FrancophonIA/ELRC3.0 huggingface dataset:
English: WHAT TOPAMAX IS AND WHAT IT IS USED FOR:
Slovenian: KAJ JE ZDRAVILO TOPAMAX IN ZA KAJ GA UPORABLJAMO
English: Topiramate is a sulfamate-substituted monosaccharide.
Slovenian: Topiramat je s sulfamatom substituiran monosaharid.
English: Very common Common
Slovenian: zelo pogosti pogosti
English: Risperidone
Slovenian: Risperidon
English: [See Annex I - To be completed nationally] {Name and Address} <{tel}> <{fax}> <{e-mail}>
Slovenian: [glejte Dodatek I - Izpolni država članica] {Ime in naslov} <{tel}> <{fax}> <{e-mail}>
English: Concomitant administration of Topamax and alcohol or other CNS depressant medicinal products has not been evaluated in clinical studies.
Slovenian: Sočasne uporabe zdravila Topamax z alkoholom ali drugimi zdravili, ki delujejo zaviralno na osrednje živčevje, niso ovrednotili v kliničnih študijah.
English: Topiramate is not extensively metabolized (~20%) in healthy volunteers.
Slovenian: Pri zdravih prostovoljcih se topiramat le malo presnavlja (~20 %).
English: Topiramate increased the frequency at which γ-aminobutyrate (GABA) activated GABAA receptors, and enhanced the ability of GABA to induce a flux of chloride ions into neurons, suggesting that topiramate potentiates the activity of this inhibitory neurotransmitter.
Slovenian: Topiramat je tudi povečal pogostnost aktivacije receptorjev GABAA z γ-aminobutiratom in okrepil sposobnost GABA za sprožanje pretoka kloridnih ionov v nevrone, kar kaže, da topiramat okrepi delovanje tega zaviralnega živčnega prenašalca.
English: These measures generally result in a decrease in intraocular pressure.
Slovenian: Z omenjenimi ukrepi običajno lahko dosežemo zmanjšanje očesnega tlaka.
English: Topiramate inhibits the enzyme CYP 2C19 and may interfere with other substances metabolized via this enzyme (e.g., diazepam, imipramin, moclobemide, proguanil, omeprazol).
Slovenian: Topiramat zavira delovanje encina CYP 2C19 in lahko vpliva na druge učinkovine, ki se presnavljajo s tem encimom (npr. diazepam, imipramin, moklobemid, progvanil, omeprazol).
English: Similarly, the link between migraine and ischaemic stroke is not proven.
Slovenian: Podobno ni dokazana povezava med migreno in ishemično kapjo.
English: Plasma clearance of topiramate is decreased in patients with moderate to severe hepatic impairment.
Slovenian: Plazemski očistek topiramata je zmanjšan pri bolnikih z zmerno do hudo jetrno okvaro.
English: In the adult population, topiramate at doses equal to or higher than 100 mg showed greater reductions in monthly migraine attacks than placebo.
Slovenian: V populaciji odraslih bolnikov je topiramat v odmerkih vsaj 100 mg pokazal večja zmanjšanja mesečnega števila napadov migrene v primerjavi s placebom.
English: • Drowsiness or sleepiness
Slovenian: • dremavost ali zaspanost
English: Studies in mice receiving concomitant administration of topiramate and carbamazepine or phenobarbital showed synergistic anticonvulsant activity, while combination with phenytoin showed additive anticonvulsant activity.
Slovenian: Študije pri miših, ki so jim sočasno dajali topiramat in karbamazepin ali fenobarbital, so pokazale sinergistično antikonvulzivno delovanje, medtem ko je bilo pri kombiniranju s fenitoinom vidno aditivno antikonvulzivno delovanje.
English: The results of this study indicate that topiramate Cmax increased by 27% and AUC increased by 29% when HCTZ was added to topiramate.
Slovenian: Izsledki študije so pokazali, da se je po dodatku HCTZ topiramatu Cmax topiramata povečala za 27 %, AUC pa za 29 %.
English: A 15% decrease in the AUCτ,ss of pioglitazone with no alteration in Cmax,ss was observed.
Slovenian: Opazili so 15 % zmanjšanje vrednosti AUCτ,ss za pioglitazon, brez sprememb v vrednosti Cmax,ss, vendar ta izsledek ni bil statistično značilen.
