FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Clopidogrel er blevet evalueret sikkerhedsmæssigt hos mere end 42.000 patienter, der har deltaget i kliniske studier, inklusive over 9.000 patienter, der blev behandlet i mindst 1 år.
English: Name and address of the manufacturer(s) responsible for batch release KRKA, d.d., Novo mesto
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse KRKA, d.d., Novo mesto
English: • You should tell your doctor if a surgery (including dental) is planned.
Danish: • bør De fortælle Deres læge, hvis De skal have foretaget en planlagt operation (herunder tandoperation).
English: A patient with poor metaboliser status will possess two loss-of-function alleles as defined above.
Danish: En patient med status som poor metabolisers vil besidde to ikke-funktionelle alleller, som beskrevet ovenfor.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet som er beskrevet i markedsføringstilladelsen (Modul 1.8.1), er på plads og fungerer før og mens produktet markedsføres.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 September 2009
Danish: Dato for første tilladelse: September 21, 2009
English: Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.8%) and ASA (6.0%).
Danish: En analyse med total mortalitet som sekundært endpoint viste ingen signifikant forskel mellem clopidogrel (5,8 %) og ASA (6,0 %).
English: In addition, clinical tolerance was good in
Danish: Den kliniske tolerance var endvidere god hos alle patienter.
English: • if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel
Danish: • hvis De er overfølsom (allergisk) over for clopidogrel eller et af de øvrige indholdsstoffer i
English: 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.
Danish: 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 NSAID'er.
English: Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in the table below.
Danish: Bivirkninger der opstod enten under de kliniske studier eller der spontant blev indberettet er beskrevet i tabellen nedenfor.
English: Clopidogrel Qualimed is not intended for use in children or adolescents.
Danish: Clopidogrel Qualimed er ikke beregnet til anvendelse hos børn og unge.
English: Some other medicines may influence the use of Clopidogrel Qualimed or vice versa.
Danish: Visse typer medicin kan påvirke brugen af Clopidogrel Qualimed eller omvendt.
English: You should not breastfeed while taking this medicine.
Danish: De må ikke amme, når De tager denne medicin.
English: 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.
Danish: Blødning er den mest almindeligt rapporterede bivirkning fra både kliniske studier, såvel som fra post-marketing erfaring, hvor den mestendels blev rapporteret i løbet af behandlingens første måned.
English: Cmax occurs approximately 30 to 60 minutes after
Danish: Cmax opnås efter ca. 30-60 minutter aefter administration.
English: The elimination halflife of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Danish: Halveringstiden for elimination af den cirkulerende (inaktive) hovedmetabolit var 8 timer efter en enkelt og efter gentagen administration.
English: 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).
Danish: 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 <1/1.000); meget sjælden
English: It may be given with or without food.
Danish: Kan indtages med ogeller uden mad.
English: In the myocardial infarction subgroup, most of the patients received ASA for the first few days following the acute myocardial infarction.
Danish: I delgruppen med myokardieinfarkt fik de fleste patienter ASA i de første dage efter det akutte myokardieinfarkt.
English: • Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
Danish: • Aktiv patologisk blødning såsom ulcus pepticum eller intrakraniel blødning.
English: Approximately 88% of patients received concomitant ASA (range of 1 to 23 mg/kg/day).
Danish: Ca. 88% af patienterne fik samtidig ASA (interval 1 til 23 mg/kg/dag).
English: 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).
Danish: Dyreforsøg viser ikke direkte eller indirekte skadelige virkninger for graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne indlægsseddel grundigt inden De begynder at tage medicinen.
English: Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Danish: Distribution Clopidogrel og den cirkulerende (inaktive) hovedmetabolit binder reversibelt in vitro til humane plasmaproteiner (henholdsvis 98 % og 94 %).
English: The mean time between shunt palliation and first administration of study medicinal product was 20 days.
Danish: Den gennemsnitlige tid fra anlæggelse af palliativ shunt til første administration af forsøgslægemidlet var 20 dage.
English: Like all medicines, Clopidogrel Qualimed can cause side effects, although not everybody gets them.
Danish: Clopidogrel Qualimed kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: 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.
Danish: Patienterne skal kontrolleres omhyggeligt for tegn på blødninger, herunder okkulte blødninger, især i behandlingens første uger og/eller efter invasive hjerteindgreb eller -kirurgi.
English: TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Danish: TTP er en potentielt letal tilstand, der kræver øjeblikkelig behandling, der omfatter plasmaferese.
English: • if you have a risk of bleeding such as
Danish: • hvis De har risiko for blødning som f.eks:
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or
Danish: Dette var ensartet blandt undergrupperne af patienter, defineret ved baseline karakteristika og typen af fibrinolytika eller heparinbehandling.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: During non clinical studies in rat and baboon, the most frequently observed effects were liver changes.
Danish: I ikke-kliniske forsøg på rotter og bavianer var de hyppigst forekommende virkninger leverforandringer.
English: • if you suffer from severe liver disease;
Danish: • hvis De lider af en alvorlig leversygdom
English: The influence of CYP2C19 genotype on clinical outcomes in patients treated with clopidogrel has not been evaluated in prospective, randomised, controlled trials.
Danish: Indflydelsen af CYP2C19-genotype på det kliniske udfald hos patienter i behandling med clopidogrel, er ikke blevet evalueret i prospektive, randomiserede, kontrollerede studier.
English: This was associated with a reduction of the mean inhibition of platelet aggregation by 15% and 11%, respectively.
Danish: Dette var associeret med en reduktion i den gennemsnitlige trombocythæmning på henholdsvis 15 % og 11 %.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg Deres læge eller apoteket til råds, før De tager nogen form for medicin.
English: In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
Danish: Endvidere tydede en analyse af aldersbaserede delgrupper på, at fordelen ved clopidogrel hos patienter over 75 år var mindre end hos patienter ≤75 år.
English: • if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
Danish: • hvis de har haft en blodprop i en blodåre (arterie) i hjernen (iskæmisk apopleksi), inden for de seneste 7 dage
English: Hallucinations, confusion Taste disturbances
Danish: Hallucinationer, konfusion
English: This is linked to the way your medicine works as it prevents the ability of blood clots to form.
Danish: Dette skyldes måden Deres medicin virker på, da den forebygger blodets evne til at danne blodpropper.
English: The usual dose is one 75 mg tablet of Clopidogrel Qualimed per day to be taken orally with or without food, and at the same time each day.
Danish: Den sædvanlige dosis er én tablet Clopidogrel Qualimed à 75 mg dagligt, som tages gennem munden sammen med eller uden mad, og på samme tid hver dag.
English: Other medicinal products: 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.
Danish: 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.
English: In vitro, this metabolic pathway is mediated by CYP3A4, CYP2C19, CYP1A2 and CYP2B6.
Danish: In vitro bliver denne metaboliseringsvej medieret af CYP3A4, CYP2C19, CYP1A2 og CYP2B6.
English: In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
Danish: Hos poor metabolisers var eksponeringen nedsat med 63-71 %, sammenlignet med personer med extensive metabolisme.
English: You should take Clopidogrel Qualimed for as long as your doctor continues to prescribe it.
Danish: De skal tage Clopidogrel Qualimed, så længe som Deres læge fortsætter med at ordinere det.
English: 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
Danish: 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
English: Bleeding was the most frequently reported adverse reaction in both clopidogrel and placebo groups; however, there was no significant difference in the bleeding rate between groups.
Danish: Blødning var den hyppigst rapporterede bivirkning både i clopidogrel- og placebogruppen; der var imidletid ingen signifikant forskel i blødningsfrekvensen mellem de to grupper.
English: An appropriate dose regimen for this patient population has not been established in clinical outcome trials.
Danish: Der er ikke etableret et relevant dosisregime for denne patientpopulation i kliniske outcome-studier.
English: In a relative bioavailability study in adults, the constituted solution of clopidogrel showed a similar extent and slightly higher rate of absorption of the main circulating (inactive) metabolite compared to the authorised tablet.
