natgillin/translations-raw huggingface dataset:
The most common side effects with ChondroCelect (seen in more than 1 patient in 10) are arthralgia (joint pain), cartilage hypertrophy (overgrowth), joint crepitation (unusual crackling sounds) and swelling of the joint.
Najpogostejši neželeni učinki zdravila ChondroCelect (opaženi pri več kot 1 bolniku od 10) so artralgija (bolečine v sklepih), hipertrofija hrustanca (prekomerna rast), občutek prasketanja ali pokanja ob premikanju kolena (nenavadni pokajoči zvoki) in otekanje sklepa.
During surgery on the knee, the suspension is placed into the defect in the patient's cartilage.
Med operacijo kolena se suspenzija nanese na mesto okvare bolnikovega hrustanca.
Based on the assessment performed by the CAT, the CHMP decided that ChondroCelect's benefits are greater than its risks and recommended that it be given marketing authorisation.
Na podlagi ocene tega odbora je CHMP zaključil, da so koristi zdravila ChondroCelect večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Because ChondroCelect is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT).
Ker je zdravilo ChondroCelect zdravilo za napredno zdravljenje, ga je ocenjeval Odbor za napredno zdravljenje.
After one year, when scans were performed and samples of cartilage were examined, patients who were treated with ChondroCelect showed better structural repair of their cartilage than patients treated with microfracture.
Po enem letu se je ob pregledu slik in vzorcev hrustanca izkazalo, da se je bolnikom, ki so bili zdravljeni z zdravilom ChondroCelect, hrustanec zacelil bolje kot bolnikom, zdravljenim s postopkom mikrofrakture.
ChondoCelect is a type of advanced therapy medicine called a ‘tissue engineered product'.
Zdravilo ChondroCelect spada v skupino zdravil za napredno zdravljenje, ki se imenujejo „zdravila, izdelana s tkivnim inženiringom“.
ChondroCelect was also as effective as microfracture at improving symptoms.
Zdravilo ChondroCelect je bilo pri izboljšanju simptomov enako učinkovito kot postopek mikrofrakture.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for ChondroCelect, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
ChondroCelect must be administered by a qualified surgeon in a hospital.
Zdravilo ChondroCelect lahko odmeri samo ustrezno usposobljen kirurg v bolnišnici.
These cells are ‘characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins'.
To so karakterizirane viabilne avtologne hrustančne celice, ekspandirane ex vivo, ki izražajo specifične markerske proteine.
For the full list of all side effects reported with ChondroCelect, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila ChondroCelect, glejte navodilo za uporabo.
ChondroCelect characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
ChondroCelect karakterizirane viabilne avtologne hrustančne celice, ekspandirane ex vivo, ki izražajo specifične markerske proteine
The active substance in ChondroCelect is the patient's own cartilage cells.
Zdravilna učinkovina zdravila ChondroCelect so bolnikove lastne hrustančne celice.
The training materials for surgeons will include information on how to collect the cartilage biopsy from patients, perform the operation and follow patients up.
Izobraževalno gradivo za kirurge bo vsebovalo informacije o tem, kako bolniku odvzeti biopsijo hrustanca, kako opraviti operacijo in kako po njej spremljati bolnika.
What is the risk associated with ChondroCelect?
Kakšna tveganja so povezana z zdravilom ChondroCelect?
First, a biopsy (a small sample) is taken from the patient's cartilage in the knee.
Najprej se iz bolnikovega kolenskega hrustanca vzame biopsija (majhen vzorec).
This helps the patients to recover from the operation but also leaves enough time for the cartilage cells to implant themselves and for the knee to heal.
Tako bolniki po operaciji lažje okrevajo, obenem pa imajo hrustančne celice dovolj časa, da se vrastejo in da koleno okreva.
The materials for other healthcare professionals will include information on how to handle the collected biopsy and prepare ChondroCelect for implantation, and how to follow patients up and plan the recommended physiotherapy.
