FrancophonIA/ELRC3.0 huggingface dataset:
English: • develop visual problems such as eye pain or blurred vision while taking Zonegran
Croatian: • tegobe s vidom kao što je bol u oku ili zamagljen vid dok uzimate Zonegran.
English: • The recommended dose is 300 mg once a day.
Croatian: • Preporučena doza je 300 mg jedanput na dan.
English: Zonegran contains soya oil.
Croatian: Zonegran sadrži sojino ulje.
English: In a zonisamide placebo-controlled study conducted in paediatric and adolescent patients, the proportion of patients with impaired cognition was numerically greater in the zonisamide group compared with the placebo group.
Croatian: U placebom kontroliranom ispitivanju zonisamida provedenom u pedijatrijskih i adolescentnih bolesnika, udio bolesnika s oštećenim kognitivnim sposobnostima bio je brojčano veći u skupini koja je primala zonisamid nego u skupini koja je primala placebo.
English: 28 hard capsules 56 hard capsules 84 hard capsules 98 hard capsules 196 hard capsules
Croatian: 28 tvrdih kapsula 56 tvrdih kapsula 84 tvrde kapsule 98 tvrdih kapsula 196 tvrdih kapsula
English: • vomiting.
Croatian: • povraćanje
English: Zonegran must not be used in women of childbearing potential not using effective contraception unless clearly necessary and only if the potential benefit is considered to justify the risk to the foetus.
Croatian: Zonegran se ne smije koristiti u žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju, osim ako za time ne postoji jasna potreba i samo ako moguća korist ne opravdava mogući rizik za plod.
English: Women of childbearing potential must use effective contraception during treatment with Zonegran and for one month after discontinuation (see section 4.6).
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja Zonegranom i još mjesec dana nakon prestanka liječenja (vidjeti dio 4.6).
English: Potential for Zonegran to affect other medicinal products
Croatian: Mogući utjecaji Zonegrana na druge lijekove
English: The warnings and precautions mentioned above are also applicable to adolescent and paediatric patients.
Croatian: Prethodno navedena upozorenja i mjere opreza primjenjivi su i na adolescente i na pedijatrijske bolesnike.
English: Such electrolyte imbalance has been observed with the use of Zonegran in placebo-controlled clinical trials and in the post-marketing period.
Croatian: Takva neravnoteža elektrolita opažena je uz primjenu Zonegrana u placebom kontroliranim kliničkim ispitivanjima te u razdoblju nakon stavljanja lijeka u promet.
English: Zonegran must not be used during pregnancy unless clearly necessary and only if the potential benefit is considered to justify the risk to the foetus.
Croatian: Zonegran se ne smije uzimati u trudnoći osim ako je to nužno potrebno te samo onda kad se smatra da moguća dobrobit opravdava rizik za fetus.
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.
Croatian: Zonegran 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: 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.
Croatian: U bolesnika koji uzimaju Zonegran i razviju jake bolove u mišićima i/ili slabost, bilo u prisutnosti ili odsutnosti vrućice, preporučuje se procijeniti biljege oštećenja mišića uključujući razine kreatin fosfokinaze u serumu i aldolaze.
English: ≥ 1/100 to < 1/10
Croatian: ≥ 1/100 i < 1/10
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.
Croatian: Zonisamid se metabolizira prvenstveno redukcijskim cijepanjem benzizoksazolskog prstena osnovnog lijeka pomoću CYP3A4 i stvara 2-sulfamoilacetilfenol (SMAP), a također i N-acetilacijom.
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.
Croatian: U zdravih ispitanika doziranje ketokonazola (400 mg na dan) ili cimetidina (1200 mg na dan) u stanju dinamičke ravnoteže nije imalo klinički značajne učinke na farmakokinetiku jednokratne doze zonisamida.
English: All patients who develop a rash while taking Zonegran must be closely supervised, with additional levels of caution applied to those patients receiving concomitant antiepileptic agents that may independently induce skin rashes.
Croatian: Sve bolesnike koji razviju osip tijekom primjene Zonegrana treba pomno nadzirati, uz dodatnu pozornost usmjerenu na one bolesnike koji istodobno primaju antiepileptičke lijekove koji sami po sebi mogu prouzročiti pojavu osipa na koži.
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.
Croatian: Za neke bolesnike, a osobito one s predispozicijom za razvoj nefrolitijaze, može postojati povećan rizik od nastanka bubrežnih kamenaca i s time povezanih znakova i simptoma kao što su bubrežne kolike, bolovi u bubrezima ili bol u predjelu slabina.
