FrancophonIA/ELRC3.0 huggingface dataset:
English: very rare not known cannot be estimated from the available data
Croatian: vrlo rijetko nepoznato ne može se procijeniti iz dostupnih podataka
English: Return the pack to your pharmacist.
Croatian: Pakiranje vratite svom ljekarniku.
English: Do not store above 30°C.
Croatian: Ne čuvati na temperaturi iznad 30 °C.
English: What Zonegran is and what it is used for
Croatian: Što je Zonegran i za što se koristi
English: • if you are allergic to other sulphonamide medicines.
Croatian: • ako ste alergični na druge sulfonamidne lijekove.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Zonegran.
Croatian: Mehanizam ovog rizika nije poznat, a dostupni podaci ne isključuju mogućnost povećanog rizika za Zonegran.
English: Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: • Do not take double the dose to make up for the forgotten dose.
Croatian: • Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: • Zonegran can be taken once or twice daily, as instructed by your doctor.
Croatian: • Zonegran se može uzimati jedanput ili dvaput na dan, prema uputama liječnika.
English: All these effects and specifically weight loss may have deleterious implications for growth and development, and may lead to general deterioration of health.
Croatian: Svi ti učinci a posebice gubitak težine mogu imati štetne posljedice na rast i razvoj i mogu dovesti do narušenog općeg zdravlja.
English: • Zonegran capsules must be swallowed whole with water.
Croatian: • Kapsule Zonegrana je potrebno progutati cijele s vodom.
English: Examples include: sulphonamide antibiotics,
Croatian: Primjeri uključuju: sulfonamidne antibiotike,
English: Zonegran with food and drink Zonegran can be taken with or without food.
Croatian: Zonegran s hranom i pićem Zonegran se može uzimati s hranom ili bez nje.
English: CI95%
Croatian: Razlika CI 95%
English: If you take more Zonegran than you should
Croatian: Ako uzmete više Zonegrana nego što ste trebali
English: Make sure you are fully informed about the risks and the benefits of using zonisamide for epilepsy during pregnancy.
Croatian: Uvjerite se da ste potpuno upoznati s rizicima i koristima korištenja zonisamida za epilepsiju tijekom trudnoće.
English: Your doctor may decide that you should stop using Zonegran.
Croatian: Liječnik može odlučiti da morate prestati uzimati Zonegran.
English: Do not give this medicine to children below the age of 6 years because it is not known for this age group whether the potential benefits are greater than the risks.
Croatian: Ovaj lijek nemojte davati djeci mlađoj od 6 godina jer za tu dobnu skupinu nije poznato jesu li moguće koristi veće od rizika.
English: • Some people respond to lower doses.
Croatian: • Neke osobe reagiraju na niže doze.
English: Do not reduce your dose or stop your medicine unless your doctor tells you to.
Croatian: Nemojte smanjiti dozu ili prestati uzimati lijek osim ako Vam je to rekao liječnik.
English: • It you take Zonegran twice a day, take half the daily dose in the morning and half in the evening.
Croatian: • Uzimate li Zonegran dvaput na dan, pola dnevne doze uzmite ujutro a drugu polovicu navečer.
English: You should not stop your treatment without discussing this with your doctor.
Croatian: Ne smijete prekinuti liječenje bez konzultacija sa svojim liječnikom.
English: Zonegran may be taken with or without food (see section 5.2).
Croatian: Zonegran se može uzimati s hranom ili bez nje (vidjeti dio 5.2).
English: Zonegran capsules are packaged in blister packs supplied in boxes containing:
Croatian: Zonegran kapsule pakirane su u blisterima koji se nalaze u kutijama koje sadrže:
English: Elderly: No clinically significant differences were observed in the pharmacokinetics between young (aged 21-40 years) and elderly (65-75 years).
Croatian: Stariji: nisu primijećene klinički značajne razlike u farmakokinetici između mlađih (u dobi od 21 do 40 godina) i starijih osoba (od 65 do 75 godina).
English: Talk to your doctor or pharmacist before taking Zonegran if you:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Zonegran ako ste:
English: • are pregnant or could become pregnant (see section ‘pregnancy, breast-feeding and fertility' for further information).
Croatian: • ako ste trudni ili biste mogli zatrudnjeti (vidjeti dio „Trudnoća, dojenje i plodnost“ za više informacija).
English: • Do not chew the capsules.
Croatian: • Kapsule nemojte žvakati.
English: The duration of low bicarbonate measurements was also long (median 188 days).
Croatian: Niske razine bikarbonata u mjerenjima dugo su se održale (medijan 188 dana).
