natgillin/translations-raw huggingface dataset:
In practice this means that in intensive systems all the birds in one house will be treated even though not all are exhibiting signs of disease.
To v praksi pomeni, da se pri sistemih intenzivne reje zdravi vsa perutnina v eni hiši, čeprav vsa ne kažejo znakov bolezni.
o prevention and control of coccidiosis;
o preprečevanje in nadzor kokcidioze,
Critical evaluation
OSNOVNE INFORMACIJE
o repeat treatment can be administered after 5 days if infection is severe;
o pri hudi okužbi se lahko zdravljenje ponovi po petih dneh,
The dose and duration of treatment in all Member States for chickens and turkeys is 7 mg/kg bodyweight per day for two consecutive days.
Priporočeni odmerek in trajanje zdravljenja za piščance in purane je 7 mg/kg telesne mase na dan, in sicer dva zaporedna dneva.
However, it was noted that the indications, species and posology in the SPCs of some of the authorised products were different and these therefore need to be amended to bring them in line with the indications and dosing regimens used in the environmental risk assessment.
Hkrati je bilo ugotovljeno, da se indikacije, živalske vrste in odmerjanje v povzetkih glavnih značilnosti za nekatera odobrena zdravila razlikujejo in jih je zato potrebno spremeniti, da bodo skladni s tisto indikacijo in režimom odmerjanja, ki sta bila uporabljena v oceni tveganja za okolje.
Germany considered that the authorisation of Baycox 2.5 % solution may present a potential serious risk to the environment on the following grounds:
Nemčija je zadevo napotila na CVMP zaradi skrbi, da lahko toltrazuril pomeni morebitno resno tveganje za okolje in to iz naslednjih razlogov:
Toltrazuril is administered orally in the drinking water for the treatment of coccidiosis.
Toltrazuril je derivat triazintriona, ki se daje peroralno v vodi za pitje pri zdravljenju kokcidioze pri piščancih in puranih.
It was therefore concluded that the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided the product is used as indicated by the Marketing Authorisation Holders in their responses to questions by the Committee, i.e. a dose of 7 mg/kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.
CVMP je zaključil, da lahko imetniki ohranijo dovoljenja za promet brez potrebe po posebnih opozorilih v točki 5.3 (Okoljski podatki) povzetka glavnih značilnosti zdravila (SPC), če se bo zdravilo uporabljalo pod dogovorjenimi pogoji, tj. odmerek 7 mg/kg telesne mase dva dni zapored za zdravljenje kokcidioze pri piščancih in puranih.
Baycox 2,5 %
Stran 2/2
2794-003 Carnaxide
EMEA/402698/2008-SL
The marketing authorisation is suspended on 12 June 2007
Evropska komisija je odločbo izdala dne 26. septembra 2008.
However, there are changes required to the SPCs of some of the authorised products to bring them in line with the indications and dosing regimens used in the environmental risk assessment.
Odbor je tudi predlagal da je treba ustrezna dovoljenja za promet z zdravilom spremeniti, da bi uskladili indikacije in režime odmerjanja s tistimi, ki so bili uporabljeni v oceni tveganja za okolje.
It will be replaced by Directive (2006/118/EC) which will come into force before 2013.
Člen 35 Direktive 2001/82/ES, kakor je bil spremenjena.
Animal Health
ODBOR ZA ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI (CVMP)
Litvinovska 609/3 190 21 Praha 9
London, 26. septembra 2008 EMEA/402698/2008
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II, spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila pa v Dodatku III.
The CVMP having considered the data provided and the scientific discussion within the Committee concluded that after administration of products containing toltrazuril to the target animal the dose is excreted as a mixture of parent compound and a major metabolite toltrazuril sulfone.
CVMP je na svojem zasedanju julija 2008 ob upoštevanju vseh predloženih podatkov in znanstvene razprave soglasno sprejel mnenje, da je ovrednotenje tveganja, ki ga predstavljata toltrazuril in njegovi glavni presnovek, toltrazuril sulfon, za kopenske rastline in talno vodo, pokazalo, da je uporaba zdravil s toltrazurilom sprejemljiva.
