FrancophonIA/ELRC3.0 huggingface dataset:
English: phenobarbital, phenytoin, pregabalin, topiramate, valproate, zonisamide.
Maltese: - carbamazepine, clobazam, clonazepam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, pregabalin, topiramate, valproate, zonisamide.
English: In vitro studies using human liver microsomes showed little or no potential for retigabine to inhibit the major cytochrome P450 isoenzymes (including CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5).
Maltese: CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 u CYP3A4/5).
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).
Maltese: F'pazjenti kkurati b'retigabine fis-sett ta' ġabra ta' dejta, stat ta' konfużjoni kien irrappurtat f'9% talpazjenti, alluċinazzjonijiet fi 2% tal-pazjenti u disturbi psikotiċi f'1% tal-pazjenti (ara sezzjoni 4.4).
English: Patients could not be seizure-free for ≥21 days.
Maltese: Il-pazjenti ma setax ma jkollhomx aċċessjonijiet għal ≥21 days.
English: How to store Trobalt
Maltese: Tiħux Trobalt
English: QT interval
Maltese: Intervall QT
English: Multipack: 168 (2 packs of 84) film-coated tablets
Maltese: Pakkett b'ħafna: 168 (2 pakketti ta' 84) pillola miksija b'rita
English: Indigo carmine aluminium lake (E132) Iron oxide yellow (E172).
Maltese: Indigo carmine aluminium lake (E132) Iron oxide isfar (E172).
English: In a single-dose study, retigabine AUC was increased by approximately 30% in volunteers with mild renal impairment (creatinine clearance 50 to 80 ml/min) and by approximately 100% in volunteers with moderate to severe renal impairment (creatinine clearance <50 ml/min), relative to healthy volunteers.
Maltese: Fi studju ta' doża singola, l-AUC ta' retigabine żdiedet b'madwar 30% f'voluntiera b'indeboliment ħafif tal-kliewi (tneħħija tal-krejatinina ta'bejn 50 u 80 ml/min) u b'madwar 100% f'voluntiera b'indeboliment minn modeart sa qawwi tal-kliewi (tneħħja tal-krejatinina ta' <50 ml/min), meta mqabbla ma' voluntiera b'saħħithom.
English: Trobalt may increase the duration of anaesthesia induced by some anaesthetics (for example thiopental sodium; see section 5.1).
Maltese: Trobalt jista' jżid it-tul ta' żmien tal-anestesija indotta minn xi anestetiċi (per eżemju thiopental sodium; ara sezzjoni 5.1).
English: Suicide risk
Maltese: Riskju ta' suwiċidju
English: • lack of co-ordination; spinning sensation (vertigo); balance problems; problems walking
Maltese: • nuqqas ta' koordinazzjoni; sensazzjoni li kollox qed idur bik (vertiġini); problemi bil-bilanċ;
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.
Maltese: retigabine kien effettiv fil-prevenzjoni ta' aċċessjonijiet status epilepticus fl-annimali gerriema b'leżjonijiet epileptoġeniċi indotti bil-cobalt, u impedixxa aċċessjonijiet tonic extensor fi ġrieden ġenetikament suxxettibbli.
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.
Maltese: Studju farmakokinetiku, tas-sigurtà u tat-tollerabbiltà open-label u b'doża multipla f'ħames individwi, ta' bejn 12-il sena sa inqas minn 18-il sena b'aċċessjonijiet b'feġġa parzjali ddetermina li lfarmakokinetika ta' retigabine fl-adolexxenti kienet konsistenti mal-farmakokinetika ta' retigabine fladulti.
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.
Maltese: Barraminhekk, ġiet identifikata wkoll forma distinta ta' anormalità makulari b'karatteristiċi ta' makulopatija vitelliformi (ara sezzjoni 4.8), f'ħafna każijiet iddijanjostikata b'immaġni ta' tomografija ta' koerenza ottika (OCT - optical coherence tomography).
