natgillin/translations-raw huggingface dataset:
Antiepileptic medicinal products, including Inovelon, should be withdrawn gradually to reduce the possibility of seizures on withdrawal.
Antiepileptična zdravila, med njimi tudi Inovelon, moramo ukinjati postopoma, da zmanjšamo možnost napadov krčev ob ukinitvi zdravila.
In clinical studies discontinuation was achieved by reducing the dose by approximately 25% every two days.
V kliničnih študijah so dosegli ukinitev zdravila tako, da so odmerek zmanjševali za približno 25% vsak drugi dan.
There are insufficient data on the withdrawal of concomitant antiepileptic medicinal products once seizure control has been achieved with the addition of Inovelon.
O ukinjanju sočasnih antiepileptičnih zdravil, potem ko obvladamo epileptične napade z dodatkom Inovelona, ni na voljo dovolj podatkov.
3 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).
3 Zdravljenje z rufinamidom je povezano z vrtoglavostjo, zaspanostjo, ataksijo in motnjami hoje, ki bi lahko zvečali pojavljanje nezgodnih padcev pri tej skupini bolnikov (glejte poglavje 4. 8).
Serious antiepileptic drug hypersensitivity syndrome has occurred in association with rufinamide therapy.
V povezavi z zdravljenjem z rufinamidom se je pojavil resen sindrom preobčutljivosti za antiepileptično zdravilo.
This syndrome occurred in close temporal association to the initiation of rufinamide therapy and in the paediatric population.
Ta sindrom se je pojavljal v tesni časovni zvezi z uvedbo zdravljenja z rufinamidom in pri otrocih.
Congenital Short QT Syndrome or patients with a family history of such a syndrome).
Čeprav osnovni mehanizem tega pojava in njegova pomembnost za varnost nista znana, morajo klinični zdravniki pri ocenjevanju, ali naj predpišejo rufinamid bolnikom, pri katerih obstaja nevarnost dodatnega skrajšanja intervala QTc (n. pr. sindrom prirojenega kratkega intervala QT ali bolniki z rodbinsko anamnezo takega sindroma), uporabljati klinično presojo.
Women of childbearing potential must use contraceptive measures during treatment with Inovelon.
Ženske v rodni dobi morajo med zdravljenjem z Inovelonom uporabljati učinkovito kontracepcijo.
Physicians should try to ensure that appropriate contraception is used, and should use clinical judgement when assessing whether oral contraceptives, or the doses of the oral contraceptive components, are adequate based on the individual patients clinical situation (see Section 4.5).
Zdravniki morajo poskusiti zagotoviti, da bolnice uporabljajo ustrezno kontracepcijo, in naj pri ocenjevanju, ali zadostujejo peroralni kontraceptivi oziroma odmerki posameznih sestavin v peroralnih kontraceptivih, uporabljajo klinično presojo na podlagi kliničnega položaja posameznih bolnic (glejte poglavje 4. 5).
Inovelon contains lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Inovelon vsebuje laktozo, zato bolniki z redkimi dednimi boleznimi intoleranco galaktoze, laponskim pomanjkanjem laktaze ali glukozno- galaktozno malabsorpcijo ne smejo jemati tega zdravila.
Potential for other medicinal products to affect Inovelon
Možnost, da bi druga zdravila vplivala na Inovelon
Other anti-epileptic medicinal products Rufinamide concentrations may be decreased by co-administration with carbamazepine, phenobarbital, phenytoin, vigabatrin or primidone.
Druga antiepileptična zdravila Pri sočasni uporabi karbamazepina, fenobarbitala, fenitoina, vigabatrina ali primidona se lahko koncentracija rufinamida zniža.
For patients on Inovelon treatment who have administration of valproate initiated, significant increases in rufinamide plasma concentrations may occur.
Pri bolnikih, ki se zdravijo z Inovelonom in jim uvedejo še valproat, se lahko pri bolnikih pomembno zviša plazemska koncentracija rufinamida.
The most pronounced increases were observed in patients of low body weight (< 30 kg).
