FrancophonIA/ELRC3.0 huggingface dataset:
English: Animal experiments have shown that vigabatrin has no negative influence on fertility or pup development.
Maltese: Esperimenti fuq l-annimali urew li vigabatrin ma għandu ebda influwenza negattiva fuq il-fertilità jew l-iżvilupp tal-ferħ.
English: Group III Group I 3
Maltese: Grupp III Grupp I3
English: When provided, doses were most commonly between 7.5 to 30 g; however, ingestions up to 90 g have been reported.
Maltese: Meta pprovduti, id-dożi kienu l-aktar bejn 7.5 sa 30 g; madankollu, ġew irrappurtati inġestjonijiet sa 90 g.
English: Vigabatrin may increase the amount of amino acids in the urine possibly leading to a false positive test for certain rare genetic metabolic disorders (e.g., alpha aminoadipic aciduria).
Maltese: Vigabatrin jista' jżid l-ammont ta' amminoaċidi fl-urina li jista' jwassal għal test pożittiv falz għal ċerti disturbi metaboliċi ġenetiċi rari (eż. aċidurja alfa aminoadipika).
English: White oval tablets.
Maltese: Pilloli ovali bojod.
English: Other less frequently reported symptoms included vertigo, headache, psychosis, respiratory depression or apnoea, bradycardia, hypotension, agitation, irritability, confusion, abnormal behaviour, and speech disorder.
Maltese: Sintomi rrappurtati b'inqas frekwenza kienu jinkludu, sturdament, uġigħ ta' ras, psikożi,dipressjoni respiratorja jew apnea, bradikardija, pressjoni baxxa, aġitazzjoni, irritabilità, konfużjoni, mġiba mhux normali u disturb fid-diskors.
English: Pack size: 100 soluble tablets.
Maltese: Daqs tal-pakkett: 100 pillola li tinħall.
English: Studies with vigabatrin revealed no evidence of mutagenic or carcinogenic effects.
Maltese: L-istudji b'vigabatrin ma żvelaw ebda evidenza ta' effetti mutaġeniċi jew karċinoġeniċi.
English: Psychiatric reactions have been reported during vigabatrin therapy.
Maltese: Ġew irrappurtati reazzjonijiet psikjatriċi waqt it-terapija b'vigabatrin.
English: Vigabatrin is a water soluble compound and it is rapidly and completely absorbed from the gastrointestinal tract.
Maltese: Assorbiment Vigabatrin huwa kompost li jinħall fl-ilma u jiġi assorbit rapidament u kompletament mill-passaġġ gastro-intestinali.
English: Chronic treatment with vigabatrin may be associated with a slight decrease in haemoglobin which rarely attains significance.
Maltese: It-trattament kroniku b'vigabatrin tista' tkun assoċjata ma' tnaqqis żgħir fl-emoglobina li rarament ikun sinifikanti.
English: Available evidence suggests that the VFD is irreversible even after discontinuation of vigabatrin.
Maltese: L-evidenza disponibbli tindika li l-VFD huwa irreversibbli anki wara li vigabatrin jitwaqqaf.
English: The magnitude of suppression for ALT has been reported to vary between 30% and 100%.
Maltese: Il-kobor tas-soppressjoni għall-ALT ġie rrappurtat li jvarja bejn 30% u 100%.
English: In infantile spasms (West's Syndrome), the recommended starting dose is 50 milligrams per kilogram bodyweight daily.
Maltese: Fl-ispażmi infantili (is-Sindrome ta' West), id-doża inizjali rakkomandata hija 50 milligramma għal kull kilogramma piż tal-ġisem kuljum.
English: Each soluble tablet contains 100 mg vigabatrin.
Maltese: Kull pillola li tinħall fiha 100 mg vigabatrin.
