FrancophonIA/ELRC3.0 huggingface dataset:
English: 25, 50, 100 and 200 mg tablets: Lactose monohydrate Microcrystalline cellulose Povidone K30
Maltese: Pilloli ta' 25, 50 100 u 200 mg: Lactose monohydrate Microcrystalline cellulose Povidone K30
English: Monotherapy:
Maltese: Monoterapija:
English: diplopia, blurred vision.
Maltese: diplopija, vista mċajpra.
English: • rifampicin, which is an antibiotic
Maltese: • rifampicin, li hu antibijotiku
English: Ethinyloestradiol/ levonorgestrel combination*
Maltese: Kombinazzjoni *Ethinyloestradiol/ levonorgestrel
English: GlaxoSmithKline Slovakia s.r.o.
Maltese: Slovakkja GlaxoSmithKline Slovakia s.r.o.
English: 8 9 10 11 12 13 14 (one pocket) 15 16 17 18 19 20 21 (two pockets) 22 23 24 25 26 27 28 (two pockets)
Maltese: 8 9 10 11 12 13 14 (kontenitur wieħed) 15 16 17 18 19 20 21 (żewġ kontenituri) 22 23 24 25 26 27 28 (żewġ kontenituri)
English: Weeks 1 + 2 Weeks 3 + 4 Usual maintenance dose
Maltese: Ġimgħat 1 + 2 Ġimgħat 3 + 4 Doża normali meħtieġa
English: Middlesex UB11 1BT United Kingdom
Maltese: Middlesex UB11 1BT Renju Unit
English: 15 16 17 18 19 20 21 (2 pockets)
Maltese: 15 16 17 18 19 20 21 (2 kontenituri)
English: ‘Proportion' of patients being event free at week 76 Study SCAB2003 Bipolar I
Maltese: ‘Proporzjon' ta' pazjenti li kienu liberi minn eventi f'ġimgħa 76 Studju SCAB2003 Bi-polari I
English: Mean clearances were 0.42 mL/min/kg (chronic renal failure), 0.33 mL/min/kg (between hemodialysis) and 1.57 mL/min/kg (during hemodialysis), compared with 0.58 mL/min/kg in healthy volunteers.
Maltese: 42 mL/min/kg ((ħsara kronika fil-fwied), 0.33 mL/min/kg (bejn l-emodijalisi) u 1.57 mL/min/kg (waqt l-emodijalisi), meta mqabbla ma' 0.58 mL/min/kg f'voluntieri f'saħħithom.
English: Clinical efficacy and safety in Lennox-Gastaut syndrome
Maltese: Effikaċja klinika u sigurta' fis-sindrome ta' Lennox-Gastaut
English: Table 1: Adults and adolescents aged 13 years and above - recommended treatment regimen in epilepsy
Maltese: Tabella 1: Adulti u adolexxenti ta' minn 13-il sena 'l fuq - metodu rakkomandat ta' trattament għal epilessija
English: Free of mania p-value Log rank test
Maltese: Liberi minn mania p-value Log rank test
English: Table 6: Effects of other medicinal products on glucuronidation of lamotrigine
Maltese: Tabella 6: Effetti ta' prodotti mediċinali oħra fuq il-glukuronidazzjoni ta' lamotrigine
English: 22 23 24 25 26 27 28 (2 pockets)
Maltese: 22 23 24 25 26 27 28 (2 kontenituri)
English: • aggression or irritability
Maltese: • aggressjoni jew irritabilita'
English: The proportion of subjects with treatment failure was 84% (16/19 subjects) in the placebo arm and 58% (11/19 subjects) in the lamotrigine arm.
Maltese: Ilproporzjon ta' suġġetti b'falliment fil-kura kien ta' 84% (16/19 suġġetti) fil-fergħa tal-plaċebo u 58% (11/19 suġġetti) fil-fergħa ta' lamotrigine.
English: nystagmus, tremor, insomnia.
Maltese: nistagmus, rogħda, insomnja.
