FrancophonIA/ELRC3.0 huggingface dataset:
English: Obeticholic acid is a selective and potent agonist for the farnesoid X receptor (FXR), a nuclear receptor expressed at high levels in the liver and intestine.
Slovenian: Obetiholna kislina je selektiven in močan agonist farnezoidnega X-receptorja (FXR), jedrnega receptorja, ki se v velikih količinah izraža v jetrih in črevesju.
English: Co-administration with food does not alter the extent of absorption of obeticholic acid.
Slovenian: Sočasna uporaba s hrano ne spremeni obsega absorpcije obetiholne kisline.
English: The most common adverse reaction leading to discontinuation was pruritus.
Slovenian: Neželeni učinek, zaradi katerega so najpogosteje prekinili zdravljenje, je bil pruritus.
English: ALP and total bilirubin were assessed as categorical variables in the primary composite endpoint, as well as continuous variables over time.
Slovenian: ALP in skupni bilirubin so ocenjevali kot kategorični spremenljivki pri primarnem sestavljenem opazovanem dogodku in tudi kot zvezni spremenljivki v času.
English: Obeticholic acid is absorbed with peak plasma concentrations (Cmax) occurring at a median time (tmax) of approximately 2 hours.
Slovenian: Pri absorpciji obetiholne kisline je mediana časa (tmax), v katerem se doseže se največja koncentracija v plazmi (Cmax) približno 2 uri.
English: FXR is thought to be a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways.
Slovenian: Menijo, da je FXR ključni regulator žolčnih kislin ter vnetnih, fibrotičnih in presnovnih poti.
English: An additional third obeticholic acid metabolite, 3-glucuronide is formed but is considered to have minimal pharmacologic activity.
Slovenian: Tvori se tudi tretji presnovek obetiholne kisline, 3-glukuronid, vendar domnevajo, da ima majhen farmakološki učinek.
English: This medicine is used to treat adult patients with a type of liver disease known as primary biliary cholangitis (also known as primary biliary cirrhosis), either by itself or together with another medicine, ursodeoxycholic acid.
Slovenian: To zdravilo se uporablja za zdravljenje odraslih bolnikov z vrsto bolezni jeter, znano kot primarni biliarni holangitis (znana tudi kot primarna biliarna ciroza), bodisi samostojno ali skupaj z drugim zdravilom, ursodeoksiholno kislino.
English: No fertility data is available in humans.
Slovenian: Podatkov o vplivu na plodnost pri človeku ni.
English: If you take more OCALIVA than you should If you accidentally take too many tablets, you may experience liver related side effects such as yellowing of the skin.
Slovenian: Če pomotoma vzamete preveč tablet, se lahko pojavijo neželeni učinki, povezani z jetri, kot je porumenela koža.
English: Limited data exists in elderly patients.
Slovenian: Pri starejših bolnikih so razpoložljivi podatki omejeni.
English: Medicinal products that are affected by obeticholic acid
Slovenian: Zdravila, ki vplivajo na obetiholno kislino
English: Driving and using machines This medicine has no or negligible influence on your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev To zdravilo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: In particular, tell your doctor if you are taking so-called bile acid binding resins (cholestyramine, colestipol, colesevelam) used to lower blood cholesterol levels as they may lessen the effect of OCALIVA.
Slovenian: Zlasti povejte zdravniku, če jemljete t.i. smole za vezavo žolčnih kislin (holestiramin, kolestipol, kolesevelam), ki se uporabljajo za zniževanje ravni holesterola v krvi, saj lahko zmanjšajo učinek zdravila OCALIVA.
English: Human plasma protein binding of obeticholic acid and its conjugates is greater than 99%.
Slovenian: Porazdelitev Stopnja vezave obetiholne kisline in njenih konjugatov v humani plazmi je večja kot 99 %.
English: Following multiple-dose administration of 5, 10, and 25 mg once daily for 14 days, systemic exposures of obeticholic acid increase dose proportionally.
