FrancophonIA/ELRC3.0 huggingface dataset:
English: Nateglinide, the active ingredient in Starlix, stimulates the pancreas to produce insulin more quickly.
Maltese: Nateglinide, is-sustanza attiva fi Starlix, jistimula l-frixa biex tipproduċi linsulina iktar malajr.
English: A total of 2,122 patients received Starlix in all trials combined.
Maltese: Fl-istudji kollha b'kollox kien hemm 2,122 pazjent li ngħataw Starlix.
English: What is Starlix?
Maltese: X'inhu Starlix?
English: For the full list of all side effects reported with Starlix, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji rrappurtati bi Starlix, ara l-Fuljett ta' Tagħrif.
English: Why has Starlix been approved?
Maltese: Għaliex ġie approvat Starlix?
English: The Committee for Medicinal products for Human Use (CHMP) decided that Starlix's benefits are greater than its risks for the treatment of type 2 diabetes, in combination with metformin, in patients who are not controlled despite receiving the maximum daily dose of metformin.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Starlix huma ikbar mir-riskji tiegħu fit-trattament tad-dijabete tat-tieni tip, flimkien ma' metformin, f'pazjenti li ma jkunux ikkontrollati minkejja li jkunu qed jingħataw id-doża massima ta' metformin.
English: Starlix may in some cases cause hypoglycaemia (low blood glucose).
Maltese: Starlix f'xi każi jista' jikkawża ipogliċemija (livell baxx ta' glucosju fid-demm).
English: What is the risk associated with Starlix?
Maltese: X'inhu r-riskju assoċjat ma' Starlix?
English: How has Starlix been studied?
Maltese: Kif ġie studjat Starlix?
English: Starlix is given within one to 30 minutes before breakfast, lunch and dinner and the dose is adjusted to give the best control.
Maltese: Starlix jingħata bejn minuta u 30 minuta qabel il-kolazzjon, l-ikla ta' nofsinhar u l-ikla ta' filgħaxija u d-doża tiġi aġġustata biex tagħti l-aqwa kontroll.
English: The main studies compared Starlix to placebo (a dummy treatment), or to other medicines used in type 2 diabetes (metformin, glibenclamide or troglitazone).
Maltese: L-istudji ewlenin qabblu Starlix ma' plaċebo (trattament finta), jew ma' mediċini oħra użati fid-dijabete tat-tieni tip (metformin, glibenclamide jew troglitazone).
English: System organ class Very common
Maltese: Sistema ta' klassifika talorgani
English: The adjusted absolute difference between treatments was -1.3 % (95 % CI: -5.5, 2.8).
Maltese: Id-differenza assoluta aġġustata bejn it-trattamenti kienet - 1.3% (95 % CI: -5.5, 2.8).
English: България Ю СИ БИ България ЕООД
Maltese: Ю СИ БИ България ЕООД Teл.:
English: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Maltese: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Il-Belġju.
English: Vimpat contains sorbitol, sodium, sodium methyl parahydroxybenzoate, aspartame and propylene glycol
Maltese: Vimpat fih sorbitol, sodju, sodium methyl parahydroxybenzoate, aspartame u propylene glycol
English: Stevens-Johnson syndrome(1)
Maltese: Sindromu ta' StevensJohnson(1)
English: Elevations of ALT to ≥ 3x ULN occurred in 0.7 % (7/935) of Vimpat 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 Vimpat u 0% (0/356) tal-pazjenti fuq plaċebo.
English: Vimpat syrup contains sorbitol (E420).
Maltese: Vimpat mistura fiha sorbitol (E420).
English: Vimpat syrup contains propylene glycol (E1520).
Maltese: Vimpat mistura fiha propylene glycol (E1520).
English: Vimpat contains lacosamide.
Maltese: Vimpat fih lacosamide.
English: Vimpat is available in packs of 14, 28, 56, 60, 14 x 1 and 56 x 1 film-coated tablets.