English: Linearity
Maltese: Linearita'
English: • clumsiness and lack of co-ordination (ataxia)
Maltese: • nuqqas ta' delikatezza fil-movimenti u nuqqas ta' koordinament (atassija)
English: Very rare side effects These may affect up to 1 in 10,000 people:
Maltese: Effetti sekondarji rari ħafna Dawn jistgħu jaffettwaw sa 1 minn kull 10,000 persuni:
English: Starter pack 21 tablets, valproate add-on therapy Starter pack 42 tablets, monotherapy
Maltese: Pakkett tal-bidu 21 pillola, valproate terapija add-on Pakkett tal-bidu 42 pillola, monoterapija
English: In a study in healthy adult volunteers, 15 mg olanzapine reduced the AUC and Cmax of lamotrigine by an average of 24% and 20%, respectively.
Maltese: Fi studju fuq numru ta' voluntieri f'saħħithom, 15 mg olanzapine naqqsu l-AUC u Cmax ta' lamotrigine b'medja ta' 24% u 20% rispettivament.
English: One side has a bevelled edge and is marked “LTG” above the number 2.
Maltese: Naħa waħda ċċanfrinata u mmarkata “LTG” fuq in-numru 2.
English: UDP-glucuronyl transferases have been identified as the enzymes responsible for metabolism of lamotrigine.
Maltese: UDP-glucuronyl transferases ġew identifikati bħala enzimi risponsabbli għall-metaboliżmu ta' lamotrigine.
English: However, in a prospective study in healthy adult volunteers using doses of 200 mg lamotrigine and 1200 mg oxcarbazepine, oxcarbazepine did not alter the metabolism of lamotrigine and lamotrigine did not alter the metabolism of oxcarbazepine.
Maltese: Madankollu, fi studju prospettiv fuq voluntieri adulti f'saħħithom b'dożi ta' 200 mg lamotrigine u 1200 mg oxcarbazepine, oxcarbazepine ma bidilx il-metaboliżmu ta' lamotrigine u lamotrigine ma bidlix il-metaboliżmu ta' oxcarbazepine.
English: The age range will be modified considering that patients aged 12 years fall within the definition of adolescents.
Maltese: Il-faxxa ta' l-età sejra tiġi modifikata meta wieħed jikkunsidra li pazjenti ta' 12-il sena jaqgħu taħt iddefinizzjoni ta' adolexxenti.
English: - Quality aspects
Maltese: - Aspetti tal-kwalità
English: Major depressive episode
Maltese: Episodju ta' dipressjoni maġġuri
English: 21 tablets
Maltese: 21 pillola
English: Study SCAB2006 Bipolar I
Maltese: Studju SCAB2006
English: - Monotherapy of typical absence seizures.
Maltese: - Monoterapija tal-kriżijiet ta' assenza tipika (typical absence seizures).
English: Do not take Lamictal:
Maltese: Tieħux Lamictal:
English: - Seizures associated with Lennox-Gastaut syndrome.
Maltese: - Kriżijiet relatati mas-sindromu ta' Lennox-Gastaut.
English: In the subset of bipolar disorder trials, the rate of events was numerically, but not statistically significantly, greater for lamotrigine (29/1212 [2.4%]) compared with placebo (19/1054 [1.8%]).
Maltese: F'subset ta' studji kliniċi fuq disturbi bi-polari, ir-rata ta' eventi kienet numerikament, iżda mhux statistikament sinifikament, akbar għal lamotrigine (29/1212 [2.4%] meta mqabbla ma' plaċebo (19/1014
English: Each dispersible/chewable tablet contains 2 mg, 5 mg, 25 mg, 50 mg, 100 mg or 200 mg lamotrigine.
Maltese: Kull pillola li tixtered/ tiġi mimgħuda jkun fiha 2 mg, 5 mg, 25 mg, 50 mg, 100 mg jew 200 mg lamotrigine.
English: Belgium GlaxoSmithKline s.a. Rue du Tilleul 13, B86
Maltese: Rue du Tilleul 13, B86
English: 8 9 10 11 12 13 14 (1 pocket)
Maltese: 8 9 10 11 12 13 14 (kontenitur wieħed)
English: Lamictal belongs to a group of medicines called anti-epileptics.
Maltese: Lamictal jifforma parti mill-grupp ta' mediċini msejħa anti-epilettiċi.
