natgillin/translations-raw huggingface dataset:
Off-white to white suspension. 
peroralna suspenzija Belkasta do bela suspenzija.
• Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or lower legs; 
• huda alergijska reakcija, ki povzroči otekanje obraza, grla, dlani, stopal, gležnjev ali spodnjega dela nog,
Zebinix oral suspension contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed) and sulphites which may rarely cause severe hypersensitivity reactions and bronchospasm. 
Zdravilo Zebinix peroralna suspenzija vsebuje metilparahidroksibenzoat (E218), ki lahko povzroči alergijske reakcije (možno tudi zakasnjene), in sulfite, ki lahko redko povzročijo preobčutljivostne reakcije in bronhospazem.
The pharmacokinetics of eslicarbazepine acetate has not been evaluated in patients with severe hepatic impairment (see sections 4.4 and 5.2) and use in these patients is, therefore, not recommended. 
Pri bolnikih s hudo jetrno okvaro farmakokinetike eslikarbazepinacetata niso ocenili (glejte poglavji 4.4 in 5.2), zato uporaba pri teh bolnikih ni priporočljiva.
When initiating or discontinuing treatment with Zebinix or changing the dose, it may take 2 to 3 weeks to reach the new level of enzyme activity. 
Ob začetku ali prenehanju zdravljenja z zdravilom Zebinix, ali pri spreminjanju njegovega odmerka, lahko doseganje nove ravni encimske aktivnosti traja 2 do 3 tedne.
• Difficulty in speaking; 
• težave pri govoru,
• Blood tests showing that you have low levels of salts (including chloride) in your blood or a reduction in red blood cells; 
• krvne preiskave, ki kažejo, da imate nizke ravni soli (vključno s kloridi) v krvi ali zmanjšano število eritrocitov,
Zebinix belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where someone has repeated seizures or fits. 
Zdravilo Zebinix spada v skupino zdravil, imenovanih antiepileptiki, uporablja pa se za zdravljenje epilepsije, bolezni, pri kateri imajo bolniki ponavljajoče se epileptične napade.
At 1 year, the probability for subjects to withdraw due to either adverse reactions or lack of efficacy was 0.26 for eslicarbazepine acetate and 0.21 for carbamazepine controlled release. 
Po enem letu je bila verjetnost, da preskušanec izstopi iz študije zaradi neželenih učinkov ali pomanjkanja učinkovitosti, 0,26 za eslikarbazepinacetat in 0,21 za karbamazepin z nadzorovanim sproščanjem.
Since the relationship between exposure and drug activity is unclear, the monitoring of response to therapy (e.g., cholesterol levels) is recommended. 
Ker je povezava med izpostavljenostjo in delovanjem zdravila nejasna, se priporoca spremljanje odziva na zdravljenje (npr. kontrola koncentracije holesterola v krvi).
Adverse reactions were usually mild to moderate in intensity and occurred predominantly during the first weeks of treatment with eslicarbazepine acetate. 
Neželeni učinki so bili navadno blagi do zmerni, pojavljali pa so se predvsem v prvih tednih zdravljenja z eslikarbazepinacetatom.
• do not take oxcarbazepine (a medicine used to treat epilepsy) with Zebinix, as it is not known whether it is safe to take these medicines together. 
• ne jemljite okskarbazepina (zdravila za zdravljenje epilepsije) skupaj z zdravilom Zebinix, saj ni znano, ali je sočasno jemanje teh dveh zdravil varno.
• Seeing double or blurred vision; 
• dvojni ali zamegljen vid,
On the basis of the scientific conclusions for eslicarbazepine acetate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing eslicarbazepine acetate is unchanged subject to the proposed changes to the product information 
Na podlagi znanstvenih zaključkov za eslikarbazepinacetat skupina CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) eslikarbazepinacetat, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Adverse reactions observed in animal studies occurred at exposure levels appreciably lower than the clinical exposure levels to eslicarbazepine (the principal and pharmacologically active metabolite of eslicarbazepine acetate). 
Neželeni učinki, ki so jih opazili v študijah pri živalih, so se pojavili pri ravneh izpostavljenosti, ki so bile znatno nižje kot klinične ravni izpostavljenosti eslikarbazepinu (glavnemu in farmakološko aktivnemu presnovku eslikarbazepinacetata).
