FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: U ispitivanjima toksičnosti s ponovljenom peroralnom dozom u mladih štakora, pri razinama izloženosti sličnima onim opaženim u pedijatrijskih bolesnika pri maksimalnoj preporučenoj dozi, opažena su smanjenja tjelesne težine i promjene parametara bubrežne histopatologije i kliničke patologije te promjene ponašanja.
English: Zonisamide prevents maximal electroshock seizures and restricts seizure spread, including the propagation of seizures from cortex to sub-cortical structures and suppresses epileptogenic focus activity.
Croatian: Zonisamid sprječava najveće napadaje izazvane elektroškovima i ograničava njihovo širenje uključujući prijenos napadaja s korteksa u supkortikalne strukture te zaustavlja aktivnost epileptogenog žarišta.
English: Weight loss is potentially more serious in children (see section 4.4.
Croatian: Gubitak težine može postati ozbiljniji u djece (vidjeti dio 4.4, Pedijatrijska populacija).
English: Class (MedDRA terminology)
Croatian: Klasifikacija organskih sustava (MedDRA terminologija
English: Findings not observed in clinical studies, but seen in the dog at exposure levels similar to clinical use, were liver changes (enlargement, dark-brown discolouration, mild hepatocyte enlargement with concentric lamellar bodies in the cytoplasm and cytoplasmic vacuolation) associated with increased metabolism.
Croatian: Nalazi koji nisu bili opaženi u kliničkim ispitivanjima, ali su primijećeni u pasa pri razinama izloženosti sličnim onima u kliničkoj primjeni, bili su promjene na jetri (povećanje, promjena boje u tamnosmeđu, blago povećanje hepatocita s koncentričnim lamelarnim tjelešcima u citoplazmi i vakuolizacija citoplazme) povezano s pojačanim metabolizmom.
English: Recommended escalation and maintenance doses are given in Table 2.
Croatian: Preporuke za postupno povećavanje doze i doze održavanja navedene su u tablici 2.
English: Reduce the risk of overheating by drinking sufficient water and keeping cool - are underweight, or have lost a lot of weight as Zonisamide Mylan can cause you to lose more weight.
Croatian: Opasnost od pregrijavanja smanjite tako da pijete dovoljno vode i budete rashlađeni. - ako je Vaša tjelesna težina manja od prosječne ili ako ste mnogo izgubili na težini, jer Zonisamide Mylan može izazvati daljnji gubitak težine.
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: - take your child to a cool, shaded place - sponge your child's skin with cool (not cold) water - give your child cold water to drink - seek urgent medical assistance.
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: - sklonite dijete na hladnije mjesto u sjeni - spužvom vlažite kožu djeteta vodom normalne temperature (ne hladnom) - dajte djetetu hladnu vodu za piće - potražite hitnu medicinsku pomoć.
English: Very rare (may affect up to 1 in 10,000 people): - memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever,
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba): - gubitak pamćenja, koma, maligni neuroleptički sindrom (nemogućnost kretanja, znojenje,
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 „Rok valjanosti”.
English: Zonisamide is a benzisoxazole derivative.
Croatian: Zonisamid je derivat benzisoksazola.
English: The other ingredients are: - capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate - capsule shell: gelatin and titanium dioxide (E171) - printing ink: shellac and iron oxide red (E172)
Croatian: Drugi sastojci su: - sadržaj kapsule: mikrokristalična celuloza, hidrogenirano biljno ulje i natrijev laurilsulfat - ovojnica kapsule: želatina i titanijev dioksid (E171) - tinta za označavanje: šelak i crveni željezov oksid (E172)
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: 14 hard capsules 28 hard capsules 56 hard capsules
Croatian: 14 tvrdih kapsula 28 tvrdih kapsula 56 tvrdih kapsula
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 ozbiljniji u pedijatrijskih bolesnika i adolescenata.
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: Adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation in adults
Croatian: Dodatna terapija u liječenju parcijalnih napadaja sa ili bez sekundarne generalizacije u odraslih bolesnika
English: Week 1 + 2 Week 3 + 4 Week 5 to 10
Croatian: + 2. tjedan 3. + 4. tjedan od 5. do 10. tjedna
English: ≥ 1/1,000 to < 1/100
Croatian: ≥ 1/100 i < 1/10 manje često ≥ 1/1000 i < 1/100 rijetko
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 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: Zonisamide Mylan 100 mg are available in blister packs of 28, 56, 98 and 196 capsules and perforated unit dose blister packs of 56 x 1 capsules.
