natgillin/translations-raw huggingface dataset:
In view of the lack of genotoxicity of stiripentol and the well-known, special susceptibility of the mouse liver to tumour formation in the presence of hepatic enzyme induction, this finding is not considered to indicate a risk of tumorigenicity in patients. 
Glede nedostatka genotoksičnosti stiripentola, a dobro poznate, osobite podložnosti mišje jetere ka stvaranju tumora u prisustvu indukcije hepatičkih enzima, ne smatra se da ovaj nalaz ukazuje na rizik od tumora u ljudi.
Toxicity studies in animals (rat, monkey, mouse) have not revealed any consistent pattern of toxicity apart from liver enlargement associated with hepatocellular hypertrophy, which occurred when high doses of stiripentol were administered to both rodents and non-rodents. 
Istraživanja toksičnosti u životinja (štakora, majmuna, miševa) nisu otkrila dosljedan obrazac toksičnosti osim povećanja jetre udruženog s hepatocelularnom hipertrofijom, koja se javljala kad su visoke doze stiripentola primjenjivane i na glodavce i na ne-glodavce.
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. 
Nakon početnog perioda od 1 mjeseca, placebo (n=20) ili stiripentol (n=21) je dodan valproatu i klobazamu tijekom dvostruko slijepog perioda od 2 mjeseca.
The data were best fitted with a one compartment model with first order absorption and elimination processes. 
Podaci su se najbolje uklopili u model jednog odjeljka s apsorpcijom i eliminacijom koje odgovaraju kinetici prvog reda.
The following pharmacokinetic properties of stiripentol have been reported from studies in adult healthy volunteers and adult patients. 
Sljedeća farmakokinetička svojstva stiripentola su zabilježena iz ispitivanja na odraslim zdravim dobrovoljcima i odraslim bolesnicima.
You can also report side effects directly via the national reporting system listed in Appendix V. 
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V*.
Breast-feeding is not recommended during treatment with this medicine. 
Tijekom liječenja ovim lijekom, dojenje se ne preporučuje.
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. 
Oskudni su podaci o mogućoj inhibiciji CYP1A2, te se stoga ne mogu isključiti interakcije s teofilinom i kofeinom zbog povećanih razina teofilina i kofeina u plazmi, koje mogu nastati inhibicijom njihovog hepatičkog metabolizma, što potencijalno može dovesti do toksičnosti.
Paediatric population The dose of stiripentol is calculated on a mg/kg body weight basis. 
Pedijatrijska populacija Doza stripentola izračunava se na temelju doziranja u mg/kg tjelesne težine.
The most common side effects with stiripentol are anorexia, weight loss, insomnia, drowsiness, ataxia, hypotonia and dystonia. 
Najčešće nuspojave kod primjene stiripentola su anoreksija, gubitak na težini, nesanica, pospanost, ataksija, hipotonija i distonija.
41 children with SMEI were included in a randomised, placebo-controlled, add-on trial. 
41 dijete sa SMEI je bilo uključeno u randomiziranu placebo kontroliranu studiju dodatne terapije.
Diacomit contains aspartame, glucose, sorbitol and sodium This medicine contains 2.5 mg aspartame in each 250mg-sachet and 5 mg each 500mg-sachet. 
Diacomit sadrži aspartam, glukozu, sorbitol i natrij Ovaj lijek sadrži 2,5 mg aspartama u svakoj vrećici od 250 mg i 5 mg u svakoj vrećici od 500 mg.
- Immunosuppressants (tacrolimus, cyclosporine, sirolimus) Raised blood levels of immunosuppressants (decreased hepatic metabolism). 
- Imunosupresivi (takrolimus, ciklosporin, sirolimus) Povećanje razine imunosupresiva u krvi (smanjen hepatički metabolizam).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 04 January 2007 
Datum prvog odobrenja: 04. siječnja 2007.
Monitoring of plasma concentrations or adverse reactions is recommended. 
Preporučuje se nadzor koncentracija u plazmi i nuspojava.
60 sachets 
60 vrećica
• Because the frequency of gastrointestinal side effect with Diacomit, clobazam and valproate, 
• Zbog učestalih gastrointestinalnih nuspojava kod uzimanja Diacomita, klobazama i valproata,
Given the frequency of gastrointestinal adverse reactions to treatment with stiripentol and valproate (anorexia, loss of appetite, nausea, vomiting), the growth rate of children under this combination of treatment should be carefully monitored. 
S obzirom na učestalost gastrointestinalnih nuspojava u liječenju stiripentolom i valproatom (anoreksija, gubitak teka, mučnina, povraćanje), treba pomno nadzirati brzinu rasta u djece liječene kombinacijom ovih lijekova.
This medicine contains sorbitol: 2.4 mg in each 250mg-sachet and 4.8 mg in each 500mg-sachet. 
Ovaj lijek sadrži sorbitol: 2,4 mg u svakoj vrećici od 250 mg i 4,8 mg u svakoj vrećici od 500 mg.
The powder should be mixed in a glass of water and should be taken immediately after mixing during a meal. 
Prašak treba razmutiti u čaši vode i popiti odmah nakon miješanja tijekom obroka.
Responders were defined as having more than 50% reduction in the frequency of clonic (or tonicclonic) seizures during the second month of the double-blind period compared with baseline. 
Bolesnici s odgovorom su definirani kao oni koji su imali više od 50% smanjenja učestalosti kloničkih ( ili toničko-kloničkih) napadaja tijekom drugog mjeseca dvostruko slijepog perioda u usporedbi s početnim periodom.
