FrancophonIA/ELRC3.0 huggingface dataset:
English: Depression Bradyphrenia, insomnia, expressive language disorder, anxiety, confusional state, disorientation, aggression, mood altered, agitation, mood swings, depressed mood, anger, abnormal behaviour
Slovenian: Psihiatrične motnje depresija bradifrenija, nespečnost, motnje ekspresivnega govora, tesnoba, stanje zmedenosti, dezorientacija , agresivnost, spremenjeno razpoloženje,
English: Mood disturbances/depression and suicidal tendency, acute myopia and secondary angle closure glaucoma and metabolic acidosis have been included and identified as an important risk in the Risk Management Plan (RMP).
Slovenian: V načrtu za obvladovanje tveganja so bili vključeni in določeni kot pomembna tveganja motnje razpoloženja/depresija in samomorilno nagnjenje, akutna miopija in sekundarni glavkom zaprtega zakotja ter presnovna acidoza.
English: A contraindication for the use of topiramate for the indication of epilepsy in pregnancy and women of childbearing potential if not using effective methods of contraception was not considered warranted by the CHMP.
Slovenian: CHMP je menil, da kontraindikaciji za uporabo topiramata v okviru indikacije epilepsije, nosečnost in bolnice v rodni dobi, ki ne uporabljajo učinkovite metode kontracepcije, nista utemeljeni.
English: Topamax 15 mgGranulat in Kapseln granuals in capsule
Slovenian: Topamax 15 mgGranulat in Kapseln granule v kapsuli
English: Anhidrosis, hypoaesthesia facial, urticaria, erythema, pruritus generalised, rash macular, skin discolouration, dermatitis allergic, swelling face
Slovenian: Bolezni kože in podkožja alopecija, izpuščaj, pruritus anhidroza, obrazna hipoestezija, urtikarija, eritem, generaliziran pruritus, makularni izpuščaj, sprememba barve kože, alergijski dermatitis, otekanje obraza
English: Acidosis hyperchloraemic
Slovenian: Hiperkloremič na acidoza
English: Topamax 25 mgGranulat in Kapseln granuals in capsule
Slovenian: Topamax 25 mgGranulat in Kapseln granule v kapsuli
English: 02130 Espoo Finland
Slovenian: Janssen-Cilag OY - FI Metsänneidonkuja 8 02130 Espoo Finska
English: If the patient is unable to tolerate the titration regimen, longer intervals between dose adjustments can be used.
Slovenian: Če bolnik ne prenaša te sheme zdravljenja, lahko uporabite tudi daljše razmike med posameznimi povečanji odmerka.
English: Do not drive or use any tools or machines without talking to your doctor first.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Med zdravljenjem z zdravilom Topamax se lahko pojavijo omotica, utrujenost in motnje vida, zato ne vozite in ne upravljajte orodij ali strojev, ne da bi se prej posvetovali s svojim zdravnikom.
English: • Problems with verbal communication
Slovenian: • težave z govorom
English: UAB Johnson & Johnson Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania
Slovenian: UAB Johnson & Johnson Šeimyniškių g. 1A, LT-09312 Vilnius, Litva
English: • Low potassium levels in the blood
Slovenian: • zmanjšano koncentracijo kalija v krvi
English: Activated charcoal has been shown to adsorb topiramate in vitro.
Slovenian: Raziskave so pokazale, da se in vitro topiramat adsorbira s pomočjo aktivnega oglja.
English: • Bleeding gums
Slovenian: • krvavenje iz dlesni
English: Deafness, deafness unilateral, deafness neurosensory, ear discomfort, hearing impaired
Slovenian: Ušesne bolezni, vključno z motnjami labirinta vrtoglavica, tinitus, ušesne bolečine gluhost, enostranska gluhost, nevrosenzorič na gluhost, neprijeten občutek v ušesih, poslabšanje sluha
English: Very common side effects include:
Slovenian: Zelo pogosti neželeni učinki vključujejo:
English: Topamax and associated names (see Annex I) 15 mg hard capsules Topamax and associated names (see Annex I) 25 mg hard capsules Topamax and associated names (see Annex I) 50 mg hard capsules [See Annex I - To be completed nationally]
Slovenian: Topamax in sorodna imena (glejte Dodatek I) 15 mg trde kapsule Topamax in sorodna imena (glejte Dodatek I) 25 mg trde kapsule Topamax in sorodna imena (glejte Dodatek I) 50 mg trde kapsule
English: In mice, fetal weights and skeletal ossification were reduced at 500 mg/kg/day in conjunction with maternal toxicity.
