FrancophonIA/ELRC3.0 huggingface dataset:
English: Although the ischaemic benefit was consistent throughout the first year, greater reduction in ischaemic recurrence after ACS was observed during the initial days following the treatment initiation.
Danish: Selv om den iskæmiske fordel var konsistent i løbet af det første år, blev der observeret større reduktion i iskæmisk tilbagefald efter ACS i de første dage efter indledelsen af behandlingen.
English: Medicinal products associated with bleeding risk: There is an increased risk of bleeding due to the potential additive effect.
Danish: Lægemidler, der er forbundet med risiko for blødning: Der er en øget risiko for blødning på grund af mulig additiv effekt.
English: De-escalation of P2Y12 Inhibitor Agents in ACS
Danish: De-eskalering af P2Y12-hæmmere i ACS
English: Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.8%) and ASA (6.0%).
Danish: En analyse med total mortalitet som sekundært endepunkt viste ingen signifikant forskel mellem clopidogrel (5,8 %) og ASA (6,0 %).
English: You should not breast-feed while taking this medicine.
Danish: Du må ikke amme, når du tager denne medicin.
English: (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: Hyppighed defineres i henhold til følgende konvention: almindelig (>1/100 til <1/10), ikke almindelig (>1/1.000 til <1/100), sjælden (>1/10.000 til <1/10.000), meget sjælden <1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • If you suffer from severe liver disease.
Danish: • Hvis du lider af en alvorlig leversygdom
English: Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Danish: Clopidogrel og den cirkulerende (inaktive) hovedmetabolit binder reversibelt in vitro til humane plasmaproteiner (henholdsvis 98% og 94%).
English: Patients who had developed a previous allergic reaction and/or haematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine.
Danish: Patienter, der tidligere har udviklet en allergisk og/eller hæmatologisk reaktion over for en thienopyridin, kan have en øget risiko for at udvikle den samme eller en anden reaktion over for en anden thienopyridin.
English: It may be given with or without food.
Danish: Kan indtages med eller uden mad.
English: TOPIC and TROPICAL-ACS were designed to study how to mitigate the bleeding events while maintaining efficacy.
Danish: TOPIC og TROPICALACS blev designet til at undersøge, hvordan man kan mindske blødninger samtidig med at effekten opretholdes.
English: TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) This randomized, open-label trial included ACS patients requiring PCI.
Danish: TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) Dette randomiseret, open-label studie inkluderede ACS patienter, som kræver PCI.
English: The mean age was 71 years, 41.6% of patients were ≥75 years.
Danish: Gennemsnitligsalderen var 71 år, 41,6 % af patienterne var ≥ 75 år.
English: Pregnancy and breast-feeding It is preferable not to take this medicine during pregnancy.
Danish: Graviditet og amning Det er bedst ikke at tage denne medicin under graviditet og amning.
English: In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups.
Danish: I COMMIT var den generelle forekomst af non-cerebrale større blødninger eller cerebrale blødninger lav og ensartet i begge grupper.
English: In addition to clinical studies experience, adverse reactions have been spontaneously reported.
Danish: Ud over erfaringerne fra de kliniske studier er der spontant blevet rapporteret bivirkninger.
English: In contrast, post-hoc analyses demonstrated statistically significant increases in the bleeding risk with the more potent P2Y12 inhibitors, occurring predominantly during the maintenance phase, after the first month post-ACS.
Danish: I modsætning hertil viste post-hoc analyser statistisk signifikante stigninger i blødningsrisikoen med de mere potente P2Y12-hæmmere, overvejende under vedligeholdelsesfasen efter den første måned efter ACS.
English: plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Danish: plus acetylsalicylsyre, hvis du ikke må tage ”orale antikoagulantia”, og du ikke har risiko for alvorlig blødning.
English: Patients were treated for up to 5 years.
Danish: Patienterne blev behandlet i op til 5 år.
English: Cellulose, microcrystalline Colloidal anhydrous silica Crospovidone (type A) Macrogol 6000
Danish: Cellulose, mikrokrystallinsk Kolloidal vandfri silica Crospovidon (type A) Macrogol 6000
English: is unlikely to affect your ability to drive or to use machines.
