FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medication.
Slovenian: Bolniki z redkimi dednimi boleznimi galaktozne intolerance, laponske oblike pomanjkanja laktaze ali malabsorpcije glukoze in galaktoze ne smejo jemati tega zdravila.
English: The justification put forward by the MAH that this shortcoming is due to the limited number of subjects and qualified study centres available was considered to be acceptable.
Slovenian: Utemeljitev, ki jo je zastopal imetnik dovoljenja za promet z zdravilom, da je ta pomanjkljivost posledica majhnega števila preiskovancev in usposobljenih raziskovalnih središč, je bila upoštevana kot sprejemljiva.
English: • Feeling of movement under the skin
Slovenian: • občutek premikanja pod kožo
English: The clinical consequences were not severe in most cases, but deaths have been reported after overdoses with multiple medicinal products including topiramate.
Slovenian: Klinične posledice prevelikega odmerjanja v večini primerov niso bile hude, vendar so poročali tudi o smrtnih primerih po prevelikem odmerjanju več učinkovin, vključno s topiramatom.
English: Topamax belongs to a group of medicines called “antiepileptic medicines.” It is used:
Slovenian: Zdravilo Topamax sodi v skupino zdravil, ki jim pravimo antiepileptična zdravila in jih uporabljamo:
English: Topamax and certain other medicines can affect each other.
Slovenian: Zdravilo Topamax in nekatera druga zdravila imajo lahko medsebojen vpliv.
English: In addition the CHMP supported the deletion of any mention of the interchangeability of different products of topiramate in individual patients, in the product information.
Slovenian: Poleg tega je CHMP podprl brisanje vseh omemb zamenljivosti različnih zdravil s topiramatom pri posameznih bolnikih iz podatkov o zdravilu.
English: • Maculopathy is a disease of the macula, the small spot in the retina where vision is keenest.
Slovenian: • makulopatija je bolezen makule, to je pega na mrežnici, kjer je vid najostrejši.
English: Taking Topamax with food and drink
Slovenian: Jemanje zdravila Topamax skupaj s hrano in pijačo
English: • Topamax can be taken before, during, or after a meal.
Slovenian: • Zdravilo Topamax lahko jemljete pred, med ali po obroku.
English: - PT Estrada Consiglieri Pedroso, 69 AQueluz de Baixo 2734-503 Barcarena Portugal
Slovenian: - PT Estrada Consiglieri Pedroso, 69 AQueluz de Baixo 2734-503 Barcarena Portugalska
English: Side effects of unknown frequency
Slovenian: Neželeni učinki neznane pogostnosti:
English: The harmonisation of topiramate marketed in the EU Member States, Norway and Iceland applies to two formulations: - tablets (25 mg, 50 mg, 100 mg, 200 mg) - capsules (15 mg, 25 mg, 50 mg)
Slovenian: Uskladitev topiramata, ki je v prometu v državah članicah EU, na Norveškem in Islandiji, se nanaša na dve formulaciji: - tablete (25 mg, 50 mg, 100 mg, 200 mg) - kapsule (15 mg, 25 mg, 50 mg)
English: The results of covariate analyses in the studies TOPMAT-EPMN-104, TOPMAT-EPMN-105 and TOPMAT-EPMN-106 indicate that the efficacy of topiramate monotherapy did not differ as a function of age.
Slovenian: Rezultati kovariatne analize v študijah TOPMAT-EPMN-104, TOPMAT-EPMN-105 in TOPMAT-EPMN-106 kažejo, da učinkovitost monoterapije s topiramatom ni bila odvisna od starosti.
English: This medicinal product/food mixture is to be swallowed immediately and not chewed.
Slovenian: To mešanico zdravila in hrane naj bolnik pogoltne takoj in je ne sme žvečiti.
English: In paediatric clinical trials, topiramate was gradually withdrawn over a 2-8 week period.
Slovenian: V pediatričnih kliničnih preskušanjih so bolnikom postopoma ukinjali topiramat v času 2 do 8 tednov.
English: Mothers who breastfeed while taking Topamax must tell the doctor as soon as possible if the baby experiences anything unusual.
