FrancophonIA/ELRC3.0 huggingface dataset:
English: Retigabine was effective in adjunctive treatment of adults with partial onset seizures in three clinical studies (Table 1).
Croatian: Retigabin se pokazao učinkovitim kao dodatna terapija odraslih bolesnika s parcijalnim napadajima u tri klinička ispitivanja (Tablica 1).
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.
Croatian: U ispitivanjima na psima zabilježena je distenzija žučnog mjehura, ali bez dokaza kolestaze ili drugih znakova disfunkcije, a volumen izlučivane žuči ostao je nepromijenjen.
English: The eye examination should be repeated at least every six months whilst taking Trobalt.
Croatian: Pregled očiju tijekom uzimanja lijeka Trobalt bi trebalo ponoviti barem svakih 6 mjeseci.
English: In a study of peri- and post-natal development in rats, retigabine was associated with increased perinatal mortality following administration during pregnancy.
Croatian: U ispitivanjima peri- i postnatalnog razvoja na štakorima, retigabin se povezuje s povišenom perinatalnom smrtnošću nakon primjene tijekom skotnosti.
English: Don't chew, crush or split the tablet.
Croatian: Nemojte ju žvakati, drobiti ili usitnjavati.
English: Retigabine and its metabolites are eliminated principally by renal excretion.
Croatian: Retigabin i njegovi metaboliti prvenstveno se eliminiraju putem bubrega.
English: In the event of overdose, it is recommended that the patient is given appropriate supportive therapy as clinically indicated, including electrocardiogram (ECG) monitoring.
Croatian: U slučaju predoziranja preporučuje se primijeniti odgovarajuću suportivnu terapiju prema kliničkoj indikaciji, koja obuhvaća i monitoriranje elektrokardiograma (EKG-a).
English: Clinical efficacy of adjunctive retigabine therapy in partial onset seizures
Croatian: Klinička djelotvornost dodatne terapije retigabinom kod parcijalnih napadaja
English: These may affect up to 1 in 10 people:
Croatian: Mogu se javiti u do 1 na 10 osoba:
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%.
Croatian: Podaci o štetnim događajima prikupljeni u ispitanika iz kliničkih ispitivanja pokazali su da stopa događaja diskoloracije noktiju, usana, kože i/ili sluznice po bolesnik-godini izloženosti iznosi 3,6%.
English: Treatment will be stopped if any problems are found unless no other suitable treatments are available.
Croatian: Ako se jave bilo kakva odstupanja liječenje će biti prekinuto, osim ako drugačije liječenje nije dostupno.
English: This sometimes occur together with discolouration of parts of the eye.
Croatian: Ovo se ponekad pojavljuje zajedno sa promjenom boje ostalih dijelova oka.
English: Retigabine is also metabolised to an N-acetyl metabolite (NAMR) that is also subsequently glucuronidated.
Croatian: Retigabin se metabolizira i u N-acetil metabolit (NAMR) koji se također kasnije glukuronidira.
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.
Croatian: Retigabin je pokazao i inhibitorna svojstva u više „kindling modela“, primjerice u stanju potpuno razvijenih ponavljanih spontanih napadaja i u nekim slučajevima tijekom razvoja ponavljanih napadaja.
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:
Croatian: Nositelj odobrenja treba osigurati da se, prilikom stavljanja lijeka na tržište i nakon stavljanja lijeka na tržište,neurolozima, oftalmolozima i drugim zdravstvenim radnicima (sukladno nacionalnim zahtjevima) dostavi informativni materijal za liječnike koji sadržava sljedeće:
English: NAME OF THE MARKETING AUTHORISATION HOLDER Glaxo Group Limited
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Glaxo Group Limited
English: Elimination of retigabine occurs via a combination of hepatic metabolism and renal excretion.
Croatian: Eliminacija retigabina vrši se kombinacijom jetrenog metabolizma i bubrežnog izlučivanja.
English: Retigabine has a plasma half-life of approximately 6 to 10 hours.
