FrancophonIA/ELRC3.0 huggingface dataset:
English: A pooled analysis of safety data on 420 paediatric subjects (183 subjects aged 6 to 11 years, and 237 subjects aged 12 to 16 years with a mean duration of exposure of approximately 12 months) has shown a relatively higher reporting frequency of pneumonia, dehydration, decreased sweating, abnormal liver function tests, otitis media, pharyngitis, sinusitis and upper respiratory tract infection, cough, epistaxis and rhinitis, abdominal pain, vomiting, rash and eczema, and fever compared to the adult population (particularly in subjects aged below 12 years) and, at a low incidence, amnesia, creatinine increased, lymphadenopathy, and thrombocytopenia.
Slovenian: Združena analiza podatkov o varnosti pri 420 pediatričnih bolnikih, od katerih je bilo 183 bolnikov starih 6 do 11 let in 237 bolnikov 12 do 16 let, s povprečnim trajanjem izpostavljenosti približno 12 mesecev, je pokazala relativno večjo pogostnost poročanja o pljučnici, dehidraciji, zmanjšanem znojenju, nenormalnih testih delovanja jeter, vnetju srednjega ušesa, faringitisu, sinusitisu in okužbi zgornjih dihal, kašlju, epistaksi in rinitisu, bolečinah v trebuhu, bruhanju, izpuščaju, ekcemu in zvišani telesni temperaturi v primerjavi z odraslo populacijo (zlasti za osebe, stare manj kot 12 let), pogostnost amnezije, zvišanja kreatinina, limfadenopatije in trombocitopenije pa je bila majhna.
English: Cases of agranulocytosis, thrombocytopenia, leukopenia, aplastic anaemia, pancytopenia and leucocytosis have been reported.
Slovenian: Poročali so o primerih agranulocitoze, trombocitopenije, levkopenije, aplastične anemije, pancitopenije in levkocitoze.
English: General dosing recommendations for Zonegran in special patient populations
Slovenian: Splošna priporočila za odmerjanje zdravila Zonegran pri posebnih populacijah bolnikov
English: Therefore, Zonegran is not expected to affect the pharmacokinetics of other medicinal products via cytochrome P450-mediated mechanisms, as demonstrated for carbamazepine, phenytoin, ethinylestradiol and desipramine in vivo.
Slovenian: Zato ni pričakovati, da bi zdravilo Zonegran preko mehanizmov, povezanih s citokromom P450, vplival na farmakokinetiko drugih zdravil, kot je bilo in vivo pokazano za karbamazepin, fenitoin, etinilestradiol in desipramin.
English: Women of childbearing potential must use effective contraception during treatment with Zonegran and for one month after discontinuation (see section 4.6).
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem ter vsaj še mesec dni po končanem zdravljenju z zdravilom Zonegran (glejte poglavje 4.6).
English: Cases of decreased sweating and elevated body temperature have been reported mainly in paediatric patients (see section 4.4 Paediatric population for full warning).
Slovenian: Pojavili so se primeri zmanjšanega potenja in zvišane telesne temperature, najpogosteje pri pediatrični populaciji (glejte tudi poglavje 4.4 Pediatrična populacija za vsa opozorila).
English: Nevertheless, if a hepatic event is suspected, liver function should be evaluated and discontinuation of Zonegran should be considered.
Slovenian: Vendar pa je treba ob sumu na jetrni dogodek oceniti delovanje jeter in razmisliti o prekinitvi zdravila Zonegran.
English: If pancreatitis is evident, in the absence of another obvious cause, it is recommended that discontinuation of Zonegran be considered and appropriate treatment initiated.
Slovenian: Ob očitnem pankreatitisu in ob odsotnosti drugih očitnih razlogov je treba razmisliti o prenehanju zdravljenja z zdravilom Zonegran in začetku ustreznega zdravljenja pankreatitisa.
English: If you stop taking Zonegran
Slovenian: Če ste prenehali jemati zdravilo Zonegran
English: Zonegran should not be used as co-medication in paediatric patients with other medicinal products that predispose patients to heat related disorders; these include carbonic anhydrase inhibitors and medicinal products with anticholinergic activity.
