FrancophonIA/ELRC3.0 huggingface dataset:
English: Erythromycin, Itraconazole Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of erythromycin and itraconazole.
Croatian: Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povećanje koncentracija eritromicina i itrakonazola u plazmi.
English: An increased incidence of nephrolithiasis has been observed in patients with underlying liver disorders when treated with indinavir.
Croatian: U bolesnika s postojećom bolešću jetre liječenih indinavirom primijećena je povećana incidencija nefrolitijaze.
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of fentanyl.
Croatian: Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracija fentanila u plazmi.
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of loratidine.
Croatian: Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracija loratadina u plazmi.
English: Careful monitoring of serum levels or therapeutic effects is recommended when these medicines are concomitantly administered with indinavir/ritonavir.
Croatian: Kod istodobne primjene navedenih lijekova i indinavira/ritonavira preporučuje se pažljivo praćenje koncentracija u serumu ili terapijskih učinaka.
English: Careful monitoring of therapeutic and adverse effects is recommended when dexamethasone is concomitantly administered with indinavir/ritonavir.
Croatian: Kod istodobne primjene deksametazona i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
English: • muscle pain
Croatian: • suha usta
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of buspirone.
Croatian: Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracija buspirona u plazmi.
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of tacrolimus.
Croatian: Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracije takrolimusa u plazmi.
English: Careful monitoring of therapeutic and adverse effects is recommended when atovaquone is concomitantly administered with indinavir/ritonavir.
Croatian: Kod istodobne primjene atovakvona i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
English: Careful monitoring of therapeutic and adverse effects is recommended when dexamethasone is concomitantly administered with indinavir.
Croatian: Kod istodobne primjene deksametazona i indinavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
English: Indinavir AUC and Cmin: ↔ (Relative to Indinavir 400 mg SD)  Quinidine concentration expected (CYP3A4 inhibition by indinavir)
Croatian: AUC i Cmin indinavira: ↔ (u usporedbi s primjenom indinavira u dozi od 400 mg SD)
English: Careful monitoring of therapeutic and adverse effects is recommended when tacrolimus is concomitantly administered with indinavir/ritonavir.
Croatian: Kod istodobne primjene takrolimusa i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
English: Tell your doctor immediately.
Croatian: Odmah obavijestite liječnika.
English: The following side effects can be very serious:
Croatian: Sljedeće nuspojave mogu biti vrlo ozbiljne:
English: These could be signs of an allergic reaction.
Croatian: To mogu biti znakovi alergijske reakcije.
English: The exposure of triazolam was reduced by 36%.
Croatian: Izloženost triazolamu bila je smanjena za 36%.
English: Return the medicine to the pharmacist.
Croatian: Vratite lijek ljekarniku.
English: Maximum recommended dose
Croatian: Maksimalna preporučena doza
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Inovelon.
Croatian: Mehanizam ovog rizika nije poznat, a dostupni podaci ne isključuju mogućnost povećanog rizika i kod Inovelona.
English: Do not take a double dose to make up for forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Wash the syringe with clean water and dry thoroughly.
Croatian: Operite štrcaljku čistom vodom i dobro je osušite.
English: Environmental Risk Assessment (ERA):
Croatian: Procjena rizika za okoliš (ERA):
English: If this happens to you, do not drive or operate machinery.
Croatian: Ako se to dogodi, nemojte upravljati vozilima i raditi sa strojevima.
English: Uncontrolled open-label studies suggest sustained long-term efficacy, although no controlled study has been conducted for longer than three months.
Croatian: Nekontrolirana otvorena ispitivanja pokazuju da se djelotvornost dugotrajno održala, iako nisu provedena kontrolirana ispitivanja u trajanju duljem od tri mjeseca.
English: Rufinamide was not genotoxic and had no carcinogenic potential.
Croatian: Rufinamid nije bio genotoksičan i nije imao kancerogenog potencijala.
English: As such, drop attacks were used as one of the primary end points.
Croatian: Kao takvi, astatički napadaji koristili su se kao jedna od primarnih mjera ishoda.
English: See section 3 - ‘How to use Inovelon' for advice on taking Inovelon with food and drink.
Croatian: Vidjeti dio 3 - ‘Kako uzimati Inovelon' za savjet o uzimanju Inovelona s hranom i pićem.
