FrancophonIA/ELRC3.0 huggingface dataset:
English: Zonegran 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: Zdravilo Zonegran lahko vpliva na vašo koncentracijo, sposobnost reagiranja in povzroča zaspanost, še posebno ob začetku zdravljenja ali ko vam odmerek zvečujejo.
English: Week 1 Weeks 2 to 8 Patients of weight 20 to 55 kg
Slovenian: 1. teden 2. do 8. teden Bolniki s telesno maso 20 do 55 kg
English: Weight loss leading to deterioration of general condition and failure to take anti-epilepsy medication has been related to a fatal outcome (see section 4.8).
Slovenian: Izguba telesne mase, ki povzroči poslabšanje splošnega stanja, in nejemanje zdravil proti epilepsiji je povezano s smrtnim izidom (glejte poglavje 4.8).
English: If any of these applies to you, tell your doctor before you take Zonegran.
Slovenian: Če kar koli od zgoraj navedenega velja za vas, to povejte zdravniku, preden začnete jemati zdravilo Zonegran.
English: fever, incontinence), status epilepticus (prolonged or repeated seizures).
Slovenian: znojenje, vročina, inkontinenca), epileptični status (dolgotrajen ali ponavljajoč se napad krčev);
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to sulphonamides.
Slovenian: Preobčutljivost za učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali sulfonamide.
English: - 25 mg: 14, 28, 56 and 84 capsules - 50 mg: 14, 28, 56 and 84 capsules - 100 mg: 28, 56, 84, 98 and 196 capsules.
Slovenian: - 25 mg: 14, 28, 56 in 84 kapsul, - 50 mg: 14, 28, 56 84 kapsul, - 100 mg: 28, 56, 84, 98 in 196 kapsul.
English: Zonegran may be taken as monotherapy or added to existing therapy in adults.
Slovenian: Zdravilo Zonegran se lahko uporablja kot monoterapija ali se doda že obstoječi terapiji pri odraslih.
English: MonotherapyNewly diagnosed adult patients
Slovenian: Monoterapija - na novo diagnosticirani odrasli bolniki
English: Weight loss is potentially more serious in children (see section 4.4.
Slovenian: Izguba telesne mase je lahko pri otrocih resnejša (glejte poglavje 4.4.
English: • are younger than 12 years old, as you may be at greater risk of decreased sweating, heat stroke, pneumonia and liver problems.
Slovenian: • če ste mlajši kot 12 let, saj je pri vas morda večje tveganje za zmanjšano znojenje, vročinsko kap, pljučnico in težave z jetri.
English: Reduce the risk of kidney stones by drinking sufficient water.
Slovenian: Zmanjšajte nevarnost za ledvične kamne s pitjem zadostnih količin vode;
English: Renal clearance of unchanged zonisamide is relatively low (approximately 3.5 ml/min); about 15 - 30 % of the dose is eliminated unchanged.
Slovenian: Ledvični očistek nespremenjenega zonisamida je relativno majhen (približno 3,5 ml/min), približno 15 - 30 % odmerka se iz telesa izloči nespremenjenega.
English: The increase at steady state was slightly more than expected on the basis of dose, probably due to the saturable binding of zonisamide to erythrocytes.
Slovenian: Povečanje v stanju dinamičnega ravnovesja je bilo nekoliko večje, kot bi bilo pričakovati na osnovi odmerka, verjetno zaradi saturabilne vezave zonisamida na eritrocite.
English: Zonisamide lowers the 28-day average seizure frequency and the decrease is proportional (log-linear) to zonisamide average concentration.
Slovenian: Zonisamid zmanjšuje 28-dnevno povprečno pogostnost epileptičnih napadov, zmanjšanje pa je sorazmerno (log-linearno) povprečnim koncentracijam zonisamida.
English: Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Slovenian: Druga zdravila in zdravilo Zonegran Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Zonegran must be added to existing therapy for paediatric patients aged 6 years and above.
Slovenian: Zdravilo Zonegran je treba dodati obstoječemu zdravljenju za pediatrične bolnike, stare 6 let ali več.
