FrancophonIA/ELRC3.0 huggingface dataset:
English: Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
Danish: Medbring denne indlægsseddel, eventuelt resterende tabletter samt beholderen til hospitalet eller lægen, så de kan se hvilke tabletter, der blev indtaget.
English: Cross reactions among thienopyridines
Danish: Krydsreaktioner mellem thienopyridiner
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 almindelige indrapporterede bivirkning fra både kliniske studier, såvel som fra post-marketing erfaring, hvor den mestendels blev indrapporteret i løbet af behandlingens første måned.
English: Confusion or hallucinations
Danish: • Forvirring eller hallucinationer
English: • You should tell your doctor if surgery (including dental) is planned
Danish: • skal du fortælle din læge, hvis du skal have foretaget en planlagt operation (også hos tandlægen)
English: This may cause stomach upset and diarrhoea.
Danish: Dette kan forårsage mavetilfælde og diarré.
English: E.g. ibuprofen, diclofenac and meloxicam.
Danish: F.eks. ibuprofen, diclofenac og meloxicam.
English: Talk to your doctor if you are using or have recently used any of the following medicines:
Danish: Fortæl det til din læge, hvis du bruger eller har brugt noget af følgende medicin:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: An overdose is likely to cause an increased risk of bleeding.
Danish: En overdosis vil sandsynligvis medføre en øget blødningsrisiko.
English: The most common side effect (affects 1 to 10 users in 100) reported for medicines containing clopidogrel is bleeding.
Danish: Den almindeligste bivirkning (forekommer hos mellem 1 og 10 ud af 100 behandlede), indberettet for medicin indeholdende clopidogrel, er blødning.
English: The active substance is clopidogrel.
Danish: • Det aktive stof er clopidogrel.
English: Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (seesection 5.1).
Danish: Kliniske forsøgsdata understøtter anvendelse i op til 12 måneder, og det største udbytte blev set efter 3 måneder (se pkt.
English: • If you have severe liver disease.
Danish: • hvis du lider af alvorlig leversygdom.
English: Glomerulonephritis, blood creatinine increased
Danish: Glomerulonefrit , forhøjet blodkreatinin
English: Pregnancy and breast-feeding It is preferable not to use this medicine during pregnancy.
Danish: Graviditet og amning Det er bedst ikke at tage denne medicin under graviditet og amning.
English: TEVA Santé SA Rue Bellocier 89107 Sens France
Danish: TEVA Santé SA Rue Bellocier 89107 Sens Frankrig
English: - Bottles contain 30 or 100 film-coated tablets.
Danish: - Flaskerne indeholder 30 eller 100 filmovertrukne tabletter.
English: The recommended dose is one 75 mg tablet per day which should be swallowed with water or another liquid.
Danish: Den sanbefalede dosis er én 75 mg tablet pr. dag, som skal synkes med vand eller en anden væske.
English: Light pink to pink, capsule-shaped film-coated tablets debossed with “C75” on one side and plain on the other side.
Danish: Lyserøde til pink kapselformede filmovertrukne tabletter med "C75" præget på den ene side og ingenting på den anden side.
English: The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and 54.5% patients who received fibrinolytics.
Danish: Populationen inkluderede 27,8 % kvinder, 58,4 % patienter ≥60 år (26 % ≥70 år) og 54,5 % patienter, der fik fibrinolytika.
English: • a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,
Danish: • selektive serotoningenoptagelseshæmmere (inklusive, men ikke begrænset til fluoxetin eller fluvoxamin), medicin der normalt anvendes mod depression
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: Each tablet contains 62.16 mg lactose monohydrate and 10 mg hydrogenated castor oil.
Danish: Hver tablet indeholder 62,16 mg lactosemonohydrat og 10 mg hydrogeneret ricinusolie.
English: TEVA Santé SA, Rue Bellocier, 89107 Sens, France
Danish: TEVA Santé SA, Rue Bellocier, 89107 Sens, Frankrig
English: • Medicines used to break down blood clots (e.g. alteplase and streptokinase).
Danish: • medicin, der bruges til at opløse blodpropper (f.eks. alteplase og streptokinase).