Croatian: Zonisamide Mylan 100 mg dostupan je u blister pakiranjima s 28, 56, 98 i 196 kapsula i perforiranim blister pakiranjima djeljivim na jedinične doze s 56 × 1 kapsulom.
English: There are limited data from clinical studies in patients with a body weight of less than 20 kg.
Croatian: Podaci iz kliničkih ispitivanja provedenih u bolesnika tjelesne težine manje od 20 kg su ograničeni.
English: Unexplained rash
Croatian: Neobjašnjiv osip
English: Week 1 + 2 Weeks ≥ 3
Croatian: + 2. tjedan ≥ 3. tjedan
English: Zonisamide is a benzisoxazole derivative, which contains a sulfonamide group.
Croatian: Zonisamid je derivat benzisoksazola koji sadrži sulfonamidnu skupinu.
English: When your child is taking Zonisamide Mylan: keep your child cool especially in hot weather your child must avoid heavy exercise especially when the weather is hot give your child plenty of cold water to drink your child must not take these medicines: carbonic anhydrase inhibitors (like topiramate and acetazolamide), and anticholinergic agents (like clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).
Croatian: Kada se Vaše dijete liječi lijekom Zonisamide Mylan: - ono treba biti rashlađeno osobito za vrućeg vremena - mora izbjegavati teške tjelesne aktivnosti osobito kada su vrućine - mora piti mnogo hladne vode - ne smije uzimati nijedan od ovih lijekova: inhibitore karboanhidraze (kao što su topiramat i acetazolamid) i lijekove s antikolinergičkom aktivnošću (kao što su klomipramin, hidroksizin, difenhidramin, haloperidol, imipramin i oksibutinin).
English: Zonisamide Mylan 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: Zonisamide Mylan može u Vašeg djeteta prouzročiti smanjeno znojenje i pregrijavanje, pa ako se dijete ne liječi to može dovesti do oštećenja mozga i smrti.
English: Therefore use in patients with severe hepatic impairment is not recommended.
Croatian: Stoga se ne preporučuje primjena u bolesnika s teškim oštećenjem jetre.
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 žutog 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: In epileptic patients, steady-state dosing with zonisamide resulted in no clinically relevant pharmacokinetic effects on carbamazepine, lamotrigine, phenytoin, or sodium valproate.
Croatian: U bolesnika s epilepsijom doziranje zonisamida u stanju dinamičke ravnoteže nije rezultiralo klinički relevantnim farmakokinetičkim učincima na karbamazepin, lamotrigin, fenitoin ili natrijev valproat.
English: In addition, patients taking other medications associated with nephrolithiasis may be at increased risk.
Croatian: Osim toga, povećan je rizik za bolesnike koji uzimaju druge lijekove povezane s nefrolitijazom.
English: The other ingredients are: - capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate - capsule shell: gelatin and titanium dioxide (E171) - printing ink: shellac, black iron oxide (E172) and potassium hydroxide.
Croatian: Drugi sastojci su: - sadržaj kapsule: mikrokristalična celuloza, hidrogenirano biljno ulje i natrijev laurilsulfat - ovojnica kapsule: želatina i titanijev dioksid (E171) - tinta za označavanje: šelak, crni željezov oksid (E172) i kalijev hidroksid.
English: Caution should be exercised at initiation of treatment in elderly patients as there is limited information on the use of zonisamide in these patients.
Croatian: Liječenje bolesnika starije dobi treba započeti oprezno jer su podaci o primjeni zonisamida u tih bolesnika ograničeni.
English: In clinical studies of paediatric patients, down-titration was completed by dose reductions at weekly intervals in increments of about 2 mg/kg (i.e. in accordance with the schedule in Table 3).
Croatian: U kliničkim ispitivanjima u pedijatrijskih bolesnika doza se smanjivala za otprilike 2 mg/kg u razmacima od tjedan dana (tj. sukladno režimu navedenom u tablici 3).
English: Each hard capsule is approximately 15.8 mm in length.
Croatian: Jedna tvrda kapsula duga je približno 15,8 mm.
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/skrbnike na savjete za sprječavanje toplinskog udara i pregrijavanja u djece, navedene u Uputi o lijeku.
English: 300 to 500 mg per day (once a day or two divided doses).
Croatian: 300 do 500 mg na dan (jedanput na dan ili podijeljeno u dvije doze)
English: Do not breast-feed whilst taking, or for one month after stopping Zonisamide Mylan.
Croatian: Dojenje treba prekinuti za vrijeme uzimanja ili još mjesec dana nakon prekida uzimanja lijeka Zonisamide Mylan.
English: Subjects were titrated to the initial target dose of 600 mg carbamazepine or 300 mg of zonisamide.
