FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 4: Posology for Bortezomib Hospira combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation B+Dx
Slovenian: Preglednica 4: Odmerjanje zdravila Bortezomib Hospira pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, pri katerih je presaditev krvotvornih matičnih celic primerna.
English: M (9 mg/m P (60 mg/m
Slovenian: (60 mg/m
English: 222 subjects were enrolled into the study; 221 subjects were treated with bortezomib Hazards ratio estimate is based on a Cox model adjusted for stratification factors: ISS staging and number of prior lines.
Slovenian: b V preskušanje je bilo vključenih 222 preskušancev; 221 preskušancev se je zdravilo z bortezomibom.
English: Subcutaneous reconstitution:
Slovenian: Rekonstituirana raztopina
English: Day rest period
Slovenian: Dan premor
English: HR b (95% CI)=0.63
Slovenian: 133 (54,7 %) 165 (67,6 %) HR b (95 % IZ) = 0,63 (0,50; 0,79); vrednost p d < 0,001
English: • that Bortezomib Hospira is to be given only by IV or SC injections; no other route of administration is allowed
Slovenian: • Zdravilo Bortezomib Hospira se lahko injicira samo i.v.
English: • Brittle or weak nails
Slovenian: • krhki ali lomljivi nohti
English: Efficacy results are presented in Table 11:
Slovenian: Podatki o učinkovitosti so navedeni v preglednici 11.
English: Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ]
Slovenian: b Nanaša se na stopnjo odziva po drugi presaditvi pri posameznikih, pri katerih je bila le-ta izvedena
English: • Dosing Slide Rule
Slovenian: • odpoved ledvic
English: The recommended daily dose is 0.34 ml per kilogram body weight.
Slovenian: Priporočeni dnevni odmerek je 0,34 ml na kilogram telesne mase.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vedrop on 24 July 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vedrop, veljavno po vsej Evropski uniji, izdala 24. julija 2009.
English: Vedrop tocofersolan
Slovenian: Vedrop tokofersolan
English: It has a number of actions in the body, including protecting the nervous system from damage.
Slovenian: Ima številne učinke na telo, vključno z zaščito živčnega sistema pred poškodbami.
English: What measures are being taken to ensure the safe and effective use of Vedrop?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vedrop?
English: The full EPAR for Vedrop can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vedrop je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This dose should be adjusted according to the amount of vitamin E in the patient's blood.
Slovenian: Ta odmerek je treba prilagoditi glede na količino vitamina E v bolnikovi krvi.
English: This is a summary of the European public assessment report (EPAR) for Vedrop.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vedrop.
English: What is Vedrop and what is it used for?
Slovenian: Kaj je zdravilo Vedrop in za kaj se uporablja?
English: The most common side effect with Vedrop (which may affect up to 1 in 10 people) is diarrhoea.
Slovenian: Najpogostejši neželeni učinek zdravila Vedrop (ki se lahko pojavi pri največ 1 bolniku od 10) je driska.
English: Other information about Vedrop
Slovenian: Druge informacije o zdravilu Vedrop
English: This is because it has not been possible to obtain complete information about Vedrop due to the rarity of the disease.
Slovenian: Do tega je prišlo zato, ker zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o njem.
English: The company also presented information on the use of Vedrop in patients with cystic fibrosis, but withdrew its application for this disease during the evaluation of the medicine.
Slovenian: Družba je predstavila tudi informacije o uporabi zdravila Vedrop pri bolnikih s cistično fibrozo, vendar je med vrednotenjem zdravila umaknila svojo vlogo za to bolezen.
English: Vedrop has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Vedrop je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
English: Vitamin E is a natural substance that cannot be made by the body and is therefore needed in the diet.
Slovenian: Vitamin E je naravna snov, ki je telo ne more tvoriti in jo je zato treba zagotoviti s hrano.
English: To support the use of Vedrop, the company presented information from the scientific literature, including the results of three studies in a total of 92 children and adolescents with chronic cholestasis who were given tocofersolan for about two years.
Slovenian: Družba je v podporo uporabi zdravila Vedrop predstavila informacije iz znanstvene literature, vključno z izidi treh študij pri skupno 92 otrocih in mladostnikih s kronično holestazo, ki so približno dve leti prejemali tokofersolan.