English: Median treatment duration: 44.4 months, mean daily dose 1.48 g 2 Median treatment duration: 20.6 months, mean daily dose 1.39 g 3 Median treatment duration: 48.8 months, mean daily dose 2.10 g Median treatment duration: 23.0 months, mean daily dose 2.18 g
Maltese: 1 Tul tal-kura medja: 44.4 xhur, doża medja ta' kuljum 1.48 g 2 Tul tal-kura medja: 20.6 xhur, doża medja ta' kuljum 1.39 g 3 Tul tal-kura medja:
English: 100 mg tablet size: 9.4 mm x 5.3 mm 500 mg tablet size: 16.0 mm x 9.0 mm
Maltese: Daqs ta' pillola ta' 100 mg: 9.4 mm x 5.3 mm Daqs ta' pillola ta' 500 mg: 16.0 mm x 9.0 mm Is-soluzzjoni fl-ilma hija bajdanija u mdardra.
English: In a retrospective epidemiologic study in infants with infantile spasms (N=205), the prevalence of these changes was 22% in vigabatrin treated patients versus 4% in patients treated with other therapies.
Maltese: Fi studju epidemjoloġiku retrospettiv fit-tfal bl-ispażmi infantili (N=205), il prevalenza ta' dawn il-bidliet kienet ta' 22 % f'pazjenti ttrattati b'vigabatrin meta mqabbla ma' 4 %
English: Available data suggests that visual field defects are irreversible.
Maltese: Id-data disponibbli tindika li d-difetti fil-kamp viżiv huma irreversibbli anki wara li vigabatrin jitwaqqaf.
English: Group II 4
Maltese: Grupp II4
English: Each soluble tablet contains 500 mg vigabatrin.
Maltese: Kull pillola li tinħall fiha 500 mg vigabatrin.
English: Movement disorders including dystonia, dyskinesia and hypertonia, have been reported in patients treated with vigabatrin for infantile spasms.
Maltese: Ġew irrappurtati disturbi fil-moviment inklużi distonja, diskinesija u ipertonja, f'pazjenti b'vigabatrin għall-ispażmi infantili.
English: Common side effects (may affect up to 1 in 10 people) headache weight gain shaking (tremor ) swelling (oedema) dizziness sensation of numbness or tingling (pins and needles) reduced concentration and memory psychological problems including agitation, aggression, nervousness, irritability, depression, thought disturbance and feeling suspicious without reason (paranoia).
Maltese: sturdament sensazzjoni ta' tnemnim jew tingiż tnaqqis fil-konċentrazzjoni u fil-memorja problemi psikoloġiċi inklużi aġitazzjoni, aggressjoni, nervi, irritabilità, dipressjoni, disturbi filħsieb u suspetti mingħajr raġuni (paranoja).
English: In the brain, microvacuolation due to intramyelinic oedema has been observed in white matter tracts of rat, mouse and dog at doses of 30-50 mg/kg/day.
Maltese: Ġiet osservata mikrovakwolazzjoni fil-moħħ, minħabba edema intramijelinika fil-passaġġi tal-materja bajda tal-firien, tal-ġrieden u tal-klieb f'dożi ta' 30-50 mg/kg/jum.
English: Perimetry is seldom possible in children less than 9 years of developmental age.
Maltese: Il-perimetrija rari tkun possibbli fi tfal li għandhom inqas minn 9 snin ta' żvilupp.
English: There is no relevant use of Kigabeq in neonates (below 27 days of age) in the indication “infantile spasms” and in children and adolescents above 7 years of age in the indication “resistant partial epilepsy” (focal onset seizures).
Maltese: M'hemmx użu rilevanti ta' Kigabeq fit-trabi tat-twelid (ta' inqas minn 27 jum) fl-indikazzjoni “spażmi infantili” u fit-tfal u fl-adolexxenti ta' aktar minn seba' snin fl-indikazzjoni “epilessija parzjali reżistenti” (aċċessjonijiet tal-bidu fokali).
