FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients treated with any antipsychotic medicines, including olanzapine, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines e.g. at baseline, 12 weeks after starting olanzapine treatment and every 5 years thereafter.
Danish: Patienter, der behandles med antipsykotika herunder olanzapin, bør have kontrolleret lipider regelmæssigt i henhold til de anvendte antipsykotiske vejledninger f.eks. ved baseline, 12 uger efter start på olanzapinbehandling, og derefter hvert 5. år.
English: NAME OF THE MEDICINAL PRODUCT Olazax 7.5 mg tablets
Danish: LÆGEMIDLETS NAVN Olazax 7,5 mg tabletter
English: Store below 30°C
Danish: Opbevares ved temperaturer under 30º C
English: 6.4 Special precautions for storage Store below 30ºC
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved temperatuturer under 30ºC.
English: Consult your doctor if your symptoms return but do not stop taking Olazax unless your doctor tells you to.
Danish: Din læge vil fortælle dig, hvor mange Olazax tabletter, du skal tage og i hvor lang tid, du skal tage dem. Dagsdosis for Olazax er mellem 5 mg og -20 mg. Konsulter din læge, hvis dine symptomer vender tilbage, men stop ikke med at tage Olazax medmindre din læge siger det.
English: Dose escalation, when indicated, should be conservative in such patients (See sections 4.5 and 5.2.
Danish: Optrapning af dosis, når indiceret, bør hos sådanne patienter foretages med forsigtighed.
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely (≥ 0.01% and < 0.1%) when olanzapine is stopped abruptly.
Danish: Akutte symptomer såsom perspiration, søvnløshed, rysten, angst, kvalme eller opkastning er rapporteret sjældent (≥ 0,01 % og < 0,1 %) når olanzapin stoppes pludseligt.
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely ( ≥0.01% and < 0.1%) when olanzapine is stopped abruptly.
Danish: Akutte symptomer såsom perspiration, søvnløshed, rysten, angst, kvalme eller opkastning er rapporteret sjældent ((≥ 0,01 % og < 0,1 %) når olanzapin stoppes pludseligt.
English: What Olazax is and what it is used for What you need to know before you take Olazax How to take Olazax
Danish: Det skal du vide, før du begynder at tage Olazax Sådan skal du tage Olazax Bivirkninger
English: The frequency terms listed are defined as follows: Very common (≥1/10), common (≥1/100 to
Danish: Hyppighederne er defineret som følgende: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10).
English: Olazax 7.5 mg: yellow coloured circular flat bevelled edge tablets with ‘C' debossed on one side.
Danish: Olazax 7,5 mg leveres som gule, cirkulære tabletter med flad afrundet kant med 'C' præget på den ene side.
English: Ventricular tachycardia/fibrill ation, sudden death (see section
Danish: Ventrikulær takykardi/ven trikelflimren, pludselig død (se pkt.
English: Urinary incontinence, urinary retention
Danish: Urininkontinens Urinretention Vandladningsbesvæ r11
English: With long-term exposure (at least 24 weeks), 89.4 % gained ≥ 7 %, 55.3 % gained ≥ 15 % and 29.1 % gained ≥ 25% of their baseline body weight.
Danish: Ved langvarig eksponering (mindst 24 uger),tog 89,4% ≥7% på i vægt, 55,3% tog 15% på i vægt og 29,1% tog ≥25% af deres baseline kropsvægt på.
English: Thromboembo lism (including pulmonary embolism and deep vein thrombosis) (see section
Danish: Tromboemboli (inklusive lungeemboli og dyb venetrombose)
English: In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1 % to 1 %) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
Danish: QTc-forlængelse blev defineret som Fridericia korrigeret QT (QTcF) ≥500 millisekunder (msek) på et hvilket som helst tidspunkt post-baseline hos patienter med baseline QTcF<500 msek.
English: Olazax 5mg is supplied as a yellow coloured circular flat beveled edge tablet with ‘B' debossed on one side.
Danish: Olazax 5 mg leveres som gule, cirkulære tabletter med flad afrundet kant med 'B' præget på den ene side.
English: (≥ 5.17- < 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.
Danish: (≥ 6,2 mmol/l).
English: The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Danish: VoksneDe hyppigst rapporterede (set hos ≥ 1 % af patienter) bivirkninger, som blev set i forbindelse med anvendelse af olanzapin i kliniske forsøg, var døsighed, vægtøgning, eosinofili, forhøjede niveauer af prolaktin, kolesterol, glucose og triglycerider (Se pkt.