Maltese: Vimpat issibu f'pakketti ta' 14, 28, 56, 60, 14 x 1 u 56 x 1 pilloli miksija b'rita.
English: Irritability Feeling drunk Injection site pain or discomfort (4) Irritation(4)
Maltese: Irritability Tħossok fis-sakra Uġigħ fis-sit talinjezzjoni jew skonfort(4) irritazzjoni(4)
English: Contains sorbitol (E420), sodium methyl parahydroxybenzoate (E219), propylene glycol (E1520), sodium and aspartame (E951).
Maltese: Fih sorbitol (E420), sodium methyl parahydroxybenzoate (E219), propylene glycol (E1520), sodju u aspartame (E951).
English: Sorbitol is a source of fructose.
Maltese: Sorbitol hu sors ta' fructose.
English: Vimpat tablets and oral syrup are bioequivalent.
Maltese: Vimpat pilloli u mistura orali huma bio-ekwivalenti.
English: Each ml of Vimpat syrup contains 187 mg sorbitol (E420), 2.60 mg sodium methyl parahydroxybenzoate (E219), 2.14 mg propylene glycol (E1520), 1.42 mg sodium, and 0.032 mg aspartame (E951).
Maltese: Kull ml ta' mistura Vimpat fiha 187 mg sorbitol (E420),2.60 mg sodium methylparahydroxybenzoate (E219), 2.14 mg propylene glycol (E1520), 1.42 mg sodium, u 0.
English: (3) Reported in open-label studies.
Maltese: (2) Ara Deskrizzjoni ta' reazzjonijiet avversi magħżula (3) Irrappurtata fi studji open-label.
English: B-1420 Braine- l'Alleud
Maltese: Braine l'Alleud
English: Toxic epidermal necrolysis(1)
Maltese: Nekroliżi tossika epidermali(1)
English: Contains sodium chloride, hydrochloric acid, water for injections.
Maltese: TA' EĊĊIPJENTI Fih sodium chloride, hydrochloric acid, ilma għall-injezzjoni.
English: UCB s.r.o.
Maltese: Česká republika UCB s.r.o.
English: This is equivalent to 0.07 % of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 0.07% tal-konsum irrakkomandat fid-dieta ta' kuljum ta' sodium għal persuna adulta.
English: Vimpat 10 mg/ml syrup lacosamide
Maltese: Vimpat 10 mg/ml mistura lacosamide
English: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany.
Maltese: GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, il-Ġermanja.
English: Vimpat syrup contains 1.42 mg sodium per ml, equivalent to 0.07 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Vimpat mistura fiha 1.42 mg ta' sodium għal kull mL, ekwivalenti għal 0.07% tad-doża massima ta' kuljum rakkomandata mill-WHO ta' 2 g ta' sodium għal persuna adulta.
English: Vimpat syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria.
Maltese: Vimpat mistura fiha aspartame (E951), sors ta' phenylalanine, li tista' tkun ta' ħsara għal nies bi phenylketonuria.
English: Multipack: 168 (3 packs of 56) film-coated tablets
Maltese: U KONTENUT Pakkett multiplu:168 (3 pakketti ta' 56) pilloli miksija b'rita
English: Teл.
Maltese: Xahrejn.
English: The 14 x 1 and 56 x 1 film-coated tablet packs are available as perforated unit dose PVC/PVDC blisters sealed with an aluminium foil, the 14, 28, 56 and 168 packs are available with standard PVC/PVDC blisters sealed with an aluminium foil, the 60 packs are available in HDPE bottles with a child-resistant closure.
Maltese: Il-pakkett ta' 14 x 1 u 56 x 1 pilloli miksija b'rita ssibhom f'folji tal PVC/PVDC li jistgħu jinqasmu f'dożi singoli siġillata b'fojl tal-aluminju, il-pakketti ta' 14, 28, 56 u 168 issibhom f'folji standard tal-PVC/PVDC siġillata b'fojl tal-aluminju, is-60 pakkett huma disponibbli fi flixkien tal-HDPE b'għatu li ma jinfetaħx mit-tfal.
