FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effect with ReproCyc ParvoFLEX (which may affect more than 1 in 10 animals) is short lived redness or swelling (up to 4 cm) at the injection site.
Maltese: (li jista' jaffettwa aktar minn annimal 1 minn 10) huwa ħmura jew nefħa għal żmien qasir (sa 4 cm) fis-sit tal-injezzjoni.
English: ReproCyc ParvoFLEX (inactivated porcine parvovirosis vaccine) EMA/153444/2019
Maltese: Ħarsa ġenerali lejn ReproCyc ParvoFLEX u għalfejn huwa awtorizzat fl-UE
English: For more information about using ReproCyc ParvoFLEX, see the package leaflet or contact your veterinarian or pharmacist.
Maltese: Għal aktar informazzjoni dwar l-użu ta' ReproCyc ParvoFLEX, aqra l-fuljett ta' tagħrif jew ikkuntattja lill-veterinarju jew lill-ispiżjar tiegħek.
English: When ReproCyc ParvoFLEX is given to female pigs the animals' immune system recognises the viral protein as ‘foreign' and makes antibodies against it.
Maltese: Meta ReproCyc ParvoFLEX jingħata lill-ħnieżer nisa, is-sistema immunitarja talannimali tagħraf il-proteina virali bħala “barranija” u tagħmel antikorpi kontriha.
English: Further information on Nityr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Nityr is a medicine used to treat hereditary tyrosinaemia type 1 (HT-1).
Maltese: Nityr huwa mediċina li tintuża biex tikkura tirożinemija ereditarja tat-tip 1 (HT-1).
English: Nityr contains the active substance nitisinone and is a ‘generic medicine'.
Maltese: Nityr fih is-sustanza attiva nitisinone u huwa “mediċina ġenerika”.
English: The recommended starting dose is 1 mg per kilogram body weight per day.
Maltese: Id-doża tal-bidu rrakkomandata hija 1 mg kull kilogramm tal-piż tal-ġisem kuljum.
English: Nityr is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine.
Maltese: Nityr jintuża flimkien ma' dieta li tillimita l-konsum tal-amino aċidi msejħa tirożina u fenilalanina.
English: The active substance in Nityr, nitisinone, blocks an enzyme that converts tyrosine into harmful substances.
Maltese: Is-sustanza attiva f'Nityr, in-nitisinon, timblokka enzima li tikkonverti t-tirożina f'sustanzi perikolużi.
English: Because Nityr is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Nityr huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: For more information on generic medicines, see the question-andanswer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument mistoqsijiet-u-tweġibiet hawnhekk.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Orfadin, and do not need to be repeated for Nityr.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat bil-mediċina ta' referenza, Orfadin, u ma għandhomx għalfejn jiġu ripetuti għal Nityr.
English: How has Nityr been studied?
Maltese: Kif ġie studjat Nityr?
English: These amino acids are normally found in proteins in foods and drinks.
Maltese: Dawn l-amino aċidi normalment jinstabu fil-proteini fl-ikel u fix-xorb.
English: This means that Nityr contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Orfadin.
Maltese: Dan ifisser li Nityr fih l-istess sustanza attiva u jaħdem bl-istess mod bħal "mediċina ta' referenza" diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Orfadin.
English: What are the benefits and risks of Nityr?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Nityr?
English: As for all medicines, data on the use of Nityr are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Nityr hija ssorveljata kontinwament.
English: Side effects reported with Nityr are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Nityr huma evalwati bir-reqqa u tittieħed kull azzjoni meħtieġa għallprotezzjoni tal-pazjenti.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Nityr has been shown to have comparable quality and to be bioequivalent to Orfadin.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Nityr wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Orfadin.
English: a special diet low in tyrosine.
Maltese: Id-dieta jrid ikollha wkoll livelli baxxi ta' fenilalanina, minħabba li din tinbidel f'tirożina fil-ġisem.
English: Other information about Nityr
Maltese: Informazzjoni oħra dwar Nityr
English: The MAH(s) should provide new randomised controlled data that will be able to robustly demonstrate that the benefits of calcitonin-containing medicines outweigh risks in patients with osteoporosis taking into account the increased risk of cancer and cancer mortality associated with long term use of calcitonin.
