natgillin/translations-raw huggingface dataset:
Interaction with indinavir/ritonavir not studied Morphine levels may be decreased due to induction of glucuronidation by coadministered ritonavir. 
Koncentracije morfija mogu biti smanjene jer istodobno primijenjeni ritonavir inducira glukuronidaciju.
STEROIDS Dexamethasone 
STEROIDI Deksametazon
Indinavir and cimetidine can be co-administered without dose adjustment. 
Indinavir i cimetidin mogu se istodobno primjenjivati bez prilagođavanja doze.
CRIXIVAN 400 mg hard capsules Indinavir 
CRIXIVAN 400 mg tvrde kapsule indinavir
Between 800-mg and 1,000-mg dose levels, the deviation from dose-proportionality is less pronounced. 
Odstupanje od proporcionalnosti dozi manje je izraženo kod doza između 800 mg i 1000 mg.
This means you will take a total of four 200 mg capsules (800 mg) each day. 
To znači da ćete svaki dan uzeti ukupno četiri kapsule od 200 mg (800 mg).
Skin and subcutaneous tissue disorders 
Poremećaji kože i potkožnog tkiva vrlo često često nepoznato*
The Interactions section of the SPC for ritonavir should also be consulted for information about potential interactions. 
Za informacije o mogućim interakcijama treba pročitati i dio o interakcijama u Sažetku opisa svojstava lijeka za ritonavir.
Careful monitoring of therapeutic and adverse effects is recommended when erythromycin or itraconazole are concomitantly administered with indinavir/ritonavir. 
Kod istodobne primjene eritromicina ili itrakonazola i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Anhydrous lactose. 
Bezvodna laktoza.
Indinavir Cmin:  (Relative to Indinavir 800 mg TID alone) 
Cmin indinavira:  (u odnosu na primjenu samo indinavira u dozi od 800 mg TID)
The capsules are semi-translucent white and coded ‘CRIXIVAN 400 mg' in green. 
Kapsule su poluprozirne bijele, s oznakom ‘CRIXIVAN ™ 400 mg' zelene boje.
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophiliac patients type A and B treated with PIs. 
A i B liječenih inhibitorima proteaze prijavljeno je pojačano krvarenje, uključujući spontane kožne hematome i hemartroze.
Very common asthenia/fatigue, taste perversion, abdominal pain. 
Opći poremećaji i reakcije na mjestu primjene vrlo često astenija/umor, promjena osjeta okusa, bol u abdomenu
The capsules are semi-translucent white and coded ‘CRIXIVAN ™ 200 mg' in blue. 
Kapsule su poluprozirne bijele s oznakom ‘CRIXIVAN ™ 200 mg' plave boje.
• acid reflux 
• vraćanje kiseline iz želuca
Saquinavir 1,200 mg SD (soft gel capsule formulation) (Indinavir 800 mg TID) 
Sakvinavir 1200 mg SD (meka želatinozna kapsula) (indinavir 800 mg TID)
A dose reduction of ketoconazole should be considered when coadministered with indinavir/ritonavir. 
U slučaju istodobne primjene s indinavirom/ritonavirom treba razmotriti smanjenje doze ketokonazola.
Careful monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with indinavir. 
Kod istodobne primjene navedenih lijekova i indinavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Saquinavir 800 mg SD (soft gel capsule formulation) (Indinavir 800 mg TID) 
Sakvinavir 800 mg SD (meka želatinozna kapsula) (indinavir 800 mg TID)
Indinavir AUC24hr:220 % Indinavir Cmin:↑ 24-fold (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC24hr:  
AUC24h indinavira: 220% Cmin indinavira:↑ 24 puta (u odnosu na primjenu samo indinavira u dozi od 800 mg TID*) AUC24h ritonavira: 
Co-administration of quetiapine with indinavir is contraindicated (see section 4.3). 
Istodobna primjena kvetiapina i indinavira je kontraindicirana (vidjeti dio
ANTICONVULSANTS Carbamazepine 
Karbamazepin
Indinavir AUC24hr:68 % Indinavir Cmin: ↑ 10-fold (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC24hr:  
AUC24h indinavira:68% Cmin indinavira: ↑ 10 puta (u odnosu na primjenu samo indinavira u dozi od 800 mg TID*) AUC24h ritonavira: 
8 hours, produced AUC0-8hr values of 27,412 nM*h, peak plasma concentrations of 12,182 nM, and plasma concentrations at 8 hours post dose of 122 nM. 
