FrancophonIA/ELRC3.0 huggingface dataset:
English: A suitable warning to the effect that the possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with Topamax has been included and is supported by the CHMP.
Slovenian: Vključeno je bilo primerno opozorilo o upoštevanju možnosti zmanjšanja učinkovitosti kontracepcijskih sredstev ter povečanja vmesne krvavitve pri bolnicah, ki skupaj z zdravilom Topamax jemljejo kombinacijska peroralna kontracepcijska sredstva, ki ga je potrdil CHMP.
English: In a battery of in vitro and in vivo mutagenicity assays, topiramate did not show genotoxic potential.
Slovenian: In vitro in in vivo testi mutagenosti, niso pokazali genotoksičnosti topiramata.
English: J.C. Healthcare srl - IT Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy
Slovenian: Healthcare srl - IT Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italija
English: The active substance is topiramate.
Slovenian: Zdravilna učinkovina je topiramat.
English: Migraine prophylaxis in pregnancy and in women of childbearing potential if not using effective methods of contraception
Slovenian: Zdravljenje migrene med nosečnostjo in pri ženskah v rodni dobi, če ne uporabljajo učinkovite metode kontracepcije.
English: Topamax is available in film-coated tablets and a hard capsule formulation.
Slovenian: Zdravilo Topamax je na voljo v obliki filmsko obloženih tablet in trdih kapsul.
English: Chronic metabolic acidosis in paediatric patients can reduce growth rates.
Slovenian: Pri otrocih lahko kronična metabolična acidoza zmanjša hitrost rasti.
English: • Each Topamax film-coated tablet contains 25, 50, 100, 200 mg of topiramate.
Slovenian: • Ena filmsko obložena tableta zdravila Topamax vsebuje 25, 50, 100, 200 mg topiramata.
English: There were no significant changes in the systemic exposure of the risperidone total active moiety or of topiramate.
Slovenian: Poleg tega ni bilo pomembnih sprememb niti v sistemski izpostavljenosti aktivni frakciji risperidona ali v sistemski izpostavljenosti topiramatu.
English: Summary of Results from Additional Clinical Pharmacokinetic Drug Interaction Studies
Slovenian: Povzetek izsledkov dodatnih kliničnih študij farmakokinetičnih interakcij med zdravili Sočasno uporabljeno zdravilo
English: • have kidney problems, especially kidney stones, or are getting kidney dialysis
Slovenian: • če imate težave z ledvicami, še posebej ledvične kamne, ali če ste na dializi,
English: In clinical studies, there was no consistent relationship between plasma concentrations and efficacy or adverse events.
Slovenian: V kliničnih študijah niso opazili odvisnosti med plazemskimi koncentracijami zdravila in njegovo učinkovitostjo ter pojavljanjem neželenih učinkov.
English: Janssen-Cilag International NV - BE Turnhoutseweg 30, B-2340 Beerse, Belgium
Slovenian: Janssen-Cilag International NV - BE Turnhoutseweg 30, B-2340 Beerse, Belgija
English: 4.6 - Pregnancy and Lactation
Slovenian: 4.6 - Nosečnost in dojenje
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Topamax and associated names (see Annex I).
Slovenian: CHMP je priporočil dopolnitev dovoljenj za promet z zdravilom Topamax in z njim povezanimi imeni (glejte Dodatek I), katerih povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo so navedeni v Dodatku III.
English: The precise mechanism by which topiramate exerts its antiseizure and migraine prophylaxis effects are unknown.
Slovenian: Natančen mehanizem delovanja topiramata pri profilaksi epileptičnih napadov in migrene ni znan.
English: Plasma clearance of topiramate is unchanged in elderly subjects in the absence of underlying renal disease.
Slovenian: Plazemski očistek topiramata ostane nespremenjen pri starostnikih, ki nimajo ledvične osnovne bolezni.
English: Although there was a dose dependent decrease in EE exposure for doses between 200-800 mg/day (in epilepsy patients), there was no significant dose dependent change in EE exposure for doses of 50-200 mg/day (in healthy volunteers).
Slovenian: Čeprav se je pri odmerkih od 200 do 800 mg/dan pojavilo od odmerka odvisno zmanjšanje izpostavljenosti etinilestradiolu, ni bilo bistvenih od odmerka odvisnih sprememb v stopnji izpostavljenosti etinilestradiolu pri odmerkih od 50 do 200 mg/dan (pri zdravih prostovoljkah).