Maltese: Waqt provi kliniċi, pazjenti ttrattati b'calcitonin minħabba osteoporożi u osteoartrite kellhom żieda fir-riskju ta' kanċer wara lgħoti ta' trattament fit-tul.
English: In order to lift the suspension of the MA, National Competent Authorities shall ensure that the following conditions are fulfilled by the MAH(s) of intranasal formulations of calcitonin-containing medicines:
Maltese: Dawn il-provi wrew żieda fir-riskju assolut li jitfaċċa kanċer fost pazjenti ttrattati b'calcitonin meta mqabbel mal-plaċebo li kienet tvarja bejn 0.7% u 2.4% meta ngħatat terapija fit-tul.
English: Conditions for the lifting of the suspension of the Marketing Authorisations (intranasal formulations)
Maltese: Effetti sekondarji komuni: Kanċer (wara trattament fit-tul)
English: In vivo data
Maltese: Dejta in vivo
English: In vitro data
Maltese: Dejta in vitro
English: Double vision (diplopia).
Maltese: • Vista doppja (diplopja)
English: Syncope(2) Coordination abnormal
Maltese: Sinkope(2) Ko-ordinazzjoni abnormali
English: Convulsion(3)
Maltese: Konvulsjoni(3)
English: Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom or
Maltese: Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF
English: Packs of 14, 56, 60 or 168 tablets
Maltese: Pakketti ta' 14, 56, 60 jew 168 pillola
English: Film-coat: Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), lecithin (soya) and colorants* * The colorants are
Maltese: Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), leċitina (sojja) u sustanzi koloranti* * Is-sustanzi koloranti huma:
English: Rash(1)
Maltese: Raxx(1)
English: System organ class Very common
Maltese: Sistema talklassifika talorgani
English: The active substance, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a functionalised amino acid.
Maltese: Is-sustanza attiva, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) hija amino acid funzjonalizzat.
English: The percent reduction over placebo based on analysis of covariance was 31.72 % (95 % CI: 16.342, 44.277).
Maltese: Il-perċentwali ta' tnaqqis fuq il-plaċebo bbażat fuq l-analiżi tal-kovarjanza kien ta' 31.72 % (95 % CI: 16.342,44.277).
English: Itching, rash.
Maltese: Ħakk, raxx.
English: Convulsion.
Maltese: Konvulsjoni.
English: Elevations of ALT to ≥3x ULN occurred in 0.7 % (7/935) of Lacosamide patients and 0 % (0/356) of placebo patients.
Maltese: Livelli għolja ta' ALT sa ≥3x ULN seħħew f' 0.7% (7/935) tal-pazjenti fuq Lacosamide u 0% (0/356) tal-pazjenti fuq plaċebo.
English: Date of first authorisation: 18 September 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta 'Settembru 2017
English: Maximum recommended dose in patients ≥ 30 kg to < 50 kg up to 8 mg/kg/day
Maltese: Doża massima rakkomandata f'pazjenti ≥ 30 kg sa < 50 kg sa 8 mg/kg/jum
English: In vitro studies indicate that the enzymes CYP1A2, CYP2B6, and CYP2C9 are not induced and that CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP 2D6, and CYP2E1 are not inhibited by lacosamide at plasma concentrations observed in clinical trials.
Maltese: Studji in vitro juru li enżimi CPY1A2, CYP2B9, u CYP2C9 ma kienux indotti u li CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6, u CYP2E1 ma kienux inhibiti minn lacosamide fil-konċentrazzjonijiet tal-plażma osservati fil-provi kliniċi.
English: The typical plasma clearance was estimated to be 1.04 L/h, 1.32 L/h and 1.86 L/h for children weighing 20 kg, 30 kg and 50 kg respectively.
Maltese: L-eliminazzjoni tipika mill-plasma kienet 1.08 L/h, 1.40 L/h u 1.92 L/h għal tfal li jiżnu 20 kg, 30 kg u 50 kg, rispettivament.
English: • medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
Maltese: • mediċini għal infezzjonijiet fungali li jissejħu fluconazole, itraconazole jew ketoconazole;
English: Lacosamide Accord is available in packs of 14, 56, 60 or 168 film-coated tablets.
