natgillin/translations-raw huggingface dataset:
Each sachet contains 5 mg of aspartame, 1,000 mg of glucose liquid spray and 4.8 mg of sorbitol.
Svaka vrećica sadrži 5 mg aspartama, 1000 mg disperzije tekuće glukoze i 4,8 mg sorbitola.
• The other ingredients of the capsule are povidone K29/32, sodium starch glycolate type A and magnesium stearate.
• Drugi sastojci ove kapsule su povidon K29/32, natrijev škroboglikolat vrsta A i magnezijev stearat.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po kapsuli, tj. zanemarive količine natrija.
PHARMACEUTICAL FORM Hard capsule
OBLIK Tvrda kapsula
What Diacomit 250 mg contains
Što Diacomit 250 mg sadrži
What Diacomit is and what it is used for What you need to know before your child takes Diacomit How to take Diacomit
Što je Diacomit i za što se koristi Što morate znati prije nego
• abnormal liver function test.
• odstupanja u nalazima testa funkcije jetre.
Potential for stiripentol to interact with other medicinal products
Moguće interakcije stiripentola s drugim lijekovima
If you have any further questions on the use of this product, ask your child's doctor or pharmacist.
Ako imate dodatna pitanja o primjeni ovog lijeka, pitajte djetetovog liječnika ili ljekarnika.
Blood counts should be assessed prior to starting treatment with stiripentol.
Treba napraviti i pretrage krvne slike prije započinjanja liječenja stiripentolom.
Very common side effects (may affect more than one in 10 people):
Vrlo česte nuspojave (mogu se javiti u više od jedne na 10 osoba):
The pivotal clinical evaluation of stiripentol was in children of 3 years of age and over with SMEI.
Ključna klinička procjena stiripentola izvršena je u djece dobi 3 godine i starije, koja boluju od SMEI.
- If you have any further questions, ask your child's doctor or pharmacist.
- Ako imate dodatnih pitanja, obratite se liječniku svog djeteta ili ljekarniku.
Gelatine
Želatina
Insomnia
Insomnija
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.
Glavninu oralne doze (73%) čine urinarni metaboliti, a ostalih 13-24% je nađeno u fecesu kao nepromijenjena tvar.
Diacomit should only be administered under the supervision of a paediatrician / paediatric neurologist experienced in the diagnosis and management of epilepsy in infants and children.
Diacomit se treba primjenjivati samo pod nadzorom pedijatra / pedijatrijskog neurologa koji ima iskustva u dijagnosticiranju i zbrinjavanju epilepsije u dojenčadi i djece.
When to take Diacomit
Kada uzimati Diacomit
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.
Inhibicija CYP450 izoenzima, CYP2C19 i CYP3A4 može izazvati farmakokinetičke interakcije (inhibiciju njihovog hepatičkog metabolizma) s fenobarbitalom, primidonom, fenitoinom, karbamazepinom, klobazamom (vidjeti dio 4.2), valproatom (vidjeti dio 4.2), diazepamom (pojačana miorelaksacija), etosuksimidom i tiagabinom.
0.11 mg sodium per sachet.
0,11 mg natrija po vrećici.
Biocodex, 1 avenue Blaise Pascal - F-60000 Beauvais - France
Biocodex,1 avenue Blaise Pascal - F-60000 Beauvais - Francuska
Growth rate of children
Brzina rasta u djece
Co-administration with CYP3A4 substrates with a narrow therapeutic index should be avoided due to the markedly increased risk of severe adverse reactions.
Treba izbjegavati istodobnu primjenu stiripentola s tvarima uskog terapijskog indeka koje su supstrati CYP3A4 zbog povećanog rizika od teških nuspojava.
Use in combination with stiripentol is not recommended.
Ne savjetuje se njihova uporaba istodobno sa stiripentolom.
