4.5).
Maltese: eluxadoline ma' cyclosporine (inibitur OATP1B1) żied l-esponiment ta' eluxadoline b'bejn wieħed u ieħor 5 darbiet (ara sezzjonijiet 4.3 u 4.5).
English: OATP1B1 inhibitors
Maltese: Inibituri OATP1B1
English: Of 1,795 IBS-D patients who were enrolled in clinical studies of eluxadoline and assigned to 75 mg or 100 mg twice daily, 139 (7.7%) were at least 65 years of age, while 15 (0.8%) were at least 75 years old.
Maltese: Minn 1,795 pazjenti b'IBS-D li kienu ddaħħlu fl-istudji kliniċi ta' eluxadoline u assenjati għal 75 mg jew 100 mg darbtejn kuljum, 139 (7.7%) kellhom mill-anqas 65 sena, filwaqt li 15 (0.8%) kellhom mill-anqas 75 sena.
English: The efficacy and safety of eluxadoline in IBS-D patients was established in two randomized, multicenter, multi-national, double-blind, placebo-controlled studies (Studies 1 & 2).
Maltese: L-effikaċja u s-sigurtà ta' eluxadoline f'pazjenti b'IBS-D kienu stabbiliti f'żewġ studji randomizzati, multi-ċentriċi, multi-nazzjonali, double-blind, ikkontrollati bil-plaċebo (Studji 1 & 2).
English: Truberzi is a medicine that contains the active substance eluxadoline.
Maltese: Truberzi huwa mediċina li fiha s-sustanza attiva eluxadoline.
English: Somnolence and sedation
Maltese: Somnolenza u sedazzjoni
English: Eluxadoline increases the exposure of the co-administered OATP1B1 substrate; rosuvastatin (see section 5.2) by up to 40% of the total exposure which is usually not considered to be clinically relevant.
Maltese: Eluxadoline jżid l-esponiment għall-għoti flimkien tas-sottostrat ta' OATP1B1: rosuvastatin (ara sezzjoni 5.2) sa 40% tal-esponiment totali li normalment mhuwiex ikkunsidrat bħala klinikament relevanti.
English: In patients with IBS-D, no signal for central nervous system-mediated adverse events was identified.
Maltese: F'pazjenti b'IBS-D, ma kienx identifikat sinjal għal avvenimenti avversi medjati mis-sistema nervuża ċentrali.
English: • an average of worst abdominal pain (WAP) scores in the past 24 hours of >3.0 on a 0 to 10 scale over the week prior to randomization.
Maltese: • medja ta' punteġġi tal-agħar uġigħ addominali (WAP) fl-aħħar 24 siegħa ta' >3.0 fuq skala minn 0 sa 10 matul il-ġimgħa qabel ir-randomizzazzjoni.
English: Systemic exposure to medicinal products metabolised by CYP3A4 may be decreased when coadministered with Eluxadoline.
Maltese: Sottostrati ta' CYP3A Esponiment sistemiku għal prodotti mediċinali metabolizzati minn CYP3A4 jista' jitnaqqas meta jingħataw flimkien ma' Eluxadoline.
English: Study 2 (IBS-3002) included a 4-week single-blinded, placebo-withdrawal period upon completion of the 26-week treatment period.
Maltese: Studju 2 (IBS-3002) inkluda perjodu single-blinded, ta' twaqqif bil-plaċebo ta' 4 ġimgħat mat-tkomplija tal-perjodu ta' kura ta' 26 ġimgħa.
English: Modified capsule-shaped, pink-orange to peach film-coated tablet of approximately 8 mm x 19 mm, debossed with “FX100” on one side.
Maltese: Pillola miksija b'rita f'għamla ta' kapsula modifikata, roża-oranġjo sa kulur il-ħawħ ta' bejn wieħed u ieħor 8 mm x 19 mm, li għandha “FX100” imnaqqxa fuq naħa waħda.
English: PCTFE/PVC/Al-blister containing 14 film-coated tablets.
Maltese: Folja ta' PCTFE/PVC/Al li fiha 14-il pillola miksijin b'rita.
English: The tablets are packed in PCTFE/PVC/Al-blisters.
Maltese: Il-pilloli huma ppakkjati f'folji tal-PCTFE/PVC/Al.
English: The binding affinities (Ki) of eluxadoline for human μOR and δOR are 1.8 nM and 430 nM, respectively.
Maltese: L-affinitajiet tal-irbit (Ki) ta' eluxadoline għal μOR u δOR tal-bniedem huma 1.8 nM u 430 nM,
English: • Hypersensitivity to eluxadoline or to any of the excipients listed in section 6.1.
Maltese: •Ipersensittività għal eluxadoline jew għal kwalunkwe eċċipjent elenkat fit-taqsima 6.1.
English: • an average daily stool consistency score (BSS) of ≥5.5 and at least 5 days with a BSS score ≥5
Maltese: • medja ta' punteġġ ta' kuljum dwar il-konsistenza tal-ippurgar (BSS) ta' ≤5.5 u mill-anqas 5 ijiem b'punteġġ BSS ta' ≤5 fuq skala minn 1 sa 7 matul il-ġimgħa qabel ir-randomizzazzjoni.
English: However, patients 65 years of age and older, treated with the 75 mg dose twice daily experienced a reduced rate of serious adverse events as well as adverse events leading to discontinuation compared to patients treated with 100 mg dose twice daily (see section 4.8).
Maltese: Madankollu, pazjenti fl-età ta' 65 sena jew aktar, ikkurati bid-doża ta' 75 mg darbtejn kuljum esperjenzaw tnaqqis fir-rata ta' avvenimenti avversi serji kif ukoll ta' avvenimenti avversi li jwasslu għat-twaqqif meta mqabbla ma' pazjenti kkurati bid-doża ta' 100 mg darbtejn kuljum (ara sezzjoni 4.8).
