FrancophonIA/ELRC3.0 huggingface dataset:
English: Valproic acid passes into the breast milk.
Slovenian: Valprojska kislina prehaja v materino mleko.
English: Based on the submitted data it cannot be concluded, that efficacy of valproate in the claimed indication is dependent on chemical form or formulation.
Slovenian: Na podlagi predloženih podatkov ni mogoče zaključiti, da je učinkovitost valproata pri predlagani indikaciji odvisna od kemijske oblike ali formulacije.
English: Although the pathogenesis of bipolar disorder is unclear, it is known that mood stabilizers, such as valproate, can prevent its recurrence.
Slovenian: Čeprav patogeneza bipolarne motnje ni jasna, je znano, da lahko stabilizatorji razpoloženja, kot je valproat, preprečijo njeno ponovitev.
English: The duration of treatment is determined by the treating doctor.
Slovenian: Trajanje zdravljenja določi lečeči zdravnik.
English: WHAT {INVENTED NAME} IS AND WHAT IT IS USED FOR {Invented name} is a medicine for the treatment of […] and mania.
Slovenian: KAJ JE ZDRAVILO {LASTNIŠKO IME} IN ZA KAJ GA UPORABLJAMO {Lastniško ime} je zdravilo za zdravljenje […] in manije.
English: Antiepileptic therapy is always a long-term therapy.
Slovenian: Antiepileptično zdravljenje je vedno dolgotrajno.
English: Your doctor will determine the exact dose required on an individual basis.
Slovenian: Vaš zdravnik bo natančni odmerek ugotovil na individualni podlagi.
English: However one study is lacking a short placebo arm, which is a deficiency and brings doubts about the validity of the results.
Slovenian: Vendar pa v eni študiji ni bila prisotna kratkoročna skupina s placebom, kar je pomanjkljivost in zbuja dvome v veljavnost rezultatov.
English: With respect to the formulation, there is some evidence that gastro-resistant tablets might provide some advantages in terms of safety as compared to immediate release formulation.
Slovenian: V zvezi s formulacijo obstajajo dokazi, da bi lahko gastrorezistentne tablete imele določene prednosti z vidika varnosti v primerjavi s formulacijami s takojšnjim sproščanjem.
English: As only very small amounts are found, however, these do not generally present any risk to the child and weaning is not usually necessary.
Slovenian: Ker pa v mleko prehajajo majhne količine, v splošnem ne predstavljajo tveganja za otroka in dojenja navadno ni treba prekiniti.
English: Among the mood stabilizers lithium has the longest track record and is therefore a reasonable first choice.
Slovenian: Med stabilizatorji razpoloženja ima litij najdlje dokazano učinkovitost in je zato smiselna prva izbira.
English: Valproate is a well-known anti-epileptic substance.
Slovenian: Valproat je dobro znan antiepileptik.
English: Children may be allowed to grow out of the dose per kg body weight instead of making age-related dose adjustments, whereby EEG findings should not deteriorate.
Slovenian: Otroci lahko prerastejo odmerek na kg telesne mase, namesto da se odmerek prilagaja glede na starost, pri čemer pa se rezultati EEG ne smejo poslabšati.
English: National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Slovenian: Pristojni nacionalni organi, ki jih medsebojno usklajuje referenčna država članica, bodo zagotovili, da bo imetnik dovoljenja za promet z zdravilom izpolnil naslednje pogoje:
English: The daily dose will be determined according to age and body weight.
Slovenian: Dnevni odmerek se določi glede na starost in telesno maso.
English: Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Slovenian: Zato je treba bolnike spremljati za znake samomorilnih misli in vedenja ter razmisliti o ustreznem zdravljenju.
English: The safety profile of valproate is well characterised from forty years of experience in the treatment of epilepsy.
Slovenian: Varnostni profil valproata je dobro znan po zaslugi štiridesetih let izkušenj z zdravljenjem epilepsije.
