FrancophonIA/ELRC3.0 huggingface dataset:
English: Prescribers should also take account of the safety profile of Zonegran (see section 4.8).
Slovenian: Zdravnik, ki predpisuje Zonegran, mora upoštevati tudi varnostni profil zdravila (glejte poglavje 4.8).
English: • Zonegran could possibly increase your blood levels of medicines like digoxin and quinidine, and so a reduction in their dose may be required.
Slovenian: • Zdravilo Zonegran bi pri vas lahko zvišalo koncentracijo nekaterih zdravil v krvi, na primer digoksina in kinidina, zato bo mogoče treba zmanjšati njihov odmerek.
English: • loss of appetite, decreased blood levels of bicarbonate (a substance that prevents your blood from becoming acidic)
Slovenian: • izguba apetita, znižana koncentracija bikarbonata (snov, ki preprečuje, da bi vaša kri postala kisla) v krvi.
English: Among 465 subjects in the paediatric safety database (including a further 67 subjects from the extension phase of the controlled clinical trial) there were 7 deaths (1.5%; 14.6/1000 person-years): 2 cases of status epilepticus, of which one was related to severe weight loss (10% within 3 months) in an underweight subject and subsequent failure to take medication; 1 case of head injury/haematoma, and 4 deaths in subjects with pre-existing functional neurological deficits for various causes (2 cases of pneumonia-induced sepsis/organ failure, 1 SUDEP and 1 head injury).
Slovenian: Med 465 bolniki v podatkovni bazi za varnost pri pediatrični populaciji (vključno s še 67 bolniki iz faze podaljšanega kontroliranega kliničnega preskušanja) je umrlo 7 bolnikov (1,5 %; 14,6/1.000 oseb-let): 2 primera epileptičnega statusa, od katerih je bil eden povezan s hudo izgubo telesne mase (10 % v 3 mesecih) pri bolniku s premajhno telesno maso, ki nato ni jemal zdravil; 1 primer poškodbe glave/hematoma, 4 umrli bolniki pa so imeli že od prej funkcijske nevrološke izpade zaradi različnih vzrokov (2 primera sepse zaradi pljučnice/odpovedi organov, 1 primer SUDEP in 1 poškodba glave).
English: Zonegran is used to treat seizures that affect one part of the brain (partial seizure), which may or may not be followed by a seizure affecting all of the brain (secondary generalisation).
Slovenian: Zdravilo Zonegran se uporablja za zdravljenje epileptičnih napadov, ki prizadenejo del možganov (parcialni napadi), tem pa lahko sledi napad, ki prizadene vse možgane (sekundarna generalizacija), lahko pa tudi ne.
English: The most common side effects of Zonegran are mild.
Slovenian: Najpogostejši neželeni učinki zdravila Zonegran so blagi.
English: Although not formally studied for the treatment of overdose, haemodialysis reduced plasma concentrations of zonisamide in a patient with reduced renal function, and may be considered as treatment of overdose if clinically indicated.
Slovenian: Čeprav hemodializa ni bila formalno preizkušena kot zdravljenje za preveliko odmerjanje, zmanjša plazemsko koncentracijo zonisamida pri bolnikih z zmanjšanjo ledvično funkcijo, zato jo lahko uporabimo kot zdravljenje prevelikega odmerjanja, če je to klinično indicirano.
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 tudi poglavje 4.2).
English: The safety and efficacy of Zonegran in children aged below 6 years or those below 20 kg have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Zonegran pri otrocih, starih manj kot 6 let ali s telesno maso manj kot 20 kg, še nista bili dokazani.
English: Week 3 to 5
Slovenian: 3. do 5. teden
English: In patients taking Zonegran who develop the clinical signs and symptoms of pancreatitis, it is recommended that pancreatic lipase and amylase levels are monitored.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Zonegran, pri katerih se pojavijo klinični znaki in simptomi pankreatitisa, je priporočljivo spremljanje ravni pankreatične lipaze in amilaze.
English: In paediatric patients (aged 6 years and above), efficacy has been demonstrated with zonisamide in a double-blind, placebo-controlled study, which included 207 subjects and had a treatment duration of up to 24 weeks.
