natgillin/translations-raw huggingface dataset:
Voksne med genotype 3-HCV-infektion - ASTRAL-3 (studie 1140) ASTRAL-3 var et randomiseret åbent studie, der evaluerede 12 ugers behandling med Epclusa versus 24 ugers behandling med SOF+RBV hos patienter med genotype 3-HCV-infektion. 
Genotype 3 HCV-infected adults - ASTRAL-3 (study 1140) ASTRAL-3 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 24 weeks of treatment with SOF+RBV in patients with genotype 3 HCV infection.
Brug sammen med moderate P-gp-induktorer og/eller moderate CYP-induktorer Lægemidler, der er moderate P-gp- og/eller moderate CYP-induktorer (f.eks. efavirenz, modafinil, oxcarbazepin eller rifapentin), kan nedsætte plasmakoncentrationen af sofosbuvir og velpatasvir og medføre reduceret terapeutisk virkning af Epclusa. 
Use with moderate P-gp inducers and/or moderate CYP inducers Medicinal products that are moderate P-gp and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentrations leading to reduced therapeutic effect of Epclusa.
Hvis samtidig administration anses for nødvendig, skal Epclusa administreres sammen med mad og tages 4 timer før protonpumpehæmmeren. 
If it is considered necessary to co-administer, then Epclusa should be administered with food and taken 4 hours before proton pump inhibitor at max doses comparable to omeprazole 20 mg.
Dolutegravir (50 mg én gang dagligt)/sofosbuvir/ velpatasvir (400/100 mg én gang dagligt) 
Dolutegravir (50 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)
Digoxin (0,25 mg enkeltdosis)f/velpatasvir (100 mg enkeltdosis) 
Digoxin (0.25 mg single dose)f/ velpatasvir (100 mg single dose)
IMMUNOSUPPRESSIVA Ciclosporin (600 mg enkeltdosis)/ sofosbuvir (400 mg enkeltdosis)f 
IMMUNOSUPPRESSANTS Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)f
Epclusa i 12 uger (90) 
Epclusa 12 weeks (90)
Med enhver NS5A-RAV'er ved baseline 
With any baseline NS5A RAVs Without baseline NS5A RAVs
Voksne med genotype 2-HCV-infektion - ASTRAL-2 (studie 1139) ASTRAL-2 var et randomiseret åbent studie, der evaluerede 12 ugers behandling med Epclusa versus 12 ugers behandling med SOF+RBV hos patienter med genotype 2-HCV-infektion. 
Genotype 2 HCV-infected adults - ASTRAL-2 (study 1139) ASTRAL-2 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of treatment with SOF+RBV in patients with genotype 2 HCV infection.
Observeret: Velpatasvir 
Observed: Velpatasvir
Andetd a. Der var ingen patienter med genotype 1-HCV, der havde virologisk svigt under behandlingen. 
Otherd a No patients with genotype 1 HCV had on-treatment virologic failure.
Epclusa 24 uger (n = 90) 
Epclusa 24 weeks (n = 90)
R-methadon ↔ ↔ ↔ Dosisjustering af Epclusa eller methadon er ikke nødvendig. 
↔ ↔ ↔ No dose adjustment of Epclusa or methadone is required.
• åndenød 
• shortness of breath;
(Hæmning af P-gp og CYP'er) 
(Inhibition of P-gp and CYPs)
598 celler/μl (183-1.513 celler/μl). 
The overall mean CD4+ count was 598 cells/µL (range: 183−1513 cells/µL).
Epclusa er kontraindiceret sammen med rifabutin (se pkt. 
Epclusa is contraindicated with rifabutin (see section 4.3).
Samtidig administration af sådanne lægemidler og Epclusa frarådes (se pkt. 
Co-administration of such medicinal products with Epclusa is not recommended (see section 4.5).
Rifampicin (600 mg én gang dagligt)/velpatasvir (100 mg enkeltdosis) 
Rifampicin (600 mg once daily)/ velpatasvir (100 mg single dose)
Observeret: Sofosbuvir 
Observed: Sofosbuvir
H2-receptorantagonister Famotidin (40 mg enkeltdosis)/ sofosbuvir/velpatasvir (400/100 mg enkeltdosis)c 
H2-receptor antagonists Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
Patienterne blev randomiseret i et 1:1-forhold til behandling med Epclusa i 12 uger eller SOF+RBV i 24 uger. 
Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 24 weeks.
