FrancophonIA/ELRC3.0 huggingface dataset:
English: A small dose of another medicine, ritonavir, is normally given at the same time as a ‘booster'.
Maltese: Doża żgħira ta' mediċina oħra, ritonavir, normalment tingħata fl-istess ħin bħala “booster”.
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The active substance in Atazanavir Krka, atazanavir, is a protease inhibitor.
Maltese: Is-sustanza attiva f'Atazanavir Krka, l-atażanavir, hija inibitur tal-proteażi.
English: Atazanavir Krka (atazanavir) EMA/107659/2019
Maltese: EMA/107659/2019
English: Atazanavir Krka (atazanavir)
Maltese: Atazanavir
English: Atazanavir Krka contains the active substance atazanavir and is a ‘generic medicine'.
Maltese: Krka fih is-sustanza attiva atażanavir u huwa "mediċina ġenerika".
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Reyataz, and do not need to be repeated for Atazanavir Krka.
Maltese: Diġà saru studji fuq il-benefiċċji u r-riskji tas-sustanza attiva fl-użu awtorizzat tal-mediċina ta' referenza, Reyatez, u m'hemmx għalfejn jiġu ripetuti għal Atazanavir Krka.
English: How is Atazanavir Krka used?
Maltese: Kif jintuża Atazanavir Krka?
English: Because Atazanavir Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Atazanavir Krka huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: This means that Atazanavir Krka contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Reyataz.
Maltese: Dan ifisser li Atazanavir Krka fih l-istess sustanza attiva u jaħdem bl-istess mod bħal “mediċina ta' referenza” diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Reyatez.
English: Atazanavir Krka does not cure HIV infection or AIDS but, when used in combination with other antivirals, it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Atazanavir Krka ma jikkurax l-infezzjoni tal-HIV jew l-AIDS iżda, meta jintuża b'kombinazzjoni ma' antivirali oħra, jittardja l-ħsara li ssir lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjati mal-AIDS.
English: Atazanavir Krka, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Atazanavir Krka, meta jittieħed flimkien ma' mediċini antivirali oħra, inaqqas l-ammont tal-HIV fid-demm u jżommu f'livell baxx.
English: In younger patients, the dose of Atazanavir Krka depends on body weight.
Maltese: Informazzjoni dwar il-mediċina ta' referenza tinstab ukoll fis-sit elettroniku tal-Aġenzija.
English: This allows a lower dose of atazanavir to be used for the same antiviral effect.
Maltese: Dan jippermetti li atażanavir jintuża f'doża iżgħar għall-istess effett antivirali.
English: Atazanavir Krka is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.
Maltese: Krka normalment jingħata ma' ritonavir biex tissaħħaħ l-azzjoni tiegħu iżda f'sitwazzjonijiet speċifiċi, it-tobba jistgħu jikkunsidraw li jwaqqfu ritonavir fl-adulti.
English: The medicine is not expected to work in patients in whom many medicines in the same class as Atazanavir Krka (protease inhibitors) do not work.
Maltese: Mhuwiex mistenni li l-mediċina taħdem fuq pazjenti li fuqhom ma jkunux jaħdmu ħafna mediċini flistess klassi ta' Atazanavir Krka (inibituri tal-proteażi).
English: Why is Atazanavir Krka authorised in the EU?
Maltese: Għalfejn Atazanavir Krka ġie awtorizzat fl-UE?
English: An overview of Atazanavir Krka and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Atazanavir Krka u għaliex huwa awtorizzat fl-UE
English: The full EPAR for Tadalafil Lilly can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For erectile dysfunction, the usual dose is 10 mg at least 30 minutes before sexual activity.
Maltese: Għal disfunzjoni erettili, id-doża tas-soltu hija ta' 10 mg tal-inqas 30 minuta qabel l-attività sesswali.
English: The active substance of Tadalafil Lilly, tadalafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Is-sustanza attiva ta' Tadalafil Lilly, tadalafil, tappartjeni għal grupp ta' mediċini magħruf bħala inibituri tal-fosfodjesterażi tat-tip 5 (PDE5).
English: Tadalafil Lilly is available as tablets (2.5, 5, 10 and 20 mg) to be taken by mouth.