Slovenian: Pri odmerku 500 mg/kg/dan in v povezavi s toksičnostjo za samice, je bilo pri miših zmanjšano zakostenevanje in masa ploda.
English: In addition, a statement on the interaction of topiramate with St John's Wort was also included in the Product Information.
Slovenian: Poleg tega so v podatke o zdravilu vključili tudi izjavo o medsebojnem delovanju topiramata s šentjanževko.
English: • Hair loss
Slovenian: • izgubo las
English: Other medicinal product interactions
Slovenian: Interakcije z drugimi zdravili
English: UAB Johnson & Johnson - LT Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania
Slovenian: UAB Johnson & Johnson - LT Šeimyniškių g.1A, LT-09312 Vilnius, Litva
English: Patients have received a total daily dose up to 200 mg/day.
Slovenian: Pri nekaterih bolnikih je lahko učinkovit že skupni dnevni odmerek 50 mg/dan, uporabljali pa so tudi dnevne odmerke do 200 mg/dan.
English: ”Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome.”
Slovenian: „Dodatna terapija pri otrocih, starih 2 leti ali več, mladostnikih in odraslih bolnikih z napadi z delnim nastopom s sekundarno generalizacijo ali brez nje ali primarnimi generaliziranimi tonično-kloničnimi napadi in za zdravljenje napadov, povezanih z Lennox-Gastautovim sindromom.“
English: Subsequently, at weekly or bi-weekly intervals, the dose should be increased by 25-50 mg/day and taken in two divided doses.
Slovenian: Nato se odmerek tedensko ali dvotedensko zviša za 25-50 mg/dan ter jemlje v dveh razdeljenih odmerkih.
English: Hypokalaemia, increased appetite, polydipsia
Slovenian: Presnovne in prehranske motnje anoreksija, zmanjšanje apetita metabolična acidoza, hipokaliemija, povečanje apetita, polidipsija
English: When topiramate is added to glyburide therapy or glyburide is added to topiramate therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state.
Slovenian: Pri dodatku topiramata zdravljenju z gliburidom ali pri dodatku gliburida k zdravljenju s topiramatom je treba biti zelo pozoren na rutinsko spremljanje bolnikov, da bi pri njih dosegli zadosten nadzor sladkorne bolezni.
English: No dose adjustment is recommended for the elderly, provided that renal function is in tact.
Slovenian: Pri starostnikih ni potrebno prilagajati odmerkov, če delovanje ledvic ni prizadeto.
English: Allergic oedema*, conjunctival oedema*
Slovenian: Bolezni imunskega sistema preobčutljivos t alergijski edem*, edem veznice*
English: The dosage should then be increased at 1 or 2 week intervals by increments of 0.5 to 1 mg/kg/day, administered in two divided doses.
Slovenian: Nato odmerek povečujte v tedenskih ali dvotedenskih presledkih po 0,5 do 1 mg/kg/dan, in ga razdelite v dva odmerka na dan.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for alu/alu blister
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatlica za Alu/Alu pretisne omote
English: CHMP, the contraindication for the use of topiramate for migraine prophylaxis in pregnancy or women of child bearing potential without adequate contraception has been included by the MAH for the indication migraine prophylaxis.
Slovenian: Po priporočilu CHMP je imetnik dovoljenja za promet z zdravilom za indikacijo profilakse migrene vključil kontraindikacijo za uporabo topiramata za profilakso migrene pri nosečnicah ali ženskah v rodni dobi brez zadostne kontracepcije.
English: Rare side effects include:
Slovenian: Redki neželeni učinki vključujejo:
English: Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.
Slovenian: Monoterapija pri odraslih, mladostnikih in otrocih, starejših od 6 let, ki imajo parcialne epileptične napade z ali brez sekundarne generalizacije in primarno generalizirane tonično-klonične napade.
English: Some patients may achieve efficacy with once-a-day dosing.
