FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of a single-dose study showed that in young adult volunteers, retigabine Cmax was approximately 65% higher in females than in males, and in elderly volunteers (66 to 82 years of age), retigabine Cmax was approximately 75% higher in females compared with males.
Slovenian: Spol Rezultati študije enega odmerka so pokazali, da je Cmax retigabina pri mladih odraslih prostovoljcih približno 65 % večja pri ženskah kot pri moških ter pri starejših prostovoljcih (starih od 66 do 82 let) približno 75 % večja pri ženskah kot pri moških.
English: Retigabine is approximately 80% bound to plasma protein over the concentration range of 0.1 to 2 µg/ml.
Slovenian: Porazdelitev V razponu koncentracij od 0,1 do 2 µg/ml je retigabin približno 80 % vezan na beljakovine v plazmi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX - MULTIPACK ONLY)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA NALEPKA (Z MODRIM OKENCEM - SAMO SKUPNO PAKIRANJE)
English: Trobalt may affect some anaesthetics (for example thiopental sodium).
Slovenian: Zdravilo Trobalt lahko vpliva na nekatere anestetike (npr. natrijev tiopental).
English: The total daily starting dose is 150 mg/day and during the titration period the total daily dose should be increased by a maximum of 150 mg every week, according to the individual patient response and tolerability.
Slovenian: Celotni začetni dnevni odmerek je 150 mg/dan in med obdobjem titriranja, je treba celotni dnevni odmerek povečevati po največ 150 mg na teden, upoštevaje bolnikov odziv in prenašanje.
English: Elimination of retigabine occurs via a combination of hepatic metabolism and renal excretion.
Slovenian: Odstranjevanje retigabina poteka s kombinacijo presnove v jetrih in izločanja skozi ledvice.
English: However, the plasma levels achieved in these studies were less than those reached in humans at recommended doses (see section 5.3).
Slovenian: dosežena v teh študijah, je bila manjša, kot je dosežena pri človeku v priporočenih odmerkih (glejte poglavje 5.3).
English: The maximum total daily starting dose is 300 mg (100 mg three times daily).
Slovenian: Največji celotni začetni dnevni odmerek je 300 mg (100 mg trikrat na dan).
English: In addition, there was no clinically significant effect of the low dose combination oral contraceptive pill on the pharmacokinetics of retigabine.
Slovenian: Prav tako tudi nizkoodmerne kombinirane peroralne kontracepcijske tablete niso klinično pomembno vplivale na farmakokinetiko retigabina.
English: Other antiepileptic medicinal products
Slovenian: Drugi antiepileptiki
English: The need for treatment with antiepileptic medicinal products should be reviewed when a woman is planning to become pregnant.
Slovenian: Če ženska načrtuje nosečnost, je treba znova pretehtati potrebo po zdravljenju z antiepileptiki.
English: The majority of adverse reactions occurred in the first 8 weeks of treatment, and there was an apparent dose-relationship for confusional state only.
Slovenian: Večina neželenih učinkov se je pojavila v prvih 8 mesecih zdravljenja, očitna povezanost z odmerkom pa je bila le pri stanju zmedenosti.
English: In addition, there was a delay in auditory startle response development.
Slovenian: Poleg tega je bil razvoj zdrznitve na slušni dražljaj zapoznel.
English: These findings were apparent at exposure levels lower than those obtained with clinically recommended doses and were accompanied by maternal toxicities (including ataxia, hypokinesia, tremor and reduced body weight gain).
Slovenian: Ti izsledki so bili opazni pri izpostavljenosti, ki je manjša, kot je dosežena s klinično priporočenimi odmerki; spremljali so jih toksični učinki pri materi (vključno z ataksijo, hipokinezijo,
English: Therefore, retigabine is unlikely to affect the pharmacokinetics of substrates of the major cytochrome P450 isoenzymes through inhibition or induction mechanisms.
Slovenian: Zato ni verjetno, da bi retigabin vplival na farmakokinetiko substratov glavnih izoencimov citokroma P450 z mehanizmom zavrtja ali indukcije.
English: A small number of people being treated with antiepileptics such as Trobalt have had thoughts of harming or killing themselves.