English: St John's Wort (Hypericum perforatum).
Slovenian: Šentjanževka (Hypericum perforatum)
English: - the scope of the referral was the harmonisation of the Summary of Products Characteristics, labelling and package leaflet.
Slovenian: -Predmet napotitve je bila uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo;
English: Carbamazepine (CBZ) Valproic acid Lamotrigine Phenobarbital
Slovenian: Koncentracija zdravila Topamax fenitoin karbamazepin (CBZ) valprojska kislina lamotrigin fenobarbital
English: • Musculoskeletal stiffness
Slovenian: • mišično-kostna okorelost
English: Concomitant multiple-dose administration of topiramate, 100 to 400 mg twice a day, with phenytoin or carbamazepine shows dose proportional increases in plasma concentrations of topiramate.
Slovenian: Pri sočasnem dajanju večkratnih odmerkov topiramata od 100 mg do 400 mg dvakrat na dan skupaj s fenitoinom ali karbamazepinom je prišlo do povečanja plazemske koncentracije topiramata, ki je bilo sorazmerno odmerku.
English: When administered concomitantly with topiramate at escalating doses of 100, 250 and 400 mg/day there was a reduction in risperidone (administered at doses ranging from 1 to 6 mg/day) systemic exposure (16% and 33% for steady-state AUC at the 250 and 400 mg/day doses, respectively).
Slovenian: Pri sočasni uporabi s topiramatom v vedno večjih odmerkih (po 100, 250 in 400 mg/dan) so opazili zmanjšanje sistemske izpostavljenosti risperidonu (danem v odmerkih od 1 do 6 mg/dan) (za 16 % pri AUC v stanju dinamičnega ravnovesja pri odmerkih 250 mg/dan oziroma za 33 % pri odmerkih 400 mg/dan).
English: The maximum recommended daily dose is 500 mg/day in 2 divided doses.
Slovenian: Največji priporočeni dnevni odmerek je 500 mg/dan v dveh enakih odmerkih.
English: 9% and17% increase in AUC (40 and 80 mg propranolol q12h respectively)
Slovenian: 9 % in 17 % povečanje vrednosti AUC (za 40 mg oz. 80 mg propranolola/12 ur)
English: A low capacity binding site for topiramate in/on erythrocytes that is saturable above plasma concentrations of 4 µg/ml has been observed.
Slovenian: Na eritrocitih so opazili vezavno mesto za topiramat z majhno kapaciteto vezave, ki je nasičena že pri plazemskih koncentracijah nad 4 μg/ml.
English: The plasma and renal clearance of topiramate are decreased in patients with impaired renal function (CLCR ≤ 60 ml/min), and the plasma clearance is decreased in patients with end-stage renal disease.
Slovenian: Bolniki z zmanjšanim delovanjem ledvic imajo zmanjšan plazemski in ledvični očistek topiramata (CLCR≤ 60 ml/min) in bolniki v zadnjem stadiju ledvične bolezni imajo zmanjšan plazemski očistek.
English: This is supported by studies in rats where topiramate was co-administered with probenecid, and a significant increase in renal clearance of topiramate was observed.
Slovenian: Te izsledke so podprle tudi študije pri podganah, ki so jim topiramat dajali sočasno s probenecidom, saj so pri tem opazili bistveno povečanje ledvičnega očistka topiramata.
English: UAB Johnson & Johnson - LT Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania
Slovenian: UAB Johnson & Johnson - LT Geležinio Vilko g. 18A LT-08104 Vilnius Litva
English: A disorder affecting the blood vessels, in the fingers, toes, ears and causing pain and cold sensitivity
Slovenian: • Raynaudov sindrom (motnja, ki prizadene žile v prstih na nogah, rokah in ušesih ter povzroči bolečino in občutljivost na mraz)
English: b a % values are the changes in treatment mean Cmax or AUC with respect to monotherapy ↔ = No effect on Cmax and AUC (≤ 15% change) of the parent compound NS = Not studied *DEA = des acetyl diltiazem, DEM = N-demethyl diltiazem b Flunarizine AUC increased 14% in subjects taking flunarizine alone.
