natgillin/translations-raw huggingface dataset:
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.
V omejeni varnostni podatkovni zbirki pri bolnikih, mlajših od 4 let, neželenih učinkov niso razvrstili po starosti zaradi majhnega števila bolnikov v študiji.
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.
Blago toksičnost v jetrih so ugotovili tako pri mladih kot pri odraslih živalih pri ravneh izpostavljenosti, ki so bile nižje ali podobne tistim, ki so jih dosegli bolniki.
If your liver disease is severe the doctor may decide Inovelon is not recommended for you.
Če imate hudo bolezen jeter, se lahko zdravnik odloči, da jemanje zdravila Inovelon za vas ni priporočljivo.
The safety and efficacy of rufinamide in new-born infants or infants and toddlers aged less than 1 year have not been established.
Varnost in učinkovitost rufinamida pri novorojenčkih, dojenčkih in malih otrocih, starih 1 leto ali manj, še ni bila dokazana.
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).
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000).
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 %.
If you are taking the following medicines: phenobarbital, fosphenytoin, phenytoin or primidone, you may need to be carefully monitored for two weeks at the start of, or after the end of treatment with rufinamide, or after any marked change in the dose.
Če jemljete naslednja zdravila: fenobarbital, fosfenitoin, fenitoin ali primidon, vas bo morda treba dva tedna na začetku ali po koncu zdravljenja z rufinamidom ali po večji spremembi odmerka skrbno nadzirati.
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.
Če ste noseči ali menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
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.
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.
Each ml of oral suspension contains:
En mililiter peroralne suspenzije vsebuje:
Uncommon (between 1 in a 100 and 1 in a 1000 patients) side effects of Inovelon are: Allergic reactions and an increase in markers of liver function (hepatic enzyme increase).
Občasni neželeni učinki (pojavijo se med 1 od 100 in 1 od 1.000 bolnikov) zdravila Inovelon so: alergijske reakcije in zvišanje označevalcev jetrnih funkcij (zvišanje jetrnih encimov).
Although the underlying mechanism and safety relevance of this finding is not known, clinicians should use clinical judgment when assessing whether to prescribe rufinamide to patients at risk from further shortening their QTc duration (e.g., 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 (npr. sindrom prirojenega kratkega intervala QT ali bolniki z družinsko anamnezo takega sindroma), uporabljati klinično presojo.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
There is no specific antidote for rufinamide.
Za rufinamid ni specifičnega protistrupa.
Renal excretion was the predominant route of elimination for active substance related material, accounting for 84.7% of the dose.
Izločanje skozi ledvici je bila prevladujoča pot odstranjevanja z zdravilno učinkovino povezanih snovi iz telesa, predstavljalo je 84,7 % odmerka.
In reproductive and developmental toxicity studies, there were reductions in foetal growth and survival, and some stillbirths secondary to maternal toxicity.
V študijah toksičnosti za reprodukcijo in razvoj sta se zmanjšala rast in preživetje plodov, bilo je tudi nekaj primerov mrtvorojenosti zaradi toksičnosti za mater.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Bolnikom (in negovalcem bolnikov) moramo svetovati, da poiščejo zdravniško pomoč, če opazijo znake samomorilnih misli ali vedenja.
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.
Če vam zdravnik svetuje, da prekinete zdravljenje, se ravnajte po njegovih navodilih glede postopnega zmanjševanja odmerka zdravila Inovelon, da boste zmanjšali nevarnost, da bi epileptični napadi postali pogostejši.
In a thorough QT study, rufinamide produced a decrease in QTc interval proportional to concentration.
V temeljiti študiji intervala QT je rufinamid povzročil skrajšanje intervala QTc, ki je bilo sorazmerno koncentraciji.
Inovelon oral suspension contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).
Zdravilo Inovelon peroralna suspenzija vsebuje parahidroksibenzoate, ki lahko povzročijo alergijske reakcije (tudi zakasnele).
A small number of people being treated with antiepileptics such as Inovelon have had thoughts of harming or killing themselves.
Majhno število bolnikov, zdravljenih z antiepileptiki, kot je zdravilo Inovelon, je imelo misli o samopoškodovanju ali samomoru.
- you have Congenital Short QT Syndrome or a family history of such a syndrome (electrical disturbance of the heart), as taking rufinamide could make it worse.
- imate sindrom prirojenega kratkega intervala QT ali družinsko anamnezo tega sindroma (električna motnja srca), ker ga lahko rufinamid poslabša.
In the case of one or more missed doses, individualised clinical judgement is necessary.
Če bolnik pozabi vzeti enega ali več odmerkov, je potrebna klinična presoja za vsak primer posebej.