However, in some Member States (Czech Republic, Hungary, Italy, The Netherlands, Portugal and the United Kingdom) administration can be repeated after five days in the face of severe challenge.
Dovoljenja za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo toltrazuril in so namenjena za uporabo pri perutnini, so bila pred tem odobrena družbi Bayer HealthCare in/ali Ceva Santé Animale v Avstriji, Belgiji, Bolgariji, na Cipru, v Češki republiki, Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, na Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Sloveniji, na Nizozemskem in v Združenem kraljestvu po nacionalnih postopkih za odobritev dovoljenja za promet z zdravilom.
Bayer Hungaria Kft.Co.
Poročevalka je bila ga. R. Kearsley, soporočevalec pa g. G. J. Schefferlie.
It should be noted that a second course of treatment is not considered necessary as reported by Marketing Authorisation Holders.
Arbitražni postopek se je začel 11. oktobra 2007 s sprejetjem seznama vprašanj, na katera morajo odgovoriti imetniki dovoljenja za promet.
The data submitted by the Marketing Authorisation Holders was only for chickens and turkeys.
CVMP je predlagal ohranitev dovoljenj za promet z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo toltrazuril in so namenjena za uporabo pri piščancih in puranih.
To assess the risk to human health consideration was given to the consumer safety evaluation with regards to residues of toltrazuril in food products of animal origin.
• razširjena ocena tveganja na osnovi smernic Mednarodnega sodelovanja o uskladitvi tehničnih zahtev za registracijo zdravil za uporabo v veterinarski medicini (VICH) je jasno pokazala, da je treba pri zdravilih za uporabo v veterinarski medicini, ki vsebujejo toltrazuril in so namenjena za uporabo pri perutninskih živalskih vrstah, pričakovati, da bodo vplivala na okolje.
For the exposure assessment the equations according to the CVMP guideline (Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)) were used with modified parameters to reflect the actual use of toltrazuril.
Dne 31. avgusta 2007 je Nemčija sprožila skupno napotitev po členu 35 Direktive 2001/82/ES, kakor je bila spremenjena, za nacionalno odobreno zdravilo Baycox 2,5 % (raztopina za perutnino).
The information provided stressed the importance of the product for use in cases where coccidiostats and vaccination had failed, given the limited availability of other treatments (amprolium, sulphonamides) and the need to rotate these treatments in order to avoid/postpone the development of resistance.
Dne 10. oktobra 2007 je Evropska komisija odločila, da mora obseg napotitve vključevati vsa odobrena zdravila za uporabo v veterinarski medicini, ki vsebujejo toltrazuril (tj. referenčno zdravilo in generična zdravila, ki izvirajo iz tega) in so namenjena za uporabo pri perutninskih živalskih vrstah.
Responses to the CVMP list of questions containing the three points considered by the CVMP (as listed in the opinion) were received from Bayer HealthCare AH (Baycox) and Ceva Santé Animale (Cevazuril).
CVMP se je na zasedanju od 11. do 13. decembra 2007 strinjal z dvomesečnim podaljšanjem roka za predložitev odgovorov na seznam vprašanj, ki ga je zahtevala družba Bayer HealthCare.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 351 ZA VSA ODOBRENA ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI, KI VSEBUJEJO TOLTRAZURIL, NAMENJEN ZA UPORABO PRI PERUTNINI Mednarodno nelastniško ime (INN): Toltrazuril
Package size micrograms/0.5 ml
Velikost pakiranja mikrogramov /0,5 ml
Solution for injection Subcutaneous use pre-filled syringe (glass)
Raztopina za injiciranje Subkutana uporaba napolnjena injekcijska brizga (steklo)
Cartridge in a prefilled pen (250 micrograms/ 0.5 ml)
Vložek v napolnjenem injekcijskem peresniku (250 mikrogramov /0,5 ml)
1 pre-filled pen + 1 needle
1 napolnjen injekcijski peresnik + 1 igla
250 micrograms Solution for injection in pre-filled pen
1 napolnjena injekcijska brizga mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku
Route of Administration
Pot uporabe Ovojnina
In addition there was no evidence of unexpected safety concerns.
Poleg tega ni dokazov za nepričakovane pomisleke glede varnosti.
The recommended dose is one tablet a day, taken with food.
Priporočeni odmerek je ena tableta enkrat dnevno, zaužita s hrano.
What measures are being taken to ensure the safe and effective use of Rezolsta?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rezolsta?
Rezolsta darunavir / cobicistat
Rezolsta darunavir/kobicistat
Other information about Rezolsta
Druge informacije o zdravilu Rezolsta
Overall, 258 patients (82%) achieved this response after 24 weeks of treatment, and 253 patients (81%) at 48 weeks, which was comparable to results previously seen with darunavir plus ritonavir.
Po24 tednih zdravljenja je tak odziv skupno doseglo 258 bolnikov (82 %), po 48 tednih pa 253 bolnikov (81 %), kar je primerljivo s predhodno zabeleženimi rezultati za uporabo darunavirja v kombinaciji z ritonavirjem.
The full EPAR and risk management plan summary for Rezolsta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Rezolsta sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What benefits of Rezolsta have been shown in studies?
Kakšne koristi je zdravilo Rezolsta izkazalo v študijah?
Effectiveness was measured by a reduction in viral load (the amount of HIV-1 virus in the blood) to less than 50 copies/ml.
Učinkovitost so merili glede na zmanjšanje virusnega bremena (količine virusa HIV-1 v krvi) na manj kot 50 kopij/ml.
It is not intended to provide practical advice on how to use Rezolsta.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
This is a summary of the European public assessment report (EPAR) for Rezolsta.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rezolsta.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Rezolsta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Rezolsta večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Rezolsta is available as tablets that contain 800 mg of darunavir and 150 mg of cobicistat.
Zdravilo Rezolsta je na voljo v obliki tablet, ki vsebujejo 800 mg darunavirja in 150 mg kobicistata.
Why is Rezolsta approved?
Zakaj je bilo zdravilo Rezolsta odobreno?
What are the risks associated with Rezolsta?
Kakšna tveganja so povezana z zdravilom Rezolsta?
Darunavir is a protease inhibitor.
Darunavir je zaviralec proteaze.
A risk management plan has been developed to ensure that Rezolsta is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Rezolsta je bil pripravljen načrt obvladovanja tveganj.
When the enzyme is blocked, the virus does not reproduce normally and its increase and spread slows down.
Kadar je encim blokiran, se virus ne razmnožuje normalno, kar upočasni naraščanje količine virusa in njegovo širjenje.
It must also not be used together with certain other medicines as it may interact with them, thereby reducing the effectiveness of treatment or increasing the risk of side effects.
Prav tako se ne sme uporabljati z nekaterimi drugimi zdravili, saj lahko pride do njihovega medsebojnega delovanja, zaradi česar se zmanjša učinkovitost zdravljenja ali poveča tveganje neželenih učinkov.
What is Rezolsta and what is it used for?
Kaj je zdravilo Rezolsta in za kaj se uporablja?
The most serious side effects were rash, diabetes, hypersensitivity (allergic) reactions, vomiting, and ‘immune reconstitution syndrome'.
Najresnejši neželeni učinki so bili izpuščaji, sladkorna bolezen, preobčutljivostne (alergijske) reakcije, bruhanje in „sindrom imunske obnove“.
It blocks an enzyme called protease, which the HIV virus needs to make new copies of itself.
Zavira encim, imenovan proteaza, ki ga virus HIV potrebuje za podvajanje.
Both active substances have already been shown to be effective, and combining them into a single tablet was considered to be more convenient than taking them separately, reducing the risk of errors.
Za obe zdravilni učinkovini je bila učinkovitost že dokazana, njihova združitev v eno samo tableto pa je bila ocenjena kot bolj priročna kot njuno ločeno jemanje, saj se tako zmanjša tveganje napak.
Rezolsta contains two active substances.
Zdravilo Rezolsta vsebuje dve zdravilni učinkovini.
Rezolsta, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Rezolsta v kombinaciji z drugimi zdravili proti virusu HIV zmanjša količino virusa HIV v krvi in jo ohranja na nizki ravni.
Rezolsta is an antiviral medicine used, in combination with other medicines, to treat adults with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo Rezolsta je protivirusno zdravilo, ki se uporablja v kombinaciji z drugimi zdravili za zdravljenje odraslih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Immune reconstitution syndrome happens when the patient's immune system starts working again and fights existing infections, causing inflammation at the site of the infection.
Do sindroma imunske obnove pride, ko prične bolnikov imunski sistem ponovno delovati ter se boriti proti obstoječim okužbam, kar povzroči vnetje na mestu okužbe.
For more information about treatment with Rezolsta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Rezolsta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rezolsta, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Rezolsta in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Cobicistat acts as a ‘booster' to enhance the effects of darunavir, by prolonging the time in which it acts in the body.
Kobicistat deluje kot ojačevalec, ki krepi učinke darunavirja, tako da podaljšuje čas njegovega delovanja v telesu.
Because darunavir and cobicistat have both previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Rezolsta produced similar effects and levels of darunavir in the blood to the two active substances given separately, and to darunavir given with a different booster medicine, ritonavir (an established combination).
Ker je bila učinkovitost darunavirja in kobicistata že dokazana in ker sta odobrena za zdravljenje okužbe z virusom HIV, so bile izvedene študije v glavnem namenjene dokazovanju, da zdravilo Rezolsta dosega enake učinke in ravni darunavirja v krvi kakor zadevni zdravilni učinkovini, uporabljeni ločeno, ter kakor darunavir, uporabljen z drugim ojačevalcem, tj. ritonavirjem (uveljavljena kombinacija).
The most common side effects with Rezolsta (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), and rash.
Najpogostejši neželeni učinki zdravila Rezolsta (ki lahko prizadenejo več kot 1 osebo od 10) so driska, navzeja (slabost) in izpuščaji.
Darunavir is currently authorised as Prezista and cobicistat as Tybost.
Darunavir je trenutno odobren kot zdravilo Prezista, kobicistat pa kot zdravilo Tybost.
Rezolsta does not cure HIV infection or AIDS, but it can delay or reverse the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Rezolsta ne zdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ali ga okrepi ter zavre razvoj okužb in bolezni, ki so povezane z aidsom.
Rezolsta must not be taken by patients who have severely reduced liver function.
Zdravila Rezolsta ne smejo jemati bolniki s hudo okvaro jeter.
Rezolsta can only be obtained with a prescription and treatment should only be started by a doctor who is experienced in managing HIV infection.
Izdaja zdravila Rezolsta je le na recept, zdravljenje pa lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
For practical information about using Rezolsta, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Rezolsta naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The medicine is for use only in patients who have not received HIV treatment before or previously treated patients whose disease is not expected to be resistant to darunavir and who are healthy enough and have HIV virus levels below a certain threshold.
Lahko ga uporabljajo le bolniki, ki še niso prejemali zdravil proti virusu HIV, ali že zdravljeni bolniki, pri katerih ni pričakovati, da je virus HIV odporen na darunavir, ter so dovolj zdravi in so njihove ravni virusa HIV pod določenim pragom.
The European Commission granted a marketing authorisation valid throughout the European Union for Rezolsta on 19/11/2014.
Evropska komisija je dovoljenje za promet z zdravilom Rezolsta, veljavno po vsej Evropski uniji, izdala
For the full list of all side effects reported with Rezolsta, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rezolsta, glejte navodilo za uporabo.
Rezolsta contains the active substances darunavir and cobicistat.
Zdravilo Rezolsta vsebuje zdravilni učinkovini darunavir in kobicistat.
How is Rezolsta used?
Kako se zdravilo Rezolsta uporablja?
How does Rezolsta work?
Kako zdravilo Rezolsta deluje?
In addition, one main study was carried out to examine the safety and effectiveness of darunavir and cobicistat given with other HIV medicines, in 313 adult patients with HIV who had not been previously treated or who had been previously treated and whose infection was not expected to be resistant to darunavir.
