FrancophonIA/ELRC3.0 huggingface dataset:
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: C OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Trobalt is for oral use.
Slovenian: Zdravilo Trobalt je za peroralno uporabo.
English: A reduction in the initial and maintenance dose of Trobalt is recommended in elderly patients.
Slovenian: Pri starejših bolnikih je priporočljivo zmanjšati začetni in vzdrževalni odmerek zdravila Trobalt.
English: Patients were randomized to placebo or retigabine at 600, 900 or 1,200 mg/day (see Table 1).
Slovenian: Bolnike so randomizirali na placebo ali na 600, 900 ali 1.200 mg retigabina na dan (glejte preglednico 1).
English: The drug interaction potential was, therefore, evaluated based on a pooled analysis across clinical studies and whilst not considered as robust as stand-alone clinical interaction studies, the results support the in vitro data.
Slovenian: Možnost medsebojnega delovanja je bila zato ocenjena na podlagi kumulativne analize kliničnih študij; ti rezultati sicer ne veljajo za tako trdne kot rezultati samostojne klinične študije medsebojnega delovanja, vendar podpirajo podatke, dobljene in vitro.
English: Hypokinesia
Slovenian: hipokinezija
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX - MULTIPACK ONLY)
Slovenian: PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA (BREZ MODREGA OKENCA - SAMO SKUPNO PAKIRANJE)
English: The safety and efficacy of retigabine in children below 18 years of age has not yet been established (see section 5.2).
Slovenian: Varnost in učinkovitost retigabina pri otrocih, mlajših od 18 let, še nista ugotovljeni (glejte poglavje
English: Trobalt is used to treat seizures that affect one part of the brain (partial seizure), which may or may not extend to larger areas on both sides of the brain (secondary generalisation).
Slovenian: (parcialni napad), ki se lahko ali ne širi na večja področja obeh strani možganov (sekundarna generalizacija).
English: • if you have an existing heart problem • if you have low potassium (hypokalaemia) or low magnesium (hypomagnesaemia) in your
Slovenian: • če imate nizek kalij (hipokaliemija) ali nizek magnezij (hipomagneziemija) v krvi,
English: After taking a missed dose, at least 3 hours should be allowed before the next dose and then the normal dosing schedule should be resumed.
Slovenian: Po zaužitju izpuščenega odmerka morajo preteči vsaj 3 ure, preden vzame naslednji odmerek; nato mora zdravilo jemati naprej po običajni shemi.
English: In a second single-dose study in subjects with end stage renal disease receiving chronic haemodialysis (n= 8), initiation of dialysis at approximately 4 hours after a single dose of retigabine (100 mg) resulted in a median reduction in retigabine plasma concentrations of 52% from the start to end of dialysis.
Slovenian: V drugi študiji enkratnih odmerkov pri preiskovancih s končno odpovedjo ledvic na kronični hemodializi (n = 8) je začetek dialize približno 4 ure po enkratnem odmerku retigabina (100 mg) povzročil mediano znižanje koncentracije retigabina v plazmi od začetka do konca dialize za 52 %.
English: − The need to inform patients that TROBALT may cause or potentiate symptoms of urinary retention/urinary hesitation
Slovenian: − Bolnike je treba obvestiti, da zdravilo TROBALT lahko povzroči ali potencira simptome retence urina/zastajanja curka urina.
English: Drinking alcohol with Trobalt can make your vision blurred.
Slovenian: Pitje alkohola hkrati z jemanjem zdravila Trobalt lahko povzroči zamegljen vid.
English: After both single and multiple oral doses, retigabine is rapidly absorbed with median tmax values generally between 0.5 and 2 hours.
Slovenian: Retigabin se po enem in večkratnih peroralnih odmerkih hitro absorbira in mediana tmax je na splošno med 0,5 in 2 uri.
English: Tell your doctor if you experience any changes in vision whilst you are being treated with Trobalt.
