FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism of action of retigabine on potassium channels has been well documented, however other mechanisms by which retigabine may assert an antiepileptic effect have yet to be fully elucidated.
Slovenian: Mehanizem delovanja retigabina na kalijeve kanale je dobro dokumentiran, medtem ko bo druge mehanizme, po katerih retigabin morda deluje antiepileptično, treba v celoti še pojasniti.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Trobalt should be made taking into account the benefit of breast-feeding to the child and the benefit of Trobalt therapy to the woman.
Slovenian: Pri odločitvi za nadaljevanje/prekinitev dojenja oz. za nadaljevanje/prekinitev zdravljenja z zdravilom Trobalt je treba upoštevati korist dojenja za otroka in korist zdravljenja z zdravilom Trobalt za žensko.
English: This stabilises the resting membrane potential and controls the sub-threshold electrical excitability in neurons, thus preventing the initiation of epileptiform action potential bursts.
Slovenian: To stabilizira membranski potencial v mirovanju, uravnava podpražno električno vzdražnost v nevronih in tako prepreči začetek epileptiformnih izbruhov akcijskega potenciala.
English: However, this effect is not considered clinically significant, therefore no adjustment of the Trobalt dose is recommended.
Slovenian: Vendar ta učinek ne velja za klinično pomemben, zato prilagoditev odmerka zdravila Trobalt ni potrebna.
English: Retigabine also displayed inhibitory properties in multiple kindling models, for example, in the fully kindled state and in some cases during the kindling development.
Slovenian: Retigabin je pokazal tudi zaviralne lastnosti v več modelih raznetenja ("kindling"), npr. v polno raznetenem stanju in v nekaterih primerih med razvojem raznetenja.
English: Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Slovenian: Zato je treba bolnike nadzirati glede samomorilnih misli in samomorilnega vedenja ter pretehtati ustrezno zdravljenje.
English: Your doctor will discuss with you whether treatment with Trobalt should be continued.
Slovenian: Zdravnik se bo z vami pogovoril o tem, ali naj zdravljenje z zdravilom Trobalt nadaljujete.
English: Heart conditions Trobalt can affect heart rhythm.
Slovenian: Srčne motnje Zdravilo Trobalt lahko vpliva na srčni ritem.
English: Across all studies, patients had a mean duration of epilepsy of 22 years and a median baseline seizure frequency ranging from 8 to 12 per 28 days.
Slovenian: V vseh študijah so imeli bolniki epilepsijo povprečno 22 let in mediano izhodiščno pogostnost napadov od 8 do 12 na 28 dni.
English: TW8 9GS
Slovenian: TW8 9GS Velika Britanija
English: You may need extra check-ups (including an electrocardiogram [ECG], which is a test which records the electrical activity of your heart) while
Slovenian: Morda boste med jemanjem zdravila Trobalt potrebovali dodatne preglede (vključno z elektrokardiogramom [EKG]; to je preiskava, ki beleži električno delovanje vašega srca).
English: NAMR has antiepileptic activity, but is less potent than retigabine in animal seizure models.
Slovenian: NAMR deluje antiepileptično, vendar je v modelih napadov pri živalih manj močan kot retigabin.
English: Animal studies have shown excretion of retagabine and/or its metabolites in breast milk.
Slovenian: Študije na živalih so pokazale izločanje retigabina in/ali njegovih presnovkov v materinem mleku.
English: Reproductive toxicology
Slovenian: Reproduktivna toksičnost
English: Date of latest renewal: 14 January 2016
Slovenian: Datum zadnjega podaljšanja: 14.01.2016
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.
English: What Trobalt is and what it is used for
Slovenian: Kaj je zdravilo Trobalt in za kaj ga uporabljamo
English: Glaxo Wellcome S.A. Avda Extremadura 3 Aranda de Duero E-09400 Burgos Spain
Slovenian: Glaxo Wellcome S.A. Avda Extremadura 3 Aranda de Duero E-09400 Burgos Španija
English: You may become aware of blurring of your central vision and notice trouble with reading or recognizing faces.