Croatian: Ispitanici su bili titrirani do početne ciljne doze od 600 mg karbamazepina ili 300 mg zonisamida.
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 Zonisamide Mylan 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 lijeka Zonisamide Mylan.
English: Each hard capsule is approximately 14.4 mm in length.
Croatian: Jedna tvrda kapsula duga je približno 14,4 mm.
English: - This may be increased by up to 100 mg at intervals of two weeks.
Croatian: - Ta se doza može povećavati za do 100 mg u razmacima od dva tjedna.
English: Do not take Zonisamide Mylan - if you are allergic to zonisamide or any of the other ingredients of this medicine (listed in section 6).
Croatian: • alergični na zonisamid ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6),
English: Zonisamide Mylan 25 mg and 50 mg are available in blister packs of 14, 28, 56 capsules and perforated unit dose blister packs of 14 x 1 capsules.
Croatian: Zonisamide Mylan 25 mg i 50 mg dostupni su u blister pakiranjima s 14, 28, 56 kapsula i perforiranim blister pakiranjima djeljivim na jedinične doze s 14 × 1 kapsulom.
English: Unit Dose Blisters: 14 x 1 hard capsules
Croatian: Blisteri djeljivi na jedinične doze: 14 × 1 tvrda kapsula
English: It should be noted that zonisamide is a benzisoxazole derivative, which contains a sulfonamide group.
Croatian: Treba voditi računa da je zonisamid derivat benzisoksazola koji sadrži sulfonamidnu skupinu.
English: Efficacy results for Monotherapy Study 310 Zonisamide Carbamazepine n (ITT population) Six months seizure freedom
Croatian: Zonisamid Karbamazepin n (ITT populacija) Šest mjeseci bez napadaja
English: 6 to 8 mg/kg/day (once a day)
Croatian: 6 do 8 mg/kg na dan (jedanput na dan)
English: Unit Dose Blisters: 56 x 1 hard capsules
Croatian: Blisteri djeljivi na jedinične doze: 56 × 1 tvrda kapsula
English: Elevated intraocular pressure of any aetiology, if left untreated, can lead to serious sequelae including permanent vision loss.
Croatian: Ako se ne liječi, povišeni intraokularni tlak bilo koje etiologije može dovesti do ozbiljnih posljedica, uključujući trajni gubitak vida.
English: Dosage escalation and maintenance
Croatian: Postupno povećavanje i održavanje doze
English: Weight decreased Blood creatinine phosphokinase increased Alanine aminotransferase increased
Croatian: Pretrage sniženi bikarbonati smanjena težina, povišena kreatinin fosfokinaza u krvi, povišena alanin aminotransferaza, povišena aspartat aminotransferaza poremećeni rezultati analize mokraće
English: Zonisamide 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: Zonisamid 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 antikolinergičkom aktivnošću.
English: Specialist 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: Potential for zonisamide to affect other medicinal products Anti-epileptic medicinal products
Croatian: Mogući utjecaji zonisamida na druge lijekove
English: Subjects who experienced a seizure were titrated to the next target dose i.e. 800 mg carbamazepine or 400 mg of zonisamide.
Croatian: Ispitanici koji su imali napadaj titrirani su na sljedeću ciljnu dozu, tj. 800 mg karbamazepina ili 400 mg zonisamida.
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 osobe koje o njima skrbe treba upozoriti da, ovisno o stanju bolesnika, vode računa o održavanju hidracije i izbjegavanju izlaganja bolesnika visokim temperaturama te napornim tjelesnim aktivnostima.
English: CYP3A4-inducing agents; or with renal or hepatic impairment
Croatian: - bez lijekova induktora CYP3A4 ili kod oštećenja bubrega ili jetre
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: Renal clearance of single doses of zonisamide was positively correlated with creatinine clearance.
Croatian: Bubrežni klirens jednokratnih doza zonisamida pozitivno je korelirao s klirensom kreatinina.
English: Week 2 Week 3 to 5
Croatian: 2. tjedan od 3. do 5. tjedna
English: This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma.
Croatian: Ovaj sindrom može biti povezan sa supracilijarnom efuzijom koja rezultira pomicanjem leće i šarenice prema naprijed, uz sekundarni glaukom zatvorenog kuta.
English: Women of childbearing potential must use effective contraception during treatment with zonisamide, and for one month after discontinuation.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja zonisamidom i još mjesec dana nakon prestanka liječenja.
English: Caution should be used when treating patients with history of eye disorders with zonisamide.
Croatian: Potreban je oprez kada se bolesnike s poremećajima oka u anamnezi liječi zonisamidom.
