natgillin/translations-raw huggingface dataset:
Treatment usually starts with a low dose, which is gradually increased to the recommended dose over three days.
Zdravljenje se navadno začne z majhnim odmerkom, ki se v treh dneh postopoma poveča na priporočeni odmerek.
After starting Diacomit, the dose of clobazam may need to be reduced.
Po uvedbi zdravila Diacomit bo morda potrebno zmanjšati odmerek klobazama.
The dose of valproate does not normally need to be adjusted.
Odmerka valproata navadno ni treba prilagajati.
Decisions regarding the use of Diacomit in younger children should be made on a patient-by-patient basis: it can only be given to younger children if the diagnosis of SMEI has been confirmed.
Odločitev o uporabi zdravila Diacomit pri mlajših otrocih je treba sprejeti za vsak posamezni primer posebej: mlajšim otrokom se lahko daje le, če je bila diagnoza hude mioklonične epilepsije v otroštvu potrjena.
Diacomit should be given at the same time as food, but not with dairy products, carbonated drinks, fruit juice, or food or drinks that contain caffeine or theophylline (a substance found in black and green tea, among other products).
Zdravilo Diacomit je treba jemati sočasno s hrano, toda ne z mlečnimi izdelki, gaziranimi pijačami, sadnim sokom ali živili in pijačami, ki vsebujejo kofein ali teofilin (snov, ki jo najdemo na primer v črnem in zelenem čaju).
Reproduction is authorised provided the source is acknowledged. ‘ neurotransmitter ’ called gamma-aminobutyric acid (GABA) in the gaps between nerve cells in the brain.
Kako zdravilo Diacomit deluje?
Neurotransmitters are substances in the body that relay signals from a nerve cell to another cell.
Natančen način, na katerega stiripentol, zdravilna učinkovina zdravila Diacomit, deluje kot antiepileptik, ni popolnoma znan.
The effects of Diacomit were first tested in experimental models before being studied in humans.
Učinki zdravila Diacomit so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The two main studies of Diacomit involved 65 children between three and 18 years of age.
Dve glavni študiji zdravila Diacomit sta vključevali 65 otrok, starih med tri in 18 let.
The studies compared the effectiveness of Diacomit capsules or sachets and placebo (a dummy treatment), when they were added to the children ’ s existing treatment with clobazam and valproate.
V študijah so primerjali učinkovitost kapsul in vrečk zdravila Diacomit in placeba (zdravila brez zdravilne učinkovine), ki so ju dodajali obstoječemu zdravljenju otrok s klobazamom in valproatom.
The main measure of effectiveness was the number of patients who ‘ responded ’ to treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, ki so se „ odzvali “ na zdravljenje.
A patient was classified as a ‘ responder ’ if the number of seizures in the second month of treatment was at least 50% lower than the number in the month before treatment was started.
Bolnik je bil razvrščen kot „ odziven “, če se je število epileptičnih napadov v drugem mesecu zdravljenja z zdravilom Diacomit zmanjšalo vsaj za 50% v primerjavi z mesecem pred uvedbo zdravila Diacomit.
In the first study, 71% of the patients taking Diacomit responded to treatment (15 out of 21), compared with 5% of the placebo group (1 out of 20).
V prvi študiji se je na zdravljenje odzvalo 71% bolnikov, ki so prejemali zdravilo Diacomit (15 bolnikov od 21), v primerjavi s 5% bolnikov v skupini, ki je prejemala placebo (1 bolnik od 9).
Similar results were seen in the second study, with 67% responding to Diacomit (8 out of 12) and 9% to placebo (1 out of 9).
Vendar ni jasno, ali se je ta učinek pojavil zaradi samega zdravila Diacomit ali zvišanih ravni drugih antiepileptikov.
The most common side effects with Diacomit (seen in more than 1 in 10 patients) are anorexia (loss of appetite), weight loss, insomnia (difficulty sleeping), drowsiness, ataxia (inability to co-ordinate muscle movements), hypotonia (low muscle strength) and dystonia (muscle disorders).
