FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to launch of Mysimba in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the prescriber guide with the National Competent Authority.
Slovenian: Pred prihodom zdravila Mysimba na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike vodnika za predpisovanje zdravila.
English: When α-MSH is released, POMC neurons simultaneously release β-endorphin, an endogenous agonist of the mu-opioid receptors.
Slovenian: Ko se α-MSH sprošča, nevroni POMC simultano sproščajo β-endorfin, endogeni agonist mu-opioidnih receptorjev.
English: In addition, there have been rare spontaneous postmarketing reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock associated with bupropion.
Slovenian: Dodatno so bila po začetku trženja pridobljena redka spontana poročila o multiformnem eritemu, Stevens-Johnsonovem sindromu in anafilaktičnem šoku v povezavi z bupropionom.
English: Preclinical data suggests that naltrexone and bupropion may have greater than additive effects in this region to reduce food intake when administered together.
Slovenian: Predklinični podatki kažejo, da imata lahko naltrekson in bupropion več kot le aditivne učinke v tem območju za zmanjšanje vnosa hrane, če se uporabita skupaj.
English: Genotoxicity:
Slovenian: Genotoksičnost:
English: The relevance of these observations to human fertility is not known.
Slovenian: Pomen teh izsledkov za plodnost pri človeku ni znan.
English: Due to these reasons, naltrexone / bupropion should be used with caution in patients over 65 years of age and is not recommended in patients over 75 years of age.
Slovenian: Zaradi teh razlogov je treba naltrekson/bupropion uporabljati previdno pri bolnikih nad 65 let, pri bolnikih nad 75 let pa se ne priporočata.
English: Use of naltrexone / bupropion with other OCT2 substrates (e.g., metformin) in clinical trials did not indicate the need for dose adjustment or other precautions.
Slovenian: Pri uporabi naltreksona/bupropiona skupaj z drugimi substrati za OCT2 (npr. metformin) v kliničnih preskušanjih ni bila zaznana potreba po prilagoditvi odmerkov ali drugih previdnostnih ukrepih.
English: There are no known pharmacokinetic interactions between naltrexone and alcohol.
Slovenian: Ni znanih farmakokinetičnih interakcij med naltreksonom in alkoholom.
English: Naltrexone and 6-beta-naltrexol are not metabolised by cytochrome P450 enzymes and in vitro studies indicate that there is no potential for inhibition or induction of important isozymes.
Slovenian: Naltrekson in 6-beta-naltreksol se ne presnavljata z encimi citokroma P450, in vitro študije pa kažejo, da ni možnosti zaviranja ali indukcije pomembnih izoencimov.
English: Additionally, Week 16 Responders who received naltrexone / bupropion had a high retention rate with 87% completing 1 year of treatment.
Slovenian: Poleg tega so odzivni preiskovanci 16. tedna, ki so prejemali naltrekson/bupropion, zabeležili visoko stopnjo zadržanja, saj je 87 % preiskovancev zaključilo 1-letno zdravljenje.
English: Full analysis set+
Slovenian: Celotna analiza+
English: You should inform your doctor before taking this medicine:
Slovenian: Preden začnete jemati to zdravilo, morate obvestiti svojega zdravnika:
English: Clinical experience included varying prandial conditions and supports the use of naltrexone / bupropion tablets with food.
Slovenian: Klinične izkušnje vključujejo raznolike razmere glede zaužitja hrane in podpirajo uporabo tablet kombinacije naltrekson/bupropion skupaj s hrano.
English: The treatment effects observed in obese and overweight subjects with type 2 diabetes mellitus (Study NB-304) were somewhat less pronounced than those observed in the other Phase 3 studies.
Slovenian: Učinki zdravljenja, ki so jih opazili pri debelih preiskovancih in preiskovancih s čezmerno telesno maso s sladkorno boleznijo tipa 2 (študija NB-304), so bili nekoliko manj izraziti kot učinki, ki so jih opazili v drugih študijah 3. faze.
