FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment includes discontinuation of zonisamide, as rapidly as possible in the judgment of the treating physician, and appropriate measures to reduce intraocular pressure.
Croatian: Liječenje uključuje što brži prekid primjene zonisamida prema procjeni nadležnog liječnika i poduzimanje odgovarajućih mjera za snižavanje intraokularnog tlaka.
English: Hard capsules
Croatian: Tvrde kapsule
English: Zonisamide Mylan may be taken as monotherapy or added to existing therapy in adults.
Croatian: Zonisamide Mylan se može uzimati kao monoterapija ili ga se može dodati već postojećoj terapiji u odraslih.
English: A 50% or greater reduction from baseline in seizure frequency during the 12-week stable dose period was seen in 50% of the zonisamide-treated subjects and 31% of the patients on placebo.
Croatian: Smanjenje od 50% ili više u odnosu na početnu učestalost napadaja tijekom razdoblja stabilne doze od 12 tjedana opaženo je u 50% ispitanika liječenih zonisamidom i 31% bolesnika koji su primali placebo.
English: Effect of zonisamide on cytochrome P450 enzymes
Croatian: Učinak zonisamida na enzime citokroma P450
English: Zonisamide is excreted in human milk; the concentration in breast milk is similar to maternal plasma.
Croatian: Zonisamid se izlučuje u majčino mlijeko u ljudi; koncentracija u majčinu mlijeku slična je koncentraciji u plazmi majke.
English: Prescribers should also take account of the safety profile of zonisamide (see section 4.8).
Croatian: Propisivači lijeka moraju voditi računa i o sigurnosnom profilu zonisamida (vidjeti dio 4.8).
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.
Croatian: Zonisamid je uzrokovao razvojne abnormalnosti u miševa, štakora i pasa i bio je embrioletalan u majmuna kada se primjenjivao tijekom organogeneze u dozama i razinama zonisamida u plazmi majke sličnim ili nižim od terapijskih razina u ljudi.
English: These studies show that the median reduction in partial seizure frequency is related to zonisamide dose with sustained efficacy at doses of 300-500 mg per day.
Croatian: Ova ispitivanja pokazuju da je medijan smanjenja učestalosti parcijalnih napadaja povezan s dozom zonisamida uz održanu djelotvornost pri dozama od 300 do 500 mg na dan.
English: There have been cases of accidental and intentional overdose in adult and paediatric patients.
Croatian: Zabilježeni su slučajevi nehotičnog i namjernog predoziranja u odraslih i pedijatrijskih bolesnika.
English: There are no clinical data available on the effects of zonisamide on human fertility.
Croatian: Nema kliničkih podataka o učincima zonisamida na plodnost u ljudi.
English: - Zonisamide Mylan should be used carefully in adults when taken with medicines that can cause kidney stones, like topiramate or acetazolamide.
Croatian: - Zonisamide Mylan treba u odraslih primjenjivati pažljivo kad se uzima s lijekovima koji mogu prouzročiti nastanak bubrežnih kamenaca, poput topiramata ili acetazolamida.
English: Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhoea, surgery, ketogenic diet, or medicinal products) may be additive to the bicarbonate lowering effects of zonisamide.
Croatian: Stanja ili terapije koje su predispozicija acidozi (kao što su bolest bubrega, teški respiratorni poremećaji, epileptički status, proljev, kirurški zahvat, ketogena dijeta ili lijekovi) mogu povećati učinke zonisamida na sniženje bikarbonata.
English: If you take more Zonisamide Mylan than you should If you may have taken more Zonisamide Mylan 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.
Croatian: Ako ste možda uzeli više lijeka Zonisamide Mylan nego što ste trebali, kažite osobi koja brine o Vama (rodbina ili prijatelj), svom liječniku ili ljekarniku ili otiđite u hitnu službu najbliže bolnice, a lijek ponesite sa sobom.
English: Zonisamide has been administered to over 1,200 patients in clinical studies, more than 400 of whom received zonisamide for at least 1 year.
Croatian: U kliničkim ispitivanjima zonisamid je primjenjivalo 1200 bolesnika, a više od njih 400 primalo je zonisamid najmanje 1 godinu.
English: No specific antidotes for zonisamide overdose are available.
