FrancophonIA/ELRC3.0 huggingface dataset:
English: In a repeated-dose oral toxicity study in juvenile rats, at exposure levels similar to those observed in paediatric patients at the maximum recommended dose, decreases in body weight and changes in renal histopathology and clinical pathology parameters and behavioural changes were observed.
Slovenian: V študiji peroralne toksičnosti pri ponavljajočih odmerkih pri podganjih mladičih v stopnjah izpostavljenosti, podobnih tistim, ki so jih opazili pri pediatričnih bolnikih pri največjem priporočenem odmerku, so opazili zmanjšanje telesne mase in spremembe ledvične histopatologije in kliničnih patoloških parametrov ter spremembe v vedenju.
English: Oral bioavailability is not affected by food, although peak plasma and serum concentrations may be delayed.
Slovenian: Na peroralno biološka uporabnost hrana ne vpliva, čeprav so najvišje plazemske in serumske koncentracije dosežene kasneje.
English: Cases of decreased sweating and elevated body temperature have been reported mainly in paediatric patients.
Slovenian: Primeri zmanjšanega potenja in zvišane telesne temperature so se pojavili predvsem pri pediatrični populaciji.
English: Mylan S.A.S Tél: + 33 4 37 25 75 00
Slovenian: Mylan S.A.S Tel: + 33 4 37 25 75 00
English: It should be noted that zonisamide is a benzisoxazole derivative, which contains a sulfonamide group.
Slovenian: Treba se je zavedati, da je zonisamid benzisoksazolni derivat, ki vsebuje sulfonamidno skupino.
English: In accordance with current clinical practice, discontinuation of zonisamide in patients with epilepsy must be accomplished by gradual dose reduction, to reduce the possibility of seizures on withdrawal.
Slovenian: V skladu s trenutno klinično prakso je treba zonisamid ukiniti s postopnim zmanjševanjem odmerka zaradi zmanjšanja možnosti pojavljanja epileptičnih napadov ob odtegnitvi.
English: A small number of people being treated with antiepileptics such as zonisamide have had thoughts of harming or killing themselves.
Slovenian: Pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki kot je zdravilo Zonisamid Mylan, so se pojavile misli o samopoškodovanju ali samomoru;
English: The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/min (see also section 4.2.
Slovenian: Plazemska AUC zonisamida se je pri bolnikih z očistkom kreatinina < 20 ml/min povečala za 35 % (glejte poglavje 4.2).
English: Multiple antiepileptic medicinal product therapy may be associated with a higher risk of congenital malformations than monotherapy.
Slovenian: Antiepileptično zdravljenje z več zdravili je lahko povezano z večjim tveganjem za prirojene okvare kot monoterapija.
English: Specialist advice should be given to women who are of childbearing potential regarding the possible effects of zonisamide on the foetus and these risks should be discussed with the patient in relation to the benefits before starting treatment.
Slovenian: Ženske v rodni dobi naj dobijo nasvet zdravnika specialista o možnih učinkih zonisamida na plod, pred začetkom zdravljenja pa se je treba z bolnico pogovoriti o njegovih nevarnostih v primerjavi s koristnimi učinki.
English: There are limited data from clinical studies in patients with a body weight of less than 20 kg.
Slovenian: Podatkov iz kliničnih študij z bolniki s telesno maso manj kot 20 kg je malo.
English: rare
Slovenian: redki
English: Physicians should draw the attention of paediatric patients and their parents/carers to the Patient Alert Box (in the package leaflet) on preventing heat stroke (see section 4.4: Paediatric Population).
Slovenian: Zdravniki morajo prediatrične bolnike in njihove starše/negovalce opozoriti na okvirček z opozorili za bolnika (v navodilu z uporabo) glede preprečevanja vročinske kapi (glejte poglavje 4.4; Pediatrična populacija).
English: Carbonic anhydrase inhibitors
Slovenian: Zaviralci karboanhidraze
English: The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/min.
Slovenian: Plazemska AUC zonisamida se pri bolnikih z očistkom kreatinina < 20 ml/min poveča za 35 %.
