FrancophonIA/ELRC3.0 huggingface dataset:
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 koja se odnosi na sigurnost pedijatrijskih ispitanika (uključujući dodatnih 67 ispitanika iz faze produžetka kontroliranog kliničkog ispitivanja), bilo je 7 smrtnih slučajeva (1,5%; 14,6/1000 osobagodina), i to 2 slučaja statusa epileptikusa 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 zbog različitih uzroka (2 slučaja sepse/zatajenja organa prouzročenih upalom pluća, 1 slučaj iznenadne neobjašnjive smrti bolesnika s epilepsijom (SUDEP) i 1 ozljeda glave).
English: When you take Zonisamide Mylan on its own: - The starting dose is 100 mg taken once a day.
Croatian: Kada uzimate samo Zonisamide Mylan: - Početna doza je 100 mg jedanput na dan.
English: • The child should stay cool especially in hot weather
Croatian: • ono treba biti rashlađeno osobito za vrućeg vremena
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: 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 hiperkalcurije.
English: The frequencies are arranged according to the following scheme:
Croatian: Učestalosti su razvrstane na sljedeći način:
English: 28 hard capsules 56 hard capsules 98 hard capsules 196 hard capsules
Croatian: 28 tvrdih kapsula 56 tvrdih kapsula 98 tvrdih kapsula 196 tvrdih kapsula
English: If substantial undesirable weight loss occurs, discontinuation of zonisamide should be considered.
Croatian: Ako dođe do znatnog neželjenog gubitka težine, potrebno je razmotriti prekid liječenja zonisamidom.
English: If elevated, in the absence of another obvious cause such as trauma or grand mal seizures, it is recommended that zonisamide discontinuation be considered and appropriate treatment initiated.
Croatian: Ako su povišeni, a u odsutnosti nekog drugog očitog uzroka kao što su trauma ili grand mal napadaji, preporučuje se razmotriti ukidanje zonisamida i započeti odgovarajuće liječenje.
English: Appropriate evaluation and monitoring of serum bicarbonate levels should be carried out in patients taking zonisamide who have underlying conditions which might increase the risk of acidosis, in patients who are at an increased risk of adverse consequences of metabolic acidosis and in patients with symptoms suggestive of metabolic acidosis.
Croatian: Odgovarajuću procjenu i nadzor razina bikarbonata u serumu treba provoditi u bolesnika koji uzimaju zonisamid a imaju osnovne bolesti koje mogu povećati rizik od acidoze, u bolesnika za koje postoji povećan rizik od štetnih posljedica metaboličke acidoze i u bolesnika sa simptomima koji upućuju na metaboličku acidozu.
English: Review of post-marketing data suggests that patients aged 65 years or older report a higher frequency than the general population of the following events: Stevens-Johnson syndrome (SJS) and Drug Induced Hypersensitivity syndrome (DIHS).
Croatian: Analiza podataka nakon stavljanja lijeka u promet pokazuje da je u bolesnika u dobi od 65 godina ili starijih, u usporedbi s općom populacijom, zabilježena veća učestalost sljedećih događaja: StevensJohnsonov sindrom (SJS) i lijekom izazvani sindrom preosjetljivosti (od engl.
English: An in vitro study shows that zonisamide is a weak inhibitor of P-gp (MDR1) with an IC50 of 267 µmol/l and there is the theoretical potential for zonisamide to affect the pharmacokinetics of substances which are P-gp substrates.
Croatian: U in vitro ispitivanju pokazalo se da je zonisamid slab inhibitor P-glikoproteina (P-gp) (MDR1) s IC50 od 267 µmol/l pa postoji teoretska mogućnost da će zonisamid utjecati na farmakokinetiku tvari koje su supstrati P-gp-a.
English: The long term effect of weight loss in the paediatric population on growth and development is unknown.
Croatian: Nepoznati su dugoročni učinci gubitka težine na rast i razvoj u pedijatrijskoj populaciji.
English: The dose regime is 6-8 mg/kg/day up to a maximum dose of 500 mg/day.
Croatian: Doza iznosi od 6 do 8 mg/kg na dan do maksimalne doze od 500 mg na dan.
English: 117 Allee des Parcs, 69 800 Saint Priest, France
Croatian: 117 Allee des Parcs, 69 800 Saint Priest, Francuska
English: These effects are unlikely to be of clinical significance when zonisamide 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 zonisamide dose may be required.
Croatian: Nije vjerojatno da će ti učinci biti klinički značajni kada se zonisamid 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 zonisamida.