English: • poor muscle coordination, dizziness, poor memory, sleepiness, double vision
Croatian: • loša koordinacija mišića, omaglica, oslabljeno pamćenje, pospanost, dvoslike
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).
Croatian: • ne smije uzimati nijedan od ovih lijekova: inhibitore karboanhidraze (kao što su topiramat i acetazolamid) i antikolinergičke lijekove (kao što su klomipramin, hidroksizin, difenhidramin, haloperidol, imipramin i oksibutinin).
English: If you forget to take Zonegran
Croatian: Ako ste zaboravili uzeti Zonegran
English: System Organ Class (MedDRA terminology†)
Croatian: Klasifikacija organskih sustava (MedDRA terminologija†)
English: • Your child must avoid heavy exercise especially when the weather is hot
Croatian: • mora izbjegavati teške tjelesne aktivnosti osobito kada su vrućine
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.
Croatian: Ispitivanja in vitro na mikrosomima ljudske jetre ne pokazuju ili pokazuju malu inhibiciju (< 25%) izoenzima 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 ili 3A4 citokroma P450 pri koncentracijama zonisamida koje su bile približno dva ili više puta veće od klinički značajnih koncentracija slobodnog zonisamida u serumu.
English: Week 3 to 5
Croatian: 2. tjedan od 3. do 5. tjedna
English: Zonegran can cause children to sweat less and overheat and if the child is not treated this can lead to brain damage and death.
Croatian: Zonegran može u djece prouzročiti smanjeno znojenje i pregrijavanje, a ako se dijete ne liječi to može dovesti do oštećenja mozga i smrti.
English: - Enzyme induction: Exposure to zonisamide is lower in epileptic patients receiving CYP3A4-inducing agents such as phenytoin, carbamazepine, and phenobarbitone.
Croatian: - Indukcija enzima: izloženost zonisamidu manja je u bolesnika s epilepsijom koji primaju lijekove koji induciraju CYP3A4, kao što su fenitoin, karbamazepin i fenobarbiton.
English: Women planning a pregnancy should meet with their specialists to reassess treatment with Zonegran and to consider other therapeutic options.
Croatian: Žene koje planiraju trudnoću moraju posjetiti specijaliste radi ponovne procjene liječenja Zonegranom i razmatranja drugih terapijskih opcija.
English: Do not take Zonegran: • if you are allergic to zonisamide or any of the other ingredients of this medicine (listed in section
Croatian: • ako ste alergični na zonisamid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6),
English: There are limited data from the use of Zonegran in pregnant women.
Croatian: Podaci o primjeni Zonegrana u trudnica su ograničeni.
English: • have signs of increased acid level in the blood- headaches, drowsiness, shortness of breath and loss of appetite.
Croatian: • opazite znakove povećane razine kiseline u krvi - glavobolje, osjećate omamljenost, nedostatak zraka i gubitak apetita.
English: Adjunctive therapy - with CYP3A4inducing agents (see section 4.5)
Croatian: Dodatna terapija - s lijekovima induktorima CYP3A4 (vidjeti dio 4.5)
English: Nevertheless, if a hepatic event is suspected, liver function should be evaluated and discontinuation of Zonegran should be considered.
Croatian: Ipak, u slučaju sumnje na događaj povezan s jetrom, funkciju jetre treba provjeriti i razmotriti prekid liječenja Zonegranom.
English: Zonegran contains the active substance zonisamide, and is used as an antiepileptic medicine.
Croatian: Zonegran sadrži djelatnu tvar zonisamid i koristi se kao lijek protiv epilepsije.
English: • skin rashes, itching, allergic reactions, fever, tiredness, flu-like symptoms, hair loss.
Croatian: • osipi po koži, svrbež, alergijske reakcije, vrućica, umor, simptomi nalik gripi, gubitak kose
English: In the event kidney stones are detected, Zonegran should be discontinued.
Croatian: U slučaju da se otkriju bubrežni kamenci, liječenje Zonegranom treba prekinuti.
English: Date of first authorisation: 10/03/2005 Date of latest renewal:
Croatian: Datum posljednje obnove odobrenja: 21. prosinca 2009.
English: Adults - recommended dosage escalation and maintenance regimen
Croatian: Tablica 1 Odrasli - preporučeni režim postupnog povećavanja i održavanja doze Režim liječenja
English: Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germany.
