natgillin/translations-raw huggingface dataset:
Potential for rufinamide to affect other medicinal products
Možnost, da bi rufinamid vplival na druga zdravila
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.
Nato prašek zamešajte v približno pol kozarca (100 ml) vode in takoj spijte.
The adverse event profile was similar to that in children 4 years of age and older, adolescents, and adults.
Profil neželenih učinkov je bil podoben tistemu pri otrocih, starih 4 leta ali starejših, mladostnikih in odraslih.
Reversibility of all findings was demonstrated after stopping treatment.
Po prekinitvi zdravljenja so dokazali reverzibilnost vseh ugotovitev.
If you stop taking Inovelon
Če ste prenehali jemati zdravilo Inovelon
What you need to know before you take Inovelon
Kaj morate vedeti, preden boste vzeli zdravilo Inovelon
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.
Če ste mogoče vzeli več zdravila Inovelon, kot bi smeli, to nemudoma povejte zdravniku ali farmacevtu ali pojdite na nezgodni oddelek najbližje bolnišnice, zdravilo pa vzemite s seboj.
Do not use this medicine after the expiry date which is stated on the bottle label and carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki plastenke in kartonski škatli.
QUALITATIVE AND QUANTITATIVE COMPOSITION Oral Tablet
KAKOVOSTNA IN KOLIČINSKA SESTAVA Peroralna tableta
Benign bone neoplasms (osteomas) and hyperostosis seen in mice were considered a result of the activation of a mouse specific virus by fluoride ions released during the oxidative metabolism of rufinamide.
Pojavljanje benignih kostnih tumorjev (osteomov) in hiperostoze, ki so jo opazili pri miših, so razlagali kot posledico aktivacije virusa, specifičnega za miši, s fluoridnimi ioni, ki se sproščajo med oksidativno presnovo rufinamida.
Rufinamide is for oral use.
Rufinamid je za peroralno uporabo.
Use in patients with severe hepatic impairment is not recommended.
Uporaba zdravila pri bolnikih s hudo okvaro jeter ni priporočljiva.
You can also break the tablets into two equal halves and swallow with water.
Tablete lahko tudi razdelite na enaki polovici, ki ju pogoltnete z vodo.
Push down and turn cap to open bottle
Zaporko potisnite navzdol in obrnite, da plastenko odprete.
SPECIAL STORAGE CONDITIONS Do not store above 30ºC.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 ºC.
Use in patients with hepatic impairment has not been studied.
Uporabe zdravila pri bolnikih z okvaro jeter niso proučevali.
If the recommended calculated dose of Inovelon is not achievable, the dose should be given to the nearest whole 100 mg tablet.
Če priporočenega izračunanega odmerka zdravila Inovelon ni mogoče doseči, moramo dati odmerek, ki je najbližji 100-miligramski tableti.
Toxicities observed in dogs at levels similar to human exposure at the maximum recommended dose were liver changes, including bile thrombi, cholestasis and liver enzyme elevations thought to be related to increased bile secretion in this species.
Toksični učinki, ki so jih ugotovili pri psih pri izpostavljenosti, podobni človeški izpostavljenosti pri največjem priporočenem odmerku, so bile spremembe jeter, vključno z žolčnimi trombi, holestazo in zvišanjem jetrnih encimov, za katere mislijo, da so povezani z zvečanim izločanjem žolča pri tej vrsti.
Pneumonia Influenza Nasopharyngitis Ear infection Sinusitis
Redki pljučnica gripa nazofaringitis okužba ušesa sinusitis
Infections: ear infection, flu, nasal congestion, chest infection.
okužbe: okužbe ušes, gripa, nahod, okužbe pljuč.
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).
Studies in animals revealed no teratogenic effect, but foetotoxicity in the presence of maternal toxicity was observed (see section 5.3).
Študije na živalih niso pokazale nikakršnega teratogenega učinka, pač pa so opazili toksičnost za plod ob sočasni toksičnosti za mater (glejte poglavje 5.3).
Inovelon is used with other medicines to treat seizures associated with Lennox-Gastaut syndrome in adults, adolescents and children from 1 year of age.
Zdravilo Inovelon se uporablja z drugimi zdravili za zdravljenje epileptičnih napadov, povezanih z Lennox-Gastautovim sindromom pri odraslih, mladostnikih in otrocih, starih več kot 1 leto.
Coordination Abnormal* Nystagmus Psychomotor hyperactivity disorders
motena koordinacija* nistagmus psihomotorična hiperaktivnost
Inovelon (rufinamide tablets) 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).