Slovenian: Zdravilo Zonegran se pri pediatričnih bolnikih ne sme uporabljati skupaj z drugimi zdravili, zaradi katerih je bolnik bolj nagnjen k motnjam, povezanim z vročino; ta zdravila vključujejo zaviralce karboanhidraze in zdravila z antiholinergično aktivnostjo.
English: Increasing fluid intake and urine output may help reduce the risk of stone formation, particularly in those with predisposing risk factors.
Slovenian: Povečanje vnosa tekočine in izločanja urina lahko pripomore k zmanjšanju nevarnosti nastanka ledvičnih kamnov, predvsem pri bolnikih z dejavniki tveganja, ki zvečujejo dovzetnost za nastanek ledvičnih kamnov.
English: If elevated, in the absence of another obvious cause such as trauma or grand mal seizures, it is recommended that Zonegran discontinuation be considered and appropriate treatment initiated.
Slovenian: Če sta zvišani in ni drugih očitnih razlogov, kot na primer travma ali epileptični napad grand mal, je treba razmisliti o prenehanju zdravljenja z zdravilom Zonegran in začetku ustreznega zdravljenja.
English: • feel unusually tired or feverish, have a sore throat, swollen glands, or find that you bruise more easily, as this may mean you have a blood disorder.
Slovenian: • če se počutite nenavadno utrujeni ali vročični, imate vneto žrelo, otekle bezgavke ali opazite, da vam brez omembe vrednega vzroka nastajajo modrice, ker bi to lahko pomenilo, da imate bolezen krvi;
English: Ophthalmologic findings can include myopia, anterior chamber shallowing, and ocular hyperaemia (redness) and increased intraocular pressure.
Slovenian: Oftalmološke ugotovitve lahko vključujejo miopijo, poplitvitev sprednjega prekata, očesno hiperemijo (rdečino) in zvišan znotrajočesni tlak.
English: All patients who develop a rash while taking Zonegran must be closely supervised, with additional levels of caution applied to those patients receiving concomitant antiepileptic agents that may independently induce skin rashes.
Slovenian: Vse bolnike, pri katerih se med jemanjem zdravila Zonegran pojavi izpuščaj, je treba skrbno nadzirati, še posebej pa je treba biti pozoren pri tistih bolnikih, ki sočasno prejemajo antiepileptična zdravila, ki lahko že sama povzročajo kožne izpuščaje.
English: Zonegran is a benzisoxazole derivative, which contains a sulphonamide group.
Slovenian: Zdravilo Zonegran je derivat benzisoksazola, ki vsebuje sulfonamidno skupino.
English: Excipients: 0.002 mg of sunset yellow FCF (E110) and 0.147 mg of allura red AC (E129).
Slovenian: Pomožne snovi: 0,002 mg barvila sončno rumeno FCF (E110) in 0,147 mg barvila alurno rdeče AC (E129).
English: The risk of zonisamide induced metabolic acidosis appears to be more frequent and severe in paediatric and adolescent patients.
Slovenian: Zdi se, da je tveganje metabolne acidoze zaradi zonisamida večje in potek težji pri pediatričnih bolnikih in mladostnikih.
English: • With other antiepileptic medicines to treat seizures in adults, adolescents, and children aged
Slovenian: • z drugimi antiepileptiki za zdravljenje epileptičnih napadov pri odraslih, mladostnikih in otrocih, starih 6 let ali več.
English: Therefore, modification of Zonegran dosing should not be necessary when co-administered with known CYP3A4 inhibitors.
Slovenian: Zato prilagajanje odmerka zonisamida pri sočasnem zdravljenju z znanimi zaviralci CYP3A4 ni potrebno.
English: If substantial undesirable weight loss occurs, discontinuation of Zonegran should be considered.
Slovenian: V primeru znatne neželene izgube telesne mase je treba razmisliti o prekinitvi zdravljenja z zdravilom Zonegran.
English: Women planning a pregnancy should meet with their specialists to reassess treatment with Zonegran and to consider other therapeutic options.
Slovenian: Ženske, ki načrtujejo zanositev, se morajo posvetovati z zdravnikom specialistom, da se ponovno oceni zdravljenje z zdravilom Zonegran in razmisli o drugih možnostih zdravljenja.