Slovenian: Matere, ki dojijo svoje otroke med jemanjem zdravila Topamax, morajo čimprej povedati svojemu zdravniku, če se pri dojenčku pojavijo nenavadni znaki.
English: The investigation of topiramate as monotherapy in the paediatric population related to a minority (~20%) of the patients evaluated in the randomized controlled studies of topiramate monotherapy who were children (≤16 years of age).
Slovenian: Preučevanje topiramata kot monoterapije pri otrocih se je nanašalo na manjšino (~20 %) bolnikov, ovrednotenih v randomiziranih nadzorovanih študijah monoterapije s topiramatom, ki so bili otroci (stari ≤16 let).
English: Symptoms include acute onset of decreased visual acuity and/or ocular pain.
Slovenian: Med simptome sodi akuten pojav zmanjšane ostrine vida in/ali očesnih bolečin.
English: There are no data to support a claim for efficacy as monotherapy in patients younger than 6 years.
Slovenian: Ni pa podatkov v podporo učinkovitosti monoterapije pri bolnikih, mlajših od 6 let.
English: The excretion of topiramate in human milk has not been evaluated in controlled studies.
Slovenian: Izločanje topiramata v materino mleko tudi pri človeku ni bilo preučevano v nadzorovanih študijah.
English: • Sprinkle all of the capsule's contents onto a spoonful of soft food, taking care to see that the entire prescribed dosage is sprinkled onto the food.
Slovenian: • Stresite vso vsebino kapsule na žličko mehke hrane in pazite, da boste pri tem uporabili celoten predpisani odmerek.
English: ↔ = No effect on plasma concentration (≤ 15% change) ** = Plasma concentrations increase in individual patients ↓ = Plasma concentrations decrease NS = Not studied
Slovenian: ↔ = ne vpliva na plazemske koncentracije (sprememba ≤ 15 %) ** = povečane plazemske koncentracije pri posameznih bolnikih ↓ = zmanjšane plazemske koncentracije NP = niso proučevali
English: These phenomena may be the consequence of an overdose, a decrease in plasma concentrations of concomitantly used anti-epileptics, progress of the disease, or a paradoxical effect.
Slovenian: Ta pojav je lahko posledica prekomernega odmerjanja, zmanjšanja plazemskih koncentracij sočasno uporabljenih antiepileptičnih zdravil, napredovanja bolezni ali pa je paradoksalen.
English: Pizotifen Diltiazem25% decrease in AUC of diltiazem and 18% decrease in DEA, and ↔ for DEM*
Slovenian: pizotifen diltiazem25 % zmanjšanje vrednosti AUC za diltiazem in 18 % zmanjšanje DEA, ter ↔ za DEM*
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Slovenian: Bolnikom (in njihovim negovalcem) tudi svetujte, naj poiščejo zdravniško pomoč, če se pojavijo znaki samomorilnih misli ali samomorilnega vedenja.
English: Paediatric population (children over 6 years of age)
Slovenian: Pediatrična populacija (otroci, starejši od 6 let)
English: No paediatric subjects have been investigated in any of the migraine studies and therefore no efficacy or safety claim has been made.
Slovenian: Uporaba pri otrocih ni bila raziskana v nobeni študiji migren, zato niso možne trditve o učinkovitosti ali varnosti.
English: The MAH provided a review of data collections from J&J PRD's own pharmacovigilance database and prospective pregnancy registries, which identified potential risks to the foetus of pregnant women treated with topiramate.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil pregled zbirk podatkov iz lastne baze farmakovigilančnih podatkov družbe J&J PRD ter prospektivnih registrov nosečnosti, v katerih so odkrili možna tveganja za plod v nosečnici, ki jemlje topiramat.
English: Nutritional supplementation
Slovenian: Prehranski dodatki
English: • Reduced sense of touch or sensation
Slovenian: • zmanjšan občutek za dotik ali občutenje
English: This pharmacologic effect is much weaker than that of acetazolamide, a known carbonic anhydrase inhibitor, and is not thought to be a major component of topiramate's antiepileptic activity.
Slovenian: Ta farmakološki učinek topiramata pa je šibkejši od učinka acetazolamida, ki je znan zaviralec karboanhidraze, zato menijo, da ne predstavlja pomembne komponente antiepileptične aktivnosti topiramata.