Slovenian: Pri nekaterih bolnikih bo zdravljenje lahko učinkovito že pri jemanju zdravila enkrat na dan.
English: Unless safety concerns require an abrupt withdrawal of the concomitant AED, a gradual discontinuation at the rate of approximately onethird of the concomitant AED dose every 2 weeks is recommended.
Slovenian: Priporočljivo je postopno ukinjanje sočasno uporabljenega antiepileptika, in sicer za približno eno tretjino odmerka na vsaka 2 tedna, razen kadar je zaradi varnosti potrebna hitra ukinitev sočasno uporabljenega antiepileptika.
English: • have a growth problem
Slovenian: • če imate motnje rasti,
English: When Topamax is added to pioglitazone therapy or pioglitazone is added to Topamax therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state.
Slovenian: Pri dodatku zdravila Topamax zdravljenju s pioglitazonom ali pri dodatku pioglitazona zdravljenju z zdravilom Topamax je treba biti zelo pozoren na rutinsko spremljanje bolnikov, da bi pri njih dosegli zadosten nadzor sladkorne bolezni.
English: Dose and titration rate should be guided by clinical response.
Slovenian: Odmerek zdravila in hitrost prilagajanja odmerka sta odvisna od bolnikovega kliničnega odziva.
English: Hyperchloremic, non-anion gap, metabolic acidosis (i.e. decreased serum bicarbonate below the normal reference range in the absence of respiratory alkalosis) is associated with topiramate treatment.
Slovenian: zmanjšana koncentracije hidrogenkarbonata v serumu pod normalno referenčno vrednost, brez respiratorne alkaloze).
English: UAB Johnson & Johnson - LT Šeimyniškių g.1A, LT-09312 Vilnius,
Slovenian: UAB Johnson & Johnson Šeimyniškių g. 1A, LT-09312 Vilnius,
English: What Topamax contains
Slovenian: Kaj vsebuje zdravilo Topamax
English: An increased incidence of mood disturbances and depression has been observed during topiramate treatment.
Slovenian: Med zdravljenjem s topiramatom so opažali povečano pojavnost motenj razpoloženja in depresije.
English: A meta-analysis of randomised placebo-controlled trials of anti-epileptic drugs has shown a small increased risk of suicidal ideation and behaviour.
Slovenian: Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih s placebom nadzorovanih preskušanj antiepileptikov.
English: Topamax gélules 15 mg 15 milligram(s)
Slovenian: Topamax gélules 15 mg 15 miligramov
English: The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of topiramate.
Slovenian: Sočasna uporaba topiramata ni bistveno vplivala na farmakokinetiko HCTZ v stanju dinamičnega ravnovesja.
English: Patients taking estrogen containing contraceptives should be asked to report any change in their bleeding patterns.
Slovenian: Bolnicam, ki jemljejo estrogenska kontracepcijska sredstva, morate torej naročiti, naj vas obvestijo o kakršnihkoli spremembah v pojavljanju vmesnih krvavitev, ker je kontracepcijska učinkovitost kontraceptiva lahko zmanjšana, tudi če ne pride do vmesne krvavitve.
English: Depressed level of consciousness, grand mal convulsion, visual field defect, complex partial seizures, speech disorder, psychomotor hyperactivity, syncope, sensory disturbance, drooling, hypersomnia, aphasia, repetitive speech, hypokinesia, dyskinesia, dizziness postural, poor quality sleep, burning sensation, sensory loss, parosmia, cerebellar syndrome, dysaesthesia, hypogeusia, stupor, clumsiness, aura, ageusia, dysgraphia, dysphasia, neuropathy peripheral, presyncope, dystonia,
Slovenian: Bolezni živčevja parestezije, somnolenca, omotica motnje pozornosti, motnje spomina, amnezija, kognitivne motnje, motnje mišljenja, zmanjšanje psihomotoričn ih sposobnosti, konvulzije, motnje koordinacije, tremor, letargija, hipoestezija, nistagmus, disgevzija, motnje ravnotežja, disartrija, intencijski tremor, sedacija zmanjšana stopnja zavesti, konvulzije grand mal, motnje vidnega polja, kompleksni parcialni epileptični napadi, motnje govora, psihomotoričn a hiperaktivnost , sinkopa, senzorične motnje, slinjenje, hipersomnija, afazija, ponavljajoč govor, hipokinezija, diskinezija, posturalna omotica, slaba kakovost spanja, pekoč občutek, izguba apraksija, motnje v cirkadianem ritmu spanja, hiperestezija, hipozmija, anozmija, esencialni tremor, akinezija, neodzivnost na dražljaje senzorike, parozmija, cerebelarni sindrom, disestezija, hipogevzija, stupor, okornost, pojav avre, agevzija, disgrafija, disfazija, periferna nevropatija, presinkopa, distonija, mravljinčenje
English: ”Adjunctive therapy for adults, adolescents and children aged 2 years and above with partial onset seizures with or without secondary generalisation or primary generalized tonic-clonic seizures……….”