Slovenian: Po 14-dnevni uporabi večkratnih odmerkov po 5, 10 in 25 mg enkrat na dan se sistemska izpostavitev obetiholni kislini povečuje sorazmerno z odmerkom.
English: Treatment-emergent pruritus generally started within the first month following the initiation of treatment.
Slovenian: Pruritus, ki se je pojavil zaradi zdravljenja se je na splošno začel v prvem mesecu po začetku zdravljenja.
English: What OCALIVA is and what it is used for
Slovenian: Kaj je zdravilo OCALIVA in za kaj ga uporabljamo
English: Approximately 60% of patients had a history of pruritus upon enrollment in the phase III study.
Slovenian: Ob vstopu v študijo faze III je približno 60 % bolnikov imelo pruritus v anamnezi.
English: Management and dose adjustment for severe pruritus Management strategies include the addition of bile acid binding resins or antihistamines.
Slovenian: Obravnavanje in prilagajanje odmerka pri hudem pruritusu Strategije obravnavanja vključujejo dodajanje smol, ki vežejo žolčne kisline, ali antihistaminikov.
English: - Film-coat: Polyvinyl alcohol, part hydrolysed (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), iron oxide yellow (E172).
Slovenian: - Filmska obloga: polivinilalkohol, delno hidroliziran (E1203), titanov dioksid (E171), makrogol 3350 (E1521), smukec (E553b), rumeni železov oksid (E172).
English: A phase III, randomised, double-blind, placebo-controlled, parallel-group, 12-month study (POISE) evaluated the safety and efficacy of OCALIVA in 216 patients with PBC who were taking UDCA for at least 12 months (stable dose for ≥ 3 months) or who were unable to tolerate UDCA and did not receive UDCA for ≥3 months.
Slovenian: V randomizirani, dvojno slepi, s placebom nadzorovani, vzporedni 12-mesečni študiji faze III (POISE) so ocenili varnost in učinkovitost zdravila OCALIVA pri 216 bolnikih s PBC, ki so vsaj 12 mesecev jemali UDCA (stabilni odmerek ≥ 3 mesece) ali ki niso mogli prenašati UDCA in niso prejemali UDCA ≥ 3 mesece.
English: The conjugates can be deconjugated in the ileum and colon by intestinal microbiota, leading to the conversion to obeticholic acid that can be reabsorbed or excreted in faeces, the principal route of elimination.
Slovenian: Konjugate lahko v ileumu in kolonu dekonjugirajo črevesni mikrobioti, kar povzroči konverzijo v obetiholno kislino, ki se lahko znova absorbira ali pa se izloči z blatom, kar je glavna pot izločanja.
English: At month 3, 9 (38%) OCALIVA-treated patients achieved a response to the composite endpoint, compared to 1 (4%) placebo-treated patient.
Slovenian: Po 3 mesecih je 9 (38 %) bolnikov, ki so prejemali zdravilo OCALIVA, doseglo skupni opazovani dogodek, v primerjavi z 1 bolnikom, ki je prejemal placebo (4 %).
English: Therefore, a modified dose regimen for patients with moderate or severe hepatic impairment is required to achieve plasma exposure levels similar to patients with no hepatic impairment (see section
Slovenian: Zato je pri bolnikih z zmerno ali hudo jetrno okvaro zahtevan prilagojen režim odmerjanja, da se doseže raven izpostavitve v plazmi, podobna tisti pri bolnikih brez jetrne okvare (glejte poglavje 4.2).
English: * Adverse reactions are defined as events occurring at a rate of greater than or equal to 5% of patients on obeticholic acid treatment arm and at an incidence greater than or equal to 1% higher than in the placebo treatment arm.
Slovenian: * Neželeni učinki so opredeljeni kot dogodki, ki so pojavljajo pri 5 % ali več bolnikov v skupini, ki prejema obetiholno kislino, ali 1 % ali več kot v skupini, ki prejema placebo.
English: The majority of pruritus occurred within the first month of treatment and tended to resolve over time with continued dosing.
