FrancophonIA/ELRC3.0 huggingface dataset:
English: Make sure you are fully informed about the risks and the benefits of using zonisamide for epilepsy during pregnancy.
Croatian: Pobrinit se da ste potpuno upoznati s rizicima i koristima uzimanja zonisamida za liječenje epilepsije tijekom trudnoće.
English: Some patients, especially those not taking CYP3A4-inducing agents, may respond to lower doses.
Croatian: Neki bolesnici, posebice oni koji ne uzimaju induktore CYP3A4, odgovor mogu postići pri nižim dozama.
English: Decrease at weekly intervals in increments of: 20 - 28 kg 25 to 50 mg / day* 29 - 41 kg 50 to 75 mg / day* 42 - 55 kg 100 mg / day* >55 kg
Croatian: Smanjivanje doze u razmacima od tjedan dana za: 20 - 28 kg 25 do 50 mg na dan* 29 - 41 kg 50 do 75 mg na dan* 42 - 55 kg 100 mg na dan* > 55 kg
English: Zonisamide exposure increases with time until steady state is achieved by approximately 8 weeks.
Croatian: Izloženost zonisamidu povećava se s vremenom sve dok se ne postigne stanje dinamičke ravnoteže za otprilike 8 tjedana.
English: Therefore, withdrawal of concomitant anti-epileptic medicinal products must be undertaken with caution.
Croatian: Stoga ustezanje istodobnih antiepileptičkih lijekova treba provoditi oprezno.
English: Posology - adults
Croatian: Doziranje - odrasli
English: The incidence of marked decreases in weight of 20% or more was 0.7%.
Croatian: Incidencija izrazitog smanjenja težine od 20% ili više iznosila je 0,7%.
English: The metabolites, which could not be detected in plasma, are devoid of anticonvulsant activity.
Croatian: Metaboliti koji nisu mogli biti detektirani u plazmi potpuno su lišeni antikonvulzivnog djelovanja.
English: If you feel that the effect of Zonisamide Mylan is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako smatrate da je učinak lijeka Zonisamide Mylan prejak ili preslab obratite se svom liječniku ili ljekarniku.
English: The duration of low bicarbonate measurements was also long (median 188 days).
Croatian: Niske razine bikarbonata u mjerenjima dugo su se održale (188 dana).
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 55 kg.
Croatian: Napomena: a 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: Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX15
Croatian: Farmakoterapijska skupina: antiepileptici, drugi antiepileptici, ATK oznaka: N03AX15
English: Zonisamide Mylan with food and drink Zonisamide Mylan can be taken with or without food.
Croatian: Zonisamide Mylan s hranom i pićem Zonisamide Mylan se može uzimati s hranom ili bez nje.
English: The safety and efficacy of zonisamide in children aged below 6 years or those below 20 kg have not yet been established.
Croatian: Sigurnost i djelotvornost zonisamida u djece mlađe od 6 godina ili one težine manje od 20 kg još nisu ustanovljene.
English: Uncommon Very Rare
Croatian: Manje često Vrlo rijetko
English: Treatment Regimen
Croatian: Režim liječenja
English: Renal clearance of unchanged zonisamide is relatively low (approximately 3.5 ml/min); about 15 - 30 % of the dose is eliminated unchanged.
Croatian: Bubrežni klirens nepromijenjenog zonisamida relativno je nizak (približno 3,5 ml/min); oko 15 - 30% eliminira se nepromijenjeno.
English: However, given that some patients may experience drowsiness or difficulty with concentration, particularly early in treatment or after a dose increase, patients must be advised to exercise caution during activities requiring a high degree of alertness, e.g., driving or operating machines.
Croatian: Međutim, s obzirom da neki bolesnici mogu osjećati omamljenost ili teškoće s koncentracijom, osobito na početku liječenja ili nakon povećanja doze, bolesnicima treba savjetovati da budu oprezni u aktivnostima koje zahtijevaju visoki stupanj pozornosti, npr. upravljanje vozilima ili rukovanje strojevima.
