FrancophonIA/ELRC3.0 huggingface dataset:
English: In rodent models, stiripentol appears to increase brain levels of gamma-aminobutyric acid (GABA) - the major inhibitory neurotransmitter in mammalian brain.
Maltese: F'mudelli ta' annimali gerriema, stiripentol jidher li jżid il-livelli fil-moħħ ta'gamma-aminobutyric acid (GABA) - in-newrotrasmittatur inibitur maġġur fil-moħħ tal-mammiferi.
English: Common side effects (may affect up to1 in 10 people):
Maltese: Effetti sekondarji komuni (jista' jaffettwa sa persuna 1 minn 10 pazjenti):
English: This medicine contains sorbitol: 2.4 mg in each 250mg-sachet and 4.8 mg in each 500mg-sachet.
Maltese: 2.4 mg f'kull qartas ta' 250 mg u 4.8 mg f'kull qartas ta' 500 mg.
English: Raised γ-GT
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: A French compassionate use program included children from 6 months of age because the diagnosis of Dravet's syndrome may be made with confidence at that age in some patients.
Maltese: Programm ta' użu kompassjonanti Franċiż inkluda tfal minn età ta' 6 xhur minħabba li d-djanjożi tassidromu ta' Dravet jista' jsir b'kunfidenza f'dik l-età f'xi pazjenti.
English: Biocodex, 7 avenue Gallieni - F-94250 Gentilly - France Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex.fr
Maltese: Gentilly - Franza Tel : + 33 1 41 24 30 00 - e-mail: webar@biocodex.fr
English: 15 (71%) patients were responders on stiripentol (including nine free of clonic or tonic-clonic seizures), whereas there was only one (5%) on placebo (none was seizure free; stiripentol 95% CI 52.1-90.7 vs. placebo 0-14.6).
Maltese: Dawk li rrispondew kienu mfissra bħala li kellhom aktar minn 50% tnaqqis filfrekwenza ta' aċċessjonijiet kloniċi (jew toniċi-kloniċi) waqt it-tieni xahar tal-perijodu double-blind imqabbla mal-linja bażi. 15-il (71%) pazjent kienu dawk fuq stiripentol li rrispondew (inklużi disgħa ħielsa minn aċċessjonijiet kloniċi jew toniċi-kloniċi), filwaqt kien hemm wieħed biss (5%) fuq plaċebo (l-ebda minnhom ma' kienu ħielsa mill-aċċessjonijiet; stiripentol 95% CI 52.1-90.
English: If your child has problems with certain ingredients of Diacomit (e.g. aspartame, glucose, sorbitol).
Maltese: Aspartame, glucose, sorbitol).
English: - Effects on other antiepileptic drugs (AEDs)
Maltese: - Effetti ta' AEDs oħra
English: The recommended dose of 50 mg/kg/day is based on the available clinical study findings and was the only dose of Diacomit evaluated in the pivotal studies (see section 5.1).
Maltese: Id-doża rakkomandata ta' 50 mg/kg/jum hi bażata fuq ir-riżultati disponibbli mill-istudju kliniku u kienet l-uniku doża ta' Diacomit evalwata fl-istudji ewlenien (ara sezzjoni 5.1).
English: Liver function test abnormal
Maltese: Investigazzjonijiet γGT ogħla test tal-funzjoni talfwied b'riżultat anormali
English: • ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia
Maltese: • atassja (inkapaċita' li tikkoordina l-movimenti tal-muskoli), ipotonija (nuqqas ta' saħħa fil muskoli), distonija (kontrazzjoni involontarja tal-muskoli).
English: INFORMATION IN BRAILLE Diacomit 250 mg hard capsules
Maltese: INFORMAZZJONI BIL-BRAILLE Diacomit 250 mg kapsuli iebsin 17.
English: Stiripentol is an inhibitor of the enzymes CYP2C19, CYP3A4 and CYP2D6 and may markedly increase the plasma concentrations of substances metabolised by these enzymes and increase the risk of adverse reactions (see section 4.5).
Maltese: Stiripentol huwa inibitur ta' l-enzimi CYP2C19, CYP3A4 u CYP2D6 u jista' jżid bil-bosta l-konċentrazzjonijiet fil-plażma ta' sustanzi metabolizzati minn dawn l-enżimi u jżid ir-riskju ta' reazzjonijiet avversi (ara, sezzjoni 4.5).