English: Topiramate
Slovenian: topiramat
English: ↔ 17% increase in Cmax for 4OH propranolol (TPM 50 mg q12h)
Slovenian: ↔ 17 % povečanje vrednosti Cmax za 4-OH propranolol (TPM 50 mg/12 ur)
English: This should be done by titrating to clinical effect.
Slovenian: To opravite s titracijo odmerka do doseganja kliničnega učinka.
English: The addition or withdrawal of valproic acid does not produce clinically significant changes in plasma concentrations of Topamax and, therefore, does not warrant dosage adjustment of Topamax.
Slovenian: Pri dodatku ali ukinitvi valprojske kisline pa ni klinično pomembnih sprememb plazemske koncentracije zdravila Topamax, zato v tem primeru ni potrebna prilagoditev odmerka zdravila Topamax.
English: 20 film-coated tablets with desiccant 28 film-coated tablets with desiccant 50 film-coated tablets with desiccant 56 film-coated tablets with desiccant 60 film-coated tablets with desiccant 100 film-coated tablets with desiccant
Slovenian: 20 filmsko obloženih tablet s sušilnim sredstvom 28 filmsko obloženih tablet s sušilnim sredstvom 50 filmsko obloženih tablet s sušilnim sredstvom 56 filmsko obloženih tablet s sušilnim sredstvom 60 filmsko obloženih tablet s sušilnim sredstvom 100 filmsko obloženih tablet s sušilnim sredstvom
English: These decreases are usually mild to moderate (average decrease of 4 mmol/l at doses of 100 mg/day or above in adults and at approximately 6 mg/kg/day in paediatric patients).
Slovenian: Takšna zmanjšanja so običajno blaga do zmerna (povprečno za 4 mmol/l pri odmerkih 100 mg/dan ali več pri odraslih oziroma za približno 6 mg/kg/dan pri otrocih).
English: Topiramate showed a reduction of PTGC seizures rate in the American/CR study, and when both studies were combined.
Slovenian: Topiramat je izkazal znižanje stopnje primarnih generaliziranih tonično-kloničnih napadov v ameriško-kostariški študiji in po združitvi obeh študij.
English: Dihydroergotamine (Oral and Subcutaneous) Haloperidol
Slovenian: dihidroergotamin (peroralna in subkutana uporaba) haloperidol
English: Phenytoin and carbamazepine decrease the plasma concentration of topimarate.
Slovenian: Fenitoin in karbamazepin zmanjšujeta plazemsko koncentracijo zdravila Topamax.
English: This decrease in serum bicarbonate is due to the inhibitory effect of topiramate on renal carbonic anhydrase.
Slovenian: Zmanjšanje koncentracije hidrogenkarbonata v serumu je posledica zaviralnega učinka topiramata na encim karboanhidrazo v ledvicah.
English: It is recommended that Topamax not be used concomitantly with alcohol or other CNS depressant medicinal products.
Slovenian: Priporočljivo je, da zdravila Topamax ne uporabljate sočasno z alkoholom ali drugimi zdravili, ki delujejo zaviralno na osrednje živčevje.
English: There is evidence of renal tubular reabsorption of topiramate.
Slovenian: Obstajajo dokazi o tubularni reabsorpciji topiramata v ledvicah.
English: In addition, data from these registries and other studies suggest that, compared with monotherapy, there may be an increased risk of teratogenic effects associated with the use of anti-epileptic drugs in combination therapy.
Slovenian: Podatki iz registrov nosečnosti in drugih študij kažejo tudi na povečano tveganje za pojav teratogenih učinkov povezanih z uporabo kombinirane terapije z antiepileptiki v primerjavi z monoterapijo.
English: • Problems with handwriting
Slovenian: • težave s pisanjem
English: In healthy volunteers, there was an observed reduction (18% for AUC) in systemic exposure for lithium during concomitant administration with topiramate 200 mg/day.
Slovenian: Pri zdravih prostovoljcih so opazili zmanjšanje sistemske izpostavljenosti litiju (za 18 % pri AUC) med sočasno uporabo s topiramatom v odmerkih po 200 mg/dan.
English: There have been no new toxicology data produced by the MAH in support of topiramate, other than an oral toxicity study in juvenile rats.