English: All generalized Tonic-Clonic
Slovenian: Vsi generalizirani tonično-klonični
English: Week 1 + 2 Weeks ≥ 3
Slovenian: + 2. teden ≥ 3. tedni
English: Capsule contents Microcrystalline cellulose Sodium laurilsulfate Hydrogenated vegetable oil
Slovenian: Vsebina kapsule mikrokristalna celuloza natrijev lavrilsulfat hidrogenirano rastlinsko olje
English: 100 mg / day*
Slovenian: 100 mg/dan*
English: In the event kidney stones are detected, zonisamide should be discontinued.
Slovenian: Ob odkritju ledvičnih kamnov je treba uporabo zonisamida prekiniti.
English: Risk factors for nephrolithiasis include prior stone formation, a family history of nephrolithiasis and hypercalciuria.
Slovenian: Dejavniki tveganja za nefrolitiazo vključujejo predhodni nastanek kamnov, družinsko anamnezo nefrolitiaze in hiperkalciurijo.
English: - if you are allergic to other sulfonamide medicines.
Slovenian: • če ste alergični na druga sulfonamidna zdravila, kot so na primer: sulfonamidni antibiotiki,
English: Some patients, especially those with a predisposition to nephrolithiasis, may be at increased risk for renal stone formation and associated signs and symptoms such as renal colic, renal pain or flank pain.
Slovenian: Pri nekaterih bolnikih, zlasti pri tistih, nagnjenih k nefrolitiazi, morda obstaja tveganje za nastanek ledvičnih kamnov in z njimi povezanih znakov in simptomov, kot na primer renalne kolike, renalne bolečine ali bolečine v ledvenem predelu.
English: No clinically significant differences were observed in the pharmacokinetics between young (aged 21-40 years) and elderly (65-75 years).
Slovenian: Starejši bolniki: Med mladimi (starimi 21 - 40 let) in starejšimi (65 - 75 let) ni opaznih klinično pomembnih razlik v farmakokinetiki.
English: Prescribers should draw the attention of paediatric patients and their parent/carers to the advice in the Packaging Leaflet on preventing heat stroke and overheating in children as provided.
Slovenian: Zdravniki, ki zdravilo predpisujejo, morajo pediatrične bolnike in njihove starše/skrbnike opozoriti na navedene nasvete v navodilu za uporabo glede preprečevanja vročinske kapi in pregretja pri otrocih.
English: Zonisamide may cause weight loss.
Slovenian: Zonisamid lahko povzroči izgubo telesne mase.
English: Cognitive impairment in patients affected by epilepsy has been associated with the underlying pathology and/or the administration of anti-epileptic treatment.
Slovenian: Pri bolnikih z epilepsijo so poslabšanje kognitivnih funkcij povezali z osnovno boleznijo in/ali dajanjem zdravil proti epilepsiji.
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 zelo vroča in znojenja je zelo malo ali ga ni, otrok postane zmeden, ima mišične krče ali postaneta srčni utrip ali dihanje hitrejša:
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 škatli, za oznako EXP. Rok uporabnosti se izteče zadnji dan navedenega meseca.
English: Each hard capsule is approximately 19.3 mm in length.
Slovenian: Vsaka trda kapsula je dolga približno 19,3 mm.
English: The risk of zonisamide induced metabolic acidosis appears to be more frequent and severe in paediatric and adolescent patients.
Slovenian: Kaže, da je tveganje metabolne acidoze zaradi zonisamida pogostejše in hujše oblike pri pediatričnih bolnikih in mladostnikih.
English: When your child is taking Zonisamide Mylan: keep your child cool especially in hot weather your child must avoid heavy exercise especially when the weather is hot give your child plenty of cold water to drink your child must not take these medicines: carbonic anhydrase inhibitors (like topiramate and acetazolamide), and anticholinergic agents (like clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).
Slovenian: Če vaš otrok jemlje zdravilo Zonisamid Mylan: - mora ostati hladen, zlasti ob vročem vremenu; - se mora izogibati pretirani telesni vadbi, - mora piti veliko hladne vode, - ne sme jemati nobenega od naslednjih zdravil: zaviralcev karbonanhidraze (kot sta topiramat - in acetazolamid) in antiholinergičnih zdravil (kot so klomipramin, hidroksizin, difenhidramin, - haloperidol, imipramin in oksibutinin).
English: ≥ 1/1,000 to < 1/100
Slovenian: ≥ 1/1.000 do < 1/100
English: If the decision is made to continue patients on zonisamide in the face of persistent acidosis, alkali treatment should be considered.
Slovenian: Če se odločite za nadaljevanje zdravljenja z zonisamidom kljub perzistentni acidozi, je treba razmisliti o zdravljenju z alkalnimi zdravili.
English: If co-administration is necessary, the patient should be closely monitored and the dose of zonisamide and other CYP3A4 substrates adjusted as needed.
Slovenian: V primeru, da je sočasno jemanje zdravil nujno potrebno, je treba bolnika skrbno spremljati in odmerek zonisamida ali ostalih substratov CYP3A4 primerno prilagoditi.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from zonisamide therapy.
Slovenian: Treba se je odločiti ali prekiniti z dojenjem ali prenehati zdravljenje oziroma se trenutno vzdržati zdravljenja z zonisamidom.
English: In rats, decreased numbers of corpora lutea and implantation sites were observed at exposure levels equivalent to the maximum therapeutic dose in humans; irregular oestrus cycles and a decreased number of live foetuses were observed at exposure levels three times higher.
Slovenian: Pri podganah so opazili zmanjšano število rumenih telesc in vsaditvenih mest pri ravneh izpostavljenosti, enakih največjemu terapevtskemu odmerku pri ljudeh; pri trikrat večjih izpostavljenostih so opazili neredne estrusne cikle in manjše število živih plodov.
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 višjo pogostnost poročanja o pljučnici, dehidraciji, manjšem znojenju, nenormalnih izvidih testov 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), z manjšo pogostnostjo pa so poročali o amneziji, zvišanju kreatinina, limfadenopatiji in trombocitopeniji.
English: The pharmacokinetics of zonisamide in patients with impaired liver function have not been adequately studied.
Slovenian: Bolniki z jetrno okvaro: Farmakokinetika zonisamida pri bolnikih z jetrno okvaro ni bila ustrezno preučena.
English: If elevated, in the absence of another obvious cause such as trauma or grand mal seizures, it is recommended that zonisamide discontinuation be considered and appropriate treatment initiated.
Slovenian: Če sta povišani in ob odsotnosti drugih očitnih razlogov kot na primer travma ali epileptični napad grand mal, je treba razmisliti o prenehanju zdravljenja z zonisamidom in začetkom ustreznega zdravljenja.
English: 50 mg/day (in two divided doses)
Slovenian: 50 mg/dan (v dveh deljenih odmerkih)
English: In patients taking zonisamide, in whom severe muscle pain and/or weakness develop either in the presence or absence of a fever, it is recommended that markers of muscle damage be assessed, including serum creatine phosphokinase and aldolase levels.
Slovenian: Pri bolnikih, zdravljenih z zonisamidom, pri katerih se pojavi huda mišična bolečina in/ali oslabelost v prisotnosti povišane telesne temperature ali brez nje, je priporočljivo merjenje ravni označevalcev mišične okvare, vključno z ravnmi kreatin-kinaze in aldolaze.
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: • dodatna terapija pri zdravljenju parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih in otrocih, starih 6 let in več.
English: It is not always possible to precisely achieve the calculated dose with the commercially available capsule strengths of zonisamide.
Slovenian: Z jakostmi kapsul zonisamida, ki so komercialno na voljo, ni vedno možno natančno doseči izračunanega odmerka.
English: Monotherapy in partial seizures, with or without secondary generalisation Efficacy of zonisamide as monotherapy was established in a double-blind, parallel group, non-inferiority comparison to carbamazepine prolonged release (PR) in 583 adult subjects with newly diagnosed partial seizures with or without secondary generalised tonic-clonic seizures.
Slovenian: Monoterapija pri parcialnih epileptičnih napadih s sekundarno generalizacijo ali bre z nje Učinkovitost zonisamida kot monoterapije so dokazali v dvojno slepi primerjavi enakovrednosti z vzporednimi skupinami s karbamazepinom s podaljšanim sproščanjem pri 583 odraslih osebah z na novo diagnosticiranimi parcialnimi epileptičnimi napadi s sekundarnimi generaliziranimi toničnokloničnimi napadi ali brez njih.
English: Enzyme induction: Exposure to zonisamide is lower in epileptic patients receiving CYP3A4-inducing agents such as phenytoin, carbamazepine, and phenobarbitone.
