FrancophonIA/ELRC3.0 huggingface dataset:
English: Salicylic acid is widely distributed to all tissues and fluids in the body, including the central nervous system, breast milk, and foetal tissues.
Danish: Salicylsyre distribueres i udstrakt grad til alle væv og alle væsker i kroppen, inklusive centralnervesystemet, modermælk og fostervæv.
English: If you are breast-feeding or planning to breast-feed, 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 dette lægemiddel.
English: Reye's Syndrome is a very rare disease which can be fatal.
Danish: Reyes syndrom er en meget sjælden sygdom, der kan være letal.
English: It is unknown whether clopidogrel is excreted in human breast milk.
Danish: Det er ukendt, om clopidogrel udskilles i human mælk.
English: Doses of 100-500 mg/day:
Danish: Doser på 100-500 mg/dag:
English: The clinically relevant adverse reactions observed in four major studies, the CAPRIE study (a study comparing clopidogrel alone to ASA) and the CURE, CLARITY and COMMIT studies (studies comparing clopidogrel plus ASA to ASA alone) are discussed below.
Danish: De klinisk relevante bivirkninger observeret i fire store studier, CAPRIE-studiet (et studie, der sammenligner clopidogrel alene med ASA) og, CURE-, CLARITY- og COMMIT-studierne (studier, der sammenligner clopidogrel plus ASA med ASA alene) beskrives nedenfor.
English: As no clinical data on exposure to clopidogrel during pregnancy are available, it is preferable not to use clopidogrel during pregnancy as a precautionary measure.
Danish: Da der ikke foreligger kliniske data om eksponering for clopidogrel under graviditet, bør clopidogrel for en sikkerheds skyld ikke anvendes under graviditet.
English: The CYP2C19*1 allele corresponds to fully functional metabolism while the CYP2C19*2 and CYP2C19*3 alleles correspond to non-functional metabolism.
Danish: CYP2C19*1-allelen svarer til en fuldt funktionel metabolisme, mens CYP2C19*2 og CYP2C19*3 allelerne svarer til en ikke-funktionel metabolisme.
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 endepunkt) blev forebygget, med en relativ risikoreduktion 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), henholdsvis, i løbet af studieintervaller på 0-1, 1-3, 3-6, 6-9 og 912-måneder.
English: Clopidogrel/Acetylsalicylic acid Mylan should not be used during the first two trimesters of pregnancy unless the clinical condition of the woman requires treatment with clopidogrel/ASA.
Danish: Clopidogrel/Acetylsalicylic acid Mylan bør ikke anvendes i graviditetens første to trimestre, medmindre den kliniske situation for kvinden kræver behandling med clopidogrel/ASA.
English: • acetazolamide, a medicine used to treat glaucoma (increased ocular pressure) or epilepsy or to increase urine flow,
Danish: • acetazolamid, et lægemiddel der anvendes til at behandle glaukom (forhøjet tryk i øjet) eller epilepsi eller til at øge urinflow,
English: Do not use this medicine after the expiry date which is stated on the carton, blister and on the bottle after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen, blister eller tabletbeholderen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section 5.1).
Danish: Fordelene ved kombinationsbehandling med clopidogrel og ASA ud over 4 uger er ikke blevet undersøgt i denne sammensætning (se pkt.
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-undersøgelsen indikerer, at phenytoin og tolbutamid, som metaboliseres af CYP2C9, kan administreres samtidig med clopidogrel uden risiko.
English: In one study, when a single dose of ibuprofen 400 mg was taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81 mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred.
Danish: I en undersøgelse, hvor en enkelt dosis ibuprofen 400 mg blev indtaget inden for 8 timer før eller 30 minutter efter dosering af hurtigtopløsende acetylsalicylsyre (81 mg), forekom en nedsat virkning af ASA på dannelsen af tromboxan eller trombocythæmningen.
English: Consider the use of a parenteral antiplatelet agent in acute coronary syndrome patients requiring co-administration of morphine or other opioid agonists.
Danish: Overvej anvendelse af et parenteralt trombocythæmmende middel hos patienter med akut koronarsyndrom, som kræver samtidig administration af morfin eller andre opioidagonister.
English: By preventing this clumping in some types of blood vessels (called arteries), antiplatelet medicinal products reduce the chances of blood clots forming (a process called atherothrombosis).
Danish: Ved at forhindre denne sammenklumpning i visse typer blodkar (kaldet arterier) nedsætter et blodfortyndende præparat risikoen for, at der dannes blodpropper (en proces, der kaldes aterotrombose).
English: • paclitaxel, medicine to treat cancer,
Danish: • paclitaxel, medicin til behandling af kræft,
English: As with other oral P2Y12 inhibitors, co-administration of opioid agonists has the potential to delay and reduce the absorption of clopidogrel presumably because of slowed gastric emptying.
Danish: Som med andre orale P2Y12-hæmmere kan samtidig administration af opioid-agonister forsinke og reducere absorptionen af clopidogrel, sandsynligvis som følge af langsommere tømning af ventriklen.
English: Where elective surgery is being considered, the need for dual antiplatelet therapy should be reviewed and consideration given to the use of a single antiplatelet agent.
Danish: Ved overvejelse omkring elektiv kirurgi bør behovet for dobbelt trombocythæmmende behandling revurderes, og behandling med et enkelt trombocythæmmende middel bør overvejes.
English: If you experience prolonged bleeding when taking Clopidogrel/Acetylsalicylic acid Mylan If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Danish: Hvis du oplever længerevarende blødninger når du tager Clopidogrel/Acetylsalicylic acid Mylan Hvis du skærer dig eller kommer til skade, kan det tage lidt længere tid end normalt, før blødningen stopper.
English: • Severe renal impairment (creatinine clearance <30 ml/min).
Danish: • Stærkt nedsat nyrefunktion (kreatininclearance < 30 ml/min).
English: Marketing Authorisation Holder Mylan S.A.S.
Danish: Indehaver af markedsføringstilladelsen: Mylan S.A.S.
English: In a clinical study conducted in healthy subjects, clopidogrel did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation.
Danish: I et klinisk studie med raske forsøgspersoner nødvendiggjorde clopidogrel ikke ændring af heparindosis, og det ændrede ikke heparins virkning på koagulationen.
English: Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary.
Danish: Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Komárom, Ungarn.
English: • moclobemide, medicine to treat depression,
Danish: • moclobemid, medicin mod depression,
English: 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.
Danish: 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.
English: Ninety five patients (7%) in the guided de-escalation group and 118 patients (9%) in the control group (p non-inferiority=0.0004) had an event.
Danish: 95 patienter (7 %) i den guidede de-eskaleringsgruppe og 118 patienter (9 %) i kontrolgruppen p non-inferioritet = 0,00004) havde en hændelse.
English: 28 x 1 film-coated tablets 30 x 1 film-coated tablets
Danish: 28×1 filmovertrukne tabletter 30×1 filmovertrukne tabletter
English: • if you have a risk of bleeding such as: a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
Danish: • hvis du har risiko for blødninger f.eks. på grund af: - en sygdom, der medfører risiko for indre blødninger (såsom et mavesår).
English: These occurred at doses representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day and were a consequence of an effect on hepatic metabolising enzymes.
Danish: De optrådte ved doser, der repræsenterede mindst 25 gange eksponeringen hos mennesker, der får den kliniske dosis på 75 mg/dag, og var en konsekvens af effekten på levermetaboliseringsenzymerne.
English: Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy.
Danish: Data fra epidemiologiske studier tyder på en øget risiko for abort, hjertemisdannelser og gastroskise efter brug af prostaglandinsyntesehæmmere tidligt i graviditeten.
English: Caution is recommended when co-administering salicylates with acetazolamide as there is an increased risk of metabolic acidosis.
Danish: Forsigtighed anbefales ved samtidig administration af salicylater og acetazolamid, da der er øget risiko for metabolisk acidose.
