FrancophonIA/ELRC3.0 huggingface dataset:
English: In the event of an abnormal blood count or liver function test finding, the clinical decision for continuing use or adjusting the dose of stiripentol in conjunction with adjusting the doses of clobazam and valproate needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks (see section 4.4).
Croatian: U slučaju abnormalnosti u krvnoj slici ili jetrenim probama, za svakog bolesnika ponaosob mora se donijeti klinička odluka o nastavku primjene ili o podešavanju doze stiripentola, zajedno s podešavanjem doza klobazama i valproata, uzimajući u obzir moguće kliničke prednosti ili moguće rizike (vidjeti dio 4.4).
English: Each sachet contains 2.5 mg of aspartame, 500 mg of glucose liquid spray and 2.4 mg of sorbitol.
Croatian: Svaka vrećica sadrži 2,5 mg aspartama, 500 mg disperzije tekuće glukoze i 2,4 mg sorbitola.
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).
Croatian: 15 (71%) bolesnika je imalo odgovor na stiripentol (uključujući 9 bez kloničkih ili toničko-kloničkih napadaja), dok je iz placebo skupine samo 1 (5%) imao odgovor (nijedan nije bio bez napadaja; stiripentol 95% CI 52,1-90,7 naspram placebo 0-14,6).
English: • abnormal liver function test
Croatian: • odstupanja u nalazima testa funkcije jetre
English: Caution must be exercised if clinical circumstances require combining stiripentol with substances metabolised by CYP2C19 (e.g. citalopram, omeprazole) or CYP3A4 (e.g. HIV protease inhibitors, antihistamines such as astemizole, chlorpheniramine, calcium channel blockers, statins, oral contraceptives, codeine) due to the increased risk of adverse reactions (see further in this section for antiepileptic medicines).
Croatian: Mora se biti oprezan u slučaju kad kliničke okolnosti zahtijevaju kombiniranje stiripentola s tvarima koje metabolizira CYP2C19 (na primjer citalopram, omeprazol) ili CYP3A4 (kao što su inhibitori HIV proteaze, antihistaminici poput astemizola, klorfeniramina, blokatori kalcijskih kanala, statini, oralni kontraceptivi, kodein) zbog povećanog rizika od nuspojava (vidjeti nadalje u ovom dijelu za antiepileptičke lijekove).
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.
Croatian: Klirens iz plazme se značajno smanjuje pri visokim dozama; pada od približno 40 l/kg/dan pri dozi od 600 mg/dan do oko 8 l/kg/dan pri dozi od 2400 mg.
English: In vitro studies suggested that stiripentol phase 1 metabolism is catalyzed by CYP1A2, CYP2C19 and CYP3A4 and possibly other enzymes.
Croatian: Ispitivanja in vitro sugeriraju da je faza 1 metabolizma stiripentola katalizirana putem enzima CYP1A2, CYP2C19 i CYP3A4, a moguće i drugim enzimima.
English: What Diacomit 250 mg looks like and contents of the pack Diacomit 250 mg hard capsule is pink.
Croatian: Kako Diacomit 250 mg izgleda i sadržaj pakiranja Diacomit 250 mg tvrde kapsule su ružičaste boje.
English: Cartons contain either 30, 60 or 90 sachets.
Croatian: Kutije sadrže 30, 60 ili 90 vrećica.
English: Stiripentol should not be taken with milk or dairy products (yoghurt, soft cream cheese, etc.), carbonated drinks, fruit juice or food and drinks that contain caffeine or theophylline.
Croatian: Stiripentol se ne smije uzimati s mlijekom ili mliječnim proizvodima (jogurt, mekani krem sir, itd.), gaziranim napitcima, voćnim sokovima ili hranom i napitcima koji sadrže kofein ili teofilin.
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).
Croatian: Stiripentol nije bio teratogen u ispityivanju na štakorima i kunićima; u jednom ispitivanju na miševima, ali ne i u nekolicini drugih ispitivanja, mala incidencijija rascijepa nepca je primijećena na razini doza toksičnih po majku (800 mg/kg/dan).Ova ispitivanja na miševima i kunićima su provedena prije uvođenja zahtijeva „Dobre laboratorijske prakse“.
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).