Therefore, their occurrence after treatment with eslicarbazepine acetate cannot be excluded. 
Zato njihovega pojava po zdravljenju z zdravilom eslikarbazepinacetatom ni mogoče izključiti.
• Eye movement changes, fuzzy vision or red eye; 
• spremembe premikanja oči, zamegljen vid ali rdeče oči,
Interactions with other antiepileptic medicinal products 
Interakcije z drugimi antiepileptiki
If signs and symptoms suggestive of these reactions appear, Zebinix should be withdrawn immediately and an alternative treatment considered (as appropriate). 
Če se pojavijo znaki in simptomi, ki kažejo na te reakcije, je treba zdravilo Zebinix takoj ukiniti in razmisliti o drugačnem zdravljenju (skladno s potrebami).
Population pharmacokinetics indicate that in the subgroup of children aged from 2 to 6 years, doses of 27.5 mg/kg/day and 40 mg/kg/day are required in order to achieve exposures that are equivalent to the therapeutic doses of 20 and 30 mg/kg/day in children above 6 years of age. 
Populacijska farmakokinetika kaže, da so v podskupini otrok, starih od 2 do 6 let, potrebni odmerki 27,5 mg/kg/dan in 40 mg/kg/dan, da se dosežejo izpostavljenosti, enakovredne terapevtskim odmerkom 20 in 30 mg/kg/dan pri otrocih, starih več kot 6 let.
Second or third degree atrioventricular (AV) block. 
Atrioventrikularni (AV) blok druge ali tretje stopnje.
On the other hand effective antiepileptic therapy must not be interrupted since the worsening of the disease is harmful to both the mother and the unborn child. 
Po drugi strani se zdravljenje z antiepileptiki ne sme prekiniti, saj je poslabšanje bolezni lahko škodljivo za mater in nerojenega otroka.
Based on comparative bioavailability data for the tablet and the suspension formulations, switching patients from one formulation to the other can be done. 
Na podlagi komparativnih podatkov o biološki razpoložljivosti za tableto in suspenzijo je bolniku mogoče zamenjati farmacevtsko obliko.
Your doctor should be able to advise if a blood test is necessary before taking Zebinix. 
Vaš zdravnik vam bo svetoval, ali je pri vas treba opraviti krvni test, preden začnete uporabljati zdravilo Zebinix.
Studies in animals have shown reproductive toxicity (see Fertility). 
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte Plodnost).
The CHMP recommends that the terms of the marketing authorisation(s) should be varied. 
Skupina CHMP zato priporoča spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom.
Concomitant use of eslicarbazepine acetate with oxcarbazepine is not recommended because this may cause overexposure to the active metabolites. 
Sočasna uporaba eslikarbazepinacetata z okskarbazepinom ni priporočljiva, saj lahko povzroči preveliko izpostavljenost aktivnim presnovkom.
• Low blood pressure or a fall in blood pressure on standing up; 
• nizek krvni tlak ali padec krvnega tlaka ob vstajanju,
In the analysis of treatment failure (seizure risk) based on time to event analysis (Kaplan-Meier analysis and Cox regression), the Kaplan-Meier estimates of seizure risk at the end of the evaluation period was 0.06 with carbamazepine and 0.12 with eslicarbazepine acetate and by the end of 1 year with an additional increased risk to 0.11 with carbamazepine and 0.19 with eslicarbazepine acetate (p=0.0002). 
V analizi neuspešnosti zdravljenja (tveganje za epileptični napad) na osnovi analize časa, ki je pretekel do dogodka (Kaplan-Meierjeva analiza in Coxova regresija), je bila ocena tveganja za epileptični napad po Kaplan-Meierjevi metodi ob zaključku evalvacijskega obdobja 0,06 za karbamazepin in 0,12 za eslikarbazepinacetat, ob preteku enega leta pa se je tveganje dodatno zvišalo na 0,11 za karbamazepin in 0,19 za eslikarbazepinacetat (p = 0,0002).
In addition, there are six post-marketing cases of ‘weight increase' for which the causality was assessed as possibly related to eslicarbazepine acetate by the MAH. 