Croatian: Nisu dostupni nikakvi specifični antidoti za predoziranje zonisamidom.
English: The combination of zonisamide 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.
Croatian: Kombinacija zonisamida i drugih lijekova koji mogu dovesti do urolitijaze može povećati rizik od razvoja bubrežnih kamenaca; stoga istodobnu primjenu takvih lijekova treba izbjegavati.
English: 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.
Croatian: Ograničeni podaci pokazuju da je farmakokinetika u djece i adolescenata dozirana do stanja dinamičke ravnoteže od 1, 7 ili 12 mg/kg na dan u podijeljenim dozama, slična onoj opaženoj u odraslih nakon korekcije za tjelesnu težinu.
English: Zonisamide also has a modulatory effect on GABA-mediated neuronal inhibition.
Croatian: Zonisamid ima također modulirajući učinak na inhibiciju neurona posredovanu GABA-om.
English: Physicians treating patients with zonisamide 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.
Croatian: Liječnici koji bolesnice liječe zonisamidom trebali bi osigurati da su bolesnici potpuno upoznati o potrebi uporabe odgovarajuće učinkovite kontracepcije te na temelju kliničke prosudbe procijeniti jesu li oralni kontraceptivi, ili doze komponenata oralnih kontraceptiva, odgovarajući s obzirom na kliničku situaciju pojedine bolesnice.
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.
Croatian: Koža je vrlo ugrijana uz malo znojenja ili bez znojenja, ili je dijete postalo smeteno ili ima grčeve u mišićima, ili su djetetovi srčani otkucaji ili disanje postali ubrzani.
English: The dose may be increased more slowly if you experience side effects, are elderly or if you suffer from kidney or liver problems.
Croatian: Doza se može sporije povećavati ako Vam se pojave popratni učinci (nuspojave), ako ste stariji ili imate tegobe s bubrezima ili jetrom.
English: Carbonic anhydrase inhibitors
Croatian: Inhibitori karboanhidraze
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.
Croatian: 300 do 500 mg za djecu tjelesne težine iznad 55 kg (koja god je doza niža), a uzima se jedanput na dan.
English: • monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy (see section 5.1);
Croatian: • monoterapija u liječenju parcijalnih napadaja sa ili bez sekundarne generalizacije u odraslih s novodijagnosticiranom epilepsijom (vidjeti dio 5.1);
English: Caution is advised when starting or stopping zonisamide treatment or changing the zonisamide dose in patients who are also receiving medicinal products which are P-gp substrates (e.g. digoxin, quinidine).
Croatian: Preporučuje se oprez kada se započinje ili prekida liječenje zonisamidom ili kad se mijenja doza zonisamida u bolesnika koji primaju i lijekove koji su supstrati P-gp-a (npr. digoksin, kinidin).
English: Cases of decreased sweating and elevated body temperature have been reported mainly in paediatric patients.
Croatian: Slučajevi smanjenog znojenja i povišene tjelesne temperature zabilježeni su uglavnom u pedijatrijskih bolesnika.
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.
Croatian: Kad se uspoređuju jednake razine doza, čini se da ispitanici veće tjelesne težine imaju niže serumske koncentracije u stanju dinamičke ravnoteže, ali taj je učinak relativno umjeren.
English: very common ≥ 1/10 common
Croatian: vrlo često ≥ 1/10 često
English: The main route of excretion of zonisamide metabolites and unchanged drug is via the urine.
Croatian: Glavni je put izlučivanja metabolita zonisamida i nepromijenjenog lijeka preko mokraće.
English: A study showed that babies born to mothers using zonisamide during pregnancy were smaller than expected for their age at birth, compared with babies born to mothers treated with lamotrigine monotherapy.
Croatian: Ispitivanje je pokazalo da su novorođenčad koju su rodile majke koje su uzimale zonisamid tijekom trudnoće premala u odnosu na očekivanu veličinu za dob pri rođenju, u usporedbi s novorođenčadi koju su rodile majke liječene monoterapijom lamotriginom.
English: Zonisamide is almost completely absorbed after oral administration, generally reaching peak serum or plasma concentrations within 2 to 5 hours of dosing.
