natgillin/translations-raw huggingface dataset:
The frequency, type and severity of these adverse reactions were similar to that in children 4 years of age and older, adolescents and adults. 
Učestalost, vrsta i težina ovih nuspojava bile su slične onima u djece u dobi od 4 godine i starije, adolescenata i odraslih.
Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. 
Stoga bolesnike treba nadzirati zbog moguće pojave znakova razmišljanja o samoubojstvu i samoubilačkog ponašanja te razmotriti odgovarajuće liječenje.
A specific interaction study in healthy subjects revealed no influence of rufinamide at a dose of 400 mg twice daily on the pharmacokinetics of olanzapine, a CYP1A2 substrate. 
Posebno ispitivanje interakcije u zdravih ispitanika nije otkrilo da rufinamid u dozi od 400 mg dvaput na dan utječe na farmakokinetiku olanzapina, supstrata CYP1A2.
- The active substance is rufinamide. 
- Djelatna tvar je rufinamid.
A small number of people being treated with antiepileptics such as Inovelon have had thoughts of harming or killing themselves. 
Malobrojne osobe koje se liječe antiepilepticima kao što je Inovelon, pomišljale su na samoozljeđivanje ili samoubojstvo.
During pregnancy, interruption of an effective antiepileptic can be detrimental to both the mother and the foetus if it results in aggravation of the illness. 
Prekid učinkovitog antiepileptičkog liječenja tijekom trudnoće može biti štetan kako za majku, tako i za plod ako dovede do pogoršanja bolesti.
Instructions on how to use the syringe and adaptor are provided below: 
Upute za uporabu štrcaljke i nastavka su u daljnjem tekstu:
Leave the adaptor in place and replace cap on bottle. 
Ostavite nastavak na mjestu i vratite zatvarač na bocu.
The main pathway of metabolism is hydrolysis of the carboxylamide group to the pharmacologically inactive acid derivative CGP 47292. 
Glavni metabolički put je hidroliza karboksilamidne skupine čime nastaje farmakološki neaktivan kiseli derivat CGP 47292.
In clinical studies discontinuation was achieved by reducing the dose by approximately 25% every two days. 
U kliničkim je ispitivanjima prestanak primjene postignut snižavanjem doze za približno 25% svaka dva dana.
If you are taking the following medicines: phenobarbital, fosphenytoin, phenytoin or primidone, you may need to be carefully monitored for two weeks at the start of, or after the end of treatment with rufinamide, or after any marked change in the dose. 
Ako uzimate sljedeće lijekove: fenobarbital, fosfenitoin, fenitoin ili primidon, možda ćete trebati biti pod nadzorom dva tjedna od početka ili završetka liječenja rufinamidom ili nakon svake znatnije promjene doze.
The pharmacokinetics of a single 400 mg dose of rufinamide were not altered in subjects with chronic and severe renal failure compared to healthy volunteers. 
Farmakokinetika rufinamida, nakon jednokratne doze od 400 mg, nije bila promijenjena u ispitanika s kroničnim i teškim zatajenjem bubrega, u usporedbi sa zdravim dobrovoljcima.
You are advised not to breast-feed while taking Inovelon, as it is not known if rufinamide will be present in breast milk. 
Savjetuje se da ne dojite za vrijeme uzimanja Inovelona, jer nije poznato izlučuje li se rufinamid u majčino mlijeko.
Parahydroxybenzoates 
Parahidroksibenzoati
Coordination Abnormal* Nystagmus Psychomotor hyperactivity disorders 
poremećena koordinacija* Nistagmus psihomotorička hiperaktivnost
In a radiotracer study in three healthy volunteers, the parent compound (rufinamide) was the main radioactive component in plasma, representing about 80% of the total radioactivity, and the metabolite CGP 47292 constituting only about 15%. 
U ispitivanju s radiološki obilježenim spojem u tri zdrava ispitanika, prekursor (rufinamid) je bio glavna radioaktivna komponenta u plazmi, čineći oko 80% ukupne radioaktivnosti, dok je metabolit CGP 47292 činio samo oko 15%.
