FrancophonIA/ELRC3.0 huggingface dataset:
English: Risk related to stiripentol
Maltese: Riskju relatat ma' stiripentol
English: In a French compassionate use program for stiripentol, topiramate was added to stiripentol, clobazam and valproate in 41% of 230 cases.
Maltese: Fi programm ta' użu kompassjonanti Franċiż għal stiripentol, topiramate kien miżjud ma' stiripentol, clobazam u valproate f' 41% ta' 230 każijiet.
English: Hyperkinesias
Maltese: Iperkinesi
English: Abnormal laboratory findings
Maltese: Riżultati abnormali tal-laboratorju
English: Paediatric population
Maltese: Populazzjoni pedjatrika
English: Size 0, white capsule
Maltese: Daqs 0, kapsula bajda
English: 90 sachets
Maltese: 90 borża
English: • aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable);
Maltese: • aggressivita', irritabilita', aġitazzjoni, eċċitabilita' eċċessiva (stat ta' eċċitabilita' mhux tas-soltu);
English: Povidone (K29/32) Sodium starch glycolate (type A) Magnesium stearate
Maltese: Povidone (K29/32) Sodium starch glycolate (tip A) Magnesium stearate
English: Effect of stiripentol on cytochrome P450 enzymes
Maltese: L-effett ta' stiripentol fuq enżimi ta' cytochrome P450
English: Date of latest renewal: 08 January 2014
Maltese: Data tal-aħħar tiġdid: 08 ta' Jannar 2014
English: Biocodex AB Isafjordsgatan 36
Maltese: Isafjordsgatan 36
English: 7 avenue Gallieni - F-94250 Gentilly
Maltese: 7 avenue Gallieni - F-94250
English: Biocodex, 1 avenue Blaise Pascal - F-60000 Beauvais - France
Maltese: 1 avenue Blaise Pascal - F-60000
English: 0.32 mg sodium per capsule.
Maltese: 0.32 mg sodium għal kull kapsula.
English: 60 sachets
Maltese: 60 borża
English: phenobarbital, primidone, phenytoin, carbamazepine, diazepam.
Maltese: - mediċini anti-epilettiċi li fihom: phenobarbital, primidone, phenytoin, carbamazepine, diazepam.
English: - Immunosuppressants (tacrolimus, cyclosporine, sirolimus) Raised blood levels of immunosuppressants (decreased hepatic metabolism).
Maltese: - Immunosoppressanti (tacrolimus, cyclosporine, sirolimus) Livelli fid-demm mgħollija ta' l-immunosoppressanti (metaboliżmu epatiku mnaqqas).
English: tutti frutti flavour (contains sorbitol), carmellose sodium, hydroxyethylcellulose.
Maltese: togħma ta' tutti frutti (fiha s-sorbitol), carmellose sodium, hydroxyethylcellulose.
English: 0.16 mg sodium per capsule.
Maltese: 0.16 mg sodium għal kull kapsula.
English: • double vision when used in combination with the antiepileptic medicine carbamazepine;
Maltese: • vista doppja meta jintuża flimkien mal-mediċina anti-epilettika carbamazepine;
English: Potential medicinal product interactions affecting stiripentol
Maltese: Interazzjonijiet potenzjali ta' prodotti mediċinali li jolqtu lil stiripentol
English: BATCH NUMBER Lot
Maltese: NUMRU TAL-LOTT Lot.
English: Diacomit contains aspartame, glucose, sorbitol and sodium This medicine contains 2.5 mg aspartame in each 250mg-sachet and 5 mg each 500mg-sachet.
Maltese: Diacomit fih aspartame, glucose, sorbitol u sodium Din il-mediċina fiha 2.5 mg asparame f'kull qartas ta' 250 mg u 5 mg kull qartas ta' 500 mg.