English: Proposed doses for first titration step (75 mg/kg/day) (Day 3)
Maltese: Dożi proposti għall-ewwel pass ta' titrazzjoni (75 mg/kg/jum) (it-Tielet Jum)
English: Undesirable effects ranked under headings of frequency are listed below, using the following convention:
Maltese: L-effetti mhux mixtieqa huma kklassifikati taħt l-intestaturi tal-frekwenza permezz tal-konvenzjoni li ġejja:
English: - Observed at inclusion - Observed at first conclusive evaluation - Observed at last conclusive evaluation
Maltese: - Osservat flinklużjoni - Osservat flewwel valutazzjoni konklużiva - Osservat flaħħar valutazzjoni konklużiva
English: The most commonly reported adverse reaction related to vigabatrin are visual field defects (ranging from mild to severe and occurring usually after months to years of vigabatrin therapy), psychiatric disorders such as agitation, excitation, aggression, nervousness, depression, paranoid reaction, nervous system disorders such as marked sedation, stupor and confusion.
Maltese: (li jvarjaw minn ħfief sa severi u li normalment iseħħu wara xhur sa snin ta' terapija b'vigabatrin), disturbi psikjatriċi bħal aġitazzjoni, eċċitament, aggressjoni, nervi, dipressjoni, reazzjoni paranojde, disturbi fis-sistema nervuża bħal sedazzjoni evidenti, insensittività u konfużjoni.
English: Blood and lymphatic system disorders anaemia
Maltese: Disturbi taddemm u tassistema limfatika anemija
English: These events have been reversible following dose reduction or discontinuation of vigabatrin (see section 4.8).
Maltese: Dawn l-avvenimenti kienu riversibbli wara li tnaqqset id-doża jew twaqqaf vigabatrin (ara s-sezzjoni 4.8).
English: Patients were split in three treatment groups: patients currently treated with vigabatrin (group I), patients previously exposed to vigabatrin (group II) and patients never exposed to vigabatrin (group III).
Maltese: Il-pazjenti nqasmu fi tliet gruppi ta' kura: pazjenti attwalment ittrattati b'vigabatrin (grupp I), pazjenti li qabel kienu esposti għal vigabatrin (grupp II) u pazjenti li qatt ma kienu esposti għal vigabatrin
English: Look for symptoms suggestive of such thoughts: disturbed sleep, loss of appetite or weight, isolation, loss of interest for favorite activities.
Maltese: Oqgħod attent għal sintomi li jindikaw tali ħsibijiet: rqad disturbat, nuqqas ta' aptit jew piż, iżolament, telf ta' interess fl-attivitajiet favoriti.
English: Such reactions have been fully reversible following dose reduction or discontinuation of vigabatrin (see section 4.4).
Maltese: Dawn ir-reazzjonijiet kienu kompletament riversibbli wara li tnaqqset id-doża jew twaqqaf vigabatrin (ara s-sezzjoni 4.4).
English: For younger patients electroretinography should be used (see Visual Field Defects).
Maltese: F'pazjenti iżgħar għandha tintuża l elettroretinografija (ara Difetti fil-Kamp Viżiv).
English: Abnormal Magnetic Resonance Imaging (MRI) signal changes characterised by increased T2 signal and restricted diffusion in a symmetric pattern involving the thalamus, basal ganglia, brain stem, and cerebellum have been observed in some infants treated with vigabatrin for infantile spasms.
Maltese: Sinjali ta' Immaġnijiet b'Riżonanza Manjetika Anormali Ġew osservati bidliet fis-sinjali tal-Immaġnijiet b'Riżonanza Manjetika (Magnetic Resonance Imaging MRI) anormali kkaratterizzati minn żieda fis-sinjal T2 u diffużjoni limitata f'mudell simmettriku li jinvolvu t-talamus, il-gangliji tal-bażi, iz-zokk ċerebrali u ċ-ċervellett f'xi trabi ttrattati b'vigabatrin għall-ispażmi infantili.
English: The onset is usually after months to years of vigabatrin therapy.
Maltese: Dawn jibdew normalment wara xhur sa snin ta' terapija b'vigabatrin.
