FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP decided that Memantine Merz's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Memantine Merz opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: However, when these results were considered along with those of the three additional studies, it was noted that the effect of Memantine Merz was smaller in patients with mild disease.
Danish: Men når disse resultater blev sammenholdt med resultaterne af de tre supplerende undersøgelser, fremgik det, at virkningen af Memantine Merz var mindre hos patienter med let sygdom.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine Merz by the patient.
Danish: Behandlingen må kun iværksættes, hvis der er en plejer tilstede, som regelmæssigt overvåger patientens indtagelse af Memantine Merz.
English: Memantine Merz was more effective than placebo at controlling the symptoms of Alzheimer's disease.
Danish: Memantine Merz var mere effektivt end placebo til at begrænse symptomerne på Alzheimers sygdom.
English: Memantine Merz has been studied in three main studies including a total of 1,125 patients with Alzheimer's disease, some of whom had taken other medicines for their disease in the past.
Danish: Memantine Merz blev anvendt i tre hovedundersøgelser med i alt 1 125 patienter med Alzheimers sygdom, hvoraf nogle tidligere havde fået anden medicin mod sygdommen.
English: Memantine Merz is used to treat patients with moderate to severe Alzheimer's disease.
Danish: Memantine Merz anvendes til behandling af patienter med moderat til svær Alzheimers sygdom.
English: Memantine Merz is also available as an oral solution, which is supplied with a pump that delivers 5 mg memantine hydrochloride with each activation.
Danish: Memantine Merz fås også som en oral opløsning, der leveres med en pumpe, som afgiver 5 mg memantinhydrochlorid ved hver aktivering.
English: Memantine Merz memantine hydrochloride
Danish: Memantine Merz memantinhydrochlorid
English: Memantine Merz must not be used in people who are hypersensitive (allergic) to memantine hydrochloride or any of the other ingredients.
Danish: Memantine Merz må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for memantinhydrochlorid eller andre af indholdsstofferne.
English: Memantine Merz was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.
Danish: Memantine Merz blev desuden anvendt i tre supplerende undersøgelser med i alt 1 186 patienter med let til svær sygdom.
English: The active substance in Memantine Merz, memantine hydrochloride, is an antidementia medicine.
Danish: Det aktive stof i Memantine Merz, memantinhydrochlorid, er et middel mod demens.
English: Memantine Merz is a medicine that contains the active substance memantine hydrochloride.
Danish: Memantine Merz er et lægemiddel, der indeholder det aktive stof memantinhydrochlorid.
English: In the study of moderately severe to severe disease, patients taking Memantine Merz had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores.
Danish: I undersøgelsen af patienter med moderat svær til svær sygdom resulterede Memantine Merz efter 28 uger i færre symptomer end placebo, målt både på samlet score og funktionsscore.
English: For the full list of all side effects reported with Memantine Merz, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Memantine Merz fremgår af indlægssedlen.
English: Other information about Memantine Merz
Danish: Andre oplysninger om Memantine Merz:
English: What is the risk associated with Memantine Merz?
Danish: Hvilken risiko er der forbundet med Memantine Merz?
English: In the two studies of mild to moderate disease, patients on Memantine Merz had less severe symptoms after 24 weeks, as measured on the global and cognitive scores.
Danish: I de to undersøgelser af let til moderat sygdom havde de patienter, der fik Memantine Merz, efter 24 uger færre alvorlige symptomer.
English: Why has Memantine Merz been approved?
Danish: Hvorfor blev Memantine Merz godkendt?
English: What is Memantine Merz?
Danish: Hvad er Memantine Merz?
English: How has Memantine Merz been studied?
Danish: Hvordan blev Memantine Merz undersøgt?
English: What is Memantine Merz used for?
Danish: Hvad anvendes Memantine Merz til?
English: How is Memantine Merz used?
Danish: Hvordan anvendes Memantine Merz?
English: How does Memantine Merz work?
Danish: Hvordan virker Memantine Merz?
English: What benefit has Memantine Merz shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Memantine Merz?
English: Most of them occurred during the first months of treatment.
Danish: De fleste tilfælde opstod i de første måneder af behandlingen.
English: From post-marketing surveillance
Danish: Overvågning efter markedsføring
English: Your doctor may ask you to undergo blood tests to check your liver function.
Danish: Din læge vil muligvis bede dig om at få taget blodprøver for at tjekke din leverfunktion.
English: Patients with such form of the disease may derive less benefit from treatment.
Danish: Patienter med denne form for sygdom vil muligvis have mindre gavn af behandlingen.
English: • Current and/or history of liver disease
Danish: • Nuværende og/eller tidligere leversygdom
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Danish: Bilag III Ændringer til relevante afsnit i produktresumé og indlægsseddel
English: As some patients may experience loose stools or diarrhoea, the recommended starting dose is 50 mg once daily with evening meal for the first 2 to 4 weeks of treatment, after which the recommended daily dose is 50mg twice daily.
Danish: Da nogle patienter kan opleve løs afføring eller diarré, er den anbefalede startdosis 50 mg dagligt sammen med aftenmåltidet i de første 2-4 behandlingsuger, hvorefter den anbefalede dosis er 50 mg to gange dagligt.
English: As a rule, these effects abate with continuing treatment.
Danish: Disse bivirkninger aftager generelt ved fortsat behandling.
English: It takes some time for [Invented Name] to have its effect.
Danish: Det tager nogen tid, før [Særnavn] begynder at virke.
English: Treatment of symptoms in patients with osteoarthritis of the hip or knee, with delayed effect.
Danish: Behandling af symptomer hos patienter med hofte- eller knæartrose, med forsinket virkning.
English: [The dose recommendation for adults should be as follows]
Danish: Dosering [Dosisanbefalingen for voksne skal være som følger]
English: [The following wording should also be reflected in this section] Diacerein is not recommended in patients older than 65 years.
Danish: [Følgende ordlyd skal ligeledes afspejles i denne sektion] Diacerein anbefales ikke til patienter over 65 år.
English: If you have diarrhoea while taking this medicine, stop taking [Invented Name] and contact your doctor to discuss which other treatments you can take.
Danish: Hvis du får diarré, mens du tager medicinen, skal du stoppe med at tage [Særnavn] og kontakte din læge for at tale om, hvilke andre behandlingsmuligheder du har.
English: In some cases, diarrhoea was severe with complications such as dehydration and disorders of fluid and electrolyte balance.
Danish: I nogle tilfælde var diarré alvorlig med komplikationer såsom dehydrering og forstyrrelser i elektrolyt- og væskebalancen.
English: How to take [Invented Name]
Danish: Sådan skal du tage [Særnavn]
English: The treatment should be taken with food, one with breakfast and the other with evening meal.
Danish: [Særnavn] bør tages sammen med mad, én til morgenmåltidet og én til aftenmåltidet.
English: Caution should be exercised in patients receiving diuretics, because dehydration and hypokalaemia may occur.
Danish: Der bør udvises forsigtighed hos patienter, der får diuretika, da dehydrering og hypokaliæmi kan forekomme.
English: Before treatment with diacerein is initiated, the patient should be questioned about possible comorbid conditions and past or concurrent liver disease and screened for major causes of active hepatic disease.
Danish: Før behandlingen med diacerein igangsættes, bør patienten spørges om eventuelle komorbide tilstande og tidligere eller nuværende leversygdom og skal screenes for væsentlige årsager til aktiv leversygdom.
English: 4.4 Special warnings and precautions for use [The wording on diarrhoea and hepatotoxicity in this section should be presented and read as follows]
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen [Formuleringen, der omhandler diarré og hepatotoksicitet i dette afsnit, skal præsenteres og lyde som følger]
English: Tell your doctor immediately if you have abdominal pain, jaundice (yellow discolouration of the eyes or skin), impaired consciousness or itching of the skin, as these may indicate serious conditions such as liver disease.
Danish: Fortæl det straks til din læge, hvis du får mavesmerter, gulsot (gul misfarvning af øjne og hud), nedsat bevidsthed eller hudkløe, da det kan være tegn på alvorlige tilstande såsom leversygdom.
English: Patients should be advised to limit their alcohol intake while on treatment with diacerein.
Danish: Patienterne bør opfordres til at begrænse deres alkoholindtagelse, mens de er i behandling med diacerein.
English: [The following wording should be reflected in this section] In some cases, diarrhoea can be severe with life threatening complications such as fluid loss and electrolyte disturbances.
Danish: [følgende formulering skal afspejles i denne sektion] I nogle tilfælde kan diarré være alvorlig med livstruende komplikationer såsom væsketab og forstyrrelser i elektrolytbalancen.
English: 4.1 Therapeutic indications [This section should be read as follows]
Danish: 4.1 Terapeutiske indikationer [Afsnittet skal have følgende ordlyd]
English: Warnings and precautions [The following wording should be reflected in this section]
Danish: Advarsler og forsigtighedsregler [Følgende ordlyd skal afspejles i denne sektion]
English: Concomitant intake of laxatives should be avoided.
Danish: Samtidig behandling med laksantia bør undgås.
English: Treatment with diacerein is not recommended in patients with rapidly progressive hip osteoarthritis, as they may have a weaker response to diacerein.
Danish: Behandling med diacerein anbefales ikke til patienter med hurtigt progredierende hofteartrose, da disse patienter kan reagere dårligere på diacerein.
English: Intake of diacerein can lead to diarrhoea and hypokalaemia.
Danish: Indtagelse af diacerein kan medføre diarré og hypokaliæmi.
English: [The following contraindication should be added in this section and replace any existing wording on hepatic insufficiency]
Danish: [Følgende kontraindikation skal indsættes i dette afsnit og erstatte enhver ordlyd om leverinsufficiens]
English: Patients should be advised to stop diacerein treatment in case of diarrhoea and contact their physician to discuss treatment alternatives.
Danish: Patienterne bør informeres om, at de skal stoppe behandlingen med diacerein, hvis de får diarré, og kontakte deres læge for at drøfte behandlingsalternativer.
English: Signs of hepatic injury should be monitored and caution should be exercised when diacerein is used concomitantly with other medicinal products associated with hepatic injury.
Danish: Tegn på leverskade bør overvåges, og der skal udvises forsigtighed, når diacerein gives sammen med andre lægemidler, der er forbundet med leverskade.
English: Particular caution should also be exercised in case of hypokalaemia in patients treated with cardiac glycosides (digitoxin, digoxin) (see section 4.5).
Danish: Der bør udvises særlig forsigtighed i tilfælde af hypokaliæmi hos patienter i behandling med hjerteglykosider (digitoxin, digoxin) (se pkt.
English: Treatment with diacerein should be stopped if elevation of hepatic enzymes or suspected signs or symptoms of liver damage are detected.
Danish: Behandlingen med diacerein bør stoppes, hvis der observeres forhøjede leverenzymer, eller hvis der opstår mistanke om tegn eller symptomer på leverskade.
English: Patients should be advised about the signs and symptoms of hepatotoxicity and must be advised to immediately contact their physician in case of appearance of symptoms suggestive of liver damage.
Danish: Patienterne bør informeres om tegn og symptomer på hepatotoksicitet og om, at de straks skal opsøge deres læge, hvis de får symptomer, som kan tyde på leverskade.
English: What [Invented Name] is and what it is used for [This section should be read as follows] [Invented Name] contains diacerein and is used to relieve symptoms of osteoarthritis of the hip or knee.
Danish: Virkning og anvendelse [Afsnittet skal lyde som følger] [Særnavn] indeholder diacerein og anvendes til at lindre symptomer på artrose (slidgigt) i hofte eller knæ.
English: Treatment with [Invented Name] is therefore not recommended for a specific form of hip osteoarthritis called rapidly progressive (worsening) hip osteoarthritis.
Danish: Behandling med [Særnavn] anbefales derfor ikke til den type artrose (slidgigt) i hoften, som er kendetegnet ved at udvikle sig og forværres hurtigt.
English: The capsules must be swallowed intact, without opening them, with a glass of water.
Danish: Kapslerne skal tages med et glas vand, sluges hele og må ikke åbnes.
English: Patients should be monitored for signs and symptoms of hepatic injury (see section 4.4).
Danish: Patienterne skal overvåges for tegn og symptomer på leverskade (se pkt.
English: [The following side effects should be inserted in this paragraph] Very common side effects (may affect more than 1 in 10 people treated): - diarrhoea, - abdominal pain
Danish: [Nedenstående bivirkninger skal indsættes i dette afsnit] Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 behandlede): - diarré - mavesmerter
English: Very common (> 1/10): diarrhoea, abdominal pain.
Danish: GASTROINTESTINALE FORSTYRRELSER Meget almindelig (> 1/10): Diarré, abdominalsmerter.
English: Liver problems including raised liver enzymes in the blood and hepatitis (inflammation in the liver) have been reported in some patients taking diacerein.
Danish: Der har været indberetninger om leverproblemer, herunder forhøjede leverenzymer i blodet og hepatitis (leverbetændelse) hos nogle patienter, som har taget diacerein.
English: Caution must be exercised in the concomitant administration of diuretics (high-ceiling loop and thiazides) and/or cardiac glycosides (digitoxin, digoxin), as the risk of arrhythmia is increased (see section 4.4).
Danish: Der skal udvises forsigtighed hos patienter, der er i samtidig behandling med diuretika (loop-diuretika og thiazider) og/eller hjerteglykosider (digitoxin, digoxin), da risikoen for arytmi er øget (se pkt.
English: The amendments to the Summary of Product Characteristics and package leaflets may need to be subsequently updated by the national competent authorities, in liaison with the Reference Member State if appropriate
Danish: Det kan efterfølgende være nødvendigt, at de relevante nationale myndigheder, i samarbejde med referencelandet, opdaterer ændringerne til produktresumé og indlægsseddel.
English: Cases of acute liver injury, including elevated serum hepatic enzymes and cases of hepatitis have been reported in the post-marketing phase with diacerein.
Danish: Der er indberettet tilfælde af akut leverskade, herunder forhøjede leverenzymer i serum og tilfælde af hepatitis efter markedsføring af diacerein.
English: A diagnosis of liver disease is a contraindication to diacerein use (see section 4.3).
Danish: Diagnosen leversygdom er kontraindikation for behandling med diacerein (se pkt.
English: [In addition, any existing dose recommendation for patients with hepatic impairment should be deleted from this section as diacerein is now contraindicated in patients with liver disease.]
Danish: [Herudover skal enhver dosisanbefaling for patienter med nedsat leverfunktion slettes fra dette afsnit, da diacerein nu er kontraindiceret til patienter med leversygdom.]
English: [The following side effects should be inserted in this paragraph] Common side effects (may affect up to 1 in 10 people treated): - frequent bowel movements, - flatulence - pruritus (itching), rash, eczema (itchy, red rash).
Danish: [Nedenstående bivirkninger skal indsættes i dette afsnit] Almindelige bivirkninger (forekommer hos op til 1 ud af 10 behandlede): - hyppigere afføring, - flatulens (luft i maven) - kløe, udslæt, eksem (kløende, rødt udslæt)
English: [The following wording should be reflected in this section] It is recommended that you start treatment with one capsule in the evening for the first 2-4 weeks, after which the dose can be increased to two capsules per day.
Danish: Det anbefales, at du starter behandlingen med én kapsel om aftenen i de første 2-4 uger.
English: [Invented Name] with food, drink and alcohol [The following wording should be reflected in this section] Drinking alcohol while taking [Invented Name] may increase the risk of liver damage.
Danish: [Følgende ordlyd skal afspejles i denne sektion] Hvis du drikker alkohol sammen med [Særnavn], kan det øge risikoen for leverskade.
English: [In addition, any existing dose recommendation in case of hepatic impairment should be deleted from this section as diacerein is now contraindicated in patients with liver disease.]
Danish: [Herudover skal enhver dosisanbefaling ved nedsat leverfunktion slettes fra dette afsnit, da diacerein nu er kontraindiceret til patienter med leversygdom.]
English: You should limit your alcohol consumption while you are undergoing treatment with [Invented Name].
Danish: Du bør begrænse dit alkoholindtag, mens du er i behandling med [Særnavn].
English: Uncommon (≥ 1/1000 and < 1/100): Cases of elevated hepatic enzymes in serum.
Danish: LEVER OG GALDEVEJE Ikke almindelig (≥ 1/1000 til < 1/100): Forhøjede leverenzymer i serum.
English: Common (> 1/100 and < 1/10): frequent bowel movements, flatulence.
Danish: Almindelig (> 1/100 til < 1/10): Øgede tarmbevægelser, flatulens.
English: Common (> 1/100 and < 1/10): pruritus, rash, eczema.
Danish: HUD OG SUBKUTANE VÆV Almindelig (> 1/100 til < 1/10): Pruritus, udslæt, eksem.
English: Possible side effects
Danish: 4.8 Bivirkninger
English: [Invented Name] should be taken with food, one with breakfast and the other with the evening meal.
Danish: Brug af [Særnavn] sammen med mad, drikke og alkohol
English: [The following text should be reflected in this section]
Danish: [Følgende tekst skal afspejles i denne sektion]
English: [The following wording should be reflected in this section]
Danish: [Følgende ordlyd skal afspejles i denne sektion]
English: Other medicines and [Invented Name] [The following wording should be reflected in this section] Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Intake of diacerein frequently leads to diarrhoea (see section 4.8) that can consequently lead to dehydration and hypokalaemia.
Danish: 4.8), som kan føre til dehydrering og hypokaliæmi.
English: Elevated serum hepatic enzyme levels and symptomatic acute hepatic injury have been reported with diacerein in the post-marketing phase (see section 4.8).
Danish: Efter markedsføring er der blevet indberettet tilfælde af forhøjede leverenzymer i serum og symptomatisk akut leverskade relateret til diacerein (se pkt.
English: What you need to know before you take [Invented Name] Do not take [Invented Name]: [The following contraindication should be added here and replace any existing wording on hepatic insufficiency]
Danish: Tag ikke [Særnavn]: [Følgende kontraindikation skal tilføjes her og erstatte enhver formulering om leverinsufficiens] - hvis du har eller har haft leverproblemer.
English: (Invented) Name
Danish: (Særnavn) navn
English: Pharmaceutical Form
Danish: Lægemiddelform Administration Emballlage
English: MA EU Number
Danish: Markedsføringsti lladelsesnummer (EU)
English: Content Pack Size
Danish: Pakningsstørrelse
English: Responses were maintained on average for around 14 months.
Danish: Responsen blev i gennemsnit fastholdt i ca. 14 måneder.
English: Treatment can continue for as long as the patient benefits from it.
Danish: Behandlingen kan fortsætte, så længe patienten har gavn af den.
English: Further information on Alunbrig can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Alunbrig.
Danish: Yderligere information om Alunbrig findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Alunbrig.
English: The medicine is available as tablets (30 mg, 90 mg and 180 mg).
Danish: Lægemidlet fås som tabletter (30 mg, 90 mg og 180 mg).
English: Out of patients who received 90 mg Alunbrig a day and increased to 180 mg after 7 days, around 56% showed a complete or partial response to the medicine.
Danish: Ud af de patienter, der fik 90 mg Alunbrig daglig og blev sat op til 180 mg efter syv dage, udviste ca. 56 % en fuldstændig eller delvis respons på lægemidlet.
English: As for all medicines, data on the use of Alunbrig are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Alunbrig løbende overvåget.
English: Other information about Alunbrig
Danish: Andre oplysninger om Alunbrig
English: The recommended starting dose is 90 mg taken once a day for the first 7 days and then increased to 180 mg once a day afterwards.
Danish: Den anbefalede startdosis er 90 mg en gang daglig i de første syv dage, som derefter øges til 180 mg en gang daglig.
English: For more information about using Alunbrig, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Alunbrig, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The most common side effects with Alunbrig (which may affect more than 1 in 4 people) are hyperglycaemia (high blood sugar levels), hyperinsulinaemia (high blood insulin levels), anaemia (low red blood cell counts), nausea (feeling sick), low white blood cell counts including decreased levels of the white blood cells called lymphocytes, diarrhoea, tiredness, cough, headache, hypophosphataemia (low blood levels of phosphates), rash, vomiting, dyspnoea (difficulty breathing), hypertension (high blood pressure), myalgia (muscle pain), peripheral neuropathy (damage to the nerves in the extremities) and blood test results indicating abnormalities of liver (increased levels of ALT and AST and alkaline phosphatase), pancreas (increased lipase and amylase), muscle function (increased CPK) or blood clotting (increased APTT).
Danish: De hyppigste bivirkninger ved Alunbrig (som optræder hos mere end 1 ud af 4 patienter) er hyperglykæmi (forhøjet blodsukker), hyperinsulinæmi (forhøjet insulinindhold i blodet), anæmi (lavt antal røde blodlegemer), kvalme, lavt antal hvide blodlegemer, herunder nedsat antal af en type hvide blodlegemer kaldet lymfocytter, diarré, træthed, hoste, hovedpine, hypofosfatæmi (for lavt fosfatindhold i blodet), udslæt, opkastning, dyspnø (vejrtrækningsbesvær), hypertension (højt blodtryk), myalgi (muskelsmerter), perifer neuropati (beskadigelse af nerverne i ekstremiteterne) og resultater af blodprøver, som viser abnormiteter i leveren (forhøjet ALAT og ASAT og alkalisk fosfatase), bugspytkirtlen (forhøjet lipase og amylase), muskelfunktion (forhøjet CPK) eller blodstørkning (forhøjet APTT).
English: What measures are being taken to ensure the safe and effective use of Alunbrig?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Alunbrig?
English: Alunbrig was not compared with any other treatment or placebo (a dummy treatment).
Danish: Alunbrig blev ikke sammenlignet med anden behandling eller placebo (en uvirksom behandling).
English: The European Medicines Agency decided that Alunbrig's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Alunbrig opvejer risiciene, og at det kan godkendes til anvendelse i EU.