FrancophonIA/ELRC3.0 huggingface dataset:
English: • Zonegran could possibly increase your blood levels of medicines like digoxin and quinidine, and so a reduction in their dose may be required.
Croatian: • Zonegran bi mogao povisiti razinu lijekova kao što su digoksin i kinidin u Vašoj krvi, stoga može biti potrebno smanjiti dozu tih lijekova.
English: None of these risk factors can reliably predict stone formation during zonisamide treatment.
Croatian: Ni zbog jednog od tih čimbenika rizika ne može se pouzdano predvidjeti nastanak bubrežnih kamenaca za vrijeme liječenja zonisamidom.
English: • ecchymosis (a small bruise caused by blood leaking from broken blood vessels in the skin).
Croatian: • ekhimoza (mala modrica koju uzrokuje istjecanje krvi iz oštećenih krvnih žila u koži)
English: • The starting dose is 50 mg daily taken in two equal doses of 25 mg.
Croatian: • Početna je doza 50 mg na dan, a uzima se u dvije jednake doze od 25 mg.
English: Zonisamide is excreted in human milk; the concentration in breast milk is similar to maternal plasma.
Croatian: Zonisamid se izlučuje u majčino mlijeko; koncentracija u majčinu mlijeku slična je koncentraciji u plazmi majke.
English: PVC/PVDC/aluminium blisters, packs of 14, 28, 56 and 84 hard capsules.
Croatian: PVC/PVDC/aluminij blisteri, pakiranja s 14, 28, 56 i 84 tvrdih kapsula.
English: The anticonvulsant activity of zonisamide has been evaluated in a variety of models, in several species with induced or innate seizures, and zonisamide appears to act as a broad-spectrum anti-epileptic in these models.
Croatian: Antikonvulzivno djelovanje zonisamida procijenjeno je na različitim modelima u više životinjskih vrsta s induciranim ili prirodnim napadajima i čini se da zonisamid u tim modelima djeluje kao antiepileptik širokog spektra.
English: Serious rashes occur in association with Zonegran therapy, including cases of Stevens-Johnson syndrome.
Croatian: Povezano s terapijom Zonegranom javlja se ozbiljan osip, uključujući slučajeve Stevens-Johnsonovog sindroma.
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 očekivano za dob pri rođenju, u usporedbi s novorođenčadi koju su rodile majke liječene monoterapijom lamotriginom.
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.
Croatian: • otežano disanje, oticanje lica, usana ili jezika ili teški osip na koži jer ti simptomi mogu značiti da imate tešku alergijsku reakciju
English: Anti-epileptic medicinal products
Croatian: Antiepileptički lijekovi
English: • Zonegran should be used carefully in adults when taken with medicines that can cause kidney stones, like topiramate or acetazolamide.
Croatian: • Zonegran u odraslih treba primjenjivati s oprezom kad se uzima s lijekovima koji mogu prouzročiti nastanak bubrežnih kamenaca, poput topiramata ili acetazolamida.
English: The combination of Zonegran with other medicinal products that may lead to urolithiasis may enhance the risk of developing kidney stones; therefore the concomitant administration of such medicinal products should be avoided.
Croatian: Kombinacija Zonegrana i drugih lijekova koji mogu dovesti do urolitijaze može povećati rizik od razvoja bubrežnih kamenaca; stoga istodobnu primjenu takvih lijekova treba izbjegavati.
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 malen.
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.
Croatian: Liječnici koji bolesnice liječe Zonegranom 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: What Zonegran contains The active substance in Zonegran is zonisamide.
Croatian: Što Zonegran sadrži Djelatna tvar u Zonegranu je zonisamid.
English: Prescribers should also take account of the safety profile of Zonegran (see section 4.8).
Croatian: Propisivači lijeka moraju voditi računa i o sigurnosnom profilu Zonegrana (vidjeti dio 4.8).
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.
Croatian: Potreban je savjet specijaliste ženama u reproduktivnoj dobi o mogućim učincima Zonegrana na plod i o tim rizicima naspram koristima treba razgovarati s bolesnicom prije početka liječenja.
English: PVC/PVDC/aluminium blisters, packs of 28, 56, 84, 98 and 196 hard capsules.
Croatian: PVC/PVDC/aluminij blisteri, pakiranja s 28, 56, 84, 98 i 196 tvrdih kapsula.
