FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1139/001 30 film-coated tablets EU/1/16/1139/003 100 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1139/001 30 filmsko obloženih tablet EU/1/16/1139/003 100 filmsko obloženih tablet
English: Table 1: Dosage Regimen by PBC Patient Population Staging/Classification Non-Cirrhotic or
Slovenian: Preglednica 1: Režim odmerjanja pri populaciji bolnikov s PBC Stopnja/razvrstitev Brez jetrne ciroze ali razred A po lestvici ChildPugh
English: Patients were randomised (1:1:1) to receive once daily placebo, OCALIVA 10 mg, or OCALIVA titration (5 mg titrated to 10 mg at 6 months dependent on therapeutic response/tolerability).
Slovenian: Bolnike so randomizirali (1:1:1), tako da so enkrat na dan prejemali placebo, 10 mg zdravila OCALIVA ali pa so jim odmerek zdravila OCALIVA titrirali (po 6 mesecih so odmerek 5 mg pri titraciji zvečali na10 mg glede na terapevtski odziv/prenašanje).
English: Paediatric population No pharmacokinetic studies were performed with obeticholic acid in patients less than 18 years of age.
Slovenian: Pediatrična populacija Pri bolnikih, mlajših od 18 let, niso opravili nobenih farmakokinetičnih študij z obetiholno kislino.
English: ALP less than 1.67-times ULN, n (%)
Slovenian: ALP manj kot 1,67-kratna vrednost ULN, n (%) Zmanjšanje ALP za vsaj 15 %, n (%)
English: These glycine and taurine conjugates of obeticholic acid are absorbed in the small intestine leading to enterohepatic recirculation.
Slovenian: Ti glicinski in tavrinski konjugati obetiholne kisline se absorbirajo v tankem črevesu in vstopajo v enterohepatični obtok.
English: INFORMATION IN BRAILLE OCALIVA 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI OCALIVA 5 mg
English: INFORMATION IN BRAILLE OCALIVA 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI OCALIVA 10 mg
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.
Slovenian: Biokemijski odziv na samostojno zdravljenje z zdravilom OCALIVA so ocenili pri 51 bolnikih s PBC, pri katerih je bila vrednost ALP 1,67-kratna vrednost ULN ali večja in/ali skupni bilirubin večji od vrednosti ULN (24 bolnikov je prejemalo 10 mg zdravila OCALIVA enkrat na dan, 27 bolnikov pa placebo) z zbirno analizo podatkov iz randomizirane, dvojno slepe, s placebom nadzorovane 12mesečne študije 3. faze (POISE) in randomizirane, dvojno slepe, s placebom nadzorovane 3-mesečne študije.
English: These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids.
Slovenian: Ta mehanizma omejita skupno količino žolčnih kislin v obtoku in obenem spodbujata holerezo ter tako zmanjšata izpostavitev jeter žolčnim kislinam.
English: 5 mg once weekly
Slovenian: 5 mg enkrat na teden
English: In the post marketing setting, serious liver injury and death have been reported with more frequent dosing of obeticholic acid than recommended in patients with moderate to severe decreases in liver function.
Slovenian: Po začetku trženja zdravila so pri pogostejšem odmerjanju obetiholne kisline, kot je priporočeno pri bolnikih z zmernim do hudim zmanjšanjem delovanja jeter, poročali o hudih poškodbah jeter in smrti.
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.
Slovenian: Povprečno zmanjšanje gamaglutamil-transferaze (GGT) V skupini, kjer so bolniki prejemali 10 mg zdravila OCALIVA na dan je bilo povprečno zmanjšanje (IZ 95 %) GGT 178 (137, 219) e./l, v skupini, kjer so bolnikom odmerek zdravila OCALIVA titrirali, 138 (102, 174) e./l, v skupini, kjer so prejemali placebo, pa 8 (-48, 32) e./l.
English: Elevations in alanine amino transferase (ALT) and aspartate aminotransferase (AST) have been observed in patients taking obeticholic acid.
Slovenian: Pri bolnikih, ki jemljejo obetiholno kislino, so opazili zvečanje vrednosti alanin-aminotransferaze (ALT) in aspartat-aminotransferaze (AST).