Maltese: Lacosamide Accord issibu f'pakketti ta' 14, 56, 60 jew 168 pillola.
English: In treated patients who completed titration and started withdrawing antiepileptic medicinal products ( 284 and 99 respectively), monotherapy was maintained in 71.5 % and 70.7 % of patients respectively for 57-105 days (median 71 days), over the targeted observation period of 70 days.
Maltese: Fil-pazjenti trattati li lestew it-titrazzjoni u bdew innaqqsu l-prodotti ta' kontra l-epilessija ( 284 u 99 rispettivament), monoterapija kienet mantenuta f' 71.5 % u 70.7 % tal-pazjenti rispettivament għal 57-105 ġurnata (medda ta' 71 ġurnata), fuq il-perjodu ta' osservazzjoni mmirrat ta' 70 ġurnata.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 September 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 18 ta 'Settembru 2017
English: 14 film-coated tablets 56 film-coated tablets 60 film-coated tablets 168 film-coated tablets 14 x 1 film-coated tablet 56 x 1 film-coated tablet
Maltese: 14-il pillola miksija b'rita 56 pillola miksija b'rita 60 pillola miksija b'rita 168 pillola miksija b'rita 14 x 1 pillola miksija b'rita 56 x 1 pillola miksija b'rita
English: 100 mg/day or 200 mg/day
Maltese: 100 mg/jum jew 200 mg/jum 100 mg/jum
English: • Lacosamide Accord is used in adults, adolescents and children aged 4 years and older.
Maltese: • Lacosamide Accord jintuża fl-adulti, fl-adoloxxenti u fit-tfal ta' 4 snin u aktar.
English: Microcrystalline cellulose Hydroxy propyl cellulose-L Hydroxy propyl cellulose (low substituted) Silica, colloidal, anhydrous Crospovidone
Maltese: Microcrystalline cellulose Hydroxy propyl cellulose-L Hydroxy propyl cellulose (sostitut b'mod baxx) Silica, colloidal, anhydrous Crospovidone
English: Lacosamide Accord contains lacosamide.
Maltese: Lacosamide Accord fih lacosamide.
English: Tablet core: Microcrystalline cellulose, hydroxy propyl cellulose-L, hydroxy propyl cellulose (low substituted), silica colloidal anhydrous, crospovidone and magnesium stearate.
Maltese: Microcrystalline cellulose, hydroxy propyl cellulose-L, hydroxy propyl cellulose (sostitut b'mod baxx), silica colloidal anhydrous, crospovidone and magnesium stearate.
English: The 14 x 1 or 56 x 1 tablet pack is available as perforated unit dose PVC-PVDC/Aluminium blisters sealed with an aluminium foil, all other packs are available with standard PVC-PVDC/Aluminium blisters sealed with an aluminium foil.
Maltese: Il-pakkett ta' 14 x 1 u 56 x 1 ssibu f'folji tal PVC/PVDC/Aluminju li jistgħu jinqasmu f'dożi singoli ssiġillati b'fojl tal-aluminju, il-pakketti l-oħra kollha ssibhom f'folji standard talPVC/PVDC/Aluminju ssiġillati b'fojl tal-aluminju.
English: Overall the proportion of subjects with a 50% reduction in seizure frequency was 23 %, 34 %, and 40 % for placebo, lacosamide 200 mg/day and lacosamide 400 mg/day.
Maltese: Il-proporzjon ta' persuni fuq kollox bi tnaqqis ta' 50% filfrekwenza ta' aċċessjonijiet kien ta' 23%, 34%,u 40% għal-plaċebo, lacosamide 200 mg/ġurnata u lacosamide 400 mg/ġurnata.
English: In adjunctive clinical trials in epilepsy patients, the incidence rate of reported first-degree AV Block is uncommon, 0.7 %, 0 %, 0.5 % and 0 % for lacosamide 200 mg, 400 mg, 600 mg or placebo, respectively.
Maltese: F'provi kliniċi aġġuntivi f'pazjenti epilettiċi, r-rata ta'l-inċidenza ta' blokk AV tal-ewwel grad rappurtat mhuwiex komuni, 0.7%, 0%, 0.5% u 0% għal lacosamide 200 mg, 400 mg, 600 mg jew placebo, rispettivament.