English: Interactions involving other psychoactive agents
Maltese: Interazzjonijiet li jinvolvu aġenti oħra psikoattivi
English: A study in healthy adult volunteers evaluated the effect of repeat doses of lamotrigine (up to 400 mg/day) on cardiac conduction, as assessed by 12-lead ECG.
Maltese: Studju fuq voluntieri adulti f'saħħithom evalwa l-effett ta' dożi ripetuti ta' lamotrigine ((sa 400 mg/kuljum) fuq trasmissjoni kardijaka, kif assessjat bi 12-lead ECG.
English: • diarrhoea
Maltese: • dijareja
English: Depression free p-value Log rank test
Maltese: Liberi minn dipressjoni p-value Log rank test
English: Mean plasma half-lives were 42.9 hours (chronic renal failure), 57.4 hours (between hemodialysis) and 13.0 hours (during hemodialysis), compared with 26.2 hours in healthy volunteers.
Maltese: Il-medja ta' half-lives fil-plasma kienet 42.9 sigħat (ħsara kronika fil-fwied), 57.4 sigħat (bejn l-emodijalisi) u 13.0 sigħat (waqt l-emdodijalisi), meta mqabbla ma' 26.2 sigħat fil-każ ta' voluntieri f'saħħithom.
English: These experiments also suggested that metabolism of lamotrigine was unlikely to be inhibited by clozapine, fluoxetine, phenelzine, risperidone, sertraline or trazodone.
Maltese: Dawn l-esperimenti indikaw ukoll li l-metaboliżmu ta' lamotrigine mhux probabbli li jkun inibit bi clozapine, fluoxetene, phenelzine, risperidone, sertraline jew trazodone.
English: <Glaxo Wellcome GmbH & Co., Industriestrasse 32-36, 23843 Bad Oldesloe, Germany.>
Maltese: <Glaxo Wellcome GmbH & Co., Industriestrasse 32-36, 23843 Bad Oldesloe, Ġermanja.> <GlaxoSmithKline EOOD, Gradinarska Street 5, Sofia 1510, Bulgarija.> <Glaxo Wellcome S.A., Avda.
English: 42 tablets
Maltese: 42 pilloli
English: 0.15 mg/kg/day* (once a day)
Maltese: 0.15 mg/kg/kulju m* (darba kuljum)
English: Intervention free p-value Log rank test
Maltese: Liberi minn intervent p-value Log rank test
English: Excipient: Each tablet contains 109.0 mg lactose.
Maltese: Kull pillola fiha 109.0 mg lattosju.
English: The indication will specify that the target population is “Children and adolescents aged 2 to 12 years“.
Maltese: L-indikazzjonijiet jispeċifikaw li l-popolazzjoni fil-mira hija "Tfal u adolexxenti ta' bejn sentejn u 12-il sena".
English: Germany GlaxoSmithKline GmbH & Co. KG
Maltese: Ġermanja GlaxoSmithKline GmbH & Co.
English: Effect of hormonal contraceptives on lamotrigine pharmacokinetics In a study of 16 female volunteers, dosing with 30 µg ethinyloestradiol/150 µg levonorgestrel in a combined oral contraceptive pill caused an approximately two-fold increase in lamotrigine oral clearance, resulting in an average 52% and 39% reduction in lamotrigine AUC and Cmax, respectively.
Maltese: Effett ta' kontraċettivi ormonali fuq il-farmakokinetiċi ta' lamotrigine Fi studju fuq 16 voluntieri nisa, dożaġġ ta' 30 µg ethinyloestradiol/150 µg levonorgestrel f'pillola kontraċettiva kombinata li tittieħed mill-ħalq ikkawżat żjieda ta' aktar minn darbtejn f'dik li hi tneħħija orali ta' lamotrigine, b'riżultat ta' tnaqqis medju ta' 52% u 39% fl-AUC u Cmax ta' lamotrigine, rispettivament.
English: GlaxoSmithKline EOOD, Ivan Vazov complex Dimitar Manov street, bl.10, Sofia 1408
Maltese: Dimitar Manov street, bl.10, Sofia 1408
English: Excipient: Each tablet contains 23.5 mg lactose.
Maltese: Kull pillola fiha 23.5 mg lattosju.