English: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany or
Maltese: GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Il-Ġermanja.
English: 1 ml Vimpat syrup contains 10 mg lacosamide.
Maltese: 1 ml mistura Vimpat fiha 10 mg lacosamide.
English: Date of first authorisation: 29 August 2008 Date of latest renewal: 31 July 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 29 ta' Awwissu Data tal-aħħar tiġdid: 31 ta' Lulju 2013
English: Allée de la Recherche 60 B-1070 Bruxelles Belgium
Maltese: B-1070 Bruxelles Il-Belġju
English: One tablet of Vimpat 150 mg contains 150 mg lacosamide.
Maltese: Pillola waħda ta' Vimpat 150 mg fiha 150 mg lacosamide.
English: Vimpat 50 mg and Vimpat 100 mg are available in packs of 168 film-coated tablets and Vimpat 150 mg and Vimpat 200 mg are available in multipacks comprising 3 cartons, each containing 56 tablets.
Maltese: Vimpat 50 mg u Vimpat 100 mg issibu f'pakketti ta' 168 pillola miksija b'rita u Vimpat 150 mg u Vimpat 200 mg issibu f'pakketti multipli li jikkonsistu f'3 kaxxi, kull waħda fiha 56 pillola.
English: EU/1/08/470/001 EU/1/08/470/002 EU/1/08/470/003 EU/1/08/470/004
Maltese: EU/1/08/470/002 EU/1/08/470/003 EU/1/08/470/004
English: 14 film-coated tablets 56 film-coated tablets 168 film-coated tablets 56 x 1 film-coated tablet 14 x 1 film-coated tablet 28 film-coated tablets 60 film-coated tablets
Maltese: 14 pilloli miksija b'rita 56 pilloli miksija b'rita 168 pilloli miksija b'rita 56 x 1 pillola miksija b'rita 14 x 1 pillola miksija b'rita 28 pilloli miksija b'rita 60 pillola miksija b'rita
English: 150 mg (1 tablet Vimpat 150 mg)
Maltese: 150 mg (pillola Vimpat 150 mg waħda)
English: 100 mg (1 tablet Vimpat 100 mg)
Maltese: 100 mg (pillola Vimpat 100 mg waħda)
English: One tablet of Vimpat 50 mg contains 50 mg lacosamide.
Maltese: Pillola waħda ta' Vimpat 50 mg fiha 50 mg lacosamide.
English: 200 mg (1 tablet Vimpat 200 mg)
Maltese: 200 mg (pillola Vimpat 200 mg waħda)
English: Liver function test abnormal(2) Hepatic enzyme increased (> 2x ULN) (1)
Maltese: Testijiet talfunzjoni tal-fwied mhux normali(2) Żieda fl-enżimi tal-fwied (> 2x ULN) (1)
English: For longer term treatment Vimpat tablets and syrup are available.
Maltese: Għal trattament fit-tul, hemm disponibbli Vimpat pilloli u mistura.
English: Using Vimpat
Maltese: Tieħux Vimpat
English: Taking Vimpat on its own - This is for information only.
Maltese: Meta tuża Vimpat waħdu - Din hija għal skopijiet ta' informazzjoni biss.
English: Vimpat 10 mg/ml syrup
Maltese: Vimpat 10 mg/ml mistura
English: UCB Pharma B.V. Tel.: + 31 / (0)76-573 11 40
Maltese: Tel.: + 31 / (0)76-573 11 40
English: 14 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablet 14 x 1 film-coated tablet 28 film-coated tablets 60 film-coated tablets
Maltese: 14 pilloli miksija b'rita 56 pilloli miksija b'rita 56 x 1 pillola miksija b'rita 14 x 1 pillola miksija b'rita 28 pilloli miksija b'rita 60 pillola miksija b'rita
English: Vimpat 50 mg Vimpat 100 mg Vimpat 150 mg Vimpat 200 mg film-coated tablets lacosamide
Maltese: Vimpat 50 mg Vimpat 100 mg Vimpat 150 mg Vimpat 200 mg pilloli miksija b'rita lacosamide
English: One tablet of Vimpat 200 mg contains 200 mg lacosamide.
