FrancophonIA/ELRC3.0 huggingface dataset:
English: Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population.
Croatian: Općeniti rizik vezan uz epilepsiju i antiepileptičke lijekove Već je pokazano da je u potomstvu žena koje imaju epilepsiju prevalencija malformacija dva do tri puta veća nego stopa od približno 3% u općoj populaciji.
English: The dose is adjusted by the doctor according to your child's age, weight and condition, generally 50 mg per kg bodyweight and per day.
Croatian: Dozu određuje liječnik prema djetetovoj dobi, težini i stanju, uglavnom iznosi 50 mg po kg tjelesne težine dnevno.
English: The population estimate for the absorption rate constant Ka was 2.08 hr-1 (standard deviation of random effect = 122%).
Croatian: Procjena konstante brzine apsorpcije Ka u populacijije bila 2,08 h-1 (standardna devijacija randomnog učinka = 122%).
English: As the flavouring component contains small amount of sorbitol, patients with hereditary problems of fructose intolerance should not take this medicine.
Croatian: Kako komponenta koja daje okus sadrži nešto malo sorbitola, bolesnici s nasljednim problemima netolerancije na fruktozu ne bi smjeli uzimati ovaj lijek.
English: Anorexia, loss of appetite, weight loss
Croatian: Anoreksija, gubitak teka, gubitak na težini
English: The hard capsules are supplied in plastic bottles containing 30, 60 or 90 capsules in cardboard cartons.
Croatian: Tvrde kapsule su pakirane u plastične bočice koje sadrže 30, 60 ili 90 kapsula, u kartonskim kutijama.
English: Distribution Stiripentol binds extensively to circulating plasma proteins (about 99%).
Croatian: Stiripentol se opsežno veže za cirkulirajuće proteine plazme (oko 99%).
English: It should always be taken in combination with clobazam and valproate under the direction of a doctor.
Croatian: On se uvijek mora uzimati u kombinaciji s klobazamom i valproatom pod liječničkim nadzorom.
English: Increased plasma benzodiazepine levels may occur via decreased hepatic metabolism leading to excessive sedation.
Croatian: Povećanje razine benzodiazepina u plazmi može nastati zbog smanjenja hepatičkog metabolizma, što vodi u prekomjernu sedaciju.
English: The median age was 7.3 years (range: 1 to 17.6 years) and the median daily dose of stiripentol was 45.4 mg/kg/day (range: 27.1 to 89.3 mg/kg/day) received in two or three divided doses.
Croatian: Medijan dobi je bio 7,3 godine (raspon: 1 do 17,6 godina), a medijan dnevne doze stiripentola je bio 45,4 mg/kg/dan (raspon: 27,1 do 89,3 mg/kg/dan) primijenjen u dvije ili tri podijeljene doze.
English: Stiripentol powder for oral suspension in sachet contains aspartame, a source of phenylalanine.
Croatian: Stiripentol prašak za oralnu suspenziju u vrećici sadrži aspartam, izvor fenilananina.
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).
Croatian: Obratite se liječniku Vašeg djeteta u slučaju bilo kakvih nuspojava, jer liječnik mora prilagoditi dozu ovog lijeka i drugog antiepileptičkog lijeka (drugih antiepileptičkih lijekova).
English: chlorpromazine (used for mental illness such as psychosis).
Croatian: klorpromazin (koristi se u liječenju mentalnih bolesti poput psihoze).
English: The capsule should be swallowed whole with a glass of water.
Croatian: Kapsule treba progutati cijele s čašom vode.
English: As a consequence, it is recommended that children between 6 months and 3 years of age are carefully monitored whilst on stiripentol therapy.
Croatian: Kao posljedica toga, preporuka je da se djeca dobi od 6 mjeseci do 3 godine pomno nadziru dok su na terapiji stiripentolom.
English: Stiripentol dosage escalation should be gradual, starting with 20mg/kg/day for 1 week, then 30mg/kg/day for 1 week.
Croatian: Povećanje doze stiripentola treba biti postupno, počevši s 20mg/kg/dan tijekom prvog tjedna, a potom 30mg/kg/dan tijekom drugog tjedna.
English: - Valproate
Croatian: - Valproat
English: PHARMACEUTICAL FORM AND CONTENTS 30 hard capsules
Croatian: OBLIK I SADRŽAJ 30 tvrdih kapsula
English: The potential for metabolic interaction between stiripentol and valproate is considered modest and thus, no modification of valproate dosage should be needed when stiripentol is added, except for clinical safety reasons.