Slovenian: sprememba za ≤ 15 %) na vrednosti Cmax in AUC za matično spojino NP = niso proučevali *DEA = desacetildiltiazem, DEM = N-demetildiltiazem b Pri preiskovancih, ki so jemali flunarizin v monoterapiji, se je vrednost AUC za flunarizin povečala za 14 %.
English: Table 1: Topiramate Adverse Drug Reactions
Slovenian: Preglednica 1: Neželeni učinki topiramata
English: The maximum weekly incremental dose titration has been amended to 50mg/day, as opposed to the 100mg/day.
Slovenian: Največje tedensko povečanje odmerka v obdobju titracije je popravljeno na 50 mg/dan (prej 100 mg/dan).
English: • Changes in thinking and alertness, including confusion, problems with concentration, memory or slowness in thinking
Slovenian: • spremembe mišljenja in pozornosti, vljučno z zmedenostjo, težavami s koncentracijo,
English: You may loss weight if you use Topamax so your weight should be checked regularly when using this medicine.
Slovenian: Med jemanjem zdravila Topamax lahko shujšate, zato je treba redno spremljati vašo telesno maso.
English: Concomitant Drug Concentrationa
Slovenian: Koncentracija sočasno uporabljenega zdravilaa
English: The third column (topiramate concentration) describes how the coadministration of a drug listed in the first column modifies the concentration of topiramate.
Slovenian: Tretji stolpec (koncentracija topiramata) pa opisuje, kako lahko sočasna uporaba zdravila iz prvega stolpca vpliva na koncentracijo topiramata.
English: Information on dosing in patients with hepatic impairment has also been provided.
Slovenian: Zagotovljeni so bili tudi podatki o odmerjanju pri bolnikih z okvarjenim delovanjem jeter.
English: There would appear to be a reduction in all measured parameters (Cmax, Tmax and AUC) for Ethinyl Estradiol associated with concomitant topiramate administration in the epilepsy study.
Slovenian: Iz študije epilepsije je razvidno, da pride do zmanjšanja vseh izmerjenih parametrov (Cmax, Tmax in AUC) etinilestradiola, ki je povezan s sočasnim dajanjem topiramata.
English: Decreased hepatic function
Slovenian: Zmanjšano delovanje jeter
English: As in adults, hepatic enzyme inducing anti-epileptic drugs decrease the steady-state plasma concentrations.
Slovenian: Kakor pri odraslih pa lahko antiepileptiki, ki inducirajo jetrne encime, zmanjšajo njegove plazemske koncentracije v stanju dinamičnega ravnovesja.
English: As a result, higher steady-state topiramate plasma concentrations are expected for a given dose in renal-impaired patients as compared to those with normal renal function.
Slovenian: Zaradi tega lahko pri bolnikih z zmanjšanim delovanjem ledvic pri danem odmerku pričakujemo večje plazemske koncentracije topiramata v stanju dinamičnega ravnovesja kot pri bolnikih z normalnim delovanjem ledvic.
English: Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperaemia (redness) and increased intraocular pressure.
Slovenian: Oftalmološki pregled lahko pokaže miopijo, splitvenje sprednje očesne komore, očesno hiperemijo (pordelost) in zvišan očesni tlak.
English: In patients with impaired renal function (CLCR ≤ 60 mL/min) topiramate should be administered with caution as the plasma and renal clearance of topiramate are decreased.
Slovenian: Pri predpisovanju topiramata bolnikom z okvarjenim delovanjem ledvic (ClCR ≤ 60 ml/min) je potrebna previdnost, ker sta pri njih plazemski in ledvični očistek topiramata zmanjšana.
English: Topamax (topiramate) is not recommended for treatment or prevention of migraine in children due to insufficient data on safety and efficacy.
Slovenian: Zaradi nezadostnih podatkov o njegovi varnosti in učinkovitosti, zdravilo Topamax (topiramat) ni priporočljivo za zdravljenje ali preprečevanje migrene pri otrocih.
English: When topiramate was added to existing risperidone (1-6 mg/day) treatment, adverse events were reported more frequently than prior to topiramate (250-400 mg/day) introduction (90% and 54 % respectively).