Poleg tega je bilo v obdobju trženja šest primerov »povečanja telesne mase«, pri katerih je imetnik dovoljenja za promet ocenil, da je možna vzročna povezava z eslikarbazepinacetatom.
• if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients of this medicine (listed in section 6); 
• če ste alergični na eslikarbazepinacetat, druge derivate karboksamida (npr. karbamazepin ali okskarbazepin, zdravili za zdravljenje epilepsije) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Eslicarbazepine is a weak inducer of CYP3A4 and has inhibiting properties with respect to CYP2C19 (as stated in section 4.5). 
Eslikarbazepin je šibak induktor encima CYP3A4 in ima zaviralno deluje na CYP2C19 (kot je navedeno v poglavju 4.5).
If Zebinix is to be discontinued it is recommended to withdraw it gradually to minimise the potential of increased seizure frequency. 
Če je treba uporabo zdravila Zebinix prekiniti, je to priporočljivo storiti postopoma, da se zmanjša možnost zvečane pogostnosti epileptičnih napadov.
Oxcarbazepine and felbamate were not allowed as concomitant medicinal products in these studies. 
Okskarbazepin in felbamat v teh študijah nista bila dovoljena kot sočasno zdravljenje.
Contact a doctor or go to a hospital immediately if you experience any of the above symptoms. 
Takoj poiščite zdravniški nasvet ali pojdite na oddelek za nujno zdravstveno pomoč, če opazite katerega koli od teh simptomov.
Whenever possible, these individuals should be screened for this allele before starting treatment with carbamazepine or chemically-related active substances. 
Če je le mogoče, je treba pri posameznikih teh narodnosti opraviti presejalni pregled za ta alel, preden se začnejo zdraviti s karbamazepinom ali sorodnimi učinkovinami.
The safety and efficacy of eslicarbazepine acetate in children aged 6 years and below has not yet been established. 
Varnost in učinkovitost eslikarbazepinacetata pri otrocih, starih do 6 let, še nista bili dokazani.
Insert the tip of the oral syringe into the bottle adapter opening, keeping the bottle upright. 
Konico odmerne brizge vstavite v odprtino prilagodilnika steklenice, pri tem pa držite steklenico ravno.
Step 5: Hold the oral syringe in place and turn the bottle upside down. 
5. korak: Držite odmerno brizgo in obrnite steklenico navzdol.
Take special care when taking Zebinix to avoid accidental injury, such as fall. 
Med jemanjem zdravila Zebinix bodite posebno previdni, da preprečite nezgodne poškodbe, kot so padci.
From the 815 randomized patients, 401 patients were treated with eslicarbazepine acetate once-daily [271 patients (67.6%) remained at dose of 800 mg, 70 patients (17.5%) remained at dose of 1,200 mg and 60 patients (15.0%) were treated with 1,600 mg]. 
Od 815 randomiziranih bolnikov je bil 401 bolnik zdravljen z eslikarbazepinacetatom enkrat na dan [271 bolnikov (67,6 %) je ostalo pri odmerku 800 mg, 70 bolnikov (17,5 %) je ostalo pri odmerku 1.200 mg in 60 bolnikov (15,0 %) je bilo zdravljenih z odmerkom 1.600 mg].
• Sweating or having dry skin; 
• potenje ali suha koža,
Zebinix is not to be given to children aged 6 years and below. 
Zdravilo Zebinix se ne sme dajati otrokom, starim 6 let ali manj.
The risks that have been identified for Zebinix are mainly class-based, dose-dependent undesirable effects. 
Tveganja, ki so jih ugotovili za zdravilo Zebinix, so pretežno od odmerka odvisni neželeni učinki, ki so značilni za to skupino zdravil.
Pharmacodynamic effect 
Farmakodinamični učinki
In patients with pre-existing renal disease leading to hyponatraemia, or in patients concomitantly treated with medicinal products which may themselves lead to hyponatraemia (e.g. diuretics, desmopressin, carbamazepine), serum sodium levels should be examined before and during treatment with eslicarbazepine acetate. 