English: Increased levels of hepatobiliary parameters such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT) and bilirubin have occurred in paediatric and adolescent patients, without any consistent pattern in the observations of values above the upper limit of normal.
Croatian: U pedijatrijskih i adolescentnih bolesnika pojavile su se povećane razine hepatobilijarnih parametara kao što su alanin aminotransferaza (ALT), aspartat aminotransferaza (AST), gamaglutamiltransferaza (GGT) i bilirubin, ali bez dosljednog obrasca u opaženim vrijednostima iznad gornje granice normale.
English: PP = Per Protocol Population; ITT = Intent To Treat Population *Primary endpoint
Croatian: PP = populacija per protocol (bolesnici koji su završili ispitivanje prema planu); ITT = populacija s namjerom liječenja (intent-to-treat, tj. svi uključeni bolesnici)
English: Pharmacodynamic effects 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: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije toplinski udar
English: In clinical studies in healthy subjects, steady-state dosing with zonisamide did not affect serum concentrations of ethinylestradiol or norethisterone in a combined oral contraceptive.
Croatian: U kliničkim ispitivanjima zdravih ispitanika, doziranje zonisamida u stanju dinamičke ravnoteže nije utjecalo na koncentracije etinilestradiola ili noretisterona u serumu u kombiniranom oralnom kontraceptivu.
English: The warnings and precautions mentioned above are also applicable to adolescent and paediatric patients.
Croatian: Prethodno navedena upozorenja i mjere opreza primjenjiva su i na adolescente i na pedijatrijske bolesnike.
English: Zonisamide Mylan is indicated as:
Croatian: Zonisamide Mylan je indiciran kao:
English: This leaflet was last revised in MM/YYYY
Croatian: Ova uputa je zadnji puta revidirana u
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 zonisamide treatment.
Croatian: Hiperkloremična metabolička acidoza bez anionskog procjepa (tj. smanjena razina bikarbonata u serumu ispod normalnog raspona vrijednosti u odsutnosti respiratorne alkaloze) povezana je s liječenjem zonisamidom.
English: Therefore, zonisamide 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 zonisamid utjecao na farmakokinetiku drugih lijekova putem mehanizama posredovanih citokromom P450, kao što se pokazalo in vivo za karbamazepin, fenitoin, etinilestradiol i desipramin.
English: Examples include: sulfonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetes medicines.
Croatian: Primjeri uključuju: sulfonamidne antibiotike, tiazidne diuretike i lijekove protiv šećerne bolesti iz skupine sulfonilureje.
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 očekivati nastanak bubrežnih kamenaca za vrijeme liječenja zonisamidom.
English: Since zonisamide and its metabolites are excreted renally, it should be discontinued in patients who develop acute renal failure or where a clinically significant sustained increase in serum creatinine is observed.
Croatian: Budući da se zonisamid i njegovi metaboliti izlučuju putem bubrega, liječenje treba obustaviti u bolesnika koji razviju akutno zatajenje bubrega ili kad je opažen klinički značajan ustrajni porast kreatinina u serumu.
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 lijekove s antikolinergičkom aktivnošću (kao što su klomipramin, hidroksizin, difenhidramin, haloperidol, imipramin i oksibutinin).
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 relevantne učinke na farmakokinetiku jednokratne doze zonisamida.
English: What you need to know before you take Zonisamide Mylan
Croatian: Što morate znati prije nego počnete uzimati Zonisamide Mylan
English: Appropriate evaluation and monitoring of serum bicarbonate levels should be carried out in this population (see section 4.4 - Metabolic acidosis for full warning; see section 4.8 for incidence of low bicarbonate).
Croatian: U ovoj populaciji treba provoditi odgovarajuću procjenu i nadzor razina bikarbonata u serumu (za sva upozorenja vidjeti dio 4.4 - Metabolička acidoza; za incidenciju niske razine bikarbonata vidjeti dio 4.8).
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 two-fold or greater than clinically relevant unbound serum concentrations.
Croatian: Ispitivanja in vitro na humanim mikrosomima 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 važnih nevezanih koncentracija u serumu.
English: Zonisamide can cause children to sweat less and overheat and if the child is not treated this can lead to brain damage and death.
Croatian: Zonisamid može u djece prouzročiti smanjeno znojenje i pregrijavanje, a ako se dijete ne liječi to može dovesti do oštećenja mozga i smrti.
