FrancophonIA/ELRC3.0 huggingface dataset:
English: In the subsequent 1-year open-label extension (Part II) of the phase III study (ITT set N=225) the total responder rate was 46.7% (steadily increasing from 44.9% (weeks 1-4) to 57.5% (weeks > 40)).
Slovenian: del) študije III. faze (nabor ITT N = 225) je bila skupna stopnja odziva 46,7 % (ki je enakomerno naraščala od 44,9 % (1.-4. teden) do 57,5 % (> 40. teden)).
English: What Zebinix looks like and contents of the pack
Slovenian: Izgled zdravila Zebinix in vsebina pakiranja
English: Gently pull the plunger of the oral syringe to the desired volume.
Slovenian: Nežno povlecite bat odmerne brizge do želene količine.
English: Zebinix contains methyl parahydroxybenzoate (E218) and sulphites
Slovenian: Zdravilo Zebinix vsebuje metilparahidroksibenzoat (E218) in sulfite
English: Eslicarbazepine acetate metabolites are eliminated from the systemic circulation primarily by renal excretion, in the unchanged and glucuronide conjugate forms.
Slovenian: Izločanje Presnovki eslikarbazepinacetata se izločajo iz sistemskega obtoka predvsem skozi ledvice, v nespremenjeni obliki in kot glukuronidni konjugat.
English: Based on individual response, the dose of eslicarbazepine acetate may need to be increased if used concomitantly with carbamazepine.
Slovenian: Glede na odziv posameznega bolnika bo morda treba odmerek eslikarbazepinacetata povečati, kadar se ga uporablja sočasno z karbamazepinom.
English: In vitro eslicarbazepine is a weak inducer of CYP3A4 and UDP-glucuronyl transferases.
Slovenian: Eslikarbazepin je in vitro šibek spodbujevalec encima CYP3A4 in UDPglukuroniltransferaz.
English: If you stop taking Zebinix
Slovenian: Če ste prenehali jemati zdravilo Zebinix
English: Place the oral syringe into the mouth against the inside of the cheek.
Slovenian: 9. korak: Odmerno brizgo si dajte v usta proti notranjosti lic.
English: Depending on the response to Zebinix, the dose may be increased by 10 mg per kg body weight, at intervals of one or two weeks, up to 30 mg per kg body weight.
Slovenian: Glede na odziv na zdravilo Zebinix se lahko odmerek povečuje po 10 mg na kg telesne mase v eno- ali dvotedenskih intervalih, do 30 mg na kg telesne mase.
English: The maximum dose is 1,200 mg once daily (see section 5.1).
Slovenian: Največji odmerek je 1.200 mg enkrat dnevno (glejte poglavje 5.1).
English: 200 ml bottle oral syringe (10 ml) (outer pack only)
Slovenian: 200-ml steklenica odmerna brizga (10 ml) (samo zunanja ovojnina)
English: However, based on individual response, the dose may be increased.
Slovenian: Glede na odziv posameznika se odmerek lahko zveča do
English: Plasma levels of eslicarbazepine acetate usually remain below the limit of quantification, following oral administration.
Slovenian: Ravni eslikarbazepinacetata v plazmi po peroralni uporabi običajno ostanejo pod ravnijo kvantifikacije.
English: • Tingling and/or feeling numb in any part of your body;
Slovenian: • bolečina v prsnem košu, • občutek mravljinčenja in/ali otrplosti v katerem koli delu telesa,
English: • Disturbances in the sense of smell;
Slovenian: • motnje vonja,
English: The proportion of patients with exacerbation (increase of ≥25%) compared to the baseline period was 14.2%.
Slovenian: Delež bolnikov s poslabšanjem (povečanjem ≥ 25 %) v primerjavi z izhodiščem je bil
English: • if you have kidney problems.
Slovenian: • če imate težave z ledvicami.
English: • if you have blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of your lips, face, eyelids, throat or tongue.
Slovenian: • če imate mehurje ali luščenje kože in/ali sluznic, izpuščaj, težave pri požiranju ali dihanju in otekanje ustnic, obraza, vek, grla ali jezika.
English: A study in healthy subjects showed no effect of eslicarbazepine acetate 1,200 mg once daily on digoxin pharmacokinetics, suggesting that eslicarbazepine acetate has no effect on the transporter Pglycoprotein.