Studies in new-born infants or infants and toddlers under 1 year of age have not been conducted. 
Ispitivanja u novorođenčadi ili dojenčadi i male djece u dobi do 1 godine nisu provedena.
Peak concentration (Cmax) and plasma AUC of rufinamide increase less than proportionally with doses in both fasted and fed healthy subjects and in patients, probably due to dose-limited absorption behaviour. 
Vršne koncentracije (Cmax) i AUC u plazmi rufinamida povećavaju se manje nego proporcionalno dozama i u zdravih ispitanika i bolesnika kako natašte, tako i na pun želudac, vjerojatno zbog dozom ograničene apsorpcije.
White, slightly viscous suspension. 
Bijela, blago viskozna suspenzija.
After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis. 
Nakon akutnog predoziranja, želudac se može isprazniti ispiranjem ili izazivanjem povraćanja.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 January 2007 
Datum prvog odobrenja: 16. siječnja 2007.
- if you are allergic to rufinamide or triazole derivatives or any of the other ingredients of Inovelon (listed in section 6). 
- ako ste alergični na rufinamid ili derivate triazola ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
The prescribed dose of Inovelon oral suspension can be administered via an enteral feeding tube. 
Propisana doza Inovelon oralne suspenzije može se primijeniti putem sonde za enteralnu prehranu.
Tell the doctor if you are taking the blood thinner - warfarin. 
Obavijestite liječnika ako uzimate lijek za razrjeđivanje krvi - varfarin.
Antiepileptic medicines and Inovelon 
Antiepileptički lijekovi i Inovelon
- you have Congenital Short QT Syndrome or a family history of such a syndrome (electrical disturbance of the heart), as taking rufinamide could make it worse. 
- imate sindrom kongenitalno skraćenog QT intervala ili Vam je netko u obitelji imao takav sindrom (električni poremećaj srca), jer ga uzimanje rufinamida može pogoršati. - imate tegobe s jetrom.
Studies with other oral or implant contraceptives have not been conducted. 
Nisu provedena ispitivanja drugih kontraceptiva za peroralnu primjenu ili implantaciju.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. 
Bolesnicima (i skrbnicima tih bolesnika) treba savjetovati da potraže medicinski savjet ako se pojave znakovi razmišljanja o samoubojstvu i samoubilačko ponašanje.
QUALITATIVE AND QUANTITATIVE COMPOSITION Oral Tablet 
KVALITATIVNI I KVANTITATIVNI SASTAV
After single doses, food increases the bioavailability (AUC) of rufinamide by approximately 34% and the peak plasma concentration by 56%. 
Nakon jednokratne doze rufinamida hrana povećava njegovu bioraspoloživost (AUC) za približno 34%, a njegovu vršnu koncentraciju u plazmi za 56%.
Problems associated with nerves including: difficulty walking, abnormal movement, convulsions/seizures, unusual eye movements, blurred vision, trembling. 
Tegobe povezane sa živcima, uključujući: otežano hodanje, nenormalne kretnje, konvulzije/napadaje, neobične pokrete očiju, zamagljen vid, drhtanje.
Moreover, effective antiepileptic therapy should not be interrupted abruptly, since the aggravation of the illness is detrimental to both the mother and the foetus. 
Nadalje, učinkovita antiepileptička terapija ne smije se naglo prekidati, budući da pogoršanje bolesti šteti kako majci, tako i plodu.
Other medicines and Inovelon 
Drugi lijekovi i Inovelon
Inovelon oral suspension and Inovelon film-coated tablets have been demonstrated to be bioequivalent. 
Inovelon oralna suspenzija i Inovelon filmom obložene tablete pokazale su se bioekvivalentnima.
Aluminium/aluminium blisters, packs of 10, 30, 50, 60 and 100 film-coated tablets. 
Aluminij/aluminij blisteri, pakiranja od 10, 30, 50, 60 i 100 filmom obloženih tableta.
Warnings and precautions Talk to your doctor or pharmacist if: - you have Congenital Short QT Syndrome or a family history of such a syndrome (electrical disturbance of the heart), as taking rufinamide could make it worse. 
