FrancophonIA/ELRC3.0 huggingface dataset:
English: The toxicity profile of rufinamide in juvenile animals was similar to that in adult animals.
Slovenian: Profil toksičnosti rufinamida pri mladih živalih je bil podoben kot pri odraslih živalih.
English: Inovelon should not be given to children younger than 1 year of age since there is not enough information on its use in this age group.
Slovenian: Otroci, mlajši od 1 leta, ne smejo dobivati zdravila Inovelon, saj ni dovolj informacij za uporabo v tej starostni skupini.
English: The plasma elimination half-life is approximately 6-10 hours in healthy subjects and patients with epilepsy.
Slovenian: Razpolovni čas odstranjevanja iz plazme je pri zdravih osebah in bolnikih z epilepsijo približno 6-10 ur.
English: Do not use this medicine if you notice that the appearance of the medicine has changed.
Slovenian: Ne uporabljajte tega zdravila, če opazite spremenjen izgled zdravila.
English: 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”.
Slovenian: Ker negovalci težko natančno razlikujejo tonične in atonične napade, se je mednarodni ekspertni odbor otroških nevrologov dogovoril, naj se te vrste napadov združijo in imenujejo tonično-atonični napadi ali “drop atake”.
English: The clinical development program has included over 1,900 patients, with different types of epilepsy, exposed to rufinamide.
Slovenian: V program kliničnega razvoja zdravila je bilo vključenih več kot 1.900 bolnikov z različnimi vrstami epilepsije, ki so bili izpostavljeni rufinamidu.
English: Rufinamide modulates the activity of sodium channels, prolonging their inactive state.
Slovenian: Rufinamid modulira aktivnost natrijevih kanalčkov, tako da podaljšuje njihovo neaktivno stanje.
English: It may take a while to find the best dose of Inovelon for you.
Slovenian: Mogoče bo trajalo nekaj časa, preden se določi najprimernejši odmerek zdravila Inovelon za vas.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Slovenian: E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
English: If this reaction is suspected, rufinamide should be discontinued and alternative treatment started.
Slovenian: Če posumimo na to reakcijo, moramo rufinamid ukiniti in začeti z alternativnim zdravljenjem.
English: Environmental risk assessment studies have shown that rufinamide is very persistent in the environment (see section 6.6).
Slovenian: Študije ocene tveganja za okolje so pokazale, da je rufinamid zelo obstojen v okolju (glejte poglavje 6.6).
English: Tell the doctor if you are taking digoxin (a medicine used to treat heart conditions).
Slovenian: Obvestite svojega zdravnika, če jemljete digoksin (zdravilo, ki se uporablja za zdravljenje bolezni srca).
English: Studies with other oral or implant contraceptives have not been conducted.
Slovenian: Študij z drugimi peroralnimi kontraceptivi ali kontracepcijskimi vsadki niso opravili.
English: Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Slovenian: Zato moramo bolnike nadzirati glede znakov samomorilnih misli in vedenja in razmisliti o ustreznem zdravljenju.
English: 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.
Slovenian: Ker farmakokinetika rufinamida pri starejših bolnikih ni spremenjena (glejte poglavje 5.2), prilagajanje odmerka pri bolnikih, starejših od 65 let, ni potrebno.
English: No special requirements for disposal.
Slovenian: Odstranjevanje: ni posebnih zahtev za odstranjevanje.
English: White, slightly viscous suspension.
Slovenian: Bela, nekoliko viskozna suspenzija.
English: Patients must be advised to exercise caution during activities requiring a high degree of alertness, e.g., driving or operating machinery.
Slovenian: Bolnikom je treba svetovati, naj bodo previdni med opravljanjem del, pri katerih je potrebna velika zbranost, na primer pri vožnji ali upravljanju s stroji.
English: As the disorder is variable in its expression, other organ system signs and symptoms not noted here may occur.
Slovenian: Ker se sindrom pojavlja v različnih oblikah, lahko nastopijo tudi znaki in simptomi s strani drugih organskih sistemov, ki tu niso omenjeni.
