FrancophonIA/ELRC3.0 huggingface dataset:
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
Danish: Anvendelsen af en depotformulering kan være at foretrække frem for andre formuleringer for at undgå høje peak plasmakoncentrationer (se pkt.
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: Fødselsdefekter, der er rapporteret, omfatter spina bifida (hvor knoglerne i rygsøjlen ikke er korrekt udviklet); ansigts- og kraniemisdannelser; misdannelser af hjerte, nyre, urinveje og kønsorganer; defekte lemmer (arme og ben).
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.
Danish: Disse patienter skal have udførlig information om graviditetsforebyggelse og bør henvises til præventionsrådgivning, hvis de ikke anvender effektiv prævention.
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: • Inden dette lægemiddel bliver ordineret til dig, vil din læge have forklaret, hvad der kan ske med dit barn, hvis du bliver gravid, mens du tager valproat.
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 større risiko end andre kvinder for at få et barn med fosterskader, der kræver medicinsk behandling.
English: Pregnancy, breast feeding and fertility [This section should be amended to include the below wording]
Danish: Graviditet, amning og frugtbarhed [Dette afsnit skal ændres til at omfatte nedenstående ordlyd]
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:
Danish: Indehaverne af markedsføringstilladelsen for alle lægemidler, der indeholder valproat og relaterede substanser, som er registreret i EU, skal ændre produktinformationen (indsætning, erstatning eller sletning af tekst, alt efter hvad der er relevant) for at afspejle ordlyden som angivet nedenfor, og sammenholdt med de videnskabelige konklusioner:
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.
Danish: Hvis valproat er den eneste egnede behandling, bør behovet for at anvende effektiv prævention og alle andre forhold i forbindelse med præventionsprogrammet diskuteres.
English: • Tell your doctor if you want to have a baby.
Danish: • Fortæl det til din læge, hvis du ønsker at få et barn.
English: Every effort should be made by the specialist to switch the female children to alternative treatment before they reach adulthood.
Danish: Specialisten bør gøre alt for at pigerne skiftes til anden behandling, inden de når voksenalderen.
English: Pregnancy must be excluded before start of treatment with valproate.
Danish: Graviditet skal udelukkes før behandling med valproat påbegyndes.
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.
Danish: Under graviditet kan toniske kloniske anfald og status epilepticus med hypoksi hos moderen indebære en særlig risiko for dødsfald hos moderen og det ufødte barn.
English: What you need to know before you take <invented name>
Danish: Det skal du vide, før du begynder at tage <Særnavn>
English: Valproate should not be used in female children and women of childbearing potential unless other treatments are ineffective or not tolerated.
Danish: Valproat bør ikke anvendes til piger og fertile kvinder, medmindre andre behandlinger er ineffektive eller ikke tolereres.
English: Specialized prenatal monitoring should take place to detect the possible occurrence of neural tube defects or other malformations.
Danish: Specialiseret prænatal overvågning bør finde sted for at detektere mulige forekomster af neuralrørsdefekter eller andre misdannelser.
English: Valproate should preferably be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation.
Danish: Valproat bør fortrinsvis ordineres som monoterapi og ved den laveste effektive dosis, om muligt som en depotformulering.
English: • the patients are advised not to stop valproate medication and to immediately contact a specialist in case of planned or suspected pregnancy.
Danish: • patienterne rådes til ikke at stoppe valproatbehandling og til straks at kontakte en specialist i tilfælde af planlagt eller formodet graviditet.
English: Do not take <invented name> [This section should be amended to include the below wording]
Danish: Tag ikke <Særnavn> [Dette afsnit skal ændres til at omfatte nedenstående ordlyd]
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: • Autismespektrumforstyrrelser er oftere diagnosticeret hos børn udsat for valproat, og der er nogle tegn på, at børn kan være mere tilbøjelige til at udvikle symptomer på ADHD (Attention Deficit Hyperactivity Disorder).
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.
Danish: • Individuelle omstændigheder skal evalueres i hvert tilfælde, og patienten skal involveres i diskussionen for at sikre hendes engagement, diskutere terapeutiske muligheder og sikre hendes forståelse af risiciene og de nødvendige foranstaltninger for at minimere risiciene.
English: • Pregnancy must be excluded before start of treatment with <Invented name> with the result of a pregnancy test, confirmed by your doctor.
Danish: • Graviditet skal udelukkes inden behandlingsstart med <Særnavn> med resultatet af en graviditetstest, som er bekræftet af din læge
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.
Danish: Hvis skift ikke er muligt, skal kvinden modtage yderligere rådgivning vedrørende valproats risici for det ufødte barn for at støtte hendes informerede beslutning vedrørende familieplanlægning.
English: A patient guide and patient card should be provided to all women of childbearing potential using valproate.
Danish: En patientvejledning og et patientkort bør gives til alle fertile kvinder, som anvender valproat.
English: Talk to your doctor or family planning clinic if you need advice on contraception.
Danish: Tal med din læge eller familieplanlægningsklinik, hvis du har brug for råd om prævention.
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.
Danish: Din læge vil gennemgå den årlige kvittering for information om risiko med dig, og vil bede dig om at underskrive den og beholde den. Du vil også modtage et patientkort fra apoteket for at minde dig om risici ved valproat under graviditet.
English: Bipolar disorder <and> <migraine>
Danish: Bipolar lidelse <og> <migræne>
English: Annual treatment reviews by a specialist The specialist should at least annually review whether valproate is the most suitable treatment for the patient.
Danish: Årlig gennemgang af behandling hos en specialist Specialisten skal mindst en gang om året evaluere, om valproat er den bedst egnede behandling af patienten.
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.
Danish: Din specialist kan beslutte at ændre dosis af <Særnavn> eller skifte dig til en anden medicin, eller stoppe behandlingen med <Særnavn>, længe før du bliver gravid - dette er for at sikre, at din sygdom er stabil.
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.
Danish: Behandling med valproat må ikke påbegyndes hos fertile kvinder uden negativt resultat af en graviditetstest (plasma graviditetstest), bekræftet af en sundhedsperson, for at udelukke utilsigtet anvendelse under graviditet.
English: You and your partner could receive counselling and support regarding the valproate exposed pregnancy.
Danish: Du og din partner kan få vejledning og støtte vedrørende graviditeten, som er udsat for valproat.
English: Your doctor will give you information on preventing pregnancy, and may refer you to a specialist for advice on birth control.
Danish: Din læge vil informere dig om forebyggelse af graviditet og kan henvise dig til en specialist i rådgivning om prævention.
English: In case of pregnancy
Danish: I tilfælde af graviditet
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.
Danish: For at hjælpe sundhedspersonale og patienter med at undgå valproateksponering under graviditet har indehaveren af markedsføringstilladelsen udarbejdet uddannelsesmaterialer for at underbygge advarslerne og vejlede om anvendelse af valproat hos fertile kvinder og om detaljerne i præventionsprogrammet.
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 født af mødre, der har været behandlet med valproat, er i alvorlig fare for fosterskader og problemer med udviklingen, der kan være alvorligt invaliderende.
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>
Danish: O JEG BEGYNDER BEHANDLING MED <SÆRNAVN> O JEG TAGER <SÆRNAVN> OG PLANLÆGGER IKKE AT FÅ ET BARN O JEG TAGER <SÆRNAVN> OG PLANLÆGGER AT FÅ ET BARN O JEG ER GRAVID OG JEG TAGER <SÆRNAVN>
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.
Danish: Individuelle forhold bør vurderes i hvert enkelt tilfælde, når præventionsmetoden vælges, ved at patienten involveres i diskussionen for at sikre hendes engagement og overholdelse af de valgte foranstaltninger.
English: • the patient understands the need to urgently consult her physician in case of pregnancy.
Danish: • patienten forstår behovet for straks at konsultere sin læge i tilfælde af graviditet.
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.
Danish: • patienten er vejledt med hensyn til prævention og at patienten er i stand til at overholde retningslinjerne for anvendelse af effektiv prævention (for yderligere oplysninger henvises der til underafsnittet om prævention i denne advarselsboks) uden afbrydelse under hele behandlingstiden med valproat.
English: However the available evidence does not suggest it prevents the birth defects or malformations due to valproate exposure.
Danish: Den foreliggende evidens tyder dog ikke på, at det forhindrer fosterskader eller misdannelser som følge af valproateksponering.
English: • Your doctor will try to switch you to another medicine, or stop treatment with <Invented name> a long time before you become pregnant.
Danish: • Din læge vil forsøge at skifte dig til en anden medicin, eller stoppe behandlingen med <Særnavn> længe før du bliver gravid.
English: Section 4.2 Posology and method of administration
Danish: Punkt 4.2 Dosering og administration
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.
Danish: • Du må ikke stoppe med at bruge din svangerskabsforebyggelse (prævention), før du har talt med din læge, og I sammen har lagt en plan for at sikre, at dit helbred og din graviditet er overvåget, og risikoen for dit barn er begrænset.
English: If you are planning to have a baby, first schedule an appointment with your doctor.
Danish: Hvis du planlægger at få et barn, skal du først have en konsultation hos din læge.
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.
Danish: • patienten forstår behovet for at konsultere sin læge, så snart hun planlægger graviditet for at sikre rettidig diskussion og skift til andre behandlingsmuligheder forud for befrugtning, og inden prævention afbrydes.
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.
Danish: Hvis du senere beslutter dig for, at du vil have et barn, må du ikke stoppe med at tage din medicin eller afbryde din prævention, før du har diskuteret det med din læge.
English: • the patient has acknowledged that she has understood the hazards and necessary precautions associated with valproate use (Annual Risk Acknowledgement Form).
Danish: • patienten har kvitteret for, at hun har forstået de risici og nødvendige forholdsregler, der er forbundet med brug af valproat (årlig kvittering for information om risiko).
English: Valproate is contraindicated as treatment for epilepsy during pregnancy unless there is no suitable alternative to treat epilepsy.
Danish: Valproat er kontraindiceret som behandling af epilepsi under graviditet, medmindre der ikke findes et egnet alternativ til behandling af epilepsi.
English: Folate supplementation before the pregnancy may decrease the risk of neural tube defects which may occur in all pregnancies.
Danish: Folattilskud før graviditeten kan reducere risikoen for neuralrørsdefekter, som kan opstå under alle graviditeter.
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.
Danish: • patienten har forstået og anerkendt risikoen for medfødte misdannelser og neurologiske udviklingsforstyrrelser, herunder omfanget af disse risici, for børn udsat for valproat in utero.
English: • Make sure you are referred to a specialist for prenatal monitoring in order to detect possible occurrences of malformations.
Danish: • Sørg for, at du bliver henvist til en specialist i prænatal (foster) overvågning for at opdage mulige forekomster af misdannelser.
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:
Danish: Hvis en gravid kvinde på trods af de kendte risici ved anvendelse af valproat under graviditet og efter nøje overvejelse af anden behandling, under særlige omstændigheder skal have valproat mod epilepsi, anbefales det at:
English: • First schedule an appointment with your doctor.
Danish: • Få først en konsultation med din læge.
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).
Danish: Præventionsprogram Valproat har et højt teratogent potentiale, og børn udsat for valproat in utero har stor risiko for medfødte misdannelser og neurologiske udviklingsforstyrrelser (se pkt.
English: • For epilepsy, you must not use <Invented name> if you are pregnant, unless nothing else works for you.
Danish: • Ved epilepsi må du ikke tage <Særnavn> hvis du er gravid, medmindre intet andet virker for dig.
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.
Danish: • Hvis du er forælder til eller plejer af en pige, der bliver behandlet med valproat, skal du kontakte lægen, når dit barn, der bruger valproat, får sin første menstruation.
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.
Danish: • De ordinerende læger skal sikre, at forældre/plejere af piger forstår nødvendigheden af at kontakte en specialist ved menarche hos pigen, der bruger valproat.
English: Pregnancy test
Danish: Graviditetstest
English: • the patient understands the need to undergo pregnancy testing prior to initiation of treatment and during treatment, as needed.
Danish: • patienten forstår behovet for at gennemføre graviditetstestning før behandlingsstart og under behandling efter behov.
English: • Do not stop taking <Invented name> unless your doctor tells you to.
Danish: • Du må ikke stoppe med at tage <Særnavn>, medmindre din læge siger det.
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.
Danish: Specialisten skal gennemgå den årlige kvittering for information om risiko ved behandlingsstart og i løbet af hver årlig evaluering og sikre, at patienten har forstået indholdet af den.
English: Women of childbearing potential who are prescribed valproate must use effective contraception, without interruption during the entire duration of treatment with valproate.
Danish: Fertile kvinder, der har fået ordineret valproat, skal anvende effektiv prævention uden afbrydelse gennem hele behandlingen med valproat.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Danish: <De> <Du> eller <Deres> <dine> pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V*.
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>.
Danish: JEG TAGER <SÆRNAVN> OG PLANLÆGGER IKKE AT FÅ ET BARN Hvis du fortsætter behandlingen med <Særnavn>, men ikke har planer om at få et barn, skal du sørge for at bruge en effektiv præventionsmetode uden afbrydelse under hele din behandling med <Særnavn>.
English: Ask your doctor about taking folic acid when planning to have a baby.
Danish: Spørg din læge til råds om at tage folsyre, når du planlægger at få et barn.
English: [This section should be amended to include the below wording in all indications]
Danish: [Dette afsnit skal ændres til at indeholde nedenstående formulering for alle indikationer]
English: Valproate as treatment for bipolar disorder <and prophylaxis of migraine attacks> is contraindicated for use during pregnancy.
Danish: Valproat som behandling af bipolar lidelse <og profylakse af migræneanfald> er kontraindiceret til anvendelse under graviditet.
English: • For bipolar disorder <and> <migraine>, you must not use <Invented name> if you are pregnant.
Danish: • Ved bipolar lidelse <og> <migræne> må du ikke tage <Særnavn>, hvis du er gravid.
English: Every effort should be made to switch to appropriate alternative treatment prior to conception, and before contraception is discontinued (see section 4.6).
Danish: Alle bestræbelser skal gøres for at skifte til anden passende behandling før befrugtning, og inden præventionen afbrydes (se pkt.
English: • You must discuss the appropriate methods of birth control (contraception) with your doctor.
Danish: • Du skal diskutere passende metoder til svangerskabsforebyggelse (prævention) med din læge.
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.
Danish: En årlig kvittering for information om risiko skal anvendes ved behandlingsstart og under hver årlig evaluering af valproatbehandling hos specialisten.
English: Valproate is contraindicated as treatment for bipolar disorder <and migraine> during pregnancy.
Danish: Valproat er kontraindiceret som behandling af bipolar lidelse <og migræne> under graviditet.
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.
Danish: Alle patienter med valproateksponeret graviditet og deres partnere skal henvises til en specialist inden for <teratologi> {skal tilpasses afhængigt af sundhedssystemet} til evaluering og rådgivning vedrørende den eksponerede graviditet.
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.
Danish: • Den ordinerende læge skal sikre, at pigers forældre/plejere ved pigens menarche får udførlig information om risikoen for medfødte misdannelser og neurologiske udviklingsforstyrrelser, herunder omfanget af disse risici, for børn udsat for valproat in utero.
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.
Danish: Ved indikation(erne) <bipolar lidelse> <og> < migræne>, hvis en kvinde planlægger at blive gravid, skal en specialist, der har erfaring med behandling af <bipolar lidelse> <migræne> konsulteres, og behandlingen med valproat skal seponeres og om nødvendigt skiftes til en anden behandling før befrugtning, og inden prævention afbrydes.
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.
Danish: Under dette besøg vil din læge sørge for, at du er klar over og har forstået alle de risici og vejledninger, der er forbundet med anvendelse af valproat under graviditeten.
English: However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
Danish: Det er dog usandsynligt, at det vil mindske risikoen for fosterskader, som er forbundet med brug af valproat.
English: [This section should be amended to include the following wording]
Danish: [Dette punkt skal ændres, så det indeholder følgende ordlyd]