natgillin/translations-raw huggingface dataset:
Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
I modsætning hertil viste post-hoc analyser statistisk signifikante stigninger i blødningsrisikoen med de mere potente P2Y12hæmmere, overvejende under vedligeholdelsesfasen efter den første måned efter ACS.
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.
BATCHNUMMER Batch
BATCH NUMBER
Absorptionen er mindst 50 % baseret på urinudskillelse af clopidogrels metabolitter.
Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Ca. 88 % af patienterne fik samtidig ASA (interval 1 til 23 mg/kg/dag).
Approximately 88% of patients received concomitant ASA (range of 1 to 23 mg/kg/day).
• hvis du lider af en alvorlig leversygdom.
• if you suffer from severe liver disease;
Ved steady state var den gennemsnitlige hæmningsgrad, der blev iagttaget med en dosis på 75 mg/dag, mellem 40 % og 60 %.
At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
Cellulose, mikrokrystallinsk Silica, kolloid vandfri Crospovidon (type A) Macrogol 6000
Cellulose, microcrystalline Colloidal anhydrous silica Crospovidone (type A) Macrogol 6000
Advarsler og forsigtighedsregler Kontakt lægen, før du tager Clopidogrel Mylan, hvis nogen af følgende situationer gælder for dig:
Warnings and precautions Talk to your doctor before taking Clopidogrel Mylan if any of the situations mentioned below apply to you:
Den aktive metabolit dannes hovedsageligt af CYP2C19 med bidrag fra flere andre CYP-enzymer, inklusive CYP1A2, CYP2B6 og CYP3A4.
The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.
For de patienter der ikke gennemgik angiografi, var det primære endepunkt død, gentaget myokardieinfarkt ved dag 8 eller ved udskrivelse fra hospitalet.
For patients who did not undergo angiography, the primary endpoint was death or recurrent myocardial infarction by Day 8 or by hospital discharge.
Lyserøde, runde og bikonvekse filmovertrukne tabletter.
Pink, round and biconvex film-coated tablets.
Din læge bør have udskrevet Clopidogrel Mylan plus acetylsalicylsyre, hvis du ikke må tage ”orale antikoagulantia”, og du ikke har risiko for alvorlig blødning.
Your doctor should have prescribed Clopidogrel Mylan plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
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.
Hvis du får langvarige blødninger, mens du tager Clopidogrel Mylan Hvis du skærer dig eller kommer til skade, kan det tage lidt længere end normalt, før blødningen stopper.
If you experience prolonged bleeding when taking Clopidogrel Mylan If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Hos poor metabolisers var eksponeringen nedsat med 63-71 %, sammenlignet med personer med extensive metabolisers.
In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
Patienter med en bekræftet diagnose på erhvervet hæmofili skal varetages og behandles af specialister, og clopidogrel skal seponeres.
Patients with a confirmed diagnosis of acquired haemophilia should be managed and treated by specialists, and clopidogrel should be discontinued
7 filmovertrukne tabletter - kalenderblisterpakning: EU/1/09/559/012 14 filmovertrukne tabletter - kalenderblisterpakning: EU/1/09/559/013 28 filmovertrukne tabletter - kalenderblisterpakning: EU/1/09/559/014 56 filmovertrukne tabletter - kalenderblisterpakning: EU/1/09/559015 84 filmovertrukne tabletter - kalenderblisterpakning: EU/1/09/559/016
7 film-coated tablets - calendar blister: EU/1/09/559/012 14 film-coated tablets - calendar blister: EU/1/09/559/013 28 film-coated tablets - calendar blister: EU/1/09/559/014 56 film-coated tablets - calendar blister: EU/1/09/559/015 84 film-coated tablets - calendar blister: EU/1/09/559/016
7 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 30x1 filmovertrukne tabletter 50 filmovertrukne tabletter 50x1 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 30x1 film-coated tablets 50 film-coated tablets 50x1 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
De klinisk relevante bivirkninger observeret i CAPRIE-, CURE-, CLARITY, COMMITog ACTIVE-A-studierne beskrives nedenfor.
The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Polyvinylalkohol Titandioxid (E171) Rød jernoxid (E172) Gul jernoxid (E172) Talcum
Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) Talc
I CURE, CLARITY, ACTIVE-A og et af kohortestudier (Trenk) blev der ikke observeret nogen øget forekomst af hændelser, baseret på metabolismestatus.
In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
• Pædiatrisk population Clopidogrels bør ikke bruges til børn på grund af usikkerhed om virkningen (se pkt.
• Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
Hvis du har glemt en dosis af Clopidogrel Mylan, 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.