Croatian: Zonisamid se gotovo potpuno apsorbira nakon peroralne primjene, uglavnom dosegnuvši vršne koncentracije u serumu ili plazmi najčešće unutar 2 do 5 sati nakon doziranja.
English: What Zonisamide Mylan looks like and contents of the pack
Croatian: Kako Zonisamide Mylan izgleda i sadržaj pakiranja
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.
Croatian: Potreban je savjet specijaliste ženama u reproduktivnoj dobi o mogućim učincima zonisamida na plod i o tim rizicima naspram koristima treba razgovarati s bolesnicom prije početka liječenja.
English: In adults, efficacy has been demonstrated with zonisamide in 4 double-blind, placebo-controlled studies of periods of up to 24 weeks with either once or twice daily dosing.
Croatian: U odraslih bolesnika djelotvornost zonisamida dokazana je u 4 dvostruko slijepa, placebom kontrolirana ispitivanja u trajanju do 24 tjedna, uz dozu jedanput ili dvaput na dan.
English: Zonisamide Mylan is not recommended for children who are underweight or have a small appetite, and should be used with caution in those below 20 kg.
Croatian: Zonisamide Mylan se ne preporučuje za djecu kojoj je tjelesna težina manja od prosječne ili koja imaju slab apetit, a u djece težine manje od 20 kg treba ga primjenjivati s oprezom.
English: The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/min (see also section 4.2.
Croatian: AUC zonisamida u plazmi povećao se za 35% u ispitanika s klirensom kreatinina < 20 ml/min (vidjeti također dio 4.2).
English: It is chemically unrelated to other anti-epileptic agents.
Croatian: Kemijski nije srodan drugim antiepileptičkim lijekovima.
English: The amounts by which bicarbonate is decreased are usually small - moderate (average decrease of approximately 3.5 mEq/l at daily doses of 300 mg in adults); rarely patients can experience more severe decreases.
Croatian: Razine sniženja količine bikarbonata obično su male do umjerene (u odraslih prosječno smanjenje iznosi približno 3,5 mEq/l pri dozama od 300 mg na dan); rijetko se u bolesnika javljaju izrazita sniženja.
English: Twelve months seizure freedom PP-population ITT-population < 4 seizures during 3 month baseline period > 4 seizures during 3 month baseline period
Croatian: Dvanaest mjeseci bez napadaja PP populacija ITT populacija < 4 napadaja tijekom početnog razdoblja od 3 mjeseca > 4 napadaja tijekom početnog razdoblja od 3 mjeseca
English: The effects at this dose level were reversible during the recovery period.
Croatian: Tijekom razdoblja oporavka učinci na toj razini doze bili su reverzibilni.
English: Preventing overheating and dehydration in children
Croatian: Sprječavanje pregrijavanja i dehidracije u djece
English: The elimination half-life was independent of dose and not affected by repeat administration.
Croatian: Poluvijek eliminacije nije ovisio o dozi, a ponavljana primjena nije imala utjecaja na njega.
English: In patients taking zonisamide who develop the clinical signs and symptoms of pancreatitis, it is recommended that pancreatic lipase and amylase levels are monitored.
Croatian: U bolesnika koji uzimaju zonisamid i razviju kliničke znakove i simptome pankreatitisa, preporučuje se nadzor razina pankreatične lipaze i amilaze.
English: The most frequently reported are cleft lip, cardiovascular malformations and neural tube defect.
Croatian: Najčešće su bili prijavljivani rascjep usne, kardiovaskularne malformacije i poremećaj neuralne cijevi.
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.
Croatian: Prividni klirens zonisamida u stanju dinamičke ravnoteže nakon peroralne primjene iznosi oko 0,70 l/h, a terminalni poluvijek eliminacije je oko 60 sati u odsutnosti induktora enzima CYP3A4.
English: It is an anti-epileptic medicine with weak carbonic anhydrase activity in-vitro.
Croatian: To je antiepileptički lijek sa slabom aktivnošću karboanhidraze in vitro.