Croatian: Poluživot retigabina u plazmi je oko 6 do 10 sati.
English: Don't stop unless your doctor advises you to.
Croatian: Nemojte prestati s uzimanjem osim ako Vam to ne savjetuje liječnik.
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.
Croatian: Odluku o nastavku/prekidu dojenja ili nastavku/prekidu terapije lijekom Trobalt treba donijeti uzimajući u obzir prednosti dojenja za dijete kao i prednosti terapije lijekom Trobalt za majku.
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.
Croatian: Uz to, retigabin je bio djelotvoran u sprječavanju napadaja tijekom epileptičkih statusa u glodavaca s kobaltom induciranim epileptogenim lezijama i u inhibiranju toničkih ekstenzornih napadaja u genetski podložnih miševa.
English: During an 8-week baseline period, patients had to experience ≥4 partial onset seizures per 28 days.
Croatian: Tijekom početnog razdoblja u trajanju od 8 tjedana, bolesnici su morali imati 4 ili više parcijalnih napadaja tijekom 28 dana.
English: There is no information about the safety of Trobalt in pregnant women.
Croatian: Ne postoje podaci o sigurnosti primjene lijeka Trobalt u trudnica.
English: However, the plasma levels achieved in these studies were less than those reached in humans at recommended doses (see section 5.3).
Croatian: Međutim, razine koncentracije u plazmi u tim ispitivanjima bile su niže od onih koje nalazimo u ljudi pri preporučenim dozama (vidjeti dio 5.3).
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).
Croatian: Nuspojave povezane s tegobama pražnjenja, uključujući retenciju urina, zabilježene su u 5% bolesnika koji su primali retigabin u skupnim podacima o sigurnosti (vidjeti dio 4.4).
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).
Croatian: U raznim modelima za ispitivanje napadaja, retigabin je povisio prag za induciranje napadaja maksimalnim elektrošokom, pentilentetrazolom, pikrotoksinom i N-metil-D-aspartatom (NMDA).
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).
Croatian: Opisani nalazi zamijećeni su pri dozama izloženosti koje su bile niže od onih koje su klinički preporučene, a pratili su ih i toksični učinci na majku (uključujući ataksiju, hipokineziju, tremor i smanjenje dobivanja na težini).
English: Mental health problems These are common in people taking Trobalt, and are most likely to happen during the first few months of treatment.
Croatian: Česti su kod ljudi koji uzimaju Trobalt i najveća vjerojatnost da se dogode je tijekom prvih par mjeseci liječenja.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANA UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
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:
Croatian: Ako uzmete previše tableta lijeka Trobalt, možda ćete imati veću vjerojatnost za pojavu nuspojava ili nekog od sljedećih simptoma:
English: There is limited experience of overdose with retigabine.
Croatian: Postoje ograničena iskustva kod predoziranja retigabinom.
English: For patients with end-stage renal disease receiving haemodialysis, the three daily doses should be taken as usual on the dialysis day.
Croatian: Bolesnici u završnom stadiju bolesti bubrega na hemodijalizi moraju na dan dijalize uzeti sve tri dnevne doze prema uobičajenom rasporedu.
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.
Croatian: U otvorenom ispitivanju farmakokinetike višestrukih doza, sigurnosti i podnošljivosti, u pet ispitanika u dobi od 12 godina do manje od 18 godina s parcijalnim napadajima, utvrđeno je da je farmakokinetika retigabina u adolescenata bila u skladu s farmakokinetikom retigabina u odraslih.
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.
Croatian: Individual Corrected QT Interval - QTcI) do 6,7 ms (gornja granica od 95% CI u jednom smjeru 12,6 ms).
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.
Croatian: U ispitivanju na dobrovoljcima, kod dva ispitanika javila se srčana aritmija (srčani arest/asistola ili ventrikularna tahikardija) i to unutar 3 sata nakon primanja jednostruke doze retigabina od 900 mg.
English: System Organ Class
Croatian: Klasifikacija organskog sustava
English: Weight increased Increased appetite
Croatian: • povećanje tjelesne težine; povećanje apetita
English: Trobalt can make you feel dizzy or drowsy and cause double or blurred vision.
