FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes.
Maltese: Studji in vitro elettrofiżjoloġiċi wrew li lacosamide jinkoraġġixxi selettivament linattivazzjoni bil-mod tal-kanali voltage-gated tas-sodju, li jirrisulta fl-istabilta` tal-membrani newronali ipereċċitabbli.
English: Lacosamide UCB 150 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Maltese: Lacosamide UCB 150 mg <Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata> 56 x 1 u 14 x 1 pillola miksija b'rita
English: Lacosamide 600 mg/day was also shown to be effective in controlled adjunctive therapy trials, although the efficacy was similar to 400 mg/day and patients were less likely to tolerate this dose because of CNS- and gastrointestinal-related adverse reactions.
Maltese: Lacosamide 600 mg/ġurnata kien muri effettiv fi provi b'terapija miżjuda kkontrollati, għalkemm l-effikaċja kienet simili għal 400 mg/ġurnata u l-pazjenti x'aktarx inqas ittolleraw din id-doża minħabba reazzjonijiet mhux mixtieqa relatati mas-CNS u dawk gastro-intestinali.
English: EU/1/19/1383/022 14 film-coated tablets EU/1/19/1383/023 14 x 1 film-coated tablet EU/1/19/1383/024 28 film-coated tablets EU/1/19/1383/025 56 film-coated tablets EU/1/19/1383/026 56 x 1 film-coated tablet
Maltese: EU/1/19/1383/022 14 pilloli miksija b'rita EU/1/19/1383/023 14 x 1 pillola miksija b'rita EU/1/19/1383/024 28 pilloli miksija b'rita EU/1/19/1383/025 56 pilloli miksija b'rita EU/1/19/1383/026 56 x 1 pillola miksija b'rita EU/1/19/1383/027 56 x 1 pillola miksija b'rita
English: Each vial contains 20 ml.
Maltese: Kull vjala fiha 20 ml.
English: Lacosamide UCB 10 mg/ml solution for infusion lacosamide
Maltese: Lacosamide UCB 10 mg/ml soluzzjoni għall-infużjoni lacosamide
English: Children and adolescents weighing less than 50 kg Use the oral syringe and the adaptor provided in this pack.
Maltese: Tfal u adoloxxenti li jiżnu inqas minn 50 kg • Uża s-siringa orali u l-adapter ipprovduti f'dan il-pakkett.
English: Taking Lacosamide UCB with other antiepileptic medicines - Children and adolescents with a body weight of 20 kg to under 30 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 20 kg sa inqas minn 30 kg - Din hija għal skopijiet ta' informazzjoni biss.
English: Glycerol (E422)
Maltese: N03AX18
English: Based on the analysis of pooled placebo-controlled clinical trials in adjunctive therapy in 1,308 patients with partial-onset seizures, a total of 61.9 % of patients randomised to lacosamide and 35.2 % of patients randomised to placebo reported at least 1 adverse reaction.
Maltese: Skond l-analiżi ta' provi kliniċi ikkontrollati bil-plaċebo dwar terapija aġġuntiva miġbura minn 1,308 pazjent b' aċċessjonijiet tat-tip partial-onset, total ta' 61.9% tal-pazjenti magħżula bl-addoċċ biex jieħdu lacosamide u 35.2% tal-pazjenti magħżula bl-addoċċ biex jieħdu l-plaċebo irrappurtaw millinqas reazzjoni mhux mixtieq wieħed.
English: Open the bottle by pressing the cap while turning it anti-clockwise (figure 1).
Maltese: Iftaħ il-flixkun billi tippressa t-tapp waqt li ddawru kontra l-arloġġ (figura 1).
English: Treatment initiation pack (in adolescent and children weighing 50 kg or more and adults only) Lacosamide UCB 50 mg film-coated tablets
Maltese: Pakkett tal-bidu tat-trattament (f'adoloxxenti u tfal li jiżnu 50 kg jew aktar u adulti biss) Lacosamide UCB 50 mg pilloli miksija b'rita
English: Dizziness Headache
Maltese: Użu minn ġol-vina
English: Each vial of 20 ml solution for infusion contains 200 mg lacosamide.
Maltese: Kull fjala ta' 20 ml ta' soluzzjoni għall-infużjoni fiha 200 mg ta'lacosamide.
