FrancophonIA/ELRC3.0 huggingface dataset:
English: If you do become pregnant you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing.
Slovenian: Če zanosite, vas bodo zelo natančno nadzorovali, tako glede vodenja vaše bolezni kot glede preverjanja razvoja še nerojenega otroka.
English: FIRST PRESCRIPTION
Slovenian: PRVIČ PREDPISANO ZDRAVILO
English: [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Slovenian: [Za zdravila v Prilogi I je treba obstoječe informacije o zdravilu (z vstavljanjem, nadomeščanjem ali črtanjem besedila, kot je ustrezno) spremeniti tako, da bodo odražale dogovorjene formulacije, navedene spodaj.]
English: If based on a careful evaluation of the risks and the benefits valproate treatment is continued during the pregnancy, it is recommended to: - Use the lowest effective dose and divide the daily dose valproate into several small doses to be taken throughout the day.
Slovenian: Če je po skrbni oceni tveganj in koristi zdravljenja z valproatom odločeno, da se zdravljenje nadaljuje med nosečnostjo, je priporočljivo: - Uporabiti najmanjši učinkoviti odmerek valproata in dnevni odmerek razdeliti na več manjših odmerkov, uporabljenih čez dan.
English: Available data show an increased incidence of minor and major malformations.
Slovenian: Dostopni podatki kažejo večjo incidenco blažjih in hujših malformacij.
English: Intelligence quotient (IQ) measured in school aged children (age 6) with a history of valproate exposure in utero was on average 7-10 points lower than those children exposed to other antiepileptics.
Slovenian: Inteligenčni količnik (IQ) pri otrocih šolske starosti (6 let), in utero izpostavljenih valproatu, je bil v povprečju od 7 do 10 točk nižji kot pri otrocih, izpostavljenih drugim antiepileptikom.
English: Data derived from a meta-analysis (including registries and cohort studies) has shown that 10.73% of children of epileptic women exposed to valproate monotherapy during pregnancy suffer from congenital malformations (95% CI: 8.16 -13.29).
Slovenian: Podatki metaanalize (vključno s podatki iz registrov in kohortnih študij) so pokazali, da ima prirojene malformacije 10,73 % otrok žensk z epilepsijo, med nosečnostjo izpostavljenih monoterapiji z valproatom (95 IZ: 8,16-13,29).
English: Although the role of confounding factors cannot be excluded, there is evidence in children exposed to valproate that the risk of intellectual impairment may be independent from maternal IQ.
Slovenian: Čeprav vloge motečih dejavnikov ni mogoče izključiti, obstajajo dokazi, da je lahko pri otrocih, izpostavljenih valproatu, tveganje za intelektualno okvaro neodvisno od inteligenčnega količnika matere.
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 postopka arbitraže.
English: This hemorrhagic syndrome is related to thrombocytopenia, hypofibrinogenemia and/or to a decrease in other coagulation factors.
Slovenian: Hemoragični sindrom je povezan s trombocitopenijo, hipofibrinogenemijo in/ali znižanjem drugih koagulacijskih faktorjev.
English: Congenital malformations
Slovenian: Prirojene malformacije
English: Congenital malformations and developmental disorders (see section 4.4 and section 4.6).
Slovenian: Prirojene malformacije in razvojne motnje (glejte poglavji 4.4 in 4.6).
English: Data have shown that exposure to valproate in utero can have adverse effects on mental and physical development of the exposed children.
Slovenian: Podatki kažejo, da ima lahko izpostavljenost valproatu in utero neželene učinke na duševni in telesni razvoj izpostavljenih otrok.
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 hibe, ki bodo zahtevale zdravljenje.
English: Stop taking valproate and schedule an urgent appointment with your doctor.
Slovenian: Nehajte jemati valproat in se takoj dogovorite za nujen obisk pri zdravniku.
English: Pregnancy, breast feeding and fertility [This section should be amended to include the below wording]
Slovenian: Nosečnost, dojenje in plodnost [To poglavje je treba dopolniti, tako da vključuje spodnje besedilo]
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Slovenian: Priloga III Spremembe ustreznih poglavij v povzetku glavnih značilnosti zdravila in navodilu za uporabo
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 hibe 10 od 100 otrok žensk, ki jemljejo valproat.