The bioavailability of rufinamide is dependent on dose.
Biološka uporabnost rufinamida je odvisna od odmerka.
All seizures were classified according to the International League Against Epilepsy Revised Classification of Seizures.
Vse napade so razvrstili v skladu z revidirano klasifikacijo napadov Mednarodne lige proti epilepsiji.
It is not known if rufinamide is excreted in human breast milk.
Ni znano, ali se rufinamid izloča v materino mleko.
PHARMACEUTICAL FORM AND CONTENTS Oral suspension 460 ml.
FARMACEVTSKA OBLIKA IN VSEBINA peroralna suspenzija 460 ml
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.
Metaanaliza randomiziranih, s placebom kontroliranih preskušanj antiepileptikov je pokazala tudi majhno povečanje tveganja samomorilnih misli in vedenja.
Rufinamide is active in a range of animal models of epilepsy.
Rufinamid deluje pri več različnih živalskih modelih epilepsije.
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.
Zdravilo Inovelon vsebuje laktozo, zato bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
This indicates minimal risk of drug-drug interactions by displacement from binding sites during concomitant administration of other substances.
To kaže, da je tveganje interakcij med zdravili zaradi izrinjanja z vezavnih mest med sočasno uporabo drugih učinkovin minimalno.
Decreased body weight gain was observed in both juvenile and adult rats and dogs.
Upočasnjeno naraščanje telesne mase so ugotavljali tako pri mladih kot pri odraslih podganah in psih.
Inovelon oral suspension also contains sorbitol and, therefore, should not be administered to patients with rare hereditary problems of fructose intolerance.
Zdravilo Inovelon peroralna suspenzija vsebuje tudi sorbitol, zato ga bolniki z redko dedno intoleranco za fruktozo ne smejo jemati.
The pharmacokinetic interactions between rufinamide and other antiepileptic medicinal products have been evaluated in patients with epilepsy, using population pharmacokinetic modelling.
Farmakokinetične interakcije med rufinamidom in drugimi antiepileptičnimi zdravili so ocenjevali pri bolnikih z epilepsijo s populacijskim modeliranjem farmakokinetike.
A specific interaction study in healthy subjects revealed no influence of rufinamide at a dose of 400 mg twice daily on the pharmacokinetics of olanzapine, a CYP1A2 substrate.
Posebna študija interakcij pri zdravih osebah ni pokazala, da bi rufinamid v odmerku 400 mg dvakrat na dan vplival na farmakokinetiko olanzapina, ki je substrat CYP1A2.
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).
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).
After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis.
Po akutnem prevelikem odmerku lahko spraznimo želodec z izpiranjem želodca ali s sprožitvijo bruhanja.
Treatment with rufinamide should be initiated by a physician specialised in paediatrics or neurology with experience in the treatment of epilepsy.
Zdravljenje z rufinamidom naj uvede specialist pediater ali nevrolog z izkušnjami pri zdravljenju epilepsij.
Instructions on how to use the syringe and adaptor are provided below:
Spodaj so navodila za uporabo brizge in nastavka:
The frequency, type and severity of these adverse reactions were similar to that in children 4 years of age and older, adolescents and adults.
Pogostnost, vrsta in izraženost teh neželenih učinkov so bile podobne tistim pri otrocih, starih 4 leta ali starejših, mladostnikih in odraslih.
If you have been told by the doctor that you have an intolerance to some sugars, contact the doctor before taking this medicinal product.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, povprašajte zdravnika, preden vzamete to zdravilo.
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 študiji 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 %.
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.
Možnosti, da bi tudi rufinamid utegnil zmanjšati izpostavljenost učinkovinam, ki jih presnavljajo drugi encimi ali ki jih transportirajo transportne beljakovine, na primer P-glikoprotein, ne smemo izključiti.
If at any time you have these thoughts contact your doctor immediately (see section 2).
Če ste kadar koli tako razmišljali, o tem takoj obvestite svojega zdravnika (glejte poglavje 2).
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.
Za zagotovitev pravilnega odmerka je treba po dajanju peroralne suspenzije cevko za enteralno hranjenje vsaj enkrat sprati z 1 ml vode.
Treatment should be supportive and may include haemodialysis (see section 5.2).
Zdravljenje naj bo podporno in lahko vključuje hemodializo (glejte poglavje 5.2).
In this study, 25 patients were exposed to rufinamide as adjunctive therapy for 24 weeks at a dose of up to 45 mg/kg/day, in 2 divided doses.