Maltese: Pillola waħda ta' Vimpat 200 mg fiha 200 mg lacosamide.
English: Lacosamide is less than 15 % bound to plasma proteins.
Maltese: Lacosamide huwa marbut b' inqas minn 15% malproteini fil-plażma.
English: Aggression Agitation(1) Euphoric mood(1) Psychotic disorder(1) Suicide attempt (1) Suicidal ideation Hallucination (1)
Maltese: Aggressjoni Agitazzjoni(1) Burdata ewforika(1) Mard psikotiku(1)
English: Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Maltese: Sorbitol jista' jikkawża skumdità gastrointestinali u effett lassativ ħafif.
English: This was reported with lacosamide in 4.8 % (3/62) in elderly patients versus 1.6 % (6/382) in younger adult patients.
Maltese: Dan kien irrappurtat b'lacosamide f' 4.8% (3/62) pazjenti anzjani versus 1.6% (6/382) f'pazjenti adulti iżgħar.
English: When you take Vimpat with other antiepileptic medicines The usual starting dose of Vimpat is 50 mg (5 ml) twice a day.
Maltese: Meta tieħu Vimpat ma' mediċini ta' kontra l-epilessija oħra Id-doża tal-bidu ta' Vimpat li normalment tingħata hija ta' 50 mg (5 ml) darbtejn kuljum.
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 %), pyrexia (13.0 %), convulsion (7.8 %), decreased appetite (5.9 %), pharyngitis (4.7 %), lethargy (2.7 %) and abnormal behaviour (1.7 %).
Maltese: 7 %), rimettar (14.7 %), ħedla ta' ngħas (14.0 %), sturdament (13.5 %), deni (13.0 %), konvulżjoni (7.8 %), nuqqas ta' aptit (5.9 %), farinġite (4.7 %), letarġija (2.7 %) u mġiba anormali (1.7 %).
English: Method of administration
Maltese: MANIFATTURA RESPONSABBLI
English: Vimpat 200 mg are blue, oval film-coated tablets of approximately 16.6 mm x 7.8 mm with a debossed ‘SP' on one side and ‘200' on the other side.
Maltese: • Vimpat 200 mg huma blu, pilloli ovali miksija b'rita b'dimensjonijiet ta' madwar 16.6 mm x 7.8 mm, b'‘SP' imnaqqax fuq naħa waħda u ‘200' fuq in-naħa l-oħra.
English: Atrial Flutter (1,2)
Maltese: Fibrillazzjoni atrijali(1,2)
English: Vimpat syrup contains sodium methyl parahydroxybenzoate (E219), which may cause allergic reactions (possibly delayed).
Maltese: Vimpat mistura fiha sodium methyl parahydroxybenzoate (E219), li jista' jikkawża reazzjonijiet allerġiċi (possibilment imdewmin).
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 jinduċu 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: Vimpat 100 mg film-coated tablets: yellow iron oxide (E172) Vimpat 150 mg film-coated tablets: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)
Maltese: Vimpat 100 mg pilloli miksijin b'rita: yellow iron oxide (E172) Vimpat 150 mg pilloli miksijin b'rita: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)
English: One tablet of Vimpat 100 mg contains 100 mg lacosamide.
Maltese: Pillola waħda ta' Vimpat 100 mg fiha 100 mg lacosamide.