English: haematological abnormalities including neutropenia, leucopenia, anaemia, thrombocytopenia, pancytopenia, aplastic anaemia, agranulocytosis.
Maltese: Rari ħafna: anormalitajiet ematoloġiċi inklużi newtropenija, lewkopenija, anemija, tromboċitopenija,
English: Lamotrigine has a slight inhibitory effect on dihydrofolic acid reductase, hence there is a possibility of interference with folate metabolism during long-term therapy (see section 4.6).
Maltese: Lamotrigine għandu l-effett ħafif ta' impeditur fuq dihydrofolic acid reductase, għalhekk hemm ilpossibilta' ta' xi tfixkil ma' folate metabolism waqt terapija fit-tul (ara sezzjoni 4.6) .
English: Acute ingestion of doses in excess of 10 to 20 times the maximum therapeutic dose has been reported.
Maltese: Ġew rappurtati każijiet fejn ittieħdu 10 sa 20 darba aktar mid-doża massima terapewtika.
English: Initial, escalation and maintenance doses should generally be reduced by approximately 50% in patients with moderate (Child-Pugh grade B) and 75% in severe (Child-Pugh grade C) hepatic impairment.
Maltese: Id-dożi tal-bidu, dawk li jiżdiedu u dawk ta' stabbilizzazzjoni ġeneralment għandhom jitnaqqsu b'50% f'pazjenti b'indeboliment tal-fwied moderat (Child-Pugh grad B) u b'75% f'dawk b'indeboliment gravi (Child-Pugh grad Ċ).
English: toxic epidermal necrolysis.
Maltese: nekroliżi tossika tal-ġilda.
English: Certain AEDs (such as phenytoin, carbamazepine, phenobarbitone and primidone) which induce hepatic drug-metabolising enzymes induce the glucuronidation of lamotrigine and enhance the metabolism of lamotrigine.
Maltese: Xi AEDs (bħal phenytoin, carbamazepine, phenobarbitone u primidone) li jinduċu enzimi tal-fwied li jimmetabolizzaw il-mediċina jinduċu l-glukuronidazzjoni ta' lamotrigine u jsaħħu l-metaboliżmu ta' lamotrigine.
English: 16 18 20 22 24 26 28 (one pocket)
Maltese: 16 18 20 22 24 26 28 (kontenitur wieħed)
English: On average, approximately 20% (range = 5.6 to 35.1) of the amount of lamotrigine present in the body was eliminated during a 4-hour hemodialysis session.
Maltese: Bħala medja, madwar 20% (skala = 5.6 sa 35.1) mill-ammont ta' lamotrigine preżenti fil-ġisem ġie eliminat waqt sessjoni ta' 4 sigħat emodijalisi.
English: The indication will specify that the target population is “Adults and adolescents aged 13 years and above”.
Maltese: L-indikazzjoni tispeċifika li l-popolazzjoni fil-mira hija "Adulti u adolexxenti minn 13-il sena 'l fuq".
English: Lamotrigine is rapidly and completely absorbed from the gut with no significant first-pass metabolism.
Maltese: Lamotrigine jiġi assorbit malajr u kompletament mill-imsaren mingħajr ebda metaboliżmu first-pass sinifikanti.
English: 15 17 19 21 23 25 27 (one pocket)
Maltese: 15 17 19 21 23 25 27 (kontenitur wieħed)
English: Fertility Animal experiments did not reveal impairment of fertility by lamotrigine (see section 5.3).
Maltese: Fertilita' Esperimenti fuq annimali ma wrew ebda indeboliment ta' fertilita' b'lamotrigine (ara sezzjoni 5.3).
English: hypersensitivity syndrome** (including such symptoms as, fever, lymphadenopathy, facial oedema, abnormalities of the blood and liver, disseminated intravascular coagulation, multi-organ failure).
Maltese: Disturbi fis-sistema immuni Rari ħafna: sindrome ta' sensittivita' eċċessiva** (inklużi sintomi bħal deni, limfadenopatija, edema filwiċċ, anormalitajiet fid-demm u fil-fwied, koagulazjoni intravaskulari mxerrda, ħsara f'diversi organi tal-ġisem).
English: Serious potentially life-threatening skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's Syndrome) have been reported.