English: This explanation was considered to be reasonable and the proposed indication for the use of topiramate as adjunctive therapy in adults with primary generalized tonic-clonic seizures can be considered to be sufficiently supported.
Slovenian: Ta razlaga je štela za razumno, zato se lahko predlagana indikacija za uporabo topiramata kot dodatne terapije pri odraslih s primarnimi generaliziranimi tonično-kloničnimi napadi razume kot zadostno podprta.
English: • Tissue calcification (calcinosis).
Slovenian: • poapnevanje tkiv (kalcinoza).
English: The teratogenic effects seen in rats and rabbits were similar to those seen with carbonic anhydrase inhibitors, which have not been associated with malformations in humans.
Slovenian: Teratogeni učinki pri podganah in kuncih so bili podobni učinkom pri zaviralcih karboanhidraze, ki jih niso povezali z malformacijami pri ljudeh.
English: Chronic metabolic acidosis increases the risk of renal stone formation and may potentially lead to osteopenia.
Slovenian: Kronična metabolična acidoza povečuje tveganje za nastanek ledvičnih kamnov in lahko vodi v osteopenijo.
English: • Decrease or loss of appetite
Slovenian: • zmanjšanje ali izgubo apetita
English: • Loss of strength
Slovenian: • izgubo moči
English: • Frequent urination
Slovenian: • pogosto uriniranje
English: Treatment should be appropriately supportive and the patient should be well hydrated.
Slovenian: Uvedite ustrezno podporno zdravljenje in zagotovite dobro hidracijo bolnika.
English: A small number of people being treated with anti-epileptic medicines such as Topamax have had thoughts of harming or killing themselves.
Slovenian: Pri majhnem številu ljudi, ki so se zdravili z antiepileptiki, na primer z zdravilom Topamax, so se pojavile misli na samopoškodovanje ali samomor.
English: Daily doses up to 30 mg/kg/day have been studied and were generally well tolerated.
Slovenian: Preučevali so dnevne odmerke do 30 mg/kg/dan in otroci so jih običajno dobro prenašali.
English: The safety of topiramate was evaluated from a clinical trial database consisting of 4,111 patients (3,182 on topiramate and 929 on placebo) who participated in 20 double-blind trials and 2,847 patients who participated in 34 open-label trials, respectively, for topiramate as adjunctive treatment of primary generalized tonic-clonic seizures, partial onset seizures, seizures associated with Lennox-Gastaut syndrome, monotherapy for newly or recently diagnosed epilepsy or migraine prophylaxis.
Slovenian: Varnost topiramata so ovrednotili s pomočjo podatkovne baze kliničnih preskušanj za 4.111 bolnikov (3.182 bolnikov, zdravljenih s topiramatom, in 929 bolnikov, prejemalo placebo), ki so sodelovali v 20 dvojno slepih preskušanjih, ter 2.847 bolnikov, ki so sodelovali v 34 odprtih preskušanjih dodatnega zdravljenja primarno generaliziranih tonično-kloničnih epileptičnih napadov, parcialnih epileptičnih napadov, epileptičnih napadov povezanih z Lennox-Gastautovim sindromom ter pri monoterapiji novo diagnosticirane ali pred kratkim diagnosticirane epilepsije in profilaksi migrene.
English: In double blind clinical trials, suicide related events (SREs) (suicidal ideation, suicide attempts and suicide) occurred at a frequency of 0.5% in topiramate treated patients (46 out of 8,652 patients treated) and at a nearly 3 fold higher incidence than those treated with placebo (0.2%; 8 out of 4,045 patients treated).
Slovenian: V dvojno slepih kliničnih preskušanjih so se s samomorom povezani dogodki (suicide related events (SREs) - samomorilno razmišljanje, poskus samomora, samomor) pri bolnikih, ki so se zdravili s topiramatom, pojavljali s pogostnostjo 0,5% (pri 46 bolnikih na 8.652 zdravljenih bolnikov) in s skoraj trikrat višjo pojavnostjo kot pri placebu (0,2%; pri 8 bolnikih na 4.045 zdravljenih bolnikov).
