FrancophonIA/ELRC3.0 huggingface dataset:
English: Clopidogrel ratiopharm can be given to the following groups
Danish: Clopidogrel ratiopharm kan gives til følgende patientgrupper:
English: Clopidogrel ratiopharm can be started between a few days and 35 days after the attack;
Danish: Behandling med Clopidogrel ratiopharm kan påbegyndes få dage efter anfaldet og indtil 35 dage efter,
English: Clopidogrel ratiopharm is a ‘generic medicine'.
Danish: Clopidogrel ratiopharm er et ‘generisk lægemiddel'.
English: Clopidogrel ratiopharm can be started between seven days and six months after
Danish: Behandlingen med Clopidogrel ratiopharm kan påbegyndes 7 dage efter slagtilfældet og indtil 6 måneder efter,
English: Because Clopidogrel ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Danish: Da Clopidogrel ratiopharm er et generisk lægemiddel, der er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Clopidogrel ratiopharm is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel ratiopharm er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: Because Clopidogrel ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel ratiopharm er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: What are the benefits and risks of Clopidogrel ratiopharm?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel ratiopharm?
English: Other information about Clopidogrel ratiopharm
Danish: Andre oplysninger om Clopidogrel ratiopharm:
English: The active substance in Clopidogrel ratiopharm, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel ratiopharm, clopidogrel, er et blodpladeaggregationshæmmende middel.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel ratiopharm den 23. september 2009.
English: Why has Clopidogrel ratiopharm been approved?
Danish: Hvorfor er Clopidogrel ratiopharm blevet godkendt?
English: How has Clopidogrel ratiopharm been studied?
Danish: Hvordan er Clopidogrel ratiopharm blevet undersøgt?
English: What is Clopidogrel ratiopharm used for?
Danish: Hvad anvendes Clopidogrel ratiopharm til?
English: How is Clopidogrel ratiopharm used?
Danish: Hvordan anvendes Clopidogrel ratiopharm?
English: How does Clopidogrel ratiopharm work?
Danish: Hvordan virker Clopidogrel ratiopharm?
English: Your doctor will decide if Trevaclyn is right for you.
Danish: Lægen vil beslutte, om Trevaclyn er rigtigt for Dem.
English: • Take Trevaclyn once a day, in the evening or at bedtime.
Danish: • Tag Trevaclyn én gang dagligt, om aftenen eller ved sengetid.
English: • It is important to follow the advice given in section 3 How to take Trevaclyn.
Danish: • Det er vigtigt, at De følger vejledningen i afsnit 3 Sådan skal De tage Trevaclyn.
English: Trevaclyn with food, drink and alcohol
Danish: Brug af Trevaclyn sammen med mad, drikke og alkohol
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/458/012
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/458/012
English: • Take Trevaclyn with food.
Danish: • Tag Trevaclyn sammen med mad.
English: Efficacy and safety of Trevaclyn in combination with simvastatin > 40 mg were not included in this study.
Danish: Trevaclyns sikkerhed og effekt i kombination med simvastatin > 40 mg var ikke inkluderet i denne undersøgelse.
English: Some people get dizzy after taking Trevaclyn.
Danish: Nogle mennesker kan føle sig svimle, efter de har taget Trevaclyn.
English: The name of your medicine is Trevaclyn.
Danish: Navnet på Deres medicin er Trevaclyn.
English: It is not known if Trevaclyn will harm your unborn baby.
Danish: Det er ukendt, om Trevaclyn kan skade Deres ufødte barn.
English: Laropiprant is highly bound (> 99 %) to plasma proteins, and its binding is independent of concentration.
Danish: Laropiprant er i høj grad (> 99 %) bundet til plasmaproteiner, og dets binding er uafhængig af koncentrationen.
English: Do not take Trevaclyn if
Danish: Tag ikke Trevaclyn hvis
English: Talk with your doctor before taking Trevaclyn if:
Danish: Tal med lægen, før De tager Trevaclyn hvis:
English: • Your doctor should do a blood test before you start taking Trevaclyn to check how well your liver is working.
Danish: • Lægen bør tage en blodprøve, før De begynder at tage Trevaclyn for at kontrollere, hvor godt Deres lever virker.
English: Therefore, patients with a risk for hypophosphatemia should be closely followed.
Danish: Derfor bør patienter med risiko for at få hypofosfatæmi følges tæt.
English: Therefore, Trevaclyn should not be used during pregnancy unless clearly necessary.