Slovenian: Imetnik dovoljenja za promet z zdravilom v podporo topiramatu ni pridobil novih toksikoloških podatkov, razen študije peroralne toksičnosti pri mladih podganah.
English: • Increased appetite
Slovenian: • zvečan apetit
English: On rare occasions, the addition of topiramate to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome.
Slovenian: V redkih primerih lahko dodatek zdravila Topamax k zdravljenju s fenitoinom zahteva prilagoditev odmerka fenitoina za doseganje optimalnega kliničnega učinka.
English: The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response.
Slovenian: Nato odmerek povečujte v tedenskih ali dvotedenskih presledkih po 1 do 3 mg/kg/dan (ki naj ga prejmejo v dveh enakih odmerkih), da boste dosegli optimalen klinični odziv.
English: In patients with bipolar disorder, the pharmacokinetics of lithium were unaffected during treatment with topiramate at doses of 200 mg/day; however, there was an observed increase in systemic exposure (26% for AUC) following topiramate doses of up to 600 mg/day.
Slovenian: Pri bolnikih z bipolarno motnjo zdravljenje s topiramatom v odmerkih po 200 mg/dan ni vplivalo na farmakokinetiko litija, vendar so opazili povečanje sistemske izpostavljenosti (za 26 % pri AUC) pri jemanju topiramata v odmerkih do 600 mg/dan.
English: However, differences in AUC for the total active moiety between treatment with risperidone alone and combination treatment with topiramate were not statistically significant.
Slovenian: Vendar razlike v AUC aktivne frakcije risperidona pri zdravljenju samo z risperidonom in v kombinaciji s topiramatom niso bile statistično značilne.
English: The mean Cmax following multiple, twice a day oral doses of 100 mg to healthy subjects was 6.76 µg/ml.
Slovenian: Srednja vrednost Cmax po večkratnem dajanju 100 mg peroralnih odmerkov dvakrat na dan pri zdravih prostovoljcih je znašala 6,76 μg/ml.
English: Following oral administration of 100 mg topiramate to healthy subjects, a mean peak plasma concentration (Cmax) of 1.5 µg/ml was achieved within 2 to 3 hours (Tmax).
Slovenian: Po peroralnem dajanju 100 mg topiramata zdravim preiskovancem je bila srednja vrednost njegove največje plazemske koncentracije (Cmax) 1,5 μg/ml dosežena v 2 do 3 urah (Tmax).
English: In clinical trials, daily dosages were decreased in weekly intervals by 50-100 mg in adults with epilepsy and by 25-50 mg in adults receiving topiramate at doses up to 100 mg/day for migraine prophylaxis.
Slovenian: V kliničnih preskušanjih so dnevne odmerke zmanjševali v razmikih po en teden, in sicer za 50-100 mg pri odraslih z epilepsijo in za 25-50 mg pri odraslih, ki so prejemali topiramat v odmerkih do 100 mg/dan za profilakso migrene.
English: Drink fluids right after to make sure all of the food and medicine mixture is swallowed.
Slovenian: Takoj potem popijte malo tekočine, da boste zagotovo pogoltnili vso mešanico hrane in zdravila.
English: The addition of Topamax to other antiepileptic drugs (phenytoin, carbamazepine, valproic acid, phenobarbital, primidone) has no effect on their steady-state plasma concentrations, except in the occasional patient, where the addition of Topamax to phenytoin may result in an increase of plasma concentrations of phenytoin.
Slovenian: Dodatek zdravila Topamax drugim antiepileptikom (fenitoinu, karbamazepinu, valprojski kislini, fenobarbitalu, primidonu) ne vpliva na njihove plazemske koncentracije v stanju dinamičnega ravnovesja, razen pri nekaterih bolnikih, pri katerih lahko dodatek zdravila Topamax zdravljenju s fenitoinom povzroči povečanje plazemske koncentracije fenitoina, ki bi lahko nastalo kot posledica zaviranja poliformne izooblike specifičnega encima (CYP2C19).
English: A pharmacokinetic interaction study of patients with epilepsy indicated the addition of topiramate to lamotrigine had no effect on steady state plasma concentration of lamotrigine at topiramate doses of 100 to 400 mg/day.