English: Elderly If you are 65 years or older, you may be more likely than a younger adult to get the following symptoms:
Maltese: Jekk għandek 65 sena jew aktar, huwa aktar probabbli minn adult iżgħar li inti jkollok is-sintomi li ġejjin:
English: The maximum total maintenance dose is 1,200 mg/day.
Maltese: L-ogħla doża totali ta' manteniment hija 1,200 mg/kuljum.
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).
Maltese: - rata ta' dawk li jwieġbu għall-kura(iddefinita bħala l-perċentwal ta' pazjenti bi tnaqqis ta' ≥50% fil-frekwenza tat-total ta' aċċessjonijiet parzjali fuq 28 ġurnata) mil-linja bażi għall-fażi ta' manteniment (Studji 301 u 302 biss).
English: The total clearance of retigabine from plasma following intravenous dosing is typically 0.4 to 0.6 l/h/kg.
Maltese: It-tneħħija totali ta' retigabine mill-plażma wara għoti ta' doża minn ġol-vina hija tipikament bejn 0.4 u 0.6 l/siegħa/kg.
English: Trobalt with alcohol
Maltese: Trobalt mal-alkoħol
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%
Maltese: II indikaw li: - phenytoin jista' jnaqqas l-esponiment sistemiku ta' retigabine b'35% - carbamazepine jista' jnaqqas l-esponiment sistemiku ta' retigabine bi 33%
English: The most frequently reported defects are cleft lip, cardiovascular malformations and neural tube defects.
Maltese: L-aktar difetti rrappurtati b'mod frekwenti huma qasma fix-xoffa, deformazzjonijiet kardjovaskulari u difetti fit-tubu tan-nervituri.
English: • balance problems, lack of co-ordination, spinning sensation (vertigo), problems walking
Maltese: • problemi bil-bilanċ, nuqqas ta' koordinazzjoni, tħoss kollox idur bik (vertiġini), problemi biex timxi
English: Trobalt is one of a group of medicines called antiepileptics.
Maltese: Trobalt huwa wieħed minn grupp ta' mediċini msejħa mediċini kontra l-epilessija.
English: Retigabine has a plasma half-life of approximately 6 to 10 hours.
Maltese: Retigabine għandu half-life fil-plażma ta' madwar 6 sa 10 sigħat.
English: Other medicines and Trobalt
Maltese: Mediċini oħra u Trobalt
English: Trobalt may affect some anaesthetics (for example thiopental sodium).
Maltese: Trobalt jista' jaffettwa xi anestetiċi (per eżempju thiopental sodium).
English: Croscarmellose sodium
Maltese: Ematurja Kromaturja
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.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: In vitro studies indicate that retigabine acts primarily through opening neuronal potassium channels (KCNQ2 [Kv7.2] and KCNQ3 [Kv7.3]).
Maltese: Studji in vitro jindikaw li retigabine jaħdem primarjament billi jiftaħ il-kanali newronali tal-potassium (KCNQ2 [Kv7.2] u KCNQ3 [Kv7.3]).
English: Symptoms and signs
Maltese: Sinjali u sintomi
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.
Maltese: Il-farmakokinetika ta' retigabine hija essenzjalment lineari fuq il-medda ta'doża singola ta' bejn il25 u s-600 mg f'voluntiera b'saħħithom u sa 1,200 mg kuljum f'pazjenti bl-epilessija, mingħajr l-ebda akkumulazzjoni mhux mmistennija wara għoti ripetut.
English: There is limited experience of overdose with retigabine.
Maltese: Hemm esperjenza limitata b'doża eċċessiva ta' retigabine.
English: An effective maintenance dose is expected to be between 600 mg/day and 1,200 mg/day.
Maltese: Doża ta' manteniment effettiva hija mistennija li tkun bejn 600 mg/jum u 1,200 mg/jum.
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.
