natgillin/translations-raw huggingface dataset:
Sofosbuvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study. 
V razvojni študiji pri podganah pred kotitvijo in po njej sofosbuvir ni povzročil nobenih neželenih učinkov na vedenje, razmnoževanje ali razvoj potomcev.
If you get any side effects, talk to your doctor or pharmacist. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Ribavirin Dose 
Odmerek ribavirina
e These are medicinal products within class where similar interactions could be predicted. 
d. Območje 70-143 %, znotraj katerega ni farmakokinetičnih interakcij e. To so zdravila v skupini, kjer je bilo mogoče predvideti podobne interakcije.
No patients with genotype 2 or 4 HCV infection in the Epclusa + RBV 12 weeks group experienced virologic failure. 
V skupini, ki je prejemala zdravilo Epclusa + RBV 12 tednov, ni noben bolnik z okužbo s HCV genotipa 2 ali 4 doživel virološkega neuspeha.
Dosed 1 hr Before Dialysis 
Odmerjen o 1 uro pred dializo
No patients with genotype 2, 4 or 6 HCV infection experienced virologic failure. 
Virološkega neuspeha ni doživel noben bolnik z okužbo s HCV genotipa 2, 4 ali 6.
Rilpivirine ↔ ↔ ↔ No dose adjustment of Epclusa or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required. 
Rilpivirin ↔ ↔ ↔ Odmerka zdravila Epclusa ali emtricitabina/rilpivirina/dizoprok siltenofovirijev fumarata ni treba prilagajati.
Patient populationa 
Starejši bolniki
If you have any questions about your medicines, please ask your doctor or pharmacist. 
Če imate dodatna vprašanja glede zdravil, se posvetujte z zdravnikom ali farmacevtom.
Table 3: Interactions between Epclusa and other medicinal products 
Preglednica 3: Interakcije med zdravilom Epclusa in drugimi zdravili Zdravila po terapevtskih področjih/možni mehanizem interakcije
(20 mg once daily)/ 
(400/100 mg enkrat na dan)
ANTIARRHYTHMICS Amiodarone 
NARKOTIČNI ANALGETIKI
Table 14 presents the SVR12 for the ASTRAL-4 study by HCV genotype. 
V preglednici 14 je predstavljen SVR12 za študijo ASTRAL-4 po genotipih HCV.
Epclusa 12 weeks (n = 90) 
12 tednov (n = 90)
Epclusa is contraindicated with rifabutin (see section 4.3). 
Zdravilo Epclusa je kontraindicirano v kombinaciji z rifabutinom (glejte poglavje 4.3).
Table 10 presents the SVR12 for the ASTRAL-1 study by HCV genotypes. 
V preglednici 10 je predstavljen SVR12 za študijo ASTRAL-1 po genotipih HCV.
Co-administration of such medicinal products with Epclusa is not recommended (see section 4.5). 
Sočasna uporaba teh zdravil z zdravilom Epclusa ni priporočljiva (glejte poglavje 4.5).
Renal impairment No dose adjustment of Epclusa is required for patients with mild or moderate renal impairment. 
Ledvična okvara Pri bolnikih z blago ali zmerno ledvično okvaro prilagajanje odmerka zdravila Epclusa ni potrebno.
Table 11: SVR12 in study ASTRAL-2 (HCV genotype 2) 
Preglednica 11: SVR12 v študiji ASTRAL-2 (HCV genotipa 2) Zdravilo Epclusa
The proportions of patients with genotype 1, 2, 3, 4 or 6 HCV were 78%, 4%, 15%, 3%, and < 1% (1 patient), respectively. 
Delež bolnikov z okužbo s HCV genotipa 1 je bil 78 %, genotipa 2 4 %, genotipa 3 15 %, genotipa 4 3 % in genotipa 6 < 1 % (1 bolnik).
No dose adjustment of Epclusa or atorvastatin is required. 
Odmerka zdravila Epclusa ali atorvastatina ni treba prilagajati.
Outcome for patients without SVR12 Ontreatment virologic failure 
Izid za osebe brez SVR12
Breast-feeding Do not breast-feed during treatment with Epclusa. 
Med zdravljenjem z zdravilom Epclusa ne smete dojiti.
↔ ↔ ↔ No dose adjustment of Epclusa, darunavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required. 
↔ ↔ ↔ Odmerka zdravila Epclusa, darunavirja (okrepljenega z ritonavirjem) ali emtricitabina/dizoproksiltenofovi rat fumarata ni treba prilagajati.