English: Case reports indicate that fertility dysfunctions are reversible after treatment discontinuation.
Slovenian: Opisi primerov navajajo, da so motnje plodnosti po prenehanju zdravljenja reverzibilne.
English: Studies in preschool children exposed in utero to valproate show that up to 30-40% experience delays in their early development such as talking and walking later, lower intellectual abilities, poor language skills (speaking and understanding) and memory problems.
Slovenian: Študije pri predšolskih otrocih, in utero izpostavljenih valproatu, kažejo, da je pri 30 do 40 % upočasnjen zgodnji razvoj, tako da npr. začnejo govoriti pozneje, pozneje shodijo, imajo slabše intelektualne zmožnosti, slabe jezikovne veščine (govorjenje in razumevanje) in težave s spominom.
English: Do not stop taking your contraception, until you have discussed this with your doctor.
Slovenian: Ne prenehajte uporabljati kontracepcije, dokler se ne posvetujete z zdravnikom.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from <invented name> therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba ali za prenehanje dojenja ali za prekinitev/prenehanje zdravljenja z zdravilom <Izmišljeno ime>, upoštevaje korist dojenja za otroka in korist zdravljenja za žensko.
English: You should talk to your doctor well before you become pregnant so that you 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: Z zdravnikom se morate posvetovati precej prej, preden zanosite: tako boste opravili več ukrepov, da bo nosečnost potekala s čim manj zapleti in da bo tveganje za nerojenega otroka čim manjše.
English: • It can cause serious birth defects and can affect the way in which the child develops as it grows.
Slovenian: • Povzroči lahko resne prirojene hibe in prizadene otrokov razvoj med rastjo.
English: Female children, female adolescents and woman of childbearing potential (see above and section 4.4)
Slovenian: Deklice, mladostnice in ženske v rodni dobi (glejte zgoraj in poglavje 4.4)
English: • Do not stop using your contraception before you have talked to your doctor and worked together on a plan to ensure your epilepsy/bipolar disorder is controlled and the risks to your baby are reduced.
Slovenian: • Ne prenehajte uporabljati kontracepcije, dokler se ne posvetujete z zdravnikom in skupaj z njim oblikujete načrta, da bo epilepsija/bipolarna motnja obvladana, tveganje za otroka pa čim manjše.
English: However the available evidence does not suggest it prevents the birth defects or malformations due to valproate exposure.
Slovenian: Vendar dostopni dokazi ne kažejo, da prepreči prirojene hibe ali malformacije zaradi izpostavljenosti valproatu.
English: Therefore, platelet count, fibrinogen plasma level, coagulation tests and coagulation factors should be investigated in neonates.
Slovenian: Zato je treba pri novorojenčkih kontrolirati število trombocitov, koncentracijo fibrinogena v plazmi, koagulacijske teste in koagulacijske faktorje.
English: Preferably <invented name> should be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation to avoid high peak plasma concentrations.
Slovenian: Zdravilo <Izmišljeno ime> naj bo po možnosti uporabljeno kot samostojno zdravljenje (monoterapija) in v najmanjšem učinkovitem odmerku, če je mogoče, v obliki s podaljšanim sproščanjem, da bi preprečili visoke vrhove koncentracije v plazmi.
English: If you are trying for a baby you should not use valproate.
Slovenian: Če poskušate zanositi, ne smete uporabljati valproata.
English: Female children, female adolescents, women of childbearing potential and pregnant women
Slovenian: Deklice, mladostnice, ženske v rodni dobi in nosečnice
English: - To institute specialized prenatal monitoring in order to detect the possible occurrence of neural tube defects or other malformations.
Slovenian: - Uvesti specializiran predporodni nadzor, da bi odkrili morebitne defekte nevralne cevi ali druge malformacije.
English: If you decide later you want to have a child you should not stop taking your medicine until you have discussed this with your doctor and agreed a plan for switching you onto another product if this is possible.
Slovenian: Če se pozneje odločite, da želite otroka, ne smete prenehati jemati tega zdravila, ne da bi se prej posvetovali z zdravnikom in se z njim dogovorili za prehod na zdravljenje z drugim zdravilom, če je to mogoče.
English: Available data suggest that antiepileptic polytherapy including valproate is associated with a greater risk of congenital malformations than valproate monotherapy.
Slovenian: Dostopni podatki kažejo, da je antiepileptična politerapija, ki vključuje valproat, povezana z večjim tveganjem za prirojene malformacije kot monoterapija z valproatom.
English: Female children/Female adolescents/Women of childbearing potential/Pregnancy:
Slovenian: Deklice/mladostnice/ženske v rodni dobi/nosečnice:
English: • Do not take valproate if you are pregnant or if you are a women of childbearing potential and you are not using effective contraception.
Slovenian: • Ne jemljite valproata, če ste noseči ali če ste v rodni dobi in ne uporabljate učinkovite kontracepcije.
English: Your doctor may decide to change the dose of valproate or switch you to another medicine before you start trying for a baby.
Slovenian: Zdravnik vam bo morda spremenil odmerek valproata ali bo valproat nadomestil s kakšnim drugim zdravilom, še preden poskusite zanositi.
English: If this is the first time you have been prescribed valproate your doctor will have explained the risks to an unborn child if you become pregnant.
Slovenian: Če vam je zdravnik valproat predpisal prvič, vam bo pojasnil, kakšna so tveganja za nerojenega otroka v primeru, da zanosite.
English: [For all products referred to in Annex I]
Slovenian: [Za vsa zdravila, navedena v Prilogi I]
English: The most common types of malformations include neural tube defects, facial dysmorphism, cleft lip and palate, craniostenosis, cardiac, renal and urogenital defects, limb defects (including bilateral aplasia of the radius), and multiple anomalies involving various body systems.
Slovenian: Med najpogostejšimi malformacijami so defekti nevralne cevi, dismorfizmi obraza, heiloshiza in palatoshiza, kraniostenoza, srčne, ledvične in urogenitalne hibe, hibe udov (vključno z obojestransko aplazijo koželjnice) in multiple anomalije, ki zajamejo različne telesne sisteme.
English: The benefit and risk should be carefully reconsidered at regular treatment reviews, at puberty and urgently when a woman of childbearing potential treated with <invented name> plans a pregnancy or if she becomes pregnant.
Slovenian: Koristi in tveganja je treba skrbno znova oceniti v rednih presledkih med zdravljenjem, v puberteti ter nujno, če ženska v rodni dobi, ki jemlje zdravilo <Izmišljeno ime>, namerava zanositi ali zanosi.
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 hibe in razvojne težave, zaradi katerih so lahko resno prizadeti.
English: Available data show that children exposed to valproate in utero are at increased risk of autistic spectrum disorder (approximately three-fold) and childhood autism (approximately five-fold) compared with the general study population.
Slovenian: Dostopni podatki kažejo, da imajo otroci, in utero izpostavljeni valproatu, večje tveganje za spekter avtističnih motenj (približno trikratno) in otroški avtizem (približno petkratno) v primerjavi s splošno proučevano populacijo.
English: Valproate administration may also impair fertility in men (see section 4.8).
Slovenian: Uporaba valproata lahko poslabša tudi plodnost moških (glejte poglavje 4.8).
English: The prescriber must ensure that the patient is provided with comprehensive information on the risks alongside relevant materials, such as a patient information booklet, to support her understanding of the risks.
Slovenian: Zdravnik, ki predpiše zdravilo, mora poskrbeti, da bolnica poleg ustreznih gradiv (na primer informativne knjižice za bolnice) dobi izčrpne informacije o tveganjih, da bo lahko razumela tveganja.
English: The use of a prolonged release formulation may be preferable to other treatment formulations in order to avoid high peak plasma concentrations.
Slovenian: Oblika zdravila s podaljšanim sproščanjem ima prednost pred drugimi oblikami, saj prepreči visoke vrhove koncentracije v plazmi.
English: The risk is dose dependent but a threshold dose below which no risk exists cannot be established.
Slovenian: Tveganje je odvisno od odmerka, toda praga odmerka, pod katerim tveganja ni, ni mogoče ugotoviti.
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 v zgodnjem otroštvu težave z razvojem od 30 do 40 % tistih predšolskih otrok, katerih matere so med nosečnostjo jemale valproat.
English: However, it it unlikely that it will reduce the risk of birth defects associated with valproate use.
Slovenian: Ni pa verjetno, da bi zmanjšala tveganje za prirojene hibe, povezane z uporabo valproata.
English: [The text below should be inserted in all indications].
Slovenian: [Spodnje besedilo je treba vstaviti za vse indikacije.]
English: <Invented name> should not be used in female children, in female adolescents, in women of childbearing potential and in pregnant women unless other treatments are ineffective or not tolerated.
Slovenian: Zdravila <Izmišljeno ime> se ne sme uporabljati pri deklicah, mladostnicah, ženskah v rodni dobi in nosečnicah, razen če so druga zdravila neučinkovita ali jih bolnica ne prenese.
English: Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies.
Slovenian: Folna kislina lahko pri vseh nosečnicah zmanjša splošno tveganje za pojav spine bifide in zgodnji spontani splav.
English: [This section should be amended to include the following wording]
Slovenian: [To poglavje je treba dopolniti, tako da vključuje naslednje besedilo]
English: • If you are a woman capable of becoming pregnant your doctor should only prescribe valproate for you if nothing else works for you.
Slovenian: • Če ste ženska v rodni dobi, vam sme zdravnik predpisati valproat le, če vam ne pomaga nobeno drugo zdravilo.
English: - Folate supplementation before the pregnancy may decrease the risk of neural tube defects common to all pregnancies.
Slovenian: - Dodajanje folata pred nosečnostjo; to lahko zmanjša tveganje za defekte nevralne cevi, kot velja za vse nosečnosti.
English: Treatment should only be initiated if other treatments are ineffective or not tolerated (see section 4.3, 4.4 and 4.6) and the benefit and risk should be carefully reconsidered at regular treatment reviews.
Slovenian: To zdravilo se sme uvesti le, če druga zdravila niso učinkovita ali jih bolnica ne prenese (glejte poglavja 4.3, 4.4 in 4.6), koristi in tveganja pa je treba skrbno ocenjevati v rednih presledkih.
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 hibami 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: Hematological disorders have been shown in breastfed newborns/infants of treated women (see section 4.8).
Slovenian: Pri dojenih novorojenčkih/dojenčkih zdravljenih žensk so ugotovili hematološke motnje (glejte poglavje 4.8).
English: Treatment should only be initiated if other treatments are ineffective or not tolerated (see section 4.4 and 4.6) and the benefit and risk should be carefully reconsidered at regular treatment reviews.
Slovenian: To zdravilo se sme uvesti le, če druga zdravila niso učinkovita ali jih bolnica ne prenese (glejte poglavji 4.4 in 4.6), koristi in tveganja pa je treba skrbno ocenjevati v rednih presledkih.
English: • If a woman plans a pregnancy or becomes pregnant, valproate therapy should be stopped.
Slovenian: • Če ženska načrtuje nosečnost ali zanosi, je treba zdravljenje z valproatom končati.
English: [The following text should be inserted in all products referred to in Annex I]
Slovenian: [Naslednje besedilo je treba vstaviti pri vseh zdravilih, navedenih v Prilogi I]
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 pomanjkanja pozornosti shiperaktivnostjo (ADHD - attention deficit/hyperactivity disorder).
English: If you are continuing treatment with valproate and you are now thinking of trying for a baby you must not stop taking either your valproate or your contraceptive medicine until you have discussed this with your prescriber.
Slovenian: Če nadaljujete zdravljenje z valproatom in zdaj želite zanositi, ne smete prenehati uporabljati valproata in tudi ne kontracepcije, dokler se ne posvetujete z zdravnikom, ki vam je predpisal valproat.
English: In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible (see section 4.6).
Slovenian: Pri ženskah, ki nameravajo zanositi, si je treba prizadevati, da bi prešle na drugo ustrezno zdravilo, preden zanosijo, če je to mogoče (glejte poglavje 4.6).
English: <Invented name> should not be used in female children, in female adolescents, in women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated because of its high teratogenic potential and risk of developmental disorders in infants exposed in utero to valproate.
Slovenian: Zdravila <Izmišljeno ime> se ne sme uporabljati pri deklicah, mladostnicah, ženskah v rodni dobi in nosečnicah, razen če so druga zdravila neučinkovita ali jih bolnica ne prenese; valproat spremljata velika možnost teratogenosti in tveganje za razvojne motnje pri otrocih, ki so mu izpostavljeni in utero.
English: Amenorrhoea, polycystic ovaries and increased testosterone levels have been reported in women using valproate (see section 4.8).
Slovenian: Pri ženskah, ki so jemale valproat, so bili opisani amenoreja, policistični jajčniki in zvišana koncentracija testosterona (glejte poglavje 4.8).
English: If you are a female of childbearing age you should use an effective method of contraception throughout your treatment.
Slovenian: Če ste ženska v rodni dobi, morate ves čas zdravljenja uporabljati učinkovito kontracepcijo.
English: • Prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate (see sections 4.4 and 4.6).
Slovenian: • Za profilakso migrenskih napadov pri nosečnicah in ženskah v rodni dobi, ki med zdravljenjem z valproatom ne uporabljajo učinkovite kontracepcije (glejte poglavji 4.4 in 4.6).
English: [This statement below should be inserted at the top of the package leaflet for all products referred to in Annex I] ▼This medicine is subject to additional monitoring.
Slovenian: [Spodnjo navedbo je treba vstaviti na vrh navodila za uporabo za vsa zdravila, navedena v Prilogi I] ▼Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: If you are taking valproate and you think you are pregnant or might be pregnant contact your doctor at once.
Slovenian: Če jemljete valproat in mislite, da ste noseči, ali da bi lahko bili noseči, se takoj posvetujte z zdravnikom.
English: <Invented name> is contraindicated as migraine prophylaxis in pregnant women and in women of childbearing potential, who do not use effective methods of contraception, as sufficient therapeutic alternatives are present (see section 4.3).
Slovenian: Zdravilo <Izmišljeno ime> je kontraindicirano za profilakso migrene pri nosečnicah in ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, ker je na voljo dovolj terapevtskih alternativ (glejte poglavje 4.3).
English: - Cases of hemorrhagic syndrome have been reported very rarely in neonates whose mothers have taken valproate during pregnancy.
Slovenian: Tveganje pri novorojenčkih - Zelo redko so pri novorojenčkih mater, ki so med nosečnostjo jemale valproat, zabeležili hemoragični sindrom.
English: The risk seems to be dose-dependent but a threshold dose below which no risk exists, cannot be established based on available data.
Slovenian: Po vsem sodeč je tveganje odvisno od odmerka, toda na podlagi dostopnih podatkov ni mogoče ugotoviti praga odmerka, pod katerim tveganja ni.
English: • Pregnancy must be excluded before start of treatment with valproate.
Slovenian: • Pred začetkom zdravljenja z valproatom je treba izključiti nosečnost.
English: If a Woman wants to plan a Pregnancy [The sentence below should be inserted only where the marketing authorisation currently includes the epilepsy indication]
Slovenian: Če želi ženska načrtovati nosečnost [Spodnji stavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo epilepsija.]
English: • In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible.
Slovenian: • Pri ženskah, ki nameravajo zanositi, si je treba prizadevati, da bi prešle na ustrezno drugo zdravilo, preden zanosijo, če je to mogoče.
English: <Invented name> treatment must be started and supervised by a doctor specialised in the treatment of migraine.
Slovenian: Zdravljenje z zdravilom <Izmišljeno ime> mora začeti in nadzorovati zdravnik specialist za zdravljenje migrene.
English: • The need to rapidly consult her physician if she is thinking of becoming pregnant or there is a possibility of pregnancy.
Slovenian: • Potrebo po tem, da se mora takoj posvetovati z zdravnikom, če razmišlja, da bi zanosila,
English: • Tell your doctor at once if you know you are pregnant or think you might be pregnant.
Slovenian: • Zdravnika morate takoj obvestiti, če veste, da ste noseči, ali mislite, da bi lahko bili noseči.
English: Limited data suggests that children exposed to valproate in utero may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD).
Slovenian: Maloštevilni podatki kažejo, da imajo lahko otroci, in utero izpostavljeni valproatu, večjo verjetnost za simptome motnje pomanjkanja pozornosti s hiperaktivnostjo (ADHD - attention deficit/hyperactivity disorder).