English: - acute mania and for the prevention of recurrence in patients with bipolar disorder - Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive.
Slovenian: - akutna manija in za preprečevanje ponovnega pojava pri bolnikih s polarno motnjo - manije, pri kateri ste lahko vzburjeni, vzneseni, nemirni, navdušeni ali hiperaktivni.
English: The major potentially serious safety concerns relate to liver dysfunction and pancreatitis.
Slovenian: Glavni morebitni resni zadržki glede varnosti so povezani z nepravilnim delovanjem jeter in pankreatitisom.
English: Chemical forms and formulations of valproate
Slovenian: Kemijske oblike in formulacije valproata
English: However, it has recently been estimated that up to 40% of the patients with bipolar disorder do not or insufficiently respond to an adequate lithium therapy.
Slovenian: Vendar pa nedavne ocene kažejo, da se do 40 % bolnikov z bipolarno motnjo ne odziva oziroma se nezadostno odziva na ustrezno zdravljenje z litijem.
English: In addition, valproate has been used as the reference comparator treatment in many Phase III studies of atypical antipsychotic drugs in the treatment and prevention of mania.
Slovenian: Poleg tega se valproat uporablja kot referenčno primerjalno zdravilo v mnogih študijah faze III atipičnih antipsihotikov pri zdravljenju in preprečevanju manije.
English: They should be swallowed whole or in halves, not chewed, and taken with plenty of fluid (e.g. a glass of water).
Slovenian: Pogoltniti je treba cele ali polovice z veliko tekočine (npr. kozarcem vode).
English: Dedicated studies have shown that valproate can be used safely in combination with antipsychotic drugs.
Slovenian: Posebne študije so pokazale, da je valproat mogoče varno uporabljati v kombinaciji z antipsihotičnimi zdravili.
English: The treatment of bipolar disorder includes management of the current mood episode and prevention of recurrence of next mood episodes.
Slovenian: Zdravljenje bipolarne motnje vključuje obvladovanje trenutne razpoloženjske epizode in preprečevanje ponovitev naslednjih razpoloženjskih epizod.
English: 1.3 Chemical forms and formulations of valproate
Slovenian: 1.3 Kemijske oblike in formulacije valproata
English: After 12 months of treatment following a manic index episode, 41% of patients treated with valproate were still in remission compared to 24% of patients in the lithium group and 13% of patients in the placebo group.
Slovenian: Po 12 mesecih zdravljenja po manični indeksni epizodi je bilo 41 % bolnikov, zdravljenih z valproatom, še vedno v remisiji v primerjavi s 24 % bolnikov v skupini z litijem in 13 % bolnikov v skupini s placebom.
English: As such, this represents one of the largest bodies of clinical trial data relating to the pharmacotherapy of bipolar disorder.
Slovenian: Tako to predstavlja enega največjih naborov podatkov s kliničnih preskušanj v zvezi z zdravljenjem bipolarne motnje z zdravili.
English: Concerning recurrence prevention of mood episodes, evidence of efficacy of valproate is mainly based on two double-blind studies with a maintenance period of 52 weeks and 20 months duration, respectively (Bowden et al., 2000 and Calabrese et al., 2005).
Slovenian: Z vidika preprečevanja ponovitev razpoloženjskih epizod temeljijo dokazi učinkovitosti valproata predvsem na dveh dvojno slepih študijah z obdobjem vzdrževanja 52 tednov oziroma trajanjem 20 mesecev (Bowden et al., 2000 in Calabrese et al., 2005).
English: After the Commission Decision the National Competent Authorities will update the product information as required.
Slovenian: Pristojni nacionalni organi bodo po odločbi Komisije posodobili informacije o zdravilu v skladu z zahtevami.
English: No unexpected signals have been identified from post-marketing surveillance.
Slovenian: Pri nadzoru zdravila v obdobju trženja ni bilo opaziti nepričakovanih znakov.
