FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Tadalafil Lilly?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tadalafil Lilly?
English: This may reduce the problems with the flow of urine which are symptoms of benign prostatic hyperplasia.
Slovenian: To lahko zmanjša težave v pretoku urina, ki so simptom benigne hiperplazije prostate.
English: The other three studies included 853 patients taking Tadalafil Lilly once a day at doses of 2.5 or 5 mg.
Slovenian: V druge tri študije je bilo vključenih 853 bolnikov, ki so zdravilo Tadalafil Lilly jemali enkrat dnevno v odmerku 2,5 ali 5 mg.
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.
Slovenian: Rezultati enega od vprašalnikov, s katerim so moški ocenjevali svoje stanje na lestvici od 0 (huda erektilna disfunkcija) do 30 (odsotnost erektilne disfunkcije), so pokazali, da se je stanje bolnikov izboljšalo s približno 15 pred zdravljenjem na 23 po zdravljenju z odmerkom 10 mg in na 25 po zdravljenju z odmerkom 20 mg zdravila 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).
Slovenian: Prav tako ga ne smejo jemati bolniki, ki so kadar koli imeli težave z vidom v enem očesu zaradi dotoka krvi v očesni živec (nearteritična anteriorna ishemična optična nevropatija ali NAION).
English: Tadalafil Lilly contains the active substance tadalafil and is the same as Cialis, which is already authorised in the European Union (EU).
Slovenian: Zdravilo Tadalafil Lilly vsebuje zdravilno učinkovino tadalafil in je enako zdravilu Cialis, ki je že odobreno v Evropski uniji (EU).
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).
Slovenian: V štirih glavnih študijah, ki so vključevale 1 500 bolnikov, od katerih so imeli nekateri erektilno disfunkcijo, se je rezultat po IPSS pri bolnikih, ki so jemali zdravilo Tadalafil Lilly v odmerku 5 mg, po 12 tednih znižal bolj (od 4,8 do 6,3 točke) kot pri bolnikih, ki so jemali placebo (od 2,2 do 4,4 točke).
English: The most common side effects with Tadalafil Lilly are headache, indigestion, back pain and muscle pain, which are more common at higher doses.
Slovenian: Najpogostejši neželeni učinki zdravila Tadalafil Lilly so glavobol, prebavne motnje, bolečine v hrbtu in bolečine v mišicah, ki pa so pogostejši pri večjih odmerkih.
English: Tadalafil Lilly is a medicine used to treat men with erectile dysfunction (sometimes called impotence).
Slovenian: Tadalafil Lilly je zdravilo, ki se uporablja za zdravljenje moških z erektilno disfunkcijo (imenovano tudi impotenca).
English: The active substance of Tadalafil Lilly, tadalafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Slovenian: Zdravilna učinkovina v zdravilu Tadalafil Lilly, tadalafil, spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5).
English: The company that makes Cialis has agreed that its scientific data can be used for Tadalafil Lilly (‘informed consent').
Slovenian: Družba, ki proizvaja zdravilo Cialis, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Tadalafil Lilly („uporaba dokumentacije s soglasjem“).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tadalafil Lilly have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Tadalafil Lilly upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: In men with benign prostatic hyperplasia, or both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.
Slovenian: Priporočeni odmerek za moške z benigno hiperplazijo prostate ali moške z benigno hiperplazijo prostate in erektilno disfunkcijo je 5 mg enkrat na dan.
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).
Slovenian: Zdravilo Tadalafil Lilly se ne sme jemati skupaj z nitrati (vrsto zdravil za zdravljenje angine pektoris) ali zdravili razreda spodbujevalcev gvanilat ciklaze, kot je riocigvat (zdravilo za zdravljenje pljučne hipertenzije, tj. visokega krvnega pritiska v krvnih žilah, ki oskrbujejo pljuča).
English: Men who intend to use Tadalafil Lilly frequently (twice a week or more) can take a lower dose (5 or 2.5 mg) once a day, based on the doctor's judgement.
Slovenian: Moški, ki načrtujejo pogosto uporabo zdravila Tadalafil Lilly (vsaj dvakrat tedensko), lahko glede na zdravnikovo presojo jemljejo manjši vsakodnevni odmerek (5 mg ali 2,5 mg).
English: For more information about treatment with Tadalafil Lilly, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Tadalafil Lilly preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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.
Slovenian: Kot so dokazali s študijami, je zdravilo Tadalafil Lilly učinkovito pri izboljševanju zmožnosti doseganja in vzdrževanja erekcije in pri lajšanju simptomov benigne hiperplazije prostate.
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.
Slovenian: Med normalno spolno stimulacijo nastaja cGMP v penisu, v katerem povzroči, da se gobasto tkivo penisa (corpora cavernosa) sprosti, kar omogoči dotok krvi v tkivo, posledica česar je erekcija.