English: Czech Republic Tel: 00420-2-222 45 375 e-mail: desitin@desitin.cz
Maltese: CzechRepublic Tel: 00420-2-222 45 375 e-mail: desitin@desitin.cz
English: Clearance and volume of distribution were related to body weight by an allometric model with exponents of 0.433 and 1, respectively: as body weight increased from 10 to 60 kg, apparent oral clearance increased from 2.60 to 5.65 L/hr and apparent volume of distribution increased from 32.0 to 191.8 L. As a result, elimination half-life increased from 8.5hr (for 10 kg) to 23.5 hr (for 60 kg).
Maltese: 433 u 1, rispettivament: meta l-piż tal-ġisem żdied minn 10 sa 60 kg, it-tneħħija apparenti orali ogħla minn 2.60 sa 5.65 l/hr u l-volum apparenti ta' distribuzzjoni żdied minn 32.0 sa 191.8 l.
English: Photosensitivity, rash, cutaneous allergy, urticaria
Maltese: Fotosensitività, raxx, allerġija, talġilda urtikarja
English: Thrombocytopenia *
Maltese: Tromboċitopenija *
English: PHARMACEUTICAL FORM AND CONTENTS 30 hard capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 kapsuli iebsa
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number} [product code]
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM PC: {numru} [kodiċi tal-prodott]
English: Each sachet contains 5 mg of aspartame, 1,000 mg of glucose liquid spray and 4.8 mg of sorbitol.
Maltese: Kull qartas fih 5 mg ta' aspartame, 1000 mg ta' likwidu ta' glukożju u 4.8 mg ta' sorbitol.
English: Adverse reactions encountered most often are as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Reazzjonijiet avversi li wieħed jiltaqa' magħhom ta' spiss huma kif ġej: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rare (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhix magħrufa (ma tistax tiġi stmata mit-tagħrif disponibbli).
English: 7 avenue Gallieni 94250 Gentilly France
Maltese: 7 avenue Gallieni 94250
English: 60 hard capsules
Maltese: 60 kapsuli iebsin
English: Boxes of 30, 60 and 90 sachets.
Maltese: Il-pakketti fihom 30, 60 jew 90 qartas.
English: • insomnia (sleeplessness), drowsiness;
Maltese: • insomnja (nuqqas ta' rqad), ngħas;
English: A past history of psychoses in the form of episodes of delirium.
Maltese: Storja ta' psikosi fil-forma ta' episodji ta' dilirju.
English: In the absence of available clinical data, caution should be taken with the following clinically relevant interactions with stiripentol:
Maltese: Fin-nuqqas ta' dejta klinika disponibbli, għandha tittieħed il-kawtela ma' l-interazzjonijiet klinikament relevanti li ġejjin ma' stiripentol:
English: • loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium valproate);
Maltese: • telf ta' l-aptit, tnaqqis fil-piż (speċjalment meta jingħata mal-mediċina anti-epilettika sodium valproate);
English: MARKETING AUTHORISATION HOLDER Biocodex, 7 Avenue Gallieni, 94250 Gentilly, France.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Biocodex, 7 Avenue Gallieni, 94250
English: Bottles of 30, 60 and 90 capsules in cardboard cartons.
Maltese: Fliexken ta' 30, 60 u 90 kapsula f'pakketti tal-kartun.
English: • The capsule shell is made of gelatine, titanium dioxide (E171).
Maltese: • Il-qoxra tal-kapsula hija magħmula minn gelatin, titanium dioxide (E171).
English: The following pharmacokinetic properties of stiripentol have been reported from studies in adult healthy volunteers and adult patients.
Maltese: Il-proprjetajiet farmakokinetiċi li ġejjin dwar stiripentol ġie rraportat minn studju fuq voluntiera adulti u pazjenti adulti.
