FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Stiripentol se ne sme jemati z mlekom ali mlečnimi izdelki (jogurt, sir za mazanje itn.), gaziranimi pijačami, sadnim sokom ali živili in pijačami, ki vsebujejo kofein ali teofilin.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte PrilogoI: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: • raised levels of liver enzymes, especially when given with either of the antiepileptic medicines carbamazepine and sodium valproate;
Slovenian: • zvišane ravni jetrnih encimov, zlasti pri sočasnem dajanju s karbamazepinom ali natrijevim valproatom - zdraviloma proti epilepsiji;
English: • if your child is allergic to stiripentol or to any of the other ingredients of Diacomit (listed in section 6).
Slovenian: • če je vaš otrok alergičen na stiripentol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • abnormal liver function test.
Slovenian: • nenormalne vrednosti jetrnih testov.
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).
Slovenian: Dnevno odmerjanje klobazama ali valproata ali obojega je treba znižati, če se pojavijo neželeni učinki med zdravljenjem s stiripentolom (glejte poglavje 4.2).
English: Boxes of 30, 60 and 90 sachets.
Slovenian: Škatle s 30, 60 in 90 vrečicami.
English: Povidone (K29/32) Sodium starch glycolate (type A) Magnesium stearate
Slovenian: Povidon (K29/32) Natrijev karboksimetilškrob (tip A) Magnezijev stearat
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.
Slovenian: Diacomit vsebuje aspartam, glukozo, sorbitol in natrij To zdravilo vsebuje 2,5 mg aspartama v vsaki 250-mg vrečici in 5 mg v vsaki 500-mg vrečici.Aspartam je vir fenilalanina.
English: • Because of the frequency of gastrointestinal side effects with Diacomit, clobazam and valproate, such as anorexia, loss of appetite, vomiting, your child's growth rate should be carefully monitored.
Slovenian: • zaradi pogostnosti gastrointestinalnih neželenih učinkov zdravila Diacomit, klobazama in valproata, kot so anoreksija, izguba apetita in bruhanje, je treba skrbno spremljati hitrost rasti otroka.
English: Most stiripentol is excreted via the kidney.
Slovenian: Večina stiripentola se izloči preko ledvic.
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).
Slovenian: Klinična odločitev za uporabo zdravila Diacomit pri otrocih s SMEI, ki so mlajši od 3 let, mora biti sprejeta glede na posameznega bolnika ob upoštevanju potencialnih koristnih učinkov in tveganj (glejte poglavje 4.2).
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.
Slovenian: Klinična odločitev za uporabo stiripentola med nosečnostjo mora biti sprejeta glede na posamezno bolnico ob upoštevanju potencialnih koristnih učinkov in tveganj.
English: Aggressiveness, irritability, behaviour disorders, opposing behaviour, hyperexcitability, sleep disorders
Slovenian: Psihiatrične motnje nespečnost agresivnost, razdražljivost, vedenjske motnje, nasprotujoče obnašanje, hiperekscitabilnost, motnje spanja
English: Capsule core
Slovenian: Notranjost kapsul
English: Gelatine
Slovenian: Želatina
English: For the interaction of stiripentol with food, see section 4.5.
Slovenian: Za informacije o interakcijah stiripentola s hrano glejte poglavje 4.5.
English: • The capsule shell is made of gelatine, titanium dioxide (E171).
Slovenian: • Ovojnica kapsule je izdelana iz želatine in titanovega dioksida (E171).
English: Do NOT take Diacomit with milk or dairy products (yoghurt, soft cream cheeses, etc), fruit juice, fizzy drinks or food and drinks that contain caffeine or theophylline (for example cola, chocolate, coffee, tea and energy drinks).
Slovenian: Jemanje zdravila Diacomit skupaj s hrano in pijačo Zdravila Diacomit NE jemljite z mlekom in mlečnimi izdelki (jogurti, siri za mazanje itd), sadnim sokom, gaziranimi pijačami ali živili in pijačami, ki vsebujejo kofein ali teofilin (npr. kola, čokolada, kava, čaj in energijski napitki).
English: • if your child has ever experienced attacks of delirium (a mental state with confusion,
Slovenian: • če je vaš otrok kdaj imel napade delirija (duševno stanje zmedenosti, vznemirjenosti, nemira in halucinacij).
English: As a consequence, it is recommended that children between 6 months and 3 years of age are carefully monitored whilst on stiripentol therapy.
