natgillin/translations-raw huggingface dataset:
The PRAC in accordance with Article 107j(3) of Directive 2001/83/EC, recommended by majority that a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study, as well as a drug utilisation study (see Annex IV - Conditions of marketing Authorisations); b. the marketing authorisation holders should implement risk minimisation measures; c. the marketing authorisations of the cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products (see Annex I) should be varied (in accordance with changes to the product information as set out in Annex III). 
• v zvezi z alopecijo je PRAC na podlagi vseh razpoložljivih podatkov o varnosti, zlasti v zvezi s tveganji za resne trombembolične dogodke, in zelo omejenih podatkov o učinkovitosti v skladu s členom 116 Direktive 2001/83/ES zaključil, da razmerje med tveganji in koristmi ni pozitivno, zato tovrstna zdravila ne bi smela biti več indicirana za to terapevtsko indikacijo; je PRAC v skladu s členom 107j(3) Direktive 2001/83/ES z večino priporočil: a. naj imetniki dovoljenj za promet sponzorirajo študijo varnosti zdravila v obdobju trženja in nadaljnje vrednotenje rezultatov študije ter tudi študijo uporabe zdravila (glejte Prilogo IVPogoji dovoljenj za promet z zdravili); b. naj imetniki dovoljenj za promet izvajajo ukrepe za zmanjšanje tveganja; c. spremembo (skladno s spremembami informacij o zdravilu, kot je navedeno v Prilogi III) pogojev dovoljenj za promet z zdravili, ki vsebujejo ciproteron acetat/etinilestradiol (2 mg/0,035 mg) (glejte Prilogo I).
Cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products are known to increase risk of thromboembolic events (TE). 
Zdravila, ki vsebujejo ciproteron acetat/etinilestradiol (2 mg/0,035 mg), dokazano povečujejo tveganje za trombembolične dogodke (TED).
The product was authorised firstly in Germany in 1985 and followed the rest of the EU countries. 
Poleg tega zavira sintezo androgenov z negativnim povratnim učinkom na os hipotalamus - hipofizajajčniki.Zdravilo je bilo leta 1985 najprej odobreno v Nemčiji, nato pa še v ostalih državah EU.
A total of 175 cases (all serious, medically confirmed (38.3%, n=67 in total) and non-medically confirmed (61.7%, n=108 in total)) reporting thrombotic / thromboembolic events (TE) irrespective of their nature (arterial, venous and unspecified) occurring in female patients in association with CPA/EE (2mg/0.035mg) were received by the MAH from worldwide sources additionally to the 968 TE cases presented in the main analysis. 
n = skupno 67) in zdravniško nepotrjenih (61,7 %, n = skupno 108)) trombotičnih/trombemboličnih dogodkih (TED) vseh vrst (arterijski, venski ali neopredeljeni), ki so se pri ženskah pojavili v povezavi s CPA/EE (2 mg/0,035 mg).
In this study, around 60% of women prescribed a CPA/EE-containing preparation specifically reported in the baseline questionnaire that their CPA/EE (2mg/0.035mg) prescription was due to acne and/or polycystic ovary syndrome (PCOS). 
V tej študiji je približno 60 % žensk, ki so jim predpisali sredstva, ki vsebujejo CPA/EE, na vprašalniku ob začetku študije izrecno navedlo, da so recept za CPA/EE (2 mg/0,035 mg) prejele zaradi aken in/ali sindroma policističnih jajčnikov (polycystic ovary syndrome - PCOS).
Finally educational material for prescribers on the risk of VTEs and ATEs as well for patients for awareness of the VTEs and ATEs symptoms have been requested by PRAC for submission within the risk management plan. 
PRAC je zahteval tudi, da se v okviru načrta za obvladovanje tveganja predloži izobraževalno gradivo o tveganju za VTE in ATE za zdravstvene delavce, ki bodo predpisovali zdravilo, in gradivo za ozaveščanje bolnic o simptomih VTE in ATE.
Off Label Use 
Uporaba, ki ni skladna z indikacijami
The protocol of drug utilisation study in order to better characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription should be also be submitted as part of the RMP. 
V okviru RMP je treba predložiti tudi protokol študije uporabe zdravila, s katero bi bolje razjasnili prakse pri predpisovanju teh zdravil med običajno klinično uporabo pri reprezentativni skupini zdravstvenih delavcev, ki predpisujejo ta zdravila, in opredelili glavne razloge za predpisovanje.
