FrancophonIA/ELRC3.0 huggingface dataset:
English: Genotoxicity studies have not detected any mutagenic or clastogenic activity.
Slovenian: V genotoksičnih študijah niso odkrili mutagenih ali klastogenih aktivnosti.
English: However, effective anti-epileptic therapy should not be interrupted during pregnancy, since the aggravation of the illness may be detrimental to both the mother and the foetus.
Slovenian: Vendar učinkovitega zdravljenja proti epilepsiji med nosečnostjo ne smemo prekiniti, saj je lahko poslabšanje bolezni škodljivo tako za nosečnico kot za plod.
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.
Slovenian: Splošna tveganja, ki so povezana z epilepsijo in zdravili proti epilepsiji Dokazano je, da je pogostnost malformacij pri otrocih žensk z epilepsijo dva do trikrat večja od pogostnosti približno 3 % v splošni populaciji.
English: Treatment is supportive (symptomatic measures in intensive care units).
Slovenian: Zdravljenje je podporno (simptomatski ukrepi v enoti intenzivne nege).
English: The following pharmacokinetic properties of stiripentol have been reported from studies in adult healthy volunteers and adult patients.
Slovenian: Spodaj opisane farmakokinetične lastnosti stiripentola so bile ugotovljene v študijah pri zdravih odraslih prostovoljcih in odraslih bolnikih.
English: In the treated population, an increase in malformations has been noted with polytherapy.
Slovenian: V populaciji, ki se zdravi, so povečanje pogostnosti malformacij opazili pri politerapiji.
English: midazolam or triazolam (medicines used to reduce anxiety and sleeplessness - in combination with Diacomit they may make your child very sleepy);
Slovenian: midazolam ali triazolam (zdravila za zmanjšanje občutka tesnobe in zaspanosti - v kombinaciji z zdravilom Diacomit lahko postane vaš otrok zelo zaspan);
English: Tell your child's doctor or pharmacist if your child is using, has recently used or might use any other medicines.
Slovenian: Obvestite otrokovega zdravnika ali farmacevta, če vaš otrok jemlje, je pred kratkim jemal ali bo morda jemal katerokoli drugo zdravilo.
English: A French compassionate use program included children from 6 months of age because the diagnosis of Dravet's syndrome may be made with confidence at that age in some patients.
Slovenian: V francoski program sočutne uporabe so vključili otroke starejše od 6 mesecev, ker lahko diagnozo Dravetovega sindroma pri nekaterih bolnikih z gotovostjo postavimo šele pri tej starosti.
English: Your child should take Diacomit with food, it should NOT be taken on an empty stomach.
Slovenian: Otroka mora vzeti zdravilo Diacomit skupaj s hrano in ga NE SME jemati na prazen želodec.
English: Caution is advised when combining stiripentol with other substances that inhibit or induce one or more of these enzymes.
Slovenian: Svetujemo previdnost pri kombinaciji stiripentola z drugimi snovmi, ki zavirajo ali sprožajo enega ali več teh encimov.
English: Stiripentol is quickly absorbed, with a time to peak plasma concentration of about 1.5 hours.
Slovenian: Stiripentol se hitro absorbira s časom do najvišje koncentracije v plazmi 1,5 ure.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing severity.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: chlorpromazine (used for mental illness such as psychosis).
Slovenian: klorpromazin (za zdravljenje duševnih bolezni, npr. psihoz).
English: Stopping treatment suddenly can lead to an outbreak of seizures.
Slovenian: Nenadna prekinitev zdravljenja lahko povzroči izbruh napadov.
English: This finding is considered to be an adaptive response to a high metabolic burden on the liver.
Slovenian: To odkritje se šteje kot adaptivni proces na veliko presnovno breme jeter.
English: A dose adjustment may be necessary.
Slovenian: Morda bo potrebno prilagoditi odmerek.
English: In a French compassionate use program for stiripentol, topiramate was added to stiripentol, clobazam and valproate in 41% of 230 cases.
Slovenian: V francoskem programu sočutne uporabe stiripentola so kombinaciji stiripentola, klobazama in valproata v 41 % primerov od 230 dodali topiramat.
English: In this case, please see below: “Diacomit contains aspartame, glucose, sorbitol and sodium”.
