FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to take a dose of Clopidogrel Teva Pharma, 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 har glemt en dosis af Clopidogrel Teva Pharma, 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: By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).
Danish: Ved at forhindre denne sammenklumpning nedsætter medicinen, der opløser blodpropper, risikoen for, at der dannes blodpropper (en proces, der kaldes trombose).
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 clopidrogrel er blevet evalueret i 5 dobbeltblindede studier, der omfattede mere end 88.000 patienter: 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 eller anden standardterapi.
English: EU/1/09/561/001 7 film-coated tablets EU/1/09/561/002 14 film-coated tablets EU/1/09/561/003 28 film-coated tablets EU/1/09/561/004 30 film-coated tablets EU/1/09/561/005 50 film-coated tablets EU/1/09/561/006 56 film-coated tablets EU/1/09/561/007 84 film-coated tablets EU/1/09/561/008 90 film-coated tablets EU/1/09/561/009 100 film-coated tablets EU/1/09/561/010 28x1 film-coated tablets EU/1/09/561/011 50x1 film-coated tablets
Danish: EU/1/09/561/001 7 filmovertrukne tabletter EU/1/09/561/002 14 filmovertrukne tabletter EU/1/09/561/003 28 filmovertrukne tabletter EU/1/09/561/004 30 filmovertrukne tabletter EU/1/09/561/005 50 filmovertrukne tabletter EU/1/09/561/006 56 filmovertrukne tabletter EU/1/09/561/007 84 filmovertrukne tabletter EU/1/09/561/008 90 filmovertrukne tabletter EU/1/09/561/009 100 filmovertrukne tabletter EU/1/09/561/010 28x1 filmovertrukne tabletter EU/1/09/561/011 50x1 filmovertrukne tabletter
English: Your doctor should have prescribed Clopidogrel Teva Pharma plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding
Danish: Din læge bør have udskrevet Clopidogrel Teva Pharma plus acetylsalicylsyre, hvis duikke må tage ”orale antikoagulantia”, og du ikke har en risiko for alvorlig blødning.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (28x1 film-coated tablets)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERKORT (28x1 filmovertrukne tabletter)
English: The ACTIVE-A study (N=7,554) was a multicenter, randomized, double-blind, placebo-controlled study which compared clopidogrel 75 mg/day + ASA (N=3,772) to placebo + ASA (N=3,782).
Danish: ACTIVE-A-studiet (N = 7.554) var et multicenter, randomiseret, dobbeltblindt, placebokontrolleret studie, som sammenlignede clopidogrel 75 mg/dag + ASA (N = 3.772) med placebo + ASA (N = 3.782).
English: The CYP2C19*1 allele corresponds to fully functional metabolism while the CYP2C19*2 and CYP2C19*3 alleles are nonfunctional.
Danish: CYP2C19*1-allelen svarer til en fuldt funktionel metabolisme, mens CYP2C19*2- og CYP2C19*3allelerne ikke er funktionelle.
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: The recommended dose for ASA was 75 to 100 mg/day.
Danish: Den anbefalede ASA-dosis var 75 til 100 mg/dag.
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 bypassoperation hos patienter, der indstillede behandlingen mere end 5 dage før indgrebet.
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43/1/97007-0
Danish: ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43/1/97007-0
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
Danish: Farmakoterapeutisk klassifikation: Antitrombotiske midler, trombocytfunktionshæmmende midler eksklusive heparin, ATC-kode: B01AC-04.
English: Perforated unit dose blister of OPA/Al/PVC-Al containing 28x1 and 50x1 film-coated tablets in the box.
Danish: Perforerede enhedsdosisblistere af OPA/Al/PVC-Al indeholdende 28x1 og 50x1 filmovertrukne tabletter.
English: The most common side effect reported with Clopidogrel Teva Pharma is bleeding.
Danish: Den almindeligste bivirkning, indberettet med Clopidogrel Teva Pharma er blødning.