V tej študiji je bilo 25 bolnikov 24 tednov izpostavljenih rufinamidu kot adjuvantnemu zdravilu v odmerku do 45 mg/kg/dan v 2 razdeljenih odmerkih.
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).
Such evaluations indicate that sex does not affect the pharmacokinetics of rufinamide to a clinically relevant extent.
Takšne ocene kažejo, da spol ne vpliva na farmakokinetiko rufinamida v klinično pomembnem obsegu.
Women of child-bearing potential using hormonal contraceptives are advised to use an additional safe and effective contraceptive method (see sections 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).
These recommendations should also be considered when rufinamide is used concomitantly with substances with a narrow therapeutic window such as warfarin and digoxin.
Ta priporočila veljajo tudi takrat, ko se rufinamid uporablja sočasno z učinkovinami z majhno terapevtsko širino, na primer z varfarinom in digoksinom.
If you experience side effects, your doctor may increase the dose more slowly.
Če opazite neželene učinke, vam lahko zdravnik povečuje odmerek počasneje.
Turn upside down and withdraw the prescribed amount of Inovelon from the bottle.
Plastenko obrnite navzdol in izvlecite predpisano količino zdravila Inovelon iz plastenke.
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).
- Inovelon is a white slightly viscous suspension.
- Zdravilo Inovelon je bela, nekoliko viskozna suspenzija.
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 pogostnosti vseh napadov in tonično-atoničnih napadov, izboljšanje globalne ocene teže napadov in zvečanje verjetnosti zmanjšanja pogostnosti napadov odvisno od koncentracij rufinamida.
The mean CYP3A4 activity, assessed as clearance of triazolam, was increased by 55% after 11 days of treatment with rufinamide 400 mg twice daily.
Povprečna aktivnost CYP3A4, ocenjena kot očistek triazolama, se je po 11 dneh zdravljenja z rufinamidom v odmerku 400 mg dvakrat na dan zvišala za 55 %.
If you take more Inovelon than you should
Če ste vzeli večji odmerek zdravila Inovelon, kot bi smeli
Other antiepileptic medicinal products
Druga antiepileptična zdravila
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.
Plastenka iz orientiranega polietilen tereftalata (o-PET) z za otroke varno polipropilensko (PP) zaporko; ena plastenka vsebuje 460 ml suspenzije v zunanji kartonasti škatli.
The prescribed dose of Inovelon oral suspension can be administered via an enteral feeding tube.
Predpisani odmerek peroralne suspenzije Inovelon se lahko daje prek cevke za enteralno hranjenje.
In clinical trials rufinamide discontinuation was achieved by reducing the dose by approximately 25% every two days (see section 4.4).
V kliničnih preskušanjih so dosegli ukinitev rufinamida tako, da so odmerek zmanjševali za približno 25 % vsak drugi dan (glejte poglavje 4.4).
Tell the doctor if you are taking hormonal/oral contraceptives, e.g., “The pill”.
Obvestite svojega zdravnika, če jemljete hormonske/peroralne kontraceptive, na primer »tabletko«.
What Inovelon is and what it is used for
Kaj je zdravilo Inovelon in za kaj ga uporabljamo
- you experience difficulty walking, abnormal movement, dizziness or sleepiness inform the doctor, if any of these happen.
- opazite težave s hojo, neobičajne gibe, omotičnost ali zaspanost, to povejte zdravniku, če se zgodi kaj od navedenega.
Marketing Authorisation Holder: Eisai GmbH
Imetnik dovoljenja za promet: Eisai GmbH
- if you are allergic to rufinamide or triazole derivatives or any of the other ingredients of Inovelon (listed in section 6).
- če ste alergični na rufinamid ali derivate triazola ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Status epilepticus cases have been observed during treatment with rufinamide in clinical development studies, whereas no such cases were observed with placebo.
V kliničnih razvojnih študijah so med zdravljenjem z rufinamidom zasledili primere epileptičnega statusa, medtem ko takih primerov pri placebu niso zasledili.
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, omotica, utrujenost in zaspanost.
Maximum plasma levels are reached approximately 6 hours after administration.
Najvišje koncentracije v plazmi so dosežene približno 6 ur po uporabi zdravila.
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 pogostnosti, ki jih predpisuje MedDRA.
Rufinamide should be withdrawn gradually to reduce the possibility of seizures on withdrawal.
Rufinamid moramo ukinjati postopoma, da zmanjšamo možnost napadov krčev ob ukinitvi zdravila.
When rufinamide treatment is to be discontinued, it should be withdrawn gradually.
Ko želimo zdravljenje z rufinamidom prekiniti, moramo to storiti postopoma.