Croatian: Mogućnost metaboličke interakcije između stiripentola i valproata se smatra skromnom, te stoga nije potrebno mijenjati doziranje valproata uz dodatnu terapiju stiripentolom, osim iz razloga kliničke sigurnosti.
English: By reporting side affects you can help provide more information on the safety of this medicine.
Croatian: Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
English: • double vision when used in combination with the antiepileptic medicine carbamazepine;
Croatian: • dvostruka slika kada se uzima u kombinaciji s antiepileptičkim lijekom karbamazepinom;
English: As a result, pharmacokinetic interactions of metabolic origin with other medicines may be expected.
Croatian: Posljedično, mogu se očekivati farmakokinetičke interakcije metaboličkog podrijetla s drugim lijekovima.
English: Tell your doctor if your child is taking any of the following medicines:
Croatian: Obavijestite liječnika ako Vaše dijete uzima neki od sledećih lijekova:
English: If you have the impression that the effect of this medicine is too strong or too weak, talk to your child's doctor or pharmacist.
Croatian: Ako imate dojam da je djelovanje ovog lijeka prejako ili preslabo, obratite se liječniku Vašeg djeteta ili ljekarniku.
English: • loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium valproate);
Croatian: • gubitak teka, gubitak težine (posebno u kombinaciji s antiepileptičkim lijekom natrijevim valproatom);
English: Patients with rare glucosegalactose malabsorption should not take this medicine, as the formulation contains glucose.
Croatian: Bolesnici s rijetkom malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek, jer farmaceutski oblik sadrži glukozu.
English: Your child's doctor will tell you the new dose of the other antiepileptic medicine(s).
Croatian: Liječnik vašeg djeteta će Vas uputiti o novoj dozi drugog(ih) antiepileptika.
English: Patients then received stiripentol in an open fashion.
Croatian: Poslije toga je stiripentol davan bolesnicima otvoreno.
English: • ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia
Croatian: • ataksija (nesposobnost koordinacije mišićnih pokreta), hipotonija (gubitak snage mišića),
English: PHARMACEUTICAL FORM Powder for oral suspension Pale pink crystalline powder
Croatian: OBLIK Prašak za oralnu suspenziju Blijedo ružičasti kristalni prašak
English: A dose-adjustment may be necessary for substances metabolised by CYP2D6 and that are individually dose titrated.
Croatian: Može biti neophodna prilagodba doze za tvari koje metabolizira CYP2D6 i čija se doza individualno titrira.
English: No impact on fertility was detected in animal studies (see section 5.3).
Croatian: Nije otkriven utjecaj na plodnost u ispitivanjima na životinjama (vidjeti dio 5.3).
English: A population pharmacokinetic study was conducted in 35 children with Dravet Syndrome treated with stiripentol and two substances not known to affect stiripentol pharmacokinetics, valproate and clobazam.
Croatian: Populacijsko farmakokinetičko ispitivanje je provedeno u 35 djece s Dravetovim sindromom, liječene stiripentolom i s druge dvije tvari za koje se ne zna da utječu na farmakokinetiku stiripentolavalproatom i klobazamom.
English: These capsules should be swallowed whole with water.
Croatian: Ove kapsule treba progutati cijele s vodom.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, foetal development, parturition or postnatal development at non-maternotoxic doses (see section 5.3).
Croatian: Ispitivanja na životinjama ne pokazuju izravne niti neizravne štetne učinke po trudnoću, fetalni razvoj, porođaj ili postnatalni razvoj na razini netoksičnih doza po majku (vidjeti dio 5.3).
English: Stiripentol is quickly absorbed, with a time to peak plasma concentration of about 1.5 hours.
Croatian: Stiripentol se brzo apsorbira, i za otprilike 1,5 sat dostiže najvišu razinu koncentracije u plazmi.
English: Size 0, white capsule
Croatian: Bijela kapsula veličine 0
English: • The active substance is stiripentol.
Croatian: • Djelatna tvar je stiripentol.
English: - If your child takes medicines containing: caffeine (this substance helps restore mental alertness) or theophylline (this substance is used in case of asthma).
Croatian: - Ako Vaše dijete uzima lijekove koji sadrže: kofein (ova tvar pomaže vraćanju mentalne budnosti) ili teofilin (ova tvar se koristi u slučaju astme).
English: In animal models, stiripentol antagonizes seizures induced by electric shock, pentetrazole and bicuculline.
Croatian: U životinjskim modelima, stiripentol djeluje protiv napadaja izazvanih elektrošokom, pentetrazolom i bikukulinom.
English: Your child should take this medicine two or three times a day at regular intervals as directed by your child's doctor, for example morning - noon - bed-time to cover the night-and-day period.
