FrancophonIA/ELRC3.0 huggingface dataset:
English: There is limited information on the use of rufinamide in this group, so the dose of your medicine may need to be increased more slowly.
Croatian: Podaci o primjeni rufinamida u ove skupine su ograničeni, tako da će Vam dozu lijeka morati sporije povećavati.
English: The bioavailability of rufinamide is dependent on dose.
Croatian: Bioraspoloživost rufinamida ovisi o dozi.
English: Adults and children taking valproate at the same time as rufinamide will result in high levels of rufinamide in the blood.
Croatian: Odrasli i djeca koji uzimaju valproat u isto vrijeme kad i rufinamid imat će visoke razine rufinamida u krvi.
English: In the case of one or more missed doses, individualised clinical judgement is necessary.
Croatian: Ako se propusti jedna ili više doza, potrebno je postupiti prema kliničkoj procjeni u pojedinom slučaju.
English: Ask the doctor or pharmacist for advice before taking any medicine at the same time as Inovelon.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek u isto vrijeme kad i Inovelon.
English: Therefore, it is recommended that you use an additional safe and effective contraceptive method (such as a barrier method, e.g., condoms) when taking Inovelon.
Croatian: Stoga se preporučuje da za vrijeme uzimanja Inovelona koristite dodatnu sigurnu i djelotvornu kontracepcijsku metodu (kao što je mehanička metoda, npr. kondom).
English: If you stop taking Inovelon
Croatian: Ako prestanete uzimati Inovelon
English: Inovelon should be administered with food (see section 5.2).
Croatian: Inovelon treba primjenjivati s hranom (vidjeti dio 5.2).
English: The plasma elimination half-life is approximately 6-10 hours in healthy subjects and patients with epilepsy.
Croatian: Poluvijek eliminacije iz plazme iznosi približno 6-10 sati kako u zdravih ispitanika, tako i u bolesnika s epilepsijom.
English: Inovelon oral suspension also contains sorbitol and, therefore, should not be administered to patients with rare hereditary problems of fructose intolerance.
Croatian: Inovelon oralna suspenzija također sadrži sorbitol te se stoga ne smije davati bolesnicima s rijetkim nasljednim poremećajem nepodnošenja fruktoze.
English: Rufinamide modulates the activity of sodium channels, prolonging their inactive state.
Croatian: Rufinamid mijenja aktivnost natrijevih kanala, produljujući njihovo neaktivno stanje.
English: Multiple dosing of 7,200 mg/day was associated with no major signs or symptoms.
Croatian: Višekratna doza od 7200 mg na dan nije bila povezana s nekim jačim znakovima ili simptomima.
English: Inovelon tablets must be taken twice daily with water, in the morning and in the evening.
Croatian: Inovelon tablete moraju se uzimati dvaput na dan s vodom, ujutro i navečer.
English: There is no specific antidote for rufinamide.
Croatian: Nema posebnog antidota za rufinamid.
English: In the treated population, an increase in malformations has been noted with polytherapy; however, the extent to which the treatment and/or the illness is responsible has not been elucidated.
Croatian: U liječene je populacije povećana učestalost malformacija zabilježena kod politerapije; međutim, nije razjašnjeno u kojem je opsegu za to odgovorno liječenje, a u kojem sama bolest.
English: Oriented-polyethylene terephthalate (o-PET) bottle with a child-resistant polypropylene (PP) closure; each bottle contains 460 ml of suspension in an outer cardboard carton.
Croatian: Boca od orijentiranog polietilen tereftalata (o-PET) sa sigurnosnim zatvaračem za djecu od polipropilena (PP); jedna boca sadrži 460 ml suspenzije u kartonskoj kutiji.
English: When given twice daily at 12-hourly intervals, rufinamide accumulates to the extent predicted by its terminal half-life, indicating that the pharmacokinetics of rufinamide are time-independent (i.e. no autoinduction of metabolism).
Croatian: Kad se daje dvaput na dan u razmacima od 12 sati, rufinamid se nakuplja u opsegu predviđenom njegovim terminalnim poluvijekom, što pokazuje da farmakokinetika rufinamida ne ovisi o vremenu (tj. nema autoindukcije metabolizma).
English: Therefore, consideration should be given to a dose reduction of Inovelon in patients who are initiated on valproate therapy (see section 4.2).
Croatian: Stoga treba razmotriti sniženje doze Inovelona u bolesnika u kojih se započinje terapija valproatom (vidjeti dio 4.2).
