FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were randomised in a 1:1:1 ratio to treatment with Epclusa for 12 weeks, Epclusa + RBV for 12 weeks or Epclusa for 24 weeks.
Danish: Patienterne blev randomiseret i et 1:1:1-forhold til behandling med Epclusa i 12 uger, Epclusa + RBV i 12 uger eller Epclusa i 24 uger.
English: Epclusa for 12 weeks
Danish: Epclusa i 12 uger
English: It is not known whether sofosbuvir or velpatasvir, the two active substances of Epclusa, pass into human breast milk.
Danish: de to aktive stoffer i Epclusa, udskilles i mælken hos mennesker.
English: In these healthy volunteer studies, there were no untoward effects observed at these dose levels, and adverse events were similar in frequency and severity to those reported in the placebo groups.
Danish: De højeste dokumenterede doser af sofosbuvir og velpatasvir var henholdsvis en enkeltdosis på 1.200 mg og en enkeltdosis på 500 mg. I disse studier med raske frivillige blev der ikke set nogen uønskede virkninger ved disse dosisniveauer, og bivirkningerne var sammenlignelige i hyppighed og sværhedsgrad med dem, der blev rapporteret i placebogrupperne.
English: Table 11: SVR12 in study ASTRAL-2 (HCV genotype 2)
Danish: Tabel 11: SVR12 i studie ASTRAL-2 (HCV-genotype 2)
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Danish: ANTIVIRALE MIDLER MOD HIV: PROTEASEHÆMMERE Atazanavir boostet med ritonavir (300/100 mg én gang dagligt) + emtricitabin/ tenofovirdisoproxilfumarat (200/300 mg én gang dagligt)/sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)c, d
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Danish: ANTIMYKOBAKTERIELLE MIDLER Rifampicin (600 mg én gang dagligt)/sofosbuvir (400 mg enkeltdosis)d (Induktion af P-gp og CYP'er)
English: No dose adjustment of Epclusa, raltegravir or emtricitabine/ tenofovir disoproxil fumarate is required.
Danish: Dosisjustering af Epclusa, raltegravir eller emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig.
English: cirrhosis and Model for End Stage Liver Disease (MELD) score ≤ 15 at baseline, respectively.
Danish: Henholdsvis 90 % og 95 % af patienterne havde CPTklasse B-cirrose og MELD (Model for End Stage Liver Disease)-score ≤ 15 ved baseline.
English: Of the 267 treated patients, the median age was 59 years (range: 40 to 73); 70% of the patients were male; 90% were White, 6% were Black; 42% had a baseline body mass index of at least 30 kg/m2.
Danish: 70 % af patienterne var mænd, 90 % var hvide, 6 % var sorte, 42 % havde baseline-BMI ≥ 30 kg/m2.
English: If ribavirin is co-administered with Epclusa, refer to the Summary of Product Characterisitics for ribavirin for detailed recommendations regarding pregnancy, contraception, and breast-feeding.
Danish: Se produktresuméet for ribavirin for yderligere anbefalinger om graviditet, kontraception og amning, hvis ribavirin administreres sammen med Epclusa.
English: Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ velpatasvir (100 mg once daily)d
Danish: 0,215 mg/0,25 mg/ ethinylestradiol 0,025 mg)/velpatasvir (100 mg én gang dagligt)d
English: For ribavirin dose modifications, refer to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Danish: Se produktresuméet for det lægemiddel, der indeholder ribavirin, vedrørende dosisjustering af ribavirin.
English: What Epclusa is and what it is used for What you need to know before you take Epclusa How to take Epclusa
Danish: Det skal du vide, før du begynder at tage Epclusa Sådan skal du tage Epclusa Bivirkninger
English: As a precautionary measure, Epclusa use is not recommended during pregnancy.
Danish: For en sikkerheds skyld frarådes Epclusa under graviditet.
