natgillin/translations-raw huggingface dataset:
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%.
U usporedbi s očekivanom incidencijom u općoj populaciji od oko 3%, rizik od kongenitalnih malformacija djece se kod majki koje su liječene antiepilepticima povećava 2 ili 3 puta.
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.
Tijekom terapije lijekom Trobalt morate koristiti pouzdanu metodu kontracepcije kako biste izbjegli mogućnost da ostanete trudni.
Adjustment of the Trobalt dose is recommended in patients with moderate to severe renal impairment but no adjustment of the Trobalt dose is recommended in patients with mild renal impairment (see section 4.2).
Preporučuje se prilagodba doze lijeka Trobalt u bolesnika s umjerenim do teškim oštećenjem bubrega, ali nije potrebna prilagodba doze u bolesnika s blagim oštećenjem bubrega (vidjeti dio 4.2).
There was no evidence of teratogenicity following administration of retigabine to pregnant animals during the period of organogenesis.
Dokazi o teratogenosti nisu utvrđeni nakon primjene retigabina kod skotnih životinja tijekom razdoblja organogeneze.
No signs of gall bladder dysfunction were seen clinically.
Klinički nisu pronađeni znaci disfunkcije žučnog mjehura.
Eye disorders caused by changes in the centre of the retina (maculopathy) have been reported in people taking Trobalt (see Section 4).
Poremećaji u oku uzrokovani promjenama u središtu mrežnice (makulopatija) zamijećeni su u osoba koje uzimaju Trobalt (pogledajte dio 4).
Therefore, co-administration with inhibitors or inducers of cytochrome P450 enzymes is unlikely to affect the pharmacokinetics of retigabine or NAMR.
Stoga nije vjerojatno da bi istovremena primjena s inhibitorima ili induktorima enzima citokrom P450 utjecala na farmakokinetiku retigabina ili NAMR-a.
A blue-grey discolouration of the skin, lips or nails has also been reported in people taking Trobalt for several years (See Section 4).
Plavo-siva promjena boje kože, usana ili noktiju zabilježena je kod ljudi koji su više godina uzimali Trobalt (pogledajte dio 4).
Your doctor will weigh up the benefit to you against any risk to your baby of taking Trobalt while you are breast-feeding.
Vaš liječnik će procijeniti Vašu korist od uzimanja lijeka Trobalt dok dojite u usporedbi s bilo kojim rizikom za Vaše dijete.
A blue-grey discolouration of the skin, lips or nails: this is very common in people taking Trobalt for several years.
Plavo-siva promjena boje kože, usana ili noktiju: vrlo je česta u osoba koje više godina uzimaju
Therefore, retigabine is unlikely to affect the pharmacokinetics of substrates of the major cytochrome P450 isoenzymes through inhibition or induction mechanisms.
Stoga nije vjerojatno da bi retigabin imao utjecaja na farmakokinetiku supstrata glavnih citokrom P450 izoenzima putem inhibicijskih ili indukcijskih mehanizama.
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.
Promjena boje pojedinih dijelova oka, uključujući mrežnicu (stražnja unutarnja strana oka): to može biti vrlo često u osoba koje više godina uzimaju Trobalt.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
Talk to your doctor about breast-feeding while you are taking Trobalt.
Razgovarajte sa svojim liječnikom o dojenju tijekom liječenja lijekom Trobalt.
Adjustment of the Trobalt dose is recommended in patients with moderate or severe hepatic impairment (see section 4.2).
Preporučuje se prilagodba doze lijeka Trobalt u bolesnika s umjerenim ili teškim oštećenjem jetre (vidjeti dio 4.2).
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%
II ukazuju da: - fenitoin može smanjiti sistemsku izloženost retigabina za 35% - karbamazepin može smanjiti sistemsku izloženost retigabina za 33%
How to store Trobalt
Kako čuvati Trobalt
• if you have an existing heart problem • if you have low potassium (hypokalaemia) or low magnesium (hypomagnesaemia) in your
• imate nisku razinu kalija (hipokalijemiju) ili magnezija (hipomagnezijemiju) u Vašoj krvi • imate 65 ili više godina
• constipation; feeling sick (nausea); indigestion; dry mouth
• zatvor; mučnina; probavne tegobe; suha usta
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.