Slovenian: Obvestite svojega zdravnika, če med zdravljenjem z zdravilom Trobalt opazite kakršne koli spremembe vida.
English: In these patients it is recommended that an electrocardiogram (ECG) is recorded before initiation of treatment with Trobalt and in those with a corrected QT interval >440ms at baseline, an ECG should be recorded on reaching the maintenance dose.
Slovenian: Takšnim bolnikom je pred začetkom zdravljenja z zdravilom Trobalt priporočljivo posneti elektrokardiogram (EKG); tistim, ki imajo korigirani interval QT izhodiščno > 440 ms, je treba EKG
English: Tell your doctor if any of these apply to you, or if you notice any unusual changes in your heart beat (such as beating too fast or too slow).
Slovenian: Če kaj od tega velja za vas, ali če opazite kakšne nenavadne spremembe srčnega ritma (npr. prehitro ali prepočasno bitje srca), morate to povedati zdravniku.
English: An effective maintenance dose is expected to be between 600 mg/day and 1,200 mg/day.
Slovenian: Pričakovani učinkoviti vzdrževalni odmerek je med 600 mg/dan in 1.200 mg/dan.
English: Retigabine has been shown to interfere with clinical laboratory assays of both serum and urine bilirubin, which can result in falsely elevated readings.
Slovenian: Ugotovljeno je, da retigabin moti klinične laboratorijske teste bilirubina v serumu in urinu; posledica so lahko lažno zvišane vrednosti.
English: It is recommended that the Trobalt dose is reduced over a period of at least 3 weeks, unless safety concerns require an abrupt withdrawal (see section 4.2).
Slovenian: Odmerek zdravila Trobalt je priporočljivo zmanjševati v obdobju vsaj 3 tednov, razen če je zaradi varnostnih razlogov potrebna nenadna prekinitev (glejte poglavje 4.2).
English: If you stop taking Trobalt
Slovenian: Če ste prenehali jemati zdravilo Trobalt
English: Thereafter, the total daily dose is increased by a maximum of 150 mg every week, according to the individual patient response and tolerability.
Slovenian: Potem je treba celotni dnevni odmerek povečevati po največ 150 mg na teden, upoštevaje bolnikov odziv in prenašanje.
English: Data from an in vitro study showed that the N-acetyl metabolite of retigabine (NAMR) inhibited P-glycoprotein-mediated transport of digoxin in a concentration-dependent manner.
Slovenian: Podatki iz študije in vitro so pokazali, da N-acetilni presnovek retigabina (NAMR) od koncentracije odvisno zavre transport digoksina, posredovan s P-glikoproteinom.
English: Interaction with anaesthetics
Slovenian: Medsebojno delovanje z anestetiki
English: In a range of seizure models, retigabine increased the threshold for seizure induction produced by maximal electroshock, pentylenetetrazol, picrotoxin and N-methyl-D-aspartate (NMDA).
Slovenian: V različnih modelih napadov je retigabin zvišal prag sprožitve napadov, izzvanih z največjim elektrošokom, pentilentetrazolom, pikrotoksinom in N-metil-D-aspartatom (NMDA).
English: A blue-grey discolouration of the skin, lips or nails: this is very common in people taking Trobalt for several years.
Slovenian: Modro-sive spremembe barve kože, ustnic ali nohtov: To je zelo pogosto pri bolnikih, ki jemljejo zdravilo Trobalt več let.
English: Do not stop treatment without discussing it with your doctor.
Slovenian: Ne prekinite zdravljenja, ne da bi se prej posvetovali s svojim zdravnikom.
English: Haemodialysis has been shown to reduce the plasma concentrations of retigabine and NAMR by approximately 50%.
Slovenian: Ugotovljeno je, da hemodializa za približno 50 % zniža koncentracijo retigabina in NAMR v plazmi.
English: Maximum doses in repeat dose toxicity studies were limited by the exaggerated pharmacologic effects of retigabine (including ataxia, hypokinesia and tremor).