Slovenian: Pri pediatričnih bolnikih (starih 6 let ali več) so učinkovitost dokazali v dvojno slepi, s placebom kontrolirani študiji z zonisamidom, v katero je bilo vključenih 207 bolnikov, ki se je zdravilo do 24 tednov.
English: You might also feel sick, have a sore stomach, muscle twitches, eye movement, feel faint, have a slowed heart beat, and reduced breathing and kidney function.
Slovenian: Lahko vam je tudi slabo, imate bolečine v želodcu, trzanje mišic in oči, mogoče se vam zdi, da boste omedleli, imate upočasnjen srčni utrip in zmanjšano delovanje pljuč in ledvic.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zonegran therapy.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Zonegran.
English: Zonisamide also has a modulatory effect on GABA-mediated neuronal inhibition.
Slovenian: Zonisamid ima tudi modulatorni učinek na nevronsko inhibicijo, posredovano z GABA.
English: Steady-state dosing of either ketoconazole (400 mg/day) or cimetidine (1200 mg/day) had no clinically relevant effects on the single-dose pharmacokinetics of zonisamide given to healthy subjects.
Slovenian: Odmerjanje v stanju dinamičnega ravnovesja tako ketokonazola (400 mg/dan) kot cimetidina (1200 mg/dan) ni imelo klinično pomembnih učinkov na farmakokinetiko enkratnega odmerka zonisamida pri zdravih preiskovancih.
English: • if you are allergic to other sulphonamide medicines.
Slovenian: • če ste alergični na druga sulfonamidna zdravila, kot so na primer: sulfonamidni antibiotiki,
English: In clinical studies co-administration of lamotrigine had no apparent effect on zonisamide pharmacokinetics.
Slovenian: V kliničnih študijah sočasno zdravljenje z lamotriginom ni imelo očitnih učinkov na farmakokinetiko zonisamida.
English: PVC/PVDC/aluminium blisters, packs of 14, 28, 56 and 84 hard capsules.
Slovenian: PVC/PVDC/aluminijasti pretisni omoti, škatle s 14, 28, 56 in 84 trdimi kapsulami.
English: Do not take Zonegran: • if you are allergic to zonisamide or any of the other ingredients of this medicine (listed in section
Slovenian: • če ste alergični na zonisamid ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6);
English: Zonegran is not recommended for children who are underweight or have a small appetite, and should be used with caution in those below 20 kg.
Slovenian: Zdravilo Zonegran ni priporočljivo za otroke, ki imajo premajhno telesno maso ali imajo slab apetit, pri tistih, ki tehtajo manj kot 20 kg, pa ga je treba uporabljati previdno.
English: Marketing Authorisation Holder Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germanye-mail: medinfo_de@eisai.net
Slovenian: Imetnik dovoljenja za promet z zdravilom Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Nemčija e-mail: medinfo_de@eisai.net
English: If Zonegran is prescribed during pregnancy, patients should be fully informed of the potential harm to the foetus and use of the minimal effective dose is advised along with careful monitoring.
Slovenian: Če se zdravilo Zonegran predpiše v nosečnosti, je treba bolnico obvestiti o vseh možnih tveganjih za plod; svetujeta se uporaba najmanjšega še učinkovitega odmerka in skrbno spremljanje.
English: Elderly: No clinically significant differences were observed in the pharmacokinetics between young (aged 21-40 years) and elderly (65-75 years).
Slovenian: Starejši: Med mladimi (starimi 21 - 40 let) in starejšimi (65 - 75 let) ni opaznih klinično pomembnih razlik v farmakokinetiki.
English: Zonisamide caused developmental abnormalities in mice, rats, and dogs, and was embryolethal in monkeys, when administered during the period of organogenesis at zonisamide dosage and maternal plasma levels similar to or lower than therapeutic levels in humans.
Slovenian: Zonisamid je povzročil razvojne nepravilnosti pri miših, podganah in psih, pri opicah je povzročil smrt zarodka, če je bil dan v času organogeneze v odmerkih in koncentracijah v materini plazmi, podobnimi ali nižjimi, kot so terapevtske koncentracije pri ljudeh.