English: - If you take Zonisamide Mylan twice a day, take half the daily dose in the morning and half in the evening.
Croatian: - Uzimate li Zonisamide Mylan dvaput na dan, pola dnevne doze uzmite ujutro a drugu polovicu navečer.
English: Symptoms include acute onset of decreased visual acuity and/or ocular pain.
Croatian: Simptomi uključuju akutni nastup smanjene oštrine vida i/ili bol u oku.
English: Your doctor may decide that you should stop using Zonisamide Mylan.
Croatian: Liječnik može odlučiti da morate prestati uzimati Zonisamide Mylan.
English: At a higher dose level (2-3-fold systemic exposure compared to therapeutic exposure) renal histopathological effects were more severe and only partially reversible.
Croatian: Na višoj razini doze (2 - 3 puta većoj od sistemske izloženosti u usporedbi s terapijskom izloženošću) učinci na histopatologiju bubrega bili su teži i samo djelomično reverzibilni.
English: Linearity / non-linearity
Croatian: Linearnost / nelinearnost
English: Slightly greater than expected accumulation occurs relative to single dosing.
Croatian: Akumulacija nešto veća od očekivane događa se uz jednokratnu dozu.
English: In addition there have been isolated cases of Sudden Unexplained Death in Epilepsy Patients (SUDEP) receiving zonisamide.
Croatian: Osim toga, bilo je izoliranih slučajeva iznenadne neobjašnjive smrti bolesnika s epilepsijom (Sudden Unexplained Death in Epilepsy Patients - SUDEP) koji su primali zonisamid.
English: The recommended adult dose
Croatian: Preporučena doza za odrasle
English: Example: A child who weighs 25 kg should take 25 mg once a day for the first week, and then increase the daily dose by 25 mg at the start of each week until a daily dose between 150 to 200 mg is reached.
Croatian: Primjer: Dijete težine 25 kg treba uzimati 25 mg jedanput na dan prvih tjedan dana, a zatim se dnevna doza treba povećavati za 25 mg na početku svakog tjedna sve dok se ne dosegne dnevna doza između 150 mg i 200 mg.
English: Women planning a pregnancy should meet with their specialists to reassess treatment with zonisamide and to consider other therapeutic options.
Croatian: Žene koje planiraju trudnoću moraju posjetiti specijaliste radi ponovne procjene liječenja zonisamidom i razmatranja drugih terapijskih opcija.
English: Weight loss leading to deterioration of general condition and failure to take anti-epilepsy medication has been related to a fatal outcome (see section 4.8).
Croatian: Gubitak težine koji vodi do propadanja općeg stanja i propusta u uzimanju antiepileptika povezan je sa smrtnim ishodom (vidjeti dio 4.8).
English: In these cases it is therefore recommended that the zonisamide total dose should be rounded up or down to the nearest available dose that can be achieved with commercially available capsule strengths of zonisamide (25 mg, 50 mg and 100 mg).
Croatian: Stoga se u tim slučajevima preporučuje zaokružiti ukupnu dozu zonisamida na najbližu višu ili nižu dostupnu dozu koja se može postići jačinama kapsula zonisamida dostupnima na tržištu (25 mg, 50 mg i 100 mg).
English: A pooled analysis of safety data on 95 elderly subjects has shown a relatively higher reporting frequency of oedema peripheral and pruritus compared to the adult population.
Croatian: Objedinjena analiza sigurnosnih podataka za 95 starijih ispitanika pokazala je relativno veću učestalost izvješća o perifernom edemu i pruritusu u usporedbi s odraslom populacijom.
English: 08184 Palau-Solita i Plegamans - Barcelona Spain
Croatian: 08184 Palau-Solita i Plegamans - Barcelona Španjolska
English: As with all antiepileptic medicines, sudden discontinuation of zonisamide should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.
