FrancophonIA/ELRC3.0 huggingface dataset:
English: 24 mg of powder (corresponding to 1 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab.
Slovenian: 24 mg praška (kar ustreza 1 milijonu i.e.) v viali (iz stekla tipa I), z zamaškom (iz butilne gume) in zaporko s ploščico (iz aluminija) s pokrovčkom (iz polipropilena) in 1 ml vode za injekcije v ampuli (iz stekla tipa I), z 1 injekcijsko brizgo, 2 injekcijskima iglama in 1 čistilnim tamponom.
English: Endocrine disorders Common:
Slovenian: Bolezni endokrinega sistema
English: Please discard these appropriately and safely.
Slovenian: Zavrzite jih v skladu z lokalnimi predpisi.
English: EU/1/99/128/037 8 pens
Slovenian: EU/1/99/128/037 8 peresnikov
English: Leukopaenia
Slovenian: Ščitnik
English: Do not touch the tip of the syringe.
Slovenian: Vzemite brizgo iz ovojnine, pri tem pa se ne smete dotakniti vrha brizge.
English: Interferon alfa-2b (6 MIU/m
Slovenian: Vrednost p a interferon alfa-2b (100 ali 150c µg/
English: 1 ml of solution (corresponding to 10 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flipoff seal (aluminium) with a bonnet (polypropylene)
Slovenian: 1 ml raztopine (kar ustreza 10 milijonom i.e.) v viali (iz stekla tipa I), z zamaškom (iz halobutilne gume) in zaporko s ploščico (iz aluminija) s pokrovčkom (iz polipropilena) Velikost pakiranja: 1 komplet ali
English: Important advice for women
Slovenian: Pomembni nasveti za ženske
English: Key messages:
Slovenian: Ključna sporočila:
English: Your doctor will advise you further.
Slovenian: Dodatno vam bo svetoval zdravnik.
English: It may harm them, even if their symptoms seem the same as yours.
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Pristojni organi držav članic lahko v nadaljevanju posodobijo informacije o zdravilu v povezavi z referenčno državo članico, kot je ustrezno, v skladu s postopki iz poglavja 4 naslova III Direktive 2001/83/ES.
English: Your doctor will discuss this with you but you must also follow the advice in section 2 of this leaflet.
Slovenian: Zdravnik se bo z vami pogovoril o tem, a upoštevati morate tudi nasvete v 2. poglavju tega navodila.
English: Annex III Amendments to relevant sections of the Product Information
Slovenian: Priloga III Spremembe ustreznih poglavij informacij o zdravilu
English: Teratogenicity and Developmental Effects
Slovenian: Teratogenost in učinki na razvoj
English: If a woman plans a pregnancy
Slovenian: Če ženska načrtuje nosečnost
English: The higher the dose, the higher the risks but all doses carry a risk.
Slovenian: Tveganje je toliko večje, kolikor večji je odmerek, vendar pa tveganje spremlja vse odmerke.
English: You and your partner could receive counselling and support regarding the valproate exposed pregnancy.
Slovenian: Vi in vaš partner sta lahko deležna svetovanja in podpore v zvezi z nosečnostjo, izpostavljeno valproatu.
English: Children affected can be slow to walk and talk , intellectually less able than other children, and have difficulty with language and memory.
Slovenian: Prizadeti otroci pozneje shodijo in začnejo pozneje govoriti, so intelektualno manj sposobni od drugih otrok ter imajo težave z jezikom in spominom.
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Slovenian: Te spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so izid napotitvenega postopka.
English: This compares to 2 to 3 babies in every 100 born to women who don't have epilepsy.
Slovenian: Za primerjavo: takšne napake se pojavijo pri 2 do 3 od 100 otrok žensk, ki nimajo epilepsije.
English: The daily dose should be divided into at least two single doses (see section 4.6).
Slovenian: Dnevni odmerek je treba razdeliti na vsaj dva enkratna odmerka (glejte poglavje 4.6).
English: • Use the lowest effective dose and divide the daily dose of valproate into several small doses to be taken throughout the day.
Slovenian: • uporabljati najmanjši učinkoviti odmerek in razdeliti dnevni odmerek valproata na več majhnih odmerkov, ki jih ženska jemlje v teku dneva.
English: <Invented name> is contraindicated in the following situations:
Slovenian: Zdravilo <Izmišljeno ime> je kontraindicirano v naslednjih primerih:
English: The risks of valproate when taken during pregnancy (irrespective of the disease for which valproate is used)
Slovenian: Tveganja uporabe valproata med nosečnostjo (ne glede na bolezen, za katero se uporablja valproat)
English: If valproate is the only suitable treatment, the need for using effective contraception and all other conditions of pregnancy prevention programme should be discussed.