Slovenian: Opazite lahko zameglitev centralnega vida in težave s prepoznavanjem obrazov.
English: It is recommended that patients are advised about the possible effects on vision if they take Trobalt with alcohol.
Slovenian: Bolnike je priporočljivo seznaniti, kakšni so možni učinki na vid, če vzamejo zdravilo Trobalt skupaj z alkoholom.
English: Consequently, the efficacy and safety of retigabine when taken concomitantly with antiepileptic medicinal products that were less commonly used as background treatment in the clinical studies, including levetiracetam, has not been definitely shown.
Slovenian: Posledično učinkovitost in varnost retigabina, ko se jemlje istočasno z antiepileptičnimi zdravili, ki se uporabljajo manj pogosto kot nadomestno zdravljenje v kliničnih študijah, vključno z levetiracetamom, ni bila jasno dokazana.
English: It is used together with other anti-epileptic medicines to treat adults who continue to experience seizures and where other combinations of antiepileptic medicines have not worked well.
Slovenian: Uporablja se skupaj z drugimi zdravili za zdravljenje epilepsije pri odraslih pri katerih so še vedno prisotni epileptični napadi in tam, kjer druge kombinacije zdravil za zdravljenje epilepsije niso bile učinkovite.
English: Absolute oral bioavailability of retigabine relative to an intravenous dose is approximately 60%.
Slovenian: Absolutna peroralna biološka uporabnost retigabina glede na intravenski odmerek je približno 60 %.
English: • not being able to pass urine (urinary retention).
Slovenian: • nezmožnost odvajanja urina (retenca urina).
English: − The need to inform patients on adverse events related to QT interval prolongation
Slovenian: − Bolnike je treba obvestiti o neželenih učinkih, povezanih s podaljšanjem intervala QT.
English: Very rare:
Slovenian: Redki: Zelo redki:
English: Mutations in the KCNQ channels underlie several human inheritable disorders, including epilepsy (KCNQ2 and 3).
Slovenian: Mutacije kanalov KCNQ so pri človeku osnova za več prirojenih motenj, vključno z epilepsijo (KCNQ2 in 3).
English: * Statistically significant, p≤0.05 ~ Dose not studied
Slovenian: * Statistično značilno, p ≤ 0,05
English: • blood in the urine; abnormally coloured urine
Slovenian: • kri v urinu, nenormalno obarvan urin,
English: • memory problems
Slovenian: • težave s spominom,
English: The total clearance of retigabine from plasma following intravenous dosing is typically 0.4 to 0.6 l/h/kg.
Slovenian: Celotni očistek retigabina iz plazme po intravenski uporabi je po navadi od 0,4 do 0,6 l/uro/kg.
English: Potassium channels are one of the voltage-gated ion channels found in neuronal cells and are important determinants of neuronal activity.
Slovenian: Kalijevi kanali so eni od napetostno odvisnih ionskih kanalov v nevronskih celicah in pomembno določajo aktivnost nevronov.
English: When Cmax was normalized for weight, the values were approximately 30% higher in young females than in males and 40% higher in elderly females compared with males.
Slovenian: Po normalizaciji Cmax za telesno maso so bile vrednosti pri mladih ženskah približno 30 % večje kot pri moških in pri starejših ženskah 40 % večje kot pri moških.
English: No dose adjustment of digoxin is needed.
Slovenian: Odmerka digoksina ni treba prilagoditi.
English: Each tablet contains 50 mg, 100 mg, 200 mg, 300 mg or 400 mg retigabine.
Slovenian: Ena tableta vsebuje 50 mg, 100 mg, 200 mg, 300 mg ali 400 mg retigabina.
English: Not all pack sizes may be available in your country.
Slovenian: V vaši državi morda na trgu ni vseh navedenih pakiranj.
English: Summary of percentage changes in 28-day total partial seizure frequency and responder rates
Slovenian: Povzetek odstotnih sprememb v 28-dnevni celotni pogostnosti parcialnih napadov in deležev odzivnih bolnikov
English: In vitro studies indicate that retigabine acts primarily through opening neuronal potassium channels (KCNQ2 [Kv7.2] and KCNQ3 [Kv7.3]).
