natgillin/translations-raw huggingface dataset:
• ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia
• ataksija (nezmožnost usklajenega gibanja mišic), hipotonija (zmanjšana moč mišičja), distonija
- If your child takes medicines containing: caffeine (this substance helps restore mental alertness) or theophylline (this substance is used in case of asthma).
- Če vaš otrok jemlje zdravila, ki vsebujejo: kofein (te snovi pripomorejo k vzpostavitvi mentalne budnosti) ali teofilin (te snovi se uporabljajo v primeru astme).
These interactions may result in increased systemic levels of these active substances that may lead to enhanced pharmacological effects and to an increase in adverse reactions.
Te interakcije lahko povzročijo zvišane sistemske koncentracije teh zdravilnih učinkovin, kar lahko privede do povečanja farmakoloških učinkov ter pogostnosti neželenih učinkov in reakcij.
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.
Povprečna starost otrok je bila 7,3 leta (razpon: 1 do 17,6 let) povprečni dnevni odmerek stiripentola pa 45,4 mg/kg/dan (razpon: 27,1 do 89,3 mg/kg/dan), prejet v dveh ali treh razdeljenih odmerkih.
Your child's doctor has prescribed this medicine to help treat your child's epilepsy.
Otrokov zdravnik je predpisal to zdravilo za epilepsijo pri vašem otroku.
To eliminate these side effects, your child's doctor may have to change the dose of Diacomit or one of the other medicines prescribed for your child.
Da bi ti neželeni učinki izginili, bo otrokov zdravnik morda spremenil odmerke zdravila Diacomit ali enega od drugih zdravil, ki so bila predpisana otroku.
The influence of other antiepileptic medicinal products on stiripentol pharmacokinetics is not well established.
Vpliv drugih zdravil proti epilepsiji na farmakokinetiko stiripentola ni dobro raziskan.
If your child is pregnant or breast-feeding, think she may be pregnant or is planning to have a baby, ask your doctor for advice before taking this medicine.
Če je vaša hčerka noseča ali doji oz. če menite, da bi lahko bila noseča, ali če načrtuje zanositev, se posvetujte z zdravnikom pred jemanjem tega zdravila.
• Your child should not take Diacomit after the expiry date, which is stated on the label.
• Vaš otrok zdravila Diacomit ne sme uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
There are no clinical study data to support the clinical safety of stiripentol administered at daily doses greater than 50 mg/kg/day.
Podatkov iz kliničnih študij, ki bi podprli klinično varnost stiripentola v dnevnih odmerkih več kot 50 mg/kg/dan, ni.
What Diacomit is and what it is used for What you need to know before your child takes Diacomit How to take Diacomit
Kaj je zdravilo Diacomit in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok vzel zdravilo Diacomit Kako jemati zdravilo Diacomit
21 patients on stiripentol had moderate side-effects (drowsiness, loss of appetite) compared with eight on placebo, but side-effects disappeared when the dose of comedication was decreased in 12 of the 21 cases (Chiron et al, Lancet, 2000).
Enaindvajset bolnikov, ki so jemali stiripentol, je imelo zmerne neželene učinke (zaspanost, izguba apetita) v primerjavi z osmimi bolniki, ki so jemali placebo, vendar so neželeni učinki izzveneli, ko so odmerke sočasno uporabljenih zdravil zmanjšali pri 12 od 21 bolnikov (Chiron et al, Lancet, 2000).
In case stiripentol therapy is continued during breast-feeding, the breast-fed infant should be carefully observed for potential adverse effects.
V primeru nadaljevanja zdravljenja s stiripentolom med dojenjem je treba dojenčka natančno spremljati za možne neželene učinke.
It is well absorbed by the oral route since the majority of an oral dose is excreted in urine.
Peroralno se dobro absorbira, ker se večina peroralnega odmerka izloči z urinom.
Driving and using machines This medicine may make your child feel sleepy.
Vpliv na sposobnost upravljanja vozil in strojev Zaradi tega zdravila lahko postane vaš otrok zaspan.
• aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable);
• agresivnost, razdražljivost, vznemirjenost, hiperekscitabilnost (stanje prekomerne vzdražljivosti);
The two formulations were bioequivalent in terms of AUC but not in terms of Cmax.
Obe farmacevtski obliki sta bili bioekvivalentni v smislu AUC, vendar ne tudi v smislu največje plazemske koncentracije Cmax.
Many of the above adverse reactions are often due to an increase in plasma levels of other anticonvulsant medicinal products (see sections 4.4 and 4.5) and may regress when the dose of these medicinal products is reduced.
Veliko zgoraj navedenih neželenih učinkov je posledica zvišanih plazemskih koncentracij drugih antikonvulzivnih zdravil (glejte poglavji 4.4 in 4.5), ki lahko izzvenijo po znižanju odmerka teh zdravil.
In such a case, it is assumed that a significant fraction of the administered dose has been absorbed systemically from the digestive tract.
V tem primeru se šteje, da se je večji delež danega odmerka že absorbiral v sistem iz prebavnega trakta.
Stiripentol binds extensively to circulating plasma proteins (about 99%).
Stiripentol se veliki meri veže na krožeče plazemske beljakovine (približno 99 %).
Your child should not use any tools, machines, ride or drive if affected in this way.
Vaš otrok v takšnem stanju ne sme upravljati orodij, strojev ali voziti.
Monitoring of plasma concentrations or adverse reactions is recommended.
Priporočljivo je spremljanje plazemskih koncentracij ali neželenih učinkov.
Paediatric population The dose of stiripentol is calculated on a mg/kg body weight basis.
Odmerek stiripentola se izračuna na osnovi mg/kg telesne mase.
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.
Zvišanje koncentracij v stanju dinamičnega ravnovesja pri kombiniranju stiripentola, valproata in klobazama je podobno pri odraslih in otrocih, čeprav je variabilnost med preiskovanci velika.
What Diacomit is and what it is used for
Kaj je zdravilo diacomit in za kaj ga uporabljamo
- Chlorpromazine Stiripentol enhances the central depressant effect of chlorpromazine.
- Klorpromazin Stiripentol poveča učinek klorpromazina na osrednje živčevje.
Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX17
Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki, oznaka ATC: N03AX17
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.
Dajanje zdravila Diacomit mora potekati pod nadzorom pediatra/pediatričnega nevrologa, ki ima izkušnje z diagnostiko in obravnavo epilepsije pri dojenčkih in otrocih.
In animal models, stiripentol antagonizes seizures induced by electric shock, pentetrazole and bicuculline.
V živalskih modelih je stiripentol antagonist napadov, ki jih sprožijo udar električnega toka, pentetrazol in bikukulin.
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.
Večanje odmerka v nadaljevanju je odvisno od starosti bolnika: - otroci, mlajši od 6 let, tretji teden prejmejo dodatnih 20 mg/kg/dan, tako da začnejo prejemati priporočen odmerek 50 mg/kg/dan v treh tednih; - otroci, stari 6 do 12 let, vsak teden prejmejo dodatnih 10 mg/kg/dan, tako da začnejo prejemati priporočen odmerek 50 mg/kg/dan v štirih tednih; - otroci in mladostniki, stari 12 let in več, vsak teden prejmejo dodatnih 5 mg/kg/dan, dokler ne dosežejo odmerka, najprimernejšega po klinični presoji.
• insomnia (sleeplessness), drowsiness;
• insomnija (nespečnost), zaspanost;
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.
Dokazano je tudi, da stiripentol pospeši prenos, ki ga posredujejo GABAA receptorji v nezrelem hipokampusu podgan, in poveča povprečno trajanje odprtosti (vendar ne frekvence) kloridnih kanalčkov GABAA receptorjev z mehanizmom, ki je podoben kot pri barbituratih.
Tell your doctor if your child is taking any of the following medicines:
Obvestite zdravnika, če vaš otrok jemlje katero naslednjih zdravil:
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 na odsotnost genotoksičnosti stiripentola in dobro poznane, posebne občutljivosti jeter miši za nastanek tumorjev pri indukciji jetrnih encimov se ta rezultat ne predstavlja povečanega tveganja za pojav tumorjev pri bolnikih.