English: Zonegran must not be used during pregnancy unless clearly necessary and only if the potential benefit is considered to justify the risk to the foetus.
Slovenian: Uporaba zdravila Zonegran med nosečnostjo ni dovoljena, razen kadar je to nujno potrebno in samo če se oceni, da možna korist upravičuje tveganje za plod.
English: Efficacy results for Monotherapy Study 310 Zonisamide Carbamazepine n (ITT population) Six months seizure freedom
Slovenian: Preglednica 6 Rezultati učinkovitosti za študijo monoterapije 310 zonisamid karbamazepin n (populacija ITT) Šest mesecev brez epileptičnega napada razl.
English: • suffer from liver problems, as your dose of Zonegran may need adjusting.
Slovenian: • če imate težave z jetri, ker bo vaš odmerek zdravila Zonegran morda potrebno prilagoditi;
English: It is not always possible to precisely achieve the calculated dose with the commercially available capsule strengths of Zonegran.
Slovenian: Z jakostmi kapsul zdravila Zonegran, ki so komercialno na voljo, ni vedno možno natančno doseči izračunanega odmerka.
English: If your child's skin feels very hot with little or no sweating, becomes confused, has muscle cramps, or your child's heartbeat or breathing becomes rapid:
Slovenian: Če postane koža vašega otroka na otip zelo vroča in je znojenja zelo malo ali ga ni, ali otrok postane zmeden ali ima mišične krče ali postaneta srčni utrip ali dihanje hitrejša:
English: • low blood potassium levels, convulsions/seizures.
Slovenian: • znižana koncentracija kalija v krvi, konvulzije/epileptični napadi.
English: Subjects who experienced a further seizure were titrated to the maximal target dose of 1200 mg carbamazepine or 500 mg zonisamide.
Slovenian: Osebe, ki so imele še en epileptični napad, so bile titrirane na največji ciljni odmerek 1200 mg karbamazepina ali 500 mg zonisamida.
English: • The starting dose is 1 mg per kg of body weight taken once a day.
Slovenian: • Začetni odmerek je 1 mg na kg telesne mase enkrat na dan.
English: System Organ Class (MedDRA terminology)
Slovenian: Organski sistem (po MedDRA klasifikaciji)
English: If you are a woman of childbearing age you must use adequate contraception while taking and for one month after stopping Zonegran.
Slovenian: Če ste ženska v rodni dobi, morate uporabljati primerno obliko kontracepcije med zdravljenjem in še mesec dni po končanem zdravljenju z zdravilom Zonegran.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adolescent and paediatric patients (aged 6 years and above)
Slovenian: Adjuvantno zdravljenje pri zdravljenju parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje, pri mladostnikih in pediatričnih bolnikih (starih 6 let ali več)
English: Complex partial All generalized Tonic-Clonic Secondary Tonic-Clonic Generalized Tonic-Clonic
Slovenian: Preprosti parcialni Kompleksni parcialni Vsi generalizirani toničnoklonični
English: Acute myopia and secondary angle closure glaucoma
Slovenian: Akutna miopija in sekundarni glavkom zaprtega zakotja
English: Findings not observed in clinical studies, but seen in the dog at exposure levels similar to clinical use, were liver changes (enlargement, dark-brown discolouration, mild hepatocyte enlargement with concentric lamellar bodies in the cytoplasm and cytoplasmic vacuolation) associated with increased metabolism.
Slovenian: Pri psih, ki so bili izpostavljeni podobnim koncentracijam kot v klinični uporabi, ne pa tudi v kliničnih študijah, so opazili spremembe na jetrih (povečanje, temnorjavo obarvanje, rahlo povečanje hepatocitov s koncentričnimi lamelarnimi telesci v citoplazmi ter citoplazemska vakuolizacija), povezane s povečano presnovo.