Slovenian: Razmišljanje o samopoškodovanju ali samomoru Pri majhnem številu oseb, ki so dobivale zdravila proti epilepsiji, kakršno je zdravilo Trobalt, se je pojavilo razmišljanje o samopoškodovanju ali samomoru.
English: All patients enrolled were to have had seizures that were not adequately controlled with 1 to 3 concomitant antiepileptic medicinal products, and more than 75% of all patients were taking ≥2 concurrent antiepileptic medicinal products.
Slovenian: Vsi vključeni bolniki so imeli napade, ki niso bili ustrezno obvladani z 1 do 3 sočasnimi antiepileptiki, in več kot
English: The other ingredients are: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide (E171) , talc (E553b), Lecithin (SOY) and Xanthan gum.
Slovenian: Pomožne snovi so: premreženi natrijev karmelozat, hipromeloza, magnezijev stearat, mikrokristalna celuloza, polivinilalkohol, titanov dioksid (E171), smukec (E553b), sojin lecitin in ksantanski
English: The 200 mg tablets also contain iron oxide yellow (E172).
Slovenian: 200-mg tablete vsebujejo tudi rumeni železov oksid (E172).
English: There is no evidence for hepatic oxidative metabolism of retigabine or NAMR by cytochrome P450 enzymes.
Slovenian: Dokazov o jetrni oksidativni presnovi retigabina ali NAMR z encimi citokroma P450 ni.
English: Eye disorders caused by changes in the centre of the retina (maculopathy) have been reported in people taking Trobalt (see Section 4).
Slovenian: Poročali so o težavah z očmi, ki so jih povzročile spremembe v centru mrežnice (makulopatija) pri ljudeh, ki so jemali zdravilo Trobalt (glejte poglavje 4).
English: All patients should undergo comprehensive ophthalmological examinations at baseline and at least every six months, which should include visual acuity, slit-lamp examination, dilated fundus photography, and macular OCT imaging.
Slovenian: Pri vseh bolnikih je treba izhodiščno in vsaj vsakih 6 mesecev opraviti izčrpen oftalmološki pregled, ki mora vključevati pregled ostrine vida, pregled s špranjsko svetilko, slikanje očesnega ozadja ob dilataciji in optično koherentno tomografijo (OCT) makule.
English: The arrhythmias spontaneously resolved, and both volunteers recovered without sequelae.
Slovenian: Motnje srčnega ritma so minile spontano in oba prostovoljca sta okrevala brez posledic.
English: Urinary retention, dysuria and urinary hesitation were reported in controlled clinical studies with retigabine, generally within the first 8 weeks of treatment (see section 4.8).
Slovenian: V kontroliranih kliničnih študijah retigabina so bile opisane retenca urina, dizurija in zastajanje curka urina, na splošno v prvih 8 tednih zdravljenja (glejte poglavje 4.8).
English: No signs of gall bladder dysfunction were seen clinically.
Slovenian: Klinično niso opazili znakov motenega delovanja žolčnika.
English: • balance problems, lack of co-ordination, spinning sensation (vertigo), problems walking
Slovenian: • težave z ravnotežjem, zmanjšana koordinacija, občutek vrtenja (vrtoglavica), težave s hojo,
English: Retigabine overdoses in excess of 2,500 mg/day were reported during clinical studies.
Slovenian: Med kliničnimi študijami so bili opisani primeri prevelikega odmerjanja retigabina preko 2.500 mg/dan.
English: Trobalt may increase the duration of anaesthesia induced by some anaesthetics (for example thiopental sodium; see section 5.1).
Slovenian: Zdravilo Trobalt lahko podaljša trajanje anestezije z nekaterimi anestetiki (npr. z natrijevim tiopentalom, glejte poglavje 5.1).
English: Therefore, co-administration with inhibitors or inducers of cytochrome P450 enzymes is unlikely to affect the pharmacokinetics of retigabine or NAMR.
Slovenian: Zato ni verjetno, da bi sočasna uporaba z zaviralci ali induktorji encimov citokroma P450 vplivala na farmakokinetiko retigabina ali NAMR.