A study in patients with severe renal impairment indicated that no dose adjustments are required for these patients (see section 5.2).
Študija pri bolnikih s hudo okvaro ledvic je pokazala, da prilagajanje odmerkov pri teh bolnikih ni potrebno (glejte poglavje 5.2).
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 poimenovanje skupine hude epilepsije, ko doživljate ponavljajoče se epileptične napade različnih vrst.
If the recommended calculated dose of Inovelon is not achievable, the dose should be given to the nearest 0.5 ml of rufinamide.
Če priporočenega izračunanega odmerka zdravila Inovelon ni mogoče doseči, moramo dati odmerek, ki je najbližji 0,5 ml rufinamida.
Hypersensitivity*
Sindrom preobčutljivosti*
You must only take Inovelon during your pregnancy if the doctor tells you to.
Med nosečnostjo lahko zdravilo Inovelon jemljete le, če vam to svetuje zdravnik.
An adverse effect not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to human use, was myelofibrosis of the bone marrow in the mouse carcinogenicity study.
Neželen učinek, ki ga niso opažali v kliničnih študijah, ugotovili pa so ga pri živalih pri izpostavljenostih, ki so bile podobne kot klinična izpostavljenost in z možno relevantnostjo za uporabo pri ljudeh, je bila mielofibroza kostnega mozga v študiji kancerogenosti pri miših.
It belongs to a group of medicines called antiepileptics, which are used to treat epilepsy (a condition where someone has seizures or fits).
Sodi v skupino zdravil, imenovanih antiepileptiki, ki se uporabljajo za zdravljenje epilepsije (bolezen z epileptičnimi napadi ali krči).
Inovelon may cause dizziness, somnolence and blurred vision.
Inovelon lahko povzroči vrtoglavost, zaspanost in zamegljen vid.
Preparation: The press-in-bottle adapter (PIBA) which is supplied in the product carton should be inserted firmly into the neck of the bottle before use and remain in place for the duration of the usage of the bottle.
Priprava: Vtisljivi nastavek PIBA, priložen v škatli z zdravilom, pred uporabo čvrsto vstavite v grlo plastenke, kjer naj ostane ves čas uporabe plastenke.
The most common adverse reactions resulting in discontinuation from the rufinamide treatment group were rash and vomiting.
Najpogostejša neželena učinka, ki sta povzročila izključitev iz skupine zdravljenja z rufinamidom, sta bila izpuščaj in bruhanje.
Antiepileptic medicines and Inovelon
Antiepileptična zdravila in zdravilo Inovelon
Peak concentration (Cmax) and plasma AUC of rufinamide increase less than proportionally with doses in both fasted and fed healthy subjects and in patients, probably due to dose-limited absorption behaviour.
Najvišja koncentracija (Cmax) in plazemska AUC rufinamida se zvečata manj kot sorazmerno odmerkom pri zdravih preiskovancih tako na tešče kot po obroku hrane in pri bolnikih, verjetno zato, ker je absorpcija omejena z odmerkom.
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 pogostnosti malformacij; vendar ni jasno, koliko sta za to kriva zdravljenje in/ali bolezen.
If the patient has difficulty with swallowing, tablets can be crushed and administered in half a glass of water.
Bolnik, ki ima težave s požiranjem, lahko tablete zdrobi in vzame s polovico kozarca vode.
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.
Zato vam med jemanjem zdravila Inovelon priporočamo uporabo dodatnih varnih in učinkovitih kontracepcijskih metod (kot so pregradne metode, na primer kondom).
Studies in new-born infants or infants and toddlers under 1 year of age have not been conducted.
Študij pri novorojenčkih, dojenčkih in malih otrocih do 1 leta starosti niso opravili.
If they happen to you tell your doctor or go to a hospital immediately:
Če se pojavijo, o tem takoj obvestite svojega zdravnika ali pojdite v bolnišnico.
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.
Če se pri bolnikih pojavi nova vrsta napadov in/ali imajo pogosteje epileptični status kot sicer, ki se razlikuje od stanja ob izhodišču, je treba ponovno pretehtati razmerje med koristjo in tveganjem zdravljenja.
AED treatment during pregnancy should be carefully discussed with the treating physician.
O zdravljenju z antiepileptičnimi zdravili v nosečnosti se je treba natančno pogovoriti z lečečim zdravnikom.
If you forget to take Inovelon
Če ste pozabili vzeti zdravilo Inovelon
Ask the doctor or pharmacist for advice before taking any medicine at the same time as Inovelon.
Posvetujte se z zdravnikom ali s farmacevtom, preden sočasno z zdravilom Inovelon vzamete katero koli zdravilo.