Slovenian: Največje odmerke v študijah toksičnosti ponavljajočih se odmerkov so omejili čezmerni farmakološki učinki retigabina (vključno z ataksijo, hipokinezijo in tremorjem).
English: The effect of retigabine on human fertility has not been established.
Slovenian: Vpliv retigabina na plodnost pri človeku ni ugotovljen.
English: The requirements for submission of periodic safety updates reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: The gall bladder distension in the dog resulted in focal compression of the liver.
Slovenian: Razširitev žolčnika pri psih je povzročila fokalno kompresijo jeter.
English: Retigabine pharmacokinetics are essentially linear over the single-dose range of 25 to 600 mg in healthy volunteers and up to 1,200 mg daily in patients with epilepsy, with no unexpected accumulation following repeated administration.
Slovenian: Farmakokinetika retigabina je v bistvu linearna v območju enkratnega odmerka od 25 do 600 mg pri zdravih prostovoljcih ter do 1.200 mg na dan pri bolnikih z epilepsijo.
English: Non-clinical data reveal no special hazard for humans based on studies of genotoxicity or carcinogenic potential.
Slovenian: Neklinični podatki na osnovi običajnih študij genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: Croscarmellose sodium Hypromellose Magnesium stearate Microcrystalline cellulose.
Slovenian: Jedro tablete premreženi natrijev karmelozat hipromeloza magnezijev stearat mikrokristalna celuloza
English: However, there was no apparent gender difference in weight-normalized clearance, and since retigabine is titrated according to individual patient response and tolerability, dose-adjustments are not required on the basis of gender.
Slovenian: Vendar se za telesno maso normalizirani očistek med spoloma ni očitno razlikoval; ker titriranje retigabina poteka glede na odziv in prenašanje posameznega bolnika, prilagajanje odmerka glede na spol ni potrebno.
English: If you are not sure what to do, ask your doctor or pharmacist.
Slovenian: Če niste prepričani, kaj storiti, se posvetujte s svojim zdravnikom ali farmacevtom.
English: In retigabine-treated patients in the pooled dataset, confusional state was reported in 9% of patients, hallucinations in 2% of patients and psychotic disorders in 1% of patients (see section 4.4).
Slovenian: V kumulativnem naboru podatkov je bilo pri bolnikih, zdravljenih z retigabinom, stanje zmedenosti zabeleženo pri 9 % bolnikov, halucinacija pri 2 % bolnikov in psihotične motnje pri 1 % bolnikov (glejte poglavje 4.4).
English: Peripheral oedema
Slovenian: periferni edemi
English: The total daily starting dose is 150 mg, and it is recommended that during the titration period, the total daily dose is increased by 50 mg every week, to a maximum total dose of 600 mg/day.
Slovenian: Celotni začetni dnevni odmerek je 150 mg; med obdobjem titriranja je priporočljivo celotni dnevni odmerek povečevati po 50 mg na teden do največjega celotnega odmerka 600 mg/dan.
English: Don't take any more Trobalt than your doctor has recommended.
Slovenian: Ne vzemite več zdravila Trobalt, kot vam je naročil zdravnik.
English: Trobalt must be withdrawn gradually to minimise the potential for rebound seizures.
Slovenian: Zdravilo Trobalt je treba opustiti postopoma, da bi čim bolj zmanjšali možnost pojava odtegnitvenih napadov ("rebound").
English: Trobalt 50 mg film-coated tablets Trobalt 100 mg film-coated tablets Trobalt 200 mg film-coated tablets Trobalt 300 mg film-coated tablets Trobalt 400 mg film-coated tablets
Slovenian: Trobalt 50 mg filmsko obložene tablete Trobalt 100 mg filmsko obložene tablete Trobalt 200 mg filmsko obložene tablete Trobalt 300 mg filmsko obložene tablete Trobalt 400 mg filmsko obložene tablete retigabin
English: The maximum total maintenance dose is 1,200 mg/day.