English: • Reducing the dosage of obeticholic acid to: ▪ 5 mg every other day, for patients intolerant to 5 mg once daily ▪ 5 mg once daily, for patients intolerant to 10 mg once daily
Slovenian: • zmanjšanje odmerka obetiholne kisline na: 5 mg vsak drug dan pri bolnikih, ki ne prenašajo odmerka 5 mg enkrat na dan; 5 mg enkrat na dan pri bolnikih, ki ne prenašajo odmerka 10 mg enkrat na dan;
English: Very common side effects (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti neželeni učinki (lahko se pojavijo pri več kot 1 od 10 bolnikov): bolečine v trebuhu občutek utrujenosti
English: Skip the missed dose and take your next dose when you would normally take it. Do not take a double dose to make up for a forgotten tablet.
Slovenian: Preskočite izpuščeni odmerek in vzemite naslednjega ob času, ko bi ga običajno vzeli.
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.
Slovenian: Opis: za potrditev učinkovitosti in varnosti zdravila OCALIVA bo imetnik dovoljenja za promet z zdravilom izvedel in predložil rezultate študije 747-302, potrditvene, dvojno slepe, randomizirane, s placebom nadzorovane, multicentrine študije, ki bo preučevala klinično korist, povezano z zdravljenjem z zdravilom OCALIVA pri bolnikih s PBC, ki se ne odzivajo na zdravljenje z UDCA ali ga ne prenašajo, kar bo temeljilo na kliničnih opazovanih dogodkih.
English: • Continue to increase the dosage to 10 mg twice weekly, as tolerated, to achieve optimal response.
Slovenian: • nadaljevanje zvečevanja odmerka na 10 mg dvakrat na teden, glede na to, kako bolnik prenaša zdravilo, da se doseže optimalen odziv.
English: If you forget to take OCALIVA
Slovenian: Če ste pozabili vzeti zdravilo OCALIVA
English: No dose adjustment is required for patients with renal impairment (see section 5.2).
Slovenian: Pri bolnikih z ledvično okvaro prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: Maximum Dosage
Slovenian: Največji odmerek
English: For Child-Pugh Class B or C or Decompensated Cirrhotic patients:
Slovenian: Bolniki razreda B in C po Child-Pughovi lestvici ali bolniki z dekompenzirano jetrno cirozo:
English: In a pre- and post-natal toxicity study in rats, the tauro-conjugate of obeticholic acid was found in pups nursing from dams dosed with obeticholic acid
Slovenian: V študiji toksičnosti pred skotitvijo in po njej na podganah so tavrokonjugat obetiholne kisline ugotovili pri mladičih, ki so se dojili pri samicah, ki so prejamle obetiholno kislino.
English: Obeticholic acid is metabolised in the liver and intestines.
Slovenian: Obetiholna kislina se presnavlja v jetrih in črevesu.
English: Do not take OCALIVA: - if you are allergic to obeticholic acid or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila OCALIVA: - če ste alergični na obetiholno kislino ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate popolno blokado žolčnega sistema (jeter, žolčnika in žolčevodov).
English: • Reducing the dosage of obeticholic acid to: ▪ 5 mg once weekly, for patients intolerant to 5 mg twice weekly ▪ 10 mg once weekly, for patients intolerant to 10 mg twice weekly
Slovenian: • zmanjšanje odmerka obetiholne kisline na: 5 mg enkrat na teden pri bolnikih, ki ne prenašajo odmerka 5 mg dvakrat na teden, 10 mg enkrat na teden pri bolnikih, ki ne prenašajo odmerka 10 mg dvakrat na teden;
English: • Continue to increase the dosage to 10 mg once daily, as tolerated, to achieve optimal response.
Slovenian: • nadaljevanje zvečevanja odmerka do 10 mg enkrat na dan, glede na to, kako bolnik prenaša zdravilo, da se doseže optimalni odziv;
English: Child-Pugh Class B or C or Decompensated Cirrhotic
Slovenian: Razred B ali C po lestvici ChildPugh ali dekompenzirana jetrna ciroza
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
Slovenian: Titriranje odmerka Pri bolnikih, ki po 6 mesecih zdravljenja niso dosegli zadostnega znižanja alkalne fosfataze (ALP) in/ali skupnega bilirubina, bolniki pa prenašajo zdravljenje z obetiholno kislino, se titrira do 10 mg enkrat na dan
English: The highest single dose exposure of obeticholic acid in healthy volunteers has been at the 500 mg dose.
Slovenian: Največja izpostavitev pri enkratnem odmerku obetiholne kisline pri zdravih prostovoljcih je bila 500 mg. 12 dni zapored so dajali ponavljajoče odmerke po 250 mg.
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).