English: If you miss taking more than one dose, seek advice from the doctor.
Croatian: Ako propustite uzeti više od jedne doze, potražite savjet liječnika.
English: Do not take Inovelon:
Croatian: Nemojte uzimati Inovelon:
English: If you take more Inovelon than you should
Croatian: Ako uzmete više Inovelona nego što ste trebali
English: Date of latest renewal: 09 January 2012
Croatian: Datum posljednje obnove odobrenja: 9. siječnja 2012.
English: If you forget to take a dose, continue taking the medicine as normal.
Croatian: Ako ste zaboravili uzeti dozu, nastavite uzimati lijek kao i obično.
English: Reversibility of all findings was demonstrated after stopping treatment.
Croatian: Dokazana je reverzibilnost svih nalaza nakon prestanka liječenja.
English: Inovelon with food and drink
Croatian: Inovelon s hranom i pićem
English: Rufinamide was evenly distributed between erythrocytes and plasma.
Croatian: Rufinamid je bio ravnomjerno distribuiran između eritrocita i plazme.
English: After first opening: 90 days.
Croatian: 3 godine Nakon prvog otvaranja: 90 dana.
English: The doctor may need to adjust the dose.
Croatian: Liječnik će Vam možda trebati prilagoditi dozu.
English: Risk related to epilepsy and antiepileptic medicinal products in general:
Croatian: Rizik povezan s epilepsijom i antiepileptičkim lijekovima općenito:
English: It may take a while to find the best dose of Inovelon for you.
Croatian: Može proći neko vrijeme prije nego se utvrdi najbolja doza Inovelona za vas.
English: Inovelon should not be given to children younger than 1 year of age since there is not enough information on its use in this age group.
Croatian: Inovelon se ne smije davati djeci mlađoj od 1 godine, budući da nema dovoljno informacija o njegovoj primjeni u ovoj dobnoj skupini.
English: The formation of small amounts of glutathione conjugates cannot be completely excluded.
Croatian: Stvaranje malih količina konjugata glutationa ne može se potpuno isključiti.
English: These events led to rufinamide discontinuation in 20% of the cases.
Croatian: Ti su događaji doveli do prekida primjene rufinamida u 20% slučajeva.
English: This medicinal product could have potential risk for the environment.
Croatian: Ovaj lijek može predstavljati potencijalni rizik za okoliš.
English: The study was mainly designed for safety and not adequately powered to show a difference with regards to the seizure efficacy variables.
Croatian: Ispitivanje je uglavnom bilo ustrojeno za utvrđivanje sigurnosti i nije imalo odgovarajuću snagu da bi pokazalo razliku s obzirom na varijable djelotvornosti u pogledu napadaja.
English: Talk to your doctor or pharmacist if:
Croatian: Obratite se liječniku ili ljekarniku ako:
English: Do not use this medicine if you notice that the appearance of the medicine has changed.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da se izgled lijeka promijenio.
English: As dose increases, the bioavailability decreases.
Croatian: Kako se doza povećava, tako se bioraspoloživost smanjuje.
English: Manufacturer: Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, UK.
Croatian: Proizvođač: Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Ujedinjeno Kraljevstvo.
English: Each ml of oral suspension contains:
Croatian: Jedan ml oralne suspenzije sadrži:
English: Age characterisation in patients less than 4 years was not identified in the limited safety database due to small number of patients in the study.
Croatian: Dobna karakterizacija u bolesnika mlađih od 4 godine nije bila utvrđena u ograničenoj bazi sigurnosnih podataka zbog malog broja bolesnika u ovom ispitivanju.
English: Rufinamide is almost exclusively eliminated by metabolism.
Croatian: Rufinamid se gotovo isključivo eliminira metabolizmom.
English: Inovelon should be taken with food.
Croatian: Inovelon treba uzimati s hranom.
English: No data are available (see section 5.2).
Croatian: Nema dostupnih podataka (vidjeti dio 5.2).
English: You must only take Inovelon during your pregnancy if the doctor tells you to.
Croatian: Smijete uzimati Inovelon tijekom trudnoće samo ako Vam je tako rekao liječnik.
English: You can also break the tablets into two equal halves and swallow with water.
Croatian: Tablete također možete prelomiti na dvije jednake polovice i progutati s vodom.
English: Rufinamide was not teratogenic in mice, rats or rabbits.