Slovenian: Zato je priporočljivo natančno spremljanje otrok, starih od 6 mesecev do 3 let, ki se zdravijo stiripentolom.
English: - If you have any further questions, ask your child's doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z otrokovim zdravnikom ali farmacevtom.
English: Titanium dioxide (E171) Erythrosine (E127) Indigotine (E132)
Slovenian: Titanov dioksid (E 171) Eritrozin (E127) Indigotin (E132)
English: Anorexia, loss of appetite, weight loss
Slovenian: Presnovne in prehranske motnje anoreksija, izguba apetita, zmanjšanje telesne mase
English: Each sachet contains 5 mg of aspartame, 1,000 mg of glucose liquid spray and 4.8 mg of sorbitol.
Slovenian: Vsaka vrečica vsebuje 5 mg aspartama, 1000 mg glukoze, pripravljene z razprševalnim sušenjem, in 4,8 mg sorbitola.
English: Stiripentol is not recommended for use in patients with impaired hepatic and/or renal function (see section 4.4).
Slovenian: Uporaba stiripentola ni priporočljiva pri bolnikih z okvarjenim delovanjem jeter ali ledvic ali obojim (glejte poglavje 4.4).
English: If you have any further questions on the use of this product, ask your child's doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z otrokovim zdravnikom ali s farmacevtom.
English: • The other ingredients of the capsule are povidone K29/32, sodium starch glycolate type A and magnesium stearate.
Slovenian: • Pomožne snovi v kapsuli so: povidon K29/32, natrijev karboksimetilškrob tipa A in magnezijev stearat.
English: These substances should not be used in conjunction with stiripentol in the management of Dravet's syndrome.
Slovenian: Teh snovi se pri obravnavi Dravetovega sindroma ne sme uporabiti sočasno s stiripentolom.
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.
Slovenian: Klinična odločitev za uporabo stiripentola pri otrocih s SMEI, ki so mlajši od 3 let, mora biti sprejeta glede na posameznega bolnika ob upoštevanju potencialnih koristnih učinkov in tveganj.
English: Your child should always take the contents of each sachet exactly as your child's doctor has told you.
Slovenian: Vaš otrok mora vzeti vsebino vrečice natančno po navodilih otrokovega zdravnika.
English: Levetiracetam does not undergo hepatic metabolism to a major extent.
Slovenian: Levetiracetam se večinoma ne presnavlja v jetrih.
English: - Effects on other antiepileptic drugs (AEDs)
Slovenian: - Učinki na druga zdravila proti epilepsiji
English: Biocodex,7 avenue Gallieni - F-94250 Gentilly - France Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex.fr
Slovenian: Biocodex, 7 avenue Gallieni - F-94250 Gentilly - Francija Tel: + 33 1 41 24 30 00 - E-pošta: webar@biocodex.fr
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija trombocitopenija*
English: Blood count
Slovenian: Krvna slika
English: - Immunosuppressants (tacrolimus, cyclosporine, sirolimus) Raised blood levels of immunosuppressants (decreased hepatic metabolism).
Slovenian: Zdravila za zaviranje imunske odzivnosti (takrolimus, ciklosporin, sirolimus) Zvišane koncentracije zdravil za zaviranje imunske odzivnosti v krvi (zmanjšana presnova v jetrih).
English: The pivotal clinical evaluation of stiripentol was in children of 3 years of age and over with SMEI.
Slovenian: Ključne raziskave uporabe stiripentola so bile opravljene pri otrocih starih 3 leta in več, ki so imeli SMEI.
English: 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.
Slovenian: Glede na pogostnost gastrointestinalnih neželenih učinkov pri zdravljenju s stiripentolom in valproatom (anoreksija, izguba apetita, navzea, bruhanje) je treba ob uporabi omenjene kombinacije zdravljenja skrbno spremljati hitrost rasti otroka.
English: This warning is not only restricted to medicinal products but also to a considerable number of foods and nutritional products aimed at children: Patient should not drink cola drinks, which contain significant quantities of caffeine or chocolate, which contains trace amounts of theophylline (see section 4.2).
Slovenian: Bolnik ne sme uživati pijače kole, ki vsebuje znatne količine kofeina, ali čokolade, ki vsebuje sledove teofilina (glejte poglavje 4.2).
English: Size 2 pink capsule
Slovenian: trde kapsule rožnate kapsule velikosti 2
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.