English: • abnormal muscle breakdown (you may feel pain or weakness in your muscles) which can lead to kidney problems.
Croatian: • nenormalno propadanje mišića (možete osjećati bol ili slabost u mišićima) koje može dovesti do tegoba s bubrezima
English: Note: a. To ensure a therapeutic dose is maintained the weight of a child should be monitored and the dose reviewed as weight changes occur up to a weight of 55kg.
Croatian: Kako bi se osiguralo održavanje terapijske doze, potrebno je nadzirati djetetovu tjelesnu težinu i mijenjati dozu u skladu s promjenom težine do 55 kg.
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 proteine u ljudskoj 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: • have previously suffered from kidney stones, as you may be at increased risk of developing more kidney stones.
Croatian: • ako ste prethodno patili od bubrežnih kamenaca jer u Vas možda postoji rizik da ćete razviti još više bubrežnih kamenaca.
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 you are allergic to peanut or soya, do not use this medicinal product.
Croatian: Ako ste alergični na kikiriki ili soju, nemojte uzimati ovaj lijek.
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-acetil-transferazama i konjugacijom s glukuronskom kiselinom; stoga tvari koje mogu inducirati ili inhibirati te enzime mogu utjecati na farmakokinetiku zonisamida:
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 njihove njegovatelje s mogućim ozbiljnim posljedicama toplinskog udara, sa situacijama u kojima može doći do toplinskog udara, kao i s mjerama koje treba poduzeti u slučaju bilo kakvih znakova i simptoma.
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.
Croatian: Djelotvornost zonisamida kao monoterapije ustanovljena je u dvostruko slijepoj usporedbi neinferiornosti s karbamazepinom produljenog otpuštanja (PR) u 583 odrasla ispitanika s novodijagnosticiranim parcijalnim napadajima sa ili bez sekundarno generaliziranih toničko-kloničkih napadaja.
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 bio je povećan za 35% u ispitanika s klirensom kreatinina < 20 ml/min (vidjeti također dio 4.2).
English: If pancreatitis is evident, in the absence of another obvious cause, it is recommended that discontinuation of Zonegran be considered and appropriate treatment initiated.
Croatian: Ako je pankreatitis očigledan, u odsutnosti nekog drugog očitog uzroka preporučuje se razmotriti ukidanje Zonegrana i započeti odgovarajuće liječenje.
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 bilo potrebno).
English: The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/min.
Croatian: AUC zonisamida u plazmi bio je povećan za 35% u ispitanika s klirensom kreatinina < 20 ml/min.
English: Patients with an impaired liver function: The pharmacokinetics of zonisamide in patients with impaired liver function have not been adequately studied.
Croatian: Bolesnici s oštećenom funkcijom jetre: farmakokinetika zonisamida u bolesnika s oštećenom funkcijom jetre nije odgovarajuće ispitana.
English: Therefore, modification of Zonegran dosing should not be necessary when co-administered with known CYP3A4 inhibitors.
Croatian: Stoga modifikacija doziranja Zonegrana nije potrebna kada se primjenjuje istodobno s poznatim inhibitorima CYP3A4.
English: PP = Per Protocol Population; ITT = Intent To Treat Population *Primary endpoint
Croatian: PP = populacija koja je završila ispitivanje prema planu ispitivanja (engl. per protocol); ITT = populacija predviđena za liječenje (engl. intent-to-treat)
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 izrazitija sniženja.
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.
Croatian: U kliničkim ispitivanjima Zonegran se primjenjivao u više od 1200 bolesnika, a više od njih 400 primalo je Zonegran najmanje 1 godinu.
English: • if you are allergic to peanut or soya, do not use this medicinal product.
Croatian: • ako ste alergični na kikiriki ili soju, nemojte uzimati ovaj lijek.
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.
Croatian: U bolesnika koji uzimaju Zonegran i razviju kliničke znakove i simptome pankreatitisa, preporučuje se nadzor razina pankreatične lipaze i amilaze.
English: • The recommended daily dose is between 300 mg and 500 mg.
Croatian: • Preporučena je dnevna doza između 300 mg i 500 mg.
English: A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in adult and paediatric patients receiving zonisamide.
Croatian: Sindrom koji se sastoji od akutne miopije povezane sa sekundarnim glaukomom zatvorenog kuta zabilježen je u odraslih i pedijatrijskih bolesnika koji su primali zonisamid.