Croatian: Kod ove mlađe grupe bolesnika, dodatnu terapiju stiripentolom tsmije se započeti isključivo ako je dijagnoza SMEI klinički potvrđena (vidjeti dio 5.1).
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).
Croatian: Touretteova sindroma, na primjer glasovnih ispada i nekontroliranih, ponovljenih pokreta tijela); - ergotamin (koristi se za liječenje migrene); - dihidroergotamin (koristi se za ublažavanje znakova i simptoma smanjene mentalne sposobnosti uslijed procesa starenja); - halofantrin (lijek za liječenje malarije); - kinidin (koristi se za liječenje nepravilnog srčanog ritma); - bepridil (koristi se za kontrolu boli u prsištu); - ciklosporin, takrolimus, sirolimus (sva tri lijeka koriste se za sprečavanje odbacivanja presađenih organa - jetre, bubrega i srca); - statini (simvastatin i atorvastatin, oba se koriste za smanjenje količine kolesterola u krvi).
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.
Croatian: Na osnovi ispitivanja in vitro, smatra se da su glavni jetreni citokrom P450 izoenzimi uključeni u fazu 1 metabolizma CYP1A2, CYP2C19 i CYP3A4.
English: How to take Diacomit
Croatian: Kako uzimati Diacomit
English: Diacomit is also available as 250 mg and 500 mg powder for oral suspension in sachets.
Croatian: Diacomit je dostupan i kao prašak od 250 i 500 mg za oralnu suspenziju u vrećicama.
English: The impact of macrolides and azole antifungal medicinal products on stiripentol metabolism, that are known to be inhibitors of CYP3A4 and substrates of the same enzyme, is not known.
Croatian: Nepoznat je utjecaj makrolida i azolnih antimikotika, za koje se zna da su inhibitori CYP3A4 i supstrati ovog istog enzima, na metabolizam stiripentola.
English: 6.4 Special precautions for storage Store in the original package in order to protect from light.
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: Biocodex,7 avenue Gallieni - F-94250 Gentilly - France Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex.fr
Croatian: Biocodex, 7 avenue Gallieni - F-94250 Gentilly - Francuska Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex.fr
English: Polypropylene bottle with tamper-evident seal and polyethylene screw cap.
Croatian: Polipropilenska bočica sa zaštitnim zatvaračem s evidencijom otvaranja i polietilenskim zatvaračem s navojem.
English: Diacomit 250 mg hard capsule Diacomit 500 mg hard capsule stiripentol
Croatian: Diacomit 250 mg tvrde kapsule Diacomit 500 mg tvrde kapsule stiripentol
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: You should check with your child's doctor or pharmacist if you are not sure.
Croatian: Ako niste sigurni, morate provjeriti s djetetovim liječnikom ili ljekarnikom.
English: - Effects on other antiepileptic drugs (AEDs)
Croatian: - Utjecaj na ostale antiepileptike
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.
Croatian: Uz dodatnu primjenu stiripentola u djece s Dravetovim sindromom zabilježeno je približno dvostruko do trostruko povećanje razine klobazama u plazmi, odnosno petorostruko povećanje razine norklobazama u plazmi.
English: Stiripentol is not recommended for use in patients with impaired hepatic and/or renal function (see section 4.4).
Croatian: Stiripentol se ne preporučuje za primjenu u bolesnika s oštećenjem jetrene i/ili bubrežne funkcije. (vidjeti dio 4.4).
English: - If your child gets any side effects, talk to your child's doctor or pharmacist.
Croatian: - Ako u svog djeteta primijetite bilo koju nuspojavu, obratite se liječniku svog djeteta ili ljekarniku.
English: Unless otherwise clinically indicated, liver function should be checked every 6 months.
Croatian: Pretrage funkcije jetre treba raditi svakih 6 mjeseci, ukoliko drukčije nije klinički indicirano.
English: 7 avenue Gallieni 94250 Gentilly France
Croatian: 7 avenue Gallieni 94250 Gentilly Francuska
English: It should be assessed prior to starting treatment with stiripentol.
Croatian: Treba uraditi pretrage jetrenih funkcija prije započinjanja liječenja stiripentolom.