Slovenian: Večina primerov pruritusa se je pojavila v prvem mesecu zdravljenja, sčasoma pa so med nadaljevanjem odmerjanja večinoma izginili.
English: • Temporarily interrupting obeticholic acid dosing for up to 2 weeks followed by restarting at a reduced dosage if applicable.
Slovenian: • začasna prekinitev odmerjanja obetiholne kisline do 2 tedna, nato pa ponovni začetek z zmanjšanim odmerkom, če je to ustrezno;
English: The adverse reactions reported with OCALIVA in the phase III clinical study are listed in the table below by MedDRA system organ class and by frequency.
Slovenian: Neželeni učinki, o katerih so poročali pri uporabi zdravila OCALIVA v klinični študiji faze III, so v spodnji preglednici razvrščeni po organskih sistemih po MedDRA in po pogostnosti.
English: Frequency of adverse reactions in PBC patients*
Slovenian: Preglednica 2: Pogostnost neželenih učinkov pri bolnikih s PBC*
English: Your doctor will determine whether you should discontinue breast-feeding or discontinue/abstain from OCALIVA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for you.
Slovenian: Z zdravnikom se bosta skupaj odločila, ali boste prekinili dojenje ali prenehali/začasno prenehali jemati zdravilo OCALIVA, pri čemer je treba upoštevati korist dojenja za otroka in korist zdravljenja za vas.
English: Patients were included in the trial if the alkaline phosphatase (ALP) was greater than or equal to 1.67 times upper limit of normal (ULN) and/or if total bilirubin was greater than 1 x ULN but less 2 x ULN.
Slovenian: Bolnike so vključili v preskušanje, če je bila raven alkalne fosfataze (ALPalkaline phosphatase) večja ali enaka 1,67-kratni zgornji meji normalne vrednosti (ULN-upper limit of normal) in/ali je bila raven skupnega bilirubina večja od 1 x ULN, vendar manjša od 2 x ULN.
English: If you experience itching that is difficult to tolerate, talk to your doctor.
Slovenian: Če se pojavi srbenje, ki ga težko prenašate, se posvetujte z zdravnikom.
English: It is unknown whether obeticholic acid is excreted in human milk.
Slovenian: Ni znano, ali se obetiholna kislina izloča v materino mleko.
English: Animal studies do not indicate any direct or indirect effects on fertility or reproduction (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost ali sposobnost razmnoževanja (glejte poglavje 5.3).
English: • The other ingredients are: - Tablet core: Microcrystalline cellulose (E460), sodium starch glycolate (Type A), magnesium stearate.
Slovenian: • Druge sestavine zdravila so: - Jedro tablete: mikrokristalna celuloza (E460), natrijev karboksimetilškrob (tip A), magnezijev stearat.
English: Limited data exists in patients with mild and moderate renal impairment and no data exists in severe renal impairment.
Slovenian: Pri bolnikih z blago in zmerno ledvično okvaro so podatki omejeni, pri bolnih s hudo ledvično okvaro pa podatkov ni.
English: Yellow, 7.6 mm X 7.4 mm triangular tablet debossed with ‘INT' on one side and ‘10' on the other side.
Slovenian: Rumena, trikotna tableta velikosti 7,6 x 7,4 mm, z vtisnjeno oznako »INT« na eni in »10« na drugi strani.
English: There is no relevant use of obeticholic acid in the paediatric population in the treatment of primary biliary cholangitis (PBC).
Slovenian: Ustrezne uporabe obetiholne kisline za zdravljenje primarnega biliarnega holangitisa (PBC) pri pediatrični populaciji ni.
English: The levels of some medicines such as theophylline (a medicine to help breathing) or tizanidine (a medicine to relieve the stiffness and restriction of muscles) may be increased and need to be monitored by your doctor while taking OCALIVA.
Slovenian: Med jemanjem zdravila OCALIVA se lahko ravni nekaterih zdravil, kot je npr. teofilin (zdravilo, ki pomaga pri dihanju) ali tizanidin (zdravilo za lajšanje togosti in oviranega delovanja mišic), zvečajo in jih bo zdravnik moral spremljati.
