FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Victoza have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Victoza upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Slovenian: HbA1c kaže, kako dobro je uravnana glukoza v krvi.
English: In some patients, the dose can be further increased to 1.8 mg one week later to achieve better control of blood glucose.
Slovenian: Pri nekaterih bolnikih se lahko odmerek po enem tednu dodatno poveča na 1,8 mg, da se doseže boljši nadzor nad ravnmi glukoze v krvi.
English: What is Victoza and what is it used for?
Slovenian: Kaj je zdravilo Victoza in za kaj se uporablja?
English: It is not intended to provide practical advice on how to use Victoza.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: In these studies, the main measure of effectiveness was the reduction in the amount of a substance in the blood called glycosylated haemoglobin (HbA1c) after six months or one year of treatment.
Slovenian: V teh študijah je bilo glavno merilo učinkovitosti zmanjšanje količine snovi v krvi, imenovane glikirani hemoglobin (HbA1c), po šestih mesecih ali enem letu.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne proizvaja dovolj insulina za vzdrževanje primerne ravni glukoze (sladkorja) v krvi ali pri kateri telo insulina ne more učinkovito uporabiti.
English: This helps with the control of blood glucose levels.
Slovenian: To pomaga uravnavati ravni glukoze v krvi.
English: The most common side effects with Victoza (seen in more than 1 patient in 10) are nausea and diarrhoea.
Slovenian: Najpogostejša neželena učinka zdravila Victoza (opažena pri več kot 1 bolniku od 10) sta navzea in driska.
English: In addition to the above studies, Victoza was shown to be effective in reducing adverse cardiovascular (heart and blood vessels) effects.
Slovenian: Poleg navedenih študij se je zdravilo Victoza izkazalo za učinkovito pri zmanjšanju neželenih učinkov na srčnožilni sistem (sistem srca in krvnih žil).
English: • as an ‘add-on' to other diabetes medicines.
Slovenian: • kot dodatek pri zdravljenju z drugimi zdravili za zdravljenje sladkorne bolezni.
English: What benefits of Victoza have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Victoza izkazalo v študijah?
English: What are the risks associated with Victoza?
Slovenian: Kakšna tveganja so povezana z zdravilom Victoza?
English: When Victoza is added to existing treatment containing metformin or a thiazolidinedione, the doses of these medicines do not have to be changed.
Slovenian: Kadar se zdravilo Victoza dodaja obstoječemu zdravljenju z metforminom ali tiazolidindionom, odmerkov teh zdravil ni treba spreminjati.
English: Why is Victoza approved?
Slovenian: Zakaj je bilo zdravilo Victoza odobreno?
English: Victoza is a solution for injection available in pre-filled pens (6 mg/ml).
Slovenian: Zdravilo Victoza je na voljo v obliki raztopine za injiciranje v napolnjenih peresnikih (6 mg/ml).
English: Victoza is used:
Slovenian: Zdravilo Victoza se uporablja:
English: For more information about treatment with Victoza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Victoza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Results from this study show that Victoza at a dose of 1.2 mg reduced HbA1c by 0.8 percentage points, whereas Victoza at a dose of 1.8 mg led to reductions of 1.1 percentage points.
Slovenian: Rezultati te študije kažejo, da je zdravilo Victoza v odmerku 1,2 mg zmanjšalo ravni HbA1c za 0,8 odstotne točke, medtem ko je v odmerku 1,8 mg povzročilo zmanjšanje za 1,1 odstotne točke.
English: For practical information about using Victoza, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Victoza naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Victoza was effective at controlling blood glucose in six main studies involving 4,155 adults with type 2 diabetes.
Slovenian: Zdravilo Victoza so proučevali v šestih glavnih študijah, v katere je bilo vključenih 4 155 odraslih s sladkorno boleznijo tipa 2.
English: For the full list of all side effects and restrictions with Victoza, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Victoza glejte navodilo za uporabo.
English: The active substance in Victoza, liraglutide, is an ‘incretin mimetic'.
Slovenian: Zdravilna učinkovina v zdravilu Victoza, liraglutid, je „mimetik inkretina“.
English: The triple therapies containing Victoza led to a reduction of between 1.3 and 1.5 percentage points compared with a reduction equal or less than 0.5 points without Victoza.
