FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Copalia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Copalia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP decided that Copalia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Copalia opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Copalia.
English: What is the risk associated with Copalia?
Danish: Hvilken risiko er der forbundet med Copalia?
English: The most common side effects with Copalia (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Danish: De hyppigste bivirkninger ved Copalia (sm optræder hos mellem 1 og 10 patienter ud af 100) er hovedpine, betændelse i næse og hals (nasopharyngitis), influenza, lavt kaliumindhold i blodet (hypokaliæmi), forskellige former for hævelser (ødemer), træthed, rødmen, kraftesløshed (asteni) og hedeture.
English: The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Copalia and people taking the separate medicines.
Danish: Virksomheden fremlagde desuden dokumentation for, at blodets indhold af amlodipin og valsartan er den samme hos personer, der får Copalia, som hos dem, der får lægemidlerne hver for sig.
English: For the full list of all side effects reported with Copalia, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Copalia fremgår af indlægssedlen.
English: Copalia must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Danish: Copalia må ikke anvendes til patienter med svær lever- eller galdeblæresygdom, patienter med visse hjerteproblemer eller patienter med svær hypotension (lavt blodtryk).
English: Copalia 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: Copalia må heller ikke anvendes i kombination med lægemidler, der indeholder aliskiren (som også anvendes til behandling af essentiel hypertension), hos patienter med type 2-diabetes eller patienter med moderat eller svær nyresygdom.
English: The dose of Copalia to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Danish: Den dosis Copalia, der skal anvendes, afhænger af, hvilken dosis amlodipin eller valsartan patienten fik tidligere.
English: Why has Copalia been approved?
Danish: Hvorfor blev Copalia godkendt?
English: Copalia must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Danish: Copalia må ikke anvendes til patienter, der er overfølsomme (allergiske) over for amlodipin eller andre lægemidler i gruppen af "dihydropyridinderivater", valsartan eller andre af indholdsstofferne.
English: What is Copalia?
Danish: Hvad er Copalia?
English: Copalia contains two active substances, amlodipine and valsartan.
Danish: Copalia indeholder to aktive stoffer, amlodipin og valsartan.
English: Copalia is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Danish: Copalia anvendes til patienter med essentiel hypertension (forhøjet blodtryk), når blodtrykket ikke kan kontrolleres tilstrækkeligt med amlodipin eller valsartan alene.
English: Copalia is a medicine that contains two active substances, amlodipine and valsartan.
Danish: Copalia er et lægemiddel, der indeholder de to aktive stoffer amlodipin og valsartan.
English: Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan.
Danish: Hos de patienter, der fik amlodipin alene, faldt blodtrykket med 10,0 mmHg, sammenlignet med 11,8 mmHg hos dem, der desuden fik 160 mg valsartan.
English: What is Copalia used for?
Danish: Hvad anvendes Copalia til?
English: How has Copalia been studied?
Danish: Hvordan blev Copalia undersøgt?
English: What benefit has Copalia shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Copalia?
English: How is Copalia used?
Danish: Hvordan anvendes Copalia?
English: How does Copalia work?
Danish: Hvordan virker Copalia?
English: Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), indgivelsesvej(e), indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne
English: Napp Pharmaceuticals Ltd. Cambridge Science Park Milton Road
Danish: Storbritannien Napp Pharmaceuticals Ltd. Cambridge Science Park Milton Road
English: Oxycodone hydrochloride/ Naloxone hydrochloride
Danish: Oxycodonhydrochlorid / Naloxonhydrochlorid
English: Sweden Mundipharma AB Mölndalsvägen 30B Göteborg
Danish: Mundipharma AB Mölndalsvägen 30B Göteborg
English: Norpharma A/S Slotsmarken 15, Horsholm
Danish: Norpharma A/S Slotsmarken 15, Hørsholm
English: Mundipharma Pharmaceuticals Ltd. 13, Othellos Street, Dhali Industrial Zone, Nicosia Cyprus
Danish: 13, Othellos Street, Dhali Industrial Zone, Nicosia Cypern
English: Mundipharma Pharmaceuticals Srl Via G. Serbelloni 4, Milano
Danish: Via G. Serbelloni 4, Milano
English: Mundipharma Pharmaceuticals Ltd. Millbank House, Arkle Road Sandyford, Dublin 18 Ireland
Danish: Millbank House, Arkle Road Sandyford, Dublin 18 Irland
English: Germany Mundipharma GmbH Mundipharma Str. 2, Limburg
Danish: Mundipharma GmbH Mundipharma Str. 2, Limburg
English: Luxembourg Mundipharma Comm. VA Blarenberglaan 3C
Danish: Luxemborg Mundipharma Comm. VA Blarenberglaan 3C Mechelen
English: Germany Mundipharma GmbH Mundipharma Str. 2
Danish: Mundipharma GmbH Mundipharma Str. 2 Limburg
English: Denmark Norpharma A/S Slotsmarken 15, Horsholm
Danish: Norpharma A/S Slotsmarken 15 Hørsholm 2970 Danmark
English: Belgium Mundipharma Comm. VA Blarenberglaan 3C,
Danish: Mundipharma Comm. VA Blarenberglaan 3C, Mechelen
English: Luxembourg Mundipharma Comm. VA Blarenberglaan 3C,
Danish: Luxemborg Mundipharma Comm. VA Blarenberglaan 3C, Mechelen
English: Further information on Rizmoic can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/rizmoic
Danish: Yderligere information om Rizmoic findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/rizmoic
English: The recommended dose is one tablet once daily, which the patient can take with or without a laxative.
Danish: Den anbefalede dosis er én tablet én gang dagligt, som patienten kan tage med eller uden afføringsmiddel.
English: As for all medicines, data on the use of Rizmoic are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Rizmoic løbende overvåget.
English: It contains the active substance naldemedine.
Danish: Det indeholder det aktive stof naldemedin.
English: The majority of side effects in patients with or without cancer were mild to moderate.
Danish: De fleste af bivirkningerne hos patienter med eller uden kræft var milde til moderate.
English: The patient must stop taking Rizmoic when they are no longer taking an opioid.
Danish: Patienten skal holde op med at tage Rizmoic, når der ikke længere tages et opioid.
English: For more information about using Rizmoic, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Rizmoic, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Rizmoic is available as 200 microgram tablets.
Danish: Rizmoic fås som 200-mikrogram-tabletter.
English: Other information about Rizmoic
Danish: Andre oplysninger om Rizmoic
English: The European Medicines Agency therefore decided that Rizmoic's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Rizmoic opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Rizmoic?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rizmoic?
English: Furthermore, the side effects of Rizmoic, which mainly affected the gut, were mostly mild or moderate.
Danish: Desuden var bivirkningerne ved Rizmoic, som hovedsagelig påvirkede tarmen, for det meste milde eller moderate.
English: Side effects reported with Rizmoic are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Rizmoic vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
English: Constipation is the most common side effect of opioid pain medicines and many standard laxatives are not effective in treating the condition.
Danish: Forstoppelse er den hyppigste bivirkning ved smertestillende opioide lægemidler, og mange almindelige afføringsmidler er ikke effektive til behandling af tilstanden.
English: An overview of Rizmoic and why it is authorised in the EU
Danish: En oversigt over Rizmoic, og hvorfor det er godkendt i EU
English: Rizmoic can only be obtained with a prescription.
Danish: Rizmoic udleveres kun efter recept.
English: Because molecules of naldemedine were designed not be able to enter into the brain, the medicine does not block opioids from working on pain receptors in the brain and therefore does not interfere with pain relief.
Danish: Fordi molekylerne i naldemedin er designet til ikke at komme ind i hjernen, blokerer lægemidlet ikke opioidernes virkning på smertereceptorerne i hjernen og hindrer derfor ikke smertelindring.
English: Rizmoic must not be used in patients with a blocked or perforated bowel or patients at high risk of bowel blockage.
Danish: Rizmoic må ikke anvendes hos patienter med blokeret eller perforeret tarm eller patienter med høj risiko for blokering af tarmen.
English: The studies compared Rizmoic with placebo (a dummy treatment) to see if treatment would consistently increase the number of patients who can pass stools and allow them to do so at least 3 times a week during treatment.
Danish: I studierne blev Rizmoic sammenlignet med placebo (en uvirksom behandling) for at se, om behandlingen konsekvent ville øge antallet af patienter, der havde afføring, og give dem afføring mindst tre gange om ugen under behandlingen.
English: What is Rizmoic and what is it used for?
Danish: Hvad er Rizmoic, og hvad anvendes det til?
English: In two other studies, involving 307 patients taking opioids for cancer pain, 74% of patients taking Rizmoic for two weeks achieved the desired outcome compared with 36% of patients taking placebo.
Danish: I to andre studier, der omfattede 307 patienter, som tog opioider for kræftsmerter, opnåede 74 % af de patienter, der tog Rizmoic i to uger, det ønskede resultat sammenlignet med 36 % af de patienter, der tog placebo.
English: Why is Rizmoic authorised in the EU?
Danish: Hvorfor blev Rizmoic godkendt i EU?
English: The active substance in Rizmoic, naldemedine, works by attaching to and blocking receptors in the gut (mu-, delta- and kappa-opioid receptors), through which opioid medicines cause constipation.
Danish: Det aktive stof i Rizmoic, naldemedin, virker ved at binde til og blokere receptorerne i tarmen (mu-, delta- og kappaopioidreceptorerne), hvorigennem opioidlægemidler forårsager forstoppelse.
English: The most common side effects with Rizmoic in patients without cancer (which may affect up to 1 in 10 people) are abdominal pain (belly ache), diarrhoea, nausea and vomiting.
Danish: De hyppigste bivirkninger ved Rizmoic hos patienter uden kræft (som kan forekomme hos op til 1 ud af 10 personer) er mavesmerter, diarré, kvalme og opkastning.
English: In patients with cancer, the most common side effects were diarrhoea (seen in more than 1 in 10 people) and abdominal pain (seen in up to 1 in 10 people).
Danish: Hos kræftpatienter var de hyppigste bivirkninger diarré (som optræder hos mere end 1 ud af 10 personer) og mavesmerter (som optræder hos op til 1 ud af 10 personer).
English: In two of the studies, involving 1095 patients taking opioids for chronic (long-term) pain caused by a condition other than cancer, 50% of patients taking Rizmoic for 12 weeks achieved the desired outcome, compared with 34% of patients taking placebo.
Danish: I to af studierne, der omfattede 1.095 patienter, som tog opioider for kroniske (langvarige) smerter forårsaget af en anden sygdom end kræft, opnåede 50 % af de patienter, der tog Rizmoic i 12 uger, det ønskede resultat sammenlignet med 34 % af de patienter, der tog placebo.
English: What are the risks associated with Rizmoic?
Danish: Hvilke risici er der forbundet med Rizmoic?
English: Rizmoic has been shown to improve bowel movement in patients taking opioids pain medicines for long-term pain (including cancer pain).
Danish: Det er påvist, at Rizmoic forbedrer afføringen hos patienter, som tager smertestillende opioide lægemidler for langvarige smerter (herunder kræftsmerter).
English: Rizmoic is a medicine for treating constipation caused by opioid pain relief medicines in patients who have previously been treated with a laxative (a medicine that triggers bowel movements).
Danish: Rizmoic er et lægemiddel til behandling af forstoppelse forårsaget af smertestillende opioide lægemidler hos patienter, som tidligere er blevet behandlet med et laksativ (afføringsmiddel).
English: Studies have shown that Rizmoic is effective at improving bowel movement in patients who are currently taking laxatives or had taken laxatives in the past.
Danish: Studierne har vist, at Rizmoic effektivt forbedrer afføringen hos patienter, der tager afføringsmidler eller tidligere har taget afføringsmidler.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rizmoic have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Rizmoic.
English: How is Rizmoic used?
Danish: Hvordan anvendes Rizmoic?
English: What benefits of Rizmoic have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Rizmoic?
English: How does Rizmoic work?
Danish: Hvordan virker Rizmoic?
English: Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Administration Emballage Indhold
English: Tmax is between 3 and 8 hours.
Danish: tmax er mellem 3 og 8 timer.
English: ● Do not take a double dose to make up for a forgotten dose.
Danish: • De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: for 7 days.
Danish: 7 dage.
English: The volume of distribution is around 10 l/kg.
Danish: Fordelingsvolumen er ca. 10 l/kg.
English: You may experience increased symptoms as described in section 4.
Danish: De kan opleve forøgede symptomer, som beskrevet i pkt.
English: ● other NMDA-antagonists at the same time should be avoided.
Danish: • andre NMDA-antagonister bør undgås.
English: Once daily
Danish: Én gang dagligt
English: ● cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
Danish: • cimetidin, ranitidin, procainamid, quinidin, quinin, nikotin
English: 20 days, more than 99% being excreted renally.
Danish: 20 dage, mere end 99% blev udskilt via nyrerne.
English: Adverse reactions are ranked according to system organ class, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opdelt efter organklassesystem med følgende betegnelser: Meget almindelig (1/10), almindelig (1/100 til <1/10), ikke almindelig (1/1.000 til <1/100), sjælden (1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: ● dantrolene, baclofen
Danish: • dantrolen, baklofen
English: ● hydrochlorothiazide (or any combination with hydrochlorothiazide)
Danish: • hydrochlorothiazid (eller en hvilken som helst kombination med hydrochlorothiazid)
English: As the effects have neither been observed in long term studies in rodents nor in non-rodents, the clinical relevance of these findings is unknown.
Danish: Da virkningerne hverken er observeret i langtidsstutudier med gnavere eller med ikke-gnavere, er den kliniske relevans af disse observationer ukendt.
English: Children and adolescents Memantine ratiopharm is not recommended for children and adolescents under the age of 18 years.
Danish: Børn og unge Memantine ratiopharm anbefales ikke til børn og unge under 18 år.
English: ● In general, taking too much Memantine ratiopharm should not result in any harm to you.
Danish: • Generelt burde indtagelse af for meget Memantine ratiopharm ikke være skadeligt for Dem.
English: Polyvinyl alcohol (E 1203)
Danish: Polyvinylalkohol (E 1203)
English: Talc (E 553b)
Danish: Talcum (E 553b)
English: ● If you find you have forgotten to take your dose of Memantine ratiopharm, wait and take your next dose at the usual time.
Danish: • Hvis De har glemt at tage Deres dosis af Memantine ratiopharm, skal De vente og tage Deres næste dosis på det sædvanlige tidspunkt.
English: It is not known whether memantine is excreted in human breast milk but, taking into consideration the lipophilicity of the substance, this probably occurs.
Danish: Det er ukendt, om memantin udskilles i human brystmælk, men i betragtning af stoffets lipofilicitet forventes dette at være tilfældet.
English: Slabinská 30, 03680 Martin Slovakia
Danish: Slabinská 30, 03680 Martin Slovakiet
English: SL-03680 Martin Slovakia
Danish: SL-03680 Martin Slovakiet
English: In particular, Memantine ratiopharm may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
Danish: I særdeleshed kan Memantine ratiopharm ændre virkningen af følgende lægemidler, og lægen kan derfor være nødt til at ændre doseringen:
English: ● amantadine, ketamine, dextromethorphan
Danish: • amantadin, ketamin, dextromethorfan
English: Polysorbate 80 (E 433)
Danish: Polysorbat 80 (E 433)
English: ● amantadine (for the treatment of Parkinson's disease),
Danish: • amantadin (til behandling af Parkinsons sygdom)
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine ratiopharm reassessed by your doctor on a regular basis.
Danish: I disse situationer bør behandlingen overvåges nøje, og den kliniske gavn af Memantine ratiopharm skal regelmæssigt vurderes af Deres læge.
English: ● dopaminergic agonists (substances such as L-dopa, bromocriptine)
Danish: • dopaminerge agonister (stoffer såsom L-dopa, bromokriptin)
English: If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
Danish: Hvis De har nedsat nyrefunktion (nyreproblemer), bør Deres læge nøje overvåge Deres nyrefunktion og om nødvendigt tilpasse memantin-dosen derefter.
English: Memantine ratiopharm should be administered orally once a day and should be taken at the same time every day.
Danish: Memantine ratiopharm gives oralt én gang om dagen og bør indtages på samme tidspunkt hver dag.
English: The Memantine ratiopharm treatment initiation pack is only to be used for the beginning of the treatment with Memantine ratiopharm.
Danish: Startpakken til behandling med Memantine ratiopharm må kun anvendes i begyndelsen af behandlingen med Memantine ratiopharm.
English: Take one tablet once a day.
Danish: Tag én tablet én gang dagligt.
English: Not known (frequency cannot be estimated from the available data): ● Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data): • Betændelse i bugspytkirtlen, leverbetændelse (hepatitis) og psykotiske reaktioner.
English: - In post-marketing experience, isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
Danish: - Efter markedsføringen er der rapporteret enkeltstående tilfælde af stigninger i INR (International normalized ratio) hos patienter i samtidig behandling med warfarin.
English: Memantine ratiopharm belongs to a group of medicines called NMDA-receptor antagonists.
Danish: Memantine ratiopharm hører til en gruppe af lægemidler kaldet NMDA-receptor-antagonister.
English: There are no or limited amount of data from the use of memantine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af memantin til gravide kvinder.
English: - The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.
Danish: - Virkemåden antyder, at effekten af L-dopa, dopaminerge agonister og antikolinergika kan forstærkes ved samtidig behandling med NMDA-antagonister såsom memantin.
English: Pharmacotherapeutic group: Psychoanaleptics.
Danish: Farmakoterapeutisk klassifikation: Psychoanaleptica.
English: Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
Danish: Samtidig brug af N-metyl-D-aspartat(NMDA)-antagonister såsom amantadin, ketamin eller dextromethorfan bør undgås.
English: Other Anti-dementia drugs, ATC code: N06DX01.
Danish: Andre antidemenspræparater, ATC-kode: N06DX01.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister pack after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisterpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The most frequently occurring adverse reactions with a higher incidence in the memantine group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%).
Danish: Bivirkninger, der forekom oftest og med en højere incidens i gruppen behandlet med memantin end i gruppen behandlet med placebo, var svimmelhed (hhv. 6,3% vs. 5,6%), hovedpine (5,2% vs. 3,9%), forstoppelse (4,6% vs. 2,6%), sløvhed (søvntrang) (3,4% vs. 2,2%) og hypertension (4,1% vs. 2,8%).
English: - There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT.
Danish: - Der er mulighed for en reduktion i serumkoncentrationen af hydrochlorothiazid (HCT), når memantin administreres sammen med HCT eller sammen med kombinationspræparater med HCT.
English: This is increased to one tablet once a day (1x 10 mg) in the second week and to one and a half tablets once a day in the third week.
Danish: Denne øges til en tablet én gang dagligt (1x 10 mg) i den anden uge og til halvanden tablet én gang dagligt i den tredje uge.
English: Headache Fatigue 1 Hallucinations have mainly been observed in patients with severe Alzheimer's disease.
Danish: Hovedpine Udmattelse 1 Hallucinationer er hovedsageligt observeret hos patienter med svær Alzheimers sygdom.
English: The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week.
Danish: Den anbefalede vedligeholdelsesdosis er 20 mg én gang dagligt, som nås i begyndelsen af den 4. uge.