Risk related to stiripentol
Tveganja, ki so povezana s stiripentolom
In the event of clinical signs of adverse reactions or overdose of clobazam (i.e., drowsiness, hypotonia, and irritability in young children), this daily dose was reduced by 25% every week.
V primeru kliničnih znakov neželenih učinkov ali prekomernega odmerjanja klobazama (tj. zaspanost, hipotonija in razdražljivost pri majhnih otrocih) so dnevni odmerek zmanjšali za 25 % tedensko.
Effect of stiripentol on cytochrome P450 enzymes
Vpliv stiripentola na encime citokroma P450
In view of the indication, administration of stiripentol during pregnancy and in women of childbearing potential would not be expected.
Upoštevaje indikacije se ne pričakuje uporaba stiripentola med nosečnostjo ali pri ženskah v rodni dobi.
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).
Odziv so zabeležili pri 15 (71 %) bolnikih, ki so jemali stiripentol (vključno z 9 bolniki brez kloničnih ali tonično-kloničnih napadov), in pri enem bolniku (5 %), ki je jemal placebo (noben bolnik brez napadov; 95 % IZ: stiripentol 52,1-90,7 v primerjavi s placebom 0-14,6).
Percentage of change from baseline was higher on stiripentol (-69%) than on placebo (+7%), p<0.0001.
Odstotek razlike od izhodiščnega obdobja je bila višja pri stiripentolu (-69 %) kot pri placebu (+7 %), p<0,0001.
Dose increases should be gradual, taking place over a few weeks while the dose(s) of the other antiepileptic medicine(s) is (are) reduced at the same time.
Odmerek je treba večati postopno v obdobju več tednov, med tem je treba sočasno zmanjšati odmerke drugih protiepileptičnih zdravil.
For food and drinks to be avoided, see the section “Diacomit with food and drink” above.
Seznam živil in pijač, ki se jim je treba izogniti, je naveden v poglavju „Jemanje zdravila Diacomit skupaj s hrano in pijačo“.
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.
Presnovki stiripentola v urinu so skupaj predstavljali večino (73 %) peroralnega akutnega odmerka, v blatu pa so odkrili še dodatnih 13-24 % odmerka v nespremenjeni obliki.
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.
Odmerek določi zdravnik, in sicer ustrezno starosti, telesni masi in stanju otroka; na splošno 50 mg na kg telesne mase in na dan.
There are no clinical study data to support the use of stiripentol as monotherapy in Dravet's syndrome.
Ni podatkov iz kliničnih študij, ki bi podprli uporabo stiripentola kot monoterapijo pri Dravetovem sindromu.
If your child experiences any problems when switching from taking the capsules to the powder for oral suspension or vice versa please inform your doctor.
Če se pri vašem otroku pojavijo težave po zamenjavi kapsul s praškom za peroralno suspenzijo ali obratno, takoj o tem obvestite zdravnika.
Abnormal laboratory findings
Neobičajni rezultati laboratorijskih preiskav
The consequences are increased plasma levels of these anticonvulsants with potential risk of overdose.
Posledice so zvišanje plazemskih koncentracij teh antikonvulzivov z možnim tveganjem prevelikega odmerjanja.
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.
Če je vaš otrok vzel večji odmerek zdravila Diacomit, kot bi smel Obvestite otrokovega zdravnika, če veste ali menite, da je otrok vzel večji odmerek zdravila, kot bi smel.
As the flavouring component contains small amount of sorbitol, patients with hereditary problems of fructose intolerance should not take this medicine.
Ker zdravilo kot aromo vsebuje majhno količino sorbitola, ga bolniki z redko dedno intoleranco za fruktozo ne smejo jemati.
During pregnancy, effective antiepileptic treatment must NOT be stopped.
Med nosečnostjo učinkovitega zdravljenja proti epilepsiji ne smete prekiniti.
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).