Slovenian: Zdravljenje s tremi zdravili, ki je vključevalo zdravilo Victoza, je povzročilo zmanjšanje za 1,3 do 1,5 odstotne točke, v primerjavi z zdravljenjem brez zdravila Victoza, pri katerem je bilo zmanjšanje enako ali manjše od 0,5 odstotne točke.
English: Victoza is a medicine used in addition to diet and exercise in adults who have type 2 diabetes.
Slovenian: Zdravilo Victoza se uporablja kot dodatek dieti in telesni vadbi pri odraslih s sladkorno boleznijo tipa 2.
English: Adding Victoza to treatment with basal insulin plus metformin reduced HbA1c by 0.7 percentage points, compared with 0.4 points when adding Victoza to insulin aspart.
Slovenian: Pri dodajanju zdravila Victoza kombinaciji bazalnega insulina in metformina so se ravni HbA1c zmanjšale za 0,7 odstotne točke v primerjavi z 0,4 odstotne točke pri dodajanju zdravila Victoza insulinu aspartu.
English: Victoza is given by the patient once a day by injection under the skin in the abdomen, thigh or upper arm.
Slovenian: Bolnik si ga injicira v podkožje na trebuhu, stegnu ali nadlakti enkrat na dan.
English: Combinations containing Victoza were more effective at controlling blood glucose than combinations without the medicine.
Slovenian: Kombinacije, ki so vključevale zdravilo Victoza, so bile učinkovitejše pri uravnavanju glukoze v krvi kot kombinacije brez tega zdravila.
English: How does Victoza work?
Slovenian: Kako zdravilo Victoza deluje?
English: Victoza contains the active substance liraglutide.
Slovenian: Zdravilo Victoza vsebuje zdravilno učinkovino liraglutid.
English: Dual therapies containing Victoza and metformin or glimepiride led to reductions in HbA1c of around 1 percentage point compared with no reduction without Victoza.
Slovenian: Zdravljenje z dvema zdraviloma, ki je vključevalo kombinacijo zdravila Victoza in metformina ali glimepirida, je zmanjšalo ravni HbA1c za približno 1 odstotno točko, medtem ko pri zdravljenju, ki ni vključevalo zdravila Victoza, zmanjšanja ni bilo.
English: In two ‘triple therapy' studies, Victoza with metformin and either glimepiride or rosiglitazone (a thiazolidinedione) were compared with treatments that included placebo or another anti-diabetes medicine instead of Victoza.
Slovenian: v dveh študijah zdravljenja s tremi zdravili so zdravilo Victoza v kombinaciji z metforminom ter bodisi glimepiridom ali roziglitazonom (tiazolidindionom) primerjali z zdravljenjem, ki je vključevalo placebo ali drugo zdravilo za zdravljenje sladkorne bolezni namesto zdravila Victoza.
English: The starting dose of Victoza is 0.6 mg. After at least one week, the dose is increased to 1.2 mg.
Slovenian: Po najmanj enem tednu se odmerek poveča na 1,2 mg.
English: Victoza used on its own was more effective at controlling blood glucose than glimepiride.
Slovenian: Zdravilo Victoza je bilo kot samostojno zdravilo pri nadzoru ravni glukoze v krvi učinkovitejše od glimepirida.
English: How is Victoza used?
Slovenian: Kako se zdravilo Victoza uporablja?
English: In another triple therapy study, Victoza was compared with a single dose of a short-acting insulin, insulin aspart, when added to treatment with basal insulin (a long-acting insulin) plus metformin.
Slovenian: V drugi študiji zdravljenja s tremi zdravili so zdravilo Victoza primerjali z enkratnim odmerkom insulina s kratkotrajnim delovanjem, tj. insulina asparta, pri čemer so oba dodajali kombinaciji bazalnega insulina in metformina.
English: In two ‘dual therapy' studies, Victoza plus metformin or Victoza plus glimepiride were compared with metformin or glimepiride taken with a placebo (a dummy treatment).
Slovenian: V dveh študijah zdravljenja z dvema zdraviloma so zdravilo Victoza v kombinaciji z metforminom ali zdravilo Victoza v kombinaciji z glimepiridom primerjali z metforminom ali glimepiridom, ki so ju bolniki jemali v kombinaciji s placebom (zdravilom brez zdravilne učinkovine).
English: When Victoza is added to treatment with a sulphonylurea or insulin, the doctor should consider lowering the dose of the other medicine to reduce the risk of having hypoglycaemia (low blood glucose).
Slovenian: mora zdravnik razmisliti o zmanjšanju odmerka teh zdravil, da se zmanjša tveganje za pojav hipoglikemije (nizkih ravni glukoze v krvi).
English: In one ‘monotherapy' study, Victoza on its own was compared with glimepiride (a sulphonylurea).
Slovenian: V eni študiji zdravljenja z enim zdravilom so zdravilo Victoza, ki so ga bolniki jemali kot samostojno zdravilo, primerjali z glimepiridom (sulfonilsečnino).
English: The use of the infusion should be temporary.
Slovenian: Infuzijo je treba uporabljati le začasno.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Keppra on 29 September 2000.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Keppra, veljavno po vsej Evropski uniji, odobrila dne 29. septembra 2000.
English: In all of these studies, the main measure of effectiveness was the change in the number of seizures before and during treatment.
Slovenian: V vseh teh študijah je bilo glavno merilo učinkovitosti sprememba števila napadov pred zdravljenjem in med njim.
English: The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Slovenian: Natančen način delovanja levetiracetama še vedno ni pojasnjen, toda zdi se, da vpliva na beljakovino, imenovano sinaptični vezikularni protein 2A, ki se nahaja v predelih med živčnimi celicami in sodeluje pri sproščanju kemičnih prenašalcev iz živčnih celic.
English: All of the patients were taking at least one other anti-epileptic medicine.
Slovenian: Vsi bolniki so jemali še najmanj eno drugo zdravilo proti epilepsiji.
English: The full EPAR for Keppra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Keppra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Secondary generalisation occurs when the overactivity later reaches the whole brain.
Slovenian: Sekundarna generalizacija se pojavi, ko prekomerno delovanje čez čas zajame celotne možgane.
English: Epilepsy is caused by excessive electrical activity in the brain.
Slovenian: Epilepsijo povzroča prekomerna električna dejavnost v možganih.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Slovenian: To je vrsta epilepsije, pri kateri prevelika električna aktivnost na samo eni strani možganov povzroči simptome, kot so nenadni sunkoviti gibi določenega dela telesa, motnje sluha, voha ali vida, odrevenelost ali nenaden občutek strahu.
English: The oral solution may be mixed in a glass of water before it is taken.
Slovenian: Peroralno raztopino lahko pred zaužitjem zmešamo s kozarcem vode.
English: In both groups, 73% of the patients experienced no seizures for six months once on an adequate dose.
Slovenian: V obeh skupinah je bilo 73 % bolnikov brez napadov šest mesecev od začetka prejemanja ustreznega odmerka.
English: The study measured how many patients remained free of seizures for six months once they had reached their effective dose.
Slovenian: V študiji so beležili, koliko bolnikov je bilo brez napadov v obdobju šest mesecev od takrat, ko so dosegli učinkovit odmerek.
English: The CHMP decided that Keppra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Keppra večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: This helps Keppra to stabilise electrical activity in the brain and prevent seizures.
Slovenian: To omogoča zdravilu Keppra, da stabilizira električno aktivnost v možganih in prepreči napade.
English: However, there were too few patients aged below 12 years to support the use of Keppra for this type of seizure in this age group.
Slovenian: Vendar pa je bilo otrok, mlajših od 12 let, premalo, da bi bila potrjena uporaba zdravila Keppra za to vrsto napadov pri bolnikih v tej starostni skupini.
English: Lower doses are used in patients who have problems with their kidneys (such as older patients).
Slovenian: Manjši odmerki se uporabljajo pri bolnikih, ki imajo težave z delovanjem ledvic (na primer pri starejših bolnikih).
English: This document is a summary of the European public assessment report (EPAR) for Keppra.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Keppra.
English: For more information about treatment with Keppra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Keppra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: • partial-onset seizures with or without generalisation in patients from one month of age;
Slovenian: • napadov parcialnega izvora z generalizacijo ali brez nje pri bolnikih, starejših od enega meseca;
English: Other information about Keppra:
Slovenian: Druge informacije o zdravilu Keppra:
English: Keppra tablets are swallowed with liquid.
Slovenian: Tablete Keppra je treba pogoltniti s tekočino.
English: It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg), as an oral solution (100 mg/ml), and as a concentrate that is made up into a solution for infusion (drip into a vein, 100 mg/ml).
Slovenian: Na voljo je v obliki tablet (250 mg, 500 mg, 750 mg in 1 000 mg), peroralne raztopine (100 mg/ml) in koncentrata za pripravo raztopine za infundiranje (kapalne infuzije v veno, 100 mg/ml).
English: The oral solution is recommended when starting treatment in children under six years old or weighing less than 25 kg.
Slovenian: Peroralna raztopina se priporoča na začetku zdravljenja otrok, ki so mlajši od šest let ali tehtajo manj kot 25 kg.
English: What benefit has Keppra shown during the studies?
Slovenian: Kakšne koristi je zdravilo Keppra izkazalo med študijami?
English: • in partial-onset seizures, it has been studied in three main studies in a total of 904 patients aged 16 years and over.
Slovenian: • pri napadih parcialnega izvora, in sicer v treh glavnih študijah pri skupno 904 bolnikih, starih 16 let in več.
English: Keppra has also been compared with placebo in 314 patients aged between one month and 17 years;
Slovenian: Zdravilo Keppra so primerjali tudi s placebom pri 314 bolnikih, starih od enega meseca do 17 let;
English: • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Slovenian: • primarno generaliziranih tonično-kloničnih napadov (daljših napadov, vključno z izgubo zavesti) pri bolnikih, starejših od 12 let, z idiopatsko generalizirano epilepsijo (vrsto epilepsije, za katero se domneva, da je genetskega izvora).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Keppra.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Keppra, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: This can be increased up to 21 mg/kg twice a day.
Slovenian: Ta se lahko poveča do 21 mg/kg dvakrat na dan.
English: The most common side effects with Keppra (seen in more than 1 patient in 10) are nasopharyngitis (inflammation of the nose and throat), somnolence (sleepiness), and headache.
Slovenian: Najpogostejši neželeni učinki zdravila Keppra (opaženi pri več kot 1 bolniku od 10) so nazofaringitis (vnetje nosu in grla), zaspanost in glavobol.
English: As an add-on treatment, Keppra was more effective than placebo:
Slovenian: Kot dopolnilno zdravljenje je bilo zdravilo Keppra učinkovitejše od placeba:
English: Keppra must not be used in people who are hypersensitive (allergic) to levetiracetam, to other pyrrolidone derivatives (medicines with a similar structure to levetiracetam), or to any of the other ingredients.
Slovenian: Zdravila Keppra ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) levetiracetam ali druge pirolidonske derivate (zdravila s podobno zgradbo kot levetiracetam) ali na katero koli drugo sestavino zdravila.
English: Keppra was also more effective than placebo in children;
Slovenian: Zdravilo Keppra je bilo učinkovitejše od placeba tudi pri otrocih;
English: With Keppra at a dose of 2,000 mg, the reduction was 27%, and with 3,000 mg, it was around 39%.
Slovenian: Z zdravilom Keppra v odmerku 2 000 mg se je število napadov zmanjšalo za 27 %, v odmerku 3 000 mg pa za okoli 39 %.
English: What is the risk associated with Keppra?
Slovenian: Kakšna tveganja so povezana z zdravilom Keppra?
English: In these studies, Keppra at doses of 1,000, 2,000 or 3,000 mg per day, was compared with placebo (a dummy treatment) over 12 to 14 weeks.
Slovenian: V teh študijah so zdravilo Keppra v odmerkih 1 000 mg, 2 000 mg ali 3 000 mg na dan primerjali s placebom (zdravilom brez zdravilne učinkovine) v obdobju 12 do 14 tednov.
English: • for partial onset seizures, placebo treatment reduced the weekly number of seizures by 6 to 7%, while the reduction with Keppra at a dose of 1,000 mg per day was between 18 and 33%, depending on the study.
Slovenian: • pri napadih parcialnega izvora, pri katerih je zdravljenje s placebom tedensko število napadov zmanjšalo za 6 do 7 %, medtem ko je zdravljenje z zdravilom Keppra v odmerku 1 000 mg na dan to število zmanjšalo za 18 do 33 %, odvisno od študije.
English: • in primary generalised tonic-clonic seizures, Keppra was compared with placebo in 164 patients aged four years or over.