Slovenian: Največji celotni vzdrževalni odmerek je 1.200 mg/dan.
English: The primary efficacy endpoints were: - percentage change in the 28-day total partial seizure frequency from baseline to the double-blind phase (titration and maintenance phases combined) in all three studies - responder rate (defined as the percentage of patients with a ≥50% reduction in 28-day total partial seizure frequency) from baseline to the maintenance phase (Studies 301 and 302 only).
Slovenian: Primarna opazovana dogodka učinkovitosti sta bila: - odstotna sprememba 28-dnevne celotne pogostnosti parcialnih napadov od izhodišča do dvojno slepe faze (kombinirani fazi titriranja in vzdrževanja) v vseh treh študijah, - delež odzivnih bolnikov (opredeljen kot odstotek bolnikov s ≥ 50 % zmanjšanjem 28-dnevne celotne pogostnosti parcialnih napadov) od izhodišča do vzdrževalne faze (samo študiji 301 in
English: Retigabine and its metabolites are eliminated principally by renal excretion.
Slovenian: Retigabin in njegovi presnovki se v glavnem izločijo skozi ledvice.
English: There is no information about the safety of Trobalt in pregnant women.
Slovenian: Ni podatkov o varnosti za zdravilo Trobalt pri nosečnicah.
English: In a single-dose study, retigabine was eliminated more slowly by healthy elderly volunteers (66 to 82 years of age) relative to healthy young adult volunteers, resulting in a higher AUC (approximately 40 to 50%) and longer terminal half-life (30%) (see section 4.2).
Slovenian: V študiji enega odmerka je bilo odstranjevanje retigabina počasnejše pri zdravih starejših prostovoljcih (starih od 66 do 82 let) kot pri zdravih mlajših odraslih prostovoljcih; posledica sta bili večja AUC (približno 40 do 50 %) in daljši terminalni razpolovni čas (30 %) (glejte poglavje 4.2).
English: The risk of congenital malformations is increased by a factor of 2 to 3 in the offspring of mothers treated with antiepileptic medicinal products compared with the expected incidence in the general population of approximately 3%.
Slovenian: Pri otrocih mater, zdravljenih z antiepileptiki, je tveganje za prirojene hibe 2- do 3-krat večje od pričakovane incidence med prebivalstvom na splošno, ki je približno 3 %.
English: There was no meaningful change in digoxin Cmax.
Slovenian: Cmax digoksina se ni pomembno spremenila.
English: However, steady-state data from a limited number of patients in smaller phase II studies indicated that: - phenytoin can reduce retigabine systemic exposure by 35% - carbamazepine can reduce retigabine systemic exposure by 33%
Slovenian: faze so pokazali, da: - lahko fenitoin zmanjša sistemsko izpostavljenost retigabinu za 35 %, - lahko karbamazepin zmanjša sistemsko izpostavljenost retigabinu za 33 %.
English: In addition, a single supplemental dose is recommended immediately after haemodialysis.
Slovenian: Priporoča se, da bolnik takoj po hemodializi vzame še en odmerek.
English: How to store Trobalt
Slovenian: Kako jemati zdravilo Trobalt
English: Trobalt with alcohol
Slovenian: Zdravilo Trobalt z alkoholom
English: Very common side effects These may affect more than 1 in 10 people:
Slovenian: Zelo pogosti neželeni učinki Pojavijo se lahko pri več kot 1 od 10 oseb:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Glaxo Group Limited
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Glaxo Group Limited
English: In a developmental study in rats whose mothers were treated with retigabine during pregnancy, there was a delay in auditory startle response development of the offspring (see section 5.3).
Slovenian: V razvojni študiji podgan so pri mladičih samic, ki so med nosečnostjo prejemale retigabin, ugotovili zapoznel razvoj zdrznitve na slušni dražljaj (glejte poglavje 5.3).