English: NAME OF THE MEDICINAL PRODUCT Olazax 20 mg tablets
Danish: LÆGEMIDLETS NAVN Olazax 20 mg tabletter
English: What Olazax contains - The active substance is olanzapine - Each tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine - The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951),
Danish: • Øvrige indholdstoffer er mannitol (E 421), mikrokrystallinsk cellulose, aspartame (E 951),
English: Hepatitis (including hepatocellular, cholestatic or mixed liver injury)11
Danish: Hepatitis (inklusive hepatocell ulær kolestatis k eller blandet leverskad e) 11
English: The frequency terms listed are defined as follows: Very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000), very rare (<1/10,000), not known (cannot be estimated from the data available).
Danish: Hyppighederne er defineret som følgende: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000til <1/100), sjælden (≥1/10.000 til 1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The frequency terms listed are defined as follows: Very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000), very rare (< 01/10,000), not known (cannot be estimated from the data available).
Danish: Hyppighederne er defineret som følgende: Meget almindelig (≥ 1/10), almindelig (≥1/100til <1/10), ikke almindelig (≥1/1.000til <1/100), sjælden (≥1/10.000til 1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism all possible risk factors of VTE e.g. immobilisation of patients, should be identified and preventive measures undertaken.
Danish: På trods af dette bør alle mulige risikofaktorer for venøse tromboembolier identificeres, f.eks. immobilisation, og forebyggende foranstaltninger, f.eks. immobilisering af patienter, i værksættes, da patienter, som lider af skizofreni, ofte har sygdomsbetingede risikofaktorer for venøse tromboembolier.
English: Excipient with known effect: Each tablet contains 0.23 mg aspartame For the full list of excipients, see section 6.1.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 0,23 mg aspartam Alle hjælpestoffer er anført under pkt.6.1
English: Dystonia
Danish: Fertilitet
English: Olazax 20 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘F' debossed on other side.
Danish: Olazax 20 mg leveres som gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og 'F' præget på den anden side.
English: Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l)
Danish: Ændring i fastende glucoseniveau fra let forhøjet niveau ved baseline (≥ 5,56 - < 7 mmol/l) til højt niveau (≥ 7 mmol/l) var meget almindeligt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/09/597/001
English: Changes in total fasting cholesterol levels from borderline at baseline
Danish: Størrelsen af ændringer i faste totalkolesterol, LDL-kolesterol,
English: Yellow coloured circular flat bevelled edge tablets with ‘C' debossed on one side.
Danish: Tablet Gule, cirkulære tabletter med flad afrundet kant med 'C' præget på den ene side.
English: Excipient with known effect: Each tablet contains 0.46 mg aspartame For the full list of excipients, see section 6.1.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 0,46 mg aspartam Alle hjælpestoffer er anført under pkt.6.1
English: In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (- 6.0) versus haloperidol (- 3.1).
Danish: Studiet viste en prospektiv sekundær analyse af ændring i stemningslejeniveauet fra før behandling til endt behandling en statistisk signifikant forbedring(p=0,001) til fordel for patienter behandlet med olanzapin (-6,0) i forhold til patienter behandlet med haloperidol (-3,1).
English: Neuroleptic malignant syndrome (see section
Danish: Malignt neuroleptikas yndrom (se pkt.
English: Olazax 15 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Danish: Olazax 15 mg leveres som gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og 'E' præget på den anden side.
English: Ventricular tachycardia/fibrillat ion, sudden death
Danish: Ventrikulær takykardi/ventr ikel-flimren, pludselig død (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/09/597/005
English: MARKETING AUTHORISATION HOLDER Glenmark Pharmaceuticals s.r.o.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Glenmark Pharmaceuticals s.r.o.
English: Excipient with known effect: Each tablet contains 0.69 mg aspartame For the full list of excipients, see section 6.1.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 0,69 mg aspartam Alle hjælpestoffer er anført under pkt.6.1
English: NAME OF THE MEDICINAL PRODUCT Olazax 5 mg tablets
Danish: LÆGEMIDLETS NAVN Olazax 5 mg tabletter
English: BN
Danish: B.
English: NAME OF THE MEDICINAL PRODUCT Olazax 15 mg tablets
Danish: LÆGEMIDLETS NAVN Olazax 15 mg tabletter
English: NAME OF THE MEDICINAL PRODUCT Olazax 10 mg tablets
Danish: LÆGEMIDLETS NAVN Olazax 10 mg tabletter
English: If this happens after you have been given Olazax, tell your doctor.
Danish: Tag kun anden medicin sammen med Olazax, hvis din læge siger, at du må.
English: Yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Danish: Gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og ”E” præget på den anden side.
English: Olazax 10 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘D' debossed on other side.
Danish: Olazax 10 mg leveres som gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og 'D' præget på den anden side.
English: If you take more Olazax than you should
Danish: Hvis du har taget for meget Olazax
English: milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1 % to 1 %) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
Danish: I de klini ske forsøg var klinisk betydningsfulde QTc-forlængelser usædvanlige (0,1 % til 1 %) hos de patienter, som blev behandlet med olanzapin.
English: - Keep this leaflet.
Danish: (Se pkt.
English: Urinary hesitation11
Danish: Rabdomyol yse11
English: Excipient with known effect: Each tablet contains 0.35 mg aspartame For the full list of excipients, see section 6.1.
Danish: Hver tablet indeholder 0,35 mg aspartam Alle hjælpestoffer er anført under pkt.6.1
English: Eosinophil ia and Systemic Symptoms (DRESS)
Danish: Lægemiddelfr emkaldt reaktion med eosinofili og systemiske symptomer (DRESS)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg olanzapine.
Danish: NGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg olanzapin
English: Renal and/or hepatic impairment
Danish: Demensrelaterede psykoser og/eller adfærdsforstyrrelser
English: See section 4.
Danish: som ikke er nævnt her.Se punkt 4.
English: Yellow coloured circular flat bevelled edge with ‘OL' debossed on one side and ‘F' debossed on other side.
Danish: Gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og ”F” præget på den anden side.
English: < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Danish: (≥ 2,26 mmol/l).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/597/003
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines e.g. measuring of blood glucose at baseline, 12 weeks after starting olanzapine treatment and annually thereafter Patients treated with any antipsychotic medicines, including olanzapine, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Danish: Patienter i behandling med antipsykotika herunder olanzapin bør observeres for tegn og symptomer på hyperglykæmi (som polydipsi, polyuri, polyfagi og svaghed).
English: 15Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
Danish: 15 Ændringer i de totale kolesterolniveauer ved faste fra normale ved baseline (< 4,39 mmol/l) op til
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg olanzapine Excipient with known effect: Each tablet contains 0.92 mg aspartame For the full list of excipients, see section 6.1.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 0, 92 mg aspartam Alle hjælpestoffer er anført under pkt.6.1
English: 13 Following short term treatment (median duration 22 days), weight gain ≥ 7 % of baseline body weight (kg) was very common (40.6 %), ≥ 15% of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
Danish: 13 Efter kortvarig behandling (gennemsnitlig varighed 22 dage), var øget vægt ≥ 7% af baseline legemsvægt (kg) meget almindelig (40,6%), ≥ 15% af baseline legemsvægt var almindelig (7,1%) og ≥25% var almindelig (2,5%).
English: 6.5 Nature and contents of container Aluminium/aluminium blisters in cartons of 28, 56 tablets per carton Not all pack sizes may be marketed 6.6 Special precautions for disposal No special requirements
Danish: 6.4 Særlige opbevaringsforhold Opbevares ved temperaturer under 30º C 6.5 Emballagetype og pakningsstørrelser Aluminium/aluminium blisterkort i kartoner á 28, 56 tabletter pr. karton.
English: 13Following short term treatment (median duration 22 days), weight gain ≥ 7% of baseline body weight (kg) was very common (40.6 %), ≥ 15 % of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
Danish: 913 Efter kortvarig behandling (gennemsnitlig varighed 22 dage), var øget vægt ≥ 7 % af baseline legemsvægt (kg) var meget almindelig (40,6 %), ≥ 15 % af baseline legemsvægt var almindelig (7,1 %) og ≥25 % var almindelig (2,5%).
English: Thrombocytopenia1
Danish: Trombocyt openi11
English: Your doctor will urgently review your treatment.
Danish: Lægen vil straks gennemgå din behandling.
English: • For migraine prevention (in countries where this use is authorised)
Danish: • Til forebyggelse af migræne (i lande, hvor denne anvendelse er godkendt):
English: Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland.
Danish: Lægemidler indeholdende valproat er godkendt via nationale procedurer i alle EU's medlemsstater samt i Norge og Island.
English: * The Coordination Group for Mutual Recognition and Decentralised Procedures - Human
Danish: * Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker
English: Speak to your doctor if you have any questions about which contraceptive method is appropriate for you.
Danish: Tal med lægen, hvis du har spørgsmål om, hvilken præventionsmetode der er egnet for dig.
English: Healthcare professionals in the EU will be sent a dear healthcare professional letter plus additional educational material concerning these recommendations.
Danish: Sundhedspersoner i EU vil få tilsendt et direkte brev samt supplerende oplysningsmateriale om disse anbefalinger.
English: These recommendations follow a review of recent studies showing developmental problems in up to 30 to 40% of pre-school children exposed to valproate in the womb, including delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability.1,2,3,4,5
Danish: Disse anbefalinger følger efter en gennemgang af nyere undersøgelser, som viser udviklingsproblemer hos op mod 30-40 % af førskolebørn, der har været udsat for valproat i fostertilværelsen, herunder forsinket udvikling af gang og tale, hukommelsesbesvær, vanskeligheder ved tale og sprog samt nedsatte intellektuelle evner.1,2,3,4,5
English: • If you can become pregnant, you should use an effective method of contraception.