English: Capsule contents Microcrystalline cellulose Sodium laurilsulfate Hydrogenated vegetable oil
Croatian: Sadržaj kapsule mikrokristalična celuloza natrijev laurilsulfat hidrogenirano biljno ulje
English: Heat stroke and dehydration Preventing overheating and dehydration in children
Croatian: Toplinski udar i dehidracija Sprječavanje pregrijavanja i dehidracije u djece
English: Zonisamide is 40 - 50 % bound to human plasma proteins, with in vitro studies showing that this is unaffected by the presence of various antiepileptic medicinal products (i.e., phenytoin, phenobarbitone, carbamazepine, and sodium valproate).
Croatian: Zonisamid je 40 - 50% vezan na humane proteine u plazmi, s tim da ispitivanja in vitro pokazuju da na to ne utječe prisutnost različitih antiepileptičkih lijekova (tj. fenitoina, fenobarbitona, karbamazepina i natrijeva valproata).
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).
Croatian: U kliničkim ispitivanjima u odraslih bolesnika doza se smanjivala za 100 mg u razmacima od tjedan dana, uz istodobnu prilagodbu doza drugih antiepileptičkih lijekova (gdje je to potrebno).
English: In some cases, the overdoses were asymptomatic, particularly where emesis or lavage was prompt.
Croatian: U nekim slučajevima predoziranja su bila asimptomatska, osobito onda kada su povraćanje ili ispiranje želuca uslijedili brzo.
English: Studies in animals have shown changes in fertility parameters (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su promjene u parametrima plodnosti (vidjeti dio 5.3).
English: Oral bioavailability is not affected by food, although peak plasma and serum concentrations may be delayed.
Croatian: Hrana ne utječe na peroralnu bioraspoloživost iako vršne koncentracije u plazmi i serumu mogu biti odgođene.
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.
Croatian: Ako je pankreatitis očigledan, u odsutnosti nekog drugog očitog uzroka preporučuje se razmotriti ukidanje zonisamida i započeti odgovarajuće liječenje.
English: Fluctuation in serum or plasma concentrations over a dosing interval is low (< 30%).
Croatian: U serumskim ili plazmatskim koncentracijama fluktuacija je niska (< 30%) tijekom intervala doziranja.
English: Therefore, modification of zonisamide dosing should not be necessary when co-administered with known CYP3A4 inhibitors.
Croatian: Stoga modifikacija doziranja zonisamida nije potrebna kada se primjenjuje istodobno s poznatim inhibitorima CYP3A4.
English: The most common adverse reactions in controlled adjunctive-therapy studies were somnolence, dizziness and anorexia.
Croatian: Najčešće nuspojave u kontroliranim ispitivanjima s dodatnom terapijom bile su somnolencija, omaglica i anoreksija.
English: The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/min.
Croatian: AUC zonisamida u plazmi povećao se za 35% u ispitanika s klirensom kreatinina < 20 ml/min.
English: Physicians should discuss with patients and their carers the potential seriousness of heat stroke, situations in which it might arise, as well as action to take in the event of any signs or symptoms.
Croatian: Liječnici moraju upoznati bolesnike i osobe koje o njima skrbe s potencijalnim ozbiljnim posljedicama toplinskog udara, sa situacijama u kojima može doći do toplinskog udara, a također i s mjerama koje treba poduzeti u slučaju bilo kakvih znakova i simptoma.
English: The mechanism of action of zonisamide is not fully elucidated, but it appears to act on voltage-sensitive sodium and calcium channels, thereby disrupting synchronised neuronal firing, reducing the spread of seizure discharges and disrupting subsequent epileptic activity.
Croatian: Mehanizam djelovanja zonisamida nije potpuno razjašnjen, ali čini se da on djeluje na natrijeve i kalcijeve kanale osjetljive na napon pri čemu prekida sinkronizirano ispaljivanje neurona, smanjujući širenje napadaja i prekidajući posljedičnu epileptičnu aktivnost.
English: Zonisamide is metabolised partly by CYP3A4 (reductive cleavage), and also by N-acetyl-transferases and conjugation with glucuronic acid; therefore, substances that can induce or inhibit these enzymes may affect the pharmacokinetics of zonisamide:
Croatian: Zonisamid se metabolizira djelomično enzimom CYP3A4 (redukcijsko cijepanje) a također i N-acetiltransferazama i konjugacijom s glukuronskom kiselinom; stoga tvari koje mogu inducirati ili inhibirati te enzime mogu utjecati na farmakokinetiku zonisamida:
English: Mylan S.A.S 117 allee des Parcs, 69 800 Saint Priest, France
Croatian: Mylan S.A.S 117 allee des Parcs, 69 800 Saint Priest, Francuska
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.
