FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy of lacosamide as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine CR in 886 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Maltese: L'effikaċja ta' lacosamide b' monotherapy kienet stabbilita f' taqbil mhux inferjuri, double blind ta' grupp parallel, ma' carbamazepine CR f' 886 pazjent ta' 16 -il sena ‘l fuq b'dijanjożi ġdida jew riċenti ta' epilessija.
English: Suicidal ideation Hallucination (1)
Maltese: Aggressjoni Aġitazzjoni(1)
English: The other ingredients are: sodium chloride, hydrochloric acid, water for injections.
Maltese: • L-ingredjenti l-oħra huma: sodium chloride, hydrochloric acid, ilma għall-injezzjoni.
English: Pinkish, oval film-coated tablets with approximate dimensions of 10.4 mm x 4.9 mm, and debossed with ‘SP' on one side and ‘50' on the other side.
Maltese: 10.4 mm x 4.9 mm, b'‘SP' imnaqqxa fuq naħa waħda u ‘50' fuq in-naħa l-oħra.
English: A 200 ml amber glass bottle with white polypropylene screw cap, a measuring cup and an oral syringe with an adaptor.
Maltese: Flixkun ta' 200 ml tal-ħġieġ kulur ambra b'tap abjad bil-kamin tal-polypropylene u tazza ta' kejl u siringa b'adapter.
English: Tablet coat
Maltese: Spażmi muskolari
English: The dose was based on dose-response and ranged from 400 to 1,200 mg/day for carbamazepine CR and from 200 to 600 mg/day for lacosamide.
Maltese: Id-doża kienet ibbażata fuq rispons għaddoża u kienet fuq medda minn 400 sa 1200 mg/ġurnata għal carbamazepine CR u minn 200 sa 600 mg/ġurnata għal lacosamide.
English: Sodium (salt): o there are 7.09 mg sodium in each graduation mark (5 ml) of the measuring cup.
Maltese: • Sodju (melħ): o hemm 7.09 mg soidum f'kull marka ta' kejl (5 ml) tat-tazza ta' kejl.
English: Carton 14 tablets - week 4
Maltese: Pakkett 14-il-pillola - ġimgħa 4
English: Muscle spasms
Maltese: IL-BELĠJU
English: PC:
Maltese: L-Manifattur :
English: Lacosamide UCB solution for infusion can be administered without further dilution, or may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml (5 %) or lactated Ringer's solution.
Maltese: Is-soluzzjoni għall-infużjoni Lacosamide UCB jista' jittieħed mingħajr ma jiġi dilwit aktar, jew jista' jiġi dilwit b'dawn is-soluzzjonijiet li ġejjin: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml jew soluzzjoni lactated Ringer's.
English: Lacosamide UCB 50 mg Lacosamide UCB 100 mg Lacosamide UCB 150 mg Lacosamide UCB 200 mg film-coated tablets lacosamide
Maltese: Lacosamide UCB 50 mg Lacosamide UCB 100 mg Lacosamide UCB 150 mg Lacosamide UCB 200 mg pilloli miksija b'rita lacosamide
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of syrup contains 10 mg lacosamide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull ml ta' mistura fih 10 mg lacosamide.
English: The efficacy of lacosamide in children aged 4 years and older has been extrapolated from data of adolescents and adults with partial-onset seizures, for whom a similar response was expected provided the paediatric dose adaptations are established (see section 4.2) and safety has been demonstrated (see section 4.8).
Maltese: L-effikaċja ta' lacosamide fi tfal li kellhom 4 snin u aktar ġiet estrapolata minn data ta' adoloxxenti u adulti b'aċċessjonijiet b'feġġa parzjali, li għalihom kien mistenni rispons simili diment li l-adattamenti tad-doża pedjatrika jkunu ġew stabbiliti (ara s-sezzjoni 4.2) u s-sigurtà tkun intweriet (ara s-sezzjoni 4.8).