English: If at any time you have these thoughts contact your doctor immediately (see section 2).
Croatian: Ako u bilo kojem trenutku pomislite takvo što, odmah se javite liječniku (vidjeti dio 2).
English: The addition or withdrawal of these medicinal products or adjusting of the dose of these medicinal products during rufinamide therapy may require an adjustment in dosage of rufinamide (see section 4.2).
Croatian: Dodavanje ili ukidanje tih lijekova ili prilagodba njihove doze tijekom terapije rufinamidom može iziskivati prilagodbu doze rufinamida (vidjeti dio 4.2).
English: Inovelon may cause dizziness, somnolence and blurred vision.
Croatian: Inovelon može izazvati omaglicu, somnolenciju i zamagljen vid.
English: If you have been told by the doctor that you have an intolerance to some sugars, contact the doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: Some patients may respond to lower doses and your doctor may adjust the dose depending on how you respond to the treatment.
Croatian: Budući da neki bolesnici mogu reagirati i na niže doze, liječnik Vam može prilagoditi dozu ovisno o Vašem odgovoru na liječenje.
English: All patients who develop a rash while taking rufinamide must be closely monitored.
Croatian: Svi bolesnici, koji za vrijeme uzimanja rufinamida razviju osip, moraju se pažljivo nadzirati.
English: If you experience side effects, your doctor may increase the dose more slowly.
Croatian: Ako osjetite nuspojave, liječnik Vam može sporije povećavati dozu.
English: However, plasma levels were reduced by approximately 30% when haemodialysis was applied after administration of rufinamide, suggesting that this may be a useful procedure in case of overdose (see sections 4.2 and 4.9).
Croatian: Međutim, razine u plazmi bile su snižene za približno 30% kad se nakon davanja rufinamida primijenila hemodijaliza, što pokazuje da to može biti koristan postupak u slučaju predoziranja (vidjeti dio 4.2 i 4.9).
English: Taking these data into consideration, rufinamide should not be used during pregnancy, or in women of childbearing age not using contraceptive measures, unless clearly necessary.
Croatian: S obzirom na ove podatke, rufinamid se ne smije primjenjivati u trudnoći ili u žena reproduktivne dobi koje ne primjenjuju mjere kontracepcije, osim ako je to prijeko potrebno.
English: Rufinamide should be withdrawn gradually to reduce the possibility of seizures on withdrawal.
Croatian: Rufinamid treba postupno ukidati, kako bi se smanjila mogućnost napadaja prilikom prestanka primjene.
English: Higher rufinamide doses may result in a more pronounced induction.
Croatian: Više doze rufinamida mogu dovesti do izraženije indukcije.
English: These recommendations should also be considered when rufinamide is used concomitantly with substances with a narrow therapeutic window such as warfarin and digoxin.
Croatian: Ove preporuke također treba uzeti u obzir kad se rufinamid primjenjuje istodobno s tvarima koje imaju usku terapijsku širinu, kao što su varfarin i digoksin.
English: When rufinamide treatment is to be discontinued, it should be withdrawn gradually.
Croatian: Kad liječenje rufinamidom treba prekinuti, to treba učiniti postupno.
English: Suicidal ideation
Croatian: Razmišljanje o samoubojstvu
English: Such evaluations indicate that sex does not affect the pharmacokinetics of rufinamide to a clinically relevant extent.
Croatian: Takve procjene pokazuju da spol ne utječe na farmakokinetiku rufinamida u klinički važnoj mjeri.
English: Rufinamide has been shown to induce the cytochrome P450 enzyme CYP3A4 and may therefore reduce the plasma concentrations of substances which are metabolised by this enzyme.
Croatian: Pokazalo se da rufinamid inducira enzim citokroma P450 CYP3A4 i stoga može smanjiti koncentracije u plazmi onih tvari koje taj enzim metabolizira.
English: Furthermore, rufinamide does not inhibit the activity of cytochrome P450 enzymes (see section 5.2).
Croatian: Nadalje, rufinamid ne inhibira aktivnost enzima citokroma P450 (vidjeti dio 5.2).
English: Marketing Authorisation Holder: Eisai GmbH
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: Eisai GmbH
English: If patients develop new seizure types and/or experience an increased frequency of status epilepticus that is different from the patient's baseline condition, then the benefit-risk ratio of the therapy should be reassessed.