Slovenian: V primerih, ko so obstoječemu zdravljenju z risperidonom (1-6 mg/dan) dodali topiramat, so pogosteje poročali o neželenih učinkih, kot pred uvedbo topiramata (250-400 mg/dan).
English: Do not stop taking this medicine unless told to do so by your doctor.
Slovenian: Ne prenehajte jemati zdravila, če vam tega ne svetuje vaš zdravnik, saj se bodo simptomi lahko povrnili.
English: 4.3 - Contraindications
Slovenian: 4.3 - Kontraindikacije
English: Janssen-Cilag Pharma GmbHPfarrgasse 75 A-1232 Wien, Austria
Slovenian: Janssen-Cilag Pharma GmbHPfarrgasse 75 A-1232 Wien, Avstrija
English: 16% increase in AUC (TPM 50 mg q12h)
Slovenian: 16 % povečanje vrednosti AUC (TPM 50 mg/12 ur)
English: The recommended initial target dose range for topiramate monotherapy in children over 6 years of age is 100 mg/day depending on clinical response, (this is about 2.0mg/kg/day in children 6-16 years).
Slovenian: Priporočeni začetni ciljni odmerek za monoterapijo s topiramatom pri otrocih, starejših od 6 let, je od 100 mg/dan (to je približno 2,0 mg/kg/dan pri otrocih starih 6-16 let), odvisno od otrokovega kliničnega odziva.
English: • Swollen glands in the neck armpit or groin
Slovenian: • otekle žleze bezgavke na vratu pod pazduho ali v dimljah
English: Clinical laboratory results indicated decreases in serum potassium after topiramate or HCTZ administration, which were greater when HCTZ and topiramate were administered in combination.
Slovenian: Izvidi kliničnih laboratorijskih preiskav so pokazali zmanjšanje serumske koncentracije kalija po jemanju topiramata ali HCTZ, ki je bilo večje, kadar so bolniki prejemali HCTZ in topiramat sočasno.
English: • Painful urination
Slovenian: • bolečine pri uriniranju
English: There have been no clinical studies evaluating this potential interaction.
Slovenian: Tega medsebojnega delovanja niso preučevali v nobeni klinični študiji.
English: About 300 patients between the age of 6 and 16 years old have been included in the clinical development of topiramate as monotherapy.
Slovenian: V klinični razvoj topiramata kot monoterapije so vključili približno 300 bolnikov, starih od 6 do 16 let.
English: • Each Topamax hard capsule contains 15, 25, 50 mg of topiramate.
Slovenian: • Ena trda kapsula zdravila Topamax vsebuje 15, 25, 50 mg topiramata.
English: The clinical significance of the effect of metformin on topiramate pharmacokinetics is unclear.
Slovenian: Tudi klinični pomen vpliva metformina na farmakokinetiko topiramata ni pojasnjen.
English: In addition, patients taking other medicinal products associated with nephrolithiasis may be at increased risk.
Slovenian: Poleg tega imajo lahko povečano tveganje tudi bolniki, ki jemljejo druga zdravila, katerih uporaba je povezana s pojavom ledvičnih kamnov.
English: Additional pharmacokinetic drug interaction studies
Slovenian: Dodatne študije farmakokinetičnih interakcij med zdravili
English: Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien, Austria
Slovenian: Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien, Avstrija
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Slovenian: Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: <{Ime države članice}> <{Ime zdravila}> <{Ime države članice}> <{Ime zdravila}>
English: When enzyme inducing medicinal products are withdrawn, topiramate levels will increase.
Slovenian: Po ukinitvi zdravil, ki inducirajo encime, se koncentracija topiramata poveča.
English: In rabbits, dosage-related maternal toxicity was noted down to 10 mg/kg/day with embryo/fetal toxicity (increased lethality) down to 35 mg/kg/day, and teratogenic effects (rib and vertebral malformations) at 120 mg/kg/day.
Slovenian: Pri kuncih so opazili od odmerka odvisno toksičnost za samice pri 10 mg/kg/dan s toksičnostjo za zarodek/plod (povečana smrtnost) pri 35 mg/kg/dan in teratogene učinke (malformacije reber in vretenc) pri 120 mg/kg/dan.
English: Addition or withdrawal of phenytoin and carbamazepine to adjunctive therapy with Topamax may require adjustment of the dose of Topamax.