Najbolj izraženo zvišanje so opazili pri bolnikih z nizko telesno maso (< 30 kg).
Therefore, consideration should be given to a dose reduction of Inovelon in patients < 30 kg who are initiated on valproate therapy (see Section 4.2).
Zato je treba pri bolnikih, katerih telesna masa je manjša od 30 kg, ki jim uvedemo zdravljenje z valproatom, pretehtati možnost zmanjšanja odmerka Inovelona (glejte poglavje 4. 2).
The addition or withdrawal of these drugs or adjusting of the dose of these drugs during Inovelon therapy may require an adjustment in dosage of Inovelon.
Če med zdravljenjem z Inovelonom katero od teh zdravil dodamo ali ukinemo ali prilagodimo njegov odmerek, bo mogoče treba prilagoditi odmerjanje Inovelona.
Potential for Inovelon to affect other medicinal products
Možnost, da bi Inovelon vplival na druga zdravila
Other anti-epileptic medicinal products The pharmacokinetic interactions between rufinamide and other anti-epileptic drugs have been evaluated in patients with epilepsy using population pharmacokinetic modelling.
Druga antiepileptična zdravila Farmakokinetične interakcije med rufinamidom in drugimi antiepileptičnimi zdravili so ocenjevali pri bolnikih z epilepsijo s populacijskim modeliranjem farmakokinetike.
Rufinamide appears not to have clinically relevant effect on carbamazepine, lamotrigine, phenobarbital, topiramate or valproate steady state concentrations.
Zdi se, da rufinamid ni klinično pomembno vplival na ravnovesne koncentracije karbamazepina, lamotrigina, fenobarbitala, topiramata
Since rufinamide may decrease phenytoin clearance and increase 4 average steady state plasma concentrations of co-administered phenytoin, consideration should be given to reducing the dose of phenytoin.
Ker lahko rufinamid zmanjša očistek fenitoina in zviša povprečne ravnovesne plazemske koncentracije sočasno danega fenitoina, je treba pretehtati možnost zmanjšanja odmerka fenitoina.
Oral contraceptives Co-administration of rufinamide 800 mg b. i. d. and a combined oral contraceptive (ethinyloestradiol 35 μ g and norethindrone 1 mg) for 14 days resulted in a mean decrease in the ethinyl estradiol AUC0-24 of 22% and in norethindrone AUC0-24 of 14%.
Peroralni kontraceptivi Sočasna 14- dnevna uporaba rufinamida v odmerku 800 mg dvakrat na dan in kombiniranega peroralnega kontraceptiva (etinilestradiola v odmerku 35 μg in noretindrona v odmerku 1 mg) je povzročila povprečno zmanjšanje AUC0- 24 etinilestradiola za 22% in AUC0- 24 noretindrona za 14%.
Women of child-bearing potential using hormonal contraceptives are advised to use an additional safe and effective contraceptive method (see Section 4.4 and 4.6).
Ženskam v rodni dobi, ki uporabljajo hormonska kontracepcijska sredstva, svetujemo, naj dodatno uporabljajo še eno od varnih in učinkovitih kontracepcijskih metod (glejte poglavji 4. 4 in 4. 6).
Cytochrome P450 enzymes Rufinamide is metabolised by hydrolysis, and is not metabolised to any notable degree by cytochrome P450 enzymes.
Encimi s citokromom P450 Rufinamid se presnavlja s hidrolizo, encimi s citokromom P450 pa ga ne presnavljajo v znatnejši meri.
Furthermore, rufinamide does not inhibit the activity of cytochrome P450 enzymes (see Section 5.2).
Nadalje rufinamid ne zavira aktivnosti encimov s citokromom P450 (glejte poglavje 5. 2).
Rufinamide has been shown to induce the cytochrome P450 enzyme CYP3A4 and may therefore reduce the plasma concentrations of drugs which are metabolised by this enzyme.
Pokazali so, da rufinamid inducira encim, odvisen od citokroma P450 CYP3A4, in zato lahko zniža plazemske koncentracije zdravil, ki jih presnavlja ta encim.
