natgillin/translations-raw huggingface dataset:
Do not stop treatment without discussing it with your doctor.
Nemojte prekidati liječenje bez prethodnog razgovora sa svojim liječnikom.
• psychotic disorders (severe mental health problems)
• zbunjenost • psihotične poremećaje (teške mentalne zdravstvene tegobe)
Trobalt with alcohol
Trobalt s alkoholom
• changes in liver function, which will show up in blood tests.
• promjene funkcije jetre vidljive u krvnim pretragama.
This is most likely to happen during the first few months of treatment with Trobalt.
Veća vjerojatnost da se to dogodi je tijekom prvih par mjeseci liječenja lijekom Trobalt.
• memory problems
• probleme s pamćenjem
However, this effect is not considered clinically significant, therefore no adjustment of the Trobalt dose is recommended.
Međutim, taj se učinak ne smatra klinički značajnim te se stoga ne preporučuje prilagodba doze lijeka Trobalt.
If you forget to take Trobalt
Ako ste zaboravili uzeti Trobalt
The safety and efficacy of retigabine in children below 18 years of age has not yet been established (see section 5.2).
Sigurnost i djelotvornost retigabina u djece mlađe od 18 godina nisu još ustanovljene (vidjeti dio 5.2).
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).
U otvorenim ispitivanjima koja su se provela u nastavku tri placebom kontrolirana ispitivanja zadržana je perzistentnost djelotvornosti tijekom evaluacijskog razdoblja od barem 12 mjeseci (365 bolesnika).
It is recommended that patients are advised about the possible effects on vision if they take Trobalt with alcohol.
Preporučuje se savjetovati bolesnike o mogućim utjecajima na vid ako uzimaju Trobalt s alkoholom.
A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Metaanalize randomiziranih ispitivanja antiepileptika kontroliranih placebom također su pokazale malo povišeni rizik od suicidalnih misli i ponašanja.
Study 302 (n=538; n=471)
Ispitivanje 302 (n=538; n=471)
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.
Kada se vrijednost Cmax normalizirala prema tjelesnoj težini, vrijednosti su bile oko 30% više kod mlađih žena nego kod mlađih muškaraca te 40% više kod starijih žena nego kod starijih muškaraca.
Retigabine is approximately 80% bound to plasma protein over the concentration range of 0.1 to 2 µg/ml.
Retigabin je približno 80% vezan na proteine plazme u koncentracijskom rasponu od 0,1 do 2 µg/ml.
Heart conditions Trobalt can affect heart rhythm.
Trobalt može utjecati na srčani ritam.
Therefore, based upon the safety profile of Trobalt the CHMP concluded that the MAH should submit one additional renewal application in 5 years.
Stoga, na temelju sigurnosnog profila lijeka Trobalt, CHMP je zaključio da nositelj odobrenja treba podnijeti još jedan zahtjev za obnovu odobrenja za stavljanje lijeka u promet, za 5 godina.
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 Španjolska
Retigabine mg/day mg/day mg/day
Retigabin mg/dan mg/dan mg/dan
Each tablet contains 50 mg, 100 mg, 200 mg, 300 mg or 400 mg retigabine.
Jedna tableta sadrži 50 mg, 100 mg, 200 mg, 300 mg ili 400 mg retigabina.
The percentage decrease in plasma concentration during dialysis ranged from 34% to 60% except for one subject who had a 17% reduction.
Postotak smanjenja koncentracije lijeka u plazmi tijekom dijalize je bio u rasponu od 34% do 60% osim u jednog ispitanika u kojeg je zabilježena redukcija od 17%.
Glaxo Wellcome, S.A, Avda.
Naziv i adresa Glaxo Wellcome, S.A, Avda.
There are only limited data on the safety and efficacy of retigabine in patients aged 65 years and above.
Postoje samo ograničeni podaci o sigurnosti i djelotvornosti retigabina u bolesnika u dobi od 65 godina i starijih.
Patients could not be seizure-free for ≥21 days.
Bolesnici nisu mogli biti bez napadaja tijekom razdoblja od 21 i više dana.
Do not use this medicine after the expiry date which is stated on the pack.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju.
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.
Istovremeno liječenje s više antiepileptika povezuje se s većim rizikom kongenitalnih malformacija nego monoterapija te bi se stoga, kad god je to moguće, trebala koristiti monoterapija.