Maltese: Fil-firien, retigabine żied il-ħin tal-irqad indott permezz ta' thiopental sodium minn madwar 4 min għal 53 min, u l-ħin ta' rqad indott minn propofol minn madwar 8 min għal 12-il minuta.
English: The percentage decrease in plasma concentration during dialysis ranged from 34% to 60% except for one subject who had a 17% reduction.
Maltese: It-tnaqqis perċentwali fil-konċentrazzjoni fil-plażma matul dijaliżi varja minn 34% sa 60% għajr għal individwu wieħed li kellu tnaqqis ta' 17%.
English: No dose reduction is required in patients with mild hepatic impairment (Child-Pugh score 5 to 6; see section 5.2).
Maltese: Child-Pugh minn 5 sa 6; ara sezzjoni 5.2).
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.
Maltese: retigabine kienet madwar 65% ogħla fin-nisa milli fl-irġiel, u f'voluntiera anzjani (età minn 66 sa 82 sena) is-Cmax ta' retigabine kienet madwar 75% ogħla fin-nisa meta mqabbla mal-irġiel.
English: Dysphagia
Maltese: Disurja
English: The 50 mg and 400 mg tablets also contain indigo carmine aluminium lake (E132) and carmine (E120).
Maltese: Il-pilloli ta' 50 mg u 400 mg fihom ukoll indigo carmine aluminium lake (E132) u carmine (E120).
English: Co-administration of ethanol (1.0 g/kg) with retigabine (200 mg) resulted in an increase in visual blurring in healthy volunteers.
Maltese: L-għoti fl-istess ħin ta' ethanol (1.0 g/kg) u retigabine (200 mg) wassal għal żieda f'tiċpir tal-vista f'voluntiera b'saħħithom.
English: Maximum doses in repeat dose toxicity studies were limited by the exaggerated pharmacologic effects of retigabine (including ataxia, hypokinesia and tremor).
Maltese: Dożi massimi fi studji ta' effett tossiku minn dożi ripetuti kienu limitati mill-effetti farmakoloġiċi eżaġerati ta' retigabine (inkluż atassja, ipokinesja u tregħid).
English: There is no evidence for hepatic oxidative metabolism of retigabine or NAMR by cytochrome P450 enzymes.
Maltese: M'hemm l-ebda evidenza ta' metaboliżmu epatiku ossidattiv ta' retigabine jew NAMR permezz talenzimi taċ-ċitokroma P450.
English: 84 film-coated tablets
Maltese: 84 pillola miksija b'rita
English: A substantial fraction of the retigabine dose is converted to inactive N-glucuronides.
Maltese: Porzjon sostanzjali tad-doża ta' retigabine tibidel fi glukuronidi-N inattivi.
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.
Maltese: Dejta minn pazjenti anzjani tindika li huma aktar probabbli li jesperjenzaw ċerti avvenimenti fissistema nervuża ċentrali, inklużi ħedla tan-ngħas, amnesija, koordinazzjoni mhux normali, vertiġini, tregħid, disturb fil-bilanċ, indeboliment tal-memorja u disturb fil-mixi.
English: 50 mg tablets:
Maltese: Pilloli ta' 50 mg:
English: A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe hepatic impairment (Child-Pugh score ≥7; see section 5.2).
Maltese: Tnaqqis ta' 50% fid-dożi tal-bidu u d-doża ta' manteniment ta' Trobalt huwa rrakkomandat f'pazjenti b'indeboliment moderat jew qawwi tal-fwied (punteġġ Child-Pugh ≥7; ara sezzjoni 5.2).
English: There are only limited data on the safety and efficacy of retigabine in patients aged 65 years and above.
Maltese: Hemm biss dejta limitata dwar is-sigurtà u l-effikaċja ta' retigabine f'pazjenti li għandhom 65 sena jew aktar.
English: Pack containing 84 film-coated tablets; multi-pack comprising 168 (2 x 84) film-coated tablets.