The mean CYP3A activity, assessed as clearance of triazolam, was increased by 55% after 11 days of treatment with rufinamide 400 mg b. i. d.
Povprečna aktivnost CYP3A, ocenjena kot očistek triazolama, se je po 11 dneh zdravljenja z rufinamidom v odmerku 400 mg dvakrat na dan zvišala za 55%.
The exposure of triazolam was reduced by 36%.
Izpostavljenost triazolamu se je zmanjšala za 36%.
It may not be excluded that rufinamide may decrease the exposure also of drugs metabolized by other enzymes, or transported by transport proteins such as P-glycoprotein.
Možnosti, da bi rufinamid utegnil zmanjšati tudi izpostavljenost zdravilom, ki jih presnavljajo drugi encimi ali ki jih transportirajo transportne beljakovine, na primer P- glikoprotein, ne smemo izključiti.
It is recommended that patients treated with drugs that are metabolised by the CYP3A enzyme system are to be carefully monitored for two weeks at the start of, or after the end of treatment with Inovelon, or after any marked change in the dose.
Priporočamo, da v začetku in po koncu zdravljenja z Inovelonom ter po vsaki večji spremembi odmerka dva tedna dolgo skrbno spremljate bolnike, zdravljene z zdravili, ki jih presnavlja encimski system CYP3A.
A dose adjustment of the concomitantly administered drug may need to be considered.
Mogoče bo treba pretehtati možnost prilagoditve odmerka zdravila, ki ga bolnik sočasno jemlje.
These recommendations should also be considered when rufinamide is used concomitantly with drugs with a narrow therapeutic window such as warfarin and digoxin.
Ta priporočila veljajo tudi takrat, ko se rufinamid uporablja sočasno z zdravili z majhno terapevtsko širino, na primer z varfarinom in digoksinom.
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.
Izkazalo se je, da je pri otrocih žensk z epilepsijo prevalenca malformacij dvakrat do trikrat večja od približno 3- odstotne prevalence v splošni populaciji.
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.
Pri zdravljeni populaciji so pri sočasnem zdravljenju z več različnimi zdravili opazili zvečanje pogostosti malformacij; vendar ni jasno, koliko sta za to kriva zdravljenje in/ ali bolezen.
Moreover, effective anti-epileptic therapy must not be interrupted, since the aggravation of the illness is detrimental to both the mother and the foetus.
Poleg tega učinkovitega antiepileptičnega zdravljenja ne smemo prekiniti, ker je poslabšanje bolezni škodljivo tako za mater kot za plod.
Studies in animals revealed no teratogenic effect but foetotoxicity in presence of maternal toxicity (see Section 5.3).
Raziskave na živalih niso pokazale nikakršnega teratogenega učinka, pač pa toksičnost za plod ob sočasni toksičnosti za mater (glejte poglavje 5. 3).
For rufinamide, no clinical data on exposed pregnancies are available
Za rufinamid ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
Women of childbearing potential must use contraceptive measures during treatment with Inovelon.
5 Ženske v rodni dobi morajo med zdravljenjem z Inovelonom uporabljati kontracepcijo.
5 judgement when assessing whether oral contraceptives, or the doses of the oral contraceptive components, are adequate based on the individual patients clinical situation (see Section 4.5).
Zdravniki morajo poskusiti zagotoviti, da bolnice uporabljajo ustrezno kontracepcijo, in naj pri ocenjevanju, ali zadostujejo peroralni kontraceptivi oziroma odmerki posameznih sestavin v peroralnih kontraceptivih, uporabljajo klinično presojo na podlagi kliničnega položaja posameznih bolnic (glejte poglavje 4. 5).
Is not known if rufinamide is excreted in human breast milk.
Ni znano, ali se rufinamid izloča v materino mleko.
Due to the potential harmful effects for the breast fed infant, the lactation should be avoided during maternal treatment with rufinamide.
Zaradi možnih škodljivih učinkov na dojenčka naj mati med zdravljenjem z rufinamidom preneha dojiti.
Depending on the individual sensitivity, Inovelon may have a mild to severe influence on the ability to drive or use machines.