U pedijatrijskih bolesnika zaraženih HIV om režim doziranja u kojem su primali 500 mg/m indinavira u obliku tvrdih kapsula svakih 8 sati rezultirao je vrijednošću AUC0-8h od 27 412 nM*h, vršnoj koncentraciji u plazmi od 12 182 nM i koncentraciji u plazmi 8 sati nakon primjene doze od 122 nM.
• pain on urination 
• bol pri mokrenju
Efavirenz AUC and Cmin : ↔ 
AUC i Cmin efavirenza: ↔
Careful monitoring of therapeutic and adverse effects is recommended when morphine is concomitantly administered with indinavir/ritonavir. 
Kod istodobne primjene morfija i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Hepato-biliary disorders 
INHIBITORI PDE5
Indinavir and isoniazid can be co-administered without dose adjustment. 
Indinavir i izoniazid mogu se istodobno primjenjivati bez prilagođavanja doze.
Interaction with indinavir/ritonavir not studied Ritonavir induces glucuronidation and as a result is expected to decrease the plasma concentrations of atovaquone. 
Ritonavir inducira glukuronidaciju pa se očekuje smanjenje koncentracija atovakvona u plazmi.
Medicinal products interactions 
Interakcije s drugim lijekovima
The capsules are semi-translucent white and coded ‘CRIXIVAN 200 mg' on them in blue. 
Kapsule su poluprozirne bijele, s oznakom ‘CRIXIVAN ™ 200 mg' plave boje.
liver function abnormalities 
Oštećenje funkcije jetre
Dose reduction of CRIXIVAN to 600 mg every 8 hours is recommended with administering itraconazole concurrently. 
Kod istodobne primjene s itrakonazolom preporučuje se smanjiti dozu lijeka CRIXIVAN na 600 mg svakih 8 sati.
In some patients, resolution of the interstitial nephritis did not occur following discontinuation of indinavir therapy; renal insufficiency, renal failure, leucocyturia (see section 4.4). 
U nekih bolesnika nije došlo do povlačenja intersticijskog nefritisa nakon prekida liječenja indinavirom.
Careful monitoring of therapeutic and adverse effects is recommended when carbamazepine is concomitantly administered with indinavir/ritonavir. 
Kod istodobne primjene karbamazepina i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of ketoconazole. 
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povećanje koncentracija ketokonazola u plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when fentanyl is concomitantly administered with indinavir/ritonavir. 
Kod istodobne primjene fentanila i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Decreases in methadone AUC has been observed with other ritonavir-boosted protease inhibitors. 
Kod primjene drugih inhibitora proteaze pojačanih ritonavirom primijećeno je smanjenje AUC-a metadona.
Careful monitoring of therapeutic and adverse effects is recommended when ketoconazole is concomitantly administered with indinavir/ritonavir. 
Kod istodobne primjene ketokonazola i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Increased methadone dose may be necessary when concomitantly administered with indinavir/ritonavir. 
Kod istodobne primjene s indinavirom/ritonavirom možda će biti potrebno povećanje doze metadona.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of carbamazepine. 
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracija karbamazepina u plazmi.
Indinavir AUC:  46 % Indinavir Cmin:  57 % (Relative to Indinavir 800 mg TID alone) An increased dose (1,000 mg TID) of indinavir does not compensate for the inducing effect of efavirenz. 
AUC indinavira:  46% Cmin indinavira:  57% (u odnosu na primjenu samo indinavira u dozi od 800 mg TID)
Careful monitoring of therapeutic and adverse effects is recommended when loratidine is concomitantly administered with indinavir/ritonavir. 
Kod istodobne primjene loratadina i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
An increase in thyroidal weight and thyroidal follicular cell hyperplasia, due to an increase in thyroxine clearance, was seen in rats treated with indinavir at doses  160 mg/kg/day. 