English: This should be checked regularly.
Slovenian: Količino vitamina E je treba redno preverjati.
English: Because vitamin E dissolves in fats but not in water, it can only be absorbed from the gut into the body alongside fat particles.
Slovenian: Ker se vitamin E topi v maščobah, in ne v vodi, se lahko iz črevesja v telo absorbira le skupaj z maščobnimi delci.
English: What are the risks associated with Vedrop?
Slovenian: Kakšna tveganja so povezana z zdravilom Vedrop?
English: What benefits of Vedrop have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Vedrop izkazalo v študijah?
English: It is not intended to provide practical advice on how to use Vedrop.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Why is Vedrop approved?
Slovenian: Zakaj je bilo zdravilo Vedrop odobreno?
English: The European Medicines Agency decided that Vedrop's benefits are greater than its risks and recommended that Vedrop be given marketing authorisation.
Slovenian: Evropska agencija za zdravila je sklenila, da so koristi zdravila Vedrop večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: The studies showed that Vedrop could correct vitamin E levels in patients with chronic cholestasis and that it might improve or prevent neurological symptoms, especially in patients aged below three years.
Slovenian: Študije so pokazale, da lahko zdravilo Vedrop poveča ravni vitamina E pri bolnikih s kronično holestazo in da bi lahko izboljšalo ali preprečilo nevrološke simptome, zlasti pri bolnikih, mlajših od treh let.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vedrop 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 Vedrop upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Vedrop is a medicine used to treat or prevent vitamin E deficiency (low vitamin E levels).
Slovenian: Zdravilo Vedrop se uporablja za zdravljenje ali preprečevanje pomanjkanja vitamina E (nizkih ravni vitamina E).
English: For more information about treatment with Vedrop, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vedrop preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For the full list of all side effects and restrictions with Vedrop, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Vedrop glejte navodilo za uporabo.
English: Vedrop must not be used in premature babies.
Slovenian: Zdravilo Vedrop se ne sme uporabljati pri nedonošenčkih.
English: Tocofersolan can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet.
Slovenian: Tokofersolan se lahko absorbira iz črevesja otrok, ki imajo težave z absorpcijo maščob in vitamina E iz hrane.
English: The active substance in Vedrop, tocofersolan, is vitamin E that has been made water soluble by attaching it to a chemical called polyethylene glycol.
Slovenian: Zdravilna učinkovina v zdravilu Vedrop, tokofersolan, je vitamin E, izdelan tako, da se topi v vodi, ker se veže na kemično snov, imenovano polietilen glikol.
English: Since Vedrop has been approved under exceptional circumstances, the company that markets the medicine is required to provide further data on the safety and effectiveness of Vedrop in patients with congenital or hereditary chronic cholestasis.
Slovenian: Ker je zdravilo Vedrop pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, priskrbela nadaljnje podatke o varnosti in učinkovitosti zdravila Vedrop pri bolnikih s kongenitalno ali dedno kronično holestazo.
English: This can increase vitamin E levels in the blood and help to prevent damage to the nervous system due to vitamin E deficiency.
Slovenian: Pri tem se povečajo ravni vitamina E v krvi in preprečijo poškodbe živčnega sistema, nastale zaradi pomanjkanja vitamina E.
English: Congenital or hereditary chronic cholestasis is an inherited disease causing problems with the flow of bile from the liver to the gut.
Slovenian: Kongenitalna ali dedna kronična holestaza je dedna bolezen, ki povzroča težave pri prehajanju žolča iz jeter v črevesje.
English: Vedrop can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in treating patients with congenital or hereditary chronic cholestasis.
Slovenian: Predpisovanje in izdaja zdravila Vedrop je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s kongenitalno ali dedno kronično holestazo.
English: What information is still awaited for Vedrop?
Slovenian: Katere informacije o zdravilu Vedrop še pričakujemo?
English: For practical information about using Vedrop, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Vedrop naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut.
Slovenian: Uporablja se pri otrocih, mlajših od 18 let, s kongenitalno ali dedno kronično holestazo, pri katerih absorpcija vitamina E iz črevesja ne poteka.
English: Patients with cholestasis may have low vitamin E levels because they have problems absorbing fats from the gut.