Odvisno od občutljivosti posameznika lahko Inovelon blago do močno vpliva na sposobnost vožnje in upravljanja s stroji.
Patients must be advised to exercise caution during activities requiring a high degree of alertness, e. g., driving or operating machinery.
Bolnikom je treba svetovati, naj bodo previdni med opravljanjem del, pri katerih je potrebna velika zbranost, na primer pri vožji ali upravljanju s stroji.
The clinical development program has included over 1,900 patients, with different types of epilepsy, exposed to rufinamide.
V program kliničnega razvoja zdravila je bilo vključenih več kot 1. 900 bolnikov z različnimi vrstami epilepsije, ki so bili izpostavljeni rufinamidu.
The most commonly reported adverse reactions overall were headache, dizziness, fatigue, and somnolence.
Neželeni učinki, o katerih so na splošno najpogosteje poročali, so bili glavobol, vrtoglavost, utrujenost in zaspanost.
The most common adverse reactions observed at a higher incidence than placebo in patients with Lennox-Gastaut syndrome were somnolence and vomiting.
Najpogostejša neželena učinka, ki sta se pri bolnikih z Lennox- Gastautovim sindromom pojavljala z incidenco, ki je bila večja kot pri placebu, sta bila zaspanost in bruhanje.
The discontinuation rate in Lennox-Gastaut syndrome due to adverse reactions was 8.2% for patients receiving Inovelon and 0% for patients receiving placebo.
Zaradi neželenih učinkov je od bolnikov z Lennox- Gastautovim sindromom prekinilo zdravljenje 8, 2% bolnikov, ki so dobivali Inovelon, in 0% tistih, ki so jemali placebo.
The most common adverse reactions resulting in discontinuation from the Inovelon treatment group were rash and vomiting.
Najpogostejša neželena učinka, ki sta povzročila izključitev iz skupine zdravljenja z Inovelonom, sta bila izpuščaj in bruhanje.
Adverse reactions reported with an incidence greater than placebo, during the Lennox-Gastaut syndrome double-blind studies or in the overall rufinamide-exposed population, are listed in the table below by MedDRA preferred term, system organ class and by frequency.
Neželeni učinki z incidenco, večjo od placeba, v dvojno slepih študijah Lennox- Gastautovega sindroma ali v celotni populaciji, izpostavljeni rufinamidu, so navedeni v spodnji preglednici po imenih, organskih sistemih in pogostosti, ki jih predpisuje MedDRA.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 < 1/ 10), uncommon (≥ 1/ 1,000 < 1/ 100).
Pogostosti so definirane takole: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 < 1/ 10), občasni (≥ 1/ 1. 000 < 1/ 100).
System Organ Class Infections and Infestations Immune system
Organski
Very
sistem
Common
zelo
Uncommon
pogosti pogosti
disorders
Infekcijske in parazitske bolezni Bolezni
Hypersensitivity*
pljučnica Gripa nazofaringitis okužbe ušes Sinuzitis Rinitis
Metabolism and Nutrition disorders Psychiatric disorders
imunskega sistema Presnovne in prehranske motnje Psihiatrične motnje
Anorexia Eating disorder Decreased appetite Anxiety Insomnia
anoreksija motnja hranjenja zmanjšan tek anksioznost nespečnost
Somnolence* Headache Dizziness*
zaspanost * glavobol
Status epilepticus* Convulsion Coordination Abnormal*
epileptični status * Konvulzije
6 System Organ Class
6 Organski
Common Nystagmus Psychomotor hyperactivity Tremor
pogosti pogosti
Eye Disorders
vrtoglavost *
Diplopia Vision blurred
motena koordinacija * Nistagmus psihomotorična hiperaktivnost Tremor
Ear and Labyrinth disorders
Očesne bolezni
Vertigo
dvojni vid zamegljen vid
Epistaxis
vrtoglavica
Gastrointestinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora
Nausea Vomiting
krvavitev iz nosu
Abdominal pain upper Constipation Dyspepsia Diarrhoea
Bolezni prebavil Bolezni jeter,
Hepato-biliary
navzea bruhanje
Hepatic enzyme
bolečine v zgornjem delu trebuha Zaprtje dispepsija Driska
disorders Skin and subcutaneous
žolčnika in žolčevodov Bolezni kože in podkožja
Rash*
Izpuščaj * Akne
increase
zvišanje jetrnih encimov
tissue disorders Musculoskeletal and connective tissue and bone disorders
Bolezni mišično - skeletnega sistema in vezivnega tkiva
Acne Back pain
Bolečine v križu
General disorders Fatigue and administration site conditions
Splošne težave utrujenost in spremembe na mestu aplikacije
Gait disturbance*
motnje hoje *
Investigations Injury, poisoning *Cross refer to Section 4.4.