Gradivo za druge zdravstvene delavce bo vsebovalo informacije o rokovanju z odvzetimi biopsijami in pripravi zdravila ChondroCelect za vsajanje, o spremljanju bolnikov po operaciji in načrtovanju priporočene fizioterapije.
There was no clear evidence of a difference in the change of KOOS in patients treated with ChondroCelect and those treated with microfracture.
V spremembi KOOS pri bolnikih, zdravljenih z zdravilom ChondroCelect, in tistih, zdravljenih s postopkom mikrofrakture, ni bilo jasnih razlik.
These cells repair the defects in the knee by producing new cartilage.
Te celice s tvorbo novega hrustanca popravijo okvare kolena.
Why has ChondroCelect been approved?
Zakaj je bilo zdravilo ChondroCelect odobreno?
ChondroCelect is used in adults to repair damage to the cartilage in the knee.
Zdravilo ChondroCelect se uporablja za zdravljenje okvar kolenskega hrustanca pri odraslih osebah.
ChondroCelect was compared with microfracture (a type of surgery used to treat defects in cartilage) in one main study involving 118 adult patients with symptoms caused by defects in their knee cartilage.
Zdravilo ChondroCelect so v glavni študiji s 118 odraslimi bolniki s simptomi, ki jih povzročijo okvare kolenskega hrustanca, primerjali s postopkom mikrofrakture (vrsto operacije, s katero se odpravljajo okvare hrustanca).
It is used when there is a single defect in the cartilage of the femoral condyle (the bottom end of the thighbone) that is causing symptoms.
Uporablja se, kadar simptome povzroča posamezna okvara hrustanca femoralnega kondila (spodnjega dela stegnenice).
A biological membrane is then used as a seal to keep the cells in place while the cartilage repairs.
Biološka membrana, ki deluje kot tesnilo, zadržuje celice na mestu okvarjenega hrustanca.
ChondroCelect was more effective than microfracture at healing the defects in the cartilage.
Zdravilo ChondroCelect se je pri zdravljenju okvar hrustanca izkazalo za učinkovitejše od postopka mikrofrakture.
How has ChondroCelect been studied?
Kako je bilo zdravilo ChondroCelect raziskano?
What is ChondroCelect used for?
Za kaj se zdravilo ChondroCelect uporablja?
How is ChondroCelect used?
Kako se zdravilo ChondroCelect uporablja?
What is ChondroCelect?
Kaj je zdravilo ChondroCelect?
How does ChondroCelect work?
Kako zdravilo ChondroCelect deluje?
All divergent opinions have been resolved.
Razrešena so bila vsa razhajajoča se mnenja.
All patients recovered fully with supportive care.
Vsi bolniki so s podporno oskrbo povsem okrevali.
• Ringing in the ears
• zvonjenje v ušesih
No significant issues were identified during the procedure.
Med postopkom ni bilo odkritih pomembnih vprašanj.
Use in elderly patients (over 65 years of age)
Uporaba pri starejših bolnikih (nad 65 let)
This is especially true at the beginning of the treatment and after increase in dose.
To še posebej velja na začetku zdravljenja in po povečanju odmerka.
The significance of these findings is unknown, but they have been associated with delayed development.
Pomen teh ugotovitev ni znan, vendar jih povezujajo z upočasnjenim razvojem.
Adults and adolescents:
Odrasli in mladostniki:
The data from this additional post-hoc analysis are summarised in the table below:
Podatki te dodatne post hoc analize so povzeti v spodnji tabeli:
Risk related to epilepsy and antiepileptic medicinal products in general
Tveganje, povezano z epilepsijo in antiepileptičnimi zdravili na splošno
Instruction for all areas of indication
Navodila za vsa indikacijska področja
Epilepsy typically requires long-term therapy.
Epilepsija praviloma zahteva dolgotrajno zdravljenje.
Your doctor will determine what dose is appropriate for you.