English: The safety profile of lacosamide in placebo-controlled (see study details in section 5.1) and in openlabel studies (n=408) in adjunctive therapy in children from 4 years of age was consistent with the safety profile observed in adults although the frequency of some adverse reactions (somnolence, vomiting and convulsion) was increased and additional adverse reactions (nasopharyngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behaviour) have been reported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %), somnolence (14.0 %), dizziness (13.5 %),
Maltese: Il-profil ta' sigurtà ta' lacosamide fi studji kkontrollati bil-plaċebo (ara d-dettalji tal-istudju f'sezzjoni 5.1) u open-label (n=408) f'terapija aġġuntiva fi tfal mill-età ta' 4 snin kien konsistenti malprofil tas-sigurtà osservat fl-adulti għalkemm il-frekwenza ta' wħud mir-reazzjonijiet avversi (ħedla ta' ngħas, rimettar u konvulżjoni) żdiedet u ġew irrappurtati reazzjonijiet avversi addizzjonali (nasofarinġite, deni, farinġite, nuqqas ta' aptit, letarġija u mġiba anormali) f'pazjenti pedjatriċi: nasofarinġite (15.
English: Monitor closely patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease (e.g. myocardial ischemia, heart failure) when lacosamide dose is higher than 400 mg/day (see Method of administration below and section 4.4).
Maltese: Pazjenti bi problemi magħrufa ta' konduzzjoni kardijaċi, fuq mediċini oħra li jtawwlu l-interval PR, jew mard tal-qalb sever (e.ż. storja ta' infart mijokardijaku, insuffiċjenza tal-qalb) għandhom jiġu segwiti mill-viċin meta d-doża ta' lacosamide tkun akbar minn 400 mg/ġurnata (Ara Metodu ta' teħid hawn taħt u s-sezzjoni 4.4).
English: The treatment initiation pack contains 4 cartons, each carton with 14 Lacosamide UCB film-coated tablets of 50 mg, 100 mg, 150 mg and 200 mg.
Maltese: Il-pakkett tal-bidu tat-trattament fih 4 kaxxi, kull kaxxa b'14-il pillola Lacosamide UCB miksija b'rita ta'50 mg, 100 mg, 150 mg u 200 mg.
English: The requirements for submission of periodic safety update 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 web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurta` għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornamenti sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: If you are taking Lacosamide UCB and you are experiencing symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek medical advice immediately (see section 4).
Maltese: Jekk qed tieħu Lacosamide UCB u qed tesperjenza sintomi ta' taħbit tal-qalb mhux normali (bħal taħbit tal-qalb bil-mod, mgħaġġel jew irregolari, palpitazzjonijiet, qtugħ ta' nifs, tħossok sturdut/a, ħass ħażin) fittex parir mediku immedjatament (ara sezzjoni 4).
English: For longer term treatment Lacosamide UCB tablets and syrup are available.
Maltese: Għal trattament fit-tul, hemm disponibbli Lacosamide UCB pilloli u mistura.
English: INFORMATION IN BRAILLE Lacosamide UCB 10 mg/ml (only for the outer carton)
Maltese: INFORMAZZJONI BIL-BRAILLE Lacosamide UCB 10 mg/ml (għall-pakkett ta' barra biss)
English: One tablet of Lacosamide UCB 100 mg contains 100 mg lacosamide.
Maltese: Pillola waħda ta' Lacosamide UCB 100 mg fiha 100 mg lacosamide.
English: Discontinuation
Maltese: Astenja
English: Conversion to or from oral and intravenous administration can be done directly without titration.
Maltese: Konverżjoni għal jew minn amministrazzjoni orali u ġol-vini tista' ssir direttament mingħajr titrazzjoni.
English: Adjunctive therapy doses to be taken twice daily for children and adolescents from 4 years of age weighing 20 kg to under 30 kg(1):
Maltese: Dożi ta' terapija aġġuntiva li għandhom jittieħdu darbtejn kuljum għal tfal u adoloxxenti minn 4 snin ta' età li jiżnu 20 kg sa inqas minn 30 kg (1):
English: In reproductive and developmental toxicity studies in rodents and rabbits, no teratogenic effects but an increase in numbers of stillborn pups and pup deaths in the peripartum period, and slightly reduced live litter sizes and pup body weights were observed at maternal toxic doses in rats corresponding to systemic exposure levels similar to the expected clinical exposure.