English: It should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8).
Maltese: Għandha tingħata taħt superviżżjoni medika b'konsiderazzjoni għall-potenzjal ta' żieda fl-inċidenza ta' arritmija kardijaka serja u reazzjonijiet mhux mixtieqa tas-sistema nervuża ċentrali (ara sezzjoni 4.8).
English: 08039 Barcelona, Spain
Maltese: Zona Franca 08040 Barcellona SPANJA
English: Atrioventricular block(1,2)
Maltese: Blokk Atrijuventrikulari(1,
English: The efficacy and safety of lacosamide in conversion to monotherapy has been assessed in a historicalcontrolled, multicentre, double-blind, randomized trial.
Maltese: L'effikaċja u s-sigurta` ta' lacosamide fil-bdil għal monotherapy kienet mkejjla f' prova randomizzata, double-blind, multiċentrali, u ikkontrollata bl-istorja.
English: Subjects with moderate hepatic impairment (Child-Pugh B) showed higher plasma concentrations of lacosamide (approximately 50 % higher AUCnorm).
Maltese: Persuni b'indeboliment moderat tal-fwied (Child-Pugh B) wrew konċentrazzjoni ogħla ta' lacosamide fil-plażma (AUCnorm madwar 50% ogħla).
English: 50 mg tablet: Iron oxide red (E172), iron oxide black (E172), indigo carmine aluminum lake (E132) 100 mg tablet: Iron oxide yellow (E172)
Maltese: Pillola 50 mg: : Iron oxide red (E172), iron oxide black (E172), indigo carmine aluminum lake (E132) Pillola 100 mg: Iron oxide yellow (E172)
English: Children (from 4 years of age) and adolescents weighing below 50 kg
Maltese: Tfal (minn età ta' 4 snin) u adoloxxenti li jiżnu inqas minn 50 kg
English: 150 mg tablet: Iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172) 200 mg tablet: Indigo carmine aluminum lake (E132)
Maltese: Pillola 150 mg: Iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172) Pillola 200 mg: Indigo carmine aluminum lake (E132)
English: 50 mg: Each film-coated tablet contains 0.105 mg of lecithin (soya) 100 mg: Each film-coated tablet contains 0.210 mg of lecithin (soya) 150 mg: Each film-coated tablet contains 0.315 mg of lecithin (soya) 200 mg: Each film-coated tablet contains 0.420 mg of lecithin (soya) For the full list of excipients, see section 6.1.
Maltese: 50 mg: Kull pillola miksija b'rita fiha 0.105 mg ta' leċitina (sojja) 100 mg: Kull pillola miksija b'rita fiha 0.210 mg ta' leċitina (sojja) 150 mg: Kull pillola miksija b'rita fiha 0.315 mg ta' leċitina (sojja) 200 mg: Kull pillola miksija b'rita fiha 0.420 mg ta' leċitina (sojja) Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: • medicines for bacterial infections called clarithromycin or rifampicin;
Maltese: • mediċini użati fil-kura ta' infezzjonijiet batterjali bħal clarithromycin jew rifampicin;
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 dejta in vitro.
English: Hepatic enzyme increased (> 2x ULN) (1)
Maltese: Żieda fl-enżimi talfwied (> 2x ULN)
English: 14 film-coated tablets.
Maltese: 14-il pillola miksija.
English: The pharmacokinetics and safety of a single loading dose of intravenous lacosamide were determined in a multicenter, open-label study designed to assess the safety and tolerability of rapid initiation of lacosamide using a single intravenous loading dose (including 200 mg) followed by twice daily oral dosing (equivalent to the intravenous dose) as adjunctive therapy in adult subjects 16 to 60 years of age with partial-onset seizures.
Maltese: Il-farmakokinetika u s-sigurta` ta' doża singola kbira tal-bidu ta' lacosamide għal ġol-vini kienu ddeterminati f' studju multiċentrali, open-label iddisinjat sabiex jkejjel is-sigurta` u t-tolerabilta` talbidu mgħaġġel ta' lacosamide b' doża għal ġol-vini singola kbira tal-bidu (inkluż 200 mg) segwita minn doża orali darbtejn kuljum (ekwivalenti għad-doża għal ġol-vini) bħala terapija aġġuntiva f'pazjenti adulti ta' 16 sa 60 sena b' aċċessjonijiet partial-onset.