Upozorenja i mjere opreza Obratite se liječniku ili ljekarniku ako: - imate sindrom kongenitalno skraćenog QT intervala ili Vam je netko u obitelji imao takav sindrom (električni poremećaj srca), jer ga uzimanje rufinamida može pogoršati. - imate tegobe s jetrom.
If the recommended calculated dose of Inovelon is not achievable, the dose should be given to the nearest 0.5 ml of rufinamide. 
Ukoliko se preporučena izračunata doza Inovelona ne može postići, potrebno je dati dozu zaokruženu na najbližih 0,5 ml rufinamida.
If you have any suspension left in the bottle more than 90 days after it was first opened, do not use it. Do not use the suspension if you notice that the appearance or smell of your medicine has changed. 
Ako Vam je u boci preostalo nešto suspenzije nakon što je proteklo više od 90 dana od prvog otvaranja boce, ne upotrebljavajte je.
The adverse event profile was similar to that in children 4 years of age and older, adolescents, and adults. 
Profil nuspojava bio je sličan onome u djece u dobi od 4 godine i starije, adolescenata i odraslih.
Status epilepticus cases have been observed during treatment with rufinamide in clinical development studies, whereas no such cases were observed with placebo. 
Tijekom kliničkih ispitivanja u svrhu razvoja lijeka, opaženi su slučajevi epileptičkog statusa tijekom liječenja rufinamidom, dok takvi slučajevi nisu bili opaženi uz placebo.
A dose adjustment of the concomitantly administered medicinal product may need to be considered. 
Možda će trebati razmotriti prilagodbu doze istodobno primijenjenog drugog lijeka.
Children aged between 1 and 4 years of age 
Djeca u dobi od 1 do 4 godine
- you experience difficulty walking, abnormal movement, dizziness or sleepiness inform the doctor, if any of these happen. 
- ako Vam se pojave teškoće s hodanjem, neprirodni pokreti, omaglica ili pospanost, obavijestite svog liječnika ako se dogodi išta od navedenog.
Push down and turn cap to open bottle 
Potisnite prema dolje i zakrenite zatvarač da otvorite bocu.
Rufinamide is metabolised by hydrolysis, and is not metabolised to any notable degree by cytochrome P450 enzymes. 
Rufinamid se metabolizira hidrolizom i ne metaboliziraju ga u nekom znatnom stupnju enzimi citokroma P450.
The oral suspension should be shaken vigorously before every administration. 
Prije svake primjene oralnu suspenzija treba žustro promućkati.
Other antiepileptic medicinal products 
Drugi antiepileptički lijekovi
In clinical trials rufinamide discontinuation was achieved by reducing the dose by approximately 25% every two days (see section 4.4). 
U kliničkim se ispitivanjima prekid primjene rufinamida postigao snižavanjem doze za približno 25% svaka dva dana (vidjeti dio 4.4).
Co-administration of rufinamide 800 mg twice daily and a combined oral contraceptive (ethinyloestradiol 35 μg and norethindrone 1 mg) for 14 days resulted in a mean decrease in the ethinyl estradiol AUC0-24 of 22% and in norethindrone AUC0-24 of 14%. 
Istodobna primjena rufinamida u dozi od 800 mg dvaput na dan i kombiniranih oralnih kontraceptiva (35 μg etinilestradiola i 1 mg noretindrona) tijekom 14 dana, dovela je do prosječnog smanjenja AUC0-24 etinilestradiola za 22% i AUC0-24 noretindrona za 14%.
The Least Square mean change of the Child Behaviour Checklist (CBCL) Total Problems score after 2 years of treatment were 53.75 for the any other AED group and 56.35 for the rufinamide group (LS mean difference [95% CI] +2.60 [-10.5,15.7]; p=0.6928), and the difference between treatments was -2.776 (95% CI: -13.3, 7.8, p=0.5939). 
Child Behaviour Checklist (CBCL) Total Problems) nakon 2 godine liječenja iznosila je 53,75 za skupinu koja je uzimala neke druge antiepileptičke lijekove i 56,35 za skupinu koja je uzimala rufinamid (razlika srednje vrijednosti dobivene metodom najmanjih kvadrata [95% CI] +2,60 [-10,5,15,7]; p=0,6928), a razlika između liječenja bila je -2,776 (95% CI: -13,3, 7,8, p=0,5939).
