natgillin/translations-raw huggingface dataset:
It is recommended that patients are advised about the risk of these possible effects.
Bolnike je priporočljivo seznaniti s tveganjem teh možnih učinkov.
Patients could not be seizure-free for ≥21 days.
Bolniki niso smeli biti brez napadov ≥ 21 dni.
The clinical significance of this finding is not known.
Klinični pomen tega izsledka ni znan.
Further management should be as recommended by the national poisons centre, where available.
Nadaljnje ukrepanje mora upoštevati priporočila nacionalnega centra za zastrupitve, če so ta na voljo.
Interaction with digoxin
Medsebojno delovanje z digoksinom
The relevance of these models to human epilepsy, however, is not known.
Vendar pomen teh modelov za epilepsijo pri človeku ni znan.
• changes in liver function, which will show up in blood tests.
• spremembe v delovanju jeter; to se pokaže pri preiskavah krvi.
If you are going to have an operation under a general anaesthetic:
Če imate predvideno operacijo v splošni anesteziji:
Do not use this medicine after the expiry date which is stated on the pack.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pakiranju.
• effects on heart rhythm.
• vpliv na srčni ritem.
The safety and efficacy are not yet known in this age group.
Varnost in učinkovitost v tej starostni skupini še nista znani.
• psychotic disorders (severe mental health problems)
• psihotične motnje (hude težave z duševnim zdravjem),
Extremadura 3, 09400 Aranda De Duero, Burgos, Spain.
Extremadura 3, 09400 Aranda De Duero, Burgos, Španija.
Your doctor should recommend that you have an eye examination before starting treatment.
Zdravnik vam bo svetoval, da pred začetkom zdravljenja opravite očesni pregled.
If you are over 65 years you will usually be given a reduced starting dose and your doctor may limit the maximum dose to 900 mg a day.
Če ste starejši od 65 let, vam bodo ponavadi dali zmanjšan začetni odmerek; vaš zdravnik lahko zmanjša največji odmerek na 900 mg na dan.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali, ali pa boste morda začeli jemati katero koli zdravilo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 March 2011
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 28.3.2011
Interaction with alcohol
Medsebojno delovanje z alkoholom
The long-term prognosis of these findings is currently unknown, but some of the reports have been associated with visual impairment.
Dolgoročna prognoza teh izsledkov trenutno ni znana, a nekateri opisani primeri so bili povezani z okvaro vida.
Laboratory tests
Laboratorijske preiskave
Currently available pharmacokinetic data are described in section 5.2, but no recommendation on a posology can be made.
Farmakokinetični podatki, ki so trenutno na voljo, so opisani v poglavju 5.2, vendar priporočil o odmerjanju ni mogoče podati.
Only 14% of retigabine is excreted in the faeces.
Samo 14 % retigabina se izloči v blatu.
In some cases changes to the pigmentation in the eyes may improve after you stop taking Trobalt.
V nekaterih primerih se lahko spremembe v pigmentaciji v očeh izboljšajo, ko prenehate jemati zdravilo Trobalt.
Doses greater than 900 mg/day are not recommended (see sections 4.4 and 5.2).
Odmerki nad 900 mg/dan niso priporočljivi (glejte poglavji 4.4 in 5.2).
Treatment will be stopped if any problems are found unless no other suitable treatments are available.
Če se pojavijo nepravilnosti, boste zdravljenje končali, razen če ni na voljo nobenih drugih ustreznih zdravil.
Trobalt must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability.
Odmerjanje Zdravilo Trobalt je treba titrirati glede na odziv posameznega bolnika, da bi optimizirali ravnovesje med učinkovitostjo in prenašanjem.
Trobalt can affect the results of some tests.
Zdravilo Trobalt lahko vpliva na izvide nekaterih preiskav.
You must talk to your doctor about the effect of your epilepsy on driving and using machines.
Z zdravnikom se morate posvetovati o vplivu vaše epilepsije na sposobnost upravljanja vozil in strojev.
Glaxo Wellcome, S.A, Avda.
Izdelovalec Glaxo Wellcome, S.A, Avda.
Then leave at least 3 hours before your next dose.
