FrancophonIA/ELRC3.0 huggingface dataset:
English: The geometric mean ratios and 90% CIs for the comparison of plasma exposure (AUC and AUC(0-t)) to simvastatin after administration of the fixed dose combination Cholib 145 mg/20 mg tablet and after co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program, were within the 80-125% bioequivalence interval.
Danish: De geometriske gennemsnitlige ratioer og 90 % konfidensintervaller for sammenligningen af eksponeringen af simvastatin i plasma (AUC og AUC(0-t)) efter administration af fastdosiskombinationen Cholib 145 mg/20 mg tabletter og efter samtidig administration af separate tabletter med fenofibrat 145 mg og simvastatin 20 mg, som anvendt i det kliniske program, lå indenfor 80-125 % bioækvivalensintervallet.
English: • increase in “creatine phosphokinase” - produced by the muscle - shown in tests
Danish: • forhøjet kreatinfosfokinase - (produceres af nyrerne) - vist ved prøver
English: Effects on the pharmacokinetics of other medicinal products Fenofibrate and simvastatin are not CYP 3A4 inhibitors or inducers.
Danish: Fenofibrat og simvastatin er ikke CYP 3A4-hæmmere eller -inducere.
English: The geometric mean ratios and 90% CIs for the comparison of AUC, AUC(0-t) and Cmax for fenofibric acid, simvastatin and simvastatin acid of the fixed dose combination Cholib 145 mg/40 mg tablet and the co-administration of the separate 145 mg fenofibrate and 40 mg simvastatin tablets as used in the clinical program, were all within the 80-125% bioequivalence interval.
Danish: De geometriske gennemsnitlige ratioer og 90 % konfidensintervaller for sammenligningen af AUC, AUC(0-t) og Cmax for fenofibrinsyre, simvastatin og simvastatinsyre i fastdosiskombinationen Cholib 145 mg/40 mg tabletter og den samtidige administration af separate tabletter 145 mg fenofibrat og 40 mg simvastatin, som anvendt i det kliniske program, lå alle indenfor 80-125 % bioækvivalensintervallet.
English: N Means (SD) Treatment Comparison*
Danish: Behandlingsgruppe N Middelværdier (SD)
English: Sexual dysfunction uncommon
Danish: Seksuel dysfunktion
English: Avoid when taking Cholib
Danish: Undgå indtag under behandling med Cholib
English: Non-HDL-C (mmol/L)
Danish: Non-HDL-koleste rol (mmol/l)
English: The geometric mean ratios and 90% CIs for the comparison of AUC, AUC(0-t) and Cmax of the active metabolites, fenofibric acid and simvastatin acid, of the fixed dose combination Cholib 145 mg/20 mg tablet and the co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program, were all within the 80-125% bioequivalence interval.
Danish: De geometriske gennemsnitlige ratioer og 90 % konfidensintervaller for sammenligningen af AUC, AUC(0-t) og Cmax for de aktive metabolitter, fenofibrinsyre og simvastatinsyre, af fastdosiskombinationen Cholib 145 mg/20 mg tabletter og den samtidige administration af fenofibrattabletter 145 mg og simvastatintabletter 20 mg, som anvendt i det kliniske program, lå alle indenfor 80-125 % bioækvivalensintervallet.
English: Fenofibric acid is not eliminated by hemodialysis.
Danish: Fenofibrinsyre elimineres ikke ved hæmodialyse.
English: HDL-C
Danish: HDL-kolesterol
English: • increase in “urea” - produced by the kidneys - shown in tests
Danish: • forhøjet urinstof - (produceres af nyrerne) - vist ved prøver
English: In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment.
Danish: Statinbehandlingen bør afbrydes under hele behandlingsforløbet med fusidinsyre hos patienter, for hvem brug af fusidinsyre menes at være afgørende.
English: Cholib 145 mg/20 mg film-coated tablets
Danish: Cholib 145 mg/20 mg filmovertrukne tabletter
English: What Cholib is and what it is used for What you need to know before you take Cholib How to take Cholib
Danish: Det skal du vide, før du begynder at tage Cholib Sådan skal du tage Cholib Bivirkninger
English: Cholib 145 mg/40 mg film-coated tablets
Danish: Cholib 145 mg/40 mg filmovertrukne tabletter
English: HDL-C (mmol/L)
Danish: HDL-kolesterol (mmol/l)
English: Platelet count increased
Danish: Forhøjet trombocyttal
English: One film-coated tablet contains 145 mg of fenofibrate and 20 mg of simvastatin.
Danish: En filmovertrukket tablet indeholder 145 mg fenofibrat og 20 mg simvastatin.
English: One film-coated tablet contains 145 mg of fenofibrate and 40 mg of simvastatin.
Danish: En filmovertrukket tablet indeholder 145 mg fenofibrat og 40 mg simvastatin.
English: Cholib 145 mg/40 mg tablets fenofibrate/simvastatin
Danish: Cholib 145 mg/40 mg tabletter fenofibrat/simvastatin
English: Cholib 145 mg/20 mg tablets fenofibrate/simvastatin
Danish: Cholib 145 mg/20 mg tabletter fenofibrat/simvastatin
English: If any of the above applies to you, talk to your doctor or pharmacist before taking Cholib.
Danish: Tal med lægen eller apotekspersonalet, inden du tager Cholib, hvis noget af ovenstående gælder for dig.
English: Statin monotherapy
Danish: Monoterapi med statin
English: The film-coated tablet (tablet) is a, oval, biconvex, brick red coloured 19.3 x 9.3 mm tablet with bevelled edges and the inscription 145/40 on one side and the Abbott logo on the other side.
Danish: Den filmovertrukne tablet er en oval, bikonveks, murstensrød, 19,3 x 9,3 mm tablet med skråkanter og præget med 145/40 på den ene side og Abbotts logo på den anden side.
English: 0503 atorvastatin 10 mg atorvastatin 10 mg simvastatin 20 mg atorvastatin 20 mg simvastatin 40 mg
Danish: 0503 atorvastatin atorvastatin simvastatin 20 mg atorvastatin simvastatin 40 mg
English: Hepatobiliary disorders Transaminases increased common
Danish: Forhøjede transaminaser
English: The film-coated tablet (tablet) is a, oval, biconvex, tan coloured 19.3 x 9.3 mm tablet with bevelled edges and the inscription 145/20 on one side and the Abbott logo on the other side.
Danish: Den filmovertrukne tablet er en oval, bikonveks, gyldenbrun, 19,3 x 9,3 mm tablet med skråkanter og præget med 145/20 på den ene side og Abbotts logo på den anden side.
English: Cholib 145 mg/20 mg film-coated tablets fenofibrate/simvastatin
Danish: Cholib 145 mg/20 mg filmovertrukne tabletter fenofibrat/simvastatin
English: Cholib 145 mg/40 mg film-coated tablets fenofibrate/simvastatin
Danish: Cholib 145 mg/40 mg filmovertrukne tabletter fenofibrat/simvastatin
English: Oval, biconvex, brick red coloured, 19.3 x 9.3 mm film-coated tablet with bevelled edges and the inscription 145/40 on one side and the Abbott logo on the other side.
Danish: Ovale, bikonvekse, murstensrøde, 19,3 x 9,3 mm filmovertrukne tabletter med skråkanter og præget med 145/40 på den ene side og Abbotts logo på den anden side.
English: Each tablet contains 145 mg of fenofibrate and 20 mg of simvastatin
Danish: En tablet indeholder 145 mg fenofibrat og 20 mg simvastatin
English: Each tablet contains 145 mg of fenofibrate and 40 mg of simvastatin
Danish: En tablet indeholder 145 mg fenofibrat og 40 mg simvastatin
English: Each tablet contains 145 mg of fenofibrate and 20 mg of simvastatin.
Danish: En tablet indeholder 145 mg fenofibrat og 20 mg simvastatin.
English: Each tablet contains 145 mg of fenofibrate and 40 mg of simvastatin.
Danish: En tablet indeholder 145 mg fenofibrat og 40 mg simvastatin.
English: CYP 3A4 inhibitors: fluconazole, verapamil, or diltiazem (see sections 4.3 and 4.4).
Danish: Der skal udvises forsigtighed ved kombination af Cholib med visse andre mindre potente CYP 3A4-hæmmere: fluconazol, verapamil eller diltiazem (se pkt.
English: Oval, biconvex, tan coloured, 19.3 x 9.3 mm film-coated tablet with bevelled edges and the inscription 145/20 on one side and the Abbott logo on the other side.
Danish: Ovale, bikonvekse, gyldenbrune, 19,3 x 9,3 mm filmovertrukne tabletter med skråkanter og præget med 145/20 på den ene side og Abbotts logo på den anden side.
English: Gemfibrozil, Other statins and fibrates
Danish: Gemfibrozil, andre statiner og fibrater Kontraindiceret ved behandling med Cholib Amiodaron
English: Complications of cholelithiasis (e.g. cholecystitis, cholangitis, biliary colic etc)
Danish: Komplikationer ved galdesten (f.eks. galdeblærebetændelse, galdegangsbetændelse, galdestenskolik osv.)
English: Blood glucose increased not known
Danish: Forhøjet blodglucose
English: Blood urea increased rare
Danish: Forhøjet urinstof i blodet
English: Blood creatinine increased (see sections 4.3 and 4.4)
Danish: Forhøjet kreatinin i blodet (se pkt.
English: Mylan Healthcare B.V. Tel: +31 (0)20 426 33 00
Danish: Tel: +31 (0)20 426 33 00
English: The European Commission granted a marketing authorisation valid throughout the European Union for Brilique on 3 December 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Brilique den 3. december 2010.
English: The doctor may, for health reasons, tell them not to take aspirin.
Danish: Lægen kan af sundhedsmæssige årsager give patienten besked om ikke at tage aspirin.
English: They should take Brilique for a year unless the doctor asks them to stop it earlier.
Danish: Patienterne skal tage Brilique i et år, medmindre lægen beder dem stoppe tidligere.
English: This is a summary of the European public assessment report (EPAR) for Brilique.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Brilique.
English: Other information about Brilique
Danish: Andre oplysninger om Brilique
English: The full EPAR for Brilique can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Brilique findes på agenturets websted under: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (60 and 90 mg).
Danish: Det leveres som tabletter (60 og 90 mg).
English: Patients
Danish: Patienter, der får
English: For more information about treatment with Brilique, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Brilique, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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 Brilique.
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 Brilique skal anvendes.
English: It must also not be used in patients taking other medicines which have a strong blocking effect on one of the liver enzymes (CYP3A4).
Danish: Det må heller ikke anvendes til patienter, der tager andre lægemidler, som har en stærkt blokerende virkning på et af leverenzymerne (CYP3A4).
English: What is the risk associated with Brilique?
Danish: Hvilken risiko er der forbundet med Brilique?
English: This means that it helps to prevent blood clots from forming.
Danish: Det betyder, at det hjælper med til at modvirke dannelse af blodpropper.
English: The patients also took aspirin and were treated for up to 3 years.
Danish: Patienterne tog desuden aspirin og blev behandlet i op til tre år.
English: The patients also took aspirin and were treated for up to a year.
Danish: Patienterne tog også aspirin og blev behandlet i op til et år.
English: Brilique is a medicine that contains the active substance ticagrelor.
Danish: Brilique er et lægemiddel, der indeholder det aktive stof ticagrelor.
English: The CHMP decided that Brilique's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Brilique opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Brilique.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom taking Brilique should also be taking aspirin as directed by their doctor.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Why has Brilique been approved?
Danish: Hvorfor blev Brilique godkendt?
English: What is Brilique?
Danish: Hvad er Brilique?
English: Patients took Brilique twice a day in a dose of either 60 mg or 90 mg.
Danish: Patienterne tog Brilique to gange dagligt i en dosis på enten 60 mg eller 90 mg.
English: Brilique was shown to be beneficial to patients who have had a heart attack or unstable angina.
Danish: Brilique viste sig af have en gavnlig virkning på patienter, der har haft et hjerteanfald eller ustabil angina.
English: These are medicines such as ketoconazole (used to treat fungal infections), clarithromycin (an antibiotic), atazanavir and ritonavir (medicines used in HIV-positive patients) and nefazodone (used to treat depression).
Danish: Disse lægemidler er f.eks. ketoconazol (mod svampeinfektioner), clarithromycin (et antibiotikum), atazanavir og ritonavir (til hivpositive patienter) og nefazodon (mod depression).
English: Ticagrelor stops the platelets aggregating by blocking the action of a substance called ADP when it attaches to the surface of the platelets.
Danish: Ticagrelor forhindrer blodpladerne i at klæbe sig sammen ved at blokere virkningen af et stof, der kaldes ADP, når det binder sig til blodpladernes overflade.
English: The main measure of effectiveness for both studies was based on the number of patients having another heart attack, a stroke or dying from a cardiovascular disease.
Danish: Det primære mål for virkningen i begge undersøgelser var antallet af patienter, der fik et nyt hjerteanfald, et slagtilfælde eller døde af en hjerte-kar-sygdom.
English: The most common side effects with Brilique (seen in more than 1 patient in 10) are dyspnoea (difficulty breathing), bleeding and raised uric acid level in the blood.
Danish: De hyppigste bivirkninger ved Brilique (som optræder hos flere end 1 ud af 10 patienter) er dyspnø (åndedrætsbesvær), blødning og forhøjet urinsyreindhold i blodet.
English: For longer treatment, the dose of Brilique should be reduced to one 60-mg tablet twice a day.
Danish: Ved længerevarende behandling skal dosen af Brilique reduceres til én 60 mg-tablet to gange dagligt.
English: Brilique is used together with aspirin (acetylsalicylic acid) to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes.
Danish: Brilique anvendes sammen med aspirin (acetylsalicylsyre) til forebyggelse af aterotrombotiske hændelser (problemer, der skyldes blodpropper og åreforkalkning), såsom hjerteanfald og slagtilfælde.
English: Brilique was compared with clopidogrel (another inhibitor of platelet aggregation) in a main study involving over 18,000 adults who had had a heart attack or had unstable angina.
Danish: Brilique blev sammenlignet med clopidogrel (et andet stof, der hæmmer blodpladernes aggregering) i en hovedundersøgelse med over 18 000 voksne, som havde haft et hjerteanfald eller havde ustabil angina.
English: In another main study, Brilique was compared with placebo (a dummy treatment) in over 21,000 adults who had a heart attack one to three years previously and were at high risk of an atherothrombotic event.
Danish: I en anden hovedundersøgelse blev Brilique sammenlignet med placebo (en uvirksom behandling) hos over 21 000 voksne, som havde haft et hjerteanfald 1-3 år tidligere og som har høj risiko for en aterotrombotisk hændelse.
English: Brilique is also used in adults who had a heart attack a year or more ago and are at a high risk of an atherothrombotic event.
Danish: Brilique anvendes desuden til voksne, som har haft et hjerteanfald for mindst et år siden, og som har høj risiko for en aterotrombotisk hændelse.
English: The CHMP considered that in patients with acute coronary artery syndrome, Brilique at a dose of 90 mg twice daily and given with aspirin, reduces the risk of atherothrombotic events such as heart attack, stroke and death from a cardiovascular event.
Danish: Hos patienter med akut koronart syndrom vurderede CHMP, at Brilique i en dosis på 90 mg to gange dagligt og givet sammen med aspirin mindsker risikoen for aterotrombotiske hændelser såsom hjerteanfald, slagtilfælde eller død som følge af en kardiovaskulær hændelse.
English: In the first main study (in patients with acute coronary syndrome), 9.3% of the patients taking Brilique had another heart attack, stroke or died from a cardiovascular disease compared with 10.9% of patients taking clopidogrel.
Danish: I den første hovedundersøgelse (hos patienter med akut koronart syndrom) fik 9,3 % af de patienter, der blev behandlet med Brilique, endnu et hjerteanfald, et slagtilfælde eller døde af en hjerte-kar-sygdom sammenlignet med 10,9 % af de patienter, der blev behandlet med clopidogrel.
English: When the blood clots, this is due to cell fragments in the blood called platelets aggregating (sticking together).
Danish: Når blodet koagulerer, skyldes det, at cellefragmenterne i blodet (blodpladerne) klæber sig sammen.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent a stroke or another heart attack.
Danish: Dermed bliver blodpladerne mindre klæbrige, hvilket mindsker risikoen for, at der opstår en blodprop, og det er med til at forebygge slagtilfælde eller endnu et hjerteanfald.
English: In the second main study (in patients with a history of the heart attack), 7.8% of patients taking Brilique 60 mg twice a day had another heart attack, stroke or died from cardiovascular disease compared with 9.0% of patients taking placebo.
Danish: I den anden hovedundersøgelse (hos patienter, der tidligere havde haft hjerteanfald) fik 7,8 % af patienter, der tog 60 mg Brilique to gange dagligt, endnu et hjerteanfald, et slagtilfælde eller døde af en hjerte-kar-sygdom sammenlignet med 9,0 % af patienter, der fik placebo.
English: For patients with acute coronary syndrome, the starting dose of Brilique is two 90-mg tablets taken at once, followed by a regular dose of one 90-mg tablet twice a day.
Danish: For patienter med akut koronart syndrom er startdosen af Brilique to 90 mg-tabletter, der tages samtidig, hvorefter den faste dosis er én 90 mg-tablet to gange dagligt.
English: For the full list of restrictions with Brilique, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger ved Brilique fremgår af indlægssedlen.
English: What benefit has Brilique shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Brilique?
English: Brilique must not be used in patients who have severe liver disease or are currently bleeding, or in patients who have had bleeding within the brain.
Danish: Brilique må ikke anvendes til patienter, som lider af svær leversygdom, har en aktiv blødning eller har haft en hjerneblødning.
English: For the full list of all side effects reported with Brilique, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Brilique fremgår af indlægssedlen.
English: How has Brilique been studied?
Danish: Hvordan blev Brilique undersøgt?
English: For patients who have had a heart attack a year or more ago (but less than 2 years ago) and are at high risk of an atherothrombotic event, the dose of Brilique is one 60-mg tablet twice a day.
Danish: For patienter, som har haft et hjerteanfald for 1-2 år siden, og som har høj risiko for en aterotrombotisk hændelse, er dosen af Brilique én 60 mg-tablet to gange dagligt.
English: What is Brilique used for?
Danish: Hvad anvendes Brilique til?
English: The active substance in Brilique, ticagrelor, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Brilique, ticagrelor, forhindrer blodpladerne i at aggregere (klæbe sig sammen).
English: It is used in adults with acute coronary syndrome, a group of conditions in which blood flow in the vessels supplying the heart is blocked so heart tissue cannot work properly or dies, and which includes heart attack and unstable angina (a severe type of chest pain).
Danish: Det anvendes til voksne med akut koronart syndrom, som er en gruppe tilstande, hvor blodgennemstrømningen i de blodkar, der forsyner hjertet, er blokeret, så hjertevævet ikke virker, som det skal, eller dør.
English: Benefit regarding heart attack, stroke and death from a cardiovascular event has also been shown in patients who had a heart attack at least one year ago and have a high risk of an atherothrombotic event and a lower 60 mg dose twice daily dose is recommended for these patients.
Danish: I forbindelse med hjerteanfald, slagtilfælde eller død som følge af en kardiovaskulær hændelse er der desuden påvist en gavnlig virkning hos patienter, som har haft et hjerteanfald for mindst et år siden og har høj risiko for en aterotrombotisk hændelse.
English: How does Brilique work?
Danish: Hvordan virker Brilique?
English: How is Brilique used?
Danish: Hvordan anvendes Brilique?
English: The European Commission granted a marketing authorisation valid throughout the EU for Zylagren on 21 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zylagren den 21. september 2009.
English: The full EPAR for Clopidogrel BGR can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Clopidogrel BGR findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Previously known as Zylagren
Danish: Tidligere kaldet Zylagren.
English: The name of the medicine was changed to Clopidogrel BGR on 14 July 2014.
Danish: Lægemidlets navn blev ændret til Clopidogrel BGR den 14. juli 2014.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Danish: Dette forhindrer dem i at blive »klæbrige« og mindsker således risikoen for, at der dannes blodpropper, og medvirker til at forebygge endnu et hjerte- eller slagtilfælde.
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel BGR.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel BGR.
English: For more information about treatment with Clopidogrel BGR, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Clopidogrel BGR, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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 Clopidogrel BGR.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Clopidogrel BGR skal anvendes.
English: The standard dose of Clopidogrel BGR is one 75 mg tablet once a day.
Danish: Standarddosis af Clopidogrel BGR er en tablet à 75 mg en gang dagligt.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries);
Danish: • patienter med perifer arteriesygdom (problemer med blodgennemstrømningen i arterierne).
English: Clopidogrel BGR can be given to the following groups of patients:
Danish: Clopidogrel BGR kan gives til følgende patientgrupper:
English: This means that Clopidogrel BGR is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel BGR er identisk med et »referencelægemiddel«, som allerede er godkendt i Den Europæiske Union, og som hedder Plavix.