FrancophonIA/ELRC3.0 huggingface dataset:
English: In acute coronary syndrome, Iscover has been compared with placebo (a dummy treatment) in one study involving over 12,000 patients with non-ST segment elevation, 2,172 of whom had a stent inserted during the study (CURE study, lasting up to a year).
Slovenian: Pri akutnem koronarnem sindromu so zdravilo Iscover primerjali s placebom (zdravilom brez zdravilne učinkovine) v študiji z 12 000 bolniki brez dviga spojnice ST, od katerih so 2 172 med študijo vstavili stent (študija CURE, ki je trajala do enega leta).
English: How has Iscover been studied?
Slovenian: Kako je bilo zdravilo Iscover raziskano?
English: What is Iscover used for?
Slovenian: Za kaj se zdravilo Iscover uporablja?
English: In atrial fibrillation, Iscover has been compared with placebo (both taken together with aspirin) in one main study involving around 7,500 patients who had at least one risk factor for vascular events and who could not take vitamin K antagonist therapy.
Slovenian: Pri atrijski fibrilaciji je bilo zdravilo Iscover primerjano s placebom (oba jemana skupaj z aspirinom) v eni glavni študiji, v kateri je sodelovalo okoli 7 500 bolnikov, ki so imeli vsaj en dejavnik tveganja za vaskularni dogodek in ki ne morejo prejemati zdravljenja z antagonistom vitamina K. Bolniki so bili zdravljeni povprečno tri leta, glavno merilo učinkovitosti pa je bilo število bolnikov, ki so doživeli bodisi srčni napad, ishemično kap ali so umrli.
English: What is Iscover?
Slovenian: Kaj je zdravilo Iscover?
English: How is Iscover used?
Slovenian: Kako se zdravilo Iscover uporablja?
English: To retain protection, horses need to be revaccinated.
Slovenian: Za ohranitev zaščite je treba konje ponovno cepiti.
English: It contains inactivated (killed) whole virus of two equine influenza (flu) strains (‘A/equine-2/South Africa/4/03' and ‘A/equine-2/Newmarket/2/93') and tetanus toxoid (chemically inactivated toxin from the tetanus bacterium).
Slovenian: Vsebuje inaktivirana (uničena) cela virusa dveh sevov influence (gripe) konj („A/konjski-2/Južna Afrika/4/03“, „A/konjski-2/Newmarket/2/93“) in toksoid tetanusa (kemično oslabljen toksin iz bakterije tetanusa).
English: Horses are very susceptible to tetanus.
Slovenian: Konji so zelo občutljivi na tetanus.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Prequenza Te on 8 July 2005.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Equilis Prequenza Te, veljavno po vsej Evropski uniji, odobrila dne 8. julija 2005.
English: The studies also compared the clinical signs and virus excretion of a group of vaccinated animals with those of a control group, (i.e. which did not receive the vaccine or received a competitive product).
Slovenian: V študijah so primerjali tudi klinične znake in izločanje virusa pri cepljenih živalih in živalih iz kontrolne skupine (tj. tistih, ki niso prejele cepiva ali so prejele konkurenčno cepivo).
English: The vaccine also stimulates protection against tetanus to prevent mortality.
Slovenian: Cepivo spodbuja tudi zaščito pred tetanusom za preprečevanje umrljivosti.
English: The duration of protection was five months after primary vaccination and 12 months after the first revaccination for equine influenza and 17 months after primary vaccination and 24 months after the first revaccination for tetanus.
Slovenian: Zaščita je trajala pet mesecev po osnovnem cepljenju in 12 mesecev po prvem ponovnem cepljenje za influenco konj ter 17 mesecev po prvem cepljenju in 24 mesecev po prvem ponovnem cepljenju za tetanus.
English: Other information about Equilis Prequenza Te:
Slovenian: Druge informacije o zdravilu Equilis Prequenza Te:
English: When a horse is given the vaccine, the immune system recognises the virus and toxoid as ‘foreign' and makes antibodies against them.