• insomnia (sleeplessness), drowsiness;
• nesanica, omamljenost;
In such a case, it is assumed that a significant fraction of the administered dose has been absorbed systemically from the digestive tract.
U takvom slučaju se smatra da je probavni sustav apsorbirao znatan dio primijenjene doze.
In case of switch between capsule and powder formulation it should be done under the close supervision of the doctor.
Zamjena farmaceutskog oblika u vidu kapsule i farmaceutskog oblika u vidu praška mora se raditi pod strogim nadzorom liječnika.
What Diacomit 500 mg looks like and contents of the pack Diacomit 500 mg hard capsules are white.
Kako Diacomit 500 mg izgleda i sadržaj pakiranja Diacomit 500 mg tvrde kapsule su bijele boje.
Drowsiness, ataxia, hypotonia, dystonia
Omamljenost, ataksija, hipotonija, distonija
If your child stops taking Diacomit
Ako Vaše dijete prestane uzimati Diacomit
Povidone (K29/32) Sodium starch glycolate (type A) Magnesium stearate
Povidon (K29/32) Natrijev škroboglikolat (vrsta A) Magnezijev stearat Ovojnica kapsule Želatina
0.22 mg sodium per sachet.
0,22 mg natrija po vrećici.
• The capsule shell is made of gelatine, titanium dioxide (E171), erythrosine (E127), indigotin
• Ovojnica kapsule se sastoji od želatine, titanijeva dioksida (E171), eritrozina (E127), indigotina
Sodium starch glycolate (type A)
Natrijev škroboglikolat (vrsta A)
Stiripentol potentiates the efficacy of other anticonvulsants, such as carbamazepine, sodium valproate, phenytoin, phenobarbital and many benzodiazepines, as the result of pharmacokinetic interactions.
Kao posljedica farmakokinetičkih interakcija, stiripentol pojačava djelotvornost drugih antikonvulziva, kao što su karbamazepin, natrijev valproat, fenitoin, fenobarbital i mnogi benzodiazepini.
The sachet formulation has a slightly higher Cmax than the capsules and thus the formulations are not bioequivalent.
Prašak kao farmaceutski oblik ima nešto višu vrijednost Cmax od kapsula, te stoga ova dva oblika nisu bioekvivalentna.
MARKETING AUTHORISATION HOLDER Biocodex, 7 Avenue Gallieni, 94250 Gentilly, France.
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Biocodex, 7 Avenue Gallieni, 94250 Gentilly, Francuska.
Cmax of the sachet was slightly higher (23%) compared with the capsule and did not meet the criteria for bioequivalence.
Cmax praška je bila neznatno veća (23%) u usporedbi s kapsulama, te ne udovoljila kriterije bioekvivalencije.
Capsule core
Jezgra kapsule
Blood count
Krvna slika
Data are limited about the use of stiripentol under 12 months of age.
Podaci o primjeni stiripentola kod djece mlađe od 12 mjeseci su oskudni.
Systemic exposure to stiripentol increases markedly compared to dose proportionality.
Sistemska izloženost stiripentolu se značajno povećava u usporedbi s onom razmjernoj dozi.
Powder for oral suspension in sachet 30 sachets
Prašak za oralnu suspenziju u vrećici 30 vrećica
(involuntary muscle contractions).
distonija (nevoljno grčenje mišića).
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).
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).
Each sachet contains 2.5 mg of aspartame, 500 mg of glucose liquid spray and 2.4 mg of sorbitol.
Svaka vrećica sadrži 2,5 mg aspartama, 500 mg disperzije tekuće glukoze i 2,4 mg sorbitola.
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).
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).
• abnormal liver function test
• odstupanja u nalazima testa funkcije jetre
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).
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).
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.
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.
In vitro studies suggested that stiripentol phase 1 metabolism is catalyzed by CYP1A2, CYP2C19 and CYP3A4 and possibly other enzymes.