Danish: I et studie af den relative biotilgængelighed hos voksne absorberedes opløsningen af clopidogrel i et lignende omfang og med en lidt højere absorptionsrate af den cirkulerende (inaktive) hovedmetabolit sammenlignet med den godkendte tablet.
English: Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications.
Danish: Overdosering efter administration af clopidogrel kan føre til forlænget blødningstid og efterfølgende blødningskomplikationer.
English: In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute
Danish: På grund af manglende data kan clopidogrel ikke anbefales i de første 7 dage efter et akut iskæmisk slagtilfælde.
English: When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Danish: Når personer med poor metabolisme fik 600 mg/150 mg regimet, var eksponeringen for den aktive metabolit større end ved 300 mg/75 regimet.
English: Patients were randomised to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years.
Danish: Patienterne blev randomiseret til clopidogrel 75 mg/dag eller ASA 325 mg/dag og blev kontrolleret i 1-3 år.
English: Store in the original package in order to protect from moisture and light.
Danish: Opbevares i den originale pakning for at beskytte mod fugt og lys.
English: If you stop taking Clopidogrel Qualimed: Do not stop the treatment unless your doctor tells you so.
Danish: Hvis De holder op med at tage Clopidogrel Qualimed De må ikke stoppe behandlingen medmindre Deres læge fortæller Dem, at De skal gøre det..
English: If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, clopidogrel should be discontinued 7 days prior to surgery.
Danish: For patienter, der skal have foretaget elektiv kirurgi, og hvor en midlertidig antitrombotisk virkning ikke er ønskelig, bør clopidogrel seponeres 7 dage før indgrebet.
English: When given to lactating rats, clopidogrel caused a slight delay in the development of the offspring.
Danish: Når diegivende rotter fik clopidogrel, opstod der en mindre forsinkelse i ungernes udvikling.
English: Glomerulonephritis, blood creatinine increased
Danish: Glomerulonefritis, øget blodkreatinin
English: Recent myocardial infarction (MI), recent stroke or established peripheral arterial disease
Danish: Nyligt myokardieinfarkt (MI), nylig apopleski eller påvist perifer arteriel lidelse
English: Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Danish: Andre alleler, der associeres med manglende eller nedsat metabolisme er mindre hyppige og, inkluderer CYP2C19*4, *5, *6, *7 og *8.
English: The PSUR submission schedule for Clopidogrel Qualimed film coated tablets should follow PSURs submission schedule for the reference medicinal product.
Danish: Den planlagte PSUR-indsendelse for Clopidogrel Qualimed filmovertrukne tabletter bør følge den planlagte PSUR-indsendelse for referencelægemidlet.
English: In the long-term safety follow-up of this study, 26 patients with the shunt still in place at one year of age received clopidogrel up to 18 months of age.
Danish: I den forlængede sikkerhedsopfølgning af studiet fik 26 patienter, der stadig havde shunten indopereret, da de fyldte 1 år, clopidogrel til de var op til 18 måneder gamle.
English: The binding is non-saturable in vitro over a wide concentration
Danish: Bindingen er umættet in vitro over et bredt koncentrationsområde.
English: After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Danish: Efter enkelt og gentagne orale doser på 75 mg/dag bliver clopidogrel hurtigt absorberet.
English: Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Danish: Den publicerede forekomst af poor metaboliser-genotyper er ca. 2 % for kaukasiske personer, 4 % for negroide og 14 % for kinesiske.
English: 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 Qualimed by referring to the calendar printed on the blister.
Danish: For pakninger med 7, 14, 28, 56 stk. og 84 stk. tabletter kan De kontrollere på hvilken dag De sidst tog en Clopidogrel Qualimed tablet ved at se på kalenderen, der er trykt på blisterpakningen.
English: 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.
Danish: Ud over ovenstående oplysninger om specifik lægemiddelinteraktion er der ikke udført interaktionsstudier med clopidogrel og visse lægemidler, som almindeligvis gives til patienter med aterotrombotiske sygdomme.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture and light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale yderpakning for at beskytte mod fugt og lys.
English: 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).
Danish: 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).