Maltese: Tadalafil Lilly jiġi bħala pilloli (2.5, 5, 10 u 20 mg) li għandhom jittieħdu mill-ħalq.
English: This is a summary of the European public assessment report (EPAR) for Tadalafil Lilly.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Tadalafil Lilly.
English: Tadalafil Lilly has also been shown to improve the symptoms of benign prostatic hyperplasia as measured using the international prostate symptom score (IPSS), which ranges from 0 (no symptoms) to 35 (severe symptoms).
Maltese: Intwera wkoll li Tadalafil Lilly jtejjeb is-sintomi tal-iperplasija bennina tal-prostata kif imkejjel bl-użu tal-punteġġ internazzjonali tas-sintomi tal-prostata (IPSS, international prostate symptom score), li jvarja minn 0 (ebda sintomu) għal 35 (sintomi severi).
English: In four main studies involving 1,500 patients, some of whom also had erectile dysfunction, patients taking Tadalafil Lilly at a dose of 5 mg had greater reductions in IPSS (4.8 to 6.3 points) after 12 weeks than those taking placebo (2.2 to 4.4 points).
Maltese: F'erba' studji ewlenin li involvew 1,500 pazjent, li xi wħud minnhom kellhom ukoll disfunzjoni erettili, il-pazjenti li kienu qed jieħdu Tadalafil Lilly f'doża ta' 5 mg kellhom tnaqqis akbar fl-IPSS (4.8 sa 6.3 punti) wara 12-il ġimgħa milli dawk li kienu qed jieħdu l-plaċebo (2.2 sa 4.4 punti).
English: Six of the studies included 1,328 patients who took the medicine before sexual activity.
Maltese: Sitta mill-istudji inkludew 1,328 pazjent li ħadu l-mediċina qabel l-attività sesswali.
English: Other information about Tadalafil Lilly
Maltese: Informazzjoni oħra dwar Tadalafil Lilly
English: Results for one of the questionnaires, in which men rated their condition on a scale of 0 (indicating severe erectile dysfunction) to 30 (no erectile dysfunction), showed that patients improved from about 15 before treatment, to 23 and 25 after treatment with Tadalafil Lilly 10 and 20 mg, respectively.
Maltese: Ir-riżultati għal wieħed mill-kwestjonarji, li fih l-irġiel ikklassifikaw il-kundizzjoni tagħhom fuq skala ta' minn 0 (li tindika disfunzjoni erettili severa) għal 30 (ebda disfunzjoni erettili), urew li l-pazjenti tjiebu minn madwar 15 qabel il-kura, għal 23 u 25 wara l-kura b'Tadalafil Lilly 10 mg u 20 mg, rispettivament.
English: Why is Tadalafil Lilly approved?
Maltese: Għaliex ġie approvat Tadalafil Lilly?
English: It must also not be taken by patients who have ever had loss of vision in one eye because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy, NAION).
Maltese: Dan lanqas ma għandu jintuża minn pazjenti li xi darba sofrew minn telf fil-vista minħabba problema fil-fluss tad-demm lejn in-nerv fl-għajn (newropatija ottika iskemika anterjuri mhux arteritika, NAION) (non-arteritic anterior ischemic optic neuropathy).
English: Tadalafil Lilly must not be taken with nitrates (a type of medicine used for angina) or medicines of the class ‘guanylate cyclase stimulators' such as riociguat (a medicine for high blood pressure in the vessels supplying the lungs, known as pulmonary hypertension).
Maltese: Tadalafil Lilly m'għandux jittieħed man-nitrati (tip ta' mediċina użata għall-kura talanġina) jew mediċini tal-klassi “guanylate cyclase stimulators” bħal riociguat (mediċina għall-pressjoni tad-demm għolja fil-vażijiet li jfornu lill-pulmuni, magħrufa bħala ipertensjoni pulmonari).
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection.
Maltese: Waqt stimulazzjoni sesswali normali, il-pene jipproduċi cGMP, li jwassal għar-rilassament tal-muskolu tat-tessut artab tal-pene (il-corpora cavernosa), b'hekk jippermetti l-fluss tad-demm fil-corpora, u jipproduċi l-erezzjoni.
English: The other three studies included 853 patients taking Tadalafil Lilly once a day at doses of 2.5 or 5 mg.
Maltese: Ittliet studji l-oħrajn inkludew 853 pazjent li kienu qed jieħdu Tadalafil Lilly darba kuljum f'dożi ta' 2.5 jew 5 mg.
English: It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Maltese: Dan jaħdem billi jimblokka l-enzima fosfodjesterażi, li normalment tkisser sustanza magħrufa bħala monofosfat gwanożin ċikliku (cGMP).
English: The company that makes Cialis has agreed that its scientific data can be used for Tadalafil Lilly (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Cialis qablet li d-dejta xjentifika tiegħu tista' tintuża għal Tadalafil Lilly (“kunsens infurmat”).
English: The dose may be increased to 20 mg if the 10 mg dose is not effective.
Maltese: Jekk id-doża ta' 10 mg ma tkunx effettiva, id-doża tista' tiżdied għal 20 mg.
English: Tadalafil Lilly is a medicine used to treat men with erectile dysfunction (sometimes called impotence).
Maltese: Tadalafil Lilly huwa mediċina li tintuża biex tikkura rġiel b'disfunzjoni erettili (li xi drabi tissejjaħ impotenza).
English: This may reduce the problems with the flow of urine which are symptoms of benign prostatic hyperplasia.
Maltese: Dan jista' jnaqqas il-problemi bil-fluss tal-awrina li huma sintomi ta' iperplasija bennina tal-prostata.
English: Tadalafil Lilly contains the active substance tadalafil and is the same as Cialis, which is already authorised in the European Union (EU).
Maltese: Tadalafil Lilly fih is-sustanza attiva tadalafil u hu l-istess bħal Cialis, li diġà huwa awtorizzat fl-Unjoni Ewropea (UE).
English: In men with benign prostatic hyperplasia, or both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.
Maltese: F'irġiel b'iperplasija bennina tal-prostata, jew b'kemm iperplasija bennina tal-prostata kif ukoll b'disfunzjoni erettili, id-doża rakkomandata hija ta' 5 mg darba kuljum.
English: What are the risks associated with Tadalafil Lilly?
Maltese: X'inhuma r-riskji assoċjati ma' Tadalafil Lilly?
English: For the full list of all side effects with Tadalafil Lilly, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Tadalafil Lilly, ara l-fuljett ta' tagħrif.
English: By blocking the breakdown of cGMP, Tadalafil Lilly restores erectile function during sexual stimulation and also improves the blood flow to, and relaxes the muscles of, the prostate and bladder.
Maltese: Meta jimblokka t-tkissir ta' cGMP, Tadalafil Lilly jerġa' jġib il-funzjoni erettili waqt l-istimulazzjoni sesswali u jtejjeb ukoll il-fluss tad-demm għall-prostata u l-bużżieqa tal-awrina, u jirrilassa l-muskoli tagħhom.
English: As shown in studies, Tadalafil Lilly is effective at improving the ability to get and maintain erections and at relieving the symptoms of benign prostatic hyperplasia.
Maltese: Kif intwera mill-istudji, Tadalafil Lilly huwa effettiv biex ittejjeb l-abbiltà li wieħed ikollu erezzjoni u jżommha u biex inaqqas is-sintomi tal-iperplasija bennina tal-prostata.
English: It can also be used in men to treat the signs and symptoms of benign prostatic hyperplasia (enlarged prostate gland that is not cancerous, which leads to problems with the flow of urine).
Maltese: Dan jista' jintuża wkoll f'irġiel għall-kura tas-sinjali u s-sintomi ta' iperplasija bennina tal-prostata (tkabbir tal-glandola tal-prostata li mhix kanċeruża, li twassal għal problemi fil-fluss tal-awrina).
English: Final report: 2020
Maltese: Rapport finali: 2020
English: Final report: 2023
Maltese: Rapport finali: 2023
English: Interventional study 747-401:
Maltese: Studju Intervenzjonali 747-401:
English: Placebo (N=73)
Maltese: Plaċebo (N = 73)
English: Interventional study 747-302:
Maltese: Studju Intervenzjonali 747-302:
English: ATC code: A05AA04
Maltese: A05AA04
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL- BRAILLE
English: Responders, n (%) Corresponding 95% CI p-valued
Maltese: Dawk li rrispondew, n (%) Korrispondenti 95% CI valur-p d
English: System Organ Class
Maltese: Klassi tas-Sistema tal-Organi
English: - Film-coat: Polyvinyl alcohol, part hydrolysed (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), iron oxide yellow (E172).
Maltese: Poly (vinyl alcohol), part hydrolysed (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), iron oxide yellow (E172).
English: Intercept Pharma Spain S.L.U.
Maltese: Intercept Pharma Spain S.
English: INFORMATION IN BRAILLE OCALIVA 5 mg
Maltese: INFORMAZZJONI BIL- BRAILLE OCALIVA 5 mg
English: Dose/Time proportionality
Maltese: Doża/Proporzjonalità tal-ħin
English: There are limited pharmacokinetic data in elderly patients (≥ 65 years).
Maltese: Hemm dejta farmakokinetika limitata f'pazjenti anzjani (≥ 65 sena).
English: Poly(vinyl alcohol), partially hydrolysed (E1203) Titanium dioxide (E171)
Maltese: Poly(vinyl alcohol), partially hydrolysed (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521)
English: INFORMATION IN BRAILLE OCALIVA 10 mg
Maltese: INFORMAZZJONI BIL- BRAILLE OCALIVA 10 mg
English: Date of latest renewal: 12 December 2018
Maltese: Data tal-aħħar tiġdid: 12 Diċembru 2018
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D <Barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: The Fisher's exact test was used to calculate the 95% Confidence Intervals (Cis).
Maltese: Il-Fisher's exact test kien użat sabiex jiġu kkalkulati Intervalli ta' Kunfidenza (Confidence intervals, Cis) ta' 95%.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12/12/2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 12/12/2016
English: Frequency of adverse reactions in PBC patients*
Maltese: Frekwenza ta' reazzjonijiet avversi f'pazjenti b'PBC*
English: OCALIVA Titrationc (N = 70)
Maltese: Titrazzjoni ta' OCALIVA c (N = 70)
English: Mean reduction in ALP
Maltese: Tnaqqis medju ta' ALP
English: Mean reduction in gamma-glutamyl transferase (GGT) The mean (95% CI) reduction in GGT was 178 (137, 219) U/L in the OCALIVA 10 mg arm, 138 (102, 174) U/L in the OCALIVA titration arm, and 8 (-48, 32) U/L in the placebo arm.
Maltese: Tnaqqis medju ta' gamma-glutamyl transferase (GGT) It-tnaqqis medju (95% CI) ta' gamma-glutamyl transferase (GGT) kien 178 (137, 219) U/L fil-parti tal-istudju b'OCALIVA 10 mg, 138 (102, 174) U/L fil-parti tal-istudju b'titrazzjoni ta' OCALIVA, u 8 (-48, 32) U/L fil-parti tal-istudju bi plaċebo.
English: FXR is thought to be a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways.
Maltese: FXR huwa maħsub li huwa regolatur importanti talperkorsi ta' aċidu tal-bili, infjammatorji, fibrotiċi, u metaboliċi.
English: dOCALIVA titration and OCALIVA 10 mg versus placebo.
Maltese: d Gruppi ta' Titrazzjoni ta' OCALIVA u OCALIVA 10 mg kontra plaċebo.
English: Elevations in alanine amino transferase (ALT) and aspartate aminotransferase (AST) have been observed in patients taking obeticholic acid.
Maltese: Żidiet f'alanine amino transferase (ALT) u aspartate aminotransferase (AST) ġew osservati f'pazjenti li qed jieħdu obeticholic acid.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskuloskeletriċi u tat-tessuti konnettivi
English: In subjects with mild, moderate and severe hepatic impairment (Child-Pugh Class A, B, and C, respectively), mean AUC of total obeticholic acid, the sum of obeticholic acid and its two active conjugates, increased by 1.13-, 4- and 17-fold, respectively, compared to subjects with normal hepatic function following single-dose administration of 10 mg obeticholic acid.