Slovenian: Dodajanje ali odtegnitev fenitoina in karbamazepina v dodatnem zdravljenju z zdravilom Topamax lahko zahteva prilagoditev odmerka zdravila Topamax.
English: • Kidney stones
Slovenian: • ledvične kamne
English: Topamax and associated names (see Annex I) 25, 50, 100 and200 mg film-coated tablets Topamax and associated names 15, 25 and 50 mg hard capsules
Slovenian: Topamax in sorodna imena (glejte Dodatek I) 25, 50, 100 in 200 mg filmsko obložene tablete Topamax in sorodna imena 15, 25 in 50 mg trde kapsule
English: Six metabolites, formed through hydroxylation, hydrolysis and glucuronidation, have been isolated, characterized and identified from plasma, urine and faeces of humans.
Slovenian: Iz plazme, urina in blata ljudi so opravili izolacijo, karakterizacijo in identifikacijo šestih presnovkov, ki nastanejo s hidroksilacijo, hidrolizo in glukuronidacijo topiramata.
English: If you forget to take Topamax
Slovenian: Če ste pozabili vzeti zdravilo Topamax
English: As with other antiepilepsy medicines, there is a risk of harm to the unborn child if Topamax is used during pregnancy.
Slovenian: Kot pri drugih zdravilih proti epilepsiji obstaja namreč tveganje za nastanek okvar pri nerojenem otroku, če noseča mati jemlje zdravilo Topamax med nosečnostjo, zato se morate temeljito seznaniti s tveganji in koristmi uporabe zdravila Topamax za zdravljenje epilepsije med nosečnostjo.
English: United Kingdom Janssen-Cilag Limited - GB Saunderton
Slovenian: Združeno kraljestvo Janssen-Cilag Limited - GB Saunderton
English: Depending on underlying conditions, appropriate evaluation including serum bicarbonate levels is recommended with topiramate therapy.
Slovenian: Odvisno od bolnikovih osnovnih bolezni priporočamo pri zdravljenju s topiramatom ustrezne preiskave, vključno z določanjem serumske koncentracije hidrogenkarbonata.
English: In patients with end-stage renal failure, since topiramate is removed from plasma by haemodialysis, a supplemental dose of Topamax equal to approximately one-half the daily dose should be administered on haemodialysis days.
Slovenian: Ker se topiramat s hemodializo izloči iz plazme, je treba bolnikom s končno odpovedjo ledvic na dializi dati dodaten odmerek zdravila Topamax na dan hemodialize v velikosti približno polovice dnevnega odmerka.
English: 4.2 - Posology
Slovenian: 4.2 - Odmerjanje
English: Sumatriptan (Oral and Subcutaneous)
Slovenian: sumatriptan (peroralna in subkutana uporaba)
English: The recommended total daily dose of topiramate for prophylaxis of migraine headache is 100 mg/day administered in two divided doses.
Slovenian: Priporočeni skupni dnevni odmerek topiramata za profilakso migrenskih glavobolov je 100 mg/dan, razdeljen na dva enaka odmerka.
English: The volume of distribution varied inversely with the dose.
Slovenian: Porazdelitveni volumen topiramata je bil močno odvisen od odmerka.
English: The usual daily dose is 200-400 mg in two divided doses.
Slovenian: Običajen dnevni odmerek zdravila je od 200-400 mg, razdeljen na dva enaka odmerka.
English: These adverse reactions could potentially be dangerous in patients driving a vehicle or operating machinery, particularly until such time as the individual patient's experience with the medicinal products established.
Slovenian: Povzroči lahko tudi motnje vida in/ali zamegljen vid. Ti neželeni učinki so lahko nevarni pri tistih bolnikih, ki vozijo vozila ali upravljajo s stroji, še posebej dokler ni znan vpliv zdravila na bolnika.
English: When concomitant antiepileptic drugs (AEDs) are withdrawn to achieve monotherapy with topiramate, consideration should be given to the effects this may have on seizure control.
Slovenian: Pri ukinitvi sočasne terapije z drugimi antiepileptiki, da bi uvedli monoterapijo s topiramatom, je treba upoštevati morebitne vplive ukinitve na obvladovanje epileptičnih napadov.
English: You should avoid drinking alcohol when taking Topamax.