Zdravilo Inovelon (tablete rufinamida) so dajali v dvojno slepi, s placebom kontrolirani študiji v odmerkih do 45 mg/kg/dan 84 dni 139 bolnikom z nezadostno kontroliranimi epileptičnimi napadi (tako z atipičnimi absencami kot drop atakami), povezanimi z Lennox-Gastautovim sindromom.
In addition, the study investigated the cognitive development, behaviour and language development of subjects treated with rufinamide compared to subjects receiving any-other-AED.
Poleg tega so v študiji raziskovali kognitivni razvoj, vedenje in razvoj govora pri bolnikih, zdravljenih z rufinamidom, v primerjavi z bolniki, ki so prejemali katero koli drugo antiepileptično zdravilo.
The suspension should be taken twice daily in the morning and in the evening, in two equally divided doses.
Suspenzijo je treba vzeti dvakrat na dan, zjutraj in zvečer, razdeljeno na dva enaka odmerka.
Withdrawal of rufinamide
Ukinjanje rufinamida
Patients receiving valproate:
Bolniki, ki prejemajo valproat:
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: CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 or CYP4A9/11-2.
Rufinamid kaže malo ali nič signifikantne sposobnosti za delovanje in- vitro kot kompetitiven zaviralec ali zaviralec na podlagi mehanizma naslednjih človeških encimov, odvisnih od P450: CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 ali CYP4A9/11-2.
Nasogastric tube (NG): Polyvinyl chloride (PVC) tube of not greater than 40 cm in length and diameter of tube 5 Fr. 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.
Nazogastrična cevka: cevka iz polivinilklorida (PVC), dolga največ 40 cm, s premerom cevke 5 Fr. Za zagotovitev pravilnega odmerka je treba po dajanju peroralne suspenzije cevko za enteralno hranjenje vsaj enkrat sprati z 1 ml vode.
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 je, da rufinamid inducira encim CYP3A4 citokroma P450, in zato lahko zniža plazemske koncentracije učinkovin, ki jih presnavlja ta encim.
Inovelon tablets must be taken twice daily with water, in the morning and in the evening.
Zdravilo Inovelon tablete morate jemati z vodo dvakrat na dan, zjutraj in zvečer.
Cytochrome P450 enzymes
Encimi s citokromom P450
The Least Square mean change of the Child Behaviour Checklist (CBCL) Total Problems score after 2 years of treatment were 53.75 for the any other AED group and 56.35 for the rufinamide group (LS mean difference [95% CI] +2.60 [-10.5,15.7]; p=0.6928), and the difference between treatments was -2.776 (95% CI: -13.3, 7.8, p=0.5939).
Povprečna sprememba z metodo najmanjših kvadratov pri rezultatu vseh težav na ocenjevalni lestvici vedenja za otroke (Child Behaviour Checklist (CBCL) Total Problems score) po 2 letih zdravljenja je bila 53,75 v skupini s katerim koli drugim antiepileptičnim zdravilom in 56,35 za skupino z rufinamidom (povprečna razlika z metodo najmanjših kvadratov [95 % IZ] +2,60 [-10,5, 15,7]; p=0,6928), razlika med zdravili pa je bila -2,776 (95 % IZ: -13,3, 7,8, p=0,5939).
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.
Odmerek bo določil zdravnik glede na vašo starost, telesno maso in sočasno zdravljenje z drugim zdravilom, imenovanim valproat.
Co-administration of rufinamide 800 mg twice daily and a combined oral contraceptive (ethinyloestradiol 35 μg 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%.
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 %.
Potential for other medicinal products to affect rufinamide
Možnost, da bi druga zdravila vplivala na rufinamid
If you are a woman of childbearing age, you must use contraceptive measures while taking Inovelon.
Če ste ženska v rodni dobi, morate tačas, ko jemljete zdravilo Inovelon, uporabljati kontracepcijo.
Dizziness, headache, nausea, vomiting, sleepiness, fatigue.
omotica, glavobol, navzea, bruhanje, zaspanost, utrujenost.
In rats, decreased cellularity of the bone marrow and thymic atrophy were observed only in the carcinogenicity study.
Pri podganah so zmanjšano celičnost kostnega mozga in atrofijo timusa opazili samo v študiji kancerogenosti.
Due to the potential harmful effects for the breast-fed infant, breast-feeding should be avoided during maternal treatment with rufinamide.
Zaradi možnih škodljivih učinkov na dojenčka naj mati med zdravljenjem z rufinamidom preneha dojiti.
There is limited information on the use of rufinamide in older people.
Podatki o uporabi rufinamida pri starejših bolnikih so omejeni.
Tell your doctor if you are taking valproate as the dose of Inovelon may need to be reduced by your doctor.