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).
Slovenian: Zdravilo Tadalafil Lilly je tudi dokazano izboljšalo simptome benigne hiperplazije prostate, izmerjene z mednarodno lestvico simptomov prostate (IPSS) v razponu med 0 (odsotnost simptomov) do 35 (hudi simptomi).
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).
Slovenian: Lahko se uporablja tudi za zdravljenje znakov in simptomov benigne hiperplazije prostate (povečane prostate, ki ni rakava, kar privede do težav v pretoku urina) pri moških.
English: What is Tadalafil Lilly and what is it used for?
Slovenian: Kaj je zdravilo Tadalafil Lilly in za kaj se uporablja?
English: All the studies compared Tadalafil Lilly with placebo (a dummy treatment) and measured improvements using questionnaires completed before and after treatment.
Slovenian: V vseh študijah so zdravilo Tadalafil Lilly primerjali s placebom (zdravilom brez zdravilne učinkovine) in izboljšanje merili z vprašalniki, ki so jih bolniki izpolnili pred zdravljenjem in po njem.
English: For practical information about using Tadalafil Lilly, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Tadalafil Lilly naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: therefore concluded that Tadalafil Lilly's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Tadalafil Lilly večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Tadalafil Lilly is available as tablets (2.5, 5, 10 and 20 mg) to be taken by mouth.
Slovenian: Zdravilo Tadalafil Lilly je na voljo v obliki tablet (2,5 mg, 5 mg, 10 mg in 20 mg), ki se jemljejo peroralno.
English: Tadalafil Lilly must not be used in men with certain cardiovascular (heart and blood vessel) conditions or when sexual activity is inadvisable.
Slovenian: Zdravila Tadalafil Lilly ne smejo uporabljati moški z določenimi kardiovaskularnimi (srčno-žilnimi) boleznimi ali moški, pri katerih je spolna aktivnost odsvetovana.
English: What are the risks associated with Tadalafil Lilly?
Slovenian: Kakšna tveganja so povezana z zdravilom Tadalafil Lilly?
English: What benefits of Tadalafil Lilly have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Tadalafil Lilly izkazalo v študijah?
English: Results also reported improved erections with Tadalafil Lilly compared with those taking placebo.
Slovenian: Prav tako so poročali o izboljšani erekciji po jemanju zdravila Tadalafil Lilly v primerjavi s placebom.
English: Other information about Tadalafil Lilly
Slovenian: Druge informacije o zdravilu Tadalafil Lilly
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.
Slovenian: Zdravilo Tadalafil Lilly s preprečevanjem razgradnje cGMP med spolno stimulacijo obnovi erektilno funkcijo in prav tako izboljša pretok krvi v prostato in mehur ter sprosti tamkajšnje mišice.
English: For the full list of all side effects with Tadalafil Lilly, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tadalafil Lilly, glejte navodilo za uporabo.
English: Why is Tadalafil Lilly approved?
Slovenian: Zakaj je bilo zdravilo Tadalafil Lilly odobreno?
English: It is not intended to provide practical advice on how to use Tadalafil Lilly.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: How is Tadalafil Lilly used?
Slovenian: Kako se zdravilo Tadalafil Lilly uporablja?
English: How does Tadalafil Lilly work?
Slovenian: Kako zdravilo Tadalafil Lilly deluje?
English: Tadalafil Lilly has been shown to improve the ability to get and maintain an erection in nine main studies involving over 2,000 men with erectile dysfunction.
Slovenian: V devetih glavnih študijah, ki so vključevale več kot 2 000 moških z erektilno disfunkcijo, so dokazali, da zdravilo Tadalafil Lilly izboljša zmožnost doseganja in vzdrževanja erekcije.
English: Further, see sections 4.4 and 5.2.
Slovenian: Nadalje glejte poglavji 4.4 in 5.2.
English: Missing values were considered a non-response.
Slovenian: Manjkajoče vrednosti so upoštevane kot odsotnost odziva.
English: Children and adolescents This medicine is not for use in children or adolescents.
Slovenian: Otroci in mladostniki To zdravilo ni namenjeno uporabi pri otrocih in mladostnikih.
English: Your doctor will discuss any change of dose with you.
Slovenian: Zdravnik se bo z vami pogovoril o kakršni koli spremembi odmerka.
English: Elderly (> 65 years)
Slovenian: Starejši bolniki (> 65 let)
English: The study population was predominantly female (91%) and white (94%).
Slovenian: Populacija v študiji je bila večinoma ženska (91 %) in bele rase (94 %).
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}><{mesec LLLL}>.
English: The most commonly reported adverse reactions were pruritus (63%) and fatigue (22%).