Po tem morajo preteči najmanj 3 ure, preden vzamete naslednji odmerek.
Elderly If you are 65 years or older, you may be more likely than a younger adult to get the following symptoms:
Če ste stari 65 let ali več, je večja verjetnost pri vas kot pri mlajših odraslih bolnikih, da boste dobili naslednje simptome:
A substantial fraction of the retigabine dose is converted to inactive N-glucuronides.
Znaten delež odmerka retigabina se spremeni v neaktivne N-glukuronide.
This is more likely to affect you:
Verjetnost, da se to zgodi, je večja:
In addition, retigabine and NAMR did not induce CYP1A2 or CYP3A4/5 in human primary hepatocytes.
Poleg tega retigabin in NAMR nista inducirala CYP1A2 ali CYP3A4/5 v človeških primarnih hepatocitih.
Trobalt is not recommended for children and adolescents aged under 18.
Zdravilo Trobalt ni priporočljivo za otroke in mladostnike, mlajše od 18 let.
Your doctor may gradually adjust your dose over a few weeks so that your seizures are better controlled, and side effects are kept to a minimum.
Zdravnik vam lahko odmerek v nekaj tednih postopoma prilagodi, tako da so vaši napadi bolje obvladani in je neželenih učinkov čim manj.
Uncertainties about the impact of this risk on patients remain as there is a possibility of functional abnormalities associated with retinopathy including potentially severe visual impairment.
Ostajajo negotovosti glede vpliva tega tveganja na bolnike, kajti obstaja možnost funcionalnih motenj povezanih z retinopatijo, vključno s potencialno hudo okvaro vida.
In open-label extensions of the three placebo-controlled studies, persistence of efficacy was maintained over an evaluation period of at least 12 months (365 patients).
V odprtih podaljšanjih treh s placebom kontroliranih študij se je učinkovitost ohranila v vsaj 12-mesečnem obdobju ocenjevanja (365 bolnikov).
The effect of food on Cmax under usual clinical conditions is not expected to be clinically relevant.
Ni pričakovati, da bi bil vpliv hrane na Cmax pod normalnimi kliničnimi pogoji klinično pomemben.
If you suddenly stop taking Trobalt, your seizures may come back or get worse.
Če nenadoma nehate jemati zdravilo Trobalt, se vam napadi lahko povrnejo ali poslabšajo.
In the event of overdose, it is recommended that the patient is given appropriate supportive therapy as clinically indicated, including electrocardiogram (ECG) monitoring.
V primeru prevelikega odmerjanja je bolniku priporočljivo zagotoviti podporno zdravljenje, kot je klinično indicirano, vključno z elektrokardiografskim (EKG) spremljanjem.
Take extra care until you know how Trobalt and alcohol affect you.
Bodite posebej pozorni, dokler ne veste, kako zdravilo Trobalt in alkohol vplivata na vas.
Therefore, based upon the safety profile of Trobalt the CHMP concluded that the MAH should submit one additional renewal application in 5 years.
Na osnovi varnostnega profila zdravila Trobalt CHMP zato zaključuje, da mora imetnik DzP predložiti še eno dodatno vlogo za podaljšanje dovoljenja za promet čez 5 let.
Don't take more than one dose at a time to make up for missed doses.
Ne vzemite več kot en odmerek naenkrat, da bi nadomestili pozabljenega.
Tell the person who orders the test that you are taking Trobalt.
Povejte osebi, ki je naročila preiskavo, da jemljete zdravilo Trobalt.
The maternal toxicities interfered with higher dosing of the dams and hence deduction of safety margins with regard to human therapy.
Maternalni toksični učinki so ovirali večje odmerjanje pri samicah in s tem sklepanje o varnostnih mejah, kar zadeva zdravljenje pri človeku.
Don't drive or use machines until you know how Trobalt affects you.
Ne upravljajte vozil ali strojev, dokler ne veste, kako zdravilo Trobalt vpliva na vas.
Your doctor may decide that Trobalt is not suitable for you.
Zdravnik se lahko odloči, da zdravilo Trobalt za vas ni primerno.
If patients miss one dose or more, it is recommended that they take a single dose as soon as they remember.
Če bolnik izpusti enega ali več odmerkov, je priporočljivo, da vzame en odmerek, takoj ko se spomni.
If you need a blood or urine test
Če morate opraviti preiskavo krvi ali urina
If you miss any doses, just take one dose as soon as you remember.
Če ste pozabili vzeti katerikoli odmerek, preprosto vzemite pozabljeni odmerek, čim se spomnite.
Trobalt may be taken with or without food (see section 5.2).
Zdravilo Trobalt se lahko jemlje s hrano ali brez nje (glejte poglavje 5.2).
The studies were not designed to evaluate specific combinations of antiepileptic medicinal products.
Študije niso bile oblikovane tako, da bi raziskale specifične kombinacije aniepileptičnih zdravil.
Trobalt is one of a group of medicines called antiepileptics.
Zdravilo Trobalt spada v skupino zdravil, imenovanih antiepileptiki.
In women being treated for epilepsy, sudden discontinuation of antiepileptic medicine therapy should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.
Pri ženskah, ki se zdravijo zaradi epilepsije, se je treba izogniti nenadni prekinitvi antiepileptikov, kajti to namreč lahko povzroči izbruh napadov, ki imajo lahko resne posledice za žensko in nerojenega otroka.
If you have kidney or liver problems, your doctor may give you a reduced dose of Trobalt.
Če imate težave z ledvicami ali jetri, vam zdravnik lahko predpiše manjši odmerek zdravila Trobalt.
• if you are 65 years of age or above
• če ste stari 65 let ali več,
This is most likely to happen during the first few months of treatment with Trobalt.
Verjetnost tega je največja v prvih mesecih zdravljenja z zdravilom Trobalt.
The percentage decrease in plasma concentration during dialysis ranged from 34% to 60% except for one subject who had a 17% reduction.
Odstotek znižanja koncentracije v plazmi med dializo je segal od 34 % do 60 % razen pri enem preiskovancu, pri katerem je bilo znižanje 17 %.
Other medicines and Trobalt
Druga zdravila in zdravilo Trobalt
Prior to launch in each Member State, and also after changes to the key elements in the educational material the MAH shall agree the final educational material with the National Competent Authority.
Pred dajanjem zdravila na trg in po spremembah ključnih elementov v izobraževalnem gradivu se mora imetnik dovoljenja za promet v vsaki državi članici dogovoriti o končnem izobraževalnem gradivu z nacionalnim prisojnim organom.
It works by preventing the brain overactivity that causes epileptic seizures (also called fits).
Deluje tako, da prepreči prekomerno dejavnost možganov, ki povzroči epileptične napade (imenujemo jih tudi "napadi krčev").
If continued, the patient should be monitored more closely.
V primeru nadaljevanja zdravljenja je treba bolnika natančneje spremljati.
The increase did not appear to be dependent on retigabine dose and is not considered clinically relevant.
Ni bilo videti, da bi bilo povečanje odvisno od odmerka retigabina in zato ne velja za klinično pomembno.
It is recommended that patients are advised about the risk of such adverse reactions at treatment initiation and following each titration step, and that they are advised not to drive or operate machinery until they have established how Trobalt affects them.
Bolnike je priporočljivo seznaniti s tveganji takšnih neželenih učinkov na začetku zdravljenja in po vsaki stopnji titriranja odmerka ter jim svetovati, naj ne vozijo in ne upravljajo s stroji, dokler ne ugotovijo, kako zdravilo Trobalt vpliva nanje.
The rate of progression of vitelliform maculopathy and its impact on retinal and macular function and vision is unclear.
Hitrost napredovanja viteliformne makulopatije in njenega vpliva na funkcijo mrežnice in makule ter vida ni jasna.
In a population pharmacokinetic analysis, retigabine clearance increased with increasing body surface area.
V populacijski farmakokinetični analizi se je očistek retigabina povečeval s povečevanjem telesne površine.
These effects generally occurred within the first 8 weeks of treatment, and frequently led to treatment withdrawal in affected patients.
Ti učinki so se na splošno pojavili v prvih 8 tednih zdravljenja in so pri prizadetih bolnikih pogosto povzročili prenehanje zdravljenja.
Patients (and caregivers of patients) should be advised to seek medical advice if signs of suicidal ideation or behaviour emerge.