English: Population pharmacokinetic analyses in different age groups estimated that concomitant treatment with other antiepileptic medicinal products known to be enzyme inducers (carbamazepine, phenytoin, phenobarbital, in various doses) decreased the overall systemic exposure of lacosamide by 25 % in adults and 17 % in paediatric patients.
Maltese: Analiżi farmakokinetika tal-popolazzjoni fi gruppi ta' età differenti ħarġet stima li trattament flimkien ma' prodotti mediċinali ta' kontra l-epilessija oħra magħrufa li jindottaw l-enżimi (carbamazepine, phenytoin, phenobarbital, f'dożi varji) naqqas l-esponiment sistemiku totali ta' lacosamide b'25 % fl-adulti u 17 % fil-pazjenti pedjatriċi.
English: Aggression Agitation(1) Euphoric mood(1) Psychotic disorder(1) Suicide attempt (1)
Maltese: Aggressjoni Aġitazzjoni(1) Burdata ewforika(1) Mard psikotiku(1)
English: • dizziness;
Maltese: • Jieklu inqas mis-soltu.
English: Titanium dioxide (E171) Lecithin (soya) Iron oxide red (E172) Iron oxide black (E172) Iron oxide yellow (E172)
Maltese: Titanium dioxide (E171) Lecithin (soya) Iron oxide red (E172) Iron oxide black (E172)
English: Listed below are the normal recommended doses of Lacosamide Accord for different age groups and weights.
Maltese: Hawn taħt hawn imniżżlin id-dożi rakkomandati normali ta' Lacosamide Accord għal gruppi ta' età u piżijiet differenti.
English: Lacosamide Accord 150 mg are salmon, oval, approximately 15.0 x 6.9 mm, coated tablets, debossed “L” on one side and “150” on other side.
Maltese: Lacosamide Accord 150 mg huma pilloli miksija b'rita kulur is-salamun, ovali, madwar 15.0 x 6.9 mm, b'“L” imnaqqxa fuq naħa waħda u “150” fuq in-naħa l-oħra.
English: The discontinuation rate due to adverse events observed with lacosamide was 21.0 % (13/62) in elderly patients versus 9.2 % (35/382) in younger adult patients.
Maltese: Ir-rata ta' twaqqif minħabba ġrajjiet avversi osservata b'lacosamide kienet ta' 21.0% (13/62) f'pazjenti anzjani versus 9.2% (35/382) f'pazjenti adulti iżgħar.
English: Irritability, trouble sleeping, depression;
Maltese: Irritibiltà, tbati biex torqod, depressjoni;
English: • a herbal medicine used to treat mild anxiety and depression called St.John's wort
Maltese: • mediċina erbali li tintuża biex tikkura ansjetà u dipressjoni ħafifa li tissejjaħ St.John's wort
English: In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of the Odesmethyl metabolite.
Maltese: Dejta in vitro juri li CYP2C9, CYP2C19 u CYP3A4 jistgħu jikkatalizzaw il-formazzjoni tal-metabolit O-desmethyl.
English: Adolescents and children weighing 50 kg or more, and adults Monotherapy
Maltese: Adoloxxenti u tfal li jiżnu 50 kg jew aktar, u adulti Monoterapija
English: • a medicine for HIV called ritonavir;
Maltese: • mediċina għall-kura tal-HIV li tissejjaħ ritonavir;
English: Lacosamide Accord film-coated tablets are packed in PVC-PVDC/Aluminium blisters.
Maltese: Lacosamide Accord pilloli miksija b'rita huma ppakkjati f'folji tal-PVC-PVDC/tal-Aluminju.
English: In the monotherapy clinical trial comparing lacosamide to carbamazepine CR, the extent of increase in PR interval was comparable between lacosamide and carbamazepine.
Maltese: F' prova klinika ta' monoterapija li tqabbel lacosamide ma' carbamazepine (CR), iż-żieda fl-interval PR kienet komparabbli bejn lacosamide u carbamazepine.