English: Eligible patients on a stable dose regimen of 1 to ≤ 3 antiepileptic medicinal products, who still experienced at least 2 partial onset seizures during the 4 weeks prior to screening with seizure-free phase no longer than 21 days in the 8-week period prior to entry into the baseline period, were randomised to receive either placebo (n=172) or lacosamide (n=171).
Maltese: Il-pazjenti eliġibbli fuq reġim ta' dożaġġ stabbli ta' bejn 1 u ≤ 3 prodotti mediċinali antiepilettiċi, li esperjenzaw mill-inqas żewġ aċċessjonijiet b'feġġa parzjali matul 1-4 ġimgħat ta' qabel l-eżami b'fażi mingħajr aċċessjonijiet mhux itwal minn 21 jum fil-perjodu ta' 8 ġimgħat qabel id-dħul fil-perjodu ta' linja bażi, ġew randomizzati biex jirċievu jew plaċebo (n=172) jew lacosamide (n=171).
English: BATCH NUMBER
Maltese: Pakkett tan-nofs
English: Salmon, oval film-coated tablets with approximate dimensions of 15.1 mm x 7.0 mm, and debossed with ‘SP' on one side and ‘150' on the other side.
Maltese: 1 mm x 7.0 mm, b'‘SP' imnaqqax fuq naħa waħda u ‘150' fuq in-naħa l-oħra.
English: Lacosamide UCB 200 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Maltese: Lacosamide UCB 200 mg <Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata> 56 x 1 u 14 x 1 pillola miksija b'rita
English: Dark yellow, oval film-coated tablets with approximate dimensions of 13.2 mm x 6.1 mm, and debossed with ‘SP' on one side and ‘100' on the other side.
Maltese: Pilloli miksija b'rita ovali, sofor skuri, b'dimensjonijiet ta' madwar 13.2 mm x 6.1 mm, u mnaqqxin b'‘SP' imnaqqxa fuq naħa waħda u ‘100' fuq in-naħa l-oħra.
English: Strawberry flavour (contains propylene glycol, maltol) Masking flavour (contains propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol, deionised water) purified water
Maltese: 6.1 Lista ta' eċċipjenti glycerol (E422) carmellose sodium sorbitol liquid (crystallizing) (E420) polyethylene glycol 4000 sodium chloride citric acid, anhydrous acesulfame potassium (E950) sodium methylparahydroxybenzoate (E219) togħma ta' frawli (fih propylene glycol maltol, deionised water) masking flavour (fih propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol deionised water) ilma purifikat
English: In a study in elderly men and women including 4 patients > 75 years of age, AUC was about 30 and 50 % increased compared to young men, respectively.
Maltese: F'studji fl-anzjani, irġiel u nisa inkluż 4 pazjenti > 75 sena, AUC kien rispettivament madwar 30 u 50% ogħla meta mqabbla ma' dak f'irġiel ta' età żgħira.
English: Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adolescents and children from 4 years of age weighing 50 kg or more and in adults 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, addoloxxenti u tfal mill-età ta' 4 snin b'epilessija.
English: In children weighing from 40 to under 50 kg, a maximum dose of 10 mg/kg/day is recommended.
Maltese: Fi tfal li jiżnu minn 40 sa inqas minn 50 kg, hija rrakkomandata doża massima ta' 10 mg/kg/jum.
English: Irritability Feeling drunk
Maltese: Għajja Irritability
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for infusion contains 10 mg lacosamide.
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni għall-infużjoni fih 10 mg ta'lacosamide.
English: Lacosamide UCB 50 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Maltese: Lacosamide UCB 50 mg <Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata> 56 x 1 u 14 x 1pillola miksija b'rita
English: Caution is recommended in concomitant treatment with strong inhibitors of CYP2C9 (e.g. fluconazole) and CYP3A4 (e.g. itraconazole, ketoconazole, ritonavir, clarithromycin), which may lead to increased systemic exposure of lacosamide.
Maltese: (e.ż. itraconazole, ketoconazole, ritonavir, clarithromycin), li jistgħu jwasslu għal żieda fl-esponiment sistemiku ta' lacosamide.