Očistek in volumen porazdelitve sta bila povezana s telesno maso z alometričnim modelom z eksponentoma 0,433 oziroma 1: ko se je telesna masa večala od 10 do 60 kg, se je navidezni peroralni očistek povečal z 2,60 na 5,65 l/uro, navidezni volumen porazdelitve pa se je povečal z 32,0 na 191,8 l. Zato se je razpolovna doba izločanja povečala z 8,5 ur (za 10 kg) na 23,5 ur (za 60 kg).
If your child forgets to take Diacomit
Če vaš otrok pozabi vzeti zdravilo Diacomit
Co-administration with CYP3A4 substrates with a narrow therapeutic index should be avoided due to the markedly increased risk of severe adverse reactions.
Sočasnemu dajanju substratov CYP3A4 z ozkim terapevtskim indeksom se je treba izogibati zaradi zelo povečanega tveganja za hude neželene učinke.
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.
Možnost presnovne interakcije med stiripentolom in valproatom se šteje za majhno, zato sprememba odmerjanja valproata po dodatku stiripentola ni potrebna razen zaradi klinične varnosti.
Dose adjustments of other antiepileptics used in combination with stiripentol
Prilagoditev odmerkov drugih zdravil proti epilepsiji, ki se uporabljajo sočasno s stiripentolom
• if your child has kidney or liver problems.
• če ima vaš otrok težave z ledvicami ali jetri,
It is recommended that if a switch of formulations is required this is done under clinical supervision, in case of problems with tolerability (see section 5.2).
Če je treba farmacevtski obliki zamenjati, je priporočeno, da se to stori pod zdravniškim nadzorom zaradi morebitnih težav s toleranco (glejte poglavje 5.2).
The capsules should not be chewed.
Kapsul ne sme žvečiti.
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.
V ključnih študijah je bil ob uvedbi stiripentola dnevni odmerek klobazama 0,5 mg/kg/dan, običajno razdeljen v odmerka dvakrat dnevno.
- Cisapride, halofantrine, pimozide, quinidine, bepridil Increased risk of cardiac arrhythmias and torsades de pointes/wave burst arrhythmia in particular.
- Cisaprid, halofantrin, pimozid, kinidin, bepridil Povečano tveganje srčnih aritmij in zlasti pojava torsades de pointes/aritmije s porušitvijo valov.
Paediatric population pharmacokinetic study
Farmakokinetična študija na pediatrični populaciji
Clinical monitoring of plasma levels of other anticonvulsants when combined with stiripentol with possible dose adjustments is recommended.
Priporočeno je klinično spremljanje plazemskih ravni drugih antikonvulzivov, če se dajejo sočasno s stiripentolom, z možnostjo prilagoditve odmerkov.
The main metabolic processes are demethylenation and glucuronidation, although precise identification of the enzymes involved has not yet been achieved.
Glavni presnovni proces je demetilacija in glukuronidacija, vendar encimov, ki sodelujejo pri presnovi, še niso natančno določili.
Your child should not take a double dose to make up for a forgotten individual dose.
Vaš otrok ne sme vzeti dvojnega odmerka, če je pozabil vzeti prejšnji odmerek.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se posvetujte z njim, preden vzamete to zdravilo.
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).
V tej skupini mlajših bolnikov se lahko dodatno zdravljenje s stiripentolom začne šele, ko je diagnoza SMEI klinično potrjena (glejte poglavje 5.1).
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.
V ključnih študijah so ob pojavu gastrointestinalnih neželenih učinkov, kot na primer izguba apetita, izguba telesne mase, dnevni odmerek valproata znižali za približno 30 % tedensko.
PHARMACEUTICAL FORM Powder for oral suspension Pale pink crystalline powder
Prašek za peroralno suspenzijo Bledo rožnat kristaličen prašek
The sachet formulation has a slightly higher Cmax than the capsules and thus the formulations are not bioequivalent.
Prašek za peroralno suspenzijo v vrečici ima nekoliko višji Cmax kot kapsule, zato farmacevtski obliki nista bioekvivalentni.
Unless otherwise clinically indicated, liver function should be checked every 6 months.
