natgillin/translations-raw huggingface dataset:
• Tissue calcification (calcinosis).
• poapnevanje tkiv (kalcinoza).
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.
Teratogeni učinki pri podganah in kuncih so bili podobni učinkom pri zaviralcih karboanhidraze, ki jih niso povezali z malformacijami pri ljudeh.
Chronic metabolic acidosis increases the risk of renal stone formation and may potentially lead to osteopenia.
Kronična metabolična acidoza povečuje tveganje za nastanek ledvičnih kamnov in lahko vodi v osteopenijo.
• Decrease or loss of appetite
• zmanjšanje ali izgubo apetita
• Loss of strength
• izgubo moči
• Frequent urination
• pogosto uriniranje
Treatment should be appropriately supportive and the patient should be well hydrated.
Uvedite ustrezno podporno zdravljenje in zagotovite dobro hidracijo bolnika.
A small number of people being treated with anti-epileptic medicines such as Topamax have had thoughts of harming or killing themselves.
Pri majhnem številu ljudi, ki so se zdravili z antiepileptiki, na primer z zdravilom Topamax, so se pojavile misli na samopoškodovanje ali samomor.
Daily doses up to 30 mg/kg/day have been studied and were generally well tolerated.
Preučevali so dnevne odmerke do 30 mg/kg/dan in otroci so jih običajno dobro prenašali.
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.
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.
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).
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).
In newly diagnosed patients, topiramate showed benefit in monotherapy in two (TOPMAT-EPMN-105 and TOPMAT-EPMN-106) out of the three studies conducted.
Pri bolnikih z novo diagnozo je topiramat izkazal koristne učinke v monoterapiji v dveh (TOPMATEPMN-105 in TOPMAT-EPMN-106) izmed treh izvedenih študij.
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).
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).
This adverse reaction is not due to a pharmacokinetic interaction.
Ta neželeni učinek ni posledica farmakokinetične interakcije med zdravili.
↔ 31% increase in AUC of the reduced metabolite
↔ 31 % povečanje vrednosti AUC za reduciran presnovek
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).
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).
No evidence of tolerance has been demonstrated in man.
Pri človeku tudi ni bilo znakov pojava tolerance na zdravilo.
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).
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).
In situations where rapid withdrawal of topiramate is medically required, appropriate monitoring is recommended (see section 4.2 for further details).
Kadar je zaradi zdravstvenih razlogov treba hitro ukiniti zdravilo, je priporočeno ustrezno spremljanje bolnika (za dodatne podatke glejte poglavje 4.2).
Clinical studies have been conducted to assess the potential pharmacokinetic drug interaction between topiramate and other agents.
Opravljene so bile klinične študije za oceno morebitnih farmakokinetičnih interakcij med topiramatom in drugimi zdravili.
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.
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.
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.
Zdravnik običajno predpiše zdravilo Topamax v majhnem odmerku in ga potem počasi povečuje, dokler ne najde najbolj primernega odmerka.
In some countries, topiramate was approved as a second- line prophylactic migraine medication.
V nekaterih državah je bil topiramat odobren kot profilaktično migrensko zdravilo druge izbire.
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.
Zdravila Topamax ne smete uporabljati za zdravljenje migrene, če ste noseči ali lahko zanosite in ne uporabljate učinkovite kontracepcije.
In clinical trials as adjunctive therapy, 200 mg was the lowest effective dose.
V kliničnih preskušanjih dodatnega zdravljenja je bil 200 mg odmerek najmanjši še učinkovit odmerek.
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.
Nosečnice je treba, pred predpisovanjem topiramata, temeljito poučiti o znanih tveganjih nenadzorovane epilepsije za nosečnost in tveganjih, ki jih predstavlja uporaba zdravila za plod.
Patients with normal renal function may take 4 to 8 days to reach steady-state plasma concentrations.
Pri bolnikih z normalnim delovanjem ledvic lahko traja od 4 do 8 dni, da dosežejo plazemske koncentracije v stanju dinamičnega ravnovesja.
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:
Po razpravi o besedilu te indikacije je bilo za CHMP naslednje besedilo sprejemljivo za uporabo topiramata kot monoterapije za epilepsijo:
Minimal alterations in the pharmacokinetics of the total active moiety (risperidone plus 9hydroxyrisperidone) and no alterations for 9-hydroxyrisperidone were observed.