An increased risk for thrombotic / thromboembolic events (that may be fatal in 1-2% of cases) is listed in the Core company data sheet (CCDS) for CPA/EE (2mg/0.035mg). 
V krovnem dokumentu farmacevtske družbe (Core Company Data Sheet - CCDS) za CPA/EE (2 mg/0,035 mg) je navedeno povečano tveganje za trombotične/trombembolične dogodke (ki se lahko v 1-2 % primerov končajo s smrtnim izidom).
This translates into the global spontaneous reporting rate of 0.10 fatal TE reports per 100,000 womenyears with CPA/EE (2mg/0.035mg). 
To pomeni, da je bila globalna stopnja spontanega poročanja 0,10 poročila o TED s smrtnim izidom na 100 000 žensk-let s CPA/EE (2 mg/0,035 mg).
With exception of study report AI58, no cases of VTEs or ATEs were reported in patients from the 10 MAH- sponsored clinical trials with (CPA/EE) (2mg/0.035mg). 
Razen v poročilu o študiji AI58 v 10 kliničnih preskušanjih s CPA/EE (2 mg/0,035 mg), ki jih je podprl imetnik dovoljenja za promet, pri bolnicah niso zabeležili primerov VTE ali ATE.
This translates into a global spontaneous reporting rate of 1.2 non-fatal TE reports per 100,000 women-years with CPA/EE (2mg/0.035mg). 
To pomeni, da je bila globalna stopnja spontanega poročanja 1,2 poročila o TED brez smrtnega izida na 100 000 žensk-let s CPA/EE (2 mg/0,035 mg).
In this study, around 60% of women prescribed a CPA-containing preparation specifically reported in the baseline questionnaire that their CPA/EE (2mg/0.035mg) prescription was due to acne and/or PCOS. 
V tej študiji je približno 60 % žensk, ki so jim predpisali sredstva, ki vsebujejo CPA, na vprašalniku ob začetku študije izrecno navedlo, da so recept za CPA/EE (2 mg/0,035 mg) prejele zaradi aken in/ali sindroma policističnih jajčnikov.
The PRAC is of the opinion that the benefits of CPA/EE (2mg/0.035mg) containing medicinal products continue to outweigh the risks in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age. 
PRAC je menil, da so koristi zdravil, ki vsebujejo CPA/EE (2 mg/0,035 mg), še naprej večje od z njimi povezanih tveganj pri zdravljenju zmernih do hudih oblik aken, povezanih z občutljivostjo za androgene (z ali brez seboreje), in/ali hirzutizma pri ženskah v rodnem obdobju.
The PRAC concluded that the benefit-risk balance of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products is favourable as the benefits continue to outweigh the risks in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. 
PRAC je zaključil, da je razmerje med koristmi in tveganji za zdravila, ki vsebujejo ciproteron acetat/etinilestradiol (2 mg/0,035 mg), pozitivno, saj so koristi zdravil še naprej večje od z njimi povezanih tveganj pri zdravljenju zmernih do hudih oblik aken, povezanih z občutljivostjo za androgene (z ali brez seboreje), in/ali hirzutizma pri ženskah v rodnem obdobju.
• The PRAC is of the opinion that the benefits of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products continue to outweigh the risks in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age. 
• PRAC je menil, da so koristi zdravil, ki vsebujejo ciproteron acetat/etinilestradiol (2 mg/0,035 mg), še naprej večje od z njimi povezanih tveganj pri zdravljenju zmernih do hudih oblik aken, povezanih s preobčutljivostjo za androgene (z ali brez seboreje), in/ali hirzutizma pri ženskah v rodnem obdobju.
This translates into reporting rate of 1.05 ADR reports per 100,000 women-years with CPA/EE (2mg/0.035mg). 
To pomeni, da je bila stopnja poročanja 1,05 poročila o neželenih učinkih na 100 000 žensk-let s CPA/EE (2 mg/0,035 mg).
This translates into reporting rate of 0.07 ADR reports per 100,000 women-years with CPA/EE (2mg/0.035mg). 
To pomeni, da je bila stopnja poročanja 0,07 poročila o neželenih učinkih na 100 000 žensk-let s CPA/EE (2 mg/0,035 mg).
French assessment report February 2013 Rationale for the triggering of procedure under Article 107i of Directive 2001/83/EC on cyproterone/ethinylestradiol (2mg/0.035mg) presented by ANSM, France history of VTE before prescribing EE-containing medicinal products (e.g. combined oral contraceptives (COC)) is, therefore, recommended in the product information of the products. 