English: You should also be given acetylsalicylic acid (a substance used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
Danish: Du bør også få acetylsalicylsyre (et stof, som anvendes til at afhjælpe smerter og sænke feber såvel som til at forebygge dannelse af blodpropper).
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Danish: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Storbritannien
English: • Heparin (medicine used to prevent blood clotting).
Danish: • heparin (medicin, der bruges til at forebygge dannelse af blodpropper).
English: • Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1)
Danish: • Pædiatrisk population Clopidogrel bør ikke bruges til børn på grund af usikkerhed om virkningen (se pkt.
English: Cmax occurs approximately 30 to 60 minutes after dosing.
Danish: Cmax opnås ca. 3060 minutter efter administration
English: In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
Danish: På grund af manglende data kan clopidogrel ikke anbefales til akut iskæmisk slagtilfælde inden for 7 dage efter akut iskæmisk stroke.
English: Clopidogrel has no or negligible influence on the ability to drive and use machines.
Danish: Clopidogrel påvirker ikke eller kun i ubetydelig grad, evnen til at føre motorkøretøj og betjene maskiner.
English: • You have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
Danish: • hvis du har haft en blodprop i en åre (arterie) i hjernen (iskæmisk slagtilfælde) inden for de seneste syv dage.
English: Computerweg 10, 3542 DR Utrecht, The Netherlands
Danish: Computerweg 10 3542 DR Utrecht Holland
English: However, if you are in any doubt, bleeding becomes serious or you experience unexpected bleeding from unusual parts of your body you should contact your doctor straight away (see section 2 ‘Warnings and precautions').
Danish: Hvis du er bekymret over din blødning, hvis blødningen bliver alvorlig, eller hvis du oplever uventet blødning fra usædvanlige kropsdele, skal du omgående kontakte din læge (se afsnit 2 ”Advarsler og forsigtighedsregler”).
English: Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters.
Danish: • Bemærk, at anvisning i hvordan tabletten fjernes fra blisterfolien, kan ses på æsken til blisterne,
English: This medicinal product contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Danish: Dette lægemiddel indeholder hydrogeneret ricinusolie, som kan give maveproblemer og diarré.
English: Teva Pharmaceuticals Polska Sp. z o.o.
Danish: Polska Teva Pharmaceuticals Polska Sp. z o.o.
English: • Non-steroidal anti-inflammatory medicines (used to treat painful inflammatory conditions of the joints or muscles).
Danish: • non-steroide antiinflammatorisk medicin (NSAID'er) (anvendes til behandling af smertefulde inflammatoriske tilstande i led eller muskler).
English: • You have hardening of the arteries and have recently suffered from a heart attack, a stroke or have a condition known as “peripheral arterial disease” (diseases of the blood vessels except those in the brain and heart).
Danish: • du lider af åreforkalkning og for nylig har haft et hjerteanfald, slagtilfælde eller har en sygdom, der kaldes "perifer arteriesygdom" (sygdom i blodkarrene med undtagelse af dem i hjernen og hjertet).
English: Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely co-administered with clopidogrel.
Danish: Data fra CAPRIE-studiet indikerer, at phenytoin og tolbutamid, som metaboliseres af CYP2C9, uden risiko kan administreres samtidig med clopidogrel.
English: Severe reduction in certain blood cells leading to increased risk of bleeding or bruising, increased risk of infections, pale skin and extreme tiredness
Danish: • Alvorlig reduktion af visse blodplader, der fører til øget risiko for blødning eller blå mærker, øget risiko for infektioner, bleg hud og ekstrem træthed
English: For minor cuts and injuries, e.g. cutting yourself shaving, this is usually of no concern.
Danish: Ved mindre sår og skader, som hvis du f.eks. skærer dig under barbering, er dette som regel ikke noget problem.
English: • If you are suffering from another condition which is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
Danish: • hvis du lider af en anden sygdom, der forårsager blødning, såsom et mavesår eller blødning i hjernen.
English: • Carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy.
Danish: • carbamazepin eller oxcarbazepin, medicin der anvendes mod bestemte former for epilepsi.
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 indgivet samtidig med atenolol, nifedipin eller både atenolol og nifedipin.
English: • Fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections.
Danish: • fluconazol, voriconazol, ciprofloxacin eller chloramphenicol, der anvendes til behandling af bakterie- og svampeinfektioner.
English: If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine.
Danish: Hvis du ammer eller planlægger at amme, skal du tale med din læge, før du tager denne medicin.
English: • 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.
Danish: • 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.
English: If you suffer from hardening of the arteries (“atherosclerosis”) there is an increased risk of a blood clot forming in your blood vessels.
Danish: Hvis du lider af åreforkalkning ("aterosklerose"), er der en øget risiko for, at der dannes blodpropper i dine blodårer.
English: 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.
Danish: Nye kardiovaskulære hændelser (primært endpoint) 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.
English: 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.
Danish: Sikkerheden og effekten af clopidogrel er blevet evalueret i 5 dobbeltblindede studier, der omfattede mere end 88.000 patienter i 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 og anden standardterapi.
English: LIST OF EXCIPIENTS It also contains lactose and hydrogenated castor oil.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også lactose og hydrogeneret ricinusolie.
English: 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.
Danish: 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.
English: This benefit was consistent across all prespecified subgroups including patients' age and gender, infarct location, and type of fibrinolytic or heparin used.
Danish: Denne fordel var konsekvent blandt alle præspecificerede undergrupper, hvor der både blev taget hensyn til patientens alder, køn, hvor infarktet var lokaliseret og den type fibrinolytika eller hepariner, der blev anvendt til behandling.
English: • Signs of liver problems such as yellowing of the skin and whites of 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')
Danish: • tegn på leverproblemer, såsom gulfarvning af huden og det hvide i øjnene (gulsot), uanset om det er relateret til blødning, som forekommer under huden som små røde prikker og/eller forvirring (se afsnit 2 ”Advarsler og forsigtighedsregler”)
English: Lactose monohydrate Cellulose, microcrystalline Hydroxypropylcellulose (E463) Crospovidone (type A) Hydrogenated castor oil Sodium laurilsulfate
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Hydroxypropylcellulose (E463) Crospovidon (Type A) Hydrogeneret ricinusolie Natriumlaurylsulfat
English: You should continue taking Clopidogrel Teva Pharma B.V. for as long as your doctor has told you to take it.
Danish: Du skal fortsætte med at tage Clopidogrel Teva Pharma B.V., så længe din læge udskriver det til dig.
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Teva Pharma B.V. and acetylsalicylic acid for this condition.
Danish: Du bør være blevet informeret om, at ”orale antikoagulantia” er mere effektive mod denne sygdom end acetylsalicylsyre eller kombinationen af Clopidogrel Teva Pharma B.V.
English: • Swelling in the mouth or skin disorders such as rashes, itching and blistering of the skin.
Danish: • hævelser i munden eller hudlidelser, såsom udslæt, kløe og blærer på huden.
English: • You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
Danish: • du har haft en alvorlig form for smerter i brystet, som kaldes hjertekrampe (ustabil angina pectoris) eller et hjerteanfald (myokardieinfarkt).
English: In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR=-4.0%; CI: -22.5 to 11.7 [p=0.639]).
Danish: Hos de patienter, som alene indgik i studiet 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]).
English: • If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for clopidogrel eller et af de øvrige indholdsstoffer i dette lægemiddel
English: In CHARISMA and one cohort study (Simon), an increased event rate was observed only in poor metabolisers when compared to extensive metabolisers.
Danish: I CHARISMA og et kohortestudie (Simon) sås kun en øget hyppighed af hændelser hos poor metabolisers i sammenligning med personer med extensive metabolisers.
English: Although the administration of clopidogrel 75 mg/day did not modify the pharmacokinetics of S-warfarin or International Normalised Ratio (INR) in patients receiving long-term warfarin therapy, coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent effects on hemostasis.
Danish: Selvom administration af 75 mg clopidogrel daglig ikke ændrede S-warfarins farmakokinetik eller International Normalised Ratio (INR) hos patienter i langtidsbehandling med warfarin, øgede samtidig administration af clopidogrel og warfarin blødningsrisikoen på grund af uafhængig effekt på hæmostasen
English: If you forget to take a dose of Clopidogrel Teva Pharma B.V., but don't remember within 12 hours of the missed dose, skip the missed dose and take the next tablet at the usual time.