Če ni drugih kliničnih indikacij, je treba jetrno funkcijo preveriti vsakih 6 mesecev.
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 biološka uporabnost kapsul v primerjavi s praškom za peroralno suspenzijo v vrečici je bila predmet študije pri zdravih prostovoljcih moškega spola, ki so prejeli enkraten peroralni odmerek 1000 mg.
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.
Kot odziv so šteli najmanj 50 % znižanje pogostnosti kloničnih (ali tonično-kloničnih) napadov v drugem mesecu dvojno slepega dela raziskave v primerjavi z izhodiščnim obdobjem.
Stiripentol is extensively metabolized, 13 different metabolites having been found in urine.
Stiripentol se obsežno presnavlja; v urinu so odkrili 13 različnih presnovkov.
Carbamazepine, phenytoin and phenobarbital
Karbamazepin, fenitoin in fenobarbital
Your child must NOT take Diacomit
Vaš otrok NE sme jemati zdravila Diacomit
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.
Populacijska farmakokinetična študija je bila opravljena pri 35 otrocih z Dravetovim sindromom, ki se zdravijo s stiripentolom ter valproatom in klobazamom, pri katerih pa vpliv na farmakokinetiko stiripentola ni znan.
Treatment should be continued for as long as efficacy is observed.
Z zdravljenjem nadaljujte, dokler opažate učinke.
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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.
Po izhodiščnem obdobju 1 meseca so kombinaciji valproata in klobazama v dvojno slepem obdobju 2 mesecev dodali placebo (n=20) ali stiriopentol (n=21).
In the mouse there was only a small increase in the incidence of hepatic adenomas and carcinomas in animals treated with 200 or 600 mg/kg/day for 78 weeks but not in those given 60 mg/kg/day.
Pri miših je prišlo do majhnega zvečanja pojavnosti jetrnih adenomov in karcinomov, če so živali prejemale 200 ali 600 mg/kg/dan 78 tednov.
• loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium valproate);
• izguba apetita, hujšanje (zlasti pri kombiniranju z natrijevim valproatom - zdravilom proti epilepsiji);
5 How to store Diacomit Contents of the pack and other information
5 Shranjevanje zdravila Diacomit Vsebina pakiranja in dodatne informacije
Liver function
Jetrna funkcija
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na kapsulo, kar v bistvu pomeni »brez natrija«.
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.
Kako jemati prašek za peroralno suspenzijo Diacomit Prašek zmešajte v kozarcu vode in vsebino popijte takoj po pripravi, med obrokom.
Unless otherwise clinically indicated, blood counts should be checked every 6 months.
Če ni drugih kliničnih indikacij, je treba krvno sliko preveriti vsakih 6 mesecev.
The recommended dose of 50 mg/kg/day is based on the available clinical study findings and was the only dose of Diacomit evaluated in the pivotal studies (see section 5.1).
Priporočen odmerek 50 mg/kg/dan temelji na rezultatih in ugotovitvah klinične študije in je edini odmerek Diacomita, ki so ga ovrednotili v študijah, ki podpirajo vlogo za pridobitev dovoljenja za promet (glej poglavje 5.1).
This could occur by inhibition of synaptosomal uptake of GABA and/or inhibition of GABA transaminase.
To je lahko posledica zaviranja privzema GABA v sinapsah ali zaviranja GABA-transaminaze ali obojega.
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.
Predvideva se, da se pri topiramatu ne pojavlja potencialno tekmovanje za zaviranje CYP2C19, ker so za to verjetno potrebne 5-15-krat višje plazemske koncentracije od koncentracij, ki so v plazmi pri standardnem priporočenem odmerku topiramata ter načrtu odmerjanja.
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The combination with Diacomit should be avoided as it may increase their blood levels, leading to digestive disorders, racing heart and insomnia.
Kombiniranju teh snovi z zdravilom Diacomit se je treba izogibati, saj lahko pride do zvišanja njunih koncentracij v krvi, kar povzroči prebavne težave, hitro bitje srca in nespečnost.