English: Additional information on special populations:
Croatian: Dodatni podaci o posebnim populacijama
English: Zonegran may cause weight loss.
Croatian: Zonegran može prouzročiti gubitak težine.
English: Erythrocyte/plasma ratios are about 15 at low concentrations and about 3 at higher concentrations.
Croatian: Omjer eritrociti/plazma iznosi oko 15 pri niskim koncentracijama, a oko 3 pri višim koncentracijama.
English: • have eye problems such as glaucoma.
Croatian: • imate tegobe s očima poput glaukoma
English: Zonegran is indicated as:
Croatian: Zonegran je indiciran kao:
English: • swelling of the feet and legs.
Croatian: • oticanje stopala i nogu
English: The metabolites, which could not be detected in plasma, are devoid of anticonvulsant activity.
Croatian: Metaboliti, koji se nisu mogli otkriti u plazmi, potpuno su lišeni antikonvulzivnog djelovanja.
English: General dosing recommendations for Zonegran in special patient populations
Croatian: Opće preporuke za doziranje Zonegrana 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:
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:
English: When you take Zonegran with other antiepileptic medicines:
Croatian: Kada uzimate Zonegran s drugim lijekovima protiv epilepsije:
English: Fluctuation in serum or plasma concentrations over a dosing interval is low (< 30 %).
Croatian: Fluktuacija koncentracija u serumu ili plazmi tijekom intervala doziranja je niska (< 30%).
English: Other medicines and Zonegran
Croatian: Drugi lijekovi i Zonegran
English: Zonisamide was not genotoxic and has no carcinogenic potential.
Croatian: Zonisamid nije bio genotoksičan i nije kancerogen.
English: An updated RMP should be submitted: o At the request of the European Medicines Agency; o 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: Ažurirani RMP treba dostaviti: o na zahtjev Europske agencije za lijekove; o prilikom 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 izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Patients must not take this medicinal product if they are allergic to peanut or soya.
Croatian: Bolesnici ne smiju uzimati ovaj lijek ako su alergični na kikiriki ili soju.
English: • severe rashes or skin peeling (at the same time you may feel unwell or develop a fever).
Croatian: • teški osipi ili ljuštenje kože (a istodobno se možete osjećati loše ili razviti vrućicu)
English: When Zonegran treatment is to be discontinued, it should be withdrawn gradually (see section 4.4).
Croatian: Kada liječenje Zonegranom treba prekinuti, to se treba učiniti postupno (vidjeti dio 4.4).
English: If you may have taken more Zonegran than you should, tell a carer (relative or friend), your doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking your medicine with you.
Croatian: Ako ste možda uzeli više Zonegrana nego što ste trebali, kažite osobi koja brine o Vama (rodbina ili prijatelj), svom liječniku ili ljekarniku ili otiđite u hitnu službu najbliže bolnice, a lijek ponesite sa sobom.
English: The incidence of marked decreases in weight of 20% or more was 0.7%.
Croatian: Incidencija izrazitog smanjenja težine za 20% ili više iznosila je 0,7%.
English: In addition there have been isolated cases of Sudden Unexplained Death in Epilepsy Patients (SUDEP) receiving Zonegran.
Croatian: Osim toga, bilo je izoliranih slučajeva iznenadne neobjašnjive smrti bolesnika s epilepsijom (Sudden Unexplained Death in Epilepsy Patients - SUDEP) koji su primali Zonegran.
English: Posology - Adults
Croatian: Doziranje - odrasli
English: Week 1 Weeks 2 to 8 Patients of weight 20 to 55 kg
Croatian: 1. tjedan 2. do 8. tjedan Bolesnici težine 20 do 55 kg
English: • If you forget to take a dose, don't worry: take the next dose when it is due.
Croatian: • Ako zaboravite uzeti svoju dozu, ne brinite: sljedeću dozu uzmite kada bude vrijeme po uobičajenom rasporedu.
English: Hatfield, Hertfordshire, AL10 9SN United Kingdom
Croatian: Hatfield, Hertfordshire, AL10 9SN Ujedinjeno Kraljevstvo
English: - 25 mg: 14, 28, 56 and 84 capsules - 50 mg: 14, 28, 56 and 84 capsules - 100 mg: 28, 56, 84, 98 and 196 capsules.
Croatian: - 25 mg: 14, 28, 56 i 84 kapsule - 50 mg: 14, 28, 56 i 84 kapsule - 100 mg: 28, 56, 84, 98 i 196 kapsula.