Slovenian: Ravni vitamina E pri bolnikih s holestazo so morda nizke zato, ker imajo težave z absorpcijo maščob iz črevesja.
English: Vedrop contains the active substance tocofersolan.
Slovenian: Zdravilo Vedrop vsebuje zdravilno učinkovino tokofersolan.
English: How does Vedrop work?
Slovenian: Kako zdravilo Vedrop deluje?
English: How is Vedrop used?
Slovenian: Kako se zdravilo Vedrop uporablja?
English: Bile is a fluid produced in the liver that helps to absorb fats from the gut.
Slovenian: Žolč je tekočina, ki jo tvorijo jetra in sodeluje pri absorpciji maščob iz črevesja.
English: Vedrop is available as a solution to be given by mouth.
Slovenian: Zdravilo Vedrop je na voljo v obliki raztopine, ki se daje peroralno.
English: The main measures of effectiveness were the level of vitamin E in the blood and the number of children whose neurological symptoms improved or stayed the same.
Slovenian: Vsi bolniki so imeli pomanjkanje vitamina E, ki se ni odzvalo na druga peroralna zdravljenja z vitaminom E. Glavno merilo učinkovitosti so bile ravni vitamina E v krvi in število otrok, pri katerih so se nevrološki simptomi izboljšali ali ostali nespremenjeni.
English: Usually this is for at least 6 to 12 months and may be for many years.
Slovenian: Običajno traja vsaj od 6 do 12 mesecev in lahko tudi več let.
English: You must use an effective method of contraception.
Slovenian: Uporabljati morate učinkovito metodo kontracepcije.
English: b All No Effect Boundaries are 70%-143%.
Slovenian: b Vse meje brez učinka so 70 %-143 %.
English: The clinical relevance of these substitutions is not known.
Slovenian: Klinična pomembnost teh substitucij ni znana.
English: Date of first authorisation: 09 January 2017
Slovenian: Datum prve odobritve: 09. januar 2017
English: Wait and take the next dose at the regular time.
Slovenian: Počakajte in naslednji odmerek vzemite ob običajnem času.
English: The recommended dose is one tablet once a day with food.
Slovenian: Priporočeni odmerek je ena tableta enkrat na dan s hrano.
English: a All interaction studies are conducted in healthy volunteers.
Slovenian: a Vse študije interakcij so opravili pri zdravih prostovoljcih.
English: Appropriate precautions must continue to be used.
Slovenian: Še naprej je treba uporabljati ustrezne previdnostne ukrepe.
English: Treatment should continue for as long as your doctor tells you.
Slovenian: Zdravljenje nadaljujte tako dolgo, kot vam predpiše zdravnik.
English: Age, gender and ethnicity
Slovenian: Starost, spol in etnična pripadnost
English: Keep the tablet bottle with you so that you can easily describe what you have taken.
Slovenian: Vsebnik s tabletami imejte s seboj, da boste znali opisati, kaj ste vzeli.
English: • Swelling of the face, lips, tongue or throat (angioedema)
Slovenian: • otekanje obraza, ustnic, jezika ali grla (angioedem)
English: Experience beyond 48 weeks in Study 108 and Study 110
Slovenian: Izkušnje po 48. tednih v študiji 108 in študiji 110
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Pogostnosti so opredeljene kot sledi: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10) ali občasni (≥ 1/1.000 do < 1/100).
English: Talk to your doctor if you are taking:
Slovenian: Posvetujte se z zdravnikom, če jemljete:
English: With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
Slovenian: Če traja zdravljenje dlje kot 2 leti, se priporoča redno ocenjevanje, s katerim se potrdi, da je nadaljevanje izbrane terapije še naprej ustrezno za bolnika.
English: Patients with creatinine clearance < 30 mL/min
Slovenian: Bolniki s kreatininskim očistkom < 30 ml/min
English: • Take care not to pass on your hepatitis B to other people.
Slovenian: • Poskrbite, da hepatitisa B ne boste prenesli na druge ljudi.
English: You must continue to take precautions to avoid this.
Slovenian: Še naprej morate z ustreznimi ukrepi poskrbeti, da to preprečite.
English: Keep the bottle tightly closed.
Slovenian: Vsebnik shranjujte tesno zaprto.