Croatian: Vaše dijete mora uzimati ovaj lijek dva ili tri puta dnevno u redovnim razmacima, kako je odredio njegov liječnik, na primjer jutro - podne - pred spavanje, kako bi se pokrio noćni i dnevni period.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: As a result, no pharmacokinetic metabolic drug interaction between stiripentol and levetiracetam is anticipated.
Croatian: Shodno tomu, ne očekuje se farmakokinetička metabolička interakcija stiripentola i levetiracetama.
English: The initiation of adjunctive therapy with stiripentol should be undertaken gradually using upwards dose escalation to reach the recommended dose of 50 mg/kg/day administered in conjunction with clobazam and valproate.
Croatian: Započinjanje dodatne terapije sa stiripentolom treba provesti postupnim povećavanjem doze do preporučene doze od 50 mg/kg/dan, primijenjene zajedno s klobazamom i valproatom.
English: • sleep disorders (abnormal sleeping);
Croatian: • poremećaji sna (promjene spavanja);
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).
Croatian: Ovo upozorenje nije ograničeno samo na lijekove, nego i na znatan broj namirnica i prehrambenih pripravaka namijenjenih djeci: Bolesnici ne bi smjeli piti kola napitke koji sadrže znatne količine kofeina, ili jesti čokoladu, koja sadrži teofilin u tragovima (vidjeti dio 4.2).
English: Further dosage escalation is age dependent: - children less than 6 years should receive an additional 20 mg/kg/day in the third week, thus achieving the recommended dose of 50 mg/kg/day in three weeks; - children from 6 to less than 12 years should receive an additional 10 mg/kg/day each week, thus achieving the recommended dose of 50 mg/kg/day in four weeks; - children and adolescents 12 years and older should receive an additional 5 mg/kg/day each week until the optimum dose is reached based on clinical judgment.
Croatian: Daljnje povećanje doze ovisi o dobi: - djeca mlađa od 6 godina bi trebala primiti dodatnih 20 mg/kg/dan tijekom trećeg tjedna, dostižući tako preporučenu dozu od 50 mg/kg/dan za tri tjedna; - djeca od 6 do manje od 12 godina trebala bi primiti dodatnih 10 mg/kg/dan svaki tjedan, dostižući tako preporučenu dozu od 50 mg/kg/dan za četiri tjedna; - djeca i adolescenti u dobi od 12 godina i stariji trebali bi primiti dodatnih 5 mg/kg/dan svaki tjedan sve dok se ne dostigne optimalna doza na temelju kliničke procjene.
English: In rodent models, stiripentol appears to increase brain levels of gamma-aminobutyric acid (GABA) - the major inhibitory neurotransmitter in mammalian brain.
Croatian: Čini se da u štakora, stiripentol povećava razine gama-aminomaslačne kiseline (GABA) u mozgu - glavnog inhibitornog neurotransmitera u mozgu sisavaca.
English: In a French compassionate use program for stiripentol, topiramate was added to stiripentol, clobazam and valproate in 41% of 230 cases.
Croatian: U jednom francuskom programu milosrdne primjene stiripentola, topiramat je dodan stiripentolu, klobazamu i valproatu u 41% of 230 slučajeva.
English: In the pivotal studies in the event of gastrointestinal adverse reactions such as loss of appetite, loss of weight, the daily dose of valproate was reduced by around 30% every week.
Croatian: U ključnim ispitivanjima u slučajevima gastrointestinalnih nuspojava, kao što su gubitak teka, gubitak težine, dnevna doza valproata se svakog tjedna smanjivala za oko 30%.
English: Tell your child's doctor or pharmacist if your child is using, has recently used or might use any other medicines.
Croatian: Obavijestite liječnika svog djeteta ili ljekarnika ako vaše dijete uzima, nedavno je uzimalo ili bi moglo uzimati bilo koji drugi lijek.
English: The two formulations were bioequivalent in terms of AUC but not in terms of Cmax.
Croatian: Ova dva farmaceutska oblika su bila bioekvivalentna obzirom na AUC, ali ne i obzirom na Cmax.
English: • Your child should not take Diacomit after the expiry date, which is stated on the label.
Croatian: • Vaše dijete ne smije uzimati Diacomit nakon isteka roka valjanosti, navedenog na pakiranju.
English: Undesirable combinations (to be avoided unless strictly necessary) - Rye ergot alkaloids (ergotamine, dihydroergotamine) Ergotism with possibility of necrosis of the extremities (inhibition of hepatic elimination of rye ergot).
Croatian: Nepoželjne kombinacije ( izbjegavati ukoliko nije strogo neophodno) - Alkaloidi ražene glavice (ergotamin, dihidroergotamin) Ergotizam s mogućnosti nekroze udova (inhibicija hepatičke eliminacije alkaloida ražene glavice)
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V*.