English: Read the package leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għassuq.
English: EU/1/06/367/005 60 hard capsules
Maltese: EU/1/06/367/005 60 kapsuli iebsin
English: NAME OF THE MEDICINAL PRODUCT Diacomit 500 mg hard capsules
Maltese: Diacomit 500 mg kapsuli iebsin
English: Data on the potential for inhibition of CYP1A2 are limited, and therefore, interactions with theophylline and caffeine cannot be excluded because of the increased plasma levels of theophylline and caffeine which may occur via inhibition of their hepatic metabolism, potentially leading to toxicity.
Maltese: Dejta fuq il-potenzjal ta' inibizzjoni ta' CYP1A2 hija ristretta, u għaldaqstant, interazzjonijiet ma' theophylline u kaffeina ma jistgħux jiġu esklużi minħabba ż-żieda fil-livelli ta' theophylline u kaffeina fil-plażma li jistgħu jseħħu minħabba l- impediment tal-metaboliżmu epatiku tagħhom, li potenzjalment jista' jwassal għal tossiċità.
English: With regard to topiramate, it is considered that potential competition of inhibition on CYP2C19 should not occur because it probably requires plasma concentrations 5-15 times higher than plasma concentrations obtained with the standard recommended topiramate dose and dosage schedules.
Maltese: Fir-rigward ta' topiramate, huwa kkunsidrat li l-kompetizzjoni potenzjali ta' inibizzjoni fuq CYP2C19 m'għandhiex isseħħ peress li probabbli teħtieġ konċentrazzjonijiet fil-plażma 5-15 il-darba ogħla minn konċentrazzjonijiet fil-plażma miksuba bid-doża u skedi ta' dożaġġ standard irrakkomandati ta' topiramate.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/007-9
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/367/007-9
English: In this younger group of patients, adjunctive therapy with stiripentol should only be started when the diagnosis of SMEI has been clinically confirmed (see section 5.1).
Maltese: F'dan il-grupp ta' pazjenti iżgħar terapija aġġuntiva bi stiripentol għandha tiġi mibdija meta d-dijanjosi ta' SMEI tkun ġiet klinikament kkonfermata (ara sezzjoni 5.1).
English: It is recommended that if a switch of formulations is required this is done under clinical supervision, in case of problems with tolerability (see section 5.2).
Maltese: Huwa rakkomandat li jekk ikun hemm bżonn ta' bidla fil-formulazzjonijiet dan isir taħt superviżjoni klinika, f'każ li jinqalgħu problemi ta' tollerabilità (ara sezzjoni 5.2).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/007 30 sachets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/367/007 30 borża
English: The pivotal clinical evaluation of stiripentol was in children of 3 years of age and over with SMEI.
Maltese: Effikaċja klinika u sigurtà L-evalwazzjoni klinika ewlenija ta' stiripentol kienet fi tfal ta' età ta' 3 snin jew aktar b'SMEI.
English: It is used in conjunction with clobazam and valproate (other antiepileptic medicines) to treat a certain form of epilepsy called severe myoclonic epilepsy in infancy (Dravet's syndrome), which affects children.
Maltese: Huwa jintuża flimkien ma' clobazam u valproate (mediċini antiepilettiċi oħra) biex tiġi kkurata ċerta forma ta' epilessija msejħa epilessija mijoklonika akuta fl-infanzja (sindrome ta' Dravet), li taffettwa lit-tfal.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/010 30 sachets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/367/010 30 qartas
English: NAME OF THE MEDICINAL PRODUCT Diacomit 250 mg hard capsules
Maltese: Diacomit 250 mg kapsuli iebsin
English: Plasma clearance decreases markedly at high doses; it falls from approximately 40 l/kg/day at the dose of 600 mg/day to about 8 l/kg/day at the dose of 2,400 mg. Clearance is decreased after repeated administration of stiripentol, probably due to inhibition of the cytochrome P450 isoenzymes responsible for its metabolism.
Maltese: It-tneħħija tonqos wara amministrazzjoni ripetuta ta' stiripentol, probabbilment minħabba inibizzjoni tal-iżoenzimi cytochrome P450 risponsabbli għal metaboliżmu tiegħu.
English: EU/1/06/367/003 90 hard capsules
Maltese: EU/1/06/367/003 90 kapsuli iebsin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/004-6
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/367/004-6
English: The impact of macrolides and azole antifungal medicinal agents on stiripentol metabolism, that are known to be inhibitors of CYP3A4 and substrates of the same enzyme, is not known.
Maltese: L-impatt fuq il-metaboliżmu ta' stiripentol minn macrolides u prodotti mediċinali kontra l-fungu tat-tip azole, li huma magħrufa bħala inibituri ta' CYP3A4 u sottostrati ta' l-istess enzima mhuwiex magħruf.
English: What Diacomit 250 mg contains
Maltese: INDIVIDWALI 250 mg
English: EU/1/06/367/006 90 hard capsules
Maltese: EU/1/06/367/006 90 kapsuli iebsin
English: What Diacomit 250 mg looks like and contents of the pack Diacomit 250 mg hard capsule is pink.
Maltese: Id-dehra ta' Diacomit 250 mg u l-kontenut tal-pakkett Il-kapsuli iebsin ta' Diacomit 250 mg huma roża.
English: Stiripentol has also been shown to enhance GABAA receptor-mediated transmission in the immature rat hippocampus and increase the mean open-duration (but not the frequency) of GABAA receptor chloride channels by a barbiturate-like mechanism.
Maltese: Stiripentol ukoll deher li jtejjeb it-trasmissjoni medjata minn riċettaturi GABAA filħippokampus tal-far immatur u jżid it-tul ta' żmien miftuħ medju (iżda mhux il-frekwenza) ta' kanali tal-klorur tar-riċettaturi GABA minn mekkaniżmu bħal tal-barbiturati.
English: EU/1/06/367/002 60 hard capsules
Maltese: EU/1/06/367/002 60 kapsuli iebsin
English: • fatigue (tiredness).
Maltese: • dardir, rimettar;
English: excitement, restlessness and hallucinations).
Maltese: eċitament, irrikwitezza u alluċinazzjonijiet).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/001-3
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/367/001-3
English: 21 patients on stiripentol had moderate side-effects (drowsiness, loss of appetite) compared with eight on placebo, but side-effects disappeared when the dose of comedication was decreased in 12 of the 21 cases (Chiron et al, Lancet, 2000).
Maltese: Il-persentaġġ ta' bidla mill-linja bażi kien ogħla fuq stiripentol (-69%) milli fuq il-plaċebo (+7%), p<0.0001. 21 pazjent fuq stiripentol kellhom effetti mhux mixtieqa moderati (ngħas, telf ta' aptit) imqabbla ma' tmienja fuq il-plaċebo, imma leffetti mhux mixtieqa sparrixew meta d-doża ta' medikazzjoni konkomitanti kienet imnaqqsa fi 12 mill-21 każ (Chiron et al, Lancet, 2000).
English: As a result, no pharmacokinetic metabolic drug interaction between stiripentol and levetiracetam is anticipated.
Maltese: L-influwenza ta' prodotti mediċinali antiepilettiċi oħra fuq il-farmakokinetiċi ta' stiripentol mhix stabbilita sew.
English: Studies in the rat on fertility and general reproductive performance and on pre- and postnatal development were uneventful except for a minor reduction in the survival of pups nursed by mothers exhibiting toxic responses to stiripentol at a dose of 800 mg/kg/day (see section 4.6).
Maltese: Studji fuq il-fertilità fil-far u l-eżekuzzjoni riproduttiva ġenerali u fuq l-iżvilupp ta' qabel u ta' wara t-twelid kienu bla problemi ħlief għal tnaqqis żgħir fis-sopravivenza tal-ġriewi imreddgħin minn ommijiet li kienu qed juru reazzjonijiet tossiċi għal stiripentol f'doża ta' 800 mg/kg/kuljum (ara, sezzjoni, 4.6).
English: Potential for stiripentol to interact with other medicinal products
Maltese: Il-potenzjal għal stiripentol li jaffettwa prodotti mediċinali oħra
English: Paediatric population The dose of stiripentol is calculated on a mg/kg body weight basis.
Maltese: Id-doża ta' stiripentol hija kkalkulata skont il-piż korporali b'mg/kgs.
English: The capsule should be swallowed whole with a glass of water.
Maltese: Il-kapsula għandha tinbela sħiħa ma' tazza ilma waqt ikla.
English: • raised levels of liver enzymes, especially when given with either of the antiepileptic medicines carbamazepine and sodium valproate;
Maltese: • livelli ogħla ta' enzimi tal-fwied, speċjalment meta jingħata ma' xi waħda mill-mediċini anti epilettiċi carbamazepine u sodium valproate;
English: NAME OF THE MEDICINAL PRODUCT Diacomit 500 mg hard capsules stiripentol
Maltese: Diacomit 500 mg kapsuli iebsin stiripentol
English: Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.
Maltese: Diacomit huwa indikat biex jintuża flimkien ma' clobazam u valproate bħala terapija miżjuda għal aċċessjonijiet toniċi-kloniċi ġeneralizzati refrattarji f'pazjenti b'epilessija mijoklonika severa fit-tfulija (SMEI, sindromu ta' Dravet) li l-aċċessjonijiet tagħhom m'humiex ikontrollati adegwatament b'clobazam u valproate.
English: Tabulated list of adverse reaction
Maltese: Disturbi taddemm u tas-sistema limfatika
English: NAME OF THE MEDICINAL PRODUCT Diacomit 250 mg hard capsules stiripentol
Maltese: Diacomit 250 mg kapsuli iebsin stiripentol
English: Treatment is supportive (symptomatic measures in intensive care units).
Maltese: It-trattament hu t'appoġġ (miżuri sintomatiċi fittaqsimiet tal-kura intensiva).
English: Very common Common
Maltese: Komuni Ħafna Komuni
English: Nausea, vomiting
Maltese: Meta għandek tieħu Diacomit
English: • if your child has ever experienced attacks of delirium (a mental state with confusion,
Maltese: • jekk it-tifel/tifla tiegħek xi darba esperjenzaw attakki ta' delirju (stat mentali b'konfużjoni,
English: Stiripentol, the active ingredient of Diacomit, belongs to a group of medicines called antiepileptics.
Maltese: Stiripentol, is-sustanza attiva ta' Diacomit, jappartjeni għal kategorija ta' mediċini msejħa antiepilletiċi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 sachet contains 250 mg stiripentol.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Qartas 1 fih 250 mg stiripentol
English: There are no clinical study data to support the clinical safety of stiripentol administered at daily doses greater than 50 mg/kg/day.
Maltese: M'hemmx tagħrif minn studji kliniċi li jissostanza s-sigurtà klinika ta' stiripentol li jingħata f'dożi ta' kuljum ikbar minn 50 mg/kg/jum.
English: Undesirable combinations (to be avoided unless strictly necessary) - Rye ergot alkaloids (ergotamine, dihydroergotamine) Ergotism with possibility of necrosis of the extremities (inhibition of hepatic elimination of rye ergot).
Maltese: Kombinazzjonijiet mhux mixtieqa (li għandhom jiġu evitati kemm-il darba mhux strettament meħtieġ) - Alkalojdi ergot tas-segala (ergotamine, dihydroergotamine) Ergotiżmu b'possibbilità ta' nekrożi ta' l-estremitajiet (inibizzjoni ta' l-eliminazzjoni epatika ta' ergot tas-segala).
English: What Diacomit 500 mg looks like and contents of the pack Diacomit 500 mg hard capsules are white.
Maltese: Id-dehra ta' Diacomit 500 mg u l-kontenut tal-pakkett Il-kapsuli iebsin ta' Diacomit 500 mg huma bojod.
English: Breastfeeding
Maltese: Eskrezzjoni
English: Psychiatric disorders
Maltese: Disturbi psikjattriċi
English: Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population.
Maltese: Riskju relatat mal-epilessija u prodotti mediċinali anti-epilettiċi in ġenerali Ġiet murija li l-prevalenza ta' malformazzjonijiet hija tnejn jew tliet darbiet akbar mir-rata ta' madwar 3% fil-popolazzjoni inġenerali fil-wild ta' nisa bl-epilessija.
