FrancophonIA/ELRC3.0 huggingface dataset:
English: The specialist should discuss the annual risk acknowledgement form, at initiation and during each annual review and ensure that the patient has understood its content.
Slovenian: Specialist se mora o letnem obrazcu o seznanitvi s tveganji z bolnico pogovoriti ob uvedbi zdravila in ob vsakem letnem ovrednotenju ter poskrbeti, da bolnica razume vsebino dokumenta.
English: • the patient has understood and acknowledged the risks of congenital malformations and neurodevelopmental disorders including the magnitude of these risks for children exposed to valproate in utero.
Slovenian: • da bolnica razume in potrdi poznavanje tveganj za prirojene malformacije in nevrorazvojne motnje, vključno z razsežnostjo teh tveganj za otroke, izpostavljene valproatu in utero.
English: Individual circumstances should be evaluated in each case, when choosing the contraception method involving the patient in the discussion, to guarantee her engagement and compliance with the chosen measures.
Slovenian: Pri izbiri načina kontracepcije je treba v vsakem primeru oceniti individualne okoliščine in bolnico vključiti v pogovor, da je zagotovljena njena zavzetost in sodelovalnost iz izbranim načinom/izbranimi načini.
English: Treatment of bipolar disorder <and prophylaxis of migraine attacks>
Slovenian: Zdravljenje bipolarne motnje <in profilaksa napadov migrene>
English: • In patients who experienced menarche, the prescribing specialist must reassess the need for valproate therapy annually and consider alternative treatment options.
Slovenian: • Pri bolnicah, ki so že imele menarho, mora predpisujoči specialist vsako leto znova ovrednotiti potrebo po zdravljenju z valproatom in presoditi o možnostih drugačnega zdravljenja.
English: • the patients are advised not to stop valproate medication and to immediately contact a specialist in case of planned or suspected pregnancy.
Slovenian: • bolnici naročiti, naj v primeru načrtovane ali domnevne nosečnosti ne neha jemati valproata, temveč naj se nemudoma posvetuje s specialistom.
English: • Tell your doctor immediately if you are pregnant or think you might be pregnant.
Slovenian: • Zdravnika morate nemudoma obvestiti, če ste noseči ali mislite, da bi lahko bili noseči.
English: • The prescriber must ensure that parents/caregivers of female children who have experienced menarche are provided with comprehensive information about the risks of congenital malformations and neurodevelopmental disorders including the magnitude of these risks for children exposed to valproate in utero.
Slovenian: • Zdravnik, ki predpiše zdravilo, mora poskrbeti, da so starši/skrbniki deklice, ki je dobila menarho, izčrpno seznanjeni s tveganji za prirojene napake in nevrorazvojne motnje, vključno z razsežnostjo teh tveganj pri otrocih, izpostavljenih valproatu in utero.
English: All patients with a valproate exposed pregnancy and their partners should be referred to a specialist experienced in <teratology> {to be adapted depending on health care system} for evaluation and counselling regarding the exposed pregnancy.
Slovenian: Vse bolnice, pri katerih je prišlo do izpostavljenosti valproatu med nosečnostjo, in njihove partnerje je treba napotiti k specialistu, ki ima izkušnje na področju <teratologije> {to je treba prilagoditi glede na zdravstveni sistem} za oceno in svetovanje glede izpostavljene nosečnosti.
English: Women of childbearing potential who are prescribed valproate must use effective contraception, without interruption during the entire duration of treatment with valproate.
Slovenian: Ženske v rodni dobi, ki jemljejo valproat, morajo uporabljati učinkovito kontracepcijo neprekinjeno med celotnim trajanjem zdravljenja.
English: • The prescribers must ensure that parents/caregivers of female children understand the need to contact the specialist once the female child using valproate experiences menarche.
Slovenian: • Zdravnik, ki predpiše zdravilo, mora poskrbeti, da starši/skrbniki deklic razumejo, da se morajo obrniti na specialista, ko deklica, ki uporablja valproat, dobi menarho.
English: • You must discuss the appropriate methods of birth control (contraception) with your doctor.
Slovenian: • Z zdravnikom se morate posvetovati o primernih načinih preprečevanja nosečnosti (kontracepcije).
English: Ask your doctor about taking folic acid.
Slovenian: Z zdravnikom se posvetujte o jemanju folne kisline.
English: [This section should be amended to include the following wording]
Slovenian: [To poglavje je treba spremeniti tako, da vključuje naslednje besedilo.]
English: • If you are a parent or a caregiver of a female child treated with valproate, you should contact the doctor once your child using valproate experiences menarche.
Slovenian: • Če ste starš ali skrbnik deklice, ki prejema valproat, se morate obrniti na zdravnika, ko z valproatom zdravljena deklica dobi prvo menstruacijo (menarho).
English: Do not stop taking <Invented name> unless your doctor tells you to as your condition may become worse.
Slovenian: Ne prenehajte jemati zdravila <Izmišljeno ime>, razen če vam tako naroči zdravnik, kajti stanje se vam lahko poslabša.
English: • Valproate carries a risk if taken during pregnancy.
Slovenian: • Med nosečnostjo uporabljani valproat je povezan s tveganjem.
English: • Do not stop taking <Invented name> unless your doctor tells you to.
Slovenian: • Ne prenehajte jemati zdravila <Izmišljeno ime>, če vam tega ne naroči zdravnik.
English: I AM TAKING <invented name> AND NOT PLANNING TO HAVE A BABY If you are continuing treatment with <Invented name> but you are not planning to have a baby make sure you are using an effective method of contraception without interruption during your entire treatment with <Invented name>.
Slovenian: JEMLJEM ZDRAVILO <Izmišljeno ime> IN NE NAČRTUJEM NOSEČNOSTI Če nadaljujete zdravljenje z zdravilom <Izmišljeno ime>, a ne načrtujete nosečnosti, poskrbite, da boste med celotnim trajanjem zdravljenja z zdravilom <Izmišljeno ime> neprekinjeno uporabljali učinkovito kontracepcijo.
English: Your doctor will refer you to a specialist experienced in the management of bipolar disorder <or>< migraine> or epilepsy, so that alternative treatment options can be evaluated early on.
Slovenian: Vaš zdravnik vas bo napotil k specialistu, ki ima izkušnje z vodenjem bipolarne motnje <ali> <migrene> ali epilepsije, tako da bo mogoče zgodaj pretehtati druge možnosti zdravljenja.
English: • You must get thorough counselling on the risks of <Invented name> during pregnancy,
Slovenian: • Deležni morate biti temeljitega svetovanja o tveganjih zdravila <Izmišljeno ime> med nosečnostjo, vključno s teratogenostjo in razvojnimi učinki pri otrocih.
English: An annual risk acknowledgement form needs to be used at time of treatment initiation and during each annual review of valproate treatment by the specialist.
Slovenian: Letni obrazec o seznanitvi s tveganji mora specialist uporabiti ob uvedbi zdravljenja z valproatom in na vsakem letnem ponovnem ovrednotenju zdravljenja z valproatom.
English: Valproate is prescribed and dispensed according to the Valproate Pregnancy Prevention Programme (sections 4.3 and 4.4).
Slovenian: Valproat je treba predpisovati in izdajati v skladu s programom za preprečevanje nosečnosti med uporabo valproata (glejte poglavji 4.3 in 4.4).
English: If this is the first time you have been prescribed <Invented name> your doctor will have explained the risks to an unborn child if you become pregnant.
Slovenian: ZAČENJAM ZDRAVLJENJE Z ZDRAVILOM <Izmišljeno ime> Če vam je zdravnik zdravilo <Izmišljeno ime> tokrat predpisal prvič, vam bo pojasnil, kakšna so tveganja za nerojenega otroka v primeru, da zanosite.
English: • You must use an effective method of birth control (contraception) during your entire treatment with <Invented name>.
Slovenian: • Učinkovit način preprečevanja nosečnosti (kontracepcijo) morate uporabljati med celotnim trajanjem zdravljenja z zdravilom <Izmišljeno ime>.
English: The patients with a valproate exposed pregnancy and their partners should be referred to a specialist experienced in <teratology> {to be adapted depending on health care system} for evaluation and counselling regarding the exposed pregnancy (see section 4.6).
Slovenian: Bolnice, pri katerih je prišlo do izpostavljenosti valproatu med nosečnostjo, in njihove partnerje je treba napotiti k specialistu, ki ima izkušnje na področju <teratologije> {to je treba prilagoditi glede na zdravstveni sistem} za oceno in svetovanje glede izpostavljene nosečnosti (glejte poglavje
English: • the patient understands the need for regular (at least annual) review of treatment by a specialist experienced in the management of epilepsy, or bipolar disorders <or migraine>.
Slovenian: • da bolnica razume potrebo po rednih ponovnih ovrednotenjih zdravljenja (vsaj enkrat na leto), ki jih opravi specialist z izkušnjami na področju vodenja epilepsije ali bipolarne motnje <ali migrene>.
English: • Tell your doctor if you want to have a baby.
Slovenian: • Zdravniku morate povedati, če želite zanositi.
English: Every effort should be made to switch to appropriate alternative treatment prior to conception, and before contraception is discontinued (see section 4.6).
Slovenian: Na vsak način si je treba prizadevati, da bolnica preide na ustrezno drugo zdravilo, preden zanosi in preden neha uporabljati kontracepcijo (glejte poglavje 4.6).
English: • You must get regular (at least annual) appointments with a specialist experienced in the management of bipolar disorder or epilepsy <or> < migraine>.
Slovenian: • Redno (vsaj enkrat na leto) morate obiskati specialista, ki ima izkušnje z vodenjem bipolarne motnje ali epilepsije <ali> <migrene>.
English: • the patient card is provided with every valproate dispensing and that the patients understand its content.
Slovenian: • poskrbeti, da bolnica ob vsaki izdaji valproata dobi opozorilno kartico za bolnice in razume njeno vsebino.
English: For the indication(s) <bipolar disorder> <and> < migraine> if a woman is planning to become pregnant a specialist experienced in the management of <bipolar disorder> <migraine> must be consulted and treatment with valproate should be discontinued and if needed switched to an alternative treatment prior to conception, and before contraception is discontinued.
Slovenian: Če ženska prejema valproat zaradi <bipolarne motnje> <ali> <migrene> in namerava zanositi, se mora posvetovati s specialistom, ki ima izkušnje z vodenjem <bipolarne motnje> <ali> <migrene>; zdravljenje z valproatom je treba prenehati in, če je treba, preiti na drugo zdravilo, preden ženska zanosi in preden preneha uporabljati kontracepcijo.
English: <Invented name> treatment must be started and supervised by a doctor specialised in the treatment of <epilepsy> <or> <bipolar disorders> <or> <migraine>.
Slovenian: Zdravljenje z zdravilom <Izmišljeno ime> mora začeti in nadzorovati zdravnik specialist za zdravljenje <epilepsije> <ali> <bipolarne motnje> <ali> <migrene>.
English: A patient guide and patient card should be provided to all women of childbearing potential using valproate.
Slovenian: Vodnik za bolnice in opozorilno kartico za bolnice je treba izročiti vsaki ženski v rodni dobi, ki uporablja valproat.
English: If a woman using valproate becomes pregnant, she must be immediately referred to a specialist to consider alternative treatment options.
Slovenian: Če ženska, ki uporablja valproat, zanosi, jo je treba nemudoma napotiti k specialistu za presojo o drugih možnostih zdravljenja.
English: Every effort should be made to switch to appropriate alternative treatment prior to conception, and before contraception is discontinued (see section 4.4).
Slovenian: Na vsak način si je treba prizadevati, da bolnica preide na ustrezno drugo zdravilo, preden zanosi in preden neha uporabljati kontracepcijo (glejte poglavje 4.4).
English: If, despite the known risks of valproate in pregnancy and after careful consideration of alternative treatment, in exceptional circumstances a pregnant woman must receive valproate for epilepsy, it is recommended to:
Slovenian: Če mora nosečnica v izrednih primerih zaradi epilepsije prejemati valproat kljub znanim tveganjem tega zdravila med nosečnostjo in po skrbnem pretehtanju drugih tveganj, je priporočljivo:
English: You will be referred to a specialist experienced in the management of bipolar disorder, <migraine> or epilepsy, so that alternative treatment options can be evaluated.
Slovenian: Napotili vas bodo k specialistu, ki ima izkušnje z vodenjem bipolarne motnje, <migrene> ali epilepsije, tako da bo mogoče pretehtati druge možnosti zdravljenja.
English: Valproate is contraindicated as treatment for bipolar disorder <and migraine> during pregnancy.
Slovenian: Valproat je med nosečnostjo kontraindiciran za zdravljenje bipolarne motnje <ali migrene>.
English: Valproate as treatment for epilepsy is contraindicated in pregnancy unless there is no suitable alternative treatment (see sections 4.3 and 4.4).
Slovenian: Valproat je v nosečnosti kontraindiciran za zdravljenje epilepsije, razen če ni nobenega primernega drugega zdravila (glejte poglavji 4.3 in 4.4).
English: Pregnancy planning.
Slovenian: Načrtovanje nosečnosti
English: Once you are able to have a baby, you will need to make sure you use an effective method of contraception without interruption throughout your treatment with <Invented name>.
Slovenian: Ko bo obstajala možnost, da zanosite, boste morali poskrbeti za neprekinjeno uporabo učinkovite kontracepcije med celotnim trajanjem zdravljenja z zdravilom <Izmišljeno ime>.
English: • in pregnancy (see section 4.4 and 4.6).
Slovenian: • Med nosečnostjo (glejte poglavji 4.4 in 4.6).
English: If a woman using valproate becomes pregnant, she must be immediately referred to a specialist to re-evaluate treatment with valproate and consider alternative options.
Slovenian: Če ženska, ki uporablja valproat, zanosi, jo je treba nemudoma napotiti k specialistu, da ponovno ovrednoti zdravljenje z valproatom in presodi o drugih možnostih zdravljenja.
English: • in pregnancy (see sections 4.3 and 4.6).
Slovenian: • Med nosečnostjo (glejte poglavji 4.3 in 4.6).
English: O I AM STARTING TREATMENT WITH <INVENTED NAME> O I AM TAKING <INVENTED NAME> AND NOT PLANNING TO HAVE A BABY O I AM TAKING <INVENTED NAME> AND PLANNING TO HAVE A BABY O I AM PREGNANT AND I AM TAKING <INVENTED NAME>
Slovenian: Med spodnjimi možnostmi izberite tisto, ki velja za vas, in preberite ustrezne informacije: O ZAČENJAM ZDRAVLJENJE Z ZDRAVILOM <IZMIŠLJENO IME> O JEMLJEM ZDRAVILO <IZMIŠLJENO IME> IN NE NAČRTUJEM NOSEČNOSTI O JEMLJEM ZDRAVILO <IZMIŠLJENO IME> IN NAČRTUJEM NOSEČNOST O SEM NOSEČA IN JEMLJEM ZDRAVILO <IZMIŠLJENO IME>
English: For the indication epilepsy, if a woman is planning to become pregnant, a specialist experienced in the management of epilepsy, must reassess valproate therapy and consider alternative treatment options.
Slovenian: Če nosečnost načrtuje bolnica, ki zdravilo prejema zaradi epilepsije, mora specialist, ki ima izkušnje z vodenjem epilepsije, ponovno oceniti zdravljenje z valproatom in presoditi možnosti za drugačno zdravljenje.
English: • For epilepsy, you must not use <Invented name> if you are pregnant, unless nothing else works for you.
Slovenian: • Če ste noseči, zdravila <Izmišljeno ime> ne smete uporabljati za zdravljenje epilepsije, razen če vam ne pomaga nobeno drugo zdravilo.
English: Female children and women of childbearing potential Valproate must be initiated and supervised by a specialist experienced in the management of epilepsy, bipolar disorder or <migraine>.
Slovenian: Zdravljenje z valproatom mora uvesti in nadzorovati specialist, ki ima izkušnje z vodenjem epilepsije, bipolarne motnje <ali migrene>.
English: Valproate is contraindicated for use in women of childbearing potential unless the conditions of the pregnancy prevention programme are fulfilled (see sections 4.3 and 4.4).
Slovenian: Valproat je kontraindiciran pri ženskah v rodni dobi, razen če so izpolnjeni pogoji programa za preprečevanje nosečnosti (glejte poglavji 4.3 in 4.4).
English: • You must discuss contraception (birth control) with your doctor.
Slovenian: • O kontracepciji se morate posvetovati z zdravnikom.
English: • the patient has received the patient guide.
Slovenian: • da bolnica prejme vodnik za bolnice.
English: If you are a female able to have a baby you must use effective method of birth control (contraception) without interruptions during your entire treatment with <Invented name>.
Slovenian: Če ste ženska, ki lahko zanosi, morate uporabljati učinkovit način preprečevanja nosečnosti (kontracepcijo) neprekinjeno med celotnim trajanjem zdravljenja z zdravilom <Izmišljeno ime>.
English: [This section should be amended to include the following box]
Slovenian: [To poglavje je treba spremeniti tako, da vključuje naslednji okvir.]
English: Even if she has amenorrhea she must follow all the advice on effective contraception.
Slovenian: Bolnica mora upoštevati vse nasvete za učinkovito kontracepcijo, tudi če ima amenorejo.
English: Talk to your doctor or family planning clinic if you need advice on contraception.
Slovenian: Če potrebujete nasvet o kontracepciji, se posvetujte z zdravnikom ali obiščite ambulanto za načrtovanje družine.
English: • For bipolar disorder <and> <migraine>, you must not use <Invented name> if you are pregnant.
Slovenian: • Če ste noseči, zdravila <Izmišljeno ime> ne smete uporabljati za bipolarno motnjo <ali> <migreno>.
English: • in women of childbearing potential, unless the conditions of the pregnancy prevention programme are fulfilled (see section 4.4 and 4.6).
Slovenian: • Pri ženskah v rodni dobi, razen če so izpolnjeni pogoji programa za preprečevanje nosečnosti (glejte poglavji 4.4 in 4.6).
English: • in women of childbearing potential, unless the conditions of the pregnancy prevention programme are fulfilled (see sections 4.3 and 4.6).
Slovenian: • Pri ženskah v rodni dobi, razen če so izpolnjeni pogoji programa za preprečevanje nosečnosti (glejte poglavji 4.3 in 4.6).
English: • For epilepsy, if you are a woman able to have a baby, you must not take <Invented name> unless you use effective method of birth control (contraception) during your entire treatment with <Invented name>).
Slovenian: • Če ste ženska, ki lahko zanosi, zdravila <Izmišljeno ime> ne smete jemati za epilepsijo, razen če med celotnim trajanjem zdravljenja z zdravilom <Izmišljeno ime> uporabljate učinkovit način preprečevanja nosečnosti (kontracepcijo).
English: • For bipolar disorder <and> <migraine>, if you are a woman able to have a baby, you must not take <Invented name>, unless you use effective method of birth control (contraception) during your entire treatment with <Invented name>).
Slovenian: • Če ste ženska, ki lahko zanosi, zdravila <Izmišljeno ime> ne smete jemati za bipolarno motnjo <ali> <migreno>, razen če med celotnim trajanjem zdravljenja z zdravilom <Izmišljeno ime> uporabljate učinkovit način preprečevanja nosečnosti (kontracepcijo).
English: I AM TAKING <invented name> AND PLANNING TO HAVE A BABY
Slovenian: JEMLJEM ZDRAVILO <Izmišljeno ime> IN NAČRTUJEM NOSEČNOST Če načrtujete nosečnost, se najprej dogovorite za obisk pri zdravniku.
English: Valproate as treatment for bipolar disorder <and prophylaxis of migraine attacks> is contraindicated for use during pregnancy.
Slovenian: Valproat je med nosečnostjo kontraindiciran za zdravljenje bipolarne motnje <in preprečevanje napadov migrene>.
English: Pregnant women
Slovenian: Nosečnice
English: • in pregnancy unless there is no suitable alternative treatment (see sections 4.3 and 4.6).
Slovenian: • Med nosečnostjo, razen če ni nobenega drugega primernega zdravila (glejte poglavji 4.3 in
English: [This sentence below should be adapted to National requirements] Make sure you read the patient guide that you will receive from your doctor.
Slovenian: Poskrbite, da boste prebrali vodnik za bolnice, ki vam ga bo izročil zdravnik.
English: • Ask your doctor about taking folic acid when trying for a baby.
Slovenian: • Če želite zanositi, se z zdravnikom posvetujte o jemanju folne kisline.
English: Your doctor will discuss the Annual Risk Acknowledgement Form and will ask you to sign it and keep it. You will also receive a Patient Card from your pharmacist to remind you of valproate risks in pregnancy.
Slovenian: Od farmacevta boste prejeli tudi opozorilno kartico za bolnice kot opozorilo na tveganja uporabe valproata med nosečnostjo.
English: Ask your doctor about taking folic acid when planning to have a baby.
Slovenian: Ko načrtujete nosečnost, se z zdravnikom posvetujte o jemanju folne kisline.
English: • Schedule an urgent appointment with your doctor if you are pregnant or think you might be pregnant.
Slovenian: • Če načrtujete nosečnost ali če ste noseči, se takoj posvetujte z zdravnikom.
English: Schedule an urgent appointment with your doctor if you want to become pregnant or if you think you are pregnant.
Slovenian: Če želite zanositi ali menite, da ste noseči, se dogovorite za nujen pregled pri zdravniku.
English: See section 4.
Slovenian: Glejte poglavje
English: 2 Communication from the Commission to the European Parliament and the Council.
Slovenian: 1 Sporočilo Komisije Evropskemu parlamentu in Svetu.
English: Several new tasks have started only in 2015 or are still to commence.
Slovenian: Nekatere od novih nalog so se začele šele leta 2015 oziroma se sploh še niso začele.
English: Hence, transparency is one of the Agency's top priorities.
Slovenian: Zato je preglednost ena izmed prednostnih nalog agencije.
English: Timely access to promising medicines
Slovenian: Pravočasen dostop do obetavnih zdravil
English: Improving the quality and efficiency of regulatory work
Slovenian: Izboljšanje kakovosti in učinkovitosti regulativnega dela
English: The Agency sees stable, increasing trends in these activities.
Slovenian: Agencija opaža stabilen in naraščajoč trend teh dejavnosti.
English: Until then, the Agency will focus on ensuring that the existing legal framework is used as effectively as possible and carry out the necessary preparations for the entry into effect of the revised legislation.
Slovenian: Do takrat se bo agencija osredotočala na zagotavljanje čim učinkovitejše uporabe obstoječega zakonodajnega okvira in izvajala potrebne priprave za začetek veljavnosti revidirane zakonodaje.
English: At the same time, legislative changes are expanding the responsibilities of medicines regulators in Europe.
Slovenian: Hkrati zakonodajne spremembe širijo dolžnosti regulativnih organov za zdravila v Evropi.
English: Addressing public-health priorities
Slovenian: Obravnava prednostnih nalog za javno zdravje
English: Programming of human and financial resources for decentralised agencies 2014-2020; http://ec.europa.eu/budget/library/biblio/documents/fin_fwk1420/COM_2013_519_en.pdf
Slovenian: Načrtovanje človeških in finančnih virov za decentralizirane agencije v obdobju 2014-2020; http://ec.europa.eu/budget/library/biblio/documents/fin_fwk1420/COM_2013_519_en.pdf.
English: Alongside old problems such as antimicrobial resistance, new diseases and issues emerge.
Slovenian: Poleg starih problemov, kot je protimikrobna odpornost, se porajajo nove bolezni in nova vprašanja.
English: This is particularly important with continued economic pressures on the Member States, and regulatory authorities being required to cut costs while delivering their responsibilities.
Slovenian: To je še zlasti pomembno zaradi stalnega gospodarskega pritiska na države članice in zahtev, ki jih prejemajo regulativni organi, naj zmanjšajo stroške in hkrati opravijo svoje dolžnosti.
English: The availability of sustainable, high-quality scientific and regulatory expertise will be a critical success factor in addressing the progress in regulatory science.
Slovenian: Razpoložljivost vzdržnega, visokokakovostnega znanstvenega in regulativnega znanja bo ključni dejavnik uspeha pri obravnavanju napredka v regulativni znanosti.