Najpogostejši neželeni učinki zdravila Diacomit (opaženi pri več kot 1 bolniku od 10) so anoreksija (izguba teka), izguba telesne mase, nespečnost, zaspanost, ataksija (nezmožnost usklajenega gibanja mišic), hipotonija (zmanjšana moč mišičja) in distonija (bolezen mišičja).
For the full list of all side effects reported with Diacomit, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Diacomit, glejte navodilo za uporabo.
Diacomit should not be used in people who may be hypersensitive (allergic) to stiripentol or to any of the other ingredients.
Zdravila Diacomit ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) stiripentol ali katero koli drugo sestavino zdravila.
It must not be used in patients who have had psychoses (a serious mental state with a distorted sense of reality) with attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations).
Prav tako se ne sme uporabljati pri bolnikih z anamnezo psihoz (hudih duševnih stanj z motenim smislom za stvarnost) z napadi delirija (duševnim stanjem zmedenosti, razburjenosti, nemirnosti in halucinacij).
The Committee for Medicinal Products for Human Use (CHMP) concluded that Diacomit had shown its effectiveness in SMEI, albeit in studies that were limited and did not last as long as the Committee expected.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je zdravilo Diacomit pokazalo učinkovitost proti hudi mioklonični epilepsiji v otroštvu, četudi samo v študijah, ki so bile omejene in niso trajale tako dolgo, kot je Odbor pričakoval.
It decided that Diacomit’ s benefits are greater than its risks for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patients with SMEI (or Dravet’ s syndrome) whose seizures are not adequately controlled with clobazam and valproate.
Odločil je, da so koristi zdravila Diacomit večje od z njim povezanih tveganj pri njegovi uporabi v kombinaciji s klobazamom in valproatom kot dodatno zdravljenje neodzivnih generaliziranih tonično- kloničnih napadov pri bolnikih s hudo mioklonično epilepsijo v otroštvu (SMEI ali Dravetov sindrom), pri katerih epileptičnih napadov ne moremo zadostno nadzorovati s klobazamom in valproatom.
The Committee recommended that Diacomit be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Diacomit odobri dovoljenje za promet.
Diacomit has been given ‘ Conditional Approval’.
Za zdravilo Diacomit je bila sprejeta „ pogojna odobritev “.
This means that there is more evidence to come about the medicine.
To pomeni, da pričakujemo še več dokazov o zdravilu.
What information is still awaited for Diacomit?
Katere informacije o zdravilu Diacomit še pričakujemo?
The company that makes Diacomit will carry out a study comparing Diacomit and clobazam, as an add-on to existing treatment in children whose symptoms are not adequately controlled with clobazam and valproate.
Družba, ki izdeluje zdravilo Diacomit, bo izvedla študijo, v katerih bo primerjala zdravilo Diacomit s klobazamom kot dodatno zdravljenje otrok, katerih simptomi niso zadostno nadzorovani s klobazamom in valproatom.
Which measures are being taken to ensure the safe use of Diacomit?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Diacomit?
The company that makes Diacomit will monitor the effects of the medicine on problems with the stomach and gut and on growth rate, particularly when combined with valproate.
Družba, ki izdeluje zdravilo Diacomit, bo spremljala učinke tega zdravila glede težav, ki prizadenejo želodec in črevesje, in stopnje rasti, predvsem v kombinaciji z valproatom.
It will also monitor the effects of combining Diacomit with other medicines on the risk of long-term problems affecting the brain and nervous system.
Prav tako bo spremljala učinke kombinacije zdravila Diacomit z drugimi zdravili na tveganje za pojav dolgotrajnih težav, ki prizadenejo možgane in živčevje.
Other information about Diacomit:
2/ 3 Druge informacije o zdravilu Diacomit:
The European Commission granted a marketing authorisation valid throughout the European Union for Diacomit to Biocodex on 4 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Diacomit, veljavno po vsej Evropski uniji, odobrila družbi Biocodex dne 4. januarja 2007.
2/ 3 The summary of opinion of the Committee for Orphan Medicinal Products for Diacomit is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Diacomit je na voljo tukaj.
The full EPAR for Diacomit can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Diacomit je na voljo tukaj.
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Powder for oral suspension Powder for oral suspension Powder for oral suspension Powder for oral suspension Powder for oral suspension Powder for oral suspension
Kapsule, trde Kapsule, trde Kapsule, trde Kapsule, trde Kapsule, trde Kapsule, trde Prašek za peroralno
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
Bottle (PP) Bottle (PP) Bottle (PP) Bottle (PP) Bottle (PP) Bottle (PP) Sachet (paper/ Al/ PE) Sachet (paper/ Al/ PE) Sachet (paper/ Al/ PE) Sachet (paper/ Al/ PE) Sachet (paper/ Al/ PE) Sachet (paper/ Al/ PE)
Plastenka (PP) Plastenka (PP) Plastenka (PP) Plastenka (PP) Plastenka (PP) Plastenka (PP)
30 capsules 60 capsules 90 capsules 30 capsules 60 capsules 90 capsules 30 sachets 60 sachets 90 sachets 30 sachets 60 sachets 90 sachets
30 kapsul 60 kapsul 90 kapsul 30 kapsul 60 kapsul 90 kapsul
Each capsule contains 250 mg of stiripentol
Ena kapsula vsebuje 250 mg stiripentola.
0.16 mg sodium per capsule.
0, 16 mg natrija v vsaki kapsuli.
Hard capsules
Trde kapsule
Size 2 pink capsule
Rožnate kapsule velikosti 2
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.
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.
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.
The dose of Diacomit is calculated on a mg/ kg body weight basis.
Odmerek zdravila Diacomit se izračuna na osnovi mg/ kg telesne mase.
The initiation of adjunctive therapy with Diacomit should be undertaken over 3 days using upwards dose escalation to reach the recommended dose of 50 mg/ kg/ day administered in conjunction with clobazam and valproate.
Uvedba dodatnega zdravljenja z zdravilom Diacomit se opravi v 3 dneh, z zviševanjem odmerka do priporočenega odmerka 50 mg/ kg/ dan, ki se daje sočasno s klobazamom in valproatom.
This recommended dose is based on the available clinical study findings and was the only dose of Diacomit evaluated in the pivotal studies.
Priporočeni odmerek temelji na razpoložljivih izsledkih kliničnih študij in je edini preučevan odmerek zdravila Diacomit v ključnih študijah tega zdravila.
(See, section 5.1)
(glejte poglavje 5. 1)
There are no clinical study data to support the clinical safety of Diacomit administered at daily doses greater than 50mg/ kg/ day.
Podatkov iz kliničnih študij, ki bi podprli klinično varnost zdravila Diacomit v dnevnih odmerkih več kot 50 mg/ kg/ dan, ni.
There are no clinical study data to support the use of Diacomit as monotherapy in Dravet’ s syndrome.
Ni podatkov iz kliničnih študij, ki bi podprli uporabo zdravila Diacomit kot monoterapijo pri Dravetovem sindromu.
Dose adjustments of other antiepileptics used in combination with Diacomit Despite the absence of comprehensive pharmacology data on potential drug interactions, the following advice regarding modification of the dose and dosage schedules of other anti-epileptic medicinal products administered in conjunction with Diacomit is provided based on clinical experience.
Prilagoditev odmerkov drugih zdravil proti epilepsiji, ki se uporabljajo sočasno z zdravilomDiacomit Čeprav ni obsežnih farmakoloških podatkov o možnih interakcijah zdravila, so na osnovi kliničnih izkušenj predlagani naslednji ukrepi za spremembo odmerkov in načrtov odmerjanja drugih zdravil proti epilepsiji, ki se uporabljajo sočasno z zdravilom Diacomit.
In the pivotal studies, when the use of Diacomit was initiated, the daily dose of clobazam was 0.5 mg/ kg/ day usually administered in divided doses, twice daily.
2 V ključnih študijah je bil ob uvedbi zdravila Diacomit dnevni odmerek klobazama 0, 5 mg/ kg/ dan, običajno razdeljen v odmerka dvakrat dnevno.
In the event of clinical signs of side effects or overdosage 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.
Approximately two to three fold increases in clobazam and five fold increases in norclobazam plasma levels respectively have been reported with co- administration of Diacomit in children with Dravet’ s syndrome.
Pri sočasnem dajanju zdravila Diacomit otrokom z Dravetovim sindromov so opazili približno dva - do trikratno zvišanje plazemskih koncentracij klobazama in petkratno zvišanje plazemskih koncentracij norklobazama.
The potential for metabolic interaction between Diacomit and valproate is considered modest and thus, no modification of valproate dosage should be needed when Diacomit is added, except for clinical safety reasons.
Možnost presnovne interakcije med zdravilom Diacomit in valproatom se šteje za majhno, zato sprememba odmerjanja valproata po dodatku zdravila Diacomit ni potrebna razen zaradi klinične varnosti.
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.
Abnormal Laboratory Findings In the event of an abnormal blood count or liver function test finding, the clinical decision for continuing use or adjusting the dose of Diacomit in conjunction with adjusting the doses of clobazam and valproate needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks (See, section 4.4).
(glejte poglavje 4. 4)
Effects of food Diacomit must always be taken with food as it degrades rapidly in an acidic environment (e. g. exposure to gastric acid in an empty stomach).
Učinki hrane Zdravilo Diacomit je treba vedno vzeti s hrano, saj v kislem okolju hitro razpade (npr. izpostavitev želodčni kislini v praznem želodcu).
Diacomit 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.
Zdravilo Diacomit 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.
Effect of formulation The sachet formulation has a slightly higher Cmax than the capsules and thus the formulations are not bioequivalent.
Učinki farmacevtske oblike Prašek za peroralno suspenzijo v vrečkah ima nekoliko višji Cmax kot kapsule, zato farmacevtski obliki nista bioekvivalentni.
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 pivotal clinical evaluation of Diacomit was in children of 3 years of age and over with SMEI.
Otroci, mlajši od 3 let Ključne raziskave uporabe zdravila Diacomit so bile opravljene pri otrocih starih 3 leta in več, ki so imeli SMEI.
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.
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.
In this younger group of patients, adjunctive therapy with Diacomit 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 z zdravilom Diacomit začne šele, ko je diagnoza SMEI klinično potrjena.
Data are limited about the use of Diacomit under 12 months of age.
(glejte poglavje 5. 1) Podatki o uporabi zdravila Diacomit pri otrocih, mlajših od 12 mesecev, so omejeni.
Patients with renal and hepatic impairment Diacomit is not recommended for use in patients with impaired hepatic and/ or renal function (See, section 4.4)
Bolniki z okvarjenim delovanjem ledvic in jeter Uporaba zdravila Diacomit ni priporočljiva pri bolnikih z okvarjenim delovanjem jeter ali ledvic ali obojim (glejte poglavje 4. 4).
3 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
Carbamazepine, iphenytoin and phenobarbital should not be used in conjunction with Diacomit in the management of Dravet’ s syndrome.
Pri obravnavi Dravetovega sindroma se sočasno z zdravilom Diacomit ne sme uporabiti karbamazepina, ifenitoina in fenobarbitala.
The daily dosage of clobazam and/ or valproate should be reduced according to the onset of side effects whilst on Diacomit therapy (See, section 4.2).
(glejte poglavje 4. 2)
Given the frequency of gastrointestinal adverse reactions to treatment with Diacomit and valproate (anorexia, loss of appetite, nausea, vomiting), the growth rate of children under this combination of treatment should be carefully monitored.
Glede na pogostnost gastrointestinalnih neželenih učinkov pri zdravljenju z zdravilom Diacomit in valproatom (anoreksija, izguba apetita, navzea, bruhanje) je treba, ob uporabi omenjene kombinacije, zdravljenja skrbno spremljati hitrost rasti otroka.
Neutropenia may be associated with the administration of Diacomit, clobazam and valproate.
3 Z dajanjem zdravila Diacomit, klobazama in valproata je lahko povezana nevtropenija.
Blood counts should be assessed prior to starting treatment with Diacomit.
Pred zdravljenjem z zdravilom Diacomit je potrebno pregledati krvno sliko.
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.
Liver function should be assessed prior to starting treatment with Diacomit.
Pred zdravljenjem z zdravilom Diacomit je potrebno pregledati jetrno funkcijo.
In the absence of specific clinical data in patients with impaired hepatic or renal function, Diacomit is not recommended for use in patients with impaired hepatic and/ or renal function.
Zaradi pomanjkanja specifičnih kliničnih podatkov o bolnikih z okvarjenim delovanjem jeter ali ledvic uporaba zdravila Diacomit pri teh bolnikih ni priporočljiva.
Stiripentol is an inhibitor of the enzymes CYP2C19, CYP3A4 and CYP2D6 and may markedly increase the plasma concentrations of drugs metabolised by these enzymes and increase the risk of adverse effects (See, section 4.5.).
Stiripentol je zaviralec encimov CYP2C19 in CYP3A4 in CYP2D6 ter lahko bistveno zviša plazemske koncentracije zdravil, ki se presnavljajo preko teh dveh encimov lahko poveča tveganje neželenih učinkov.
In vitro studies suggested that stiripentol phase 1 metabolism is catalyzed by CYP1A2, CYP2C19 and CYP3A4 and possibly other enzymes.
(glejte poglavje 4. 5) In vitro študije so nakazale, da so pri 1. fazi stiripentol metabolizma katalizatorji CYP1A2, CYP2C19, CYP3A4 in verjetno drugi encimi.
Caution is advised when combining stiripentol with other drugs that inhibit or induce one or more of these enzymes..
Svetujemo previdnost pri kombinaciji stiripentola z drugimi zdravili, ki zavirajo ali sprožajo enega ali več the encimov.
Potential medicinal product interactions affecting stiripentol The influence of other antiepileptic medicinal products on stiripentol pharmacokinetics is not well established.
Možne interakcije, ki vplivajo na stiripentol Vpliv drugih zdravil proti epilepsiji na farmakokinetiko stiripentola ni dobro raziskan.
Caution is advised when combining stiripentol with other drugs that inhibit or induce one or more of these enzymes
Svetujemo previdnost pri kombinaciji stiripentola z drugimi zdravili, ki zavirajo ali sprožajo enega ali več the encimov.
Many of these interactions have been partially confirmed by in vitro studies and in clinical trials.
Vpliv stiripentola na encime citokroma P450 Veliko navedenih interakcij je bilo delno potrjenih v študijah in vitro ter v kliničnih preskušanjih.
The increase in steady state levels with the combined use of Diacomit, valproate, and clobazam is similar in adults and children, though inter-individual variability is marked.
Zvišanje koncentracij v stanju dinamičnega ravnovesja pri kombiniranju zdravila Diacomit, valproata in klobazama je podobno pri odraslih in otrocih, čeprav je variabilnost med preiskovanci velika.
These interactions may result in increased systemic levels of these active substances that may lead to enhanced pharmacological effects and to an increase in side effects and 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.
HIV protease inhibitors, antinistamines such as astemizole, chlorpheniramine, calcium channel blockers, statins, oral 4 contraceptives, codeine) due to the increased risk of adverse events (see further in this section for antiepileptic drugs).
Če klinične okoliščine zahtevajo kombiniranje stiripentola z zdravili, ki se presnavljajo s CYP2C19 (npr. citalopram, omeprazol) ali CYP3A4 (npr. več zaviralcev proteaze HIV, antihistaminiki, kot je astemizol, klorfeniramin, zaviralci kalcijevih kanalčkov, statini, peroralni kontraceptivi, kodein), je potrebna previdnost zaradi povečanja tveganja neželenih učinkov (za zdravila proti epilepsiji poglejte nadaljevanje poglavja).
Monitoring of plasma concentrations or adverse effects is recommended.
Priporočljivo je spremljanje plazemskih koncentracij ali neželenih učinkov.
Co-administration with CYP3A4 substrates with a narrow therapeutic index should be avoided due to the markedly increased risk of severe adverse effects.
Sočasnemu dajanju substratov CYP3A4 z ozkim terapevtskim indeksom se je treba izogibati zaradi zelo povečanega tveganja za hude neželene učinke.
Data on the potential for inhibition of CYP1A2 are limited, and therefore, interactions with theophylline and caffeine cannot be excluded.
Podatki o možnosti zaviranja CYP1A2 so omejeni, zato interakcij s teofilinom in kofeinom ne moremo izključiti.