English: • if you are allergic to tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na tenofoviralafenamid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Other types of medicines
Slovenian: Druge vrste zdravil
English: Exacerbation of hepatitis
Slovenian: Poslabšanje hepatitisa
English: Regular reassessment is recommended after treatment discontinuation to detect virological relapse.
Slovenian: Priporoča se redno ocenjevanje po prekinitvi zdravljenja za odkrivanje virološkega relapsa.
English: Tests may also show: • Increased level of a liver enzyme (ALT) in the blood
Slovenian: Preskusi lahko pokažejo tudi naslednje učinke: • povečana raven jetrnega encima (ALT) v krvi
English: Study 110 (HBeAg-Positive)
Slovenian: Študija 110 (HBeAg-pozitivni)
English: Discuss with your doctor the precautions needed to avoid infecting others.
Slovenian: Z zdravnikom se posvetujte o ustreznih ukrepih, s katerimi boste preprečili prenos okužbe na druge.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vsebniku in škatli poleg oznake „EXP“.
English: d A sensitive CYP3A4 substrate.
Slovenian: d Občutljiv substrat CYP3A4.
English: If you feel dizzy when taking Vemlidy, do not drive and do not use any tools or machines.
Slovenian: Če ste omotični po jemanju zdravila Vemlidy, ne vozite in ne uporabljajte orodij ali strojev.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Effects on drug levels.a,b Mean ratio (90% confidence interval) for AUC, Cmax, Cmin
Slovenian: Učinek na raven zdravila.a,b Povprečno razmerje (90-% interval zaupanja) za AUC, Cmax, Cmin
English: If you are not sure whether you have HIV, your doctor should offer you HIV testing before you start taking Vemlidy for hepatitis B.
Slovenian: Če niste prepričani, ali imate HIV, vam mora zdravnik ponuditi testiranje za HIV, preden začnete jemati zdravilo Vemlidy za hepatitis B.
English: There is insufficient information on the effects of tenofovir in newborns/infants.
Slovenian: Ni dovolj podatkov o učinku tenofovirja na novorojenčke/dojenčke.
English: Liver flares are especially serious, and sometimes fatal in patients with decompensated liver disease.
Slovenian: Jetrni izbruhi so posebno resni in so včasih pri bolnikih z dekompenzirano boleznijo jeter smrtni.
English: Study 108 (HBeAg-Negative)
Slovenian: Študija 108 (HBeAg-negativni)
English: Table 5: HBV DNA and additional efficacy parameters at Week 96a
Slovenian: Preglednica 5: HBV DNA in dodatni parametri učinkovitosti v 96. tednua
English: If you stop taking Vemlidy, you will need regular health checks and blood tests for several months to check your hepatitis B infection.
Slovenian: Če prenehate jemati zdravilo Vemlidy, boste morali hoditi na redne zdravstvene preglede in krvne preiskave še več mesecev, da se vaša okužba s hepatitisom B preverja.
English: EU/1/16/1154/001 30 film-coated tablets EU/1/16/1154/002 90 (3 bottles of 30) film-coated tablets
Slovenian: EU/1/16/1154/001 30 filmsko obloženih tablet EU/1/16/1154/002 90 (3 HDPE vsebniki po 30) filmsko obloženih tablet
English: The adverse reactions are listed below by body system organ class and frequency based on the Week 96 analysis.
Slovenian: Neželeni učinki so spodaj navedeni po organskih sistemih in pogostnosti, na osnovi analize v 96. tednu.
English: Differences in pharmacokinetics according to gender were not considered to be clinically relevant.
Slovenian: Farmakokinetične razlike glede na spol niso bile upoštevane kot klinično pomembne.
English: Treatment discontinuation Treatment discontinuation may be considered as follows (see section 4.4):
Slovenian: O prekinitvi zdravljenja je možno razmisliti kot sledi (glejte poglavje 4.4):
English: Your doctor may need to carry out blood tests to monitor your liver function.
Slovenian: Vaš zdravnik bo morda moral redno izvajati krvne preiskave, s katerimi bo spremljal delovanje vaših jeter.
English: A risk to the breast-fed newborns/infants cannot be excluded; therefore, Vemlidy should not be used during breast-feeding.
Slovenian: Tveganja za dojenega novorojenčka/otroka ne moremo izključiti, zato se zdravilo Vemlidy med dojenjem ne sme uporabljati.