Opazili so le minimalne spremembe v farmakokinetiki aktivne frakcije (risperidon in 9-hidroksirisperidon), brez sprememb pri 9-hidroksirisperidonu.
No study has shown that good migraine control prevents gestational hypertension or pre eclampsia.
Nobena študija ni dokazala, da dobro obvladovanje migrene prepreči gestacijsko hipertenzijo ali preeklampsijo.
• Take Topamax exactly as prescribed.
• Zdravilo Topamax jemljite natančno tako, kot vam je bilo predpisano.
The results provided by this study reinforce those derived from the Study YP in children with Partial Onset Seizure.
Rezultati te študije potrjujejo rezultate študije YP pri otrocih z napadi z delnim nastopom.
It is recommended that women of child bearing potential use adequate contraception.
Ženske v rodni dobi morajo uporabljati ustrezno kontracepcijo.
The film-coated tablet and hard capsule formulations are bioequivalent.
Farmacevtski obliki filmsko obložene tablete in trde kapsule sta bioekvivalntni.
Drug-drug interaction studies conducted under single dose conditions in healthy volunteers and multiple dose conditions in patients with bipolar disorder, yielded similar results.
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.
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.
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.
INFORMATION IN BRAILLE Not applicable.
PODATKI V BRAILLOVI PISAVI Navedba smiselno ni potrebna.
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.
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.
Topiramate is only weakly effective in blocking clonic seizures induced by the GABAA receptor antagonist, pentylenetetrazole.
Topiramat je le slabo učinkovit pri zaviranju kloničnih epileptičnih napadov, ki jih povzroča antagonist receptorjev GABAA, pentilentetrazol.
The supplemental dose should be administered in divided doses at the beginning and completion of the haemodialysis procedure.
Dodatni odmerek se daje razdeljen na dva odmerka na začetku in koncu hemodialize.
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).
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).
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.
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.
While using Topamax, agents like these should be avoided since they may create a physiological environment that increases the risk of renal stone formation.
Med uporabo zdravila Topamax se je treba izogibati tovrstnim zdravilom, ker lahko ustvarijo fiziološko okolje, ki povečuje tveganje za nastanek ledvičnih kamnov.
Rarely, patients have experienced decreases to values below 10 mmol/l.
Le redko je prišlo do zmanjšanja koncentracije pod 10 mmol/l.
Topiramate exhibits low intersubject variability in plasma concentrations and, therefore, has predictable pharmacokinetics.
Topiramat je pokazal majhno variabilnost plazemskih koncentracij med posamezniki, torej ima predvidljivo farmakokinetiko.
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[{Ime in naslov} <{tel}> <{fax}> <{e-mail}>]
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.
Ponovljivost učinka in njegova razvidnost pri treh živalskih vrstah (glodalcih in neglodalcih) kažeta na možno tveganje za človeka.
For the sake of consistency it was agreed to merge both adjunctive therapy indications to read:
Zaradi doslednosti se je CHMP strinjal, da se združita obe indikaciji dodatne terapije, in sicer naslednji način:
The evidence of the efficacy and safety of topiramate as monotherapy in the treatment of epilepsy has been presented from 4 randomised controlled studies.
Predloženi so bili dokazi o učinkovitosti in varnosti topiramata kot monoterapije za zdravljenje epilepsije iz 4 randomiziranih nadzorovanih študij.
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.
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.
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.
Klinični razvoj v zvezi s ključnimi vprašanji na splošno izpolnjuje Navodila CHMP o kliničnih raziskavah zdravil za zdravljenje epileptičnih motenj.
Overall numbers of fetal malformations in mice were increased for all drug-treated groups (20, 100 and 500 mg/kg/day).
Pri miših je bilo celokupno število malformacij plodov povečano v vseh skupinah, ki so prejemale učinkovino (20, 100 in 500 mg/kg/dan).
Based on the recovery of radioactivity from the urine the mean extent of absorption of a 100 mg oral dose of 14C-topiramate was at least 81%.
Če so jo izračunali na podlagi merjenja radioaktivnosti v urinu, je bila srednja stopnja absorpcije 100 mg peroralnega odmerka topiramata-C14 najmanj 81 %.
Drink plenty of fluids during the day to prevent kidney stones while taking Topamax.