Danish: • Hvis du kan blive gravid, skal du bruge effektiv prævention.
English: They are marketed under several brand names including: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil and Valhel.
Danish: De markedsføres under en række handelsnavne, herunder Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil og Valhel.
English: In some EU Member States they are also authorised to prevent migraine headaches.
Danish: I visse EUmedlemsstater er de desuden godkendt til forebyggelse af migræne.
English: The recommendations on the use of valproate in women and girls will be implemented by EU Member States according to an agreed timetable.
Danish: Anbefalingerne om anvendelse af valproat hos kvinder og piger skal gennemføres af EUmedlemsstaterne i henhold til en vedtagen tidsplan.
English: As valproate medicines in the EU are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) for a position.
Danish: Da lægemidler indeholdende valproat alle er godkendt nationalt, blev PRAC's anbefalinger overgivet til koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh) med henblik på, at den skulle fremsætte en udtalelse.
English: The review of valproate medicines started in October 2013 at the request of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Article 31 of Directive 2001/83/EC, following the publication of new data on the risks of malformations and developmental problems in babies exposed to valproate in the womb.
Danish: Gennemgangen af lægemidler indeholdende valproat blev indledt i oktober 2013 på anmodning af Det Forenede Kongeriges lægemiddelstyrelse (Medicines and Healthcare products Regulatory Agency (MHRA)) i medfør af artikel 31 i direktiv 2001/83/EF, efter at der var blevet offentliggjort nye data om udviklingsproblemer hos spædbørn, der var blevet udsat for valproat i fostertilværelsen.
English: • For treatment of epilepsy and bipolar disorder in female patients who can have children
Danish: • Vedrørende behandling af epilepsi og bipolær sygdom hos kvindelige patienter, som kan få børn:
English: • Tell your doctor at once if you become pregnant, think you might be pregnant or are planning to become pregnant.
Danish: • Sig det straks til lægen, hvis du bliver gravid, har mistanke om, at du kan være gravid, eller ønsker at blive gravid.
English: In addition, children exposed to valproate in the womb are at an approximately 11% risk of malformations at birth (such as neural tube defects and cleft palate)9 compared with a 2 to 3% risk for children in the general population.
Danish: Børn, der har været udsat for valproat i fostertilværelsen, har derudover ca. 11 % risiko for misdannelser ved fødslen (såsom neuralrørsdefekt og ganespalte)9, sammenholdt med en risiko på 2-3 % for børn i den almindelige befolkning.
English: • Valproate medicines can cause malformations and problems with early development of children if they are exposed to these medicines in the womb.
Danish: • Lægemidler indeholdende valproat kan medføre misdannelser og problemer med børns tidlige udvikling, hvis de udsættes for disse lægemidler i fostertilværelsen.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards across the EU for medicines authorised via national procedures.
Danish: CMDh repræsenterer EU's medlemsstater og har ansvaret for harmonisering af sikkerhedsnormerne i EU for lægemidler, der godkendes ved nationale procedurer.
English: The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA's Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Gennemgangen blev først foretaget af Udvalget For Risikovurdering inden for Lægemiddelovervågning (PRAC), som er EMA's udvalg med ansvar for vurdering af sikkerhedsspørgsmål vedrørende humanmedicinske lægemidler, og som fremsatte et sæt anbefalinger.
English: Previous data have shown that children exposed to valproate in the womb are also at increased risk of autistic spectrum disorder (around 3 times higher than in the general population) and childhood autism (5 times higher than in the general population).
Danish: Det er tidligere blevet påvist, at børn, der er blevet udsat for valproat i fostertilværelsen, også har øget risiko for forstyrrelser i det autistiske spektrum (ca. 3 gange højere end hos den almindelige befolkning) og autisme i barndommen (5 gange højere end hos den almindelige befolkning).
English: The warnings aim to ensure that patients are aware of the risks and that they take valproate only when clearly necessary.
Danish: Advarslerne skal sikre, at patienterne kender risiciene og kun tager valproat, når det er klart nødvendigt.
English: Information to healthcare professionals Following an evaluation of the data on the risks of valproate use during pregnancy, the recommendations for the use of valproate in women and girls have been updated:
Danish: Information til sundhedspersoner Efter en vurdering af data vedrørende risiciene ved anvendelse af valproat under graviditet er anbefalingerne for anvendelse af valproat hos kvinder og piger ført ajour:
English: Valproate medicines are used to treat epilepsy and bipolar disorder.
Danish: Lægemidler indeholdende valproat bruges til behandling af epilepsi og bipolær sygdom.