English: The starting dose and dosage titration by PBC patient population is shown in Table 1.
Slovenian: Začetni odmerek in titriranje odmerka pri populaciji bolnikov s primarnim biliarnem holangitisom (PBC) sta prikazana v spodnji preglednici.
English: Responders, n (%) Corresponding 95% CI p-valued
Slovenian: Preiskovanci, ki se odzivajo, n (%) Ustrezen 95-odstotni IZ vrednost pd ni na voljo
English: The majority (93%) of patients received treatment in combination with UDCA and a small number of patients (7%) unable to tolerate UDCA received placebo, OCALIVA (10 mg) or OCALIVA titration (5 mg to 10 mg) as monotherapy.
Slovenian: Večina (93 %) bolnikov je prejemala zdravljenje v kombinaciji z UDCA, majhen delež bolnikov (7 %), ki niso prenašali UDCA, pa je prejel placebo, zdravilo OCALIVA (10 mg) ali pa so jim odmerek zdravila OCALIVA titrirali (s 5 mg na 10 mg) kot monoterapijo.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to fertility, reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na plodnost ter sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol, as well as, by increasing transport of bile acids out of the hepatocytes.
Slovenian: Aktivacija FXR zmanjša znotrajcelično koncentracijo žolčnih kislin v hepatocitih, tako da zavre sintezo de novo iz holesterola in zveča transport žolčnih kislin iz hepatocitov.
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.
Slovenian: f Pri 92 % sodelujočih bolnikov je bila povprečna izhodiščna vrednost skupnega bilirubina 0,65 mg/dl in je bila znotraj normalnega razpona (tj. manjša ali enaka vrednosti ULN).
English: Percentage of PBC patients achieving the primary composite endpointa at month 6 and month 12 with or without UDCAb OCALIVA 10 mgc (N = 73)
Slovenian: Preglednica 3 Odstotek bolnikov s PBC, ki so dosegli primarni sestavljeni opazovani dogodeka po 6 in 12 mesecih z UDCA ali brez njegab OCALIVA 10 mgc (N = 73)
English: Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce efficacy of obeticholic acid.
Slovenian: Smole, ki vežejo žolčne kisline, kot so holestiramin, kolestipol ali kolesevelam, adsorbirajo žolčne kisline in zmanjšajo njihovo absorpcijo, lahko pa tudi zmanjšajo učinkovitost obetiholne kisline.
English: Your doctor will do blood tests to monitor the health of your liver when you start treatment and regularly from there on.
Slovenian: Zdravnik bo ob začetku zdravljenja in nato redno opravljal krvne preiskave za spremljanje zdravja vaših jeter.
English: P-values are obtained using the Cochran-Mantel-Haenszel General Association test stratified by intolerance to UDCA and pretreatment ALP greater than 3-times ULN and/or AST greater than 2-times ULN and/or total bilirubin greater than ULN.
Slovenian: Cochran-Mantel-Haenszelovim testom splošne asociacije, razvrščenem po intoleranci za UDCA in predhodnem zdravljenju ALP, večjem od 3-kratne ULN, in/ali AST, večjem od 2-kratne ULN, in/ali celokupnem bilirubinu, večjem od ULN.
English: In PBC patients who received OCALIVA 25 mg once daily (2.5 times the highest recommended dosage) or 50 mg once daily (5 times the highest recommended dosage), a dose-dependent increase in the incidence of liver-related adverse reactions (e.g., ascites, primary biliary cholangitis flare, new onset jaundice), and transaminase and bilirubin elevations (up to greater than 3-times upper limit of normal [ULN]) were reported.