English: If you take more Trobalt than you should If you take too many tablets of Trobalt, you may be more likely to have side effects, or any of these symptoms:
Slovenian: Če ste vzeli večji odmerek zdravila Trobalt, kot bi smeli Če vzamete preveč tablet zdravila Trobalt, lahko obstaja večja verjetnost neželenih učinkov ali katerega od teh simptomov: • vznemirjenost, agresivnost ali razdražljivost,
English: An open-label, multiple dose pharmacokinetic, safety and tolerability study in five subjects aged between 12 years to less than 18 years with partial onset seizures determined that the pharmacokinetics of retigabine in adolescents were consistent with the pharmacokinetics of retigabine in adults.
Slovenian: Pri petih preiskovancih starih med 12 in manj kot 18 let, ki imajo konvulzije s parcialnim začetkom, so z odprto, farmakokinetično, varnostno in tolerančno študijo večkratnega odmejanja ugotovili, da je farmakokinetika retigabina pri mladostnikih skladna s farmakokinetiko pri odraslih.
English: The majority of events occurred in the first 8 weeks of treatment, and there was no apparent dose-relationship.
Slovenian: Večina učinkov se je pojavila v prvih 8 mesecih zdravljenja in očitne povezanosti z odmerkom ni bilo opaziti.
English: The following convention has been used for the classification of adverse reactions:
Slovenian: Tabelarični pregled neželenih učinkov Za razvrstitev neželenih učinkov je uporabljen naslednji dogovor:
English: However, this increase is not considered to be clinically meaningful, and since retigabine is titrated according to individual patient response and tolerability, dose-adjustments are not required on the basis of body weight.
Slovenian: Vendar to povečanje ne velja za klinično pomembno; ker titriranje retigabina poteka glede na odziv in prenašanje posameznega bolnika, prilagajanje odmerka glede na telesno maso ni potrebno.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Glaxo Group Limited
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Glaxo Group Limited
English: Data from elderly patients indicates that they may be more likely to experience certain central nervous system events, including somnolence, amnesia, coordination abnormal, vertigo, tremor, balance disorder, memory impairment and gait disturbance.
Slovenian: Podatki pri starejših bolnikih kažejo, da je verjetneje, da bodo starejši imeli določene neželene učinke centralnega živčnega sistema, vključno s somnolenco, amnezijo, nenormalno koordinacijo, vrtoglavico, tremorjem, motnjami ravnotežja, okvaro spomina in motnjami hoje.
English: Eye disorders caused by changes in the centre of the retina (maculopathy): this can be common in people taking Trobalt.
Slovenian: Težave z očmi, ki jih povzročajo spremembe v centru mrežnice (makulopatija): pri ljudeh, ki jemljejo zdravilo Trobalt so lahko pogoste.
English: The most frequently reported defects are cleft lip, cardiovascular malformations and neural tube defects.
Slovenian: Najpogosteje opisane hibe so heiloshiza, malformacije srca in ožilja in defekti nevralne cevi.
English: In addition, cases of acquired vitelliform-type maculopathy have been identified, both in clinical studies and as spontaneous reports.
Slovenian: Dodatno so bili v kliničnih študijah in spontano poročani primeri pridobljene viteliformne makulopatije.
English: When applicable, a cover letter highlighting the main changes should also be included as part of the educational materials.
Slovenian: • Navodilo za predpisovanje za zdravnike.Kadar je smiselno, mora biti del izobraževalnega gradiva tudi dopis, v katerem so poudarjene glavne spremembe.
English: INSTRUCTIONS ON USE
Slovenian: NAVODILO ZA UPORABO
English: Uncommon side effects These may affect up to 1 in 100 people:
Slovenian: Občasni neželeni učinki Pojavijo se lahko pri največ 1 od 100 oseb:
English: Problems passing urine
Slovenian: Težave z odvajanjem urina
English: Trobalt is indicated as adjunctive treatment of drug-resistant partial onset seizures with or without secondary generalization in patients aged 18 years or older with epilepsy, where other appropriate combinations with other medicinal products have proved inadequate or have not been tolerated.