English: 150 mg (1 tablet Lacosamide Accord 150 mg)
Maltese: 150 mg (pillola Lacosamide Accord 150 mg waħda)
English: LABORATORI FUNDACIÓ DAU C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040 Barcelona, Spain or
Maltese: Zona Franca, Barcellona, 08040 Barcellona, Spanja jew
English: WESSLING Hungary Kft, Anonymus u. 6., Budapest, 1045, Hungary
Maltese: 6., Budapest, 1045, L-Ungerija jew
English: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona SPAIN
Maltese: Laboratori Fundacio Dau C/ C, 12-14
English: • a herbal medicine used to treat mild anxiety and depression called St.John's wort.
Maltese: • mediċina erbali li tintuża biex tikkura ansjetà u dipressjoni ħafifa li tissejjaħ St John's wort.
English: Lacosamide Accord with alcohol As a safety precaution do not take Lacosamide Accord with alcohol.
Maltese: Lacosamide Accord ma' ikel, xorb u alkoħol Bħala prekawzjoni ta' sigurtà tiħux Lacosamide Accord mal-alkoħol.
English: Based on data in adults, in paediatric patients weighing less than 50 kg with mild to moderate hepatic impairment, a reduction of 25 % of the maximum dose should be applied.
Maltese: Abbażi ta' data fl-adulti, f'pazjenti pedjatriċi li jiżnu inqas minn 50 kg b'indeboliment tal-fwied moderat, għandu jiġi applikat tnaqqis ta' 25% tad-doża massima.
English: • Swallow the Lacosamide Accord tablet with a glass of water.
Maltese: • Ibla' l-pillola Lacosamide Accord b'tazza ilma.
English: • Lacosamide Accord may be used on its own or with other antiepileptic medicines.
Maltese: • Lacosamide Accord jista' jintuża waħdu jew flimkien ma' mediċini oħra ta' kontra l-epilessija.
English: In comparison, plasma clearance was estimated at 1.92 L/h in adults (70 kg body weight).
Maltese: B'paragun għal dan, l-eliminazzjoni mill-plasma ġiet stmata 1.92 L/h f'pazjenti adulti (70 kg piż tal-ġisem).
English: Multiorgan hypersensitivity reactions
Maltese: Reazzjonijiet ta' sensittivita` eċċessiva f' organi multipli
English: 200 mg (1 tablet Lacosamide Accord 200 mg)
Maltese: 200 mg (pillola Lacosamide Accord 200 mg waħda)
English: The treatment initiation pack contains 4 cartons, each carton with 14 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 ta'50 mg, 100 mg, 150 mg u 200 mg.
English: Adolescents and children weighing 50 kg or more, and adults
Maltese: Adoloxxenti u tfal li jiżnu 50 kg jew aktar, u adulti
English: 100 mg (1 tablet Lacosamide Accord 100 mg)
Maltese: 100 mg (pillola Lacosamide Accord 100 mg waħda)
English: 50 mg (1 tablet Lacosamide Accord 50 mg)
Maltese: 50 mg (pillola Lacosamide Accord 50 mg waħda)
English: Although no pharmacokinetic data on the interaction of lacosamide with alcohol are available, a pharmacodynamic effect cannot be excluded.
Maltese: Għalkemm m'hemmx dejta farmakokinetika dwar l-interazzjoni ta'lacosamide flimkien ma' l'alkoħol, ma jistax jiġi eskluż effett farmakodinamiku.
English: Lacosamide Accord 200 mg are blue, oval, approximately 16.4 x 7.6 mm, coated tablets, debossed “L” on one side and “200” on other side.
Maltese: Pilloli miksija b'rita blu, ovali, madwar 16.4 x 7.6 mm, b' “L” imnaqqxa fuq naħa waħda u “200” fuq in-naħa l-oħra.
English: What Lacosamide Accord looks like and contents of the pack Lacosamide Accord 50 mg are pink, oval, approximately 10.3 x 4.8 mm, coated tablets, debossed “L” on one side and “50” on other side.
Maltese: • Lacosamide Accord 50 mg huma pilloli miksija b'rita roża, ovali, madwar 10.3 x 4.8 mm, b'“L” imnaqqxa fuq naħa waħda u “50” fuq in-naħa l-oħra.
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 middejta disponibli).