U štakora koji su primali doze indinavira ≥ 160 mg/kg na dan primijećeno je povećanje težine štitnjače i folikularna hiperplazija štitnjače zbog povećanog klirensa tiroksina.
Careful monitoring of therapeutic and adverse effects is recommended when buspirone is concomitantly administered with indinavir/ritonavir. 
Kod istodobne primjene buspirona i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Efavirenz AUC:  
AUC efavirenza: 
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. 
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povećanje koncentracija eritromicina i itrakonazola u plazmi.
An increased incidence of nephrolithiasis has been observed in patients with underlying liver disorders when treated with indinavir. 
U bolesnika s postojećom bolešću jetre liječenih indinavirom primijećena je povećana incidencija nefrolitijaze.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of fentanyl. 
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracija fentanila u plazmi.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of loratidine. 
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracija loratadina u plazmi.
Careful monitoring of serum levels or therapeutic effects is recommended when these medicines are concomitantly administered with indinavir/ritonavir. 
Kod istodobne primjene navedenih lijekova i indinavira/ritonavira preporučuje se pažljivo praćenje koncentracija u serumu ili terapijskih učinaka.
Careful monitoring of therapeutic and adverse effects is recommended when dexamethasone is concomitantly administered with indinavir/ritonavir. 
Kod istodobne primjene deksametazona i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
• muscle pain 
• suha usta
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of buspirone. 
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracija buspirona u plazmi.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of tacrolimus. 
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracije takrolimusa u plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when atovaquone is concomitantly administered with indinavir/ritonavir. 
Kod istodobne primjene atovakvona i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Careful monitoring of therapeutic and adverse effects is recommended when dexamethasone is concomitantly administered with indinavir. 
Kod istodobne primjene deksametazona i indinavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Indinavir AUC and Cmin: ↔ (Relative to Indinavir 400 mg SD)  Quinidine concentration expected (CYP3A4 inhibition by indinavir) 
AUC i Cmin indinavira: ↔ (u usporedbi s primjenom indinavira u dozi od 400 mg SD)
Careful monitoring of therapeutic and adverse effects is recommended when tacrolimus is concomitantly administered with indinavir/ritonavir. 
Kod istodobne primjene takrolimusa i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Tell your doctor immediately. 
Odmah obavijestite liječnika.
The following side effects can be very serious: 
Sljedeće nuspojave mogu biti vrlo ozbiljne:
These could be signs of an allergic reaction. 
To mogu biti znakovi alergijske reakcije.
The exposure of triazolam was reduced by 36%. 
Izloženost triazolamu bila je smanjena za 36%.
Return the medicine to the pharmacist. 
Vratite lijek ljekarniku.
Maximum recommended dose 
Maksimalna preporučena doza
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Inovelon. 
Mehanizam ovog rizika nije poznat, a dostupni podaci ne isključuju mogućnost povećanog rizika i kod Inovelona.
Do not take a double dose to make up for forgotten dose. 
Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
Wash the syringe with clean water and dry thoroughly. 
Operite štrcaljku čistom vodom i dobro je osušite.
Environmental Risk Assessment (ERA): 
Procjena rizika za okoliš (ERA):
If this happens to you, do not drive or operate machinery. 
Ako se to dogodi, nemojte upravljati vozilima i raditi sa strojevima.
Uncontrolled open-label studies suggest sustained long-term efficacy, although no controlled study has been conducted for longer than three months. 
Nekontrolirana otvorena ispitivanja pokazuju da se djelotvornost dugotrajno održala, iako nisu provedena kontrolirana ispitivanja u trajanju duljem od tri mjeseca.
Rufinamide was not genotoxic and had no carcinogenic potential. 
Rufinamid nije bio genotoksičan i nije imao kancerogenog potencijala.
As such, drop attacks were used as one of the primary end points. 
Kao takvi, astatički napadaji koristili su se kao jedna od primarnih mjera ishoda.
See section 3 - ‘How to use Inovelon' for advice on taking Inovelon with food and drink. 
Vidjeti dio 3 - ‘Kako uzimati Inovelon' za savjet o uzimanju Inovelona s hranom i pićem.
If you miss taking more than one dose, seek advice from the doctor. 