English: As conclusion the recurrence prevention of both mania and depression has not been demonstrated.
Slovenian: Iz navedenega sledi, da preprečevanje ponovitev manije in depresije ni bilo dokazano.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Slovenian: Bolnikom (in skrbnikom bolnikov) je treba svetovati, naj se posvetujejo z zdravnikom, če se pojavijo znaki samomorilnih misli ali vedenja.
English: In other words, the conducted studies demonstrate efficacy of valproate in the treatment of acute mania over 21 days, but evidence for the maintenance of the treatment effect up to 12 weeks of treatment is not considered complete.
Slovenian: Drugače povedano, izvedene študije dokazujejo učinkovitost valproata pri zdravljenju akutne manije nad 21 dni, vendar se dokazi o ohranitvi učinka zdravljenja do 12 tednov zdravljenja ne štejejo za popolne.
English: Bipolar disorder is a severe mental disorder characterized by recurrent episodes of mania and depression, which as a recurrent affective illness produces significant distress and dysfunction, ranking among the top 30 causes of worldwide disability.
Slovenian: Bipolarna motnja je huda duševna motnja, za katero so značilne ponavljajoče se epizode manije in depresije, ki kot ponavljajoča se afektivna bolezen povzroča hudo stisko in disfunkcijo, ki je med 30 najpogostejšimi vzroki nezmožnosti v svetovnem merilu.
English: Following the European Commission Decision the Risk Management Plan should be submitted with any new application for extending the indication regarding the treatment of mania in bipolar disorder.
Slovenian: V skladu z odločbo Evropske komisije je treba načrt za obvladovanje tveganja predložiti z vsako novo vlogo za razširitev indikacije v zvezi z zdravljenjem manije pri bipolarni motnji.
English: In most of the EU Member States valproate is also approved (as valproic acid, sodium valproate, valproate semisodium) for the treatment of patients with bipolar disorder (approved in 25 European countries, in 21 countries with a first-line indication).
Slovenian: V večini držav članic EU je valproat (kot valprojska kislina, natrijev valproat, seminatrijev valproat) odobren tudi za zdravljenje bolnikov z bipolarno motnjo (odobren v 25 evropskih državah, v 21 državah kot zdravilo prve izbire).
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 POSEBNA OPOZORILA IN PREVIDNOSTNI UKREPI
English: The safety and efficacy of {invented name} for the treatment of manic episodes in bipolar disorder have not been evaluated in patients aged less than 18 years.
Slovenian: Varnosti in učinkovitosti zdravila {lastniško ime} za zdravljenje maničnih epizod pri bipolarni motnji niso ocenili pri bolnikih, mlajših od 18 let.
English: There is also some evidence for maintenance of effect in treatment of acute mania episode (up to 12 weeks), although the 12 weeks studies lack a placebo arm, which is a deficiency.
Slovenian: Obstaja tudi nekaj dokazov ohranitve učinka pri zdravljenju epizod akutne manije (do 12 tednov), čeprav v 12-tedenski študiji ni bilo skupine s placebom, kar je pomanjkljivost.
English: The evidence of the efficacy of valproate in the treatment of bipolar disorder comes from sixteen randomised, comparative double-blind or open-label clinical trials.
Slovenian: Dokazi učinkovitosti valproata pri zdravljenju bipolarne motnje izhajajo iz šestnajstih randomiziranih, primerjalnih, dvojno slepih ali odprtih kliničnih preskušanj.
English: Ratiopharm Nederland B.V. Florapark 4
Slovenian: Nizozemska ratiopharm Nederland bv Florapark 4
English: Experience with long-term use of Valproinsäure-ratiopharm chrono is limited, particularly in children under 6 years of age.
Slovenian: Izkušnje z dolgotrajno uporabo zdravila [BLAGOVNA ZNAMKA] so omejene, predvsem pri otrocih, mlajših od šest let.
English: Mania occurs in an illness called “bipolar disorder”.
Slovenian: Manija se pojavi pri bolezni, imenovani »bipolarna motnja«.
English: Withdrawal must take the form of a gradual dose reduction over a period of one to two years.
Slovenian: Zdravljenje je treba prekiniti s postopnim zmanjševanjem odmerka v enem ali dveh letih.
English: Note: These amendments to the summary of product characteristics and package leaflet are valid at the time of the Commission Decision.
Slovenian: Opomba: Te spremembe povzetka glavnih značilnosti zdravila in navodila za uporabo so veljavne ob izdaji odločbe Komisije
English: {Invented name} can be used when lithium can not be used.
Slovenian: Zdravilo {lastniško ime} se lahko uporablja, kadar ni mogoče uporabiti litija.
English: The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect.
Slovenian: Odmerek je treba povečati čim hitreje, kot je mogoče, da se doseže najmanjši terapevtski odmerek, ki omogoča želeni klinični učinek.
English: This medicine should not be used during pregnancy and in women of child-bearing potential unless clearly necessary (i.e. in situations where other treatments are ineffective or not tolerated).
Slovenian: To zdravilo se ne sme uporabljati med nosečnostjo in pri ženskah v rodni dobi, razen če je to nujno potrebno (tj. kadar so druge oblike zdravljenja neučinkovite ali jih bolnica ne prenaša).
English: Therefore the CHMP recommended that valproate in the indication treatment of acute episodes is restricted to modified-release (solid oral) formulations.
Slovenian: Zato je CHMP priporočil, da se valproat pri indikaciji zdravljenja akutnih epizod uporablja le v obliki (trdnih peroralnih) formulacij s prirejenim sproščanjem.
English: Therefore, in women envisaging a pregnancy, valproate should not be used for the treatment of manic episodes, unless safer alternatives prove to be ineffective or are not tolerated.
Slovenian: Zato se pri ženskah, ki nameravajo zanositi, valproat ne sme uporabljati za zdravljenje maničnih epizod, razen če so varnejše alternative dokazano neučinkovite ali jih bolnica ne prenaša.
English: A teratogenic risk associated with the use of valproate in pregnant women, including the potential for delayed intellectual development has been identified following in utero exposure to valproate.
Slovenian: Tveganje za teratogenost, povezano z uporabo valproata pri nosečnicah, vključno z morebitnim zakasnjenim intelektualnim razvojem, je bilo opredeljeno glede na izpostavljenost valproatu v maternici (in utero).
English: The MAHs should look into their respective safety databases and add the appropriate frequency of occurrence to the above additional adverse events.
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo preveriti svoje zbirke podatkov o varnosti in vanje dodati ustrezno pogostnost ponovitev zgoraj navedenih dodatnih neželenih učinkov.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Slovenian: Dojenje Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
English: It could be critisised that the latter study was not placebo-controlled; however the use of lithium in bipolar disorder, especially in the recurrence prevention is the established standard of care.
Slovenian: Kot kritiko lahko navedemo, da zadnja študija ni bila nadzorovana s placebom, vendar pa je uporaba litija pri bipolarni motnji, zlasti pri preprečevanju ponovitev, uveljavljena oblika standardnega zdravljenja.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: In 2008, in light of the results of the US FDA meta-analysis of clinical trial data for antiepileptics, and in light of the spontaneous and literature reports, the PhVWP concluded that any antiepileptic drug may be associated with a low risk of suicidal thoughts and behaviour.
Slovenian: Leta 2008 je ob upoštevanju rezultatov metaanalize podatkov kliničnega preskušanja antiepileptikov ameriškega urada FDA ter ob upoštevanju poročil na lastno pobudo in poročil iz literature delovna skupina za farmakovigilanco sklenila, da je kateri koli antiepileptik mogoče povezati z nizkim tveganjem samomorilnih misli in vedenja.
English: Following the literature presented as well the post-marketing experience the adverse events of “nausea”, “sedation” and “extrapyrimidal disorders” are proposed to be added to the Section 4.8 “Undesirable effects” of the SPC.
Slovenian: Glede na predloženo literaturo in izkušnje v obdobju trženja zdravila se predlaga, da se neželeni učinki „navzeja“, „sedacija“ in „ekstrapiramidne motnje“ dodajo v poglavje 4.8 „Neželeni učinki“ povzetka glavnih značilnosti zdravila.
English: There is a positive benefit-risk relation with regard to the aforementioned indication.
Slovenian: V zvezi z navedeno indikacijo je razmerje med koristmi in tveganji pozitivno.
English: 4.6 Pregnancy and lactation
Slovenian: 4.6 NOSEČNOST IN DOJENJE
English: In case of gastrointestinal side-effects due to treatment, the prolonged-release tablets should be taken during or after a meal.
Slovenian: Če se zaradi zdravljenja pojavijo gastrointestinalni neželeni učinki, je treba tablete s podaljšanim sproščanjem jemati med obrokom ali po njem.
English: In children and adolescents:
Slovenian: Pri otrocih in mladostnikih:
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: Mania
Slovenian: Manija
English: It was highlighted that although the indication exists in many Member States, sustained efficacy both in acute mania as well as in the prevention of recurrence of mood episodes has not been clearly demonstrated in well designed clinical trials which comply with the requirements of the CPMP Note for Guidance on Clinical Investigation of Medicinal products for the Treatment and Prevention of Bipolar Disorder (CPMP/EWP/567/98).
Slovenian: Poudarjeno je bilo, da kljub razpoložljivosti zdravila v več državah članicah trajna učinkovitost pri akutni maniji in pri preprečevanju ponovitve razpoloženjskih epizod z dobro zasnovanimi kliničnimi preskušanji, ki so v skladu z zahtevami „Navodila CPMP glede smernice o kliničnem raziskovanju zdravil pri zdravljenju in preprečevanju bipolarne motnje“ (CPMP/EWP/567/98), ni bila jasno dokazana.
English: A meta-analysis of randomised placebo controlled trials of antiepileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Slovenian: Tudi metaanaliza randomiziranih, s placebom nadzorovanih preskušanj antiepileptikov je pokazala rahlo povečano tveganje samomorilnih misli in vedenja.
English: However, for theoretical reasons slow-release formulations could be advantageous for compliance reasons and also for avoiding high plasma peaks which may be accompanied by frequent adverse effects.
Slovenian: Vendar pa so lahko teoretično gledano formulacije s počasnim sproščanjem ugodnejše glede skladnosti kot tudi za preprečevanje visokih koncentracij v plazmi, ki jih utegnejo spremljati pogosti neželeni učinki.
English: Rua Quinta do PinheiroEdifício Tejo 6° Piso Carnaxide
Slovenian: Rua Quinta do PinheiroEdifício
English: Based on the literature references provided it can be concluded that there is evidence for the efficacy of valproate in the acute treatment of manic episode, which has been demonstrated in placebo controlled studies of three weeks.
Slovenian: Na podlagi razpoložljivega referenčnega gradiva je mogoče zaključiti, da obstajajo dokazi učinkovitosti valproata pri akutnem zdravljenju maničnih epizod, ki so bili potrjeni s tritedenskimi študijami, nadzorovanimi s placebom.
English: Generally, in the treatment of seizures no dose reduction or withdrawal of the medicine should be attempted until the patient has been free of seizures for at least two to three years.
Slovenian: Pri zdravljenju epileptičnih napadov navadno ni treba zmanjšati odmerka ali prekiniti jemanja zdravila, če je bolnik brez epileptičnih napadov vsaj dve ali tri leta.
English: If you are a woman of child-bearing age, you have to use effective contraception during treatment.
Slovenian: Če ste ženska v rodni dobi, morate med zdravljenjem uporabljati učinkovito kontracepcijo.
English: The available studies on the use of valproate to treat patients with bipolar disorder have shown that the drug was generally well tolerated and revealed no unexpected safety concern.
Slovenian: Razpoložljive študije o uporabi valproata pri zdravljenju bolnikov z bipolarno motnjo so pokazale, da so bolniki zdravilo v splošnem dobro prenašali in da ni bilo nepričakovanih zadržkov glede varnosti.
English: HOW TO TAKE {INVENTED NAME}
Slovenian: KAKO JEMATI ZDRAVILO {LASTNIŠKO IME}
English: A specialist doctor (neurologist, neuropaediatrician) should decide upon dose titration, the duration of treatment and withdrawal of Valproinsäure-ratiopharm chrono on an individual basis.
Slovenian: Zdravnik specialist (nevrolog, nevropediater) mora titracijo odmerka, trajanje zdravljenja in prekinitev jemanja zdravila [BLAGOVNA ZNAMKA] določiti glede na posameznika.
English: Taking into account that in different EU member States the authorised valproate products may have or not the indication for the bipolar disorder the CHMP has the following proposal:
Slovenian: Ker v različnih državah članicah EU odobrena zdravila z valproatom vsebujejo indikacijo za zdravljenje bipolarne motnje oziroma te indikacije ne vsebujejo, je CHMP predlagal naslednje:
English: The mean daily dose usually ranges between 1000 and 2000 mg <valproate>.
Slovenian: Srednji dnevni odmerek je navadno od 1000 do 2000 mg <valproata>.
English: {Invented name} is used in the treatment of
Slovenian: Zdravilo {lastniško ime} se uporablja za zdravljenje
English: In the two-arm study performed by Calabrese and co-workers (2005) patients in the valproate group performed better in several efficacy parameters compared to the lithium group (in a statistically nonsignificant way), however significantly more patients in the lithium group experienced various adverse effects (tremor, polyuria, polydipsia) compared to the valproate group.
Slovenian: V dvokraki študiji, ki so jo izvedli Calabrese in sodelavci (2005), so se bolniki v skupini z valproatom bolje izkazali pri več parametrih učinkovitosti kot skupina z litijem (na statistično nepomemben način), vendar pa je v skupini z litijem bistveno več bolnikov občutilo različne neželene učinke (tremor, poliurijo, polidipsijo) kot v skupini z valproatom.
English: In addition, in clinical trials a starting dose of 20 mg <valproate>/kg body weight has also shown an acceptable safety profile.
Slovenian: V kliničnih preskušanjih je tudi začetni odmerek 20 mg <valproata>/kg telesne mase pokazal sprejemljiv varnostni profil.
English: In addition the time to recurrence of manic and depression events has not shown differences.
Slovenian: Poleg tega se čas do ponovitve maničnih in depresivnih epizod ne razlikuje.
English: The need for a Risk Management Plan was discussed with the MAHs.
Slovenian: O potrebi po načrtu za obvladovanje tveganja so potekale razprave z imetniki dovoljenja za promet z zdravili.
English: In addition, in clinical trials a starting dose of 20 mg sodium valproate/kg body weight has also shown an acceptable safety profile.
Slovenian: V kliničnih preskušanjih je tudi začetni odmerek 20 mg natrijevega valproata/kg telesne mase pokazal sprejemljiv varnostni profil.
English: On the basis of the evidence available to the PhVWP, it was agreed that SPCs for all antiepileptics across the European Union should be modified with regard to suicidality with the addition of a warning
Slovenian: Delovna skupina za farmakovigilanco je na podlagi dokazov, ki jih je imela na voljo, zaključila, da je treba povzetke glavnih značilnosti za vse antiepileptike v Evropski uniji spremeniti ob upoštevanju samomorilnosti z dodatno navedbo opozorila.