Slovenian: „Dodatna terapija pri odraslih bolnikih, mladostnikih in otrocih, starih 2 leti ali več, z napadi z delnim nastopom s sekundarno generalizacijo ali brez nje ali primarnimi generaliziranimi toničnokloničnimi napadi……….“
English: When Topamax is added or withdrawn in patients on metformin therapy, careful attention should be given to the routine monitoring for adequate control of their diabetic disease state.
Slovenian: Pri dodatku ali ukinitvi zdravila Topamax bolnikom, ki se zdravijo z metforminom, je treba biti zelo pozoren na rutinsko spremljanje bolnikov, da bi pri njih dosegli zadosten nadzor sladkorne bolezni.
English: THE REACH AND SIGHT OF CHILDREN
Slovenian: POGLEDA OTROK
English: • Vomiting
Slovenian: • vetrove
English: Check with your doctor or pharmacist before taking Topamax if you:
Slovenian: Pred jemanjem zdravila Topamax se posvetujte s svojim zdravnikom ali s farmacevtom:
English: Topamax may make your birth control pills less effective.
Slovenian: • kontracepcijske tablete, ker lahko zdravilo Topamax zmanjša njihovo učinkovitost.
English: Subjects with known renal impairment may require a longer time to reach steady-state at each dose
Slovenian: Za doseganje stanja dinamičnega ravnovesja po vsakem odmerku, je pri bolnikih z okvarjenim delovanjem ledvic lahko potrebno več časa.
English: Topamax 25 mg Kapseln 25 milligram(s)
Slovenian: Topamax 25 mg Kapseln 25 miligramov
English: TOPAMAX 100 mg tabs 100 milligram(s)
Slovenian: TOPAMAX 100 mg tabs 100 miligramov
English: Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome
Slovenian: Dodatna terapija pri otrocih, starejših od 2 let, mladostnikih in odraslih, ki imajo parcialne epileptične napade z ali brez sekundarne generalizacije ali primarno generalizirane tonično-klonične napade in za zdravljenje epileptičnih napadov v povezavi z Lennox-Gastautovim sindromom.
English: Titration should begin at 25 mg nightly for 1 week.
Slovenian: Zdravljenje začnite z odmerkom 25 mg vsak večer en teden.
English: It is recommended that patients on topiramate treatment should be monitored for weight loss.
Slovenian: Pri bolnikih, ki se zdravijo s topiramatom je priporočeno spremljanje telesne mase.
English: A decrease in Topamax (topiramate) dosage may be required if clinically indicated.
Slovenian: Če je klinično indicirano, bo potrebno zmanjšati odmerek zdravila Topamax (topiramat).
English: TOPAMAX 200 mg tabs 200 milligram(s)
Slovenian: TOPAMAX 200 mg tabs 200 miligramov
English: • Stomach pain
Slovenian: • suha usta
English: • Localized swelling in the skin
Slovenian: • otekline na koži
English: TOPAMAX 25 mg tabs 25 milligram(s)
Slovenian: TOPAMAX 25 mg tabs 25 miligramov
English: Topamax 50 mg Kapseln 50 milligram(s)
Slovenian: Topamax 50 mg Kapseln 50 miligramov
English: The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with Topamax.
Slovenian: Pri bolnicah, ki jemljejo kombinirane peroralne kontraceptive sočasno z zdravilom Topamax, je torej treba pomisliti na možnost zmanjšane kontracepcijske učinkovitosti zdravila in močnejše vmesne krvavitve.