English: PHARMACEUTICAL FORM Hard capsule
Maltese: GĦAMLA FARMAĊEWTIKA Kapsuli iebsin
English: Inhibition of CYP450 isoenzyme CYP2C19 and CYP3A4 may provoke pharmacokinetic interactions (inhibition of their hepatic metabolism) with phenobarbital, primidone, phenytoin, carbamazepine, clobazam (see section 4.2), valproate (see section 4.2), diazepam (enhanced myorelaxation), ethosuximide, and tiagabine.
Maltese: Inibizzjoni ta' CYP450 iżoenzima CYP2C19 u CYP3A4 jistgħu jqanqlu interazzjonijiet farmakokinetiċi (inibitur tal-metaboliżmu epatiku tagħhom) ma' phenobarbital, primidone, phenytoin, carbamazepine, clobazam (ara, sezzjoni 4.2), valproate (ara, sezzjoni 4.2), diazepam (rilassjoni talmuskoli mtejjba), ethosuximide, u tiagabine.
English: Diacomit 250 mg hard capsule Diacomit 500 mg hard capsule stiripentol
Maltese: Diacomit 250 mg kapsuli iebsin Diacomit 500 mg kapsuli ebsin stiripentol
English: In this case, please see below: “Diacomit contains aspartame, glucose, sorbitol and sodium”.
Maltese: F'dan il-każ ara hawn isfel: “Diacomit fih aspartame, glucose, sorbitol u sodium”.
English: Aggressiveness, irritability, behaviour disorders, opposing behaviour, hyperexcitability, sleep disorders
Maltese: Aggressività, irritabilità, disturbi ta' mġieba, mġieba opposta, ipereċitabilità, disturbi fl-irqad
English: Many of these interactions have been partially confirmed by in vitro studies and in clinical trials.
Maltese: Ħafna minn dawn l-interazzjonijiet ġew ikkonfermati parzjalment minn studji in vitro u provi kliniċi.
English: s r.o
Maltese: IL-PROVVISTA U L
English: 41 children with SMEI were included in a randomised, placebo-controlled, add-on trial.
Maltese: 41 tfal b'SMEI kienu inklużi fi studju add-on, randomizzat u kkontrollat bil-plaċebo.
English: PHARMACEUTICAL FORM Powder for oral suspension Pale pink crystalline powder
Maltese: Trab għal sospensjoni orali Trab roża ċar ikkristalizzat
English: • rash, skin allergy, urticaria (pinkish, itchy swellings on the skin);
Maltese: • raxx, allerġija tal-ġilda, urtikarja (nefħiet roża li jġegħluk tħokk fuq il-ġilda);
English: 90 hard capsules
Maltese: 90 kapsuli iebsin
English: In vitro studies suggested that stiripentol phase 1 metabolism is catalyzed by CYP1A2, CYP2C19 and CYP3A4 and possibly other enzymes.
Maltese: Studji in vitro issuġġerixxew li l-metaboliżmu ta' fażi 1 ta' stiripentol hu katalizzat minn CYP1A2, CYP2C19 u CYP3A4 u possibbilment minn enzimi oħrajn.
English: Neutropenia may be associated with the administration of stiripentol, clobazam and valproate.
Maltese: In-newtropenja tista' tkun assoċjata ma' l-amministrazzjoni ta' stiripentol, clobazam u valproate.
English: Phone: +46 8 615 2760 e-mail: info@biocodex.no
Maltese: +46 8 615 2760 e-mail: info@biocodex.no
English: There are slight differences between the Diacomit capsules and powder for oral suspension.
Maltese: Hemm differenzi kemxejn żgħar bejn il-kapsuli Diacomit u t-trab għal suspensjoni orali.
English: Stiripentol powder for oral suspension in sachet contains aspartame, a source of phenylalanine.
Maltese: It-trab stiripentol għal sospensjoni orali fi qratas fih l-aspartame, sors ta' phenylalanine.