English: In newly diagnosed patients, topiramate showed benefit in monotherapy in two (TOPMAT-EPMN-105 and TOPMAT-EPMN-106) out of the three studies conducted.
Slovenian: Pri bolnikih z novo diagnozo je topiramat izkazal koristne učinke v monoterapiji v dveh (TOPMATEPMN-105 in TOPMAT-EPMN-106) izmed treh izvedenih študij.
English: Proper hydration prior to and during activities such as exercise or exposure to warm temperatures may reduce the risk of heat-related adverse reactions (see section 4.8).
Slovenian: Poleg tega lahko z ustrezno hidracijo pred in med različnimi dejavnostmi, na primer telesno vadbo ali izpostavljenostjo visokim temperaturam, zmanjšamo tudi tveganje za pojav neželenih učinkov zaradi vročine (glejte poglavje 4.8).
English: This adverse reaction is not due to a pharmacokinetic interaction.
Slovenian: Ta neželeni učinek ni posledica farmakokinetične interakcije med zdravili.
English: ↔ 31% increase in AUC of the reduced metabolite
Slovenian: ↔ 31 % povečanje vrednosti AUC za reduciran presnovek
English: Here, the seizure types studies included both partial onset seizures (defined as partial, complex partial, or partial evolving into secondarily generalized seizures) and generalized seizures (defined as generalized tonic-clonic, tonic, or clonic seizures).
Slovenian: V tem primeru so bili med preučevane vrste napadov vključeni napadi z delnim nastopom (opredeljeni kot delni, kompleksni delni ali delni, ki prehajajo v sekundarno generalizirane napade) in generalizirani napadi (opredeljeni kot generalizirani tonično-klonični, tonični ali klonični napadi).
English: No evidence of tolerance has been demonstrated in man.
Slovenian: Pri človeku tudi ni bilo znakov pojava tolerance na zdravilo.
English: Since many medicinal products are excreted into human milk, a decision must be made whether to suspend breast-feeding or to discontinue/ abstain from topiramate therapy taking into account the importance of the medicinal product to the mother (section 4.4).
Slovenian: Ker se številne učinkovine izločajo v mleko se je treba odločiti, ali naj mati preneha dojiti, ali pa ji boste začasno ali popolnoma ukinili zdravljenje s topiramatom, pri čemer je treba upoštevati pomembnost zdravila za mater (glejte poglavje 4.4).
English: In situations where rapid withdrawal of topiramate is medically required, appropriate monitoring is recommended (see section 4.2 for further details).
Slovenian: Kadar je zaradi zdravstvenih razlogov treba hitro ukiniti zdravilo, je priporočeno ustrezno spremljanje bolnika (za dodatne podatke glejte poglavje 4.2).
English: Clinical studies have been conducted to assess the potential pharmacokinetic drug interaction between topiramate and other agents.
Slovenian: Opravljene so bile klinične študije za oceno morebitnih farmakokinetičnih interakcij med topiramatom in drugimi zdravili.
English: Although not achieving statistical significance in a given age group 2-5 yrs, 6-9 yrs, 10-15 yrs and ≥16 yrs, the general trend is toward numerical superiority to placebo in each age group.
Slovenian: Čeprav rezultati niso dosegli statistične pomembnosti v določenih starostnih skupinah, 2-5 let, 6-9 let, 10-15 let in ≥16 let, pa v vsaki starostni skupini splošni trend kaže številsko superiornost nad placebom.
English: Your doctor will usually start you on a low dose of Topamax and slowly increase your dose until the best dose is found for you.
Slovenian: Zdravnik običajno predpiše zdravilo Topamax v majhnem odmerku in ga potem počasi povečuje, dokler ne najde najbolj primernega odmerka.
English: In some countries, topiramate was approved as a second- line prophylactic migraine medication.
Slovenian: V nekaterih državah je bil topiramat odobren kot profilaktično migrensko zdravilo druge izbire.
English: You should not take Topamax for migraine prevention if you are pregnant or you are able to become pregnant and you are not using effective contraception.
Slovenian: Zdravila Topamax ne smete uporabljati za zdravljenje migrene, če ste noseči ali lahko zanosite in ne uporabljate učinkovite kontracepcije.
English: In clinical trials as adjunctive therapy, 200 mg was the lowest effective dose.
