FrancophonIA/ELRC3.0 huggingface dataset:
English: • swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.
Danish: • hævelser i munden eller hudproblemer såsom udslæt og kløe, blister på huden.
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 en risiko for blødninger f.eks. på grund af: en sygdom, der medfører risiko for indre blødninger (såsom et mavesår).
English: A metabolic acidosis also arises due to the presence of salicylates.
Danish: Metabolisk alkalose opstår også som følge af salicylater.
English: After first opening bottle: 30 days
Danish: Efter første anbrud af tabletbeholderen: 30 dage
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 lægen, før du tager dette lægemiddel.
English: Due to the presence of both components of the medicinal product, Clopidogrel/Acetylsalicylic acid Teva is contraindicated in case of:
Danish: På grund af tilstedeværelsen af begge komponenter i lægemidlet er Clopidogrel/Acetylsalicylsyre Teva kontraindiceret i tilfælde af:
English: Following therapeutic doses, approximately 10% is found excreted in the urine as salicylic acid, 75% as salicyluric acid, 10% phenolic- and 5% acyl-glucuronides of salicylic acid.
Danish: Efter terapeutiske doser findes ca. 10 % af det udskilte i urinen som salicylsyre, 75 %som salicylurinsyre, 10 % som phenol- og 5 % som acylglukuronid af salicylsyre.
English: The primary endpoint was the occurrence of the composite of an occluded infarct-related artery on the predischarge angiogram, or death or recurrent MI before coronary angiography.
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: Salicylate metabolism is saturable and total body clearance decreases at higher serum concentrations due to the limited ability of the liver to form both salicyluric acid and phenolic glucuronide.
Danish: Salicylatmetabolismen kan mættes, og den totale kropsclearance falder ved højere serumkoncentrationer grundet leverens begrænsede evne til at danne både salicylurinsyre og phenolisk glukuronid.
English: In a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
Danish: I et klinisk studie foretaget med raske studiepersoner øgede samtidige administration af clopidogrel og naproxen okkult gastrointestinalt blodtab.
English: If you stop taking Clopidogrel/Acetylsalicylic acid Teva Do not stop the treatment unless your doctor tells you so.
Danish: Hvis du holder op med at tage Clopidogrel/Acetylsalicylsyre Teva: Du må ikke stoppe behandlingen, medmindre din læge har bedt dig om det.
English: In addition, IPA was 32% (24 hours) and 61% (Day 5), which were greater than in the poor metabolisers receiving the 300 mg/75 mg regimen, and were similar to the other CYP2C19 metaboliser groups receiving the 300 mg/75 mg regimen.
Danish: Desuden var IPA på 32 % (24 timer) og 61 % (dag 5), hvilket var større end hos personer med ringe metabolisme der modtog 300 mg/75 mg-regimet, og var omtrent ens med de andre grupper af CYP2C19-metabolisers der modtog 300 mg/75 mg-regimet.
English: • methotrexate, a medicine used to treat severe joint disease (rheumatoid arthritis) or skin disease
Danish: • methotrexat, et lægemiddel der anvendes til at behandle alvorlige ledsygdomme (reumatoid artrit) eller hudsygdomme (psoriasis).
English: • If you have a medical condition that include 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, løbenæse og polypper (en udvækst i næsen).
English: Titanium dioxide (E171) Talc
Danish: Titandioxid (E171) Talcum
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 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 % (95 % 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: • 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.
English: Clopidogrel: During non-clinical studies in rat and baboon, the most frequently observed effects were liver changes.
Danish: Clopidogrel: I prækliniske studier på rotter og bavianer var den hyppigst forekommende effekt leverforandringer.
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 studiepersoner nødvendiggjorde clopidogrel ikke ændring af heparindosis, og det ændrede ikke heparins virkning på koagulationen.
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 fibrinolytikaeller heparinbehandling.
English: Specific pharmacokinetic studies performed with radiolabelled clopidogrel have shown that the parent compound or its metabolites are excreted in the milk.
Danish: Specifikke farmakokinetiske studier med radioaktivt mærket clopidogrel har vist, at udgangsstoffet eller dets metabolitter udskilles i mælk.
English: • You should also tell your doctor immediately if you develop a medical condition (also 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 ‘Possible side effects').
Danish: • skal du også straks kontakte din læge, hvis du udvikler en tilstand (også 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 'Bivirkninger').