Maltese: Pakketti li fihom 84 pillola miksija b'rita; pakkett b'ħafna li fih 168 (2 x 84) pillola miksija b'rita.
English: Based on a study conducted in healthy volunteers, therapeutic doses of retigabine (600-1,200 mg/day) resulted in a minor (8-18%) increase in digoxin AUC following a single oral dose of digoxin.
Maltese: Fuq il-bażi ta' studju mwettaq f'voluntiera b'saħħithom, dożi terapewtiċi ta' retigabine (6001,200 mg/kuljum) irriżultaw f'żieda minuri (8-18%) fl-AUC ta' digoxin wara doża orali waħdanija ta' digoxin.
English: Interaction with alcohol
Maltese: Interazzjoni mal-alkoħol
English: The cumulative incidences of an event at 1 year, 2 years, 3 years, 4 years and 5 years of exposure are approximately 1%, 1.8%, 4.4%, 10.2% and 16.7% respectively.
Maltese: sena u fil-ħames sena ta' espożizzjoni huma madwar 1%, 1.8%, 4.4%, 10.
English: 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).
Maltese: F'estensjonijiet open-label tat-tliet studji kkontrollati bi plaċebo, persistenza fl-effikaċja nżammet fuq perijodu ta' evalwazzjoni ta' mill-inqas 12-il xahar (365 pazjent).
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).
Maltese: F'medda ta' mudelli ta' aċċessjonijiet, retigabine żied il-punt ta' meta jkun hemm induzzjoni ta' aċċessjoni magħmula permezz ta' xokk elettriku massimu, pentylenetetrazol, picrotoxin u N-methyl-D-aspartate (NMDA).
English: Retigabine overdoses in excess of 2,500 mg/day were reported during clinical studies.
Maltese: Dożi eċċessiv b'retigabine ta' aktar minn 2,500 mg/jum kienu rrappurtati waqt studji kliniċi.
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%.
Maltese: Ir-riskju ta' deformazzjonijiet konġenitali jiżdied b'fattur ta' 2 sa 3 fil-wild ta' ommijiet ikkurati bi prodotti mediċinali għal kontra l-epilessija meta mqabbla mal-inċidenza mistennija ta' madwar 3% fil popolazzjoni ġenerali.
English: The 100 mg and 300 mg tablets also contain indigo carmine aluminium lake (E132) and iron oxide yellow (E172).
Maltese: Il-pilloli ta' 100 mg u 300 mg fihom ukoll indigo carmine aluminium lake (E132) u iron oxide isfar (E172).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu//.
English: Retigabine may increase the duration of anaesthesia induced by some anaesthetics (for example thiopental sodium).
Maltese: Retigabine jista' jżid it-tul ta' żmien ta' anestesija indotta minn xi anestetiċi (per eżempju thiopental sodium).
English: Balance disorder Memory impairment
Maltese: Disturb fil-bilanċ Indeboliment talmemorja
English: 200 mg tablets:
Maltese: Pilloli ta' 200 mg:
English: INFORMATION IN BRAILLE trobalt 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE trobalt 50 mg
English: 400 mg tablets:
Maltese: Pilloli ta' 400 mg:
English: Purple, round, film-coated tablets of 5.6 mm, marked with “RTG 50” on one side.
Maltese: Pilloli vjola,tondi, miksijin b'rita ta' 5.6 mm, immarkati b'“RTG 50” fuq naħa waħda.
English: Trobalt is for oral use.
Maltese: Trobalt huwa għal użu orali.
English: Three multicentre, randomized, double-blind, placebo-controlled studies in a total of 1239 adult patients have been conducted to assess the efficacy of retigabine as adjunctive therapy of partial onset seizures, with or without secondary generalisation.