Danish: Trevaclyn bør derfor ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Cases of overdose have been reported; the maximum dose of Trevaclyn taken was 5,000 mg/100 mg. All patients recovered without sequelae.
Danish: Der er rapporteret om tilfælde af overdosering; den højeste dosis, der var taget, var 5.000 mg/100 mg. Alle patienterne kom sig uden følgevirkninger.
English: If you get dizzy, you should avoid driving or operating machines after taking Trevaclyn.
Danish: Hvis De bliver svimmel, skal De undgå at køre bil eller betjene maskiner, efter De har taget Trevaclyn.
English: Therefore, Trevaclyn should not be used in children and adolescents under 18 years of age.
Danish: Derfor må Trevaclyn ikke anvendes til børn og teenagere under 18 år.
English: The frequencies of adverse reactions are ranked according to the following: 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: Bivirkningsfrekvenserne er opstillet i henhold til følgende: 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).
English: Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Trevaclyn.
Danish: Diæt og anden ikke-farmakologisk behandling (f.eks. motion, vægtreduktion) bør fortsætte under behandlingen med Trevaclyn.
English: Side effects of Trevaclyn are:
Danish: Trevaclyns bivirkninger er:
English: • In the event of an overdose, the following side effects were reported:
Danish: • I forbindelse md overdosis har man set følgende bivirkninger:
English: The effect on lipids was similar whether Trevaclyn was given as monotherapy or was added to ongoing statin therapy with or without ezetimibe.
Danish: Indvirkningen på lipider var den samme, hvad enten Trevaclyn blev givet som monoterapi eller blev tilføjet til den igangværende statinbehandling med eller uden ezetimibe.
English: If you stop taking Trevaclyn Do not stop taking Trevaclyn without talking to your doctor.
Danish: De må ikke holde op med at tage Trevaclyn uden at tale med lægen.
English: Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Trevaclyn.
Danish: Acetylsalicylsyre giver ikke yderligere reduktion af flushing, ud over den der opnås ved Trevaclyn.
English: It is unknown whether there is an increased risk of myopathy in other Asian patients treated with Trevaclyn co-administered with simvastatin or ezetimibe/simvastatin.
Danish: Det vides ikke, om der er en øget risiko for myopati hos andre asiatiske patienter, som behandles med Trevaclyn samtidigt med simvastatin eller ezetimibe/simvastatin.
English: Patients receiving Trevaclyn concomitantly with acetylsalicylic acid and clopidogrel should be closely monitored as recommended in the Summary of Product Characteristics for those medicinal products and should be told that it might take longer than usual to stop bleeding and that they should report any unusual bleeding (site or duration) to their physician.
Danish: Patienter, der får Trevaclyn sammen med acetylsalicylsyre og clopidogrel, bør monitoreres tæt som anbefalet i produktresuméet for disse lægemidler, og skal informeres om, at det kan tage længere tid end normalt at stoppe en blødning, og at de skal indberette al unormal blødning (sted eller varighed) til lægen.
English: If muscle pain, weakness or cramps occur while a patient is receiving Trevaclyn with a statin, their CK levels should be measured.
Danish: Hvis muskelsmerter, -svaghed eller -kramper opstår, mens patienten er i behandling med Trevaclyn sammen med et statin, skal CK-koncentrationerne måles.
English: Physicians contemplating combined therapy with statins and Trevaclyn should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and when the dose of either medicinal product is increased.
Danish: Læger, som overvejer kombinationsbehandling med statiner og Trevaclyn, bør nøje overveje de mulige fordele i forhold til risikoen og bør monitorere patienterne nøje med henblik på tegn og symptomer på muskelsmerte, -ømhed eller -svaghed, især i de første måneder af behandlingen, og når doseringen af et af lægemidlerne øges.
English: The Coronary Drug Project, a five year study completed in 1975, showed that nicotinic acid had a statistically significant benefit in decreasing nonfatal, recurrent myocardial infarctions (MI) in men 30 to 64 years old with a history of MI.
Danish: Coronary Drug Project, en femårig undersøgelse, der afsluttedes i 1975, viste, at nicotinsyre havde en statistisk signifikant positiv indvirkning på reduktionen af nonfatale, tilbagevendende myokardieinfarkter (MI) hos mænd i alderen 30-64 år med MI i anamnesen.
English: Flushing is the most common adverse reaction of Trevaclyn.
Danish: Flushing er den mest almindelige bivirkning ved Trevaclyn.
English: The pharmacokinetic interaction of Trevaclyn with statins has been studied only with simvastatin (see section 4.4).
Danish: Trevaclyns farmakokinetiske interaktion med statiner er kun blevet undersøgt for simvastatin (se pkt.
English: When Trevaclyn is co-administered with a statin, please refer to the Summary of Product Characteristics for that particular medicinal product.
Danish: Når Trevaclyn gives samtidigt med et statin henvises til produktresuméet for dette specifikke lægemiddel.
English: The incidence and frequency of moderate or greater flushing in patients treated with Trevaclyn for the duration of the study decreased.
Danish: Incidensen og hyppigheden af moderat og mere udbredt flushing hos patienter, der fik Trevaclyn i hele studiets varighed, faldt.
English: However, the plasma concentration of a metabolite of midazolam, 1'-hydroxymidazolam, was increased approximately 2-fold with multiple doses of laropiprant.
Danish: Plasmakoncentrationen af en af midazolams metabolitter, l'-hydroxymidazolam, steg imidlertid ca. 2 gange ved flergangsdosering af laropiprant.
English: However, if you do not take Trevaclyn for 7 or more days in a row, talk to your doctor before restarting Trevaclyn.
Danish: Men hvis De ikke har taget Trevaclyn i 7 dage eller mere i træk, skal De tale med lægen, før De igen begynder at tage Trevaclyn.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret {MM/YYYY}
English: If Trevaclyn is missed for less than 7 consecutive days, patients can resume therapy at the last administered dose.
Danish: Hvis patienten har undladt at tage Trevaclyn i færre end 7 på hinanden følgende dage, kan behandlingen genoptages ved den senest administrerede dosis.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of Trevaclyn to the woman.
Danish: Beslutning om, hvorvidt amningen eller behandlingen skal fortsætte/ophøre, bør tages i forhold til den gavnlige virkning af amning for barnet og den gavnlige virkning af Trevaclyn for kvinden.
English: Drinking alcohol or hot drinks or eating spicy foods can enhance the effects of flushing and should therefore be avoided around the time of ingestion of Trevaclyn.
Danish: Indtagelse af alkohol eller varme drikke eller krydret mad kan forstærke flushing-effekten og bør derfor undgås omkring tidspunktet for indtagelse af Trevaclyn.
English: • Your doctor may also want you to periodically have blood tests after you start taking Trevaclyn, to check how well your liver is working and for other side effects.
Danish: • Lægen vil måske også tage blodprøver af og til, efter De er begyndt at tage Trevaclyn for at kontrollere, hvor godt Deres lever virker, og om der er andre bivirkninger.
English: Trevaclyn was consistently efficacious across all prespecified patient subpopulations defined by race, gender, baseline LDL-C, HDL-C and TG levels, age and diabetes status.
Danish: Trevaclyn var konsekvent effektivt på tværs af alle på forhånd specificerede patientundergrupper i henhold til race, køn, LDL-C, HDL-C og TG ved baseline, alder og diabetesstatus.
English: Trevaclyn has not been studied in children and adolescents who are under 18 years of age.
Danish: Trevaclyn er ikke undersøgt hos børn og unge under 18 år.
English: In clinical trials, over 5,700 patients received Trevaclyn alone or with an HMG-CoA reductase inhibitor.
Danish: I kliniske undersøgelser har mere end 2.500 patienter fået Trevaclyn alene eller sammen med en HMG-CoA-reduktasehæmmer.
English: Trevaclyn contains nicotinic acid, which at therapeutic doses is a lipid-modifying agent, and laropiprant, a potent, selective antagonist of the prostaglandin D2 (PGD2) receptor subtype 1 (DP1).
Danish: Trevaclyn indeholder nicotinsyre, som i terapeutiske doser er et lipidmodificerende stof, og laropiprant, der er en potent, selektiv prostaglandin D2-antagonist (PGD2) receptorsubtype 1 (DP1).
English: • Taking aspirin before you take Trevaclyn does not reduce your flushing more than taking Trevaclyn alone.
Danish: • At tage acetylsalicylsyre før De tager Trevaclyn vil ikke mindske Deres rødmen mere, end hvis De tager Trevaclyn alene.
English: As with other nicotinic acid medicinal products, caution should be used when Trevaclyn is used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive medicinal products such as nitrates, calcium channel blockers, or adrenergic blocking agents.
Danish: Som med andre nicotinsyrepræparater bør der udvises forsigtighed, når Trevaclyn anvendes til patienter med ustabil angina eller patienter i den akutte fase af myokardieinfarkt, især når disse patienter også får vasoaktive lægemidler, såsom nitrater, calciumkanalblokkere eller adrenerge blokkere.
English: To preserve the modified-release properties, the tablets must not be split, broken, crushed, or chewed before swallowing.
Danish: For at bevare egenskaberne ved den modificerede udløsning må tabletterne ikke deles, brydes, knuses eller tygges, før de sluges.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Indehaveren af markedsføringstilladelsen skal udføre de lægemiddelovervågningsaktiviteter, som er beskrevet i lægemiddelovervågningsplanen (ifølge aftalen i RMP modul 1.8.2 i markedsføringstilladelsen), og enhver efterfølgende opdatering af RMP, som er godkendt af Udvalget for Lægemidler til Mennesker (CHMP).
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på fremstilleren(fremstillerne) ansvarlig(e) for batchfrigivelse
English: If you forget to take Trevaclyn
Danish: Hvis De har glemt at tage Trevaclyn
English: INFORMATION IN BRAILLE Trevaclyn
Danish: INFORMATION I BRAILLESKRIFT Trevaclyn
English: Because nicotinic acid and its metabolites are excreted through the kidneys, Trevaclyn should be used with caution in patients with renal dysfunction.
Danish: Da nicotinsyre og dets metabolitter udskilles via nyrerne, bør Trevaclyn anvendes med forsigtighed hos patienter med nyreinsufficiens.
English: Trevaclyn should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.
Danish: Trevaclyn bør anvendes med forsigtighed hos patienter, som indtager væsentlige mængder alkohol og/eller har leversygdom i anamnesen.
English: In these studies, the percentage of patients taking Trevaclyn, nicotinic acid (pooled prolonged-release formulations) or pooled placebo/simvastatin who discontinued due to any flushing-related symptom (redness, warmth, itching and tingling) was 7.2 %, 16.6 %, and 0.4 %, respectively.
Danish: I disse undersøgelser var procentdelen af patienter, der fik Trevaclyn, nicotinsyre (depotformuleringer, poolede) eller placebo/simvastatin (poolet), og som stoppede behandlingen på grund af flushing-relaterede symptomer (rødme, varme, kløe og prikken i huden) henholdsvis 7,2 %, 16,6 % og 0,4 %.
English: Not known: frequency cannot be estimated from the available data Additionally, the following were reported during post-marketing experience with Trevaclyn and/or other nicotinic acid products (alone and/or with certain other cholesterol-lowering medicines).
Danish: Ikke kendt: hyppigheden kan ikke vurderes ud fra tilgængelige data Desuden er der efter markedsføring rapporteret om en pludselig alvorlig allergisk reaktion (anafylaktisk chok) med Trevaclyn og/eller andre nicotinsyrepræparater (alene og/eller sammen med visse andre kolesterolsænkende lægemidler).
English: Supplements containing nicotinic acid: Vitamins or other nutritional supplements containing (≥ 50 mg/day) of nicotinic acid (or nicotinamide) have not been studied with Trevaclyn.
Danish: Kosttilskud med nicotinsyre: Vitaminer eller andre ernæringstilskud med (≥ 50 mg /dag) nicotinsyre (eller nicotinamid) er ikke blevet undersøgt sammen med Trevaclyn.
English: In three large clinical trials measuring patient-reported flushing symptoms, patients taking Trevaclyn experienced less flushing than those taking nicotinic acid (prolonged-release formulations).
Danish: I tre store kliniske undersøgelser, hvor patientrapporterede flushing-symptomer blev målt, oplevede de patienter, der tog Trevaclyn, mindre flushing end de patienter, der tog nicotinsyre (depotformuleringer).
English: Trevaclyn is not recommended in pregnancy unless clearly necessary.
Danish: Trevaclyn må ikke anvendes under graviditet, med mindre det er klart nødvendigt.
English: Switching from immediate-release (crystalline) nicotinic acid to Trevaclyn has not been studied.
Danish: Skift fra nicotinsyre med umiddelbar udløsning (krystallinsk) til Trevaclyn er ikke undersøgt.
English: Should an increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥ 3 X ULN persist, reduction of dose or withdrawal of Trevaclyn is recommended.
Danish: Hvis en forhøjelse i alaninaminotransferase (ALAT) eller aspartataminotransferase (ASAT) af ≥ 3 x ULN (øvre normalgrænse) varer ved, bør Trevaclyn reduceres eller seponeres.
English: It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated.
Danish: Trevaclyn kan anvendes som monoterapi hos patienter, hvor HMG-CoA-reduktasehæmmere anses for at være uhensigtsmæssige eller ikke tåles.
English: Trevaclyn is indicated for the treatment of dyslipidaemia, particularly in adult patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol) and in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial).
Danish: Trevaclyn er indiceret til behandling af dyslipidæmi, især hos voksne patienter med kombineret dyslipidæmi (karakteriseret ved forhøjede koncentrationer af LDL-kolesterol og triglycerider samt lavt HDL-kolesterol) og hos voksne patienter med primær hyperkolesterolæmi (heterozygot familiær og non-familiær).
English: What you need to know before you take Trevaclyn
Danish: Det skal De vide, før De begynder at tage Trevaclyn
English: A multicenter, randomized, double-blind, placebo-controlled 32-week study to assess the effects of withdrawal of laropiprant showed that dyslipidaemic patients in whom laropiprant was withdrawn after 20 weeks on Trevaclyn experienced significantly more flushing than patients who continued taking Trevaclyn in terms of number of days per week with moderate or greater flushing, p< 0.001, Figure 2.
Danish: Et randomiseret, dobbeltblindet, placebokontrolleret 32-ugers multicenterstudie til at vurdere virkningen af seponering af laropiprant viste, at patienter med dyslipidæmi, hvor laropiprant blev seponeret efter 20 uger på Trevaclyn, oplevede signifikant mere flushing end patienter, som fortsatte med at tage Trevaclyn i form af antal dage pr. uge med moderat eller mere udbredt flushing, p<0,01, figur 2.
English: Trevaclyn contains a sugar called lactose.
Danish: Trevaclyn indeholder et sukkerstof, der kaldes lactose.
English: In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Trevaclyn experienced significantly fewer days per week with moderate or greater flushing compared to nicotinic acid (prolonged-release formulation taken as a 12-week multi-step 500 mg to 2,000 mg titration) (p< 0.001).
Danish: I den anden undersøgelse (16 uger), hvor acetylsalicylsyre var tilladt, oplevede de patienter, der fik Trevaclyn, signifikant færre dage pr. uge med moderat eller mere udbredt flushing sammenlignet med nicotinsyre (taget som depotformulering med multi-step titrering fra 500 mg til 2.000 mg over 12 uger) (p < 0,001).
English: In controlled clinical studies, the incidence of clinically important elevations in serum transaminases (ALT and/or AST ≥ 3 X ULN, consecutive) was 1.0 % for patients treated with Trevaclyn with or without a statin.
Danish: I kontrollerede kliniske undersøgelser var incidensen af klinisk relevante stigninger i serumtransaminaser (ALAT og/eller ASAT ≥ 3 x ULN (øvre normalgrænse) konsekutivt) 1,0 % for patienter, der blev behandlet med Trevaclyn med eller uden et statin.
English: Paediatric population Trevaclyn: No studies have been performed in paediatric patients.
Danish: Pædiatrisk population Trevaclyn: Der er ikke udført undersøgelser med børn.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Trevaclyn in paediatric patients from 7-18 years old in heterozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Trevaclyn hos pædiatriske patienter i alderen 7-18 år med heterozygot familiær hyperkolesterolæmi (se pkt.
English: Physicians should consider the nicotinic acid intake from vitamins and nutritional supplements when prescribing Trevaclyn.
Danish: Lægen bør overveje indtaget af nicotinsyre fra vitaminer og enæringstilskud, når Trevaclyn ordineres.
English: Further analysis showed Trevaclyn (2000 mg/40 mg) co-administered with simvastatin when compared with simvastatin alone significantly increased apo A-I (8.6 %, 2.3 % respectively) and significantly decreased Lp(a) (-19.8 %, 0.0 % respectively ).
Danish: Yderligere analyse viste, at Trevaclyn (2.000 mg/40 mg) administreret sammen med simvastatin, i sammenligning med simvastatin alene, øgede apo-A-I signifikant (henholdsvis 8,6 %, 2,3 %) og reducerede Lp(a) signifikant (henholdsvis -19,8 %, 0,0 %).