Ako propustite uzeti više od jedne doze, potražite savjet liječnika.
Do not take Inovelon: 
Nemojte uzimati Inovelon:
If you take more Inovelon than you should 
Ako uzmete više Inovelona nego što ste trebali
Date of latest renewal: 09 January 2012 
Datum posljednje obnove odobrenja: 9. siječnja 2012.
If you forget to take a dose, continue taking the medicine as normal. 
Ako ste zaboravili uzeti dozu, nastavite uzimati lijek kao i obično.
Reversibility of all findings was demonstrated after stopping treatment. 
Dokazana je reverzibilnost svih nalaza nakon prestanka liječenja.
Inovelon with food and drink 
Inovelon s hranom i pićem
Rufinamide was evenly distributed between erythrocytes and plasma. 
Rufinamid je bio ravnomjerno distribuiran između eritrocita i plazme.
After first opening: 90 days. 
3 godine Nakon prvog otvaranja: 90 dana.
The doctor may need to adjust the dose. 
Liječnik će Vam možda trebati prilagoditi dozu.
Risk related to epilepsy and antiepileptic medicinal products in general: 
Rizik povezan s epilepsijom i antiepileptičkim lijekovima općenito:
It may take a while to find the best dose of Inovelon for you. 
Može proći neko vrijeme prije nego se utvrdi najbolja doza Inovelona za vas.
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. 
Inovelon se ne smije davati djeci mlađoj od 1 godine, budući da nema dovoljno informacija o njegovoj primjeni u ovoj dobnoj skupini.
The formation of small amounts of glutathione conjugates cannot be completely excluded. 
Stvaranje malih količina konjugata glutationa ne može se potpuno isključiti.
These events led to rufinamide discontinuation in 20% of the cases. 
Ti su događaji doveli do prekida primjene rufinamida u 20% slučajeva.
This medicinal product could have potential risk for the environment. 
Ovaj lijek može predstavljati potencijalni rizik za okoliš.
The study was mainly designed for safety and not adequately powered to show a difference with regards to the seizure efficacy variables. 
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.
Talk to your doctor or pharmacist if: 
Obratite se liječniku ili ljekarniku ako:
Do not use this medicine if you notice that the appearance of the medicine has changed. 
Ovaj lijek se ne smije upotrijebiti ako primijetite da se izgled lijeka promijenio.
As dose increases, the bioavailability decreases. 
Kako se doza povećava, tako se bioraspoloživost smanjuje.
Manufacturer: Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, UK. 
Proizvođač: Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Ujedinjeno Kraljevstvo.
Each ml of oral suspension contains: 
Jedan ml oralne suspenzije sadrži:
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. 
Dobna karakterizacija u bolesnika mlađih od 4 godine nije bila utvrđena u ograničenoj bazi sigurnosnih podataka zbog malog broja bolesnika u ovom ispitivanju.
Rufinamide is almost exclusively eliminated by metabolism. 
Rufinamid se gotovo isključivo eliminira metabolizmom.
Inovelon should be taken with food. 
Inovelon treba uzimati s hranom.
No data are available (see section 5.2). 
Nema dostupnih podataka (vidjeti dio 5.2).
You must only take Inovelon during your pregnancy if the doctor tells you to. 
Smijete uzimati Inovelon tijekom trudnoće samo ako Vam je tako rekao liječnik.
You can also break the tablets into two equal halves and swallow with water. 
Tablete također možete prelomiti na dvije jednake polovice i progutati s vodom.
Rufinamide was not teratogenic in mice, rats or rabbits. 
Rufinamid nije bio teratogen u miševa, štakora i kunića.
A change in the dose of the other medicines may be needed as they may become slightly less effective when given with rufinamide. 
Možda bude potrebno promijeniti doze drugih lijekova, jer mogu postati malo manje djelotvorni kad se daju s rufinamidom.
The toxicity profile of rufinamide in juvenile animals was similar to that in adult animals. 
Profil toksičnosti rufinamida u mladih životinja bio je sličan onome u odraslih životinja.
Children (1-12 years) 
Djeca (u dobi od 1-12 godina)
Maximum plasma levels are reached approximately 6 hours after administration. 