Croatian: Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Njemačka
English: Cases of decreased sweating and elevated body temperature have been reported mainly in paediatric patients (see section 4.4 Paediatric population for full warning).
Croatian: Slučajevi smanjenog znojenja i povišene tjelesne temperature zabilježeni su uglavnom u pedijatrijskih bolesnika (za sva upozorenja vidjeti dio 4.4, Pedijatrijska populacija).
English: How to take Zonegran
Croatian: Kako uzimati Zonegran
English: • The other ingredients that are present in the capsule contents are: microcrystalline cellulose, hydrogenated vegetable oil (from soyabean) and sodium laurilsulfate.
Croatian: • Drugi sastojci koje sadrži kapsula: mikrokristalična celuloza, hidrogenirano biljno ulje (sojino) i natrijev laurilsulfat.
English: • have signs of overheating - high body temperature but little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion.
Croatian: • znakovi pregrijanosti - visoka tjelesna temperatura, ali uz malo znojenja ili bez znojenja, brzi otkucaji srca i brzo disanje, grčevi u mišićima i smetenost
English: Caution must be exercised in treating patients with mild to moderate hepatic impairment, and a slower titration of Zonegran may be required.
Croatian: Treba postupati oprezno u liječenju bolesnika s blagim do umjerenim oštećenjem jetre i može biti potrebna sporija titracija Zonegrana.
English: The most common side effects of Zonegran are mild.
Croatian: Najčešće nuspojave Zonegrana su blage.
English: • The capsule shell contains: gelatin, titanium dioxide (E171), shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
Croatian: • Ovojnica kapsule sadrži: želatinu, titanijev dioksid (E171), šelak, propilenglikol, kalijev hidroksid, crni željezov oksid (E172).
English: In epileptic patients, steady-state dosing with Zonegran resulted in no clinically relevant pharmacokinetic effects on carbamazepine, lamotrigine, phenytoin, or sodium valproate.
Croatian: U bolesnika s epilepsijom doziranje Zonegrana u stanju dinamičke ravnoteže nije rezultiralo klinički značajnim farmakokinetičkim učincima na karbamazepin, lamotrigin, fenitoin ili natrijev valproat.
English: Monotherapy in partial seizures, with or without secondary generalisation
Croatian: Monoterapija pri parcijalnim napadajima, sa ili bez sekundarne generalizacije
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.
Croatian: Bolesnike ili njihove njegovatelje treba upozoriti da, ovisno o stanju bolesnika, vode računa o održavanju hidracije i izbjegavanju izlaganja bolesnika visokim temperaturama te napornim tjelesnim aktivnostima.
English: • On its own to treat seizures in adults.
Croatian: • kao samostalni lijek za liječenje napadaja u odraslih
English: The risk of zonisamide induced metabolic acidosis appears to be more frequent and severe in younger patients.
Croatian: Rizik od metaboličke acidoze uzrokovane zonisamidom čini se da je učestaliji i teži u mlađih bolesnika.
English: Zonegran can cause your child to sweat less and overheat and if your child is not treated this can lead to brain damage and death.
Croatian: Zonegran može u Vašeg djeteta prouzročiti smanjeno znojenje i pregrijavanje, pa ako se dijete ne liječi, to može dovesti do oštećenja mozga i smrti.
English: If your child's skin feels very hot with little or no sweating, becomes confused, has muscle cramps, or your child's heartbeat or breathing becomes rapid:
Croatian: Ako je koža Vašega djeteta vrlo ugrijana uz malo znojenja ili bez znojenja, dijete je postalo smeteno, ima grčeve u mišićima, ili su djetetovi srčani otkucaji ili disanje postali ubrzani:
English: Zonegran hard capsules are for oral use.
Croatian: Zonegran tvrde kapsule primjenjuju se peroralno.
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.
Croatian: U štakora smanjeni broj žutih tijela i mjesta ugnježđenja opaženi su pri razinama izloženosti jednakim maksimalnoj terapijskoj dozi u ljudi; pri tri puta većim razinama izloženosti opaženi su neredoviti ciklusi estrusa i manji broj živih fetusa.