Maltese: Ġew irrappurtati każijiet serji ta' raxx fil-ġilda ta' periklu għall-ħajja, inklużi s-sindrome Stevens-Johnson u nekroliżi tossika tal-ġilda (Sindrome ta' Lell).
English: Effect of lamotrigine on hormonal contraceptive pharmacokinetics In a study of 16 female volunteers, a steady state dose of 300 mg lamotrigine had no effect on the pharmacokinetics of the ethinyloestradiol component of a combined oral contraceptive pill.
Maltese: Fi studju fuq 16 voluntieri nisa, doża steady-state ta' 300 mg lamotrigine ma kella ebda effett fuq ilfarmakokinetiċi tal-komponent ethinyloestradiol ta' pillola kontraċettiva orali kombinata.
English: Lamictal is not indicated for the acute treatment of manic or depressive episodes”.
Maltese: Lamictal mhuwiex indikat għat-trattament akut ta' episodji ta' manija jew depressivi".
English: Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom
Maltese: Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN Renju Unit
English: A total of 256 subjects between 1 to 24 months of age have been exposed to lamotrigine in the dose range 1 to 15 mg/kg/day for up to 72 weeks.
Maltese: Total ta' 256 suġġett ta' bejn 1 u 24 xahar kien espost għal lamotrigine f'doża li tvarja bejn 1 u 15mg/kg/kuljum sa 72 ġimgħa.
English: Binding to plasma proteins is about 55%; it is very unlikely that displacement from plasma proteins would result in toxicity.
Maltese: It-twaħħil ma' proteini tal-plasma hu madwar 55%; mhu xejn probabbli li t-teħid ta' post il-proteini talplasma għandu jirriżulta f'xi tossiċita'.
English: The other ingredients are: calcium carbonate, low substituted hydroxypropyl cellulose, aluminium magnesium silicate, sodium starch glycolate (Type A), povidone K30, saccharin sodium, magnesium stearate, blackcurrant flavour.
Maltese: Is-sustanzi l-oħra huma: karbonat tal-kalċju, low substituted hydroxypropyl cellulose, aluminium magnesium silicate, sodium starch glycolate (Tip A), povidone K30, sodju tas-sakkarina, stearat tal-manjesju, sustanza b'togħma ta' ribes.
English: 2 4 6 8 10 12 14 (no pocket)
Maltese: 2 4 6 8 10 12 14 (kontenitur wieħed)
English: They are marked ‘GSCX7' on one side; and ‘50' on the other.
Maltese: Huma mmarkati ‘GSCX7' fuq naħa waħda; u ‘50' fuq in-naħa l-oħra.
English: Adults aged 18 years and above - Prevention of depressive episodes in patients with bipolar I disorder who experience predominantly depressive episodes (see section 5.1).
Maltese: Adulti ta' minn 18-il sena 'l fuq - Prevenzjoni ta' episodji depressivi f'pazjenti b'mard bipolari I li jgħaddu minn episodji ta' depressjoni predominanti (ara sezzjoni 5.1)
English: Hence an article 30 procedure (Directive 2001/83/EC) for harmonisation of the SPC of lamotrigine across Europe has been initiated by the Marketing Authorisation Holder.
Maltese: Għalhekk inbdiet proċedura skond l-Artikolu 30 (Direttiva 2001/83/KE) għall-armonizzazzjoni ta' l-SPC ta' lamotriġina fl-Ewropa mill-MAH.
English: In a study of subjects with Gilbert's Syndrome, mean apparent clearance was reduced by 32% compared with normal controls but the values are within the range for the general population.
Maltese: Fi studju ta' pazjenti bisSindrome Gilbert, jidher li l-medja ta' tneħħija tnaqqset bi 32% meta mqabbla ma' kontrolli normali imma lvaluri huma fl-iskala applikabbli għall-popolazzjoni ġenerali.
English: Haematological abnormalities may or may not be associated with the hypersensitivity syndrome (see Immune system disorders**).
Maltese: Anormalitajiet ematoloġiċi jistgħu ikunu assoċjati mas-sindrome ta' sensittivita' eċċessiva u jistgħu ma jkunux (ara Disturbi fis-sistema immuni**).
