natgillin/translations-raw huggingface dataset:
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.
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.
Ovaj se poremećaj manifestirao raznim znakovima i simptomima; međutim, bolesnici tipično, iako ne isključivo, imaju vrućicu i osip povezane sa zahvaćenošću drugih organskih sustava.
Paediatric Population (age 1 to less than 4 years)
Pedijatrijska populacija (u dobi od 1 do manje od 4 godine)
The clinical development program has included over 1,900 patients, with different types of epilepsy, exposed to rufinamide.
Klinički program razvoja lijeka uključio je više od 1900 bolesnika s različitim vrstama epilepsije koji su bili izloženi rufinamidu.
Risk related to rufinamide:
Rizik povezan s rufinamidom:
Inovelon oral suspension contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).
Inovelon oralna suspenzija sadrži parahidroksibenzoate koji mogu prouzročiti alergijske reakcije (moguće i odgođene).
As the disorder is variable in its expression, other organ system signs and symptoms not noted here may occur.
Budući da ovaj poremećaj ima raznoliku kliničku sliku, mogu se pojaviti i drugi znakovi i simptomi organskih sustava, koji ovdje nisu navedeni.
See the doctor immediately as very occasionally this may become serious.
Odmah posjetite liječnika, jer ti znakovi ponekad mogu postati ozbiljni.
Patients must be advised to exercise caution during activities requiring a high degree of alertness, e.g., driving or operating machinery.
Bolesnicima treba savjetovati da budu oprezni tijekom aktivnosti koje zahtijevaju visok stupanj pozornosti, kao što su upravljanje vozilima i rad sa strojevima.
The maximum daily dose will depend on whether or not you are also taking valproate.
Maksimalna dnevna doza ovisi o tome uzimate li i valproat.
What Inovelon contains
Što Inovelon sadrži
The effect was modest to moderate.
Taj je učinak bio slab do umjeren.
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.
Meta-analiza randomiziranih, placebom kontroliranih ispitivanja antiepileptičkih lijekova također je pokazala malo povećan rizik od razmišljanja o samoubojstvu i samoubilačkog ponašanja.
Turn upside down and withdraw the prescribed amount of Inovelon from the bottle.
Okrenite bocu naopako i izvucite propisanu količinu Inovelona iz boce.
If this reaction is suspected, rufinamide should be discontinued and alternative treatment started.
Ako se sumnja na ovu reakciju, rufinamid treba prekinuti i započeti drugi oblik liječenja.
Depending on the individual sensitivity, rufinamide may have a minor to major influence on the ability to drive and use machines.
Ovisno o osjetljivosti pojedine osobe, rufinamid može malo do jako utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
Lennox-Gastaut syndrome is the name given to a group of severe epilepsies in which you may experience repeated seizures of various types.
Lennox-Gastautov sindrom je naziv za skupinu teških epilepsija kod kojih se mogu ponavljati različite vrste napadaja.
If they happen to you tell your doctor or go to a hospital immediately:
Ako se pojave, odmah obavijestite liječnika ili otiđite u bolnicu:
It belongs to a group of medicines called antiepileptics, which are used to treat epilepsy (a condition where someone has seizures or fits).
Pripada skupini lijekova koji se zovu antiepileptici i primjenjuju se za liječenje epilepsije (stanja kad netko ima napadaje ili konvulzije).
Children generally have lower clearance of rufinamide than adults, and this difference is related to body size with rufinamide clearance increasing with body weight.
Djeca općenito imaju niži klirens rufinamida od odraslih, a ta je razlika povezana s veličinom tijela jer se klirens rufinamida povećava s tjelesnom težinom.
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.
Ako liječnik propiše ili preporuči dodatno liječenje za epilepsiju (npr. valproat), morate reći liječniku da uzimate Inovelon, jer će možda trebati prilagoditi dozu.
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.
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.
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.
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.
What Inovelon is and what it is used for What you need to know before you take Inovelon How to use Inovelon
Što je Inovelon i za što se koristi Što morate znati prije nego počnete uzimati Inovelon Kako uzimati Inovelon
Alternatively, use the score line to break the tablet into two equal halves.