English: Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum alanine aminotransferase (ALT).
Slovenian: Spontana poslabšanja kroničnega hepatitisa B so relativno pogosta; za njih so značilna prehodna povečanja serumske alanin aminotransferaze (ALT).
English: After initiating antiviral therapy, serum ALT may increase in some patients.
Slovenian: Po uvedbi protivirusnega zdravljenja se lahko serumska ALT pri nekaterih bolnikih poveča.
English: The binding of tenofovir to human plasma proteins is less than 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
Slovenian: Vezava tenofovirja na človeške plazemske beljakovine je bila manj kot 0,7 % in je neodvisna od koncentracij za razpon 0,01-25 μg/ml.
English: Angioedema1, urticaria1
Slovenian: Občasni angioedem1, urtikarija1
English: Adults and adolescents (aged 12 years and older with body weight at least 35 kg): one tablet once daily.
Slovenian: Odrasli in mladostniki (stari 12 let in več s telesno maso vsaj 35 kg): ena tableta enkrat na dan.
English: The binding of tenofovir alafenamide to human plasma proteins in samples collected during clinical studies was approximately 80%.
Slovenian: Vezava tenofoviralafenamida na človeške plazemske beljakovine v vzorcih, zbranih med kliničnimi študijami, je bila približno 80 %.
English: Each tablet contains 95 mg lactose (as monohydrate).
Slovenian: Ena tableta vsebuje 95 mg laktoze (v obliki monohidrata).
English: • Talk to your doctor if you also have hepatitis C or D. Vemlidy has not been tested on patients who have hepatitis C or D as well as hepatitis B.
Slovenian: • Posvetujte se z zdravnikom, če imate tudi hepatitis C ali D. Zdravilo Vemlidy ni bilo testirano na bolnikih, ki imajo poleg hepatitisa B tudi hepatitis C ali D.
English: Vemlidy film-coated tablets should be taken with food.
Slovenian: Zdravilo Vemlidy filmsko obložene tablete je treba jemati s hrano.
English: After Week 96, patients either remained on their original blinded treatment or received open-label Vemlidy.
Slovenian: Po 96. tednu so bolniki bodisi nadaljevali z izvornim slepim zdravljenjem ali pa so odprto prejemali zdravilo Vemlidy.
English: Treatment outcomes of Study 108 and Study 110 through Week 48 are presented in Table 3 and Table 4.
Slovenian: Izidi zdravljenja za študijo 108 in študijo 110 do konca 48. tedna so predstavljeni v preglednici 3 in preglednici 4.
English:  If any of these side effects get serious tell your doctor.
Slovenian:  Če kateri od teh neželenih učinkov postane resen, to povejte zdravniku.
English: Animal studies do not indicate harmful effects of tenofovir alafenamide on fertility.
Slovenian: Študije na živalih ne kažejo škodljivih učinkov tenofoviralafenamida na plodnost.
English: It is not an inhibitor or inducer of CYP3A in vivo.
Slovenian: In vivo ni zaviralec ali induktor CYP3A.
English: • Talk to your doctor before you stop taking Vemlidy for any reason, particularly if you are experiencing any side effects or you have another illness.
Slovenian: • Posvetujte se z zdravnikom, preden prenehate jemati zdravilo Vemlidy zaradi katerega koli razloga, zlasti če se pojavijo kateri koli neželeni učinki ali imate drugo bolezen.
English: Patients should be informed that dizziness has been reported during treatment with Vemlidy.
Slovenian: Bolnike je treba obvestiti, da so med zdravljenjem z zdravilom Vemlidy poročali o omotici.
English: Changes in measures of renal function
Slovenian: Spremembe v izmerjenem delovanju ledvic
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Vemlidy in one or more subsets of the paediatric population in the treatment of chronic hepatitis B (see sections 4.2 and 5.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Vemlidy za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa B (za podatke o uporabi pri pediatrični populaciji glejte poglavji 4.2 in 5.2).
English: Therefore, hepatobiliary and renal parameters should be closely monitored in this patient population (see section 5.2).
Slovenian: Zato je treba pri tej populaciji bolnikov skrbno nadzirati hepatobiliarne in ledvične parametre (glejte poglavje 5.2).