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 200 mg film-coated tablets lacosamide
Maltese: TAL-PRODOTT MEDIĊINALI Lacosamide UCB 200 mg pilloli miksija b'rita lacosamide
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 10 mg/ml syrup lacosamide
Maltese: TAL-PRODOTT MEDIĊINALI Lacosamide UCB 10 mg/ml mistura lacosamide
English: Lacosamide UCB 100 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Maltese: Lacosamide UCB 100 mg <Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata> 56 x 1 u 14 x 1 pillola miksija b'rita
English: Lacosamide UCB may make you dizzy - this could increase the risk of accidental injury or a fall.
Maltese: Lacosamide UCB jista' jistordik - dan jista' jżid ir-riskju ta'
English: EU/1/19/1383/016 14 film-coated tablets EU/1/19/1383/017 14 x 1 film-coated tablet EU/1/19/1383/018 28 film-coated tablets EU/1/19/1383/019 56 film-coated tablets EU/1/19/1383/020 56 x 1 film-coated tablet
Maltese: EU/1/19/1383/016 14 pilloli miksija b'rita EU/1/19/1383/017 14 x 1 pillola miksija b'rita EU/1/19/1383/018 28 pilloli miksija b'rita EU/1/19/1383/019 56 pilloli miksija b'rita EU/1/19/1383/020 56 x 1 pillola miksija b'rita
English: Pregnancy and breast-feeding
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIKI
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 50 mg film-coated tablets lacosamide
Maltese: TAL-PRODOTT MEDIĊINALI Lacosamide UCB 50 mg pilloli miksija b'rita lacosamide
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: (2) Dosage in adolescents 50 kg or more is the same as in adults.
Maltese: Adoloxxenti u tfal li jiżnu 50 kg jew aktar u adulti
English: (4) Local adverse reactions associated with intravenous administration.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: If you take more than 12.5 ml of syrup each day and are on a controlled sodium diet, take this into consideration.
Maltese: Jekk tieħu aktar minn 12.5 ml ta' mistura kuljum u qiegħed fuq dieta ta' sodju ikkontrollat, ikkunsidra dan.
English: the package marked ‘Week 2' contains 14 tablets of 100 mg,
Maltese: • il-pakkett immarkat ‘ Ġimgħa 2'14-il pillola ta' 100 mg,
English: Balance disorder Memory impairment Cognitive disorder Somnolence Tremor
Maltese: Taqlib tal-bilanċ Indeboliment talmemorja Mard talkonjizzjoni Ngħas
English: Lacosamide UCB 150 mg film-coated tablets
Maltese: Lacosamide UCB 150 mg pilloli miksija b'rita
English: the package marked ‘Week 3' contains 14 tablets of 150 mg,
Maltese: • il-pakkett immarkat ‘ Ġimgħa 3'14-il pillola ta' 150 mg,
English: Tel: + 48 22 696 99 20
Maltese: UCB Pharma Sp. z o.o. Tel.: + 48 22 696 99 20
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 elettronikutal-Aġenzija Ewropea għallMediċini : http://www.ema.europa.eu/.
English: Lacosamide UCB 50 mg film-coated tablets
Maltese: Lacosamide UCB 50 mg pilloli miksijin b'rita
English: Uncommon: may affect up to 1 in 100 children Feeling sleepy or lacking in energy (lethargy).
Maltese: Mhux komuni: jistgħu jaffettwaw sa 1 minn kull 100 tifel jew tifla • Iħossuhom bi ngħas jew b'nuqqas ta' enerġija (letarġija).
English: Taking Lacosamide UCB with other antiepileptic medicines - Children above 4 years of age weighing less than 20 kg - This is for information only.
Maltese: Meta tieħu 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: The maximum recommended dose is 400 mg/day.
Maltese: Id-doża massima rrikkmandata hija 400 mg/ġurnata.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 film-coated tablet contains 150 mg lacosamide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Pillola miksija b'rita waħda fiha 150 mg lacosamide.
English: UCB Pharma Sp. z o.o.
Maltese: UCB Pharma S.p.A.
English: Thus, the 600 mg/day dose is not recommended.
Maltese: Għalhekk id-doża ta' 600 mg/ġurnata mhix rakkomandata.
