FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, platelet count, fibrinogen plasma level, coagulation tests and coagulation factors should be investigated in neonates.
Danish: Derfor bør trombocyttallet, fibrinogenniveauet i plasma, koagulationstest og koagulationsfaktorer undersøges hos nyfødte.
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.
Danish: Hvis det er første gang, du har fået ordineret valproat, har din læge forklaret de risici, et ufødt barn udsættes for, hvis du bliver gravid.
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).
Danish: Data fra en meta-analyse (der inkluderede register- og kohortestudier) viste, at 10,73 % af de børn, der blev født af kvinder med epilepsi, der havde været i behandling med valproat-monoterapi under graviditeten, havde medfødte misdannelser (95 % CI: 8,16-13,29).
English: • The need to use effective contraception.
Danish: • Nødvendigheden af at bruge effektiv prævention.
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.
Danish: • Hvis du tager valproat under graviditet, har du en højere risiko end andre kvinder for at få et barn med misdannelser, der kræver lægelig behandling.
English: Developmental disorders
Danish: Udviklingsforstyrrelser
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.
Danish: • Du må ikke stoppe med at bruge prævention, før du har talt med din læge og sammen med lægen lagt en plan for at sikre, at din epilepsi/bipolære lidelse er under kontrol, og at risiciene for dit barn er reduceret.
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.
Danish: Studier hos førskolebørn, som var blevet eksponeret for valproat in utero, viser, at op til 30-40 % oplever forsinkelser i deres tidlige udvikling, såsom senere tale og gang, lavere intellektuelle evner, dårlige sprogfærdigheder (tale og forståelse) og hukommelsesproblemer.
English: However, this syndrome must be distinguished from the decrease of the vitamin-K factors induced by phenobarbital and enzymatic inducers.
Danish: Dette syndrom skal imidlertid skelnes fra det fald i vitamin Kafhængige koagulationsfaktorer, der induceres af phenobarbital og enzymatiske induktorer.
English: Data have shown that exposure to valproate in utero can have adverse effects on mental and physical development of the exposed children.
Danish: Data har vist at eksponering for valproat in utero kan have negative virkninger på den mentale og fysiske udvikling hos de eksponerede børn.
English: How to take <invented name>
Danish: Sådan skal du tage <særnavn>
English: Your doctor may decide to change the dose of valproate or switch you to another medicine before you start trying for a baby.
Danish: Din læge kan beslutte at ændre din dosis af valproat eller skifte til et andet lægemiddel, før du prøver at blive gravid.
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.
Danish: Intelligenskvotient (IQ) målt hos skolebørn (6 år gamle), som var blevet eksponeret for valproat in utero, var gennemsnitlig 7-10 point lavere end hos børn, der havde været eksponeret for andre antiepileptika.
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.
Danish: • Før din læge udskriver denne medicin, vil han/hun forklare dig, hvad der kan ske med din baby, hvis du bliver gravid, mens du tager valproat.
English: - To institute specialized prenatal monitoring in order to detect the possible occurrence of neural tube defects or other malformations.
Danish: - Indlede specialiseret prænatal monitorering for at påvise mulig forekomst af neuralrørsdefekter eller andre misdannelser.
English: Amenorrhoea, polycystic ovaries and increased testosterone levels have been reported in women using valproate (see section 4.8).
Danish: Amenorré, polycystiske ovarier og øget testosteronniveau er rapporteret hos kvinder, der tager valproat (se pkt.
English: [For all products referred to in Annex I]
Danish: [For alle produkter som er nævnt i bilag I]
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.
Danish: Fordele og risici bør revurderes nøje ved regelmæssige vurderinger af behandlingen, ved pubertet og øjeblikkeligt, når en kvinde i den fødedygtige alder, der er i behandling med <særnavn>, planlægger at blive gravid, eller hvis hun bliver gravid.
English: Risk in the neonate
Danish: Risiko hos den nyfødte
English: This hemorrhagic syndrome is related to thrombocytopenia, hypofibrinogenemia and/or to a decrease in other coagulation factors.
Danish: Dette hæmoragiske syndrom er relateret til trombocytopeni, hypofibrinogenæmi og/eller fald i andre koagulationsfaktorer.
English: - Withdrawal syndrome (such as, in particular, agitation, irritability, hyper-excitability, jitteriness, hyperkinesia, tonicity disorders, tremor, convulsions and feeding disorders) may occur in neonates whose mothers have taken valproate during the last trimester of their pregnancy.