Croatian: Od lijeka Trobalt možete imati omaglice ili biti pospani i možete vidjeti dvostruko ili imati zamućen vid.
English: 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.
Croatian: Pri započinjanju terapije, kao i nakon svakog titracijskog koraka, preporučuje se obavijestiti bolesnike o tim rizicima te ih savjetovati da ne upravljaju vozilima i strojevima dok ne utvrde kako Trobalt djeluje na njih.
English: Retigabine has been shown to interfere with clinical laboratory assays of both serum and urine bilirubin, which can result in falsely elevated readings.
Croatian: Pokazano je da retigabin može interferirati s kliničkim laboratorijskim nalazom bilirubina u serumu i urinu što može rezultirati lažno povišenim nalazima.
English: Maximum doses in repeat dose toxicity studies were limited by the exaggerated pharmacologic effects of retigabine (including ataxia, hypokinesia and tremor).
Croatian: Najviše doze u ispitivanjima toksičnosti ponavljajućih doza bile su ograničene prekomjernim farmakološkim učincima retigabina (uključujući ataksiju, hipokineziju i tremor).
English: • lack of co-ordination; spinning sensation (vertigo); balance problems; problems walking
Croatian: • nedostatak koordinacije; osjećaj vrtnje (vrtoglavica); problemi s ravnotežom; teškoće pri hodu
English: The majority of events occurred in the first 8 weeks of treatment, and there was no apparent dose-relationship.
Croatian: Većina ih je zabilježena tijekom prvih 8 tjedana terapije i nije primijećena očigledna povezanost s dozom.
English: After both single and multiple oral doses, retigabine is rapidly absorbed with median tmax values generally between 0.5 and 2 hours.
Croatian: Nakon jedne i nakon više peroralnih doza retigabin se brzo apsorbira s medijanom vrijednosti tmax općenito između 0,5 i 2 sata.
English: In addition, cases of acquired vitelliform-type maculopathy have been identified, both in clinical studies and as spontaneous reports.
Croatian: Dodatno su identificirani slučajevi stečene makulopatije viteliformnog tipa iz kliničkih ispitivanja i iz spontanih prijava.
English: Retigabine is extensively metabolised in humans.
Croatian: Retigabin se u ljudi ekstenzivno metabolizira.
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.
Croatian: Nadalje, temeljem skupnih podataka, nije bilo klinički značajnih djelovanja sljedećih antiepileptika na farmakokinetiku retigabina: - lamotrigin, levetiracetam, okskarbazepin, topiramat, valproat.
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.
Croatian: U ispitivanju jednokratne doze rezultati su pokazali da je u mladih odraslih dobrovoljaca vrijednost Cmax retigabina bila oko 65% viša kod žena nego kod muškaraca, a u starijih dobrovoljaca (starosti od 66 do 82 godine) vrijednost Cmax retigabina bila je oko 75% viša kod žena nego kod muškaraca.
English: Non-clinical data reveal no special hazard for humans based on studies of genotoxicity or carcinogenic potential.
Croatian: Neklinički podaci temeljeni na ispitivanjima genotoksičnosti ili kancerogenog potencijala nisu pokazali posebne opasnosti za ljude.
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.
Croatian: U drugom ispitivanju jednokratne doze u ispitanika u završnom stadiju bolesti bubrega na kroničnoj hemodijalizi (n=8), početak dijalize oko 4 sata nakon primjene jedne doze retigabina (100 mg), rezultirao je medijanom smanjenja plazmatske koncentracije retigabina od 52%, od početka pa do kraja dijalize.
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.
Croatian: Kod štakora, retigabin je produljio vrijeme spavanja koje je bilo inducirano natrijevim tiopentalom s oko 4 minute na 53 minute, a vrijeme spavanja koje je bilo inducirano s propofolom s oko 8 minuta na
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
Croatian: Trobalt 50 mg filmom obložene tablete Trobalt 100 mg filmom obložene tablete Trobalt 200 mg filmom obložene tablete Trobalt 300 mg filmom obložene tablete Trobalt 400 mg filmom obložene tablete retigabin
English: At no observed effect levels, animal exposure in these studies was generally less than that reached in humans at recommended clinical doses.