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)
Croatian: • Ako Vaše dijete uzima lijekove koji se metaboliziraju nekim jetrenim enzimima: - citalopram (koristi se u liječenju depresivnih epizoda), - omeprazol (koristi se u slučaju čira na želucu) - inhibitori proteaza HIV-a (koristi se u liječenju HIV-a) - astemizol, klorfeniramin (antihistaminici) - blokatori kalcijskih kanala (koriste se u liječenju boli u prsnom košu ili poremećaja srčanog ritma), - oralna kontracepcijska sredstva, - propranolol, karvedilol, timolol (koriste se u liječenju visokog krvnog tlaka), - fluoksetin, paroksetin, sertralin, imipramin, klomipramin (antidepresivi), - haloperidol (antipsihotici), - kodein, dekstrometorfan, tramadol (koriste se u liječenju boli)
English: Diacomit 250 mg powder for oral suspension in sachet Diacomit 500 mg powder for oral suspension in sachet stiripentol
Croatian: Diacomit 250 mg prašak za oralnu suspenziju u vrećicama Diacomit 500 mg prašak za oralnu suspenziju u vrećicama stiripentol
English: INFORMATION IN BRAILLE Diacomit 500 mg powder for oral suspension
Croatian: PODACI NA BRAILLEOVOM PISMU Diacomit 500 mg prašak za oralnu suspenziju
English: In the absence of specific clinical data in patients with impaired hepatic or renal function, stiripentol is not recommended for use in patients with impaired hepatic and/or renal function (see section 4.2).
Croatian: U odsustvu specifičnih kliničkih podataka za bolesnike s oštećenjem jetrene ili bubrežne funkcije, stiripentol se ne preporučuje za primjenu u bolesnika s oštećenjem jetrene i/ili bubrežne funkcije (vidjeti dio 4.2).
English: BIOCODEX 7 avenue Gallieni 94250 Gentilly France
Croatian: BIOCODEX 7 avenue Gallieni 94250 Gentilly Francuska
English: Glucose liquid spray dried Sodium
Croatian: Suha disperzija tekuće glukoze Natrij
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.
Croatian: S obzirom da stiripentol inhibira CYP2D6 in vitro u koncentacijama koje se klinički dostižu u plazmi, tvari koje se metaboliziraju ovim izoenzimo kao što su: beta blokatori (propranolol, karvedilol, timolol), antidepresivi (fluoksetin, paroksetin, sertralin, imipramin, klomipramin), antipsihotici (haloperidol), analgetici (kodein, dekstrometorfan, tramadol) mogu imati metaboličke interakcije sa stiripentolom.
English: In the absence of specific clinical data in patients with impaired hepatic or renal function, Stiripentol is not recommended for use in patients with impaired hepatic and/or renal function (see section 4.2).
Croatian: U odsustvu specifičnih kliničkih podataka za bolesnike s oštećenjem jetrene ili bubrežne funkcije, stiripentol se ne preporučuje za primjenu u bolesnika s oštećenjem jetrene i/ili bubrežne funkcije (vidjeti dio 4.2)..
English: Diacomit is also available as 250 mg and 500 mg capsules for oral use
Croatian: Diacomit je dostupan i u obliku kapsula od 250 mg i 500 mg za primjenu kroz usta.
English: INFORMATION IN BRAILLE Diacomit 250 mg powder for oral suspension
Croatian: PODACI NA BRAILLEOVOM PISMU Diacomit 250 mg prašak za oralnu suspenziju
English: LIST OF EXCIPIENTS Contains sodium.
Croatian: POPIS POMOĆNIH TVARI Sadrži natrij.
English: • Your child's liver function should be assessed prior to starting Diacomit and checked every 6
Croatian: Vaše dijete počne uzimati Diacomit, mora mu se napraviti pretraga jetrene funkcije i moraju se vršiti provjere svakih 6 mjeseci.
English: The clinical decision for use of Diacomit in children with SMEI less than 3 years of age needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks (see section 4.2).
Croatian: Kliničku odluku o primjeni stiripentola u djece sa SMEI mlađe od 3 godine treba donijeti ponaosob za svakog bolesnika uzimajući u obzir potencijalnu kliničku korist i rizike (vidjeti dio 4.2).
English: Each hard capsule contains 500 mg of stiripentol.
Croatian: Jedna tvrda kapsula sadrži 500 mg stiripentola.