English: Children and adolescents (5-18 years): Limited data indicate that pharmacokinetics in children and adolescents dosed to steady state at 1, 7 or 12 mg/kg daily, in divided doses, are similar to those observed in adults, after adjustment for bodyweight.
Slovenian: Otroci in mladostniki (5 - 18 let): Omejeni podatki kažejo, da je farmakokinetika pri otrocih in mladostnikih v stanju dinamičnega ravnovesja pri odmerkih 1, 7 ali 12 mg/kg na dan v deljenih odmerkih podobna kot pri odraslih po prilagoditvi glede na telesno maso.
English: In addition there have been isolated cases of Sudden Unexplained Death in Epilepsy Patients (SUDEP) receiving Zonegran.
Slovenian: Poleg tega so se pri bolnikih, ki so jemali Zonegran, pojavili posamezni primeri nenadne nepojasnjene smrti pri bolnikih z epilepsijo (SUDEP - “Sudden Unexplained Death in Epilepsy Patients”).
English: Date of first authorisation: 10/03/2005 Date of latest renewal:
Slovenian: Datum prve odobritve: Datum zadnjega podaljšanja: 21/12/2009
English: In some cases of weight decrease there was a delay in transition to the next Tanner stage and in bone maturation.
Slovenian: V nekaterih primerih zmanjšanja telesne mase je prišlo tudi do zakasnitve pri prehodu na naslednjo stopnjo po Tannerju in zorenju kosti.
English: When Zonegran treatment is to be discontinued, it should be withdrawn gradually (see section 4.4).
Slovenian: Ko želimo zdravljenje z zdravilom Zonegran prekiniti, moramo to storiti postopoma (glejte poglavje 4.4).
English: If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Zonegran (by gradual discontinuation or reduction of a therapeutic dose) as osteopenia may develop.
Slovenian: Če se metabolna acidoza razvije in vztraja, je treba razmisliti o zniževanju odmerka ali prekinitvi zdravljenja z zdravilom Zonegran (s postopno ukinitvijo ali zniževanjem terapevtskega odmerka), saj se lahko razvije osteopenija.
English: • Zonegran should be used carefully in adults when taken with medicines that can cause kidney stones, like topiramate or acetazolamide.
Slovenian: • Zdravilo Zonegran je treba pri odraslih previdno uporabljati, kadar se jemlje skupaj z zdravili, ki lahko povzročajo ledvične kamne, na primer s topiramatom ali acetazolamidom.
English: Age ( 12 years) and gender, after adjustment for body weight effects, have no apparent effect on zonisamide exposure in epileptic patients during steady-state dosing.
Slovenian: Starost (≥ 12 let) in spol, po prilagoditvi odmerkov zaradi telesne mase, nimata očitnih učinkov na izpostavljenost zonisamidu pri epileptičnih bolnikih med odmerjanjem v stanju dinamičnega ravnovesja.
English: • have previously suffered from kidney stones, as you may be at increased risk of developing more kidney stones.
Slovenian: • če ste že prej imeli ledvične kamne, ker ste mogoče v večji nevarnosti za pojav novih ledvičnih kamnov.
English: • If your doctor advises you to stop taking Zonegran your dose will be reduced gradually to lower the risk of more seizures.
Slovenian: • Če vam bo zdravnik svetoval, da prenehajte jemati zdravilo Zonegran, vam bo odmerek zmanjševal postopoma, da bi zmanjšal nevarnost pogostejših epileptičnih napadov.
English: Review of post-marketing data suggests that patients aged 65 years or older report a higher frequency than the general population of the following events: Stevens-Johnson syndrome (SJS) and Drug Induced Hypersensitivity syndrome (DIHS).
Slovenian: Pregled podatkov iz obdobja trženja kaže, da sta pri bolnikih, starih 65 let ali več, naslednja neželena učinka pogostejša kot pri splošni populaciji: Stevens-Johnsonov sindrom (SJS) in z zdravili povzročen sindrom preobčutljivosti (DIHS - Drug Induced Hypersensitivity syndrome).
English: • Do not take double the dose to make up for the forgotten dose.