Danish: påvirker din evne til at køre eller betjene maskiner.
English: Bleeding is the most common reaction reported both in clinical studies as well as in post-marketing experience where it was mostly reported during the first month of treatment.
Danish: Blødning er den mest almindeligt indrapporterede bivirkning fra både kliniske studier, såvel som fra post-marketing erfaring, hvor den mestendels blev indrapporteret i løbet af behandlingens første måned.
English: In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
Danish: Hos poor metabolisers var eksponeringen nedsat med 63-71 % sammenlignet med extensive metabolisers.
English: than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Danish: Kontakt din læge eller nærmeste skadestue, på grund af den øgede blødningsrisiko.
English: Based on enrollment criteria, physicians enrolled patients in ACTIVE-W if they were candidates for vitamin K antagonist (VKA) therapy (such as warfarin).
Danish: Baseret på indrulleringskriterier indrullerede læger patienter i ACTIVE-W, hvis de var kandidater til behandling med vitamin K-antagonist (VKA) (såsom warfarin).
English: The influence of CYP2C19 genotype on clinical outcomes in patients treated with clopidogrel has not been evaluated in prospective, randomised, controlled trials.
Danish: Indflydelsen af CYP2C19-genotype på det kliniske udfald hos patienter i behandling med clopidogrel er ikke blevet evalueret i prospektive, randomiserede, kontrollerede studier.
English: In addition, a subgroup analysis by age suggested that the benefitof clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
Danish: Endvidere tydede en analyse af aldersbaserede delgrupper på, at fordelen ved clopidogrel hos patienter over 75 år var mindre end hos patienter ≤75 år.
English: When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Danish: Når poor metabolisers fik 600 mg/150 mg regimet var eksponeringen for den aktive metabolit større end ved 300 mg/75 regimet.
English: In cases of confirmed isolated activated Partial Thromboplastin Time (aPTT) prolongation with or without bleeding, acquired haemophilia should be considered.
Danish: I tilfælde af bekræftet isoleret forlængelse af aktiveret partiel tromboplastintid (APTT) med eller uden blødning bør erhvervet hæmofili overvejes.
English: The requirements for submission of (PSURs) reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Overall, 645 of 646 patients with STEMI or NSTEMI or unstable angina were analyzed (de-escalated DAPT (n=322); unchanged DAPT (n=323)).
Danish: I alt blev 645 af 646 patienter med STEMI eller NSTEMI eller ustabil angina analyseret (de-eskaleret DAPT (n = 322); uændret DAPT (n = 323)).
English: The prasugrel-only patients were continued on prasugrel for 11.5 months.
Danish: Patienterne, som blev behandlet med prasugrel alene, blev fortsat behandlet med prasugrel i 11,5 måneder.
English: Therefore, the guided de-escalation arm had patients on either prasugrel (40%) or clopidogrel (60%).
Danish: Derfor havde den guidede deeskaleringsarm patienter behandlet med enten prasugrel (40%) eller clopidogrel (60%).
English: Glomerulonephritis, blood creatinine increased
Danish: Glomerulonefritis, forhøjet blodkreatinin
English: The incidence of severe cases was similar for clopidogrel and ASA.
Danish: Forekomsten af svære tilfælde var ens for clopidogrel og ASA.
English: Patients with a confirmed diagnosis of acquired haemophilia should be managed and treated by specialists, and clopidogrel should be discontinued.
Danish: Patienter med en bekræftet diagnose på erhvervet hæmofili skal varetages og behandles af specialister, og clopidogrel skal seponeres.
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Danish: De klinisk relevante bivirkninger observeret i CAPRIE-, CURE-, CLARITY, COMMIT og ACTIVE-A-studierne beskrives nedenfor.
English: Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies, and showed no genotoxic activity.
Danish: Clopidogrel er testet in vitro og in vivo i en række genotoksicitets forsøg og udviste ingen genotoksisk aktivitet.