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 
Vključenih ni bilo nobenih bolnikov z okužbo s HCV genotipa 5. 76 % bolnikov je imelo alele IL28B ne-CC (CT ali TT); 56 % je imelo izhodiščne ravni HCV RNK najmanj 800.000 i.e./ml, 55 % se je predhodno že zdravilo; 90 % bolnikov je imelo cirozo stopnje B po CPT in 95 % jih je imelo rezultat ≤ 15 na lestvici za oceno jetrne odpovedi (MELD, Model for End Stage Liver Disease) ob izhodišču.
Clinical studies in patients without cirrhosis and patients with compensated cirrhosis Genotype 1, 2, 4, 5 and 6 HCV-infected adults - ASTRAL-1 (study 1138) ASTRAL-1 was a randomised, double-blind, placebo-controlled study that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of placebo in patients with genotype 1, 2, 4, 5, or 6 HCV infection. 
Klinične študije pri bolnikih brez ciroze in pri bolnikih s kompenzirano cirozo Odrasli bolniki z okužbo s HCV genotipa 1, 2, 4, 5 in 6 HCV - ASTRAL-1 (študija 1138) ASTRAL-1 je bila randomizirana, dvojno slepa s placebom nadzorovana študija, v kateri so ocenili
Table 12: SVR12 in study ASTRAL-3 (HCV genotype 3) 
Preglednica 12: SVR12 v študiji ASTRAL-3 (HCV genotipa 3) Zdravilo Epclusa
Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate is required. 
↔ ↔ ↔ Odmerka zdravila Epclusa ali elvitegravirja/kobicistata/ emtricitabina/ dizoproksiltenofovirijevega fumarata ni treba prilagajati.
HMG-CoA REDUCTASE INHIBITORS Atorvastatin (40 mg single dose) + sofosbuvir / velpatasvir (400/ 100 mg once daily)d 
ZAVIRALCI REDUKTAZE HMG-CoA Atorvastatin (40 mg enkratni odmerek) + sofosbuvir/velpatasvir
Epclusa is contraindicated with rifampicin (see section 4.3). 
Zdravilo Epclusa je kontraindicirano v kombinaciji z rifampicinom (glejte poglavje 4.3).
Epclusa [Outer packaging only] 
PODATKI V BRAILLOVI PISAVI Epclusa [samo zunanja ovojnina]
ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d 
ZDRAVILA ZA ZDRAVLJENJE OKUŽB Z MIKOBAKTERIJAMI Rifampicin (600 mg enkrat na dan)/sofosbuvir (400 mg enkratni odmerek)d (indukcija P-gp in citokromov CYP)
Dolutegravir (50 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily) 
Dolutegravir (50 mg enkrat na dan)/sofosbuvir/velpatasvir
No NS5B nucleoside inhibitor (NI) RAVs were observed at failure in the 2 patients. 
Pri teh dveh bolnikih niso zabeležili nobene različice, povezane z odpornostjo na nukleozidne zaviralce NS5B (RAV NI NS5B; NI - nucleoside inhibitor) ob neuspehu.
NARCOTIC ANALGESICS Methadone (Methadone maintenance therapy [30 to 130 mg daily])/ sofosbuvir (400 mg once daily)d 
(vzdrževalna terapija z metadonom [30 do 130 mg/dan])/sofosbuvir
Velpatasvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study at AUC exposures approximately 5-fold higher than the human exposure at the recommended clinical dose. 
V študiji razvoja pri podganah pred kotitvijo in po njej pri izpostavljenosti vrednostim na podlagi AUC, ki so bile približno 5-krat večje od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, velpatasvir ni povzročil nobenih neželenih učinkov na vedenje, razmnoževanje ali razvoj potomcev.
tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ 
-siltenofovirijev fumarat (600/200/300 mg enkrat na dan)/sofosbuvir/velpatasvir
TN and TE with or without cirrhosis, with ESRD requiring dialysis 
GS-US-342-4062 PN in PZ s cirozo ali brez nje, z ESRD, zaradi katere je potrebna dializa
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 
Z ritonavirjem okrepljeni lopinavir (4 × 200 mg/50 mg enkrat na dan) + emtricitabin/ dizoproksil-tenofovirijev fumarat (200/300 mg enkrat na dan)/sofosbuvir/velpatasvir
Epclusa should be taken with food 4 hours before using a proton pump inhibitor. 
Če uporabljate zaviralec protonske črpalke, je treba zdravilo Epclusa vzeti s hrano 4 ure pred zaviralcem protonske črpalke;
Clinical monitoring, looking for signs of bleeding and anaemia, is recommended when dabigatran etexilate is co-administered with Epclusa. 
Ko se dabigatran eteksilat daje sočasno z zdravilom Epclusa, se priporoča klinično spremljanje glede znakov krvavitve in anemije.
Genotypes 2, 4, 5 or 6 Total 
Genotip 2, 4, 5 ali 6 Skupaj
No patients with genotype 5 HCV infection were enrolled. 
Virološkega neuspeha ni doživel noben bolnik z okužbo s HCV
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 
Z ritonavirjem okrepljeni darunavir (800 mg/100 mg enkrat na dan) + emtricitabin/ dizoproksil-tenofovirijev fumarat (200/300 mg enkrat na dan)/sofosbuvir/velpatasvir
Table 4: Activity of sofosbuvir and velpatasvir against full-length or chimeric laboratory replicons 
Preglednica 4: Aktivnost sofosbuvirja in velpatasvirja proti laboratorijskim replikonom polne dolžine ali himeričnim laboratorijskim replikonom Genotip replikona Sofosbuvir EC50, nMa Velpatasvir EC50, nMa
No dose adjustment of Epclusa, raltegravir or emtricitabine/ tenofovir disoproxil fumarate is required. 
Odmerka zdravila Epclusa, raltegravirja ali emtricitabina/dizoproksiltenofovi rat fumarata ni treba prilagajati.
Observed: Atorvastatin 
Atorvas tatin
Table 14: SVR12 in study ASTRAL-4 by HCV genotype 
Preglednica 14: SVR12 v študiji ASTRAL-4 po genotipu HCV Zdravilo Epclusa
Of the 266 treated patients, the median age was 58 years (range: 23 to 81); 59% of the patients were male; 88% were White, 7% were Black; 33% had a baseline body mass index of at least 30 kg/m2; 62% had non-CC IL28B alleles (CT or TT); 80% had baseline HCV RNA levels of at least 800,000 IU/mL; 14% had compensated cirrhosis and 15% were treatment-experienced. 
88 % je bilo belcev, 7 % je bilo črncev; 33 % jih je imelo izhodiščni indeks telesne mase najmanj 30 kg/m2; 62 % bolnikov je imelo alele IL28B ne-CC (CT ali TT); 80 % bolnikov je imelo izhodiščne ravni HCV RNK najmanj 800.000 i.e./ml; 14 % jih je imelo kompenzirano cirozo in 15 % bolnikov se je predhodno že zdravilo.
Otherd a No patients with genotype 1 HCV had on-treatment virologic failure. 
Drugod a. Virološkega neuspeha med zdravljenjem ni doživel noben bolnik z okužbo s HCV genotipa 1.
Refer to tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate Summary of Product Characteristics for recommendations on renal monitoring. 
Za priporočila o spremljanju ledvic glejte povzetke glavnih značilnosti zdravila za dizoproksiltenofovirijev fumarat, emtricitabin/dizoproksiltenofovirijev fumarat ali elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirijev fumarat.
Ketoconazole (200 mg twice daily)/ velpatasvir (100 mg single dose)d 
Ketokonazol (200 mg enkrat na dan)/velpatasvir (100 mg enkratni odmerek)d (zaviranje P-gp in citokromov CYP)
No dose adjustment of Epclusa, atazanavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required. 
atazanavirja (okrepljenega z ritonavirjem) ali emtricitabina/dizoproksiltenofovi rat fumarata ni treba prilagajati.
Co-administration with such medicinal products is not recommended with Epclusa (see section 4.4). 
Sočasna uporaba teh zdravil z zdravilom Epclusa ni priporočljiva (glejte poglavje 4.4).
Medicinal products that increase gastric pH are expected to decrease the concentration of velpatasvir. 
Pričakuje se, da bodo zdravila, ki povečujejo vrednost pH v želodcu,
Of the 740 treated patients, the median age was 56 years (range: 18 to 82); 60% of the patients were male; 79% were White, 9% were Black; 21% had a baseline body mass index of at least 30 kg/m2; the proportions of patients with genotype 1, 2, 4, 5, or 6 HCV infection were 53%, 17%, 19%, 5% and 7%, respectively; 69% had non-CC IL28B alleles (CT or TT); 74% had baseline HCV RNA levels of at least 800,000 IU/mL; 19% had compensated cirrhosis; and 32% were treatment-experienced. 
HCV genotipa 1, 17 % genotipa 2, 19 % genotipa 4, 5 % genotipa 5 in 7 % genotipa 6; 69 % bolnikov je imelo alele IL28B ne-CC (CT ali TT); 74 % bolnikov je imelo izhodiščne ravni RNK HCV najmanj 800.000 i.e./ml; 19 % jih je imelo kompenzirano cirozo in 32 % bolnikov se je predhodno že zdravilo.
Epclusa 12 weeks (n = 624) 
Zdravilo Epclusa 12 tednov (624)
What Epclusa is and what it is used for What you need to know before you take Epclusa How to take Epclusa 
Kaj morate vedeti, preden boste vzeli zdravilo Epclusa
92.9% to 98.0% 82.8% to 96.4% 92.8% to 98.6% 
Brez sprememb 54,0 % (115/213) 80,8 % (172/213) 94,8 % (202/213) 81,2 % (173/213) 88,3 % (188/213) Višji rezultat
BOTTLE AND CARTON LABELLING 
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI OZNAČEVANJE NA NALEPKI PLASTENKE IN ŠKATLI
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. 
Pri bolniku z okužbo s HCV genotipa 3 z izhodiščnimi RAV NS5A, ki ni dosegel SVR12, je prišlo do substitucije NS5A Y93H ob izhodišču.
Baseline RAVs had no relevant impact on SVR12 rates in patients infected with genotype 1, 2, 4, 5 and 6 HCV, as summarised in Table 6. 
Izhodiščni RAV niso imeli pomembnega učinka na stopnje SVR12 pri bolnikih z okužbo s HCV
Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 12 weeks. 
Epclusa ali za 12-tedensko zdravljenje s SOF + RBV.
3a 4a 
4a
Iron oxide red 
Zaviralci protonske črpalke
SVR12 95% Outcome for patients without SVR Ontreatment virologic failure 
SVR12 Izid za osebe brez SVR12
Genotype 2, 4 and 6 
genotipa 2, 4, 5 ali 6.
Dosed 1 
PRILOGA II
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 
Z ritonavirjem okrepljeni atazanavir (300/100 mg enkrat na dan) + emtricitabin/ dizoproksil-tenofovirijev fumarat (200/300 mg enkrat na dan)/sofosbuvir/velpatasvir
Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 24 weeks. 
Epclusa ali za 24-tedensko zdravljenje s SOF + RBV.
Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate (150/ 150/ 200/ 10 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d 
alafenamidtenofovirijev fumarat (150/150/200/10 mg enkrat na dan)/sofosbuvir/velpatasvir
Of the 552 treated patients, the median age was 52 years (range: 19 to 76); 62% of the patients were male; 89% were White, 9% were Asian; 1% were Black; 20% had a baseline body mass index of at least 30 kg/m2; 61% had non-CC IL28B alleles (CT or TT); 70% had baseline HCV RNA levels of at least 800,000 IU/mL, 30% had compensated cirrhosis and 26% were treatment-experienced. 
89 % je bilo belcev, 9 % je bilo Azijcev; 1 % je bilo črncev; 20 % jih je imelo izhodiščni indeks telesne mase najmanj 30 kg/m2; 61 % bolnikov je imelo alele IL28B ne-CC (CT ali TT); 70 % bolnikov je imelo izhodiščne ravni RNK HCV najmanj 800.000 i.e./ml; 30 % jih je imelo kompenzirano cirozo in 26 % bolnikov se je predhodno že zdravilo.
Increased score (Worsening) 
Višji rezultat
Pravastatin (40 mg single dose)/ velpatasvir (100 mg once daily)d 
Pravastatin (40 mg enkratni odmerek)/velpatasvir (100 mg enkrat na dan)d (zaviranje prenašalca OATP1B)
IMMUNOSUPPRESSANTS Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)f 
Ciklosporin (600 mg enkratni odmerek)f/
• Get advice from a doctor or pharmacist if you take medicines used to treat stomach ulcers, 
• Če jemljete zdravila, ki se uporabljajo za zdravljenje želodčnih razjed, zgage ali refluksa kisline, se posvetujte z zdravnikom ali farmacevtom, saj lahko znižajo količino velpatasvirja v krvi.
Ethinyl estradiol 
Norgestimat/etinilestradiol
Posology 
Albumin
Do not stop the treatment. 
Ne prekinite zdravljenja.
• if you are taking another type of medicine (see ‘Taking other medicines'). 
• če jemljete druge vrste zdravil (glejte “Jemanje drugih zdravil”)
White (n=1356) Black (n=966) Chinese (n=573) 
Belci (n = 1356) Črnci (n = 966) Kitajci (n = 573)
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 
EU/1/08/464/001 - škatle s 14 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/002- škatle s 14 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/003 - škatle z 28 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/004 - škatle z 28 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/005 - škatle s 30 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/006 - škatle s 30 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/007 - škatle s 50x1 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/008 - škatle s 50x1 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/009 - škatle z 84 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/010 - škatle z 84 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/011 - škatle z 90 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/012 - škatle z 90 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/013 - škatle s 100 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/014 - škatle s 100 filmsko obloženimi tabletam v aluminijastih pretisnih omotih EU/1/08/464/018 - škatle s 7 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/019 - škatle s 7 filmsko obloženimi tabletami v aluminijastih pretisnih omotih
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 July 2008 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 16. julij 2008
Detailed information on this product is available on the website of the European Medicines Agency 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
Therefore, concomitant use of Proton Pump Inhibitors should be avoided unless absolutely necessary. 
Zato naj bi se sočasni uporabi zaviralcev protonske črpalke izognili, razen če ni nujno potrebna.
6, boulevard de l'Europe, F-21800 Quétigny, France 
6, Boulevard de l'Europe, F-21800 Quétigny, Francija
Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks. 
kombiniranim zdravljenjem je potrebno začeti čim prej po nastopu simptomov in z njim nadaljevati vsaj štiri tedne.
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 
Ker CAPRIE nima moči za oceno učinkovitosti v posameznih podskupinah, ni jasno, ali so razlike pri zmanjšanju relativnega tveganja glede na vključitvene pogoje resnične ali slučajne.
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. 
Varnost klopidogrela so vrednotili pri več kot 42.000 bolnikih, ki so sodelovali v kliničnih študijah, vključno z več kot 9.000 bolniki, ki so se zdravili 1 leto ali več.
Platelets are very small structures in the blood, smaller than red or white blood cells, which clump together during blood clotting. 
Trombociti so zelo majhne strukture v krvi, manjše kot rdeče ali bele krvne celice, ki se zlepljajo pri strjevanju krvi.
- a recent serious injury - a recent surgery (including dental) - a planned surgery (including dental) in the next seven days 
- nedavna huda poškodba - nedaven kirurški poseg (vključno na zobeh) - načrtovan kirurški poseg (vključno na zobeh) v naslednjih 7 dneh
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%. 
Relativna razlika antitrombocitnega odziva med genotipskima skupinama se med študijami razlikuje glede na metodo, uporabljeno za oceno odziva, a je praviloma večja od 30 %.
It is preferable not to use this product during pregnancy and breast-feeding. 
Priporočljivo je, da se tega zdravila v nosečnosti in med dojenjem ne uporablja.
Some other medicines may influence the use of Clopidogrel BMS or vice versa. 
Nekatera druga zdravila lahko vplivajo na uporabo klopidogrela in obratno.
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. 
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2.0 z datumom 25. september 2007, predstavljeni v Modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
The incidence of severe cases was 1.4% for clopidogrel and 1.6% for ASA. 
Incidenca hujših primerov je bila 1,4 % za klopidogrel in 1,6 % za ASA.
The elimination half-life of the main circulating (inactive) metabolite was 8 hours after single and repeated administration. 
Razpolovni čas izločanja glavnega krožečega (neaktivnega) metabolita je bil 8 ur po enkratnem in večkratnem dajanju.
Taking Clopidogrel BMS with food and drink Clopidogrel BMS may be taken with or without food. 
Jemanje zdravila Clopidogrel BMS skupaj s hrano in pijačo Klopidogrel lahko jemljete s hrano ali brez nje.
The binding is non-saturable in vitro over a wide concentration 
Pri vezavi in vitro ni nasičenja v širokem koncentracijskem
Contact your doctor immediately if you experience: - fever, signs of infection or extreme tiredness. 
Nemudoma se posvetujte s svojim zdravnikom, če se pri vas pojavijo: - zvišana telesna temperatura, znaki okužbe ali huda utrujenost.
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). 
Njihova pogostnost je navedena upoštevaje naslednji dogovor: pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000).
Patients should be told that it might take longer than usual to stop bleeding when they take clopidogrel (alone or in combination with ASA), and that they should report any unusual bleeding (site or duration) 
Bolniki morajo biti obveščeni, da je lahko čas, potreben za zaustavitev krvavitve, daljši kot ponavadi, ko jemljejo klopidogrel (sam ali v kombinaciji z ASA) in da morajo poročati svojemu zdravniku o kakršnikoli neobičajni krvavitvi (mesto ali trajanje).