English: • sleep disorders (abnormal sleeping);
Maltese: • disturbi ta' l-irqad (irqad abnormali);
English: Approximately two to three-fold increases in clobazam and five-fold increases in norclobazam plasma levels respectively have been reported with co-administration of stiripentol in children with Dravet's syndrome.
Maltese: Żidiet fil-livelli tal-plażma ta' madwar tnejn sa tliet darbiet għal clobazam u ta' ħames darbiet għal norclobazam rispettivament ġew irrapportati b'amministrazzjoni konkomitanti ta' stiripentol fi tfal bis-sindromu ta' Dravet.
English: Glucose liquid spray dried Sodium
Maltese: Ż-ŻGĦAR EWLENIN TEST FUQ IT-TIKKETTA TAL-QARTAS
English: Do NOT take Diacomit with milk or dairy products (yoghurt, soft cream cheeses, etc), fruit juice, fizzy drinks or food and drinks that contain caffeine or theophylline (for example cola, chocolate, coffee, tea and energy drinks).
Maltese: TIĦUX Diacomit mal-ħalib jew ma' prodotti tal-ħalib (jogurt, ġobon artab frisk, eċċ.), meraq tal-frott, xarbiet bil-gass jew ikel u xorb li fihom il-kafeina jew it-teofillina (pereżempju cola, ċikkulata, kafe', te u xarbiet tal-enerġija).
English: What Diacomit 500 mg contains
Maltese: INDIVIDWALI 500 mg
English: The increase in steady state levels with the combined use of stiripentol, valproate, and clobazam is similar in adults and children, though inter-individual variability is marked.
Maltese: Iż-żieda fil-livelli ta' stat fiss kostanti bl-użu kkombinat ta' stiripentol, valproate, u clobazam huwa simili fl-adulti u fit-tfal, għalkemm l-varjabilità bejn l-individwi hija kbira.
English: A population pharmacokinetic study was conducted in 35 children with Dravet Syndrome treated with stiripentol and two substances not known to affect stiripentol pharmacokinetics, valproate and clobazam.
Maltese: Sar studju farmakokinetiku tal-popolazzjoni fuq 35 tifel u tifla kkurati bi stiripentol għas-Sindromu ta' Dravet u żewġ sustanzi li mhumiex magħrufin li jaffettwaw il-farmakokinetiċi ta' stiripentol, valproate u clobazam.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/004 30 hard capsules
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/367/004 30 kapsuli iebsin
English: Increased plasma benzodiazepine levels may occur via decreased hepatic metabolism leading to excessive sedation.
Maltese: Livelli ta' benzodiazepine fil-plażma miżjuda jistgħu jseħħu permezz ta' metaboliżmu epatiku mnaqqas li jwassal għal sedazzjoni eċċessiva.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Stiripentol was not teratogenic when tested in the rat and rabbit; in one study in the mouse, but not in several other similar studies, a low incidence of cleft palate formation was observed at a maternotoxic dose (800 mg/kg/day).
Maltese: Stiripentol ma kienx teratoġeniku meta ttestjat fil-far jew fil-fenek; f'wieħed mill-istudji fil-ġurdien, iżda mhux f'bosta studji oħra simili, inċidenza baxxa ta' formazzjoni tas-saqaf tal-ħalq maqsum kienet osservata f'doża maternotossika (800 mg/kg/kuljum).
English: Co-administration with CYP3A4 substrates with a narrow therapeutic index should be avoided due to the markedly increased risk of severe adverse reactions.
Maltese: Għandha tiġi evitata l-amministrazzjoni konkomitanti ma' sottostrati CYP3A4 b'indiċi terapewtiċi dojoq minħabba r-riskju bil-bosta miżjud ta' reazzjonijiet avversi serji.
English: Detailed information on this medicine is available on the European Medicine Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europea.eu/.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/001 30 hard capsules
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/367/001 30 kapsuli iebsin
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 sachet contains 500 mg stiripentol.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Qartas 1 fih 500 mg stiripentol
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europea.eu/.