English: Patients should be cautioned about driving or operating hazardous machinery in case naltrexone/bupropion may affect their ability to engage in such activities (see sections 4.4 and 4.8)
Slovenian: Bolnike je treba posvariti glede vožnje ali upravljanja nevarnih strojev med zdravljenjem, saj lahko naltrekson/bupropion vpliva na njihovo sposobnost opravljanja takih dejavnosti (glejte poglavji 4.4 in 4.8)
English: Although citalopram is not primarily metabolised by CYP2D6, in one study, bupropion increased the Cmax and AUC of citalopram by 30% and 40%, respectively.
Slovenian: Čeprav se citalopram primarno ne presnavlja z encimom CYP2D6, sta se v eni študiji zaradi uporabe bupropiona povečali vrednosti Cmax in AUC za citalopram, in sicer Cmax za 30 %, AUC pa za 40 %.
English: In contrast, formation of threohydrobupropion has been reported in the literature to be mediated by 11-beta-hydroxysteroid dehydrogenase 1.
Slovenian: Nasprotno pa v literaturi poročajo, da se tvorba treohidrobupropiona posreduje prek 11-beta-hidroksisteroid dehidrogenaze 1.
English: Following twice daily administration of naltrexone / bupropion, naltrexone does not accumulate, while 6-beta-naltrexol accumulates over time.
Slovenian: Po aplikaciji kombinacije naltrekson/bupropion dvakrat dnevno se naltrekson ne akumulira, medtem ko se 6-beta-naltreksol sčasoma akumulira.
English: Mysimba may be discontinued by your doctor after 16 weeks if you have not lost at least 5 percent of your initial body weight.
Slovenian: Zdravnik vam lahko po 16-ih tednih ukine zdravilo Mysimba, če niste zmanjšali svoje izhodiščne telesne mase za vsaj 5 %.
English: 6.4 Special precautions for storage Do not store above 30°C.
Slovenian: 6.4 Posebna navodila za shranjevanje Shranjujte pri temperaturi do 30°C.
English: • quinolones (antibiotics such as ciprofloxacine to treat infections);
Slovenian: • kinoloni (antibiotiki, kot je ciprofloksacin, za zdravljenje okužb);
English: • steroids (except drops, creams, or lotions for eye and skin conditions or inhalers for breathing disorders such as asthma);
Slovenian: • steroidi (razen kapljic, krem ali mazil za bolezni oči in kože ali inhalatorjev za težave z dihanjem, kot je astma);
English: Fasting glucose, mg/dL
Slovenian: Glukoza na tešče, mg/dl
English: • Medicines used in the treatment of HIV infection and AIDS, such as efavirenz and ritonavir;
Slovenian: • zdravila, ki se uporabljajo za zdravljenje okužbe s HIV in aidsa, kot sta efavirenz in ritonavir;
English: The consumption of alcohol during naltrexone / bupropion treatment should be minimised or avoided.
Slovenian: Uživanje alkohola med zdravljenjem z naltreksonom/bupropionom je treba čim bolj zmanjšati ali preprečiti.
English: Liver changes are seen in animal studies with bupropion but these reflect the action of a hepatic enzyme inducer.
Slovenian: V študijah na živalih z bupropionom so opazili jetrne spremembe, toda te kažejo na delovanje induktorja jetrnih encimov.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/988/001 112 tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/988/001 112 tablet
English: In clinical studies, 23.8% of subjects receiving naltrexone / bupropion and 11.9% of subjects receiving placebo discontinued treatment due to an adverse event.
Slovenian: V kliničnih študijah je bilo pri 23,8 % preiskovancev, ki so prejemali naltrekson/bupropion, in pri 11,9 % preiskovancev, ki so prejemali placebo, zdravljenje prekinjeno zaradi neželenega učinka.
English: Although clinical data do not identify a pharmacokinetic interaction between bupropion and alcohol, there have been rare reports of adverse neuropsychiatric events or reduced alcohol tolerance in patients drinking alcohol during bupropion treatment.
Slovenian: Čeprav na podlagi kliničnih podatkov ni bila ugotovljena farmakokinetična interakcija med bupropionom in alkoholom, so bila pridobljena redka poročila o neželenih nevropsihiatričnih dogodkih ali zmanjšani toleranci na alkohol pri bolnikih, ki so uživali alkohol med zdravljenjem z bupropionom.
English: Patients must be advised to exercise caution while driving or operating machines during treatment with naltrexone/bupropion, especially at the beginning of the treatment or during the titration phase.