English: For patients who did not undergo angiography, the primary endpoint was death or recurrent myocardial infarction by Day 8 or by hospital discharge.
Danish: For de patienter, der ikke gennemgik angiografi, var det primære endepunkt død, gentaget myokardieinfarkt ved dag 8 eller ved udskrivelse fra hospitalet.
English: The ACTIVE-W study demonstrated that anticoagulant treatment with vitamin K antagonists was more effective than with clopidogrel and ASA.
Danish: ACTIVE-W-studiet viste, at antikoagulansbehandling med vitamin K-antagonister var mere effektiv end med clopidogrel og ASA.
English: The population included 27.8% women, 58.4% patients ≥ 60 years (26% ≥ 70 years) and 54.5% patients who received fibrinolytics.
Danish: Populationen inkluderede 27,8 % kvinder, 58,4 % patienter ≥ 60 år (26 % ≥ 70 år) og 54,5 % patienter, der fik fibrinolytika.
English: contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Danish: indeholder clopidogrel og tilhører en lægemiddelgruppe, der kaldes blodfortyndende medicin.
English: The de-escalated patients underwent high platelet reactivity (HPR) testing.
Danish: De de-eskalerede patienter gennemgik høj trombocytreaktivitet (HPR) test.
English: Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Danish: Andre alleler, der associeres med manglende eller nedsat metabolisme er mindre hyppige og inkluderer CYP2C19*4, *5, *6, *7 og *8.
English: Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
Danish: Samlet set var clopidogrel 75 mg/dag sammenligneligt med ASA 325 mg/dag i CAPRIE-studiet uafhængigt af alder, køn og race.
English: Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Danish: Absorptionen er mindst 50% baseret på udskillelse af clopidogrels metabolitter i urinen.
English: Bleeding time prolonged, neutrophil count decreased, platelet count decreased * Information related to clopidogrel with frequency “not known”.
Danish: Forlænget blødningstid, fald i neutrofiltal, fald i trombocyttal * Information relateret til clopidogrel med hyppighed ”ikke kendt”.
English: • Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
Danish: • Pædiatrisk population Clopidogrel bør ikke bruges til børn på grund af usikkerhed om virkningen (se pkt.
English: Clopidogrel has no or negligible influence on the ability to drive and use machines.
Danish: Clopidogrel påvirker ikke, eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: It is unknown whether clopidogrel is excreted in human breast milk.
Danish: Det vides ikke, om clopidogrel udskilles i human mælk.
English: Because the active metabolite is formed by CYP450 enzymes, some of which are polymorphic or subject to inhibition by other medicinal products, not all patients will have adequate platelet inhibition.
Danish: Da den aktive metabolit dannes af CYP450-enzymer, hvoraf nogle er polymorfe eller genstand for hæmning af andre lægemidler, vil ikke alle patienter opnå passende trombocytaggregation.
English: The ACTIVE-W and ACTIVE-A studies, separate trials in the ACTIVE program, included patients with atrial fibrillation (AF) who had at least one risk factor for vascular events.
Danish: ACTIVE-W- og ACTIVE-A-studierne, der er separate studier i ACTIVE-programmet, inkluderede patienter med atrieflimren (AF), der havde mindst én risikofaktor for vaskulære hændelser.
English: This leaflet was last revised in MM/YYYY.
Danish: Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised.
Danish: Monitorering for tegn på overfølsomhed tilrådes hos patienter med allergi over for thienopyridiner.
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Krka d.d.
Danish: Du bør være blevet informeret om, at ”orale antikoagulantia” er mere effektive mod denne sygdom end acetylsalicylsyre eller kombinationen af Clopidogrel Krka d.d.
English: The patient population included 19.7% women and 29.2% patients ≥ 65 years.
Danish: Patientpopulationen bestod af 19,7 % kvinder og 29,2 % af patienterne var over 65 år.
English: In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
Danish: I CURE, CLARITY, ACTIVE-A og et af kohortestudierne (Trenk) blev der ikke observeret nogen øget forekomst af hændelser, baseret på metabolismestatus.
English: Switching from a more potent P2Y12 receptor inhibitor to clopidogrel in association with aspirin after acute phase in ACS has been evaluated in two randomized investigator-sponsored studies (ISS)TOPIC and TROPICAL-ACS - with clinical outcome data.
Danish: Skift fra en mere potent P2Y12 receptorhæmmer til clopidogrel i association med aspirin efter akut fase i ACS er blevet evalueret i to randomiserede investigator-sponsoreret studier (ISS) - TOPIC og TROPICAL-ACS - med kliniske outcome data.
English: For patients over 75 years of age clopidogrel should be initiated without a loading dose.
Danish: Hos patienter, der er ældre end 75 år, bør behandlingen med clopidogrel indledes uden en mætningsdosis.
English: There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers or antacids interfere with antiplatelet activity of clopidogrel.
Danish: Der foreligger ikke beviser for, at andre lægemidler, der reducerer mavesyren, såsom H2-blokkere eller antacida, påvirker clopidogrels antitrombotiske aktivitet.
English: If you forget to take a dose of Clopidogrel Krka d.d., but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Danish: Hvis du har glemt en dosis af Clopidogrel Krka d.d., men kommer i tanke om det i løbet af 12 timer, skal du omgående tage tabletten og dernæst tage den næste tablet til sædvanlig tid.
English: You should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
Danish: Du bør også få acetylsalicylsyre (et stof, som indgår i mange lægemidler, og som anvendes til at afhjælpe smerter og sænke feber såvel som til at forebygge dannelse af blodpropper).
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Danish: 7 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter
English: (4 tablets of 75 mg) once at the start of treatment.
Danish: (4 tabletter på75mg) én gang.
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 patienter):
English: 9/l); requirement for clopidogrel or oral anticoagulants (OAC); or intolerance to any of the two compounds.
Danish: 9 / l), behov for clopidogrel eller orale antikoagulantia (OAK), eller intolerance over for clopidogrel eller acetylsalicylsyre.
English: Titanium dioxide (E171)Red iron oxide (E172) Yellow iron oxide (E172) Talc
Danish: Polyvinylalkohol Titandioxid (E171) Rød jernoxid (E172) Gul jernoxid (E172) Talcum
English: Kounis syndrome (vasospastic allergic angina / allergic myocardial infarction) in the context of a hypersensitivity reaction due to clopidogrel*
Danish: Kounis syndrom (vasospastisk allergisk angina / allergisk myokardieinfarkt) i forbindelse med en allergisk reaktion på grund af clopidogrel*
English: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Danish: Andre lægemidler: Der er gennemført en række andre kliniske studier med clopidogrel og anden samtidig medicinering for at undersøge muligheden for farmakodynamisk og farmakokinetisk interaktion.
English: Since the CAPRIE trial was not powered to evaluate efficacy of individual subgroups, it is not clear whether the differences in relative risk reduction across qualifying conditions are real, or a result of chance.
Danish: Da CAPRIE-studiet imidlertid ikke havde statistisk styrke til at evaluere virkningen i de enkelte delgrupper, kan det ikke udledes, hvorvidt forskellene i relativ risikoreduktion på tværs af inklusionskriterierne er reelle eller tilfældige.
English: No clinically significant pharmacodynamic interactions were observed when clopidogrel was coadministered with atenolol, nifedipine, or both atenolol and nifedipine.
Danish: Der blev ikke observeret nogen klinisk signifikante farmakodynamiske interaktioner, når clopidogrel blev indgivet samtidig med atenolol, nifedipin eller både atenolol og nifedipin.
English: - signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions').
Danish: - tegn på leverproblemer såsom gulning af huden og/eller øjnene (gulsot), uanset om det sker i forbindelse med blødninger, som viser sig under huden som små røde prikker, og/eller forvirring (se afsnit 2'Advarsler og forsigtighedsregler”).
English: Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra eksisterende oplysninger): Overfølsomhedsreaktioner med bryst- eller mavesmerter, vedvarende symptomer på lavt blodsukker.
English: Some other medicines may influence the use of Clopidogrel Krka d.d.