Preiskave Poškodbe in zastrupitve * Glejte poglavje 4. 4.
Weight decrease Head injury Contusion
Hujšanje poškodbe glave kontuzije
There is no specific antidote for Inovelon.
Za Inovelon ni specifičnega protistrupa.
Treatment should be supportive and may include haemodialysis (see Section 5.2).
Zdravljenje naj bo podporno in lahko vključuje hemodializo (glejte poglavje 5. 2).
Multiple dosing of 7,200 mg/ day was associated with no major signs or symptoms.
Odmerjanje večkrat po 7. 200 mg na dan ni bilo povezano s pomembnejšimi znaki ali simptomi.
7 Pharmacotherapeutic group: anti-epileptics, carboxamide derivatives; ATC-code:
Farmakoterapevtska skupina: antiepileptiki, derivati karboksamida; oznaka ATC:
Mechanism of action Rufinamide modulates the activity of sodium channels, prolonging their inactive state.
Mehanizem delovanja Rufinamid modulira aktivnost natrijevih kanalčkov, tako da podaljšuje njihovo neaktivno stanje.
Clinical experience Inovelon was administered in a double blind, placebo-controlled study, at doses of up to 45 mg/ kg/ day for 84 days, to 139 patients with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (including both atypical absence seizures and drop attacks). Male or female patients (between 4 and 30 years of age) were included if they were being treated with 1 to 3 concomitant fixed-dose antiepileptic drugs.
V študijo so vključili bolnike in bolnice (stare od 4 leta do 30 let), ki so sočasno jemali še 1 do 3 antiepileptična zdravila v stalno enakih odmerkih.
14.5% on the placebo arm, p=0.0041).
Ugotovili so signifikantno izboljšanje vseh treh primarnih spremenljivk: spremembe celotne pogostosti epileptičnih napadov v odstotkih na 28 dni v vzdrževalni fazi glede na izhodišče (- 35, 8% pri Inovelonu v primerjavi z – 1, 6% pri placebu, p= 0, 0006), števila tonično- atoničnih napadov (- 42, 9% pri Inovelonu v primerjavi z 2, 2% pri placebu, p = 0, 0002) in ocene teže epileptičnih napadov iz globalne ocene, ki jo je opravil eden od staršev ali skrbnik na koncu dvojno slepe faze (precejšnje ali zelo veliko izboljšanje pri 32, 2% pri Inovelonu v primerjavi s 14, 5% v kraku s placebom, p=0, 0041).
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 modeliranje farmakokinetike/ farmakodinamike je pokazalo, da je bilo zmanjšanje pogostosti vseh napadov in tonično- kloničnih napadov, izboljšanje globalne ocene teže napadov in zvečanje verjetnosti zmanjšanja pogostosti napadov odvisno od koncentracij rufinamida.
Absorption Maximum plasma levels are reached approximately 6 hours after administration.
Absorpcija Najvišje koncentracije v plazmi so dosežene približno 6 ur po vzetju zdravila.
After single doses food increases the bioavailability (AUC) of rufinamide by approximately 34% and the peak plasma concentration by 56%.
Po enkratnih odmerkih hrana zveča biološko uporabnost (AUC) rufinamida za približno 34% in najvišjo koncentracijo v plazmi za 56%.
Distribution 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.