Povejte zdravniku, če jemljete valproat, ker vam bo mogoče zdravnik moral zmanjšati odmerek zdravila Inovelon.
Follow the manufacturer's instructions for the feeding tube to administer the medicine.
Pri dajanju zdravila upoštevajte navodila proizvajalca cevke za hranjenje.
Other medicines and Inovelon
Druga zdravila in zdravilo Inovelon
No data on the interaction of rufinamide with alcohol are available.
Podatkov o medsebojnem delovanju rufinamida z alkoholom ni na voljo.
Do not use this medicine after the expiry date which is stated on the blister and carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in kartonski škatli.
Each carton contains 1 bottle, 2 syringes and 1 press-in-bottle adapter (PIBA).
Ena škatla vsebuje 1 steklenico, 2 brizgi in 1 vtisljivi nastavek (PIBA).
The discontinuation rate in Lennox-Gastaut syndrome due to adverse reactions was 8.2% for patients receiving rufinamide and 0% for patients receiving placebo.
Zaradi neželenih učinkov je od bolnikov z Lennox-Gastautovim sindromom prekinilo zdravljenje 8,2 % bolnikov, ki so dobivali rufinamid, in 0 % tistih, ki so jemali placebo.
30.0 - 50.0 kg
razpon telesne mase 30,0 - 50,0 kg
Use in children from 1 year to less than 4 years of age
Uporaba pri otrocih, starih od 1 leta do 4 let
Serious antiepileptic medicinal product hypersensitivity syndrome including DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) and Stevens-Johnson syndrome have occurred in association with rufinamide therapy.
Med zdravljenjem z rufinamidom so se pojavili hudi preobčutljivostni sindromi, povezani z uporabo antiepileptičnega zdravila, vključno s pojavom DRESS (“Drug Reaction with Eosinophilia and Systemic Symptoms”) ter Stevens-Johnsonovim sindromom.
If women treated with rufinamide plan to become pregnant, the continued use of this product should be carefully weighed.
Če ženska, ki se zdravi z rufinamidom, želi zanositi, je treba skrbno pretehtati nadaljnje jemanje tega zdravila.
Rufinamide appears not to have a clinically relevant effect on carbamazepine, lamotrigine, phenobarbital, topiramate, phenytoin or valproate steady state concentrations.
Zdi se, da rufinamid ni klinično pomembno vplival na koncentracije karbamazepina, lamotrigina, fenobarbitala, topiramata, fenitoina ali valproata v stanju dinamičnega ravnovesja.
Children aged between 1 and 4 years of age
Otroci, stari od 1 do 4 let
The cap fits properly when the PIBA is in place.
Zaporka se prilega, ko je vtisljivi nastavek PIBA nameščen.
Hypersensitivity to the active substance, triazole derivatives or to any of the excipients listed in section 6.1.
Preobčutljivost za zdravilno učinkovino, triazolne derivate ali katero koli pomožno snov, navedeno v poglavju 6.1.
For rufinamide, no clinical data on exposed pregnancies are available.
Za rufinamid ni na voljo kliničnih podatkov za nosečnice, ki so bile izpostavljene zdravilu.
A total of 12 patients received any other AED at the investigator's discretion in the control arm.
Vsega skupaj 12 bolnikov v kontrolni skupini je prejelo katero koli drugo antiepiletično zdravilo po presoji raziskovalca.
Inovelon contains sorbitol
Zdravilo Inovelon vsebuje sorbitol
Weight decrease Head injury
Preiskave hujšanje poškodbe glave
Reporting of side effects If you get any side effects, talk to your doctor.
Poročanje o neželenih učinkih Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
What Inovelon looks like and contents of the pack
Izgled zdravila Inovelon in vsebina pakiranja
Inovelon should be administered with food (see section 5.2).
Zdravilo Inovelon je treba jemati s hrano (glejte poglavje 5.2).
Inovelon contains a medicine called rufinamide.
Zdravilo Inovelon vsebuje zdravilno učinkovino, imenovano rufinamid.
- If you have any further questions, ask the doctor or pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
A recent population PK analysis of rufinamide on data pooled from 139 subjects (115 LGS patients and 24 healthy subjects), including 83 paediatric LGS patients (10 patients aged 1 to < 2 years, 14 patients aged 2 to < 4 years, 14 patients aged 4 to < 8 years, 21 patients aged 8 to < 12 years and 24 patients aged 12 to < 18 years) indicated that when rufinamide is dosed on a mg/kg/day basis in LGS subjects aged 1 to < 4 years, comparable exposure to that in LGS patients aged ≥ 4 years, in which efficacy has been demostrated, is achieved.
