natgillin/translations-raw huggingface dataset:
Clopidogrel Winthrop var mere effektivt end aspirin til forebyggelse af nye iskæmiske hændelser.
Clopidogrel Winthrop was more effective than aspirin at preventing new ischaemic events.
Der var 939 hændelser i Clopidogrel Winthrop- gruppen og 1 020 i aspirin- gruppen.
There were 939 events in the Clopidogrel Winthrop group, and 1,020 in the aspirin group.
Dette svarer til en relativ risikoreduktion på 9% sammenlignet med aspirin Riskoreduktion betyder, at færre patienter vil få nye iskæmiske hændelser, når de får Clopidogrel Winthrop, end hvis de får aspirin.
This corresponds to a relative reduction in risk of 9% compared with aspirin.
Det vil sige, at ca.
Risk reduction means that fewer patients will have new ischaemic events when they receive Clopidogrel Winthrop, than if they receive aspirin.
10 patienter af 1 000 vil undgå en ny iskæmisk hændelse to år efter at de er begyndt at tage Clopidogrel Winthrop istedet for aspirin.
In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Clopidogrel Winthrop instead of aspirin.
I forbindelse med myokardieinfarkt med forhøjet ST- segmentet havde færre af de Clopidogrel Winthrop - behandlede patienter hændelser end de placebo- behandlede patienter (262 i forhold til 377 i CLARITY- undersøgelsen og 2 121 i forhold til 2 310 i COMMIT- undersøgelsen).
In ST segment elevation myocardial infarction, fewer patients on Clopidogrel Winthrop had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Dette viser, at Clopidogrel Winthrop mindsker risikoen for en hændelse.
This showed that Clopidogrel Winthrop reduces the risk of an event.
Hvilken risiko er der forbundet med Clopidogrel Winthrop?
What is the risk associated with Clopidogrel Winthrop?
De almindeligste bivirkninger ved Clopidogrel Winthrop (der ses hos mellem 1 og 10 patienter af hver 100) er hæmatom (en blodsamling under huden), epistaksis (næseblod), gastrointestinale blødninger (blødninger i mave eller tarm), diarré, mavesmerter, fordøjelsesbesvær, blå mærker og blødning på punkturstedet.
The most common side effects with Clopidogrel Winthrop (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal (tummy) pain, dyspepsia (indigestion), bruising and bleeding where the skin is punctured.
Den fuldstændige liste over alle de indberettede bivirkninger for Clopidogrel Winthrop fremgår af indlægssedlen.
For the full list of all side effects reported with Clopidogrel Winthrop, see the Package Leaflet.
Clopidogrel Winthrop må ikke anvendes af personer, der kan være overfølsomme (allergisk) over for clopidogrel eller nogen af indholdsstofferne, eller af patienter med alvorlige leversygdomme eller en sygdom, som kan forårsage blødninger.
Clopidogrel Winthrop should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients, or in patients who have severe liver disease, or have a disease which may cause bleeding.
Hvorfor blev Clopidogrel Winthrop godkendt?
Why has Clopidogrel Winthrop been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Clopidogrel Winthrop er større end risiciene hos voksne ved forebyggelse af aterotrombotiske hændelser.
The Committee for Medicinal Products for Human Use (CHMP) decided that Clopidogrel Winthrop’ s benefits are greater than its risks in adults for the prevention of atherothrombotic events.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Winthrop.
The Committee recommended that Clopidogrel Winthrop be given marketing authorisation.
2/ 3 Andre oplysninger om Clopidogrel Winthrop:
Other information about Clopidogrel Winthrop:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Winthrop til Sanofi Pharma Bristol- Myers Squibb SNC den 16. juli 2008.
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Winthrop to Sanofi Pharma Bristol-Myers Squibb SNC on 16 July 2008.
Den fuldstændige EPAR for Clopidogrel Winthrop findes her.
The full EPAR for Clopidogrel Winthrop is available here.
Clopidogrel Winthrop 75 mg filmovertrukne tabletter
Clopidogrel Winthrop 75 mg film-coated tablets
Behandling med clopidogrel bør indledes med en enkelt initial stabiliseringsdosis på 300 mg, hvorefter behandlingen består af 75 mg en gang daglig (sammen med acetylsalicylsyre (ASA) 75 mg - 325 mg/ dag).
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).
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.
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.
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.
På grund af manglende data kan clopidogrel ikke anbefales til akut iskæmisk slagtilfælde (inden for 7
In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
Der er begrænset erfaring med behandling af patienter med nyresygdom.
3 Therapeutic experience with clopidogrel is limited in patients with renal impairment.
Clopidogrel Winthrop indeholder laktose.
Clopidogrel Winthrop contains lactose.
Imidlertid er det på grund af manglen på interaktionsforsøg med andre NSAID’ er ikke umiddelbart klart, om der er øget risiko for gastrointestinal blødning med alle NSAID - præparater.