English: Biocodex, 7 avenue Gallieni - F-94250 Gentilly - France Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex.fr
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Biocodex,7 avenue Gallieni - F-94250 Gentilly - Francuska Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex.fr
English: Povidone (K29/32) Sodium starch glycolate type A Glucose liquid, spray dried Erythrosine (E127) Titanium dioxide (E171) Aspartame (E951)
Croatian: • Drugi sastojci vrećice su povidon K29/32, natrijev škroboglikolat vrsta A, tekuća glukoza (suha disperzija), eritrozin (E127), titanijev dioksid (E171), aspartam (E951), tutti frutti okus (sadrži sorbitol), karmelozanatrij, hidroksietilceluloza.
English: Each hard capsule contains 250 mg of stiripentol.
Croatian: Jedna tvrda kapsula sadrži 250 mg stiripentola.
English: How to store Diacomit
Croatian: Kako čuvati Diacomit
English: Unless otherwise clinically indicated, blood counts should be checked every 6 months.
Croatian: Pretrage krvne slike treba raditi svakih 6 mjeseci, ukoliko drukčije nije klinički indicirano.
English: INFORMATION IN BRAILLE Diacomit 500 mg hard capsules
Croatian: PODACI NA BRAILLEOVOM PISMU Diacomit 500 mg tvrde kapsule
English: INFORMATION IN BRAILLE Diacomit 250 mg hard capsules
Croatian: PODACI NA BRAILLEOVOM PISMU Diacomit 250 mg tvrde kapsule
English: Clinical supervision is recommended if switching between the stiripentol capsule and powder for oral suspension in sachet formulations.
Croatian: Preporuka je da se u slučaju zamjene farmaceutskih oblika stiripentol kapsula praškom za oralnu suspenziju u vrećici i obrnuto, zamjena radi pod kliničkim nadzorom.
English: Thrombocytopenia
Croatian: Karmelozanatrij
English: EU/1/06/367/012 90 sachets
Croatian: EU/1/06/367/012 90 vrećica
English: 0.16 mg sodium per capsule.
Croatian: Pomoćna tvar s poznatim učinkom 0,16 mg natrija po kapsuli.
English: EU/1/06/367/011 60 sachets
Croatian: EU/1/06/367/011 60 vrećica
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 mg of stiripentol.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna kapsula sadrži 500 mg stiripentola.
English: Driving and using machines This medicine may make your child feel sleepy.
Croatian: Ovaj lijek može izazvati pospanost u Vašeg djeteta.
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.
Croatian: Diacomit je indiciran za istodobnu primjenu uz klobazam i valproat kao dodatna terapija refraktornih generaliziranih toničko-kloničkih napadaj u bolesnika s teškom mioklonom epilepsijom dječje dobi (engl.
English: EU/1/06/367/008 60 sachets
Croatian: EU/1/06/367/008 60 vrećica
English: Each sachet contains 500 mg of stiripentol.
Croatian: Jedna vrećica sadrži 500 mg stiripentola.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 250 mg stiripentol.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 kapsula sadrži 250 mg stiripentola.
English: The clinical decision for use of stiripentol in children with SMEI less than 3 years of age needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks.
Croatian: Klinička odluka za uporabu primjenu stiripentolau djece sa SMEI mlađe od 3 godine mora se donijeti za svakog bolesnika ponaosob i uzimajući u obzir moguće kliničke prednosti i moguće rizike.
English: Phone: +46 8 615 2760 e-mail: info@biocodex.no
Croatian: Tel: +46 8 615 2760 e-mail: info@biocodex.no
English: • Your child's blood count should be assessed prior to starting Diacomit and checked every 6
Croatian: Vaše dijete počne uzimati Diacomit, mora mu se napraviti pretraga krvne slike i moraju se vršiti provjere svakih 6 mjeseci.
English: 0.32 mg sodium per capsule.
Croatian: Pomoćna tvar s poznatim učinkom 0,32 mg natrija po kapsuli.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 500 mg stiripentol.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 kapsula sadrži 500 mg stiripentola.
English: The clinical decision for use of stiripentol in pregnancy needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks.
Croatian: Kliničku odluku o primjeni stiripentola treba donijeti ponaosob za svaku Bolesnicicu uzimajući u obzir potencijalnu kliničku korist i rizike.
English: Despite the absence of comprehensive pharmacology data on potential drug interactions, the following advice regarding modification of the dose and dosage schedules of other anti-epileptic medicinal products administered in conjunction with stiripentol is provided based on clinical experience.