U ispitivanju jednokratne doze, AUC retigabina je bio povišen za oko 30% u dobrovoljaca s blagim oštećenjem bubrega (klirens kreatinina 50 do 80 ml/min), te za oko 100% u dobrovoljaca s umjerenim do teškim oštećenjem bubrega (klirens kreatinina <50 ml/min) u usporedbi sa zdravim dobrovoljcima.
Very common Common
Vrlo česte nuspojave
phenobarbital, phenytoin, pregabalin, topiramate, valproate, zonisamide.
- karbamazepin, klobazam, klonazepam, gabapentin, lamotrigin, levetiracetam, okskarbazepin, fenobarbital, fenitoin, pregabalin, topiramat, valproat, zonisamid.
The 50 mg and 400 mg tablets also contain indigo carmine aluminium lake (E132) and carmine (E120).
Tablete od 50 mg i 400 mg također sadrže indigo carmine aluminium lake (E132) i karmin (E120).
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Ispitivanja interakcija s drugim lijekovima provedena su samo na odraslim osobama.
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.
Ukupna dnevna početna doza je 150 mg, te se tijekom titracijskog razdoblja preporučuje ukupnu dnevnu dozu povisiti svakog tjedna za 50 mg, do najviše ukupne doze od 600 mg/dan.
The effect of retigabine on human fertility has not been established.
Nije utvrđen učinak retigabina na plodnost u ljudi.
• balance problems, lack of co-ordination, spinning sensation (vertigo), problems walking
• probleme s ravnotežom, nedostatak koordinacije, osjećaj vrtnje (vrtoglavica), teškoće pri hodu • nevoljno drhtanje.
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).
U kontroliranim kliničkim ispitivanjima retigabina zabilježena je retencija urina, dizurija i odgoda početka mokrenja, općenito unutar prvih 8 tjedana liječenja (vidjeti dio 4.8).
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.
U bolesnika koji razviju navedene promjene, liječenje lijekom Trobalt treba se nastaviti tek nakon pažljive ponovne procjene omjera rizika i koristi njegove primjene.
C OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
It works by preventing the brain overactivity that causes epileptic seizures (also called fits).
Djeluje tako da sprječava pretjeranu aktivnost mozga koja uzrokuje epileptičke napadaje.
The following convention has been used for the classification of adverse reactions:
Sljedeće dogovorene vrijednosti su korištene za klasifikaciju učestalosti nuspojava: Vrlo često:
No dose reduction is required in patients with mild hepatic impairment (Child-Pugh score 5 to 6; see section 5.2).
Nije potrebno smanjivanje doze u bolesnika s blagim oštećenjem jetre (Child-Pugh zbroj bodova 5-6; vidjeti dio 5.2).
It is unknown whether retigabine is excreted in human breast milk.
Nije poznato izlučuje li se retigabin u ljudsko mlijeko.
How to take
Kako uzimati lijek
The doctor may decide to give you a reduced dose.
Liječnik će možda odlučiti dati
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).
Ispitivanja in vitro u kojima su se koristili ljudski mikrosomi jetre pokazala su mali ili nikakav potencijal retigabina za inhibiranje glavnih citokrom P450 izoenzima (uključujući CYP1A2, CYP2A6,
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.
Ako se zamijete promjene u pigmentaciji mrežnice, viteliformna makulopatija ili promjene vida, liječenje lijekom Trobalt treba nastaviti tek nakon pažljive ponovne procjene potencijalnih rizika u odnosu na korist.
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).
halucinacije u 2% bolesnika i psihotični poremećaji u 1% bolesnika (vidjeti dio 4.4).
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.
Za prestanak uzimanja lijeka Trobalt važno je da se doza postupno smanjuje tijekom razdoblja od barem 3 tjedna.
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.
Međutim, prema spolu nije postojala očita razlika klirensa normaliziranog po tjelesnoj težini, a kako se retigabin titrira prema individualnom odgovoru i podnošljivosti bolesnika, prilagodbe doze prema spolu nisu potrebne.
The majority of adverse reactions occurred in the first 8 weeks of treatment, and there was an apparent dose-relationship for confusional state only.
Većina ih je zabilježena tijekom prvih 8 tjedana terapije, a očigledna povezanost s dozom primijećena je samo za smeteno stanje.
The active substance is retigabine.
Djelatna tvar je retigabin.
The 100 mg and 300 mg tablets also contain indigo carmine aluminium lake (E132) and iron oxide yellow (E172).
Tablete od 100 mg i 300 mg također sadrže indigo carmine aluminium lake (E132) i žuti željezov oksid (E172).
Retigabine may increase the duration of anaesthesia induced by some anaesthetics (for example thiopental sodium).
Retigabin može produljiti vrijeme trajanja anestezije koja je inducirana nekim anesteticima (primjerice natrijevim tiopentalom).
Retigabine overdoses in excess of 2,500 mg/day were reported during clinical studies.
Tijekom kliničkih ispitivanja zabilježena su predoziranja retigabinom s više od 2500 mg/dan.
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.
Trobalt je indiciran kao dodatna terapija parcijalnih napadaja rezistentnih na lijekove sa ili bez sekundarne generalizacije u bolesnika s epilepsijom u dobi od 18 godina ili starijih, kada su se ostale odgovarajuće kombinacije s drugim lijekovima pokazale neadekvatne ili se nisu podnosile.
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.
Ako se zamijete pigmentacija mrežnice, viteliformna makulopatija ili promjene vida, liječenje lijekom Trobalt smije se nastaviti samo nakon pažljive ponovne procjene omjera koristi i rizika.
The maximum starting dose of Trobalt is 100 mg, taken three times a day (a total of 300 mg a day).
Najviša početna doza lijeka Trobalt je 100 mg tri puta na dan (ukupno 300 mg na dan).
In vitro data indicated a low potential for interaction with other antiepileptic medicinal products (see section 5.2).
Podaci in vitro ukazivali su na niski potencijal za interakciju s drugim antiepileptičkim lijekovima
Caution should be taken when Trobalt is prescribed with medicinal products known to increase QT interval and in patients with known prolonged QT interval, congestive cardiac failure, ventricular hypertrophy, hypokalaemia or hypomagnesaemia and in patients initiating treatment who are 65 years of age and above.
interval, bolesnika s kongestivnim zatajenjem srca, ventrikularnom hipertrofijom, hipokalijemijom ili hipomagnezijemijom, kao i kod uvođenja liječenja bolesnicima u dobi od 65 godina ili starijih.
− Caution when using TROBALT in patients with a cardiac disease or those taking medicines concomitantly known to cause QT prolongation
intervala - oprez prilikom korištenja lijeka TROBALT u bolesnika s bolestima srca ili bolesnika koji istovremeno uzimaju lijekove za koje je poznato da produljuju QT interval - potreba informiranja bolesnika da TROBALT može uzrokovati stanje konfuzije,
− 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.
pregled slit lampom, fotografiju fundusa s dilatacijom i makularni prikaz optički koherentnom tomografijom (OCT), na početku i potom barem svakih 6 mjeseci tijekom trajanja liječenja.
The need for treatment with antiepileptic medicinal products should be reviewed when a woman is planning to become pregnant.
Kada žena planira trudnoću, potrebu za terapijom antiepilepticima treba revidirati.
There is no evidence for hepatic oxidative metabolism of retigabine or NAMR by cytochrome P450 enzymes.
Nema dokaza o oksidativnom metabolizmu putem citokrom P450 enzima u jetri ni za retigabin niti za NAMR.
Discolouration of parts of the eye, including the retina (inside the back of the eye) has been reported in people taking Trobalt for several years (see Section 4).
Promjena boje dijelova oka, uključujući mrežnicu (stražnja unutarnja strana oka) zamijećena je kod ljudi koji više godina uzimaju Trobalt (pogledajte dio 4).
It is not known whether the active substance of Trobalt can pass into breast-milk.
Nije poznato prelazi li djelatna tvar lijeka Trobalt u majčino mlijeko.
The maximum dose is 400 mg taken three times a day (a total of 1,200 mg a day).
Najviša doza je 400 mg tri puta na dan (ukupno 1200
Haemodialysis has been shown to reduce the plasma concentrations of retigabine and NAMR by approximately 50%.
Pokazalo se da se hemodijalizom može smanjiti koncentracija retigabina i NAMR u plazmi za oko
There were no reported sequelae.
Sekvele nisu zabilježene.
There were no treatment-related effects of retigabine on fertility in animal studies.
U ispitivanjima na životinjama nije bilo učinaka na plodnost povezanih s terapijom retigabinom.
Increased liver function tests
Poremećaji jetre i žuči povišene vrijednosti jetrenih proba
Tel.: + 48 (0)22 576 9000
GSK Services Sp. z.o.o. Tel.: + 48 (0)22 576 9000
• if you have kidney or liver problems.
• imate li 65 godina ili više • imate li problema s bubrezima ili jetrom.
Česká republika GlaxoSmithKline s.r.o.
Slovenská republika GlaxoSmithKline Slovakia s. r. o.
Each pack contains blisters of 84 or 2 x 84 film-coated tablets.
Jedno pakiranje sadrži blistere s 84 ili 2 x 84 filmom obložene tablete.
• difficulty in starting to urinate (urinary hesitation)
• teškoće pri započinjanju mokrenja (otežano mokrenje)
Trobalt contains the active substance retigabine.
Što je Trobalt i za što se koristi Trobalt sadrži djelatnu tvar retigabin.
Very common side effects These may affect more than 1 in 10 people:
Mogu se javiti u više od 1 na 10 osoba:
Nervous system disorders
Poremećaji živčanog sustava omaglica somnolencija1
Confusional state, psychotic disorders and hallucinations were reported in controlled clinical studies with retigabine (see section 4.8).
U kontroliranim kliničkim ispitivanjima retigabina zabilježeni su smeteno stanje, psihotični poremećaji i halucinacije (vidjeti dio 4.8).
84 film-coated tablets Component of a multipack, can't be sold separately
Dio višestrukog pakiranja, ne može se prodavati zasebno.
• drowsiness
• pospanost
Disturbance in attention
• problemi s pažnjom
Trobalt must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability.
Kako bi se postigao optimalan odnos djelotvornosti i podnošljivosti, Trobalt se mora titrirati prema individualnom terapijskom odgovoru bolesnika.
• tremors; sudden jerking of muscles (myoclonus)
• nevoljno drhtanje; iznenadni trzaji mišića (mioklonus) • trnci ili utrnulost ruku i nogu
Skin rash Hyperhidrosis
Poremećaji kože i potkožnog tkiva kožni osip hiperhidroza
Pack containing 84 film-coated tablets; multi-pack comprising 168 (2 x 84) film-coated tablets.
Pakiranje sadrži 84 filmom obložene tablete, a višestruko pakiranje 168 (2 x 84) filmom obloženih tableta.
50 mg tablets:
Tablete od 50 mg:
• tingling or numbness of the hands or feet
• oticanje potkoljenica i stopala
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.
Kako bi se procijenila djelotvornost retigabina kao dodatne terapije kod parcijalnih napadaja s ili bez sekundarne generalizacije, provedena su tri multicentrična, randomizirana, dvostruko slijepa ispitivanja kontrolirana placebom na ukupno 1239 odrasla bolesnika.
You must look out for certain symptoms while you are taking Trobalt, to reduce the risk of any problems.
Kako biste umanjili rizik od mogućih problema, morate pripaziti na određene simptome tijekom uzimanja lijeka Trobalt.
6.6 Special precautions for disposal No special requirements.
6.4 Posebne mjere pri čuvanju lijeka Lijek ne zahtjeva posebne uvjete čuvanja.
Summary of percentage changes in 28-day total partial seizure frequency and responder rates
Sažetak postotka promjene ukupnog broja parcijalnih napadaja tijekom 28 dana i stope bolesnika s odgovorom
A reduction in the initial and maintenance dose of Trobalt is recommended in elderly patients.
preporučuje se smanjenje početne doze i doze održavanja lijeka Trobalt za 50%.
Packs containing 21or 84 film-coated tablets.
Pakiranje sadrži 21 ili 84 filmom obložene tablete.
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.
U usporedbi sa zdravim dobrovoljcima, AUC retigabina je bio povišen za oko 50% u dobrovoljaca s umjerenim oštećenjem jetre (Child-Pugh zbroj bodova 7 do 9), te za oko 100% u dobrovoljaca s teškim oštećenjem jetre
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.
Ukupna dnevna početna doza je 150 mg/dan, te se tijekom titracijskog razdoblja prema individualnom terapijskom odgovoru i podnošljivosti bolesnika treba povisiti svakog tjedna za najviše 150 mg.
Laboratoire GlaxoSmithKline Tél.
Magyarország GlaxoSmithKline Kft.
Don't stop taking Trobalt without advice Take Trobalt for as long as your doctor recommends.
Uzimajte Trobalt onoliko dugo koliko Vam je liječnik preporučio.
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).
Tijekom dugoročnih kliničkih ispitivanja s retigabinom prijavljene su promjene pigmentacije u tkivima oka (diskoloracija) koje uključuju i promjene na mrežnici, a ponekad su, ali ne i uvijek, bile praćene promjenama pigmentacije kože, usana ili noktiju (vidjeti sljedeći odlomak i dio 4.8).
Purple, round, film-coated tablets of 5.6 mm, marked with “RTG 50” on one side.
Ljubičaste, okrugle, filmom obložene tablete promjera 5,6 mm, s oznakom "RTG 50" na jednoj strani.
The European Medicines Agency has waived the obligation to submit the results of studies with Trobalt in paediatric patients aged 0 to below 2 years with Lennox Gastaut Syndrome (see section 4.2 for information on paediatric use).
Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Trobalt u pedijatrijskih bolesnika od 0 do 2 godine s Lennox Gastaut sindromom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
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.
Svim bolesnicima potrebno je provesti sveobuhvatan oftalmološki pregled na početku liječenja i zatim barem svakih šest mjeseci, koji mora uključivati ispitivanje vidne oštrine, pregled slit lampom, fotografiju fundusa s dilatacijom i optički koherentnu tomografiju (OCT) makule.
No dose adjustment is required in patients with mild renal impairment (creatinine clearance 50 to 80 ml/min; see section 5.2).
U bolesnika s umjerenim ili teškim oštećenjem bubrega (klirens kreatinina <50 ml/min; vidjeti dio 5.2)
Each pack contains blisters of 21or 84 film-coated tablets.
Jedno pakiranje sadrži blistere s 21 ili 84 filmom obložene tablete.
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).
Tijekom dugoročnih kliničkih ispitivanja s retigabinom prijavljene su promjene pigmentacije (diskoloracija) kože, usana ili noktiju, ponekad, ali ne i uvijek, praćene pigmentnim promjenama u tkivima oka, (vidjeti prethodni odlomak i dio 4.8).
200 mg tablets:
Tablete od 200 mg:
Study 205 (n=396; n=303)
Ispitivanje 205 (n=396; n=303) Ukupni broj parcijalnih napadaja (medijan) % promjene
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Nuspojavu možete prijaviti izravno putem nacionalnog sustava za prijavu navedenog u Dodatku V.
Tel: + 386 (0)1 280 25 00 medical.x.si@gsk.com
GlaxoSmithKline d.o.o. Tel: + 386 (0)1 280 25 00 medical.x.si@gsk.com
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).
• postotak promjene ukupnog broja parcijalnih napadaja tijekom 28 dana od početnog razdoblja do dvostruko-slijepe faze (kombinirane faze titracije i održavanja) u sva tri ispitivanja
400 mg tablets:
Tablete od 400 mg:
Green, round, film-coated tablets of 7.1 mm, marked with “RTG 100” on one side.
Zelene, okrugle, filmom obložene tablete promjera 7,1 mm, s oznakom "RTG 100" na jednoj strani.