Slovenian: Zdravilo Diacomit se uporablja skupaj s klobazamom in valproatom kot dodatno zdravljenje neodzivnih generaliziranih tonično-kloničnih napadov pri bolnikih s hudo mioklonično epilepsijo v otroštvu (SMEI - severe myoclonic epilepsy in infancy, Dravetov sindrom), kadar krčev ne moremo zadostno nadzorovati s klobazamom in valproatom.
English: • Your child's liver function should be assessed prior to starting Diacomit and checked every 6
Slovenian: • pred začetkom jemanja zdravila Diacomit je treba pri otroku pregledati delovanje jeter in ga preverjati vsakih 6 mesecev,
English: Your child must not stop taking this medicine unless the doctor tells you to.
Slovenian: Če je vaš otrok prenehali jemati zdravilo Diacomit Vaš otrok ne sme prenehati jemati tega zdravila, če tega ne naroči zdravnik.
English: 0.11 mg sodium per sachet.
Slovenian: 0,11 mg natrija v vsaki vrečici.
English: • Your child's blood count should be assessed prior to starting Diacomit and checked every 6
Slovenian: • pred začetkom jemanja zdravila Diacomit je treba pregledati otrokovo krvno sliko in jo preverjati vsakih 6 mesecev,
English: In case of switch between capsule and powder formulation it should be done under the close supervision of the doctor.
Slovenian: Zamenjava kapsul s praškom mora potekati pod strogim nadzorom zdravnika.
English: • nausea, vomiting;
Slovenian: • slabost, bruhanje;
English: The population estimate for the absorption rate constant Ka was 2.08 hr-1 (standard deviation of random effect = 122%).
Slovenian: Populacijska ocena za konstanto hitrosti absorpcije Ka je bila 2,08 ur
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.
Slovenian: Vpliv makrolidov in azolnih protiglivičnih zdravil, ki so znani zaviralci CYP3A4 in substrati tega encima, na presnovo stiripentola ni znan.
English: 0.22 mg sodium per sachet.
Slovenian: 0,22 mg natrija v vsaki vrečici.
English: Please consult your child's doctor in the event of any side effects as the doctor may have to adjust the dose of this medicine and the other antiepileptic medicine(s).
Slovenian: Če se pojavijo neželeni učinki, se posvetujte z otrokovim zdravnikom, saj bo morda prilagodil odmerek zdravila Diacomit in drugih zdravil proti epilepsiji.
English: Caution should be exercised when prescribing to pregnant women and use of efficient methods of contraception is advisable.
Slovenian: Pri predpisovanju zdravila nosečnicam je potrebna previdnost.
English: 7 avenue Gallieni 94250 Gentilly France
Slovenian: 7 avenue Gallieni 94250 Gentilly Francija
English: What Diacomit 500 mg looks like and contents of the pack Diacomit 500 mg hard capsules are white.
Slovenian: Izgled zdravila Diacomit 500 mg in vsebina pakiranja Diacomit 500 mg trde kapsule so bele barve.
English: In vitro studies suggested that stiripentol phase 1 metabolism is catalyzed by CYP1A2, CYP2C19 and CYP3A4 and possibly other enzymes.
Slovenian: In vitro študije so nakazale, da so pri 1. fazi stiripentol metabolizma katalizatorji CYP1A2, CYP2C19, CYP3A4 in verjetno drugi encimi.
English: Tel: + 33 1 41 24 30 00 e-mail: webar@biocodex.fr
Slovenian: Tel: + 33 1 41 24 30 00 E-pošta: webar@biocodex.fr
English: Cartons contain either 30, 60 or 90 sachets.
Slovenian: Škatle vsebujejo 30, 60 ali 90 vrečic.
English: Diacomit is also available as 250 mg and 500 mg capsules for oral use
Slovenian: Zdravilo Diacomit je na voljo tudi v obliki 250 mg in 500 mg kapsul za peroralno uporabo.
English: The powder should be mixed in a glass of water and should be taken immediately after mixing during a meal.
Slovenian: Prašek zmešajte v kozarcu vode in vsebino popijte takoj po pripravi, med obrokom.
English: Glucose liquid spray dried Sodium
Slovenian: Tekoča glukoza, pripravljena z razprševalnim sušenjem Natrij
English: Breast-feeding is not recommended during treatment with this medicine.