English: In the central visual field (within 30 degree of eccentricity), frequently an annular nasal defect is seen.
Maltese: Fil-kamp viżiv ċentrali, (fi 30 grad ta' eċċentriċità), spiss ikun jidher difett nażali annulari.
English: Epidemiology of VFD in patients with refractory partial epilepsy was observed in an observational, open-label, multicentre, comparative, parallel group, Phase IV study, including 734 patients, at least 8 years old, with refractory partial epilepsy for at least one year.
Maltese: IV, open label, ta' osservazzjoni, komparattiv, bi grupp parallel u f'diversi ċentri li kien jinkludi 734 pazjent, ta' mill-inqas 8 snin, b'epilessija parzjali refrattorja għal mill-inqas sena.
English: Controlled and long-term clinical trials have shown that vigabatrin is an effective anticonvulsant agent when given as first line treatment in patients with infantile spasms and as add-on therapy in patients with epilepsy not controlled satisfactorily by conventional therapy.
Maltese: Provi kliniċi kkontrollati u fit-tul urew li vigabatrin huwa aġent antikonvulsiv effettiv meta jingħata bħala trattament tal-ewwel linja f'pazjenti bi spażmi infantili u bħala terapija supplimentari f'pazjenti b'epilessija mhux ikkontrollata b'mod sodisfaċenti minn terapija konvenzjonali.
English: Vigabatrin-associated retinotoxicity has been observed in 80-100% of albino rats at the dose of 300 mg/kg/day orally, but not in pigmented rats, dogs or monkeys.
Maltese: Ġiet osservata retinotossiċità assoċjata ma' vigabatrin fi 80-100% tal-firien albino fid-doża orali ta'
English: Psychiatric events (e.g., agitation, depression, abnormal thinking, paranoid reactions) have been reported during vigabatrin treatment.
Maltese: Ġew irrapportati avvenimenti psikjatriċi (eż. aġitazzjoni, dipressjoni, ħsieb anormali, reazzjonijiet paranojdi) waqt it-trattament b'vigabatrin.
English: Based on the available data the first oscillatory potential and 30 Hz flicker responses of the electroretinogram appear to be correlated with a vigabatrin associated VFD.
Maltese: Skont id-data disponibbli l-ewwel potenzjal oxxilatorju u reazzjonijiet ta' flutwazzjoni ta' 30 Hz talelettroretinogramma jidhru li huma korrelatati ma' VFD assoċjata ma' vigabatrin.
English: Subsequent dosing can be titrated by 25 mg/kg/day increments every 3 days up to the maximum recommended dose of 150 mg/kg/day.
Maltese: Id-dożaġġ sussegwenti jista' jkun ittitrat b'żidiet ta' 25 mg/kg/jum kull tlett ijiem sad-doża massima rakkomandata ta' 150 mg/kg/jum.
English: As routine MRI surveillance of this paediatric population is not recommended, the frequency of MRI abnormalities cannot be reliably estimated from the available data.
Maltese: Peress li s-sorveljanza ta' MRI ta' rutina ta' din ilpopolazzjoni pedjatrika mhix rakkomandata, il-frekwenza tal-anormalitajiet tal-MRI ma jistgħux ikunu stmati b'mod affidabbli mid-data disponibbli.
English: These phenomena may also be the consequence of an overdose, a decrease in plasma concentrations of concomitant antiepileptic treatment, or a paradoxical effect.
Maltese: Dawn il-fenomeni jistgħu jkunu wkoll il-konsegwenza ta' doża eċċessiva, tnaqqis fil-konċentrazzjonijiet tat-trattament antiepilettiku konkomitanti fil-plażma, jew effett paradossali.
English: Very common side effects (may affect more than 1 in 10 people) excitation or restlessness tiredness and pronounced sleepiness joint pain
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) eċċitament jew irrekwitezza għeja u ngħas qawwi uġigħ fil-ġogi
English: The gastric tube should be rinsed with 10 ml of water.