Slovenian: V tem primeru glejte spodnje besedilo z naslovom: „ Diacomit vsebuje aspartam, glukozo, sorbitol in natrij“.
English: However, some patients may experience dizziness and ataxia that may affect ability to drive and use machines and patients should not drive or use machinery whilst on stiripentol therapy.
Slovenian: Vendar se pri nekaterih bolnikih lahko pojavita omotica in ataksija, ki lahko vplivata na sposobnost vožnje in upravljanja s stroji, zato bolniki, ki se zdravijo s stiripentolom, ne smejo voziti ali upravljati s stroji.
English: (E132).
Slovenian: indigotina (E132).
English: • decrease of platelet level in the blood;
Slovenian: • zmanjšanje števila trombocitov v krvi;
English: - Statins (atorvastatin, simvastatin, etc.)
Slovenian: - Statini (atorvastatin, simvastatin idr.)
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.
Slovenian: Vaš otrok mora vzeti to zdravilo dvakrat ali trikrat dnevno v rednih časovnih presledkih po navodilih zdravnika, na primer zjutraj - opoldne - pred spanjem, da se zajame čas dneva in noči.
English: • The active substance is stiripentol.
Slovenian: • Učinkovina je stiripentol.
English: Potential for stiripentol to interact with other medicinal products
Slovenian: Potencial stiripentola za interakcije z drugimi zdravili
English: Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.
Slovenian: Preden vaš otrok začne jemati to zdravilo natančno preberite navodilo, ker vsebuje pomembne podatke.
English: * Thrombocytopenia data are derived from both clinical trials and post-marketing experience.
Slovenian: * Podatki o trombocitopeniji izhajajo iz kliničnih preskušanj in izkušenj na podlagi trženja.
English: If your child has problems with certain ingredients of Diacomit (e.g. aspartame, glucose, sorbitol).
Slovenian: Če ima vaš otrok težave z določenimi sestavinami zdravila Diacomit (npr. aspartam, glukoza, sorbitol).
English: Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.
Slovenian: Na voljo ni nekliničnih ali kliničnih podatkov, na podlagi katerih bi lahko ocenili uporabo aspartama pri dojenčkih, mlajših od 12 tednov.
English: - antiepileptic medicines containing:
Slovenian: - zdravila proti epilepsiji, ki vsebujejo:
English: Stiripentol dosage escalation should be gradual, starting with 20mg/kg/day for 1 week, then 30mg/kg/day for 1 week.
Slovenian: Odmerjanje stiripentola mora biti potopno, tj. začnite z odmerkom 20 mg/kg/dan 1 teden, nato 30 mg/kg/dan naslednji teden.
English: Patients with rare glucosegalactose malabsorption should not take this medicine, as the formulation contains glucose.
Slovenian: Bolniki z redko malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila, saj vsebuje glukozo.
English: In the absence of available clinical data, caution should be taken with the following clinically relevant interactions with stiripentol:
Slovenian: Ker ni kliničnih podatkov je potrebna previdnost pri naslednjih klinično pomembnih interakcijah s stiripentolom:
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: This includes any possible side effects not listed in this leaflet.
Slovenian: To velja tudi za vse neželene učinke, ki niso omenjeni v tem navodilu.
English: There are slight differences between the Diacomit capsules and powder for oral suspension.
Slovenian: Manjše razlike so opazne med kapsulami Diacomit in praškom za peroralno suspenzijo.
English: Cmax of the sachet was slightly higher (23%) compared with the capsule and did not meet the criteria for bioequivalence.
Slovenian: Cmax praška za peroralno suspenzijo v vrečici je bila nekoliko večja (23 %) v primerjavi s kapsulo in ni izpolnjevala bioekvivalenčnih kriterijev.
English: As a result, pharmacokinetic interactions of metabolic origin with other medicines may be expected.
Slovenian: Posledično lahko pričakujemo farmakokinetične interakcije presnovnega izvora z drugimi zdravili.
English: • ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia
Slovenian: • ataksija (nezmožnost usklajenega gibanja mišic), hipotonija (zmanjšana moč mišičja), distonija
English: - If your child takes medicines containing: caffeine (this substance helps restore mental alertness) or theophylline (this substance is used in case of asthma).
Slovenian: - Če vaš otrok jemlje zdravila, ki vsebujejo: kofein (te snovi pripomorejo k vzpostavitvi mentalne budnosti) ali teofilin (te snovi se uporabljajo v primeru astme).
English: 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.
Slovenian: Te interakcije lahko povzročijo zvišane sistemske koncentracije teh zdravilnih učinkovin, kar lahko privede do povečanja farmakoloških učinkov ter pogostnosti neželenih učinkov in reakcij.
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.
Slovenian: 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.
English: Your child's doctor has prescribed this medicine to help treat your child's epilepsy.
Slovenian: Otrokov zdravnik je predpisal to zdravilo za epilepsijo pri vašem otroku.
English: 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.
Slovenian: Da bi ti neželeni učinki izginili, bo otrokov zdravnik morda spremenil odmerke zdravila Diacomit ali enega od drugih zdravil, ki so bila predpisana otroku.
English: The influence of other antiepileptic medicinal products on stiripentol pharmacokinetics is not well established.
Slovenian: Vpliv drugih zdravil proti epilepsiji na farmakokinetiko stiripentola ni dobro raziskan.
English: 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.
Slovenian: 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.
English: • Your child should not take Diacomit after the expiry date, which is stated on the label.
Slovenian: • Vaš otrok zdravila Diacomit ne sme uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: There are no clinical study data to support the clinical safety of stiripentol administered at daily doses greater than 50 mg/kg/day.
Slovenian: Podatkov iz kliničnih študij, ki bi podprli klinično varnost stiripentola v dnevnih odmerkih več kot 50 mg/kg/dan, ni.
English: What Diacomit is and what it is used for What you need to know before your child takes Diacomit How to take Diacomit
Slovenian: Kaj je zdravilo Diacomit in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok vzel zdravilo Diacomit Kako jemati zdravilo Diacomit
English: 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).
Slovenian: 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).
English: In case stiripentol therapy is continued during breast-feeding, the breast-fed infant should be carefully observed for potential adverse effects.
Slovenian: V primeru nadaljevanja zdravljenja s stiripentolom med dojenjem je treba dojenčka natančno spremljati za možne neželene učinke.
English: It is well absorbed by the oral route since the majority of an oral dose is excreted in urine.
Slovenian: Peroralno se dobro absorbira, ker se večina peroralnega odmerka izloči z urinom.
English: Driving and using machines This medicine may make your child feel sleepy.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zaradi tega zdravila lahko postane vaš otrok zaspan.
English: • aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable);
Slovenian: • agresivnost, razdražljivost, vznemirjenost, hiperekscitabilnost (stanje prekomerne vzdražljivosti);
English: The two formulations were bioequivalent in terms of AUC but not in terms of Cmax.
Slovenian: Obe farmacevtski obliki sta bili bioekvivalentni v smislu AUC, vendar ne tudi v smislu največje plazemske koncentracije Cmax.
English: 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.
Slovenian: 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.
English: - Valproate
Slovenian: - Valproat
English: In such a case, it is assumed that a significant fraction of the administered dose has been absorbed systemically from the digestive tract.
Slovenian: V tem primeru se šteje, da se je večji delež danega odmerka že absorbiral v sistem iz prebavnega trakta.
English: Stiripentol binds extensively to circulating plasma proteins (about 99%).
Slovenian: Stiripentol se veliki meri veže na krožeče plazemske beljakovine (približno 99 %).
English: Your child should not use any tools, machines, ride or drive if affected in this way.
Slovenian: Vaš otrok v takšnem stanju ne sme upravljati orodij, strojev ali voziti.
English: Monitoring of plasma concentrations or adverse reactions is recommended.
Slovenian: Priporočljivo je spremljanje plazemskih koncentracij ali neželenih učinkov.
English: Paediatric population The dose of stiripentol is calculated on a mg/kg body weight basis.
Slovenian: Odmerek stiripentola se izračuna na osnovi mg/kg telesne mase.
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.
Slovenian: Zvišanje koncentracij v stanju dinamičnega ravnovesja pri kombiniranju stiripentola, valproata in klobazama je podobno pri odraslih in otrocih, čeprav je variabilnost med preiskovanci velika.