90 sachets 
90 vrećica
• raised levels of liver enzymes, especially when given with either of the antiepileptic medicines carbamazepine and sodium valproate; 
• povišene razine jetrenih enzima, posebno ako se lijek uzima s bilo kojim od dva antiepileptička lijeka - karbamazepinom i natrijevim valproatom;
If your child forgets to take Diacomit 
Ako Vaše dijete zaboravi uzeti Diacomit
* Thrombocytopenia data are derived from both clinical trials and post-marketing experience. 
* Podaci o trombocitopeniji su dobivenii iz kliničkih ispitivanja i postmarketinškog iskustva.
- Cisapride, halofantrine, pimozide, quinidine, bepridil Increased risk of cardiac arrhythmias and torsades de pointes/wave burst arrhythmia in particular. 
- Cisaprid, halofantrin, pimozid, kinidin, bepridil Povećanje rizika od srčanih aritmija, a osobito od ventrikularne aritmije tipa torsades de pointes.
Patients aged ≥ 18 years of age 
≥ 18 godina
There are no clinical study data to support the clinical safety of stiripentol administered at daily doses greater than 50 mg/kg/day. 
Nema podataka iz kliničkih studija koji bi poduprli kliničku sigurnost stiripentola primijenjenog u dnevnim dozama većim od 50 mg/kg/danu.
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. 
Smatra se da moguća kompeticija inhibicije CYP2C19 ne nastaje zato što vjerojatno zahtijeva koncentracije u plazmi 5-15 puta veće nego koncentracije koje se dostižu standardnim preporučenim dozama topiramata i njegovim rasporedom uzimanja.
Size 2 pink capsule 
Ružičasta kapsula veličine 2
At therapeutic concentrations, stiripentol significantly inhibits several CYP450 isoenzymes: for example, CYP2C19, CYP2D6 and CYP3A4. 
U terapijskim koncentracijama, stiripentol značajno inhibira nekoliko CYP450 izoenzima, na primjer CYP2C19, CYP2D6 i CYP3A4.
Clinical monitoring of plasma levels of other anticonvulsants when combined with stiripentol with possible dose adjustments is recommended. 
Savjetuje se kliničko praćenje razina drugih antikonvulziva u plazmi i eventualna prilagodba doza pri kombiniranju sa stiripentolom.
Stiripentol must always be taken with food as it degrades rapidly in an acidic environment (e.g. exposure to gastric acid in an empty stomach). 
Stiripentol se uvijek mora uzimati s hranom jer se brzo razgrađuje u kiselom okolišu (kao što je izloženost želučanoj kiselini u praznom želucu).
Potential medicinal product interactions affecting stiripentol 
Moguće interakcije s drugim lijekovima koje utječu na stiripentol
In view of the indication, administration of stiripentol during pregnancy and in women of childbearing potential would not be expected. 
S obzirom na indikaciju, ne očekuje se primjena stiripentola tijekom trudnoće i u žena koje mogu rađati.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free'. 
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po vrećici, tj. zanemarive količine natrija.
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). 
NEMOJTE uzimati Diacomit s mlijekom ili mliječnim proizvodima (jogurt, meki krem sirevi, itd.), s voćnim sokom, gaziranim pićima ili hranom i pićima koji sadrže kofein ili teofilin (kao što su kokakola, čokolada, kava, čaj, energetski napitci).
Dose adjustments of other antiepileptics used in combination with stiripentol 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. 
Prilagodba doze ostalih antiepileptika koji se primjenjuju u kombinaciji 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.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET LABEL TEXT 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TEKST NA VREĆICI
Based on the clinical observations in this group of patients, there is no evidence to suggest that a change in topiramate dose and dosage schedules is needed if coadministered with stiripentol. 
Na temelju kliničkog promatranja ove skupine bolesnika, nije bilo dokaza koji bi ukazali na potrebu za promjenom doze ili rasporeda uzimanja topiramata pri istodobnoj primjeni sa stiripentolom.
BIOCODEX 1 avenue Blaise Pascal, 60000 Beauvais FRANCE 
BIOCODEX 1 avenue Blaise Pascal, 60000 Beauvais FRANCUSKA
• The capsule shell is made of gelatine, titanium dioxide (E171). 
• Ovojnica kapsule se sastoji od želatine, titanijeva dioksida (E171).
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. 
Relativna bioraspoloživost kapsula i praška za oralnu suspenziju u vrećici je istraživana u zdravih muških dobrovoljaca poslije jednokratne peroralne primjene doze od 1000 mg.
If your child has problems with certain ingredients of Diacomit (e.g. aspartame, glucose, sorbitol). 
Ako Vaše dijete ima problema s nekim sastojcima Diacomita (na primjer aspartam, glukoza, sorbitol), pogledajte u tom slučaju u daljem tekstu: “ Diacomit sadrži aspartam, glukozu, sorbitol i natrij”.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL TEXT 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU TEKST NA BOČICI
The powder should be mixed in a glass of water and should be taken immediately after mixing. 
Prašak treba razmutiti u čaši vode i popiti odmah nakon miješanja.
Abnormal laboratory findings 
Poremećene laboratorijske pretrage
What Diacomit 500 mg contains 
Što Diacomit 500 mg sadrži
Paediatric population pharmacokinetic study 
Farmakokinetička ispitivanja u pedijatrijskoj populaciji
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).