Pri bolnikih z obstoječo boleznijo ledvic, ki vodi v hiponatriemijo, ali pri bolnikih, ki sočasno prejemajo zdravila, ki lahko sama povzročajo hiponatriemijo (npr. diuretiki, dezmopresin, karbamazepin), je treba pred zdravljenjem z eslikarbazepinacetatom in med njim preveriti raven natrija.
Zebinix is used: • on its own (monotherapy) in adult patients with newly diagnosed epilepsy 
Zdravilo Zebinix se uporablja: • samostojno (monoterapija) pri odraslih bolnikih z na novo diagnosticirano epilepsijo.
A population pharmacokinetics analysis of phase III studies in epileptic adult patients indicated that concomitant administration with valproate or levetiracetam did not affect the exposure to eslicarbazepine but this has not been verified by conventional interaction studies. 
Valproat in levetiracetam Analiza populacijske farmakokinetike v študijah III. faze pri odraslih bolnikih z epilepsijo je pokazala, da sočasno dajanje valproata ali levetiracetama ne vpliva na izpostavljenost eslikarbazepinu, vendar to ni bilo potrjeno z običajnimi študijami interakcij.
Each ml of oral suspension contains 2.0 mg of methyl parahydroxybenzoate (E218) and approximately 0.00001 mg of sulphites. 
En ml peroralne suspenzije vsebuje 2,0 mg metilparahidroksibenzoata (E218) in približno 0,00001 mg sulfitov.
Rare adverse reactions such as bone marrow depression, anaphylactic reactions, systemic lupus erythematosus or serious cardiac arrhythmias did not occur during the placebo-controlled studies of the epilepsy program with eslicarbazepine acetate. 
Redki neželeni učinki, kot so depresija kostnega mozga, anafilaktične reakcije, sistemski erimatozni lupus ali hude srčne aritmije, se med študijami, nadzorovanimi s placebom programa zdravljenja epilepsije z eslikarbazepinacetatom, niso pojavile.
• hormonal contraceptives (such as the contraceptive pill) since Zebinix may make these less effective; 
• hormonski kontraceptivi (kot je kontracepcijska tabletka), saj lahko zdravilo Zebinix povzroči zmanjšano učinkovitost;
If you take more Zebinix than you should 
Če ste vzeli večji odmerek zdravila Zebinix, kot bi smeli
In the subsequent 3 open-label extensions (ITT set N=148), the overall responder rate was 26.6% when compared to baseline Parts III-V (i.e. the last 4 weeks in part II). 
V poznejših 3 nezaslepljenih podaljšanih obdobjih (nabor ITT N = 148) je bila splošna stopnja odziva 26,6 % v primerjavi z izhodiščno vrednostjo delov III do V (tj. zadnjimi 4 tedni II.
Symptoms include decreased level of thyroid hormone levels (seen in blood tests), cold intolerance, large tongue, thin and brittle fingernails or hair and low body temperature; 
Simptomi vključujejo zmanjšane ravni ščitničnega hormona (to pokažejo krvne preiskave) slabo prenašanje mraza, povečanje jezika, tenke in krhke nohte ali lase ter nizko telesno temperaturo,
Symptoms observed after an overdose of eslicarbazepine acetate are primarily associated with central nervous symptoms (e.g. seizures of all types, status epilepticus) and cardiac disorders (e.g. cardiac arrhythmia). 
Simptomi, ki jih opazimo pri prevelikem odmerjanju eslikarbazepinacetata, so primarno povezani s simptomi osrednjega živčevja (npr. vse vrste epileptičnih napadov, epileptični status) in srčnimi boleznimi (npr. srčna aritmija).
14 patients (9.2%) completed open-label treatment with ESL through Part V. The most common reason for withdrawal during any part of the study was sponsor request (30 patients in part III [19.7% of the patients who entered part III], 9 in part IV [9.6% of the patients who entered part IV], and 43 in part V [64.2% of the patients who entered Part V]). 
Najpogostejši razlog za izstop v katerem koli delu študije je bila zahteva sponzorja (30 bolnikov v III. delu [19,7 % bolnikov, ki so vstopili v III. del], 9 bolnikov v IV. delu [9,6 % bolnikov, ki so vstopili v IV. del] in 43 bolnikov v V. delu [64,2 % bolnikov, ki so vstopili v V. del]).