Nedavna analiza populacijske farmakokinetike rufinamida na podlagi podatkov, zbranih pri 139 preiskovancih (115 bolnikov z LGS in 24 zdravih preiskovancev), vključno s 83 pediatričnimi bolniki z LGS (10 bolnikov, starih od 1 do < 2 leti, 14 bolnikov, starih od 2 do < 4 let, 14 bolnikov, starih od 4 do < 8 let, 21 bolnikov, starih od 8 do < 12 let, in 24 bolnikov, starih od 12 do < 18 let), je pokazala, da pri odmerjanju rufinamida na osnovi mg/kg/dan pri osebah z LGS, starih od 1 do < 4 let, dosežemo primerljivo izpostavljenost kot pri bolnikih z LGS, starih ≥ 4 leta, pri katerih je bila učinkovitost dokazana.
Regarding the immunotoxic potential, small thymus and thymic involution were observed in dogs in a 13-week study with significant response at the high dose in male.
V zvezi z imunotoksičnim potencialom so pri psih v 13-tedenski študiji opazili majhen timus in involucijo timusa s signifikantnim odzivom na visok odmerek pri moških osebkih.
- you suffer an increase in the number or severity or duration of your seizures, you should contact the doctor immediately if this happens.
- se vam poveča število ali trajanje napadov ali če vaši napadi postanejo hujši, to nemudoma povejte zdravniku.
- you get a skin rash or fever.
- dobite kožni izpuščaj ali povišano telesno temperaturo.
The film-coating consists of hypromellose, macrogols (8000), titanium dioxide (E171), talc and ferric oxide red (E172).
Filmsko oblogo sestavljajo hipromeloza, makrogoli (8000), titanov dioksid (E171), smukec in rdeči železov oksid (E172).
Status epilepticus
Epileptični status
Population pharmacokinetic modelling has been used to evaluate the influence of sex on the pharmacokinetics of rufinamide.
Za oceno vpliva spola na farmakokinetiko rufinamida so uporabili populacijsko modeliranje farmakokinetike.
Additional information on special populations
Dodatni podatki o posebnih skupinah bolnikov
Thus, clinically significant interactions mediated through inhibition of cytochrome P450 system by rufinamide are unlikely to occur.
Zato ni verjetno, da bi nastopile klinično pomembne interakcije, ki bi jih posredovala inhibicija sistema citokroma P450 z rufinamidom.
Adverse reactions were usually mild to moderate in severity.
Neželeni učinki so bili po izraženosti navadno blagi do zmerni.
EXPIRY DATE EXP (MM/YYYY)
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP (MM/LLLL)
Inovelon oral suspension and Inovelon film-coated tablets may be interchanged at equal doses.
Zdravilo Inovelon peroralna suspenzija in zdravilo Inovelon filmsko obložene tablete sta v enakih odmerkih zamenljiva.
Women of childbearing potential must use contraceptive measures during treatment with rufinamide.
Ženske v rodni dobi morajo med zdravljenjem z rufinamidom uporabljati kontracepcijo.
Like all medicines, Inovelon can cause side effects, although not everybody gets them.
Možni neželeni učinki Kot vsa zdravila ima lahko tudi zdravilo Inovelon neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Male and female patients (between 4 and 30 years of age) were eligible if they had a history of multiple seizure types, which had to include atypical absence seizures and drop attacks (i.e., tonic-atonic or astatic seizures); were being treated with 1 to 3 concomitant fixed dose antiepileptic medicinal products; a minimum of 90 seizures in the month before the 28-day baseline period; an EEG within 6 months of study entry demonstrating a pattern of slow spike-and-wave complexes (2.5 Hz); a weight of at least 18 kg; and a CT scan or MRI study confirming the absence of a progressive lesion.
Bolniki obeh spolov (stari od 4 do 30 let) so bili primerni, če so imeli anamnezo več vrst napadov, med katerimi so morale biti tudi atipične absence in drop atake (tj., tonično-atonični ali astatični napadi); če so se sočasno zdravili z 1 do 3 antiepileptičnimi zdravili v stalno enakih odmerkih; če so imeli vsaj 90 napadov v mesecu pred 28-dnevnim izhodiščnim obdobjem; če so imeli v 6 mesecih po vključitvi v študijo EEG, ki je kazal vzorec počasnih kompleksov trn-val (2,5 Hz); če so tehtali vsaj 18 kg; in če je slikanje s CT ali MRI potrdilo odsotnost progresivne lezije.