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions').
Danish: Hvis du er bekymret over blødningen, skal du omgående kontakte din læge (se afsnit 2 'Advarsler og forsigtighedsregler').
English: - For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.
Danish: - Hvis det er mere end 12 timer siden: patienten bør tage den næste dosis som planlagt og bør ikke tage dobbelt dosis.
English: At high ASA doses, the elimination of salicylic acid follows zero-order kinetics (i.e., the rate of elimination is constant in relation to plasma concentration), with an apparent half-life of 6 hours or higher.
Danish: Ved høje doser ASA følger eliminationen af salicylsyre 0. ordens kinetik (dvs. at eliminationshastigheden er konstant uden relation til plasmakoncentrationen) med en observeret halveringstid på 6 timer eller mere.
English: If a dose is missed: - Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Danish: Hvis en dosis springes over: - Hvis det er mindre end 12 timer efter den planlagte dosering: patienten bør straks tage den planlagte dosis og derefter tage den næste dosis ved næste planlagte dosering.
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 99 % hos asiater med nedsat metabolisme.
English: Metamizole
Danish: Metamizol
English: Cases of Reye's syndrome have occurred following the use of salicylates during varicella infections (see section 4.4).
Danish: Tilfælde af Reyes syndrom er set efter brug af salicylater under varicellainfektion (se pkt.
English: Patients on aspirin and a more potent P2Y12 blocker and without adverse event at one month were assigned to switch to fixed-dose aspirin plus clopidogrel (de-escalated dual antiplatelet therapy (DAPT)) or continuation of their drug regimen (unchanged DAPT).
Danish: Patienter behandlet med aspirin og en mere potent P2Y12-hæmmer, og uden bivirkning ved en måned blev skiftet til fast dosis aspirin plus clopidogrel (de-eskaleret dobbelt trombocythæmmende behandling (DAPT)), eller fortsatte deres medicinregime (uændret DAPT).
English: Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure.
Danish: Tenofovir Samtidig administration af tenofovirdisoproxilfumarat og NSAID'er kan øge risikoen for nyresvigt.
English: The co-primary endpoints were death from any cause and the first occurrence of re-infarction, stroke or death.
Danish: De primære sammensatte endepunkter var død uanset årsag og den første forekomst af re-infarkt, apopleksi eller død.
English: 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.
Danish: I CURE var der ikke overrepræsentation af større blødninger med clopidogrel plus ASA inden for 7 dage efter koronar bypass hos patienter, der seponerede behandlingen mere end 5 dage før indgrebet.
English: Patients were required to have either ECG changes compatible with new ischaemia or elevated cardiac enzymes or troponin I or T to at least twice the upper limit of normal.
Danish: Patienterne skulle have enten ekg-forandringer, som var kompatible med ny iskæmi, eller forhøjede værdier af hjerteenzymer eller troponin I eller T på mindst 2 × øvre grænse for normalområdet.
English: Therefore, concomitant use of clopidogrel with boosted ART should be discouraged.
Danish: Samtidig anvendelse af clopidogrel og boostet ART bør derfor frarådes.
English: Unit dose blisters
Danish: Enhedsdosis, blister
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis.
Danish: Gastrointestinal og retroperitoneal blødning med dødeligt udfald, pankreatitis.
English: • In patients with gout since low doses of ASA increase urate concentrations.
Danish: • Hos patienter med urinsur gigt, da lave doser ASA øger koncentrationen af urinsyre.
English: Patients should be told about the signs and symptoms of GI undesirable effects and what steps to take if they occur.
Danish: Patienterne børinformeres om tegn og symptomer på gastrointestinale bivirkninger og hvilke forholdsregler, de skal tage, hvis de opstår.
English: 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.
Danish: 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.
English: • Alcohol may increase the risk of gastrointestinal injury when taken with ASA.
Danish: • Alkohol kan øge risikoen for gastrointestinale skader, når det indtages sammen med ASA.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med arvelig galaktoseintolerans, en særlig form for arvelig laktasemangel (Lapp lactase deficiency) eller glucose/galaktosemalabsorption bør ikke anvende dette lægemiddel.
English: The cumulative incidence of all bleeding events (BARC class 1 to 5) was 9% (114 events) in the guided deescalation group versus 11% (137 events) in the control group (p=0.14).
Danish: Den kumulative forekomst af alle blødningshændelser (BARC klasse 1 til 5) var 9 % (114 hændelser) i den guidede de-eskaleringsgruppe versus 11 % (137 hændelser) i kontrolgruppen (p = 0,14).
English: • nicorandil, medicine to treat cardiac chest pain.
Danish: • nicorandil, medicin til behandling af hjerte-relaterede smerter i brystkassen.
English: Apart from the specific medicinal product interaction information described above, interaction studies with Clopidogrel/Acetylsalicylic acid Mylan and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed.
Danish: Bortset fra de specifikke lægemiddelinteraktioner, der er beskrevet ovenfor, er der ikke udført interaktionsstudier med Clopidogrel/Acetylsalicylic acid Mylan og lægemidler, som almindeligvis gives til patienter med aterotrombotisk sygdom.
English: The decrease was associated with a 39% (loading dose) and 21% (maintenance dose) reduction of inhibition of platelet aggregation.
Danish: Denne nedgang var associeret med en 39 % (initial stabiliseringsdosis) og 21 % (vedligeholdelsesdosis) reduktion i trombocythæmning.
English: The primary endpoint was the occurrence of the composite of an occluded infarct-related artery on the pre- discharge angiogram, or death or recurrent MI before coronary angiography.
Danish: Det primære endepunkt var forekomsten af en kombination af okkluderede arterier, der var relateret til infarkt på angiogrammet, før patienten blev udskrevet, død eller tilbagevendende MI før koronarangiografi.
English: In vitro and in vivo, clopidogrel is metabolised according to two main metabolic pathways: one mediated by esterases and leading to hydrolysis into its inactive carboxylic acid derivative (85% of circulating metabolites), and one mediated by multiple cytochromes P450.
Danish: In vitro og in vivo, clopidogrel metaboliseres afhængigt af to hovedmetaboliske veje: En esterasemedieret, hvorved det hydrolyseres til dets inaktive karboxylsyrederivat (85 % af de cirkulerende metabolitter), og en medieret af flere cytochrom P450isoenzymer.
English: However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.
Danish: Disse datas begrænsninger og usikkerheder vedrørende ekstrapolering af ex vivo data på den kliniske situation antyder, at der ikke kan drages endelige konklusioner vedrørende jævnlig anvendelse af ibuprofen, og en klinisk relevant effekt anses ikke for at være sandsynlig ved lejlighedsvis anvendelse af ibuprofen.
English: The lethal dose of acetylsalicylic acid is 25-30 g. Plasma salicylate concentrations above 300 mg/l (1.67 mmol/l) suggest intoxication.
Danish: Den letale dosis af acetylsalicylsyre er 25 - 30 g. En plasmakoncentration af acetylsalicylsyre på over 300 mg/l (1,67 mmol/l) tyder på forgiftning.
English: No effect on hepatic metabolising enzymes was observed in humans receiving clopidogrel at the therapeutic dose.
Danish: Der blev ikke observeret nogen effekt på levermetaboliseringsenzymerne hos mennesker, der fik clopidogrel i terapeutiske doser.
English: • methotrexate, a medicine used to treat severe joint disease (rheumatoid arthritis) or skin disease (psoriasis),
Danish: • methotrexat, et lægemiddel der anvendes til at behandle alvorlige ledsygdomme (reumatoid artrit) eller hudsygdomme (psoriasis),
English: The Cmax of the active metabolite is twice as high following a single 300 mg clopidogrel loading dose as it is after four days of 75 -mg maintenance dose.
Danish: Cmax for den aktive metabolit er dobbelt så høj efter en enkelt 300 mg clopidogrel initial mætningsdosis, som den er efter fire dage med en 75 mg vedligeholdelsesdosis.
English: Less pronounced reductions of metabolite exposure has been observed with pantoprazole or lansoprazole.
Danish: Der er observeret en mindre udtalt reduktion af eksponeringen for den aktive metabolit med pantoprazol eller lansoprazol.
English: In vitro studies have shown the increase in repaglinide exposure is due to inhibition of CYP2C8 by the glucuronide metabolite of clopidogrel.
Danish: In-vitro-studier har vist, at den øgede eksponering for repaglinid skyldes hæmning af CYP2C8 ved glukuronidmetabolitten af clopidogrel.
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 inden for 5 dage før bypassoperationen, var forekomsten 9,6 % for clopidogrel plus ASA og 6,3 % for ASA.
English: If prompt correction of prolonged bleeding time is required, platelet transfusion may reverse the effects of clopidogrel.
Danish: Ved behov for hurtig behandling af forlænget blødningstid kan trombocytinfusion muligvis modvirke effekten af clopidogrel.
English: Alcohol may increase the risk of gastrointestinal injury when taken with ASA.
Danish: Alkohol kan øge risikoen for gastrointestinale skader, når det indtages sammen med ASA.
English: In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality.
Danish: Administration af en prostaglandinssyntesehæmmer til dyr har vist sig at resultere i øget forekomst af præ- og postimplantationstab, og embryo-føtal dødelighed.
English: This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel plus ASA group and 363 (5.8%) in the ASA group].
Danish: Fordelen må hovedsageligt tilskrives den statistisk signifikante reduktion i forekomsten af myokardieinfarkt [287 (4,6 %) i clopidogrel plus ASA-gruppen og 363 (5,8 %) i ASA-gruppen].
English: Clopidogrel plus ASA significantly reduced the relative risk of death from any cause by 7% (p = 0.029), and the relative risk of the combination of re-infarction, stroke or death by 9% (p = 0.002), representing an absolute reduction of 0.5% and 0.9%, respectively.
Danish: Clopidogrel plus ASA reducerede signifikant den relative dødsrisiko uanset årsag med 7 % (p = 0,029) og den relative risiko for kombinationen af re-infarkt, apopleksi eller død med 9 % (p = 0,002), hvilket repræsenterer en absolut reduktion på henholdsvis 0,5 % og 0,9 %.
English: Due to the irreversible binding, platelets exposed are affected for the remainder of their lifespan (approximately 7-10 days) and recovery of normal platelet function occurs at a rate consistent with platelet turnover.
Danish: På grund af den irreversible binding hæmmes trombocytaggregationen i resten af trombocytternes levetid (ca. 7-10 dage), og normal trombocytfunktion generhverves med den hastighed, hvormed trombocytterne omsættes.
English: • You should also tell your doctor immediately if you develop a medical condition 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).
Danish: • Skal du også straks kontakte din læge, hvis du udvikler en tilstand kendt som trombotisk trombocytopenisk purpura eller TTP, der giver feber og små blødninger under huden (det kan vise sig som små, røde prikker) med eller uden uforklarlig ekstrem træthed, forvirring, gulfarvning af huden eller øjnene (gulsot) (se afsnit 4).
English: a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
Danish: - en blødningsforstyrrelse, der giver tendens til indre blødninger (blødning inde i et af kroppens væv, organer eller led).
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 konsistent i alle præspecificerede undergrupper, hvor der blev taget hensyn til patientens alder, køn, hvor infarktet var lokaliseret, og den type fibrinolytikum eller heparin, der blev anvendt til behandling.
English: 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.
Danish: I alt 99,7 % af patienterne fik fibrinolytika (fibrinspecifik: 68,7 %, ikke-fibrinspecifik: 31,1 %), 89,5 % fik heparin, 78,7 % betablokkere, 54,7 % ACE-hæmmere og 63 % statiner.