Croatian: Rufinamid nije bio teratogen u miševa, štakora i kunića.
English: A change in the dose of the other medicines may be needed as they may become slightly less effective when given with rufinamide.
Croatian: Možda bude potrebno promijeniti doze drugih lijekova, jer mogu postati malo manje djelotvorni kad se daju s rufinamidom.
English: The toxicity profile of rufinamide in juvenile animals was similar to that in adult animals.
Croatian: Profil toksičnosti rufinamida u mladih životinja bio je sličan onome u odraslih životinja.
English: Children (1-12 years)
Croatian: Djeca (u dobi od 1-12 godina)
English: Maximum plasma levels are reached approximately 6 hours after administration.
Croatian: Maksimalne razine u plazmi postižu se približno 6 sati nakon primjene.
English: It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population.
Croatian: Pokazalo se da je u djece žena s epilepsijom prevalencija malformacija dva do tri puta veća nego u općoj populaciji, u kojoj iznosi približno 3%.
English: What Inovelon looks like and contents of the pack
Croatian: Kako Inovelon izgleda i sadržaj pakiranja
English: Like all medicines, Inovelon can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Inovelon može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
English: Tell the doctor if you are taking digoxin (a medicine used to treat heart conditions).
Croatian: Obavijestite liječnika ako uzimate digoksin (lijek koji se primjenjuje za liječenje srčanih bolesti).
English: A pharmacokinetic study in older healthy volunteers did not show a significant difference in pharmacokinetic parameters compared with younger adults.
Croatian: Farmakokinetičko ispitivanje u starijih zdravih dobrovoljaca nije pokazalo značajnu razliku u farmakokinetičkim parametrima u usporedbi s mlađim odraslim osobama.
English: Rash and/or fever.
Croatian: Osip i/ili vrućica.
English: Tell the doctor if you are taking hormonal/oral contraceptives, e.g., “The pill”.
Croatian: Obavijestite liječnika ako uzimate hormonsku/oralnu kontracepciju, npr., „pilulu“.
English: - you get a skin rash or fever.
Croatian: - ako dobijete kožni osip ili vrućicu.
English: Pharmacotherapeutic group: antiepileptics, carboxamide derivatives; ATC code: N03AF03.
Croatian: Farmakoterapijska skupina: antiepileptici, derivati karboksamida; ATK oznaka: N03AF03.
English: Patients should be monitored during the switch over period.
Croatian: U razdoblju zamjene bolesnike treba nadzirati.
English: Inovelon may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment or after a dose increase.
Croatian: Inovelon Vam može izazvati osjećaj omaglice, omamljenosti i utjecati na vid, osobito na početku liječenja ili nakon povećanja doze.
English: Decreased body weight gain was observed in both juvenile and adult rats and dogs.
Croatian: Smanjeni dobitak na tjelesnoj težini bio je opažen i u mladih i u odraslih štakora i pasa.
English: Do not reduce the dose or stop this medicine unless the doctor tells you to.
Croatian: Nemojte snižavati dozu ili prestati uzimati ovaj lijek osim ako Vam tako nije rekao liječnik.
English: What Inovelon is and what it is used for
Croatian: Što je Inovelon i za što se koristi
English: Patients and carers should exercise caution until they are familiar with the potential effects of this medicinal product.
Croatian: Bolesnici i skrbnici moraju biti oprezni dok se ne upoznaju s mogućim učincima ovog lijeka.
English: To ensure adequate dosing, after administration of the oral suspension, the enteral feeding tube must be flushed at least once with 1 ml of water.
Croatian: Kako bi se osiguralo odgovarajuće doziranje, nakon primjene oralne suspenzije, sonda za enteralnu prehranu mora se isprati najmanje jednom s 1 ml vode.
English: If you have difficulty swallowing, you can crush the tablet, then mix the powder in about half a glass (100 ml) of water and drink immediately.
Croatian: Ako imate poteškoća s gutanjem, možete zdrobiti tabletu, zatim pomiješati prašak u napola punoj čaši vode (100 ml) i odmah je popiti.
English: Tell the 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, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući one koje ste nabavili bez recepta.
English: Change in the types of seizures you experience/more frequent seizures which last a long time (called status epilepticus).