Slovenian: Digoksin Študija pri zdravih osebah je pokazala, da uporaba 1.200 mg eslikarbazepinacetata enkrat na dan nima učinka na farmakokinetiko digoksina, kar kaže na to, da eslikarbazepinacetat nima učinka na transportni P-glikoprotein.
English: Zebinix oral suspension may be taken with or without food.
Slovenian: Zdravilo Zebinix peroralna suspenzija lahko jemljete s hrano ali brez nje.
English: 20 tablets 30 tablets 60 tablets 90 tablets
Slovenian: 20 tablet 30 tablet 60 tablet 90 tablet
English: Similar to adults, eslicarbazepine acetate is extensively converted to eslicarbazepine.
Slovenian: Podobno kot pri odraslih se eslikarbazepinacetat obširno pretvori v eslikarbazepin.
English: Zebinix 50 mg/ml oral suspension
Slovenian: Zebinix 50 mg/ml peroralna suspenzija
English: In children above 6 years, 36 patients (35.0%) in the eslicarbazepine acetate group compared to 29 patients (30.2%) in the placebo group were responders (p=0.4759) and the least square mean reduction in standardised seizure frequency was higher in the eslicarbazepine acetate group compared to placebo (-24.4% versus -10.5%); however, the difference of 13.9% was not statistically significant (p=0.1040).
Slovenian: Pri otrocih, starih nad 6 let, je bilo odzivnih 36 bolnikov (35,0 %) v skupini z eslikarbazepinacetatom v primerjavi z 29 bolniki (30,2 %) v skupini s placebom (p = 0,4759), in povprečno zmanjšanje najmanjših kvadratov v standardizirani pogostnosti napadov je bilo večje v skupini z eslikarbazepinacetatom v primerjavi s placebom (-24,4 % v primerjavi z -10,5 %); vendar razlika 13,9 % ni bila statistično značilna (p = 0,1040).
English: The efficacy of eslicarbazepine acetate as monotherapy has been demonstrated in a double-blind, active controlled (carbamazepine controlled release) study, involving 815 randomized adult patients with newly diagnosed partial-onset seizures.
Slovenian: Učinkovitost eslikarbazepinacetata kot monoterapije so dokazali v dvojno slepi, z aktivno učinkovino (karbamazepin z nadzorovanim sproščanjem) kontrolirani študiji, v katero je bilo zajetih 815 randomiziranih odraslih bolnikov z na novo diagnosticiranimi parcialnimi epileptičnimi napadi.
English: The total median standardised seizure frequency was 2.4 (resulting in a median relative change from Baseline Part III-V of -22.9%).
Slovenian: Skupna mediana standardizirana pogostnost epileptičnih napadov je bila 2,4 (kar pomeni mediano relativno spremembo -22,9 % v primerjavi z izhodiščno vrednostjo delov III do V).
English: The use of Zebinix is associated with an abnormality in ECG (electrocardiogram) called increase in PR interval.
Slovenian: Uporaba zdravila Zebinix je povezana z nenormalnim pojavom pri elektrokardiogramu (EKG),
English: • Weight increase.
Slovenian: • povečanje telesne mase.
English: BIAL - Portela & Cª , SA
Slovenian: BIAL - Portela & Cª , S.A.
English: Zebinix may make hormonal contraceptives such as the contraceptive pill less effective.
Slovenian: Hormonski kontraceptivi, kot so kontracepcijske tablete, so lahko zaradi zdravila Zebinix manj učinkovita.
English: The safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients were evaluated in one non-controlled study, with a duration of 26 weeks, in 72 elderly (aged ≥ 65 years).
Slovenian: Varnost in učinkovitost eslikarbazepinacetata kot dodatnega zdravljenja pri parcialnih epileptičnih napadih pri starejših bolnikih so ocenili v eni nenadzorovani študiji, ki je trajala 26 tednov, z
English: Zebinix is not recommended if you have severe kidney problems.
Slovenian: Uporaba zdravila Zebinix ni priporočena, če imate hude težave z ledvicami.
English: In vivo eslicarbazepine showed an inducing effect on the metabolism of medicinal products that are mainly eliminated by metabolism through CYP3A4 (e.g. Simvastatin).