English: Cardiac disorders
Maltese: Ritmu u konduzzjoni kardijaċi
English: Other medicines and Lacosamide UCB
Maltese: Mediċini oħra u Lacosamide UCB
English: Lacosamide should be administered to adult and paediatric patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks.
Maltese: Lacosamide għandu jingħata lil pazjenti adulti u pedjatriċi b'indeboliment sever talfwied meta l-benefiċċji terapewtiċi mistennija huma akbar mir-riskji possibli.
English: Carton 14 tablets - week 3
Maltese: Pakkett tan-nofs Pakkett 14-il-pillola - ġimgħa 3
English: The administered lacosamide doses ranged from 2 to 17.8 mg/kg/day in twice daily intake, with a maximum of 600 mg/day for children weighing 50 kg or more.
Maltese: Id-dożi amministrati ta' lacosamide varjaw minn 2 sa 17.8 mg/kg/jum f'teħid darbtejn kuljum, b'massimu ta' 600 mg/jum għal tfal li jiżnu 50 kg jew aktar.
English: Lacosamide UCB 200 mg film-coated tablets
Maltese: Lacosamide UCB 200 mg pilloli miksija b'rita
English: No adverse reactions on male or female fertility or reproduction were observed in rats at doses producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the maximum recommended human dose (MRHD).
Maltese: L'ebda effetti avversi fuq il-fertilita`maskili jew feminili jeww ir-riproduzzjoni fil-firien ġeww osservati b'dożi li jipproduċu espożizzjonijiet fil-plażma (AUC) sa madwar darbtejn l-AUC tal-plażma fil-bniedem bid-doża massima rrikkmandata fil-bniedem (MRHD).
English: The most frequently reported adverse reactions (≥ 10 %) with lacosamide treatment were dizziness, headache, nausea and diplopia.
Maltese: L-iżjed effett mhux mixtieq li ġie rappurtat (≥10%) b'lacosamide kienu sturdament, uġigħ ta' ras, dardir u diplowpja.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for lacosamide.
Maltese: Il-mekkaniżmu ta' dan ir-riskju mhux magħruf u d-data preżenti ma teskludix il-possibilta` ta' żieda fir-riskju b' lacosamide.
English: Thus, moderate inhibitors of CYP2C19 are unlikely to affect systemic lacosamide exposure to a clinically relevant extent.
Maltese: Għalhekk, inhibituri moderati ta' CYP2C19, x'aktarx mhumiex ser jaffettwaw l-esponiment sistemiku ta' lacosamide sa punt li hu klinikament relevant.
English: Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have been reported in patients treated with some antiepileptic medicinal products.
Maltese: Reazzjonijiet ta' sensittivita` eċċessiva f' organi multipli Sensittivita' eċċessiva f' organi multipli (bħal Reazzjoni tal-mediċina b'Esinofilja u Sintomi sistemiċi, DRESS) kienu rrapportati f'pazjenti trattati b'xi prodotti mediċinali ta' kontra l-epilessija.
English: Interaction trials showed that lacosamide had no effect on the pharmacokinetics of digoxin.
Maltese: Ilkonċentrazzjonijiet ta' progesterone ma kienux affetwati meta l-prodotti mediċinali ngħataw flimkien.
English: These differences between elderly and younger adult patients were similar to those observed in the active comparator group.
Maltese: Dawn id-differenzi bejn anzjani u pazjenti adulti iżgħar kienu simili ma' dawk osservati fil-grupp ta' qbil attiv.
English: Carton of 168 film-coated tablets containing 3 Cartons of 56 film-coated tablets (with Blue box)
Maltese: Kartuna ta' 168 pillola miksija b'rita li fihom 3 Kartuniet ta' 56 pillola miksija b'rita(bil-Blue box)
English: After this, each graduation mark (0.25 ml) corresponds to 2.5 mg of lacosamide (for example 4 graduation marks corresponds to 10 mg).
Maltese: Wara dan, kull marka ta' kejl (0.25 ml) tikkorrispondi għal 2.5 mg ta' lacosamide (pereżempju 4 marki ta' kejl jikkorrispondu għal 10 mg).
English: There is limited clinical data in the elderly patients with epilepsy, particularly at doses greater than 400 mg/day (see sections 4.4, 4.8, and 5.1).