Slovenian: Študije in vitro kažejo, da retigabin deluje predvsem z odpiranjem nevronskih kalijevih kanalov (KCNQ2 [Kv7.2] in KCNQ3 [Kv7.3]).
English: Administration of retigabine with a high fat meal resulted in no change in the overall extent of retigabine absorption, but food reduced the between-subject variability in Cmax (23%) compared to the fasted state (41%), and led to an increase in Cmax (38%).
Slovenian: Uporaba retigabina z zelo mastnim obrokom je sicer povzročila, da se celotni delež absorpcije retigabina ni spremenil, vendar hrana zmanjša interindividualno variabilnost Cmax (23 %) v primerjavi z jemanjem na prazen želodec (41 %) in poveča Cmax (38 %).
English: Retigabine was statistically significantly superior to placebo at 600 mg/day (one study), 900 mg/day (two studies) and 1,200 mg/day (two studies).
Slovenian: Retigabin je bil statistično značilno superioren placebu v odmerku 600 mg/dan (ena študija), 900 mg/dan (dve študiji) in 1.200 mg/dan (dve študiji).
English: Retigabine had no effect on fertility or general reproductive performance.
Slovenian: Retigabin ne vpliva na plodnost ali splošno sposobnost razmnoževanja.
English: Trobalt must be used with caution in this population and a reduced initial and maintenance dose is recommended (see sections 4.2 and 5.2).
Slovenian: Zdravilo Trobalt je treba v tej populaciji uporabljati previdno in priporočljiva sta manjši začetni in vzdrževalni odmerek (glejte poglavji 4.2 in 5.2).
English: In rats, retigabine increased the sleep time induced by thiopental sodium from approximately 4 min to 53 min, and the propofol-induced sleep time from approximately 8 min to 12 min.
Slovenian: Pri podganah je retigabin podaljšal čas spanja, povzročenega z natrijevim tiopentalom, s približno 4 na 53 minut in čas spanja, povzročenega s propofolom, s približno 8 na 12 minut.
English: phenobarbital, phenytoin, pregabalin, topiramate, valproate, zonisamide.
Slovenian: okskarbazepina, fenobarbitona, fenitoina, pregabalina, topiramata, valproata, zonisamida.
English: Retigabine has a plasma half-life of approximately 6 to 10 hours.
Slovenian: Plazemski razpolovni čas retigabina je približno 6 do 10 ur.
English: Trobalt is not recommended during pregnancy and in women of childbearing age, not using contraception.
Slovenian: Zdravilo Trobalt se med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije, ne priporoča.
English: A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Slovenian: Metaanaliza randomiziranih, s placebom kontroliranih preskušanj antiepileptikov je tudi pokazala majhno povečanje tveganja samomorilnega razmišljanja in vedenja.
English: The eye examination should be repeated at least every six months whilst taking Trobalt.
Slovenian: Očesni pregled je treba ponavljati vsaj na šest mesecev med jemanjem zdravila Trobalt.
English: In addition to adverse reactions seen at therapeutic doses, symptoms of retigabine overdose included agitation, aggressive behaviour and irritability.
Slovenian: Poleg neželenih učinkov, ugotovljenih pri terapevtskih odmerkih, so simptomi prevelikega odmerjanja retigabina vključevali agitiranost, agresivno vedenje in razdražljivost.
English: There are only limited data on the safety and efficacy of retigabine in patients aged 65 years and above.
Slovenian: Podatkov o učinkovitosti in varnosti retigabina pri bolnikih, starih 65 let in več, je malo.
English: Therapy with multiple antiepileptic medicinal products is associated with a higher risk of congenital malformations than monotherapy and therefore monotherapy should be used whenever possible.
Slovenian: Zdravljenje z več antiepileptiki spremlja večje tveganje prirojenih hib kot monoterapijo, zato je treba uporabiti monoterapijo, kadar je le mogoče.
English: These are common in people taking Trobalt, and can lead to not being able to pass urine at all.