No significant changes in rufinamide concentration are observed following co-administration with lamotrigine, topiramate or benzodiazepines. 
Ne opažaju se značajne promjene koncentracije rufinamida nakon istodobne primjene lamotrigina, topiramata ili benzodiazepina.
Due to the potential harmful effects for the breast-fed infant, breast-feeding should be avoided during maternal treatment with rufinamide. 
Zbog mogućih štetnih učinaka na dojenče, potrebno je izbjegavati dojenje dok se majka liječi rufinamidom.
In addition, patients have experienced: anxiety, insomnia, nose bleeds, acne, rash, back pain, infrequent periods, bruising, head injury (as a result of accidental injury during a seizure). 
Osim toga, bolesnici su imali: tjeskobu, nesanicu, krvarenje iz nosa, akne, osip, bol u leđima, rijetke menstruacije, modrice, ozljede glave (posljedica slučajne ozljede tijekom napadaja).
Inovelon has been given to you by your doctor to reduce the number of your seizures or fits. 
Inovelon Vam je dao liječnik kako bi se smanjio broj napadaja koje imate.
There is limited information on the use of rufinamide in older people. 
Informacije o primjeni rufinamida u starijih osoba su ograničene.
No data on the interaction of rufinamide with alcohol are available. 
Nema dostupnih podataka o interakciji rufinamida s alkoholom.
In this study, 25 patients were exposed to rufinamide as adjunctive therapy for 24 weeks at a dose of up to 45 mg/kg/day, in 2 divided doses. 
U tom je ispitivanju 25 bolesnika bilo izloženo rufinamidu kao dodatnoj terapiji tijekom 24 tjedna u dozi do 45 mg/kg na dan podijeljenoj u dvije doze.
Caution and careful dose titration is recommended when treating patients with mild to moderate hepatic impairment. 
Preporučuje se oprez i pažljivo titriranje doze kod liječenja bolesnika s blago do umjereno oštećenom funkcijom jetre.
Infections: ear infection, flu, nasal congestion, chest infection. 
Infekcije: infekcija uha, gripa, začepljenost nosa, infekcija u prsnom košu.
Inovelon (rufinamide tablets) was administered in a double blind, placebo-controlled study, at doses of up to 45 mg/kg/day for 84 days, to 139 patients with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (including both atypical absence seizures and drop attacks). 
Inovelon (tablete rufinamida) je bio primijenjen u dvostruko slijepom, placebom kontroliranom ispitivanju, u dozama do 45 mg/kg na dan tijekom 84 dana, u 139 bolesnika s Lennox-Gastautovim sindromom, u kojih napadaji nisu bili pod odgovarajućom kontrolom (uključujući i atipične apsans napadaje i astatičke napadaje).
In a thorough QT study, rufinamide produced a decrease in QTc interval proportional to concentration. 
U temeljitom ispitivanju učinaka na QT interval, rufinamid je izazvao skraćenje QTc intervala koje je bilo proporcionalno koncentraciji.
Toxicities observed in dogs at levels similar to human exposure at the maximum recommended dose were liver changes, including bile thrombi, cholestasis and liver enzyme elevations thought to be related to increased bile secretion in this species. 
Toksičnosti opažene u pasa, pri razinama izloženosti sličnima onima u ljudi kod maksimalne preporučene doze, bile su promjene na jetri, uključujući žučne ugruške, kolestazu i povišene jetrene enzime, za što se misli da je povezano s pojačanim izlučivanjem žuči u ove vrste.
No data are available on the effects on fertility following treatment with rufinamide. 
Nema dostupnih podataka o učincima na plodnost nakon liječenja rufinamidom.
Inovelon contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) These ingredients may cause allergic reactions (possibly delayed). 
Inovelon sadrži metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216) Ovi sastojci mogu izazvati alergijske reakcije (moguće i odgođene).