Razlogi za sproženje postopka po členu 107i Direktive 2001/83/ES za ciproteron/etinilestradiol (2 mg/0,035 mg), ki jih je predstavila ANSM, Francija.
Several observational studies have assessed the VTE risk with use of CPA/EE (2mg/0.035mg). 
V primerjalnih krakih teh študij uporabljajo hormonska sredstva, ki vsebujejo CPA/EE (2 mg/0,035 mg).
Hormone preparations containing CPA/EE (2mg/0.035mg) are part of the comparator arms in these studies. 
Tveganje za VTE pri uporabi CPA/EE (2 mg/0,035 mg) so ocenjevali v več opazovalnih študijah.
1 July 2010 
1. julija 2010
The final opinion was converted into a Decision by the European Commission on 1 July 2010. 
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 1. julija 2010.
The referral procedure started on 13 May 2009. 
Napotitveni postopek se je začel dne 13. maja 2009.
Opinion following an Article 35 
Mnenje v zvezi z napotitvijo v skladu s členom 35
The detailed grounds for the re-examination were submitted to the Agency by 18 January 2010 and the procedure started on 19 January 2010. 
Podrobna utemeljitev zahtevka za ponovni pregled je bila agenciji predložena 18. januarja 2010, postopek pa se je začel 19. januarja 2010.
Written explanations were provided by the applicants/marketing authorisation holders on 18 August 2009. 
Predlagatelji/imetniki dovoljenj za promet z zdravilom so pisna pojasnila predložili 18. avgusta 2009.
The rapporteur and co-rapporteur appointed were: Mrs R. Kearsley and Dr J.G. 
Za poročevalca je bila imenovana ga. R. Kearsley, za soporočevalca pa dr. J.G.
During its meeting of 8-10 December 2009 the CVMP appointed Dr J. Hederová as the rapporteur and Dr J. Bureš as the co-rapporteur for the re-examination procedure. 
CVMP je na seji od 8. do 10. decembra 2009 za poročevalko pri ponovnem pregledu imenoval dr. J. Hederovo, za soporočevalca pa dr. J. Bureša.
The issues considered during the re-examination related to the evaluation of the prudent use warnings for specific products and not to the overall CVMP recommendation. 
V ponovnem pregledu so bile obravnavane zadeve v zvezi s presojo opozoril o preudarni rabi za določena zdravila, ne pa splošno priporočilo CVMP.
The aim of the referral was to ensure that the products identified are indicated only for appropriate conditions, that dosage strategies are set to minimise the likelihood of development of antimicrobial resistance and that appropriate withdrawal periods are fixed to guarantee consumer protection. 
Cilj napotitve je bil zagotoviti, da so evidentirana zdravila indicirana le za ustrezna stanja, da so strategije odmerjanja določene tako, da zmanjšajo verjetnost razvoja odpornosti proti protimikrobnim zdravilom, in da so določene ustrezne karence, ki zagotavljajo zaščito potrošnika.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended summary of product characteristics and package leaflet in the Annex III. 
Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II, dopolnjena povzetek glavnih značilnosti zdravila in navodilo za uporabo pa v Dodatku III.
On 23 November 2009, Ascor Chimici s.r.l., and on 3 December 2009, Ceva Santé Animale notified the Agency of their intention to request the re-examination of the CVMP opinion adopted on 11 November 
in Ceva Santé Animale sta 23. novembra 2009 oziroma 3. decembra 2009 obvestili agencijo o svoji nameri, da bosta zahtevali ponovni pregled mnenja CVMP z dne 11. novembra 2009.
On 28 April 2009, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC, regarding all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species. 
Evropska komisija je agenciji 28. aprila 2009 predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2001/82/ES za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kinolone, vključno s fluorokinoloni, in so namenjena za uporabo pri živalskih vrstah za proizvodnjo živil.
referral for all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species 
za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kinolone, vključno s fluorokinoloni, in so namenjena za uporabo pri živalskih vrstah za proizvodnjo živil
On 15 May 2009 the European Commission submitted a revised notification to the Agency, in which it agreed to the CVMP proposal to take a step-wise approach to achieve the aim mentioned above and to limit the scope of the current referral procedure to the harmonisation of the warnings on prudent use included in the Summary of Product Characteristics (SPCs) for these classes of veterinary medicinal product in line with those recommended in the CVMP document “Reflection paper on the use of fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006)”. 