English: INFORMATION IN BRAILLE Diacomit 500 mg hard capsules
Maltese: INFORMAZZJONI BIL-BRAILLE Diacomit 500 mg kapsuli iebsin
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 04 January 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 04 ta' Jannar 2007
English: At therapeutic concentrations, stiripentol significantly inhibits several CYP450 isoenzymes: for example, CYP2C19, CYP2D6 and CYP3A4.
Maltese: F'konċentrazzjonijiet terapewtiċi, stiripentol jinibixxi sinifikattivament bosta iżoenzimi CYP450, per eżempju, CYP2C19, CYP2D6 u CYP3A4.
English: Each sachet contains 2.5 mg of aspartame, 500 mg of glucose liquid spray and 2.4 mg of sorbitol.
Maltese: Kull qartas fih 2.5 mg ta' aspartame, 500 mg ta' sprej ta' likwidu ta' glukożju u 2.4 mg ta' sorbitol.
English: For the interaction of stiripentol with food, see section 4.5.
Maltese: Għall-interazzjoni ta' stiripentol mal-ikel, ara sezzjoni 4.5.
English: Stiripentol potentiates the efficacy of other anticonvulsants, such as carbamazepine, sodium valproate, phenytoin, phenobarbital and many benzodiazepines, as the result of pharmacokinetic interactions.
Maltese: Stiripentol jqawwi l-effikaċja ta' antikonvulsanti oħra, bħal ma huma carbamazepine, sodium valproate, phenytoin, phenobarbital u ħafna benzodiazepines, bħala riżultat ta' interazzjonijiet farmakokinetiċi.
English: Other medicines and Diacomit
Maltese: Mediċini oħra u Diacomit
English: Stiripentol is extensively metabolized, 13 different metabolites having been found in urine.
Maltese: Stiripentol huwa metabolizzat b'mod estensiv, b'13-il metabolit differenti jinstab fl-awrina.
English: Increased risk of dose-dependent adverse reactions such as rhabdomyolysis (decreased hepatic metabolism of cholesterol-lowering medicinal product).
Maltese: Riskju miżjud ta' reazzjonijiet avversi dipendenti fuq id-doża bħal ma huma rabdomijoliżi (metaboliżmu epatiku mnaqqas tal-prodott mediċinali li jbaxxi l-kolesterol).
English: Phone: +46 8 615 2760 E-mail: info@biocodex.se
Maltese: +46 8 615 2760 e-mail: info@biocodex.se
English: INFORMATION IN BRAILLE Diacomit 250 mg powder for oral suspension
Maltese: INFORMAZZJONI BIL-BRAILLE Diacomit 250 mg trab għal sospensjoni orali
English: The second effect of stiripentol is mainly based on metabolic inhibition of several isoenzymes, in particular CYP450 3A4 and 2C19, involved in the hepatic metabolism of other anti-epileptic medicines.
Maltese: It-tieni effett ta' stiripentol huwa bbażat prinċipalment fuq inibizzjoni metabolika ta' diversi iżoenzimi, in partikolari CYP450 u 2C19, involuti fil-metaboliżmu epatiku ta' mediċini antiepilettiċi (kontra l-epilessija) oħra.
English: The median age was 7.3 years (range: 1 to 17.6 years) and the median daily dose of stiripentol was 45.4 mg/kg/day (range: 27.1 to 89.3 mg/kg/day) received in two or three divided doses.
Maltese: L-età medjana kienet ta' 7.3 snin (firxa: 1 sa 17.6 snin) u d-doża medjana ta' kuljum ta' stiripentol kienet ta' 45.4 mg/jum (firxa: 27.1 sa 89.3 mg/kg/jum) li nqammu f'żewġ jew tliet dożi
English: INFORMATION IN BRAILLE Diacomit 500 mg powder for oral suspension
Maltese: INFORMAZZJONI BIL-BRAILLE Diacomit 500 mg trab għal sospensjoni orali
English: Clinical supervision is recommended if switching between the stiripentol capsule and powder for oral suspension in sachet formulations.