English: Potential for Zonegran to affect other medicinal products
Slovenian: Možni učinki zdravila Zonegran na druga zdravila
English: Monotherapy in partial seizures, with or without secondary generalisation
Slovenian: Monoterapija pri parcialnih epileptičnih napadih s sekundarno generalizacijo ali brez nje
English: Adverse reactions in a randomised, controlled monotherapy trial comparing zonisamide with carbamazepine prolonged release System Organ Class (MedDRA terminology†)
Slovenian: Preglednica 5 Neželeni učinki, ki so jih v randomiziranem, kontroliranem preskušanju monoterapije, v katerem so primerjali zonisamid s karbamazepinom s podaljšanim sproščanjem Organski sistem (terminologija
English: Absolute bioavailability is estimated to be approximately 100%.
Slovenian: Presnova pri prvem prehodu naj bi bila zanemarljiva, absolutna biološka uporabnost je približno 100 %.
English: • have signs of increased acid level in the blood- headaches, drowsiness, shortness of breath and loss of appetite.
Slovenian: • če imate znake zvišane ravni kisline v krvi - glavobole, ste zaspani, imate kratko sapo in zmanjšan apetit.
English: • decreased sweating, overheating.
Slovenian: • zmanjšano znojenje, pregrevanje telesa;
English: The skin feels very hot with little or no sweating, or the child becomes confused or has muscle cramps, or the child's heartbeat or breathing become rapid.
Slovenian: Koža postane na otip koža zelo vroča in znojenja je zelo malo ali ga ni, ali otrok postane zmeden ali ima mišične krče ali postaneta srčni utrip ali dihanje hitrejša:
English: • adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.
Slovenian: • adjuvantna terapija pri zdravljenju parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih in otrocih, starih 6 let in več.
English: 28 hard capsules 56 hard capsules 84 hard capsules 98 hard capsules 196 hard capsules
Slovenian: 28 trdih kapsul 56 trdih kapsul 84 trdih kapsul 98 trdih kapsul 196 trdih kapsul
English: The anticonvulsant activity of zonisamide has been evaluated in a variety of models, in several species with induced or innate seizures, and zonisamide appears to act as a broad-spectrum anti-epileptic in these models.
Slovenian: Antikonvulzivna aktivnost zonisamida je bila ocenjena v več modelih in na več vrstah tako z induciranimi kot prirojenimi epileptičnimi napadi.
English: Caution should be exercised at initiation of treatment in elderly patients as there is limited information on the use of Zonegran in these patients.
Slovenian: Pri starejših bolnikih je na začetku zdravljenja potrebna previdnost, saj je podatkov o zdravljenju teh bolnikov z zdravilom Zonegran malo.
English: Zonegran 25 mg, 50 mg, and 100 mg hard capsules zonisamide
Slovenian: Zonegran 25 mg, 50 mg in 100 mg trde kapsule zonisamid
English: • On its own to treat seizures in adults.
Slovenian: • kot samostojno zdravilo za zdravljenje epileptičnih napadov pri odraslih,
English: No specific antidotes for Zonegran overdose are available.
Slovenian: Za preveliko odmerjanje zdravila Zonegran ni na voljo specifičnega antidota.
English: Zonegran contains Hydrogenated vegetable oil (from soyabean).
Slovenian: Zdravilo Zonegran vsebuje hidrogenirano rastlinsko olje (sojino).
English: Paediatric population (aged 6 years and above) - recommended dosage escalation and maintenance regimen
Slovenian: Preglednica 2 Pediatrična populacija (starost 6 let ali več) - priporočeni režim stopnjevanja odmerka in vzdrževalnega odmerka
English: Zonegran contains sunset yellow FCF (E110) and allura red AC (E129) Zonegran 100 mg hard capsules contain a yellow colour called sunset yellow FCF (E110) and a red colour called allura red AC (E129), which may cause allergic reactions.
Slovenian: Zdravilo Zonegran vsebuje barvili sončno rumeno FCF (E110) in alurno rdeče AC (E129) Zdravilo Zonegran 100 mg trde kapsule vsebujejo rumeno barvilo, imenovano sončno rumeno FCF (E110), in rdeče barvilo, imenovano alurno rdeče AC (E129), ki lahko povzročata alergijske reakcije.
English: These effects are unlikely to be of clinical significance when Zonegran is added to existing therapy; however, changes in zonisamide concentrations may occur if concomitant CYP3A4-inducing anti-epileptic or other medicinal products are withdrawn, dose adjusted or introduced, an adjustment of the Zonegran dose may be required.