Čez dan pijte veliko tekočine, da boste preprečili nastanek ledvičnih kamnov med jemanjem zdravila Topamax.
In addition, there was no change in steady state plasma concentration of topiramate during or after removal of lamotrigine treatment (mean dose of 327 mg/day).
Poleg tega tudi ni bilo sprememb v plazemskih koncentracijah topiramata v stanju dinamičnega ravnovesja med ali po ukinitvi zdravljenja z lamotriginom (srednji odmerek je bil 327 mg/dan).
Tell your doctor if your menstrual bleeding changes while you are taking birth control pills and Topamax.
Povejte svojemu zdravniku, če se vam med jemanjem kontracepcijskih tablet in zdravila Topamax spremeni menstruacijska krvavitev.
- SI Šmartinska 53, Ljubljana, Slovenia
- SI Šmartinska 53, Ljubljana, Slovenija
• Problems with learning
• težave pri učenju
Following extensive discussion on the use of topiramate in the prophylaxis of migraine, the following text was considered to be acceptable to the CHMP:
Po obsežni razpravi o uporabi topiramata za profilakso migrene je bilo za CHMP sprejemljivo naslednje besedilo:
↔ 20% increase in Cmax and AUC of nortriptyline metabolite
↔ 20 % povečanje vrednosti Cmax in AUC za nortriptilinov presnovek
You should also to talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to Topamax.
Z zdravnikom se morate posvetovati tudi preden vzamete katerokoli drugo zdravilo, ki vsebuje topiramat, ki vam ga dajo v lekarni namesto zdravila Topamax.
In patients with or without a history of seizures or epilepsy, antiepileptic drugs including topiramate should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency.
Pri bolnikih z ali brez epileptičnih napadov oziroma epilepsije v anamnezi je treba antiepileptike, vključno s topiramatom, ukinjati postopoma, da bi kar najbolj zmanjšali nevarnost za pojav epileptičnih napadov ali za povečanje njihove pogostnosti.
ADRs identified in clinical trials, and during post-marketing experience (as indicated by “*”) are listed by their incidence in clinical trials in Table 1.
Neželeni učinki, ki so jih opazili v kliničnih preskušanjih in v okviru postmarketinških izkušenj z uporabo zdravila (označeno z *), so podani v Preglednici 1, skupaj z incidencami v kliničnih preskušanjih.
Therefore the following harmonised indication for the treatment of seizures associated with Lennox-Gastaut syndrome was adopted by the CHMP.
Zato je CHMP sprejel naslednjo usklajeno indikacijo zdravljenja napadov, povezanih z LennoxGastautovim sindromom.
These dosing recommendations apply to all adults including the elderly in the absence of underlying renal disease.
Podana priporočila za odmerjanje veljajo za vse odrasle, vključno s starostniki, ki nimajo ledvične osnovne bolezni.
Janssen-Cilag AB - SE Box 7073 192 07 Sollentuna, Sverige
Janssen-Cilag AB - SE Box 7073 192 07 Sollentuna, Švedska
- SI Smartinska cesta 53, 1000 Ljubljana, Slovenia
- SI Smartinska cesta 53, 1000 Ljubljana, Slovenija
Your doctor will decide if you can take Topamax.
Zdravnik bo presodil, ali smete jemati zdravilo Topamax.
Pregnancy registry data suggest that there may be an association between the use of Topamax during pregnancy and congenital malformations (e.g., craniofacial defects, such as cleft lip/palate, hypospadias, and anomalies involving various body systems).
Podatki iz registrov nosečnosti kažejo na povezavo med uporabo zdravila Topamax med nosečnostjo in kongenitalnimi malformacijami (npr. kraniofacialni defekti kot je volčje žrelo, hipospadije in anomalije, ki vključujejo več telesnih sistemov).
Topiramate is effectively removed from plasma by haemodialysis.
Topiramat se učinkovito odstranjuje iz plazme s hemodializo.
• Abnormal blood counts, including reduced white blood cell count or platelet count, or increased eosinophils
• nenormalno število krvnih celic, vključno z zmanjšanim številom levkocitov ali trombocitov ali povečano število eozinofilcev
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The MAH justifies this difference stating that the imbalance in baseline seizure rate, in seizure severity and selective discontinuation rate among the groups could have contributed to the underestimation of topiramate efficacy.