Slovenian: Pri zdravljenju z 10 mg zdravila OCALIVA in pri titriranju odmerka OCALIVA (s 5 mg na 10 mg) se je število bolnikov, ki so pri vseh časovnih točkah v študiji dosegli primarni sestavljeni opazovani dogodek, klinično in statistično pomembno zvečal (p < 0,0001) glede na placebo (glejte preglednico 3).
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.
Slovenian: Po enkratnem odmerku 10 mg obetiholne kisline se je pri preskušancih z blago, zmerno in hudo jetrno okvaro (razred A, B in C po Child-Pughovi lestvici) povprečna vrednost AUC skupne obetiholne kisline in njenih dveh aktivnih konjugatov povečala za faktor 1,13 (razred A), 4 (razred B) in 17 (razred C) glede na preskušance z normalnim delovanjem jeter.
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.
Slovenian: Po dnevni uporabi je razmerje presnovka in osnovne učinkovine pri glicinskih konjugatih obetiholne kisline 13,8, pri tavrinskih pa 12,3.
English: If you stop taking OCALIVA
Slovenian: Če ste prenehali jemati zdravilo OCALIVA
English: b In the trial there were 16 patients (7%) who were intolerant and did not receive concomitant UDCA: 6 patients
Slovenian: Za izračun 95-odstotnih intervalov zaupanja (IZ) so uporabili Fisherjev eksaktni test. b V preskušanju, v katerem je imelo 16 bolnikov (7 %) intoleranco in niso prejeli sočasnega UDCA: 6 bolnikov
English: • Temporarily interrupting obeticholic acid dosing for up to 2 weeks followed by restarting at a reduced dosage.
Slovenian: • začasna 2-tedenska prekinitev odmerjanja obetiholne kisline, ki ji sledi vnovično zdravljenje z zmanjšanim odmerkom;
English: If you take bile acid binding resins, take this medicine at least 4-6 hours before or at least 4-6 hours after the bile acid binding resin (see section "Other medicines and OCALIVA").
Slovenian: Če jemljete smole za vezavo žolčnih kislin, vzemite to zdravilo najmanj 4-6 ur pred jemanjem smole za vezavo žolčnih kislin ali 4-6 ur po tem (glejte poglavje »Druga zdravila in zdravilo OCALIVA«).
English: Population pharmacokinetic analysis indicated that gender does not influence obeticholic acid pharmacokinetics.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da spol ne vpliva na farmakokinetiko obetiholne kisline.
English: dOCALIVA titration and OCALIVA 10 mg versus placebo.
Slovenian: d Primerjava titracije zdravila OCALIVA in 10 mg zdravila OCALIVA s placebom.
English: Obeticholic acid is conjugated with glycine or taurine in the liver and secreted into bile.
Slovenian: Obetiholna kislina se konjugira z glicinom ali tavrinom v jetrih in se izloča v žolč.
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.
Slovenian: O hudem pruritusu so poročali pri 23 % bolnikov, zdravljenih z 10 mg zdravila OCALIVA na dan, 19 % bolnikov v skupini, ki so ji odmerek zdravila OCALIVA titrirali, in pri 7 % bolnikov v skupini,
English: For Non-Cirrhotic or Child-Pugh Class A patients:
Slovenian: Bolniki brez jetrne ciroze ali bolniki razreda A po Child-Pughovi lestvici:
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora orofaringealne bolečine
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.
Slovenian: Po dnevni uporabi obetiholne kisline se akumulirajo njeni glicinski in tavrinski konjugati, pri katerih so farmakološki učinki in vitro podobni učinkom prvotne učinkovine.
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).
Slovenian: V primerjavi z bolniki, ki so zdravljenje začeli z odmerkom 10 mg enkrat na dan v skupini, ki je prejemala 10 mg zdravila OCALIVA, je bila pri bolnikih v skupini, kjer so odmerek zdravila OCALIVA titrirali, pogostnost pruritusa manjša (70 % v primerjavi s 56 %), stopnja prekinitev zdravljenja pa je bila manjša (10 % v primerjavi z 1 %).
English: You should continue to take OCALIVA for as long as your doctor tells you to. Do not stop taking the medicine without talking to your doctor first.
Slovenian: Ne prenehajte uporabe tega zdravila, ne da bi se prej posvetovali z zdravnikom.
English: No dose adjustment is required for elderly patients (see section 5.2).
Slovenian: Odmerka pri njih ni treba prilagajati (glejte poglavje 5.2).