Maltese: It-tubu gastriku għandu jitlaħlaħ b'10 ml ilma.
English: Very rare side effects (may affect up to 1 in 10,000 people) other eye problems such as pain in eyes (optic neuritis) and loss of vision, including colour vision (optic atrophy) hallucinations (feeling, seeing or hearing things that are not there) liver problems
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna 1 f'10,000) problemi oħrajn tal-għajnejn bħal uġigħ fl-għajnejn (newrite ottika) u telf tal-vista, inkluż vista tal-kuluri (atrofija ottika)
English: encephalo pathy optic neuritis brain MRI abnormalities.
Maltese: f'pazjenti oħrajn ikkurati b'terapiji oħrajn.
English: Visual field defects
Maltese: Difetti fil-kamp viżiv
English: optic atrophy
Maltese: atrofija ottika
English: However, in rabbits, a slight increase in the incidence of cleft palate at doses of 150-200 mg/kg was seen.
Maltese: Madankollu, dehret żieda żgħira fl-inċidenza ta' palatoskiżi fil-fniek f'dożi ta' 150-200 mg/kg.
English: Nervous system disorders somnolenc e speech disorder, headache, dizziness, paraesthesia, disturbance in attention and memory impairment, mental impairment (thought disturbance), tremor coordination abnormal (ataxia)
Maltese: disturbi flattenzjoni u indeboliment tal-memorja, indeboliment mentali (disturbi fil ħsieb), rogħda koordinazzjoni anormali (atassija)
English: De uts chland
Maltese: TA' KIF JINGĦATA
English: Table 2: Number of soluble tablets according to body weight and starting dose in resistant partial epilepsy
Maltese: Tabella 2: Numru ta' pilloli li jinħallu skont il-piż tal-ġisem u d-doża inizjali f'epilessija parzjali reżistenti
English: One tablet (500 mg)
Maltese: Nofs pillola (500 mg)
English: The recommended starting dose is 50 mg/kg/day.
Maltese: Id-doża tal-bidu rakkomandata hija ta' 50 mg/kg/jum.
English: For children aged 1 month to less than 7 years
Maltese: Għal tfal minn xahar sa inqas minn 7 snin
English: 15 to 30 kg:
Maltese: 0.5 sa 1 g/jum minn 15 sa 30 kg:
English: Number of tablets (strength) Morning
Maltese: In-numru ta' pilloli (qawwa)
English: Vigabatrin is not significantly metabolised.
Maltese: Bijotrasformazzjoni Vigabatrin mhuwiex metabolizzat b'mod sinifikanti.
English: One soluble tablet of Kigabeq 100 mg contains 100 mg vigabatrin One soluble tablet of Kigabeq 500 mg contains 500 mg vigabatrin - The other ingredients are: crospovidone type B, mannitol, sodium stearyl fumarate
Maltese: Ma dehret l-ebda teratoġeniċità fil-firien f'dożi sa 150 mg/kg (3 darbiet id-doża talbniedem) jew fil-fniek f'dożi sa 100 mg/kg.
English: In isolated case reports in renal failure patients receiving therapeutic doses of vigabatrin, haemodialysis reduced vigabatrin plasma concentrations by 40% to
Maltese: F'rapporti ta' każijiet iżolati f'pazjenti b'insuffiċjenza renali li ngħataw dożi terapewtiċi ta' vigabatrin, l-emodijalisi naqqset il-konċentrazzjonijiet ta' vigabatrin fil-plażma b'40% sa 60%.
English: PHARMACEUTICAL FORM AND CONTENTS 50 soluble tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 50 pillola li tinħall
English: Suomi/Finland ORPHELIA Pharma SAS Puh/Tel: + 33 1 42 77 08 18
Maltese: ORPHELIA Pharma SAS Puh/Tel: + 33 1 42 77 08 18
English: After administration of a single 37-50 mg/kg dose of an oral solution vigabatrin tmax was approximately 2.5 hours in neonates and infants, and 1 hour in children.