Slovenian: Med jemanjem zdravila Topamax se morate izogibati pitju alkohola.
English: The clinical significance of this change is unknown.
Slovenian: Klinični pomen te spremembe ni znan.
English: Slovak Republic Johnson & Johnson, s.r.o - SK Plynárenská 7/B
Slovenian: Johnson & Johnson, s.r.o - SK Plynárenská 7/B 824 78 Bratislava Slovaška
English: • Irregular heartbeat or slowness of the heart beat
Slovenian: • nereden ali počasen utrip srca
English: • Skin rash and/or itchy skin.
Slovenian: • kožni izpuščaj in/ali srbečo kožo
English: Bradycardia, sinus bradycardia, palpitations
Slovenian: Srčne bolezni bradikardija, sinusna bradikardija palpitacije
English: If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topamax.
Slovenian: Če niste prepričani, ali se zgornja navedba nanaša na vas, se pogovorite s svojim zdravnikom ali farmacevtom, preden boste začeli jemati zdravilo Topamax.
English: Do not take Topamax
Slovenian: Ne jemljite zdravila Topamax
English: There would appear to be both a clinically and statistically significant evidence of efficacy with topiramate as add-on treatment to commonly used AEDs in POS indications.
Slovenian: Kaže, da pri indikacijah napadov z delnim nastopom obstajajo tako klinično kot tudi statistično pomembni dokazi učinkovitosti topiramata kot dodatka k zdravljenju z običajno uporabljenimi zdravili proti epilepsiji.
English: Overall, plasma clearance is approximately 20 to 30 ml/min in humans following oral administration.
Slovenian: Običajno znaša plazemski očistek topiramata pri človeku po peroralni uporabi približno 20 do 30 ml/min.
English: The clinical significance of these findings is not known.
Slovenian: Klinični pomen teh izsledkov ni znan.
English: Topiramate is classified as a sulfamate-substituted monosaccharide.
Slovenian: Topiramat uvrščamo v skupino s sulfamatom substituiranih monosaharidov.
English: 5.3 - Preclinical safety data
Slovenian: 5.3 - Predklinični podatki o varnosti
English: This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma.
Slovenian: Ta sindrom je lahko povezan tudi s supraciliarnim izlivom, ki povzroči pomik očesne leče in šarenice naprej ter sekundarni glavkom zaprtega zakotja.
English: Stevens-Johnson syndrome* erythema multiforme*, skin odour abnormal, periorbital oedema*, urticaria localised
Slovenian: StevensJohnsonov sindrom*, multiformni eritem*, nenormalen vonj kože, periorbitalni edem*, omejena urtikarija toksična epidermaln a nekroliza*
English: Regarding the posology for topiramate, in general the titration schedules in monotherapy and adjunct therapy in Section 4.2 Posology of the SPC are consistent across MS SPCs, although there are differences depending on age range for use.
Slovenian: Monoterapija epilepsije pri otrocih in odraslih bolnikih Glede odmerjanja topiramata so na splošno režimi titracije pri monoterapiji in dodatni terapiji v poglavju 4.2 Odmerjanje v povzetku glavnih značilnosti zdravila dosledni v vseh povzetkih glavnih značilnosti zdravila v posameznih državah članicah, čeprav obstajajo razlike pri uporabi glede na starostne razpone.
English: The results from the ANCOVA models indicate that age did not have an impact on treatment effect (pvalue>=0.20) for all three seizure types (POS, PGTS, or LGS).
Slovenian: Rezultati modelov ANCOVA kažejo, da starost ni imela vpliva na učinek zdravljenja (vrednost p >=0,20) pri nobeni od treh vrst napadov (napadi z delnim nastopom, primarni generalizirani toničnoklonični napadi ali napadi, povezani z Lennox-Gastautovim sindromom).
English: In nonclinical studies of fertility, despite maternal and paternal toxicity as low as 8 mg/kg/day, no effects on fertility were observed, in male or female rats with doses up to 100 mg/kg/day.
Slovenian: Kljub temu, da je bila toksičnost pri samcih in samicah nizka (8 mg/kg/dan), v nekliničnih študijah plodnosti niso opazili učinkov na plodnost samcev in samic podgan pri odmerkih do 100 mg/kg/dan.