Croatian: Prilagodba doze ostalih antiepileptika koji se primjenjuju u koùbinaciji sa stiripentolom Unatoč nepostojanju sveobuhvatnih farmakoloških podataka o mogućim interakcijama s drugim lijekovima, na temelju kliničkog iskustva se daju sljedeći savjeti glede promjene doze i rasporeda uzimanja drugih antiepileptičkih lijekova koji se primjenjuju istodobno sa stiripentolom.
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).
Croatian: Postotak promjene od početne vrijednosti je bio veći u skupini na stiripentolu ( 69%) nego u placebo skupini (+7%), p< 0,0001. 21 bolesnik na stiripentolu je imao umjerene nuspojave (omamljenost, gubitak teka) u usporedbi s 8 iz placebo skupine, ali su nuspojave nestale u 12 od 21 slučaja kad je doza drugih lijekova smanjena (Chiron et al, Lancet, 2000).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/004 30 hard capsules
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/367/004 30 tvrdih kapsula
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/001 30 hard capsules
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/367/001 30 tvrdih kapsula
English: Each sachet contains 250 mg of stiripentol.
Croatian: Jedna vrećica sadrži 250 mg stiripentola.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg of stiripentol.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna kapsula sadrži 250 mg stiripentola.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/010-12
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/367/010-12
English: • if your child is allergic to stiripentol or to any of the other ingredients of Diacomit (listed in section 6).
Croatian: Vaše dijete NE smije uzimati Diacomit • ako je Vaše dijete alergično na stiripentol ili na neki drugi sastojak Diacomita (naveden u dijelu
English: EU/1/06/367/009 90 sachets
Croatian: EU/1/06/367/009 90 vrećica
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 sachet contains 250 mg stiripentol.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 vrećica sadrži 250 mg stiripentola.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 500 mg of stiripentol.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna vrećica sadrži 500 mg stiripentola.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Diacomit 250 mg powder for oral suspension in sachet stiripentol
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE Diacomit 250 mg prašak za oralnu suspenziju u vrećici stiripentol
English: NAME OF THE MEDICINAL PRODUCT Diacomit 500 mg hard capsules stiripentol
Croatian: NAZIV LIJEKA Diacomit 500 mg tvrde kapsule stiripentol
English: EU/1/06/367/005 60 hard capsules
Croatian: EU/1/06/367/005 60 tvrdih kapsula
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Diacomit 500 mg powder for oral suspension in sachet stiripentol
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE Diacomit 500 mg prašak za oralnu suspenziju u vrećici stiripentol
English: NAME OF THE MEDICINAL PRODUCT Diacomit 250 mg hard capsules
Croatian: NAZIV LIJEKA Diacomit 250 mg tvrde kapsule
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 sachet contains 500 mg stiripentol.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 vrećica sadrži 500 mg stiripentola.
English: Carbamazepine, phenytoin and phenobarbital
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Karbamazepin, fenitoin i fenobarbital
English: NAME OF THE MEDICINAL PRODUCT Diacomit 500 mg hard capsules
Croatian: NAZIV LIJEKA Diacomit 500 mg tvrde kapsule
English: NAME OF THE MEDICINAL PRODUCT Diacomit 250 mg hard capsules stiripentol
Croatian: NAZIV LIJEKA Diacomit 250 mg tvrde kapsule stiripentol
English: Most stiripentol is excreted via the kidney.
Croatian: Glavnina stiripentola se izlučuje putem bubrega.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/010 30 sachets
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/367/010 30 vrećica
English: NAME OF THE MEDICINAL PRODUCT Diacomit 250 mg powder for oral suspension in sachet
Croatian: NAZIV LIJEKA Diacomit 250 mg prašak za oralnu suspenziju u vrećici
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/007 30 sachets
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/367/007 30 vrećica
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 250 mg of stiripentol.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna vrećica sadrži 250 mg stiripentola.
English: EU/1/06/367/002 60 hard capsules
Croatian: EU/1/06/367/002 60 tvrdih kapsula
English: NAME OF THE MEDICINAL PRODUCT Diacomit 500 mg powder for oral suspension in sachet
Croatian: NAZIV LIJEKA Diacomit 500 mg prašak za oralnu suspenziju u vrećici