English: Children generally have lower clearance of rufinamide than adults, and this difference is related to body size with rufinamide clearance increasing with body weight.
Slovenian: Otroci imajo na splošno manjši očistek rufinamida kot odrasli, ta razlika pa je povezana z velikostjo telesa, pri čemer se očistek rufinamida povečuje v odvisnosti od telesne mase.
English: The main pathway of metabolism is hydrolysis of the carboxylamide group to the pharmacologically inactive acid derivative CGP 47292.
Slovenian: Poglavitna presnovna pot je hidroliza karboksilamidne skupine v farmakološko neaktivni kislinski derivat CGP 47292.
English: Some patients may respond to lower doses and your doctor may adjust the dose depending on how you respond to the treatment.
Slovenian: Nekateri bolniki se lahko odzovejo že na manjše odmerke, zato lahko zdravnik odmerek prilagodi glede na vaš odziv na zdravljenje.
English: During pregnancy, interruption of an effective antiepileptic can be detrimental to both the mother and the foetus if it results in aggravation of the illness.
Slovenian: V nosečnosti je prekinitev učinkovitega antiepileptičnega zdravljenja lahko škodljiva tako za mater kot za plod, če povzroči poslabšanje bolezni.
English: Moreover, effective antiepileptic therapy should not be interrupted abruptly, since the aggravation of the illness is detrimental to both the mother and the foetus.
Slovenian: Poleg tega učinkovitega antiepileptičnega zdravljenja ne smemo nenadoma prekiniti, ker je poslabšanje bolezni škodljivo tako za mater kot za plod.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 January 2007
Slovenian: Datum prve odobritve: 16. januar 2007 Datum zadnjega podaljšanja: 9. januar 2012
English: Inovelon with food and drink
Slovenian: Zdravilo Inovelon skupaj s hrano in pijačo
English: Inovelon may make the pill not effective at preventing pregnancy.
Slovenian: Zdravilo Inovelon lahko povzroči neučinkovitost tabletke za preprečevanje nosečnosti.
English: Risk related to rufinamide:
Slovenian: Tveganje, ki je povezano z rufinamidom:
English: See the doctor immediately as very occasionally this may become serious.
Slovenian: Takoj pojdite k zdravniku, ker lahko to, čeprav zelo redko, postane resno.
English: Change in the types of seizures you experience/more frequent seizures which last a long time (called status epilepticus).
Slovenian: Sprememba vrste epileptičnega napada, ki ga doživite/pogostejši napadi, ki trajajo dalj časa (imenujejo se status epilepticus).
English: 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.
Slovenian: Če vam zdravnik predpiše ali priporoči dodatno zdravilo za zdavljenje epilepsije (na primer valproat), morate zdravniku povedati, da jemljete zdravilo Inovelon, ker vam bo mogoče treba prilagoditi odmerek.
English: However, no effects on morphology and function, including learning or memory, were observed in the offspring.
Slovenian: Vendar pa pri potomcih niso ugotovili nikakršnih učinkov na morfologijo in funkcijo, med drugim na učenje in spomin.
English: Inovelon has been given to you by your doctor to reduce the number of your seizures or fits.
Slovenian: Zdravilo Inovelon vam je vaš zdravnik predpisal za zmanjšanje števila vaših epileptičnih napadov ali krčev.
English: All patients who develop a rash while taking rufinamide must be closely monitored.
Slovenian: Vse bolnike, pri katerih se med jemanjem rufinamida razvije izpuščaj, moramo skrbno spremljati.
English: Patients with rare, hereditary problems of fructose intolerance should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo ne smejo jemati tega zdravila.
English: - 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).
Slovenian: - če jemljete to zdravilo in vam kadar koli pride na misel, da bi se poškodovali ali ubili, se nemudoma obrnite na svojega zdravnika ali pojdite v bolnišnico (glejte poglavje 4).
English: Higher rufinamide doses may result in a more pronounced induction.
Slovenian: Večji odmerki rufinamida utegnejo povzročiti izrazitejšo indukcijo.