Slovenian: • Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Zonegran is indicated as:
Slovenian: Zdravilo Zonegran je indicirano kot:
English: System Organ Class (MedDRA terminology†)
Slovenian: Organski sistem (terminologija MedDRA†)
English: If you feel that the effect of Zonegran is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če imate občutek, da je učinek zdravila Zonegran premočan ali prešibak, se posvetujte z zdravnikom ali s farmacevtom.
English: Anti-epileptic medicinal products
Slovenian: Antiepileptična zdravila
English: • have thoughts of harming or killing yourself.
Slovenian: • če razmišljate o tem, da bi se samopoškodovali ali naredili samomor.
English: Contact your doctor as soon as possible if you:
Slovenian: Čimprej obvestite svojega zdravnika:
English: Parent drug and SMAP can additionally be glucuronidated.
Slovenian: Izhodiščno zdravilo in SMAP se lahko dodatno glukuronidirata.
English: When you take Zonegran with other antiepileptic medicines:
Slovenian: Pri jemanju zdravila Zonegran skupaj z drugimi antiepileptiki:
English: - CYP3A4 inhibition: Based upon clinical data, known specific and non-specific CYP3A4 inhibitors appear to have no clinically relevant effect on zonisamide pharmacokinetic exposure parameters.
Slovenian: - zaviranje CYP3A4: Glede na klinične podatke znani specifični ali nespecifični zaviralci CYP3A4 nimajo klinično pomembnih učinkov na farmakokinetične parametre izpostavljenosti zonisamidu.
English: Patients or their carers must be warned to take care to maintain hydration and avoid exposure to excessive temperatures and strenuous physical exercise depending on the condition of the patient.
Slovenian: Bolnike ali njihove skrbnike je treba opozoriti na zadostno hidracijo ter na izogibanje izpostavljenosti visokim temperaturam in fizično napornim dejavnostim, ob upoštevanju stanja bolnika.
English: If you may have taken more Zonegran than you should, tell a carer (relative or friend), your doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking your medicine with you.
Slovenian: Če ste vzeli večji odmerek zdravila Zonegran, kot bi smeli Če ste vzeli večji odmerek zdravila Zonegran, kot bi smeli, o tem takoj obvestite svojega skrbnika (sorodnika ali prijatelja), svojega zdravnika ali farmacevta ali pa se zglasite na oddelku za nujno medicinsko pomoč najbližje bolnišnice in s seboj prinesite zdravilo.
English: Due to the long retention time of zonisamide in the body, breast-feeding must not be resumed until one month after Zonegran therapy is completed.
Slovenian: Zaradi dolgega zadrževanja zonisamida v telesu se z dojenjem ne sme spet začeti prej kot mesec dni po prenehanju zdravljenja z zdravilom Zonegran.
English: Sulphonamide reactions
Slovenian: Reakcije na sulfonamid
English: • vomiting.
Slovenian: • bruhanje;
English: Paediatric population (aged 6 years and above)
Slovenian: Pediatrična populacija (starost 6 let ali več)
English: • Take your child to a cool, shaded place
Slovenian: • otroka spravite na hladno in v senco,
English: • Zonegran is meant to be taken as a long-term medicine.
Slovenian: • Zdravilo Zonegran je zdravilo, ki je namenjeno za dolgotrajno zdravljenje.
English: • agitation, irritability, confusion, depression
Slovenian: • agitiranost, razdražljivost, zmedenost, depresivnost;
English: A total of 70.4% of paediatric subjects who received ZNS in the controlled study or its open label extension had at least one treatment-emergent bicarbonate measurement below 22 mmol/L.
Slovenian: Skupaj 70,4 % pediatričnih bolnikov, ki so prejemali zonisamid v kontrolirani študiji ali odprtem podaljšku študije, je imelo zaradi zdravljenja vsaj eno izmerjeno vrednost bikarbonata nižjo od 22 mmol/l.
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) and abnormal liver enzymes (uncommon).
Slovenian: Pri otrocih, starih 6-17 let, so neželeni učinki skladni s tistimi, opisanimi spodaj, z naslednjimi izjemami: pljučnica, dehidracija, zmanjšanje potenja (pogosti) in nenormalni rezultati jetrnih encimov (občasni).