Maltese: Hemm data klinika limitata f' anzjani partikolarment f'dożi akbar minn 400 mg/ġurnata (ara sezzjonijiet 4,4.
English: • The other ingredients are:
Maltese: Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq:
English: These trials, involving 1,308 patients with a history of an average of 23 years of partial-onset seizures, were designed to evaluate the efficacy and safety of lacosamide when administered concomitantly with 1-3 antiepileptic medicinal products in patients with uncontrolled partial-onset seizures with or without secondary generalisation.
Maltese: Dawn il-provi li inkludew 1308 pazjenti b'storja ta' medja ta' 23 sena ta' aċċessjonijiet ta' tip partial onset, kienu ddiżinjati sabiex jitkejlu l-effikaċja u s-sigurta' ta' lacosamide meta jingħata flimkien ma' 1-3 prodotti mediċinali ta' kontra l-epilessija f'pazjenti b' aċċessjonijiet mhux kontrollati tat-tip partial onset kemm bi kif ukoll mingħajr ġeneralizzazzjoni sekondarja.
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 400 mg (200 mg twice a day).
Maltese: Id-doża ta' manteniment tista' tkompli tiġi miżjuda f'intervalli ta' 50 mg darbtejn kuljum (100 mg/ġurnata) sa doża massima ta' kuljum rakkomandata ta' 400 mg (200 mg darbtejn kuljum), skond ir-rispons u t-tolerabbilta`.
English: The minimum extractable volume is 1 ml which is 10 mg of lacosamide.
Maltese: Il-volum minimu li jista' jinstilet huwa 10 mg ta' lacosamide.
English: Furthermore an interaction trial with omeprazole (CYP2C19-inhibitor) demonstrated no clinically relevant changes in lacosamide plasma concentrations indicating that the importance of this pathway is minor.
Maltese: Barra minn dan, prova ta' interazzjoni b' omeprazole (inibitur-CYP 2C19) m'urietx tibdil klinikament relevanti filkonċentrazzjonijiet ta' lacosamide fil-plażma li indika li l-importanza ta' dan is-sensiela ta' reazzjonijiet hija żgħira.
English: Wash the oral syringe with water only (figure 13).
Maltese: • Aħsel is-siringa orali bl-ilma biss (figura 13).
English: A maximum dose of 250 mg/day is recommended for paediatric patients weighing 50 kg or more and for adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal disease.
Maltese: Doża massima ta' 250 mg/ġurnata hija rakkomandata għal pazjenti pedjatriċi li jiżnu 50 kg jew aktar u pazjenti adulti b'indeboliment sever tal-kliewi (CLCR ≤30 ml/min) jew b'mard tal-kliewi fl'aħħar fażi u trid tittieħed attenzjoni meta tiġi titrata d-doża.
English: A spinning sensation (vertigo), feeling drunk;
Maltese: • Sensazzjoni li kollox idur bik (vertigo), tħossok fis-sakra;
English: The measuring cup is suitable for adults, adolescents and children weighing 50 kg and above.
Maltese: It-tazza ta' kejl hija adattata għall-adulti, l-adoloxxenti u t-tfal li jiżnu 50 kg jew aktar.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1383/021
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1383/021
English: Lacosamide UCB 100 mg film-coated tablets
Maltese: Lacosamide UCB 100 mg pilloli miksija b'rita
English: Taking 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 tieħu 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: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1383/027
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1383/027
English: Following a 4-hour haemodialysis treatment, AUC of lacosamide is reduced by approximately 50 %.
Maltese: Wara trattament t'emodijaliżi ta' 4 sigħat, AUC ta' lacosamide kien mnaqqas b'madwar 50%.
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 100 mg film-coated tablets lacosamide
Maltese: TAL-PRODOTT MEDIĊINALI Lacosamide UCB 100 mg pilloli miksija b'rita lacosamide
English: Acesulfame potassium (E950)
Maltese: TWISSIJA(IET) SPEĊJALI
English: In paediatric patients weighing 50 kg or more and in adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal disease, a maximum dose of 250 mg/day is recommended and the dose titration should be performed with caution.