Danish: Hvis du glemmer at tage en dosis Clopidogrel Teva Pharma B.V., men ikke husker det inden for 12 timer efter den glemte dosis, skal du springe den glemte dosis over og tage den næste tablet til sædvanlig tid.
English: For patients over 75 years of age clopidogrel should be initiated without a loading dose.
Danish: Patienter, der er ældre end 75 år, bør ikke indlede behandlingen med clopidogrel med en stabiliseringsdosis.
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Danish: Bulløs dermatitis (toksisk epidermal nekrolyse, Stevens Johnson Syndrom, erythema multiforme), angioødem, , lægemiddelindu ceret overfølsomheds syndrom, medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS), erytematøst eller eksfoliativt udslæt, urticaria, eksem, lichen planus
English: This is linked to the way that your medicine works.
Danish: Dette skyldes medicinens virkemåde.
English: A total of 23.0% of patients received anti-arrhythmics, 52.1% beta-blockers, 54.6% ACE inhibitors, and 25.4% statins.
Danish: I alt fik 23,0% af patienterne antiarytmika, 52,1% betablokkere, 54,6% ACEhæmmere og 25,4% statiner.
English: • Fever, signs of infection (e.g. sore throat), pale skin or extreme tiredness.
Danish: • feber, tegn på infektion (f.eks. ondt i halsen), bleg hud eller ekstrem træthed.
English: 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.
Danish: 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 Plavix 75 mg/dag.
English: Risk Management Plan (RMP)
Danish: • Risikostyringsprogram.
English: Tests are available to identify a patient's CYP2C19 genotype.
Danish: Test er tilgængelige til at identificere en patients CYP2C19genotype
English: These may be due to a decrease of some blood cells
Danish: Dette kan skyldes, at niveauet af nogle blodlegemer er blevet for lavt
English: This could indicate that you are suffering from a serious condition called thrombotic thrombocytic purpura (rare disorder of the blood clotting system which causes multiple blood clots to form around the body)
Danish: Dette kan være tegn på, at du lider af en alvorlig tilstand, der kaldes trombotisk trombocytisk purpura (en sjælden lidelse, der påvirker blodets evne til at størkne, hvilket forårsager, at der dannes flere blodpropper rundt omkring i kroppen)
English: Discard any remaining tablets 30 days after first opening of the bottle.
Danish: Eventuelt resterende tabletter skal kasseres 30 dage efter åbning af flasken.
English: - For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.
Danish: − Mere end 12 timer efter planlagt administration: patienten skal tage næste dosis som planlagt og ikke tage dobbelt dosis
English: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A.
Danish: België/Belgique/Belgien
English: Discard any remaining tablets 100 days after first opening of the bottle.
Danish: Eventuelt resterende tabletter skal kasseres 100 dage efter åbning af flasken.
English: • Oral anticoagulants (oral medicines used to stop blood clotting) such as warfarin.
Danish: • orale antikoagulantia (medicin der tages gennem munden til forebyggelse af blodpropper), såsom warfarin.
English: 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).
Danish: Specielt i en post-hoc analyse af 2172 patienter som fik indsat stent (17 % af den totale population i CURE-studiet, StentCURE), viste data, at clopidogrel sammenlignet med placebo medførte en signifikant RRR på 26,2 %, med hensyn til primære endepunkter (CV-død, MI, slagtilfælde) og desuden en signifikant RRR på 23,9 % med hensyn til andet primært endepunkt (CV-død, MI, slagtilfælde eller refraktær iskæmi).
English: Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Danish: Forebyggelse af aterorombotiske og tromboemboliske hændelser ved atrieflimrgen Hos voksne patienter med atrieflimren, der har mindst én risikofaktor for vaskulære hændelser, og som ikke kan tage vitamin K-antagonist (VKA)-behandling, og som har en lav blødningsrisiko, er clopidogrel i kombination med ASA indiceret til forebyggelse af aterotrombotiske og tromboemboliske hændelser inklusive apopleksi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON of bottles (30 or 100 film-coated tablets)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE med flasker (30 eller 100 filmovertrukne tabletter)