However, due to the lack of interaction studies with other NSAIDs it is presently unclear whether there is an increased risk of gastrointestinal bleeding with all NSAIDs.
Hverken digoxins eller theofyllins farmakokinetik blev ændret ved samtidig administration af
4 The pharmacokinetics of digoxin or theophylline were not modified by the co-administration of clopidogrel.
Dette kunne muligvis føre til forhøjede plasmaniveauer af lægemidler som phenytoin og tolbutamid samt de NSAID’ er, som metaboliseres af cytochrom P450 2C9.
This could potentially lead to increased plasma levels of medicinal products such as phenytoin and tolbutamide and the NSAIDs, which are metabolised by Cytochrome P450 2C9.
Ud over ovenstående oplysninger om specifik lægemiddelinteraktion er der ikke udført interaktions - forsøg med clopidogrel og visse lægemidler, som almindeligvis gives til patienter med aterotrombotiske sygdomme.
Apart from the specific medicinal product interaction information described above, interaction studies with clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed.
Imidlertid fik de patienter, som indgik i kliniske forsøg med clopidogrel, en lang række ledsagende lægemidler såsom diuretika, beta- blokkere, ACE- hæmmere, calcium - antagonister, 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.
Som forholdsregel bør amning ophøre under behandling med Clopidogrel Winthrop.
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Winthrop.
Der forekom ikke overrepræsentation af større blødninger med clopidogrel + ASA inden for 7 dage efter koronar bypass hos patienter, der indstillede behandlingen mere end 5 dage før indgrebet (4, 4% clopidogrel+ASA versus 5, 3% placebo+ASA).
There was no excess in major bleeds with clopidogrel + ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery (4.4% clopidogrel+ASA vs.
Hos patienter, som fortsatte med
5.3% placebo+ASA).
5 behandlingen indtil 5 dage før bypassoperationen, var forekomsten 9, 6% for clopidogrel+ASA og 6, 3% for placebo+ASA.
In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for clopidogrel+ASA, and 6.3% for placebo+ASA.
I CLARITY var der en generel stigning i antallet af blødninger i clopidrogrel+ASA- gruppen (17, 4%) versus placebo+ASA- gruppen (12, 9%).
In CLARITY, there was an overall increase in bleeding in the clopidogrel + ASA group (17.4%) vs. the placebo + ASA group (12.9%). The incidence of major bleeding was similar between groups (1.3% versus 1.1% for the clopidogrel + ASA and the placebo + ASA groups, respectively).
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.
This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
I COMMIT var den generelle forekomst af non- cerebrale større blødninger eller cerebrale blødninger lav og ensartet i begge grupper (0, 6% versus 0, 5% i hhv. clopidogrel+ASA og placebo+ASA - gruppen).
In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups (0.6% versus 0.5% in the clopidogrel + ASA and the placebo + ASA groups, respectively).
Øjne
6
Øjenblødning (konjunctival, okular, retinal
System Organ Class
Øre og labyrint
Uncommon
Vertigo
Rare
Vaskulære sygdomme
Very rare
Hæmatom
Eye disorders
Alvorlig blødning, blødning i operationssår, vaskulitis, hypotension
Eye bleeding (conjunctival, ocular, retinal)
Luftveje, thorax og mediastinum
Ear and labyrinth disorders
Næseblod
Vertigo
Blødning i luftvejene (hæmoptyse, pulmonær blødning), bronkospasmer, interstitiel pneumoni
Vascular disorders
6 Systemorganklasse
Haematoma
Almindelig
Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension
Ikke almindelig
Respiratory, thoracic and mediastinal disorders
Sjælden
Epistaxis
Meget sjælden
Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis
Gastrointestinal blødning, diarré, mavesmerter, dyspepsi
Gastrointestinal haemorrhage, diarrhoea, abdominal
Mavesår og duodenalt ulcus gastritis, opkastning, kvalme, forstoppelse, flatulens
Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea,
Gastrointestinal og retroperitoneal blødning med fatalt udfald, bugspytkirtelbetændelse, colitis (inklusive ulcerosa eller lymfocytisk colitis), stomatitis
Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis,
Lever og galdeveje
pain, dyspepsia constipation, flatulence
Akut leversvigt, hepatitis, unormal leverfunktionstest
colitis (including ulcerative or lymphocytic colitis), stomatitis
Hud og subkutane væv
Hepato-biliary disorders
Blå mærker
Skin and subcutaneous tissue disorders
Udslæt, kløe, hudblødning (purpura)
Bruising Rash, pruritus, skin bleeding (purpura)
Almene symptomer Blødning ved og reaktioner på injektionssteder administrationsstedet
General disorders
Feber
Bleeding at
Undersøgelser
Fever
Forlænget blødningstid, fald i neutrofiltal, fald i trombocyttal.
and administration puncture site site conditions Investigations
Trombocytfunktionshæmmende midler eksklusive heparin, ATC - kode:
Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code:
Clopidogrel hæmmer også den trombocytaggregation, som andre agonister inducerer ved at blokere for, at frigjort ADP forstærker trombocytaktiveringen.