Croatian: Ako bolesnici razviju novu vrstu napadaja i/ili im se poveća učestalost epileptičkog statusa koji se razlikuje od onog početnog, onda treba ponovno procijeniti omjer koristi i rizika terapije.
English: Environmental risk assessment studies have shown that rufinamide is very persistent in the environment (see section 6.6).
Croatian: Studije procjene rizika za okoliš pokazale su da je rufinamid vrlo postojan u okolišu (vidjeti dio 6.6).
English: Inovelon may make the pill not effective at preventing pregnancy.
Croatian: Zbog Inovelona pilula može postati nedjelotvorna u sprječavanju trudnoće.
English: - if you take this medicine and have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away (see section 4).
Croatian: - ako uzimate ovaj lijek i u bilo kojem trenutku počnete razmišljati o samoozljeđivanju ili samoubojstvu, odmah se obratite liječniku ili otiđite u bolnicu (vidjeti dio 4).
English: Population pharmacokinetic/pharmacodynamic modelling demonstrated that the reduction of total and tonic-atonic seizure frequencies, the improvement of the global evaluation of seizure severity and the increase in probability of reduction of seizure frequency were dependent on rufinamide concentrations.
Croatian: Populacijsko farmakokinetičko/farmakodinamičko modeliranje pokazalo je da su smanjena učestalost ukupnih i toničko-atoničkih napadaja, poboljšana opća procjena težine napadaja i povećana vjerojatnost smanjenja učestalosti napadaja ovisili o koncentracijama rufinamida.
English: Rufinamide treatment has been associated with dizziness, somnolence, ataxia and gait disturbances, which could increase the occurrence of accidental falls in this population (see section 4.8).
Croatian: Liječenje rufinamidom povezano je s omaglicom, somnolencijom, ataksijom i poremećajem hoda, što može dovesti do učestalijih slučajnih padova u ove populacije (vidjeti dio 4.8).
English: What you need to know before you take Inovelon Do not take Inovelon: - if you are allergic to rufinamide or triazole derivatives or any of the other ingredients of Inovelon (listed in section 6).
Croatian: Što morate znati prije nego počnete uzimati Inovelon Nemojte uzimati Inovelon: - ako ste alergični na rufinamid ili derivate triazola ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: PHARMACEUTICAL FORM AND CONTENTS Oral suspension 460 ml.
Croatian: OBLIK I SADRŽAJ Oralna suspenzija 460 ml.
English: Rufinamide is active in a range of animal models of epilepsy.
Croatian: Rufinamid djeluje kod raznih životinjskih modela epilepsije.
English: Treatment with rufinamide should be initiated by a physician specialised in paediatrics or neurology with experience in the treatment of epilepsy.
Croatian: Liječenje rufinamidom treba započeti liječnik specijalist pedijatrije ili neurologije s iskustvom u liječenju epilepsije.
English: The discontinuation rate in Lennox-Gastaut syndrome due to adverse reactions was 8.2% for patients receiving rufinamide and 0% for patients receiving placebo.
Croatian: Primjena kod Lennox-Gastautovog sindroma prekinuta je zbog nuspojava u 8,2% bolesnika koji su primali rufinamid i 0% bolesnika koji su primali placebo.
English: Inovelon oral suspension must be taken twice every day, once in the morning and once in the evening.
Croatian: Inovelon oralna suspenzija mora se uzimati dvaput na dan svaki dan, jedanput ujutro i drugi put navečer.
English: Mild toxicity in the liver was observed in juvenile as well as in adult animals at exposure levels lower than or similar to those reached in patients.
Croatian: Blaga toksičnost za jetru bila je opažena kako u mladih, tako i u odraslih životinja pri razini izloženosti nižoj ili sličnoj onoj koja se postiže u bolesnika.
English: Central Nervous System reactions
Croatian: Reakcije središnjeg živčanog sustava
English: In reproductive and developmental toxicity studies, there were reductions in foetal growth and survival, and some stillbirths secondary to maternal toxicity.
Croatian: Ispitivanja reproduktivne i razvojne toksičnosti pokazala su smanjenje fetalnog rasta i preživljenja, kao i nešto mrtvorođenosti, koja nastaje sekundarno kod toksičnosti u majke.
English: Population pharmacokinetic modelling has been used to evaluate the influence of sex on the pharmacokinetics of rufinamide.
Croatian: Populacijsko farmakokinetičko modeliranje uporabilo se za procjenu utjecaja spola na farmakokinetiku rufinamida.