Slovenian: Izkazalo se je, da ima eslikarbazepin in vivo spodbujevalni učinek na presnovo zdravil, ki se izločajo predvsem prek sistema CYP3A4 (npr. simvastatin).
English: After first opening, oral suspension may be used for up to 2 months Open date: ---/---/--
Slovenian: EXP Po prvem odprtju se lahko peroralna suspenzija uporablja do 2 mesece.
English: The steady state plasma concentrations are attained after 4 to 5 days of once daily dosing, consistent with an effective half-life in the order of 20-24 hours.
Slovenian: Koncentracije v stanju dinamičnega ravnovesja so dosežene po 4 do 5 dneh odmerjanja enkrat na dan, kar je skladno z efektivnim razpolovnim časom 20-24 h. V študijah pri zdravih osebah je bil razpolovni čas eslikarbazepina
English: Children with ≥60 kg Children with 60 kg or more body weight should take the same dose as adults.
Slovenian: Otroci s ≥ 60 kg Otroci s 60 kg telesne mase ali več jemljejo enak odmerek kot odrasli.
English: Eisai B.V. Tél/Tel: + 31 (0) 900 575 3340
Slovenian: Tél/Tel: + 31 (0) 900 575 3340
English: Zebinix may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment.
Slovenian: Zaradi zdravila Zebinix ste lahko omotični ali dremavi in utegnete imeti motnje vida, zlasti na začetku zdravljenja.
English: Forty-two patients (50.6%) in the eslicarbazepine acetate group compared to 10 patients (25.0%) in the placebo group were responders (≥50% reduction of standardised seizure frequency), resulting in a significant difference (p=0.009).
Slovenian: Dvainštirideset bolnikov (50,6 %) v skupini z eslikarbazepinacetatom v primerjavi z 10 bolniki (25,0 %) v skupini s placebom je bilo odzivnih (≥ 50-% zmanjšanje standardizirane pogostnosti napadov), kar je povzročilo značilno razliko (p = 0,009).
English: In patients concomitantly treated with carbamazepine and eslicarbazepine acetate in placebocontrolled studies, the following adverse reactions were observed: diplopia (11.4% of subjects with concomitant carbamazepine, 2.4% of subjects without concomitant carbamazepine), abnormal coordination (6.7% with concomitant carbamazepine, 2.7% without concomitant carbamazepine), and dizziness (30.0% with concomitant carbamazepine, 11.5% without concomitant carbamazepine), see section 4.5.
Slovenian: Pri bolnikih, ki so v študijah, nadzorovanih s placebom, sočasno prejemali karbamazepin in eslikarbazepinacetat, so opazili naslednje neželene učinke: diplopija (11,4 % oseb, ki so sočasno prejemale karbamazepin, 2,4 % oseb, ki niso sočasno prejemali karbamazepina), nenormalna koordinacija (6,7 % pri sočasni uporabi karbamazepina, 2,7 % brez sočasne uporabe karbamazepina), in omotica (30,0 % pri sočasni uporabi karbamazepina, 11,5 % brez sočasne uporabe karbamazepina),
English: • Medicine toxicity;
Slovenian: • toksičnost zaradi zdravila,
English: The least square mean reduction in standardised seizure frequency from baseline to maintenance period was significantly (p<0.001) higher with eslicarbazepine acetate (-34.8%) compared to placebo (13.8%).
Slovenian: Povprečno zmanjšanje najmanjših kvadratov (LS) v standardizirani pogostnosti napadov od izhodišča do vzdrževalnega obdobja je bilo značilno (p < 0,001) večje z eslikarbazepinacetatom (-34,8 %) v primerjavi s placebom (-13,8 %).
English: Coordination abnormal, memory impairment, amnesia, hypersomnia, sedation, aphasia, dysaesthesia, dystonia, lethargy, parosmia, cerebellar syndrome, convulsion, peripheral neuropathy, nystagmus, speech disorder, dysarthria, burning sensation, paraesthesia, migraine
Slovenian: somnolenca glavobol, motnje pozornosti, tremor, ataksija, motnje ravnotežja nenormalna koordinacija, motnje spomina, amnezija, hipersomnija, sedacija, afazija, disestezija, distonija, letargija, parozmija, cerebralni sindrom, napadi, periferna nevropatija, nistagmus, motnje govora, disartrija,
English: Toxic epidermal necrolysis, StevensJohnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, urticaria
Slovenian: Johnsonov sindrom, reakcija na zdravilo z eozinofilijo in sistemskimi simptomi, angioedem, urtikarija
English: • Charcoal (dark) stool;
Slovenian: • ogleno (temno) blato,
English: The efficacy of eslicarbazepine acetate as conversion to monotherapy was evaluated in 2 double-blind, randomized controlled studies in 365 adult patients with partial-onset seizures.