Zdravnik bo določil odmerek, ki bo primeren za vas.
This medicinal product is authorised in the Member States of the EEA under the following names: Austria
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: Avstrija
NA NA 47.2
NP 47,2
You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
Ne vozite, ne upravljajte zapletenih strojev in ne sodelujte pri drugih dejavnostih, ki so lahko nevarne, dokler ne veste, kako to zdravilo vpliva na vašo zmožnost za takšne dejavnosti.
The benefits of prolonged therapy must therefore be weighed against the potential risks of such therapy.
Zato je treba koristi dolgotrajnega zdravljenja pretehtati v primerjavi z možnimi tveganji takšne terapije.
hepatitis, jaundice
hepatitis, zlatenica
Risk related to gabapentin
Tveganje, povezano z gabapentinom
Take as directed by the doctor.
Jemljite po navodilu zdravnika.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale vpliv na reproduktivno toksičnost (glejte poglavje 5.3).
The treatment is started with a low initial dose which is gradually increased over a period of approximately 3 days.
Zdravljenje se začne z majhnim začetnim odmerkom, ki se postopoma povečuje približno 3 dni.
• Anorexia, increased appetite
• anoreksija, povečan apetit
PHARMACEUTICAL FORM AND CONTENTS XX capsules or XX tablets [To be completed nationally]
FARMACEVTSKA OBLIKA IN VSEBINA XX kapsul ali XX tablet [Izpolni država članica]
It is usually given in 3 divided doses, by taking the capsule(s) or tablet(s) each day, usually once in the morning, once in the afternoon and once in the evening.
Ponavadi se daje v 3 deljenih odmerkih z jemanjem kapsul(e) ali tablet(e) vsak dan, običajno enkrat zjutraj, enkrat popoldne in enkrat zvečer.
Gabapentin demonstrated no genotoxic potential.
Gabapentin ni pokazal genotoksičnega potenciala.
In spite of these modest results, taking into consideration the adequate safety profile and the medical need in this paediatric population, the CHMP agreed to the following indication:
Kljub tem skromnim rezultatom CHMP ob upoštevanju zadostnega varnostnega profila in zdravstvene potrebe v tej populaciji otrok soglaša z naslednjo indikacijo:
Children aged 6 years and above:
Otroci, stari 6 let in več:
• Non-clinical issues
• Neklinična vprašanja
Dosing instructions for children under 12 years of age are provided under a separate sub-heading later in this section.
Navodila za odmerjanje pri otrocih pod 12 let so opisana v nadaljevanju, v ločenem podpoglavju tega poglavja.
The relevance of these pancreatic acinar cell tumors in male rats to carcinogenic risk in humans is unclear.
Pomen teh tumorjev pankreatičnih acinarnih celic pri podganjih samcih za kancerogeno tveganje pri človeku ni jasen.
Pharmacotherapeutic groups: Other antiepileptics ATC code: N03AX12
Farmakoterapevtska skupina: drugi antiepileptiki, oznaka ATC: N03AX12
Even, if they were only of mild or moderate degree, these undesirable effects could be potentially dangerous in patients driving or operating machinery.
Tudi če so ti neželeni učinki le blagi ali zmerni, so lahko potencialno nevarni pri bolnikih, ki vozijo ali upravljajo s stroji.
Causality with gabapentin is unclear (see section 4.4).
Vzročna povezanost z gabapentinom ni jasna (glejte poglavje 4.4).
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF NEURONTIN AND ASSOCIATED NAMES (see Annex I)
ZAKLJUČNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA NEURONTIN IN POVEZANIH IMEN (glejte Dodatek I)
Although gabapentin can be removed by haemodialysis, based on prior experience it is usually not required.
Gabapentin je sicer mogoče odstraniti s hemodializo, toda na podlagi predhodnih izkušenj to ponavadi ni potrebno.
The dose to be given to your child will be decided by your doctor as it is calculated against your child's weight.
Odmerek, ki ga boste dajali otroku, bo določil zdravnik, ker ga je treba izračunati glede na otrokovo telesno maso.
There are no adequate data from the use of gabapentin in pregnant women.
Ni zadostnih podatkov o uporabi gabapentina pri nosečnicah.
Cmax (µg/ml) tmax (hr) T1/2 (hr) AUC (0-8) µg•hr/ml) Ae% (%)
Cmax (µg/ml) tmax (ure) t1/2 (ure) AUC (0-8) µg•ure/ml) Ae% (%)
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE [To be completed nationally]
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI [Izpolni država članica]
Apart from these findings, clinical investigations in this age group do not indicate an adverse event profile different from that observed in younger patients.
Razen teh ugotovitev klinične raziskave v tej starostni skupini ne kažejo drugačnega profila neželenih učinkov, kot je ugotovljen med mlajšimi bolniki.
Gabapentin may have minor or moderate influence on the ability to drive and use machines.
Gabapentin ima lahko blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
The CHMP agreed that the indication should not be restricted to patients refractory to standard medication.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da indikacije ne bi smeli omejiti na bolnike, ki se ne odzivajo na standardna zdravila.
Gabapentin is not bound to plasma proteins and has a volume of distribution equal to 57.7 litres.
Gabapentin ni vezan na beljakovine v plazmi in njegov volumen porazdelitve je 57,7 litrov.
Elimination pharmacokinetics (pharmacokinetic parameters which do not include F such as CLr and T1/2), are best described by linear pharmacokinetics.
Eliminacijsko farmakokinetiko (farmakokinetiko parametrov, ki ne vključujejo F, npr. CLr in t1/2) najbolje opiše linearna farmakokinetika.
It is not possible to differentiate if the developmental delay is caused by genetic, social factors, maternal epilepsy or the antiepileptic therapy.
Diferencialno ni mogoče ugotoviti, ali so vzrok razvojnega zaostanka genetski dejavniki, socialni dejavniki, materina epilepsija ali antiepileptična terapija.
The precise mechanism of action of gabapentin is not known.
Natančen mehanizem delovanja gabapentina ni znan.
Your doctor will usually build up your dose gradually.
Zdravnik bo odmerek praviloma povečeval postopoma.
Do not suddenly discontinue taking this medicine as this may lead to breakthrough seizure, which could have serious consequences for you and your baby.
Zdravila ne smete nehati jemati nenadoma, ker to lahko povzroči nenaden napad krčev, ki ima lahko resne posledice za vas in otroka.
Food, including a high-fat diet, has no clinically significant effect on gabapentin pharmacokinetics.
Hrana, vključno z zelo mastno, nima klinično pomembnega vpliva na farmakokinetiko gabapentina.
Dosage is determined by the treating physician according to individual tolerance and efficacy.
Odmerek določi lečeči zdravnik glede na individualno prenašanje in učinkovitost.
Dubravska cesta 2, 841 04 Bratislava, Slovak Republic
Dubravska cesta 2, 841 04 Bratislava, Slovaška
Pharmacokinetic parameters are given in Table 3.
Farmakokinetične parametre prikazuje tabela 3.
Always swallow the capsules or tablets whole with plenty of water.
Kapsule oz. tablete morate vedno pogoltniti cele in z veliko vode.
Total Daily Dosea (mg/day)
celotni dnevni odmereka (mg/dan)
• Viral infection
• virusna okužba
Take along any capsules or tablets that are left, the container and the label so that the hospital can easily tell what medicine you have taken.
S seboj vzemite kapsule ali tablete, ki so morda ostale, vsebnik in nalepko, da bo osebje v bolnišnici vedelo, kakšno zdravilo ste vzeli.
Reduced dosages are for patients with renal impairment (creatinine clearance < 79 ml/min).
Manjši odmerki so za bolnike z okvaro ledvic (očistek kreatinina < 79 ml/min).
Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CHMP considered that the benefit/risk ratio of neurontin and associated names is favourable relating to:
CHMP na podlagi dokumentacije, ki jo je predložil MAH, in znanstvene razprave znotraj Odbora meni, da je razmerje med koristmi in tveganji za zdravilo Neurontin in povezana imena ugodno v zvezi z:
Therefore, patients should be carefully observed for signs of CNS depression, such as somnolence, and the dose of gabapentin or morphine should be reduced appropriately.
Zato je treba bolnike natančno opazovati glede znakov depresije osrednjega živčevja, npr. somnolence, odmerek gabapentina ali morfina pa ustrezno zmanjšati.
If you are taking any medicines containing morphine, please tell your doctor or pharmacist as morphine may increase the effect of [Neurontin and associated names].
Če jemljete zdravila, ki vsebujejo morfin, morate to povedati zdravniku ali farmacevtu, kajti morfin lahko poveča učinek zdravila [Neurontin in povezana imena].
In patients with poor general health, i.e., low body weight, after organ transplantation etc., the dose should be titrated more slowly, either by using smaller dosage strengths or longer intervals between dosage increases.
Pri bolnikih, ki so v slabem zdravstvenem stanju, tj. imajo majhno telesno maso, so bili deležni presaditve organa itn., je treba odmerek titrirati počasneje, bodisi z uporabo manjših odmernih jakosti ali z daljšimi presledki med povečanji odmerka.
The therapy may be initiated by titrating the dose as described in Table 1.
Terapijo je mogoče začeti s titriranjem odmerka, kot prikazuje tabela 1.
The Netherlands Pfizer BV Rivium Westlaan 142
Nizozemska Pfizer BV Rivium Westlaan 142
Under treatment with gabapentin cases of acute pancreatitis were reported.
Med zdravljenjem z gabapentinom so opisani primeri akutnega pankreatitisa.
Coadministration of gabapentin with antacids containing aluminium and magnesium, reduces gabapentin bioavailability up to 24%.
Sočasna uporaba gabapentina z antacidi, ki vsebujejo aluminij in magnezij, zmanjša biološko uporabnost gabapentina do 24 %.
150b-300 a Total daily dose should be administered as three divided doses.
150b-300 a Celotni dnevni odmerek je treba razdeliti na tri dele.
If a patient requires dosing longer than 5 months for the treatment of peripheral neuropathic pain, the treating physician should assess the patient's clinical status and determine the need for additional therapy.
Če bolnik zaradi perifernih nevropatskih bolečin potrebuje več kot 5-mesečno zdravljenje, mora lečeči zdravnik oceniti bolnikovo klinično stanje in ugotoviti, ali je potrebna dodatna terapija.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine [this text will only be included in the capsules SPC].
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze tega zdravila ne smejo jemati [To besedilo bo vključeno le v SmPC-ju pri kapsulah].
− if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of [Neurontin and associated names].
− če ste alergični na (preobčutljivi za) gabapentin ali katerokoli sestavino zdravila [Neurontin in povezana imena].
Benefit/Risk considerations
Pomisleki glede razmerja med koristmi in tveganji
It is therefore recommended to verify such a positive dipstick test result by methods based on a different analytical principle such as the Biuret method, turbidimetric or dye-binding methods, or to use these alternative methods from the beginning.
Zato je pozitiven izvid s testnim trakom priporočljivo preveriti z načini, ki temeljijo na drugačnem analitičnem principu - npr. z biuretsko ali turbidimetrično metodo, ali vezavo barvila - ali že uvodoma uporabiti enega takšnih načinov.
Epilepsy: [Neurontin and associated names] is used to treat various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not).
Epilepsija: zdravilo [Neurontin in povezana imena] uporabljamo za zdravljenje različnih vrst epilepsije (napadov, ki so uvodoma omejeni na določene dele možganov, ne glede na to, ali se napad razširi na druge dele možganov ali ne).
