natgillin/translations-raw huggingface dataset:
Не се препоръчва едновременно приложение на Epclusa със схеми на лечение, съдържащи ефавиренц (вж. точка 4.4). 
Co-administration of Epclusa with efavirenz-containing regimens is not recommended (see section 4.4).
Рифампицин (600 mg веднъж дневно)/велпатасвир (100 mg единична доза) 
Rifampicin (600 mg once daily)/ velpatasvir (100 mg single dose)
Такролимус (5 mg единична доза)е/софосбувир (400 mg единична доза)г 
Tacrolimus (5 mg single dose)f/ sofosbuvir (400 mg single dose)d
Велпатасвир е също субстрат и на OATP1B. In vitro е наблюдаван бавен метаболизъм на велпатасвир чрез CYP2B6, CYP2C8 и CYP3A4. 
In vitro, slow metabolic turnover of velpatasvir by CYP2B6, CYP2C8 and CYP3A4 was observed.
Рилпивирин ↔ ↔ ↔ Не се налага корекция на дозата на Epclusa или емтрицитабин/ рилпивирин/ тенофовир дизопроксил фумарат. 
Rilpivirine ↔ ↔ ↔ No dose adjustment of Epclusa or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Едновременното приложение на такива лекарствени продукти с Epclusa не се препоръчва (вж. точка 4.4). 
Co-administration with such medicinal products is not recommended with Epclusa (see section 4.4).
Таблица 14 представя стойностите за ТВО12 за проучването ASTRAL-4 по HCV генотип. 
Table 14 presents the SVR12 for the ASTRAL-4 study by HCV genotype.
Генотипове 1, 2, 3, 4, 5 и 6 НП и ЛП без цироза или с компенсирана цироза, с HCV/HIV-1 коинфекция 
TN and TE, without cirrhosis or with compensated cirrhosis, with HCV/HIV-1 co-infection
Кетоконазол (200 mg два пъти дневно)/велпатасвир (100 mg единична доза)г 
Ketoconazole (200 mg twice daily)/ velpatasvir (100 mg single dose)d
↔ ↔ ↔ Не се налага корекция на дозата на Epclusa, лопинавир (усилен с ритонавир) или емтрицитабин/ тенофовир дизопроксил фумарат. 
↔ ↔ ↔ No dose adjustment of Epclusa, lopinavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Вижте Кратката характеристика на продукта, съдържащ тенофовир дизопроксил фумарат за препоръки относно наблюдението на бъбречната функция. 
Refer to the tenofovir disoproxil fumarate-containing product's Summary of Product Characteristics for recommendations on renal monitoring (see section 4.4).
При проучване за преи постнаталното развитие при плъхове софосбувир не показва нежелани ефекти по отношение на поведението, репродукцията или развитието на потомството. 
Sofosbuvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study.
Правастатин (40 mg единична доза)/велпатасвир (100 mg веднъж дневно)г 
Pravastatin (40 mg single dose)/ velpatasvir (100 mg once daily)d
Петима пациенти с липсващ статус за цироза от групата на SOF+RBV за 24 седмици са били изключени от този анализ на подгрупи. 
Without cirrhosis 98% (160/163) With cirrhosis a Five patients with missing cirrhosis status in the SOF+RBV 24 week group were excluded from this subgroup analysis.
И при двамата пациенти не са наблюдавани варианти, свързани с резистентност към NS5B нуклеозидни инхибитори (NI) при вирусологичния неуспех. 
No NS5B nucleoside inhibitor (NI) RAVs were observed at failure in the 2 patients.
Окскарбазепин 
Carbamazepine
↓ Велпатасвир 
↔ Velpatasvir
↔ Велпатасвир 
↓ Velpatasvir
Ралтегравир ↔ ↔ ↓ 
Ciclosporin ↔ ↔
Според фармакокинетичния анализ на популациите телесното тегло няма клинично значим ефект върху експозицията на софосбувир или велпатасвир. 