Slovenian: 4.1 Terapevtske indikacije Zdravilo Trobalt je indicirano za dodatno zdravljenje proti zdravilom odpornih konvulzij s parcialnim začetkom (s sekundarno generalizacijo ali brez nje) pri bolnikih z epilepsijo, starih 18 let ali več, v primerih, ko se druge primerne kombinacije z drugimi zdravili izkažejo za nezadostne ali jih bolnik ne prenaša.
English: Mental health problems These are common in people taking Trobalt, and are most likely to happen during the first few months of treatment.
Slovenian: Te so pri osebah, ki jemljejo zdravilo Trobalt, pogoste in verjetnost njihovega pojava je največja v prvih mesecih zdravljenja z zdravilom Trobalt.
English: There was an apparent dose-relationship for dizziness, somnolence, confusional state, aphasia, coordination abnormal, tremor, balance disorder, memory impairment, gait disturbance, blurred vision and constipation.
Slovenian: somnolentnost, stanje zmedenosti, afazijo, nenormalno koordinacijo, tremor, motnje ravnotežja, okvaro spomina, motnje hoje, zamegljen vid in zaprtost.
English: Further, based on pooled data, there were no clinically significant effects of the following antiepileptic medicinal products on retigabine pharmacokinetics: - lamotrigine, levetiracetam, oxcarbazepine, topiramate, valproate.
Slovenian: Razen tega na podlagi kumulativnih podatkov naslednji antiepileptiki niso klinično pomembno vplivali na farmakokinetiko retigabina: - lamotrigin, levetiracetam, okskarbazepin, topiramat, valproat.
English: Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Trobalt remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Slovenian: OSNOVE ZA ŠE ENO DODATNO PODALJŠANJE Na osnovi podatkov, ki so na voljo od prve odobritve dovoljenja za promet, CHMP meni, da je razmerje med koristjo in tveganjem za zdravilo Troblat, še vedno pozitivno, vendar je potrebno skrbno spremljati njegov varnostni profil zaradi sledečih razlogov: Pri uporabi zdravila Troblat so opazili težave z očmi, vključno s pigmentnimi spremembami mrežnice.
English: A mean increase in Individual Corrected QT Interval (QTcI) of up to 6.7 ms (upper bound of 95% one-sided CI 12.6 ms) was observed within 3 hours of dosing.
Slovenian: V treh urah po uporabi so opazili povprečno podaljšanje individualnega korigiranega intervala QT (QTcI) do 6,7 ms (zgornja meja enostranskega 95% IZ: 12,6 ms).
English: In a single-dose study in healthy volunteers and subjects with end stage renal disease, the retigabine AUC was increased by approximately 100% in the subjects with end stage renal disease relative to healthy volunteers.
Slovenian: V študiji enkratnega odmerka pri zdravih prostovoljcih in preiskovancih s končno odpovedjo ledvic je bila AUC retigabina približno 100 % večja pri preiskovancih s končno odpovedjo ledvic kot pri zdravih prostovoljcih.
English: 84 film-coated tablets
Slovenian: 84 filmsko obloženih tablet
English: A post-hoc analysis across multiple healthy volunteer studies demonstrated a 20% reduction in retigabine clearance in healthy black volunteers relative to healthy Caucasian volunteers.
Slovenian: Post hoc analiza več študij zdravih prostovoljcev je pokazala pri zdravih prostovoljcih črnske rase 20 % manjši očistek retigabina kot pri zdravih prostovoljcih bele rase.
English: Adverse event data from clinical trial subjects showed a rate of event of discolouration of the nails, lips, skin and/or mucosa per patient year of exposure of 3.6%.
Slovenian: Podatki o neželenih učinkih, zbrani pri preiskovancih kliničnih preskušanj, so pokazali 3,6-odstoten delež sprememb barve nohtov, ustnic, kože in/ali sluznic na bolnikov-let izpostavljenosti.