Slovenian: Te so pri osebah, ki jemljejo zdravilo Trobalt, pogoste in lahko povzročijo, da oseba sploh ne more odvajati urina.
English: If breakthrough seizures occur towards the end of dialysis then an additional supplemental dose may be considered at the start of subsequent dialysis sessions.
Slovenian: V primeru izbruha napadov proti koncu dialize pride v poštev uporaba dodatnega odmerka na začetku vseh nadaljnjih dializ.
English: What is in this leaflet What Trobalt is and what it is used for What you need to know before you take Trobalt
Slovenian: Kaj je zdravilo Trobalt in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Trobalt
English: The cumulative incidences of an event at 1 year, 2 years, 3 years, 4 years and 5 years of exposure are approximately 1%, 1.8%, 4.4%, 10.2% and 16.7% respectively.
Slovenian: Kumulativne incidence tega učinka so: 1 % po 1 letu, 1,8 % po 2 letih, 4,4 % po 3 letih, 10,2 % po 4 letih in 16,7 % po 5 letih izpostavljenosti.
English: In vitro data indicated a low potential for interaction with other antiepileptic medicinal products (see section 5.2).
Slovenian: Podatki in vitro so pokazali majhno možnost medsebojnega delovanja z drugimi antiepileptiki (glejte poglavje 5.2).
English: Marketing Authorisation Holder Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom.
Slovenian: Imetnik dovoljenja za promet Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex TW8 9GS, Velika Britanija.
English: Read the package leaflet before use Oral use
Slovenian: Pred uporabo preberite priloženo navodilo.
English: Therefore Trobalt may be taken with or without food.
Slovenian: Zato se lahko zdravilo Trobalt jemlje s hrano ali brez nje.
English: Elderly patients may be at increased risk of central nervous system events, urinary retention and atrial fibrillation.
Slovenian: Starejši bolniki imajo lahko večje tveganje za pojave v centralnem živčnem sistemu, retence urina in atrijske fibrilacije.
English: Like all medicines, Trobalt can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Trobalt neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: There was no effect on sleep time induced by halothane or methohexital sodium.
Slovenian: Na čas spanja, povzročenega s halotanom ali natrijevim metoheksitalatom, ni vplival.
English: Tell your doctor as soon as possible if you get any of these symptoms.
Slovenian: Zdravniku morate čim prej povedati, če se vam pojavi kateri od teh simptomov.
English: A total of approximately 84% of the dose is recovered in the urine, including the N-acetyl metabolite (18%), N-glucuronides of the parent active substance and of the N-acetyl metabolite (24%), or parent active substance (36%).
Slovenian: V celoti se v urinu pojavi približno 84 % odmerka, vključno z N-acetilnim presnovkom (18 %), N-glukuronidi matične učinkovine in N-acetilnega presnovka (24 %) ali matične učinkovine (36 %).
English: Trobalt must be used with caution in patients at risk of urinary retention, and it is recommended that patients are advised about the risk of these possible effects.
Slovenian: Zdravilo Trobalt je treba previdno uporabljati pri bolnikih, ki imajo tveganje za pojav retence urina; bolnike je priporočljivo seznaniti o tveganju za pojav takih neželenih učinkov.
English: Co-administration of ethanol (1.0 g/kg) with retigabine (200 mg) resulted in an increase in visual blurring in healthy volunteers.
Slovenian: Sočasna uporaba etanola (1,0 g/kg) in retigabina (200 mg) je pri zdravih prostovoljcih povzročila povečanje zamegljenosti vida.
English: In pooled safety data from three multicentre, randomised, double-blind, placebo-controlled studies, adverse reactions were generally mild to moderate in intensity, and were most commonly reported in the first 8 weeks of treatment.
Slovenian: Na podlagi kumulativnih podatkov o varnosti iz treh multicentričnih, randomiziranih, dvojno slepih, s placebom kontroliranih študij so bili neželeni učinki na splošno blagi do zmerni in so bili najpogosteje opisani v prvih 8 tednih zdravljenja.