English: • Risk Management Plan (RMP)
Danish: • Risikostyringsprogram
English: Warnings and precautions If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Teva Pharma:
Danish: Advarsler og forsigtighedsregler Hvis nogen af følgende situationer gælder for dig, skal du oplyse det til din læge, før du tager Clopidogrel Teva Pharma:
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: Bleeding time prolonged, neutrophil count decreased, platelet count decreased * Information related to clopidogrel with frequency “not known”.
Danish: Undersøgelser i neutrofiltal, fald i trombocyttal * Information relateret til clopidogrel med hyppighed ”ikke kendt”.
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Danish: Gastrointestinal og retroperitoneal blødning med dødelig udgang, pancreatitis, colitis (inklusive ulcerøs eller forstoppelse, flatulens lymfocytisk colitis), stomatitis
English: Driving and using machines Clopidogrel Teva Pharma is unlikely to affect your ability to drive or to use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt at Clopidogrel Teva Pharma påvirker din evne til at køre eller betjene maskiner.
English: Clopidogrel Teva Pharma contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Danish: Clopidogrel Teva Pharma indeholder clopidogrel og tilhører en lægemiddelgruppe, der kaldes blodfortyndende medicin.
English: In a dose escalation study of 86 neonates or infants up to 24 months of age at risk for thrombosis (PICOLO), clopidogrel was evaluated at consecutive doses of 0.01, 0.1 and 0.2 mg/kg in neonates and infants and 0.15 mg/kg only in neonates.
Danish: I et dosiseskaleringsstudie med 86 nyfødte eller spædbørn op til 24 måneder med risiko for trombose (PICOLO) blev clopidogrel evalueret ved konsekutive doser på 0,01, 0,1 og 0,2 mg/kg til nyfødte og spædbørn og ved 0,15 mg/kg alene til nyfødte.
English: Then, the recommended dose is one 75 mg tablet of Clopidogrel Teva Pharma per day as described above.
Danish: Derefter er den anbefalede dosis 1 Clopidogrel Teva Pharma-tablet på 75 mg daglig som beskrevet ovenfor.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets 28x1 film-coated tablets 50x1 film-coated tablets
Danish: 7 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter 28x1 filmovertrukne tabletter 50x1 filmovertrukne tabletter
English: Polyvinyl alcohol Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) Talc
Danish: PolyvinylalkoholTitandioxid (E171) Rød jernoxid (E172) Gul jernoxid
English: • If you are allergic 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: • 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 fortælle det til din læge, hvis du udvikler en medicinsk tilstand (trombocytisk trombocytopenisk purpura eller TTP), der giver feber og blå mærker under huden, der kan fremstå som røde små prikker, med eller uden uforklarlig udtalt træthed, forvirring, gulfarvning af huden eller øjnene (gulsot) (se pkt.
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), 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, StevensJohnson syndrom, erythema multiforme), akut generaliseret eksantematøs pustulose (AGEP), angioødem, lægemiddelinduceret overfølsomhedssyndrom, medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS), erytematøst eller eksfoliativt udslæt, urticaria, eksem, lichen planus
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 clopidogrel 75 mg/dag.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (7, 14, 28, 30, 50, 56, 84, 90, 100, 50x1 film-coated tablets)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER (7, 14, 28, 30, 50, 56, 84, 90, 100, 50x1 filmovertrukne tabletter)
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Teva Pharma in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Danish: Hvis du har haft alvorlige smerter i brystet (hjertekrampe (ustabil angina pectoris) eller hjerteanfald), kan din læge ordinere Clopidogrel Teva Pharma i kombination med acetylsalicylsyre, som er et stof, der indgår i mange typer medicin til smertelindring og febersænkning.
English: As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Teva Pharma.
Danish: Som forholdsregel bør amning ophøre under behandling med Clopidogrel Teva Pharma.
English: Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Danish: Glycoprotein IIb/IIIa-hæmmere: Clopidogrel skal anvendes med forsigtighed til patienter, der samtidig behandles med glycoprotein IIb/IIIa-hæmmere (se pkt.
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Pharma (4 tablets of 75 mg) once at the start of treatment.
Danish: Hvis du har haft alvorlige brystsmerter (ustabil angina pectoris eller hjertetilfælde), vil din læge måske indlede behandlingen med at give dig 300 mg Clopidogrel Teva Pharma på en gang (4 tabletter på 75 mg).
English: Tests are available to determine a patient's CYP2C19 genotype.
Danish: Der er test tilgængelige til at bestemme en patients CYP2C19-genotype
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Teva Pharma.
Danish: Hvis du mener, at ovenstående gælder for dig, eller hvis du overhovedet er i tvivl, så rådfør dig med din læge, inden du tager Clopidogrel Teva Pharma.
English: - signs of liver problems such as yellowing of the skin and/or 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/eller øjnene (gulsot), uanset om det sker i forbindelse med blødninger, som viser sig under huden som små røde prikker, og/eller forvirring (se pkt.
English: The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent myocardial infarction (<35 days), recent ischaemic stroke (between 7 days and 6 months) or established peripheral arterial disease (PAD).
Danish: CAPRIE-studiet omfattede 19.185 patienter med aterotrombose manifesteret ved nyligt myokardieinfarkt (<35 dage), nyligt iskæmisk apopleksi (mellem 7 dage og 6 måneder) eller påviste perifere kredsløbsforstyrrelser (PAD).
English: Clopidogrel Teva Pharma is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Danish: Clopidogrel Teva Pharma tages af voksne for at forebygge dannelse af blodpropper (trombi) i blodårer (arterier), som er blevet stive ved en proces kaldet aterotrombose, hvilket kan føre til f.eks. apopleksi, hjerteanfald og død (aterotrombotiske hændelser).
English: • Adult patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
Danish: • Voksne patienter med akut koronarsyndrom: - akut koronarsyndrom uden elevation af ST-segmentet (ustabil angina eller myokardieinfarkt uden forekomst af Q-takker), herunder patienter, som får indsat stent efter perkutant koronarindgreb, i kombination med acetylsalicylsyre (ASA).
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group.
Danish: I CLARITY var der en generel stigning i antallet af blødninger i clopidrogrel plus ASA-gruppen versus placebo plus ASA-gruppen.
English: You have been prescribed Clopidogrel Teva Pharma to help prevent blood clots and reduce the risk of these severe events because: - You have a condition of hardening of arteries (also known as atherosclerosis), and - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
Danish: De har fået ordineret Clopidogrel Teva Pharma til forebyggelse af blodpropper og nedsættelse af risikoen for disse alvorlige hændelser, fordi: - du lider af åreforkalkning (også kaldet aterosklerose) - og - du tidligere har haft et hjerteanfald, apopleksi eller kredsløbsforstyrrelser i arme eller ben- eller - du har haft en alvorlig form for smerter i brystet, som kaldes hjertekrampe (ustabil angina pectoris) eller hjerteanfald (myokardieinfarkt).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrochlorid).
English: • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
Danish: • hvis du har en aktiv blødning såsom et mavesår eller en blødning i hjernen.
English: Clopidogrel Teva Pharma contains hydrogenated castor oil This may cause stomach upset or diarrhoea.
Danish: Clopidogrel Teva Pharma indeholder hydrogeneret ricinusolie, der kan give maveproblemer og diarré.
English: Do not take Clopidogrel Teva Pharma
Danish: Tag ikke Clopidogrel Teva Pharma
English: Each film-coated tablet contains 13 mg of hydrogenated castor oil.
Danish: Hver filmovertrukket tablet indeholder 13 mg hydrogeneret ricinusolie.
English: If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Teva Pharma.
Danish: Hvis du er gravid eller ammer har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager Clopidogrel Teva Pharma.
English: Boxes of 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in blisters or boxes of 28x1 and 50x1 film-coated tablets in perforated unit dose blisters are available.
Danish: Æsker med 7, 14, 28, 30, 50, 56, 84, 90 og 100 filmovertrukne tabletter i blisterpakning eller æsker med 28x1 og 50x1 filmovertrukne tabletter i perforerede enhedsdosisblistere.
English: Patients received clopidogrel (75 mg/day, n=22,961) or placebo (n=22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge.
Danish: Patienterne fik clopidogrel (75 mg/dag, n=22961) eller placebo (n=22891), i kombination med ASA (162 mg/dag) i 28 dage eller indtil udskrivelse fra hospitalet.
English: As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs), or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Danish: Ligesom andre antitrombolytika skal clopidogrel anvendes med forsigtighed til patienter med risiko for tiltagende blødninger pga. traumer, kirurgi eller andre patologiske tilstande samt til patienter, der samtidigt behandles med ASA, heparin, glycoprotein IIb/IIIa-hæmmere eller non-steroide antiinflammatoriske lægemidler (NSAID'er) inklusive cox-2-hæmmere eller selektive serotoningenoptagelseshæmmere (SSRI'er), eller andre lægemidler forbundet med risiko for blødning, såsom pentoxifyllin (se pkt.
English: Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*
Danish: Serumsygdom, anafylaktiske reaktioner, krydsallergiske reationer mellem thienopyridiner (såsom ticlopidin, prasugrel) (se pkt.
English: In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p=0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR = 23.7%; CI: 8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to 18.7 [p=0.258]).
Danish: I en delgruppeanalyse af inklusionsgrupperne (myokardieinfarkt, iskæmisk apopleksi og PAD) syntes udbyttet at være størst (dvs. den opnåede statisk signifikans ved p=0,003) hos patienter, som indgik på grund af PAD (især de patienter, som tidligere også havde haft et myokardieinfarkt) (RRR = 23,7 %, CI: 8,9 til 36,2) og mindst (afveg ikke signifikant fra ASA) hos patienter med apopleksi (RRR = 7,3 %, CI: -5,7 til 18,7 [p=0,258]).
English: Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Danish: Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrochlorid).
English: The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Teva Pharma per day to be taken orally with or without food, and at the same time each day.
Danish: Den anbefalede dosis, herunder også til patienter med ”atrieflimmer” (uregelmæssig hjerterytme), er én tablet Clopidogrel Teva Pharma på 75 mg daglig på samme tidspunkt hver dag.
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, hjerteanfald) og desuden en signifikant RRR på
English: Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence
Danish: Mavesår og duodenalt ulcus, gastritis, opkastning, kvalme,
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: 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: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 September 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: • Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.
Danish: - Tabletovertræk: Polyvinylalkohol, titandioxid (E171), rødt jernoxid (E172), gul jernoxid
English: Eye bleeding (conjunctival, ocular, retinal)
Danish: Øjne okular, retinal)
English: The PSUR submission schedule for Clopidogrel Teva Pharma film coated tablets should follow PSURs submission schedule for the reference medicinal product.
Danish: Planen for fremsendelse af den periodiske sikkerhedsopdateringsrapport for Clopidogrel Teva Pharma skal følge planen for fremsendelse af den periodiske sikkerhedsopdateringsrapport for referencelægemidlet.
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p=0.045), which corresponds, for every 1000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Danish: I intention-to-treat-analysen blev der observeret 939 tilfælde i clopidogrelgruppen og 1.020 tilfælde i ASA-gruppen (relativ risikoreduktion (RRR) 8,7 % [95 % CI: 0,2-16,4], p=0,045), hvilket for hver 1000 patienter, der blev behandlet i 2 år, svarer til, at yderligere 10 [CI: 0-20] patienter beskyttes mod et nyt iskæmisk tilfælde.