Benign bone neoplasms (osteomas) and hyperostosis seen in mice were considered a result of the activation of a mouse specific virus by fluoride ions released during the oxidative metabolism of rufinamide. 
Dobroćudne koštane novotvorine (osteomi) i hiperostozu opažene u miševa, smatra se rezultatom aktivacije virusa koji specifično napada miševe putem iona fluora oslobođenih tijekom oksidativnog metabolizma rufinamida.
Serious antiepileptic medicinal product hypersensitivity syndrome including DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) and Stevens-Johnson syndrome have occurred in association with rufinamide therapy. 
Terapija rufinamidom povezana je s ozbiljnim sindromom preosjetljivosti na antiepileptički lijek, uključujući reakciju na lijek s eozinofilijom i sistemskim simptomima (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) i Stevens-Johnsonov sindrom.
Rufinamide has demonstrated little or no significant capacity in -vitro to act as a competitive or mechanism-based inhibitor of the following human P450 enzymes: CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 or CYP4A9/11-2. 
Pokazano je da rufinamid nema nikakvu ili gotovo nikakvu značajnu sposobnost da in vitro djeluje kao kompetitivni ili na mehanizmu temeljeni inhibitor sljedećih enzima P450 u ljudi: CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 ili CYP4A9/11-2.
Women of child-bearing potential using hormonal contraceptives are advised to use an additional safe and effective contraceptive method (see sections 4.4 and 4.6). 
Ženama koje mogu zatrudnjeti i koje upotrebljavaju hormonsku kontracepciju savjetuje se da upotrebljavaju dodatne sigurne i učinkovite kontracepcijske metode (vidjeti dio 4.4 i 4.6).
Pneumonia Influenza Nasopharyngitis Ear infection Sinusitis 
Rijetko upala pluća Influenca Nazofaringitis infekcija uha Sinusitis
1.2 mg methyl parahydroxybenzoate (E218), 0.3 mg propyl parahydroxybenzoate (E216), 250 mg sorbitol (E420) 
1,2 mg metilparahidroksibenzoata (E218), 0,3 mg propilparahidroksibenzoata (E216), 250 mg sorbitola (E420).
- you suffer an increase in the number or severity or duration of your seizures, you should contact the doctor immediately if this happens. 
- ako Vam se poveća broj ili težina ili trajanje napadaja, odmah se javite liječniku ako se to dogodi.
The oral dosing syringes are graduated in 0.5 ml increments. 
Štrcaljke za oralno doziranje graduirane su na 0,5 ml.
Inovelon contains lactose 
Inovelon sadrži laktozu
Dizziness, headache, nausea, vomiting, sleepiness, fatigue. 
Omaglica, glavobolja, mučnina, povraćanje, pospanost, umor.
Potential for rufinamide to affect other medicinal products 
Mogućnost utjecaja rufinamida na druge lijekove
The most commonly reported adverse reactions overall were headache, dizziness, fatigue, and somnolence. 
Najčešće ukupno zabilježene nuspojave bile su glavobolja, omaglica, umor i somnolencija.
The syringes are graduated in 0.5 ml increments. 
Štrcaljke su graduirane na 0,5 ml.
In addition, the study investigated the cognitive development, behaviour and language development of subjects treated with rufinamide compared to subjects receiving any-other-AED. 
Uz to, ispitivanjem se istražio kognitivni razvoj, ponašanje i razvoj jezika u ispitanika liječenih rufinamidom u usporedbi s ispitanicima koji su primali neke druge antiepileptičke lijekove.
For dosing, please use the syringe and adaptor provided. 
Za doziranje uporabite priloženu štrcaljku i nastavak.
You may experience the following side effects with this medicine. 
Uz ovaj lijek možete osjetiti sljedeće nuspojave.
Rufinamide appears not to have a clinically relevant effect on carbamazepine, lamotrigine, phenobarbital, topiramate, phenytoin or valproate steady state concentrations. 
Čini se da rufinamid nema klinički važan učinak na koncentracije karbamazepina, lamotrigina, fenobarbitala, topiramata, fenitoina ili valproata u stanju dinamičke ravnoteže.
