FrancophonIA/ELRC3.0 huggingface dataset:
English: Bleeding events defined as all BARC occurred in 30 patients (9.3%) in the de-escalated DAPT group and in 76 patients (23.5%) in the unchanged DAPT group (p<0.01).
Danish: Blødningshændelser defineret som alle BARC forekom hos 30 patienter (9,3 %) i den de-eskalerede DAPT-gruppe og hos 76 patienter (23,5 %) i den uændrede DAPT-gruppe (p<0,01).
English: In patients suffering from acute coronary syndrome:
Danish: Hos patienter med akut koronarsyndrom
English: - In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Danish: Hos voksne patienter med atrieflimren, der har mindst én risikofaktor for vaskulære hændelser, og som ikke kan tage vitamin K-antagonist (VKA)-behandling, og som har en lav blødningsrisiko, er clopidogrel i kombination med ASA indiceret til forebyggelse af aterotrombotiske og tromboemboliske hændelser inklusive apopleksi.
English: A total of 23.0% of patients received anti-arrhythmics, 52.1% beta-blockers, 54.6% ACE inhibitors, and 25.4% statins.
Danish: I alt fik 23,0% af patienterne antiarytmika, 52,1% betablokkere, 54,6% ACE- hæmmere og 25,4% statiner.
English: Musculo-skeletal bleeding (haemarthrosis), arthritis,
Danish: Muskuloskeletal blødning (blødudtrædning i led), artrit,
English: In particular, in a post-hoc analysis in 2,172 patients (17% of the total CURE population) who underwent stent placement (Stent-CURE), the data showed that clopidogrel compared to placebo, demonstrated a significant RRR of 26.2% favouring clopidogrel for the co-primary endpoint (CV death, MI, stroke) and also a significant RRR of 23.9% for the second co-primary endpoint (CV death, MI, stroke or refractory ischaemia).
Danish: Specielt i en post-hoc analyse af 2.172 patienter som fik indsat stent (17 % af den totale population i CURE-studiet, StentCURE), viste data, at clopidogrel sammenlignet med placebo medførte en signifikant RRR på 26,2 %, med hensyn til primære endepunkter (CV død, MI, hjerteanfald) og desuden en signifikant RRR på23,9 % med hensyn til andet primært endepunkt (CV død, MI, hjerteanfald eller refraktær iskæmi).
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Apotex
Danish: Hvis du mener, at ovenstående gælder for dig, eller hvis du overhovedet er i tvivl, så rådfør dig med din læge, inden du tager Clopidogrel Apotex.
English: Each film-coated tablet contains 2.5 mg of lactose (as monohydrate).
Danish: Hver filmovertrukket tablet indeholder2,5 mg lactose (som monohydrat).
English: In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75-100 mg daily) should be initiated and continued in combination with clopidogrel (see section 5.1).
Danish: Hos patienter med atrieflimren bør clopidogrel gives som en enkelt daglig dosis på 75 mg. ASAbehandling (75-100 mg daglig) bør initieres og fortsættes i kombination med clopidogrel (se pkt.
English: The primary outcome, a composite of cardiovascular death, stroke, urgent revascularization, and BARC (Bleeding Academic Research Consortium) bleeding ≥2 at 1 year post ACS, occurred in 43 patients (13.4%) in the de-escalated DAPT group and in 85 patients (26.3%) in the unchanged DAPT group (p<0.01).
Danish: Det primære udfald, en blanding af kardiovaskulær død, slagtilfælde, umiddelbar revaskularisering og BARC (Bleeding Academic Research Consortium- Akademisk forskningskonsortium for blødning) blødning ≥2 ved 1 år efter ACS, forekom hos 43 patienter (13,4 %) i den de-eskalerede DAPT-gruppe og hos 85 patienter (26,3 %) i den uændrede DAPT-gruppe (p<0,01).
English: The 2x2 factorial design COMMIT trial included 45,852 patients presenting within 24 hours of the onset of the symptoms of suspected MI with supporting ECG abnormalities (i.e. ST elevation, ST depression or left bundle-branch block).