English: Week 1 + 2 Week 3 + 4 Week 5 + 6
Croatian: + 2. tjedan 3. + 4. tjedan 5. + 6. tjedan
English: Risk factors for nephrolithiasis include prior stone formation, a family history of nephrolithiasis and hypercalciuria.
Croatian: Čimbenici rizika za nefrolitijazu uključuju prethodnu pojavu bubrežnih kamenaca, obiteljsku povijest nefrolitijaze i hiperkalcijuriju.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zonegran therapy.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja Zonegranom.
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).
Croatian: U djece u dobi od 6 do 17 godina, nuspojave su se podudarale s niže opisanima uz sljedeće iznimke: upala pluća, dehidracija, smanjeno znojenje (često) i poremećeni jetreni enzimi (manje često).
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.
Croatian: U skladu s postojećom kliničkom praksom, u bolesnika s epilepsijom Zonegran se mora ukinuti postupnim snižavanjem doze kako bi se umanjila mogućnost napadaja povezanih s ukidanjem lijeka.
English: These effects are unlikely to be of clinical significance when Zonegran is added to existing therapy; however, changes in zonisamide concentrations may occur if concomitant CYP3A4-inducing anti-epileptic or other medicinal products are withdrawn, dose adjusted or introduced, an adjustment of the Zonegran dose may be required.
Croatian: Nije vjerojatno da će ti učinci biti klinički značajni kada se Zonegran dodaje već postojećoj terapiji; međutim, promjene u koncentracijama zonisamida mogu nastupiti ako se istodobno primjenjivani antiepileptički lijekovi koji induciraju CYP3A4 ili drugi lijekovi ukidaju, ako im se mijenja doza ili se uvode u liječenje i tada može biti potrebna prilagodba doze Zonegrana.
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 izbijanje neurona, smanjujući širenje napadaja i prekidajući posljedičnu epileptičnu aktivnost.
English: If the decision is made to continue patients on Zonegran in the face of persistent acidosis, alkali treatment should be considered.
Croatian: Kada se odluči da bolesnici nastave uzimati Zonegran unatoč ustrajnoj acidozi, treba razmotriti liječenje alkalnim preparatima.
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).
Croatian: • starije dobi, jer Vašu dozu Zonegrana možda treba prilagoditi i kod Vas je veća vjerojatnost pojave alergijske reakcije, teškog osipa na koži, oticanja stopala i nogu te svrbeža kada uzimate Zonegran (vidjeti dio 4. Moguće nuspojave)
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 mg do 8 mg po kilogramu za djecu tjelesne težine do 55 kg ili od
English: If elevated, in the absence of another obvious cause such as trauma or grand mal seizures, it is recommended that Zonegran discontinuation be considered and appropriate treatment initiated.
Croatian: Ako su povišeni, a u odsutnosti nekog drugog očitog uzroka kao što su trauma ili veliki epileptički napadaji (tzv. grand mal), preporučuje se razmotriti ukidanje Zonegrana i započeti odgovarajuće liječenje.
English: If substantial undesirable weight loss occurs, discontinuation of Zonegran should be considered.
Croatian: Ako dođe do znatnog neželjenog gubitka težine, potrebno je razmotriti prekid liječenja Zonegranom.
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).
Croatian: • otečene žlijezde, poremećaji krvi (smanjeni broj krvnih stanica zbog čega se može povećati mogućnost nastanka infekcije i možete biti blijedi, osjećati se umorno i kao da imate vrućicu, lako
English: Zonisamide is a benzisoxazole derivative.
Croatian: Zonisamid je derivat benzizoksazola.
English: Blister Pack
Croatian: Blister pakiranje
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.
Croatian: U kliničkim ispitivanjima u zdravih ispitanica, doziranje Zonegrana u stanju dinamičke ravnoteže nije utjecalo na koncentracije etinilestradiola ili noretisterona u serumu u kombiniranom oralnom kontraceptivu.
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.
Croatian: Također, možete osjećati mučninu, imati bolove u želucu, trzanje mišića, pokrete oka, možete osjećati nesvjesticu, imati usporene otkucaje srca, smanjeno disanje i smanjenu funkciju bubrega.
English: There is no need for dose adjustment with any of the AEDs including CYP3A4 inducers.
Croatian: Nema potrebe za prilagodbom doze ni uz jedan antiepileptik, uključujući induktore CYP3A4.
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.
Croatian: 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: 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.
Croatian: U odraslih bolesnika djelotvornost Zonegrana dokazana je u 4 dvostruko slijepa, placebom kontrolirana ispitivanja u trajanju do 24 tjedna, uz dozu jedanput ili dvaput na dan.
English: Therefore, Zonegran is not expected to affect the pharmacokinetics of other medicinal products via cytochrome P450-mediated mechanisms, as demonstrated for carbamazepine, phenytoin, ethinylestradiol and desipramine in vivo.
Croatian: Stoga se ne očekuje da bi Zonegran utjecao na farmakokinetiku drugih lijekova putem mehanizama posredovanih citokromom P450, kao što se pokazalo in vivo za karbamazepin, fenitoin, etinilestradiol i desipramin.
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).
Croatian: Među 465 ispitanika u bazi podataka o sigurnosti primjene u pedijatrijskih ispitanika (uključujući dodatnih 67 ispitanika iz faze produžetka kontroliranog kliničkog ispitivanja), bilo je 7 smrtnih slučajeva (1,5%; 14,6/1000 osoba-godina), i to 2 slučaja epileptičkog statusa od kojih je jedan bio povezan s teškim gubitkom težine (10% unutar 3 mjeseca) u jednog ispitanika s tjelesnom težinom manjom od prosječne i posljedičnom nemogućnošću uzimanja lijeka; 1 slučaj ozljede glave/hematoma i 4 smrtna slučaja u ispitanika s prethodno postojećim funkcionalnim neurološkim deficitima različitih uzroka (2 slučaja sepse/zatajenja organa prouzročenih upalom pluća, 1 slučaj iznenadne neobjašnjive smrti bolesnika s epilepsijom (SUDEP) i 1 ozljeda glave).
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.
Croatian: • bol u mišićima ili osjećaj slabosti, jer to može biti znak nenormalne razgradnje mišića što može dovesti do tegoba s bubrezima
English: • Give your child cold water to drink
Croatian: • dajte djetetu hladnu vodu za piće
English: Hyperchloraemic, non-anion gap, metabolic acidosis (i.e. decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) is associated with Zonegran treatment.
Croatian: Hiperkloremična metabolička acidoza bez anionskog procjepa (tj. smanjene razine bikarbonata u serumu ispod normalnog raspona vrijednosti u odsutnosti kronične respiratorne alkaloze) povezana je s liječenjem Zonegranom.
English: • are underweight, or have lost a lot of weight as Zonegran can cause you to lose more weight.
Croatian: • ako je Vaša tjelesna težina manja od prosječne ili ako ste mnogo izgubili na težini jer Zonegran može izazvati daljnji gubitak težine.
English: Marketing Authorisation Holder Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germanye-mail: medinfo_de@eisai.net
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Njemačka e-mail: medinfo_de@eisai.net
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 brzo uslijedili povraćanje ili ispiranje želuca.
English: • With other antiepileptic medicines to treat seizures in adults, adolescents, and children aged
Croatian: • s drugim lijekovima protiv epilepsije za liječenje napadaja u odraslih, adolescenata i djece u dobi od 6 i više godina.
English: 14 hard capsules 28 hard capsules 56 hard capsules 84 hard capsules
Croatian: 14 tvrdih kapsula 28 tvrdih kapsula 56 tvrdih kapsula 84 tvrde kapsule
English: • loss of appetite, decreased blood levels of bicarbonate (a substance that prevents your blood from becoming acidic)
Croatian: • gubitak apetita, smanjene razine bikarbonata u krvi (tvar koja sprječava da Vam krv postane kisela)
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.
Croatian: Ako je propisan Zonegran tijekom trudnoće, bolesnice moraju biti upoznate u potpunosti s mogućim štetnim posljedicama za plod i savjetuje se primjena minimalne učinkovite doze, uz pažljivo praćenje.
English: • liver problems, kidney failure, increased blood levels of creatinine (a waste product that your kidneys should normally remove).
Croatian: • tegobe s jetrom, zatajenje bubrega, povećane razine kreatinina u krvi (otpadni produkt koji bi u normalnim okolnostima Vaši bubrezi trebali ukloniti)
English: In clinical studies co-administration of lamotrigine had no apparent effect on zonisamide pharmacokinetics.
Croatian: U kliničkim ispitivanjim istodobna primjena lamotrigina nije imala vidljiv učinak na farmakokinetiku zonisamida.