Maltese: F'studji dwar l-effett tossiku fuq ir-riproduzzjoni u l-iżvillup f' annimali gerriema u ġrieden, ma kienux osservati effetti teratoġeniċi imma kien hemm żieda fin-numru ta' frieħ li twieldu mejta u mwiet ta' frieħ fil-perjodu ta' wara t-twelid u tnaqqis żgħir ħafna fid-daqs tal-boton u fil-piz tal-frieħ b'dożi tossiċi fl-omm fil-firien li jikkorrespondu għal livelli ta' esponiment sistemiċi simili għal esponiment kliniku mistenni.
English: Lacosamide UCB solution for infusion was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in glass or PVC bags at temperatures up to 25°C.
Maltese: Lacosamide UCB soluzzjoni għall-infużjoni instab li kien fiżikament kompatibli u stabbli kimikament meta mħallat ma dawn id-dilwenti li ġejjin għal mill-inqas 24 siegħa u maħżuna fil-ħġieġ jew basket tal-PVC f'temperaturi sa 25ºC.
English: Using Lacosamide UCB with other antiepileptic medicines - Children above 4 years of age weighing less than 20 kg - This is for information only.
Maltese: Meta tuża Lacosamide UCB ma' mediċini ta' kontra l-epilessija oħra - Tfal ta' età 'l fuq minn 4 snin li jiżnu inqas minn 20 kg - Din hija għal skopijiet ta' informazzjoni biss.
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 10 mg/ml syrup
Maltese: IL-PRODOTT MEDIĊINALI Lacosamide UCB 10 mg/ml mistura
English: Lacosamide UCB is used in adults, adolescents and children aged 4 years and older.
Maltese: • Lacosamide UCB jintuża fl-adulti, fl-adoloxxenti u fit-tfal ta' 4 snin u aktar.
English: Adjunctive therapy doses to be taken twice daily for children and adolescents from 4 years of age weighing 30 kg to under 50 kg(1):
Maltese: Dożi ta' terapija aġġuntiva li għandhom jittieħdu darbtejn kuljum għal tfal u adoloxxenti minn 4 snin ta' età li jiżnu 30 kg sa inqas minn 50 kg (1):
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u il-folja wara EXP.
English: Elderly (over 65 years of age)
Maltese: Anzjani ( aktar minn 65 sena)
English: Liver function test abnormal(2)
Maltese: Testijiet talfunzjoni tal-fwied mhux normali(2)
English: Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
Maltese: • Rata ta' tħabbit tal-qalb mnaqqsa, palpitazzjonijiet, polz irregolari jew tibdil ieħor fl-attività elettrika ta' qalbek (disturb tal-konduzzjoni);
English: Ventricular tachyarrhythmia (1)
Maltese: Ipersensitivita` ghal mediċina(1)
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 10 mg/ml infusion lacosamide
Maltese: TAL-PRODOTT MEDIĊINALI Lacosamide UCB 10 mg/ml infużjoni lacosamide
English: PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 56 pilloli miksija b'rita.
English: Age associated decreased renal clearance with an increase in AUC levels should be considered in elderly patients (see following paragraph ‘renal impairment' and section 5.2).
Maltese: AUC assocjat ma' l-eta` (ara ‘Użu f'pazjenti b'indeboliment renali' hawn fuq u s-sezzjoni 5.2).
English: 1 bottle of 200 ml contains 2,000 mg lacosamide.
Maltese: Flixkun wieħed ta' 200 ml fih 2,000 mg lacosamide.
English: Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day).
Maltese: Skond ir-rispons u t-tolerabbilta¦, id-doża ta' manteniment tista' tiżdied aktar f'intervalli ta' ġimgħa b' 50 mg darbtejn kuljum (100 mg/ġurnata), sa doża massima rakkomandata ta' 300 mg darbtejn kuljum (600 mg/kuljum).
English: Carton 14 tablets - week 2
Maltese: Pakkett 14-il-pillola - ġimgħa 2
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 150 mg film-coated tablets <For 56 x 1 and 14 x 1 film-coated tablet> Lacosamide UCB 150 mg tablets lacosamide
Maltese: TAL-PRODOTT MEDIĊINALI Lacosamide UCB 150 mg pilloli miksija b'rita <Għal 56 x 1 u 14 x 1 pillola miksija b'rita> Lacosamide UCB 150 mg pilloli lacosamide
English: Based on the analysis of data from a non-inferiority monotherapy clinical trial comparing lacosamide to carbamazepine controlled release (CR), the most frequently reported adverse reactions (≥10%) for lacosamide were headache and dizziness.