Slovenian: Pri bolnikih s PBC, ki so prejemali 25 mg zdravila OCALIVA enkrat na dan (2,5-kratni največji priporočeni odmerek) ali 50 mg enkrat na dan (5-kratni največji priporočeni odmerek), so poročali o zvečanju incidence jetrnih neželenih učinkov, odvisnem od odmerka (npr. ascitesu, izbruhu primarnega biliarnega holangitisa, novem pojavu zlatenice), ter zvečanju ravni transaminaz in bilirubina (do več kot 3-kratne zgornje meje normalne vrednosti [ULN]).
English: The impact of mild hepatic impairment (Child-Pugh Class A) on the pharmacokinetics of obeticholic acid was negligible, therefore, no dose adjustment is necessary for patients with mild hepatic impairment.
Slovenian: Vpliv blage jetrne okvare (razred A po Child-Pughovi lestvici) na farmakokinetiko obetiholne kisline je bil zanemarljiv, zato pri bolnikih z blago jetrno okvaro odmerka ni treba prilagajati.
English: What you need to know before you take OCALIVA
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo OCALIVA
English: Exposures of glyco- and tauro-obeticholic acid, and total obeticholic acid increase more than proportionally with dose.
Slovenian: Izpostavitev gliko- in tavroobetiholni kislini ter skupni obetiholni kislini se povečuje več kot sorazmerno z odmerkom.
English: OCALIVA is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Slovenian: Zdravilo OCALIVA je indicirano za zdravljenje primarnega biliarnega holangitisa (znanega tudi kot primarna biliarna ciroza) v kombinaciji z ursodeoksiholno kislino (UDCA - ursodeoxycholic acid) pri odraslih, pri katerih odziv na UDCA ni ustrezen, ali kot samostojno zdravljenje pri odraslih, ki ne prenašajo UDCA.
English: Population pharmacokinetic analysis, developed using data from patients up to 65 years old, indicated that age is not expected to significantly influence obeticholic acid clearance from the circulation.
Slovenian: Populacijska farmakokinetična analiza na podlagi podatkov bolnikov, starih do 65 let, je pokazala, da starost ne bi smela pomembno vplivati na očistek obetiholne kisline iz obtoka.
English: In general itching of the skin is a very common side effect that begins within the first month following the start of treatment with OCALIVA and usually becomes less severe over time..
Slovenian: Srbenje je na splošno zelo pogost neželeni učinek, ki se začne v prvem mesecu po začetku zdravljenja z zdravilom OCALIVA in običajno sčasoma postane manj hudo.
English: OCALIVA contains the active substance obeticholic acid (farnesoid X-receptor agonist) which helps to improve how your liver works by reducing the production and build up of bile in the liver and also reducing inflammation.
Slovenian: Zdravilo OCALIVA vsebuje učinkovino obetiholno kislino (agonist farnezoidnega receptorja X), ki pomaga izboljšati delovanje jeter, tako da zmanjša tvorbo in kopičenje žolča v jetrih ter zmanjša vnetje.
English: This medicine has been given ‘conditional approval'.
Slovenian: Zdravilo je pridobilo tako imenovano "pogojno dovoljenje za promet".
English: Description: In order to confirm the efficacy and safety of OCALIVA, the MAH should conduct and submit the results of study 747-401, a double-blind, randomised, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of OCALIVA in patients with PBC and moderate to severe hepatic impairment.
Slovenian: Opis: za potrditev učinkovitosti in varnosti zdravila OCALIVA bo imetnik dovoljenja za promet z zdravilom izvedel in predložil rezultate študije 747-401, dvojno slepe, randomizirane, s placebom nadzorovane študije, ki bo ocenila učinkovitost, varnost in farmakokinetiko zdravila OCALIVA pri bolnikih s PBC in zmerno do hudo jetrno okvaro.
English: There is little information about the effects of OCALIVA in pregnancy.
Slovenian: Podatkov o vplivih zdravila OCALIVA med nosečnostjo je malo.
English: See table 1 for dose recommendations.
Slovenian: Bolniki z jetrno okvaro Glejte preglednico 1 za priporočila glede odmerjanja.
English: Pack sizes 1 bottle with 30 or 100 film-coated tablets.