Slovenian: Študija farmakokinetičnih interakcij pri bolnikih z epilepsijo je pokazala, da dodatek topiramata lamotriginu ne vpliva na plazemske koncentracije lamotrigina v stanju dinamičnega ravnovesja pri odmerkih topiramata od 100 do 400 mg/dan.
English: Janssen-Cilag SpA - IT Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy
Slovenian: Janssen-Cilag SpA - IT Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italija
English: 4.4 - Special warnings and precautions for use
Slovenian: 4.4 - Posebna opozorila in previdnostni ukrepi
English: General dosing recommendations for Topamax in special patient populations
Slovenian: Splošna priporočila za odmerjanje zdravila Topamax pri posebnih populacijah bolnikov
English: • Pain in the kidney area and/or bladder caused by kidney stones
Slovenian: • bolečino v predelu ledvic in/ali mehurja, zaradi ledvičnih kamnov
English: The pharmacokinetic profile of topiramate compared to other antiepileptic drugs shows a long plasma halflife, linear pharmacokinetics, predominantly renal clearance, absence of significant protein binding, and lack of clinically relevant active metabolites.
Slovenian: V primerjavi z drugimi antiepileptiki kaže farmakokinetični profil topiramata dolgo razpolovno dobo v plazmi ter linearno farmakokinetiko, izločanje pretežno z ledvicami, ni pomembne vezave na beljakovine in klinično pomembnih aktivnih presnovkov.
English: Janssen-Cilag A/S - DK Hammerbakken 19, 3460 Birkerød, Denmark
Slovenian: Janssen-Cilag A/S - DK Hammerbakken 19, 3460 Birkerød, Danska
English: Sometimes the dose of some of your other medicines or Topamax will have to be adjusted.
Slovenian: Včasih je treba tudi prilagoditi odmerek drugih zdravil, ki jih jemljete, ali pa odmerek zdravila Topamax.
English: Venlafaxine Flunarizine
Slovenian: venlafaksin flunarizin
English: In well-controlled add-on trials, no correlation has been demonstrated between trough plasma concentrations of topiramate and its clinical efficacy.
Slovenian: V dobro nadzorovanih preskušanjih dodatnega zdravljenja s topiramatom niso ugotovili korelacije med najnižjimi plazemskimi koncentracijami topiramata in njegovo klinično učinkovitostjo.
English: • Muscle spasms, muscle twitching or muscle weakness
Slovenian: • mišične krče, trzanje mišic ali šibkost mišic
English: High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Slovenian: High Wycombe Buckinghamshire HP14 4HJ Združeno kraljestvo
English: Metabolic acidosis
Slovenian: Metabolična acidoza
English: It has been noted that weight loss is a pertinent feature of treatment with topiramate in some patients and a warning stating that patients on long term topiramate treatment should be regularly weighed and monitored for continuing weight loss has been included.
Slovenian: Izpostavljeno je bilo, da je zmanjšanje telesne mase pri določenih bolnikih pomembna značilnost zdravljenja s topiramatom, zato je bilo vključeno opozorilo, da je treba redno ugotavljati telesno maso bolnikov na dolgoročnem zdravljenju s topiramatom ter jih spremljati zaradi morebitne nadaljnje izgube telesne mase.
English: ≥1/1,000 to <1/100
Slovenian: ≥ 1/1000 do < 1/100
English: Effects of other antiepileptic medicinal products on Topamax
Slovenian: Vpliv drugih antiepileptikov na zdravilo Topamax
English: Systemic exposure of the active metabolites, 4-trans-hydroxy-glyburide (M1) and 3-cis-hydroxyglyburide (M2), were also reduced by 13% and 15%, respectively.
Slovenian: Tudi stopnja sistemske izpostavljenosti aktivnim presnovkom je bila zmanjšana, in sicer za 13 % pri 4-trans-hidroksi-gliburidu (M1) in za 15 % pri 3-cis-hidroksigliburidu (M2).
English: Effects of Topamax on other antiepileptic medicinal products
Slovenian: Vpliv zdravila Topamax na druge antiepileptike
English: In rats, topiramate crosses the placental barrier.
Slovenian: Pri podganah topiramat prehaja preko placente.
English: It is recommended that therapy be initiated at a low dose followed by titration to an effective dose.