FI.PT@gsk.com
gskcyprus@gsk.com
Elderly patients may be at increased risk of central nervous system events, urinary retention and atrial fibrillation.
Stariji bolesnici mogu imati povišeni rizik za poremećaje u središnjem živčanom sustavu, retenciju urina i fibrilaciju atrija.
Urinary retention
Retencija urina
A small number of people being treated with antiepileptics such as Trobalt have had thoughts of harming or killing themselves.
Mali broj ljudi na terapiji antiepilepticima poput lijeka Trobalt pomišljali su na samoozljeđivanje ili samoubojstvo.
Don't take any more Trobalt than your doctor has recommended.
Nemojte uzimati više lijeka Trobalt nego što Vam je preporučio liječnik.
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 potencijal membrane u mirovanju i regulira električnu podražljivost neurona ispod praga podražaja sprječavajući stoga početak epileptiformnih izbijanja akcijskih potencijala.
A substantial fraction of the retigabine dose is converted to inactive N-glucuronides.
Značajan dio doze retigabina pretvara se u neaktivne Nglukuronide.
Absolute oral bioavailability of retigabine relative to an intravenous dose is approximately 60%.
Apsolutna peroralna bioraspoloživost retigabina prema intravenskoj dozi je oko 60%.
NAMR has antiepileptic activity, but is less potent than retigabine in animal seizure models.
NAMR ima antiepileptičko djelovanje, ali je u životinjskim modelima napadaja manje potentan od retigabina.
The total clearance of retigabine from plasma following intravenous dosing is typically 0.4 to 0.6 l/h/kg.
Ukupan klirens retigabina iz plazme nakon intravenoznog doziranja je tipično 0,4 do 0,6 l/h/kg.
If breakthrough seizures occur towards the end of dialysis then an additional supplemental dose may be considered at the start of subsequent dialysis sessions.
Ako pri kraju dijalize dođe do napadaja, može se razmotriti primjena još jedne dopunske doze na početku sljedećih dijaliza.
The studies were not designed to evaluate specific combinations of antiepileptic medicinal products.
Ispitivanja nisu bila osmišljena za procjenu određenih kombinacija antiepileptika.
You can take Trobalt with or without food.
Trobalt možete uzimati s hranom ili bez nje.
The rate of progression of vitelliform maculopathy and its impact on retinal and macular function and vision is unclear.
Stupanj progresije viteliformne makulopatije i njen utjecaj na funkciju mrežnice, makule i na vid nije jasan.
If you are not sure what to do, ask your doctor or pharmacist.
Ako niste sigurni što trebate učiniti, upitajte svog liječnika ili ljekarnika.
Retigabine had no effect on fertility or general reproductive performance.
Retigabin nije imao učinka na plodnost ili opću reproduktivnu funkciju.
Tell your doctor if any of these applies to you.
Obavijestite svog liječnika ako se nešto od navedenog odnosi na Vas.
Trobalt is not recommended during pregnancy and in women of childbearing age, not using contraception.
Trobalt se ne preporučuje tijekom trudnoće, kao ni ženama u reproduktivnoj dobi koje ne koriste kontracepcijska sredstva.
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.
Nakon uzimanja te propuštene doze treba proći barem tri sata prije uzimanja sljedeće doze, nakon čega treba nastaviti s uobičajenim rasporedom doziranja.
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.
Treba izbjegavati nagle prekide antiepileptičke terapije kod žena s epilepsijom jer bi to moglo uzrokovati napadaje s ozbiljnim posljedicama za ženu i nerođeno dijete.
The tablets should be swallowed whole, and not chewed, crushed or divided.
Tablete se trebaju progutati cijele, a ne smiju se žvakati, mrviti ili lomiti u dijelove.
Your doctor will discuss with you whether treatment with Trobalt should be continued.
Liječnik će s Vama raspraviti treba li liječenje s lijekom Trobalt nastaviti.
A total of approximately 84% of the dose is recovered in the urine, including the N-acetyl metabolite (18%), N-glucuronides of the parent active substance and of the N-acetyl metabolite (24%), or parent active substance (36%).
Ukupno oko 84% doze pronalazimo u urinu, uključujući N-acetil metabolit (18%), N-glukuronide izvorne djelatne tvari i N-acetil metabolita (24%), ili izvornu djelatnu tvar (36%).