English: - Inovelon is a white slightly viscous suspension.
Croatian: - Inovelon je bijela, blago viskozna suspenzija.
English: Preparation: The press-in-bottle adapter (PIBA) which is supplied in the product carton should be inserted firmly into the neck of the bottle before use and remain in place for the duration of the usage of the bottle.
Croatian: Priprema: nastavak (PIBA) koji je priložen u kutiji s lijekom treba čvrsto utisnuti u vrat boce prije uporabe i ostaviti ga tako sve vrijeme uporabe boce.
English: Uncommon (between 1 in a 100 and 1 in a 1000 patients) side effects of Inovelon are: Allergic reactions and an increase in markers of liver function (hepatic enzyme increase).
Croatian: Manje česte nuspojave Inovelona (između 1 na 100 i 1 na 1000 bolesnika): Alergijske reakcije i povišeni pokazatelji funkcije jetre (povećanje jetrenih enzima).
English: Inovelon contains sorbitol
Croatian: Inovelon sadrži sorbitol
English: - If you have any further questions, ask the doctor or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: Follow the manufacturer's instructions for the feeding tube to administer the medicine.
Croatian: Slijedite upute proizvođača sonde za prehranu za primjenu lijeka.
English: Although the underlying mechanism and safety relevance of this finding is not known, clinicians should use clinical judgment when assessing whether to prescribe rufinamide to patients at risk from further shortening their QTc duration (e.g., Congenital Short QT Syndrome or patients with a family history of such a syndrome).
Croatian: Iako mehanizam u podlozi ove promjene i važnost ovog nalaza za sigurnost primjene rufinamida nisu poznati, liječnici se trebaju osloniti na kliničku prosudbu kad procjenjuju hoće li propisati rufinamid bolesnicima pod rizikom od daljnjeg skraćenja QTc intervala (npr. bolesnicima sa sindromom kongenitalno skraćenog QT intervala ili onima koji u obiteljskoj anamnezi imaju taj sindrom).
English: Hypersensitivity to the active substance, triazole derivatives or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar, derivate triazola ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: The mean CYP3A4 activity, assessed as clearance of triazolam, was increased by 55% after 11 days of treatment with rufinamide 400 mg twice daily.
Croatian: Prosječna aktivnost CYP3A4, procijenjena kao klirens triazolama, bila je povećana za 55% nakon 11 dana liječenja rufinamidom u dozi od 400 mg dvaput na dan.
English: The pharmacokinetic interactions between rufinamide and other antiepileptic medicinal products have been evaluated in patients with epilepsy, using population pharmacokinetic modelling.
Croatian: Farmakokinetičke interakcije između rufinamida i drugih antiepileptičkih lijekova u bolesnika s epilepsijom procijenjene su pomoću populacijskog farmakokinetičkog modeliranja.
English: All seizures were classified according to the International League Against Epilepsy Revised Classification of Seizures.
Croatian: Svi su napadaji bili klasificirani prema Revidiranoj klasifikaciji napadaja Međunarodne lige za borbu protiv epilepsije.
English: Studies in animals revealed no teratogenic effect, but foetotoxicity in the presence of maternal toxicity was observed (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala da postoje teratogeni učinci, ali je kod toksičnosti za majku opažena fetotoksičnost (vidjeti dio 5.3).
English: In in -vitro studies, only a small fraction of rufinamide (34%) was bound to human serum proteins with albumin accounting for approximately 80% of this binding.
Croatian: U ispitivanjima in vitro, samo je mali udio rufinamida (34%) bio vezan za proteine u ljudskom serumu, od čega približno 80% za albumin.
English: If women treated with rufinamide plan to become pregnant, the continued use of this product should be carefully weighed.
Croatian: Ako žene liječene rufinamidom planiraju zatrudnjeti, potrebno je pažljivo odvagnuti nastavak primjene ovog lijeka.
English: Tell your doctor if you are taking valproate as the dose of Inovelon may need to be reduced by your doctor.
Croatian: Obavijestite svog liječnika ako uzimate valproat, jer će Vam liječnik možda trebati sniziti dozu Inovelona.
English: Consult the doctor, even if these events occurred at any time in the past.
Croatian: Potražite savjet liječnika, čak i ako se navedeno događalo i prije.
English: Treatment should be supportive and may include haemodialysis (see section 5.2).