Maltese: Is-superviżjoni klinika hija rakkomandata jekk pazjenti jinqalbu minn mal-kapsula stiripentol u t-trab għal suspensjoni orali fil-formulazzjonijiet tal-qratas.
English: Relative bioavailability between the capsules and powder for oral suspension in sachet formulations has been studied in healthy male volunteers after a 1,000 mg single oral administration.
Maltese: Il-bijodisponibilità relattiva bejn il-kapsuli u t-trab għal suspensjoni orali f'formulazzjonijiet tal-qratas ġiet studjata f'voluntiera rġiel b'saħħithom wara l-għoti ta' 1 000 mg mill-ħalq f'darba.
English: Powder for oral suspension in sachet 30 sachets
Maltese: Trab għal suspensjoni orali f'qartas 30 borża
English: EU/1/06/367/011 60 sachets
Maltese: EU/1/06/367/011 60 qartas
English: Stiripentol binds extensively to circulating plasma proteins (about 99%).
Maltese: Stiripentol jingħaqad b'mod estensiv ma' proteini fil-plażma li qegħdin fiċ-ċirkolazzjoni (madwar 99%).
English: In animal models, stiripentol antagonizes seizures induced by electric shock, pentetrazole and bicuculline.
Maltese: F'mudelli ta' annimali, stiripentol jantagonizza l-aċċessjonijiet sensitizzati permezz ta' xokk elettriku, pentetrazole u bicuculline.
English: This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kapsula, jiġifieri hija essenzjalment ‘ħielsa mis-sodium'.
English: • The other ingredients of the capsule are povidone K29/32, sodium starch glycolate type A and magnesium stearate.
Maltese: • Is-sustanzi l-oħra tal-kapsula huma povidone K29/32, sodium starch glycolate type A u magnesium stearate.
English: EU/1/06/367/012 90 sachets
Maltese: EU/1/06/367/012 90 qartas
English: 0.22 mg sodium per sachet.
Maltese: 0.22 mg sodju kull qartas.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 250 mg stiripentol.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA 1 kapsula fiha 250 mg stiripentol.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 500 mg stiripentol.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA 1 kapsula fiha 500 mg stiripentol.
English: • The capsule shell is made of gelatine, titanium dioxide (E171), erythrosine (E127), indigotin
Maltese: • Il-qoxra tal-kapsula hija magħmula minn gelatin, titanium dioxide (E171), erythrosine (E127),
English: Capsule core
Maltese: 90 kapsuli iebsa
English: Further dosage escalation is age dependent: - children less than 6 years should receive an additional 20 mg/kg/day in the third week, thus achieving the recommended dose of 50 mg/kg/day in three weeks; - children from 6 to less than 12 years should receive an additional 10 mg/kg/day each week, thus achieving the recommended dose of 50 mg/kg/day in four weeks; - children and adolescents 12 years and older should receive an additional 5 mg/kg/day each week until the optimum dose is reached based on clinical judgment.
Maltese: Kull żieda fid-doża oħra tiddependi mill-età: - tfal li għandhom inqas minn 6 snin għandhom jirċievu 20 mg/kg/jum addizzjonali fit-tielet ġimgħa, b'hekk tinkiseb id-doża rakkomandata ta' 50 mg/kg/jum fi tliet ġimgħat: - tfal li għandhom minn 6 snin sa inqas minn 12-il sena għandhom jirċievu 10 mg/kg/jum addizzjonali kull ġimgħa, b'hekk tintlaħaq id-doża rakkomandata ta' 50 mg/kg/jum f'erba' ġimgħat.
English: Each hard capsule contains 250 mg of stiripentol.
Maltese: Kull kapsula iebsa fiha 250 mg ta' stiripentol.
English: EU/1/06/367/008 60 sachets
Maltese: EU/1/06/367/008 60 borża
English: Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX17
Maltese: Antiepilletiċi, antiepilletiċi oħra, Kodiċi ATC:
English: Each hard capsule contains 500 mg of stiripentol.