Maltese: Ibbażat fuq l-analiżi ta' data minn prova klinika ta' monoterapija mhux inferjuri li tqabbel lacosamide ma' carbamazepine relaxx ikkontrollat (CR), l-iżjed reazzjonijiet avversi rapportati frekwentament (≥10%) għal lacosamide kienu uġiegħ ta' ras u sturdament.
English: The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (frequency cannot be estimated from available data).
Maltese: Il-frekwenzi ġew definiti bħala: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100) mhux magħruf (ma jistax jiġi kkalkulat middata disponibli).
English: Packs of 14, 28 and 56 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Maltese: Pakketti ta' 14, 28 u 56 pillola miksija b'rita f'folja tal-PVC/PVDC issiġillata b'fojl tal-aluminju.
English: Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Maltese: Lacosamide UCB huwa indikat bħala monoterapija u terapija miżjuda fit-trattament ta' aċċessjonijiet tat-tip ‘partial-onset' kemm b'ġeneralizzazzjoni sekondarja kif ukoll mingħajr, f'adulti, adoloxxenti u tfal mill-età ta' 4 snin b'epilessija.
English: Lacosamide did not affect the AUC of midazolam (metabolised by CYP3A4, lacosamide given 200 mg twice a day), but Cmax of midazolam was slightly increased (30 %).
Maltese: Lacosamide ma kellux effett fuq l-AUC ta' midazolam (immetabolizzat b' CYP3A4, lacosamide jingħata 200 mg darbtejn kuljum) imma is-Cmax ta' midazolam kienet miżjuda ftit (30%).
English: Starting dose: 0.1 ml/kg
Maltese: Doża tal-bidu : 0.1 ml/kg
English: This will be until you reach a maintenance dose of between 100 mg and 300 mg twice a day.
Maltese: Dan se jkun sakemm tilħaq id-doża ta' manteniment bejn 100 mg u 300 mg darbtejn kuljum.
English: Lacosamide UCB treatment initiation pack contains 4 different packages (one for each tablet strength) with 14 tablets each, for the first 2 to 4 weeks of therapy depending on the patient's response and tolerability.
Maltese: Il-pakkett tal-bidu tat-trattament Lacosamide UCB fih 4 pakketti differenti ( wieħed għal kull pillola ta' saħħa differenti) b'14 il-pillola kull wieħed, għall-ewwel 2 sa 4 ġimgħat ta' terapija skond irrispons u t-tollerabbilta` tal-pazjent.
English: Fall
Maltese: sodju
English: Conversion to monotherapy
Maltese: Bdil għal monoterapija
English: Lacosamide should be used with caution in patients with underlying proarrhythmic conditions such as patients with known cardiac conduction problems or severe cardiac disease (e.g. myocardial ischaemia/infarction, heart failure, structural heart disease or cardiac sodium channelopathies) or patients treated with medicinal products affecting cardiac conduction, including antiarrhythmics and sodium channel blocking antiepileptic medicinal products (see section 4.5), as well as in elderly patients.
Maltese: Ġie osservat titwil relatat mad-doża fl-interval PR b'lacosamide f'studji kliniċi. Lacosamide għandu jintuża b'kawtela f'pazjenti b'kondizzjonijiet proarritmiċi sottostanti bħal pazjenti bi problemi magħrufa ta' konduzzjoni kardijaka jew mard tal-qalb sever (e.ż. iskemja/infart mijokardijaku, insuffiċjenza tal-qalb,, mard tal-qalb strutturali jew kanalopatiji tas-sodju kardijaċi) jew pazjenti kkuratipazjenti trattati bi prodotti mediċinali li jaffettwawjaffettwaw il-konduzzjoni kardijaka, inkluż antiarritmiċi u prodotti mediċinali antiepilettiċi li jimblokkawjimblokkaw il-kanal tas-sodju (ara sezzjoni 4.5), kif ukoll f'pazjenti anzjani.
English: There is experience with twice daily infusions of Lacosamide UCB for up to 5 days.
Maltese: Hemm esperjenza b'infużjonijiet ta' darbtejn kuljum ta' Lacosamide UCB sa 5 ijiem.