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: Merckle GmbH Ludwig-Merckle-Strasse 3 D-89143 Blaubeuren-Weiler Germany
Danish: Merckle GmbH Ludwig-Merckle-Strasse 3 D-89143 Blaubeuren-Weiler Tyskland
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 i dyr har vist sig at resultere i øget forekomst af præ- og postimplantationstab, og embryo-føtal dødelighed.
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 støddosis, som den er efter fire dage med 75 mg vedligeholdelsesdosis.
English: Some other medicines may influence the use of Clopidogrel/Acetylsalicylic acid Teva or vice versa.
Danish: Nogle andre lægemidler kan påvirke brugen af Clopidogrel/Acetylsalicylsyre Teva eller omvendt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the combination of clopidogrel/acetylsalicylic 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 kombinationen clopidogrel/acetylsalicylsyre i alle undergrupper af den pædiatriske population ved behandling af koronar aterosklerose (se pkt.
English: Patients with a confirmed diagnosis of acquired haemophilia should be managed and treated by specialists, and Clopidogrel/Acetylsalisylic acid should be discontinued.
Danish: Patienter med en bekræftet diagnose på erhvervet hæmofili skal varetages og behandles af specialister, og clopidogrel/acetylsalicylsyre skal seponeres.
English: Low doses (up to 100 mg/day):
Danish: ASA: Lave doser (op til 100 mg/dag):
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: - Inden for mindre end 12 timer efter planlagt dosering: Patienten bør straks tage den planlagte dosis og derefter tage den næste dosis ved næste planlagte dosering.
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 regulær anvendelse af ibuprofen, og en klinisk relevant effekt anses ikke for at være sandsynlig ved lejlighedsvis anvendelse af ibuprofen.
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, slagtilfælde eller død med 9 % (p = 0,002), hvilket repræsenterer en absolut reduktion på henholdsvis 0,5 % og 0,9 %.
English: The following symptoms can also arise: hyperthermia and perspiration, leading to dehydration, restlessness, convulsions, hallucinations and hypoglycaemia.
Danish: Følgende symptomer kan også opstå: Hypertermi og perspiration førende til dehydrering, rastløshed, kramper, hallucinationer og hypoglykæmi.
English: • severe abdominal pain with or without back pain
Danish: • alvorlige mavesmerter med eller uden rygsmerter
English: Oral use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT Keep out of the sight and reach of children.
Danish: Oral anvendelse SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn.
English: ASA: The following symptoms are associated with moderate intoxication: dizziness, headache, tinnitus, confusion and gastrointestinal symptoms (nausea, vomiting and gastric pain).
Danish: ASA: Følgende symptomer er forbundet med moderat forgiftning: Svimmelhed, hovedpine, tinnitus, konfusion og gastrointestinale symptomer (kvalme, opkastning og mavesmerter).
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 x øvre grænse for normalområdet.
English: Apart from the specific medicinal product interaction information described above, interaction studies with the combination of clopidogrel/acetylsalicylic acid 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 kombinationen clopidogrel/acetylsalicylsyre og lægemidler, som almindeligvis gives til patienter med aterotrombotisk sygdom.
English: Yellow, film-coated capsule shaped tablets.
Danish: Gule, filmovertrukne, kapselformede tabletter.
English: Clopidogrel/Acetylsalicylic acid Teva is not intended for use in children or adolescents less than 18 years of age.
Danish: Clopidogrel/Acetylsalicylsyre Teva er ikke tiltænkt anvendelse hos børn og unge under 18 år.
English: Lactose monohydrate Microcrystalline cellulose Hydroxypropylcellulose 100 cP Crospovidone (type A) Stearic Acid
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Hydroxypropylcellulose 100 cP Crospovidon (type A) Stearinsyre
English: EXP After first opening bottle use within 30 days.
Danish: EXP Efter første anbrud af tabletbeholderen: Anvendes inden for 30 dage.
English: • inflammation of small vessels.
Danish: • betændelse i små kar.
English: In patients with acute ST-segment elevation MI, safety and efficacy of clopidogrel have been evaluated in 2 randomised, placebo-controlled, double-blind studies, CLARITY and COMMIT.
Danish: Hos patienter med akut myokardieinfarkt (MI) med ST-segment elevation blev sikkerheden ved og virkningen af clopidrogrel vurderet i 2 randomiserede, placebo-kontrollerede, dobbeltblindede studier kaldet CLARITY og COMMIT.
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 og Reyes syndrom, når lægemidler, der indeholder acetylsalicylsyre, gives til børn og unge med en virusinfektion.
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 dagligt 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 uafhængige virkninger på hæmostasen.
English: • heparin or any other injectable medicine used to reduce blood clotting,
Danish: • heparin eller anden medicin til indsprøjtning til at nedsætte dannelse af blodpropper.
English: A pharmacodynamic interaction between the combination of clopidogrel/acetylsalicylic acid and heparin is possible, leading to increased risk of bleeding.
Danish: En farmakodynamisk interaktion mellem clopidogrel/acetylsalicylsyre og heparin er mulig, hvilket kan medføre øget blødningsrisiko.
English: Adverse reactions that occurred with clopidogrel alone, with ASA alone* or with clopidogrel in combination with ASA either during clinical studies or that were spontaneously reported are presented in the table below.
Danish: Bivirkninger, der enten opstod under monoterapi med henholdsvis clopidogrel eller ASA* eller under kombinationsbehandling med clopidogrel og ASA i de kliniske studier eller blev spontant indberettet, er beskrevet i tabellen nedenfor.
English: If you forget to take Clopidogrel/Acetylsalicylic acid Teva If you forget to take a dose of Clopidogrel/Acetylsalicylic acid Teva, but remember within 12 hours of your usual time, take your tablet straight away and then take your next tablet at the usual time.
Danish: Hvis du har glemt at tage en dosis Clopidogrel/Acetylsalicylsyre Teva 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: Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Danish: Muskuloskeletal blødning (hæmartrose), artrit, artralgi, myalgi
English: • sore mouth (stomatitis)
Danish: • ømhed i munden (stomatitis)
English: Omeprazole 80 mg once daily administered either at the same time as clopidogrel or with 12 hours between the administrations of the two drugs decreased the exposure of the active metabolite by 45% (loading dose) and 40% (maintenance dose).
Danish: 80 mg omeprazol en gang daglig administreret enten samtidigt med clopidogrel eller med 12 timers mellemrum nedsatte eksponeringen for den aktive metabolit med 45 % (støddosis) og 40 % (vedligeholdelsesdosis).
English: Thienopyridines may cause mild to severe allergic reactions such as rash, angioedema, or haematological cross-reactions such as thrombocytopaenia and neutropaenia.
Danish: Thienopyridiner kan forårsage lette til svære allergiske reaktioner, såsom udslæt, angioødem eller hæmatologiske krydsreaktioner, såsom trombocytopeni og neutropeni.
English: In TRITON-TIMI 38 and 3 of the cohort studies (Collet, Sibbing, Giusti) the combined group of patients with either intermediate or poor metaboliser status had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers.
Danish: I TRITON-TIMI 38 og 3 af kohortestudierne (Collet, Sibbing, Giusti), havde den kombinerede gruppe af patienter med status som enten moderat eller ringe metaboliser en højere hyppighed af kardiovaskulære hændelser (død, myokardieinfarkt og slagtilfælde) eller stenttrombose sammenlignet med personer med udtalt metabolisme.
English: Tests are available to identify a patient's CYP2C19 genotype.
Danish: Tests er tilgængelige til at identificere en patients CYP2C19genotype.
English: Since SSRIs affect platelet activation and increase the risk of bleeding, the concomitant administration of SSRIs with clopidogrel should be undertaken with caution.
Danish: Da SSRI'er påvirker trombocytaktiveringen og øger risikoen for blødning, skal samtidig administration af SSRI'er og clopidogrel ske med forsigtighed.
English: In patients with recent transient ischaemic attack or stroke who are at high risk of recurrent ischaemic events, the combination of ASA and clopidogrel has been shown to increase major bleeding.
Danish: Hos patienter med nyligt transitorisk cerebral iskæmi eller apopleksi, og med høj risiko for tilbagevendende iskæmiske tilfælde har kombinationen af clopidogrel og ASA vist at kunne øge risikoen for alvorlig blødning.
English: Patients should be told about the signs and symptoms of GI undesirable effects and what steps to take if they occur (see section 4.8).
Danish: Patienterne bør informeres om tegn og symptomer på gastrointestinale bivirkninger og hvilke forholdsregler, de skal tage, hvis de opstår (se pkt.
English: Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly.