Slovenian: Ko konj prejme cepivo, imunski sistem prepozna virus in toksoid kot „tujka“ in začne proti njima tvoriti protitelesa.
English: The vaccine also contains purified tetanus toxoid.
Slovenian: Cepivo vsebuje tudi prečiščen toksoid tetanusa.
English: The toxoid is a toxin processed in order to remove its toxic effect, but still allow it to be recognised by the immune system.
Slovenian: Toksoid je toksin, obdelan tako, da nima več strupenega učinka, vendar ga imunski sistem še vedno prepozna.
English: Horses developed protective levels of antibodies two weeks after primary vaccination.
Slovenian: Zaščitne ravni protiteles so se pri konjih razvile dva tedna po osnovnem cepljenju.
English: Equilis Prequenza Te is a vaccine for use in horses.
Slovenian: Equilis Prequenza Te je cepivo, ki se uporablja pri konjih.
English: Tetanus is an acute, often fatal disease caused by the toxin (poison) produced by the bacterium Clostridium tetani.
Slovenian: Tetanus je akutna bolezen, ki ima pogosto smrten izid, povzroča pa jo toksin (strup) bakterije Clostridium tetani.
English: For the full vaccination schedule see the package leaflet.
Slovenian: Za celoten razpored cepljenja glejte navodilo za uporabo.
English: Equilis Prequenza Te contains inactivated whole virus of the influenza strains against which the vaccine is indicated.
Slovenian: Zdravilo Equilis Prequenza Te vsebuje inaktivirane cele viruse sevov influence, za katere je cepivo indicirano.
English: The studies showed that Equilis Prequenza Te is an effective vaccine against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality, in horses from 6 months of age.
Slovenian: Študije so pokazale, da je zdravilo Equilis Prequenza Te učinkovito cepivo proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi ter proti tetanusu za preprečevanje umrljivosti pri konjih, starejših od šest mesecev.
English: The safety of the initial formulation of Equilis Prequenza Te was studied in several studies under laboratory and field conditions in a large number of horses, from 2 months of age.
Slovenian: Varnost zdravila prvotne formulacije cepiva Equilis Prequenza Te so raziskovali v več študijah, izvedenih v laboratorijskih in terenskih pogojih na številnih konjih, starejših od dveh mesecev.
English: The current formulation of Equine Prequenza Te has been shown to produce similar results to those shown in the initial studies.
Slovenian: Za trenutno formulacijo cepiva Equilis Prequenza Te je bilo dokazano, da ima podobne rezultate, kot so bili doseženi v prvotnih študijah.
English: Regarding tetanus, the main measure of effectiveness was the production of protective levels of antibodies against tetanus toxoid.
Slovenian: Pri tetanusu je bilo glavno merilo učinkovitosti tvorjenje zaščitnih ravni protiteles proti toksoidu tetanusa.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Prequenza Te exceeded the risks for the approved indications and the Committee recommended that Equilis Prequenza Te be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi cepiva Equilis Prequenza Te večje od z njim povezanih tveganj, kadar se zdravilo uporablja za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
English: For ethical reasons no challenge (infection) experiment was performed against tetanus.
Slovenian: Iz etičnih razlogov za tetanus niso izvedli nobenega poskusa z izzivanjem okužbe.
English: The viruses included in the current formulation of Equilis Prequenza Te are grown in mammalian cells, unlike those in the initial formulation, which were grown in hens' eggs.
Slovenian: Viruse, ki so vključeni v trenutno formulacijo cepiva Equilis Prequenza Te, gojijo v celicah sesalcev, virusi v prvotni formulaciji cepiva pa so bili gojeni v kokošjih jajcih.
English: The effectiveness of Equilis Prequenza Te was initially studied in several trials under laboratory and field conditions.
Slovenian: Učinkovitost zdravila Equilis Prequenza Te so prvotno raziskali v več preskušanjih, izvedenih v laboratorijskih in terenskih pogojih.
English: What is the risk associated with Equilis Prequenza Te?
Slovenian: Kakšna tveganja so povezana s cepivom Equilis Prequenza Te?
English: What benefit has Equilis Prequenza Te shown during the studies?
Slovenian: Kakšne koristi je zdravilo Equilis Prequenza Te izkazalo med študijami?
English: The main measure of effectiveness of Equilis Prequenza Te against equine influenza was the production of protective levels of antibodies against the influenza components.
Slovenian: Glavno merilo učinkovitosti cepiva Equilis Prequenza Te proti influenci konj je bilo tvorjenje zaščitnih ravni protiteles proti sestavinam influence.
English: Equilis Prequenza Te is used to vaccinate horses from six months of age against equine influenza and tetanus.
Slovenian: Cepivo Equilis Prequenza Te se uporablja za cepljenje konj, ki so starejši od šestih mesecev, proti influenci konj in tetanusu.
English: Why has Equilis Prequenza Te been approved?
Slovenian: Zakaj je bilo zdravilo Equilis Prequenza Te odobreno?
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to these virus strains or to the unmodified toxin.
Slovenian: Ob ponovni izpostavitvi sevom virusov ali nespremenjenemu toksinu v prihodnosti bo imunski sistem hitreje izdelal protitelesa.
English: How has Equilis Prequenza Te been studied?
Slovenian: Kako je bilo zdravilo Equilis Prequenza Te raziskano?
English: The antibodies will then help to protect against equine influenza and tetanus.
Slovenian: Protitelesa pomagajo zaščititi žival pred influenco konj in tetanusom.
English: The withdrawal period for Equilis Prequenza Te is zero days.
Slovenian: Karenca za cepivo Equilis Prequenza Te je nič dni.
English: How does Equilis Prequenza Te work?
Slovenian: Kako zdravilo Equilis Prequenza Te deluje?
English: What is Equilis Prequenza Te?
Slovenian: Kaj je zdravilo Equilis Prequenza Te?
English: What is Equilis Prequenza Te used for?
Slovenian: Za kaj se zdravilo Equilis Prequenza Te uporablja?
English: October 26,
Slovenian: 26. oktober
English: Then carry on taking your tablets at regular times as usual.
Slovenian: Nato nadaljujte jemanje tablet ob rednem času, kot po navadi.
English: If you notice any of the following:
Slovenian: Če opazite katerega od naslednjih znakov:
English: You need to know about important symptoms to look out for.
Slovenian: Poznati morate pomembne simptome, na katere morate biti pozorni.
English: Steady state was achieved by Day 15.
Slovenian: Stanje dinamičnega ravnovesja je bilo doseženo 15. dan.
English: Date of first authorisation: 30 June 2014 Date of latest renewal: 14 February 2019
Slovenian: Datum prve odobritve: 30. junij 2014 Datum zadnjega podaljšanja: 14. februar 2019
English: Descriptions of these effects can be found in other sections (see sections 2 and 4).
Slovenian: Opis teh učinkov lahko najdete v drugih poglavjih (glejte poglavji 2 in 4).
English: At 1 year At 2 years At 3 years At 4 years At 5 years
Slovenian: Po 1 letu Po 2 letih Po 3 letih Po 4 letih Po 5 letih
English: BRAF V600 testing
Slovenian: Testiranje BRAF V600
English: Do not stop unless your doctor advises you to.
Slovenian: Ne prenehajte ga jemati, razen če vam to svetuje zdravnik.
English: The majority of bleeding events were mild.
Slovenian: Večina krvavitev je bila blagih.
English: Read all the information in this leaflet for guidance.
Slovenian: Za smernice preberite vse informacije v tem navodilu.
English: • if you are allergic to trametinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na trametinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: This means that:
Slovenian: To pomeni, da:
English: For October 2011, 47% of subjects had crossed over, while for May 2013, 65% of subjects had crossed over.
Slovenian: Do oktobra 2011 je prešlo 47 % bolnikov, do maja 2013 pa 65 %.
English: Binding of trametinib to human plasma proteins is 97.4%.
Slovenian: Vezava trametiniba na beljakovine v človeški plazmi je 97,4 %.
English: The safety and efficacy of trametinib have not been established in children and adolescents (<18 years).
Slovenian: Varnost in učinkovitost trametiniba pri otrocih in mladostnikih (< 18 let) nista bili dokazani.
English:  Read the information “Possible serious side effects” in section 4 of this leaflet.
Slovenian:  Preberite informacije "Možni resni neželeni učinki" v poglavju 4 tega navodila.
English: Liver events were detected in clinical trials with monitoring every four weeks.
Slovenian: Jetrne dogodke so v kliničnih študijah odkrivali s pregledi na vsake štiri tedne.
English: Treatment for all patients continued until disease progression, death or withdrawal.
Slovenian: Zdravljenje vseh bolnikov se je nadaljevalo do napredovanja bolezni, smrti ali umika iz študije.
English: - The other ingredients are
Slovenian: - Druge sestavine zdravila so
English: The increase in exposure (Cmax and AUC) was dose-proportional following repeat dosing.
Slovenian: Povečanje izpostavljenosti (Cmax in AUC) je bilo po ponavljajočem se odmerjanju sorazmerno odmerku.
English: Mekinist with food and drink
Slovenian: Zdravilo Mekinist skupaj s hrano in pijačo
English: May 20,
Slovenian: 20. maj
English: Do not take Mekinist:
Slovenian: Ne jemljite zdravila Mekinist:
English: Chemotherapy a
Slovenian: Kemoterapija a
English: For trametinib monotherapy, more than 90% of these liver events occurred within the first 6 months of treatment.
Slovenian: Pri uporabi trametiniba v monoterapiji je do več kot 90 % teh jetrnih dogodkov prišlo v prvih 6 mesecih zdravljenja.
English: The potential for these events in patients with low platelet counts (<75,000) has not been established as such patients were excluded from clinical trials.
Slovenian: Možnost za takšne dogodke pri bolnikih z majhnim številom trombocitov (< 75.000) ni ugotovljena, ker so bili takšni bolniki izključeni iz kliničnih preskušanj.
English: Name and address of the manufacturers responsible for batch release Glaxo Wellcome, S.A.
Slovenian: Ime in naslov izdelovalcev, odgovornih za sproščanje serij Glaxo Wellcome, S.A.
English: There are no adequate and well-controlled studies of trametinib in pregnant women.
Slovenian: Pri nosečnicah ni ustreznih in dobro kontroliranih študij trametiniba.
English: Less than 0.1% of the excreted dose was recovered as parent in urine.
Slovenian: Manj kot 0,1 % izločenega odmerka se je pojavilo v urinu kot matična snov.
English: There is no specific treatment for overdose.
Slovenian: Za preveliko odmerjanje ni specifičnega zdravljenja.
English: Do not throw away medicines in wastewater or household waste.
Slovenian: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: Cut-off dates
Slovenian: Presečni datumi
English: Mekinist can harm the unborn baby.
Slovenian: Zdravilo Mekinist lahko škoduje nerojenemu otroku.
English: The trametinib dose should not exceed 2 mg once daily.
Slovenian: Odmerek trametiniba ne sme preseči 2 mg enkrat na dan.
English: Table 12 Survival data from the primary and post-hoc analyses
Slovenian: Preglednica 12 Podatki o preživetju iz primarne analize in post hoc analizi
English: The deacetylation is mediated by the carboxyl-esterases 1b, 1c and 2, with possible contributions by other hydrolytic enzymes.
Slovenian: Deacetilacija poteka s karboksilesterazami 1b, 1c in 2, z možno vpletenostjo drugih hidrolitičnih encimov.
English: Because many medicinal products are excreted in human milk, a risk to the breast-feeding infant cannot be excluded.
Slovenian: Pri človeku se v materino mleko izločajo številna zdravila, zato tveganja za dojenega dojenčka ni mogoče izključiti.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: • Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Pregnancy, breast-feeding and fertility Mekinist is not recommended for use during pregnancy.
Slovenian: Nosečnost, dojenje in plodnost Zdravila Mekinist ni priporočljivo uporabljati med nosečnostjo.
English: Your doctor or nurse should check your blood pressure during treatment with Mekinist.
Slovenian: Zdravnik ali medicinska sestra vam mora med zdravljenjem z zdravilom Mekinist kontrolirati krvni tlak.
English: Mild and moderate renal impairment had no effect on trametinib exposure (<6% for either group).
Slovenian: Blaga in zmerna okvara ledvic nista vplivali na izpostavljenost trametinibu (< 6 % v eni in drugi skupini).
English: Patients should be made aware of potential for fatigue, dizziness or eye problems that might affect these activities.
Slovenian: Bolnike je treba seznaniti z možnostjo za utrujenost, omotico in težave z očmi, ki lahko vplivajo na takšne dejavnosti.
English: Although smaller female subjects are predicted to have higher exposure than heavier male subjects, these differences are unlikely to be clinically relevant and no dosage adjustment is warranted.
Slovenian: Čeprav imajo manjše ženske predvidoma višjo izpostavljenost kot težji moški, ni verjetno, da bi bile te razlike klinično pomembne, in prilagoditev odmerka ni potrebna.
English: earlier in section 4)
Slovenian: zgoraj v poglavju 4)
English: It is important to take Mekinist on an empty stomach because food affects the way the medicine is absorbed into your body (see section 3).
Slovenian: Pomembno je, da zdravilo Mekinist vzamete na prazen želodec, kajti hrana vpliva na absorpcijo zdravila v telesu (glejte poglavje 3).
English: Extremadura, 3, 09400, Aranda De Duero, Burgos, Spain Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Slovenian: Extremadura, 3, 09400, Aranda De Duero, Burgos, Španija Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Velika Britanija
English: More frequent dose adjustments (see Tables 1 and 2 above) may be required in patients >65 years of age (see section 4.8).
Slovenian: Pogostejše prilagajanje odmerka (glejte zgornji preglednici 1 in 2) je lahko potrebno pri bolnikih, starih > 65 let (glejte poglavje 4.8).
English: Once opened, the bottle may be stored for 30 days at not more than 30°C.
Slovenian: Po prvem odprtju je lahko plastenka shranjena 30 dni pri temperaturi do 30 °C.
English: Contains desiccant, do not remove or eat.
Slovenian: Vsebuje sušilo; ne odstranite ga in ne zaužijte ga.
English: Before starting treatment, tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Pred začetkom zdravljenja obvestite zdravnika, medicinsko sestro ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Take Mekinist at about the same time each day.
Slovenian: Zdravilo Mekinist vzemite vsak dan ob približno istem času.
English: High blood pressure
Slovenian: Visok krvni tlak
English: Don't take more Mekinist than your doctor has recommended, since this may increase the risk of side effects.
Slovenian: Ne vzemite več zdravila Mekinist, kot vam je naročil zdravnik, saj to lahko poveča tveganje za neželene učinke.
English: * The intensity of clinical adverse reactions graded by the Common Terminology Criteria for Adverse Events v4.0 (CTC-AE)
Slovenian: * Izrazitost kliničnih neželenih učinkov je ocenjena po CTC-AE (Common Terminology Criteria for Adverse Events) v4.0
English: Mekinist can affect how well your heart pumps blood.
Slovenian: Zdravilo Mekinist lahko vpliva na to, kako dobro srce črpa kri.
English: Table 1 Recommended dose level reductions
Slovenian: Preglednica 1 Priporočena znižanja dnevnega odmerka
English: Keep a list of the medicines you take, so you can show it to your doctor, nurse or pharmacist when you get a new medicine.
Slovenian: Vodite seznam zdravil, ki jih jemljete, da ga boste lahko pokazali zdravniku, medicinski sestri ali farmacevtu, ko dobite kakšno novo zdravilo.
English: It is currently unknown if hormonal contraceptives are affected by trametinib.
Slovenian: Trenutno ni znano, ali trametinib vpliva na hormonske kontraceptive.