Croatian: U drugim slučajevima, predoziranje je bilo popraćeno simptomima kao što su somnolencija, mučnina, gastritis, nistagmus, mioklonus, koma, bradikardija, smanjena funkcija bubrega, hipotenzija i respiratorna depresija.
English: Adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adolescent and paediatric patients (aged 6 years and above) 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.
Croatian: Dodatna terapija u liječenju parcijalnih napadaja sa ili bez sekundarne generalizacije u adolescenata i pedijatrijskih bolesnika (u dobi od 6 i više godina) U pedijatrijskih bolesnika (u dobi od 6 i više godina), djelotvornost zonisamida dokazana je u dvostruko slijepom, placebom kontroliranom ispitivanju koje je uključilo 207 ispitanika, a trajanje liječenja iznosilo je do 24 tjedna.
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
Croatian: - Preporučena je dnevna doza od 6 do 8 mg po kilogramu za djecu tjelesne težine do 55 kg ili od
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.
Croatian: Iako nije službeno ispitivana u liječenju predoziranosti, hemodijaliza je smanjila koncentracije zonisamida u plazmi u bolesnika sa smanjenom funkcijom bubrega te se može uzeti u obzir za liječenje predoziranosti ako je klinički indicirano.
English: Changes in renal histopathology and clinical pathology parameters were considered to be related to carbonic anhydrase inhibition by zonisamide.
Croatian: Promjene parametara bubrežne histopatologije i kliničke patologije smatrale su s povezanima s inhibicijom karboanhidraze zonisamidom.
English: • on its own to treat seizures in adults
Croatian: • kao samostalni lijek za liječenje napadaja u odraslih
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.
Croatian: U skladu s postojećom kliničkom praksom, u bolesnika s epilepsijom zonisamid se mora ukinuti postupnim snižavanjem doze kako bi se umanjila mogućnost napadaja povezanih s ustezanjem lijeka.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from zonisamide therapy.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja zonisamidom.
English: - Zonisamide Mylan could possibly increase your blood levels of medicines like digoxin and quinidine, and so a reduction in their dose may be required.
Croatian: - Zonisamide Mylan bi mogao povisiti razinu lijekova kao što su digoksin i kinidin u Vašoj krvi, stoga može biti potrebno smanjiti dozu tih lijekova.
English: Following a suspected recent overdose, emptying the stomach by gastric lavage or by induction of emesis may be indicated with the usual precautions to protect the airway.
Croatian: Nakon sumnje na nedavno predoziranje može biti indicirano pražnjenje želuca ispiranjem ili izazivanjem povraćanja uz uobičajene mjere opreza kako bi se zaštitili dišni putevi.
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.
Croatian: Ukupno 70,4% pedijatrijskih ispitanika koji su primali zonisamid u kontroliranom ispitivanju ili u njegovu otvorenom produžetku imali su barem jedno mjerenje bikarbonata ispod 22 mmol/L, što je zahtijevalo liječenje.
English: Unlike phenytoin and carbamazepine however, zonisamide acts preferentially on seizures originating in the cortex.
Croatian: Međutim, za razliku od fenitoina i karbamazepina, zonisamid prvenstveno djeluje na napadaje s izvorom u korteksu mozga.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER PAKIRANJE
English: Rhabdomyolysis
Croatian: Rabdomioliza
English: The pharmacokinetics of zonisamide in patients with impaired liver function have not been adequately studied.
Croatian: Oštećenje jetre Farmakokinetika zonisamida u bolesnika s oštećenom funkcijom jetre nije bila odgovarajuće ispitana.
English: There is no need for dose adjustment with any of the AEDs including CYP3A4 inducers.
Croatian: Nema potrebe za prilagodbom doze ni za jedan antiepileptik, uključujući induktore CYP3A4.
English: The most common side effects of Zonisamide Mylan are mild.
Croatian: Najčešće nuspojave lijeka Zonisamide Mylan su blage.