Croatian: Kao kod svih antiepileptičkih lijekova, potrebno je izbjegavati iznenadni prekid primjene zonisamida jer to može izazvati pojavu napadaja, koji mogu imati ozbiljne posljedice za ženu i nerođeno dijete.
English: Multiple antiepileptic medicinal product therapy may be associated with a higher risk of congenital malformations than monotherapy.
Croatian: Liječenje višestrukim antiepileptičkim lijekovima može biti povezano s višim rizikom od kongenitalnih malformacija nego monoterapijom.
English: Zonisamide Mylan may affect your concentration, ability to react/respond, and may make you feel sleepy, particularly at the beginning of your treatment or after your dose is increased.
Croatian: Zonisamide Mylan može utjecati na Vašu koncentraciju, sposobnost reagiranja, i može izazvati pospanost, osobito na početku liječenja ili kada Vam se poveća doza.
English: Effect of food Zonisamide Mylan may be taken with or without food (see section 5.2).
Croatian: Zonisamide Mylan se može uzimati s hranom ili bez nje (vidjeti dio 5.2).
English: A meta-analysis of randomised placebo-controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Croatian: Metaanaliza randomiziranih, placebom kontroliranih ispitivanja antiepileptičkih lijekova također je pokazala malo povećan rizik od suicidalne ideacije i ponašanja.
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications.
Croatian: Suicidalna ideacija i ponašanje zabilježeni su u bolesnika liječenih antiepileptičkim lijekovima u nekoliko indikacija.
English: If you forget to take Zonisamide Mylan - If you forget to take a dose, don't worry: take the next dose when it is due.
Croatian: Ako ste zaboravili uzeti Zonisamide Mylan - Ako zaboravite uzeti svoju dozu, ne brinite: sljedeću dozu uzmite kada je potrebno po uobičajenom rasporedu.
English: A very high plasma concentration of 100.1 μg/ml zonisamide was recorded approximately 31 hours after a patient took an overdose of zonisamide and clonazepam; the patient became comatose and had respiratory depression, but recovered consciousness five days later and had no sequelae.
Croatian: Vrlo visoka koncentracija zonisamida u plazmi od 100,1 µg/ml zabilježena je otprilike 31 sat nakon bolesnikova predoziranja zonisamidom i klonazepamom; bolesnik je postao komatozan i imao je respiratornu depresiju, ali se nakon pet dana oporavilo stanje svijesti i nije imao posljedica.
English: When a child is taking zonisamide:
Croatian: Kada se dijete liječi zonisamidom:
English: The risk of birth defect is increased by factor 2 to 3 in the offspring of mothers treated with an antiepileptic medicinal product.
Croatian: Rizik od prirođenih mana povećan je za faktor 2 do 3 u djece majki liječenih nekim antiepileptičkim lijekom.
English: System Organ Class (MedDRA terminology)
Croatian: Klasifikacija organskih sustava (MedDRA terminologija)
English: The incidence of decreased body weight is consistent across age groups (see section 4.8); however, given the potential seriousness of weight loss in children, weight should be monitored in this population.
Croatian: Incidencija smanjene tjelesne težine dosljedna je u svim dobnim skupinama (vidjeti dio 4.8), međutim, uzimajući u obzir potencijalnu ozbiljnost gubitka težine u djece, u toj je populaciji težinu potrebno nadzirati.
English: A small number of people being treated with antiepileptics such as zonisamide have had thoughts of harming or killing themselves.
Croatian: Mali broj osoba liječenih antiepileptičnim lijekovima kao što je zonisamid pomišljali su na to da se ozlijede ili na samoubojstvo.
English: Metabolic acidosis
Croatian: Metabolička acidoza
English: Subjects were randomised to carbamazepine and zonisamide received treatment for a duration of up to 24 months depending on response.