Slovenian: Učinkovitost eslikarbazepinacetata kot prehoda na monoterapijo so ocenili v 2 dvojno slepih, randomiziranih kontroliranih študijah pri 365 odraslih bolnikih s parcialnimi epileptičnimi napadi.
English: Zebinix is not recommended in patients with severe liver problems.
Slovenian: Zdravilo Zebinix ni priporočeno pri bolnikih s hudimi težavami z jetri.
English: • Initially flu-like symptoms, rash on the face then widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome);
Slovenian: • na začetku gripi podobni simptomi, izpuščaj na obrazu, nato zelo razširjen izpuščaj, visoka telesna temperatura, zvišanje jetrnih encimov, krvne anomalije (eozinofilija), povečane bezgavke in vključenost drugih organov (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi, ki ji pravimo tudi sindrom preobčutljivosti na zdravilo ali s kratico DRESS),
English: The presence of HLA-A*3101 allele may increase the risk for carbamazepine induced cutaneous reactions (mostly less severe) from 5.0% in general population to 26.0% among subjects of European ancestry, whereas its absence may reduce the risk from 5.0% to 3.8%.
Slovenian: (običajno manj resne) od 5,0 % pri splošni populaciji do 26,0 % pri potomcih evropskega porekla, medtem ko lahko njegova odsotnost tveganje zmanjša s 5,0 % na 3,8 %.
English: Aluminium / Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 20, 30, 60 or 90 tablets and in multi-packs containing 180 (2 packs of 90) tablets.
Slovenian: Pretisni omoti iz PVC/aluminija, vloženi v kartonske škatle, ki vsebujejo 20, 30, 60 ali 90 tablet in v skupnih pakiranjih, ki vsebujejo po 180 (2 pakiranji po 90) tablet.
English: Depending on how you respond to Zebinix, your dose may be increased to 1,200 mg once daily.
Slovenian: Glede na vaš odziv na zdravilo Zebinix vam zdravnik lahko odmerek zveča na 1.200 mg enkrat na dan.
English: See ‘Pregnancy and breast-feeding' section for advice about contraception.
Slovenian: Nasveti glede kontracepcije so v poglavju »Nosečnost in dojenje«.
English: In the primary efficacy analysis, in which drop-outs were considered as non-responders, 71.1% subjects were classified as seizure free in the eslicarbazepine acetate group and 75.6% in the carbamazepine controlled release group during the 26 week evaluation period (average risk difference -4.28%, 95% confidence interval: [-10,30; 1,74].
Slovenian: V primarni analizi učinkovitosti, v kateri so tiste, ki so opustili zdravljenje, obravnavali kot neodzivne, je bilo v 26-tedenskem obdobju ocenjevanja v skupini z eslikarbazepinacetatom 71,1 % preskušancev ocenjenih, da nimajo epileptičnih napadov, v skupini s karbamazepinom z nadzorovanim sproščanjem pa 75,6 % (povprečna razlika v tveganju -4,28 %, 95-% interval zaupanja: [-10,30; 1,74]).
English: • blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of your lips, face, eyelids, throat or tongue.
Slovenian: • mehurji ali luščenje kože in/ali sluznic, izpuščaj, težave pri požiranju ali dihanju in otekanje ustnic, obraza, vek, grla ali jezika.
English: Hypertension (including hypertensive crisis), hypotension, orthostatic hypotension, flushing, peripheral coldness
Slovenian: Žilne bolezni hipertenzija (vključno s hipertenzivno krizo), hipotenzija, ortostatska hipotenzija, zardevanje,
English: Zebinix contains the active substance eslicarbazepine acetate.
Slovenian: Zdravilo Zebinix vsebuje učinkovino eslikarbazepinacetat.
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih toksičnost zdravila, padci,
English: Zebinix may make you feel dizzy and/or drowsy, particularly at the beginning of treatment.