English: Contact your doctor immediately if you:
Croatian: Odmah se obratite liječniku ako Vam se pojavi:
English: Adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adolescent and paediatric patients (aged 6 years and above)
Croatian: Dodatna terapija u liječenju parcijalnih napadaja sa ili bez sekundarne generalizacije u adolescenata i pedijatrijskih bolesnika (u dobi od 6 i više godina)
English: Acute myopia and secondary angle closure glaucoma
Croatian: Akutna miopija i sekundarni glaukom zatvorenog kuta
English: • This may be increased by 1 mg per kg of body weight at intervals of one to two weeks.
Croatian: • Ta se doza može povećavati za 1 mg po kilogramu tjelesne težine u razmacima od jednog do dva tjedna.
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
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.
Croatian: Liječnici koji propisuju lijek moraju upozoriti pedijatrijske bolesnike i njihove roditelje/njegovatelje na savjete za sprječavanje toplinskog udara i pregrijavanja u djece navedene u uputi o lijeku.
English: If you are a woman of childbearing age you must use adequate contraception while taking and for one month after stopping Zonegran.
Croatian: Ako ste žena koja bi mogla zatrudnjeti, morate koristiti odgovarajuću kontracepciju dok uzimate Zonegran i još mjesec dana nakon prestanka liječenja.
English: Specialist medical advice should be given to women treated with zonisamide who are of childbearing potential.
Croatian: Potreban je savjet specijaliste ženama koje se liječe zonisamidom, a u reproduktivnoj su dobi.
English: • The starting dose is 1 mg per kg of body weight taken once a day.
Croatian: • Početna je doza 1 mg po kilogramu tjelesne težine, a uzima se jedanput na dan.
English: ≥ 1/1,000 to < 1/100
Croatian: ≥ 1/1000 i < 1/100
English: Caution should be exercised at initiation of treatment in elderly patients as there is limited information on the use of Zonegran in these patients.
Croatian: Liječenje bolesnika starije dobi treba započeti oprezno jer su podaci o primjeni Zonegrana u tih bolesnika ograničeni.
English: ≥ 1/10,000 to < 1/1,000
Croatian: ≥ 1/10 000 i < 1/1000
English: A pooled analysis of safety data on 420 paediatric subjects (183 subjects aged 6 to 11 years, and 237 subjects aged 12 to 16 years with a mean duration of exposure of approximately 12 months) has shown a relatively higher reporting frequency of pneumonia, dehydration, decreased sweating, abnormal liver function tests, otitis media, pharyngitis, sinusitis and upper respiratory tract infection, cough, epistaxis and rhinitis, abdominal pain, vomiting, rash and eczema, and fever compared to the adult population (particularly in subjects aged below 12 years) and, at a low incidence, amnesia, creatinine increased, lymphadenopathy, and thrombocytopenia.
Croatian: Objedinjena analiza podataka sigurnosti primjene za 420 pedijatrijskih bolesnika (183 ispitanika u dobi od 6 do 11 godina i 237 ispitanika u dobi od 12 do 16 godina s prosječnim trajanjem izloženosti od približno 12 mjeseci) pokazala je relativno češće zabilježenu upalu pluća, dehidraciju, smanjeno znojenje, nepravilne rezultate pretraga funkcije jetre, upalu srednjeg uha, faringitis, sinusitis i infekciju gornjih dišnih putova, kašalj, epistaksu i rinitis, bol u trbuhu, povraćanje, osip i ekcem te vrućicu u usporedbi s odraslom populacijom (osobito u ispitanika mlađih od 12 godina), a nisku incidenciju amnezije, povećanog kreatinina, limfadenopatije i trombocitopenije.
English: The risk of zonisamide induced metabolic acidosis appears to be more frequent and severe in paediatric and adolescent patients.
Croatian: Rizik od metaboličke acidoze uzrokovane zonisamidom čini se da je učestaliji i teži u pedijatrijskih bolesnika i adolescenata.
English: Zonegran is a benzisoxazole derivative, which contains a sulphonamide group.
Croatian: Zonegran je derivat benzizoksazola koji sadrži sulfonamidnu skupinu.
English: It should be noted that Zonegran is a benzisoxazole derivative, which contains a sulphonamide group.
Croatian: Treba voditi računa da je Zonegran derivat benzizoksazola koji sadrži sulfonamidnu skupinu.
English: Caution must be exercised in treating patients with renal impairment, as there is limited information on use in such patients and a slower titration of Zonegran might be required.
Croatian: U liječenju bolesnika s oštećenjem bubrega treba postupati oprezno jer su podaci o primjeni u takvih bolesnika ograničeni i mogle bi biti potrebne sporije titracije Zonegrana.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „Rok valjanosti“.