Danish: - Seponeringssyndrom (specielt agitation, irritabilitet, hyper-pirrelighed, anspændthed, hyperkinesi, tonicitetsforstyrrelser, tremor, kramper og spiseforestyrrelser) kan forekomme hos nyfødte, hvis mødre har taget valproat i sidste trimester af graviditeten.
English: The risk seems to be dose-dependent but a threshold dose below which no risk exists, cannot be established based on available data.
Danish: Risikoen synes at være dosisafhængig, men en nedre grænseværdi, hvor der ikke er en risiko, kan ikke fastsættes på baggrund af de tilgængelige data.
English: Valproate can cause birth defects and problems with early development of the child if it is taken during pregnancy.
Danish: Valproat kan forårsage fosterskader og problemer med barnets tidlige udvikling, hvis det tages under graviditet.
English: Talk to your doctor or family planning clinic if you need advice on contraception.
Danish: Tal med din læge, hvis du har brug for rådgivning om prævention.
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.
Danish: Selvom forstyrrende faktorer ikke kan udelukkes, er der evidens for, at hos børn, som har været eksponeret for valproat, kan risikoen for nedsat intelligens være uafhængig af moderens IQ.
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.
Danish: Tilgængelige data viser, at børn eksponeret for valproat in utero, har en øget risiko for autisme spektrum forstyrrelser (cirka tredobbelt) og børneautisme (cirka femdobbelt) sammenlignet med den generelle studiepopulation.
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.
Danish: Hvis du senere planlægger at blive gravid, må du ikke stoppe med at tage din medicin, før du har talt med din læge og aftalt en plan for at skifte til et andet lægemiddel, hvis dette er muligt.
English: Pregnancy, breast feeding and fertility [This section should be amended to include the below wording]
Danish: Graviditet, amning og fertilitet [Dette afsnit skal ændres til at inkludere følgende]
English: • If you are a woman capable of becoming pregnant your doctor should only prescribe valproate for you if nothing else works for you.
Danish: • Hvis du er kvinde i den fødedygtige alder, bør din læge kun ordinere valproat til dig, hvis intet andet virker for dig.
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.
Danish: De hyppigste typer misdannelser inkluderer neuralrørsdefekter, dysmorft ansigt, læbespalte og ganespalte, kraniostenose, kardiale, renale og urogenitale defekter, defekte lemmer (herunder bilateral aplasi af radius) og multiple anomalier i forskellige organsystemer.
English: Valproate administration may also impair fertility in men (see section 4.8).
Danish: Valproat kan også svække fertiliteten hos mænd (se pkt.
English: Do not stop taking your contraception, until you have discussed this with your doctor.
Danish: Du må ikke stoppe med at bruge/tage din prævention, før du har talt med din læge.
English: • If a woman plans a pregnancy or becomes pregnant, valproate therapy should be stopped.
Danish: • Hvis en kvinde planlægger at blive gravid eller bliver gravid, skal valproat seponeres.
English: Available data suggest that antiepileptic polytherapy including valproate is associated with a greater risk of congenital malformations than valproate monotherapy.
Danish: Tilgængelige data tyder på, at antiepileptisk polyterapi, herunder polyterapi med valproat, er forbundet med en højere risiko for medfødte misdannelser end valproat-monoterapi.
English: Stop taking valproate and schedule an urgent appointment with your doctor.
Danish: Du skal stoppe med at tage valproat og øjeblikkeligt bestille en konsultation hos din læge.
English: [This section should be amended to include the following box]
Danish: [Dette punkt skal tilpasse til at inkludere nedenstående boks]
English: However the available evidence does not suggest it prevents the birth defects or malformations due to valproate exposure.
Danish: Den tilgængelige dokumentation antyder dog ikke, at det forhindrer fosterskader eller misdannelser på grund af valproateksponering.
English: [The text below should be inserted in all indications].
Danish: [Nedenstående tekst skal indsættes for alle indikationer].
English: The risk is dose dependent but a threshold dose below which no risk exists cannot be established.
Danish: Risikoen er dosisafhængig, men der kan ikke fastsættes en nedre grænseværdi, hvor der ikke er en risiko.
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.
Danish: <Særnavn> bør fortrinsvist udskrives som monoterapi og i den laveste effektive dosis, og hvis muligt som depotformulering for at undgå høje maksimalkoncentrationer (peaks).
English: Pregnancy must be excluded before start of treatment with valproate.
Danish: Graviditet skal udelukkes, før behandling med valproat initieres.
English: Female children, female adolescents, women of childbearing potential and pregnant women
Danish: Piger, både børn og unge, kvinder i den fødedygtige alder og gravide kvinder
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.
Danish: Det skal besluttes enten at stoppe amningen eller at seponere/undgå behandling med <særnavn>, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: - Folate supplementation before the pregnancy may decrease the risk of neural tube defects common to all pregnancies.
Danish: - Folattilskud før graviditet kan mindske risikoen for neuralrørsdefekter for alle graviditeter.
English: • Valproate can be harmful to unborn children when taken by a woman during pregnancy.
Danish: • Valproat kan være skadeligt for ufødte børn, hvis det tages under graviditet.
English: • Pregnancy must be excluded before start of treatment with valproate.
Danish: • Graviditet skal udelukkes inden behandling med valproat.
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.
Danish: • Du må ikke tage valproat, hvis du er gravid, eller hvis du er en kvinde i den fødedygtige alder, og du ikke bruger sikker prævention.
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.
Danish: <Særnavn> bør ikke anvendes til små piger, piger i teenagealderen, kvinder i den fødedygtige alder og gravide kvinder, medmindre andre behandlinger er ineffektive eller ikke tolereres pga. det høje teratogene potentiale og risiko for udviklingsforstyrrelser hos spædbørn, der har været eksponeret for valproat in utero.
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.
Danish: De fødselsskader, som er blevet indberettet, omfatter rygmarvsbrok (hvor knoglerne i rygsøjlen ikke er korrekt udviklet); misdannelser af ansigt og kranie; misdannelser af hjerte, nyre, urinveje og kønsorganer; misdannelser af arme og ben.
English: Women of childbearing potential must use effective contraception during treatment and be informed of the risks associated with the use of <invented name> during pregnancy (see section 4.6).
Danish: Kvinder i den fødedygtige alder skal anvende effektiv prævention under behandlingen og skal informeres om de risici, der er forbundet med brug af <særnavn> under graviditet (se pkt.
English: • It can cause serious birth defects and can affect the way in which the child develops as it grows.
Danish: • Valproat kan forårsage alvorlige fosterskader og kan påvirke den måde, dit barn udvikler sig.
English: Women of childbearing potential have to use effective contraception during treatment.
Danish: Kvinder i den fødedygtige alder skal anvende effektiv prævention under behandlingen.
English: • Make sure you are using an effective method of contraception.
Danish: • Sørg for at bruge en effektiv præventionsmetode.
English: [The following text should be inserted in all products referred to in Annex I]
Danish: [Følgende tekst indsættes for alle produkter, som er nævnt i bilag I]
English: Female children/Female adolescents/Women of childbearing potential/Pregnancy:
Danish: Piger, både børn og unge/Kvinder i den fødedygtige alder/Graviditet:
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.
Danish: Børn af mødre, der har taget valproat, har stor risiko for at få fosterskader og problemer med udviklingen, hvilket kan være stærkt invaliderende.
English: However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
Danish: Det er dog ikke sandsynligt, at folat vil mindske risikoen for de fosterskader, der er forbundet med brugen af valproat.
English: Ask your doctor about taking folic acid.
Danish: Tal med din læge om at tage folattilskud.
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).
Danish: • Børn, der har været udsat for valproat i graviditeten, får oftere af vide, at de har autisme spektrum forstyrrelser, og der er nogle tegn på, at børnene kan være mere tilbøjelige til at udvikle symptomer på forstyrrelser af opmærksomhed, aktivitet og impulsitivitet (ADHD).
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.
Danish: Hvis du fortsætter din behandling med valproat, og du planlægger at blive gravid, må du ikke stoppe med hverken at tage valproat eller bruge prævention, før du har talt med din læge.
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.
Danish: [Nedenstående indsættes øverst i indlægssedlen for alle produkter, som er nævnt i bilag I] ▼Dette lægemiddel er underlagt supplerende overvågning.
English: [This statement below should be inserted at the top of the SmPC for all products referred to in Annex I] ▼This medicinal product is subject to additional monitoring.
Danish: PRODUKTRESUME [Nedenstående indsættes øverst i SmPC'et for alle produkter, som er nævnt i bilag I] ▼ Dette lægemiddel er underlagt supplerende overvågning.
English: Valproate therapy should only be continued after a reassessment of the benefits and risks of the treatment with valproate for the patient by a physician experienced in the management of
Danish: Behandling med valproat bør kun fortsættes efter en revurdering af patientens fordele og risici ved valproatbehandling.
English: If you are a female of childbearing age you should use an effective method of contraception throughout your treatment.
Danish: Hvis du er kvinde i den fødedygtige alder, skal du bruge en effektiv præventionsmetode gennem hele din behandling.
English: Limited data suggests that children exposed to valproate in utero may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD).
Danish: Begrænsede data tyder på, at børn eksponeret for valproat in utero, kan have større risiko for at udvikle symptomer på forstyrrelser af opmærksomhed, aktivitet og impulsitivitet (ADHD).
English: Hematological disorders have been shown in breastfed newborns/infants of treated women (see section 4.8).
Danish: Der er set hæmatologiske forstyrrelser hos nyfødte/spædbørn ammet af mødre, der har været i behandling (se pkt.
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. [The sentence below should be inserted only where the marketing authorisation currently includes the epilepsy and/or bipolar indications]
Danish: • Under graviditet kan tonisk kloniske anfald og status epilepticus med hypoxi hos moderen udgøre en særlig risiko for dødsfald for moderen og det ufødte barn.
English: • If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: • The need to rapidly consult her physician if she is thinking of becoming pregnant or there is a possibility of pregnancy.
Danish: • Nødvendigheden af øjeblikkeligt at konsultere sin læge, hvis hun planlægger at blive gravid eller har mistanke om, at hun er gravid.
English: - Cases of hypoglycaemia have been reported in neonates whose mothers have taken valproate during the third trimester of their pregnancy.
Danish: - Tilfælde af hypoglykæmi er rapporteret hos nyfødte, hvis mødre har taget valproat i tredje trimester af graviditeten.
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]
Danish: Hvis en kvinde planlægger at blive gravid [Sætningen nedenfor skal indsættes, når markedsføringstilladelsen omfatter indikationen epilepsi]
English: • In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible.
Danish: • Hos kvinder, der planlægger at blive gravide, bør det tilstræbes at skifte til alternativ behandling forud for undfangelse, hvis det er muligt.
English: Female children, female adolescents and woman of childbearing potential (see above and section 4.4)
Danish: Piger, både børn og unge, og kvinder i den fødedygtige alder (se ovenstående og pkt.
English: Congenital malformations and developmental disorders (see section 4.4 and section 4.6).
Danish: Medfødte misdannelser og udviklingsforstyrrelser (se pkt.
English: Once you are of childbearing age, you will need to make sure you use an effective method of contraception throughout your treatment.
Danish: Hvis du er i den fødedygtige alder, skal du sørge for at bruge en effektiv præventionsmetode gennem hele behandlingen.
English: - Cases of hypothyroidism have been reported in neonates whose mothers have taken valproate during pregnancy.
Danish: - Tilfælde af hypotyrodisme er rapporteret hos nyfødte, hvis mødre har taget valproat under graviditeten.
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).
Danish: <Særnavn> er kontraindiceret som migræneprofylakse til gravide kvinder og til kvinder i den fødedygtige alder, som ikke anvender en effektiv præventionsmetode, da der findes terapeutiske alternativer (se pkt.
English: - Cases of hemorrhagic syndrome have been reported very rarely in neonates whose mothers have taken valproate during pregnancy.
Danish: - Hæmoragisk syndrom er blevet rapporteret meget sjældent hos nyfødte, hvis mødre har taget valproat under graviditeten.
English: If you are continuing treatment with valproate but you don't plan to have a baby make sure you are using an effective method of contraception.
Danish: FORTSAT BEHANDLING, UDEN AT DU PLANLÆGGER AT BLIVE GRAVID Hvis du fortsætter behandlingen med valproat og ikke planlægger at blive gravid, skal du sørge for at bruge en effektiv præventionsmetode.
English: Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies.
Danish: Folat kan nedsætte den generelle risiko for rygmarvsbrok og tidlig abort.
English: [All text below should be inserted only where the marketing authorisation currently includes the indications epilepsy and/or bipolar disorders] Valproate therapy should not be discontinued without a reassessment of the benefits and risks of the treatment with valproate for the patient by a physician experienced in the management of <epilepsy> <or> <bipolar disorder>.
Danish: [Al tekst nedenfor skal indsættes, når markedsføringstilladelsen omfatter indikationerne epilepsi og/eller bipolær lidelse] Valproat bør ikke seponeres uden en revurdering af patientens fordele og risici ved behandlingen.
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).
Danish: • Profylakse af migræneanfald under graviditet og hos kvinder i den fødedygtige alder, som ikke anvender effektiv prævention under behandlingen med valproat (se pkt.
English: • Stop taking your valproate and schedule an urgent appointment if you are pregnant or think you might be pregnant.
Danish: • Du skal stoppe med at tage valproat og øjeblikkeligt bestille en konsultation hos din læge, hvis du er gravid eller har mistanke om, at du er gravid.