Slovenian: Bolnike je treba opozoriti, da morajo biti med zdravljenjem z naltreksonom/bupropionom pri vožnji ali upravljanju strojev previdni, zlasti med uvedbo zdravljenja ali v fazi titracije.
English: Of the overall population of 4,536 subjects in the naltrexone / bupropion Phase 3 studies, 25% had hypertension, 33% had fasting glucose levels ≥100 mg/dL (5.6 mmol/L) at baseline, 54% had dyslipidaemia at study entry, and 11% had type 2 diabetes.
Slovenian: V celotni populaciji 4.536 preiskovancev v študijah 3. faze z uporabo kombinacije naltrekson/bupropion je 25 % oseb imelo hipertenzijo, pri 33 % so bile izhodiščne ravni glukoze na tešče ≥100 mg/dl (5,6 mmol/l), 54 % je imelo dislipidemijo ob vključitvi v študijo, 11 % oseb pa je imelo sladkorno bolezen tipa 2.
English: Therefore, mild increases in creatinine observed after long-term treatment with naltrexone / bupropion are likely due to inhibition of OCT2 and not indicative of changes in creatinine clearance.
Slovenian: Zato so blaga zvišanja ravni kreatinina, ki jih opazimo po dolgotrajnem zdravljenju z naltreksonom/bupropionom, verjetno posledica zaviranja OCT2 in ne kažejo na spremembe očistka kreatinina.
English: Clinical studies of naltrexone / bupropion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects.
Slovenian: V klinične študije z naltreksonom/bupropionom ni bilo vključenih dovolj preiskovancev, starih 65 let in več, da bi lahko ugotovili, ali je njihov odziv drugačen kot pri mlajših preiskovancih.
English: The medicinal product has two components: naltrexone, a mu-opioid antagonist, and bupropion, a weak inhibitor of neuronal dopamine and norepinephrine reuptake.
Slovenian: Zdravilo ima dve sestavini: naltrekson, mu-opioidni antagonist, in bupropion, šibek zaviralec ponovnega privzema dopamina in noradrenalina nevron.
English: Patients with type 2 diabetes may be more prone to these events due to concomitant medicinal product use (e.g., metformin) or may be more likely to have underlying gastrointestinal disorders (e.g., gastroparesis) predisposing to gastrointestinal symptoms.
Slovenian: Bolniki s sladkorno boleznijo tipa 2 so morda bolj dovzetni za te učinke zaradi sočasne uporabe drugih zdravil (npr. metformina) oziroma bolj verjetno že imajo katero od bolezni prebavil (npr. gastroparezo), ki so lahko predispozicija za gastrointestinalne simptome.
English: No events of nausea, constipation, or vomiting were considered serious.
Slovenian: Noben dogodek, kar zadeva navzeo, zaprtje ali bruhanje, ni bil ocenjen kot resen.
English: No events of dizziness, dry mouth, headache, or insomnia in subjects treated with naltrexone / bupropion were considered serious.
Slovenian: Noben dogodek, kar zadeva omotico, suha usta, glavobol ali nespečnost pri preiskovancih, zdravljenih z naltreksonom/bupropionom, ni bil ocenjen kot resen.
English: Mysimba is approved for use in patients with an initial body mass index of 30 or greater; it can also be given to those with a body mass index between 27 and 30 if they have additional weight-related conditions such as controlled high blood pressure (hypertension), type 2 diabetes or high levels of lipid (fat) in the blood.
Slovenian: Zdravilo Mysimba je odobreno za uporabo pri bolnikih z izhodiščnim indeksom telesne mase, ki znaša 30 ali več; uporabiti ga je mogoče tudi pri tistih, ki imajo indeks telesne mase med 27 in 30, če imajo dodatna obolenja, povezana s telesno maso, kot so nadzorovan visok krvni tlak (hipertenzija),
English: Mysimba has been shown to cause fits (seizures) in up to 1 in 1,000 patients (see also section 4).
Slovenian: Krči (epileptični napadi) Pokazalo se je, da zdravilo Mysimba povzroča krče (epileptične napade) pri največ 1 od 1.000 bolnikov (glejte tudi poglavje 4).