English: Effect of Zonegran on cytochrome P450 enzymes
Slovenian: Učinek zdravila Zonegran na encime citokrom P450
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 ponavljajoče se dajanje nanj ni vplivalo.
English: • The starting dose is 50 mg daily taken in two equal doses of 25 mg.
Slovenian: • Začetni odmerek je 50 mg na dan, razdeljen v dva enaka odmerka po 25 mg.
English: Apparent clearance of zonisamide at steady-state after oral administration is about 0.70 l/h and the terminal elimination half-life is about 60 hours in the absence of CYP3A4 inducers.
Slovenian: Navidezni očistek zonisamida v stanju dinamičnega ravnovesja po peroralnem dajanju je 0,70 l/h, končni razpolovni čas izločanja v odsotnosti induktorjev CYP3A4 pa približno 60 ur.
English: There is inadequate information to assess the relationship, if any, between dose and duration of treatment and these events.
Slovenian: Za oceno morebitne povezave med odmerkom in trajanjem zdravljenja ter temi dogodki podatkov ni dovolj.
English: What you need to know before you take Zonegran
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zonegran
English: In clinical studies of paediatric patients, down-titration was completed by dose reductions at weekly intervals in increments of about 2 mg/kg (i.e. in accordance with the schedule in Table 3).
Slovenian: V kliničnih študijah pri pediatričnih bolnikih so odmerek v tedenskih intervalih zmanjševali za približno 2 mg/kg (tj. v skladu z načrtom v preglednici 3).
English: Specific safety issues that were encountered in the paediatric studies were: decreased appetite and weight loss, decreased bicarbonate levels, increased risk of kidney stones and dehydration.
Slovenian: Specifične težave glede varnosti, ki so jih opazili v študijah pri pediatrični populaciji, so bile: zmanjšanje apetita in izguba telesne mase, znižanje ravni bikarbonata, povečano tveganje za ledvične kamne in dehidracija.
English: Zonegran has been administered to over 1,200 patients in clinical studies, more than 400 of whom received Zonegran for at least 1 year.
Slovenian: V kliničnih študijah je zdravilo Zonegran jemalo več kot 1.200 bolnikov, več kot 400 jih je zdravilo Zonegran jemalo najmanj eno leto.
English: Zonegran hard capsules are for oral use.
Slovenian: Zonegran trde kapsule se uporabljajo peroralno.
English: • ecchymosis (a small bruise caused by blood leaking from broken blood vessels in the skin).
Slovenian: • ekhimoza (manjša podplutba zaradi uhajanja krvi iz poškodovanih žil v koži);
English: • The recommended daily dose is between 300 mg and 500 mg.
Slovenian: • Priporočeni dnevni odmerek je med 300 mg in 500 mg.
English: • have difficulty breathing, a swollen face, lips or tongue, or a severe skin rash as these symptoms may indicate that you are having a severe allergic reaction.
Slovenian: • če se pojavijo težave pri dihanju, vam otečejo obraz, ustnice ali jezik ali se pojavi hud kožni izpuščaj, ker ti simptomi lahko kažejo na to, da imate hudo alergijsko reakcijo;
English: • get a sudden pain in your back or stomach, have pain on urinating (passing water) or notice blood in your urine, as this may be a sign of kidney stones.
Slovenian: • če se pojavijo nenadne bolečine v hrbtu ali trebuhu, imate bolečine pri uriniranju (odvajanju vode) ali opazite kri v urinu, ker so to lahko znaki ledvičnih kamnov;
English: All generalized Tonic-Clonic Secondary Tonic-Clonic Generalized Tonic-Clonic
Slovenian: Sekundarni tonično-klonični Generalizirani tonično-klonični
English: Such electrolyte imbalance has been observed with the use of Zonegran in placebo-controlled clinical trials and in the post-marketing period.
Slovenian: Takšno elektrolitsko neravnovesje so opazovali po uporabi zdravila Zonegran v kliničnih preskušanjih, kontroliranih s placebom, in v obdobju trženja.
English: • difficulty sleeping, strange or unusual thoughts, feeling anxious or emotional.