Alternativno, koristite razdjelni urez za lomljenje tablete na dvije jednake polovice.
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.
Ako liječnik savjetuje prestanak liječenja, slijedite njegove upute za postupno sniženje doze Inovelona kako biste smanjili rizik od pojačanja napadaja.
If the patient has difficulty with swallowing, tablets can be crushed and administered in half a glass of water.
Ako bolesnik ima poteškoća s gutanjem, tablete se mogu zdrobiti i dati u pola čaše vode.
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.
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.
What you need to know before you take Inovelon
Što morate znati prije nego počnete uzimati Inovelon
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.
Liječnik će vam izračunati dozu prema vašoj dobi, tjelesnoj težini i prema tome uzimate li Inovelon s drugim lijekom koji se zove valproat.
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”.
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.
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.
Podaci o primjeni rufinamida u ove skupine su ograničeni, tako da će Vam dozu lijeka morati sporije povećavati.
The bioavailability of rufinamide is dependent on dose.
Bioraspoloživost rufinamida ovisi o dozi.
Adults and children taking valproate at the same time as rufinamide will result in high levels of rufinamide in the blood.
Odrasli i djeca koji uzimaju valproat u isto vrijeme kad i rufinamid imat će visoke razine rufinamida u krvi.
In the case of one or more missed doses, individualised clinical judgement is necessary.
Ako se propusti jedna ili više doza, potrebno je postupiti prema kliničkoj procjeni u pojedinom slučaju.
Ask the doctor or pharmacist for advice before taking any medicine at the same time as Inovelon.
Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek u isto vrijeme kad i Inovelon.
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.
Stoga se preporučuje da za vrijeme uzimanja Inovelona koristite dodatnu sigurnu i djelotvornu kontracepcijsku metodu (kao što je mehanička metoda, npr. kondom).
If you stop taking Inovelon
Ako prestanete uzimati Inovelon
Inovelon should be administered with food (see section 5.2).
Inovelon treba primjenjivati s hranom (vidjeti dio 5.2).
The plasma elimination half-life is approximately 6-10 hours in healthy subjects and patients with epilepsy.
Poluvijek eliminacije iz plazme iznosi približno 6-10 sati kako u zdravih ispitanika, tako i u bolesnika s epilepsijom.
Inovelon oral suspension also contains sorbitol and, therefore, should not be administered to patients with rare hereditary problems of fructose intolerance.
Inovelon oralna suspenzija također sadrži sorbitol te se stoga ne smije davati bolesnicima s rijetkim nasljednim poremećajem nepodnošenja fruktoze.
Rufinamide modulates the activity of sodium channels, prolonging their inactive state.
Rufinamid mijenja aktivnost natrijevih kanala, produljujući njihovo neaktivno stanje.
Multiple dosing of 7,200 mg/day was associated with no major signs or symptoms.
Višekratna doza od 7200 mg na dan nije bila povezana s nekim jačim znakovima ili simptomima.
Inovelon tablets must be taken twice daily with water, in the morning and in the evening.
Inovelon tablete moraju se uzimati dvaput na dan s vodom, ujutro i navečer.
There is no specific antidote for rufinamide.
Nema posebnog antidota za rufinamid.
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.
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.
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.
Boca od orijentiranog polietilen tereftalata (o-PET) sa sigurnosnim zatvaračem za djecu od polipropilena (PP); jedna boca sadrži 460 ml suspenzije u kartonskoj kutiji.
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).
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).
Therefore, consideration should be given to a dose reduction of Inovelon in patients who are initiated on valproate therapy (see section 4.2).
Stoga treba razmotriti sniženje doze Inovelona u bolesnika u kojih se započinje terapija valproatom (vidjeti dio 4.2).
If at any time you have these thoughts contact your doctor immediately (see section 2).
Ako u bilo kojem trenutku pomislite takvo što, odmah se javite liječniku (vidjeti dio 2).
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).
Dodavanje ili ukidanje tih lijekova ili prilagodba njihove doze tijekom terapije rufinamidom može iziskivati prilagodbu doze rufinamida (vidjeti dio 4.2).
