FrancophonIA/ELRC3.0 huggingface dataset:
English: Oval, blue tablets containing 90 mg (light blue), 180 mg (medium blue) and 360 mg (dark blue)
Danish: Ovale, blå tabletter indeholdende hhv. 90 mg (lyseblå), 180 mg (mellemblå) og 360 mg (mørkeblå)
English: • Whereas the dispersible tablets have to be taken on an empty stomach 30 minutes before food, the film-coated tablets can be taken on an empty stomach or with a light meal.
Danish: • Mens smeltetabletterne skal tages på tom mave 30 minutter før et måltid, skal de filmovertrukne tabletter tages på tom mave eller sammen med et let måltid.
English: • Exjade (deferasirox) is now available as film-coated tablets in addition to the already authorised dispersible tablets.
Danish: • Exjade (deferasirox) leveres nu som filmovertrukne tabletter ved siden af de allerede godkendte dispergible tabletter.
English: • You will be given a handbook with information on the two types of tablets and how to take them.
Danish: • Du vil få udleveret en håndbog med oplysninger om de to tablettyper, og hvordan du skal tage dem. Information til sundhedspersoner
English: • The dispersible tablets and the new film-coated tablets are to be taken once a day, preferably at the same time each day.
Danish: • Smeltetabletterne (dispergible tabletter) og de nye filmovertrukne tabletter skal tages én gang dagligt, fortrinsvis på samme klokkeslæt hver dag.
English: Exjade is a medicine used to treat chronic iron overload (an excess of iron in the body) in patients with beta thalassemia or other blood disorders in which patients do not have enough normal haemoglobin in the blood.
Danish: Exjade er et lægemiddel til behandling af kronisk jernophobning (for meget jern i kroppen) hos patienter med beta-thalassæmi eller andre blodsygdomme, hvor patienterne ikke har tilstrækkeligt med normalt hæmoglobin i blodet.
English: Healthcare professionals will be notified of the planned date for removing the dispersible tablets from the market.
Danish: Sundhedspersoner vil blive underrettet om den dato, hvor det er planlagt at tage smeltetabletterne af markedet.
English: Educational material will be given to patients and healthcare professionals using Exjade (deferasirox), following the introduction of a film-coated tablet to the already authorised dispersible tablet.
Danish: Der vil blive udleveret oplysningsmateriale til patienter og sundhedspersoner, der anvender Exjade (deferasirox), efter lanceringen af en filmovertrukken tablet ved siden af den allerede godkendte smeltetablet (dispergible tablet).
English: • Both types of tablets will be available for a limited period to allow doctors to switch patients from the dispersible tablets to the film-coated tablets.
Danish: • Begge typer tabletter vil være på markedet i en begrænset periode, hvorved lægerne får mulighed for at lade patienten skifte fra dispergible tabletter til filmovertrukne tabletter.
English: • Exjade film-coated tablets have been introduced.
Danish: • Exjade filmovertrukne tabletter er bragt på markedet.
English: Exjade is a medicine used to remove excessive iron from the blood of patients with beta thalassemia or other blood disorders which result in excessive iron in the blood.
Danish: Exjade er et lægemiddel til fjernelse af for højt indhold af jern i blodet hos patienter med beta-thalassæmi eller andre blodsygdomme, der medfører for højt jernindhold i blodet.
English: Dispersed in water, orange juice or apple juice.
Danish: Opløses i vand, appelsinjuice eller æblejuice Må ikke tygges eller synkes hele
English: After this time, Exjade dispersible tablets will no longer be marketed.
Danish: Efter denne periode vil Exjade dispergible tabletter ikke længere blive markedsført.
English: A smaller dose is needed of the new film-coated tablets compared to that of the dispersible tablet.
Danish: Der behøves mindre dosis af de nye filmovertrukne tabletter end af smeltetabletterne.
English: Once daily, may be taken on an empty stomach or with a light meal
Danish: Hvornår tabletterne skal tages Én gang dagligt, kan tages på tom mave eller med et let måltid
English: If you have any questions about your treatment, contact your doctor, pharmacist or nurse.
Danish: Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er mere, du vil vide.
English: The patient may receive too little or too much of the medicine if the dose is not correct when changing from one type of tablet to another.
Danish: Ved skift fra den ene type tablet til den anden kan patienten få for lidt eller for meget af lægemidlet, hvis dosis ikke er korrekt.
English: Contains lactose
Danish: Indeholder lactose
English: • Exjade dispersible tablets will not be available in the future.
Danish: • Exjade smeltetabletter vil i fremtiden ikke længere blive markedsført.
English: Both types of tablets will be available for some time, which will allow doctors to switch patients from dispersible tablets to film-coated tablets.
Danish: Derved får lægerne mulighed for at lade patienten skifte fra smeltetabletter til filmovertrukne tabletter.
English: The MAHs should identify a specific patient population for which the benefits of the product outweigh the risk.
Danish: Indehaverne af markedsføringstilladelsen skal identificere en specifik patientpopulation, hos hvem fordelene ved lægemidlet opvejer risiciene.
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Danish: Medlemsstaternes nationale kompetente myndigheder, eller i givet fald referencemedlemsstaten/-erne, skal sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelsen:
English: The European Commission granted a marketing authorisation valid throughout the EU for CoAprovel on 15 October 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for CoAprovel den 15. oktober 1998.
English: The full EPAR for CoAprovel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for CoAprovel findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for CoAprovel.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for CoAprovel.
English: Irbesartan on its own has been approved in the European Union (EU) since 1997 under the names Karvea and Aprovel.
Danish: Irbesartan alene har været godkendt i Den Europæiske Union (EU) under navnene Karvea og Aprovel siden 1997.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for CoAprovel.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for CoAprovel.
English: For more information about treatment with CoAprovel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med CoAprovel, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Other information about CoAprovel
Danish: Andre oplysninger om CoAprovel:
English: The CHMP decided that CoAprovel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved CoAprovel opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of CoAprovel.
Danish: De undersøgelser, der blev foretaget med Karvea/Aprovel i kombination med hydrochlorothiazid som enkelttabletter, blev brugt til at understøtte brugen af CoAprovel.
English: Irbesartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Irbesartan er en ”angiotensin II-receptorantagonist”, hvilket betyder, at den blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
English: CoAprovel irbesartan / hydrochlorothiazide
Danish: Irbesartan/hydrochlorothiazid
English: The most common side effects with CoAprovel (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscle).
Danish: De mest almindelige bivirkninger ved CoAprovel (der ses hos mellem 1 og 10 patienter ud af 100) er svimmelhed, kvalme eller opkastning, uregelmæssig vandladning, træthed, forhøjet indhold af urinkvælstof (BUN, et spaltningsprodukt af protein), kreatinin (et spaltningsprodukt af musklerne) og kreatininkinase (et enzym i musklerne).
English: CoAprovel was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Danish: CoAprovel var mere effektivt end placebo (en virkningsløs behandling) og hydrochlorothiazid alene til at reducere det diastoliske blodtryk.
English: What is the risk associated with CoAprovel?
Danish: Hvilken risiko er der forbundet med CoAprovel?
English: The dose of CoAprovel to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Danish: Dosen af CoAprovel afhænger af den dosis af irbesartan eller hydrochlorothiazid, som patienten tog tidligere.
English: CoAprovel in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Danish: CoAprovel 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: Care must be taken when using CoAprovel with other medicines that have an effect on blood potassium levels.
Danish: Der skal udvises forsigtighed, når CoAprovel anvendes sammen med andre lægemidler, som kan påvirke indholdet af kalium i blodet.
English: CoAprovel may be added to some other treatments for hypertension.
Danish: CoAprovel kan bruges som tillægsbehandling til visse andre behandlinger mod hypertension.
English: CoAprovel must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Danish: CoAprovel må ikke anvendes til personer, som er overfølsomme (allergiske) over for irbesartan, hydrochlorothiazid, sulfonamider eller andre af indholdsstofferne.
English: It is available as tablets (150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; 300 mg irbesartan and 25 mg hydrochlorothiazide).
Danish: Det fås som tabletter (150 mg eller 300 mg irbesartan og 12,5 mg hydrochlorothiazid; 300 mg irbesartan og 25 mg hydrochlorothiazid).
English: Why has CoAprovel been approved?
Danish: Hvorfor blev CoAprovel godkendt?
English: CoAprovel is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Danish: CoAprovel anvendes til voksne med essentiel hypertension (forhøjet blodtryk), hvis blodtryk ikke kan kontrolleres tilfredsstillende ved hjælp af irbesartan eller hydrochlorothiazid alene.
English: CoAprovel is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Danish: CoAprovel er et lægemiddel, der indeholder de to aktive stoffer irbesartan og hydrochlorothiazid.
English: CoAprovel must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Danish: CoAprovel må heller ikke gives til patienter, som har svære lever-, nyre- eller galdeproblemer, for lavt indhold af kalium i blodet eller for højt indhold af kalcium i blodet.
English: What benefit has CoAprovel shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved CoAprovel?
English: CoAprovel contains two active substances, irbesartan and hydrochlorothiazide.
Danish: CoAprovel indeholder to aktive stoffer, irbesartan og hydrochlorothiazid.
English: How has CoAprovel been studied?
Danish: Hvordan blev CoAprovel undersøgt?
English: What is CoAprovel used for?
Danish: Hvad anvendes CoAprovel til?
English: How is CoAprovel used?
Danish: Hvordan anvendes CoAprovel?
English: What is CoAprovel?
Danish: Hvad er CoAprovel?
English: How does CoAprovel work?
Danish: Hvordan virker CoAprovel?
English: Contact our press officers Monika Benstetter or Martin Harvey
Danish: Kontakt vores pressemedarbejdere Monika Benstetter eller Martin Harvey
English: Your doctor will confirm whether you should change to another treatment.
Danish: Lægen vil afgøre, om du bør skifte til anden behandling.
English: The review of ergot derivatives was initiated on 18 January 2012 at the request of France, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af ergotderivater blev indledt den 18. januar 2012 på anmodning af Frankrig i medfør af artikel 31 i direktiv 2001/83/EF.
English: The severity of such adverse effects and their possible fatal outcome was underlined.
Danish: Sværhedsgraden af sådanne bivirkninger og deres potentielle fatale udfald blev understreget.
English: • If you are unsure whether you are affected, or if you have any questions, speak with your doctor or pharmacist.
Danish: • Hvis du ikke er sikker på, om du er omfattet, eller hvis du har spørgsmål, skal du tale med lægen eller apotekspersonalet.
English: • The available efficacy data for the described indications were considered to be very limited.
Danish: • De foreliggende data om virkning ved de beskrevne indikationer blev fundet meget begrænsede.
English: Restrictions on use of medicines containing ergot derivatives
Danish: Begrænsninger i brugen af lægemidler indeholdende ergotderivater
English: • Patients currently taking these medicines for any of the above indications should have their treatment reviewed at a routine (non-urgent) medical appointment.
Danish: • Patienter, der for øjeblikket er i behandling med disse lægemidler for nogen af ovennævnte indikationer, bør få behandlingen revideret ved en rutinemæssig (ikke hastende) lægekonsultation.
English: The pharmaceutical forms and the approved indications, strengths and doses vary in different EU countries.
Danish: Lægemiddelformer og de godkendte anvendelser, styrker og doser er forskellige i forskellige EU-lande.
English: On 27 June 2013, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended restricting the use of medicines containing ergot derivatives.
Danish: Den 27. juni 2013 anbefalede EMA's udvalg for lægemidler til mennesker (CHMP) begrænsninger i brugen af lægemidler indeholdende ergotderivater.
English: In addition, scientific advisory groups held in December 2012 and October 2013 did not consider there was evidence of a therapeutic need for ergot derivatives in the indications covered by the review.
Danish: På møder i den videnskabelige rådgivende gruppe i december 2012 og oktober 2013 blev der desuden ikke fundet evidens for, at der er terapeutisk behov for ergotderivater til de indikationer, som gennemgangen omfatter.
English: There were fewer reports of fibrotic reactions with the other ergot derivatives.
Danish: Der var færre indberetninger af fibrotiske reaktioner med de øvrige ergotderivater.
English: These indications were not included in the CHMP review; therefore these products will remain authorised and may continue to be used in those indications.
Danish: Disse indikationer var ikke omfattet af CHMP's gennemgang; produkterne vil derfor fortsat være godkendt til anvendelse ved disse indikationer.
English: The re-examination concluded on 24 October 2013 with the Committee maintaining its previous recommendation, which will now be sent to the European Commission.
Danish: Den fornyede overvejelse sluttede den 24. oktober 2013 med, at udvalget fastholdt sine tidligere anbefalinger.
English: The review was initiated due to concerns identified by the French National Agency for the Safety of Medicine and Health Products (ANSM) in a national pharmacovigilance review in 2011.
Danish: Gennemgangen blev indledt på grund af problemer konstateret af den franske lægemiddelstyrelse (ANSM) ved en national gennemgang af lægemiddelovervågning i 2011.
English: 25 October 2013 EMA/652753/2013
Danish: Den 18. december 2013 EMA/27446/2014
English: At the request of a manufacturer of medicines containing dihydroergotoxine, one of the ergot derivatives, the CHMP carried out a re-examination of its opinion on this medicine.
Danish: På anmodning af en fremstiller af lægemidler indeholdende dihydroergotoxin, som er et af ergotderivaterne, foretog CHMP et fornyet overvejelse af sin udtalelse om dette lægemiddel.
English: − Orthostatic hypotension;
Danish: − Ortostatisk hypotension
English: In the EU, medicines containing ergot derivatives have been authorised by national procedures and have been marketed under various trade names.
Danish: I EU har lægemidler indeholdende ergotderivater været godkendt ved nationale procedurer og har været markedsført under forskellige handelsnavne.
English: Patients were young (mean age 41 years-old), with a short time to onset after starting dihydroergotamine (less than 2 months, mean: 2 days).
Danish: Patienterne var unge (gennemsnitsalder 41 år), og tiden til indsætten efter initiering af behandlingen med dihydroergotamin var kort (under to måneder, gennemsnit: 2 dage).
English: The French medicines agency asked the CHMP to carry out an assessment of the benefit-risk balance and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the European Union.
Danish: Den franske lægemiddelstyrelse bad CHMP om at foretage en vurdering af forholdet mellem fordele og risici og fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for disse lægemidler bør opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: • Cases of ergotism or potentially related symptoms were most frequently reported with dihydroergotamine.
Danish: • Tilfælde af ergotisme eller potentielt relaterede symptomer blev oftest indberettet med dihydroergotamin.
English: Fibrosis can be a serious, sometimes fatal disease, which is often difficult to diagnose because of delayed symptoms and may be irreversible.
Danish: Fibrose kan være en alvorlig, undertiden dødelig sygdom, som ofte er vanskelig at diagnosticere på grund af sent indsættende symptomer, og sygdommen kan have uoprettelige følger.
English: They will remain authorised for use by patients in those indications.
Danish: De vil fortsat være godkendt til disse indikationer.
English: More about the medicine
Danish: Mere om lægemidlerne
English: benefits in these indications was very limited, the CHMP concluded that the benefits in the concerned indications did not outweigh the risk of fibrosis and ergotism.
Danish: I betragtning af, at dokumentationen for disse lægemidlers fordele til disse indikationer er meget begrænset, konkluderede CHMP, at fordelene til de omhandlede indikationer ikke overstiger risikoen for fibrose og ergotisme.
English: Ergot derivatives are substances derived from a group of fungi commonly known as ergot.
Danish: Ergotderivater er stoffer, der udvindes af en gruppe svampe almindeligt kendt som ergot.
English: The CHMP noted the difficulty of diagnosing fibrosis (due to delayed onset of symptoms) and the probability of under-reporting of fibrotic reactions.
Danish: CHMP tog i betragtning, at det er vanskeligt at diagnosticere fibrose (som følge af forsinket indsætten af symptomer), og at fibrotiske reaktioner sandsynligvis underindberettes.
English: Medicines containing ergot derivatives have an effect on blood circulation and they have been used for decades to treat conditions involving circulatory problems.
Danish: Lægemidler indeholdende ergotderivater har virkning på kredsløbet og har i årtier været anvendt til behandling af sygdomme med kredsløbsproblemer.
English: • Fibrosis was most frequently reported with dihydroergotamine, including retroperitoneal, cardiac, pulmonary and pleural fibrosis.
Danish: • Fibrose blev oftest indberettet med dihydroergotamin, herunder retroperitoneal, kardial, pulmonal og pleural fibrose.
English: • Ergot derivatives are recognised as being capable of inducing fibrosis, in particular heart valve fibrosis, through serotoninergic receptor activation, which is extensively described in the literature.
Danish: • Det er anerkendt, at ergotderivater er i stand til at inducere fibrose, navnlig af hjerteklapperne, gennem aktivering af serotoninerge receptorer, hvilket er udførligt beskrevet i litteraturen.
English: − Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II);
Danish: − Supplerende behandling af claudicatio intermittens ved symptomatisk perifer arteriel okklusiv sygdom (PAOD stadium II)
English: − Ancillary treatment of Raynaud's syndrome;
Danish: − Supplerende behandling af Raynauds syndrom
English: These medicines should no longer be used to treat several conditions involving blood circulation problems or problems with memory and sensation, or to prevent migraine headaches, since the risks are greater than the benefits in these indications.
Danish: Disse lægemidler bør ikke længere bruges til behandling af forskellige sygdomme, der medfører kredsløbsproblemer eller problemer med hukommelse og følesans eller til forebyggelse af migræne, da risiciene er større end fordelene til disse indikationer.
English: − Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in the elderly (excluding Alzheimer's disease and other dementia);
Danish: − Symptomatisk behandling af kronisk patologisk kognitiv og neurosensorisk funktionsnedsættelse hos ældre (bortset fra Alzheimers sygdom og anden form for demens)
English: The CHMP noted that there is a plausible mechanism by which ergot-derivatives could cause fibrosis and ergotism.
Danish: CHMP bemærkede, at der ligger en plausibel mekanisme til grund for ergotderivaters evne til at medføre fibrose og ergotisme.
English: The CHMP opinion follows a review of available safety and efficacy data on ergot derivatives in the above indications, including clinical studies, post-marketing data in Europe and the published literature:
Danish: CHMP's udtalelse følger efter en gennemgang af de foreliggende data om sikkerheden og virkningen af ergotderivater til ovennævnte indikationer, herunder kliniske undersøgelser, data efter markedsføring i Europa og den publicerede litteratur:
English: − Acute retinopathies of vascular origin;
Danish: − Akutte retinopatier af vaskulær årsag
English: This is based on a review of data showing an increased risk of fibrosis (formation of excess connective tissue that can damage organs and body structures) and ergotism (symptoms of ergot poisoning, such as spasms and obstructed blood circulation) with these medicines.
Danish: Dette er baseret på en gennemgang af data, der viser, at lægemidlerne er forbundet med øget risiko for unormal bindevævsdannelse (fibrose), som kan beskadige organer og indre strukturer i kroppen, samt symptomer på ergotforgiftning (ergotisme) i form af spasmer og nedsat blodcirkulation.
English: − Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin;
Danish: − Supplerende behandling af synsnedsættelse og synsfeltforstyrrelser af formodet vaskulær årsag