Bolnikom (in skrbnikom bolnikov) je treba naročiti, da morajo poiskati zdravniško pomoč, če bi se pojavile samomorilne misli ali samomorilno vedenje.
If you need a blood or urine test:
Če morate opraviti preiskavo krvi ali urina:
• if you have kidney or liver problems.
• če imate težave z ledvicami ali jetri.
Risk related to Trobalt
Tveganje, povezano z zdravilom Trobalt
Trobalt can make you feel dizzy or drowsy and cause double or blurred vision.
Zdravilo Trobalt vam lahko povzroči omotico ali zaspanost in povzroči dvojen ali zamegljen vid.
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.
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.
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.
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.
This stabilises the resting membrane potential and controls the sub-threshold electrical excitability in neurons, thus preventing the initiation of epileptiform action potential bursts.
To stabilizira membranski potencial v mirovanju, uravnava podpražno električno vzdražnost v nevronih in tako prepreči začetek epileptiformnih izbruhov akcijskega potenciala.
However, this effect is not considered clinically significant, therefore no adjustment of the Trobalt dose is recommended.
Vendar ta učinek ne velja za klinično pomemben, zato prilagoditev odmerka zdravila Trobalt ni potrebna.
Retigabine also displayed inhibitory properties in multiple kindling models, for example, in the fully kindled state and in some cases during the kindling development.
Retigabin je pokazal tudi zaviralne lastnosti v več modelih raznetenja ("kindling"), npr. v polno raznetenem stanju in v nekaterih primerih med razvojem raznetenja.
Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Zato je treba bolnike nadzirati glede samomorilnih misli in samomorilnega vedenja ter pretehtati ustrezno zdravljenje.
Your doctor will discuss with you whether treatment with Trobalt should be continued.
Zdravnik se bo z vami pogovoril o tem, ali naj zdravljenje z zdravilom Trobalt nadaljujete.
Heart conditions Trobalt can affect heart rhythm.
Srčne motnje Zdravilo Trobalt lahko vpliva na srčni ritem.
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.
V vseh študijah so imeli bolniki epilepsijo povprečno 22 let in mediano izhodiščno pogostnost napadov od 8 do 12 na 28 dni.
TW8 9GS
TW8 9GS Velika Britanija
You may need extra check-ups (including an electrocardiogram [ECG], which is a test which records the electrical activity of your heart) while
Morda boste med jemanjem zdravila Trobalt potrebovali dodatne preglede (vključno z elektrokardiogramom [EKG]; to je preiskava, ki beleži električno delovanje vašega srca).
NAMR has antiepileptic activity, but is less potent than retigabine in animal seizure models.
NAMR deluje antiepileptično, vendar je v modelih napadov pri živalih manj močan kot retigabin.
Animal studies have shown excretion of retagabine and/or its metabolites in breast milk.
Študije na živalih so pokazale izločanje retigabina in/ali njegovih presnovkov v materinem mleku.
Date of latest renewal: 14 January 2016
Datum zadnjega podaljšanja: 14.01.2016
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.
What Trobalt is and what it is used for
Kaj je zdravilo Trobalt in za kaj ga uporabljamo
Glaxo Wellcome S.A. Avda Extremadura 3 Aranda de Duero E-09400 Burgos Spain
Glaxo Wellcome S.A. Avda Extremadura 3 Aranda de Duero E-09400 Burgos Španija
You may become aware of blurring of your central vision and notice trouble with reading or recognizing faces.
Opazite lahko zameglitev centralnega vida in težave s prepoznavanjem obrazov.
It is recommended that patients are advised about the possible effects on vision if they take Trobalt with alcohol.
Bolnike je priporočljivo seznaniti, kakšni so možni učinki na vid, če vzamejo zdravilo Trobalt skupaj z alkoholom.
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.
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.
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.
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.
Absolute oral bioavailability of retigabine relative to an intravenous dose is approximately 60%.
Absolutna peroralna biološka uporabnost retigabina glede na intravenski odmerek je približno 60 %.
• not being able to pass urine (urinary retention).
• nezmožnost odvajanja urina (retenca urina).