English: Table 12: SVR12 in study ASTRAL-3 (HCV genotype 3)
Danish: Tabel 12: SVR12 i studie ASTRAL-3 (HCV-genotype 3)
English: Proton pump inhibitors Omeprazole (20 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose fasted)c
Danish: Protonpumpehæmmere Omeprazol (20 mg én gang dagligt)/ sofosbuvir/velpatasvir (400/100 mg enkeltdosis fastende)c
English: Close monitoring is recommended if this medicinal product is administered with Epclusa (see sections 4.4 and 4.8).
Danish: Tæt overvågning anbefales, hvis amiodaron administreres med Epclusa (se pkt.
English: Darunavir boosted with ritonavir (800/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Danish: Darunavir boostet med ritonavir (800 mg/100 mg én gang dagligt) + emtricitabin/ tenofovirdisoproxilfumarat (200/300 mg én gang dagligt)/sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)c, d
English: ↔ ↔ ↔ No dose adjustment of Epclusa, darunavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Danish: ↔ ↔ ↔ Dosisjustering af Epclusa, darunavir (ritonavir-boostet) eller emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig.
English: Table 10: SVR12 in study ASTRAL-1 by HCV genotype
Danish: Tabel 10: SVR12 i studiet ASTRAL-1 efter HCV-genotype
English: No dose adjustment of Epclusa, atazanavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Danish: Dosisjustering af Epclusa, atazanavir (ritonavir-boostet) eller emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig.
English: When used in combination with ribavirin, refer also to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Danish: Se også produktresuméet for det lægemiddel, der indeholder ribavirin, når der anvendes kombinationsbehandling med ribavirin (RBV).
English: hr After Dialysis
Danish: Doseret 1 time efter dialyse
English: Table 14: SVR12 in study ASTRAL-4 by HCV genotype
Danish: Tabel 14: SVR12 i studiet ASTRAL-4 efter HCV-genotype
English: 76% of the patients had non-CC IL28B alleles (CT or TT); 56% had baseline HCV RNA levels of at least 800,000 IU/mL, 55% were treatment-experienced; 90% and 95% of patients had CPT Class B
Danish: 56 % havde HCV-RNA-niveau ved baseline på mindst 800.000 IE/ml.
English: Table 10 presents the SVR12 for the ASTRAL-1 study by HCV genotypes.
Danish: Tabel 10 viser SVR12 i ASTRAL-1-studiet efter HCV-genotyper.
English: Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Danish: Efavirenz/emtricitabin/ tenofovirdisoproxilfumarat (600/200/300 mg én gang dagligt)/sofosbuvir/velpatasvir (400/100 mg én gang dagligt)c, d
English: Table 17: SVR12 in study ASTRAL-5 by HCV genotype
Danish: Tabel 17: SVR12 i studiet ASTRAL-5 efter HCV-genotype
English: Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate is required.
Danish: ↔ ↔ ↔ Dosisjustering af Epclusa eller elvitegravir/cobicistat/ emtricitabin/ tenofoviralafenamidfumarat er ikke nødvendig.
English: 1.4-fold↑
Danish: 1,6 gange↑ 2,1 gange↑ 2,7 gange↑
English: Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate is required.
Danish: ↔ ↔ ↔ Dosisjustering af Epclusa eller elvitegravir/cobicistat/ emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig.
English: Lopinavir boosted with ritonavir (4x200 mg/ 50 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Danish: Lopinavir boostet med ritonavir (4 x 200 mg/50 mg én gang dagligt) + emtricitabin/ tenofovirdisoproxilfumarat (200/300 mg én gang dagligt)/sofosbuvir/ velpatasvir(400/100 mg én gang dagligt)c, d
English: Table 14 presents the SVR12 for the ASTRAL-4 study by HCV genotype.
Danish: Tabel 14 viser SVR12 i ASTRAL-4-studiet efter HCV-genotype.
English: • St. John's wort (herbal medicine used to treat depression);
Danish: • Perikon (et naturlægemiddel, der anvendes mod depression)
English: Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200/ 25/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Danish: Emtricitabin/rilpivirin/ tenofovirdisoproxilfumarat (200/25/300 mg én gang dagligt)/sofosbuvir/velpatasvir (400/100 mg én gang dagligt)c, d
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate (150/ 150/ 200/ 10 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Danish: Elvitegravir/cobicistat/ emtricitabin/ tenofoviralafenamidfumarat (150/150/200/10 mg én gang dagligt)/sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)c, d
English: Table 17 presents the SVR12 for the ASTRAL-5 study by HCV genotype.