Slovenian: Če je valproat edino primerno zdravilo, se je treba pogovoriti o potrebi po uporabi učinkovite kontracepcije in o vseh drugih pogojih programa za preprečevanje nosečnosti.
English: [*For the printed material, please refer to the guidance of the annotated QRD template.]
Slovenian: [*Za tiskano gradivo glejte smernice označene predloge QRD.]
English: These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.
Slovenian: Ti pogoji veljajo tudi za ženske, ki trenutno niso spolno aktivne, razen če predpisujoči zdravnik na podlagi prepričljivih razlogov oceni, da tveganja za nosečnost pri bolnici ni.
English: <Invented name> is contraindicated in the following situations: Treatment of epilepsy
Slovenian: Zdravilo <Izmišljeno ime> je kontraindicirano v naslednjih primerih: Zdravljenje epilepsije
English: If switching is not possible, the woman should receive further counselling regarding the valproate risks for the unborn child to support her informed decision making regarding family planning.
Slovenian: Če zamenjava ni mogoča, mora biti ženska deležna dodatnega svetovanja o tveganjih valproata za nerojenega otroka kot pomoč pri njeni obveščeni odločitvi glede načrtovanja družine.
English: MAHs of all valproate and related substances containing products authorised in the EU should amend the product information (insertion, replacement or deletion of the text, as appropriate) to reflect the wording as provided below, and in conjunction to the Scientific conclusions:
Slovenian: Imetniki dovoljenj za promet z vsemi zdravili, ki vsebujejo valproat ali sorodne snovi in so odobrena v EU, morajo informacije o zdravilu (z vstavljanjem, nadomeščanjem ali črtanjem besedila, kot je ustrezno) spremeniti tako, da bodo ustrezale spodaj navedenemu besedilu, in v skladu z znanstvenimi zaključki:
English: Every effort should be made by the specialist to switch the female children to alternative treatment before they reach adulthood.
Slovenian: Specialist si mora po najboljših močeh prizadevati, da bi deklice prešle na drugo zdravilo, preden dosežejo odraslo dobo.
English: Valproate should preferably be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation.
Slovenian: Valproat naj bi po možnosti predpisovali kot monoterapijo in v najmanjšem učinkovitem odmerku ter po možnosti v obliki s podaljšanim sproščanjem.
English: Your specialist can put several actions in place so that your pregnancy goes as smoothly as possible and any risks to you and your unborn child are reduced as much as possible.
Slovenian: Specialist lahko uporabi več ukrepov, da bo nosečnost potekala čim bolj nemoteno in da bodo tveganja za nerojenega otroka čim manjša.
English: Birth defects which have been reported include spina bifida (where the bones of the spine are not properly developed); facial and skull malformations; heart, kidney, urinary tract and sexual organ malformations; limb defects.
Slovenian: Med opisanimi prirojenimi napakami so spina bifida (pri kateri se kosti v hrbtenici ne razvijejo pravilno), malformacije obraza in lobanje, malformacije srca, ledvic, sečil in spolnih organov ter okvare udov.
English: Conditions of Pregnancy Prevention Programme: The prescriber must ensure that
Slovenian: Pogoji programa za preprečevanje nosečnosti: Zdravnik, ki predpiše zdravilo, mora poskrbeti:
English: Because valproate has been used for many years we know that in women who take valproate around 10 babies in every 100 will have birth defects.
Slovenian: Ker je valproat v uporabi že dolga leta, vemo, da bo imelo prirojene napake 10 od 100 otrok žensk, ki jemljejo valproat.
English: Your doctor will advise you further (see below under “Pregnancy, breast-feeding and fertility - Important advice for women”).
Slovenian: Dodatno vam bo svetoval zdravnik (prosimo glejte spodaj “Nosečnost, dojenje in plodnost - Pomembni nasveti za ženske”).
English: In the exceptional circumstances when <Invented name> is the only available treatment option during pregnancy, you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing.
Slovenian: V izrednih okoliščinah, ko je zdravilo <Izmišljeno ime> edina dostopna možnost zdravljenja med nosečnostjo, vas bodo zelo natančno nadzorovali, tako zaradi vodenja osnovne bolezni kot zaradi preverjanja razvoja še nerojenega otroka.
English: • If you take valproate during pregnancy you have a higher risk than other women of having a child with birth defects that require medical treatment.
Slovenian: • Če med nosečnostjo jemljete valproat, imate v primerjavi z drugimi ženskami večje tveganje, da bo imel vaš otrok prirojene napake, ki bodo zahtevale zdravljenje.
English: At least one effective method of contraception (preferably a user independent form such as an intra-uterine device or implant) or two complementary forms of contraception including a barrier method should be used.
Slovenian: Uporabljati morajo vsaj en učinkovit način kontracepcije (po možnosti način, ki ni odvisen od uporabnice, na primer maternični vložek ali vsadek), ali dva komplementarna načina kontracepcije, vključno s pregradnim načinom.
English: However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
Slovenian: Ni pa verjetno, da bi zmanjšala tveganje za prirojene napake, povezane z uporabo valproata.
English: During this visit your doctor will make sure you are well aware and have understood all the risks and advices related to the use of valproate during pregnancy.
Slovenian: Na tem obisku se bo zdravnik prepričal, ali se dobro zavedate in razumete tveganja in nasvete, povezane z uporabo valproata med nosečnostjo.
English: What you need to know before you take <invented name>
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo <izmišljeno ime>
English: In case of pregnancy
Slovenian: V primeru nosečnosti
English: If you decide later you want to have a baby you must not stop taking your medicine or your method of contraception until you have discussed this with your doctor.
Slovenian: Če se pozneje odločite, da želite otroka, ne smete prenehati jemati tega zdravila ali uporabljati kontracepcije, dokler se ne posvetujete z zdravnikom.
English: [Quick Response (QR) code: A QR code should be included in the packaging material and/or the package leaflet, and its location should take into account the overall readability.]
Slovenian: [Koda QR: Na ovojnini in/ali v navodilu za uporabo mora biti vključena koda QR; njen položaj je treba izbrati upoštevaje splošno berljivost.]
English: • It is estimated that up to 30-40% of preschool children whose mothers took valproate during pregnancy may have problems with early childhood development.
Slovenian: • Ocenjujejo, da ima težave z razvojem v zgodnjem otroštvu od 30 do 40 % tistih predšolskih otrok, katerih matere so med nosečnostjo jemale valproat.
English: Specialized prenatal monitoring should take place to detect the possible occurrence of neural tube defects or other malformations.
Slovenian: Potrebno je specializirano predporodno spremljanje, da bi odkrili možne defekte nevralne cevi ali druge malformacije.
English: However the available evidence does not suggest it prevents the birth defects or malformations due to valproate exposure.
Slovenian: Vendar izsledki, ki so na voljo, ne kažejo, da bi preprečil prirojene napake ali malformacije zaradi izpostavljenosti valproatu.
English: • Make sure you are referred to a specialist for prenatal monitoring in order to detect possible occurrences of malformations.
Slovenian: • Poskrbite, da vas bo zdravnik napotil k specialistu za predporodno spremljanje, da bi tako odkrili pojav morebitnih malformacij.
English: • Before prescribing this medicine to you, your doctor will have explained what might happen to your baby if you become pregnant whilst taking valproate.
Slovenian: • Preden vam bo zdravnik predpisal to zdravilo, vam bo pojasnil, kaj se lahko zgodi vašemu otroku, če med jemanjem valproata zanosite.
English: These patients must be provided with comprehensive information on pregnancy prevention and should be referred for contraceptive advice if they are not using effective contraception.
Slovenian: Tem bolnicam je treba zagotoviti izčrpne informacije o preprečevanju nosečnosti; če ne uporabljajo učinkovite kontracepcije, jih je treba napotiti na svetovanje o kontracepciji.
English: During pregnancy, maternal tonic clonic seizures and status epilepticus with hypoxia may carry a particular risk of death for mother and the unborn child.
Slovenian: Tonično-klonični napadi ali status epilepticus s hipoksijo pri materi lahko med nosečnostjo še posebej ogrozijo življenje matere in nerojenega otroka.
English: The use of a prolonged release formulation may be preferable to other treatment formulations in order to avoid high peak plasma concentrations (see section
Slovenian: Uporaba oblike s podaljšanim sproščanjem ima lahko prednost pred drugimi oblikami zdravila, da bi se tako izognili visokim vrhovom koncentracije v plazmi (glejte poglavje 4.2).
English: Folate supplementation before the pregnancy may decrease the risk of neural tube defects which may occur in all pregnancies.
Slovenian: Dodajanje folata pred nosečnostjo lahko zmanjša tveganje za defekte nevralne cevi, ki se lahko pojavijo pri vseh nosečnostih.
English: If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z <zdravnikom> <ali><,> <farmacevtom> <ali medicinsko sestro>.
English: Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies.
Slovenian: Folna kislina lahko zmanjša splošno tveganje za spino bifido in zgodnji spontani splav, ki obstaja pri vseh nosečnostih.
English: • the patient has acknowledged that she has understood the hazards and necessary precautions associated with valproate use (Annual Risk Acknowledgement Form).
Slovenian: • da bolnica potrdi, da razume nevarnosti in potrebne previdnostne ukrepe v zvezi z uporabo valproata (letni obrazec o seznanitvi s tveganji).
English: In order to assist healthcare professionals and patients in avoiding exposure to valproate during pregnancy, the Marketing Authorisation Holder has provided educational materials to reinforce the warnings and provide guidance regarding use of valproate in women of childbearing potential and the details of the pregnancy prevention programmeme.
Slovenian: Da bi zdravstvenim delavcem in bolnicam pomagal pri izogibanju izpostavljenosti valproatu med nosečnostjo, je imetnik dovoljenja za promet z zdravilom pripravil izobraževalna gradiva, ki poudarjajo opozorila, dajejo smernice za uporabo valproata pri ženskah v rodni dobi in navajajo podrobnosti o programu preprečevanja nosečnosti.
English: • Autistic spectrum disorders are more often diagnosed in children exposed to valproate and there is some evidence children may be more likely to develop symptoms of Attention Deficit Hyperactivity Disorder (ADHD).
Slovenian: • Pri otrocih, izpostavljenih valproatu, so pogostejše motnje iz spektra avtizma; nekaj je tudi dokazov, da so pri teh otrocih verjetnejši simptomi motnje aktivnosti in pozornosti (ADHD).
English: • the potential for pregnancy is assessed for all female patients.
Slovenian: • da pri vseh bolnicah oceni možnost nosečnosti.
English: How to take <invented name>
Slovenian: Kako jemati zdravilo <izmišljeno ime>
English: • First schedule an appointment with your doctor.
Slovenian: • Najprej se dogovorite za pregled pri zdravniku.
English: Bipolar disorder <and> <migraine>
Slovenian: Bipolarna motnja <in> <migrena>
English: • the patient understands the need to undergo pregnancy testing prior to initiation of treatment and during treatment, as needed.
Slovenian: • da bolnica razume potrebo po izvajanju testa nosečnosti pred uvedbo zdravljenja in med zdravljenjem, kot je potrebno.
English: Pregnancy test
Slovenian: Test nosečnosti
English: • Pregnancy must be excluded before start of treatment with <Invented name> with the result of a pregnancy test, confirmed by your doctor.
Slovenian: • Nosečnost je treba pred začetkom zdravljenja z zdravilom <Izmišljeno ime> izključiti z izvidom testa nosečnosti, ki ga potrdi zdravnik.
English: Pregnancy must be excluded before start of treatment with valproate.
Slovenian: Pred začetkom zdravljenja z valproatom je treba izključiti nosečnost.
English: • Do not stop using your methods of birth control (contraception) before you have talked to your doctor and worked together on a plan to ensure your condition is controlled and the risks to your baby are reduced.
Slovenian: • Ne nehajte uporabljati kontracepcije, dokler se ne posvetujete z zdravnikom in skupaj z njim oblikujete načrt, po katerem bo vaša bolezen obvladana, tveganja za otroka pa bodo majhna.
English: Annual treatment reviews by a specialist The specialist should at least annually review whether valproate is the most suitable treatment for the patient.
Slovenian: Letna specialistična ovrednotenja zdravljenja Specialist mora vsaj enkrat na leto ponovno ovrednotiti, ali je valproat najprimernejše zdravilo za bolnico.
English: Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development which can be seriously debilitating.
Slovenian: Otroci mater, ki jemljejo valproat, imajo resno tveganje za prirojene napake in razvojne težave, zaradi katerih so lahko resno prizadeti.
English: • Individual circumstances should be evaluated in each case, involving the patient in the discussion, to guarantee her engagement, discuss therapeutic options and ensure her understanding of the risks and the measures needed to minimise the risks.
Slovenian: • da v vsakem primeru oceni individualne okoliščine bolnice, bolnico vključi v razpravo in tako zagotovi njeno zavzetost, se pogovori o možnostih zdravljenja in poskrbi, da bolnica razume tveganja in ukrepe, potrebne za zmanjšanje tveganj.
English: Valproate should not be used in female children and women of childbearing potential unless other treatments are ineffective or not tolerated.
Slovenian: Pri deklicah in ženskah v rodni dobi se valproata ne sme uporabljati, razen če druga zdravila niso učinkovita ali jih bolnica ne prenese.
English: Treatment with valproate must not be initiated in women of child bearing potential without a negative pregnancy test (plasma pregnancy test) result, confirmed by a health care provider, to rule out unintended use in pregnancy.
Slovenian: Zdravljenja z valproatom se pri ženskah v rodni dobi ne sme uvesti brez negativnega izvida testa nosečnosti (plazemski test nosečnosti), ki ga potrdi zdravnik; namen tega je izključiti nenamerno uporabo valproata med nosečnostjo.
English: Your doctor will give you information on preventing pregnancy, and may refer you to a specialist for advice on birth control.
Slovenian: Zdravnik vam bo dal informacije o preprečevanju nosečnosti in morda vas bo napotil k specialistu za svetovanje o načinu preprečevanja nosečnosti.
English: <Invented name> , <INN> can seriously harm an unborn child when taken during pregnancy.
Slovenian: Jemanje zdravila <Izmišljeno ime> <INN> med nosečnostjo lahko resno škoduje nerojenemu otroku.
English: • the patient understands the need to consult her physician as soon as she is planning pregnancy to ensure timely discussion and switching to alternative treatment options prior to conception, and before contraception is discontinued.
Slovenian: • da bolnica razume, da se mora posvetovati z zdravnikom, čim načrtuje nosečnost, za zagotovitev pravočasnega pogovora in prehoda na druge terapevtske možnosti, preden zanosi in preden preneha uporabljati kontracepcijo.
English: I AM PREGNANT AND I AM USING <INVENTED NAME> Do not stop taking <Invented name>, unless your doctor tells you to as your condition may become worse.
Slovenian: SEM NOSEČA IN UPORABLJAM ZDRAVILO <Izmišljeno ime> Ne prenehajte jemati zdravila <Izmišljeno ime>, razen če vam tako naroči zdravnik, kajti stanje se vam lahko poslabša.
English: Do not stop taking <Invented name> or your contraception, until you have discussed this with your doctor.
Slovenian: Ne prenehajte uporabljati zdravila <Izmišljeno ime> ali kontracepcije, dokler se ne posvetujete z zdravnikom.
English: • Your doctor will try to switch you to another medicine, or stop treatment with <Invented name> a long time before you become pregnant.
Slovenian: • Zdravnik vam bo poskusil to zdravilo zamenjati z drugim ali bo končal vaše zdravljenje z zdravilom <Izmišljeno ime> že veliko prej, preden boste zanosili.
English: • It can cause serious birth defects and can affect the way in which the child develops as it grows.
Slovenian: • Valproat lahko povzroči resne prirojene napake in prizadene otrokov razvoj med rastjo.
English: Your specialist may decide to change the dose of <Invented name> or switch you to another medicine, or stop treatment with <Invented name>, a long time before you become pregnant - this is to make sure your illness is stable.
Slovenian: Zdravnik vam bo morda spremenil odmerek zdravila <Izmišljeno ime>, vam zamenjal to zdravilo z drugim, ali bo končal vaše zdravljenje z zdravilom <Izmišljeno ime> že veliko prej, preden boste zanosili - namen tega je zagotoviti, da je vaša bolezen stabilna.
English: Female children
Slovenian: Deklice
English: • the patient understands the need to urgently consult her physician in case of pregnancy.
Slovenian: • da bolnica ve, da se mora v primeru nosečnosti nujno posvetovati z zdravnikom.
English: • the patient is counselled regarding contraception, and that the patient is capable of complying with the need to use effective contraception (for further details please refer to subsection contraception of this boxed warning), without interruption during the entire duration of treatment with valproate.
Slovenian: • da je bolnica deležna svetovanja o kontracepciji in je sposobna izvajati učinkovito kontracepcijo (za dodatne podrobnosti glejte podpoglavje o kontracepciji v tem opozorilu v okvirju) brez prekinitve med celotnim trajanjem zdravljenja z valproatom.
English: [This section should be amended to include the below wording in all indications]
Slovenian: [To poglavje je treba dopolniti, tako da vključuje spodnje besedilo za vse indikacije.]
English: Pregnancy Prevention Programme Valproate has a high teratogenic potential and children exposed in utero to valproate have a high risk for congenital malformations and neurodevelopmental disorders (see section 4.6).
Slovenian: Valproat je povezan z veliko možnostjo teratogenih učinkov, zato imajo otroci, in utero izpostavljeni valproatu, veliko tveganje za prirojene malformacije in nevrorazvojne motnje (glejte poglavje 4.6).
English: Valproate is contraindicated as treatment for epilepsy during pregnancy unless there is no suitable alternative to treat epilepsy.
Slovenian: Valproat je med nosečnostjo kontraindiciran za zdravljenje epilepsije, razen če za njeno zdravljenje ni nobenega drugega primernega zdravila.