Tabel 13: SVR12 i udvalgte undergrupper i studie ASTRAL-3 (HCV-genotype 3) 
Table 13: SVR12 for selected subgroups in study ASTRAL-3 (HCV genotype 3)
Ciclosporin (600 mg enkeltdosis)f/ velpatasvir (100 mg enkeltdosis)d 
Ciclosporin (600 mg single dose)f/ velpatasvir (100 mg single dose)d
Ketoconazol (200 mg to gange dagligt)/velpatasvir (100 mg enkeltdosis)d 
Ketoconazole (200 mg twice daily)/ velpatasvir (100 mg single dose)d
Resultat for patienter, der ikke opnåede SVR12 Virologisk svigt under behandling 
Outcome for patients without SVR12 Ontreatment virologic failure
Pravastatin (40 mg enkeltdosis)/velpatasvir (100 mg én gang dagligt)d 
Pravastatin (40 mg single dose)/ velpatasvir (100 mg once daily)d
Af de 1.035 patienter, der blev behandlet med sofosbuvir/velpatasvir i de tre kliniske fase III-studier, blev 1.023 patienter inkluderet i analysen af NS5A-RAV'er. 
Of the 1,035 patients treated with sofosbuvir/velpatasvir in the three Phase 3 clinical studies, 1,023 patients were included in the analysis of NS5A RAVs; 7 patients were excluded as they neither achieved sustained virologic response (SVR12) nor had virologic failure and 5 additional patients were excluded as NS5A gene sequencing failed.
Patienterne blev randomiseret i et 1:1-forhold til behandling med Epclusa i 12 uger eller SOF+RBV i 12 uger. 
Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 12 weeks.
Epclusa er kontraindiceret sammen med rifampicin (se pkt. 
Epclusa is contraindicated with rifampicin (see section 4.3).
Dosisjustering af Epclusa eller pravastatin er ikke nødvendig. 
No dose adjustment of Epclusa or pravastatin is required.
Sådan skal du tage Epclusa 
How to take Epclusa
Genotype 2 eller 4 I alt 
Genotypes 2 or 4
Epclusa i 12 uger (n = 277) 
Epclusa 12 weeks (n = 277)
Epclusa er kontraindiceret sammen med carbamazepin (se pkt. 
Epclusa is contraindicated with carbamazepine (see section 4.3).
• Få rådgivning fra en læge eller apotekspersonalet, hvis du tager lægemidler, der anvendes til at behandle mavesår, halsbrand eller sure opstød, da disse kan nedsætte mængden af velpatasvir i blodet. 
• Get advice from a doctor or pharmacist if you take medicines used to treat stomach ulcers,
Genotype 2, 4, 5 eller 6 I alt 
Genotypes 2, 4, 5 or 6 Total
(40 mg enkeltdosis)/ 
(400/ 100 mg single dose fed)c
• svimmelhed 
• fainting.
Den ene genotype 3-patient, der havde NS5A-RAV'er ved baseline og ikke opnåede SVR12, havde NS5A-substitution Y93H ved baseline. 
The single genotype 3 patient who had baseline NS5A RAVs and failed to achieve SVR12 had NS5A substitution Y93H at baseline; pharmacokinetic data from this patient was consistent with non-adherence to treatment.
Epclusa i 12 uger (n = 106) 
Epclusa 12 weeks (n = 106)
HMG-CoA-REDUKTASEHÆMMERE Atorvastatin (40 mg enkelt dosis) + sofosbuvir/velpatasvir (400/100 mg én gang dagligt)d 
HMG-CoA REDUCTASE INHIBITORS Atorvastatin (40 mg single dose) + sofosbuvir / velpatasvir (400/ 100 mg once daily)d
Epclusa i 12 uger (n = 624) 
Epclusa 12 weeks (n = 624)
Epclusa i 12 uger (n = 134) 
Epclusa 12 weeks (n = 134)
Epclusa 12 uger 
Epclusa 12 weeks
Epclusa 12 uger (n = 90) 
Epclusa 12 weeks (n = 90)
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. 
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.
Epclusa i 12 uger 
Epclusa for 12 weeks
de to aktive stoffer i Epclusa, udskilles i mælken hos mennesker. 
It is not known whether sofosbuvir or velpatasvir, the two active substances of Epclusa, pass into human breast milk.
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. 
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.
Tabel 11: SVR12 i studie ASTRAL-2 (HCV-genotype 2) 
Table 11: SVR12 in study ASTRAL-2 (HCV genotype 2)
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 
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
ANTIMYKOBAKTERIELLE MIDLER Rifampicin (600 mg én gang dagligt)/sofosbuvir (400 mg enkeltdosis)d (Induktion af P-gp og CYP'er) 
ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Dosisjustering af Epclusa, raltegravir eller emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig. 
No dose adjustment of Epclusa, raltegravir or emtricitabine/ tenofovir disoproxil fumarate is required.
Henholdsvis 90 % og 95 % af patienterne havde CPTklasse B-cirrose og MELD (Model for End Stage Liver Disease)-score ≤ 15 ved baseline. 
cirrhosis and Model for End Stage Liver Disease (MELD) score ≤ 15 at baseline, respectively.
70 % af patienterne var mænd, 90 % var hvide, 6 % var sorte, 42 % havde baseline-BMI ≥ 30 kg/m2. 
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.
Se produktresuméet for ribavirin for yderligere anbefalinger om graviditet, kontraception og amning, hvis ribavirin administreres sammen med Epclusa. 
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.
0,215 mg/0,25 mg/ ethinylestradiol 0,025 mg)/velpatasvir (100 mg én gang dagligt)d 
Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ velpatasvir (100 mg once daily)d
Se produktresuméet for det lægemiddel, der indeholder ribavirin, vedrørende dosisjustering af ribavirin. 
For ribavirin dose modifications, refer to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Det skal du vide, før du begynder at tage Epclusa Sådan skal du tage Epclusa Bivirkninger 
What Epclusa is and what it is used for What you need to know before you take Epclusa How to take Epclusa
For en sikkerheds skyld frarådes Epclusa under graviditet. 
As a precautionary measure, Epclusa use is not recommended during pregnancy.
Tabel 12: SVR12 i studie ASTRAL-3 (HCV-genotype 3) 
Table 12: SVR12 in study ASTRAL-3 (HCV genotype 3)
Protonpumpehæmmere Omeprazol (20 mg én gang dagligt)/ sofosbuvir/velpatasvir (400/100 mg enkeltdosis fastende)c 
Proton pump inhibitors Omeprazole (20 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose fasted)c
Tæt overvågning anbefales, hvis amiodaron administreres med Epclusa (se pkt. 
Close monitoring is recommended if this medicinal product is administered with Epclusa (see sections 4.4 and 4.8).
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 
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
↔ ↔ ↔ Dosisjustering af Epclusa, darunavir (ritonavir-boostet) eller emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig. 
↔ ↔ ↔ No dose adjustment of Epclusa, darunavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Tabel 10: SVR12 i studiet ASTRAL-1 efter HCV-genotype 
Table 10: SVR12 in study ASTRAL-1 by HCV genotype
Dosisjustering af Epclusa, atazanavir (ritonavir-boostet) eller emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig. 
No dose adjustment of Epclusa, atazanavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Se også produktresuméet for det lægemiddel, der indeholder ribavirin, når der anvendes kombinationsbehandling med ribavirin (RBV). 
When used in combination with ribavirin, refer also to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Doseret 1 time efter dialyse 
hr After Dialysis
Tabel 14: SVR12 i studiet ASTRAL-4 efter HCV-genotype 
Table 14: SVR12 in study ASTRAL-4 by HCV genotype
56 % havde HCV-RNA-niveau ved baseline på mindst 800.000 IE/ml. 
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
Tabel 10 viser SVR12 i ASTRAL-1-studiet efter HCV-genotyper. 
Table 10 presents the SVR12 for the ASTRAL-1 study by HCV genotypes.
Efavirenz/emtricitabin/ tenofovirdisoproxilfumarat (600/200/300 mg én gang dagligt)/sofosbuvir/velpatasvir (400/100 mg én gang dagligt)c, d 
Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Tabel 17: SVR12 i studiet ASTRAL-5 efter HCV-genotype 
Table 17: SVR12 in study ASTRAL-5 by HCV genotype
↔ ↔ ↔ Dosisjustering af Epclusa eller elvitegravir/cobicistat/ emtricitabin/ tenofoviralafenamidfumarat er ikke nødvendig. 
Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate is required.
1,6 gange↑ 2,1 gange↑ 2,7 gange↑ 
1.4-fold↑
↔ ↔ ↔ Dosisjustering af Epclusa eller elvitegravir/cobicistat/ emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig. 
Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate is required.
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 
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
Tabel 14 viser SVR12 i ASTRAL-4-studiet efter HCV-genotype. 
Table 14 presents the SVR12 for the ASTRAL-4 study by HCV genotype.
• Perikon (et naturlægemiddel, der anvendes mod depression) 
• St. John's wort (herbal medicine used to treat depression);
Emtricitabin/rilpivirin/ tenofovirdisoproxilfumarat (200/25/300 mg én gang dagligt)/sofosbuvir/velpatasvir (400/100 mg én gang dagligt)c, d 
Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200/ 25/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Elvitegravir/cobicistat/ emtricitabin/ tenofoviralafenamidfumarat (150/150/200/10 mg én gang dagligt)/sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)c, d 
Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate (150/ 150/ 200/ 10 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Tabel 17 viser SVR12 i ASTRAL-5-studiet efter HCV-genotyper. 
Table 17 presents the SVR12 for the ASTRAL-5 study by HCV genotype.