English: POSSIBLE SIDE EFFECTS
Maltese: Effetti sekondarji rari
English: Excipient: Each tablet contains 46.9 mg lactose.
Maltese: Kull pillola fiha 46.9 mg lattosju.
English: These defects include cleft lip or cleft palate.
Maltese: Fost dawn id-difetti hemm hemm cleft lip jew cleft palate.
English: Nevertheless differences exist with respect to the precise wording of the epilepsy indication, restriction of age-categories, seizure types, dose recommendations and interactions.
Maltese: Madankollu jeżistu differenzi fil-formulazzjoni ta' l-indikazzjoni ta' l-epilessija, irrestrizzjoni tal-kategoriji relatati ma' l-età, it-tipi ta' kriżijiet, id-dożi rakkomandati u l-interazzjonijiet.
English: Starter pack 42 tablets, non-valproate add-on therapy
Maltese: Pakkett tal-bidu 42 pilloli valproate terapija add-on
English: PVC/PVdC/aluminium foil blister.
Maltese: Folja blister tal-PVC/PVdC/aluminju.
English: The excipients used in the formulations of the drug product and manufacturing processes are standard for the proposed pharmaceutical forms.
Maltese: L-eċċipjenti użati fil-formulazzjonijiet tal-prodott mediċinali u tal-proċessi produttivi huma standard għall-forom farmeċewtiċi proposti.
English: In a clinical study, there was no clinically significant effect of lamotrigine on QT interval in healthy adult volunteers (see section 5.1).
Maltese: Fi studju kliniku, me kien hemm ebda effett ta' sinifikanza klinika ta' lamotrigine fuq l-intervall QT f'voluntieri adulti f'saħħithom (ara sezzjoni 5.1).
English: Steady-state trough plasma concentrations of lamotrigine were not affected by concomitant pregabalin (200 mg, 3 times daily) administration.
Maltese: Konċentrazzjonijiet steady-state trough ta' lamotrigine fil-plażma ma ġewx affettwati meta ttieħed pregabalin (200 mg, 3 darbiet kuljum) fl-istess ħin.
English: Weeks 1 + 2 Weeks 3 + 4 Week 5
Maltese: Ġimgħat 1 + 2 Ġimgħat 3 +
English: In tests designed to evaluate the central nervous system effects of medicinal products, the results obtained using doses of 240 mg lamotrigine administered to healthy volunteers did not differ from placebo, whereas both 1000 mg phenytoin and 10 mg diazepam each significantly impaired fine visual motor co-ordination and eye movements, increased body sway and produced subjective sedative effects.
Maltese: F'testijiet maħsuba biex jiġu evalwati l-effetti fis-sistema nervuża ċentrali ta' prodotti mediċinali, ir-riżultati miksuba minn użu ta' dożi ta' 240 mg lamotrigine mogħtija lil voluntieri f'saħħithom ma kienux differenti minn dawk bi plaċebo, waqt li 1000 mg phenytoin u 10 mg diazepam it-tnejn kemm huma ikkawżaw indeboliment sinifikanti fil-koordinament tal-mutur viżwali u l-movimenti ta' l-għajnejn, żiedu fit-tbandil tal-ġisem u pproduċew effetti sedattivi suġġettivi.
English: The median apparent clearance of lamotrigine was 0.31, 0.24 or 0.10 mL/min/kg in patients with Grade A, B, or C (Child-Pugh Classification) hepatic impairment, respectively, compared with 0.34 mL/min/kg in the healthy controls.
Maltese: jew 0.10 mL/min/kg f'pazjenti bi Grad A, B jew Ċ (Klassifikazzjoni Child-Pugh) ta' indeboliment tal-fwied, rispettivament, meta mqabbel ma'0.34 mL/min/kg f'kontrolli f'saħħithom.
English: • hormonal contraceptives, such as the Pill (see below).
Maltese: • kontraċettivi ormonali, bħal ma hi l-Pillola (ara hawn taħt).
English: In vitro experiments indicated that the formation of lamotrigine's primary metabolite, the 2-N-glucuronide, was minimally inhibited by co-incubation with amitriptyline, bupropion, clonazepam, haloperidol or lorazepam.