Slovenian: Priporočljivo je, da zdravilo uvedete v majhnem odmerku, ki ga nato postopno zvečujete do učinkovitega odmerka.
English: You can take Topamax with or without food.
Slovenian: Zdravilo Topamax lahko jemljete s hrano ali brez.
English: • Eye problems including dry eyes, light sensitivity, involuntary twitching, tearing and decreased vision
Slovenian: • težave z očmi, vključno s suhimi očmi, občutljivostjo za svetlobo, nenamernim trzanjem,
English: Concomitant administration of topiramate and valproic acid has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either medicinal product alone.
Slovenian: Sočasna uporaba topiramata in valprojske kisline je bila povezana s pojavom hiperamonemije z ali brez encefalopatije pri bolnikih, ki so ti dve zdravili dobro prenašali posamezno.
English: The pharmacokinetics of topiramate in children, as in adults receiving add-on therapy, are linear, with clearance independent of dose and steady-state plasma concentrations increasing in proportion to dose.
Slovenian: Farmakokinetični podatki o uporabi topiramata pri otrocih, kakor tudi pri odraslih, ki so ga prejemali kot adjuvantno terapijo, so bili linearni, pri čemer je bil očistek neodvisen od odmerka, plazemske koncentracije v stanju dinamičnega ravnovesja pa so naraščale sorazmerno odmerku.
English: The pharmacokinetics of topiramate are linear with plasma clearance remaining constant and area under the plasma concentration curve increasing in a dose-proportional manner over a 100 to 400 mg single oral dose range in healthy subjects.
Slovenian: Farmakokinetika topiramata je linearna, njegov plazemski očistek je konstanten in pri zdravih preiskovancih površina pod krivuljo plazemske koncentracije v odvisnosti od časa narašča sorazmerno odmerku v razponu enkratnih peroralnih odmerkov od 100 mg do 400 mg.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: Overdoses of topiramate have been reported.
Slovenian: Poročali so o primerih prevelikega odmerjanja topiramata.
English: • Painful or burning sensations in the mouth
Slovenian: • boleč ali pekoč občutek v ustih
English: The recommended total daily dose of Topamax (topiramate) as adjunctive therapy is approximately 5 to 9 mg/kg/day in two divided doses.
Slovenian: Priporočeni skupni dnevni odmerek zdravila Topamax (topiramat) za dodatno zdravljenje je približno 5 do 9 mg/kg/dan v dveh enakih odmerkih.
English: • with other medicines to treat seizures in adults and children over age 2
Slovenian: • skupaj z drugimi zdravili za zdravljenje epileptičnih napadov pri odraslih in otrocih, starejših od
English: A number of areas of disharmony in the product information for topirmate have been evaluated by the CHMP and the revised Product Information (PI) was adopted.
Slovenian: CHMP je ovrednotil številna področja neusklajenosti podatkov o zdravilu za topiramat in sprejel popravljene podatke o zdravilu.
English: The most frequently reported AE's when topiramate was added to risperidone treatment were: somnolence (27% and 12%), paraesthesia (22% and 0%) and nausea (18% and 9% respectively).
Slovenian: Po dodatku topiramata so najpogosteje poročali o somnolenci (27% po in 12% pred uvedbo topiramata), parestezijah (22% in 0%) in navzei (18% in
English: Topiramate enhances γ-aminobutyrate-activated chloride channels and inhibits excitatory neurotransmission, through actions on kainate subtypes of glutamate receptors and ∝-amino-3-hydroxy-5-methylisoxazole-4-propionic acid receptors.
Slovenian: Topiramat pospešuje z γ-aminobutiratom aktivirane kloridne kanale in zavira eksitacijsko nevrotransmisijo zaradi učinkov na kainatne podtipe glutamatnih receptorjev in receptorjev ∝-amino-3-hidroksi-5-metilizoksazol-4-propionske kisline.
English: • Depression
Slovenian: • depresijo.
English: Nervous system disorders
Slovenian: Zaviralci osrednjega živčevja
English: The results of this study indicated that metformin mean Cmax and mean AUC0-12h increased by 18% and 25%, respectively, while mean CL/F decreased 20% when metformin was co-administered with topiramate.