V njej je sodelovalo 313 odraslih bolnikov z virusom HIV, ki še niso bili zdravljeni oziroma so že bili zdravljeni, vendar ni bilo pričakovati, da je virus HIV odporen na darunavir.
This summary was last updated in 06-2018.
Povzetek je bil nazadnje posodobljen 04-2017.
Side effects were usually mild to moderate in intensity and occurred mostly in the first week of treatment.
Ti so bili večinoma blagi do zmerni in so se v glavnem pojavili v prvem tednu zdravljenja.
Further information on Zebinix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zebinix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This reduces the activity of the nerve cells in the brain, reducing the intensity and the number of seizures.
Posledica tega je zmanjšanje aktivnosti živčnih celic v možganih ter zmanjšanje silovitosti in števila napadov.
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.
To je vrsta epilepsije, pri kateri prevelika električna dejavnost v enem delu možganov povzroči simptome, kot so nenadni sunkoviti gibi enega dela telesa, motnje sluha, voha ali vida, odrevenelost ali nenaden občutek strahu.
This compared with 25% of patients (10 out of 40) on placebo.
Ta delež je pri bolnikih, ki so prejemali placebo, znašal 25 % (10 od 40).
What measures are being taken to ensure the safe and effective use of Zebinix?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zebinix?
It is available as tablets (200 mg, 400 mg, 600 mg and 800 mg) and as a suspension to be taken by mouth.
Na voljo je v obliki tablet (200-mg, 400-mg, 600-mg in 800-mg) in v obliki suspenzije, ki se jemlje peroralno.
Other information about Zebinix
Druge informacije o zdravilu Zebinix
In these studies, all the children also received other epilepsy medicines.
V teh študijah so vsi otroci prejemali tudi druga zdravila proti epilepsiji.
A second study in children aged 2 to 18 years did not find a difference between Zebinix and placebo, this was explained by the fact that lower doses were used.
V drugi študiji pri otrocih, starih od dve do 18 let, ni bila opažena razlika med zdravilom Zebinix in placebom, kar je bilo pojasnjeno z dejstvom, da so bili uporabljeni nižji odmerki.
All of the patients also received other epilepsy medicines.
Vsi bolniki so prejemali tudi druga zdravila proti epilepsiji.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zebinix have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Zebinix upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Zebinix must not be used in people who are hypersensitive (allergic) to eslicarbazepine acetate, any of the other ingredients or other carboxamide derivatives (medicines with a similar structure to eslicarbazepine acetate, such as carbamazepine or oxcarbazepine).
Zdravila Zebinix ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) eslikarbazepin acetat, katero koli drugo sestavino zdravila ali druge derivate karboksamida (zdravil s podobno zgradbo kot eslikarbazepin acetat, kot sta karbamazepin ali oksikarbazepin).
Zebinix was effective, although slightly less than carbamazepine, at reducing seizures after 6 months of treatment: 71% of patients who took Zebinix and did not prematurely withdraw from the study (276 out of 388 patients) were seizure-free after 6 months compared with 76% of patients taking carbamazepine (300 out of 397 patients).
Zdravilo Zebinix je bilo učinkovito, četudi nekoliko manj kot karbamazepin, pri zmanjšanju napadov po šestih mesecih zdravljenja: 71-% (276 od 388) bolnikov, ki so prejemali zdravilo Zebinix in niso predčasno prekinili študije, je bilo po šestih mesecih brez napadov v primerjavi s 76-% (300 od 397) bolnikov, ki so prejemali karbamazepin.
In clinical trials, around half of the patients treated with Zebinix experienced side effects.
V kliničnih študijah je doživela približno polovica bolnikov, zdravljenih z zdravilom Zebinix, neželene učinke.
The effects of Zebinix were also studied in children with partial-onset seizures.
Učinke zdravila Zebinix so proučevali tudi pri otrocih z napadi parcialnega izvora.
Zebinix can also be used in adolescents and children above 6 years of age, in combination with existing therapies, to treat partial-onset seizures with or without secondary generalisation.
Uporablja se lahko tudi pri mladostnikih in otrocih, starejših od šest let, v kombinaciji z obstoječimi terapijami za zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje.