FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Ivozall are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Ivozall, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Why is Ivozall authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Ivozall odobreno v EU?
English: The recommended dose of Ivozall is based on the patient's height and weight.
Slovenian: Priporočeni odmerek zdravila Ivozall temelji na telesni višini in masi bolnika.
English: It is available as a solution for infusion (drip) into a vein.
Slovenian: Na voljo je kot raztopina za infundiranje (kapalno infuzijo) v veno.
English: What is Ivozall and what is it used for?
Slovenian: Kaj je zdravilo Ivozall in za kaj se uporablja?
English: For more information about using Ivozall, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Ivozall glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: There was no need for ‘bioequivalence' studies to investigate whether Ivozall is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Slovenian: Izvedba študije „bioekvivalence“, s katero bi raziskali, ali se zdravilo Ivozall absorbira podobno kot referenčno zdravilo in tako doseže enako raven učinkovine v krvi, ni bila potrebna.
English: This means that Ivozall contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Evoltra.
Slovenian: To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Evoltra.
English: This means that clofarabine resembles adenine and by taking adenine's place in the body, it interferes with the action of enzymes involved in making genetic material, called ‘DNA polymerase' and ‘RNA reductase'.
Slovenian: To pomeni, da je klofarabin podoben adeninu in s tem, ko ga nadomesti v telesu, moti delovanje encimov „DNK polimeraze“ in „RNK reduktaze“, ki sodelujeta pri izgradnji genetskega materiala.
English: Clofarabine is an ‘analogue' of adenine, one of the building blocks of the genetic material of cells (DNA and RNA).
Slovenian: Klofarabin je analog adenina, ki je eden od gradnikov genetskega materiala celic (DNK in RNK).
English: This is because Ivozall is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Slovenian: Zdravilo Ivozall se namreč daje z infundiranjem v veno, tako da učinkovina vstopa neposredno v krvni obtok.
English: The active substance in Ivozall, clofarabine, is a cytotoxic agent (a medicine that kills cells that are dividing, such as cancer cells).
Slovenian: Učinkovina zdravila Ivozall, klofarabin, je citotoksična snov (zdravilo, ki uničuje celice, ki se delijo, kot so npr. rakave celice).
English: Ivozall contains the active substance clofarabine and is a ‘generic medicine'.
Slovenian: Zdravilo Ivozall vsebuje učinkovino klofarabin in je generično zdravilo.
English: Ivozall can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Ivozall je le na recept.
English: Therefore, the Agency's view was that, as for Evoltra, the benefits of Ivozall outweigh the identified risks and it can be authorised for use in the EU.
Slovenian: Zato je menila, da koristi zdravila Ivozall enako kot pri zdravilu Evoltra odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: How does Ivozall work?
Slovenian: Kako zdravilo Ivozall deluje?
English: How has Ivozall been studied?
Slovenian: Kako je bilo zdravilo Ivozall raziskano?
English: How is Ivozall used?
Slovenian: Kako se zdravilo Ivozall uporablja?
English: In 2 out of 4 studies these differences were statistically significant.
Slovenian: V 2 študijah od 4 so bile te razlike statistično pomembne.
English: These results can be considered sufficient to support the proposed indication.
Slovenian: Ti rezultati lahko štejejo kot zadostni za podporo predlagani indikaciji.
English: • See a doctor right away.
Slovenian: • Nemudoma obiščite zdravnika.
English: Member State EU/EEA
Slovenian: Država članica (EU/EGP)
English: Not known cannot be estimated from the available data
Slovenian: neznana ni mogoče oceniti iz razpoložljivih podatkov
English: The main areas for harmonisation were as follows:
Slovenian: Glavna področja usklajevanja so bila naslednja:
English: Keep a list of all the medicines you take.
Slovenian: Napravite seznam vseh zdravil, ki jih jemljete.
English: This is further supported by the low discontinuation rate due to lack of efficacy.
Slovenian: To dodatno podpira nizka stopnja prekinitve uporabe zaradi pomanjkanja učinkovitosti.
English: • Hold the hard capsule upright so that you can read the word “TOP”
Slovenian: • Kapsulo držite pokonci, da boste lahko prebrali besedo “TOP”.
English: Topiramate is rapidly and well absorbed.
Slovenian: Topiramat se absorbira hitro in dobro.
English: • Never store any medicine and food mixture for use at a later time.
Slovenian: • Nikoli ne shranjujte mešanice zdravila in hrane za kasnejšo uporabo.