The gall bladder distension in the dog resulted in focal compression of the liver.
Distenzija žučnog mjehura u pasa rezultirala je fokalnom kompresijom na jetru.
Potassium channels are one of the voltage-gated ion channels found in neuronal cells and are important determinants of neuronal activity.
Kalijevi kanali su jedni od naponom reguliranih ionskih kanala koje nalazimo u živčanim stanicama i predstavljaju važnu determinantu živčane aktivnosti.
− The need to inform patients that TROBALT may cause or potentiate symptoms of urinary retention/urinary hesitation
- potreba informiranja bolesnika da TROBALT može uzrokovati ili potencirati simptome retencije urina/odgađanja mokrenja
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.
Potencijal interakcije lijekova procjenjivan je stoga temeljem skupne analize više kliničkih ispitivanja, i iako se ne smatraju jednako robusni kao ciljano kliničko ispitivanje interakcija, rezultati potvrđuju in vitro podatke.
Elderly If you are 65 years or older, you may be more likely than a younger adult to get the following symptoms:
Ako imate 65 ili više godina, moguće je da imate veću vjerojatnost za pojavu sljedećih simptoma u usporedbi s mlađim odraslim osobama:
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Unutar svake skupine učestalosti, nuspojave su navedene prema ozbiljnosti.
The safety and efficacy are not yet known in this age group.
Sigurnost i djelotvornost za ovu dobnu skupinu nisu još poznate.
In some cases changes to the pigmentation in the eyes may improve after you stop taking Trobalt.
U nekim slučajevima promjene pigmentacije u očima mogu se popraviti nakon što prekinete uzimanje lijeka Trobalt.
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.
Svi bolesnici koji su uključeni u ispitivanja morali su imati napadaje koji nisu bili pod adekvatnom kontrolom s istovremenom primjenom jednog do tri antiepileptika, a više od 75% svih bolesnika uzimalo je istovremeno dva ili više antiepileptička lijeka.
The increase did not appear to be dependent on retigabine dose and is not considered clinically relevant.
Porast nije bio ovisan o dozi retigabina i ne smatra se klinički značajnim.
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.
Mehanizam djelovanja retigabina na kalijeve kanale je dobro opisan, međutim druge mehanizme putem kojih retigabin može imati antiepileptogene učinke tek treba u potpunosti razjasniti.
Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Stoga treba pratiti znakove suicidalnih misli i ponašanja u bolesnika i razmotriti odgovarajuću terapiju.
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 bio statistički značajno superiorniji od placeba za doze od 600 mg/dan (jedno ispitivanje), 900 mg/dan (dva ispitivanja) i 1200 mg/dan (dva ispitivanja).
Therefore Trobalt may be taken with or without food.
Trobalt se stoga može uzimati s hranom ili bez nje.
Trobalt must be withdrawn gradually to minimise the potential for rebound seizures.
Trobalt se mora ukidati postupno kako bi se mogućnost ponovljenih napadaja svela na najmanju moguću mjeru.
However, efficacy and safety of retigabine have not been determined in adolescents.
Međutim, djelotvornost i sigurnost retigabina nije bila utvrđena u adolescenata.
Interaction with anaesthetics
Interakcija s anesteticima
Confusional state Psychotic disorders Hallucinations Disorientation Anxiety
Psihijatrijski poremećaji konfuzno stanje psihotični poremećaji halucinacije dezorijentiranost anksioznost
Approximately 30-40% of clinical trial subjects who were being treated with retigabine and underwent a skin and/or ophthalmological examination had findings of discolouration of nails, lips, skin and/or mucosa or non-retinal ocular pigmentation, and approximately 15-30% of clinical trial subjects who were being treated with retigabine and underwent an ophthalmological examination had retinal pigmentation findings.
U približno 30-40% ispitanika iz kliničkih ispitivanja liječenih retigabinom koji su bili podvrgnuti kožnom i/ili oftalmološkom pregledu pronađena je diskoloracija noktiju, usana, kože i/ili sluznice ili pigmentacija oka koja nije zahvaćala mrežnicu, dok su u približno 15-30% ispitanika iz kliničkih ispitivanja liječenih retigabinom i podvrgnutih oftalmološkom pregledu pronađeni znakovi pigmentacije mrežnice.
These effects generally occurred within the first 8 weeks of treatment, and frequently led to treatment withdrawal in affected patients.