English: In clinical studies in healthy subjects, steady-state dosing with Zonegran did not affect serum concentrations of ethinylestradiol or norethisterone in a combined oral contraceptive.
Slovenian: V kliničnih študijah pri zdravih preiskovancih odmerjanje zdravila Zonegran v stanju dinamičnega ravnovesja ni imelo vpliva na serumske koncentracije etinilestradiola ali noretisterona v kombiniranem peroralnem kontraceptivu.
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: If the decision is made to continue patients on Zonegran in the face of persistent acidosis, alkali treatment should be considered.
Slovenian: Če se odločite za nadaljevanje zdravljenja z zdravilom Zonegran kljub trdovratni acidozi, je treba razmisliti o zdravljenju z alkalnimi zdravili.
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 ponavljajočih se odmerkov pri podganjih mladičih pri ravneh 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: PVC/PVDC/aluminium blisters, packs of 28, 56, 84, 98 and 196 hard capsules.
Slovenian: PVC/PVDC/aluminijasti pretisni omoti, škatle z 28, 56, 84, 98 in 196 trdimi kapsulami.
English: • are elderly, as your dose of Zonegran may need adjusting, and you may be more likely to develop an allergic reaction, severe skin rash, swelling of the feet and legs, and itchiness when taking Zonegran (see section 4 Possible side effects).
Slovenian: • če ste starejši, ker bo vaš odmerek zdravila Zonegran morda potrebno prilagoditi in ker se utegnejo med jemanjem zdravila Zonegran pogosteje pojaviti alergijska reakcija, hud kožni izpuščaj, oteklost stopal in nog ter srbenje (glejte poglavje 4, Možni neželeni učinki);
English: In some cases, the overdoses were asymptomatic, particularly where emesis or lavage was prompt.
Slovenian: V nekaj primerih je bilo preveliko odmerjanje asimptomatsko, zlasti pri tistih, kjer se je takoj pojavilo bruhanje ali pa je bilo takoj izvedeno izpiranje želodca.
English: • hallucinations, memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating,
Slovenian: • halucinacije, izguba spomina, koma, nevroleptični maligni sindrom (nezmožnost gibanja,
English: Potential medicinal product interactions affecting Zonegran
Slovenian: Možne interakcije med zdravili, ki vplivajo na zdravilo Zonegran
English: Changes in renal histopathology and clinical pathology parameters were considered to be related to carbonic anhydrase inhibition by zonisamide.
Slovenian: Spremembe ledvične histopatologije in kliničnih patoloških parametrov so pripisali inhibiciji karboanhidraze, ki jo povzroča zonisamid.
English: Specialist advice should be given to women who are of childbearing potential regarding the possible effects of Zonegran 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 zdravila Zonegran na plod, pred začetkom zdravljenja pa se je treba z bolnico pogovoriti o njegovih nevarnostih v primerjavi s koristnimi učinki.
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, je morda večje tveganje za nastanek ledvičnih kamnov in z njimi povezanih znakov in simptomov, kot so na primer renalne kolike, renalne bolečine ali bolečine v ledvenem predelu.
English: Therefore children aged 6 years and above with a body weight of less than 20 kg should be treated with caution.
Slovenian: Zato je treba otroke, stare 6 let ali več, s telesno maso, manjšo od 20 kg, zdraviti previdno.
English: • if you are allergic to peanut or soya, do not use this medicinal product.
Slovenian: • če ste alergični na arašide ali sojo, ne jemljite tega zdravila.
English: Zonisamide AUC and Cmax values increased almost linearly after single dose over the dose range of 100-800 mg and after multiple doses over the dose range of 100-400 mg once daily.
Slovenian: Vrednosti AUC in Cmax za zonisamid se po enkratnem odmerku v intervalu od 100 do 800 mg in po večkratnem odmerku v intervalu od 100 do 400 mg enkrat na dan povečujeta skoraj linearno.
English: Physicians should draw the attention of paediatric patients and their parents/carers to the Patient Alert Box (in the package leaflet) on preventing heatstroke (see section 4.4: Paediatric population).