Maltese: Wara li ngħataw doża waħda ta' 37-50 mg/kg ta' soluzzjoni orali ta' vigabatrin it-tmax kien madwar 2.5
English: Activated charcoal has been shown to not significantly adsorb vigabatrin in an in vitro study.
Maltese: Il-karbonju attiv intwera li ma jassorbix b'mod sinifikanti l-vigabatrin fi studju in vitro.
English: Gastric administration
Maltese: Disturbi gastrointestinali dardir,
English: Since vigabatrin is eliminated via the kidneys, caution should be exercised when administering the medicinal product to patients with creatinine clearance less than 60 ml/min.
Maltese: Peress li vigabatrin jiġi eliminat permezz tal-kliewi, għandha tintuża kawtela meta l-prodott mediċinali jingħata lill-pazjenti bi tneħħija tal-kreatinina ta' inqas minn 60 ml/min.
English: Approximately 70% of a single oral dose was recovered as unchanged drug in the urine in the first 24 hours post-dose.
Maltese: Madwar 70% ta' doża orali waħda ġew irkuprati bħala mediċina mhux mibdula fl-urina fl-ewwel 24 siegħa wara ddoża.
English: Psychiatric disorders
Maltese: TAL-PRODOTT MEDIĊINALI
English: Syste m organ class
Maltese: Is-Cl/F medju ta' S
English: Skin and subcutaneou s tissue disorders rash angioede ma, urticaria
Maltese: - L-ingredjenti l-oħrajn huma: crospovidone tip B, mannitol, sodium stearyl fumarate
English: Interference with serological testing
Maltese: Effetti sekondarji serji
English: Since vigabatrin is eliminated via the kidneys, caution should be exercised in patients with a creatinine clearance of less than 60 ml/min.
Maltese: Peress li vigabatrin jiġi eliminat permezz tal-kliewi, għandha tintuża kawtela fil-pazjenti bi tneħħija tal-kreatinina ta' inqas minn 60 ml/min.
English: Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for: Treatment in monotherapy of infantile spasms (West's syndrome).
Maltese: Kigabeq hija indikata fit-tfal żgħar u fit-tfal mill-età ta' xahar sa inqas minn seba' snin għal: Kura f'monoterapija ta' spażmi infantili (sindrome ta' West).
English: Decreases in ALT and AST, which are considered to be a result of inhibition of these aminotransferases by vigabatrin, have been observed.
Maltese: Ġie osservat tnaqqis fl-ALT u fl-AST, li huma meqjusa li huma riżultat ta' inibizzjoni ta' dawn laminotransferażi minn vigabatrin.
English: Kigabeq 100 mg soluble tablets
Maltese: Kigabeq 100 mg
English: The doctor will adjust the dose during treatment as necessary.
Maltese: sitt xhur sakemm iddum it-trattament.
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications.
Maltese: Ġew irrappurtati ħsibijiet u mġiba suwiċidali f'pazjenti ttrattati bi prodotti mediċinali antiepilettiċi f'bosta indikazzjonijiet.
English: • Rinse the glass or beaker with one or two teaspoonfuls (about 5 to 10 ml) of water and give this to your child to make sure that the child receives all the medicine
Maltese: • Laħlaħ it-tazza jew il-beaker b'kuċċarina jew tnejn ilma (madwar 5 sa 10 ml) u agħti dan littifel/tifla tiegħek biex tkun ċert li t-tifel/tifla tieħu l-mediċina kollha
English: Frequency and severity have only been indirectly characterised in this population on the presence of electroretinogram or visual evoked potential anomalies.
Maltese: Il-frekwenza u s-severità kienu kkaratterizzati biss b'mod indirett f'din il-popolazzjoni fil-preżenza ta' elettroretinogramma jew anomaliji potenzjali evokati viżwalment.