Slovenian: V kliničnih preskušanjih dodatnega zdravljenja je bil 200 mg odmerek najmanjši še učinkovit odmerek.
English: During pregnancy, topiramate should be prescribed after fully informing the woman of the known risks of uncontrolled epilepsy to the pregnancy and the potential risks of the medicinal product to the foetus.
Slovenian: Nosečnice je treba, pred predpisovanjem topiramata, temeljito poučiti o znanih tveganjih nenadzorovane epilepsije za nosečnost in tveganjih, ki jih predstavlja uporaba zdravila za plod.
English: Patients with normal renal function may take 4 to 8 days to reach steady-state plasma concentrations.
Slovenian: Pri bolnikih z normalnim delovanjem ledvic lahko traja od 4 do 8 dni, da dosežejo plazemske koncentracije v stanju dinamičnega ravnovesja.
English: After discussion of the wording for this indication, the following text was considered to be acceptable to the CHMP for the use of topiramate in monotherapy for epilepsy:
Slovenian: Po razpravi o besedilu te indikacije je bilo za CHMP naslednje besedilo sprejemljivo za uporabo topiramata kot monoterapije za epilepsijo:
English: Minimal alterations in the pharmacokinetics of the total active moiety (risperidone plus 9hydroxyrisperidone) and no alterations for 9-hydroxyrisperidone were observed.
Slovenian: Opazili so le minimalne spremembe v farmakokinetiki aktivne frakcije (risperidon in 9-hidroksirisperidon), brez sprememb pri 9-hidroksirisperidonu.
English: No study has shown that good migraine control prevents gestational hypertension or pre eclampsia.
Slovenian: Nobena študija ni dokazala, da dobro obvladovanje migrene prepreči gestacijsko hipertenzijo ali preeklampsijo.
English: • Take Topamax exactly as prescribed.
Slovenian: • Zdravilo Topamax jemljite natančno tako, kot vam je bilo predpisano.
English: The results provided by this study reinforce those derived from the Study YP in children with Partial Onset Seizure.
Slovenian: Rezultati te študije potrjujejo rezultate študije YP pri otrocih z napadi z delnim nastopom.
English: It is recommended that women of child bearing potential use adequate contraception.
Slovenian: Ženske v rodni dobi morajo uporabljati ustrezno kontracepcijo.
English: The film-coated tablet and hard capsule formulations are bioequivalent.
Slovenian: Farmacevtski obliki filmsko obložene tablete in trde kapsule sta bioekvivalntni.
English: Drug-drug interaction studies conducted under single dose conditions in healthy volunteers and multiple dose conditions in patients with bipolar disorder, yielded similar results.
Slovenian: Študije medsebojnega delovanja zdravil, ki so jih opravili z enkratnim odmerjanjem pri zdravih prostovoljcih ali večkratnim odmerjanjem pri bolnikih z bipolarno motnjo, so dale podobne rezultate.
English: In addition, a 13% and 16% decrease in Cmax,ss and AUCτ,ss respectively, of the active hydroxy-metabolite was noted as well as a 60% decrease in Cmax,ss and AUCτ,ss of the active keto-metabolite.
Slovenian: Poleg tega so ugotovili 13 % zmanjšanje vrednosti Cmax,ss in 16 % zmanjšanje vrednosti AUCτ,ss za aktiven hidroksi presnovek, pa tudi 60 % zmanjšanje vrednosti Cmax,ss in AUCτ,ss za aktiven keto presnovek.
English: INFORMATION IN BRAILLE Not applicable.
Slovenian: PODATKI V BRAILLOVI PISAVI Navedba smiselno ni potrebna.
English: There were no relevant effects on long bone (tibia) growth or bone (femur) mineral density, preweaning and reproductive development, neurological development (including assessments on memory and learning), mating and fertility or hysterotomy parameters.
Slovenian: Ni bilo pomembnih učinkov na rast dolgih kosti (golenica) ali mineralno gostoto kosti (stegnenica), odstavljanje od sesanja, razvoj spolnih organov, nevrološki razvoj (vključno z oceno spomina in učenja), parjenje in plodnost ali parametre histerotomije.