Takvi učinci općenito su zamijećeni tijekom prvih 8 tjedana liječenja i često su doveli do ukidanja liječenja kod bolesnika koji su imali navedene smetnje.
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.
Nositelj odobrenja treba, prije dolaska lijeka na tržište u svakoj zemlji članici te također nakon promjena ključnih elemenata u edukacijskim materijalima, dogovoriti konačne verzije edukacijskih materijala s nacionalnim regulatornim tijelom.
• A physician's guide to prescribing.
• Vodič liječnicima za propisivanje.
What Trobalt is and what it is used for
Što se nalazi u ovoj uputi: Što je Trobalt i za što se koristi
The safety and efficacy of doses higher than 1,200 mg/day have not been established.
Sigurnost i djelotvornost doza viših od 1200 mg/dan nije utvrđena.
The most frequently reported defects are cleft lip, cardiovascular malformations and neural tube defects.
Najučestalije zabilježene malformacije su rascjep usana, kardiovaskularne malformacije i poremećaji neuralne cijevi.
• not being able to pass urine (urinary retention).
• nemogućnost mokrenja (retencija urina)
Marketing Authorisation Holder Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom.
Nositelj odobrenja za stavljanje lijeka u promet Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex TW8 9GS, Ujedinjeno Kraljevstvo.
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).
U razvojnom ispitivanju na štakorima u kojem su majke tijekom trudnoće tretirane retigabinom, u mladunaca je zabilježen zakašnjeli razvoj refleksnog odgovora na auditivni podražaj (vidjeti dio 5.3).
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).
U toj populaciji Trobalt se mora oprezno koristiti te se preporučuje smanjenje početne doze kao i doze održavanja (vidjeti dijelove 4.2 i 5.2).
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.
Koristi se zajedno s drugim lijekovima za liječenje epilepsije u odraslih osoba koje i dalje imaju napadaje i kod kojih kombinacije drugih lijekova za liječenje epilepsije nisu djelovale u potpunosti.
In pooled safety data from three multicentre, randomised, double-blind, placebo-controlled studies, adverse reactions were generally mild to moderate in intensity, and were most commonly reported in the first 8 weeks of treatment.
U skupnim podacima o sigurnosti iz tri multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana istraživanja, nuspojave su općenito bile blagog do umjerenog intenziteta, a najčešće su zabilježene tijekom prvih 8 tjedana terapije.
≥1/10,000 to <1/1,000
≥1/10 000 do <1/1000
Only 14% of retigabine is excreted in the faeces.
Samo 14% retigabina izlučuje se fecesom.
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.
Na temelju ispitivanja na zdravim dobrovoljcima, primjena terapijskih doza retigabina (600 - 1200 mg/dan) rezultirala je manjim porastom (8-18%) AUC digoksina nakon jednokratne peroralne doze digoksina.
Your doctor will monitor you more closely if treatment with Trobalt is continued.
Liječnik će Vas pomnije nadzirati ako se liječenje lijekom Trobalt nastavi.
If patients miss one dose or more, it is recommended that they take a single dose as soon as they remember.
Ako bolesnici propuste uzeti jednu ili više doza, preporučuje se da zadnju propuštenu dozu uzmu čim se sjete da su je propustili.
Tell your doctor if you experience any changes in vision whilst you are being treated with Trobalt.
Obratite se svom liječniku ako osjetite bilo kakve promjene u vidu dok se liječite lijekom Trobalt.
In addition to adverse reactions seen at therapeutic doses, symptoms of retigabine overdose included agitation, aggressive behaviour and irritability.
Uz nuspojave zabilježene pri terapijskim dozama, simptomi predoziranja retigabinom dodatno uključuju agitaciju, agresivno ponašanje i razdražljivost.
In a population pharmacokinetic analysis, retigabine clearance increased with increasing body surface area.
U populacijskoj farmakokinetičkoj analizi klirens retigabina povisivao se s povećanjem površine tijela.
Do not take Trobalt • if you are allergic to retigabine or any of the other ingredients of Trobalt (listed in section 6).
• ako ste alergični na retigabin ili neki drugi sastojak lijeka Trobalt (naveden u dijelu 6).
The maximum total maintenance dose is 1,200 mg/day.
Najviša ukupna doza održavanja je 1200 mg/dan.