English: • If you forget to take a dose, take it as soon as you remember it.
Slovenian: • Če ste pozabili vzeti odmerek zdravila, ga vzemite takoj, ko se spomnite.
English: The youngest age involved in the clinical trials was 2 years old.
Slovenian: Najmlajši otroci, ki so sodelovali v kliničnih preskušanjih, so bili stari 2 leti.
English: 56 Eirinis Avenue 56, Pefki, 15121, Greece
Slovenian: 56 Eirinis Avenue 56, Pefki, 15121, Grčija
English: The results for European trial were inconclusive mainly due to a placebo response that was greater than expected.
Slovenian: Rezultati evropskega preskušanja niso bili prepričljivi, večinoma ker je bil odziv na placebo večji od pričakovanega.
English: • Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Slovenian: • Ne vzemite dvojnega odmerka (dveh odmerkov hkrati), če ste pozabili vzeti prejšnji odmerek.
English: The results of these interactions are summarized below:
Slovenian: Vplivi teh interakcij so povzeti v nadaljevanju:
English: Suicide/suicide ideation
Slovenian: Samomor in samomorilne misli
English: After the Commission Decision the Member State Competent Authorities, in liaison with the Reference Member State, will update the product information as required.
Slovenian: Kot je zahtevano, bodo po odločbi komisije pristojni organi držav članic, po posvetovanju z referenčno državo članico, lahko posodobili informacije o zdravilu.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for topiramate.
Slovenian: Mehanizem tveganja še ni znan, vendar razpoložljivi podatki ne izključujejo možnosti povečanega tveganja za topiramat.
English: • Restlessness or increased mental and physical activity
Slovenian: • nemir ali povečano duševno in telesno aktivnost
English: Key secondary outcomes (responder rate, migraine attack rate, use of rescue medication) demonstrated a consistent response.
Slovenian: Ključni sekundarni izidi (stopnja odzivnosti, stopnja napadov migrene, uporaba reševalnega zdravila) so dokazali dosleden odziv.
English: The CHMP agreed the following wording for adults:
Slovenian: CHMP se strinja z naslednjim besedilom za odrasle bolnike:
English: Generally, 13 to 17% of topiramate is bound to plasma protein.
Slovenian: Običajno je 13 do 17 % topiramata vezanega na plazemske beljakovine.
English: However, if it is almost time for your next dose, skip the missed dose and continue as usual.
Slovenian: Če pa je že skoraj čas za naslednji odmerek, preskočite pozabljeni odmerek in nadaljujte z jemanjem zdravila kot običajno.
English: 41470 Neuss, Germany
Slovenian: 41470 Neuss, Nemčija
English: • Allergic reaction
Slovenian: • alergijsko reakcijo.
English: 5000 LT Tilburg The Netherlands
Slovenian: 5000 LT Tilburg Nizozemska
English: If at any time you have these thoughts, immediately contact your doctor.
Slovenian: Če se tudi vam kadarkoli pojavijo takšne misli, nemudoma pokličite svojega zdravnika.
English: If your doctor decides to stop this medication, your dose may be decreased gradually over a few days.
Slovenian: Če je zdravnik presodil, da morate prenehati z jemanjem tega zdravila, vam bo odmerek v nekaj dneh postopoma zmanjšal.
English: It is true that the trials were not specifically designed for recruiting resistant patients although limited information is available regarding the kind of patients finally involved in them (naïve vs previously treated/resistant patients).
Slovenian: Res je, da preskušanja niso bila specifično zasnovana za vključevanje odpornih bolnikov, čeprav so na voljo omejeni podatki o vrsti bolnikov, ki so bili na koncu vključeni (predhodno nezdravljeni ali predhodno zdravljeni/odporni bolniki).
English: 20% increase in AUC
Slovenian: 20 % povečanje vrednosti AUC
English: • Changes in mood or behaviour, including anger, nervousness, sadness
Slovenian: • spremembe razpoloženja ali vedenja, vključno z jezo, razdražljivostjo, žalostjo
English: • Disturbances in sexual function (erectile dysfunction, loss of libido)
Slovenian: • motnje spolnosti (erektilna disfunkcija, izguba libida)
English: Especially, tell your doctor or pharmacist if you are taking:
Slovenian: Še posebej morate povedati svojemu zdravniku ali farmacevtu, če jemljete:
English: • to prevent migraine headaches in adults
Slovenian: • za preprečevanje migrenskih glavobolov pri odraslih.
English: In one of the studies (TOPMAT-MIGR-003), which compared topimarate to propranolol, a similar efficacy profile was observed.
Slovenian: V eni od študij (TOPMAT-MIGR-003), kjer so primerjali topimarat s propranololom, so ugotovili podoben profil učinkovitosti.
English: There are no adequate and well-controlled studies with Topamax in pregnant women.
Slovenian: Ni zadostnih in dobro nadzorovanih študij z zdravilom Topamax pri nosečnicah.
English: Raynaud's phenomenon
Slovenian: Raynaudov fenomen
English: Mood disturbances/depression
Slovenian: Motnje razpoloženja in depresija
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Slovenian: {Ime in naslov} <{tel}> <{fax}> <{e-mail}>
English: There is currently no evidence that migraine prophylaxis during pregnancy reduces the risk of stroke.
Slovenian: Trenutno ni dokazov, da profilaksa migrene med nosečnostjo zmanjša tveganje kapi.
English: Use of lower initial doses has been reported, but has not been studied systematically.
Slovenian: Poročali so tudi o uporabi manjših začetnih odmerkov, vendar le-teh niso sistematično proučevali.
English: Topiramate did not affect metformin tmax.
Slovenian: Topiramat ni vplival na tmax metformina.
English: Adjunctive therapy for epilepsy in children and adults The proposed indication of adjunctive therapy is approved in all of 29 countries involved in the Article 30 procedure.
Slovenian: Dodatna terapija epilepsije pri otrocih in odraslih bolnikih Predlagana indikacija dodatne terapije je odobrena v vseh 29 državah, vključenih v postopku po členu 30.
English: However there is no physiological or pharmacological reason to suspect that the mechanism of action of the drug or the pathophysiology of the illness would be any different in a child of 2 years versus a child of 10 years of age.
Slovenian: Vendar ni fiziološkega ali farmakološkega razloga za dvom, da bi se mehanizma delovanja zdravila ali patofiziologija bolezni pri dveletnem otroku in desetletnem otroku razlikovala.
English: The embryofetal studies show clear evidence of the teratogenic potential of topiramate.
Slovenian: Embriofetalne študije kažejo jasne dokaze teratogenega potenciala topiramata.
English: The supplemental dose may differ based on the characteristics of the dialysis equipment being used.
Slovenian: Dodatni odmerek je lahko različen glede na lastnosti uporabljenih dializnih aparatov.
English: Therefore, it is reasonable to accept that if efficacy in a given indication has been shown in the paediatric population in general, then those results can be extrapolated to a given lower age limit.
Slovenian: Zato je razumno sprejeti, da lahko po dokazani učinkovitosti za določeno indikacijo pri otrocih na splošno rezultate prenesemo na določeno spodnjo starostno mejo.
English: In humans, the major route of elimination of unchanged topiramate and its metabolites is via the kidney (at least 81% of the dose).
Slovenian: Pri človeku je glavna pot izločanja nespremenjenega topiramata in njegovih presnovkov skozi ledvice (najmanj 81 % odmerka).
English: - the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: - Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki so jih predlagali imetniki dovoljenj za promet z zdravilom, so bili ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora;
English: This data should be interpreted with caution, as more data is needed to identify increased risks for malformations.
Slovenian: Pri interpretaciji teh podatkov je potrebna previdnost, ker je za oceno tveganja za malformacije potrebnih še več podatkov.
English: It must not be stored for future use.
Slovenian: Poleg tega mešanice tudi ne sme shranjevati za kasnejšo uporabo.
English: It is recommended that filmcoated tablets not be broken.
Slovenian: Priporočljivo je, da filmsko obloženih tablet ne drobite.
English: Where there is insufficient human data but evidence of risk from animal studies and the availability of safer alternative treatments a contraindication for the use in pregnancy is justified.
Slovenian: Če je premalo podatkov za človeka, vendar obstajajo dokazi o tveganju iz študij na živalih in varnejša alternativna zdravljenja, je kontraindikacija za uporabo med nosečnostjo upravičena.
English: Pharmacotherapeutic group: other antiepileptics, antimigraine preparations, ATC code: N03AX11
Slovenian: Farmakoterapevtska skupina: drugi antiepileptiki, zdravila proti migreni, oznaka ATC: N03AX11
English: The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Slovenian: Pogostnost pojava neželenih učinkov je določena z naslednjim dogovorom: zelo pogosti (pojavijo se pri več kot 1 na 10 uporabnikov) pogosti (pojavijo se pri 1 do 10 na 100 bolnikov) občasni (pojavijo se pri 1 do 10 na 1.000 bolnikov) redki (pojavijo se pri 1 do 10 na 10.000 bolnikov) zelo redki (pojavijo se pri manj kot 1 na 10.000 bolnikov) neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: Symptoms typically occur within 1 month of initiating topiramate therapy.
Slovenian: Simptomi se običajno pojavijo v enem mesecu po uvedbi terapije s topiramatom.
English: • Low blood pressure or decrease in blood pressure that occurs when you stand up
Slovenian: • nizek krvni tlak ali zmanjšanje krvnega tlaka ob vstajanju
English: “Adults
Slovenian: „Odrasli
English: • Increased thirst and drinking abnormally large amounts of fluid
Slovenian: • zvečano žejo in pitje nenornmlno velikih količin tekočine
English: Mydriasis may or may not be present.
Slovenian: Midriaza je lahko prisotna ali pa ne.
English: Show this list to your doctor and pharmacist before you start a new medicine.
Slovenian: Ta seznam pokažite svojemu zdravniku ali farmacevtu, preden začnete jemati novo zdravilo.
English: • Crystals in the urine
Slovenian: • kristale v urinu
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, vitamins and herbal medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, vključno z vitamini in zdravili rastlinskega izvora.
English: • Excessive skin sensitivity
Slovenian: • prekomerno občutljivost kože
English: • Ringing sound in the ears
Slovenian: • zvonenje v ušesih
English: In most cases, symptoms and signs abated with discontinuation of either medicinal product.
Slovenian: V večini primerov so se znaki in simptomi ublažili po ukinitvi katerega od obeh zdravil.
English: 4.5 - Interaction with other medicinal products and other forms of interaction Data supporting the proposed text on the potential interactions of topiramate with oral contraceptives and risperidone have been presented.
Slovenian: 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Predloženi so bili podatki, ki podpirajo predlagano besedilo o potencialnem medsebojnem delovanju topiramata s peroralnimi kontracepcijski sredstvi in risperidonom.
English: • Slow or diminished movements
Slovenian: • upočasnjeno ali zmanjšano gibanje
English: The 200 mg dose did not appear to provide additional benefit.
Slovenian: Kaže, da odmerek 200 mg ni povečal koristnih učinkov.
English: A total of 9 studies have been conducted and submitted in order to explore the efficacy of topiramate as add-on (adjunctive) therapy.
Slovenian: Opravljenih in predloženih je bilo skupno 9 študij, v katerih so raziskovali učinkovitost topiramata kot dopolnilne (dodatne) terapije.
English: • Cold extremities (e.g. hands and face)
Slovenian: • mrzle okončine (npr. roke in obraz)
English: Topiramate overdose can result in severe metabolic acidosis (see section 4.4).
Slovenian: Preveliko odmerjanje topiramata lahko povzroči hudo metabolično acidozo (glejte poglavje 4.4).
English: Topiramate is not intended for acute treatment.”
Slovenian: Topiramat ni namenjen akutnemu zdravljenju.”
English: Generally, the decrease in bicarbonate occurs early in treatment although it can occur at any time during treatment.
Slovenian: Običajno pride do zmanjšanja koncentracije hidrogenkarbonata že zgodaj v poteku zdravljenja, čeprav se lahko pojavi tudi kadarkoli med zdravljenjem.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF TOPAMAX AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA TOPAMAX IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: The changes in Cmax or AUC as a result of the interactions are summarized below.
Slovenian: Spremembe v vrednostih Cmax ali AUC zaradi tovrstnih interakcij so povzete v nadaljevanju.
English: If you miss two or more doses, contact your doctor.
Slovenian: Če pozabite vzeti dva ali več odmerkov, pokličite svojega zdravnika.
English: The efficacy of topiramate in reducing seizure frequency was consistent in all 6 studies in a large number of patients participating in these studies.
Slovenian: Učinkovitost topiramata pri zmanjšanju pogostnosti napadov je bila skladna v vseh 6 študijah s številnimi sodelujočimi bolniki.
English: • if you are allergic (hypersensitive) to topiramate or any of the other ingredients of Topamax (listed in section 6).
Slovenian: • če ste alergični (preobčutljivi) na topiramat ali katerokoli sestavino zdravila Topamax (naštete so v 6. poglavju)
English: Topiramate was teratogenic in mice, rats and rabbits.