Danish: Eksperimentelle data tyder på, at ibuprofen kan hæmme effekten af lave doser aspirin på trombocytaggregationen, når de administreres samtidigt.
English: The CYP2C19*1 allele corresponds to fully functional metabolism while the CYP2C19*2 and CYP2C19*3 alleles correspond to nonfunctional metabolism.
Danish: CYP2C19*1-allelen svarer til en fuldt funktionel metabolisme, mens CYP2C19*2- og CYP2C19*3allelerne ikke er funktionelle.
English: Salicylic acid in the combination of clopidogrel/acetylsalicylic acid has a plasma half-life of approximately 2 hours.
Danish: Salicylsyren i kombinationen clopidogrel/acetylsalicylsyre har en plasmahalveringstid på ca. 2 timer.
English: • The active substances are clopidogrel and acetylsalicylic acid.
Danish: • Aktive stoffer: clopidogrel og acetylsalicylsyre.
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 2.172 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 det primære sammensatte endepunkt (CV død, MI, apopleksi) og desuden en signifikant RRR på 23,9 % med hensyn til det andet co-primære endepunkt (CV død, MI, apopleksi eller refraktær iskæmi).
English: Do NOT take Clopidogrel/Acetylsalicylic acid Teva during third trimester of pregnancy.
Danish: Du må IKKE tage Clopidogrel/Acetylsalicylsyre Teva under graviditetens tredje trimester.
English: A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metaboliser groups (ultrarapid, extensive, intermediate and poor), evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg/day and 600 mg followed by 150 mg/day, each for a total of 5 days (steady state).
Danish: Et cross-over studie hos 40 raske studiepersoner, 10 i hver af de fire CYP2C19-metaboliske grupper (ultrahurtig, udtalt, moderat eller ringe), evaluerede farmakokinetisk og trombocythæmmende respons ved anvendelse af 300 mg efterfulgt af 75 mg/dag og 600 mg efterfulgt af 150 mg/dag, hver i alt 5 dage (steady-state).
English: Very rare, not known
Danish: Systemorganklasse Almindelig Ikke almindelig Sjælden Meget sjælden, ikke kendt
English: Consequently, the concomitant use of NSAIDs including Cox-2 inhibitors is not recommended (see section 4.4).
Danish: Derfor anbefales samtidig anvendelse af NSAID'er inklusive Cox-2 hæmmere ikke (se pkt.
English: The use of clopidogrel in CURE was associated with a decrease in the need for thrombolytic therapy (RRR = 43.3%; CI: 24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR = 18.2%; CI: 6.5%, 28.3%).
Danish: I CURE var anvendelse af clopidogrel forbundet med et aftagende behov for behandling med trombolytika (RR = 43,3 %, CI: 24,3 %; 57,5 %) og GPIIb/IIIa-hæmmere (RRR = 18,2 %, CI: 6,5 %;
English: Patients with pre-existing mastocytosis, in whom the use of acetylsalicylic acid may induce severe hypersensitivity reactions (including circulatory shock with flushing, hypotension, tachycardia and vomiting).
Danish: Patienter med mastocytose, hos hvem brug af acetylsalicylsyre kan fremkalde alvorlige overfølsomhedsreaktioner (inklusive kredsløbsshock med ansigtsrødme, hypotension, takykardi og opkastning).
English: Tests are available to determine a patient's CYP2C19 genotype.
Danish: Der er tests tilgængelige til at bestemme en patients CYP2C19-genotype.
English: No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultrarapid, extensive and intermediate metabolisers.
Danish: Det blev ikke observeret nogen betydende forskelle i eksponering for den aktive metabolit og gennemsnitlig hæmning af trombocytfunktionen (IPA) mellem ultrahurtige, udtalte eller moderate metabolisers.
English: Pack sizes of 10, 14, 28, 30, 50, 90 and 100 film-coated tablets.
Danish: Pakningsstørrelser på 10, 14, 28, 30, 50, 90 og 100 filmovertrukne tabletter.
English: • excessive gas in stomach or intestines
Danish: • luft i maven eller tarmene
English: The prevalence of CYP2C19 alleles that result in intermediate and poor CYP2C19 metabolism differs according to race/ethnicity (see Pharmacogenetics).
Danish: Hyppigheden af CYP2C19-alleller, der resulterer i moderat eller ringe CYP2C19-metabolisme, varierer afhængigt af race/etnisk tilhørsforhold (se Farmakogenetik).