natgillin/translations-raw huggingface dataset:
Imidlertid er det på grund af manglen på interaktionsstudier med andre NSAID'er ikke umiddelbart klart, om der er øget risiko for gastrointestinal blødning med alle NSAIDpræparater.
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.
Den gennemsnitlige tid fra anlæggelse af palliativ shunt til første administration af studielægemidlet var 20 dage.
The mean time between shunt palliation and first administration of study medicinal product was 20 days.
Den almindeligste bivirkning er blødning.
The most common side effect is bleeding.
Smagsforstyrrelser, ageusi
Taste disturbances, ageusia
Krydsreaktioner mellem thienopyridiner
Cross-reactions among thienopyridines
kan tages med eller uden mad.
may be taken with or without food.
En patient med status som poor metaboliser vil besidde to ikke-funktionelle alleller, som beskrevet ovenfor.
A patient with poor metaboliser status will possess two loss-of-function alleles as defined above.
På dag 14 blev blodpladefunktionstestning (PFT) udført.
At Day 14, platelet function testing (PFT) was performed.
TTP er en potentielt dødelig tilstand, der kræver øjeblikkelig behandling, der omfatter plasmaferese.
TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Selv om den iskæmiske fordel var konsistent i løbet af det første år, blev der observeret større reduktion i iskæmisk tilbagefald efter ACS i de første dage efter indledelsen af behandlingen.
Although the ischaemic benefit was consistent throughout the first year, greater reduction in ischaemic recurrence after ACS was observed during the initial days following the treatment initiation.
Lægemidler, der er forbundet med risiko for blødning: Der er en øget risiko for blødning på grund af mulig additiv effekt.
Medicinal products associated with bleeding risk: There is an increased risk of bleeding due to the potential additive effect.
De-eskalering af P2Y12-hæmmere i ACS
De-escalation of P2Y12 Inhibitor Agents in ACS
En analyse med total mortalitet som sekundært endepunkt viste ingen signifikant forskel mellem clopidogrel (5,8 %) og ASA (6,0 %).
Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.8%) and ASA (6.0%).
Du må ikke amme, når du tager denne medicin.
You should not breast-feed while taking this medicine.
Hyppighed defineres i henhold til følgende konvention: almindelig (>1/100 til <1/10), ikke almindelig (>1/1.000 til <1/100), sjælden (>1/10.000 til <1/10.000), meget sjælden <1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
(1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
• Hvis du lider af en alvorlig leversygdom
• If you suffer from severe liver disease.
Clopidogrel og den cirkulerende (inaktive) hovedmetabolit binder reversibelt in vitro til humane plasmaproteiner (henholdsvis 98% og 94%).
Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Patienter, der tidligere har udviklet en allergisk og/eller hæmatologisk reaktion over for en thienopyridin, kan have en øget risiko for at udvikle den samme eller en anden reaktion over for en anden thienopyridin.
Patients who had developed a previous allergic reaction and/or haematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine.
Kan indtages med eller uden mad.
It may be given with or without food.
TOPIC og TROPICALACS blev designet til at undersøge, hvordan man kan mindske blødninger samtidig med at effekten opretholdes.
TOPIC and TROPICAL-ACS were designed to study how to mitigate the bleeding events while maintaining efficacy.
TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) Dette randomiseret, open-label studie inkluderede ACS patienter, som kræver PCI.
TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) This randomized, open-label trial included ACS patients requiring PCI.
Gennemsnitligsalderen var 71 år, 41,6 % af patienterne var ≥ 75 år.
The mean age was 71 years, 41.6% of patients were ≥75 years.
Graviditet og amning Det er bedst ikke at tage denne medicin under graviditet og amning.
Pregnancy and breast-feeding It is preferable not to take this medicine during pregnancy.
I COMMIT var den generelle forekomst af non-cerebrale større blødninger eller cerebrale blødninger lav og ensartet i begge grupper.
In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups.
Ud over erfaringerne fra de kliniske studier er der spontant blevet rapporteret bivirkninger.
In addition to clinical studies experience, adverse reactions have been spontaneously reported.
I modsætning hertil viste post-hoc analyser statistisk signifikante stigninger i blødningsrisikoen med de mere potente P2Y12-hæmmere, overvejende under vedligeholdelsesfasen efter den første måned efter ACS.
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.
plus acetylsalicylsyre, hvis du ikke må tage ”orale antikoagulantia”, og du ikke har risiko for alvorlig blødning.
plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Patienterne blev behandlet i op til 5 år.
Patients were treated for up to 5 years.