Evropska komisija je agenciji 15. maja 2009 predložila popravljeno obvestilo, v kateri se strinja s predlogom CVMP, da se navedeni cilj doseže postopoma in da se omeji obseg trenutnega napotitvenega postopka na uskladitev opozoril o preudarni rabi, ki so v povzetkih glavnih značilnosti teh zdravil za uporabo v veterinarski medicini, v skladu s priporočenimi besedili v dokumentu CVMP „Razpravni dokument o uporabi fluorokinolonov pri živalskih vrstah za proizvodnjo živil - previdnostni ukrepi za vstavitev v povzetek glavnih značilnosti zdravila s priporočili za preudarno rabo (EMEA/CVMP/416168/2006)“.
Based on the rapporteurs' assessment of the available data, the CVMP adopted, on 11 November 2009, an opinion recommending variations of the marketing authorisations for medicinal products containing (fluoro)quinolones intended for food-producing species in order to amend the SPCs and package leaflets in those cases where these were not in line with the prudent use warnings recommended in the CVMP reflection paper on the use of fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance. 
Na podlagi poročevalčeve ocene razpoložljivih podatkov je CVMP 11. novembra 2009 sprejel mnenje, v katerem priporoča sprememb dovoljenj za promet z zdravili, ki vsebujejo (fluoro)kinolone in so namenjena živalskih vrstam za proizvodnjo živil, da bi se spremenili tisti povzetki glavnih značilnosti zdravila in navodila za uporabo, ki niso skladni s priporočenimi opozorili za preudarno rabo v razpravnem dokumentu CVMP o uporabi fluorokinolonov pri živalskih vrstah za proizvodnjo živilprevidnostni ukrepi za vstavitev v povzetek glavnih značilnosti zdravila s priporočili za preudarno rabo.
On 9 March 2010 the CVMP adopted a final opinion confirming the recommendation, included in its opinion of 11 November 2009, that variations are necessary to the terms of the marketing authorisations for veterinary medicinal products containing (fluoro)quinolones intended for foodproducing species where it has been identified that the SPC and package leaflet have not been updated in line with the precautionary phrases in the CVMP “Reflection paper on the use of fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance” (EMEA/CVMP/416168/2006). 
Dne 9. marca 2010 je CVMP sprejel končno mnenje, v katerem je potrdil priporočilo iz mnenja z dne 11. novembra 2009, da so potrebne spremembe pogojev dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo (fluoro)kinolone in so namenjena živalskim vrstam za proizvodnjo živil, za katera je bilo ugotovljeno, da povzetek glavnih značilnosti zdravila in navodilo za uporabo nista usklajena s previdnostnimi stavki v „Razpravnem dokumentu CVMP o uporabi fluorokinolonov pri živalskih vrstah za proizvodnjo živali - previdnostni ukrepi za vstavitev v povzetek glavnih značilnosti zdravila s priporočili za preudarno rabo (EMEA/CVMP/416168/2006).“ Zaključki CVMP v zvezi z določenimi zdravili, ki so bili obravnavani v ponovnem pregledu, so prikazani v Dodatku II (Znanstveni zaključki) k mnenju CVMP.
Opinion following an Article 35F F referral for all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species 
Mnenje v zvezi z napotitvijo v skladu s členom 35F F za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kinolone, vključno s fluorokinoloni, in so namenjena za uporabo pri živalskih vrstah za proizvodnjo živil EMA/302885/2010
[Actavis logo] 
[Actavis logotip]
Dose and frequency (1) 
odmerjanje in pogostnost (1)
Date of first authorisation: 03 October 2011 Date of latest renewal:08 September 2016 
Datum pridobitve dovoljenja za promet: 3. oktober 2011 Datum zadnjega podaljšanja: 8. september 2016
The results are consistent across age group. 
Rezultati so skladni znotraj posamezne starostne skupine.
A risk of birth defects for your unborn child cannot be completely excluded. 
Tveganje za defekte še nerojenega otroka ni mogoče popolnoma izključiti.
• Do not stop your treatment without your doctor's advice as this could increase your seizures. 
• Ne prekinite zdravljenja brez nasveta vašega zdravnika, ker se lahko napadi še okrepijo.
Other unidentified components accounted only for 0.6 % of the dose. 
Druge, neidentificirane sestavine predstavljajo le 0,6 % odmerka.
Levetiracetam Actavis must be taken twice a day, once in the morning and once in the evening, at about the same time each day. 
Zdravilo Levetiracetam Actavis morate jemati dvakrat na dan, enkrat zjutraj in enkrat zvečer, vsak dan ob približno istem času.
Available data in children did not suggest impact on growth and puberty. 
Podatki, ki so na razpolago pri otrocih, ne kažejo vpliva na rast in puberteto.