English: Adverse reactions in a randomised, controlled monotherapy trial comparing zonisamide with carbamazepine prolonged release System Organ Class (MedDRA terminology†)
Croatian: Tablica 5 Nuspojave iz randomiziranog, kontroliranog ispitivanja monoterapije zonisamidom u usporedbi s monoterapijom karbamazepinom produljenog otpuštanja Klasifikacija organskih sustava (MedDRA terminologija†)
English: Zonegran contains Hydrogenated vegetable oil (from soyabean).
Croatian: Zonegran sadrži hidrogenirano biljno ulje (sojino).
English: A small number of people being treated with antiepileptics such as Zonegran have had thoughts of harming or killing themselves.
Croatian: • pomišljate da se ozlijedite ili počinite samoubojstvo; mali broj osoba liječenih antiepileptičnim lijekovima kao što je Zonegran pomišljali su na to da se ozlijede ili počine samoubojstvo
English: Efficacy results for Monotherapy Study 310 Zonisamide Carbamazepine n (ITT population) Six months seizure freedom
Croatian: Tablica 6 Rezultati djelotvornosti za monoterapijsko ispitivanje 310 Zonisamid Karbamazepin n (ITT populacija) Šest mjeseci bez napadaja
English: When your child is taking Zonegran:
Croatian: Kada se Vaše dijete liječi Zonegranom:
English: • suffer from liver problems, as your dose of Zonegran may need adjusting.
Croatian: • patite od tegoba s jetrom jer Vam možda treba prilagoditi dozu Zonegrana
English: Subjects who experienced a further seizure were titrated to the maximal target dose of 1200 mg carbamazepine or 500 mg zonisamide.
Croatian: Ispitanici koji su i dalje imali napadaje titrirani su do maksimalne ciljne doze od 1200 mg karbamazepina ili 500 mg zonisamida.
English: Excipients: 0.002 mg of sunset yellow FCF (E110) and 0.147 mg of allura red AC (E129).
Croatian: Pomoćne tvari: 0,002 mg boje sunset yellow FCF (E110) i 0,147 mg boje allura red AC (E129).
English: Paediatric population (aged 6 years and above) - recommended dosage escalation and maintenance regimen
Croatian: Tablica 2 Pedijatrijska populacija (u dobi od 6 i više godina) - preporučeni režim postupnog povećavanja i održavanja doze
English: Do not breast-feed whilst taking, or for one month after stopping Zonegran.
Croatian: Dojenje treba prekinuti za vrijeme uzimanja ili još mjesec dana nakon prekida uzimanja Zonegrana.
English: Complex partial All generalized Tonic-Clonic Secondary Tonic-Clonic Generalized Tonic-Clonic
Croatian: Podvrsta napadaja (bez napadaja 6 mjeseci - PP populacija) svi parcijalni jednostavni parcijalni kompleksni parcijalni svi generalizirani toničko-klonički sekundarni toničko-klonički generalizirani toničko-klonički
English: Caution should be used in adults when Zonegran is prescribed with other medicinal products that predispose patients to heat related disorders; these include carbonic anhydrase inhibitors and medicinal products with anticholinergic activity (see also section 4.4 Paediatric population).
Croatian: Oprez je potreban u odraslih kada se Zonegran propisuje s drugim lijekovima koji u bolesnika stvaraju predispoziciju na poremećaje povezane s vrućinom; to uključuje inhibitore karboanhidraze i lijekove s antikolinergičkim djelovanjem (vidjeti također dio 4.4, Pedijatrijska populacija).
English: • breathing disorders, shortness of breath, inflammation of the lungs.
Croatian: • poremećaji disanja, nedostatak zraka, upala pluća
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.
Croatian: • iznenada Vas zaboli u leđima ili trbuhu, boli vas pri mokrenju ili opazite krv u mokraći, jer to može biti znak bubrežnih kamenaca
English: Zonegran should not be used as co-medication in paediatric patients with other medicinal products that predispose patients to heat related disorders; these include carbonic anhydrase inhibitors and medicinal products with anticholinergic activity.
Croatian: Zonegran se u pedijatrijskih bolesnika ne smije primjenjivati s drugim lijekovima koji u bolesnika stvaraju predispoziciju na poremećaje povezane s vrućinom; to uključuje inhibitore karboanhidraze i lijekove s antikolinergičkim djelovanjem.