Slovenian: • encimska indukcija: izpostavljenost zonisamidu pri epileptičnih bolnikih, ki so zdravljeni z zdravili, ki inducirajo CYP3A4, kot na primer fenitoin, karbamazepin in fenobarbiton je nižja.
English: Zonisamide is metabolised primarily through reductive cleavage of the benzisoxazole ring of the parent drug by CYP3A4 to form 2-sulfamoylacetylphenol (SMAP) and also by N-acetylation.
Slovenian: Zonisamid se v osnovi presnavlja prek redukcijske cepitve obroča benzisoksazola izvornega zdravila s CYP3A4, pri čemer se tvori 2-sulfamoilacetilfenol (SMAP - “2-sulphamoylacetylphenol”), pa tudi z N- acetilacijo.
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 pripomorejo k zmanjšanju nevarnosti nastanka ledvičnih kamnov, predvsem pri bolnikih s povišanim tveganjem za nastanek ledvičnih kamnov.
English: In epileptic patients, steady-state dosing with zonisamide resulted in no clinically relevant pharmacokinetic effects on carbamazepine, lamotrigine, phenytoin, or sodium valproate.
Slovenian: Pri bolnikih z epilepsijo odmerjanje zonisamida v stanju dinamičnega ravnovesja ni imelo klinično pomembnih farmakokinetičnih učinkov na karbamazepin, lamotrigin, fenitoin ali natrijev valproat.
English: Zonisamide 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: Zonisamida 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: Therefore, zonisamide 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 zonisamid preko mehanizmov, povezanih s citokromom P450, vplival na farmakokinetiko drugih zdravil, kot je bilo in vivo pokazano za karbamazepin, fenitoin, etinilestradiol in dezipramin.
English: Subjects were titrated to the initial target dose of 600 mg carbamazepine or 300 mg of zonisamide.
Slovenian: Osebe so bile titrirane na začetni ciljni odmerek 600 mg karbamazepina ali 300 mg zonisamida.
English: Unlike phenytoin and carbamazepine however, zonisamide acts preferentially on seizures originating in the cortex.
Slovenian: Za razliko od fenitoina in karbamazepina zonisamid deluje predvsem na epileptične napade, ki imajo izvor v korteksu.
English: Data from a registry study suggest an increase in the proportion of babies born at a low birth weight (LBW), pre-term or small for gestational age (SGA).
Slovenian: Izsledki študije izvedene na podlagi podatkov iz registra kažejo na povečanje deleža otrok z majhno porodno telesno maso, nedonošenčkov ali dojenčkov, ki so se rodili majhni za svojo gestacijsko starost.
English: Capsule shells Titanium dioxide (E171) Gelatin
Slovenian: Ovojnica kapsule titanov dioksid (E171) želatina
English: Slightly greater than expected accumulation occurs relative to single dosing.
Slovenian: Po enkratnem odmerjanju je akumulacija nekoliko višja od pričakovane.
English: Cases of agranulocytosis, thrombocytopenia, leucopenia, aplastic anaemia, pancytopenia and leucocytosis have been reported.
Slovenian: Poročali so o primerih agranulocitoze, trombocitopenije, levkopenije, aplastične anemije, pancitopenije in levkocitoze.
English: It is chemically unrelated to other anti-epileptic agents.
Slovenian: Kemijsko ni soroden drugim antiepileptičnim zdravilom.
English: Zonisamide Mylan may affect your concentration, ability to react/respond, and may make you feel sleepy, particularly at the beginning of your treatment or after your dose is increased.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Zonisamid Mylan lahko vpliva na vašo koncentracijo, sposobnost reagiranja in povzroča zaspanost, še posebno ob začetku zdravljenja ali ko vam odmerek zvečujejo.
English: Zonisamide is a benzisoxazole derivative, which contains a sulfonamide group.
Slovenian: Zonisamid je benzisoksazolni derivat, ki vsebuje sulfonamidno skupino.
English: 100 mg/day (in two divided doses)
Slovenian: 100 mg/dan (v dveh deljenih odmerkih)
English: When Zonisamide Mylan treatment is to be discontinued, it should be withdrawn gradually (see section 4.4).
Slovenian: Ko želimo zdravljenje z zdravilom Zonisamid Mylan prekiniti, moramo to storiti postopoma (glejte poglavje 4.4).