English: • agitation, irritability, confusion, depression
Croatian: • uznemirenost, razdražljivost, smetenost, depresija
English: Therefore, withdrawal of concomitant anti-epileptic medicinal products must be undertaken with caution.
Croatian: Stoga ukidanje istodobno primjenjivanih antiepileptičkih lijekova treba provoditi oprezno.
English: • anger, aggression, thoughts of suicide, suicide attempt.
Croatian: • ljutnja, agresija, misli o samoubojstvu, pokušaj samoubojstva
English: If any of these applies to you, tell your doctor before you take Zonegran.
Croatian: Ako se nešto od toga odnosi na Vas, obratite se liječniku prije nego što uzmete Zonegran.
English: Do not use this medicine if you notice any damage to the capsules, blister or carton or any visible signs of deterioration in the medicine.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakvo oštećenje na kapsulama, blisteru ili kutiji ili neki vidljivi znak propadanja lijeka.
English: Zonegran may be taken as monotherapy or added to existing therapy in adults.
Croatian: Zonegran se može uzimati kao monoterapija ili ga se može dodati već postojećoj terapiji u odraslih.
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 prijava o perifernom edemu i pruritusu u usporedbi s odraslom populacijom.
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% doze eliminira se nepromijenjeno.
English: Zonegran 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: Zonegran može utjecati na Vašu koncentraciju, sposobnost reagiranja, i može izazvati pospanost, osobito na početku liječenja ili kada Vam se poveća doza.
English: • glaucoma, which is a blockage of fluid in the eye causing increased pressure in the eye.
Croatian: • glaukom, što je blokiranje tekućine unutar oka koje uzrokuje povećan tlak u oku.
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: A very high plasma concentration of 100.1 μg/ml zonisamide was recorded approximately 31 hours after a patient took an overdose of Zonegran 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 Zonegranom i klonazepamom; bolesnik je postao komatozan i imao je respiratornu depresiju, ali mu se nakon pet dana povratila svijest i nije imao posljedica.
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 na to 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: It is not always possible to precisely achieve the calculated dose with the commercially available capsule strengths of Zonegran.
Croatian: Nije uvijek moguće precizno postići izračunatu dozu jačinama kapsula Zonegrana dostupnim na tržištu.
English: In these cases it is therefore recommended that the Zonegran total dose should be rounded up or down to the nearest available dose that can be achieved with commercially available capsule strengths of Zonegran (25 mg, 50 mg and 100 mg).
Croatian: Stoga se u tim slučajevima preporučuje zaokružiti ukupnu dozu Zonegrana na najbližu višu ili nižu moguću dozu koja se može postići jačinama kapsula Zonegrana dostupnim na tržištu (25 mg, 50 mg i 100 mg).
English: • inflammations of the pancreas (severe pain in the stomach or back)
Croatian: • upala gušterače (jaki bol u trbuhu ili leđima)
English: • Take your child to a cool, shaded place
Croatian: • Dijete sklonite na hladnije, sjenovito mjesto.
English: • If your doctor advises you to stop taking Zonegran your dose will be reduced gradually to lower the risk of more seizures.
Croatian: • Ako Vam liječnik savjetuje da prestanete uzimati Zonegran, dozu će Vam postupno smanjivati kako bi se smanjio rizik od dodatnih napadaja.
English: No specific antidotes for Zonegran overdose are available.
Croatian: Nisu dostupni nikakvi specifični antidoti za predoziranje Zonegranom.
English: Eisai Manufacturing Ltd, European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom.
Croatian: Eisai Manufacturing Ltd, European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, Ujedinjeno Kraljevstvo
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: Težina 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 100 mg na dan*
English: Generally, zonisamideinduced 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: • 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 Zonegran).
English: The safety and efficacy of Zonegran in children aged below 6 years or those below 20 kg have not yet been established.
Croatian: Sigurnost i djelotvornost Zonegrana u djece mlađe od 6 godina ili one težine manje od 20 kg još nisu ustanovljene.
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: 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 (log-linearno) prosječnoj koncentraciji zonisamida.
English: Due to the long retention time of zonisamide in the body, breast-feeding must not be resumed until one month after Zonegran therapy is completed.
Croatian: Zbog dugog zadržavanja zonisamida u tijelu, dojenje se ne smije započeti još mjesec dana nakon završetka terapije Zonegranom.
English: • difficulty sleeping, strange or unusual thoughts, feeling anxious or emotional.