Slovenian: Med zdravljenjem z zdravilom Diacomit dojenje ni priporočljivo.
English: Powder for oral suspension in sachet 30 sachets
Slovenian: Prašek za peroralno suspenzijo v vrečici 30 vrečic
English: Each sachet contains 2.5 mg of aspartame, 500 mg of glucose liquid spray and 2.4 mg of sorbitol.
Slovenian: Vsaka vrečica vsebuje 2,5 mg aspartama, 500 mg glukoze, pripravljena z razprševalnim sušenjem, in 2,4 mg sorbitola.
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).
Slovenian: Zaradi pomanjkanja specifičnih kliničnih podatkov o bolnikih z okvarjenim delovanjem jeter ali ledvic uporaba stiripentola pri teh bolnikih ni priporočljiva (glejte poglavje 4.2).
English: When to take Diacomit
Slovenian: Kdaj jemati zdravilo Diacomit
English: Capsule shell
Slovenian: Ovojnica kapsul
English: Nausea, vomiting
Slovenian: Bolezni prebavil navzea, bruhanje
English: Czech Republic Tel: 00420-2-222 45 375 e-mail: desitin@desitin.cz
Slovenian: Tel: 00420-2-222 45 375 e-mail: desitin@desitin.cz
English: What Diacomit 250 mg looks like and contents of the pack Diacomit 250 mg hard capsule is pink.
Slovenian: Izgled zdravila Diacomit 250 mg in vsebina pakiranja Diacomit 250 mg trde kapsule so rožnate barve.
English: The powder should be mixed in a glass of water and should be taken immediately after mixing.
Slovenian: Prašek zmešajte v kozarcu vode in vsebino popijte takoj po pripravi.
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.
Slovenian: Na osnovi in vitro študij je ugotovljeno, da so izoencimi glavnega jetrnega citokroma P450, vključeni v metabolizem v prvi fazi, CYP1A2, CYP2C19 in CYP3A4.
English: Data on the potential for inhibition of CYP1A2 are limited, and therefore, interactions with theophylline and caffeine cannot be excluded because of the increased plasma levels of theophylline and caffeine which may occur via inhibition of their hepatic metabolism, potentially leading to toxicity.
Slovenian: Podatki o možnosti zaviranja CYP1A2 so omejeni - interakcij s teofilinom in kofeinom torej ne moremo izključiti,saj se lahko zaradi ovirane presnove teofilina in kofeina v jetrih poveča njihova plazemska koncentracija kar lahko povzroči toksičnost.
English: Diacomit is also available as 250 mg and 500 mg powder for oral suspension in sachets.
Slovenian: Zdravilo Diacomit je na voljo tudi v obliki 250 mg in 500 mg praška za peroralno suspenzijo v vrečici.
English: Tutti frutti flavour (contains sorbitol) Carmellose sodium Hydroxyethylcellulose
Slovenian: Aroma tutti frutti (vsebuje sorbitol) Natrijev karmelozat
English: By reporting side affects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Bottles of 30, 60 and 90 capsules in cardboard cartons.
Slovenian: Plastenke s 30, 60 in 90 kapsulami.
English: 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 nonrodents.
Slovenian: V študijah toksičnosti pri živalih (podgane, opice, miši) niso odkrili enotnega vzorca toksičnosti razen povečanja jeter, ki je bila povezana s hepatocelularno hipertrofijo.
English: Liver function test abnormal
Slovenian: nenormalni testi jetrne funkcije
English: Diacomit 250 mg hard capsule Diacomit 500 mg hard capsule stiripentol
Slovenian: Diacomit 250 mg trde kapsule Diacomit 500 mg trde kapsule stiripentol
English: Blood counts should be assessed prior to starting treatment with stiripentol.
Slovenian: Pred zdravljenjem s stiripentolom je treba pregledati krvno sliko.
English: A dose-adjustment may be necessary for substances metabolised by CYP2D6 and that are individually dose titrated.
Slovenian: Pri dajanju snovi, ki se presnavljajo s CYP2D6 in kjer se odmerek določa posebej za vsakega bolnika, bo morda potrebno prilagoditi odmerek.
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.