Patients not receiving valproate:
Bolniki, ki ne prejemajo valproata:
Inovelon may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment or after a dose increase.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Inovelon lahko povzroči omotičnost, zaspanost in zamegljen vid, zlasti na začetku zdravljenja ali po povečanju odmerka.
You may experience the following side effects with this medicine.
Pri jemanju tega zdravila boste morda imeli naslednje neželene učinke.
Insert the syringe into the opening of the adaptor as far as possible.
V odprtino nastavka vstavite brizgo tako daleč, kot gre.
The tablet should be taken twice daily with water in the morning and in the evening, in two equally divided doses.
Tableto je treba vzeti dvakrat na dan z vodo, zjutraj in zvečer, v dveh enakih odmerkih.
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 syringes are graduated in 0.5 ml increments.
Oznake na brizgi naraščajo po 0,5 mililitra.
Inovelon should be taken with food.
Zdravilo Inovelon je treba jemati s hrano.
The dosing syringe should be inserted into the PIBA and the dose withdrawn from the inverted bottle.
Brizgo za odmerjanje vstavite v vtisljivi nastavek PIBA in izvlecite odmerek iz obrnjene plastenke.
Aluminium/aluminium blisters, packs of 10, 30, 50, 60 and 100 film-coated tablets.
Pretisni omoti iz aluminija/aluminija, škatle z 10, 30, 50, 60 in 100 filmsko obloženimi tabletami.
In addition, patients have experienced: anxiety, insomnia, nose bleeds, acne, rash, back pain, infrequent periods, bruising, head injury (as a result of accidental injury during a seizure).
Poleg tega so bolniki opazili še: tesnobo, nespečnost, krvavitve iz nosu, akne, izpuščaj, bolečine v hrbtu, neredne menstruacije, modrice, poškodbe glave (kot posledica poškodbe med epileptičnim napadom).
1 bottle of 460 ml contains 18400 mg rufinamide.
1 steklenica s 460 ml vsebuje 18400 mg rufinamida.
Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 1 year of age and older.
Zdravilo Inovelon je indicirano kot pomožno zdravilo pri zdravljenju epileptičnih napadov, povezanih z Lennox-Gastautovim sindromom (LGS), pri bolnikih, starih 1 leto ali starejših.
If you miss taking more than one dose, seek advice from the doctor.
Če pozabite vzeti dva ali več odmerkov, poprosite za nasvet zdravnika.
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).
Če med zdravljenjem z rufinamidom katero od teh zdravil dodamo ali ukinemo ali prilagodimo njegov odmerek, bo mogoče treba prilagoditi odmerjanje rufinamida (glejte poglavje 4.2).
What Inovelon is and what it is used for What you need to know before you take Inovelon How to use Inovelon
Kaj je zdravilo Inovelon in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Inovelon Kako jemati zdravilo Inovelon Možni neželeni učinki
The antiepileptic drug (AED) hypersensitivity syndrome occurred in close temporal association to the initiation of rufinamide therapy and in the paediatric population.
Ta preobčutljivostni sindrom, povezan z uporabo antiepileptičnega zdravila, se je pojavljal v tesni časovni zvezi z uvedbo zdravljenja z rufinamidom in pri pediatrični populaciji.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral suspension contains 40 mg rufinamide.
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml peroralne suspenzije vsebuje 40 mg rufinamida.
Additionally, Inovelon (rufinamide oral suspension) was administered in a multicentre, open-label study comparing the addition of rufinamide to the addition of any other AED of the investigator's choice to the existing regimen of 1 to 3 AEDs in paediatric patients, 1 to less than 4 years of age with inadequately controlled LGS.
Poleg tega so dajali zdravilo Inovelon (peroralno suspenzijo rufinamida) v multicentrični, odprti študiji, v kateri so primerjali dodatek rufinamida z dodatkom katerega koli drugega antiepileptičnega zdravila po presoji raziskovalca obstoječi shemi 1 do 3 antiepileptičnih zdravil pri pediatričnih bolnikih, starih od 1 do manj kot 4 leta, z nezadostno kontroliranim LGS.
If you have any suspension left in the bottle more than 90 days after it was first opened, do not use it. Do not use the suspension if you notice that the appearance or smell of your medicine has changed.
Če v plastenki ostane suspenzija dlje kot 90 dni po prvem odprtju, je ne uporabite.
Treatment should be initiated at a daily dose of 200 mg (5 ml dosing suspension given as two 2.5 ml doses, one in the morning and one in the evening).
Zdravljenje je treba začeti z dnevnim odmerkom 200 mg (odmerek 5 ml suspenzije v obliki dveh 2,5 ml odmerkov, en zjutraj in en zvečer).