Slovenian: Neželena učinka, o katerih so najpogosteje poročali, sta bila pruritus (63 %) in utrujenost (22 %).
English: After initiation of therapy, all patients should be monitored for progression of PBC disease with laboratory and clinical assessment to determine whether dosage adjustment is needed.
Slovenian: Po začetku zdravljenja je treba vse bolnike spremljati za napredovanje bolezni PBC z laboratorijsko in klinično oceno, da se ugotovi, ali je potrebno prilagoditi odmerek.
English: OCALIVA Titrationc (N = 70)
Slovenian: OCALIVA Titracijac (N = 70)
English: Contact a doctor or go to a hospital for advice immediately.
Slovenian: Takoj se obrnite na zdravnika ali bolnišnico za nasvet.
English: Clinical signs and symptoms of hepatic decompensation have also been observed.
Slovenian: Opazili so tudi klinične znake in simptome jetrne dekompenzacije.
English: In the case of overdose, patients should be carefully observed and supportive care administered, as appropriate.
Slovenian: V primeru prevelikega odmerjanja je treba bolnike pozorno opazovati in jim po potrebi nuditi podporne ukrepe.
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).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki poleg oznake »EXP«.
English: Rationale: to investigate the uncertainties related to the lack of data in a population with more advanced liver disease
Slovenian: Utemeljitev: preučiti negotovosti, povezanih s pomanjkanjem podatkov pri populaciji z bolj napredovalo jetrno boleznijo.
English: Interventional study 747-401:
Slovenian: Intervencijska študija 747-401:
English: 10 mg twice weekly (at least 3 days apart)
Slovenian: 10 mg dvakrat na teden (z razmikom vsaj 3 dni med odmerkoma)
English: Interventional study 747-302:
Slovenian: Intervencijska študija 747-302:
English: There are limited pharmacokinetic data in elderly patients (≥ 65 years).
Slovenian: Farmakokinetični podatki pri starejših bolnikih (≥ 65 let) so omejeni.
English: Urinary excretion is less than 3%.
Slovenian: Z urinom se izloči manj kot 3 %.
English: Mean reduction in ALP
Slovenian: Povprečno zmanjšanje vrednosti ALP
English: The mean age was 56 years, with the majority of patients less than 65 years old.
Slovenian: Večina bolnikov je bila mlajših od 65 let.
English: Method of administration The tablet should be taken orally with or without food.
Slovenian: Način uporabe Tableto je treba vzeti peroralno s hrano ali brez nje.
English: Date of latest renewal: 12 December 2018
Slovenian: Datum prve odobritve: 12.12.2016 Datum zadnjega podaljšanja: 12. december 2018
English: For patients experiencing severe intolerability due to pruritus, one or more of the following should be considered:
Slovenian: Pri bolnikih, pri katerih se pojavi huda intoleranca zaradi pruritusa, je treba pretehtati naslednje možnosti:
English: As a precautionary measure, you should not take OCALIVA if you are pregnant.
Slovenian: Kot previdnostni ukrep ne smete jemati zdravila OCALIVA, če ste noseči.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: All changes were reversible with discontinued dosing, and are consistent with and predict the dose-limiting toxicity in humans (systemic exposure at NOAEL was up to 24-fold higher than that seen at the maximum recommended human dose).
Slovenian: Vse spremembe so bile reverzibilne ob prekinitvi odmerjanja in skladne s toksičnostjo, ki omejuje odmerke pri človeku, ter jo tudi napovedujejo (sistemska izpostavitev pri vrednosti NOAEL je bila do 24-krat večja od izpostavitve pri največjem priporočenem odmerku pri človeku).
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Slovenian: Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
English: These events have occurred as early as within the first month of treatment.
Slovenian: Ti učinki so se pojavili tudi že v prvem mesecu zdravljenja.
English: The European Medicines Agency has waived the obligation to submit the results of studies with obeticholic acid in all subsets of the paediatric population in PBC (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z obetiholno kislino za vse podskupine pediatrične populacije pri zdravljenju PBC (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: These included increased liver weights, alterations in serum chemistry parameters (ALT, AST, LDH, ALP, GGT, and/or bilirubin), and macroscopic/microscopic alterations.
Slovenian: Ti učinki so vključevali povečano maso jeter, spremembe parametrov biokemičnih preiskav seruma (ALT, AST, LDH, ALP, GGT, in/ali bilirubin) in makroskopske/mikroskopske spremembe.
English: Depending on your body's response after 6 months your doctor may increase your dose to 10 mg once daily.
Slovenian: Glede na to, kako se vaše telo odziva, bo zdravnik po 6 mesecih morda odmerek zvečal na 10 mg enkrat na dan.
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).
Slovenian: Neželene učinke, povezane z jetri, so predvsem opazili pri odmerkih, ki so presegali največji priporočeni odmerek 10 mg enkrat na dan (glejte poglavje 4.9).