When withdrawing Trobalt, the dose must be gradually reduced over a period of at least 3 weeks (see section 4.4).
Ukidanje terapije lijekom Trobalt mora se učiniti postupnim smanjivanjem doze u razdoblju od najmanje 3 tjedna (vidjeti dio 4.4).
In vitro studies indicate that retigabine acts primarily through opening neuronal potassium channels (KCNQ2 [Kv7.2] and KCNQ3 [Kv7.3]).
In vitro ispitivanja ukazuju da retigabin primarno djeluje otvaranjem neuronskih kalijevih kanala (KCNQ2 [Kv7.2] i KCNQ3 [Kv7.3]).
In addition, retigabine and NAMR did not induce CYP1A2 or CYP3A4/5 in human primary hepatocytes.
Uz to, retigabin i NAMR u ljudskim primarnim hepatocitima nisu inducirali CYP1A2 ili CYP3A4/5.
• effects on heart rhythm.
• promjene srčanog ritma.
Risk related to Trobalt
Rizici povezani s lijekom Trobalt
In rats, retigabine and/or its metabolites crossed the placenta resulting in tissue concentrations that were similar in dams and foetuses.
U štakora retigabin i/ili njegovi metaboliti prelaze placentu rezultirajući sličnim tkivnim koncentracijama u tijelima majki i fetusa.
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.
U svim ispitivanjima, bolesnici su imali srednje trajanje epilepsije od 22 godine, a medijan učestalosti napadaja bio je u rasponu od 8 do 12 tijekom 28 dana.
If you miss any doses, just take one dose as soon as you remember.
Ako preskočite neku dozu, uzmite je čim se sjetite da ste je propustili.
Retigabine was effective in adjunctive treatment of adults with partial onset seizures in three clinical studies (Table 1).
Retigabin se pokazao učinkovitim kao dodatna terapija odraslih bolesnika s parcijalnim napadajima u tri klinička ispitivanja (Tablica 1).
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.
U ispitivanjima na psima zabilježena je distenzija žučnog mjehura, ali bez dokaza kolestaze ili drugih znakova disfunkcije, a volumen izlučivane žuči ostao je nepromijenjen.
The eye examination should be repeated at least every six months whilst taking Trobalt.
Pregled očiju tijekom uzimanja lijeka Trobalt bi trebalo ponoviti barem svakih 6 mjeseci.
In a study of peri- and post-natal development in rats, retigabine was associated with increased perinatal mortality following administration during pregnancy.
U ispitivanjima peri- i postnatalnog razvoja na štakorima, retigabin se povezuje s povišenom perinatalnom smrtnošću nakon primjene tijekom skotnosti.
Don't chew, crush or split the tablet.
Nemojte ju žvakati, drobiti ili usitnjavati.
Retigabine and its metabolites are eliminated principally by renal excretion.
Retigabin i njegovi metaboliti prvenstveno se eliminiraju putem bubrega.
In the event of overdose, it is recommended that the patient is given appropriate supportive therapy as clinically indicated, including electrocardiogram (ECG) monitoring.
U slučaju predoziranja preporučuje se primijeniti odgovarajuću suportivnu terapiju prema kliničkoj indikaciji, koja obuhvaća i monitoriranje elektrokardiograma (EKG-a).
Clinical efficacy of adjunctive retigabine therapy in partial onset seizures
Klinička djelotvornost dodatne terapije retigabinom kod parcijalnih napadaja
These may affect up to 1 in 10 people:
Mogu se javiti u do 1 na 10 osoba:
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%.
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%.
Treatment will be stopped if any problems are found unless no other suitable treatments are available.
Ako se jave bilo kakva odstupanja liječenje će biti prekinuto, osim ako drugačije liječenje nije dostupno.
This sometimes occur together with discolouration of parts of the eye.
Ovo se ponekad pojavljuje zajedno sa promjenom boje ostalih dijelova oka.
Retigabine is also metabolised to an N-acetyl metabolite (NAMR) that is also subsequently glucuronidated.
Retigabin se metabolizira i u N-acetil metabolit (NAMR) koji se također kasnije glukuronidira.
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 pokazao i inhibitorna svojstva u više „kindling modela“, primjerice u stanju potpuno razvijenih ponavljanih spontanih napadaja i u nekim slučajevima tijekom razvoja ponavljanih napadaja.