Slovenian: • pri primarno generaliziranih tonično-kloničnih napadih, pri katerih so zdravilo Keppra primerjali s placebom pri 164 bolnikih, starih štiri leta in več.
English: Keppra is a medicine that contains the active substance levetiracetam.
Slovenian: Keppra je zdravilo, ki vsebuje zdravilno učinkovino levetiracetam.
English: For the full list of all side effects reported with Keppra, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Keppra, glejte navodilo za uporabo.
English: Keppra has also been studied as an add-on treatment:
Slovenian: Zdravilo Keppra so proučevali tudi kot dopolnilno zdravljenje:
English: Keppra can also be used as an add-on to other anti-epileptic medicines to treat:
Slovenian: Zdravilo Keppra se lahko uporablja kot dopolnilno zdravljenje k drugim zdravilom proti epilepsiji za zdravljenje:
English: Keppra can be given as an infusion using the same doses at the same frequency when using the tablets or the oral solution is not possible.
Slovenian: Zdravilo Keppra se lahko daje kot infuzija v enakih odmerkih in enako pogosto, kadar uporaba tablet ali peroralne raztopine ni mogoča.
English: The active substance in Keppra, levetiracetam, is an anti-epileptic medicine.
Slovenian: Zdravilna učinkovina zdravila Keppra, levetiracetam, je zdravilo proti epilepsiji.
English: The daily dose can be increased up to 1,500 mg twice a day.
Slovenian: Dnevni odmerek se lahko poveča do največ 1 500 mg dvakrat dnevno.
English: Why has Keppra been approved?
Slovenian: Zakaj je bilo zdravilo Keppra odobreno?
English: • for myoclonic seizures, the number of seizure days per week was halved in 58% of the patients receiving Keppra and in 23% of the patients receiving placebo;
Slovenian: • pri miokloničnih napadih, pri katerih se je število dni z napadi na teden prepolovilo pri 58 % bolnikov, ki so prejemali zdravilo Keppra, in 23 % bolnikov, ki so prejemali placebo;
English: When Keppra is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Slovenian: Kadar se zdravilo Keppra dodaja drugemu zdravilu proti epilepsiji, je začetni odmerek pri bolnikih, starejših od 12 let, ki tehtajo več kot 50 kg, 500 mg dvakrat na dan.
English: • in myoclonic seizures, Keppra was studied in 122 patients aged 12 years and over, who received either Keppra or placebo in addition to their normal anti-epileptic medicine for up to 30 weeks;
Slovenian: • pri miokloničnih napadih, in sicer pri 122 bolnikih, starih 12 let in več, ki so do 30 tednov poleg svojega običajnega zdravila proti epilepsiji prejemali zdravilo Keppra ali placebo;
English: • for tonic-clonic seizures, the number of seizures fell by an average of 28% in the patients receiving placebo, compared with 57% in those receiving Keppra.
Slovenian: • pri tonično-kloničnih napadih, pri katerih se je število napadov v povprečju zmanjšalo za 28 % pri bolnikih, ki so jemali placebo, v primerjavi s 57 % pri bolnikih, ki so jemali zdravilo Keppra.
English: The patient's treatment was continued for 20 weeks once they were taking their full dose.
Slovenian: Ko je bolnik začel prejemati celotni odmerek, se je njegovo zdravljenje nadaljevalo do 20 tednov.
English: Keppra used on its own has been studied in 579 patients with partial-onset seizures aged 16 years and over, who received either Keppra or carbamazepine (another anti-epileptic medicine) for up to two years.
Slovenian: Zdravilo Keppra kot samostojno zdravilo so proučevali pri 579 bolnikih z napadi parcialnega izvora, starih 16 let in več, ki so do dve leti prejemali zdravilo Keppra ali karbamazepin (drugo zdravilo proti epilepsiji).
English: In patients aged between six months and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Slovenian: Pri otrocih od šestega meseca do 17. leta starosti, ki tehtajo manj kot 50 kg, je začetni odmerek 10 mg/kg telesne mase dvakrat dnevno, lahko pa se poveča vse do 30 mg/kg telesne mase dvakrat dnevno.
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12
Slovenian: • miokloničnih napadov (kratkih, krču podobnih sunkovitih gibov mišice ali skupine mišic) pri bolnikih z juvenilno mioklonično epilepsijo od 12. leta starosti dalje;