Clopidogrel also inhibits platelet aggregation induced by other agonists by blocking the amplification of platelet activation by released ADP.
Derfor påvirkes trombocytter, der har været udsat for clopidogrel, i resten af deres levetid, og normal trombocytfunktion generhvervelse med
Consequently, platelets exposed to clopidogrel are affected for the remainder of their lifespan and recovery of normal platelet function occurs at a rate consistent with platelet turnover.
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:
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:
Hos de patienter, som alene indgik i undersøgelsen på grund af et nyligt myokardieinfarkt, lå clopidogrel numerisk lavere, men ikke statistisk forskelligt fra ASA (RRR = 4, 0%, CI: - 22, 5 til 11, 7 [p=0, 639]).
8 infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR = -4.0%; CI: -22.5 to 11.7 [p=0.639]).
CURE- undersøgelsen omfattede 12. 562 patienter med akut koronarsyndrom uden forhøjelse af ST - segmentet (ustabil angina pectoris eller myokardieinfarkt uden forekomst af Q- takker), som indfandt sig inden for 24 timer efter starten på den seneste periode med brystsmerter eller symptomer der svarede til iskæmi.
The CURE study included 12,562 patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischaemia.
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.
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.
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)).
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)).
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
Femten procent (15, 0%) af patienterne i clopidogrel- gruppen og 21, 7% i placebogruppen opnåede det
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:
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.
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.
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.
Hovedmetabolittens kinetik var lineær (plasmakoncentrationer øgedes proportionelt med dosis) i doseringsområdet 50- 150 mg clopidogrel.
10 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.
10 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.
11 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
6. 5 Emballage (art og indhold)
6.5 Nature and content of container
Sanofi Pharma Bristol- Myers Squibb SNC 174 Avenue de France F- 75013 Paris - Frankrig
Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France F-75013 Paris – France
EU/ 1/ 08/ 465/ 001 - Pakning med 14 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 465/ 002 - Pakning med 14 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 465/ 003 - Pakning med 28 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 465/ 004 - Pakning med 28 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 465/ 005 - Pakning med 30 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 465/ 006 - Pakning med 30 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 465/ 007 - Pakning med 50x1 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 465/ 008 - Pakning med 50x1 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 465/ 009 - Pakning med 84 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 465/ 010 - Pakning med 84 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 465/ 011 - Pakning med 90 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 465/ 012 - Pakning med 90 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 465/ 013 - Pakning med 100 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 465/ 014 - Pakning med 100 filmovertrukne tabletter i blisterkort af aluminium EU/ 1/ 08/ 465/ 018 - Pakning med 7 filmovertrukne tabletter i blisterkort af PVC/ PVDC/ aluminium EU/ 1/ 08/ 465/ 019 - Pakning med 7 filmovertrukne tabletter i blisterkort af aluminium
EU/ 1/ 08/ 465/ 001 - Cartons of 14 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 002 - Cartons of 14 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 003 - Cartons of 28 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 004 - Cartons of 28 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 005 - Cartons of 30 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 006 - Cartons of 30 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 007 - Cartons of 50x1 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 008 - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 009 - Cartons of 84 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 010 - Cartons of 84 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 011 - Cartons of 90 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 012 - Cartons of 90 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 013 - Cartons of 100 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 014 - Cartons of 100 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 018 - Cartons of 7 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 019 - Cartons of 7 film-coated tablets in all aluminium blisters
Dato for første tilladelse::
Date of first authorisation:
Yderligere information om dette produkt er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside: http: // www. emea. europa. eu
Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http: / /www. emea. europa. eu/
12 1.
13 1.
Clopidogrel Winthrop 300 mg filmovertrukne tabletter
Clopidogrel Winthrop 300 mg film-coated tablets
- 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).
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).
- akut myokardieinfarkt med elevation af ST- segmentet i kombination med ASA hos
-
medicinsk behandlede patienter, der er egnede til trombolytisk behandling.
ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
5. 1).
14
- akut myokardieinfarkt med elevation af ST- segmentet:
−
bestå af en daglig dosering på 75 mg, indledt med en stabiliseringsdosis på 300 mg i kombination med ASA og med eller uden trombolytika.
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.
Kombinationsterapi bør startes så tidligt som muligt, og fortsættes i mindst 4 uger efter
Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks.
5. 1).
the
Vedligholdelsesdosis af clopidogrel bør gives som en enkelt daglig dosis på 75 mg med eller uden føde.
maintenance dose, clopidogrel should be given as a single daily dose of 75 mg with or
• Børn og unge
without food.