P-Value
P-vrednost
See leaflet for further information [This text will only be included on the labelling for the capsules]
[To besedilo bo vključeno le v označevanje pri kapsulah.]
If you take more [Neurontin and associated names] than you should Call your doctor or go to the nearest hospital emergency unit immediately.
Če ste vzeli večji odmerek zdravila [Neurontin in povezana imena], kot bi smeli Pokličite svojega zdravnika ali nemudoma pojdite na oddelek za nujno pomoč najbližje bolnišnice.
The pancreatic acinar cell tumors in male rats are low-grade malignancies, did not affect survival, did not metastasize or invade surrounding tissue, and were similar to those seen in concurrent controls.
Tumorji pankreatičnih acinarnih celic pri podganjih samcih so nizkostopenjski malignomi, ki niso vplivali na preživetje, niso metastazirali ali vdirali v okoliška tkiva in so bili podobni kot pri sočasnih kontrolnih živalih.
Although plasma gabapentin concentrations were generally between 2 µg/ml and 20 µg/ml in clinical studies, such concentrations were not predictive of safety or efficacy.
Koncentracija gabapentina v plazmi je bila v kliničnih študijah na splošno med 2 µg/ml in 20 µg/ml, vendar takšne koncentracije niso napovedovale varnosti ali učinkovitosti zdravila.
The effects of long-term (greater than 36 weeks) gabapentin therapy on learning, intelligence, and development in children and adolescents have not been adequately studied.
Učinki dolgotrajnega (več kot 36-tedenskega) zdravljenja z gabapentinom na učenje, inteligenco in razvoj otrok in mladostnikov niso zadostno raziskani.
• Safety issues
• Vprašanja o varnosti
In a study involving healthy volunteers (N=12), when a 60 mg controlled-release morphine capsule was administered 2 hours prior to a 600 mg gabapentin capsule, mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine.
Ko so v študiji zdravih prostovoljcev (n = 12) 2 uri pred zaužitjem kapsule s 600 mg gabapentina uporabili 60-mg kapsulo morfina z nadzorovanim sproščanjem, se je povprečna AUC gabapentina povečala za 44 % v primerjavi z uporabo gabapentina brez morfina.
The minimum time to reach a dose of 1800 mg/day is one week, to reach 2400 mg/day is a total of 2 weeks, and to reach 3600 mg/day is a total of 3 weeks.
Najkrajši čas za doseganje odmerka 1800 mg/dan je en teden, za doseganje 2400 mg/dan je skupno 2 tedna, za doseganje 3600 mg/dan pa skupno 3 tedne.
Neurontin United Kingdom Neurontin
Neurontin Velika Britanija Neurontin
Response (≥ 50% Improved) by Treatment and Age MITT* Population Age Category
Odgovor (≥ 50% izboljšanje) glede na zdravljenje in starostno MITT* populacijo starostna kategorija placebo gabapentin
76139 Karlsruhe, Germany
76139 Karlsruhe, Nemčija
The usual dose to control epilepsy is 25-35 mg/kg/day.
Običajen odmerek za obvladanje epilepsije je od 25 do 35 mg/kg/dan.
− if you suffer from kidney problems
− če imate težave z ledvicami
Ireland c/o Pfizer Ltd.
Irska c/o Pfizer Ltd.
If you have the impression that the effect of [Neurontin and associated names] is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek zdravila [Neurontin in povezana imena] premočan ali prešibek, se posvetujte z zdravnikom ali farmacevtom.
*The modified intent to treat population was defined as all patients randomised to study medication who also had evaluable seizure diaries available for 28 days during both the baseline and double-blind phases.
* Modificirana populacija namenjena za zdravljenje je bila opredeljena kot populacija vseh tistih bolnikov, randomiziranih na raziskovano zdravilo, ki so za 28-dnevno izhodiščno in 28-dnevno dvojno slepo obdobje vodili dnevnik epileptičnih napadov, primernih za vrednotenje.