Ispitivanja in vitro sugeriraju da je faza 1 metabolizma stiripentola katalizirana putem enzima CYP1A2, CYP2C19 i CYP3A4, a moguće i drugim enzimima.
What Diacomit 250 mg looks like and contents of the pack Diacomit 250 mg hard capsule is pink.
Kako Diacomit 250 mg izgleda i sadržaj pakiranja Diacomit 250 mg tvrde kapsule su ružičaste boje.
Cartons contain either 30, 60 or 90 sachets.
Kutije sadrže 30, 60 ili 90 vrećica.
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.
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.
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).
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“.
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).
Kod ove mlađe grupe bolesnika, dodatnu terapiju stiripentolom tsmije se započeti isključivo ako je dijagnoza SMEI klinički potvrđena (vidjeti dio 5.1).
• 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).
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).
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.
Na osnovi ispitivanja in vitro, smatra se da su glavni jetreni citokrom P450 izoenzimi uključeni u fazu 1 metabolizma CYP1A2, CYP2C19 i CYP3A4.
How to take Diacomit
Kako uzimati Diacomit
Diacomit is also available as 250 mg and 500 mg powder for oral suspension in sachets.
Diacomit je dostupan i kao prašak od 250 i 500 mg za oralnu suspenziju u vrećicama.
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.
Nepoznat je utjecaj makrolida i azolnih antimikotika, za koje se zna da su inhibitori CYP3A4 i supstrati ovog istog enzima, na metabolizam stiripentola.
6.4 Special precautions for storage Store in the original package in order to protect from light.
6.4 Posebne mjere pri čuvanju lijeka Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
Biocodex,7 avenue Gallieni - F-94250 Gentilly - France Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex.fr
Biocodex, 7 avenue Gallieni - F-94250 Gentilly - Francuska Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex.fr
Polypropylene bottle with tamper-evident seal and polyethylene screw cap.
Polipropilenska bočica sa zaštitnim zatvaračem s evidencijom otvaranja i polietilenskim zatvaračem s navojem.
Diacomit 250 mg hard capsule Diacomit 500 mg hard capsule stiripentol
Diacomit 250 mg tvrde kapsule Diacomit 500 mg tvrde kapsule stiripentol
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
You should check with your child's doctor or pharmacist if you are not sure.
Ako niste sigurni, morate provjeriti s djetetovim liječnikom ili ljekarnikom.
- Effects on other antiepileptic drugs (AEDs)
- Utjecaj na ostale antiepileptike
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.
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.
Stiripentol is not recommended for use in patients with impaired hepatic and/or renal function (see section 4.4).
Stiripentol se ne preporučuje za primjenu u bolesnika s oštećenjem jetrene i/ili bubrežne funkcije. (vidjeti dio 4.4).
- If your child gets any side effects, talk to your child's doctor or pharmacist.
- Ako u svog djeteta primijetite bilo koju nuspojavu, obratite se liječniku svog djeteta ili ljekarniku.
Unless otherwise clinically indicated, liver function should be checked every 6 months.
Pretrage funkcije jetre treba raditi svakih 6 mjeseci, ukoliko drukčije nije klinički indicirano.
7 avenue Gallieni 94250 Gentilly France
7 avenue Gallieni 94250 Gentilly Francuska
It should be assessed prior to starting treatment with stiripentol.
Treba uraditi pretrage jetrenih funkcija prije započinjanja liječenja stiripentolom.
• 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)
• 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)
Diacomit 250 mg powder for oral suspension in sachet Diacomit 500 mg powder for oral suspension in sachet stiripentol
Diacomit 250 mg prašak za oralnu suspenziju u vrećicama Diacomit 500 mg prašak za oralnu suspenziju u vrećicama stiripentol
INFORMATION IN BRAILLE Diacomit 500 mg powder for oral suspension
PODACI NA BRAILLEOVOM PISMU Diacomit 500 mg prašak za oralnu suspenziju
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).
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).
BIOCODEX 7 avenue Gallieni 94250 Gentilly France
BIOCODEX 7 avenue Gallieni 94250 Gentilly Francuska
Glucose liquid spray dried Sodium
Suha disperzija tekuće glukoze Natrij
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.
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.
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).
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)..
Diacomit is also available as 250 mg and 500 mg capsules for oral use
Diacomit je dostupan i u obliku kapsula od 250 mg i 500 mg za primjenu kroz usta.
INFORMATION IN BRAILLE Diacomit 250 mg powder for oral suspension
PODACI NA BRAILLEOVOM PISMU Diacomit 250 mg prašak za oralnu suspenziju
LIST OF EXCIPIENTS Contains sodium.
POPIS POMOĆNIH TVARI Sadrži natrij.
• Your child's liver function should be assessed prior to starting Diacomit and checked every 6
Vaše dijete počne uzimati Diacomit, mora mu se napraviti pretraga jetrene funkcije i moraju se vršiti provjere svakih 6 mjeseci.
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).
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).
Each hard capsule contains 500 mg of stiripentol.
Jedna tvrda kapsula sadrži 500 mg stiripentola.
Biocodex, 7 avenue Gallieni - F-94250 Gentilly - France Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex.fr
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
Povidone (K29/32) Sodium starch glycolate type A Glucose liquid, spray dried Erythrosine (E127) Titanium dioxide (E171) Aspartame (E951)
• 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.
Each hard capsule contains 250 mg of stiripentol.
Jedna tvrda kapsula sadrži 250 mg stiripentola.
How to store Diacomit
Kako čuvati Diacomit
Unless otherwise clinically indicated, blood counts should be checked every 6 months.
Pretrage krvne slike treba raditi svakih 6 mjeseci, ukoliko drukčije nije klinički indicirano.
INFORMATION IN BRAILLE Diacomit 500 mg hard capsules
PODACI NA BRAILLEOVOM PISMU Diacomit 500 mg tvrde kapsule
INFORMATION IN BRAILLE Diacomit 250 mg hard capsules
PODACI NA BRAILLEOVOM PISMU Diacomit 250 mg tvrde kapsule
Clinical supervision is recommended if switching between the stiripentol capsule and powder for oral suspension in sachet formulations.
Preporuka je da se u slučaju zamjene farmaceutskih oblika stiripentol kapsula praškom za oralnu suspenziju u vrećici i obrnuto, zamjena radi pod kliničkim nadzorom.
Thrombocytopenia
Karmelozanatrij
EU/1/06/367/012 90 sachets
EU/1/06/367/012 90 vrećica
0.16 mg sodium per capsule.
Pomoćna tvar s poznatim učinkom 0,16 mg natrija po kapsuli.
EU/1/06/367/011 60 sachets
EU/1/06/367/011 60 vrećica
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 mg of stiripentol.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna kapsula sadrži 500 mg stiripentola.
Driving and using machines This medicine may make your child feel sleepy.
Ovaj lijek može izazvati pospanost u Vašeg djeteta.
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.
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.
EU/1/06/367/008 60 sachets
EU/1/06/367/008 60 vrećica
Each sachet contains 500 mg of stiripentol.
Jedna vrećica sadrži 500 mg stiripentola.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 250 mg stiripentol.
NAVOĐENJE DJELATNE(IH) TVARI 1 kapsula sadrži 250 mg stiripentola.
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.
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.
Phone: +46 8 615 2760 e-mail: info@biocodex.no
Tel: +46 8 615 2760 e-mail: info@biocodex.no
• Your child's blood count should be assessed prior to starting Diacomit and checked every 6
Vaše dijete počne uzimati Diacomit, mora mu se napraviti pretraga krvne slike i moraju se vršiti provjere svakih 6 mjeseci.
0.32 mg sodium per capsule.
Pomoćna tvar s poznatim učinkom 0,32 mg natrija po kapsuli.