Croatian: Izloženost životinja u ispitivanjima pri razinama bez zamijećenih učinaka je općenito bila niža od one koja se postiže kod ljudi pri preporučenim kliničkim dozama.
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.
Croatian: Podaci prikupljeni od starijih bolesnika upućuju da će oni vjerojatnije iskusiti neke poremećaje središnjeg živčanog sustava, uključujući pospanost, amneziju, poremećenu koordinaciju, vrtoglavicu, tremor, poremećaj ravnoteže, oslabljeno pamćenje i poremećaj hodanja.
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.
Croatian: Farmakokinetika retigabina je u principu linearna za jednostruke doze od 25 do 600 mg u zdravih dobrovoljaca te do 1200 mg na dan u bolesnika s epilepsijom bez neočekivanog nakupljanja nakon opetovane primjene.
English: Eye disorders have been observed with the use of Trobalt, including pigment changes in the retina.
Croatian: Poremećaji oka bili su zamijećeni uz primjenu lijeka Trobalt, uključujući pigmentne promjene u mrežnici.
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.
Croatian: Podaci dobiveni iz in vitro ispitivanja pokazali su da N-acetil metabolit retigabina (NAMR) inhibira prijenos digoksina posredovan P-glikoproteinom ovisno o koncentraciji.
English: Co-administration of ethanol (1.0 g/kg) with retigabine (200 mg) resulted in an increase in visual blurring in healthy volunteers.
Croatian: Istovremena primjena etanola (1,0 g/kg) i retigabina (200 mg) u zdravih dobrovoljaca rezultirala je povišenom stopom zamućenja vida.
English: Discolouration of skin, nails, lips and eyes, and eye disorders caused by changes in the centre of the retina (maculopathy)
Croatian: Promjena boje kože, noktiju, usana ili očiju i poremećaji u očima uzrokovani promjenama u centru mrežnice (makulopatija).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX - MULTIPACK ONLY)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA KUTIJI (S PLAVIM OKVIROM-SAMO VIŠESTRUKO PAKIRANJE)
English: Vision abnormalities (field constriction, loss of central sensitivity, and reduced visual acuity) have been reported.
Croatian: Prijavljeni su poremećaji vida (suženje vidnog polja, gubitak centralne osjetljivosti i smanjena oštrina vida).
English: Thereafter, the total daily dose is increased by a maximum of 150 mg every week, according to the individual patient response and tolerability.
Croatian: Nakon toga, ukupna dnevna doza povisuje se svakog tjedna za maksimalno 150 mg, prema individualnom terapijskom odgovoru i podnošljivosti pojedinog bolesnika.
English: A study of cardiac conduction in healthy subjects has demonstrated that retigabine titrated to 1,200 mg/day produced a QT-prolonging effect.
Croatian: Ispitivanje srčane provodljivosti u zdravih ispitanika pokazalo je da retigabin titriran na dozu od 1200 mg/dan produljuje QT interval.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX - MULTIPACK ONLY)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA (BEZ PLAVOG OKVIRA-SAMO VIŠESTRUKO PAKIRANJE)
English: Patients were randomized to placebo or retigabine at 600, 900 or 1,200 mg/day (see Table 1).
Croatian: Bolesnici su bili randomizirani za primanje placeba ili retigabina u dozama od 600, 900 ili 1200 mg/dan (vidjeti
English: Paediatric population The pharmacokinetics of retigabine in children below 12 years of age have not been investigated.
Croatian: Nije se ispitivala farmakokinetika retigabina u djece mlađe od 12 godina.
English: ≥1/1,000 to <1/100
Croatian: ≥1/1000 do <1/100
English: In addition, there was no clinically significant effect of the low dose combination oral contraceptive pill on the pharmacokinetics of retigabine.