English: Each pack of 56 film-coated tablets for a 4-week treatment schedule contains: 14 film-coated tablets of Vimpat 50 mg 14 film-coated tablets of Vimpat 100 mg 14 film-coated tablets of Vimpat 150 mg 14 film-coated tablets of Vimpat 200 mg
Maltese: Kull pakkett ta' 56 pillola miksija b'rita għal skeda ta' trattament ta' 4 ġimgħat fiħ: 14 pilloli miksija b'rita ta' Vimpat 50 mg 14 pilloli miksija b'rita ta' Vimpat 100 mg 14 pilloli miksija b'rita ta' Vimpat 150 mg 14 pilloli miksija b'rita ta' Vimpat 200 mg
English: Vimpat 50 mg film-coated tablets polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) red iron oxide (E172) black iron oxide (E172) indigo carmine aluminium lake (E132)
Maltese: Vimpat 50 mg pilloli miksijin b'rita polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) red iron oxide (E172) black iron oxide (E172) indigo carmine aluminium lake (E132)
English: In juvenile dogs, transient and dose-related CNS clinical signs started to be observed at systemic exposure levels below the expected clinical exposure.
Maltese: Fi klieb ġuvenili, sinjali kliniċi ta' CNS temporanji u relatati mad-doża bdew jiġu osservati f'livelli ta' esponiment sistemiku taħt lesponiment kliniku mistenni.
English: Hepatic impairment
Maltese: Terapija aġġuntiva
English: 50 mg (1 tablet Vimpat 50 mg)
Maltese: 50 mg (pillola Vimpat 50 mg waħda)
English: Vimpat 100 mg film-coated tablets polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) yellow iron oxide (E172)
Maltese: Vimpat 100 mg pilloli miksijin b'rita polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) yellow iron oxide (E172)
English: Maximum recommended dose in patients < 20 kg up to 12 mg/kg/day Maximum recommended dose in patients ≥ 20 kg to < 30 kg up to 10 mg/kg/day
Maltese: Doża massima rakkomandata f'pazjenti < 20 kg sa 12 mg/kg/jum Doża massima rakkomandata f'pazjenti ≥ 20 kg sa < 30 kg sa 10 mg/kg/jum
English: UCB Pharma Ltd. Tel: + 44 / (0)1753 534 655
Maltese: Tel : + 44 / (0)1753 534 655
English: 1 vial contains 20 ml Vimpat solution for infusion equivalent to 200 mg lacosamide.
Maltese: Fjala waħda fiha 20 ml Vimpat soluzzjoni għall-infużjoni ekwivalenti għal 200 mg lacosamide.
English: This medicinal product contains 59.8 mg sodium per vial, equivalent to 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 59.8 mg ta' sodium għal kull kunjett, ekwivalenti għal 3% tad-doża massima ta' kuljum rakkomandata mill-WHO ta' 2 g ta' sodium għal persuna adulta.
English: Vimpat 100 mg are dark yellow, oval film-coated tablets of approximately 13.2 mm x 6.1 mm with a debossed ‘SP' on one side and ‘100' on the other side.
Maltese: • Vimpat 100 mg huma sofor skuri, pilloli ovali miksija b'rita, b'dimensjonijiet ta' madwar 13.2 mm x 6.1 mm b'‘SP' imnaqqxa fuq naħa waħda u ‘100' fuq in-naħa l-oħra.
English: 1 x 20 ml solution for infusion 200 mg/20 ml
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 200 mg/20 ml
English: Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision; A spinning sensation (vertigo), feeling drunk;
Maltese: • Movimenti tal-għajnejn mgħaġġla u inkontrollabli (nystagmus), vista mċajpra;
English: 200 ml syrup with measuring cup and oral syringe
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 200 ml mistura bit-tazza ta' kejl u siringa orali
English: Vimpat solution for infusion can be administered intravenously without further dilution or can be diluted with sodium chloride 9 mg/ml (0.9 %) solution for injection, glucose 50 mg/ml (5 %) solution for injection or lactated Ringer's solution for injection.
Maltese: Vimpat soluzzjoni għallinfużjoni tista' tingħata ġol-vini mingħajr dilwizzjoni ulterjuri jew tista' tiġi dilwita b'sodium chloride 9 mg/ml (0.9 %) soluzzjoni għall-injezzjonisodium, glucose 50 mg/ml (5 %) soluzzjoni għall-injezzjoni jew soluzzjoni għall-injezzjoni Ringer.