Danish: Tabel 17 viser SVR12 i ASTRAL-5-studiet efter HCV-genotyper.
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150/ 150/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Danish: Elvitegravir/cobicistat/ emtricitabin/ tenofovirdisoproxilfumarat (150/150/200/300 mg én gang dagligt)/sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)c, d
English: Outcome for patients without SVR12 On-treatment virologic failure Relapsea
Danish: Resultat for patienter, der ikke opnåede SVR12 Virologisk svigt under behandling 0/134 Recidiva
English: ↔ ↔ ↔ No dose adjustment of Epclusa, lopinavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Danish: ↔ ↔ ↔ Dosisjustering af Epclusa, lopinavir (ritonavir-boostet) eller emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig.
English: Rilpivirine ↔ ↔ ↔ No dose adjustment of Epclusa or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Danish: ↔ ↔ ↔ Dosisjustering af Epclusa eller emtricitabin/rilpivirin/ tenofovirdisoproxilfumarat er ikke nødvendig.
English: and <50 mL/min/1.73 m2)
Danish: Svært RI (eGFR < 30 ml/min/ 1,73 m2)
English: Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
Danish: Omeprazol (20 mg en gang dagligt)/ sofosbuvir/velpatasvir (400/100 mg enkeltdosis efter mad)c
English: 100% (8/8)a
Danish: Genotype 2, 4 og 6 100 % (8/8)a
English: Tenofovir alafenamide Sofosbuvir
Danish: Tenofoviralafe namid
English: Rosuvastatin (10 mg single dose)/ velpatasvir (100 mg once daily)d (Inhibition of OATP1B and BCRP)
Danish: Rosuvastatin (10 mg enkeltdosis)/velpatasvir (100 mg én gang dagligt)d
English: If you have any questions about your medicines, please ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet, hvis du har spørgsmål om dine lægemidler.
English: and <80 mL/min/1.7 3m2)
Danish: Mildt RI (eGFR ≥ 50 og < 80 ml/min/ 1,73m2)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 July 2008
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 16. juli 2008
English: • if you are taking another type of medicine (see ‘Taking other medicines').
Danish: • De får en anden slags medicin (se Anvendelse af andre lægemidler)
English: • If you suffer from severe liver disease.
Danish: • Hvis De lider af alvorlig leversygdom
English: EU/1/08/464/001 - Cartons of 14 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/002 - Cartons of 14 film-coated tablets in all aluminium blisters EU/1/08/464/003 - Cartons of 28 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/004 - Cartons of 28 film-coated tablets in all aluminium blisters EU/1/08/464/005 - Cartons of 30 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/006 - Cartons of 30 film-coated tablets in all aluminium blisters EU/1/08/464/007 - Cartons of 50x1 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/008 - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/1/08/464/009 - Cartons of 84 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/010 - Cartons of 84 film-coated tablets in all aluminium blisters EU/1/08/464/011 - Cartons of 90 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/012 - Cartons of 90 film-coated tablets in all aluminium blisters EU/1/08/464/013 - Cartons of 100 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/014 - Cartons of 100 film-coated tablets in all aluminium blisters EU/1/08/464/018 - Cartons of 7 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/019 - Cartons of 7 film-coated tablets in all aluminium blisters
Danish: EU/1/08/464/001 - Pakning med 14 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/464/002 - Pakning med 14 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/464/003 - Pakning med 28 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/464/004 - Pakning med 28 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/464/005 - Pakning med 30 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/464/006 - Pakning med 30 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/464/007 - Pakning med 50x1 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/464/008 - Pakning med 50x1 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/464/009 - Pakning med 84 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/464/010 - Pakning med 84 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/464/011 - Pakning med 90 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/464/012 - Pakning med 90 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/464/013 - Pakning med 100 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/464/014 - Pakning med 100 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/464/018 - Pakning med 7 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/464/019 - Pakning med 7 filmovertrukne tabletter i blisterkort af aluminium
English: Not all pack sizes may be marketed.