Danish: Det COMMIT-studie, som var designet med 2x2 faktor, inkluderede 45.852 patienter, der var til rådighed inden for 24 timer efter indtrådte symptomer, som var mistænkt for at være MI og hvor EKG anomalier (dvs. ST-elevation, ST-depression eller venstresidig grenblok) understøttede dette.
English: Clopidogrel Apotex contains lactose:
Danish: Clopidogrel Apotex indeholder lactose:
English: • Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
Danish: • Voksne patienter med myokardieinfarkt (fra få dage, men ikke over 35 dage), iskæmisk slagtilfælde (fra 7 dage, men ikke over 6 måneder) eller påviste perifere kredsløbsforstyrrelser.
English: Tests are available to identify a patient's CYP2C19 genotype.
Danish: Test er tilgængelige til at identificere en patientsCYP2C19-genotype.
English: Store below 25°C (for PVC/PE/PVDC/aluminium blisters)
Danish: Opbevares ved temperaturer under 25ºC (for PVC/PE/PVDC/aluminium blister) 10.
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: enheder, blev patienten ekaleret tilbage til prasugrel 5 eller 10 mg/dag i 11,5 måneder; hvis HPR <46 enheder, fortsatte patienterne på clopidogrel 75 mg/dag i 11,5 måneder..
English: The other ingredients are (see section 2 ‘Clopidogrel Apotex contains lactose'): Tablet core: hydroxypropylcellulose (E463), mannitol (E421), crospovidone (type A), citric acid monohydrate, microcrystalline cellulose, macrogol 6000, stearic acid, talc Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E171),
Danish: 2 'Clopidogrel ratiopharm indeholder lactose'): - Tabletkerne: Hydroxypropylcellulose (E463), mannitol (E421), crospovidone, (type A),citronsyremonohydrat, mikrokrystallinsk cellulose, macrogol 6000, stearinsyre, talcum - Tabletovertræk: Lactosemonohydrat (mælkesukker), hypromellose (E464), triacetin (E1518),rød jernoxid (E172) og titandioxid (E171)
English: Clopidogrel must be metabolised by CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation.
Danish: Clopidogrelskal metaboliseres af CYP450-enzymer for at danne den aktive metabolit, der hæmmer trombocytaggregationen.
English: • Adult patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
Danish: • Voksne patienter med akut koronarsyndrom akut koronarsyndrom uden elevation af ST-segmentet (ustabil angina eller myokardieinfarkt uden forekomst af Q-takker) inklusive patienter, som får indsat stent efter perkutant koronarindgreb, i kombination med acetylsalicylsyre (ASA).
English: - swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.
Danish: Hævelser i munden eller hudproblemer såsom udslæt og kløe, blaerer på huden.
English: Bullous dermatitis (toxic epidermal necrolysis,
Danish: (toksisk epidermal nekrolyse,
English: Do not take Clopidogrel Apotex:
Danish: Tag ikke Clopidogrel Apotex:
English: Fifteen percent (15.0%) of patients in the clopidogrel group and 21.7% in the placebo group reached the primary endpoint, representing an absolute reduction of 6.7% and a 36 % odds reduction in favor of clopidogrel (95% CI: 24, 47%; p < 0.001), mainly related to a reduction in occluded infarct-related arteries.
Danish: Femten procent (15,0 %) af patienterne i clopidogrel-gruppen og 21,7 % i placebogruppen opnåede det primære endepunkt, hvilket viste en absolut reduktion på 6,7 % og en odds reduktion på 36 % til fordel for clopidogrel (95 % CI: 24, 47 %; p < 0.001), der hovedsagligt var relateret til en reduktion af infarktrelaterede okkluderede arterier.
English: They are supplied in PVC/PE/PVDC/Alu blisters or in PA/ALL/PVC-Alu blisters packed in cartons containing 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets.