English: Population pharmacokinetic analysis indicated that race is not expected to influence obeticholic acid pharmacokinetics.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da ni pričakovati, da bi rasa vplivala na farmakokinetiko obetiholne kisline.
English: Liver related adverse events
Slovenian: Neželeni učinki, povezani z jetri
English: OCALIVA 10 mg film-coated tablets
Slovenian: OCALIVA 10 mg filmsko obložene tablete
English: QUALITATIVE AND QUANTITATIVE COMPOSITION OCALIVA 5 mg film-coated tablets Each film-coated tablet contains 5 mg of obeticholic acid.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA OCALIVA 5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 5 mg obetiholne kisline.
English: INR should be monitored and the dose of warfarin adjusted, if needed, to maintain the target INR range when co-administering obeticholic acid and warfarin.
Slovenian: Pri sočasni uporabi obetiholne kisline in varfarina je treba spremljati vrednost INR in po potrebi prilagoditi odmerek varfarina, da se ohrani ciljni razpon vrednosti INR.
English: Mean reductions in ALP were observed as early as Week 2 and were maintained through Month 12 for patients who were maintained on the same dosage throughout 12 months.
Slovenian: Pri bolnikih, ki so vseh 12 mesecev prejemali isti odmerek, so se tudi ohranila vseh 12 mesecev.
English: If you take any of these medicines, take OCALIVA at least 4-6 hours before or 4-6 hours after taking bile acid binding resin, giving as much time as possible.
Slovenian: Če jemljete katero koli izmed teh zdravil, vzemite zdravilo OCALIVA najmanj 4-6 ur pred jemanjem smole za vezavo žolčnih kislin ali 4-6 ur po tem, tako da bo čas med jemanjem obeh zdravil čim daljši.
English: For patients taking bile acid binding resins, obeticholic acid should be administered at least 4-6 hours before or 4-6 hours after taking a bile acid binding resin, or at as great an interval as possible (see section 4.5).
Slovenian: Bolniki, ki jemljejo smole za vezavo žolčnih kislin, morajo obetiholno kislino vzeti najmanj 4-6 ur pred jemanjem smole za vezavo žolčnih kislin ali 4-6 ur po tem (glejte poglavje 4.5).
English: or OCALIVA titration (5 mg once daily for the initial 6 months, with the option to increase to 10 mg once daily for the last 6 months, if the patient was tolerating OCALIVA but had ALP 1.67-times the ULN or greater, and/or total bilirubin above the ULN, or less than 15% ALP reduction) or placebo.
Slovenian: c Bolnike so randomizirali (1:1:1), tako da so v eni skupini prejemali 10 mg zdravila OCALIVA enkrat na dan vseh 12 mesecev preskušanja, v drugi so odmerek zdravila OCALIVA titrirali (5 mg enkrat na dan prvih 6 mesecev, z možnostjo zvečanja na 10 mg enkrat na dan zadnjih 6 mesecev, če je bolnik zdravilo OCALIVA prenašal, a je bila vrednost ALP 1,67-kratna vrednost ULN ali večja in/ali skupni bilirubin nad vrednostjo ULN ali se je vrednost ALP zmanjšala za manj kot 15 %), v tretji pa placebo.
English: Severe pruritus
Slovenian: Hudi pruritus
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.
Slovenian: Pri bolnikih z zmerno do hudo jetrno okvaro (razred B oziroma C po Child-Pughovi lestvici) je sistemska izpostavitev obetiholni kislini, njenim aktivnim konjugatom in endogenim žolčnim kislinam večja kot pri zdravih kontrolnih preskušancih.
English: Based on animal studies and intended pharmacology, obeticholic acid is not expected to interfere with breast-feeding or the growth or development of a breast-fed child. A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from obeticholic acid therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman (see section 5.3).
Slovenian: Ob upoštevanju koristi dojenja za otroka in koristi zdravljenja za mater se je treba odločiti, ali se prekine dojenje ali opusti/prekine zdravljenje z obetiholno kislino (glejte poglavje 5.3).
English: OCALIVA 5 mg film-coated tablets Yellow, 8 mm round tablet debossed with ‘INT' on one side and ‘5' on the other side.
Slovenian: Rumena, okrogla tableta s premerom 8,0 mm, z vtisnjeno oznako »INT« na eni in »5« na drugi strani.
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,
Slovenian: (8 %) v skupini z 10 mg zdravila OCALIVA, 5 bolnikov (7 %) v skupini s titracijo zdravila OCALIVA in 5 bolnikov (7 %) v skupini s placebom.