English: Heat stroke
Slovenian: Vročinska kap
English: The elimination half-life was independent of dose and not affected by repeat administration.
Slovenian: Razpolovni čas izločanja ni bil odvisen od odmerka in pogostosti dajanja.
English: General dosing recommendations for Zonisamide Mylan in special patient populations
Slovenian: Splošna priporočila za odmerjanje zdravila Zonisamid Mylan pri posebnih populacijah bolnikov
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: Women of childbearing potential must use effective contraception during treatment with zonisamide and for one month after discontinuation (see section 4.6).
Slovenian: Ženske v rodni dobi morajo med zdravljenjem ter vsaj še mesec dni po končanem zdravljenju z zonisamidom uporabljati učinkovito kontracepcijo (glejte poglavje 4.6).
English: What you need to know before you take Zonisamide Mylan
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zonisamid Mylan
English: If you are a woman of childbearing age you must use adequate contraception while taking, and for one month after stopping, Zonisamide Mylan.
Slovenian: Če ste ženska v rodni dobi, morate uporabljati primerno obliko kontracepcije med zdravljenjem in še mesec dni po končanem zdravljenju z zdravilom Zonisamid Mylan.
English: Caution should be exercised at initiation of treatment in elderly patients as there is limited information on the use of zonisamide in these patients.
Slovenian: Pri starejših bolnikih je na začetku zdravljenja potrebna previdnost, saj so podatki o zdravljenu teh bolnikov z zonisamidom omejeni.
English: Adverse reactions associated with zonisamide obtained from clinical studies and post-marketing surveillance are tabulated below.
Slovenian: Neželene reakcije, povezane z zonisamidom, ugotovljene v kliničnih študijah in nadzoru v obdobju trženja, so navedene spodaj.
English: Zonisamide Mylan 100 mg are available in blister packs of 28, 56, 98 and 196 capsules and perforated unit dose blister packs of 56 x 1 capsules.
Slovenian: Zonisamid Mylan 100 mg trde kapsule so na voljo v pretisnih omotih s po 28, 56, 98 in 196 trdih kapsul in v perforiranih pretisnih omotih za posamezni odmerek s po 56 x 1 kapsulo.
English: In children ages 6 - 17 years old, side effects were consistent with those described below with the following exceptions: pneumonia, dehydration, sweating decreased (common), abnormal liver enzymes (uncommon), middle ear infection, sore throat, sinus and chest infections, cough, nosebleeds, runny nose, stomach pain, vomiting, rash, eczema and fever.
Slovenian: Pri otrocih, starih 6-17 let, so neželeni učinki skladni s tistimi, opisanimi spodaj, z naslednjimi izjemami: pljučnico, dehidracijo, zmanjšanjem potenja (pogosti), nenormalnimi rezultati jetrnih encimov (občasni), okužbami srednjega ušesa, vnetim grlom, okužbami sinusov in prsnega koša, kašljem, krvavitvami iz nosu, izcedkom iz nosu, bolečino v trebuhu, bruhanjem, izpuščajem, ekcemom in vročino.
English: All patients who develop a rash while taking zonisamide 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 zonisamida 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: If pancreatitis is evident, in the absence of another obvious cause, it is recommended that discontinuation of zonisamide be considered and appropriate treatment initiated.
Slovenian: Ob očitnem pankreatitisu in ob odsotnosti drugih očitnih razlogov je treba razmisliti o prenehanju zdravljenja z zonisamidom in začetkom ustreznega zdravljenja pankreatitisa.
English: Zonisamide 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 zonisamida med nosečnostjo ni dovoljena, razen kadar je to nujno potrebno in samo če se oceni, da možna korist upravičuje tveganje za plod.
English: Therefore, modification of zonisamide 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: Absolute bioavailability is estimated to be approximately 100%.
Slovenian: Presnova prvega prehoda naj bi bila zanemarljiva, absolutna biološka uporabnost je približno 100 %.
English: Zonisamide Mylan can make you perspire less, which can cause your body temperature to increase.
Slovenian: Mogoče se boste zaradi zdravila Zonisamid Mylan manj znojili, zaradi česar se vam lahko zviša telesna temperatura.
English: CYP3A4-inducing agents; or with renal or hepatic impairment
Slovenian: - brez induktorjev CYP3A4 ali z okvaro ledvic ali jeter