Croatian: • teškoće sa spavanjem, čudne i neobične misli, osjećaj tjeskobe ili pretjerane osjećajnosti
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 izrazito nenormalno niske razine bikarbonata u serumu (smanjenje do manje od 17 mEq/l i za više od 5 mEq/l) bila je 3,8%.
English: • Zonegran is meant to be taken as a long-term medicine.
Croatian: • Zonegran je namijenjen kao lijek koji se uzima na dulje vrijeme.
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: 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: - 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 značajan učinak na farmakokinetičke parametre izloženosti zonisamidu.
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to sulphonamides.
Croatian: Preosjetljivost na djelatnu tvar, neku od pomoćnih tvari navedenih u dijelu 6.1 ili na sulfonamide.
English: Important information about some of the ingredients of Zonegran
Croatian: Važne informacije o nekim sastojcima Zonegrana
English: Reduce the risk of overheating by drinking sufficient water and keeping cool.
Croatian: Opasnost od pregrijavanja smanjite tako da pijete dovoljno vode i budete rashlađeni.
English: • Sponge your child's skin with cool (not cold) water
Croatian: • spužvom vlažite kožu djeteta vodom normalne temperature (ne hladnom)
English: If you feel that the effect of Zonegran is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako smatrate da je učinak lijeka Zonegran prejak ili preslab, obratite se svom liječniku ili ljekarniku.
English: In the event of signs or symptoms of dehydration, oligohydrosis, or elevated body temperature, discontinuation of Zonegran should be considered.
Croatian: U slučaju znakova ili simptoma dehidracije, oligohidroze ili povišene tjelesne temperature, potrebno je razmisliti o ukidanju Zonegrana.
English: Consideration must be given to discontinuing Zonegran in patients who develop an otherwise unexplained rash.
Croatian: Treba razmisliti o prekidu primjene Zonegrana u bolesnika u kojih se razvije inače neobjašnjiv osip.
English: What you need to know before you take Zonegran
Croatian: Što morate znati prije nego počnete uzimati Zonegran
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 postojalo je kašnjenje u prijelazu na sljedeći Tannerov stupanj te u sazrijevanju kostiju.
English: The most frequently reported are cleft lip, cardiovascular malformations and neural tube defect.
Croatian: Najčešće prijavljene nuspojave su rascjep usne, kardiovaskularne malformacije i poremećaj neuralne cijevi.
English: Zonegran 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: Zonegran 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: If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Zonegran (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 Zonegrana (postupnim ukidanjem lijeka ili smanjivanjem terapijske doze) jer se može razviti osteopenija.
English: If co-administration is necessary, the patient should be closely monitored and the dose of Zonegran and other CYP3A4 substrates adjusted as needed.
Croatian: Ako je potrebna istodobna primjena, bolesnika treba pomno nadzirati a dozu Zonegrana i drugih supstrata CYP3A4 prilagoditi prema potrebi.
English: Reduce the risk of kidney stones by drinking sufficient water.
Croatian: Smanjite rizik od nastanka bubrežnih kamenaca tako da pijete dovoljno vode.
English: • decreased sweating, overheating.
Croatian: • smanjeno znojenje, pregrijanost
English: Contact your doctor as soon as possible if you:
Croatian: Obratite se liječniku čim prije ako:
English: Effect of Zonegran on cytochrome P450 enzymes
Croatian: Učinak Zonegrana na enzime citokroma P450
English: Sulphonamide reactions
Croatian: Reakcije na sulfonamid
English: • have an unexplained skin rash, as this could develop into a more severe skin rash or skin peeling.
Croatian: • imate neobjašnjiv osip na koži, jer se to može razviti u teži osip ili ljuštenje kože
English: Zonegran 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: Zonegran se primjenjuje za liječenje napadaja koji zahvaćaju jedan dio mozga (parcijalni napadaj), nakon kojih može ali ne mora slijediti napadaj koji zahvaća cijeli mozak (sekundarna generalizacija).
English: Children and adolescents (5-18 years): Limited data indicate that pharmacokinetics in children and adolescents dosed to steady state at 1, 7 or 12 mg/kg daily, in divided doses, are similar to those observed in adults, after adjustment for bodyweight.
Croatian: Djeca i adolescenti (5 - 18 godina): ograničeni podaci pokazuju da je farmakokinetika u djece i adolescenata, dozirana do stanja dinamičke ravnoteže od 1, 7 ili 12 mg/kg na dan u podijeljenim dozama, slična onoj opaženoj u odraslih nakon korekcije za tjelesnu težinu.
English: If you stop taking Zonegran
Croatian: Ako prestanete uzimati Zonegran