English: The consequences are increased plasma levels of these anticonvulsants with potential risk of overdose.
Croatian: Posljedica je povećanje razine ovih antikonvulziva u plazmi s mogućim rizikom od predoziranja.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Ako vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: Bottles of 30, 60 and 90 capsules in cardboard cartons.
Croatian: Bočice od 30, 60 i 90 kapsula u kartonskim kutijama.
English: Likewise, the effect of stiripentol on their metabolism is not known.
Croatian: Shodno tomu, nepoznat je utjecaj stiripentola na metabolizam ovih lijekova.
English: Aggressiveness, irritability, behaviour disorders, opposing behaviour, hyperexcitability, sleep disorders
Croatian: Agresivnost, razdražljivost, poremećaji ponašanja, suprotstavljanje, hiperekscitabilnost, poremećaji sna
English: In the pivotal studies, when the use of stiripentol was initiated, the daily dose of clobazam was 0.5 mg/kg/day usually administered in divided doses, twice daily.
Croatian: U ključnim ispitivanjima, kada je započeta primjena stiripentola, dnevna doza klobazama je bila 0,5 mg/kg/dan, obično podijeljena za primjenu dva puta na dan.
English: - Topiramate
Croatian: - Topiramat
English: such as anorexia, loss of appetite, vomiting, your child's growth rate should be carefully monitored.
Croatian: kao što su anoreksija, gubitak teka, povraćanje, potrebno je pažljivo nadzirati rast Vašeg djeteta.
English: In the absence of human studies on excretion in breast milk, and given that stiripentol passes freely from plasma into milk in the goat, breast-feeding is not recommended during treatment.
Croatian: U odsustvu ispitivanja izlučivanja u majčino mlijeko u ljudi, a znajući da stiripentol prolazi slobodno iz plazme u mlijeko u koza, dojenje se ne savjetuje za vrijeme liječenja.
English: • if your child is allergic to stiripentol or to any of the other ingredients of Diacomit.
Croatian: • ako je Vaše dijete alergično na stiripentol ili na neki drugi sastojak Diacomita.
English: Uncommon Rare
Croatian: Manje često Rijetk0
English: It is used in conjunction with clobazam and valproate (other antiepileptic medicines) to treat a certain form of epilepsy called severe myoclonic epilepsy in infancy (Dravet's syndrome), which affects children.
Croatian: Koristi se dodatno uz klobazam i valproat (druge antiepileptike) u liječenju određenog oblika epilepsije koji se naziva teška mioklona epilepsija u djetinjstvu (Dravetov sindrom), koja pogađa djecu.
English: Studies in the rat on fertility and general reproductive performance and on pre- and postnatal development were uneventful except for a minor reduction in the survival of pups nursed by mothers exhibiting toxic responses to stiripentol at a dose of 800 mg/kg/day (see section 4.6).
Croatian: Ispitivanja plodnosti i opće reproduktivne sposobnosti u štakora, i prenatalnog i postnatalnog razvoja su bila bez važnih događaja osim male redukcije u preživljavanju mladunaca koji su majke dojile, a koji su pokazali toksični odgovor na stiripentol pri dozi od 800 mg/kg/dan (vidjeti dio 4.6).
English: In these children, the use of stiripentol will be done under the close supervision of the doctor.
Croatian: U ove će se djece stiripentol primjenjivati uz strogi nadzor liječnika.
English: How to take the Diacomit powder for oral suspension The powder should be mixed in a glass of water and should be taken immediately after mixing during the meal.
Croatian: Kako uzimati Diacomit prašak za oralnu suspenziju Prašak treba razmutiti u čaši vode i uzeti odmah nakon miješanja tijekom obroka.
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).
Croatian: Dnevne doze klobazama i/ili valproata treba smanjiti u skladu s javljanjem nuspojava u tijeku liječenja stiripentolom (vidjeti dio 4.2).
English: In case stiripentol therapy is continued during breast-feeding, the breast-fed infant should be carefully observed for potential adverse effects.
Croatian: U slučaju da je liječenje stiripentolom nastavljeno tijekom dojenja, dojenče treba pomno promatrati zbog mogućih nuspojava.
English: The increase in steady state levels with the combined use of stiripentol, valproate, and clobazam is similar in adults and children, though inter-individual variability is marked.
Croatian: Porast u koncentracijama u stanju dinamičke ravnoteže u kombiniranoj primjeni stiripentola, valproata i klobazama je sličan u djece i odraslih, iako je interindividualna varijabilnost znatna.