English: It is not known whether the active substance of Trobalt can pass into breast-milk.
Slovenian: Ni znano, ali lahko zdravilna učinkovina zdravila Trobalt prehaja v materino mleko.
English: Retigabine is also metabolised to an N-acetyl metabolite (NAMR) that is also subsequently glucuronidated.
Slovenian: Retigabin se presnovi tudi v N-acetilni presnovek (NAMR), ki se nato prav tako glukuronira.
English: Paediatric population The pharmacokinetics of retigabine in children below 12 years of age have not been investigated.
Slovenian: Farmakokinetika retigabina pri otrocih mlajših od 12 let ni raziskana.
English: In addition, retigabine was effective in preventing status epilepticus seizures in rodents with cobalt-induced epileptogenic lesions, and inhibiting tonic extensor seizures in genetically susceptible mice.
Slovenian: Poleg tega je retigabin učinkovito preprečil napade statusa epilepticusa pri glodalcih, ki so imeli s kobaltom povzročene epileptogene lezije, in je zavrl tonične ekstenzorske napade pri genetsko dovzetnih miših.
English: In rats, retigabine and/or its metabolites crossed the placenta resulting in tissue concentrations that were similar in dams and foetuses.
Slovenian: Pri podganah retigabin in/ali njegovi presnovki prehajajo skozi placento in dosežejo pri samicah in plodovih podobne tkivne koncentracije.
English: Weight increased Increased appetite
Slovenian: večji apetit
English: − The need to inform patients that TROBALT may cause pigment changes in ocular tissues, including the retina, and also in the skin, lips and/or nails, as well as a distinct form of macular abnormality with features of vitelliform maculopathy;
Slovenian: - Bolnike je treba obvestiti, da lahko zdravilo TROBALT povzroča pigmentne spremembe v očesnih tkivih, vključno z mrežnico, pa tudi na koži, ustnicah in/ali nohtih, kot tudi posebno obliko nenormalnosti makule z značilnostmi viteliformne makulopatije.
English: Tell your doctor immediately if you get any of these symptoms.
Slovenian: Zdravniku morate takoj povedati, če se vam pojavi kateri od teh simptomov.
English: Approximately 30-40% of clinical trial subjects who were being treated with retigabine and underwent a skin and/or ophthalmological examination had findings of discolouration of nails, lips, skin and/or mucosa or non-retinal ocular pigmentation, and approximately 15-30% of clinical trial subjects who were being treated with retigabine and underwent an ophthalmological examination had retinal pigmentation findings.
Slovenian: Približno 30 do 40 % preiskovancev kliničnih preskušanj, ki so prejemali retigabin in so opravili pregled kože in/ali oftalmološki pregled, je imelo spremembe barve nohtov, ustnic, kože in/ali sluznic ali nemrežnične pigmentacije v očesu, približno 15 do 30 % preiskovancev kliničnih preskušanj, ki so prejemali retigabin in so opravili oftalmološki pregled, pa je imelo pigmentacije mrežnice.
English: Don't chew, crush or split the tablet.
Slovenian: Ne grizite je, ne drobite in ne lomite.
English: When withdrawing Trobalt, the dose must be gradually reduced over a period of at least 3 weeks (see section 4.4).
Slovenian: V primeru prenehanja zdravljenja z zdravilom Trobalt je treba odmerek zmanjševati postopoma v obdobju vsaj 3 tednov (glejte poglavje 4.4).
English: There are no adequate data from the use of retigabine in pregnant women.
Slovenian: Za uporabo retigabina pri nosečnicah ni zadostnih podatkov.
English: Don't stop unless your doctor advises you to.
Slovenian: Ne nehajte ga jemati, razen če vam to svetuje zdravnik.
English: Distension of the gall bladder was seen in studies with dogs, but there was no evidence of cholestasis or other signs of gall bladder dysfunction, and bile ejection volume was unchanged.
Slovenian: Pri psih so ugotovili razširitev žolčnika, ni pa bilo znakov holestaze ali drugih znakov motenega delovanja žolčnika; tudi iztisni volumen žolča ni bil spremenjen.
