natgillin/translations-raw huggingface dataset:
Specielt i en post- hoc analyse af 2172 patienter som fik indsat stent (17% af den totale population i CURE- studiet, Stent- CURE), 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 på 23, 9% med hensyn til andet primært endepunkt (CV død, MI, hjerteanfald eller refraktær iskæmi).
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).
De fordele, der blev observeret for clopidogrel, var uafhængige af anden akut og langvarig behandling af kardiovaskulære sygdomme (med fx heparin/ LMWH, GPIIb/ IIIa- hæmmere, lipidsænkende lægemidler, beta - blokkere og ACE- hæmmere).
The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/ LMWH, GPIIb/ IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
Clopidogrels virkning blev observeret uden relation til doseringen af ASA (75 - 325 mg en gang daglig).
The efficacy of clopidogrel was observed independently of the dose of ASA (75-325 mg once daily).
Hos patienter med akut myokardieinfarkt (MI) med ST- segment elevation blev sikkerheden ved og effekten af clopidrogrel vurderet i 2 randomiserede, placebo- kontrollerede, dobbeltblindede undersøgelser kaldet CLARITY og COMMIT.
In patients with acute ST-segment elevation MI, safety and efficacy of clopidogrel have been evaluated in 2 randomised, placebo-controlled, double-blind studies, CLARITY and COMMIT.
CLARITY- studiet inkluderede 3491 patienter, der var til rådighed inden for 12 timer efter at et MI med elevation af ST- segmentet var indtrådt, og som det var planlagt at give en trombolytisk behandling.
The CLARITY trial included 3,491 patients presenting within 12 hours of the onset of a ST elevation MI and planned for thrombolytic therapy.
Patienterne fik clopidogrel (300 mg loading dose efterfulgt af 75 mg daglig, n=1752) eller placebo (n=1739) begge i kombination med ASA (150- 325 mg som loading dose, herefter 75- 162 mg dagligt), et fibrinolytisk middel samt heparin, når det var hensigtsmæssigt.
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.
Patientpopulationen bestod af 19, 7% kvinder og 29, 2% af patienterne var over 65 år.
The patient population included 19.7% women and 29.2% patients ≥ 65 years.
En total på 99, 7% af patienterne fik fibrinolytika (fibrinspecifik:
A total of 99.7% of patients received fibrinolytics (fibrin specific:
68, 7%, non- fibrin specifik:
68.7%, non-fibrin specific:
31, 1%), 89, 5% fik heparin, 78, 7% betablokkere, 54, 7% ACE- hæmmere og 63% statiner.
31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
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 (9 5% CI:
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), der hovedsagligt var relateret til en reduktion af infarkt - relaterede okkluderede arterier.
24, 47%; p < 0.001), mainly related to a reduction in occluded infarct-related arteries.
Det COMMIT- studie, som var designet med 2x2 faktor, inkluderede 45852 patienter, der var til rådighed inden for 24 timer efter indtrådte symptomer, som var mistænkt for at være MI og hvor EKG anomalier (dvs.
9 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.
Patienterne fik clopidogrel (75mg/ dag, n=22961) eller placebo (n=22891), i kombination med ASA (162 mg/ dag) i 28 dage eller indtil udskrivelse fra hospitalet.
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.
Det primære endepunkt var død uanset årsag og den første forekomst af re- infarkt, slagtilfælde eller død.
The co-primary endpoints were death from any cause and the first occurrence of re-infarction, stroke or death.
Populationen inkluderede 27, 8% kvinder, 58, 4% patienter ≥ 60 år (26% ≥ 70 år) og 54, 5% patienter der fik fibrinolytika.
The population included 27.8% women, 58.4% patients ≥ 60 years (26% ≥ 70 years) and 54.5% patients who received fibrinolytics.
Clopidogrel reducerede signifikant den relative dødsrisiko uanset årsag med 7% (p = 0, 029) og den relative risiko for kombinationen af re- infarkt, slagtilfæde eller død med 9% (p=0, 002), hvilket repræsenterer en absolut reduktion på henholdsvis 0, 5% og 0, 9%.
Clopidogrel significantly reduced the relative risk of death from any cause by 7% (p = 0.029), and the relative risk of the combination of re-infarction, stroke or death by 9% (p = 0.002), representing an absolute reduction of 0.5% and 0.9%, respectively.
Efter gentagne orale doser på 75 mg/ dag bliver clopidogrel hurtigt absorberet.
After repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Plasmakoncentrationerne af udgangsstoffet er imidlertid meget lave (< 0, 00025 mg) og kan ikke detekteres 2 timer efter dosering.
However, plasma concentrations of the parent compound are very low and below the quantification limit (0.00025 mg/ l) beyond 2 hours.
Absorptionen er mindst 50% baseret på urindudskillelse af clopidogrels metabolitter.
Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
85% af det cirkulerende stof i plasma.
Clopidogrel is extensively metabolised by the liver and the main metabolite, which is inactive, is the carboxylic acid derivative, which represents about 85% of the circulating compound in plasma.
Der indtraf maksimal plasmakoncentration af metabolitten (ca.
Peak plasma levels of this metabolite (approx.
1 time efter dosering.
3mg/ l after repeated 75 mg oral doses) occurred approximately 1 hour after dosing.
Clopidogrel er et prodrug.
Clopidogrel is a prodrug.
Den aktive metabolit er et thiol- derivat, som dannes ved oxidation af clopidogrel til 2- oxo- clopidogrel og efterfølgende hydrolyse.
The active metabolite, a thiol derivative, is formed by oxidation of clopidogrel to 2-oxo-clopidogrel and subsequent hydrolysis.
Oxidationen reguleres primært af cytochrom P450 isoenzym 2B6 og 3A4 og i mindre grad af 1A1, 1A2 og 2C19.
The oxidative step is regulated primarily by Cytochrome P450 isoenzymes 2B6 and 3A4 and to a lesser extent by 1A1, 1A2 and 2C19.
Den aktive thiol- metabolit, som er blevet isoleret in vitro, binder hurtigt og irreversibelt til blodpladereceptorerne, hvorved trombocytaggregationen hæmmes.
The active thiol metabolite, which has been isolated in vitro, binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation.
Denne metabolit er ikke påvist i plasma.
This metabolite has not been detected in plasma.
Hovedmetabolittens kinetik var lineær (plasmakoncentrationer øgedes proportionelt med dosis) i doseringsområdet 50- 150 mg clopidogrel.
The kinetics of the main circulating metabolite were linear (plasma concentrations increased in proportion to dose) in the dose range of 50 to 150 mg of clopidogrel.
Clopidogrel og den cirkulerende hovedmetabolit binder reversibelt in vitro til humane plasmaproteiner (henholdsvis 98% og 94%).
Clopidogrel and the main circulating metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
46% i fæces i løbet af et interval på 120 timer efter dosering.
Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Halveringstiden for elimination af den cirkulerende hovedmetabolit var 8 timer efter en enkelt og efter gentagen administration.
The elimination half- life of the main circulating metabolite was 8 hours after single and repeated administration.
Efter gentagen dosering med clopidogrel 75 mg/ dag var plasmaniveauet for den cirkulerende hovedmetabolit lavere hos forsøgspersoner med alvorlig nyresygdom (kreatininclearance 5- 15 ml/ min) sammenlignet med forsøgspersoner med moderat nyresygdom (kreatininclearance 30- 60 ml/ min) og niveauet i andre undersøgelser hos raske forsøgspersoner.
After repeated doses of 75 mg clopidogrel per day, plasma levels of the main circulating metabolite were lower in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/ min) compared to subjects with moderate renal disease (creatinine clearance from 30 to 60 ml/ min) and to levels observed in other studies with healthy subjects.
Skønt hæmning af ADP- induceret trombocytaggregation var lavere (25%) end hos raske forsøgspersoner, svarede forlængelsen af blødning til det, der blev observeret hos raske forsøgspersoner, som fik 75 mg clopidogrel daglig.
Although inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, the prolongation of bleeding was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Clopidogrels farmakokinetik og farmakodynamik blev vurderet i et forsøg med enkeltdosering og flerdosering hos såvel raske forsøgspersoner som patienter med cirrose (Child- Pugh klasse A eller B).
The pharmacokinetics and pharmacodynamics of clopidogrel were assessed in a single and multiple dose study in both healthy subjects and those with cirrhosis (Child-Pugh class A or B).
Daglig dosering i 10 dage med clopidogrel 75 mg/ dag var sikker og veltolereret.
Daily dosing for 10 days with clopidogrel 75 mg/ day was safe and well tolerated.
Clopidogrel Cmax for begge enkeltdoser og steady state for cirrose var mange gange højere end hos normale forsøgspersoner.
Clopidogrel Cmax for both single dose and steady state for cirrhotics was many fold higher than in normal subjects.
Alligevel var plasmaniveauet af den cirkulerende hovedmetabolit sammen med effekten af clopidogrel på den trombocytaggregation som ADP- inducerer og kapillærblødningstid sammenlignelig mellem de to grupper.
However, plasma levels of the main circulating metabolite together with the effect of clopidogrel on ADP-induced platelet aggregation and bleeding time were comparable between these groups.
5. 3 Prækliniske sikkerhedsdata
10 5.3 Preclinical safety data
De optrådte ved doser, der var mindst 25 gange højere end de kliniske doser på 75 mg/ dag til mennesker, og var en konsekvens af effekten på levermetaboliseringsenzymerne.
These occurred at doses representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/ day and were a consequence of an effect on hepatic metabolising enzymes.
Ved meget høje doser clopidogrel blev der hos rotter og bavianer observeret dårlig gastrisk tolerans (gastritis, gastriske erosioner og/ eller opkastning).
At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/ or vomiting) of clopidogrel was also reported in rat and baboon.
Der var ikke tegn på karcinogen virkning, når clopidogrel blev administreret i 78 uger til mus og 104 uger til rotter og givet i doser op til 77 mg/ kg/ dag (hvilket udgør mindst 25 gange eksponeringen hos mennesker, der får den kliniske dosis på 75 mg/ dag).
There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/ kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/ day).
Mannitol (E421) Macrogol 6000 Mikrokrystallinsk cellulose Hydrogeneret ricinusolie Hydroxypropylcellulose, lavsubstitueret Overtræk:
Mannitol (E421) Macrogol 6000 Microcrystalline cellulose Hydrogenated castor oil Low substituted hydroxypropylcellulose
Hypromellose (E464) Lactose Triacetin (E1518) Titandioxid (E171) Jernoxid, rød (E172) Carnaubavoks
Hypromellose (E464) Lactose Triacetin (E1518) Titanium dioxide (E171) Red iron oxide (E172) Carnauba wax
Blisterkort af PVC/ PVDC/ aluminium skal opbevares under 30ºC Blisterkort kun i aluminium kræver ingen særlige forholdsregler vedrørende opbevaringen.
In all aluminium blisters, this medicinal product does not require any special storage conditions.
6. 5 Emballage (art og indhold)
11 6.5 Nature and content of container
Blisterkort af PVC/ PVDC/ aluminium eller aluminium i kartonæsker der indeholder 7, 14, 28, 30, 50, 84, 90 og 100 filmovertrukne tabletter.
PVC/ PVDC/ Aluminium blisters or all aluminium blisters in cardboard cartons containing 7, 14, 28, 30, 84, 90 and 100 film-coated tablets.
Perforerede dosisblistere af PVC/ PVDC/ aluminium eller aluminium i kartonæsker indeholdende 50x1 filmovertrukne tabletter.
PVC/ PVDC/ Aluminium or all aluminium perforated unit-dose blister packs in cardboard cartons containing 50x1 film-coated tablets.
Bristol- Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Storbritannien
Bristol Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
EU/ 1/ 08/ 464/ 001 - Pakning med 14 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 464/ 002 - Pakning med 14 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 464/ 003 - Pakning med 28 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 464/ 004 - Pakning med 28 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 464/ 005 - Pakning med 30 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 464/ 006 - Pakning med 30 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 464/ 007 - Pakning med 50x1 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 464/ 008 - Pakning med 50x1 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 464/ 009 - Pakning med 84 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 464/ 010 - Pakning med 84 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 464/ 011 - Pakning med 90 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 464/ 012 - Pakning med 90 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 464/ 013 - Pakning med 100 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 464/ 014 - Pakning med 100 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 464/ 018 - Pakning med 7 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 464/ 019 - Pakning med 7 filmovertrukne tabletter i blisterkort af aluminium
EU/ 1/ 08/ 464/ 001 - Cartons of 14 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 002 - Cartons of 14 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 003 - Cartons of 28 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 004 - Cartons of 28 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 005 - Cartons of 30 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 006 - Cartons of 30 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 007 - Cartons of 50x1 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 008 - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 009 - Cartons of 84 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 010 - Cartons of 84 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 011 - Cartons of 90 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 012 - Cartons of 90 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 013 - Cartons of 100 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 014 - Cartons of 100 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 018 - Cartons of 7 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 019 - Cartons of 7 film-coated tablets in all aluminium blisters
Yderligere information om dette produkt er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside: http: // www. emea. europa. eu 1.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http: / /www. emea. europa. eu/
Hver tablet indeholder 12 mg lactose og 13, 2 mg ricinusolie, hydrogeneret.
Excipients: each tablet contains 12 mg lactose and 13.2 mg hydrogenated castor oil.
Lyserøde, aflange, med tallet "300" præget på den ene side og tallet "1332" på den anden side.
Pink, oblong, engraved with « 300 » on one side and « 1332 » on the other side.
- akut koronarsyndrom uden elevation af ST- segmentet (ustabil angina eller myokardieinfarkt uden
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).
forekomst af Q- takker) inklusive patienter, som får indsat stent efter perkutant koronarindgreb, i kombination med acetylsalicylsyre (ASA).
-
- akut myokardieinfarkt med elevation af ST- segmentet i kombination med ASA hos medicinsk
ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Denne 300 mg clopidogrel tablet er tiltænkt som stabiliseringsdosis hos patienter med akut koronarsyndrom:
This 300 mg tablet of clopidogrel is intended for use as a loading dose in patients suffering from acute coronary syndrome: − 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).
5. 1).
−
- akut myokardieinfarkt med elevation af ST- segmentet:
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.
Behandling med clopidogrel bør bestå
Combined therapy should be started as early
Kombinationsterapi bør startes så tidligt som muligt, og fortsættes i mindst 4 uger efter symptomerne viser sig.
as possible after symptoms start and continued for at least four weeks.
4. 8).
Due to the risk of bleeding and haematological undesirable effects, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8).
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 eller nonsteroide antiinflammatoriske lægemidler, inklusive cox- 2 hæmmere.
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 including Cox-2 inhibitors.
Patienterne skal kontrolleres omhyggeligt for tegn på blødninger, herunder okkulte blødninger, især i behandlingens første uger og/ eller efter invasive hjerteindgreb eller - kirurgi.
Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery.
Der er begrænset erfaring med clopidogrel til patienter med moderat leversygdom, som kan have blødningstendens.
14 Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses.
4. 4).
Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions that receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
ASA ændrede ikke på, at clopidogrel hæmmer den trombocytaggregation, som ADP inducerer,, men clopidogrel forstærkede virkningen af ASA den trombocytaggregation som kollagen inducerer.
ASA did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet aggregation.
Imidlertid fik de patienter, som indgik i kliniske forsøg med clopidogrel, en lang række ledsagende lægemidler såsom diuretika, beta- blokkere, ACE- hæmmere, calciumantagonister, kolesterolsænkende midler, dilatatorer med effekt på koronarkarrene, antidiabetika (inklusive insulin), antiepileptika samt GPIIb/ IIIa - hæmmere, uden at der blev påvist klinisk signifikante uønskede interaktioner.
However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
5. 3).
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Clopidogrel er blevet evalueret sikkerhedsmæssigt hos mere end 42. 000 patienter, der har deltaget i kliniske studier, inklusive over 9. 000 patienter der blev behanldet i mindst 1 år.
Clopidogrel has been evaluated for safety in more than 42,000 patients who have participated in clinical studies, including over 9,000 patients treated for 1 year or more.
Samlet set var clopidogrel 75 mg/ dag sammenligneligt med ASA 325 mg/ dag i CAPRIE uden hensyntagen til alder, køn eller race.
Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
Blødning er den mest almindeligt indrapporterede bivirkning fra både kliniske studier, såvel som fra post - marketing erfaring, hvor den mestendels blev indrapporteret i løbet behandlingens første måned.
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.
Forekomsten af større blødninger var ensartet i de to grupper (1. 3% versus 1. 1% for hhv. clopidogrel+ASA - og placebo+ASA- gruppen.) Dette var ensartet blandt undergrupperne af patienter, defineret ved baseline karakterisktika og typen af fibrinolytika eller heparinbehandling.
16 consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Hyppighed defineres i henhold til følgende konvention: almindelig (> 1/ 100 til < 1/ 10), ikke almindelig (> 1/ 1000 til < 1/ 100), sjælden (> 1/ 10000 til < 1/ 10000), meget sjælden < 1/ 10000).
Their frequency is defined using the following conventions: 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).
almindelig Blod og lymfesystem
Blood and the lymphatic system disorders
Thrombocyto - peni, leukopeni, eosinofili
Thrombocytopenia, leucopenia, eosinophilia
Systemorganklasse
Respiratory, thoracic and mediastinal disorders
Almindelig
Epistaxis
Meget sjælden
Uncommon
Luftveje, thorax og mediastinum
Rare
Næseblod
Very rare
Blødning i luftvejene (hæmoptyse, pulmonær blødning), bronkospasmer, interstitiel pneumoni
Gastrointestinal Gastrointestinal
Mave- tarmkanalen
Gastric ulcer and