Slovenian: Vendar pa se lahko pojavijo spremembe v koncentraciji zonisamida v primeru ukinitve, prilagajanja ali novega uvajanja antiepileptičnih ali drugih zdravil, ki inducirajo CYP3A4, zato bo morda potrebna prilagoditev odmerka zdravila Zonegran.
English: 14 hard capsules 28 hard capsules 56 hard capsules 84 hard capsules
Slovenian: 14 trdih kapsul 28 trdih kapsul 56 trdih kapsul 84 trdih kapsul
English: • The child must avoid heavy exercise especially when the weather is hot
Slovenian: • se mora izogibati pretirani telesni vadbi, zlasti ob vročem vremenu;
English: The main route of excretion of zonisamide metabolites and unchanged drug is via the urine.
Slovenian: Presnovki zonisamida in nespremenjeno zdravilo se pretežno izločajo z urinom.
English: Erythema multiforme Stevens-Johnson syndrome Toxic epidermal necrolysis
Slovenian: Bolezni kože in podkožja izpuščaj pruritus alopecija anhidroza multiformni eritem Stevens-Johnsonov sindrom toksična epidermalna nekroliza
English: Women of childbearing potential must use effective contraception during treatment with Zonegran, and for one month after discontinuation.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Zonegran in en mesec po njem.
English: • The starting dose is 100 mg taken once a day.
Slovenian: • Začetni odmerek je 100 mg enkrat na dan.
English: Drug-induced hypersensitivity syndrome Drug rash with eosinophilia and systemic symptoms
Slovenian: Bolezni imunskega sistema hipersenzitivnost preobčutljivostni sindrom zaradi zdravila kožni izpuščaj z eozinofilijo in s sistemskimi simptomi
English: • The child must drink plenty of cold water
Slovenian: • mora piti veliko mrzle vode;
English: Cases of decreased sweating and elevated body temperature have been reported mainly in paediatric patients.
Slovenian: Pojavili so se primeri zmanjšanega potenja in zvišane telesne temperature, najpogosteje pri pediatrični populaciji.
English: Caution must be exercised in treating patients with renal impairment, as there is limited information on use in such patients and a slower titration of Zonegran might be required.
Slovenian: Pri zdravljenju bolnikov z ledvično okvaro z zdravilom Zonegran je potrebna previdnost, saj je o zdravljenju teh bolnikov na voljo le malo podatkov, zato je pri njih potrebno počasnejše prilagajanje odmerka.
English: Zonegran must not be used in women of childbearing potential not using effective contraception unless clearly necessary and only if the potential benefit is considered to justify the risk to the foetus.
Slovenian: Ženske v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, ne smejo uporabljati zdravila Zonegran, razen kadar je to nedvomno potrebno in samo če se oceni, da možne koristi opravičujejo tveganje za plod.
English: 100 mg / day (in two divided doses)
Slovenian: 100 mg/dan (v dveh deljenih odmerkih)
English: Since zonisamide and its metabolites are excreted renally, it should be discontinued in patients who develop acute renal failure or where a clinically significant sustained increase in serum creatinine is observed.
Slovenian: Ker se zonisamid in presnovki izločajo preko ledvic, je treba pri bolnikih, pri katerih se razvije akutna ledvična odpoved ali pa se pojavi klinično pomemben vztrajen porast serumskega kreatinina, zdravljenje z zdravilom Zonegran takoj prekiniti.
English: • loss of weight, nausea, indigestion, stomach pains, diarrhoea (loose stools), constipation.
Slovenian: • hujšanje, slabost, dispepsija, bolečine v trebuhu, diareja (driska), zaprtost,
English: • suffer from kidney problems as your dose of Zonegran may need adjusting.
Slovenian: • če imate težave z ledvicami, ker bo vaš odmerek zdravila Zonegran morda potrebno prilagoditi;
English: In addition, patients taking other medications associated with nephrolithiasis may be at increased risk.
Slovenian: Povečano nevarnost za nastanek ledvičnih kamnov imajo tudi bolniki, ki jemljejo druga zdravila, povezana z nefrolitiazo.