Croatian: Ispitanici su bili randomizirani na karbamazepin i zonisamid i liječeni su u trajanju do 24 mjeseca ovisno o odgovoru.
English: It is not always possible to precisely achieve the calculated dose with the commercially available capsule strengths of zonisamide.
Croatian: Nije uvijek moguće precizno postići izračunatu dozu jačinama kapsula zonisamida dostupnima na tržištu.
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: The apparent volume of distribution is about 1.1 - 1.7 l/kg in adults indicating that zonisamide is extensively distributed to tissues.
Croatian: Prividni volumen distribucije iznosi oko 1,1 - 1,7 l/kg u odraslih što pokazuje da se zonisamid opsežno raspodjeljuje u tkiva.
English: • Increased acid level in the blood and kidney stones: Reduce these risks by ensuring that your child drinks enough water and is not taking any other medicine which could cause kidney stones (see Other medicines).
Croatian: • Povišena razina kiselina u krvi i bubrežni kamenci: smanjite ove rizike tako da vodite računa da dijete pije dovoljno vode i da ne uzima neki drugi lijek koji bi mogao prouzročiti nastanak bubrežnih kamenaca (vidjeti Drugi lijekovi i Zonisamide Mylan).
English: These effects were considered likely related to the decreased body weight and exaggerated pharmacologic effects of zonisamide at the maximum tolerated dose.
Croatian: Smatralo se da su ti učinci vjerojatno povezani sa smanjenom tjelesnom težinom i pojačanim farmakološkim učincima zonisamida pri maksimalnoj podnošljivoj dozi.
English: The increase at steady state was slightly more than expected on the basis of dose, probably due to the saturable binding of zonisamide to erythrocytes.
Croatian: Povećanje u stanju dinamičke ravnoteže bilo je nešto više od očekivanog na temelju doze, vjerojatno zbog zasićenog vezanja zonisamida na eritrocite.
English: The long term effect of low bicarbonate levels on growth and development is unknown.
Croatian: Dugoročni učinak niskih razina bikarbonata na rast i razvoj nije poznat.
English: • The child must avoid heavy exercise especially when the weather is hot
Croatian: • mora izbjegavati teške tjelesne aktivnosti osobito kada su vrućine
English: The incidence of markedly abnormally low serum bicarbonate (a decrease to less than 17 mEq/l and by more than 5 mEq/l) was 3.8%.
Croatian: Incidencija od izrazito nenormalno niskog bikarbonata u serumu (smanjenje do manje od 17 mEq/l i za više od 5 mEq/l) bila je 3,8%.
English: • Keep the child's skin cool with water
Croatian: • Djetetovu kožu vodom održavajte rashlađenu.
English: General dosing recommendations for Zonisamide Mylan in special patient populations
Croatian: Opće preporuke za doziranje lijeka Zonisamide Mylan u posebnim populacijama bolesnika
English: Use in children (aged 6 to 11 years) and adolescents (aged 12 to 17 years) weighing at least 20 kg: - The starting dose is 1 mg per kg of body weight taken once a day.
Croatian: Primjena u djece (u dobi od 6 do 11 godina) i adolescenata (u dobi od 12 do 17 godina) kojima je tjelesna težina najmanje 20 kg: - Početna je doza 1 mg po kilogramu tjelesne težine, a uzima se jedanput na dan.
English: Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Croatian: Stoga bolesnike treba nadzirati zbog moguće pojave znakova suicidalne ideacije i ponašanja te razmotriti odgovarajuće liječenje.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Croatian: Bolesnicima (i njihovim njegovateljima) treba savjetovati da potraže liječnički savjet ako se pojave znakovi suicidalne ideacije ili ponašanja.
English: Generally, zonisamide-induced metabolic acidosis occurs early in treatment although cases can occur at any time during treatment.
Croatian: Najčešće se metabolička acidoza izazvana zonisamidom javlja rano u postupku liječenja, iako se slučajevi mogu javiti u bilo kojem trenutku tijekom liječenja.