Slovenian: • motnje spanja, čudne ali neobičajne misli, tesnoba ali pretirano čustveno počutje;
English: • glaucoma, which is a blockage of fluid in the eye causing increased pressure in the eye.
Slovenian: • glavkom, ki je zapora tekočine v očesu, kar povzroči zvišanje znotrajočesnega tlaka.
English: Additional information on special populations:
Slovenian: Dodatne informacije za posebne skupine bolnikov:
English: In clinical studies of adult patients, dose reductions of 100 mg at weekly intervals have been used with concurrent adjustment of other antiepileptic medicine doses (where necessary).
Slovenian: V kliničnih študijah pri odraslih so odmerek zdravila Zonegran zmanjševali po 100 mg na teden s sočasno prilagoditvijo odmerkov drugih antiepileptičnih zdravil (po potrebi).
English: Serious rashes occur in association with Zonegran therapy, including cases of Stevens-Johnson syndrome.
Slovenian: V povezavi z zdravljenjem z zdravilom Zonegran se pojavljajo resni izpuščaji, vključno s primeri Stevens-Johnsonovega sindroma.
English: In other cases, the overdose was followed by symptoms such as somnolence, nausea, gastritis, nystagmus, myoclonus, coma, bradycardia, reduced renal function, hypotension and respiratory depression.
Slovenian: Pri drugih pa so se po prevelikem odmerjanju pojavili simptomi, kot na primer somnolenca, navzea, gastritis, nistagmus, mioklonus, koma, bradikardija, zmanjšana ledvična funkcija, hipotenzija in depresija dihanja.
English: 300 to 500 mg for a child with a body weight more than 55 kg (which ever dose is lower) taken once a day.
Slovenian: 500 mg za otroka s telesno maso več kot 55 kg (tisti odmerek, ki je manjši) enkrat na dan.
English: Zonegran contains the active substance zonisamide, and is used as an antiepileptic medicine.
Slovenian: Zdravilo Zonegran vsebuje učinkovino zonisamid in se uporablja kot antiepileptično zdravilo.
English: Adjunctive therapy - with CYP3A4inducing agents (see section 4.5)
Slovenian: Adjuvantno zdravljenje - z induktorji CYP3A4 (glejte poglavje 4.5)
English: An in vitro study shows that zonisamide is a weak inhibitor of P-gp (MDR1) with an IC50 of 267 µmol/l and there is the theoretical potential for zonisamide to affect the pharmacokinetics of substances which are P-gp substrates.
Slovenian: Študija in vitro je pokazala, da je zonisamid šibek inhibitor P-gp (MDR1) z IC50 267 µmol/l in da obstaja teoretična možnost, da bi zonisamid vplival na farmakokinetiko substanc, ki so substrati P-gp.
English: When comparing the same dose level, subjects of higher total body weight appear to have lower steady-state serum concentrations, but this effect appears to be relatively modest.
Slovenian: Ko primerjamo enako raven odmerka, imajo preiskovanci z večjo telesno maso nižje serumske koncentracije v stanju dinamičnega ravnovesja, vendar pa je ta učinek relativno skromen.
English: • Other medicines like phenytoin, carbamazepine, phenobarbitone and rifampicin can decrease your blood levels of Zonegran, which may require an adjustment of your dose of Zonegran.
Slovenian: • Druga zdravila, na primer fenitoin, karbamazepin, fenobarbiton in rifampicin, lahko zmanjšajo koncentracijo zdravila Zonegran v vaši krvi, zato bo mogoče treba prilagoditi odmerek zdravila Zonegran, ki ga jemljete.
English: • The recommended daily dose is 6 to 8 mg per kg for a child with a body weight of up to 55 kg or
Slovenian: • Priporočeni dnevni odmerek je 6 do 8 mg na kg za otroka s telesno maso do 55 kg ali 300 do
English: Patients with an impaired liver function: The pharmacokinetics of zonisamide in patients with impaired liver function have not been adequately studied.
Slovenian: Bolniki z jetrno okvaro: Farmakokinetike zonisamida pri bolnikih z jetrno okvaro niso ustrezno raziskali.