Maltese: Kull kapsula iebsa fiha 500 mg ta' stiripentol.
English: After a baseline period of 1 month, placebo (n=20) or stiripentol (n=21) was added to valproate and clobazam during a double-blind period of 2 months.
Maltese: Wara perijodu fil-linja bażi ta' riferiment ta' xahar, plaċebo (n=20) jew stiripentol (n=21) kienu miżjuda ma' valproate u clobazam waqt perijodu double-blind ta' xahrejn.
English: This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull qartas, jiġifieri hija essenzjalment ‘ħielsa mis-sodium'.
English: The daily dosage of clobazam and/or valproate should be reduced according to the onset of side effects whilst on stiripentol therapy (see section 4.2).
Maltese: Id-dożaġġ ta' kuljum ta' clobazam u/jew valproate għandu jiġi mnaqqas skont il-bidu ta' l-effetti mhux mixtieqa waqt terapija b'stiripentol (ara, sezzjoni 4.2).
English: 0.11 mg sodium per sachet.
Maltese: 0.11 mg sodju kull qartas.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/010-12
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/367/010-12
English: • medicines containing: - cisapride (used to treat symptoms of night time heartburn); - pimozide (used to treat the symptoms of Tourette's syndrome e.g. vocal outbursts and uncontrolled, repeated movements of the body); - ergotamine (used to treat migraine); - dihydroergotamine (used to relieve the signs and symptoms of decreased mental capacity due to the aging process); - halofantrine (an antimalarial treatment); - quinidine (used to treat abnormal heart rhythms); - bepridil (used to control chest pain); - cyclosporine, tacrolimus, sirolimus (all three used to prevent rejections of liver, kidney and heart transplants); - statins (simvastatin and atorvastatin, both used to reduce the amount of cholesterol in blood).
Maltese: • mediċini li fihom: - cisapride (użat biex jiġu kkurati sintomi ta' qrusa ta' l-istonku bil-lejl); - pimozide (użat biex jiġu kkurati s-sintomi tas-sindrome ta' Tourette, eż. żbroffi vokali u mhux ikkontrollati, movimenti ripetuti tal-ġisem); - ergotamine (użat għall-kura ta' l-emigranja); - dihydroergotamine (użat biex jiġu mtaffija s-sinjali u s-sintomi ta' kapaċita' mentali mnaqqsa minħabba l-proċess tax-xjuħija); - halofantrine (mediċina kontra l-malarja); - quinidine (użat għall-kura ta' ritmi abnormali tal-qalb); - bepridil (użat għall-kontroll ta' l-uġigħ fis-sider); - cyclosporine, tacrolimus, sirolimus (it-tlieta użati biex jinibixxu r-rifjut ta' trapjanti tal-fwied,
English: Urinary metabolites of stiripentol accounted collectively for the majority (73%) of an oral acute dose whereas a further 13-24% was recovered in faeces as unchanged substance.
Maltese: Metaboliti mill-awrina ta' stiripentol kollettivament kienet tgħodd għal maġġoranza (73%) ta' doża akuta orali, filwaqt li 13-24% aktar kienet irkuprata mill-ippurgar bħala mediċina mhix mibdula.
English: Size 2 pink capsule
Maltese: Daqs 2, kapsula roża
English: - medicines containing:
Maltese: Kategorija farmakoterapewtika:
English: The hard capsules are supplied in plastic bottles containing 30, 60 or 90 capsules in cardboard cartons.
Maltese: Il-kapsuli iebsin huma fornuti fi fliexken tal-plastik li jesgħu 30, 60 u 90 kapsula ġo pakketti talkartun.
English: EU/1/06/367/009 90 sachets
Maltese: EU/1/06/367/009 90 borża
English: Paediatric population pharmacokinetic study
Maltese: Studju farmakokinetiku dwar il-popolazzjoni pedjatrika
English: Sachets are made with a composite paper/aluminium/polyethylene film.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Il-qratas huma magħmula minn rita ta' karta/aluminju/polyethylene komposta.