Slovenian: Ker stiripentol zavira CYP2D6 in vitro pri koncentracijah, ki so enake kliničnim koncentracijam v plazmi, imajo lahko snovi, ki se presnavljajo preko tega izoencima (npr. zaviralci adrenergičnih receptorjev beta (propranolol, karvedilol, timolol), antidepresivi (fluoksetin, paroksetin, sertralin, imipramin, klomipramin), antipsihotiki (haloperidol), analgetiki (kodein, dekstrometorfan, tramadol)), presnovne interakcije s stiripentolom.
English: Neutropenia may be associated with the administration of stiripentol, clobazam and valproate.
Slovenian: Z dajanjem stiripentola, klobazama in valproata je lahko povezana nevtropenija.
English: MARKETING AUTHORISATION HOLDER Biocodex, 7 Avenue Gallieni, 94250 Gentilly, France.
Slovenian: Biocodex, 7 Avenue Gallieni, 94250 Gentilly, Francija.
English: Data on clinical overdose are not available.
Slovenian: Ni podatkov o primerih prevelikega odmerjanja.
English: Your child's doctor will tell you the new dose of the other antiepileptic medicine(s).
Slovenian: O novem odmerku drugih protiepileptičnih zdravil vas obvesti otrokov zdravnik.
English: • The capsule shell is made of gelatine, titanium dioxide (E171), erythrosine (E127), indigotin
Slovenian: • Ovojnica kapsule je izdelana iz želatine, titanovega dioksida (E171), eritrozina (E127),
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, ali farmacevtom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET LABEL TEXT
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: tutti frutti flavour (contains sorbitol), carmellose sodium, hydroxyethylcellulose.
Slovenian: aspartam (E951), aroma tutti frutti (vsebuje sorbitol), natrijev karmelozat, hidroksietilceluloza.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL TEXT
Slovenian: BESEDILO NA NALEPKI NA VREČICI
English: Very common side effects (may affect more than one in 10 people):
Slovenian: Zelo pogosti neželeni učinki (pojavijo se pri več kot enem od 10 bolnikov):
English: Photosensitivity, rash, cutaneous allergy, urticaria
Slovenian: Bolezni kože in podkožja fotosenzitivnost, izpuščaj, kožna alergija, urtikarija
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).
Slovenian: • zdravila, ki vsebujejo: - cisaprid (za zdravljenje simptomov zgage ponoči), - pimozid (za zdravljenje simptomov Tourettovega sindroma, npr. govornih izbruhov in nenadzorovanih ponavljajočih se gibov telesa), - ergotamin (za zdravljenje migrene), - dihidroergotamin (za lajšanje znakov in simptomov zmanjšane umske sposobnosti zaradi staranja), - halofantrin (zdravilo proti malariji), - kinidin (za zdravljenje nenormalnega ritma srca), - bepridil (za obvladovanje bolečin v prsnem košu), - ciklosporin, takrolimus, sirolimus (vsi se uporabljajo za preprečevanje zavrnitve presadkov jeter, ledvic in srca), - statine (simvastatin in atorvastatin za nižanje ravni holesterola v krvi).
English: Diacomit 250 mg powder for oral suspension in sachet Diacomit 500 mg powder for oral suspension in sachet stiripentol
Slovenian: Diacomit 250 mg prašek za peroralno suspenzijo v vrečici Diacomit 500 mg prašek za peroralno suspenzijo v vrečici stiripentol
English: Detailed information on this medicine is available on the European Medicine Agency website: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila : http://www.ema.europa.eu, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: How to take Diacomit
Slovenian: Kako jemati zdravilo Diacomit
English: It should be assessed prior to starting treatment with stiripentol.
Slovenian: Pred zdravljenjem s stiripentolom je treba pregledati jetrno funkcijo.
English: Povidone (K29/32) Sodium starch glycolate type A Glucose liquid, spray dried Erythrosine (E127) Titanium dioxide (E171) Aspartame (E951)
Slovenian: • Pomožne snovi v vrečici so: povidon K29/32, natrijev karboksimetilškrob tipa A, tekoča glukoza (pripravljena z razprševalnim sušenjem), eritrozin (E127), titanov dioksid (E171),
English: 41 children with SMEI were included in a randomised, placebo-controlled, add-on trial.
Slovenian: V randomizirano, s placebom nadzorovano preskušanje z dodatkom zdravila k obstoječemu zdravljenju so vključili 41 otrok s SMEI.
English: - If your child gets any side effects, talk to your child's doctor or pharmacist.
Slovenian: - Če pri otroku opazite katerikoli neželeni učinek, obvestite otrokovega zdravnika ali farmacevta.