Slovenian: Zdravniki morajo pediatrične bolnike in njihove starše/negovalce opozoriti na okvirček z opozorili za bolnika (v navodilu za uporabo) glede preprečevanja vročinske kapi (glejte poglavje 4.4: Pediatrična populacija).
English: • have pain in your muscles or a feeling of weakness, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems.
Slovenian: • če se pojavi bolečina v mišicah ali občutek oslabelosti, ker je to lahko znak nenormalne razgradnje mišic, ki utegne povzročiti težave z ledvicami;
English: • swollen glands, blood disorders (reduction in the number of blood cells, which can make infection more likely and can make you look pale, feel tired and feverish, and bruise more easily).
Slovenian: • otekle bezgavke, bolezni krvi (zmanjšanje števila krvničk, zaradi katerega se lažje okužite, ste bledi, utrujeni in vročični in vam brez omembe vrednega vzroka nastajajo modrice);
English: If you are allergic to peanut or soya, do not use this medicinal product.
Slovenian: Če ste alergični na arašide ali sojo, ne jemljite tega zdravila.
English: In accordance with current clinical practice, discontinuation of Zonegran 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 zdravilo Zonegran ukiniti s postopnim zmanjševanjem odmerka zaradi zmanjšanja možnosti pojavljanja epileptičnih napadov ob odtegnitvi.
English: • The other ingredients that are present in the capsule contents are: microcrystalline cellulose, hydrogenated vegetable oil (from soyabean) and sodium laurilsulfate.
Slovenian: • Druge sestavine v kapsulah so: mikrokristalna celuloza, hidrogenirano rastlinsko olje (sojino) in natrijev lavrilsulfat.
English: If you forget to take Zonegran
Slovenian: Če ste pozabili vzeti zdravilo Zonegran
English: • skin rashes, itching, allergic reactions, fever, tiredness, flu-like symptoms, hair loss.
Slovenian: • kožni izpuščaji, srbenje, alergijske reakcije, vročina, utrujenost, gripi podobni simptomi,
English: • poor muscle coordination, dizziness, poor memory, sleepiness, double vision
Slovenian: • poslabšana koordinacija mišic, omotica, motnje spomina, zaspanost, dvojni vid;
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 manjša.
English: It should be noted that Zonegran is a benzisoxazole derivative, which contains a sulphonamide group.
Slovenian: Treba se je zavedati, da je zdravilo Zonegran derivat benzisoksazola, ki vsebuje sulfonamidno skupino.
English: Adults - recommended dosage escalation and maintenance regimen
Slovenian: Preglednica 1 Odrasli - priporočeni režim stopnjevanja odmerka in vzdrževalnega odmerka Režim zdravljenja
English: Zonegran is not recommended for paediatric patients who are underweight (definition in accordance with the WHO age adjusted BMI categories) or have a decreased appetite.
Slovenian: Zdravilo Zonegran ni priporočeno pri pediatričnih bolnikih, ki imajo premajhno telesno maso (opredelitev v skladu s kategorijami za indeks telesne mase, prilagojen za starost, po SZO) ali zmanjšan apetit.
English: • inflammations of the pancreas (severe pain in the stomach or back)
Slovenian: • vnetja trebušne slinavke (hude bolečine v trebuhu ali križu);
English: • The capsule shell contains: gelatin, titanium dioxide (E171), shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
Slovenian: • Ovojnica kapsule vsebuje: želatino, titanov dioksid (E171), šelak, propilenglikol, kalijev hidroksid, črni železov oksid (E172).
English: • The recommended dose is 300 mg once a day.
Slovenian: • Priporočeni odmerek je 300 mg enkrat na dan.
English: In patients taking Zonegran, 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 zdravilom Zonegran, pri katerih se pojavi huda mišična bolečina in/ali oslabelost v prisotnosti zvišane telesne temperature ali brez nje, je priporočljivo merjenje ravni označevalcev mišične okvare, vključno z ravnmi kreatin-kinaze in aldolaze.
English: • The child must not take any of these medicines: carbonic anhydrase inhibitors (like topiramate and acetazolamide), and anticholinergic agents (like clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).