English: Adults and children taking valproate at the same time as rufinamide will result in high levels of rufinamide in the blood.
Slovenian: Odraslim in otrokom, ki sočasno z rufinamidom jemljejo valproat, se bo raven rufinamida v krvi zvišala.
English: Tell the doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
English: 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.
Slovenian: V omejeni varnostni podatkovni zbirki pri bolnikih, mlajših od 4 let, neželenih učinkov niso razvrstili po starosti zaradi majhnega števila bolnikov v študiji.
English: 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.
Slovenian: 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.
English: If your liver disease is severe the doctor may decide Inovelon is not recommended for you.
Slovenian: Če imate hudo bolezen jeter, se lahko zdravnik odloči, da jemanje zdravila Inovelon za vas ni priporočljivo.
English: The safety and efficacy of rufinamide in new-born infants or infants and toddlers aged less than 1 year have not been established.
Slovenian: Varnost in učinkovitost rufinamida pri novorojenčkih, dojenčkih in malih otrocih, starih 1 leto ali manj, še ni bila dokazana.
English: 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).
Slovenian: 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).
English: After single doses, food increases the bioavailability (AUC) of rufinamide by approximately 34% and the peak plasma concentration by 56%.
Slovenian: Po enkratnih odmerkih hrana zveča biološko uporabnost (AUC) rufinamida za približno 34 % in najvišjo koncentracijo v plazmi za 56 %.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Če ste noseči ali menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: 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.
Slovenian: 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.
English: Each ml of oral suspension contains:
Slovenian: En mililiter peroralne suspenzije vsebuje:
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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.
English: 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).
Slovenian: 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).
English: There is no specific antidote for rufinamide.
Slovenian: Za rufinamid ni specifičnega protistrupa.
English: Renal excretion was the predominant route of elimination for active substance related material, accounting for 84.7% of the dose.
Slovenian: Izločanje skozi ledvici je bila prevladujoča pot odstranjevanja z zdravilno učinkovino povezanih snovi iz telesa, predstavljalo je 84,7 % odmerka.
English: In reproductive and developmental toxicity studies, there were reductions in foetal growth and survival, and some stillbirths secondary to maternal toxicity.
Slovenian: V študijah toksičnosti za reprodukcijo in razvoj sta se zmanjšala rast in preživetje plodov, bilo je tudi nekaj primerov mrtvorojenosti zaradi toksičnosti za mater.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Slovenian: Bolnikom (in negovalcem bolnikov) moramo svetovati, da poiščejo zdravniško pomoč, če opazijo znake samomorilnih misli ali vedenja.
English: 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.
Slovenian: 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.
English: In a thorough QT study, rufinamide produced a decrease in QTc interval proportional to concentration.
Slovenian: V temeljiti študiji intervala QT je rufinamid povzročil skrajšanje intervala QTc, ki je bilo sorazmerno koncentraciji.
English: Inovelon oral suspension contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).
Slovenian: Zdravilo Inovelon peroralna suspenzija vsebuje parahidroksibenzoate, ki lahko povzročijo alergijske reakcije (tudi zakasnele).
English: A small number of people being treated with antiepileptics such as Inovelon have had thoughts of harming or killing themselves.
Slovenian: Majhno število bolnikov, zdravljenih z antiepileptiki, kot je zdravilo Inovelon, je imelo misli o samopoškodovanju ali samomoru.
English: - 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.
Slovenian: - imate sindrom prirojenega kratkega intervala QT ali družinsko anamnezo tega sindroma (električna motnja srca), ker ga lahko rufinamid poslabša.
English: In the case of one or more missed doses, individualised clinical judgement is necessary.
Slovenian: Če bolnik pozabi vzeti enega ali več odmerkov, je potrebna klinična presoja za vsak primer posebej.
English: The bioavailability of rufinamide is dependent on dose.
Slovenian: Biološka uporabnost rufinamida je odvisna od odmerka.
English: All seizures were classified according to the International League Against Epilepsy Revised Classification of Seizures.