The efficacy and safety of eslicarbazepine acetate as adjunctive therapy for partial-onset seizures in children was evaluated in one phase II study in children aged from 6 to 16 years (N=123) and one phase III study in children aged from 2 to 18 years (N=304). 
Pediatrična populacija Učinkovitost in varnost eslikarbazepinacetata kot dodatnega zdravljenja pri otrocih s parcialno epilepsijo so ocenili v eni študiji faze II pri otrocih, starih od 6 do 16 let (N = 123) in eni študiji faze III pri otrocih, starih od 2 do 18 let (N = 304).
The overall median relative decrease in Part I was greater in patients treated with ESL (-25.8%) than in patients treated with placebo (-16.4%). 
Splošno mediano relativno zmanjšanje v I. delu je bilo večje pri bolnikih, zdravljenih z eslikarbazepinacetatom (-25,8 %), kot pri bolnikih, zdravljenih s placebom (-16,4 %).
Furthermore, serum sodium levels should be determined if clinical signs of hyponatraemia occur. 
Raven natrija je treba preveriti tudi, če se pojavijo klinični znaki hiponatriemije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate carton of multipacks (without blue box) 
PODATKI NA ZUNANJI OVOJNINI Vmesna škatla pri skupnem pakiranju (brez "blue box" podatkov)
The percentage of subjects with ≥50% reduction (1581 analyzed) in seizure frequency in the phase III studies was 19.3% for placebo, 20.8% for eslicarbazepine acetate 400 mg, 30.5% for eslicarbazepine acetate 800 mg and 35.3% for eslicarbazepine acetate 1,200 mg daily. 
Odstotek bolnikov, pri katerih je prišlo do ≥ 50-odstotnega zmanjšanja (1.581 analiziranih) pogostnosti epileptičnih napadov v študijah III. faze, je 19,3 % za placebo, 20,8 % za eslikarbazepinacetat 400 mg, 30,5 % za eslikarbazepinacetat 800 mg in 35,3 % za eslikarbazepinacetat 1.200 mg na dan.
HLA-A*3101 allele- European descent and Japanese populations 
Alel HLA-A*3101- pri populacijah evropskega porekla in populacijah japonske narodnosti
• Allergy; 
• alergija,
Evidence of nephrotoxicity was observed in repeated dose-toxicity studies in the rat, but was not seen in studies in mice or dogs, and is consistent with an exacerbation of spontaneous chronic progressive nephropathy in this species. 
V študijah toksičnosti pri ponavljajočih se odmerkih pri podganah so opazili znake nefrotoksičnosti, vendar jih v študijah pri miših in psih niso opazili, kar je skladno s poslabšanjem spontane kronične progresivne nefropatije pri tej živalski vrsti.
Of the 183 patients who completed parts I and II of the study, 152 patients were enrolled into part III. 
Od 183 bolnikov, ki so dokončali I. in II.
Zebinix has been given to you by your doctor to reduce your number of seizures. 
Zdravilo Zebinix vam je zdravnik predpisal za zmanjševanje števila epileptičnih napadov.
• Slower or irregular heart beat; 
• počasnejši ali nereden srčni utrip,
• monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; 
• monoterapija pri zdravljenju parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje pri odraslih z na novo diagnosticirano epilepsijo,
Other medicines and Zebinix 
Druga zdravila in zdravilo Zebinix
In studies with eslicarbazepine in fresh human hepatocytes a mild induction of UGT1A1 mediated glucuronidation was observed. 
V študijah z eslikarbazepinom na svežih hepatocitih človeka so opazili blago indukcijo glukuronidacije, pri kateri sodeluje UGT1A1.
If signs or symptoms of hypersensitivity develop, eslicarbazepine acetate must be discontinued immediately and alternative treatment should be initiated. 
Če se pojavijo znaki ali simptomi preobčutljivosti, je treba zdravljenje z eslikarbazepinacetatom takoj prekiniti in uvesti drugačno zdravljenje.
The mechanism by which bone metabolism is affected has not been identified. 
Mehanizem vpliva na presnovo kosti še ni opredeljen.
Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients listed in section 6.1. 