Elvitegravir/cobicistat/ emtricitabin/ tenofovirdisoproxilfumarat (150/150/200/300 mg én gang dagligt)/sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)c, d 
Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150/ 150/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Resultat for patienter, der ikke opnåede SVR12 Virologisk svigt under behandling 0/134 Recidiva 
Outcome for patients without SVR12 On-treatment virologic failure Relapsea
↔ ↔ ↔ Dosisjustering af Epclusa, lopinavir (ritonavir-boostet) eller emtricitabin/ tenofovirdisoproxilfumarat er ikke nødvendig. 
↔ ↔ ↔ No dose adjustment of Epclusa, lopinavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
↔ ↔ ↔ Dosisjustering af Epclusa eller emtricitabin/rilpivirin/ tenofovirdisoproxilfumarat er ikke nødvendig. 
Rilpivirine ↔ ↔ ↔ No dose adjustment of Epclusa or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Svært RI (eGFR < 30 ml/min/ 1,73 m2) 
and <50 mL/min/1.73 m2)
Omeprazol (20 mg en gang dagligt)/ sofosbuvir/velpatasvir (400/100 mg enkeltdosis efter mad)c 
Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
Genotype 2, 4 og 6 100 % (8/8)a 
100% (8/8)a
Tenofoviralafe namid 
Tenofovir alafenamide Sofosbuvir
Rosuvastatin (10 mg enkeltdosis)/velpatasvir (100 mg én gang dagligt)d 
Rosuvastatin (10 mg single dose)/ velpatasvir (100 mg once daily)d (Inhibition of OATP1B and BCRP)
Spørg lægen eller apotekspersonalet, hvis du har spørgsmål om dine lægemidler. 
If you have any questions about your medicines, please ask your doctor or pharmacist.
Mildt RI (eGFR ≥ 50 og < 80 ml/min/ 1,73m2) 
and <80 mL/min/1.7 3m2)
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 16. juli 2008 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 July 2008
• De får en anden slags medicin (se Anvendelse af andre lægemidler) 
• if you are taking another type of medicine (see ‘Taking other medicines').
• Hvis De lider af alvorlig leversygdom 
• If you suffer from severe liver disease.
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 
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
Det er muligt, at ikke alle pakningsstørrelser markedsføres. 
Not all pack sizes may be marketed.
Dette kan ske på grund af et sjældent 
These may be due to rare decrease of some
Til behandling af denne tilstand kan Deres læge have indsat en stent i den blokerede eller forsnævrede arterie for at genoprette en effektiv blodgennemstrømning. 
For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow.
Følgelig kan en direkte effekt (let toksicitet) eller en indirekte effekt (mindre velsmagende) ikke udelukkes. 
Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be
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 %. 
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%.
Visse andre typer medicin kan påvirke brugen af Clopidogrel BMS eller omvendt. 
Some other medicines may influence the use of Clopidogrel BMS or vice versa.
Anvend ikke Clopidogrel BMS hvis De bemærker synlige tegn på fordærv. 
Do not use Clopidogrel BMS if you notice any visible sign of deterioration.
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. 
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.
Det er bedst ikke at tage dette produkt under graviditet og amning. 
It is preferable not to use this product during pregnancy and breast-feeding.
Newcastle Upon Tyne, Tyne & Wear NE3 3TT, Storbritannien og/eller 
Newcastle Upon Tyne, Tyne & Wear NE3 3TT - UK, United Kingdom and/or
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). 
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).
Som al anden medicin kan Clopidogrel BMS have bivirkninger, selvom ikke alle får bivirkninger. 
Like all medicines, Clopidogrel BMS can cause side effects, although not everybody gets them.
6, Boulevard de l'Europe, F-21800 Quétigny, Frankrig 
6, boulevard de l'Europe, F-21800 Quétigny, France
Forekomsten af svære tilfælde var 1,4% for clopidogrel og 1,6% for ASA. 
The incidence of severe cases was 1.4% for clopidogrel and 1.6% for ASA.
Kontakt Deres læge med det samme, hvis De oplever: - Feber, tegn på infektion eller alvorlig kraftesløshed (asteni). 
Contact your doctor immediately if you experience: - fever, signs of infection or extreme tiredness.
• Hvis De er overfølsom (allergisk) over for clopidogrel eller et af de øvrige indholdsstoffer i 
• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel
Absorptionen er mindst 50% baseret på udskillelse af clopidogrels 
Absorption is at least 50%, based on urinary excretion
Blodplader er meget små bestanddele i blodet, mindre end de røde og hvide blodlegemer, og de klumper sig sammen, når blodet størkner. 
Platelets are very small structures in the blood, smaller than red or white blood cells, which clump together during blood clotting.