English: In a single-dose study, retigabine AUC was increased by approximately 30% in volunteers with mild renal impairment (creatinine clearance 50 to 80 ml/min) and by approximately 100% in volunteers with moderate to severe renal impairment (creatinine clearance <50 ml/min), relative to healthy volunteers.
Slovenian: V študiji enega odmerka se je AUC retigabina v primerjavi z zdravimi prostovoljci pri prostovoljcih z blago okvaro ledvic (očistek kreatinina od 50 do 80 ml/min) povečala za približno 30 % in pri prostovoljcih z zmerno do hudo okvaro ledvic (očistek kreatinina < 50 ml/min) za približno 100 %.
English: What you need to know before you take Trobalt
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Trobalt Ne jemljite zdravila Trobalt
English: Therefore Trobalt is not recommended during pregnancy.You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Trobalt.
Slovenian: Med zdravljenjem z zdravilom Trobalt morate uporabljati zanesljivo kontracepcijsko zaščito, da ne boste zanosili.
English: The maximum dose is 400 mg taken three times a day (a total of 1,200 mg a day).
Slovenian: Največji odmerek je 400 mg trikrat na dan (skupaj 1.200 mg na dan).
English: At no observed effect levels, animal exposure in these studies was generally less than that reached in humans at recommended clinical doses.
Slovenian: (NOEL) je bila izpostavljenost živali v teh študijah na splošno manjša, kot je dosežena z uporabo priporočenih kliničnih odmerkov pri človeku.
English: There were no treatment-related effects of retigabine on fertility in animal studies.
Slovenian: V študijah na živalih niso ugotovili z retigabinom povezanih učinkov na plodnost.
English: Pack containing 84 film-coated tablets; multi-pack comprising 168 (2 x 84) film-coated tablets.
Slovenian: Pakiranje s 84 filmsko obloženimi tabletami; skupno pakiranje, ki vsebuje 168 (2 x 84) filmsko obloženih tablet.
English: In vitro studies using human liver microsomes showed little or no potential for retigabine to inhibit the major cytochrome P450 isoenzymes (including CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5).
Slovenian: CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 in CYP3A4/5).
English: If you notice such changes while taking the medicine, tell your doctor.
Slovenian: Če opazite takšne spremembe med zdravljenjem z zdravilom
English: The retigabine AUC was increased by approximately 50% in volunteers with moderate hepatic impairment (Child-Pugh score 7 to 9) and by approximately 100% in volunteers with severe hepatic impairment (Child-Pugh score >9), relative to healthy volunteers.
Slovenian: V primerjavi z zdravimi prostovoljci je bila AUC retigabina pri prostovoljcih z zmerno okvaro jeter (7 do 9 po Child-Pughu) približno 50 % večja in pri prostovoljcih s hudo okvaro jeter (> 9 po Child-Pughu) približno 100 % večja.
English: Based on these pooled data, retigabine did not cause clinically significant effects on the plasma trough concentrations of the following antiepileptic medicinal products: - carbamazepine, clobazam, clonazepam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine,
Slovenian: Na podlagi teh kumulativnih podatkov retigabin ni klinično pomembno vplival na najmanjšo plazemsko koncentracijo naslednjih antiepileptikov: - karbamazepina, klobazama, klonazepama, gabapentina, lamotrigina, levetiracetama,
English: The doctor will weigh up the benefit to you against any risk to your baby of taking Trobalt while you are pregnant.
Slovenian: Zdravnik bo pretehtal koristi, ki jih jemanje zdravila Trobalt med obdobjem nosečnosti pomeni za vas v primerjavi s kakršnimkoli tveganjem za vašega otroka.
English: Urinary retention
Slovenian: Zastoj urina
English: This sometimes occur together with discolouration of parts of the eye.
Slovenian: Spremembe barve se lahko včasih pojavijo skupaj s spremembami barve delov očesa.
English: In patients who develop these changes, treatment with Trobalt should only be continued after a careful re-assessment of the balance of benefits and risks.
Slovenian: Pri bolnikih, ki se jim razvijejo takšne spremembe se sme zdravljenje z zdravilom Trobalt nadaljevati le po skrbni ponovni oceni možnega tveganja v primerjavi s koristmi zdravljenja.