English: Topiramate is only weakly effective in blocking clonic seizures induced by the GABAA receptor antagonist, pentylenetetrazole.
Slovenian: Topiramat je le slabo učinkovit pri zaviranju kloničnih epileptičnih napadov, ki jih povzroča antagonist receptorjev GABAA, pentilentetrazol.
English: The supplemental dose should be administered in divided doses at the beginning and completion of the haemodialysis procedure.
Slovenian: Dodatni odmerek se daje razdeljen na dva odmerka na začetku in koncu hemodialize.
English: Topiramate is contraindicated in pregnancy, and in women of childbearing potential if an effective method of contraception is not used (see section 4.3 and 4.5 Interactions with oral contraceptives).
Slovenian: Topiramat je kontraindiciran med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite metode kontracepcije (glejte poglavje 4.3 in 4.5 interakcije s peroralnimi kontraceptivi).
English: Although a literature review presented by the MAH indicates that there is a potential benefit in using migraine prophylactic treatment in pregnant women suffering from migraine, it is fair to say that the vast majority of migraine improves during pregnancy, although the exact figures from studies vary.
Slovenian: Čeprav pregled gradiva, ki ga je predložil imetnik dovoljenja za promet z zdravilom, kaže na možne koristi profilaktičnega zdravljenja migrene pri nosečnicah z migreno, je treba povedati, da se velika večina migren med nosečnostjo izboljša, vendar se lahko natančne številke razlikujejo od študije do študije.
English: While using Topamax, agents like these should be avoided since they may create a physiological environment that increases the risk of renal stone formation.
Slovenian: Med uporabo zdravila Topamax se je treba izogibati tovrstnim zdravilom, ker lahko ustvarijo fiziološko okolje, ki povečuje tveganje za nastanek ledvičnih kamnov.
English: Rarely, patients have experienced decreases to values below 10 mmol/l.
Slovenian: Le redko je prišlo do zmanjšanja koncentracije pod 10 mmol/l.
English: Topiramate exhibits low intersubject variability in plasma concentrations and, therefore, has predictable pharmacokinetics.
Slovenian: Topiramat je pokazal majhno variabilnost plazemskih koncentracij med posamezniki, torej ima predvidljivo farmakokinetiko.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>]
Slovenian: [{Ime in naslov} <{tel}> <{fax}> <{e-mail}>]
English: The fact that this effect was reproducible and has been observed in three species, both rodent and non-rodent is suggestive of a potential risk to humans.
Slovenian: Ponovljivost učinka in njegova razvidnost pri treh živalskih vrstah (glodalcih in neglodalcih) kažeta na možno tveganje za človeka.
English: For the sake of consistency it was agreed to merge both adjunctive therapy indications to read:
Slovenian: Zaradi doslednosti se je CHMP strinjal, da se združita obe indikaciji dodatne terapije, in sicer naslednji način:
English: The evidence of the efficacy and safety of topiramate as monotherapy in the treatment of epilepsy has been presented from 4 randomised controlled studies.
Slovenian: Predloženi so bili dokazi o učinkovitosti in varnosti topiramata kot monoterapije za zdravljenje epilepsije iz 4 randomiziranih nadzorovanih študij.
English: In both studies, Topamax (50-200 mg/day in healthy volunteers and 200-800 mg/day in epilepsy patients) did not significantly affect exposure to NET.
Slovenian: V obeh študijah zdravilo Topamax (v odmerkih od 50-200 mg/dan pri zdravih prostovoljkah in 200-800 mg/dan pri bolnicah z epilepsijo) ni bistveno vplivalo na izpostavljenost noretisteronu.
English: The clinical development in general fulfils the CHMP Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Epileptic Disorders, with respect to the key issues.
Slovenian: Klinični razvoj v zvezi s ključnimi vprašanji na splošno izpolnjuje Navodila CHMP o kliničnih raziskavah zdravil za zdravljenje epileptičnih motenj.
English: Overall numbers of fetal malformations in mice were increased for all drug-treated groups (20, 100 and 500 mg/kg/day).
Slovenian: Pri miših je bilo celokupno število malformacij plodov povečano v vseh skupinah, ki so prejemale učinkovino (20, 100 in 500 mg/kg/dan).