Preobčutljivost na učinkovino, druge derivate karboksamida (npr. karbamazepin, okskarbazepin) ali katero koli pomožno snov, navedeno v poglavju 6.1.
The bottle can be closed with the closure with the bottle adapter still in place. 
Steklenico lahko z zaporko zaprete tudi s prilagodilnikom v njej.
Liver centrilobular hypertrophy was seen in repeated-dose toxicity studies in mice and rats and an increased incidence of liver tumours was observed in the carcinogenicity study in mice; these findings are consistent with an induction of hepatic microsomal enzymes, an effect which has not been observed in patients receiving eslicarbazepine acetate. 
V študijah toksičnosti ponavljajočih se odmerkov pri miših in podganah so opazili centrilobularno hipertrofijo jeter, v študijah kancerogenosti pri miših pa so opazili zvečano pogostnost jetrnih tumorjev; te ugotovitve so skladne z indukcijo mikrosomskih encimov v jetrih, kar je učinek, ki ga pri bolnikih, ki so prejemali eslikarbazepinacetat, niso opazili.
However, in vitro electrophysiological studies indicate that both eslicarbazepine acetate and its metabolites stabilise the inactivated state of voltage-gated sodium channels, precluding their return to the activated state and thereby preventing repetitive neuronal firing. 
Vendar elektrofiziološke študije in vitro kažejo, da eslikarbazepinacetat in njegovi presnovki stabilizirajo neaktivirano stanje natrijevih napetostnih kanalčkov, pri čemer preprečujejo, da bi se vrnili v aktivirano stanje in posledično preprečujejo ponavljajoče se sprožanje nevronov.
Each cardboard box contains a 10 ml polypropylene graduated syringe with 0.2 ml graduations, and a copolymer push-in bottle adapter. 
Vsaka škatla vsebuje 10 ml polipropilensko graduirano injekcijsko brizgo z graduacijami po 0,2 ml in kopolimerski nastavek za steklenico.
Long-term safety data in the paediatric population obtained from open label extensions of the phase III study was consistent with the known safety profile of the product with no new findings of concern. 
Podatki o dolgoročni varnosti pri pediatrični populaciji, pridobljeni v nezaslepljenih podaljšanih obdobjih študije III. faze, so bili skladni z znanim varnostnim profilom zdravila.
Contents of the pack and other information What Zebinix contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Zebinix
The other ingredients are xanthan gum (E415), macrogol-100 stearate, methyl parahydroxybenzoate (E218), saccharin sodium (E954), flavour tutti-frutti artificial (contains maltodextrin, propylene glycol, natural and artificial flavouring, and gum acacia (E414), masking flavour (contains propylene glycol, water and natural and artificial flavouring) and purified water. 
• Druge sestavine so ksantanski gumi (E415), makrogol-100 stearat, metilparahidroksibenzoat (E218), natrijev saharinat (E954), umetna aroma tutti frutti (vsebuje maltodekstrin, propilenglikol, naravne in umetne arome in arabski gumi (E414), prekrivni okus (vsebuje propilenglikol, vodo in naravne ter umetne arome) in prečiščena voda.
To ease the process you should mark the desired volume in the syringe by moving the plunger. 
4. korak: Za poenostavitev postopka označite želeno količino v brizgi s premikom bata.
Based on individual response, the dose of eslicarbazepine acetate may need to be increased and the dose of phenytoin may need to be decreased. 
Glede na odziv posameznika bo morda treba odmerek eslikarbazepinacetata povečati in odmerek fenitoina zmanjšati.
90 tablets. 
90 tablet.
Once inserted, the bottle adapter must not be removed from the bottle. 
Vstavljenega prilagodilnika ne smete odstraniti iz steklenice.
Based on individual response, the dose may be increased to 1,200 mg once daily Some patients on monotherapy regimen may benefit from a dose of 1,600 mg once daily (see section 5.1). 
Glede na odziv posameznika se odmerek lahko zveča do 1.200 mg enkrat na dan. Nekateri bolniki na monoterapiji kot režimu zdravljenja imajo lahko večjo korist pri odmerku 1.600 mg enkrat na dan (glejte poglavje 5.1).
• Dehydration; 
• dehidracija,