English: • difficulty in starting to urinate (urinary hesitation)
Slovenian: • bolečine pri odvajanju urina (dizurija), • težave pri začetku uriniranja,
English: No dose adjustment is required in patients with mild renal impairment (creatinine clearance 50 to 80 ml/min; see section 5.2).
Slovenian: Bolnikom z blago okvaro ledvic (očistek kreatinina od 50 do 80 ml/min) odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Multipack: 168 (2 packs of 84) film-coated tablets
Slovenian: Skupno pakiranje: 168 (2 pakiranji po 84) filmsko obloženih tablet
English: In a study in volunteers, cardiac arrhythmia (cardiac arrest/asystole or ventricular tachycardia) occurred in two subjects within 3 hours of receiving a single 900 mg retigabine dose.
Slovenian: V študiji prostovoljcev so se dvema osebama v treh urah po enem 900-mg odmerku retigabina pojavile motnje srčnega ritma (zastoj srca/asistolija oz. ventrikularna tahikardija).
English: Adverse reactions related to voiding dysfunction, including urinary retention, were reported in 5% of retigabine-treated patients in the pooled safety dataset (see section 4.4).
Slovenian: V kumulativnem naboru podatkov o varnosti so neželene učinke, povezane z mikcijo (vključno z retenco urina) zabeležili pri 5 % bolnikov, zdravljenih z retigabinom (glejte poglavje 4.4).
English: Discolouration of parts of the eye, including the retina (inside the back of the eye): this can be very common in people taking Trobalt for several years.
Slovenian: Spremenjena barva delov očesa, vključno z mrežnico (na zadnji notranji strani očesa): To je pogosto pri bolnikih, ki jemljejo zdravilo Trobalt več let.
English: Skin and subcutaneous disorders
Slovenian: Bolezni kože in podkožja kožni izpuščaj,
English: There is limited experience of overdose with retigabine.
Slovenian: Izkušenj s prevelikim odmerjanjem retigabina je malo.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ POGLEDA IN
English: Opaque PVC-PVDC-aluminium foil blisters.
Slovenian: Motni pretisni omoti iz PVC-PVDC-aluminijske folije.
English: Study 302 (n=538; n=471)
Slovenian: Študija 302 (n = 538, n = 471) Celotna odstotna sprememba pogostnosti parcialnih napadov (mediana)
English: The 50 mg and 400 mg tablets also contain indigo carmine aluminium lake (E132) and carmine (E120).
Slovenian: 50-mg in 400-mg tablete vsebujejo tudi indigotin (E132) in karmin (E120).
English: Adverse reactions that were most frequently reported to lead to discontinuation were dizziness, somnolence, fatigue and confusional state.
Slovenian: Neželeni učinki, ki so najpogosteje povzročili prenehanje zdravljenja, so bili omotica, somnolentnost,
English: Retigabine was effective in adjunctive treatment of adults with partial onset seizures in three clinical studies (Table 1).
Slovenian: Retigabin je bil v vseh treh kliničnih študijah učinkovit kot dodatno zdravilo za zdravljenje odraslih bolnikov z napadi s parcialnim začetkom (preglednica 1).
English: Reversibility of retinal pigmentation after retigabine discontinuation has been reported in some subjects.
Slovenian: Pri nekaterih posameznikih so poročali o reverzibilnosti pigmentacije mrežnice po prenehanju uporabe retigabina.
English: If retinal pigment, vitelliform maculopathy or vision changes are detected, treatment with Trobalt should only be continued after a careful re-assessment of the balance of benefits and risks.
Slovenian: V primeru ugotovljene pigmentacije mrežnice, viteliformne makulopatije ali sprememb vida se lahko zdravljenje z zdravilom Troblat nadaljuje le po skrbno izvedeni ponovni oceni razmerja med koristjo in tveganjem.
English: Trobalt can cause serious side effects, including an inability to pass urine (urinary retention) and mental health problems.
Slovenian: Zdravilo Trobalt lahko povzroča resne neželene učinke, med drugim nezmožnost odvajanja urina
English: Pigment changes (discolouration) of ocular tissues, including the retina have been reported in longterm clinical studies with retigabine, sometimes but not always in conjunction with pigment changes of the skin, lips or nails (see below paragraph and section 4.8).