Slovenian: Velikosti pakiranja 1 plastenka s 30 ali 100 filmsko obloženimi tabletami.
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.
Slovenian: Pri bolnikih, ki so prejemali zdravilo OCALIVA, je bilo povprečno zmanjšanje vrednosti ALP (IZ 95 %) 246 (165, 327) e./l v primerjavi s zvečanjem za 17 (-7, 42) e./l pri bolnikih, ki so prejemali placebo.
English: The European Medicines Agency will review any new information which may become available at least every year and this SmPC will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsaj enkrat letno pregledala vse nove podatke, ki bodo na voljo.
English: Oral administration of obeticholic acid above the NOAEL to mice, rats, and dogs in pivotal, repeat dose toxicity studies resulted primarily in effects on the hepatobiliary system.
Slovenian: V ključnih študijah toksičnosti pri ponavljajočih odmerkih pri miših, podganah in psih je peroralna uporaba obetiholne kisline pri odmerkih, ki so presegali vrednost NOAEL, vplivala predvsem na hepatobiliarni sistem.
English: Pack size: 30 or 100 film-coated tablets.
Slovenian: Velikost pakiranja: 30 ali 100 filmsko obloženih tablet.
English: High-density polyethylene (HDPE) bottles with a child resistant polypropylene closure and an aluminium foil induction seal.
Slovenian: Plastenke iz polietilena visoke gostote (HDPE) z za otroke varno zaporko iz polipropilena in aluminijastim indukcijskim tesnilom.
English: The percentages of patients who required interventions (i.e, dosage adjustments, treatment interruptions, or initiation of antihistamines or bile acid binding resins) were 41% in the OCALIVA 10 mg arm, 34% in the OCALIVA titration group, and 19% in the placebo group.
Slovenian: Odstotek bolnikov, pri katerih je bilo treba ukrepati (tj. prilagoditi odmerek, prekiniti zdravljenje ali začeti z uporabo antihistaminikov ali smol, ki vežejo žolčne kisline) je bil v skupini, ki je prejemala 10 mg zdravila OCALIVA, 41 %, v skupini, kjer so bolnikom odmerek zdravila OCALIVA titrirali, 34 %, v skupini, v kateri so bolniki prejemali placebo, pa 19 %.
English: Final report: 2020
Slovenian: Končno poročilo:
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 100 filmsko obloženih tablet
English: For patients in the OCALIVA titration arm whose OCALIVA dosage was increased from 5 mg once daily to 10 mg once daily, additional reductions in ALP were observed at Month 12 in the majority of patients.
Slovenian: Pri bolnikih v skupini, kjer so odmerek zdravila OCALIVA titrirali, pri katerih so odmerek zdravila OCALIVA zvečali s 5 mg enkrat na dan na 10 mg enkrat na dan, so po 12 mesecih pri večini opazili dodatno zmanjšanje vrednosti ALP.
English: Microcrystalline cellulose (E460) Sodium starch glycolate (Type A) Magnesium stearate
Slovenian: Jedro tablete mikrokristalna celuloza (E460) natrijev karboksimetilškrob (tip A) magnezijev stearat
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.
Slovenian: e Stopnje odziva so izračunali na podlagi analize opaženih primerov (tj. [n = opaženi preiskovanec, ki se odziva]/[N = populacija, ki so j nameravali zdraviti (ITT)]); odstotek bolnikov z vrednostmi po 12 mesecih v skupini, ki je prejemala 10 mg zdravila OCALIVA, je bil 86 %, v skupini, kjer so odmerek zdravila OCALIVA titrirali, 91 %, v skupini, ki je prejemala placebo, pa 96 %.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1139/002 30 film-coated tablets EU/1/16/1139/004 100 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1139/002 30 filmsko obloženih tablet EU/1/16/1139/004 100 filmsko obloženih tablet
English: Warnings and precautions Talk to your doctor or pharmacist before taking OCALIVA.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila OCALIVA se posvetujte z zdravnikom ali farmacevtom.