Maltese: F'pazjenti b'indeboliment tal-fwied ħafif, moderat jew sever (Child-Pugh Klassi A, B, u C, rispettivament), l-AUC medju ta' obeticholic acid totali, is-somma ta' obeticholic acid u ż-żewġ konġugati attivi tiegħu, żdiedu b'1.13-, 4- u 17-il darba, rispettivament, meta mqabbla ma' pazjenti b'funzjoni normali tal-fwied wara l-għoti ta' doża waħda ta' 10 mg obeticholic acid.
English: • The other ingredients are: - Tablet core: Microcrystalline cellulose (E460), sodium starch glycolate (Type A), magnesium stearate.
Maltese: - Il-qalba tal-pillola: Microcrystalline cellulose (E460), sodium starch glycolate (Type A), magnesium stearate.
English: Frequencies are defined as: 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: Il-frekwenzi huma definiti bħala: 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-dejta disponibbli).
English: Summary of the safety profile
Maltese: Sommarju tal-profil ta' sigurta'
English: Thyroid function abnormality
Maltese: Abnormalità fil-funzjoni tattirojde
English: b In the trial there were 16 patients (7%) who were intolerant and did not receive concomitant UDCA: 6 patients
Maltese: b Fil-prova kien hemm 16-il pazjent (7%) li kienu intolleranti u li ma rċivewx UDCA fl-istess ħin: 6 pazjenti
English: The mean (95% CI) reduction in ALP in OCALIVA-treated patients was 246 (165, 327) U/L compared to an increase of 17 (-7, 42) U/L in the placebo-treated patients.
Maltese: It-tnaqqis medju (95% CI) ta' ALP f'pazjenti trattati b'OCALIVA kien ta' 246 (165, 327) U/L meta mqabbel ma' żieda ta' 17 (-7, 42) U/L f'pazjenti trattati bi plaċebo.
English: Dosing frequency should be reduced for patients who progress to advanced disease (i.e. from Child-Pugh Class A to Child-Pugh Class B or C) (see sections 4.2 and 5.2).
Maltese: Il-frekwenza tad-dożaġġ għandha titnaqqas għal pazjenti li jipprogressaw għal mard avvanzat (i.e. minn Child-Pugh Klassi A għal Child-Pugh Klassi B jew Ċ) (ara sezzjoni 4.2 and 5.2).
English: Elderly (> 65 years)
Maltese: Anzjani (≥ 65 sena)
English: e Response rates were calculated based on the observed case analysis (i.e., [n=observed responder]/[N=Intention to Treat (ITT) population]); percentage of patients with Month 12 values are 86%, 91% and 96% for the OCALIVA 10 mg, OCALIVA titration and placebo arms, respectively.
Maltese: e Rati ta' rispons kienu kkalkulati bbażżati fuq l-analiżi ta' każijiet osservati (i.e., [n=rispondenti osservati]/[N=Popolazzjoni b'Intenzjoni ta' Trattament (ITT)]); perċentwal ta' pazjenti b'valuri ta' Xahar 12 huma 86%, 91% u 96% għall-partijiet tal-istudju b'OCALIVA 10 mg, b'titrazzjoni ta' OCALIVA titration u bi plaċebo, rispettivament.
English: After administration of radiolabeled obeticholic acid, greater than 87% is excreted in faeces.
Maltese: Wara l-għoti ta' obeticholic acid radjotikkettat, aktar minn 87% jiġi eliminat fl-ippurgar.
English: Eczema, Rash
Maltese: Ekżema, Raxx
English: Yellow, 7.6 mm X 7.4 mm triangular tablet debossed with ‘INT' on one side and ‘10' on the other side.
Maltese: Pillola safra, trijangulari 7.6 mm X 7.4 mm mnaqqxa b'‘INT' fuq naħa waħda u ‘10' fuq in-naħa loħra.
English: What OCALIVA contains The active substance is obeticholic acid.
Maltese: Is-sustanza attiva hi obeticholic acid.
English: The metabolite-to -parent ratios of the glycine and taurine conjugates of obeticholic acid were 13.8 and 12.3, respectively, after daily administration.