Slovenian: Topiramat je teratogen pri miših, podganah in zajcih.
English: The hard capsule formulation is provided for those patients who cannot swallow tablets, e.g. paediatric and the elderly.
Slovenian: Trde kapsule so na voljo za tiste bolnike, ki ne morejo pogoltniti tablet, npr. za otroke in starostnike.
English: Janssen-Cilag Kft. - HU 2045 Törökbálint Tó park, Hungary
Slovenian: Janssen-Cilag Kft. - HU 2045 Törökbálint Tó park, Madžarska
English: Study TOPMAT-EPMN-105 provided evidence to support the extension to the wider ‘epilepsy' indication as this is the only study which included patients with a variety of seizure syndromes other than partial onset seizures.
Slovenian: Študija TOPMAT-EPMN-105 je dala dokaze v podporo razširitvi na širšo indikacijo „epilepsije“, saj so samo v to študijo vključili bolnike z različnimi sindromi napadov razen napadov z delnim nastopom.
English: Electrophysiological and biochemical studies on cultured neurons have identified three properties that may contribute to the antiepileptic efficacy of topiramate.
Slovenian: Elektrofiziološke in biokemične študije na kultiviranih nevronih so pokazale tri lastnosti topiramata, ki bi lahko prispevale k njegovi antiepileptični učinkovitosti.
English: Queluz de Baixo 2734-503 Barcarena Portugal
Slovenian: Queluz de Baixo 2734-503 Barcarena Portugalska
English: Avoid chewing the tablets as they may leave a bitter taste.
Slovenian: Izogibajte se žvečenju tablet, ker imajo lahko v tem primeru grenak okus.
English: • Flu like illness
Slovenian: • gripi podobno bolezen
English: As part of the initial application, the MAH submitted a full non-clinical package in support of product registration including a complete package of reproductive toxicology reports.
Slovenian: Imetnik dovoljenja za promet z zdravilom je kot del prvotne vloge predložil popoln neklinični paket dokumentacije v podporo registraciji zdravila, vključno s popolnim paketom izvidov reproduktivne toksikologije.
English: Paediatric population (pharmacokinetics, up to 12 years of age)
Slovenian: Pediatrični bolniki (farmakokinetika, do 12 let starosti)
English: This was attributed to the higher percent body fat in female patients and is of no clinical consequence.
Slovenian: Ta pojav so pripisali večjemu odstotku telesne maščobe pri ženskah in ni klinično pomemben.
English: The results have been presented for the entire cohort, demonstrating a statistically significant treatment effect over the whole paediatric patient group.
Slovenian: Rezultati so bili predstavljeni za celotno kohorto z dokazom statistične pomembnosti učinka zdravljenja v celotni skupini bolnih otrok.
English: • for migraine prevention if you are pregnant or you are able to become pregnant but you are not using effective contraception (see section ‘pregnancy and breastfeeding' for further information).
Slovenian: • za zdravljenje migrene, če ste noseči ali lahko zanosite in ne uporabljate učinkovite kontracepcije (za podrobnejše informacije glejte poglavje ‘nosečnost in dojenje').
English: The proposed SPC wording reflects the non-significant difference in concentration seen and appropriately concludes that the interaction is unlikely to be of clinical significance.
Slovenian: Predlagano besedilo povzetka glavnih značilnosti zdravila odraža nepomembno razliko v koncentraciji, ki je bila ugotovljena, ter primerno zaključuje, da medsebojno delovanje verjetno nima kliničnega pomena.
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: Študij o vplivu zdravila na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: This indication is endorsed by the current recommendations of the European Federation of Neurological Societies (EFNS) task force (2006) where topiramate is considered an appropriate first-line prophylactic migraine medication based on scientific evidence from clinical trials and on expert consensus of the EFNS.
Slovenian: To indikacijo potrjujejo trenutna priporočila delovne skupine Evropske zveze nevroloških združenj (EFNS) (2006), v katerih je topiramat naveden kot primerno profilaktično migrensko zdravilo prve izbire na podlagi znanstvenih dokazov iz kliničnih preskušanj in konsenza strokovnjakov v EFNS.
English: The proposed wording in this section is considered to be acceptable by the CHMP.
Slovenian: CHMP šteje predlagano besedilo v tem poglavju za sprejemljivo.
English: Do not use Topamax after the expiry date which is on the label.
Slovenian: Zdravila Topamax ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki.