FrancophonIA/ELRC3.0 huggingface dataset:
English: The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Dafiro HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Danish: Den gennemsnitlige reduktion af blodtrykket var ca. 39,7/24,7 mmHg hos patienter, der fik Dafiro HCT, sammenlignet med 32/19,7 mmHg, 33,5/21,5 mmHg og 31,5/19,5 mmHg hos patienter, der henholdsvis fik kombinationerne valsartan/hydrochlorthiazid, valsartan/amlodipin og hydrochlorthiazid/amlodipin.
English: Dafiro HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Danish: Dafiro HCT anvendes til behandling af essentiel hypertension (forhøjet blodtryk) hos voksne, hvis blodtryk allerede er tilstrækkeligt kontrolleret med en kombination af amlopidin, valsartan og hydrochlorthiazid.
English: Treatment with the highest strength of Dafiro HCT was more effective at treating hypertension than dual combinations containing any of the two active substances.
Danish: Behandling med den højeste styrke af Dafiro HCT var mere effektiv til at behandle hypertension end tokombinationsbehandlinger, der hver indeholdt to aktive stoffer.
English: Dafiro HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Danish: Dafiro HCT er et lægemiddel, der indeholder de tre aktive stoffer amlodipin, valsartan og hydrochlorthiazid.
English: The CHMP therefore decided that Dafiro HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Dafiro HCT opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Dafiro HCT.
English: The most common side effects with Dafiro HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Danish: De hyppigste bivirkninger ved Dafiro HCT (som optræder hos mellem 1 og 10 patienter ud af 100) er hypokaliæmi (lavt kaliumindhold i blodet)), svimmelhed, hovedpine, hypotension (for lavt blodtryk), dyspepsi (halsbrand), pollakisuri (hyppig vandladning), træthed og ødem (væskeansamling).
English: Dafiro HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Dafiro HCT.
Danish: Dafiro HCT må ikke anvendes af personer, der er overfølsomme (allergiske) over for de aktive stoffer, andre sulfonamider, dihydropyridinderivater eller andre af indholdsstofferne i Dafiro HCT.
English: In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Dafiro HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Danish: Derudover blev der gennemført en hovedundersøgelse af 2 271 patienter med moderat til svær hypertension, som blev behandlet med den højeste styrke af Dafiro HCT (320 mg valsartan, 10 mg amlodipin og 25 mg hydrochlorthiazid).
English: For all doses, Dafiro HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately.
Danish: Dafiro HCT opfyldte endvidere i samtlige doser kravet om at dokumentere, at lægemidlet var sammenligneligt med kombinationerne af de individuelt aktive stoffer indtaget separat.
English: The daily dose of Dafiro HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Danish: Den daglige dosis af Dafiro HCT må ikke overskride 10 mg amlodipin, 320 mg valsartan og 25 mg hydrochlorthiazid.
English: Finally, Dafiro HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Danish: Endelig må Dafiro HCT ikke anvendes hos patienter med hypokaliæmi (lavt kaliumindhold i blodet), hyponatriæmi (lavt saltindhold i blodet) og hypercalcæmi (forhøjet calciumniveau i blodet), som ikke reagerer på behandling, og hos patienter med hyperurikæmi (forhøjet urinsyre i blodet), der udløser symptomer.
English: Other information about Dafiro HCT
Danish: Andre oplysninger om Dafiro HCT
English: For the full list of all side effects reported with Dafiro HCT, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Dafiro HCT fremgår af indlægssedlen.
English: What is the risk associated with Dafiro HCT?
Danish: Hvilken risiko er der forbundet med Dafiro HCT?
English: Dafiro HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Danish: Dafiro HCT i kombination med lægemidler, der indeholder aliskiren (som anvendes til behandling af essentiel hypertension), må ikke anvendes til patienter med diabetes eller moderat eller alvorlig nyresygdom.
English: Why has Dafiro HCT been approved?
Danish: Hvorfor blev Dafiro HCT godkendt?
English: What is Dafiro HCT?
Danish: Hvad er Dafiro HCT?
English: How has Dafiro HCT been studied?
Danish: Hvordan blev Dafiro HCT undersøgt?
English: What is Dafiro HCT used for?
Danish: Hvad anvendes Dafiro HCT til?
English: What benefit has Dafiro HCT shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Dafiro HCT?
English: How is Dafiro HCT used?
Danish: Hvordan anvendes Dafiro HCT?
English: How does Dafiro HCT work?
Danish: Hvordan virker Dafiro HCT?
English: ANNEX
Danish: Bilag
English: The educational pack should contain the following:
Danish: Uddannelsespakken bør indeholde følgende:
English: • Educational material for Healthcare Professionals
Danish: • Uddannelsesmateriale for sundhedspersonale
English: Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Danish: Før lægemidlet lanceres i de enkelte medlemslande, skal indehaveren af markedsføringstilladelsen blive enig med den relevante nationale myndighed om format og indhold af uddannelsesmaterialet.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemsstaterne bør sikre at alle betingelser eller begrænsninger med hensyn til sikker og effektiv brug af nedenfor beskrevne lægemiddel, er implementeret:
English: The educational material for Healthcare Professionals should contain the following key elements:
Danish: Uddannelsesmaterialet for sundhedspersonale bør indeholde følgende centrale punkter:
English: • Patient Alert Cards (text as agreed by the CHMP)
Danish: • Patientinformationskort (teksten skal godkendes af CHMP)
English: • That vandetanib may cause Posterior reversible encephalopathy syndrome (PRES) also known as Reversible posterior leukoencephalopathy syndrome (RPLS)
Danish: • Oplysning om, at vandetanib kan føre til posteriort reversibelt encefalopatisk syndrom (PRES) - også kendt som reversibelt posteriort leukoencefalopatisk syndrom (RPLS)
English: • The need for an ECG, and serum levels of potassium, calcium and magnesium and thyroid stimulating hormone (TSH) and the times and situations when it should be performed
Danish: • Behovet for at tage EKG og kontrollere serumværdier af kalium, calcium og magnesium samt thyroid-stimulerende hormon (TSH), og de tider og situationer, hvor det bør udføres
English: • Details of medicinal products where the co-administration of vandetanib is either contraindicated or not recommended.
Danish: • Nærmere angivelse af lægemidler, for hvilke samtidig administration af vandetanib enten er kontraindiceret eller ikke kan anbefales.
English: • Vandetanib prolongs the QTc interval and can cause Torsades de Pointes and sudden death
Danish: • Vandetanib forlænger QTc-intervallet og kan føre til torsades de pointes og pludselig død
English: Dosing can be resumed at a reduced dose after return of the ECG QTc interval to pretreatment status has been confirmed and correction of possible electrolyte imbalance has been made.
Danish: Behandlingen kan genoptages med reduceret dosis efter EKG, der bekræfter, at QTc-intervallet er vendt tilbage til niveauet før behandlingen, og afhjælpning af eventuel forstyrrelse på elektrolytbalancen.
English: • The need to counsel patients about the risk of prolonged QTc and PRES and inform them of what symptoms and signs to be aware of and the actions to take
Danish: • Behovet for at rådgive patienter om risikoen for forlænget QTc-interval og PRES og oplyse dem om symptomer, som de bør være opmærksomme på, og hvad de skal gøre i så fald
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch and thereafter, all Healthcare Professionals who are expected to use and/or prescribe Caprelsa are provided with an Educational pack.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alt sundhedspersonale, som forventes at anvende og/eller ordinere Caprelsa, forsynes med uddannelsespakken ved lanceringen og derefter.
English: Conditions or restrictions with regard to the safe and effective use of medicinal product to be implemented by the member states
Danish: Betingelser eller begrænsninger som skal implementeres af medlemsstaterne med hensyn til sikker og effektiv brug af lægemidlet.
English: • Patients who develop a single value of corrected ECG QTc interval of at least 500 msec should stop taking vandetanib.
Danish: • Patienter, der i et enkelt tilfælde får QTc-interval på EKG på mindst 500 ms, som siden korrigeres, bør holde op med at tage vandetanib.
English: • The role and use of the Patient Alert Card
Danish: • Formål med/brug af patientinformationskort.
English: Brain MRI should be performed in any patient presenting with seizures, confusion or altered mental status.
Danish: Der bør udføres en MR-skanning af hjernen hos alle patienter, der lider af krampeanfald, konfusion eller ændret mental status.
English: • If QTc increases markedly but stays below 500 msec, the advice of a cardiologist should be sought.
Danish: • En kardiolog bør konsulteres, hvis QTc stiger markant, men holder sig under 500 ms.
English: • Who have a history of Torsades de Pointes unless all risk factors that contributed to Torsades have been corrected.
Danish: • Vandetanibbehandling må ikke indledes hos patienter: o som har QTc-interval over 480 ms på EKG o som har kongenit langt QTc-syndrom o som har torsades de pointes i anamnesen, med mindre alle risikofaktorer, der bidrog til torsades de pointes, er korrigeret.
English: 28 April 2014 EMA/276477/2014
Danish: Den 28. april 2014 EMA/276477/2014
English: Restrictions on the use of methysergide-containing medicines
Danish: Begrænsninger for anvendelsen af lægemidler indeholdende methysergid
English: The pharmaceutical forms and the approved indications, strengths and doses vary in different EU countries.
Danish: Lægemiddelformerne og de godkendte anvendelser, styrker og doser varierer i de forskellige EU-lande.
English: This examination should include a re-assessment of the benefit-risk balance in the individual patient.
Danish: Denne undersøgelse skal omfatte fornyet vurdering af benefit/riskforholdet for den enkelte patient.
English: In the EU, medicines containing methysergide have been authorised by national procedures and have been marketed under various trade names.
Danish: I EU er lægemidler indeholdende methysergid blevet godkendt ved nationale procedurer og har været markedsført under forskellige handelsnavne.
English: • Following the review of methysergide-containing medicines, methysergide should now only be used for:
Danish: • Efter gennemgangen af lægemidler indeholdende methysergid bør methysergid nu kun anvendes til:
English: The CHMP opinion was sent to the European Commission, which endorsed it and issued a final legally binding decision on 28 April 2014.
Danish: CHMP's udtalelse blev indsendt til Europa-Kommissionen, som godkendte den og vedtog en endelig retligt bindende beslutning den 28. april 2014.
English: The prescribing information for physicians and information in the patients' information leaflet has been updated.
Danish: Produktinformationen til læger og informationen til patienterne i indlægssedlen er blevet opdateret.
English: However, there were no data to support this use and Methysergide should therefore no longer be used in carcinoid disease.
Danish: Der var imidlertid ingen dokumentation til støtte for denne anvendelse, og methysergid bør derfor ikke længere anvendes ved karcinoid sygdom.
English: The Agency's recommendations are based on available data on the benefits and risks of methysergide, from clinical studies, post-marketing safety reports and the scientific literature.
Danish: Agenturets anbefalinger er baseret på de foreliggende data om fordele og risici ved methysergid fra kliniske undersøgelser, sikkerhedsindberetninger efter markedsføring og den videnskabelige litteratur.
English: The review of methysergide was initiated on 24 May 2012 at the request of the French medicines agency ANSM under Article 31 of Directive 2001/83/EC following concerns about serious cases of fibrosis identified by the French agency.
Danish: Gennemgangen af methysergid blev indledt den 24. maj 2012 på anmodning af den franske lægemiddelstyrelse, ANSM, i medfør af artikel 31 i direktiv 2001/83/EF på grund af betænkeligheder med hensyn til alvorlige tilfælde af fibrose, der var konstateret af ANSM.
English: If you are being treated for this purpose, please contact your doctor to discuss alternative treatment.
Danish: Er du i behandling for denne sygdom, bedes du kontakte lægen med henblik på anden behandling.
English: The symptoms of fibrosis often take some time to appear and without screening the diagnosis may come too late to prevent severe (and potentially life-threatening) damage to organs .
Danish: Symptomerne på fibrose er ofte et stykke tid om at vise sig, og hvis man ikke screener patienten for det, kan diagnosen blive stillet for sent til at undgå svære (og potentielt livstruende) organskader.
English: The mechanism by which methysergide could cause fibrosis through serotoninergic-receptor activation is widely described in the literature.
Danish: Den mekanisme, hvorved methysergid tænkes at forårsage fibrose gennem aktivering af serotoninerge receptorer, er bredt beskrevet i litteraturen.
English: The CHMP recommendations were sent to the European Commission, which has endorsed them and issued a final legally-binding decision that is valid throughout the EU.
Danish: CHMP's anbefalinger blev indsendt til Europa-Kommissionen, som har godkendt dem og truffet en endelig retligt bindende afgørelse med gyldighed i hele EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP), which conducted the review, noted that these recommendations were necessary due to the reports of fibrosis seen with methysergide and other medicines of the same class (ergot derivatives).
Danish: Gennemgangen blev foretaget af agenturets Udvalg for Lægemidler til Mennesker (CHMP), som bemærkede, at anbefalingerne er nødvendige på grund af indberetninger om fibrose med methysergid og andre lægemidler af samme klasse (ergotderivater).
English: • If you are using methysergide to prevent migraines and cluster headaches, your doctor will check on a regular basis whether you are developing any signs or symptoms of fibrosis.
Danish: • Er du i behandling med methysergid til forebyggelse af migræne og klyngehovedpine, vil lægen regelmæssigt kontrollere, om du viser tegn eller symptomer på fibrose.
English: Based on these data a potential causal association between methysergide and fibrosis seems likely.
Danish: På grundlag af disse data må det anses for sandsynligt, at der er kausal sammenhæng mellem methysergid og fibrose.
English: • During treatment with methysergide, a treatment-free period of at least 4 weeks must be allowed between treatment courses at least every 6 months.
Danish: • Under behandlingen med methysergid skal der med højst seks måneders mellemrum være en behandlingsfri periode på mindst fire uger mellem hvert behandlingsforløb.
English: Methysergide is a medicine that belongs to the class ‘ergot alkaloids' that has been used in the EU for preventing migraines (with or without aura) and other types of throbbing headaches.
Danish: Methysergid er et lægemiddel i klassen »ergotalkaloider«, der i EU har været anvendt til forebyggelse af migræne (med eller uden forvarsel) og andre former for dunkende hovedpine.
English: Regarding the benefits, the Committee noted that there is some evidence of a clinically relevant effect of methysergide when used for prevention in patients who regularly get migraines and cluster headaches and for whom treatment options are limited.
Danish: Vedrørende fordelene bemærkede udvalget, der er nogen dokumentation for, at methysergid kan have en klinisk betydningsfuld forebyggende virkning hos patienter, der jævnligt får migræne og klyngehovedpine, og hvis behandlingsmuligheder er begrænsede.
English: • Treatment must not begin until after the patient has been examined for any pre-existing fibrotic conditions.
Danish: • Behandlingen må ikke påbegyndes, før patienten er undersøgt for eventuel præeksisterende fibrotisk sygdom.
English: Previous treatment must have included treatment with medicines of at least 2 classes for a minimum of 2 months.
Danish: Den foregående behandling skal have omfattet behandling med lægemidler af mindst to klasser i mindst to måneder.
English: Previous treatment must have included treatment with medicines of other classes for at least 4 months at the maximum tolerated dose;
Danish: Den foregående behandling skal have omfattet behandling med lægemidler af andre klasser i mindst fire måneder ved den maksimale tolererede dosis
English: • Patients should be screened for fibrosis at baseline and at least every 6 months thereafter.
Danish: • Patienterne skal screenes for fibrose ved baseline og derefter med højst seks måneders mellemrum.
English: Screening investigations may include heart ultrasound, abdominal MRI and lung function tests.
Danish: Screeningsundersøgelserne skal bestå i ekkokardiografi, MRI af abdomen og lungefunktionstest.
English: In addition, treatment should only be started and supervised by a specialist doctor with experience in treating migraine and cluster headaches.
Danish: Desuden skal behandlingen indledes og overvåges af en speciallæge med erfaring i behandling af migræne og klyngehovedpine.
English: It was also used to treat diarrhoea caused by carcinoid disease.
Danish: Det anvendes desuden til behandling af diarré forårsaget af karcinoid sygdom.
English: Treatment must be stopped if a patient develops symptoms suggestive of fibrosis unless an alternative cause is confirmed.
Danish: Behandlingen skal seponeres ved symptomer tydende på fibrose, medmindre en alternativ årsag er verificeret.
English: • Your doctor will also regularly re-assess the need for you to continue treatment with methysergide by seeing if your symptoms return after periodic breaks in treatment.
Danish: • Lægen vil desuden regelmæssigt kontrollere, om dine symptomer vender tilbage efter perioder uden behandling.
English: − Prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults, when treatment with standard medicines has failed.
Danish: − profylaktisk behandling af svær intraktabel migræne (med eller uden aura) med funktionel invaliditet hos voksne efter behandlingssvigt af sædvanlige lægemidler.
English: • Methysergide should no longer be used for treating diarrhoea caused by carcinoid disease.
Danish: • Methysergid må ikke længere anvendes til behandling af diarré forårsaget af karcinoid sygdom.
English: • Treatment with methysergide should only be started and supervised by specialised physicians with experience in treating migraine and cluster headaches.
Danish: • Behandlingen med methysergid skal indledes og overvåges af en speciallæge med erfaring i behandling af migræne og klyngehovedpine.
English: Methysergide medicines are now only to be used for preventing severe intractable migraines and cluster headaches (a type of severe, recurring headache on one side of the head, usually around the eye) when standard medicines have failed.
Danish: Lægemidler indeholdende methysergid må nu kun anvendes til forebyggelse af svær migræne, der ikke kan behandles, og klyngehovedpine (svær, tilbagevendende hovedpine i den ene side af hovedet, sædvanligvis omkring øjet), som ikke har kunnet behandles med sædvanlige lægemidler.
English: • Methysergide should no longer be used for treating diarrhoea caused by carcinoid disease (a type of slow-growing tumour).
Danish: • Methysergid må ikke længere anvendes til behandling af diarré forårsaget af karcinoid sygdom (en type langsomt voksende svulst).
English: • Methysergide-containing medicines may cause a potentially serious condition known as fibrosis, in which scar tissue accumulates in some of the body's organs.
Danish: • Lægemidler med methysergid kan forårsage sygdommen fibrose, der kan være alvorlig, og som medfører ophobning af arvæv i visse organer.
English: Methysergide has also been used for treating diarrhoea caused by carcinoid disease (a slow-growing tumour that commonly affects the gut).
Danish: Methysergid er desuden blevet anvendt til behandling af diarré forårsaget af karcinoid sygdom (en langsomt voksende svulst, sædvanligvis i tarmen).
English: − Prophylactic treatment of episodic and chronic cluster headache in adults when treatment with standard medicines has failed.
Danish: − profylaktisk behandling af episodisk og kronisk klyngehovedpine hos voksne efter behandlingssvigt af sædvanlige lægemidler.
English: On 20 February 2014, the European Medicines Agency recommended restricting the use of methysergide due to concerns that it could cause fibrosis, a condition in which fibrous (scar) tissue accumulates in the body's organs potentially damaging them.
Danish: Den 20. februar 2014 anbefalede Det Europæiske Lægemiddelagentur, at anvendelsen af methysergid begrænses på grund af betænkeligheder med hensyn til risikoen for fibrose i forbindelse hermed.
English: Patients should also be screened for fibrosis at the start of treatment and should have additional screenings every 6 months.
Danish: Patienterne skal undersøges for fibrose ved behandlingens begyndelse og derefter hver sjette måned.
English: Once treatment is started the patient must be examined for occurrence of fibrosis at 6monthly intervals.
Danish: Under behandlingen skal patienten undersøges for opståen af fibrose med højst seks måneders mellemrum.
English: As a result of this, the use of these medicines is being restricted to the prevention of severe intractable migraines and cluster headaches when standard medicines have failed.
Danish: Derfor bliver anvendelsen nu begrænset til forebyggelse af svær migræne, der ikke kan behandles, og klyngehovedpine, i tilfælde hvor sædvanlige lægemidler ikke har virket.
English: Treatment must be discontinued if symptoms of fibrosis occur.
Danish: Ved symptomer på fibrose skal behandlingen afbrydes.
English: Your doctor will stop your treatment if fibrosis is suspected.
Danish: Ved mistanke om fibrose vil lægen stoppe behandlingen.
English: You should tell your doctor if any of the following applies to you:
Danish: Sig det til lægen, hvis noget af følgende gælder for dig:
English: Adopted at the 8-11 February 2016 PRAC
Danish: Vedtaget 8.-11. februar 2016 PRAC
English: What you need to know before you take Lysodren Warnings and precautions
Danish: Det skal du vide, før du begynder at tage Lysodren Advarsler og forsigtighedsregler