No impact on fertility was detected in animal studies (see section 5.3). 
Plodnost V študijah na živalih vpliva na plodnost niso odkrili (glejte poglavje 5.3).
The mechanism of action of levetiracetam still remains to be fully elucidated. 
Mehanizem delovanja Mehanizem delovanja levetiracetama še vedno ni popolnoma pojasnjen.
Your doctor will establish the best possible treatment of overdose. 
Zdravnik vam bo določil najboljše možno zdravljenje prevelikega odmerjanja.
Elderly (65 years and older) 
Posebne populacije Starejši (65 let in starejši)
The major metabolic pathway (24 % of the dose) is an enzymatic hydrolysis of the acetamide group. 
Glavna presnovna pot (24 % odmerka) je encimska hidroliza acetamidne skupine.
He/she may decide if your dose should be adjusted. 
Odloči se bo, ali je vaš odmerek potrebno prilagoditi.
This decrease is more pronounced during the third trimester (up to 60 % of baseline concentration before pregnancy). 
To zmanjšanje koncentracije je bolj izrazito v času tretjega trimesečja (do 60% glede na običajno koncentracijo pred nosečnostjo).
No data are available. 
Na razpolago ni nobenih podatkov.
The major route of excretion was via urine, accounting for a mean 95 % of the dose (approximately 93 % of the dose was excreted within 48 hours). 
Glavna pot izločanja je z urinom, s katerim se izloči povprečno 95 % odmerka (približno 93 % odmerka se izloči v 48 urah).
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
This effect was pronounced for the younger infants, and subsided as age increased, to become negligible around 4 years of age. 
Ta učinek je bil izrazit pri mlajših dojenčkih, z naraščanjem let je upadal in postal zanemarljiv okoli 4.
• if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na levetiracetam, pirolidonske derivate ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
You should not drive or use machines until it is established that your ability to perform such activities is not affected. 
Ne smete voziti ali upravljati s stroji, dokler ni potrjeno, da ni vpliva na vašo sposobnost izvajanja teh dejavnosti.
* The colourants are: 
*barvila so:
Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected. 
Bolnikom svetujemo, naj ne vozijo ali upravljajo strojev, dokler ni potrjeno, da ni vpliva na njihovo sposobnost izvajanja teh dejavnosti.
• decreased number of all blood cell types; 
• zmanjšano število vseh tipov krvnih celic
• limp or difficulty walking 
• šepanje ali težave pri hoji
Infants 1 to less than 6 months 
Dojenčki od 1 do manj kot 6 mesecev
Levetiracetam Actavis may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. 
Zdravilo Levetiracetam Actavis lahko oslabi vašo sposobnost vožnje ali upravljanja z orodjem ali stroji, saj lahko povzroči zaspanost.
<1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000). 
redki: (≥1/10.000 do <1/1.000) in zelo redki: (<1/10.000).
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14. 
Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki, Oznaka ATC: N03AX14.
• If you suffer from kidney problems, follow your doctor's instructions. 
• če imate težave z ledvicami, upoštevajte zdravnikova navodila.
The daily dose is administered in two equally divided doses. 
Dnevni odmerek se daje razdeljen v dva enaka odmerka.
The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only. 
Bolniki so morali imeti neizzvane napade parcialnega izvora ali samo generalizirane tonično-klonične napade.
Therefore, patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. 
Zato je treba bolnike med zdravljenjem nadzirati glede znakov depresije in/ali samomorilnega razmišljanja in vedenja ter razmisliti o ustreznem zdravljenju.
Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening. 
Na primer: če je vaš dnevni odmerek 1000 mg, lahko vzamete 2 tableti po 250 mg zjutraj in 2 tableti po 250 mg zvečer.
To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. 
Za uporabo te tabele je potrebno predhodno oceniti bolnikov očistek kreatinina (CLcr) v ml/min.
• A small number of people being treated with anti-epileptics such as Levetiracetam Actavis have had thoughts of harming or killing themselves. 
• pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki kot je zdravilo Levetiracetam Actavis, so se pojavile misli na samopoškodovanje ali samomor.
Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to 
Neželeni učinki so navedeni po padajoči resnosti in njihova pogostnost je opredeljena takole: zelo pogosti: (≥1/10); pogosti: (≥1/100 do <1/10); občasni: (≥1/1.000 do <1/100);
The apparent body weight adjusted clearance was approximately 30 % higher than in epileptic adults. 
Navidezni telesni očistek je bil približno 30 % večji kot pri odraslih z epilepsijo.