Danish: De udleveres i blisterpakninger af PVC/PE/PVDC/aluminumblister eller i PA/ALL/PVC/aluminum blisterpakninger, der indeholder 7, 14, 28, 30, 50, 56, 84, 90 og 100 filmovertrukne tabletter.
English: If Clopidogrel Apotex is supplied in PVC/PE/PVDC/aluminium blisters, store below 25°C.
Danish: Hvis Clopidogrel Apotex er pakket i blisterkort af PVC/PE/PVDC/aluminium, skal det opbevares ved temperaturer under 25 ºC.
English: If you experience prolonged bleeding when taking Clopidogrel Apotex
Danish: Hvis du får langvarige blødninger, mens du tager Clopidogrel Apotex
English: In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p=0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR = 23.7%; CI: 8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to 18.7 [p=0.258]).
Danish: I en delgruppeanalyse af inklusionsgrupperne (myokardieinfarkt, iskæmisk slagtilfælde og PAD) syntes udbyttet at være størst (dvs. den opnåede statisk signifikans ved p=0,003) hos patienter, som indgik på grund af PAD (især de patienter, som tidligere også havde haft et myokardieinfarkt) (RRR =23,7 %, CI: 8,9 til 36,2) og mindst (= afveg ikke signifikant fra ASA) hos patienter med slagtilfælde (RRR = 7,3 %, CI: -5,7 til 18,7 [p=0,258]).
English: Eye bleeding (conjunctival, ocular, retinal)
Danish: Øjenblødning (konjunctival, okular, retinal
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 75 mg clopidogrel (som besilat).
English: Patients were randomized to receive either prasugrel 5 or 10 mg/d (Days 0-14) (n=1309), or prasugrel 5 or 10 mg/d (Days 0-7) then de-escalated to clopidogrel 75 mg/d (Days 8-14) (n=1309), in combination with ASA (<100 mg/day).
Danish: Patienterne blev randomiseret til enten at få prasugrel 5 eller 10 mg/dag (dag 0-14) (n=1309) eller prasugrel 5 eller 10 mg/dag (dag 0-7), hvorefter de de-eskalerede til clopidogrel 75 mg/dag (dag 8-14) (n=1309) i kombination med ASA (<100 mg/dag).
English: 2D barcode carrying the unique identifier included.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator 18.
English: Clopidogrel Apotex contains lactose.
Danish: Clopidogrel Apotex indeholder lactose.
English: As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs), or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Danish: Ligesom andre antitrombotiske midler skal clopidogrel anvendes med forsigtighed til patienter med risiko for tiltagende blødninger pga. traumer, kirurgi eller andre patologiske tilstande samt til patienter, der samtidigt behandles med ASA,heparin, glykoprotein IIb/IIIa-hæmmere, nonsteroide antiinflammatoriske lægemidler inklusive cox-2 hæmmere, eller selektive serotoningenoptagelseshæmmere (SSRI'er), eller andre lægemidler forbundet med risiko for blødning, så som pentoxifyllin (se pkt.
English: - ST segment elevation acute myocardial infarction: clopidogrel should be given as a single daily dose of 75 mg initiated with a 300-mg loading dose in combination with ASA and with or without thrombolytics.
Danish: • akut myokardieinfarkt med elevation af ST-segmentet: Behandling med clopidogrel bør bestå af en daglig dosering på 75 mg, indledt med en stabiliseringsdosis på 300 mg i kombination med ASA og med eller uden trombolytika.
English: If you have any further questions, ask your doctor or your pharmacist.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis
Danish: Gastrointestinal og retroperitoneal blødning med dødelig udfald, bugspytkirtelbetændelse, colitis
English: Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of food.
Danish: Meget sjældne bivirkninger (kan påvirke op til 1 ud af 10.000 patienter): Gulsot, alvorlige mavesmerter med eller uden rygsmerter, feber, åndedrætsbesvær ind imellem ledsaget af hoste, generelle allergiske reaktioner (f.eks. varmefølelse over hele kroppen med pludselig almen utilpashed og eventuel besvimelse), hævelse i munden, blaerer på huden, allergi på huden, ømhed i munden (stomatitis), blodtryksfald, forvirring, hallucinationer, ledsmerter, muskelsmerter, smagsforstyrrelser eller mangel på smagssans.