Croatian: Promjene u vrsti napadaja koje imate/učestaliji napadaji koji dugo traju (nazivaju se epileptički status).
English: Since the pharmacokinetics of rufinamide are not altered in older people (see section 5.2), dosage adjustment is not required in patients over 65 years of age.
Croatian: Budući da farmakokinetika rufinamida u starijih osoba nije promijenjena (vidjeti dio 5.2), nije potrebna prilagodba doze u bolesnika u dobi od 65 ili više godina.
English: However, no effects on morphology and function, including learning or memory, were observed in the offspring.
Croatian: Međutim, u potomstva nisu opaženi nikakvi učinci na morfologiju i funkciju, uključujući učenje ili pamćenje.
English: Weight decrease Head injury
Croatian: Pretrage smanjenje tjelesne težine ozljeda glave
English: If your liver disease is severe the doctor may decide Inovelon is not recommended for you.
Croatian: Ako imate tešku bolest jetre, liječnik može odlučiti da se Inovelon Vama ne preporučuje.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000).
Croatian: Učestalosti su definirane na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000).
English: The safety and efficacy of rufinamide in new-born infants or infants and toddlers aged less than 1 year have not been established.
Croatian: Sigurnost i djelotvornost rufinamida u novorođenčadi ili dojenčadi i djece mlađe od 1 godine nisu još ustanovljene.
English: Inovelon contains a medicine called rufinamide.
Croatian: Inovelon sadrži lijek koji se zove rufinamid.
English: Patients with rare, hereditary problems of fructose intolerance should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne bi trebali uzimati ovaj lijek.
English: EXP: After first opening: use within 90 days.
Croatian: Nakon prvog otvaranja: uporabiti u roku od 90 dana.
English: Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement.
Croatian: Ovaj se poremećaj manifestirao raznim znakovima i simptomima; međutim, bolesnici tipično, iako ne isključivo, imaju vrućicu i osip povezane sa zahvaćenošću drugih organskih sustava.
English: Paediatric Population (age 1 to less than 4 years)
Croatian: Pedijatrijska populacija (u dobi od 1 do manje od 4 godine)
English: The clinical development program has included over 1,900 patients, with different types of epilepsy, exposed to rufinamide.
Croatian: Klinički program razvoja lijeka uključio je više od 1900 bolesnika s različitim vrstama epilepsije koji su bili izloženi rufinamidu.
English: Risk related to rufinamide:
Croatian: Rizik povezan s rufinamidom:
English: Inovelon oral suspension contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).
Croatian: Inovelon oralna suspenzija sadrži parahidroksibenzoate koji mogu prouzročiti alergijske reakcije (moguće i odgođene).
English: As the disorder is variable in its expression, other organ system signs and symptoms not noted here may occur.
Croatian: Budući da ovaj poremećaj ima raznoliku kliničku sliku, mogu se pojaviti i drugi znakovi i simptomi organskih sustava, koji ovdje nisu navedeni.
English: See the doctor immediately as very occasionally this may become serious.
Croatian: Odmah posjetite liječnika, jer ti znakovi ponekad mogu postati ozbiljni.
English: Patients must be advised to exercise caution during activities requiring a high degree of alertness, e.g., driving or operating machinery.
Croatian: Bolesnicima treba savjetovati da budu oprezni tijekom aktivnosti koje zahtijevaju visok stupanj pozornosti, kao što su upravljanje vozilima i rad sa strojevima.
English: The maximum daily dose will depend on whether or not you are also taking valproate.
Croatian: Maksimalna dnevna doza ovisi o tome uzimate li i valproat.
English: What Inovelon contains
Croatian: Što Inovelon sadrži
English: The effect was modest to moderate.
Croatian: Taj je učinak bio slab do umjeren.
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: Meta-analiza randomiziranih, placebom kontroliranih ispitivanja antiepileptičkih lijekova također je pokazala malo povećan rizik od razmišljanja o samoubojstvu i samoubilačkog ponašanja.
English: Turn upside down and withdraw the prescribed amount of Inovelon from the bottle.
Croatian: Okrenite bocu naopako i izvucite propisanu količinu Inovelona iz boce.
English: If this reaction is suspected, rufinamide should be discontinued and alternative treatment started.
Croatian: Ako se sumnja na ovu reakciju, rufinamid treba prekinuti i započeti drugi oblik liječenja.