English: This analysis also showed no clinically significant effect of the inducers (phenytoin, carbamazepine and phenobarbital) on retigabine clearance.
Slovenian: Ta analiza tudi ni pokazala klinično pomembnega učinka induktorjev (fenitoina, karbamazepina in fenobarbitala) na očistek retigabina.
English: Discolouration of skin, nails, lips and eyes, and eye disorders caused by changes in the centre of the retina (maculopathy)
Slovenian: Spremenjena barva kože, nohtov, ustnic in oči ter težave z očmi, ki jih povzročajo spremembe v centru mrežnice (makulopatija).
English: 84 film-coated tablets Component of a multipack, can't be sold separately
Slovenian: 84 filmsko obloženih tablet Sestavina skupnega pakiranja, ni za ločeno prodajo.
English: • tingling or numbness of the hands or feet
Slovenian: • mravljinčenje ali omrtvelost v dlaneh in stopalih,
English: The MAH shall ensure that, at launch and after launch, neurologists, ophthalmologists and other healthcare professionals (according to national requirements) are provided with a physician information pack containing the following elements:
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da ob prihodu zdravila na trg in po prihodu zdravila na trg, nevrologi, oftalmologi in drugi zdravstveni delavci (skladno z nacionalnimi zahtevami), prejmejo izobraževalno gradivo za zdravnike, ki vključuje naslednje elemente: • Povzetek glavnih značilnosti zdravila
English: For patients with end-stage renal disease receiving haemodialysis, the three daily doses should be taken as usual on the dialysis day.
Slovenian: Bolniki z ledvično okvaro v končnem stadiju, ki so na hemodializi, naj vzamejo na dan dialize dnevni odmerek kot ponavadi.
English: In a study of peri- and post-natal development in rats, retigabine was associated with increased perinatal mortality following administration during pregnancy.
Slovenian: V študiji peri- in postnatalnega razvoja pri podganah je bil retigabin po uporabi med brejostjo povezan z večjo perinatalno umrljivostjo.
English: It is unknown whether retigabine is excreted in human breast milk.
Slovenian: Ni znano, ali se retigabin pri človeku izloča v materinem mleku.
English: Do not take Trobalt • if you are allergic to retigabine or any of the other ingredients of Trobalt (listed in section 6).
Slovenian: • če ste alergični na retigabin ali katerokoli drugo sestavino zdravila Trobalt (naštete so v poglavju 6).
English: If you forget to take Trobalt
Slovenian: Če ste pozabili vzeti zdravilo Trobalt
English: It may take a few weeks to find the right dose of Trobalt for you.
Slovenian: Mine lahko nekaj tednov, preden se ugotovi odmerek zdravila Trobalt, ki je pravi za vas.
English: Pharmacodynamic effects
Slovenian: Farmakodinamski učinki
English: Caution should be taken when Trobalt is prescribed with medicinal products known to increase QT interval and in patients with known prolonged QT interval, congestive cardiac failure, ventricular hypertrophy, hypokalaemia or hypomagnesaemia and in patients initiating treatment who are 65 years of age and above.
Slovenian: če je zdravilo Trobalt predpisano z zdravili, ki podaljšajo interval QT, in pri bolnikih z znanim podaljšanim QT intervalom, kongestivnim srčnim popuščanjem, hipertrofijo prekatov, hipokaliemijo ali hipomagneziemijo in pri bolnikih, ki začenjajo zdravljenje in so stari 65 let ali več.
English: Vision abnormalities (field constriction, loss of central sensitivity, and reduced visual acuity) have been reported.
Slovenian: Poročali so o motnjah vida (zoženje vidnega polja, izguba centralne občutljivosti in zmanjšana ostrina vida).
English: However, efficacy and safety of retigabine have not been determined in adolescents.
Slovenian: Učinkovitost in varnost pri mladostnikih še nista bili ugotovljeni.
English: You can take Trobalt with or without food.
Slovenian: Zdravilo Trobalt lahko vzamete s hrano ali brez nje.