English: - Complete biliary obstruction.
Slovenian: - Popolna obstrukcija žolčevoda.
English: Dose/Time proportionality
Slovenian: Razmerje odmerka in časa
English: It is not known if this medicine passes into human milk.
Slovenian: Ni znano, ali se to zdravilo izloča v mleko pri človeku.
English: Prior to initiation of treatment with obeticholic acid the patient's hepatic status must be known.
Slovenian: OdmerjanjePred začetkom zdravljenja z obetiholno kislino je treba poznati bolnikovo stanje jeter.
English: After administration of radiolabeled obeticholic acid, greater than 87% is excreted in faeces.
Slovenian: Po uporabi radioaktivno označene obetiholne kisline se več kot 87 % izloči z blatom.
English: Mean baseline ALP values ranged from 316 U/L to 327 U/L.
Slovenian: Povprečne izhodiščne vrednosti ALP so bile v razponu od 316 e./l do 327 e./l.
English: Responses occurred as early as 2 weeks and were dose dependent (OCALIVA 5 mg compared with 10 mg at 6 months, p=0.0358).
Slovenian: Odzivi so se pojavili tudi že po 2 tednih in so bili odvisni od odmerka (5 mg zdravila OCALIVA v primerjavi z 10 mg po 6 mesecih, p = 0,0358).
English: As a precautionary measure, it is preferable to avoid the use of obeticholic acid during pregnancy.
Slovenian: Kot previdnostni ukrep se je uporabi obetiholne kisline med nosečnostjo bolje izogibati.
English: Patients at an increased risk of hepatic decompensation, including those with laboratory evidence of worsening liver function and /or progression to cirrhosis, should be monitored more closely.
Slovenian: Natančneje je treba spremljati bolnike s povečanim tveganjem za jetrno dekompenzacijo, vključno s tistimi z laboratorijskimi dokazi o poslabšanju jetrne funkcije in/ali napredovanjem v jetrno cirozo.
English: There are no data on the use of obeticholic acid in pregnant women.
Slovenian: Podatkov o uporabi obetiholne kisline pri nosečnicah ni.
English: • Risk Management Plan (RMP) The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Management strategies include the addition of bile acid binding resins or antihistamines, dose reduction, reduced dosing frequency, and/or temporary dose interruption (see sections 4.2 and 4.8).
Slovenian: Strategije obravnavanja bolnikov vključujejo dodajanje smol, ki vežejo žolčne kisline, ali antihistaminikov, zmanjšanje odmerka, zmanjševanje frekvence odmerjanja in/ali začasno prekinitev odmerjanja (glejte poglavji 4.2 in 4.8).
English: Interaction with CYP1A2 substrates with narrow therapeutic index Obeticholic acid may increase the exposure to concomitant medicinal products that are CYP1A2 substrates.
Slovenian: Interakcije s substrati CYP1A2 z ozkim terapevtskim indeksom Obetiholna kislina lahko zveča izpostavljenost sočasno uporabljenim zdravilom, ki so substrati encima CYP1A2.
English: Tell your doctor or pharmacist if you experience itching of the skin (pruritus) or if the itch gets worse while on this medicine.
Slovenian: Povejte zdravniku ali farmacevtu, če se med jemanjem tega zdravila pojavi srbenje kože (pruritus) ali če srbenje postane hujše.
English: The volume of distribution of obeticholic acid is 618 L. The volume of distributions of glyco- and tauro-obeticholic acid has not been determined.
Slovenian: Volumen porazdelitve obetiholne kisline je 618 l. Volumna porazdelitve gliko- in tavroobetiholne kisline niso določili.
English: Rationale: to investigate the effect of obeticholic acid on clinical outcomes in subjects with PBC
Slovenian: Utemeljitev: preučiti učinek obetiholne kisline na klinične izide pri preiskovancih s PBC.
English: You can take OCALIVA with or without food.
Slovenian: Zdravilo OCALIVA lahko jemljete s hrano ali brez nje.
English: Therapeutic monitoring of CYP1A2 substrates with narrow therapeutic index (e.g. theophylline and tizanidine) is recommended.
Slovenian: Priporočljivo je terapevtsko spremljanje substratov encima CYP1A2 z ozkim terapevtskim indeksom (npr. teofilina in tizanidina).
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).
Slovenian: Pogostnost odmerjanja je treba zmanjšati pri bolnikih, pri katerih je bolezen napredovala (to je od razreda A do razreda B ali C po letvici Child-Pugh) (glejte poglavji 4.2 in 5.2).
English: Obeticholic acid has no or negligible influence on the ability to drive and use machines.
Slovenian: Obetiholna kislina nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravila, na katera vpliva obetiholna kislina