Slovenian: Zaradi zdravila Zebinix ste lahko omotični ali dremavi ali oboje, zlasti na začetku zdravljenja.
English: Only a few subjects (N=27) aged above 65 years were treated with eslicarbazepine acetate in monotherapy study.
Slovenian: V študiji monoterapije je bilo z eslikarbazepinacetatom zdravljenih le nekaj preskušancev, starejših od 65 let (N = 27).
English: Insert the bottle adapter in the bottle neck opening.
Slovenian: 3. korak: Prilagodilnik za steklenico vstavite v vrat steklenice.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of multipacks (including blue box)
Slovenian: Zunanja škatla skupnega pakiranja (vključno z "blue box" podatki)
English: Do not use this medicine after the expiry date, which is stated on the bottle and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na steklenici in škatli poleg oznake »EXP«.
English: Zebinix 50 mg/ml is an off-white to white oral suspension.
Slovenian: Zdravilo Zebinix 50 mg/ml je belkasta do bela peroralna suspenzija.
English: EU/1/09/514/021 20 tablets - PVC/ALU blister EU/1/09/514/022 60 tablets - PVC/ALU blister
Slovenian: EU/1/09/514/021 20 tablet - Pretisni omot iz PVC/ALU EU/1/09/514/022 60 tablet - Pretisni omot iz PVC/ALU
English: • Flushing, cold limbs;
Slovenian: • zardevanje, hladne okončine,
English: • the blood thinner - warfarin;
Slovenian: • zdravilo za redčenje krvi varfarin;
English: • carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the following side effects of Zebinix may occur in higher frequency: seeing double, abnormal coordination and dizziness;
Slovenian: • fenitoin (zdravilo za zdravljenje epilepsije), ker bo morda moral prilagoditi odmerek; • karbamazepin (zdravilo za zdravljenje epilepsije), kajti morda bo treba prilagoditi odmerek; med jemanjem zdravila Zebinix se lahko poveča pogostnost naslednjih neželenih učinkov: dvojni vid,
English: Adverse reactions associated with PR interval prolongation (e.g. AV block, syncope, bradycardia) may occur.
Slovenian: Interval PR Uporaba eslikarbazepinacetata je povezana s podaljšanjem intervala PR. Lahko se pojavijo neželeni učinki, povezani s podaljšanjem intervala PR (npr. AV-blok, sinkopa in bradikardija).
English: Remove the bottle, the oral syringe and the bottle adapter from the box Step 2.
Slovenian: 1. korak: Steklenico, odmerno brizgo in prilagodilnik za steklenico vzemite iz škatle.
English: Forty-one patients (30.6%) in the eslicarbazepine acetate group compared to 40 patients (31.0%) in the placebo group were responders (≥50% reduction of standardised seizure frequency), resulting in a non-significant difference (p=0.9017).
Slovenian: Enainštirideset bolnikov (30,6 %) v skupini z eslikarbazepinacetatom v primerjavi s 40 bolniki (31,0 %) v skupini s placebom je bilo odzivnih (≥ 50 % zmanjšanje standardizirane pogostnosti napadov), kar je povzročilo ne-značilno razliko (p = 0,9017).
English: Urticaria and angioedema cases have been reported in patients taking Zebinix.
Slovenian: Pri bolnikih, ki so jemali zdravilo Zebinix, so poročali o primerih urtikarije in angioedema.
English: Dosage should be increased in weekly or bi-weekly increments of 10 mg/kg/day up to 30 mg/kg/day,based on individual response.
Slovenian: Odmerek je možno v tedenskih ali dvotedenskih intervalih povečevati po 10 mg/kg/dan do 30 mg/kg/dan, odvisno od odziva posameznika.
English: Electrolyte imbalance, dehydration, hypochloraemia
Slovenian: Presnovne in prehranske motnje hiponatriemija, zmanjšan apetit neravnovesje elektrolitov, dehidracija, hipokloremija
English: • The active substance is eslicarbazepine acetate.
Slovenian: • Učinkovina je eslikarbazepinacetat.
English: Do not use this medicine after the expiry date, which is stated on the blister, bottle and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu, steklenici in škatli poleg oznake »EXP«.
English: Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat) may occur.