If you forget to take a dose of Clopidogrel Mylan, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Thrombocytopeni, leukopeni, eosinofili
Thrombocytopenia, leucopenia, eosinophilia
TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Tyskland
TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Germany
Du bør være blevet informeret om, at ”orale antikoagulantia” er mere effektive mod denne sygdom end acetylsalicylsyre eller kombinationen af Clopidogrel Mylan og acetylsalicylsyre.
You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Mylan and acetylsalicylic acid for this condition.
Dette var ensartet blandt undergrupperne af patienter defineret ved baseline karakteristika og typen af fibrinolytika eller heparinbehandling.
This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Den almindeligste bivirkning, der er set med Clopidogrel Mylan, er blødning.
The most common side effect reported with Clopidogrel Mylan is bleeding.
Trafik- og arbejdssikkerhed Det er usandsynligt, at Clopidogrel Mylan påvirker din evne til at køre eller betjene maskiner.
Driving and using machines Clopidogrel Mylan is unlikely to affect your ability to drive or to use machines.
Ved at forhindre denne sammenklumpning nedsætter en blodpropopløsende medicin risikoen for, at der dannes blodpropper (en proces, der kaldes trombose).
By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).
Sikkerheden og effekten af clopidogrel er blevet evalueret i 5 dobbeltblindede studier, der omfattede mere end 88.000 patienter: CAPRIE-studiet, hvor clopidogrel sammenlignes med ASA, og CURE, CLARITY, COMMIT- og ACTIVE-A-studierne, hvor clopidogrel sammenlignes med placebo, og hvor begge lægemidler gives i kombination med ASA eller anden standardterapi.
The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Clopidogrel påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
Clopidogrel has no or negligible influence on the ability to drive and use machines.
For pakninger med 7, 14, 28, 56 stk. og 84 stk. tabletter kan du kontrollere på hvilken dag du sidst tog en tablet ved at se på kalenderen, der er trykt på blisterpakningen.
For the 7, 14, 28, 56, 84 tablets (calendar blister) pack sizes, you can check the day on which you last took a tablet of Clopidogrel Mylan by referring to the calendar printed on the blister
tegn på leverproblemer såsom gulfarvning 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”).
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').
Clopidogrel Mylan indeholder clopidogrel og tilhører en lægemiddelgruppe, der kaldes blodfortyndende medicin.
Clopidogrel Mylan contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
I CURE var der ikke overrepræsentation af større blødninger med clopidogrel plus ASA inden for 7 dage efter koronar bypass hos patienter, der indstillede behandlingen mere end 5 dage før indgrebet.
In CURE, there was no excess in major bleeds with clopidogrel plus ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery.
I CHARISMA og et ken kohortestudie (Simon), sås kun en øget hyppighed af hændelser hos poor metabolisers i sammenligning med extensive metabolisers.
In CHARISMA and one cohort study (Simon), an increased event rate was observed only in poor metabolisers when compared to extensive metabolisers.
Nye kardiovaskulære hændelser (primært endepunkt) blev forebygget med relative risikoreduktioner på 22 % (CI: 8,6,-33,4) 32 % (CI: 12,8,-46,4), 4 % (CI: -26,9,-26,7), 6 % (CI: -33,5,-34,3) og 14 % (CI: -31,6,-44,2), i løbet af studiets intervaller på henholdsvis 0-1, 1-3, 3-6, 6-9 og 9-12 måneder.
New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
Hvis du bliver gravid, mens du tager Clopidogrel Mylan, skal du omgående kontakte din læge, da det frarådes at tage clopidogrel under graviditet.
If you become pregnant while taking Clopidogrel Mylan, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Patienter randomiseret i ACTIVE-programmet var dem, der blev præsenteret med dokumenteret AF, dvs. enten permanent AF eller mindst 2 episoder med intermitterende AF inden for de seneste 6 måneder, og som havde mindst én af følgende risikofaktorer: alder ≥ 75 år eller alder 55 til 74 år og enten behandlingskrævende diabetes mellitus eller dokumenteret tidligere MI eller dokumenteret koronararteriesygdom; behandlingskrævende systemisk hypertension; apopleksi, transitorisk cerebral iskæmi (TCI), eller non-CNS systemisk emboli i anamnesen; venstre ventrikel dysfunktion med venstre ventrikel uddrivningsfraktion <45 % eller dokumenteret perifer vaskulær sygdom.
Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age 75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
Som forholdsregel bør amning ophøre under behandling med Clopidogrel Mylan.
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Mylan.