Inovelon may cause dizziness, somnolence and blurred vision.
Inovelon može izazvati omaglicu, somnolenciju i zamagljen vid.
If you have been told by the doctor that you have an intolerance to some sugars, contact the doctor before taking this medicinal product.
Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
Some patients may respond to lower doses and your doctor may adjust the dose depending on how you respond to the treatment.
Budući da neki bolesnici mogu reagirati i na niže doze, liječnik Vam može prilagoditi dozu ovisno o Vašem odgovoru na liječenje.
All patients who develop a rash while taking rufinamide must be closely monitored.
Svi bolesnici, koji za vrijeme uzimanja rufinamida razviju osip, moraju se pažljivo nadzirati.
If you experience side effects, your doctor may increase the dose more slowly.
Ako osjetite nuspojave, liječnik Vam može sporije povećavati dozu.
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).
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).
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.
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.
Rufinamide should be withdrawn gradually to reduce the possibility of seizures on withdrawal.
Rufinamid treba postupno ukidati, kako bi se smanjila mogućnost napadaja prilikom prestanka primjene.
Higher rufinamide doses may result in a more pronounced induction.
Više doze rufinamida mogu dovesti do izraženije indukcije.
These recommendations should also be considered when rufinamide is used concomitantly with substances with a narrow therapeutic window such as warfarin and digoxin.
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.
When rufinamide treatment is to be discontinued, it should be withdrawn gradually.
Kad liječenje rufinamidom treba prekinuti, to treba učiniti postupno.
Suicidal ideation
Razmišljanje o samoubojstvu
Such evaluations indicate that sex does not affect the pharmacokinetics of rufinamide to a clinically relevant extent.
Takve procjene pokazuju da spol ne utječe na farmakokinetiku rufinamida u klinički važnoj mjeri.
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.
Pokazalo se da rufinamid inducira enzim citokroma P450 CYP3A4 i stoga može smanjiti koncentracije u plazmi onih tvari koje taj enzim metabolizira.
Furthermore, rufinamide does not inhibit the activity of cytochrome P450 enzymes (see section 5.2).
Nadalje, rufinamid ne inhibira aktivnost enzima citokroma P450 (vidjeti dio 5.2).
Marketing Authorisation Holder: Eisai GmbH
Nositelj odobrenja za stavljanje lijeka u promet: Eisai GmbH
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.
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.
Environmental risk assessment studies have shown that rufinamide is very persistent in the environment (see section 6.6).
Studije procjene rizika za okoliš pokazale su da je rufinamid vrlo postojan u okolišu (vidjeti dio 6.6).
Inovelon may make the pill not effective at preventing pregnancy.
Zbog Inovelona pilula može postati nedjelotvorna u sprječavanju trudnoće.
- 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).
- 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).
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.
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.
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).
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).
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).
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).
PHARMACEUTICAL FORM AND CONTENTS Oral suspension 460 ml.
OBLIK I SADRŽAJ Oralna suspenzija 460 ml.
Rufinamide is active in a range of animal models of epilepsy.
Rufinamid djeluje kod raznih životinjskih modela epilepsije.
Treatment with rufinamide should be initiated by a physician specialised in paediatrics or neurology with experience in the treatment of epilepsy.
Liječenje rufinamidom treba započeti liječnik specijalist pedijatrije ili neurologije s iskustvom u liječenju epilepsije.
The discontinuation rate in Lennox-Gastaut syndrome due to adverse reactions was 8.2% for patients receiving rufinamide and 0% for patients receiving placebo.
Primjena kod Lennox-Gastautovog sindroma prekinuta je zbog nuspojava u 8,2% bolesnika koji su primali rufinamid i 0% bolesnika koji su primali placebo.
Inovelon oral suspension must be taken twice every day, once in the morning and once in the evening.
Inovelon oralna suspenzija mora se uzimati dvaput na dan svaki dan, jedanput ujutro i drugi put navečer.
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.
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.
Central Nervous System reactions
Reakcije središnjeg živčanog sustava