English: Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Danish: Mindre end 12 timer efter planlagt administration: patienten skal straks tage den glemte dosis og tage den næste dosis som planlagt.
English: The concomitant administration of medicinal products associated with bleeding risk should be undertaken with caution (see section 4.4).
Danish: Der skal udvises forsigtighed ved samtidig administration af lægemidler, der er forbundet med risiko for blødning(se pkt.
English: • You should tell your doctor if a surgery (including dental) is planned.
Danish: • Skal du fortælle din læge, at du er i behandling med Clopidogrel Apotex hvis du skal have foretaget en planlagt operation (også hos tandlægen),
English: If you forget to take Clopidogrel Apotex
Danish: Hvis du har glemt at tage Clopidogrel Apotex
English: At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/or vomiting) of clopidogrel was also reported in rat and baboon.
Danish: Ved meget høje doser clopidogrel blev der hos rotter og bavianer observeret dårlig gastrisk tolerans(gastritis, gastriske erosioner og/eller opkastning).
English: • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
Danish: • hvis du har en aktiv blødning såsom et mavesår eller en blødning i hjernen
English: Hydroxypropylcellulose (E463) Mannitol (E421) Crospovidone (type A) Citric acid, monohydrate Macrogol 6000
Danish: Kerne: Hydroxypropylcellulose (E463) Mannitol (E421) Crospovidon (type A)
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p=0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Danish: I intention-to-treat-analysen blev der observeret 939 tilfælde i clopidogrelgruppen og 1.020 tilfælde i ASA-gruppen (relativ risikoreduktion (RRR) 8,7 % [95 % CI: 0,2-16,4], p=0,045), hvilket for hver1000 patienter, der blev behandlet i 2 år, svarer til, at yderligere 10 [CI: 0-20] patienter beskyttes mod et nyt iskæmisk tilfælde.
English: Consequently, NSAIDs including Cox-2 inhibitors and clopidogrel should be co-administered with caution (see section 4.4).
Danish: Derfor bør samtidig administration afNSAID'er inklusive cox-2 hæmmere og clopidogrel foregå med forsigtighed (se pkt.
English: After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Danish: Efter gentagen dosering med clopidogrel 75 mg/dag var hæmningen af ADP-induceret trombocytaggregation lavere (25%) hos forsøgspersoner med alvorlig nyresygdom (kreatininclearance515 ml/min) end der, der blev set hos raske forsøgspersoner.,Forlængelsen i blødningtid varimidlertid sammenlignelig med den, der blev set hos raske forsøgspersoner, som fik 75 mg clopidogrel daglig.
English: Clopidogrel Apotex 75 mg film-coated tablets clopidogrel
Danish: Clopidogrel Apotex 75 mg filmovertrukne tabletter clopidogrel
English: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300-mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Danish: • akut koronarsyndrom uden elevation af ST-segmentet (ustabil angina pectoris eller myokardieinfarkt uden forekomst af Q-takker): Behandling med clopidogrel bør indledes med en initial stabiliseringsdosis på 300 mg, hvorefter behandlingen består af75 mg en gang daglig (sammen med acetylsalicylsyre (ASA) 75 mg - 325 mg/dag).
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) or placebo (N=6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies.
Danish: Patienterne blev randomiseret til clopidogrel (300 mg initial stabiliseringsdosis efterfulgt af 75 mg/dag, N=6.259) eller placebo (N=6.303), begge i kombination med ASA(75-325 mg en gang daglig) samt anden standardbehandling.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig.
English: EU/1/09/568/017 Cartons of 90 film-coated tablets in PA/ALL/PVDC /Alu blisters EU/1/09/568/018 Cartons of 100 film-coated tablets in PA/ALL/PVDC /Alu blisters
Danish: EU/1/09/568/001-001 Pakning med 7 filmovertrukne tabletter i blisterkort af PVC/PE/PVDC/aluminium EU/1/09/568/001-002 Pakning med 14 filmovertrukne tabletter i blisterkort af PVC/PE/PVDC/aluminium
English: Packs of 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets.
