FrancophonIA/ELRC3.0 huggingface dataset:
English: With severe intoxication, serious disturbances of the acid-base equilibrium occur.
Danish: Ved alvorlig forgiftning forekommer der alvorlige forstyrrelser i syre-base-balancen.
English: TOPIC and TROPICAL-ACS were designed to study how to mitigate the bleeding events while maintaining efficacy.
Danish: TOPIC og TROPICALACS blev designet til at undersøge, hvordan man kan mindske blødninger, samtidig med at effekten opretholdes.
English: • If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Danish: • Hvis du skærer dig eller kommer til skade, kan det tage lidt længere end normalt, før blødningen stopper.
English: Subsequently a respiratory acidosis occurs as a result of a suppressive effect on the respiratory centre.
Danish: Efterfølgende forekommer respiratorisk acidose som resultat af den supprimerende effekt på respirationscentret.
English: At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
Danish: Ved steady state var den gennemsnitlige hæmningsgrad, der blev iagttaget ved en dosis på 75 mg/dag, mellem 40 % og 60 %.
English: 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.
Danish: 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.
English: Overall clopidogrel 75 mg/day was similar to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
Danish: Samlet set var clopidogrel 75 mg/dag sammenligneligt med ASA 325 mg/dag i CAPRIE uden hensyn til alder, køn eller race.
English: In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups.
Danish: I COMMIT var den generelle forekomst af non-cerebrale større blødninger eller cerebrale blødninger lav og ens i begge grupper.
English: Depression of the nervous system can lead to coma, cardiovascular collapse and respiratory arrest.
Danish: Depression af nervesystemet kan føre til koma, kardiovaskulært kollaps og respirationsstop.
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 blødning, herunder okkult blødning, især i behandlingens første uger og/eller efter invasive hjerteindgreb eller -kirurgi.
English: 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.
Danish: Patienter, der tidligere har udviklet en allergisk og/eller hæmatologisk reaktion over for et thienopyridin, kan have en øget risiko for at udvikle den samme eller en anden reaktion over for en anden thienopyridin.
English: Repeat-dose toxicity studies have shown that levels up to 200 mg/kg/day are well tolerated in rats; dogs appear to be more sensitive, probably due to the high sensitivity of canines to the ulcerogenic effects of NSAIDs.
Danish: Undersøgelser af toksicitet ved gentagne doser har vist, at niveauer op til 200 mg/kg/dag er veltolererede hos rotter; hunde er tilsyneladende mere sensitive, sandsynligvis grundet hundes høje følsomhed for ulcerogene effekter af NSAID'er.
English: Bleeding is the most common reaction reported both in clinical studies as well as in the post-marketing experience where it was mostly reported during the first month of treatment.
Danish: Blødning er den hyppigst indrapporterede bivirkning fra både kliniske studier såvel som fra postmarketing erfaring, hvor den mestendels blev indrapporteret i løbet af behandlingens første måned.
English: For patients who did not undergo angiography, the primary endpoint was death or recurrent myocardial infarction by Day 8 or by hospital discharge.
Danish: For de patienter, der ikke fik foretaget angiografi, var det primære endepunkt død, tilbagevendende myokardieinfarkt ved dag 8 eller ved udskrivelse fra hospitalet.
English: This effect lasts for the life of the platelet.
Danish: Denne effekt varer hele trombocyttens levetid.
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 fraværende eller nedsat metabolisme er mindre hyppige og inkluderer CYP2C19*4, *5, *6, *7 og *8.
English: • Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
Danish: • Aktiv patologisk blødning, såsom ulcus pepticum eller intrakraniel blødning.
English: Reproduction toxicity data show that ASA is teratogenic in several laboratory animals.
Danish: Undersøgelser om reproduktionstoksitet viser, at ASA er teratogent hos adskillige forsøgsdyr.
English: McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Danish: McDermott Laboratories Limited trading, som Gerard Laboratories trading, som Mylan Dublin, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
English: ** Information related to clopidogrel with frequency “not known”.
Danish: Relateret til clopidogrel med frekvens ”ikke kendt”.
English: Alkalising of the urine (250 mmol sodium bicarbonate for 3 hours) while monitoring the urine pH is indicated.
Danish: Alkalinisering af urinen (250 mmol natriumhydrogencarbonat over tre timer) under monitorering af urinens pH er indiceret.
English: Posology Adults and elderly
Danish: Voksne og ældre
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 har ikke påvist direkte eller indirekte skadelige virkninger på graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Acetylsalicylic acid (ASA):
Danish: Acetylsalicylsyre (ASA):
English: Therefore, the guided de-escalation arm had patients on either prasugrel (40%) or clopidogrel (60%).