Cellulose, mikrokrystallinsk Kolloidal vandfri silica Crospovidon (type A) Macrogol 6000
Cellulose, microcrystalline Colloidal anhydrous silica Crospovidone (type A) Macrogol 6000
påvirker din evne til at køre eller betjene maskiner.
is unlikely to affect your ability to drive or to use machines.
Blødning er den mest almindeligt indrapporterede bivirkning fra både kliniske studier, såvel som fra post-marketing erfaring, hvor den mestendels blev indrapporteret i løbet af behandlingens første måned.
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.
Hos poor metabolisers var eksponeringen nedsat med 63-71 % sammenlignet med extensive metabolisers.
In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
Kontakt din læge eller nærmeste skadestue, på grund af den øgede blødningsrisiko.
than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Baseret på indrulleringskriterier indrullerede læger patienter i ACTIVE-W, hvis de var kandidater til behandling med vitamin K-antagonist (VKA) (såsom warfarin).
Based on enrollment criteria, physicians enrolled patients in ACTIVE-W if they were candidates for vitamin K antagonist (VKA) therapy (such as warfarin).
Indflydelsen af CYP2C19-genotype på det kliniske udfald hos patienter i behandling med clopidogrel er ikke blevet evalueret i prospektive, randomiserede, kontrollerede studier.
The influence of CYP2C19 genotype on clinical outcomes in patients treated with clopidogrel has not been evaluated in prospective, randomised, controlled trials.
Endvidere tydede en analyse af aldersbaserede delgrupper på, at fordelen ved clopidogrel hos patienter over 75 år var mindre end hos patienter ≤75 år.
In addition, a subgroup analysis by age suggested that the benefitof clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
Når poor metabolisers fik 600 mg/150 mg regimet var eksponeringen for den aktive metabolit større end ved 300 mg/75 regimet.
When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
I tilfælde af bekræftet isoleret forlængelse af aktiveret partiel tromboplastintid (APTT) med eller uden blødning bør erhvervet hæmofili overvejes.
In cases of confirmed isolated activated Partial Thromboplastin Time (aPTT) prolongation with or without bleeding, acquired haemophilia should be considered.
Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
The requirements for submission of (PSURs) reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
I alt blev 645 af 646 patienter med STEMI eller NSTEMI eller ustabil angina analyseret (de-eskaleret DAPT (n = 322); uændret DAPT (n = 323)).
Overall, 645 of 646 patients with STEMI or NSTEMI or unstable angina were analyzed (de-escalated DAPT (n=322); unchanged DAPT (n=323)).
Patienterne, som blev behandlet med prasugrel alene, blev fortsat behandlet med prasugrel i 11,5 måneder.
The prasugrel-only patients were continued on prasugrel for 11.5 months.
Derfor havde den guidede deeskaleringsarm patienter behandlet med enten prasugrel (40%) eller clopidogrel (60%).
Therefore, the guided de-escalation arm had patients on either prasugrel (40%) or clopidogrel (60%).
Glomerulonefritis, forhøjet blodkreatinin
Glomerulonephritis, blood creatinine increased
Forekomsten af svære tilfælde var ens for clopidogrel og ASA.
The incidence of severe cases was similar for clopidogrel and ASA.
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.
De klinisk relevante bivirkninger observeret i CAPRIE-, CURE-, CLARITY, COMMIT og ACTIVE-A-studierne beskrives nedenfor.
The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Clopidogrel er testet in vitro og in vivo i en række genotoksicitets forsøg og udviste ingen genotoksisk aktivitet.
Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies, and showed no genotoxic activity.
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.
ACTIVE-W-studiet viste, at antikoagulansbehandling med vitamin K-antagonister var mere effektiv end med clopidogrel og ASA.
The ACTIVE-W study demonstrated that anticoagulant treatment with vitamin K antagonists was more effective than with clopidogrel and ASA.
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.
indeholder clopidogrel og tilhører en lægemiddelgruppe, der kaldes blodfortyndende medicin.
contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
De de-eskalerede patienter gennemgik høj trombocytreaktivitet (HPR) test.
The de-escalated patients underwent high platelet reactivity (HPR) testing.
Andre alleler, der associeres med manglende eller nedsat metabolisme er mindre hyppige og inkluderer CYP2C19*4, *5, *6, *7 og *8.
Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Samlet set var clopidogrel 75 mg/dag sammenligneligt med ASA 325 mg/dag i CAPRIE-studiet uafhængigt af alder, køn og race.
Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
Absorptionen er mindst 50% baseret på udskillelse af clopidogrels metabolitter i urinen.
Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Forlænget blødningstid, fald i neutrofiltal, fald i trombocyttal * Information relateret til clopidogrel med hyppighed ”ikke kendt”.
Bleeding time prolonged, neutrophil count decreased, platelet count decreased * Information related to clopidogrel with frequency “not known”.
• Pædiatrisk population Clopidogrel 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).
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.
Det vides ikke, om clopidogrel udskilles i human mælk.
It is unknown whether clopidogrel is excreted in human breast milk.
Da den aktive metabolit dannes af CYP450-enzymer, hvoraf nogle er polymorfe eller genstand for hæmning af andre lægemidler, vil ikke alle patienter opnå passende trombocytaggregation.
Because the active metabolite is formed by CYP450 enzymes, some of which are polymorphic or subject to inhibition by other medicinal products, not all patients will have adequate platelet inhibition.
ACTIVE-W- og ACTIVE-A-studierne, der er separate studier i ACTIVE-programmet, inkluderede patienter med atrieflimren (AF), der havde mindst én risikofaktor for vaskulære hændelser.
The ACTIVE-W and ACTIVE-A studies, separate trials in the ACTIVE program, included patients with atrial fibrillation (AF) who had at least one risk factor for vascular events.
Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ
This leaflet was last revised in MM/YYYY.
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/.
Monitorering for tegn på overfølsomhed tilrådes hos patienter med allergi over for thienopyridiner.
Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised.
Du bør være blevet informeret om, at ”orale antikoagulantia” er mere effektive mod denne sygdom end acetylsalicylsyre eller kombinationen af Clopidogrel Krka d.d.
You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Krka d.d.
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.
I CURE, CLARITY, ACTIVE-A og et af kohortestudierne (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.
Skift fra en mere potent P2Y12 receptorhæmmer til clopidogrel i association med aspirin efter akut fase i ACS er blevet evalueret i to randomiserede investigator-sponsoreret studier (ISS) - TOPIC og TROPICAL-ACS - med kliniske outcome data.
Switching from a more potent P2Y12 receptor inhibitor to clopidogrel in association with aspirin after acute phase in ACS has been evaluated in two randomized investigator-sponsored studies (ISS)TOPIC and TROPICAL-ACS - with clinical outcome data.
Hos patienter, der er ældre end 75 år, bør behandlingen med clopidogrel indledes uden en mætningsdosis.
For patients over 75 years of age clopidogrel should be initiated without a loading dose.
Der foreligger ikke beviser for, at andre lægemidler, der reducerer mavesyren, såsom H2-blokkere eller antacida, påvirker clopidogrels antitrombotiske aktivitet.
There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers or antacids interfere with antiplatelet activity of clopidogrel.
Hvis du har glemt en dosis af Clopidogrel Krka d.d., men kommer i tanke om det i løbet af 12 timer, skal du omgående tage tabletten og dernæst tage den næste tablet til sædvanlig tid.
If you forget to take a dose of Clopidogrel Krka d.d., but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Du bør også få acetylsalicylsyre (et stof, som indgår i mange lægemidler, og som anvendes til at afhjælpe smerter og sænke feber såvel som til at forebygge dannelse af blodpropper).
You should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
7 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
(4 tabletter på75mg) én gang.
(4 tablets of 75 mg) once at the start of treatment.
Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 patienter):
Uncommon side effects (may affect up to 1 in 100 people):
9 / l), behov for clopidogrel eller orale antikoagulantia (OAK), eller intolerance over for clopidogrel eller acetylsalicylsyre.
9/l); requirement for clopidogrel or oral anticoagulants (OAC); or intolerance to any of the two compounds.
Polyvinylalkohol Titandioxid (E171) Rød jernoxid (E172) Gul jernoxid (E172) Talcum
Titanium dioxide (E171)Red iron oxide (E172) Yellow iron oxide (E172) Talc
Kounis syndrom (vasospastisk allergisk angina / allergisk myokardieinfarkt) i forbindelse med en allergisk reaktion på grund af clopidogrel*
Kounis syndrome (vasospastic allergic angina / allergic myocardial infarction) in the context of a hypersensitivity reaction due to clopidogrel*
Andre lægemidler: Der er gennemført en række andre kliniske studier med clopidogrel og anden samtidig medicinering for at undersøge muligheden for farmakodynamisk og farmakokinetisk interaktion.
A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Da CAPRIE-studiet imidlertid ikke havde statistisk styrke til at evaluere virkningen i de enkelte delgrupper, kan det ikke udledes, hvorvidt forskellene i relativ risikoreduktion på tværs af inklusionskriterierne er reelle eller tilfældige.