English: Arthralgia, muscle spasms, myalgia, muscle twitching, muscular weakness, musculoskeletal chest pain
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija, mišični krči, mialgija, trzanje mišic, mišična šibkost, mišičnoskeletne otekanje sklepov*, mišičnoskeletna okorelost, bolečine v boku, mišična utrujenost neprijeten občutek v udih*
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet [To be completed nationally] METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta [Izpolni država članica]
English: • have liver problems
Slovenian: • če imate težave z jetri,
English: The effect of topiramate on bonerelated sequelae has not been systematically investigated in paediatric or adult populations.
Slovenian: Pri otrocih in pri odraslih niso sistematično preučevali vpliva zdravljenja s topiramatom na kosti.
English: The recommended total daily dose of approximately 5 - 9 mg/kg/day in two divided doses as adjunctive therapy in the paediatric population (children aged 2 years and above) was endorsed by the CHMP.
Slovenian: CHMP je potrdil priporočeni skupni dnevni odmerek kot dodatno terapijo pri otrocih (starih 2 leti in več) približno 5-9 mg/kg v dveh razdeljenih odmerkih.
English: • Swelling of the conjunctiva of the eye.
Slovenian: • oteklo vezivno tkivo v očesu.
English: • Loss of consciousness
Slovenian: • nezavest
English: Glyburide
Slovenian: Gliburid
English: • Fainting
Slovenian: • omedlevico
English: Uncommon side effects include:
Slovenian: Občasni neželeni učinki vključujejo:
English: “Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.”
Slovenian: „Monoterapija pri odraslih bolnikih, mladostnikih in otrocih, starejših od 6 let, z delnimi napadi s sekundarnimi generaliziranimi napadi ali brez njih in primarnimi generaliziranimi tonično-kloničnimi napadi.“
English: Topamax gélules 25 mg 25 milligram(s)
Slovenian: Topamax gélules 25 mg 25 miligramov
English: TOPAMAX 200 MG 200 milligram(s)
Slovenian: TOPAMAX 200 MG 200 miligramov
English: • Fullness or bloating
Slovenian: • občutek polnega trebuha ali napihovanja
English: TOPAMAX 50 mg tabs 50 milligram(s)
Slovenian: TOPAMAX 50 mg tabs 50 miligramov
English: Topiramate should be used with caution in patients with conditions or treatments that represent a risk factor for the appearance of metabolic acidosis.
Slovenian: Pri bolnikih z boleznimi ali zdravili, ki predstavljajo povečano tveganje za pojav metabolične acidoze, je treba topiramat uporabljati previdno.
English: A contraindication for the use of topiramate for the indication of migraine prophylaxis in pregnancy and in women of childbearing potential if not using effective methods of contraception has been included in the SPC in sections 4.3 and 4.6.
Slovenian: V poglavjih 4.3 in 4.6 povzetka glavnih značilnosti zdravila sta bili vključeni kontraindikaciji za uporabo topiramata v okviru profilakse migrene, nosečnost in bolnice v rodni dobi, ki ne uporabljajo učinkovite metode kontracepcije.
English: Topamax gélules 50 mg 50 milligram(s)
Slovenian: Topamax gélules 50 mg 50 miligramov
English: TOPAMAX 25 mg filmsko oblozene tablete
Slovenian: TOPAMAX 25 mg filmsko obložene tablete
English: What Topamax looks like and contents of the pack [To be completed nationally]
Slovenian: • pomožne snovi so: [Izpolni država članica] Izgled zdravila Topamax in vsebina pakiranja [Izpolni država članica]
English: TOPAMAX 50 mg filmsko oblozene tablete
Slovenian: TOPAMAX 50 mg filmsko obložene tablete
English: Examples are applesauce, custard, ice cream, porridge, pudding or yogurt.
Slovenian: • Topamax trde kapsule lahko pogoltnete cele, ali pa jih odprite in stresite njihovo vsebino na čajno žličko kakršnekoli mehke hrane, na primer jabolčnega soka, jajčne kreme, sladoleda, ovsene kaše, pudinga ali jogurta.
English: • Dizziness
Slovenian: • hripavost
English: Lithium levels should be monitored when co-administered with topiramate.