Opfølgning ved et år blev udført for 316 patienter (98,1%) i de-eskaleret DAPT-gruppen og 318 patienter (98,5%) i den uændrede DAPT-gruppe.
Follow-up at one year was performed for 316 patients (98.1%) in the de-escalated DAPT group and 318 patients (98.5%) in the unchanged DAPT group.
De øvrige indholdsstoffer er: Tabletkernen: mikrokrystallinsk cellulose, vandfri kolloid silica, crospovidon (type A), macrogol 6000, hydrogeneret ricinusolie (se afsnit 2 ”Clopidogrel Mylan indeholder hydrogeneret ricinusolie”) Filmovertrækket: polyvinylalkohol, titandioxid (E171), rødt jernoxid (E172), gul jernoxid (E172), talcum og macrogol 3000.
The other ingredients are: Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil (see section 2 ‘Clopidogrel Mylan contains hydrogenated castor oil') Film-coating: polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.
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 Mylan.
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Mylan.
Herudover blev clopidogrels farmakodynamiske aktivitet ikke påvirket signifikant af samtidig administration af phenobarbital, eller østrogen.
Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the co-administration of phenobarbital, or oestrogen.
En signifikant lavere eksponering for clopidogrels aktive metabolit og reduceret trombocythæmning er påvist hos HIV-smittede patienter i behandling med ritonavir- eller cobicistat-boostet antiretroviral terapi (ART).
A significantly lower exposure to clopidogrel active metabolite and reduced platelet inhibition have been demonstrated in HIV-infected patients treated with ritonavir- or cobicistat-boosted anti-retroviral therapies (ART).
• hvis du har haft en blodprop i en blodåre (arterie) i hjernen (iskæmisk apopleksi), inden for de seneste 7 dage
• if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days.
Der er 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), CLARITY-TIMI 28 (n=227) og TRITON-TIMI 38 (n=1.477) såvel som et antal publicerede kohortestudier.
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.
Øvrige bivirkninger omfatter
Other side effects include:
• skal du også straks fortælle det til din læge, hvis du udvikler en medicinsk tilstand (Trombocytisk Trombocytopenisk Purpura eller TTP), der giver feber og blå mærker under huden, der kan fremstå som røde små prikker, med eller uden uforklarlig udtalt træthed, forvirring, gulfarvning af huden eller øjnene (gulsot) (se afsnit 4 ”Bivirkninger”).
• You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
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).
I TRITON-TIMI 38 og 3 af kohortestudier (Collet, Sibbing, Giusti), havde den kombinerede gruppe af patienter med status som enten intermediate eller poor metabolisers en højere hyppighed af kardiovaskulære hændelser (død, myokardieinfarkt og apopleksi) eller stenttrombose sammenlignet med extensive metabolisers.
In TRITON-TIMI 38 and 3 of the cohort studies (Collet, Sibbing, Giusti) the combined group of patients with either intermediate or poor metaboliser status had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers.
Potente og moderate CYP2C19-hæmmere inkluderer for eksempel omeprazol og esomeprazol, fluvoxamin, fluoxetin, moclobemid, voriconazol, fluconazol, ticlopidin, carbamazepin, og efavirenz.
Medicinal products that are strong or moderate CYP2C19 inhibitors include, for example, omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, and efavirenz.
Patienter bør evalueres for tidligere overfølsomhed over for thienopyridiner (såsom clopidogrel, ticlopidin, prasugrel), da der er rapporteret om krydsreaktioner mellem thienopyridiner (se pkt.
Patients should be evaluated for history of hypersensitivity to thienopyridines (such as clopidogrel, ticlopidine, prasugrel) since cross-reactivity among thienopyridines has been reported (see section
De resultater, som blev opnået i populationer med forskellige karakteristika (fx ustabil angina pectoris eller myokardieinfarkt uden forekomst af Q-takker, høj- eller lavrisikogruppe, diabetes, behov for revaskularisering, alder, køn, osv.) svarede til den primære analyses resultater.
The results obtained in populations with different characteristics (e.g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis.
Den kliniske relevans af disse fund er usikker, men der har været spontane indberetninger fra HIV-smittede patienter i behandling med boostet antiretroviral terapi, som har oplevet re-okklusive hændelser efter de-obstruktion eller oplevet trombotiske hændelser under støddosisbehandling med clopidogrel.
Although the clinical relevance of these findings is uncertain, there have been spontaneous reports of HIV-infected patients treated with boosted ART, who have experienced reocclusive events after de-obstruction or have suffered thrombotic events under a clopidogrel loading treatment schedule.
Desuden var IPA på 32 % (24 timer) og 61 % (dag 5), hvilket var større end hos poor metabolisers, der fik 300 mg/7 mg-regimet, og svarede til IPA ved 300 mg/75 mg regimet hos de andre grupper af CYP2C19-metabolisers.
In addition, IPA was 32% (24 hours) and 61% (Day 5), which were greater than in the poor metabolisers receiving the 300 mg/75 mg regimen, and were similar to the other CYP2C19 metaboliser groups receiving the 300 mg/75 mg regimen.
99,7 % af patienterne fik fibrinolytika (fibrinspecifik: 68,7 %, non-fibrin specifik: 31,1 %), 89,5 % fik heparin, 78,7 % betablokkere, 54,7 % ACE-hæmmere og 63 % statiner.
A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non-fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
Derefter er den anbefalede dosis 1 tablet Clopidogrel Mylan à 75 mg dagligt, der skal indtages som beskrevet ovenfor.
Then, the recommended dose is one 75 mg tablet of Clopidogrel Mylan per day as described above.
Macrogol 3000
Macrogol 3000 (Polyethyleneglycol)
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.
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.
du har uregelmæssig hjerterytme (en sygdom kaldet ”atrieflimren”) og ikke må tage medicin kendt som orale antikoagulantia (vitamin K-antagonister), der kan forebygge dannelsen af nye blodpropper og forhindre eksisterende blodpropper i at vokse.
You have an irregular heartbeat, a condition called ‘atrial fibrillation', and you cannot take medicines known as ‘oral anticoagulants' (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing.
Patienter, der er ældre end 75 år, bør ikke indlede behandlingen med clopidogrel med en mætningsdosis.
For patients over 75 years of age clopidogrel should be initiated without a loading dose.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER (ÆSKER MED 7, 14, 28, 30, 30x1, 50, 50x1, 56, 84, 90 og 100)
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (Boxes of 7, 14, 28, 30, 30x1, 50, 50x1, 56, 84, 90 and 100)
Ved 300 mg/75 mg dosisregimet, var det trombocythæmmende respons nedsat hos poor metabolisers med en gennemsnitlig IPA (5 µM ADP) på 24 % (24 timer) og 37 % (dag 5), sammenlignet med IPA på 39 % (24 timer) og 58 % (dag 5) for extensive metabolisers og 37 % (24 timer) og 60 % (dag 5) hos intermediate metabolisers.
After the 300 mg/75 mg dose regimen, antiplatelet responses were decreased in the poor metabolisers with mean IPA (5 μM ADP) of 24% (24 hours) and 37% (Day 5) as compared to IPA of 39% (24 hours) and 58% (Day 5) in the extensive metabolisers and 37% (24 hours) and 60% (Day 5) in the intermediate metabolisers.
Efter en oral dosis af 14C-mærket clopidogrel hos mennesker blev ca. 50% udskilt i urinen og ca. 46% i fæces i løbet af 120 timer efter dosering.
C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Farmakoterapeutisk klassifikation: Trombocytfunktionshæmmende midler eksklusive heparin, ATCkode: B01AC04.
Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC code: B01AC04.
Almindelige bivirkninger (kan påvirke op til 1 ud af 10 patienter): Diarré, mavesmerter, fordøjelsesbesvær eller halsbrand.
Common side effects (may affect up to 1 in 10 people): Diarrhoea, abdominal pain, indigestion or heartburn.
En dosis på 0,2 mg/kg opnåede en gennemsnitlig procentvis hæmning på 49,3 % (5 µM ADP-induceret trombocytaggregation), hvilket er sammenligneligt med voksne, der tager clopidogrel 75 mg/dag.
The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking clopidogrel 75 mg/day.
På grund af risiko for øget plasmakoncentration skal der udvises forsigtighed ved samtidig administration af clopidogrel og lægemidler, der primært elimineres ved CYP2C8-metabolisme (f.eks. repaglinid, paclitaxel) (se pkt.
Due to the risk of increased plasma concentrations, concomitant administration of clopidogrel and drugs primarily cleared by CYP2C8 metabolism (e.g., repaglinide, paclitaxel) should be undertaken with caution (see section
I CURE var anvendelse af clopidogrel forbundet med et aftagende behov for behandling med trombolytika (RRR = 43,3 %, CI: 24,3 %, 57,5 %) og GPIIb/IIIa-hæmmere (RRR = 18,2 %, CI: 6,5 %,
The use of clopidogrel in CURE was associated with a decrease in the need of thrombolytic therapy (RRR = 43.3%; CI: 24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR = 18.2%; CI: 6.5%, 28.3%).