English: Depending on the individual sensitivity, rufinamide may have a minor to major influence on the ability to drive and use machines.
Croatian: Ovisno o osjetljivosti pojedine osobe, rufinamid može malo do jako utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Lennox-Gastaut syndrome is the name given to a group of severe epilepsies in which you may experience repeated seizures of various types.
Croatian: Lennox-Gastautov sindrom je naziv za skupinu teških epilepsija kod kojih se mogu ponavljati različite vrste napadaja.
English: If they happen to you tell your doctor or go to a hospital immediately:
Croatian: Ako se pojave, odmah obavijestite liječnika ili otiđite u bolnicu:
English: It belongs to a group of medicines called antiepileptics, which are used to treat epilepsy (a condition where someone has seizures or fits).
Croatian: Pripada skupini lijekova koji se zovu antiepileptici i primjenjuju se za liječenje epilepsije (stanja kad netko ima napadaje ili konvulzije).
English: Children generally have lower clearance of rufinamide than adults, and this difference is related to body size with rufinamide clearance increasing with body weight.
Croatian: Djeca općenito imaju niži klirens rufinamida od odraslih, a ta je razlika povezana s veličinom tijela jer se klirens rufinamida povećava s tjelesnom težinom.
English: If the doctor prescribes or recommends an additional treatment for epilepsy (e.g., valproate) you must tell the doctor you are taking Inovelon as the dose may need adjusting.
Croatian: Ako liječnik propiše ili preporuči dodatno liječenje za epilepsiju (npr. valproat), morate reći liječniku da uzimate Inovelon, jer će možda trebati prilagoditi dozu.
English: If you may have taken more Inovelon than you should, tell the doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking the medicine with you.
Croatian: Ako ste možda uzeli više Inovelona nego što ste trebali, odmah obavijestite liječnika ili ljekarnika ili otiđite u hitnu službu najbliže bolnice i ponesite sa sobom ovaj lijek.
English: It may not be excluded that rufinamide may also decrease the exposure of substances metabolised by other enzymes, or transported by transport proteins such as P-glycoprotein.
Croatian: Ne može se isključiti ni mogućnost da rufinamid može smanjiti izloženost tvarima koje metaboliziraju drugi enzimi ili ih prenose transportni proteini kao što je P-glikoprotein.
English: What Inovelon is and what it is used for What you need to know before you take Inovelon How to use Inovelon
Croatian: Što je Inovelon i za što se koristi Što morate znati prije nego počnete uzimati Inovelon Kako uzimati Inovelon
English: Alternatively, use the score line to break the tablet into two equal halves.
Croatian: Alternativno, koristite razdjelni urez za lomljenje tablete na dvije jednake polovice.
English: If the doctor advises stopping treatment, follow their instructions concerning the gradual reduction of Inovelon in order to lower the risk of an increase in seizures.
Croatian: Ako liječnik savjetuje prestanak liječenja, slijedite njegove upute za postupno sniženje doze Inovelona kako biste smanjili rizik od pojačanja napadaja.
English: If the patient has difficulty with swallowing, tablets can be crushed and administered in half a glass of water.
Croatian: Ako bolesnik ima poteškoća s gutanjem, tablete se mogu zdrobiti i dati u pola čaše vode.
English: If you are pregnant, or think you might be pregnant, or are planning to get pregnant, ask the doctor or pharmacist for advice before taking Inovelon.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete Inovelon.
English: What you need to know before you take Inovelon
Croatian: Što morate znati prije nego počnete uzimati Inovelon
English: The dose will be calculated for you by the doctor and will depend on your age, weight and whether you are taking Inovelon with another medicine called valproate.
Croatian: Liječnik će vam izračunati dozu prema vašoj dobi, tjelesnoj težini i prema tome uzimate li Inovelon s drugim lijekom koji se zove valproat.
English: As it is difficult for caregivers to precisely separate tonic and atonic seizures, the international expert panel of child neurologists agreed to group these seizure types and call them tonic-atonic seizures or “drop attacks”.
Croatian: Budući da je njegovateljima teško precizno odvojiti toničke od atoničkih napadaja, međunarodni stručni panel dječjih neurologa dogovorio se da te vrste napadaja svrsta u jednu skupinu i nazove ih toničko-atonički napadaji ili astatički napadaji.