English: The combination of Zonegran with other medicinal products that may lead to urolithiasis may enhance the risk of developing kidney stones; therefore the concomitant administration of such medicinal products should be avoided.
Slovenian: Kombinacija zdravila Zonegran z drugimi zdravili, ki lahko povzročijo urolitiazo, lahko poveča nevarnost za nastanek ledvičnih kamnov.
English: • are underweight, or have lost a lot of weight as Zonegran can cause you to lose more weight.
Slovenian: • če imate premajhno telesno maso ali če ste zelo shujšali, ker je mogoče, da boste zaradi zdravila Zonegran še bolj shujšali.
English: Paediatric population (aged 6 years and above) - recommended down-titration schedule
Slovenian: Preglednica 3 Pediatrična populacija (starost 6 let ali več) - priporočeni režim zmanjševanja odmerka
English: Zonegran 100 mg hard capsules contain a yellow colour called sunset yellow FCF (E110), and a red colour called allura red AC (E129), which may cause allergic reactions.
Slovenian: Zdravilo Zonegran 100 mg trde kapsule vsebuje rumeno barvilo, ki se imenuje sončno rumeno FCF (E110), in rdeče barvilo, ki se imenuje alurno rdeče AC (E129), ki lahko povzročita alergijske reakcije.
English: • This may be increased by 1 mg per kg of body weight at intervals of one to two weeks.
Slovenian: • Ta odmerek se lahko zvečuje v korakih po 1 mg na kg telesne mase v enotedenskih do dvotedenskih intervalih.
English: Microcrystalline cellulose Hydrogenated vegetable oil (from soyabean) Sodium laurilsulfate
Slovenian: Vsebina kapsule mikrokristalna celuloza hidrogenirano rastlinsko olje (sojino) natrijev lavrilsulfat
English: Zonegran belongs to a group of medicines (sulphonamides) that can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal.
Slovenian: Zdravilo Zonegran spada v skupino zdravil (sulfonamidi), ki lahko povzročajo hude alergijske reakcije, hude kožne izpuščaje in bolezni krvi, kar je zelo redko lahko usodno.
English: Contains also hydrogenated vegetable oil (from soyabean), sunset yellow FCF (E110) and allura red AC (E129).
Slovenian: Vsebuje tudi hidrogenirano rastlinsko olje (sojino), barvili sončno rumeno FCF (E110) in alurno rdeče AC (E129).
English: Hypokalaemia Metabolic acidosis Renal tubular acidosis
Slovenian: Presnovne in prehranske motnje anoreksija hipokaliemija metabolna acidoza renalna tubulna acidoza
English: In the event kidney stones are detected, Zonegran should be discontinued.
Slovenian: Ob odkritju ledvičnih kamnov je treba uporabo zdravila Zonegran prekiniti.
English: • develop visual problems such as eye pain or blurred vision while taking Zonegran
Slovenian: • če se med jemanjem zdravila Zonegran razvijejo težave z vidom, na primer bolečine v očeh ali zamegljen vid.
English: • This may be increased by up to 100 mg at intervals of two weeks.
Slovenian: • Ta odmerek se lahko zvečuje v korakih po največ 100 mg v dvotedenskih intervalih.
English: Zonegran contains soya oil.
Slovenian: Zdravilo Zonegran vsebuje sojino olje.
English: thiazide diuretics, and sulfonylurea antidiabetes medicines,
Slovenian: tiazidni diuretiki in sulfonilurea (zdravilo za sladkorno bolezen),
English: • breathing disorders, shortness of breath, inflammation of the lungs.
Slovenian: • dihalne motnje, kratka sapa, vnetje pljuč;
English: 300 - 500 mg/day (once a day)
Slovenian: 300 - 500 mg/dan (enkrat na dan)
English: • Give your child cold water to drink
Slovenian: • otroku dajte piti mrzlo vodo.
English: Therefore use in patients with severe hepatic impairment is not recommended.
Slovenian: Uporabe zdravila pri bolnikih z jetrno okvaro niso raziskovali, zato uporabe pri bolnikih s hudo jetrno okvaro ne priporočamo.