English: Substances interfering with CYP enzymes
Maltese: Sustanzi li jxekklu l-enzimi CYP
English: NAME OF THE MEDICINAL PRODUCT Diacomit 500 mg powder for oral suspension in sachet stiripentol
Maltese: Diacomit 500 mg trab għal sospensjoni orali fi qratas.
English: Anorexia, loss of appetite, weight loss
Maltese: Anoreksja, telf ta' aptit, telf fil-piż
English: As the flavouring component contains small amount of sorbitol, patients with hereditary problems of fructose intolerance should not take this medicine.
Maltese: Peress li l-komponent tal-benna fiha ammonti żgħar ta' sorbitol, pazjenti li għandhom problemi ereditarji ta' intolleranza għal fruttożju m'għandhomx jieħdu din il-mediċina.
English: Stiripentol is not recommended for use in patients with impaired hepatic and/or renal function (see section 4.4).
Maltese: Stiripentol mhux rakkomandat biex jintuża f'pazjenti li għandhom indeboliment fil-funzjoni tal-fwied u/jew tal-kliewi (ara, sezzjoni 4.4).
English: Diacomit is also available as 250 mg and 500 mg capsules for oral use
Maltese: Diacomit huwa disponibbli wkoll bħala kapsuli ta' 250 mg u 500 mg għal użu orali.
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (jista' jaffettwa sa persuna 1 minn 100):
English: Drowsiness, ataxia, hypotonia, dystonia
Maltese: Insomnija Aggressività, irritabilità, disturbi ta' mġieba, mġieba opposta, ipereċitabilità, disturbi fl-irqad
English: NAME OF THE MEDICINAL PRODUCT Diacomit 250 mg powder for oral suspension in sachet stiripentol
Maltese: Diacomit 250 mg trab għal sospensjoni orali fi qratas.
English: A dose-adjustment may be necessary for substances metabolised by CYP2D6 and that are individually dose titrated.
Maltese: Aġġustament fid-doża jista' jkun meħtieġ għal sustanzi metabolizzati minn CYP2D6 u li għandhom doża ttitrata individwalment.
English: The initiation of adjunctive therapy with stiripentol should be undertaken gradually using upwards dose escalation to reach the recommended dose of 50 mg/kg/day administered in conjunction with clobazam and valproate.
Maltese: Il-bidu ta' terapija aġġuntiva bi stiripentol għandha ssir b'mod gradwali permezz ta' żieda dożali 'l fuq sabiex tintlaħaq id-doża rakkomandata ta' 50 mg/kg/jum li tingħata flimkien ma' clobazam u valporate.
English: This could occur by inhibition of synaptosomal uptake of GABA and/or inhibition of GABA transaminase.
Maltese: Dan jista' jseħħ permezz ta' inibizzjoni ta' teħid sinaptosomali ta' GABA u/jew inibizzjoni ta' GABA transaminase.
English: The full EPAR for Exelon 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: It is available as capsules (1.5, 3, 4.5 and 6 mg), as an oral solution (2 mg/ml), and as transdermal patches, which release either 4.6, 9.5 or 13.3 mg rivastigmine across the skin over 24 hours.
Maltese: Jiġi f'kapsuli (1.5, 3, 4.5 u 6 mg), bħala soluzzjoni orali (2 mg/ml), u fi stikek transdermiċi, li jerħu 4.6, 9.5 jew 13.3 mg rivastigmina mill-ġilda f'24 siegħa.
English: Exelon is a medicine containing the active substance rivastigmine.
Maltese: Exelon huwa mediċina li fiha s-sustanza attiva rivastigmina.
English: The active substance in Exelon, rivastigmine, is an antidementia medicine.
Maltese: Is-sustanza attiva f'Exelon, ir-rivastigmina, hija mediċina kontra d-dimenzja.
English: This is a summary of the European public assessment report (EPAR) for Exelon.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Exelon.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Exelon on 12 May 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq lil Exelon valida fl-Unjoni Ewropea kollha fit-12 ta' Mejju 1998.
English: For the global score, patients taking Exelon capsules had in increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Maltese: Kwantu għall-punteġġ globali, il-pazjenti ttrattati bil-kapsuli Exelon kellhom żieda fis-sintomi ta' 4.1 punti apparagun ma' 4.4 punti rreġistrati fil-pazjenti ttrattati bil-plaċebo.