Body weight did not have a clinically significant effect on sofosbuvir or velpatasvir exposure according to a population pharmacokinetic analysis.
Елвитегравир ↔ ↔ ↔ Не се налага корекция на дозата на Epclusa или елвитегравир/ кобицистат/ емтрицитабин/ тенофовир алафенамид фумарат. 
Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate is required.
Фамотидин (40 mg единична доза)/ софосбувир/велпатасвир (400/100 mg единична доза)в 
Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
АНТИКОАГУЛАНТИ Дабигатран етексилат 
ANTIFUNGALS Ketoconazole
↑ Дабигатран ↔ Софосбувир ↔ Велпатасвир 
↑ Dabigatran ↔ Sofosbuvir ↔ Velpatasvir
12 седмици (n = 134) 
Epclusa 12 weeks (n = 134)
В по CPT, но не са оценявани при пациенти с цироза клас С по CPT (вж. точки 4.4, 4.8 и 5.1). 
Safety and efficacy of Epclusa have been assessed in patients with CPT Class B cirrhosis, but not in patients with CPT Class C cirrhosis (see sections 4.4, 4.8 and 5.1).
Елвитегравир ↔ ↔ ↔ Не се налага корекция на дозата на Epclusa или елвитегравир/ кобицистат/ емтрицитабин/ тенофовир дизопроксил фумарат. 
Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate is required.
Не се налага корекция на дозата на Epclusa, ралтегравир или емтрицитабин/ тенофовир дизопроксил фумарат. 
No dose adjustment of Epclusa, raltegravir or emtricitabine/ tenofovir disoproxil fumarate is required.
↔ ↔ ↔ Не се налага корекция на дозата на Epclusa, дарунавир (усилен с ритонавир) или емтрицитабин/ тенофовир дизопроксил фумарат. 
↔ ↔ ↔ No dose adjustment of Epclusa, darunavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
↓ Софосбувир ↓ Велпатасвир 
↔ Sofosbuvir ↓ Velpatasvir
↔ Софосбувир ↓ Велпатасвир 
↓ Sofosbuvir ↓ Velpatasvir
Лопинавир 
Lopinavir
Вирусологичен резултат за пациенти с инфекция с НСV генотип 1 и 3 в проучването ASTRAL-4. Epclusa за 12 седмици 
Table 15: Virologic outcome for patients with genotype 1 and 3 HCV infection in study ASTRAL-4
Не се налага корекция на дозата Epclusa или аторвастатин. 
No dose adjustment of Epclusa or atorvastatin is required.
Циклоспорин (600 mg единична доза)е/велпатасвир (100 mg единична доза)г 
Ciclosporin (600 mg single dose)f/ velpatasvir (100 mg single dose)d
Тенофовир алафенамид 
Tenofovir alafenamide Sofosbuvir
Леко БУ (eGFR ≥ 50 и < 80 ml/ min/1,73 m2) 
and <80 mL/min/1.7 3m2)
Epclusa е противопоказан с рифампицин (вж. точка 4.3). 
Epclusa is contraindicated with rifampicin (see section 4.3).
Елвитегравир/кобицистат/ емтрицитабин/тенофовир алафенамид фумарат (150/150/200 mg/10 mg веднъж дневно)/софосбувир/велпатасвир (400/100 mg веднъж дневно)в, г 
Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate (150/ 150/ 200/ 10 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Лопинавир, усилен с ритонавир (4 х 200 mg/50 mg веднъж дневно) + емтрицитабин/тенофовир дизопроксил фумарат (200/300 mg веднъж дневно)/софосбувир/велпатасвир (400/100 mg веднъж дневно)в, г 
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
HIV ПРОТЕАЗНИ ИНХИБИТОРИ Атазанавир, усилен с ритонавир (300/100 mg веднъж дневно) + емтрицитабин/ тенофовир дизопроксил фумарат (200/300 mg веднъж дневно)/софосбувир/ велпатасвир (400/100mg веднъж дневно)в, г 
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
Единственият пациент с генотип 3, който е имал NS5A RAV на изходното ниво и не е постигнал ТВО12, е имал субституция Y93H в NS5A на изходното ниво. 