Maltese: Esperimenti in vitro indikaw li l-formazzjoni tal- metabolit primarju ta' lamotrigine, il-glukuronid 2-N, ġie kemm kemm inibit b'ko-inkubazzjoni ma' amitriptyline, bupropion, clonazepam, haloperidol jew lorazepam.
English: Dose-related adverse events cannot be excluded.
Maltese: Ma jistgħux jiġu esklużi reazzjonijiet avversi relatati mad-dożi.
English: 300 mg/day 400 mg/day Maintain this dose (400 mg/day)
Maltese: 400 mg/day Żomm din iddoża (400 mg/kuljum)
English: 200 − 400 mg/day (two divided doses)
Maltese: 200 − 400 mg/kuljum (żewġ dożi maqsuma)
English: After single doses apparent clearance decreased by 12% from 35 mL/min at age 20 to 31 mL/min at 70 years.
Maltese: Wara l-għoti ta' dożi waħedhom deher li t-tneħħija naqset bi 12% minn 35 mL/min fl-eta' ta' 20 sa 31 mL/min fl-eta' ta' 70 sena.
English: In a study of patients with epilepsy, coadministration of zonisamide (200 to 400 mg/day) with lamotrigine (150 to 500 mg/day) for 35 days had no significant effect on the pharmacokinetics of lamotrigine.
Maltese: Fi studju fuq pazjenti b'epilessija, l-għoti flimkien ta'zonisamide (200 sa 400 mg mg/kuljum) ma' lamotrigine (160 sa 500 mg/kuljum) għal 35 jum ma kellu ebda effett sinifikanti fuq il-farmakokinetiċi ta' lamotrigine.
English: Doses in the range 100 - 400 mg/day used in clinical trials
Maltese: Dożi fl-iskala ta' 100-400 mg/kuljum użati fi provi kliniċi
English: Table 7: Summary of results from studies investigating the efficacy of lamotrigine in the prevention of mood episodes in patients with bipolar I disorder
Maltese: Tabella 7 : Sommarju ta' riżultati minn studji li jinvestigaw l-effikaċja ta' lamotrigine fil-prevenzjoni ta' episodji ta' mania f'pazjenti b'disturb bi-polari I
English: However, there is no evidence that lamotrigine affects the pharmacokinetics of other AEDs and data suggest that interactions between lamotrigine and medicinal products metabolised by cytochrome P450 enzymes are unlikely to occur.
Maltese: Madankollu, m'hemm xejn x'juri li lamotrigine jaffettwa l-farmakokinetiċi ta' AEDs oħra u l-informazzjoni miġbura tindika li mhux mistennija interazzjonijiet bejn lamotrigine u prodotti mediċinali metabolizzati b'enzimi taċċitokromu P450.
English: (Starter pack 21 tablets, valproate add-on therapy - calender pack showing day numbers): 1 3 5 7 9 11 13 (one pocket)
Maltese: (Pakkett tal-bidu 21 tablets, valproate terapija add-on - pakkett kalendarju li juri n-numru ta' ġranet): 1 3 5 7 9 11 13 (kontenitur wieħed)
English: “Adults 18 years and above {Tradename} is indicated for the prevention of mood episodes in patients with bipolar disorder, predominantly by preventing depressive episodes”.
Maltese: "Adulti minn 18-il sena 'l fuq {Isem kummerċjali} huwa indikat għall-prevenzjoni ta' episodji ta' burdati f'pazjenti li jbatu minn disturb bipolari, predominantament bil-prevenzjoni ta' episodji depressivi".
English: Although the Marketing Authorisation Holder has not conducted specific studies with lamotrigine monotherapy solely in patients with primary generalised tonic clonic seizures, data from controlled initial monotherapy studies (studies UK49/89, UK74) reassure on the efficacy of lamotrigine on this seizure types.
Maltese: Għalkemm il-MAH ma wettaqx studji speċifiċi b'lamotriġina użata esklussivament għall-monoterapija talkriżijiet toniko-kloniċi ġeneralizzati primarji, it-tagħrif mill-istudji kkontrollati dwar il-monoterapija inizjali (studji UK49/89, UK74) jagħti garanziji fuq l-effikaċja ta' lamotriġina fuq dawn it-tipi ta' kriżijiet.