Slovenian: Pri sočasni uporabi litija s topiramatom je torej treba spremljati koncentracije litija.
English: Infections and infestations
Slovenian: Infekcijske in parazitske bolezni nazofaringitis
English: You may find it best to do this over the small portion of food onto which you will be pouring the sprinkles.
Slovenian: • Previdno odvijte prozorni del kapsule; morda bo najbolj preprosto, če ga boste sneli kar nad majhno količino hrane in takoj stresli zrnca po njej.
English: Topamax 25mg tabletten 25 milligram(s)
Slovenian: Topamax 25mg tabletten 25 miligramov
English: • Nausea
Slovenian: • zadah
English: The dosage should then be increased at 1- or 2-week intervals by increments of 25 or 50 mg/day, administered in two divided doses.
Slovenian: Nato odmerek povečujte v tedenskih oziroma dvotedenskih presledkih po 25 ali 50 mg/dan, in ga razdelite v dva odmerka na dan.
English: Adjunctive Therapy for Primary Generalized Tonic-Clonic (PGTC) Seizures in Adults and Children Two studies YTC and YTC-E, explored the efficacy of topiramate as adjunctive therapy in primary generalised tonic-clonic (PGTC) seizures patients.
Slovenian: Učinkovitost topiramata kot dodatne terapije pri bolnikih s primarnimi generaliziranimi toničnokloničnimi napadi so raziskovali v dveh študijah: YTC in YTC-E. Ena študija je bila opravljena v ZDA in Kostariki, ena pa v Evropi.
English: TOPAMAX 25 tablets 25 milligram(s)
Slovenian: TOPAMAX 25 tablets 25 miligramov
English: TOPAMAX 100 mg filmsko oblozene tablete
Slovenian: TOPAMAX 100 mg filmsko obložene tablete
English: TOPAMAX 200 tablets 200 milligram(s)
Slovenian: TOPAMAX 200 tablets 200 miligramov
English: Overdose can happen if you are taking other medicines together with Topamax.
Slovenian: Če skupaj z zdravilom Topamax jemljete tudi druga zdravila, lahko pride do prevelikega odmerjanja.
English: TOPAMAX 100 tablets 100 milligram(s)
Slovenian: TOPAMAX 100 tablets 100 miligramov
English: Topamax 50mg tabletten 50 milligram(s)
Slovenian: Topamax 50mg tabletten 50 miligramov
English: NS
Slovenian: NP
English: • Constipation
Slovenian: • zadihanost
English: None of these risk factors can reliably predict stone formation during topiramate treatment.
Slovenian: Med dejavnike tveganja za ledvične kamne so ledvični kamni v preteklosti, ledvični kamni v družinski anamnezi in hiperkalciurija, vendar noben od teh dejavnikov tveganja ne more zanesljivo napovedati pojava ledvičnih kamnov med zdravljenjem s topiramatom.
English: HOW TO STORE TOPAMAX
Slovenian: SHRANJEVANJE ZDRAVILA TOPAMAX
English: NAME OF THE MEDICINAL PRODUCT Topamax and associated names (see Annex I) 200 mg film-coated tablets [See Annex I - To be completed nationally] topiramate STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally] LIST OF EXCIPIENTS [To be completed nationally] PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet [To be completed nationally] METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Slovenian: IME ZDRAVILA Topamax in sorodna imena (glejte Dodatek I) 200 mg filmsko obložene tablete [Izpolni država članica - glejte Dodatek I] topiramat NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN [Izpolni država članica] SEZNAM POMOŽNIH SNOVI [Izpolni država članica] FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta [Izpolni država članica] POSTOPEK IN POT(I) UPORABE ZDRAVILA peroralna uporaba Pred uporabo preberite priloženo navodilo!
English: Topamax and associated names (see Annex I) 200 mg film-coated tablets
Slovenian: Topamax in sorodna imena (glejte Dodatek I) 200 mg
English: * identified as an ADR from postmarketing spontaneous reports.
Slovenian: *Neželeni učinki iz spontanih poročil v okviru postmarketinških izkušenj - njihova pogostnost je bila izračunana na podlagi podatkov iz kliničnih preskušanj.