English: Very common (may affect more than 1 in 10 people): - agitation, irritability, confusion, depression - poor muscle coordination, dizziness, poor memory, sleepiness, double vision - loss of appetite, decreased blood levels of bicarbonate (a substance that prevents your blood from becoming acidic).
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): - uznemirenost, razdražljivost, smetenost, depresija - loša koordinacija mišića, omaglica, oslabljeno pamćenje, pospanost, dvoslike - gubitak apetita, smanjene razine bikarbonata u krvi (tvar koja sprječava da Vam krv postane kisela)
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), abnormal liver enzymes (uncommon), middle ear infection, sore throat, sinus and chest infections, cough, nosebleeds, runny nose, stomach pain, vomiting, rash, eczema and fever.
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), infekcija srednjeg uha, bol u grlu, infekcije u sinusima i u prsima, kašalj, krvarenje iz nosa, curenje iz nosa, bol u trbuhu, povraćanje, osip, ekcem i vrućica.
English: Paediatric population (aged 6 years and above) - recommended dosage escalation and maintenance regimen Treatment Regimen
Croatian: Tablica 2. Pedijatrijska populacija (u dobi od 6 i više godina) - preporučeni režim postupnog povećavanja i održavanja doze
English: Caution should be used in adults when zonisamide 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 zonisamid propisuje s drugim lijekovima koji u bolesnika stvaraju predispoziciju na poremećaje povezane s vrućinom; to uključuje inhibitore karboanhidraze i lijekove s antikolinergičkom aktivnošću (vidjeti također dio 4.4, Pedijatrijska populacija).
English: PVC-PVdC/Aluminium foil blisters in cardboard cartons containing 28, 56, 98 and 196 capsules.
Croatian: PVC-PVdC/ blisteri s aluminijskom folijom u kartonskim kutijama koje sadrže 28, 56, 98 i 196 kapsula.
English: Physicians should draw the attention of paediatric patients and their parents/carers to the Patient Alert Box (in the package leaflet) on preventing heat stroke (see section 4.4: Paediatric Population).
Croatian: Liječnici moraju upozoriti pedijatrijske bolesnike i njihove roditelje/osobe koje za njih skrbe, na uokvireni tekst (u Uputi o lijeku) sa savjetima za sprječavanje toplinskog udara (vidjeti dio 4.4, Pedijatrijska populacija).
English: There are insufficient data for the withdrawal of concomitant antiepileptic medicines once seizure control with zonisamide has been achieved in the add-on situation, in order to reach monotherapy with zonisamide.
Croatian: Nema dovoljno podataka o ukidanju drugih antiepileptičkih lijekova kada su, uz zonisamid kao dodatni lijek, napadaji stavljeni pod nadzor, a čime bi se omogućila monoterapija zonisamidom.
English: Each hard capsule is approximately 19.3 mm in length.
Croatian: Jedna tvrda kapsula duga je približno 19,3 mm.
English: How to take Zonisamide Mylan
Croatian: Kako uzimati Zonisamide Mylan
English: Adverse reactions associated with zonisamide obtained from clinical studies and post-marketing surveillance are tabulated below.
Croatian: Nuspojave povezane s primjenom zonisamida iz kliničkih ispitivanja i nakon stavljanja lijeka u promet tablično su prikazane niže.
English: If you are a woman of childbearing age you must use adequate contraception while taking, and for one month after stopping, Zonisamide Mylan.
Croatian: Ako ste žena koja bi mogla zatrudnjeti, morate rabiti odgovarajuću kontracepciju dok uzimate Zonisamide Mylan i još mjesec dana nakon prestanka liječenja.
English: 100 mg / day*
Croatian: 100 mg na dan*
English: Use in patients with hepatic impairment has not been studied.
Croatian: Primjena u bolesnika s oštećenjem jetre nije ispitana.
English: Cases of agranulocytosis, thrombocytopenia, leucopenia, aplastic anaemia, pancytopenia and leucocytosis have been reported.
Croatian: Zabilježeni su slučajevi agranulocitoze, trombocitopenije, leukopenije, aplastične anemije, pancitopenije i leukocitoze.
English: Black iron oxide (E172) Potassium hydroxide
Croatian: Tinta za označavanje šelak crni željezov oksid (E172) kalijev hidroksid
English: Age (≥ 12 years) and gender, after adjustment for body weight effects, have no apparent effect on zonisamide exposure in epileptic patients during steady-state dosing.
Croatian: Nakon prilagodbe za utjecaj tjelesne težine u bolesnika s epilepsijom, dob (≥ 12 godina) i spol nisu primjetno utjecali na izloženost zonisamidu tijekom doziranja u stanju dinamičke ravnoteže.