Slovenian: V dolgotrajnih kliničnih študijah retigabina so bile opisane pigmentne spremembe (spremembe barve) očesnih tkiv, vključno z mrežnico, včasih - a ne vedno - skupaj s pigmentnimi spremembami na koži, ustnicah ali nohtih (glejte spodnji odstavek in poglavje 4.8).
English: Each pack contains blisters of 84 or 2 x 84 film-coated tablets.
Slovenian: Vsako pakiranje vsebuje pretisne omote s 84 ali 2 x 84 filmsko obloženimi tabletami.
English: Your doctor will weigh up the benefit to you against any risk to your baby of taking Trobalt while you are breast-feeding.
Slovenian: Vaš zdravnik bo pretehtal koristi, ki jih jemanje zdravila Trobalt med obdobjem dojenja pomeni za vas, v primerjavi z morebitnim tveganjem za otroka.
English: The tablets should be swallowed whole, and not chewed, crushed or divided.
Slovenian: Tablete je treba vzeti v treh deljenih odmerkih vsak dan. Bolnik mora tablete zaužiti cele in jih ne sme grizti, drobiti ali lomiti.
English: 21 film-coated tablets 84 film-coated tablets
Slovenian: 21 filmsko obloženih tablet 84 filmsko obloženih tablet
English: Retigabine may increase the duration of anaesthesia induced by some anaesthetics (for example thiopental sodium).
Slovenian: Retigabin lahko podaljša trajanje anestezije z nekaterimi anestetiki (npr. z natrijevim tiopentalom).
English: The maximum starting dose of Trobalt is 100 mg, taken three times a day (a total of 300 mg a day).
Slovenian: Največji začetni odmerek zdravila Trobalt je 100 mg trikrat na dan (skupaj 300 mg na dan).
English: If retinal pigment changes, vitelliform maculopathy or vision changes are detected, treatment with Trobalt should only be continued after a careful re-assessment of the balance of benefits and risks.
Slovenian: V primeru ugotovljenih sprememb pigmentacije mrežnice, viteliformne makulopatije ali sprememb vida se sme zdravljenje z zdravilom Trobalt nadaljevati le po skrbni ponovni oceni možnega tveganja v primerjavi s koristmi zdravljenja.
English: Do not reduce your dose unless your doctor tells you to. To stop taking Trobalt, it is important that the dose is reduced gradually, over at least 3 weeks.
Slovenian: Pri prenehanju jemanja zdravila Trobalt je pomembno odmerek zmanjševati postopoma, v teku vsaj 3 tednov.
English: Withdrawal seizures
Slovenian: Odtegnitveni napadi
English: Study 205 (n=396; n=303)
Slovenian: Študija 205 (n = 396, n = 303) Celotna odstotna sprememba pogostnosti parcialnih napadov (mediana)
English: No dose reduction is required in patients with mild hepatic impairment (Child-Pugh score 5 to 6; see section 5.2).
Slovenian: Bolnikom z blago okvaro jeter (5 do 6 po Child-Pughu; glejte poglavje 5.2) odmerka ni treba zmanjšati.
English: Confusional state Psychotic disorders Hallucinations Disorientation Anxiety
Slovenian: halucinacije, dezorientiranost, anksioznost
English: • constipation; feeling sick (nausea); indigestion; dry mouth
Slovenian: • zaprtost, slabost v želodcu (navzea), težave z želodcem, suha usta,
English: Three multicentre, randomized, double-blind, placebo-controlled studies in a total of 1239 adult patients have been conducted to assess the efficacy of retigabine as adjunctive therapy of partial onset seizures, with or without secondary generalisation.
Slovenian: Klinična učinkovitost dodatnega zdravljenja z retigabinom pri napadih s parcialnim začetkom Za oceno učinkovitosti retigabina kot dodatnega zdravljenja napadov s parcialnim začetkom (s sekundarno generalizacijo ali brez nje) so bile opravljene tri multicentrične, randomizirane, dvojno slepe, s placebom kontrolirane študije, ki so skupaj zajele 1239 odraslih bolnikov.
English: You must look out for certain symptoms while you are taking Trobalt, to reduce the risk of any problems.