Slovenian: • ne sme jemati nobenega od naslednjih zdravil: zaviralcev karboanhidraze (kot sta topiramat in acetazolamid) in antiholinergičnih zdravil (kot so klomipramin, hidroksizin, difenhidramin, haloperidol, imipramin in oksibutinin).
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: • liver problems, kidney failure, increased blood levels of creatinine (a waste product that your kidneys should normally remove).
Slovenian: • težave z jetri, ledvična odpoved, zvišan nivo kreatinina (odpadna snov, ki se ponavadi izloča skozi ledvice) v krvi;
English: Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germany.
Slovenian: Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Nemčija
English: Reduce the risk of overheating by drinking sufficient water and keeping cool.
Slovenian: Zmanjšajte nevarnost pregretja telesa z uživanjem zadostne količine vode in zadrževanjem v hladnejšem okolju;
English: A small number of people being treated with antiepileptics such as Zonegran have had thoughts of harming or killing themselves.
Slovenian: Pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki, kot je zdravilo Zonegran, so se pojavile misli o samopoškodovanju ali samomoru;
English: Zonegran can make you perspire less, which can cause your body temperature to increase.
Slovenian: Mogoče se boste zaradi zdravila Zonegran manj znojili, zaradi česar se vam lahko zviša telesna temperatura.
English: • have signs of overheating - high body temperature but little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion.
Slovenian: • če se pojavijo znaki pregretja - visoka telesna temperatura z malo ali brez potenja, hiter srčni utrip in dihanje, mišični krči in zmedenost;
English: Zonisamide is metabolised primarily through reductive cleavage of the benzisoxazole ring of the parent drug by CYP3A4 to form 2-sulphamoylacetylphenol (SMAP) and also by N-acetylation.
Slovenian: Zonisamid se presnavlja predvsem prek redukcijske cepitve obroča benzisoksazola izhodiščnega zdravila s CYP3A4, pri čemer nastane 2-sulfamoilacetilfenol (SMAP), pa tudi z N-acetilacijo.
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 nasvete v navodilu za uporabo glede preprečevanja vročinske kapi in pregretja pri otrocih.
English: • have an unexplained skin rash, as this could develop into a more severe skin rash or skin peeling.
Slovenian: • če imate nepojasnjen kožni izpuščaj, ker bi se utegnil močno poslabšati ali bi se vam začela luščiti koža;
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 zarodkov.
English: The risk of zonisamide induced metabolic acidosis appears to be more frequent and severe in younger patients.
Slovenian: Zdi se, da je tveganje z zonisamidom inducirane metabolne acidoze večje in potek težji pri mlajših bolnikih.
English: Slightly greater than expected accumulation occurs relative to single dosing.
Slovenian: Po enkratnem odmerjanju je akumulacija nekoliko večja od pričakovane.
English: In epileptic patients, steady-state dosing with Zonegran resulted in no clinically relevant pharmacokinetic effects on carbamazepine, lamotrigine, phenytoin, or sodium valproate.
Slovenian: Pri bolnikih z epilepsijo odmerjanje zdravila Zonegran v stanju dinamičnega ravnovesja ni imelo klinično pomembnih farmakokinetičnih učinkov na karbamazepin, lamotrigin, fenitoin ali natrijev valproat.
English: When your child is taking Zonegran:
Slovenian: Če vaš otrok jemlje zdravilo Zonegran:
English: If co-administration is necessary, the patient should be closely monitored and the dose of Zonegran and other CYP3A4 substrates adjusted as needed.
Slovenian: V primeru, da je potrebno sočasno jemanje zdravil, je treba bolnika skrbno spremljati in odmerek zdravila Zonegran ali ostalih substratov CYP3A4 primerno prilagoditi;
English: When a child is taking Zonegran:
Slovenian: Če otrok jemlje zdravilo Zonegran:
English: Adverse reactions associated with Zonegran obtained from clinical studies and post-marketing surveillance are tabulated below.
Slovenian: Neželene reakcije, povezane z zdravilom Zonegran, ugotovljene v kliničnih študijah in postmarketinškem nadzoru, so navedene spodaj.