English: Because the active metabolite is formed by CYP450 enzymes, some of which are polymorphic or subject to inhibition by medicinal products, not all patients will have adequate platelet inhibition.
Danish: 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.
English: If you experience prolonged bleeding when taking Clopidogrel Qualimed If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Danish: Hvis De får langvarige blødninger, mens De tager Clopidogrel Qualimed Hvis De skærer Dem eller kommer til skade, kan det tage lidt længere end normalt, før blødningen stopper.
English: Platelet aggregation and bleeding time gradually returned to baseline values, generally within 5 days after treatment was discontinued.
Danish: Trombocytaggregation og kapillærblødningstid vendte gradvist tilbage til baselineværdierne, almindeligvis inden for 5 dage efter behandlingens ophør.
English: 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.
Danish: 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.
English: 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
Danish: 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.
English: 6.2 Incompatibilities Not applicable.
Danish: 6.2 Uforligeligheder
English: In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar
Danish: I COMMIT var den generelle forekomst af non-cerebrale større blødninger eller cerebrale blødninger lav og ensartet i begge grupper .
English: Pink, round and slightly convex film-coated tablets.
Danish: Lyserøde, runde og let konvekse filmovertrukne tabletter.
English: Do not use Clopidogrel Qualimed after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke Clopidogrel Qualimed efter den udløbsdato, der står på pakningen.
English: The safety and efficacy of clopidogrel have been evaluated in 4 double-blind studies involving over 80,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY and COMMIT studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Danish: Sikkerheden og effekten af clopidogrel er blevet evalueret i 4 dobbeltblindede studier, der omfattede mere end 80.000 patienter: CAPRIE-studiet, hvor clopidogrel sammenlignes med ASA, og CURE, CLARITY og COMMIT-studierne, hvor clopidogrel sammenlignes med placebo, og hvor begge lægemidler gives i kombination med ASA eller anden standardterapi.
English: Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure.
Danish: Trombotisk trombocytopenisk purpura (TTP) er indberettet i meget sjældne tilfælde efter behandling med clopidogrel, enkelte gange efter kort tids brug.
English: No clinically significant pharmacodynamic interactions were observed when clopidogrel was co-administered with atenolol, nifedipine, or both atenolol and nifedipine.
Danish: Der blev ikke observeret nogen klinisk signifikante farmakodynamiske interaktioner, når clopidogrel blev administreret samtidig med atenolol, nifedipin eller både atenolol og nifedipin.
English: Thrombocytopenia , leucopenia, eosinophilia
Danish: Thrombocytopeni, leukopeni, eosinofili
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON
English: It is unknown whether clopidogrel is excreted in human breast milk.
Danish: Det vides ikke, om clopidogrel udskilles i modermælk hos mennesker.
English: • Hypersensitivity to the active substance or to any of the excipients.
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
English: Thrombolytics: the safety of the concomitant administration of clopidogrel, fibrin or non-fibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction.
Danish: Trombolytika: Sikkerheden ved samtidig administration af clopidogrel, fibrin eller nonfibrinspecifikke trombolytiske midler og hepariner blev vurderet hos patienter med akut myokardieinfarkt.
English: After a single oral dose of 75 mg, clopidogrel has a half-life of approximately 6 hours.
Danish: Efter en enkelt dosering på 75 mg har clopidogrel en halveringstid på ca. 6 timer.
English: Clopidogrel is extensively metabolised by the liver.
Danish: Clopidogrel bliver i udstrakt grad metaboliseret i leveren.
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group.
Danish: I CLARITY var der en generel stigning i antallet af blødninger i clopidogrel plus ASA-gruppen versus placebo plus ASA-gruppen.
English: The CYP2C19*2 and CYP2C19*3 alleles account for the majority of reduced function alleles in Caucasian (85%) and Asian (99%) poor metabolisers.
Danish: Allelerne CYP2C19*2 og CYP2C19*3 tegner sig for størstedelen af alleler med nedsat funktion hos kaukasiske personer (85 %) og asiater (99 %) med nedsat metabolisme.