English: Hepatobiliar y disorders hepatitis
Maltese: Disturbi filfwied u filmarrara epatite
English: • Pour one or two teaspoonfuls (about 5 to 10 ml) of water into a drinking glass or beaker
Maltese: • Ferra' daqs kuċċarina waħda jew tnejn (madwar 5 sa 10 ml) ilma f'tazza jew beaker
English: The risks of treatment must be very carefully weighed against possible benefit in children.
Maltese: Ir-riskji tat trattament għandhom jitqiesu b'attenzjoni kbira meta mqabbla mal-benefiċċju possibbli fit-tfal.
English: One tablet (500 mg) and two tablets (100 mg)
Maltese: Pillola waħda (500 mg) u żewġ pilloli (100 mg)
English: Very common: excitation, agitation
Maltese: Disturbi psikjatriċi Komuni ħafna: eċċitament, aġitazzjoni
English: Pack sizes:
Maltese: Daqsijiet tal-pakketti:
English: • If your child cannot drink from the glass or beaker then you can use an oral syringe to gently squirt the mixture into your child's mouth, taking care not to cause choking: sit just in front and below your child in order that he/she has the head leaning forward and administer the mixture against his cheek
Maltese: • Jekk it-tifel/tifla ma jkunx jista' jibla'/tkunx tista' tibla', it-taħlita tista' tingħata permezz ta' tubu gastriku, permezz ta' siringa adattata.
English: A deterioration of VFD after the treatment is discontinued cannot be excluded.
Maltese: Mhux eskluż deterjorament talVFD wara li t-trattamentikun twaqqaf.
English: Other medicines and Kigabeq
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Rare reports of encephalopathic symptoms such as marked sedation, stupor and confusion in association with non-specific slow wave activity on electroencephalogram have been described soon after the initiation of vigabatrin treatment.
Maltese: Ġew deskritti rapporti rari ta' sintomi enċefalopatiċi bħal sedazzjoni kbira, insensittività u konfużjoni assoċjati ma' attività ta' mewġ bil-mod mhux speċifika fuq l-elettroenċefalogramma immedjatament wara l-bidu tat-trattament b'vigabatrin.
English: The parents and/or caregivers must be given a thorough description of the frequency and implications of the development of VFD during vigabatrin treatment.
Maltese: Il-ġenituri u/jew l-indokraturi għandhom jingħataw deskrizzjoni dettaljata tal-frekwenza u l implikazzjonijiet tal-iżvilupp ta' VFD waqt it-trattament b'vigabatrin.
English: Table 1: Number of soluble tablets according to body weight, starting dose and dose increment in infantile spasms Body we ight (kg)
Maltese: Tabella 1: Numu ta' pilloli li jinħallu skont il-piż tal-ġisem, id-doża inizjali u ż-żidiet tad-doża flispażmi infantili
English: Three tablets (100 mg)
Maltese: Nofs pillola (100 mg)
English: PHARMACEUTICAL FORM AND CONTENTS 100 soluble tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 100 pillola li tinħall
English: Two tablets (100 mg)
Maltese: Żewġ pilloli (100 mg)
English: The recommended starting dose is 40 mg/kg/day.
Maltese: Id-doża tal-bidu rakkomandata hija ta' 40 mg/kg/jum.
English: The retinal changes in albino rats were characterised as focal or multifocal disorganisation of the outer nuclear layer while the other layers of retina were not affected.
Maltese: Il-bidliet fir-retina tal-firien albino kienu kkaratterizzati bħala diżorganizzazzjoni fokali jew multifokali tas-saff nukleari ta' barra filwaqt li saffi oħrajn tar-retina ma kinux affettwati.
English: Food administration does not alter the extent of vigabatrin absorption.
Maltese: Ġiet irrappurtata doża eċċessiva ta' vigabatrin.
English: HDPE bottle closed with a child resistant tamper evident PP screw cap.
Maltese: Flixkun HDPE magħluq b'tapp bil-kamin PP reżistenti kontra t-tbagħbis evidenti mit-tfal.