− The need to inform patients on adverse events related to QT interval prolongation
− Bolnike je treba obvestiti o neželenih učinkih, povezanih s podaljšanjem intervala QT.
Very rare:
Redki: Zelo redki:
Mutations in the KCNQ channels underlie several human inheritable disorders, including epilepsy (KCNQ2 and 3).
Mutacije kanalov KCNQ so pri človeku osnova za več prirojenih motenj, vključno z epilepsijo (KCNQ2 in 3).
* Statistically significant, p≤0.05 ~ Dose not studied
* Statistično značilno, p ≤ 0,05
• blood in the urine; abnormally coloured urine
• kri v urinu, nenormalno obarvan urin,
• memory problems
• težave s spominom,
The total clearance of retigabine from plasma following intravenous dosing is typically 0.4 to 0.6 l/h/kg.
Celotni očistek retigabina iz plazme po intravenski uporabi je po navadi od 0,4 do 0,6 l/uro/kg.
Potassium channels are one of the voltage-gated ion channels found in neuronal cells and are important determinants of neuronal activity.
Kalijevi kanali so eni od napetostno odvisnih ionskih kanalov v nevronskih celicah in pomembno določajo aktivnost nevronov.
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.
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.
No dose adjustment of digoxin is needed.
Odmerka digoksina ni treba prilagoditi.
Each tablet contains 50 mg, 100 mg, 200 mg, 300 mg or 400 mg retigabine.
Ena tableta vsebuje 50 mg, 100 mg, 200 mg, 300 mg ali 400 mg retigabina.
Not all pack sizes may be available in your country.
V vaši državi morda na trgu ni vseh navedenih pakiranj.
Summary of percentage changes in 28-day total partial seizure frequency and responder rates
Povzetek odstotnih sprememb v 28-dnevni celotni pogostnosti parcialnih napadov in deležev odzivnih bolnikov
In vitro studies indicate that retigabine acts primarily through opening neuronal potassium channels (KCNQ2 [Kv7.2] and KCNQ3 [Kv7.3]).
Študije in vitro kažejo, da retigabin deluje predvsem z odpiranjem nevronskih kalijevih kanalov (KCNQ2 [Kv7.2] in KCNQ3 [Kv7.3]).
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%).
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 %).
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).
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).
Retigabine had no effect on fertility or general reproductive performance.
Retigabin ne vpliva na plodnost ali splošno sposobnost razmnoževanja.
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).
Zdravilo Trobalt je treba v tej populaciji uporabljati previdno in priporočljiva sta manjši začetni in vzdrževalni odmerek (glejte poglavji 4.2 in 5.2).
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.
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.
phenobarbital, phenytoin, pregabalin, topiramate, valproate, zonisamide.
okskarbazepina, fenobarbitona, fenitoina, pregabalina, topiramata, valproata, zonisamida.
Retigabine has a plasma half-life of approximately 6 to 10 hours.
Plazemski razpolovni čas retigabina je približno 6 do 10 ur.
Trobalt is not recommended during pregnancy and in women of childbearing age, not using contraception.
Zdravilo Trobalt se med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije, ne priporoča.
A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Metaanaliza randomiziranih, s placebom kontroliranih preskušanj antiepileptikov je tudi pokazala majhno povečanje tveganja samomorilnega razmišljanja in vedenja.
The eye examination should be repeated at least every six months whilst taking Trobalt.
Očesni pregled je treba ponavljati vsaj na šest mesecev med jemanjem zdravila Trobalt.
In addition to adverse reactions seen at therapeutic doses, symptoms of retigabine overdose included agitation, aggressive behaviour and irritability.
Poleg neželenih učinkov, ugotovljenih pri terapevtskih odmerkih, so simptomi prevelikega odmerjanja retigabina vključevali agitiranost, agresivno vedenje in razdražljivost.
There are only limited data on the safety and efficacy of retigabine in patients aged 65 years and above.
Podatkov o učinkovitosti in varnosti retigabina pri bolnikih, starih 65 let in več, je malo.
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.
Zdravljenje z več antiepileptiki spremlja večje tveganje prirojenih hib kot monoterapijo, zato je treba uporabiti monoterapijo, kadar je le mogoče.