English: Physicians treating patients with Zonegran should ensure that patients are fully informed about the need to use appropriate effective contraception, and should use clinical judgement when assessing whether oral contraceptives (OCs), or the doses of the OC components, are adequate based on the individual patient's clinical situation.
Slovenian: Zdravniki, ki za zdravljenje uporabljajo zdravilo Zonegran, morajo zagotoviti, da so bolniki v celoti obveščeni o potrebi uporabe ustrezne učinkovite kontracepcije in s klinično presojo oceniti, ali so peroralni kontraceptivi ali odmerki učinkovin v peroralnih kontraceptivih ustrezni glede na klinično stanje posameznega bolnika.
English: Efficacy of zonisamide as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine prolonged release (PR) in 583 adult subjects with newly diagnosed partial seizures with or without secondary generalised tonic-clonic seizures.
Slovenian: Učinkovitost zonisamida kot monoterapije so dokazali v dvojno slepi primerjavi neinferiornosti z vzporednimi skupinami s karbamazepinom s podaljšanim sproščanjem pri 583 odraslih osebah z na novo diagnosticiranimi parcialnimi epileptičnimi napadi s sekundarno generaliziranimi toničnoklonični napadi ali brez njih.
English: • abnormal muscle breakdown (you may feel pain or weakness in your muscles) which can lead to kidney problems.
Slovenian: • nenormalna razgradnja mišic (lahko čutite bolečine ali oslabelost mišic), ki lahko povzroči težave z ledvicami;
English: In the event of signs or symptoms of dehydration, oligohydrosis, or elevated body temperature, discontinuation of Zonegran should be considered.
Slovenian: Če se pojavijo znaki ali simptomi dehidracije, oligohidroze ali zvišane telesne temperature, je treba razmisliti o prekinitvi zdravljenja z zdravilom Zonegran.
English: Zonegran may be used:
Slovenian: Zdravilo Zonegran se lahko uporablja:
English: In adults, efficacy has been demonstrated with Zonegran in 4 double-blind, placebo-controlled studies of periods of up to 24 weeks with either once or twice daily dosing.
Slovenian: Pri odraslih je bila učinkovitost zdravila Zonegran prikazana v štirih dvojno slepih, s placebom kontroliranih študijah, ki so trajale do 24 tednov z odmerjanjem enkrat ali dvakrat na dan.
English: Important information about some of the ingredients of Zonegran
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Zonegran
English: There are limited data from the use of Zonegran in pregnant women.
Slovenian: Podatkov o uporabi zdravila Zonegran pri nosečnicah je malo.
English: In vitro studies using human liver microsomes show no or little (<25%) inhibition of cytochrome P450 isozymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A4 at zonisamide levels approximately twofold or greater than clinically relevant unbound serum concentrations.
Slovenian: In vitro študije, v katerih so uporabili humane jetrne mikrosome, niso pokazale ali pa so pokazale nizko (<25 %) inhibicijo izoencimov 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 ali 3A4 citokroma P450 pri koncentracijah zonisamida, ki so bile dvakrat ali večkrat višje od klinično pomembnih serumskih koncentracij nevezane učinkovine.
English: Most adverse effects observed in the juvenile rats were similar to those seen in the repeated-dose toxicity studies of zonisamide in adult rats, but renal tubular hyaline droplets and transitional hyperplasia were observed in the juvenile study only.
Slovenian: Večina neželenih učinkov, ki so jih opazili pri podganjih mladičih, je bila podobna tistim, ki so jih opazili v študijah toksičnosti pri ponavljajočih se odmerkih zonisamida pri odraslih podganah, vendar so renalne tubulne hialinske kapljice in tranzicijsko hiperplazijo opazili le v študiji pri mladičih.
English: This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of zonisamide on carbonic anhydrase.
Slovenian: Metabolna acidoza je posledica izgube bikarbonata preko ledvic zaradi inhibicijskega učinka zonisamida na karboanhidrazo.
English: There are limited data from clinical studies in patients with a body weight of less than 20 kg.
Slovenian: Podatkov iz kliničnih študij pri bolnikih s telesno maso, manjšo od 20 kg, je malo.