English: Women of childbearing potential must use effective contraception during treatment with zonisamide and for one month after discontinuation (see section 4.6).
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja zonisamidom i još mjesec dana nakon prestanka liječenja (vidjeti dio 4.6).
English: Such electrolyte imbalance has been observed with the use of zonisamide in placebo-controlled clinical trials and in the post-marketing period.
Croatian: Takva neravnoteža elektrolita opažena je uz primjenu zonisamida u placebom kontroliranim kliničkim ispitivanjima te u razdoblju nakon stavljanja lijeka u promet.
English: This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of zonisamide on carbonic anhydrase.
Croatian: Tu metaboličku acidozu uzrokuje gubitak bikarbonata mokraćom zbog inhibicijskog učinka zonisamida na karboanhidrazu.
English: If the decision is made to continue patients on zonisamide in the face of persistent acidosis, alkali treatment should be considered.
Croatian: Kada se odluči da bolesnici nastave uzimati zonisamid unatoč ustrajnoj acidozi, treba razmotriti liječenje alkalnim preparatima.
English: You might also feel sick, have a sore stomach, muscle twitches, eye movement, feel faint, have a slowed heartbeat, 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: Acute myopia and secondary angle closure glaucoma A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in adult and paediatric patients receiving zonisamide.
Croatian: Akutna miopija i sekundarni glaukom zatvorenog kuta 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: Zonisamide is metabolised primarily through reductive cleavage of the benzisoxazole ring of the parent drug by CYP3A4 to form 2-sulfamoylacetylphenol (SMAP) and also by N-acetylation.
Croatian: Zonisamid se metabolizira prvenstveno redukcijskim cijepanjem benzisoksazolskog prstena osnovnog lijeka pomoću CYP3A4 i stvara 2-sulfamoilacetilfenol (SMAP), a također i N-acetilacijom.
English: Data from a registry study suggest an increase in the proportion of babies born at a low birth weight (LBW), pre-term or small for gestational age (SGA).
Croatian: Podaci iz registra ukazuju na povećanje u udjelu novorođenčadi s niskom porođajnom težinom, prerano rođenih ili premalih za gestacijsku dob.
English: Adjunctive therapy - with CYP3A4inducing agents (see section 4.5)
Croatian: - s lijekovima induktorima CYP3A4 (vidjeti dio 4.5)
English: Heat stroke requiring hospital treatment and leading to death has been reported.
Croatian: Zabilježen je slučaj toplinskog udara s potrebnim bolničkim liječenjem koji je doveo do smrtnog ishoda.
English: When Zonisamide Mylan treatment is to be discontinued, it should be withdrawn gradually (see section 4.4).
Croatian: Kada liječenje lijekom Zonisamide Mylan treba prekinuti, to se treba učiniti postupno (vidjeti dio 4.4).
English: Recommended escalation and maintenance doses are given in Table 1.
Croatian: Preporuke za postupno povećavanje doze i doze održavanja navedene su u tablici 1.
English: If a higher dose is required: increase at two-weekly intervals in increments of 100 mg up to a maximum of 500 mg.
Croatian: Ako je potrebna viša doza: u razmacima od dva tjedna povećavati dozu za 100 mg do najviše 500 mg.
English: Monotherapy in partial seizures, with or without secondary generalisation Efficacy of zonisamide as monotherapy was established in a double-blind, parallel group, non-inferiority comparison to carbamazepine prolonged release (PR) in 583 adult subjects with newly diagnosed partial seizures with or without secondary generalised tonic-clonic seizures.
Croatian: Monoterapija pri parcijalnim napadajima, sa ili bez sekundarne generalizacije 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 toničkokloničkih napadaja.
English: The adverse event profile of zonisamide in paediatric patients aged 6 to 17 years in placebo-controlled clinical studies was consistent with that of adults.
Croatian: Profil štetnih događaja za zonisamid u pedijatrijskih bolesnika u dobi od 6 do 17 godina bio je u placebom kontroliranim ispitivanjima sličan onome u odraslih.
English: In the event kidney stones are detected, zonisamide should be discontinued.
Croatian: U slučaju da se otkriju bubrežni kamenci, liječenje zonisamidom treba prekinuti.
English: Zonisamide 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: Zonisamid 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: Specific safety issues that were encountered in the paediatric studies were: decreased appetite and weight loss, decreased bicarbonate levels, increased risk of kidney stones and dehydration.
Croatian: Specifične teškoće s obzirom na sigurnost primjene koje su se pojavile u pedijatrijskim ispitivanjima bile su smanjeni apetit i gubitak težine, snižene razine bikarbonata, povećan rizik od nastanka bubrežnih kamenaca i dehidracija.
English: Zonisamide 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: Zonisamid 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: The most common adverse reactions in a randomised, controlled monotherapy trial comparing zonisamide with carbamazepine prolonged release were decreased bicarbonate, decreased appetite, and decreased weight.
Croatian: Najčešće nuspojave u randomiziranom, kontroliranom ispitivanju u kojem se usporedila monoterapija zonisamida s karbamazepinom produljenog otpuštanja bile su sniženi bikarbonati, oslabljeni apetit i smanjena težina.
English: In patients taking zonisamide, 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 zonisamid i razviju im se teški bolovi u mišićima i/ili slabost, bilo u prisutnosti ili odsutnosti vrućice, preporučuje se procijeniti markere oštećenja mišića uključujući razine kreatin fosfokinaze u serumu i aldolaze.
English: All patients who develop a rash while taking zonisamide 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 zonisamida treba pomno nadzirati, uz dodatnu pozornost usmjerenu na one bolesnike koji istodobno primaju antiepileptičke lijekove koji sami za sebe mogu prouzročiti pojavu osipa na koži.
English: Capsule shells Titanium dioxide (E171) Gelatin
Croatian: Ovojnica kapsule titanijev dioksid (E171) želatina
English: What Zonisamide Mylan is and what it is used for 2.
Croatian: Što je Zonisamide Mylan i za što se koristi
English: There are limited data from the use of zonisamide in pregnant women.
Croatian: Podaci o primjeni zonisamida u trudnica su ograničeni.
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, omjer bolesnika s oštećenim kognitivnim sposobnostima bio je brojčano veći u skupini koja je primala zonisamid nego u skupini koja je primala placebo.
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 ozbiljniji u mlađih bolesnika.
English: When zonisamide treatment is to be discontinued, it should be withdrawn gradually (see section 4.4).
Croatian: Kada liječenje zonisamidom treba prekinuti, to se treba učiniti postupno (vidjeti dio 4.4).
English: Most adverse effects observed in the juvenile rats were similar to those seen in the repeated-dose toxicity studies of zonisamide in adult rats, but renal tubular hyaline droplets and transitional hyperplasia were observed in the juvenile study only.
Croatian: Većina nuspojava opažena u mladih štakora bila je slična onima u ispitivanjima toksičnosti ponovljene doze zonisamida u odraslih štakora, ali hijalne kapljice u bubrežnim kanalićima i prolazna hiperplazija bile su opažene samo u mladih štakora.
English: blurred vision or decreased vision may occur and can be signs of glaucoma.
Croatian: Mogu se javiti bol u oku, zamagljen vid ili slabljenje vida, a to mogu biti znakovi glaukoma.
English: Nevertheless, if a hepatic event is suspected, liver function should be evaluated and discontinuation of zonisamide should be considered.
Croatian: Ipak, u slučaju sumnje na događaj povezan s jetrom, funkciju jetre treba provjeriti i razmotriti prekid liječenja zonisamidom.
English: Ophthalmologic findings can include myopia, anterior chamber shallowing, and ocular hyperaemia (redness) and increased intraocular pressure.
Croatian: Oftalmološki nalazi mogu uključivati miopiju, plitku prednju očnu komoru i hiperemiju oka (crvenilo) te povišen intraokularni tlak.
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 uz to povezanih znakova i simptoma kao što su bubrežne kolike, bolovi u bubrezima ili bol u predjelu slabina.
English: Heat stroke requiring hospital treatment was diagnosed in some cases.
Croatian: U nekim je slučajevima dijagnosticiran toplinski udar koji je zahtijevao bolničko liječenje.
English: Caution must be exercised in treating patients with mild to moderate hepatic impairment, and a slower titration of Zonisamide Mylan may be required.
Croatian: Treba postupati oprezno u liječenju bolesnika s blagim do umjerenim oštećenjem jetre i može biti potrebna sporija titracija lijeka Zonisamide Mylan.
English: When you take Zonisamide Mylan with other antiepileptic medicines: - The starting dose is 50 mg daily taken in two equal doses of 25 mg. - This may be increased by up to 100 mg at intervals of one to two weeks.
Croatian: Kada uzimate Zonisamide Mylan s drugim lijekovima protiv epilepsije: - Početna je doza 50 mg na dan, a uzima se u dvije jednake doze od 25 mg.