Slovenian: Da boste zmanjšali tveganje za pojav težav, morate biti med uporabo zdravila Trobalt pozorni na določene simptome.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX21.
Slovenian: Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki.
English: Retigabine is extensively metabolised in humans.
Slovenian: Presnova retigabina je pri človeku izdatna.
English: Study 301 (n=305; n=256)
Slovenian: Študija 301 (n = 305, n = 256) Celotna odstotna sprememba pogostnosti parcialnih napadov (mediana)
English: Increased liver function tests
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišanje jetrnih funkcijskih testov
English: The 100 mg and 300 mg tablets also contain indigo carmine aluminium lake (E132) and iron oxide yellow (E172).
Slovenian: 100-mg in 300-mg tablete vsebujejo tudi indigotin (E132) in rumeni železov oksid (E172).
English: During an 8-week baseline period, patients had to experience ≥4 partial onset seizures per 28 days.
Slovenian: tedenskim izhodiščnim obdobjem so se morali bolnikom pojaviti ≥ 4 napadi s parcialnim začetkom v
English: − The need for comprehensive ophthalmological examinations including visual acuity, slit-lamp examination, dilated fundus photography and macular optical coherence tomography (OCT) imaging at treatment initiation and at least every 6 months thereafter while treatment is ongoing.
Slovenian: - V času zdravljenja je treba na začetku zdravljenja in vsaj vsakih 6 mesecev opraviti izčrpen oftalmološki pregled, vključno z ostrino vida, pregledom s špranjsko svetilko, slikanjem očesnega ozadja ob dilataciji in optično koherentno tomografijo (OCT) makule.
English: Based on a study conducted in healthy volunteers, therapeutic doses of retigabine (600-1,200 mg/day) resulted in a minor (8-18%) increase in digoxin AUC following a single oral dose of digoxin.
Slovenian: povzročili majhno (8-18%) povečanje AUC digoksina po enem samem peroralnem odmerku digoksina.
English: Confusional state, psychotic disorders and hallucinations were reported in controlled clinical studies with retigabine (see section 4.8).
Slovenian: V kontroliranih kliničnih študijah z retigabinom so bili opisani stanje zmedenosti, psihotične motnje in halucinacije (glejte poglavje 4.8).
English: Talk to your doctor about breast-feeding while you are taking Trobalt.
Slovenian: O dojenju med jemanjem zdravila Trobalt se posvetujte z zdravnikom.
English: Pigment changes (discolouration) of the skin, lips or nails have been reported in long-term clinical studies with retigabine, sometimes but not always in conjunction with pigment changes of ocular tissues (see above paragraph and section 4.8).
Slovenian: kože, ustnic in nohtov, včasih - a ne vedno - skupaj s pigmentnimi spremembami očesnih tkiv (glejte zgornji odstavek in poglavje 4.8).
English: Each pack contains blisters of 21or 84 film-coated tablets.
Slovenian: Vsako pakiranje vsebuje pretisne omote z 21 ali 84 filmsko obloženimi tabletami.
English: These may affect up to 1 in 10 people:
Slovenian: Pogosti neželeni učinki Pojavijo se lahko pri največ 1 od 10 oseb:
English: At retigabine doses of up to 750 mg/day, there was no clinically significant effect of retigabine on the pharmacokinetics of the estrogen (ethinyl estradiol) or progestogen (norethindrone) components of the oral contraceptive pill.
Slovenian: Retigabin v odmerkih do 750 mg/dan ni klinično pomembno vplival na farmakokinetiko estrogenske
English: A study of cardiac conduction in healthy subjects has demonstrated that retigabine titrated to 1,200 mg/day produced a QT-prolonging effect.
Slovenian: V študiji srčnega prevajanja je retigabin pri zdravih prostovoljcih ob titriranju do 1.200 mg/dan povzročil podaljšanje intervala QT.
English: • lack of co-ordination; spinning sensation (vertigo); balance problems; problems walking
Slovenian: • pomanjkanje koordinacije, občutek vrtenja (vrtoglavica), težave z ravnotežjem, težave s hojo, • tresenje, nenadno trzanje mišic (mioklonus),