Danish: Derfor havde den guidede deeskaleringsarm patienter behandlet med enten prasugrel (40 %) eller clopidogrel (60 %).
English: Its metabolite, salicylic acid, is highly bound to plasma proteins, but its binding is concentration dependent (nonlinear).
Danish: Dets metabolit, salicylsyre, bindes i høj grad til plasmaproteiner, men dets binding er koncentrationsafhængig (non-lineær).
English: No genotoxicity or clastogenicity issues of concern have been found with ASA.
Danish: Der er ikke fundet problemer med genotoksitet eller klastogenicitet med ASA.
English: In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
Danish: I CURE, CLARITY, ACTIVE-A og en af kohorteundersøgelserne (Trenk) blev der ikke observeret nogen øget forekomst af hændelser, baseret på metabolisk status.
English: Hearing loss* or tinnitus*
Danish: Nedsat hørelse eller tinnitus
English: • if you have had a clot in an artery of your brain (ischaemic stroke) which occurred in the last seven days.
Danish: • hvis du har haft en blodprop i en åre (arterie) i hjernen (iskæmisk slagtilfælde) inden for de seneste 7 dage.
English: • anti-retroviral medicines (medicines used to treat HIV infections)
Danish: • antiretroviral medicin (lægemidler der anvendes til behandling af HIV-infektioner),
English: • opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioids treatment.
Danish: • opioider: Når du behandles med clopidogrel, skal du fortælle det til lægen, før du får ordineret behandling med opioider.
English: Clopidogrel has been evaluated for safety in more than 42,000 patients who have participated in clinical studies, including over 30,000 patients treated with clopidogrel plus ASA, and 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 30.000 patienter behandlet med clopidogrel plus ASA og over 9.000 patienter, der blev behandlet i mindst 1 år.
English: • if you have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency because of the risk of a particular form of anaemia (low number of red blood cells).
Danish: • hvis du har en lidelse, der kaldes glucose-6-phosphatdehydrogenase (G6PD)-mangel, da G6PDmangel øger risikoen for en særlig form for anæmi (lavt antal røde blodceller).
English: Activated charcoal (adsorbent) and sodium sulphate (laxative) are then administered.
Danish: Aktivt kul (adsorbant) og natriumsulfat (laksativ) skal derefter administreres.
English: Other concomitant therapy with ASA Interactions with the following medicinal products have been reported with ASA:
Danish: Anden samtidig behandling med ASA Der er rapporteret interaktioner med følgende lægemidler og ASA:
English: • if you are allergic to clopidogrel, acetylsalicylic acid (ASA) or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for clopidogrel, acetylsalicylsyre eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Haemodialysis is the preferred treatment for severe intoxication.
Danish: Hæmodialyse er den foretrukne behandling ved alvorlig forgiftning.
English: Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Danish: Absorptionen er mindst 50 %, baseret på udskillelse af clopidogrels metabolitter i urinen.
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 % af patienterne var ≥ 60 år (26 % ≥ 70 år), og 54,5 % af patienterne fik fibrinolytika.
English: Cmax occurs approximately 30 to 60 minutes after dosing.
Danish: Cmax opnås ca. 3060 minutter efter administration.
English: Low doses (up to 100 mg/day):
Danish: Lave doser (op til 100 mg/dag):
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 ringe metabolisme modtog 600 mg/150 mg regimet, var eksponeringen for den aktive metabolit større end for 300 mg/75 mg-regimet.
English: 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.
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 tilstrækkelig trombocythæmning.
English: There is a possible association between acetylsalicylic acid (ASA) and Reye's Syndrome when products containing ASA are given to children or adolescents with a viral infection.
Danish: Der er en mulig sammenhæng mellem acetylsalicylsyre (ASA) og Reyes syndrom, når lægemidler, der indeholder ASA, gives til børn og unge med en virusinfektion.
English: Heparins were administered in more than 90% of the patients and the relative rate of bleeding between clopidogrel plus ASA and ASA alone was not significantly affected by the concomitant heparin therapy.
Danish: Heparin blev givet til over 90 % af patienterne, og den relative blødningsforekomst i grupperne clopidogrel plus ASA og ASA alene blev ikke signifikant påvirket af den ledsagende heparinbehandling.
English: C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Danish: C-mærket clopidogrel hos mennesker blev ca. 50 % udskilt i urinen og ca. 46 % i fæces i løbet af 120 timer efter dosering.