English: Zonisamide lowers the 28-day average seizure frequency and the decrease is proportional (log-linear) to zonisamide average concentration.
Croatian: Zonisamid snižava 28-dnevnu prosječnu učestalost napadaja a smanjenje je proporcionalno (loglinearno) prosječnoj koncentraciji zonisamida.
English: - Zonisamide Mylan capsules must be swallowed whole with water.
Croatian: - Kapsule lijeka Zonisamide Mylan je potrebno progutati cijele s vodom.
English: Cognitive impairment in patients affected by epilepsy has been associated with the underlying pathology and/or the administration of anti-epileptic treatment.
Croatian: Kognitivna oštećenja u bolesnika pogođenih epilepsijom povezana su s temeljnom patologijom i/ili primjenom antiepileptičke terapije.
English: In the event of signs or symptoms of dehydration, oligohydrosis, or elevated body temperature, discontinuation of zonisamide should be considered.
Croatian: U slučaju znakova ili simptoma dehidracije, oligohidroze ili povišene tjelesne temperature, potrebno je razmisliti o ukidanju zonisamida.
English: These increases are from about 5% to 8% for LBW, from about 8% to 10% for pre-term birth and from about 7% to 12% for SGA, all compared with mothers treated with lamotrigine monotherapy.
Croatian: Ta su povećanja otprilike između 5% i 8% za novorođenčad s niskom porođajnom težinom, otprilike između 8% i 10% za prerano rođenu novorođenčad i otprilike između 7% i 12% za novorođenčad premalu za gestacijsku dob, sve u usporedbi s majkama liječenima monoterapijom lamotriginom.
English: Sulfonamide reactions
Croatian: Reakcije na sulfonamide
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to sulfonamides.
Croatian: Preosjetljivost na djelatnu tvar, neku od pomoćnih tvari navedenih u dijelu 6.1 ili na sulfonamide.
English: If any of these applies to you, tell your doctor before you take Zonisamide Mylan.
Croatian: Ako se nešto od toga odnosi na Vas obratite se liječniku prije nego što uzmete Zonisamide Mylan.
English: Zonisamide AUC and Cmax values increased almost linearly after single dose over the dose range of 100-800 mg and after multiple doses over the dose range of 100-400 mg once daily.
Croatian: AUC i Cmax vrijednosti zonisamida povećale su se gotovo linearno nakon jednokratne doze u rasponu doza od 100 do 800 mg i nakon višekratnih doza u rasponu od 100 do 400 mg jedanput na dan.
English: Increasing fluid intake and urine output may help reduce the risk of stone formation, particularly in those with predisposing risk factors.
Croatian: Povećanje unosa tekućine i izlučivanja mokraće može pomoći u smanjenju rizika od nastanka kamenaca, osobito u onih s predisponirajućim čimbenicima rizika.
English: MonotherapyNewly diagnosed adult patients
Croatian: Monoterapijanovodijagnosticirani odrasli bolesnici
English: In some cases of weight decrease there was a delay in transition to the next Tanner stage and in bone maturation.
Croatian: U nekim slučajevima gubitka težine postojala je odgoda u prijelazu na sljedeći Tannerov stupanj te u sazrijevanju kostiju.
English: Rifampicin is a potent CYP3A4 inducer.
Croatian: Rifampicin je jak induktor CYP3A4.
English: Paediatric population (aged 6 years and above)
Croatian: Pedijatrijska populacija (u dobi od 6 i više godina)
English: General supportive care is indicated, including frequent monitoring of vital signs and close observation.
Croatian: Indicirana je opća potporna skrb uključujući učestali nadzor vitalnih znakova te pomno promatranje.
English: If zonisamide 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 zonisamid 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: CYP3A4 inhibition: Based upon clinical data, known specific and non-specific CYP3A4 inhibitors appear to have no clinically relevant effect on zonisamide pharmacokinetic exposure parameters.
Croatian: - Inhibicija CYP3A4: na temelju kliničkih podataka, poznati specifični i nespecifični inhibitori CYP3A4 čini se da nemaju klinički važan učinak na farmakokinetičke parametre izloženosti zonisamidu.
English: Due to the long retention time of zonisamide in the body, breast-feeding must not be resumed until one month after zonisamide therapy is completed.
Croatian: Zbog dugog zadržavanja zonisamida u tijelu, dojenje se ne smije započeti još mjesec dana nakon završetka terapije zonisamidom.
English: If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing zonisamide (by gradual discontinuation or reduction of a therapeutic dose) as osteopenia may develop.
Croatian: Ako se metabolička acidoza razvije i potraje, potrebno je razmotriti smanjenje doze ili obustavu zonisamida (postupnim ukidanjem lijeka ili smanjivanjem terapijske doze) jer se može razviti osteopenija.
English: Adults - recommended dosage escalation and maintenance regimen
Croatian: Odrasli - preporučeni režim postupnog povećavanja i održavanja doze
English: Children are most at risk especially in hot weather.
Croatian: Rizik je za djecu najveći posebice po vrućini.
English: If you stop taking Zonisamide Mylan - Zonisamide Mylan is meant to be taken as a long-term medicine.
Croatian: Ako prestanete uzimati Zonisamid Mylan - Zonisamide Mylan je namijenjen kao lijek koji se uzima na dulje vrijeme.
English: - Other medicines like phenytoin, carbamazepine, phenobarbitone and rifampicin can decrease your blood levels of Zonisamide Mylan, which may require an adjustment of your dose of Zonisamide Mylan.
Croatian: - Drugi lijekovi kao što su fenitoin, karbamazepin, fenobarbiton i rifampicin mogu smanjiti razine lijeka Zonisamide Mylan u krvi zbog čega Vam može biti potrebno prilagoditi dozu lijeka Zonisamide Mylan.
English: If co-administration is necessary, the patient should be closely monitored and the dose of zonisamide and other CYP3A4 substrates adjusted as needed.
Croatian: Ako je potrebna istodobna upotreba, bolesnika treba pomno nadzirati a dozu zonisamida i drugih supstrata CYP3A4 prilagoditi prema potrebi.
English: Consideration must be given to discontinuing zonisamide in patients who develop an otherwise unexplained rash.
Croatian: Treba razmisliti o prekidu primjene zonisamida u bolesnika u kojih se razvije inače neobjašnjiv osip.
English: Serious rashes occur in association with zonisamide therapy, including cases of Stevens-Johnson syndrome.
Croatian: Povezano s terapijom zonisamidom javlja se ozbiljan osip, uključujući slučajeve StevensJohnsonovog sindroma.
English: Zonisamide is not recommended for paediatric patients who are underweight (definition in accordance with the WHO age adjusted BMI categories) or have a decreased appetite.
Croatian: Zonisamid se ne preporučuje pedijatrijskim bolesnicima kojima je tjelesna težina manja od prosječne (definicija u skladu s preporukama Svjetske zdravstvene organizacije za kategorije indeksa tjelesne mase (BMI) prilagođene prema dobi) ili imaju oslabljen apetit.
English: Your doctor will monitor your child's blood bicarbonate levels and kidneys (see also section 4).
Croatian: Liječnik će nadzirati razine bikarbonata u krvi Vašeg djeteta i stanje bubrega (vidjeti također dio 4).
English: Zonisamide Mylan is used to treat seizures that affect one part of the brain (partial seizure), which may or may not be followed by a seizure affecting all of the brain (secondary generalisation).
Croatian: Zonisamide Mylan se upotrebljava za liječenje napadaja koji zahvaćaju jedan dio mozga (parcijalni napadaj), nakon čega može ali ne mora slijediti napadaj koji zahvaća cijeli mozak (sekundarna generalizacija).