Maltese: F'pazjenti pedjatriċi li jiżnu 50 kg jew iktar u għal pazjenti adulti b'indeboliment sever tal-kliewi (CLCR ≤30 ml/min) jew b'marda renali tal-aħħar fażi, hija rrakkomandata doża massima ta' 250 mg/kuljum.
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni: jistgħu jaffettwaw sa persuna 1 minn 100
English: When you take Lacosamide UCB with other antiepileptic medicines The usual starting dose of Lacosamide UCB is 50 mg twice a day.
Maltese: Meta tieħu Lacosamide UCB ma' mediċini ta' kontra l-epilessija oħra Id-doża tal-bidu ta' Lacosamide UCB li normalment tingħata hija ta' 50 mg darbtejn kuljum.
English: Drug hypersensitivity(1)
Maltese: Nekroliżi tossiku epidermali(1)
English: Each graduation mark (5 ml) of the measuring cup corresponds to 50 mg of lacosamide (for example 2 graduation marks correspond to 100 mg).
Maltese: Kull marka ta' kejl (5 ml) tat-tazza ta' kejl tikkorrespondi għal 50 mg lacosamide.
English: However, a higher incidence (≥ 5 % difference) of fall, diarrhoea and tremor has been reported in elderly patients compared to younger adult patients.
Maltese: Madanakollu, inċidenza akbar (≥5% differenza) ta' waqgħa, dijarea u rogħda kien rappurtat f'pazjenti anzjani meta mqabbla ma' pazjenti adulti iżgħar.
English: UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 395
Maltese: Tel: + 353 / (0)1-46 37 395
English: When you take Lacosamide UCB with other antiepileptic medicines - Start of the treatment (the first 4 weeks)
Maltese: Meta tieħu Lacosamide UCB ma' mediċini ta' kontra l-epilessija oħra - Il-Bidu tat-trattament (l-ewwel erba' ġimgħat)
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Maltese: {Isem u Indirizz} <{tel}> <{fax}> <{e-mail}>
English: 7 to 21 days.
Maltese: 7 sa 21 jum.
English: Usually at least 6 to 8 weeks.
Maltese: Normalment huwa għallinqas 6 sa 8 ġimgħat.
English: Up to 28 days.
Maltese: Sa 28 jum.
English: Immunosuppresors (i.e. ciclosporin, everolimus, sirolimus and tacrolimus):
Maltese: Immunosuppressuri (i.e. ciclosporin, everolimus, sirolimus u tacrolimus):
English: Breakpoints (according to EUCAST)
Maltese: Breakpoints (skont EUCAST)
English: - tinea pedis, - tinea corporis, - tinea cruris, - candida infections
Maltese: - tinea pedis, - tinea corporis, - tinea cruris, - infezzjonijiet b'candida
English: Cytochrome P450
Maltese: Ċitokromu P450
English: S = Susceptible, R = Resistant
Maltese: S = Suxxettibbli, R = Reżistenti
English: ≤50 (no dialysis) Regular dialysis
Maltese: ≤50 (ebda dijaliżi) Dijaliżi regolari
English: Adolescents from 12 to 17 years old
Maltese: Adoloxxenti minn 12 sa 17-il sena
English: Adolescents (from 12 to 17 years old):
Maltese: Adoloxxenti (minn 12 sa 17-il sena):
English: Maintenance dose: 6 months.
Maltese: Doża ta' manteniment: 6 xhur.
English: Fluconazole is a triazole antifungal agent.
Maltese: Fluconazole huwa sustanza antifungali triazole.
English: • Coccidioidomycosis (see section 4.4).
Maltese: • Coccidioidomycosis (ara sezzjoni 4.4).
English: Somnolence, insomnia
Maltese: Ngħas, insomnja
English: The mean AUC was 76.4 ± 20.3 µgh/ml, and the mean terminal half-life was 46.2 hours.
Maltese: L-AUC medju kien ta' 76.4 ± 20.3 µgh/ml, u l-half-life terminali medju kien ta' 46.2 sigħat.
English: Plasticised PVC bag.
Maltese: Boroż tal-PVC bil-plastik.
English: - Acute vaginal candidiasis - Candidal balanitis
Maltese: - Kandidjażi vaġinali akuta - Candidal balanitis