Imetnik dovoljenja za promet z zdravilom je utemeljil to razliko z izjavo, da je neuravnovešenost izhodiščne stopnje napadov in resnosti napadov ter selektivna stopnja prekinitve zdravljenja med skupinami lahko prispevala k podcenjevanju učinkovitosti topiramata.
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Like all medicines, Topamax can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Topamax neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Because the antiepileptic profile of topiramate differs markedly from that of the benzodiazepines, it may modulate a benzodiazepine-insensitive subtype of GABAA receptor.
Ker se antiepileptični profil topiramata močno razlikuje od antiepileptičnega profila benzodiazepinov, lahko topiramat učinkuje na za benzodiazepine neobčutljiv podtip receptorjev GABAA.
If you are losing too much weight or a child using this medicine is not gaining enough weight, you should consult your doctor.
Če preveč shujšate ali če otrok, ki jemlje to zdravilo ne pridobiva na telesni masi, se posvetujte z zdravnikom.
Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhoea, surgery, ketogenic diet, or certain medicinal products) may be additive to the bicarbonate lowering effects of topiramate.
Bolezni ali terapije, ki povečujejo nagnjenost k acidozi (na primer ledvične bolezni, hude bolezni dihal, status epilepticus, driska, kirurški poseg, ketogena dieta ali nekatera zdravila), lahko še dodatno prispevajo k zmanjševanju koncentracije hidrogenkarbonata v serumu zaradi uporabe topiramata.
Seizures associated with Lennox-Gastaut syndrome (LGS) The use of topiramate as add-on therapy in patients (adults and paediatrics) with LGS treated with up to 2 AEDs was supported by only one, controlled, rather short study.
Napadi, povezani z Lennox-Gastautovim sindromom (LGS) Uporabo topiramata kot dopolnilne terapije pri bolnikih (odraslih in otrocih) z Lennox-Gastautovim sindromom, zdravljenih z do 2 zdraviloma proti epilepsiji, je podprla le ena, nadzorovana, nekoliko kratka študija.
The second column (concomitant drug concentration) describes what happens to the concentration of the concomitant drug listed in the first column when topiramate is added.
Drugi stolpec (koncentracija sočasno uporabljenega zdravila) opisuje, kaj se zgodi s koncentracijo sočasno uporabljenega zdravila, navedenega v prvem stolpcu, pri dodatku topiramata.
• Loss of sensitivity to touch in the mouth
• izgubo občutka za dotik v ustih
Hydrochlorothiazide (HCTZ)
Hidroklorotiazid (HCTZ)
• Visual disturbance, blurred vision, double vision
• motnje vida, zamegljen vid, dvojni vid
In those women who require prophylactic treatment for migraine, an agent not shown to be teratogenic in three animal species at low dose, is preferred.
Pri ženskah, ki potrebujejo profilaktično zdravljenje migrene, se prednostno izbere učinkovina, za katero ni dokazana teratogenost pri treh živalskih vrstah z nizkim odmerkom.
Animal studies have shown excretion of topiramate in milk.
Študije pri živalih so pokazale, da se topiramat izloča v mleko samic.
There was no clinically significant effect of food on the bioavailability of topiramate.
Hrana ni klinično pomembno vplivala na biološko uporabnost topiramata.
Given that an increase in the number of adverse events (as well as the AEs leading to study discontinuation) is observed when risperidone and topiramate are administered concomitantly, the wording of this subsection has been slightly amended.
Glede na opaženo povečanje števila neželenih učinkov (kot tudi neželenih učinkov, ki povzročijo prenehanje sodelovanja v študiji) ob sočasni uporabi risperidona in topiramata, se besedilo podpoglavja nekoliko spremeni.
Increase in exposure may be attributed to accumulation during achievement of steady state.
To povečanje izpostavljenosti bi lahko pripisali kopičenju zdravila med doseganjem stanja dinamičnega ravnovesja.
Paediatric population (children aged 2 years and above)
Pediatrična populacija (otroci, stari 2 leti ali več)
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In a single-dose study, serum digoxin area under plasma concentration curve (AUC) decreased 12% due to concomitant administration of Topamax.
V študiji enkratnih odmerkov se je površina pod krivuljo plazemske koncentracije digoksina v odvisnosti od časa (AUC) zmanjšala za 12 % zaradi sočasne uporabe zdravila Topamax.