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.
Slovenian: Pri bolnikih, ki so prejemali 10 mg zdravila OCALIVA, je bila mediana časa do nastopa hudega pruritusa 11 dni, pri bolnikih, ki so jim odmerek zdravila OCALIVA titrirali 158 dni, pri bolnikih, ki so prejemali placebo, pa 75 dni.
English: Based on population pharmacokinetic analysis, renal function did not have a meaningful effect on the pharmacokinetics of obeticholic acid.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da delovanje ledvic nima bistvenega učinka na farmakokinetiko obetiholne kisline.
English: Your doctor may need to monitor how well your blood clots when taking medicines such as warfarin (a medicine to help your blood flow) with OCALIVA.
Slovenian: Pri jemanju zdravil, kot je varfarin (zdravilo, ki pomaga pri pretoku krvi), skupaj z zdravilom OCALIVA bo zdravnik morda moral spremljati, kako se strjuje vaša kri.
English: Abdominal pain and discomfort
Slovenian: Bolezni prebavil bolečine in neprijeten občutek v trebuhu obstipacija
English: No dose adjustment of concomitant UDCA is required in patients receiving obeticholic acid.
Slovenian: Pri bolnikih, ki prejemajo obetiholno kislino, ni treba prilagajati odmerka UDCA, ki se jemlje sočasno.
English: Poly(vinyl alcohol), partially hydrolysed (E1203) Titanium dioxide (E171)
Slovenian: Obloga tablete polivinilnialkohol, delno hidroliziran (E1203) titanov dioksid (E171) makrogol 3350 (E1521) smukec (E553b) rumeni železov oksid (E172)
English: OCALIVA 5 mg film-coated tablets OCALIVA 10 mg film-coated tablets obeticholic acid
Slovenian: OCALIVA 5 mg filmsko obložene tablete OCALIVA 10 mg filmsko obložene tablete obetiholna kislina
English: International normalised ratio (INR) is decreased following co-administration of warfarin and obeticholic acid.
Slovenian: Po sočasni uporabi varfarina in obetiholne kisline se internacionalno normalizirano razmerje (INR) zmanjša.
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.
Slovenian: Povprečne izhodiščne vrednosti skupnega bilirubina v vseh skupinah so bile v razponu od 10 μmol/l do 12 μmol/l.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: EU/1/16/1139/004
Slovenian: EU/1/16/1139/002 EU/1/16/1139/003 EU/1/16/1139/004
English: When concomitant bile acid binding resins are administered, obeticholic acid should be taken at least 4-6 hours before or 4-6 hours after taking a bile acid binding resin, or at as great an interval as possible.
Slovenian: Bolniki, ki sočasno uporabljajo smole za vezavo žolčnih kislin, morajo obetiholno kislino vzeti najmanj 4-6 ur pred jemanjem smole za vezavo žolčnih kislin ali 4-6 ur po tem.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja pruritus ekcem, izpuščaj
English: Oedema peripheral, Pyrexia
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost periferni edem, pireksija
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.
Slovenian: Izgled zdravila OCALIVA in vsebina pakiranja - Zdravilo OCALIVA 5 mg je rumena, okrogla filmsko obložena tableta z vtisnjeno oznako »INT«
English: Tablet core
Slovenian: Začetni odmerek
English: OCALIVA 5 mg film-coated tablets: Each film-coated tablet contains 5 mg of obeticholic acid.
Slovenian: OCALIVA 5 mg filmsko obložene tablete: Ena filmsko obložena tableta vsebuje 5 mg obetiholne kisline.
English: Obeticholic acid has minimal renal elimination with less than 3% of the dose recovered in urine.
Slovenian: V urinu so ugotovili manj kot 3 % odmerka.
English: Your doctor may adjust your dose depending on your liver function or if you experience itching that is difficult to tolerate.
Slovenian: Priporočeni odmerek je ena 5-miligramska filmsko obložena tableta, enkrat na dan, ki jo pogoltnete.Zdravnik vam bo morda prilagodil odmerek glede na vašo jetrno funkcijo ali če se je pri vas pojavilo srbenje, ki ga težko prenašate.
English: Pharmacotherapeutic group: Bile and liver therapy, Bile acid preparations.
Slovenian: Farmakoterapevtska skupina: zdravila za bolezni žolča in jeter, žolčne kisline, oznaka ATC: A05AA04