English: Syrup.
Maltese: jkollha.
English: Listed below are the normal recommended doses of Vimpat for different age groups and weights.
Maltese: Hawn taħt hawn imniżżlin id-dożi rakkomandati normali ta' Vimpat għal gruppi ta' età u piżijiet differenti.
English: Vimpat 50 mg film-coated tablets: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132)
Maltese: Vimpat 50 mg pilloli miksijin b'rita: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132)
English: Maximum recommended dose in patients ≥ 20 kg to < 30 kg up to 10 mg/kg/day
Maltese: Doża massima rakkomandata f'pazjenti ≥ 20 kg sa < 30 kg sa 10 mg/kg/jum
English: Vimpat 10 mg/ml solution for infusion lacosamide
Maltese: Vimpat 10 mg/ml soluzzjoni għall-infużjoni lacosamide
English: Breastfeeding
Maltese: Diplowpja
English: Vimpat 150 mg film-coated tablets lacosamide
Maltese: Vimpat 150 mg pilloli miksija b'rita lacosamide
English: Vimpat 50 mg are pinkish, oval film-coated tablets of approximately 10.4 mm x 4.9 mm with a debossed ‘SP' on one side and ‘50' on the other side.
Maltese: 4 mm x 4.9 mm, b'‘SP' imnaqqxa fuq naħa waħda u ‘50' fuq in-naħa l-oħra.
English: • 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 tal-ġisem, darbtejn kuljum.
English: Children and adolescents below 50 kg
Maltese: Tfal u adoloxxenti li jiżnu inqas minn 50 kg
English: UCB Pharma SA/NV
Maltese: UCB Pharma
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għal kondizzjonijiet għal-ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: Aspartame (E951): This medicine contains 0.032 mg aspartame in each ml.
Maltese: Din il-mediċina fiha 0.032 mg ta' aspartame f'kull mL.
English: Τηλ: + 357 22 05 63 00
Maltese: Lifepharma (Z.A.M.) Ltd Τηλ: + 357 22 05 63 00
English: Vimpat 200 mg film-coated tablets: indigo carmine aluminium lake (E132)
Maltese: Vimpat 200 mg pilloli miksijin b'rita: indigo carmine aluminium lake (E132) 6.2 Inkompatibilitajiet
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: (1) children and adolescents less than 50 kg should preferably start the treatment with Vimpat 10 mg/ml syrup
Maltese: (1) Tfal u adoloxxenti inqas minn 50 kg għandhom preferibbilment jibdew ittrattament b'Vimpat 10 mg/ml mistura
English: Monotherapy doses to be taken twice daily for children and adolescents from 4 years of age weighing 40 kg to under 50 kg(1) (2):
Maltese: Dożi ta' monoterapija li għandhom jittieħdu darbtejn kuljum għal tfal u adoloxxenti minn 4 snin ta' età li jiżnu 40 kg sa inqas minn 50 kg(1) (2): Piż
English: Other medicines and Vimpat
Maltese: Mediċini oħra u Vimpat
English: Vimpat 150 mg are salmon, oval film-coated tablets of approximately 15.1 mm x 7.0 mm with a debossed ‘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: Starting dose: 0.1 ml/kg
Maltese: Doża tal-bidu: 0.1 ml/kg
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 trattati bi prodotti mediċinali li jaffettwaw il-konduzzjoni kardijaka, inkluż antiarritmiċi u prodotti mediċinali antiepilettiċi li jimblokkaw il-kanal tas-sodju (ara sezzjoni 4.5), kif ukoll f'pazjenti anzjani.
English: Vimpat 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 Vimpat 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 ir-rispons u ttollerabbilta` tal-pazjent.
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 bit-tikketta mikxufa f'414 tifel/tifla b'epilessija ta' bejn 6 xhur sa 17-il sena.