Croatian: Liječenje treba biti potporno i može uključiti hemodijalizu (vidjeti dio 5.2).
English: Use in children from 1 year to less than 4 years of age
Croatian: Primjena u djece u dobi od 1 godine do manje od 4 godine
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
Croatian: Razmišljanje o samoubojstvu i samoubilačko ponašanje zabilježeni su u bolesnika liječenih antiepileptičkim lijekovima u nekoliko indikacija.
English: The frequency, type and severity of these adverse reactions were similar to that in children 4 years of age and older, adolescents and adults.
Croatian: Učestalost, vrsta i težina ovih nuspojava bile su slične onima u djece u dobi od 4 godine i starije, adolescenata i odraslih.
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 razmišljanja o samoubojstvu i samoubilačkog ponašanja te razmotriti odgovarajuće liječenje.
English: 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.
Croatian: Posebno ispitivanje interakcije u zdravih ispitanika nije otkrilo da rufinamid u dozi od 400 mg dvaput na dan utječe na farmakokinetiku olanzapina, supstrata CYP1A2.
English: - The active substance is rufinamide.
Croatian: - Djelatna tvar je rufinamid.
English: A small number of people being treated with antiepileptics such as Inovelon have had thoughts of harming or killing themselves.
Croatian: Malobrojne osobe koje se liječe antiepilepticima kao što je Inovelon, pomišljale su na samoozljeđivanje ili samoubojstvo.
English: 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.
Croatian: Prekid učinkovitog antiepileptičkog liječenja tijekom trudnoće može biti štetan kako za majku, tako i za plod ako dovede do pogoršanja bolesti.
English: Instructions on how to use the syringe and adaptor are provided below:
Croatian: Upute za uporabu štrcaljke i nastavka su u daljnjem tekstu:
English: Leave the adaptor in place and replace cap on bottle.
Croatian: Ostavite nastavak na mjestu i vratite zatvarač na bocu.
English: The main pathway of metabolism is hydrolysis of the carboxylamide group to the pharmacologically inactive acid derivative CGP 47292.
Croatian: Glavni metabolički put je hidroliza karboksilamidne skupine čime nastaje farmakološki neaktivan kiseli derivat CGP 47292.
English: In clinical studies discontinuation was achieved by reducing the dose by approximately 25% every two days.
Croatian: U kliničkim je ispitivanjima prestanak primjene postignut snižavanjem doze za približno 25% svaka dva dana.
English: 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.
Croatian: 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.
English: 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.
Croatian: Farmakokinetika rufinamida, nakon jednokratne doze od 400 mg, nije bila promijenjena u ispitanika s kroničnim i teškim zatajenjem bubrega, u usporedbi sa zdravim dobrovoljcima.
English: You are advised not to breast-feed while taking Inovelon, as it is not known if rufinamide will be present in breast milk.
Croatian: Savjetuje se da ne dojite za vrijeme uzimanja Inovelona, jer nije poznato izlučuje li se rufinamid u majčino mlijeko.
English: Parahydroxybenzoates
Croatian: Parahidroksibenzoati
English: Coordination Abnormal* Nystagmus Psychomotor hyperactivity disorders
Croatian: poremećena koordinacija* Nistagmus psihomotorička hiperaktivnost
English: 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%.
Croatian: 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%.
English: Studies in new-born infants or infants and toddlers under 1 year of age have not been conducted.
Croatian: Ispitivanja u novorođenčadi ili dojenčadi i male djece u dobi do 1 godine nisu provedena.
English: 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.
Croatian: 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.
English: White, slightly viscous suspension.
Croatian: Bijela, blago viskozna suspenzija.
English: After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis.
Croatian: Nakon akutnog predoziranja, želudac se može isprazniti ispiranjem ili izazivanjem povraćanja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 January 2007
Croatian: Datum prvog odobrenja: 16. siječnja 2007.
English: - if you are allergic to rufinamide or triazole derivatives or any of the other ingredients of Inovelon (listed in section 6).
Croatian: - ako ste alergični na rufinamid ili derivate triazola ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: The prescribed dose of Inovelon oral suspension can be administered via an enteral feeding tube.
Croatian: Propisana doza Inovelon oralne suspenzije može se primijeniti putem sonde za enteralnu prehranu.
English: Tell the doctor if you are taking the blood thinner - warfarin.
Croatian: Obavijestite liječnika ako uzimate lijek za razrjeđivanje krvi - varfarin.