Danish: Det er muligt, at ikke alle pakningsstørrelser markedsføres.
English: These may be due to rare decrease of some
Danish: Dette kan ske på grund af et sjældent
English: For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow.
Danish: Til behandling af denne tilstand kan Deres læge have indsat en stent i den blokerede eller forsnævrede arterie for at genoprette en effektiv blodgennemstrømning.
English: Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be
Danish: Følgelig kan en direkte effekt (let toksicitet) eller en indirekte effekt (mindre velsmagende) ikke udelukkes.
English: The relative difference in antiplatelet response between genotype groups varies across studies depending on the method used to evaluate response, but is typically greater than 30%.
Danish: Den relative forskel i trombocytrespons mellem genotypegrupperne varierer på tværs af studierne, afhængigt af metoden, der er anvendt til at evaluere responset, men er typisk større end 30 %.
English: Some other medicines may influence the use of Clopidogrel BMS or vice versa.
Danish: Visse andre typer medicin kan påvirke brugen af Clopidogrel BMS eller omvendt.
English: Do not use Clopidogrel BMS if you notice any visible sign of deterioration.
Danish: Anvend ikke Clopidogrel BMS hvis De bemærker synlige tegn på fordærv.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 dated 25 September 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det system til registrering af bivirknnger som er beskrevet i version 2.0 dateret 25. september 2007 og præsenteret i Modul 1.8.1. til Ansøgning om Markedsføringstilladelse, er til stede og fungerer før og under markedsføring af produktet.
English: It is preferable not to use this product during pregnancy and breast-feeding.
Danish: Det er bedst ikke at tage dette produkt under graviditet og amning.
English: Newcastle Upon Tyne, Tyne & Wear NE3 3TT - UK, United Kingdom and/or
Danish: Newcastle Upon Tyne, Tyne & Wear NE3 3TT, Storbritannien og/eller
English: Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Danish: Hyppighed defineres i henhold til følgende konvention: almindelig (>1/100 til <1/10), ikke almindelig (>1/1000 til <1/100), sjælden (>1/10000 til <1/10000), meget sjælden <1/10000).
English: Like all medicines, Clopidogrel BMS can cause side effects, although not everybody gets them.
Danish: Som al anden medicin kan Clopidogrel BMS have bivirkninger, selvom ikke alle får bivirkninger.
English: 6, boulevard de l'Europe, F-21800 Quétigny, France
Danish: 6, Boulevard de l'Europe, F-21800 Quétigny, Frankrig
English: The incidence of severe cases was 1.4% for clopidogrel and 1.6% for ASA.
Danish: Forekomsten af svære tilfælde var 1,4% for clopidogrel og 1,6% for ASA.
English: Contact your doctor immediately if you experience: - fever, signs of infection or extreme tiredness.
Danish: Kontakt Deres læge med det samme, hvis De oplever: - Feber, tegn på infektion eller alvorlig kraftesløshed (asteni).
English: • If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel
Danish: • Hvis De er overfølsom (allergisk) over for clopidogrel eller et af de øvrige indholdsstoffer i
English: Absorption is at least 50%, based on urinary excretion
Danish: Absorptionen er mindst 50% baseret på udskillelse af clopidogrels
English: Platelets are very small structures in the blood, smaller than red or white blood cells, which clump together during blood clotting.
Danish: Blodplader er meget små bestanddele i blodet, mindre end de røde og hvide blodlegemer, og de klumper sig sammen, når blodet størkner.
English: For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Clopidogrel BMS by referring to the calendar printed on the blister.