Maksimalne razine u plazmi postižu se približno 6 sati nakon primjene.
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. 
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%.
What Inovelon looks like and contents of the pack 
Kako Inovelon izgleda i sadržaj pakiranja
Like all medicines, Inovelon can cause side effects, although not everybody gets them. 
Kao i svi lijekovi, Inovelon može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
Tell the doctor if you are taking digoxin (a medicine used to treat heart conditions). 
Obavijestite liječnika ako uzimate digoksin (lijek koji se primjenjuje za liječenje srčanih bolesti).
A pharmacokinetic study in older healthy volunteers did not show a significant difference in pharmacokinetic parameters compared with younger adults. 
Farmakokinetičko ispitivanje u starijih zdravih dobrovoljaca nije pokazalo značajnu razliku u farmakokinetičkim parametrima u usporedbi s mlađim odraslim osobama.
Rash and/or fever. 
Osip i/ili vrućica.
Tell the doctor if you are taking hormonal/oral contraceptives, e.g., “The pill”. 
Obavijestite liječnika ako uzimate hormonsku/oralnu kontracepciju, npr., „pilulu“.
- you get a skin rash or fever. 
- ako dobijete kožni osip ili vrućicu.
Pharmacotherapeutic group: antiepileptics, carboxamide derivatives; ATC code: N03AF03. 
Farmakoterapijska skupina: antiepileptici, derivati karboksamida; ATK oznaka: N03AF03.
Patients should be monitored during the switch over period. 
U razdoblju zamjene bolesnike treba nadzirati.
Inovelon may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment or after a dose increase. 
Inovelon Vam može izazvati osjećaj omaglice, omamljenosti i utjecati na vid, osobito na početku liječenja ili nakon povećanja doze.
Decreased body weight gain was observed in both juvenile and adult rats and dogs. 
Smanjeni dobitak na tjelesnoj težini bio je opažen i u mladih i u odraslih štakora i pasa.
Do not reduce the dose or stop this medicine unless the doctor tells you to. 
Nemojte snižavati dozu ili prestati uzimati ovaj lijek osim ako Vam tako nije rekao liječnik.
What Inovelon is and what it is used for 
Što je Inovelon i za što se koristi
Patients and carers should exercise caution until they are familiar with the potential effects of this medicinal product. 
Bolesnici i skrbnici moraju biti oprezni dok se ne upoznaju s mogućim učincima ovog lijeka.
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. 
Kako bi se osiguralo odgovarajuće doziranje, nakon primjene oralne suspenzije, sonda za enteralnu prehranu mora se isprati najmanje jednom s 1 ml vode.
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. 
Ako imate poteškoća s gutanjem, možete zdrobiti tabletu, zatim pomiješati prašak u napola punoj čaši vode (100 ml) i odmah je popiti.
Tell the doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 
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.
Change in the types of seizures you experience/more frequent seizures which last a long time (called status epilepticus). 
Promjene u vrsti napadaja koje imate/učestaliji napadaji koji dugo traju (nazivaju se epileptički status).
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. 
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.
However, no effects on morphology and function, including learning or memory, were observed in the offspring. 
Međutim, u potomstva nisu opaženi nikakvi učinci na morfologiju i funkciju, uključujući učenje ili pamćenje.
Weight decrease Head injury 
Pretrage smanjenje tjelesne težine ozljeda glave
If your liver disease is severe the doctor may decide Inovelon is not recommended for you. 
Ako imate tešku bolest jetre, liječnik može odlučiti da se Inovelon Vama ne preporučuje.
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). 
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).
The safety and efficacy of rufinamide in new-born infants or infants and toddlers aged less than 1 year have not been established. 
Sigurnost i djelotvornost rufinamida u novorođenčadi ili dojenčadi i djece mlađe od 1 godine nisu još ustanovljene.
Inovelon contains a medicine called rufinamide. 
Inovelon sadrži lijek koji se zove rufinamid.
Patients with rare, hereditary problems of fructose intolerance should not take this medicine. 
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne bi trebali uzimati ovaj lijek.
EXP: After first opening: use within 90 days. 
Nakon prvog otvaranja: uporabiti u roku od 90 dana.