Porazdelitev V študijah in- vitro se je le majhen delež rufinamida (34%) vezal na človeške serumske beljakovine, pri čemer je albumin predstavljal približno 80% te vezave.
This indicates minimal risk of drug-drug interactions by displacement from binding sites during concomitant administration of other drugs.
To kaže, da je tveganje interakcij med zdravili zaradi izrinjanja z vezavnih mest med sočasno uporabo drugih zdravil minimalno.
Biotransformation Rufinamide is almost exclusively eliminated by metabolism.
Biotransformacija Rufinamid se odstranjuje iz telesa skoraj samo s presnovo.
Rufinamide has demonstrated little or no significant capacity in-vitro to act as a competitive or mechanism-based inhibitor of the following human P450 enzymes:
Rufinamid kaže malo ali nič sposobnosti za delovanje in- vitro kot kompetitiven inhibitor ali inhibitor na podlagi mehanizma naslednjih človeških encimov, odvisnih od P450:
CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/ 5 or CYP4A9/ 11-2.
CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/ 5 in CYP4A9/ 11- 2.
Elimination The plasma elimination half-life is approximately 6-10 hours in healthy subjects and patients with epilepsy.
Odstranjevanje iz telesa 8 Razpolovni čas odstranjevanja iz plazme je pri zdravih osebah in bolnikih z epilepsijo približno 6- 10 ur.
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).
Če rufinamid dajemo dvakrat na dan v 12- urnih presledkih, se kopiči v obsegu, ki ga napoveduje njegov končni razpolovni čas, kar kaže, da je farmakokinetika rufinamida neodvisna od časa (t. j., ni avtoindukcije presnove).
8 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%.
V raziskavi radioaktivno označenih snovi pri treh zdravih prostovoljcih je bila izhodna spojina (rufinamid) glavna radioaktivna sestavina v plazmi, saj je predstavljala okrog 80% celotne radioaktivnosti, presnovek CGP 47292 pa je predstavljal samo okrog 15%.
Renal excretion was the predominant route of elimination for drug related material, accounting for 84.7% of the dose.
Izločanje skozi ledvici je bila prevladujoča pot odstranjevanja z zdravilom povezanih snovi iz telesa, predstavljalo je 84, 7% odmerka.
The bioavailability of rufinamide is dependent on dose.
Linearnost/ nelinearnost Biološka uporabnost rufinamida je odvisna od odmerka.
As dose increases the bioavailability decreases.
Z zvečevanjem odmerka se biološka uporabnost zmanjšuje.
Pharmacokinetics in special patient groups Sex Population pharmacokinetic modelling has been used to evaluate the influence of sex on the pharmacokinetics of rufinamide.
Farmakokinetika pri posebnih skupinah bolnikov Spol Za oceno vpliva spola na farmakokinetiko rufinamida so uporabili populacijsko modeliranje farmakokinetike.
Renal impairment 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.
Okvara ledvic V primerjavi z zdravimi prostovoljci se pri osebah s kronično in težko ledvično odpovedjo farmakokinetika enkratnega 400- miligramskega odmerka rufinamida ni spremenila.
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).
Vendar pa so se plazemske koncentracije znižale za okrog 30%, če je vzetju rufinamida sledila hemodializa, kar kaže, da utegne biti v primeru prevelikega odmerka ta postopek koristen (glejte poglavji 4. 2 in 4. 9).
Hepatic impairment No studies have been performed in patients with hepatic impairment and therefore Inovelon should not be administered to patients with severe hepatic impairment.
Okvara jeter Pri bolnikih z okvarami jeter raziskav niso opravili, zato pri bolnikih s težkimi okvarami jeter Inovelona ne smemo uporabljati.
Children (2-12 years) Children generally have lower clearance of rufinamide than adults, and this difference is related to body size.
Otroci (2- 12 let) Otroci imajo na splošno manjši očistek rufinamida kot odrasli, ta razlika pa je povezana z velikostjo telesa.
Studies in new-born infants or infants and toddlers under 2 years of age have not been conducted.
Raziskav pri novorojenčkih, dojenčkih in malih otrocih do 2 let starosti niso opravili.