Danish: For pakninger med 7, 14, 28 og 84 stk. tabletter kan De tjekke på hvilken dag De sidst tog en tablet Clopidogrel BMS ved at se på kalenderen trykt på blisterpakningen.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: For yderligere oplysninger om dette lægemiddel bedes henvendelse rettet til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: You have been prescribed Clopidogrel BMS to help prevent blood clots and reduce the risk of these
Danish: De har fået recept på Clopidogrel BMS til forebyggelse af blodpropper og nedsættelse af risikoen for disse
English: Following an oral dose of 14C-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: Efter en oral dosis af 14C-mærket clopidogrel hos mennesker blev ca. 50 % udskilt i urinen og ca. 46 % i fæces i løbet af et interval på 120 timer efter dosering.
English: If you forget to take a dose of Clopidogrel BMS, 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 De glemmer at tage en dosis Clopidogrel BMS til sædvanlig tid, men kommer i tanke om det i løbet af 12 timer, skal De omgående tage tabletten og dernæst tage den næste tablet til sædvanlig tid.
English: Clopidogrel has been evaluated for safety in more than 42,000 patients who have participated in clinical studies, including 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 9.000 patienter, der blev behandlet i mindst 1 år.
English: Important information about some of the ingredients of Clopidogrel BMS:
Danish: Vigtig information om visse af indholdsstofferne i Clopidogrel BMS:
English: TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Danish: TTP er en potentielt fatal tilstand, der kræver øjeblikkelig behandling der omfatter plasmaferese.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjældne arvelige problemer med galactoseintolerans, Lapp lactase deficiency eller glucose- og/eller galactosemalabsorption, bør ikke anvende dette lægemiddel.
English: You should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
Danish: De bør også få acetylsalicylsyre (et stof, som indgår i mange lægemidler, og som anvendes til at afhjælpe smerter og sænke feber såvel som til at forebygge dannelse af blodpropper).
English: - a recent serious injury - a recent surgery (including dental) - a planned surgery (including dental) in the next seven days
Danish: - et nyligt kirurgisk indgreb (gælder også tandoperationer) - et planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage
English: • Pharmacogenetics
Danish: Farmakogenetik
English: Clopidogrel BMS is not intended for use in children or adolescents.
Danish: Clopidogrel BMS må ikke gives til børn og unge.
English: Do not use Clopidogrel BMS after the expiry date which is stated on the carton and on the blister.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på æsken og blisterpakningen.
English: EU/1/08/464/015 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/464/016 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/464/017 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters
Danish: EU/1/08/464/015 - Kartoner med 4x1 filmovertrukne tabletter i aluminium perforerede dosisblister EU/1/08/464/016 - Kartoner med 30x1 filmovertrukne tabletter i aluminium perforerede dosisblister EU/1/08/464/017 - Kartoner med 100x1 filmovertrukne tabletter i aluminium perforerede dosisblister
English: Glomerulonephritis, blood creatinine increased
Danish: Glomerulonefrit, øget blodkreatinin Feber
English: In CLARITY and one of the cohort studies (n=765; Trenk), cardiovascular event rates did not differ significantly by genotype.
Danish: I CLARITY og et af kohortestudierne (n=765; Trenk) var der ingen signifikant forskel i kardiovaskulære hændelser genotyperne imellem.
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY and COMMIT studies are discussed below.
Danish: De klinisk relevante bivirkninger observeret i CAPRIE-, CURE-, CLARITY- og COMMIT-undersøgelserne beskrives nedenfor.
English: If you experience prolonged bleeding when taking Clopidogrel BMS If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Danish: Hvis De får langvarige blødninger, mens De tager Clopidogrel BMS Hvis De skærer Dem eller kommer til skade, kan det tage lidt længere end normalt, før blødningen stopper.
English: Since the CAPRIE trial was not powered to evaluate efficacy of individual subgroups, it is not clear whether the differences in relative risk reduction across qualifying conditions are real, or a result of
Danish: Da CAPRIE-undersøgelsen imidlertid ikke havde statistisk styrke til at evaluere virkningen i de enkelte delgrupper, kan det ikke udledes, hvorvidt forskellene i relativ risikoreduktion på tværs af inklusionskriterierne er reelle eller tilfældige.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON
English: For this dose, tablets containing 75 mg are available.
Danish: Der findes tabletter der indeholder 75 mg til dette formål.