FrancophonIA/ELRC3.0 huggingface dataset:
English: The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.
Danish: Den indledende gennemgang foretages af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som vil fremsætte et sæt anbefalinger.
English: • Your doctor will carry out regular blood tests for up to 6 months after stopping treatment to check for side effects.
Danish: • Lægen vil foretage regelmæssige blodprøver i op til seks måneder efter at have stoppet behandlingen med henblik på at kontrollere for bivirkninger.
English: Following a 2017 review of the medicine's effects on the liver, the use of the medicine was restricted to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other multiple sclerosis treatments.
Danish: Efter en gennemgang i 2017 af lægemidlets virkninger på leveren blev dets anvendelse begrænset til patienter, hos hvem der er forsøgt mindst to andre sygdomsmodificerende behandlinger, og som ikke kan behandles med andre midler mod multipel sklerose.
English: Patients stopping treatment must be followed up for at least 6 months (see more details below).
Danish: Der bør følges op på patienter, hvis behandling standses, i mindst 6 måneder (se nærmere herom nedenfor).
English: A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta.
Danish: En indledende gennemgang af den foreliggende dokumentation tyder på, at de iagttagne immunreaktioner i de indberettede tilfælde kan have sammenhæng med anvendelsen af Zinbryta.
English: The company that markets Zinbryta (Biogen Idec Ltd) has already voluntarily requested a withdrawal of the medicine's marketing authorisation and has informed EMA of its intention to stop clinical studies.
Danish: Virksomheden, der markedsfører Zinbryta (Biogen Idec Ltd), har allerede frivilligt anmodet om tilbagekaldelse af lægemidlets markedsføringstilladelse og underrettet EMA om, at den har til hensigt at standse de kliniske studier.
English: Available evidence also indicates that Zinbryta could be linked to other immune-mediated disorders, such as blood dyscrasias, thyroiditis or glomerulonephritis.
Danish: Den foreliggende dokumentation peger desuden på, at Zinbryta kan have sammenhæng med andre immunmedierede lidelser, såsom bloddyskrasier, thyroiditis eller glomerulonefritis.
English: Healthcare professionals should immediately contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives.
Danish: Sundhedspersoner bør straks kontakte de patienter, der på nuværende tidspunkt er i behandling med Zinbryta, og bør ophøre med behandlingen og tage stilling til alternativer.
English: To date EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed 12 cases of immune-mediated inflammatory disorders, including encephalitis.
Danish: Hidtil har EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC) gennemgået 12 tilfælde af immunmedierede inflammatoriske lidelser, herunder encephalitis.
English: A previous PRAC review in 2017 found that unpredictable and potentially fatal immune-mediated liver injury can occur with Zinbryta for up to 6 months after stopping treatment and concluded that patients stopping treatment should be followed up.
Danish: En tidligere PRAC-gennemgang i 2017 viste, at der kan indtræffe uforudsigelig og potentielt dødelig immunmedieret leverskade med Zinbryta i op til seks måneder efter behandlingens ophør, og konkluderede, at der bør følges op på patienter, der ophører med behandlingen.
English: Start the survey
Danish: Start spørgeundersøgelsen
English: • Tell your doctor immediately if you have or experience symptoms such as persistent high temperature, severe headache, nausea (feeling sick), tiredness, yellowing of the skin or eyes and vomiting.
Danish: • Sig det straks til lægen, hvis du har eller oplever symptomer som vedvarende høj temperatur, svær hovedpine, kvalme, træthed, gulfarvning af hud eller øjne, og opkastning.
English: • Do not take another injection of Zinbryta.
Danish: • Tag ikke flere injektioner af Zinbryta.
English: On 6 March 2018, the European Medicines Agency (EMA) recommended the immediate suspension and recall of the multiple sclerosis medicine Zinbryta (daclizumab beta) following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis.
Danish: Det Europæiske Lægemiddelagentur (EMA) har anbefalet, at lægemidlet mod multipel sklerose Zinbryta (daclizumab beta) øjeblikkelig suspenderes og tilbagekaldes efter 12 indberetninger om alvorlige inflammatoriske hjernesygdomme i hele verden, herunder encephalitis og meningoencephalitis.
English: • Advise patients to immediately report symptoms of liver injury such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting.
Danish: • Bed patienterne om straks at indberette symptomer på leverskader, såsom langvarig feber, svær hovedpine, træthed, gulsot, kvalme eller opkastning.
English: • If you are in a clinical study with Zinbryta, contact the doctor treating you in the study.
Danish: • Hvis du deltager i et klinisk studie med Zinbryta, skal du kontakte den læge, der behandler dig i studiet.
English: • If you are being treated with Zinbryta, contact your doctor to discuss your treatment.
Danish: • Hvis du er i behandling med Zinbryta, skal du kontakte lægen for at drøfte din behandling.
English: To protect patients' health, the marketing authorisation in the EU of Zinbryta is now suspended and batches are to be recalled from pharmacies and hospitals.
Danish: For at beskytte patienternes helbred anbefaler EMA øjeblikkelig suspendering af lægemidlets markedsføringstilladelse i EU og tilbagekaldelse af partier fra apoteker og hospitaler.
English: No new patients should start treatment with Zinbryta.
Danish: Ingen nye patienter bør sættes i behandling med Zinbryta.
English: Consider alternative treatments as appropriate.
Danish: Overvej andre behandlinger efter omstændighederne.
English: The PRAC's recommendation to suspend Zinbryta and recall the product was sent to the European Commission, which issued a legally binding decision on 8 March 2018.
Danish: PRAC's anbefaling om at suspendere Zinbryta og tilbagekalde produktet sendes til EuropaKommissionen med henblik på en retligt bindende afgørelse.
English: • Do not start any new patients on Zinbryta.
Danish: • Sæt ikke nye patienter i behandling med Zinbryta.
English: • Patients stopping treatment should be monitored at least monthly and more frequently as clinically indicated for up to 6 months after the last dose of Zinbryta.
Danish: alt efter hvad der er klinisk indiceret, i op til seks måneder efter den sidste dosis Zinbryta.
English: • Contact your patients currently being treated with Zinbryta as soon as possible and stop their treatment.
Danish: • Kontakt snarest muligt de af dine patienter, der på nuværende tidspunkt er i behandling med
English: The areas harmonised include:
Danish: De harmoniserede områder er følgende:
English: The amended information to doctors and patients is available here.
Danish: Den ændrede information til læger og patienter findes her.
English: Nasonex and associated names are currently marketed in the following Member States of the EU: Austria, Belgium, Bulgaria, Croatia, Cyprus1, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.
Danish: Nasonex og relaterede navne markedsføres i følgende EU-medlemsstater: Østrig, Belgien, Bulgarien, Kroatien, Cypern1, Tjekkiet, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige samt Island og Norge.
English: The European Commission issued an EU-wide legally binding decision to implement these changes on 19 January 2015.
Danish: Europa-Kommissionen vedtog en afgørelse, der er retligt bindende i hele EU, den 19. januar 2015.
English: The company that markets these medicines is Merck Sharp & Dohme.
Danish: Den virksomhed, der markedsfører disse lægemidler, er Merck Sharp & Dohme.
English: What is Nasonex?
Danish: Hvad er Nasonex?
English: EMA/39886/2015
Danish: Den 19. januar 2015 EMA/39886/2015
English: 1 Nasonex is marketed in Cyprus under Art.126a of Directive 27/2004 EC, which allows a country to place a product in the market for justified public health reasons for a limited number of years.
Danish: 1 Nasonex markedsføres i Cypern i henhold til artikel 126a i direktiv 27/2004/EF, som giver mulighed for, at et land tillader markedsføring af et lægemiddel i en begrænset årrække, når det er berettiget af hensyn til folkesundheden.
English: Why was Nasonex reviewed?
Danish: Hvorfor blev Nasonex vurderet igen?
English: Questions and answers on Nasonex and associated names (mometasone furoate, 50 microgram, nasal spray)
Danish: Spørgsmål og svar om Nasonex og relaterede navne (mometasonfuroat, næsespray, 50 µg)
English: Nasonex contains the active substance mometasone furoate.
Danish: Nasonex indeholder det aktive stof mometasonfuroat.
English: On 20 November 2014, the European Medicines Agency completed a review of Nasonex and associated names.
Danish: Den 20. november 2014 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Nasonex og relaterede navne.
English: • Treatment of nasal polyps in adults (aged 18 years and older).
Danish: • behandling af næsepolypper hos voksne (på 18 år og derover).
English: The Committee also agreed that Nasonex should no longer be recommended to treat acute sinusitis, which was authorised in some Member States, because the available data to support this use were considered limited.
Danish: Udvalget fastslog desuden, at Nasonex ikke længere burde anbefales til behandling af akut bihulebetændelse, som var godkendt i visse medlemsstater, da de foreliggende oplysninger til dokumentation heraf blev betragtet som begrænsede.
English: In view of this, on 17 September 2013 the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Nasonex in the EU.
Danish: På denne baggrund indbragte Europa-Kommissionen den 17. september 2013 sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Nasonex i EU.
English: Nasonex and associated names have been authorised in EU Member States through national procedures since
Danish: Nasonex og relaterede navne har været godkendt i EU's medlemsstater via nationale procedurer siden 1997.
English: Having harmonised the indications, the CHMP also harmonised recommendations on the doses.
Danish: Efter harmonisering af indikationerne harmoniserede CHMP også doseringsanbefalingerne.
English: The CHMP agreed to that Nasonex must not be used in:
Danish: CHMP konkluderede, at Nasonex ikke måtte bruges i følgende tilfælde:
English: The CHMP also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation), 4.8 (side effects) and 5.1 (pharmacodynamic properties).
Danish: Dette gælder punkt 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen), 4.6 (fertilitet, graviditet og amning), 4.8 (bivirkninger) og 5.1 (farmakodynamiske egenskaber).
English: After reviewing the available data supporting the medicine's use, the CHMP agreed that Nasonex can be used for the following:
Danish: Efter gennemgang af de oplysninger, der dokumenterer lægemidlets anvendelse, fandt CHMP, at Nasonex kunne anvendes til følgende:
English: • Patients with known hypersensitivity (allergy) to mometasone furoate or to any other ingredients.
Danish: • ved kendt allergi (hypersensitivitet) over for mometasonfuroat eller andre af indholdsstofferne
English: The labelling and package leaflet were also revised in line with the changes to the SmPC.
Danish: Etiketteringen og indlægssedlen blev ligeledes revideret svarende til ændringerne i produktresuméet.
English: • Treatment of symptoms of seasonal allergic or perennial rhinitis in adults and in children aged three and above.
Danish: • behandling af symptomerne på sæsonbetinget allergisk eller tilbagevendende rhinitis hos voksne og børn på tre år og derover
English: • Patients who have an untreated and localised infection, such as herpes, affecting the inside of the nose.
Danish: • ved ubehandlet eller lokal indvendig infektion i næsen, såsom herpes
English: In addition, it is used in adults to treat nasal polyps (growths in the lining of the nose).
Danish: Desuden bruges det hos voksne til behandling af udvækster af næseslimhinden (polypper).
English: Nasonex is an anti-inflammatory medicine that is used in adults and children from three years of age to treat the symptoms of seasonal allergic or perennial rhinitis (inflammation of the nasal passages caused by occasional or long-term allergy).
Danish: Det bruges hos voksne og børn på tre år og derover til behandling af symptomerne på sæsonbetinget allergisk eller tilbagevendende rhinitis (betændelse i næsepassagerne, som forårsages af lejlighedsvis eller vedvarende allergi).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Nasonex and associated names in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der var behov for harmonisering af produktinformationen for Nasonex og relaterede navne i EU.
English: It is available as a nasal spray.
Danish: Det fås som næsespray.
English: As Nasonex has been authorised in the EU via national procedures, this has led to divergences across Member States in the way the medicine can be used, as seen in differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har ført til afvigelser mellem medlemsstaterne i den måde, lægemidlet kan anvendes på, som det fremgår af forskellene i produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: • Patients who have recently undergone nose surgery or who have a wound in the nose, because
Danish: • efter nylige næseoperationer eller sår i næsen, idet Nasonex kan påvirke sårhelingen.
English: Nasonex can affect wound healing.
Danish: Nasonex er et antiinflammatorisk lægemiddel.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets for Nasonex should be harmonised across the EU.
Danish: CHMP fandt det nødvendigt at harmonisere produktresuméerne, etiketteringen og indlægssedlerne i EU på baggrund af de forelagte oplysninger og den videnskabelige drøftelse i udvalget.
English: This summary was last updated in 06-2016.
Danish: Dette sammendrag blev sidst ajourført i 06-2016.
English: ‘Essential' means that the hypertension has no obvious cause.
Danish: "Essentiel" betyder, at hypertensionen ikke har nogen indlysende årsag.
English: The medicine's effects were maintained for up to a year in two of the studies.
Danish: Lægemidlets virkning holdt sig i indtil et år i to af undersøgelserne.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rasilez on 22 August 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rasilez den 22. august 2007.
English: It is available as tablets (150 and 300 mg).
Danish: Det leveres som tabletter (150 og 300 mg).
English: This is a summary of the European public assessment report (EPAR) for Rasilez.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rasilez.
English: The full EPAR for Rasilez can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Rasilez findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Rasilez
Danish: Andre oplysninger om Rasilez
English: The blood pressure was measured in ‘millimetres of mercury' (mmHg).
Danish: Blodtrykket blev målt i ”millimeter kviksølv” (mmHg).
English: Its use during the first three months of pregnancy and in women planning to become pregnant is not recommended.
Danish: Det anbefales ikke at anvende det i de første tre måneder af graviditeten og heller ikke til kvinder, der planlægger at blive gravide.
English: Rasilez has been studied in 14 main studies involving over 10,000 patients with essential hypertension.
Danish: Rasilez er blevet undersøgt i 14 hovedundersøgelser, der involverede over 10 000 patienter med essentiel hypertension.
English: The recommended dose of Rasilez is 150 mg once a day.
Danish: Den anbefalede dosis af Rasilez er 150 mg en gang dagligt.
English: What measures are being taken to ensure the safe and effective use of Rasilez?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rasilez?
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 Rasilez.
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, hvordan Rasilez skal anvendes.
English: By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall.
Danish: Når produktionen af angiotensin I blokeres, mindskes niveauerne af både angiotensin I og angiotensin II.
English: In five of the studies, the effects of Rasilez taken alone were compared with those of placebo (a dummy treatment).
Danish: I fem af undersøgelserne blev virkningerne af Rasilez anvendt alene sammenlignet med virkningerne af placebo (en virkningsløs behandling).
English: Thirteen of the studies included patients with mild to moderate hypertension, and one included patients with severe hypertension.
Danish: Tretten af undersøgelserne omfattede patienter med let til moderat hypertension, og én undersøgelse omfattede patienter med svær hypertension.
English: The dose of Rasilez may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.
Danish: Dosis af Rasilez kan øges til 300 mg én gang dagligt hos patienter, hvis blodtryk ikke er tilstrækkeligt reguleret.
English: For more information about treatment with Rasilez, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rasilez, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Rasilez is a medicine that contains the active substance aliskiren.
Danish: Rasilez er et lægemiddel, som indeholder det aktive stof aliskiren.
English: Rasilez is used to treat essential hypertension (high blood pressure) in adults.
Danish: Rasilez anvendes til behandling af essentiel hypertension (for højt blodtryk) hos voksne.
English: The CHMP therefore decided that the benefits of Rasilez are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede derfor, at fordelene ved Rasilez opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Rasilez.
English: Rasilez is for use in adults only; it must not be used in children aged less than 2 years and is not recommended for older children.
Danish: Rasilez må ikke anvendes hos børn under 2 år, og det anbefales ikke til ældre børn.
English: This may reduce the risks associated with high blood pressure, such as having a stroke.
Danish: Dette kan nedsætte de risici, der er forbundet med forhøjet blodtryk, såsom slagtilfælde.
English: Rasilez also reduced blood pressure in patients with diabetes and patients who were overweight.
Danish: Rasilez nedsatte også blodtrykket hos patienter med sukkersyge og hos overvægtige patienter.
English: The CHMP noted that Rasilez is effective in reducing blood pressure when used alone or in combination.
Danish: CHMP konstaterede, at Rasilez er effektivt til at nedsætte blodtrykket, hvad enten det anvendes alene eller i kombination.
English: It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Danish: Det blokerer aktiviteten hos det humane enzym, renin, som er med til at producere et stof i kroppen, der kaldes angiotensin I. Angiotensin I
English: Rasilez should not be taken together with fruit juice or drinks containing plant extracts such as herbal teas.
Danish: Rasilez må ikke tages sammen med frugtsaft eller drikkevarer, som indeholder planteekstrakter, såsom urtete.
English: Rasilez must not be used in patients who have had angioedema (swelling under the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, or in women who are more than three months pregnant.
Danish: Rasilez må ikke anvendes hos patienter, der har haft angioødem (hævelse under huden) ved anvendelse af aliskiren, arveligt angioødem eller angioødem af ukendt årsag, eller hos kvinder, som er mere end tre måneder henne i graviditeten.
English: The active substance in Rasilez, aliskiren, is a renin inhibitor.
Danish: Det aktive stof i Rasilez, aliskiren, er en reninhæmmer.
English: What is the risk associated with Rasilez?
Danish: Hvilken risiko er der forbundet med Rasilez?
English: Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Danish: omdannes til hormonet angiotensin II, som er en kraftig vasokonstriktor (et stof, der forsnævrer blodkarrene).
English: The studies lasted between six and 52 weeks and the main measure of effectiveness was the change in blood pressure during either the resting phase of the heartbeat (‘diastolic') or when the chambers of the heart were contracting (‘systolic').
Danish: Undersøgelserne varede mellem seks og 52 uger, og virkningen blev hovedsagelig målt på ændringen i blodtrykket, som enten var det diastoliske blodtryk (blodtrykket i hvilefasen mellem to hjerteslag) eller det systoliske blodtryk (blodtrykket i hjertekamrenes sammentrækningsfase).
English: When the results of the five studies comparing Rasilez taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Rasilez, from an average of 99.4 mmHg at the start of the study.
Danish: I de fem undersøgelser, hvor Rasilez blev anvendt alene og sammenlignet med placebo, fik patienter under 65 år i gennemsnit mindsket det diastoliske blodtryk med 9,0 mmHg efter otte ugers behandling med Rasilez 150 mg.
English: Rasilez must also not be taken with ciclosporin, itraconazole or other medicines known as ‘potent P-glycoprotein inhibitors' (such as quinidine).
Danish: Rasilez må heller ikke tages sammen med ciclosporin, itraconazol eller andre lægemidler af typen "potente Pglykoproteinhæmmere" (såsom kinidin).
English: Rasilez on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Danish: Når Rasilez blev anvendt alene, var det mere effektivt end placebo og lige så effektivt som sammenligningslægemidlerne til at nedsætte blodtrykket.
English: This was compared with a fall of 5.8 mmHg from 99.3 mmHg in the patients taking placebo.
Danish: Til sammenligning fik patienterne på placebo et fald på 5,8 mmHg fra en startværdi på 99,3 mmHg.