English: The mean volume of distribution at steady state of oral naltrexone and bupropion given as naltrexgone / bupropion, Vss/F, was 5697 liters and 880 liters, respectively.
Slovenian: Povprečni volumen porazdelitve v stanju dinamičnega ravnovesja pri peroralni aplikaciji naltreksona in bupropiona v obliki kombinacije naltrekson/bupropion, Vss/F, je za naltrekson znašal 5.697 litrov, za bupropion pa 880 litrov.
English: You should stop taking Mysimba immediately and consult your doctor if you are experiencing any symptoms of an allergic reaction such as swelling of the throat, tongue, lips, or face, difficulty swallowing or breathing, dizziness, fever, rash, pain in the joints or in the muscles, itching or hives after taking this medicine (see also section 4).
Slovenian: Zdravilo Mysimba morate takoj prenehati jemati in se posvetovati z zdravnikom, če se pri vas pojavijo simptomi alergijske reakcije, kot so otekanje žrela, jezika, ustnic ali obraza, težave s požiranjem ali dihanjem, omotica, povišana telesna temperatura, izpuščaji, bolečine v sklepih ali mišicah, srbenje ali koprivnica, potem ko vzamete to zdravilo (glejte tudi poglavje 4).
English: These results suggest that most of the total weight loss was attributable to a reduction in adipose tissue, including visceral adipose.
Slovenian: Ti rezultati kažejo, da je zmanjšanje skupne telesne mase večinoma posledica zmanjšanja maščobnega tkiva, vključno z visceralnim maščevjem.
English: Patients who experience dizziness, somnolence, loss of consciousness or seizure should be advised to avoid driving or operating machines until these adverse effects have resolved.
Slovenian: Bolnikom je treba svetovati, da se morajo v primeru pojava omotice, somnolence, izgube zavesti ali epileptičnega napada, vožnji ali upravljanju strojev izogibati, dokler ti neželeni učinki ne izzvenijo.
English: In a series of studies in healthy volunteers, ritonavir (100 mg twice daily or 600 mg twice daily) or ritonavir 100 mg plus lopinavir 400 mg twice daily reduced the exposure of bupropion and its major metabolites in a dose dependent manner by 20 to 80%.
Slovenian: seriji študij z zdravimi prostovoljci se je z uporabo ritonavirja (100 mg dvakrat dnevno ali 600 mg dvakrat dnevno) ali ritonavirja 100 mg skupaj z lopinavirjem 400 mg dvakrat dnevno zmanjšala izpostavljenost bupropiona in njegovih glavnih presnovkov v odvisnosti od odmerka, in sicer za 20 do 80 %.
English: 95% confidence intervals calculated as LS Mean ± 1.96 × Standard Error.
Slovenian: ±1,96 x standardna napaka.
English: Waist circumference, cm
Slovenian: Obseg pasu, cm
English: Following oral administration of a single 150 mg dose of bupropion hydrochloride, there was no statistically significant difference in Cmax, half-life, Tmax, AUC, or clearance of bupropion or its active metabolites between smokers and nonsmokers.
Slovenian: Po peroralni aplikaciji enkratnega odmerka 150 mg bupropionijevega klorida niso ugotovili statistično značilnih razlik pri vrednostih Cmax, razpolovnega časa, Tmax, AUC ali pri očistku bupropiona ali njegovih aktivnih presnovkov pri kadilcih v primerjavi z nekadilci.
English: Ask your doctor for advice before you drive and operate machines since Mysimba might make you feel dizzy and sleepy which may weaken your ability to concentrate and react.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Preden vozite ali upravljate stroje se posvetujte z zdravnikom, saj lahko zdravilo Mysimba povzroči občutek omotičnosti in zaspanosti, ki oslabi vašo sposobnost koncentracije in reagiranja.
English: The safety profile of naltrexone / bupropion (NB) summarised in Table 1 below is based on clinical studies performed with the fixed-dose combination (adverse reactions at an incidence of at least 0.1% and twice that of placebo).
Slovenian: V spodnji preglednici 1 povzet varnostni profil kombinacije naltrekson/bupropion (NB) temelji na kliničnih študijah, izvedenih s fiksno kombinacijo odmerkov (neželeni učinki s pojavnostjo najmanj 0,1 % in dvakrat toliko za placebo).
English: More severe hypersensitivity reactions including angioedema, dyspnoea/ bronchospasm and anaphylactic shock.
Slovenian: Hujše preobčutljivostne reakcije, vključno z angioedemom, dispnejo/bronhospazmom in anafilaktičnim šokom.
English: The most serious clinical implications of combined use of bupropion and naltrexone overdose are likely related to bupropion.
Slovenian: Najresnejši klinični zapleti prevelikega odmerjanja pri kombinirani uporabi bupropiona in naltreksona so verjetno povezani z bupropionom.
English: *** Toothache and dental caries, while not meeting the criteria for inclusion in this table, are listed based on the subset of patients with dry mouth, in which a higher incidence of toothache and dental caries was observed in subjects treated with NB versus placebo.
Slovenian: *** Zobobol in zobni karies sta, čeprav ne izpolnjujeta meril za vključitev v to preglednico, navedena na podlagi podskupine bolnikov s suhimi usti, v kateri so opazili večjo pojavnost zobobola in zobnega kariesa pri preiskovancih, ki so prejemali NB, v primerjavi s tistimi, ki so prejemali placebo.
English: NB-304 evaluated subjects with type 2 diabetes not achieving glycaemic goal of HbA1c <7% (53 mmol/mol) with oral anti-diabetes agents or on diet and exercise alone.
Slovenian: V študiji NB-304 so preučevali preiskovance s sladkorno boleznijo tipa 2, ki niso dosegli glikemičnega cilja HbA1c <7 % (53 mmol/mol) s peroralnimi antidiabetiki ali samo z dieto in telesno dejavnostjo.
English: The results from this study demonstrated that the area under the curve for plasma naltrexone and metabolites and for plasma bupropion and metabolites was increased by less than two-fold in patients with moderate and severe renal impairment, and smaller increases were observed for patients with mild renal impairment.
Slovenian: Rezultati študije so pokazali, da se je površina pod krivuljo za naltrekson in presnovke v plazmi ter za bupropion in presnovke v plazmi povečala za manj kot dvakrat pri bolnikih z zmerno in hudo ledvično okvaro, manjša povečanja pa so opazili pri bolnikih z blago okvaro ledvic.
English: Though less potent than naltrexone, 6-beta-naltrexol is eliminated more slowly and thus circulates at much higher concentrations than naltrexone.
Slovenian: se 6-beta-naltreksol izloča počasneje, zato cirkulira s precej višjimi koncentracijami kot naltrekson.
English: • Patients receiving concomitant administration of monoamine oxidase inhibitors (MAOI).
Slovenian: • Bolniki, ki sočasno prejemajo zaviralce monoaminooksidaze (MAO).
English: Plasma protein binding is not extensive for naltrexone (21%) or bupropion (84%) indicating low potential for drug interactions by displacement.
Slovenian: Vezava na proteine v plazmi pri naltreksonu (21 %) oziroma bupropionu (84 %) ni izdatna, kar pomeni, da je možnost interakcij med zdravili zaradi izrinjanja majhna.
English: The effects of combined bupropion and naltrexone use have not been studied in animals.
Slovenian: Učinkov kombinirane uporabe bupropiona in naltreksona na živalih niso preučevali.
English: Degree of hepatic impairment should be assessed using the Child-Pugh score.
Slovenian: Stopnjo jetrne okvare je treba oceniti po Child-Pughovi lestvici.
English: Naltrexone / bupropion should preferably be taken with food, as it is known that both naltrexone and bupropion plasma concentrations are increased with food and the safety and efficacy data from clinical trials is based on dosing with food.
Slovenian: Priporoča se uporaba naltreksona/bupropiona skupaj s hrano, saj je znano, da se plazemska koncentracija naltreksona in bupropiona poviša s hrano, podatki iz kliničnih preskušanj o varnosti in učinkovitosti pa temeljijo na odmerjanju skupaj s hrano.
English: Do not stop taking Mysimba without talking to your doctor first.
Slovenian: Z jemanjem zdravila Mysimba ne smete prenehati, ne da bi se pred tem posvetovali s svojim zdravnikom.
English: Naltrexone / bupropion should not be used during pregnancy or in women currently attempting to become pregnant.
Slovenian: Kombinacija naltrekson/bupropion se ne sme uporabljati med nosečnostjo ali pri ženskah, ki skušajo zanositi.
English: Administration of naltrexone / bupropion with inhibitors or inducers of UGT 1A2 and 2B7 should be undertaken with caution as these may alter the exposure of naltrexone.
Slovenian: Pri uporabi kombinacije naltrekson/bupropion skupaj z zaviralci ali induktorji encimov UGT 1A2 in 2B7 je potrebna previdnost, saj ti lahko vplivajo na izpostavljenost naltreksona.
English: In the arcuate nucleus of the hypothalamus, bupropion stimulates pro-opiomelanocortin (POMC) neurons that release alpha-melanocyte stimulating hormone (α-MSH), which in turn binds to and stimulates melanocortin 4 receptors (MC4-R).
Slovenian: V arkuatnem jedru hipotalamusa bupropion stimulira nevrone proopiomelanokortina (POMC), ki sproščajo alfa-melanocite stimulirajoči hormon (α-MSH), ki se ponovno veže na receptorje melanokortina 4 (MC4-R) in jih stimulira.
English: • Patients receiving any concomitant treatment containing bupropion or naltrexone
Slovenian: • Bolniki, ki se sočasno zdravijo s kakršnim koli zdravilom, ki vsebuje bupropion ali naltrekson
English: The most common type of seizures is generalised tonic-clonic seizures, a seizure type which can result in some cases in post-ictal confusion or memory impairment (see section 4.4).
Slovenian: Najpogostejša vrsta epileptičnih napadov so generalizirani tonično-klonični napadi, ki lahko v nekaterih primerih povzročijo postiktalno zmedenost ali motnje spomina (glejte poglavje 4.4).
English: If patients experience clinically relevant and sustained increases in blood pressure or pulse rate as a result of naltrexone / bupropion treatment, it should be discontinued.
Slovenian: Če se pri bolnikih ugotovi klinično pomembno in trajno zvišanje krvnega tlaka ali frekvence srčnega utripa kot posledica zdravljenja z naltreksonom/bupropionom, je treba zdravljenje prekiniti.
English: Naltrexone and bupropion are well absorbed from the gastrointestinal tract (>90% absorbed), however, naltrexone has a significant first pass effect thereby limiting systemic bioavailablity, with only 5-6% reaching the systemic circulation intact.
Slovenian: Naltrekson in bupropion se iz prebavil dobro absorbirata (>90-odstotna absorpcija), vendar ima naltrekson izrazit učinek prvega prehoda, zato je sistemska biološka uporabnost omejena, saj le v 5
English: Mechanism of action and pharmacodynamic effects The exact neurochemical appetite suppressant effects of naltrexone / bupropion are not fully understood.
Slovenian: Mehanizem delovanja in farmakodinamični učinki Natančni nevrokemični učinki zmanjševanja apetita pri kombinaciji naltrekson/bupropion niso povsem pojasnjeni.
English: Study NB-302 had a more intensive behavioural modification program, while the primary endpoint of Study NB-303 was at Week 28 to allow for re-randomization to different doses in the latter portion of the study.
Slovenian: Študija NB-302 je vključevala intenzivnejši program za spremembo vedenja, primarni cilj študije NB-303 pa je bil pri 28. tednu, da je bila omogočena ponovna randomizacija v skupine z različnimi odmerki v poznejši fazi študije.
English: Since there is limited information on the systemic exposure to naltrexone and bupropion in infants/newborns being breast-fed, a risk to the newborns/infants cannot be excluded.
Slovenian: Podatki o sistemski izpostavljenosti naltreksonu in bupropionu pri dojenčkih/novorojenčkih, ki so dojeni, so omejeni, zato ni mogoče izključiti tveganja za novorojenčke/dojenčke.
English: However, there is some evidence on hepatotoxicity with increasing dose, since reversible increases of liver enzymes have been found in humans with therapeutic and higher doses (see section 4.4 and 4.8).
Slovenian: Vendar obstajajo dokazi o hepatotoksičnosti pri povečevanju odmerka, kajti pri osebah, ki so prejemale terapevtske in večje odmerke, so opazili reverzibilno zvišanje jetrnih encimov (glejte poglavji 4.4 in 4.8).