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 200 mg film-coated tablets <For 56 x 1 and 14 x 1 film-coated tablet> Lacosamide UCB 200 mg tablets lacosamide
Maltese: TAL-PRODOTT MEDIĊINALI Lacosamide UCB 200 mg pilloli miksija b'rita <Għal 56 x 1 u 14 x 1 pillola miksija b'rita> Lacosamide UCB 200 mg pilloli lacosamide
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution for infusion contains 10 mg lacosamide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull ml ta' soluzzjoni għall-infużjoni fih 10 mg lacosamide.
English: EU/1/19/1383/004 14 film-coated tablets EU/1/19/1383/005 14 x 1 film-coated tablet EU/1/19/1383/006 28 film-coated tablets EU/1/19/1383/007 56 film-coated tablets EU/1/19/1383/008 56 x 1 film-coated tablet EU/1/19/1383/009 168 film-coated tablets
Maltese: EU/1/19/1383/004 14 pilloli miksija b'rita EU/1/19/1383/005 14 x 1 pillola miksija b'rita EU/1/19/1383/006 28 pilloli miksija b'rita EU/1/19/1383/007 56 pilloli miksija b'rita EU/1/19/1383/008 56 x 1 pillola miksija b'rita EU/1/19/1383/009 168 pilloli miksija b'rita
English: Each ml of syrup contains 10 mg lacosamide.
Maltese: Kull ml ta' mistura fih 10 mg lacosamide.
English: (1) children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 10 mg/ml syrup (2) Dosage in adolescents 50 kg or more is the same as in adults.
Maltese: 9 ml (90 mg) (1) Tfal u adoloxxenti inqas minn 50 kg għandhom preferibbilment jibdew b'Lacosamide UCBit-trattament 10 mg/ml mistura.
English: Take the oral syringe out of the adaptor (figure 10).
Maltese: • Oħroġ is-siringa orali mill-adapter (figura 10).
English: The other ingredients are:
Maltese: Mhux magħruf:
English: • A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
Maltese: • Raxx estiż b'bżieżaq u ġilda li titqaxxar, partikolarment madwar il-ħalq, nmieħer, għajnejn u ġenitali (Sindromu ta' Stevens-Johnson) u forma aktar severa ta'tqaxxir tal-ġilda f'iżjed minn 30% tal-wiċċ tal-ġilda (nekroliżi tossiku epidermali);
English: Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25°C for product mixed with the diluents mentioned in 6.6 and stored in glass or PVC bags.
Maltese: L-istabbilta`kimika u fiżika waqt l-użu kien muri għal 24 siegħa f'temperaturi sa 25ºC għal prodotti mħallta ma' diwenti msemmija f' 6.6 u maħżunin fil-ħġieġ jew boroż tal-PVC.
English: Dry mouth
Maltese: Viżżjoni mċajpra
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 100 mg film-coated tablets <For 56 x 1 and 14 x 1 film-coated tablet> Lacosamide UCB 100 mg tablets lacosamide
Maltese: TAL-PRODOTT MEDIĊINALI Lacosamide UCB 100 mg pilloli miksija b'rita <Għal 56 x 1 u 14 x 1 pillola miksija b'rita> Lacosamide UCB 100 mg pilloli lacosamide
English: PVC/PVDC blister sealed with an aluminium foil.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folja tal-PVC/PVDC siġillata b'fojl tal-aluminju.
English: EU/1/19/1383/010 14 film-coated tablets EU/1/19/1383/011 14 x 1 film-coated tablet EU/1/19/1383/012 28 film-coated tablets EU/1/19/1383/013 56 film-coated tablets EU/1/19/1383/014 56 x 1 film-coated tablet EU/1/19/1383/015 168 film-coated tablets
Maltese: EU/1/19/1383/010 14 pilloli miksija b'rita EU/1/19/1383/011 14 x 1 pillola miksija b'rita EU/1/19/1383/012 28 pilloli miksija b'rita EU/1/19/1383/013 56 pilloli miksija b'rita EU/1/19/1383/014 56 x 1 pillola miksija b'rita EU/1/19/1383/015 168 pilloli miksija b'rita
English: * The colourants are:
Maltese: * Is-sustanzi koloranti huma:
English: Aggression Agitation(1) Euphoric mood(1)
Maltese: Agitazzjoni(1) Burdata ewforika(1) Mard psikotiku(1)
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 50 mg film-coated tablets <For 56 x 1 and 14 x 1 film-coated tablet> Lacosamide UCB 50 mg tablets lacosamide
Maltese: TAL-PRODOTT MEDIĊINALI Lacosamide UCB 50 mg pilloli miksija b'rita <Għal 56 x 1 u 14 x 1 pillola miksija b'rita> Lacosamide UCB 50 mg pilloli lacosamide
English: In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of the O-desmethyl metabolite but the main contributing isoenzyme has not been confirmed in vivo.