Danish: Pakninger, der indeholder 7, 14, 28, 30, 50, 56, 84, 90 eller 100 filmovertrukne tabletter.
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Danish: Antallet af patienter, som oplevede det primære endpoint [kardiovaskulært dødsfald, myokardieinfarkt eller slagtilfælde] var 582 (9,3 %) i clopidogrel-gruppen og 719 (11,4 %) i placebogruppen, hvilket giver en relativ risikoreduktion på 20 % (95 % CI: 10 %-28 %; p=0,00009) for clopidogrelgruppen(en relativ risikoreduktion på 17 %, når patienterne fik konservativ behandling, 29 %, når de fik perkutan transluminal koronar angioplasti (PTCA) med eller uden stent, og 10 %, når de fik koronar bypassoperation (CABG)).
English: What Clopidogrel Apotex contains The active substance is clopidogrel.
Danish: Clopidogrel Apotex indeholder: Aktivt stof: clopidogrel.
English: This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Danish: Forekomsten af større blødninger var ensartet i de to grupper.Dette var ensartet blandt undergrupperne af patienter, defineret ved baseline karakteristika og typen af fibrinolytika eller heparinbehandling.
English: Patients received clopidogrel (75 mg/day, n=22,961) or placebo (n=22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge.
Danish: Patienterne fik clopidogrel (75 mg/dag, n=22.961) eller placebo (n=22.891), i kombination med ASA (162 mg/dag) i
English: Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Danish: Indenfor hver gruppe af bivirkninger med samme frekvens er bivirkningerne opstillet efter, hvor alvorlige bivirkningerne er.
English: Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Danish: Patienterne fik clopidogrel (300 mg stabiliseringsdosis efterfulgt af 75 mg daglig, n=1.752) eller placebo (n=1.739) begge i kombination med ASA (150-325 mg som stabiliseringsdosis, herefter 75-162 mg dagligt), et fibrinolytisk middel samt heparin, når det var hensigtsmæssigt.
English: Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Danish: Mave-tarmkanalen Gastrointestina l blødning, diarré, mavesmerter, dyspepsi
English: You should specifically tell your doctor if you take medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, omeprazole or esomeprazole, medicines to treat upset stomach, fluconazole or voriconazole, medicines to treat fungal infections,
Danish: NSAID'er), som normalt gives til behandling af smertefulde og/eller betændelseslignende tilstande i muskler eller led, o heparin eller anden medicin til indsprøjtning for at nedsætte dannelse af blodpropper, o ticlopidin, der er anden medicin mod blodpropper o selektive serotoningenoptagelseshæmmere (inklusive, men ikke begrænset tilfluoxetin og fluvoxamin), der normalt anvendes mod depression - omeprazol eller esomeprazol til behandling af for meget mavesyre - fluconazol eller voriconazol, der anvendes til behandling af svampeinfektioner - efavirenz, der anvendes til behandling af HIV- (humant immundefektvirus) infektion - carbamazepin, der anvendes mod bestemte former for epilepsi - moclobemid, medicin mod depression.
English: Marketing Authorisation Holder: Apotex Europe B.V.
Danish: Indehaveren af markedsføringstilladelsen: Apotex Europe B.V.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Apotex 75 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Clopidogrel Apotex 75 mg filmovertrukne tabletter
English: Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Danish: Hver filmovertrukken tablet indeholder 75 mg clopidogrel (som besilat).
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Danish: Antallet af patienter, som oplevede det primære endpoint [kardiovaskulært dødsfald, myokardieinfarkt, slagtilfælde eller refraktær iskæmi] var 1035 (16,5 %) i clopidogrelgruppen og1187 (18,8 %) i placebogruppen, hvilket giver en relativ risikoreduktion på 14 % (95 % CI:6 %-21 %; p=0,00005) for clopidogrelgruppen.