English: What Diacomit is and what it is used for
Slovenian: Kaj je zdravilo diacomit in za kaj ga uporabljamo
English: - Chlorpromazine Stiripentol enhances the central depressant effect of chlorpromazine.
Slovenian: - Klorpromazin Stiripentol poveča učinek klorpromazina na osrednje živčevje.
English: Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX17
Slovenian: Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki, oznaka ATC: N03AX17
English: 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.
Slovenian: Dajanje zdravila Diacomit mora potekati pod nadzorom pediatra/pediatričnega nevrologa, ki ima izkušnje z diagnostiko in obravnavo epilepsije pri dojenčkih in otrocih.
English: In animal models, stiripentol antagonizes seizures induced by electric shock, pentetrazole and bicuculline.
Slovenian: V živalskih modelih je stiripentol antagonist napadov, ki jih sprožijo udar električnega toka, pentetrazol in bikukulin.
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.
Slovenian: 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.
English: • insomnia (sleeplessness), drowsiness;
Slovenian: • insomnija (nespečnost), zaspanost;
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.
Slovenian: 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.
English: Tell your doctor if your child is taking any of the following medicines:
Slovenian: Obvestite zdravnika, če vaš otrok jemlje katero naslednjih zdravil:
English: 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.
Slovenian: 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.
English: Risk related to stiripentol
Slovenian: Tveganja, ki so povezana s stiripentolom
English: 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.
Slovenian: 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.
English: Effect of stiripentol on cytochrome P450 enzymes
Slovenian: Vpliv stiripentola na encime citokroma P450
English: In view of the indication, administration of stiripentol during pregnancy and in women of childbearing potential would not be expected.
Slovenian: Upoštevaje indikacije se ne pričakuje uporaba stiripentola med nosečnostjo ali pri ženskah v rodni dobi.
English: 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).
Slovenian: 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).
English: Percentage of change from baseline was higher on stiripentol (-69%) than on placebo (+7%), p<0.0001.
Slovenian: Odstotek razlike od izhodiščnega obdobja je bila višja pri stiripentolu (-69 %) kot pri placebu (+7 %), p<0,0001.
English: - Topiramate
Slovenian: - Topiramat
English: 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.
Slovenian: Odmerek je treba večati postopno v obdobju več tednov, med tem je treba sočasno zmanjšati odmerke drugih protiepileptičnih zdravil.
English: For food and drinks to be avoided, see the section “Diacomit with food and drink” above.
Slovenian: Seznam živil in pijač, ki se jim je treba izogniti, je naveden v poglavju „Jemanje zdravila Diacomit skupaj s hrano in pijačo“.
English: 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.
Slovenian: 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.
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.
Slovenian: Odmerek določi zdravnik, in sicer ustrezno starosti, telesni masi in stanju otroka; na splošno 50 mg na kg telesne mase in na dan.
English: There are no clinical study data to support the use of stiripentol as monotherapy in Dravet's syndrome.
Slovenian: Ni podatkov iz kliničnih študij, ki bi podprli uporabo stiripentola kot monoterapijo pri Dravetovem sindromu.
English: 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.
Slovenian: Če se pri vašem otroku pojavijo težave po zamenjavi kapsul s praškom za peroralno suspenzijo ali obratno, takoj o tem obvestite zdravnika.
English: Abnormal laboratory findings
Slovenian: Neobičajni rezultati laboratorijskih preiskav
English: The consequences are increased plasma levels of these anticonvulsants with potential risk of overdose.
Slovenian: Posledice so zvišanje plazemskih koncentracij teh antikonvulzivov z možnim tveganjem prevelikega odmerjanja.
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.
Slovenian: 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.
English: As the flavouring component contains small amount of sorbitol, patients with hereditary problems of fructose intolerance should not take this medicine.
Slovenian: Ker zdravilo kot aromo vsebuje majhno količino sorbitola, ga bolniki z redko dedno intoleranco za fruktozo ne smejo jemati.
English: During pregnancy, effective antiepileptic treatment must NOT be stopped.
Slovenian: Med nosečnostjo učinkovitega zdravljenja proti epilepsiji ne smete prekiniti.