Slovenian: imenovanim podaljšanje intervala PR. Lahko se pojavijo neželeni učinki, povezani s tem pojavom (npr. omedlevica in upočasnitev srčnega utripa).
English: How to take Zebinix
Slovenian: Kako jemati zdravilo Zebinix
English: It is unknown whether eslicarbazepine acetate is excreted in human milk.
Slovenian: Ni znano, ali se eslikarbazepinacetat/presnovki izločajo v materino mleko.
English: The oral suspension is packaged in amber glass bottles with HDPE child resistant closures containing 200 ml oral suspension, inside a cardboard box.
Slovenian: Peroralna suspenzija je pakirana v rjavkaste steklenice z za otroke varno zaporko iz HDPE, ki vsebuje 200 ml peroralne suspenzije, v kartonskih škatlah.
English: Visual impairment, oscillopsia, binocular eye movement disorder, ocular hyperaemia
Slovenian: Očesne bolezni diplopija, zamegljen vid poslabšanje vida, oscilopsija, motnje binokularnega gibanja oči, očesna hiperemija
English: - CLCR <30 ml/min: use is not recommended in patients with severe renal impairment due to insufficient data.
Slovenian: Glede na odziv posameznika se odmerek lahko zveča; - CLCR < 30 ml/min: pri bolnikih s hudo ledvično okvaro uporaba ni priporočljiva zaradi nezadostnih podatkov.
English: Dizziness; somnolence; vertigo; asthenia; gait disturbance; tremor; ataxia; balance disorder; vision blurred; diarrhoea; rash and hyponatraemia were less common in children than in adults.
Slovenian: Omotica, somnolenca, vrtoglavica, astenija, motnje pri hoji, tremor, ataksija, motnje ravnotežja, zamegljen vid, driska, izpuščaj in hiponatriemija so bili pri otrocih manj pogosti kot pri odraslih.
English: The pharmacokinetics of eslicarbazepine acetate is linear and dose-proportional in the range 400-1,200 mg both in healthy subjects and patients.
Slovenian: V razponu od 400 do 1.200 mg je farmakokinetika eslikarbazepinacetata linearna in odvisna od odmerka pri zdravih osebah in pri bolnikih.
English: • Irritability;
Slovenian: • razdražljivost,
English: Zebinix 50 mg/ml oral suspension Eslicarbazepine acetate
Slovenian: Zebinix 50 mg/ml peroralna suspenzija eslikarbazepinacetat
English: In the 10-month study decreases in bone mineral content, bone area and/or bone mineral density in lumbar vertebrae and/or femur were observed in high-dose female animals at exposure levels lower than the clinical exposure levels to eslicarbazepine in children.
Slovenian: V 10-mesečni študiji so pri velikih odmerkih in stopnjah izpostavljenosti, manjših od kliničnih stopenj izpostavljenosti eslikarbazepinu pri otrocih, pri samicah opazili zmanjšanje vsebnosti kostnih mineralov, kostnega predela in/ali mineralne gostote kosti v ledvenih vretencih in/ali stegnenici.
English: - CLCR 30-60 ml/min: initial dose of 200 mg (or 5 mg/kg in children above 6 years) once daily or
Slovenian: - CLCR 30-60 ml/min: začetni odmerek 200 mg (ali 5 mg/kg pri otrocih, starih več kot 6 let) enkrat dnevno ali 400 mg (ali 10 mg/kg pri otrocih, starih več kot 6 let) vsak drugi dan 2 tedna, nato
English: There is limited data on monotherapy regimen available in the erldely population.
Slovenian: Podatkov pri starejši populaciji na monoterapiji kot režimu zdravljenja je malo.
English: Some patients on monotherapy regimen may benefit from a dose of 1,600 mg once daily (see section 5.1).
Slovenian: 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).
English: Alopecia, dry skin, hyperhidrosis, erythema, skin disorder, pruritus, dermatitis allergic
Slovenian: Bolezni kože in podkožja izpuščaj alopecija, suha koža, hiperhidroza, eritem, bolezni kože, pruritus, alergijski dermatitis toksična epidermalna nekroliza, Stevens
English: Children with a body weight of ≥60 kg Children with a body weight of 60 kg or more should be given the same dose as for adults.
Slovenian: Otroci s telesno maso ≥ 60 kg Otroci s telesno maso 60 kg ali več morajo prejeti enak odmerek kot odrasli.