Since the CAPRIE trial was not powered to evaluate efficacy of individual subgroups, it is not clear whether the differences in relative risk reduction across qualifying conditions are real, or a result of chance.
Der blev ikke observeret nogen klinisk signifikante farmakodynamiske interaktioner, når clopidogrel blev indgivet samtidig med atenolol, nifedipin eller både atenolol og nifedipin.
No clinically significant pharmacodynamic interactions were observed when clopidogrel was coadministered with atenolol, nifedipine, or both atenolol and nifedipine.
- tegn på leverproblemer såsom gulning af huden og/eller øjnene (gulsot), uanset om det sker i forbindelse med blødninger, som viser sig under huden som små røde prikker, og/eller forvirring (se afsnit 2'Advarsler og forsigtighedsregler”).
- 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').
Ikke kendt (hyppigheden kan ikke vurderes ud fra eksisterende oplysninger): Overfølsomhedsreaktioner med bryst- eller mavesmerter, vedvarende symptomer på lavt blodsukker.
Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.
Visse andre lægemidler kan påvirke brugen af Clopidogrel Krka d.d.
Some other medicines may influence the use of Clopidogrel Krka d.d.
Hvis HPR≥46 enheder blev patienterne eskaleret tilbage til prasugrel 5 eller 10 mg/d i 11,5 måneder; hvis HPR <46 enheder fortsatte patienterne med clopidogrel 75 mg/d i 11,5 måneder.
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.
Lægemidler, der er CYP2C8-substrater: Det er vist, at clopidogrel kan øge eksponeringen for repaglinid hos raske frivillige.
CYP2C8 substrate medicinal products: Clopidogrel has been shown to increase repaglinide exposure in healthy volunteers.
Hos patienter, som fortsatte med behandlingen indtil 5 dage før bypassoperationen, var forekomsten 9,6 % for clopidogrel plus ASA og 6,3 % for placebo plus ASA.
In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for clopidogrel plus ASA, and 6.3% for placebo plus ASA.
Det primære endepunkt var forekomsten af en kombination af okkluderede arterier, der var relateret til infarkt på angiogrammet før patienten blev udskrevet, dødsfald, eller ved gentaget MI før koronarangiografi.
The primary endpoint was the occurrence of the composite of an occluded infarct-related artery on the predischarge angiogram, or death or recurrent MI before coronary angiography.
Der er observeret mindre udtalte reduktioner af eksponeringen for den aktive metabolit med pantoprazol og lansoprazol.
Less pronounced reductions of metabolite exposure has been observed with pantoprazole or lansoprazole.
Filmovertræk:
Film coating:
Der der dog foretaget et antal retrospektive analyser for at evaluere denne effekt hos patienter i behandling med clopidogrel, for hvem der foreligger resultater af genotyping: CURE (n=2.721), CHARISMA (n=2.428), CLARITYTIMI 28 (n=227), TRITON-TIMI 38 (n=1.477) og ACTIVE-A (n=601) såvel som et antal publicerede kohortestudier.
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.
България КРКА България ЕООД
КРКА България ЕООД Teл.
CYP2C19*1-allelen svarer til en fuldt funktionel metabolisme, mens CYP2C19*2 og CYP2C19*3 allelerne ikke er funktionelle.
The CYP2C19*1 allele corresponds to fully functional metabolism while the CYP2C19*2 and CYP2C19*3 alleles are nonfunctional.
ACTIVE-A-studiet (N = 7.554) var et multicenter, randomiseret, dobbeltblindt, placebokontrolleret studie, som sammenlignede clopidogrel 75 mg / dag + ASA (N = 3.772) med placebo + ASA (N = 3.782).
The ACTIVE-A study (N=7,554) was a multicenter, randomized, double-blind, placebo-controlled study which compared clopidogrel 75 mg/day + ASA (N=3,772) to placebo + ASA (N=3,782).
In vitro studier har vist, at den øgede eksponering for repaglinid skyldes hæmning af CYP2C8 ved glukuronidmetabolitten af clopidogrel.
In vitro studies have shown the increase in repaglinide exposure is due to inhibition of CYP2C8 by the glucuronide metabolite of clopidogrel.
Data fra CAPRIE- studiet indikerer at phenytoin og tolbutamid, som metaboliseres af CYP2C9, kan administreres samtidig med clopidogrel uden risiko.
Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely co-administered with clopidogrel.
Farmakoterapeutisk klassifikation: Antithrombosemidler,trombocytfunktionshæmmende midler eksklusive heparin, ATC-kode: B01AC-04.
Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC code: B01AC-04.