Maltese: Tliet studji b'ħafna ċentri, randomised, double-blind, ikkontrollati bi plaċebo f'total ta' 1239 pazjent adult saru biex jistmaw l-effikaċja ta' retigabine bħala terapija miżjuda għal aċċessjonijiet b'bidu parzjali b'ġeneralizzazzjoni sekondarja jew mingħajrha.
English: In the event of overdose, it is recommended that the patient is given appropriate supportive therapy as clinically indicated, including electrocardiogram (ECG) monitoring.
Maltese: F'każ ta' doża eċċessiva, huwa rrakkomandat li l-pazjenti jingħata terapija xierqa ta' sapport kif indikat b'mod kliniku, inkluż monitoraġġ b'elettrokardjogramma (ECG).
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.
Maltese: Analiżi post-hoc minn firxa ta' ħafna studji f'voluntiera f'saħħithom uriet tnaqqis ta' 20% fit-tneħħija ta' retigabine f'voluntiera suwed f'saħħithom meta mqabbla ma' voluntiera Kawkasiċi f'saħħithom.
English: Renal and urinary disorders
Maltese: Mhux Komuni fis-sistema urinarja
English: Class
Maltese: Sess
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.
Maltese: Kontraċettivi orali Ma kien hemm l-ebda effett klinikament sinifikanti ta' retigabine, b'dożi sa 750 mg kuljum, fuq il farmakokinetika tal-komponenti tal-pillola kontraċettiva orali estrogen (ethinyl estradiol) jew progestogen (norethindrone).
English: Eye disorders have been observed with the use of Trobalt, including pigment changes in the retina.
Maltese: Ġew osservati disturbi fl-għajnejn bl-użu ta' Trobalt, inklużi bidliet fil-pigment fir-retina.
English: A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe renal impairment (creatinine clearance <50 ml/min; see section 5.2).
Maltese: Tnaqqis ta' 50% fid-dożi tal-bidu u d-doża ta' manteniment ta' Trobalt huwa rrakkomandat f'pazjenti b'indeboliment moderat jew qawwi tal-kliewi (tneħħija tal-kreatinina <50 ml/min; ara sezzjoni 5.2).
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).
Maltese: Reazzjonijiet avversi marbuta ma' disfunzjoni tat-tbattil tal-bużżieqa tal-awrina, li tinkludi żamma tal awrina, kienu rrappurtati f'5% tal-pazjenti kkurati b'retigabine f'sett ta' ġabra ta' dejta ta' sigurtà (ara sezzjoni 4.4).
English: When withdrawing Trobalt, the dose must be gradually reduced over a period of at least 3 weeks (see section 4.4).
Maltese: Meta jitwaqqaf Trobalt, id-doża għandha titnaqqas fuq perjodu ta' mill-inqas 3 ġimgħat (ara sezzjoni 4.4).
English: Administration of retigabine with a high fat meal resulted in no change in the overall extent of retigabine absorption, but food reduced the between-subject variability in Cmax (23%) compared to the fasted state (41%), and led to an increase in Cmax (38%).
Maltese: L-għoti ta' retigabine ma' ikla b'kontenut għoli ta' xaħam ma wasslet għall-ebda tibdil fil-grad globali ta' assorbiment ta' retigabine, iżda l-ikel naqqas il-varjabilità ta' bejn l-individwi fis-Cmax (23%) meta mqabbel mal-istat ta' sawm (41%), u wassal għal żieda fis-Cmax (38%).
English: 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.
Maltese: Madwar 30-40% tal-individwi ta' provi kliniċi li kienu qegħdin jiġu kkurati b'retigabine u sarilhom eżami tal-ġilda kellhom telf tal-kulur tad-dwiefer, tax-xufftejn, tal-ġilda u/jew sejbiet tal-mukoża jew pigmentazzjoni okulari mhux retinali, u bejn wieħed u ieħor f'15-30% tal-individwi fil-provi kliniċi li kienu qed jiġu ttrattati b'retigabine u li kellhom eżaminazzjoni oftalmoloġika, kellhom sejba ta' pigmentazzjoni retinali.
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.
Maltese: Deher li seta' kien hemm relazzjoni mad-doża għal sturdament, ħedla tan-ngħas, stat ta' konfużjoni, afasja, koordinazzjoni mhux normali, rogħda, disturb fil-bilanċ, indeboliment tal-memorja, disturb fil-mixi, vista mċajpra u stitikezza.
English: INFORMATION IN BRAILLE trobalt 200 mg
Maltese: INFORMAZZJONI BIL-BRAILLE trobalt 200 mg
English: 300 mg tablets:
Maltese: Pilloli ta' 300 mg:
English: 21 film-coated tablets 84 film-coated tablets
Maltese: 21 pillola miksija b'rita 84 pillola miksija b'rita
English: The retigabine AUC was increased by approximately 50% in volunteers with moderate hepatic impairment (Child-Pugh score 7 to 9) and by approximately 100% in volunteers with severe hepatic impairment (Child-Pugh score >9), relative to healthy volunteers.
Maltese: AUC ta' retigabine żdiedet b'madwar 50% f'voluntiera b'indeboliment moderat tal-fwied (punteġġ Child-Pugh 7 sa 9) u b'madwar 100%f'voluntiera b'indeboliment qawwi tal-fwied (punteġġ
English: Česká republika GlaxoSmithKline s.r.o.
Maltese: GlaxoSmithKline s.r.o.
English: The effect of food on Cmax under usual clinical conditions is not expected to be clinically relevant.
Maltese: L-effett tal-ikel fuq is-Cmax taħt kundizzjonijiet kliniċi normali mhux mistenni li jkun klinikament rilevanti.
English: TW8 9GS
Maltese: TW8 9GS Ir-Renju Unit
English: Based on these pooled data, retigabine did not cause clinically significant effects on the plasma trough concentrations of the following antiepileptic medicinal products: - carbamazepine, clobazam, clonazepam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine,
Maltese: Barra minn hekk, fuq bażi ta' ġabra ta' dejta, ma kien hemm l-ebda effetti kliniċi sinifikanti fuq il farmakokinetika ta' retigabine minn dawn il-prodotti mediċinali għal kontra l-epilessija li ġejjin: - lamotrigine, levetiracetam, oxcarbazepine, topiramate, valproate.
English: The 200 mg tablets also contain iron oxide yellow (E172).
Maltese: Il-pilloli ta' 200 mg fihom ukoll iron oxide isfar (E172).
English: No dose adjustment is required in patients with mild renal impairment (creatinine clearance 50 to 80 ml/min; see section 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża ta' pazjenti b'indeboliment ħafif tal-kliewi (tneħħija tal-kreatinina ta' 50 sa 80 ml/min; ara sezzjoni 5.2).
English: Purple, oblong, film-coated tablets of 8.1 mm x 18 mm, marked with “RTG-400” on one side.
Maltese: Pilloli vjola, oblungi, miksijin b'rita ta' 8.1 mm x 18 mm, immarkati b'“RTG 300” fuq naħa waħda.
English: Green, oblong, film-coated tablets of 7.1 mm x 16 mm, marked with “RTG-300” on one side.
Maltese: Pilloli ħodor, oblungi, miksijin b'rita ta' 7.1 mm x 16 mm, immarkati b'“RTG 300” fuq naħa waħda.
English: Each pack contains blisters of 84 or 2 x 84 film-coated tablets.
Maltese: Kull pakkett fih folji ta' 84 jew 2 x 84 pilloli miksija b'rita.
English: Yellow, oblong, film-coated tablets of 7.1 mm x 14 mm, marked with “RTG-200” on one side.
Maltese: Pilloli sofor, tawwalin, miksijin b'rita ta' 7.1 mm x 14 mm, immarkati b'“RTG 200” fuq naħa waħda.