Croatian: Nadalje, nije bilo klinički značajnog učinka niskodoznih kombiniranih oralnih kontraceptiva na farmakokinetiku retigabina.
English: The maternal toxicities interfered with higher dosing of the dams and hence deduction of safety margins with regard to human therapy.
Croatian: Toksična djelovanja na majku su omela ispitivanja viših doza u skotnih životinja te stoga i zaključivanje o sigurnosnim granicama za terapiju u ljudi.
English: There are no adequate data from the use of retigabine in pregnant women.
Croatian: Nema dostatnih podataka o primjeni retigabina u trudnica.
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.
Croatian: Posljedično tomu, djelotvornost i sigurnost retigabina kod istovremenog uzimanja s antiepilepticima koji se rjeđe koriste kao osnovna terapija, uključujući levetiracetam, u kliničkim ispitivanjima nije sa sigurnošću dokazana.
English: Trobalt may increase the duration of anaesthesia induced by some anaesthetics (for example thiopental sodium; see section 5.1).
Croatian: Trobalt može produljiti trajanje anestezije inducirane nekim anesteticima (na primjer natrijev tiopental; vidjeti dio 5.1).
English: This analysis also showed no clinically significant effect of the inducers (phenytoin, carbamazepine and phenobarbital) on retigabine clearance.
Croatian: Ta analiza pokazala je i da nema klinički značajnog učinka induktora (fenitoin, karbamazepin i fenobarbital) na klirens retigabina.
English: You may need extra check-ups (including an electrocardiogram [ECG], which is a test which records the electrical activity of your heart) while
Croatian: Tijekom uzimanja lijeka Trobalt možda će Vam trebati dodatni pregledi (uključujući elektrokardiogram [EKG], pretragu za snimanje električne aktivnosti Vašeg srca).
English: In addition a distinct form of macular abnormality with features of vitelliform maculopathy (see section 4.8) has also been identified, in most cases diagnosed with optical coherence tomography (OCT) imaging.
Croatian: Dodatno je također identificiran različit oblik makularne abnormalnosti sa značajkama viteliformne makulopatije (vidjeti dio 4.8), najčešće dijagnosticiran optički koherentnom tomografijom (od engl.
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.
Croatian: U bolesnika kod kojih postoji rizik za razvoj retencije urina, Trobalt se mora uzimati uz mjere opreza te se preporučuje upozoriti bolesnike na mogući rizik od ovih učinaka.
English: − The need to inform patients on adverse events related to QT interval prolongation
Croatian: - potreba informiranja bolesnika o nuspojavama povezanim s produljenjem QT
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.
Croatian: Pri dozama retigabina do 750 mg dnevno nije bilo klinički značajnog učinka retigabina na farmakokinetiku estrogenske (etinilestradiol) ili progesteronske (noretindron) komponente tablete oralnih kontraceptiva.
English: Trobalt may affect some anaesthetics (for example thiopental sodium).
Croatian: Trobalt može utjecati na neke anestetike (primjerice natrijev tiopental).
English: Other antiepileptic medicinal products
Croatian: Drugi antiepileptici
English: In addition, there was a delay in auditory startle response development.
Croatian: Uz to, usporen je razvoj uplašenog odgovora na auditivni podražaj.
English: These are common in people taking Trobalt, and can lead to not being able to pass urine at all.
Croatian: Česte su kod ljudi koji uzimaju Trobalt i mogu dovesti do nemogućnosti mokrenja.
English: The 200 mg tablets also contain iron oxide yellow (E172).
Croatian: Tablete od 200 mg također sadrže žuti željezov oksid (E172).
English: Animal studies are insufficient with respect to reproductive toxicity because the plasma levels achieved in these studies were less than those reached in humans at recommended doses (see section 5.3).
Croatian: Ispitivanja reproduktivne toksičnosti kod životinja su nedostatna budući da su razine koncentracija u plazmi u tim ispitivanjima bile manje od preporučenih doza kod ljudi (vidjeti dio 5.3).