Danish: Visse andre lægemidler kan påvirke brugen af Clopidogrel Krka d.d.
English: If HPR≥46 units, the patients were escalated back to prasugrel 5 or 10 mg/d for 11.5 months; if HPR<46 units, the patients continued on clopidogrel 75 mg/d for 11.5 months.
Danish: Hvis HPR≥46 enheder blev patienterne eskaleret tilbage til prasugrel 5 eller 10 mg/d i 11,5 måneder; hvis HPR <46 enheder fortsatte patienterne med clopidogrel 75 mg/d i 11,5 måneder.
English: CYP2C8 substrate medicinal products: Clopidogrel has been shown to increase repaglinide exposure in healthy volunteers.
Danish: Lægemidler, der er CYP2C8-substrater: Det er vist, at clopidogrel kan øge eksponeringen for repaglinid hos raske frivillige.
English: In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for clopidogrel plus ASA, and 6.3% for placebo plus ASA.
Danish: Hos patienter, som fortsatte med behandlingen indtil 5 dage før bypassoperationen, var forekomsten 9,6 % for clopidogrel plus ASA og 6,3 % for placebo plus ASA.
English: The primary endpoint was the occurrence of the composite of an occluded infarct-related artery on the predischarge angiogram, or death or recurrent MI before coronary angiography.
Danish: Det primære endepunkt var forekomsten af en kombination af okkluderede arterier, der var relateret til infarkt på angiogrammet før patienten blev udskrevet, dødsfald, eller ved gentaget MI før koronarangiografi.
English: Less pronounced reductions of metabolite exposure has been observed with pantoprazole or lansoprazole.
Danish: Der er observeret mindre udtalte reduktioner af eksponeringen for den aktive metabolit med pantoprazol og lansoprazol.
English: Film coating:
Danish: Filmovertræk:
English: There have been a number of retrospective analyses, however, to evaluate this effect in patients treated with clopidogrel for whom there are genotyping results: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), and ACTIVE-A (n=601), as well as a number of published cohort studies.
Danish: Der der dog foretaget et antal retrospektive analyser for at evaluere denne effekt hos patienter i behandling med clopidogrel, for hvem der foreligger resultater af genotyping: CURE (n=2.721), CHARISMA (n=2.428), CLARITYTIMI 28 (n=227), TRITON-TIMI 38 (n=1.477) og ACTIVE-A (n=601) såvel som et antal publicerede kohortestudier.
English: КРКА България ЕООД Teл.
Danish: България КРКА България ЕООД
English: The CYP2C19*1 allele corresponds to fully functional metabolism while the CYP2C19*2 and CYP2C19*3 alleles are nonfunctional.
Danish: CYP2C19*1-allelen svarer til en fuldt funktionel metabolisme, mens CYP2C19*2 og CYP2C19*3 allelerne ikke er funktionelle.
English: The ACTIVE-A study (N=7,554) was a multicenter, randomized, double-blind, placebo-controlled study which compared clopidogrel 75 mg/day + ASA (N=3,772) to placebo + ASA (N=3,782).
Danish: ACTIVE-A-studiet (N = 7.554) var et multicenter, randomiseret, dobbeltblindt, placebokontrolleret studie, som sammenlignede clopidogrel 75 mg / dag + ASA (N = 3.772) med placebo + ASA (N = 3.782).
English: In vitro studies have shown the increase in repaglinide exposure is due to inhibition of CYP2C8 by the glucuronide metabolite of clopidogrel.
Danish: In vitro studier har vist, at den øgede eksponering for repaglinid skyldes hæmning af CYP2C8 ved glukuronidmetabolitten af clopidogrel.
English: Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely co-administered with clopidogrel.
Danish: Data fra CAPRIE- studiet indikerer at phenytoin og tolbutamid, som metaboliseres af CYP2C9, kan administreres samtidig med clopidogrel uden risiko.
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC code: B01AC-04.
Danish: Farmakoterapeutisk klassifikation: Antithrombosemidler,trombocytfunktionshæmmende midler eksklusive heparin, ATC-kode: B01AC-04.