Status epilepticus 
Epileptički status
If you forget to take Inovelon 
Ako ste zaboravili uzeti Inovelon
A study in patients with severe renal impairment indicated that no dose adjustments are required for these patients (see section 5.2). 
Ispitivanje u bolesnika s teškim oštećenjem funkcije bubrega pokazalo je da nije potrebna prilagodba doze u ovih bolesnika (vidjeti dio 5.2).
The film-coating consists of hypromellose, macrogols (8000), titanium dioxide (E171), talc and ferric oxide red (E172). 
Film-ovojnica sastoji se od hipromeloze, makrogola (8000), titanijevog dioksida (E171), talka i crvenog željezovog oksida (E172).
Thus, clinically significant interactions mediated through inhibition of cytochrome P450 system by rufinamide are unlikely to occur. 
Stoga nije vjerojatno da će nastupiti klinički značajne interakcije posredovane inhibicijom sustava citokroma P450 izazvanom rufinamidom.
Problems associated with the stomach including: stomach pain, constipation, indigestion, loose stools (diarrhoea), loss or change in appetite, weight loss. 
Tegobe povezane sa želucem, uključujući: bol u želucu, zatvor, probavne smetnje, mekane stolice (proljev), gubitak ili promjena apetita, gubitak na tjelesnoj težini.
Inovelon oral suspension and Inovelon film-coated tablets may be interchanged at equal doses. 
Inovelon oralna suspenzija i Inovelon filmom obložene tablete međusobno su zamjenjive u jednakim dozama.
There are insufficient data on the withdrawal of concomitant antiepileptic medicinal products once seizure control has been achieved with the addition of rufinamide. 
Nema dovoljno podataka o prestanku primjene istodobno davanih antiepileptičkih lijekova nakon što se jednom postigla kontrola napadaja uz dodavanje rufinamida.
A significant improvement was observed for all three primary variables: the percentage change in total seizure frequency per 28 days during the maintenance phase relative to baseline (-35.8% on Inovelon vs. -1.6% on placebo, p=0.0006), the number of tonic-atonic seizures (-42.9% on Inovelon vs. 2.2% on placebo, p=0.0002), and the seizure severity rating from the Global Evaluation performed by the parent/guardian at the end of the double-blind phase (much or very much improved in 32.2% on Inovelon vs. 14.5% on the placebo arm, p=0.0041). 
Značajno poboljšanje bilo je opaženo u sve tri primarne varijable: u postotku promjene ukupne učestalosti napadaja u 28 dana tijekom faze održavanja u odnosu na početnu vrijednost (-35,8% za Inovelon nasuprot -1,6% za placebo, p=0,0006), broju toničko-atoničkih napadaja (-42,9% za Inovelon nasuprot 2,2% za placebo, p=0,0002) i ocjeni roditelja/skrbnika na temelju ljestvice za opću procjenu težine napadaja na kraju dvostruko slijepe faze (jako ili vrlo jako poboljšanje u 32,2% ispitanika u skupini koja je primala Inovelon nasuprot 14,5% u skupini koja je primala placebo, p=0,0041).
Renal excretion was the predominant route of elimination for active substance related material, accounting for 84.7% of the dose. 
Izlučivanje putem bubrega bilo je glavni put eliminacije tvari povezanih s djelatnom tvari, čineći 84,7% doze.
AED treatment during pregnancy should be carefully discussed with the treating physician. 
O liječenju antiepileptičkim lijekovima tijekom trudnoće potrebno je detaljno razgovarati s nadležnim liječnikom.
*Cross reference to section 4.4. 
*Vidjeti također dio 4.4.
In rats, decreased cellularity of the bone marrow and thymic atrophy were observed only in the carcinogenicity study. 
U štakora su smanjena celularnost koštane srži i atrofija timusa bile opažene samo u ispitivanju kancerogenosti.
Adverse reactions were usually mild to moderate in severity. 
Nuspojave su obično bile blage do umjereno teške.
Patients receiving valproate: 
Bolesnici koji primaju valproat:
It is not known if rufinamide is excreted in human breast milk. 
Nije poznato izlučuje li se rufinamid u majčino mlijeko u ljudi.