English: If your child takes more Diacomit than he or she should Contact your child's doctor if you know or think your child has taken more medicine than he or she should have.
Croatian: Ako Vaše dijete uzme više Diacomita nego što bi smjelo Obratite se djetetovom liječniku ako znate ili mislite da je Vaše dijete uzelo više lijeka nego što je trebalo.
English: The combination with Diacomit should be avoided as it may increase their blood levels, leading to digestive disorders, racing heart and insomnia.
Croatian: Treba izbjegavati kombiniranje s Diacomitom, jer može povećati njihovu razinu u krvi, što izaziva probavne smetnje, lupanje srca i nesanicu.
English: There are no clinical study data to support the use of stiripentol as monotherapy in Dravet's syndrome.
Croatian: Nema podataka iz kliničkih studija koji bi poduprli primjenu stiripentola kao monoterapije u Dravetovom sindromu.
English: Stiripentol has also been shown to enhance GABAA receptor-mediated transmission in the immature rat hippocampus and increase the mean open-duration (but not the frequency) of GABAA receptor chloride channels by a barbiturate-like mechanism.
Croatian: Pokazano je također da u hipokampusu mladih štakora stiripentol povećava GABAA transmisiju posredovanu receptorima i povećava srednju vrijednost trajanja otvorenosti (ali ne učestalost) kloridnih kanala u GABAA receptoru, mehanizmom sličnim kao u barbiturata.
English: Increased risk of dose-dependent adverse reactions such as rhabdomyolysis (decreased hepatic metabolism of cholesterol-lowering medicinal product).
Croatian: Povećanje rizika od nuspojava ovisnih o dozi kao što je rabdomioliza (smanjen hepatički metabolizam lijeka koji snižava razinu kolesterola).
English: The second effect of stiripentol is mainly based on metabolic inhibition of several isoenzymes, in particular CYP450 3A4 and 2C19, involved in the hepatic metabolism of other anti-epileptic medicines.
Croatian: Drugi učinak stiripentola se uglavnom temelji na metaboličkoj inhibiciji nekoliko izoenzima, a osobito CYP450 3A4 i 2C19, uključenih u hepatički metabolizam drugih antiepileptičkih lijekova.
English: It is well absorbed by the oral route since the majority of an oral dose is excreted in urine.
Croatian: Dobro se apsorbira uzet peroralno jer se glavnina oralne doze izlučuje urinom.
English: The daily dosage may be administered in 2 or 3 divided doses.
Croatian: Dnevna doza može se primijeniti u 2 ili 3 podijeljene doze.
English: Clearance and volume of distribution were related to body weight by an allometric model with exponents of 0.433 and 1, respectively: as body weight increased from 10 to 60 kg, apparent oral clearance increased from 2.60 to 5.65 L/hr and apparent volume of distribution increased from 32.0 to 191.8 L. As a result, elimination half-life increased from 8.5hr (for 10 kg) to 23.5 hr (for 60 kg).
Croatian: Klirens i volumen distribucije su bili u odnosu s tjelesnom težinom, prikazano alometrijskim modelom s eksponentom 0,433 i 1: kako se tjelesna težina povećavala od 10 do 60 kg, prividni oralni klirens se povećavao od 2,60 to 5,65 L/h, a prividni volumen distribucije se povećavao od 32,0 to 191,8 L.
English: Diplopia
Croatian: Diplopija
English: • if your child has kidney or liver problems.
Croatian: • ako Vaše dijete ima problema s bubrezima ili jetrom.
English: Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX17
Croatian: Farmakoterapijska skupina: antiepileptici, drugi antiepileptici, ATK oznaka: N03AX17
English: The influence of other antiepileptic medicinal products on stiripentol pharmacokinetics is not well established.
Croatian: Utjecaj drugih antiepileptičkih lijekova na farmakokinetiku stiripentola nije dovoljno utvrđen.
English: How to take the Diacomit capsules
Croatian: Kako uzimati Diacomit kapsule
English: Stopping treatment suddenly can lead to an outbreak of seizures.
Croatian: Nagli prekid terapije može dovesti do pojave napadaja.
English: Stiripentol is an inhibitor of the enzymes CYP2C19, CYP3A4 and CYP2D6 and may markedly increase the plasma concentrations of substances metabolised by these enzymes and increase the risk of adverse reactions (see section 4.5).
Croatian: Stiripentol je inhibitor enzima CYP2C19, CYP3A4 i CYP2D6 i može znatno povećati koncentracije u plazmi tvari koje se metaboliziraju ovim enzimima i povećati rizik od nuspojava (vidjeti dio 4.5).