English: Store in a refrigerator in the original bottle.
Slovenian: Shranjujte v hladilniku v originalni plastenki.
English: An additional OS analysis was undertaken based upon the 20 May 2013 data cut, see Table 12.
Slovenian: Dodatna analiza celokupnega preživetja je bila opravljena na podlagi podatkov do 20. maja 2013, glejte preglednico 12.
English: ITT = Intent to Treat; PFS = Progression-free survival; CI = confidence interval.
Slovenian: ZNZ = z-namenom-zdravljenja, PFS = preživetje brez napredovanja, IZ = interval zaupanja.
English: 1/10,000 to <1/1,000
Slovenian:  1/10.000 do < 1/1.000
English: What Mekinist is and what it is used for
Slovenian: Kaj je zdravilo Mekinist in za kaj ga uporabljamo
English: In melanoma and other cancers, this pathway is often activated by mutated forms of BRAF which activates MEK.
Slovenian: Pri melanomu in drugih vrstah raka to pot pogosto aktivirajo mutirane oblike BRAF, ki aktivira MEK.
English: Drug-drug interactions via these hydrolytic enzymes cannot be ruled out and could influence the exposure to trametinib.
Slovenian: Interakcij zdravilo-zdravilo preko teh hidrolitičnih encimov ni mogoče izključiti in lahko vplivajo na izpostavljenost trametinibu.
English: Drug-related material was excreted predominantly in the faeces (>80% of recovered radioactivity) and to a minor extent in urine (≤19%).
Slovenian: S trametinibom povezane snovi so se večinoma izločile z blatom (> 80 % prestrežene radioaktivnosti) in v manjši meri z urinom (≤ 19 %).
English: Inter-subject variability at steady state was low (<28%).
Slovenian: Interindividualna variabilnost v stanju dinamičnega ravnovesja je bila majhna (< 28 %).
English: Avoid driving or using machines if you feel tired or weak, if you have problems with your vision or if your energy levels are low.
Slovenian: Ne upravljajte vozil in strojev, če imate težave z vidom, ste utrujeni ali šibki, ali imate malo energije.
English: A decision should be made whether to discontinue breast-feeding or discontinue trametinib, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba ali za prenehanje dojenja ali za prenehanje zdravljenja s trametinibom, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
English: The efficacy results in the primary efficacy population were consistent with those in the ITT population; therefore, only the efficacy data for the ITT population are presented in Table 11.
Slovenian: Rezultati učinkovitost v primarni populaciji učinkovitosti so se skladali z rezultati v populaciji ZNZ, zato so v preglednici 11 predstavljeni le podatki o učinkovitosti za populacijo ZNZ.
English: Most patients (66%) received no prior chemotherapy for advanced or metastatic disease.
Slovenian: Večina (66 %) oseb ni prejemala predhodne kemoterapije za napredovalo ali metastatsko bolezen.
English: • red or black stools that look like tar
Slovenian: • rdeče blato ali črno blato, ki je videti kot katran
English: All patients received study medicinal product as first-line treatment for metastatic disease.
Slovenian: Vsi bolniki so študijska zdravila prejemali kot prvo linijo zdravljenja metastatske bolezni.
English: Safety data in patients ≥75 years is limited (see section 4.8).
Slovenian: Podatkov o varnosti pri bolnikih, starih ≥ 75 let, je malo (glejte poglavje 4.8).
English: CYP3A4 oxidation is considered a minor pathway of metabolism.
Slovenian: Oksidacija s CYP3A4 velja za manj pomembno pot presnove.
English: Your doctor may decide to lower the dose if you get side effects.
Slovenian: Zdravnik se lahko odloči, da vam zniža odmerek, če se vam pojavijo neželeni učinki
English: Of the hepatic adverse reactions, increased ALT and AST were the most common events and the majority were either Grade 1 or 2.
Slovenian: Med jetrnimi neželenimi učinki sta bila najpogostejša zvišanje vrednosti ALT in AST, pri čemer je bila večina zvišanj 1. ali 2. stopnje.