English: Film-coated tablets 28 tablets
Maltese: Pilloli miksijin b'rita 28 pillola
English: Tel: + 386 (0) 590 848 40
Maltese: Ewopharma d.o.o. Tel: + 386 (0) 590 848 40
English: Modified capsule-shaped, pale yellow to light-tan film-coated tablet of approximately 7 mm x 17 mm, debossed with “FX75” on one side.
Maltese: Pillola miksija b'rita f'għamla ta' kapsula modifikata, safra ċara sa kannella ċar ta' bejn wieħed u ieħor 7 mm x 17 mm, li għandha “FX75” imnaqqxa fuq naħa waħda.
English: Study1 (IBS-3001) continued double-blinded for an additional 26 weeks for long-term safety (total of 52 weeks of treatment), followed by a 2-week follow-up.
Maltese: Studju 1 (IBS-3001) kompla doubleblinded għal 26 ġimgħa addizjonali għal sigurtà fit-tul (total ta' 52 ġimgħa ta' kura), segwiti minn follow-up ta' ġimagħtejn.
English: Dizziness Somnolence1
Maltese: Disturbi fis-sistema nervuża Sturdament Somnolenza1
English: OATP1B1 substrates
Maltese: Sottostrati ta' OATP1B1
English: Eluxadoline is a substrate of the hepatic uptake transporter OATP1B1.
Maltese: Eluxadoline huwa sottostrat tat-trasportatur OATP1B1 tal-assorbiment tal-fwied.
English: Each tablet contains 100 mg of eluxadoline.
Maltese: Kull pillola fiha 100 mg eluxadoline.
English: When the threshold for abdominal pain response was increased to ≥40% or ≥50% improvement from baseline in daily worst abdominal pain, the proportion of abdominal pain responders was 6%-7% higher for eluxadoline 100 mg twice daily compared to placebo which was statistically significant (P ≤ 0.009) for the pooled (Study 1 and Study 2) data.
Maltese: Meta l-limitu tar-rispons tal-uġigħ addominali żdied għal titjib ta' ≤40% jew ≤50% mil-linja bażi flagħar uġigħ addominali ta' kuljum, il-proporzjon ta' dawk li rrispondew, b'uġigħ addominali, kien 6%-7% ogħla għal eluxadoline 100 mg darbtejn kuljum meta mqabbel mal-plaċebo li kien sinifikanti b'mod statistiku (P ≥ 0.009) għad-data (Studju 1 u Studju 2) miġbura.
English: Eluxadoline exists predominantly as the (S,S)-diastereomer (>99%) and undergoes little or no chiral conversion in vivo.
Maltese: Eluxadoline jeżisti primarjament bħala (S,S)-diastereomer (>99%) u jgħaddi minn ftit li xejn jew ma jgħaddi mill-ebda konverżjoni ċirali in vivo.
English: inhibitory concentration [IC50] of approximately 20 µM [11 µg/mL]), although this is not expected to result in any clinically meaningful interactions.
Maltese: CYP2E1 kien kemxejn impedut (50% konċentrazzjoni inibitorja [IC50] ta' bejn wieħed u ieħor 20 µM [11 µg/mL]), għalkemm dan mhuwiex mistenni li jirriżulta f'xi interazzjoni klinikament sinifikanti.
English: - severe constipation.
Maltese: - stitikezza severa.
English: These medicines can include: - ciclosporin (immunosuppressant used to reduce inflammation); - gemfibrozil (used to lower lipid levels); - atazanavir, lopinavir, ritonavir, saquinavir, tipranavir (antiretrovirals used to treat HIV); - rifampicin (antibiotic used to treat infections).
Maltese: Dawn il-mediċini jistgħu jinkludu: - ciclosporin )immunosuppressant użat sabiex inaqqas l-infjammazzjoni); - gemfibrozil (użat sabiex ibaxxi l-livelli tal-lipidi); - atazanavir, lopinavir, ritonavir, saquinavir, tipranavir (antiretrovirali użati sabiex jikkuraw l-HIV); - rifampicin (antibjotiċi użati sabiex jikkuraw l-infezzjonijiet).
English: Overall, patients had a mean age of 45 years (range 18-80 years with 10% at least 65 years of age or older), 66% female, 86% white, 12% black, and 27% Hispanic.
Maltese: B'mod ġenerali, il-pazjenti kellhom età medja ta' 45 sena (firxa 18-80 sena b'10 % jkollhom mill-anqas 65 sena jew aktar), 66% nisa, 86%
English: The most common adverse reactions (incidence of >5%) reported were constipation (7% and 8% of patients receiving 75 mg and 100 mg respectively), nausea (8% and 7% of patients receiving 75 mg and 100 mg respectively) and abdominal pain (6% and 7% of patients receiving 75 mg and 100 mg respectively).
Maltese: pazjenti li jirċievu 75 mg u 100 mg rispettivament), nawżja (8% u 7% ta' pazjenti li jirċievu 75 mg u 100 mg rispettivament), u uġigħ addominali (6% u 7% ta' pazjenti li jirċievu 75 mg u 100 mg rispettivament).
English: Overall, there was an increased frequency of adverse events reported for patients aged 65 years or greater in the clinical studies.
Maltese: B'mod ġenerali, kien hemm żieda fil-frekwenza ta' reazzjonijiet avversi rrapportati f'pazjenti fl-età ta' 65 sena jew aktar fl-istudji kliniċi.