English: Uricosurics (benzbromarone, probenecid, sulfinpyrazone) Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid.
Danish: Urikosurika (benzbromaron, probenecid, sulfinpyrazon) Der skal udvises forsigtighed, da ASA kan hæmme effekten af urikosurika via kompetitiv elimination af urinsyre.
English: An occasional use of ASA (no more than 1,000 mg in any 24-hour period) should generally not cause a problem, but prolonged use of ASA in other circumstances should be discussed with your doctor or pharmacist.
Danish: Lejlighedsvis anvendelse af acetylsalicylsyre (ikke over 1.000 mg over en periode på 24-timer) burde generelt ikke give problemer, men hvis du tager acetylsalicylsyre gennem længere tid under andre omstændigheder, skal du diskutere det med lægen eller apotekspersonalet.
English: Patients should also be told that it might take longer than usual to stop bleeding when they take Clopidogrel/Acetylsalicylic acid Mylan, and that they should report any unusual bleeding (site or duration) to their physician.
Danish: Patienter bør også informeres om, at det kan tage længere tid end normalt at standse blødninger, når de tager Clopidogrel/Acetylsalicylic acid Mylan, samt at de bør kontakte deres læge ved enhver usædvanlig blødning (sted eller varighed).
English: The de-escalated patients underwent high platelet reactivity (HPR) testing.
Danish: De de-eskalerede patienter gennemgik testning høj trombocytreaktivitet (HPR) test.
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 CYP2C19-genotyper med ringe metabolisme er ca. 2 % for kaukasiske personer, 4 % for negroide og 14 % for kinesiske.
English: Film coated tablet (tablet)
Danish: Filmovertrukket tablet (tablet)
English: 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.
Danish: Der er dog foretaget et antal retrospektive analyser for at evaluere denne effekt hos patienter i behandling med clopidogrel, for hvem der foreligger resultater af genotypebestemmelse: CURE (n = 2721), CHARISMA (n = 2428), CLARITY- TIMI 28 (n = 227), TRITON-TIMI 38 (n = 1477) og ACTIVE-A (n = 601) såvel som et antal publicerede kohorteundersøgelser.
English: Based on the pharmacokinetic and metabolic characteristics of both compounds, clinically significant PK interactions are unlikely.
Danish: Baseret på de farmakokinetiske og metabolske karakteristika af begge stoffer er klinisk signifikante farmakokinetiske interaktioner ikke sandsynlige.
English: With moderate intoxication an attempt can be made to induce vomiting; if this fails, gastric lavage is indicated.
Danish: Ved moderat forgiftning kan det forsøges at fremprovokere opkastning; ventrikeltømning er indiceret, hvis dette mislykkes.
English: 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.
Danish: 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-sponsorerede studier (ISS) - TOPIC og TROPICAL-ACS - med kliniske outcome data.
English: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development.
Danish: Hæmning af prostaglandinsyntesen kan have negativ indvirkning på graviditeten og/eller udviklingen af embryo/foster.
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 carcinogen 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 repræsenterer mindst 25 gange eksponeringen hos mennesker, der får den kliniske dosis på 75 mg/dag).
English: This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Danish: Dette var konsistent blandt undergrupperne af patienter, defineret ved baseline-karakteristika og typen af fibrinolytika- eller heparinbehandling.
English: a recent surgery (including dental).
Danish: - et nyligt kirurgisk indgreb (gælder også tandoperationer).
English: The recommended dose is one tablet of Clopidogrel/Acetylsalicylic acid Mylan per day to be taken orally with a glass of water, with or without food.
Danish: Den anbefalede dosis er 1 tablet Clopidogrel/Acetylsalicylic acid Mylan dagligt, som indtages gennem munden med et glas vand, med eller uden mad.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. tablet, dvs. den er i det væsentlige 'natriumfrit'.
English: In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
Danish: Desuden er der beskrevet øgede forekomster af forskellige misdannelser, inklusive kardiovaskulære misdannelser, ved indgift af prostaglandinsyntesehæmmere til dyr under den organogenetiske periode.
English: Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.
Danish: Kliniske studier tyder på, at anvendelse af doser op til 100 mg om dagen til begrænset obstetrisk anvendelse i forbindelse med specialiseret monitorering er sikker.
English: The safety and efficacy of clopidogrel/acetylsalicylic acid in children and adolescents under 18 years old have not been established.
Danish: Sikkerhed og virkning af clopidogrel/acetylsalicylsyre hos børn og unge under 18 år er endnu ikke fastslået.
English: Therefore, the recommendations below for doses of 500 mg/day and above apply also for this dose range.
Danish: Derfor gælder anbefalingerne nedenfor for doser over 500 mg/dag også for dette dosisinterval.
English: Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications.
Danish: Overdosering efter administration af clopidogrel kan medføre forlænget blødningstid og efterfølgende blødningskomplikationer.
English: A metabolic acidosis also arises due to the presence of salicylates.
Danish: Metabolisk acidose opstår også som følge af salicylater.
English: Platelet aggregation and bleeding time gradually returned to baseline values, generally within 5 days after treatment was discontinued.
Danish: Trombocytaggregation og blødningstid vendte gradvist tilbage til baselineværdierne, almindeligvis inden for 5 dage efter behandlingsophør.
English: • Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) and syndrome of asthma, rhinitis, and nasal polyps.
Danish: • Overfølsomhed over for non-steroide antiinflammatoriske stoffer (NSAID'er) samt syndromet astma/rhinitis/nasale polypper.
English: 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: Sikkerheden ved samtidig administration af clopidogrel, fibrin eller ikke-fibrinspecifikke trombolytiske midler og hepariner blev bedømt hos patienter med akut myokardieinfarkt.
English: Following therapeutic doses, approximately 10% is found excreted in the urine as salicylic acid, 75% as salicyluric acid, 10% phenolic- and 5% acylglucuronides of salicylic acid.
Danish: Efter terapeutiske doser findes ca. 10 % af det udskilte i urinen som salicylsyre, 75 % som salicylurinsyre, 10 % som fenol- og 5 % som acylglukuronider af salicylsyre.
English: If you forget to take Clopidogrel/Acetylsalicylic acid Mylan If you forget to take a dose of Clopidogrel/Acetylsalicylic acid Mylan, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Danish: Hvis du glemt at tage Clopidogrel/Acetylsalicylic acid Mylan Hvis du glemmer at tage en dosis Clopidogrel/Acetylsalicylic acid Mylan til sædvanlig tid, 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.
English: In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
Danish: Hos personer med ringe metabolisme var eksponeringen nedsat med 63-71 %, sammenlignet med personer med udtalt metabolisme.
English: The plasma concentrations of the active metabolite was 20% reduced (loading dose) and 14% reduced (maintenance dose) during concomitant treatment with pantoprazole 80 mg once daily.
Danish: Plasmakoncentrationerne af den aktive metabolit blev reduceret med 20 % (initial stabiliseringsdosis) og 14 % (vedligeholdelsesdosis) ved samtidig behandling med 80 mg pantoprazol en gang daglig.
English: Recent transient ischaemic attack or stroke
Danish: Nylig transitorisk iskæmisk attak eller apopleksi
English: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic (PK) interactions.
Danish: Der er gennemført en række andre kliniske studier med clopidogrel og anden samtidig medicinering for at undersøge muligheden for farmakodynamisk og farmakokinetisk interaktioner.
English: • if you have a medical condition that includes the combination of asthma, nasal discharge (runny nose) and polyps (a type of growth in the nose).
Danish: • hvis du har en sygdom, der omfatter kombinationen af astma, rindende næse og polypper (en udvækst i næsen).
English: Although the clinical relevance of these findings is uncertain, there have been spontaneous reports of HIV-infected patients treated with boosted ART, who have experienced re-occlusive events after de-obstruction or have suffered thrombotic events under a clopidogrel loading treatment schedule.
Danish: Den kliniske relevans af disse fund er usikker, men der har været spontane indberetninger fra hiv-smittede patienter i behandling med boostet ART, som har oplevet re-okklusive hændelser efter de-obstruktion eller oplevet trombotiske hændelser under støddosisbehandling med clopidogrel.
English: There is an increased risk of bleeding due to the potential additive effect.
Danish: Lægemidler, der er forbundet med risiko for blødning Der er en øget risiko for blødning på grund af mulig additiv effekt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medical product containing clopidogrel /acetylsalicyclic acid in all subsets of the paediatric population in the treatment of coronary atherosclerosis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med referencelægemidlet indeholdende clopidogrel/acetylsalicylsyre i alle undergrupper af den pædiatriske population ved behandling af koronar aterosklerose (se pkt.
English: Cellulose microcrystalline Lactose
Danish: Mikrokrystallinsk cellulose Lactose
English: • In patients with a history of asthma or allergic disorders since they are at increased risk of hypersensitivity reactions.
Danish: • Hos patienter med astma eller allergiske sygdomme i anamnesen, da disse har forhøjet risiko for overfølsomhedsreaktioner.