English: • If your child takes medicines metabolized by certain liver enzymes: - citalopram (used in the treatment of depressive episodes), - omeprazole (used in case of gastric ulcer) - HIV protease inhibitors (used in the treatment of HIV) - astemizole, chlorpheniramine (antihistamines) - calcium channel blockers (used in the treatment of anger or troubles of heart rhythm), - oral contraceptives, - propranolol, carvedilol, timolol (used in the treatment of high blood pressure ), - fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants), - haloperidol (antipsychotics), - codeine, dextromethorphan, tramadol (used in the treatment of pain)
Maltese: • Jekk it-tifel jew it-tifla tiegħek jieħdu mediċini li jimmetabolizzaw ċertu enzimi tal-fwied: - citalopram (użat għat-trattament ta' episodji dipressivi). - omeprazole (użat fil-każ ta' ulċeri fl-istonku) - inibituri tal-protease ta' HIV (użat fit-trattament ta' HIV) - astemizole, chlorpheniramine (antistamini) - imblokkaturi tal-knali tal-kalċju (użati fit trattament ta' rabja jew problemi bir-ritmu tal-qalb) - kontraċettivi li jittieħdu mill-ħalq, - propranolol, carvedilol, timolol (użat fit-trattament tal- pressjoni għolja tad-demm), - fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidipressanti), - haloperidol (antipsikotiċi), - codeine, dextromethorphan, tramadol (użat fit-trattament tal-uġigħ)
English: Diacomit 250 mg powder for oral suspension in sachet Diacomit 500 mg powder for oral suspension in sachet stiripentol
Maltese: Diacomit 250 mg trab għal suspensjoni orali fi qratas Diacomit 500 mg trab għal suspensjoni orali fi qratas stiripentol
English: On the basis of in vitro studies, the principal liver cytochrome P450 isoenzymes involved in phase 1 metabolism are considered to be CYP1A2, CYP2C19 and CYP3A4.
Maltese: Fuq il-bażi ta' studji in vitro, l-isoenzimi prinċipali tal-fwied ta' ċitokrom P450 involuti fil-metaboliżmu ta' fażi 1 huma kkunsidrati li huma CYP1A2, CYP2C19 u CYP3A4.
English: The half-life of elimination was in the range of 4.5 hours to 13 hours, increasing with dose.
Maltese: Il-half-life ta' l-eliminazzjoni kienet fuq medda ta' 4.5 sigħat sa 13-il siegħa, u tiżdied mad-doża.
English: Levetiracetam does not undergo hepatic metabolism to a major extent.
Maltese: Hekk ukoll l-effett ta' stripentol fuq il-metaboliżmu tagħhom mhuwiex magħruf.
English: As stiripentol inhibited CYP2D6 in vitro at concentrations that are achieved clinically in plasma, substances that are metabolized by this isoenzyme like: beta-blockers (propranolol, carvedilol, timolol), antidepressants (fluoxetine, paroxetine, sertraline, imipramine, clomipramine), antipsychotics (haloperidol), analgesics (codeine, dextromethorphan, tramadol) may be subject to metabolic interactions with stiripentol.
Maltese: Peress li stiripentol jinibixxi CYP2D6 in vitro f'konċentrazzjonijiet li huma miksuba klinikament fil-plażma, sustanzi li huma metabolizzati minn din l-iżoenzima bħal: imblokkaturi-beta (propranolol, carvedilol, timolol), antidepressanti (fluoxetine, paroxetine, sertraline, imipramine, clomipramine), antipsikotiċi (haloperidol), analġesici (codeine, dextromethorphan, tramadol) jistgħu jkunu suġġetti għal interazzjonijiet metaboliċi ma' stiripentol.