Slovenian: Izsledki študije so pokazali, da se je srednja vrednost Cmax metformina povečala za 18 %, srednja vrednost AUC0-12h pa za 25 %, medtem, ko se je srednja vrednost količnika CL/F zmanjšala za 20 %, pri sočasni uporabi metformina in topiramata.
English: Other medicines you should discuss with your doctor or pharmacist include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glyburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarazine
Slovenian: Z zdravnikom ali farmacevtom se posvetujte tudi če uporabljate druga zdravila, kot so drugi antiepileptiki, risperidon, litij, hidroklortiazid, metformin, pioglitazon, gliburid, amitriptilin, propranolol, diltiazem, venlafaksin ali flunarizin.
English: • other medicines that impair or decrease your thinking, concentration, or muscle coordination (e.g.
Slovenian: • druga zdravila, ki lahko oslabijo ali zmanjšajo sposobnost razmišljanja, koncentracije ali mišične koordinacije (npr. zdravila, ki zavirajo delovanje osrednjega živčevja, kot so mišični relaksanti in pomirjevala),
English: 4.1 - Therapeutic Indications
Slovenian: 4.1 - Terapevtske indikacije
English: Action potentials elicited repetitively by a sustained depolarization of the neurons were blocked by topiramate in a time-dependent manner, suggestive of a state-dependent sodium channel blocking action.
Slovenian: Topiramat je zaviral ponavljajoče se akcijske potenciale, ki jih je sprožila stalna depolarizacija nevronov, kar kaže na blokado natrijevih kanalčkov v odvisnosti od njihovega stanja.
English: System Organ Class
Slovenian: Razvrstitev po organskih sistemih
English: If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering).
Slovenian: Če se pojavi trdovratna metabolična acidoza, po potrebi zmanjšajte odmerek topiramata ali pa ga (s postopnim zmanjševanjem odmerka) popolnoma ukinite.
English: In another study, exposure to EE was statistically significantly decreased at doses of 200, 400, and 800 mg/day (18%, 21%, and 30%, respectively) when given as adjunctive therapy in epilepsy patients taking valproic acid.
Slovenian: V drugi študiji je bila izpostavljenost etinilestradiolu statistično značilno zmanjšana pri odmerkih topiramata 200 mg/dan (za 18 %), 400 mg/dan (za 21 %) ali 800 mg/dan (za 30 %), ko so ga uporabljali kot dodatno zdravilo pri bolnicah z epilepsijo, ki so jemale valprojsko kislino.
English: • alone to treat seizures in adults and children over age 6
Slovenian: • za samostojno zdravljenje epileptičnih napadov pri odraslih in otrocih, starejših od 6 let,
English: It is metabolized up to 50% in patients receiving concomitant antiepileptic therapy with known inducers of drug metabolizing enzymes.
Slovenian: Pri bolnikih, ki prejemajo sočasno antiepileptično terapijo z znanimi induktorji encimov za presnovo zdravil, se ga presnovi do 50 %.
English: Following administration of multiple doses of 50 mg and 100 mg of topiramate twice a day, the mean plasma elimination half-life was approximately 21 hours.
Slovenian: Po dajanju večkratnih odmerkov 50 mg in 100 mg topiramata dvakrat na dan je bila srednja vrednost razpolovne dobe izločanja topiramata iz plazme približno 21 ur.
English: Topamax contains lactose.
Slovenian: Zdravilo Topamax vsebuje laktozo.
English: The clinical significance of the effect of topiramate on metformin pharmacokinetics is unclear.
Slovenian: Klinični pomen vpliva topiramata na farmakokinetiko metformina ni pojasnjen.
English: Czech Republic Janssen-Cilag s.r.o - CZ Karla Engliše 3201/6
Slovenian: Janssen-Cilag s.r.o - CZ Karla Engliše 3201/6 150 00 Praha 5
English: Whether topiramate can exert some effect on bones (i.e. apart from that described for metabolic acidosis) and as a consequence on growth, has not been fully elucidated.
Slovenian: Ni še popolnoma razjasnjeno, ali topiramat lahko učinkuje na kosti (tj. razen učinka, opisanega za presnovno acidozo) in posledično na rast, Vrednotenje podatkov otrok je predvideno v bližnji prihodnosti, trenutno pa ni potrebe po dodatnih ukrepih.