Maltese: Data in vitro juri li CYP2C9, CYP2C19 u CYP3A4 jistgħu jikkatalizzaw il-formazzjoni tal-prodott tal-metaboliżmu O- desmethyl iżda l-isoenzyme li prinċiparjament jieħu sehem ma ġiex ikkonfermat in vivo.
English: Children and adolescents weighing less than 50 kg Use the oral syringe provided in the carton box.
Maltese: Tfal u adoloxxenti li jiżnu inqas minn 50 kg • Uża s-siringa orali pprovduta fil-kaxxa tal-kartun.
English: After oral and intravenous administration of radiolabeled lacosamide, approximately 95 % of radioactivity administered was recovered in the urine and less than 0.5 % in the faeces.
Maltese: Wara t-teħid orali u minn ġol-vina ta' lacosamide radjutikkettat, madwar 95% tarradju-attivita` li ngħatat kienet misjuba fl-awrina u inqas minn 0.5% fl-ippurgar.
English: INFORMATION IN BRAILLE Lacosamide UCB 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Lacosamide UCB50 mg
English: Fill the measuring cup to the millilitre (ml) dose marker prescribed by your doctor.
Maltese: Imla t-tazza ta' kejl sal-markatur tad-doża tal-millimetru (ml) ippreskrivit mit-tabib tiegħek.
English: Adolescents and children weighing 50 kg or more and adults When you take Lacosamide UCB on its own
Maltese: Adoloxxenti u tfal li jiżnu 50 kg jew aktar u adulti biss
English: 6.1 List of excipients water for injections sodium chloride hydrochloric acid (for pH adjustment)
Maltese: Hydrochloric acid (għall-aġġustament tal-pH)
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 150 mg film-coated tablets lacosamide
Maltese: TAL-PRODOTT MEDIĊINALI Lacosamide UCB 150 mg pilloli miksija b'rita lacosamide
English: Such interactions have not been established in vivo but are possible based on in vitro data.
Maltese: Interazzjonijiet bħal dawn ma ġewx stabbiliti in vivo imma huma possibilment ibbażati fuq data in vitro.
English: In children from 4 years of age with a body weight of under 20 kg: the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
Maltese: Id-doża tal-bidu li normalment tingħata hija ta' 1 mg (0.1 ml), għal kull kilogramma (kg) tal-piż talġisem, darbtejn kuljum.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution contains 10 mg lacosamide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull ml ta' soluzzjoni għall-infużjoni fiħ 10 mg lacosamide.
English: Using Lacosamide UCB with other antiepileptic medicines - Children and adolescents with a body weight of 30 kg to under 50 kg - This is for information only.
Maltese: Meta tuża Lacosamide UCB ma' mediċini ta' kontra l-epilessija oħra - Tfal u adoloxxenti b'piż talġisem min 30 kg sa inqas minn 50 kg - Din hija għal skopijiet ta' informazzjoni biss.
English: The paediatric pharmacokinetic profile of lacosamide was determined in a population pharmacokinetic analysis using sparse plasma concentration data obtained in one placebo-controlled randomised study and three open-label studies in 414 children with epilepsy aged 6 months to 17 years.
Maltese: Il-profil farmakokinetiku pedjatriku ta' lacosamide ġie stabbilit f'analiżi farmakokinetika talpopolazzjoni permezz ta' data dwar il-konċentrazzjoni tal-plasma miksuba fi studju randomizzat ikkontrollat bil-plaċebo u tliet studji open-label f'414 tifel/tifla b'epilessija ta' bejn 6 xhur u 17-il sena.