Slovenian: Vse napade so razvrstili v skladu z revidirano klasifikacijo napadov Mednarodne lige proti epilepsiji.
English: It is not known if rufinamide is excreted in human breast milk.
Slovenian: Ni znano, ali se rufinamid izloča v materino mleko.
English: PHARMACEUTICAL FORM AND CONTENTS Oral suspension 460 ml.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA peroralna suspenzija 460 ml
English: 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.
Slovenian: Metaanaliza randomiziranih, s placebom kontroliranih preskušanj antiepileptikov je pokazala tudi majhno povečanje tveganja samomorilnih misli in vedenja.
English: Rufinamide is active in a range of animal models of epilepsy.
Slovenian: Rufinamid deluje pri več različnih živalskih modelih epilepsije.
English: 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.
Slovenian: 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.
English: This indicates minimal risk of drug-drug interactions by displacement from binding sites during concomitant administration of other substances.
Slovenian: To kaže, da je tveganje interakcij med zdravili zaradi izrinjanja z vezavnih mest med sočasno uporabo drugih učinkovin minimalno.
English: Decreased body weight gain was observed in both juvenile and adult rats and dogs.
Slovenian: Upočasnjeno naraščanje telesne mase so ugotavljali tako pri mladih kot pri odraslih podganah in psih.
English: Inovelon oral suspension also contains sorbitol and, therefore, should not be administered to patients with rare hereditary problems of fructose intolerance.
Slovenian: Zdravilo Inovelon peroralna suspenzija vsebuje tudi sorbitol, zato ga bolniki z redko dedno intoleranco za fruktozo ne smejo jemati.
English: The pharmacokinetic interactions between rufinamide and other antiepileptic medicinal products have been evaluated in patients with epilepsy, using population pharmacokinetic modelling.
Slovenian: Farmakokinetične interakcije med rufinamidom in drugimi antiepileptičnimi zdravili so ocenjevali pri bolnikih z epilepsijo s populacijskim modeliranjem farmakokinetike.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis.
Slovenian: Po akutnem prevelikem odmerku lahko spraznimo želodec z izpiranjem želodca ali s sprožitvijo bruhanja.
English: Treatment with rufinamide should be initiated by a physician specialised in paediatrics or neurology with experience in the treatment of epilepsy.
Slovenian: Zdravljenje z rufinamidom naj uvede specialist pediater ali nevrolog z izkušnjami pri zdravljenju epilepsij.
English: Instructions on how to use the syringe and adaptor are provided below:
Slovenian: Spodaj so navodila za uporabo brizge in nastavka:
English: The frequency, type and severity of these adverse reactions were similar to that in children 4 years of age and older, adolescents and adults.
Slovenian: Pogostnost, vrsta in izraženost teh neželenih učinkov so bile podobne tistim pri otrocih, starih 4 leta ali starejših, mladostnikih in odraslih.
English: If you have been told by the doctor that you have an intolerance to some sugars, contact the doctor before taking this medicinal product.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, povprašajte zdravnika, preden vzamete to zdravilo.
English: 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%.
Slovenian: 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 %.
English: 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.
Slovenian: 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.
English: If at any time you have these thoughts contact your doctor immediately (see section 2).
Slovenian: Če ste kadar koli tako razmišljali, o tem takoj obvestite svojega zdravnika (glejte poglavje 2).
English: Parahydroxybenzoates
Slovenian: Parahidroksibenzoati
English: 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.
Slovenian: Za zagotovitev pravilnega odmerka je treba po dajanju peroralne suspenzije cevko za enteralno hranjenje vsaj enkrat sprati z 1 ml vode.
English: Treatment should be supportive and may include haemodialysis (see section 5.2).
Slovenian: Zdravljenje naj bo podporno in lahko vključuje hemodializo (glejte poglavje 5.2).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Such evaluations indicate that sex does not affect the pharmacokinetics of rufinamide to a clinically relevant extent.
Slovenian: Takšne ocene kažejo, da spol ne vpliva na farmakokinetiko rufinamida v klinično pomembnem obsegu.
English: 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).
Slovenian: 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).