Maltese: Il-proporzjon tal-metabolit għall-ġenitur tal-konġugati ta' glycine u taurine ta' obethicolic acid kienu 13.8 u 12.3, rispettivament, wara għoti kuljum.
English: There is no relevant use of obeticholic acid in the paediatric population in the treatment of primary biliary cholangitis (PBC).
Maltese: Ma hemm l-ebda użu rilevanti ta' obeticholic acid fil-popolazzjoni pedjatrika fit-trattament ta' kolanġite biljari primarja (PBC - primary biliary cholangitis).
English: Further, see sections 4.4 and 5.2.
Maltese: Għal aktar, ara sezzjonijiet 4.4 u 5.2
English: Liver-related adverse events have primarily been observed at doses higher than the maximum recommended dose of 10 mg once daily (see section 4.9).
Maltese: Każijiet avversi relatati mal-fwied ġew osservati primarjament f'dożi ogħla mid-doża massima rakkomandata ta' 10 mg darba kuljum (ara sezzjoni 4.9).
English: These included increased liver weights, alterations in serum chemistry parameters (ALT, AST, LDH, ALP, GGT, and/or bilirubin), and macroscopic/microscopic alterations.
Maltese: Dawn kienu jinkludu żieda fil-piż tal-fwied, tibdil fil-parametri tat-testijiet kimiċi tad-demm (ALT, AST, LDH, ALP, GGT, u/jew bilirubin), u tibdiliet makroskopiċi/mikroskopiċi.
English: (8%) in the OCALIVA 10 mg arm, 5 patients (7%) in the OCALIVA titration arm, and 5 patients (7%) in the placebo arm. c Patients were randomized (1:1:1) to receive OCALIVA 10 mg once daily for the entire 12 months of the trial,
Maltese: (8%) fil-parti tal-istudju b'OCALIVA 10 mg, 5 pazjenti (7%) fil-parti tal-istudju b'titrazzjoni ta' OCALIVA, u 5 pazjenti (7%) fil-parti tal-istudju bi plaċebo.
English: f The mean baseline total bilirubin value was 0.65 mg/dL, and was within the normal range (i.e., less than or equal to the ULN) in 92% of the enrolled patients.
Maltese: f Il-linja bażi medja tal-valur ta' bilirubin totali kien ta' 0.65 mg/dL, u kien fil-medda normali (i.e., inqas minn jew daqs ULN) fi 92% tal-pazjenti reklutati.
English: Mean baseline ALP values ranged from 316 U/L to 327 U/L.
Maltese: Il-valuri medji ta' ALP fil-linja bażi kienu fil-medda ta' 316 U/L sa 327 U/L.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1139/002 30 film-coated tablets EU/1/16/1139/004 100 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1139/002 30 pillola miksija b'rita EU/1/16/1139/004 100 pillola miksija b'rita
English: International normalised ratio (INR) is decreased following co-administration of warfarin and obeticholic acid.
Maltese: L-International normalized ratio (INR) jonqos wara l-għoti fl-istess ħin ta' warfarin u obeticholic acid.
English: Endocrine disorders
Maltese: Disturbi endokrinoloġiċi
English: Human plasma protein binding of obeticholic acid and its conjugates is greater than 99%.
Maltese: Twaħħil ta' proteina tal-plażma umana ta' obeticholic acid u l-konġugati tiegħu hija iktar minn 99%.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1139/001 30 film-coated tablets EU/1/16/1139/003 100 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1139/001 30 pillola miksija b'rita EU/1/16/1139/003 100 pillola miksija b'rita
English: Exposures of glyco- and tauro-obeticholic acid, and total obeticholic acid increase more than proportionally with dose.
Maltese: Esponimenti ta' glyco- u tauro-obethicolic acid, u ta' obethicolic acid totali jiżdiedu iktar minn b'mod proporzjonali bid-doża.
English: An additional third obeticholic acid metabolite, 3-glucuronide is formed but is considered to have minimal pharmacologic activity.
Maltese: It-tielet metabolit addizjonali ta' obethicolic acid, 3-glucuronide jiġi ffurmat imma huwa meqjus li għandu attività farmakoloġika minima.