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.
19 до 76); 62% от пациентите са били мъже; 89% са били от бяла раса, 9% са били азиатци; 1% са били чернокожи; 20% на изходното ниво са били с индекс на телесна маса най-малко 30 kg/m2; 61% са имали не-CC IL28B алели (CT или TT); 70% на изходното ниво са имали 
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.
Ефектът върху експозицията на велпатасвир не е проучен. 
Effect on velpatasvir exposure not studied.
(n = 104) 
GT-2 (n = 104)
Циметидинд Низатидинд Ранитидинд 
ANTICONVULSANTS Phenytoin
Дарунавир, усилен с ритонавир (800 mg/100 mg веднъж дневно) + емтрицитабин/ тенофовир дизопроксил фумарат (200/300 mg веднъж дневно)/ софосбувир/велпатасвир (400/100 mg веднъж дневно)в, г 
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
Ефавиренц/емтрицитабин/теноф овир дизопроксил фумарат (600/200/300 mg/веднъж дневно)/софосбувир/велпатасвир (400/100 mg веднъж дневно)в, г 
Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Не се налага корекция на дозата на Epclusa или атазанавир (усилен с ритонавир) или емтрицитабин/ рилпивирин/тенофовир дизопроксил фумарат. 
No dose adjustment of Epclusa, atazanavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
ДАТА НА ПЪРВО 
Dosed 1
Елвитегравир/кобицистат/ емтрицитабин/тенофовир дизопроксил фумарат (150/150/200 mg/300 mg веднъж дневно)/софосбувир/велпатасвир (400/100 mg веднъж дневно)в, г 
Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150/ 150/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Проучено е взаимодействие само с велпатасвир 
Interaction only studied with velpatasvir Expected:
Не се налага корекция на дозата на Epclusa или правастатин. 
No dose adjustment of Epclusa or pravastatin is required.
↔ Софосбувир 
↓ Sofosbuvir
Интраконазолд Вориконазолд Позаконазолд Изавуконазолд 
Itraconazolee Voriconazolee Posaconazolee Isavuconazolee
Кратката характеристика на продукта, съдържащ рибавирин. 
For ribavirin dose modifications, refer to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Вирусологичен неуспех (рецидив и неуспех по време на лечението) Генотип 1a Генотип 1а 6% (3/50) Генотип 1b 11% (2/18) Генотип 3 
Genotype 1b 11% (2/18) Genotype 3
(n = 35) 
GT-5 (n = 35)
(n = 116) 
GT-4 (n = 116)
ТВО12 в проучване ASTRAL-3 (HCV генотип 3) Epclusa за 
Table 12: SVR12 in study ASTRAL-3 (HCV genotype 3)
Доза рибавирин 
Ribavirin Dose
Емтрицитабин/рилпивирин/тен офовир дизопроксил фумарат (200/25/300 mg/веднъж дневно)/ софосбувир/велпатасвир (400/100 mg веднъж дневно)в, г 
Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200/ 25/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
АНТИМИКОБАКТЕРИАЛНИ СРЕДСТВА Рифампицин (600 mg веднъж дневно)/софосбувир (400 mg единична доза)г (индуциране на P-gp и CYP) 
ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
ПРОТИВОГЪБИЧНИ Кетоконазол 
ANTICOAGULANTS Dabigatran etexilate
ТВО12 в проучване ASTRAL-2 (HCV генотип 2) Epclusa за 
Table 11: SVR12 in study ASTRAL-2 (HCV genotype 2)
СРЕДСТВА, ПОНИЖАВАЩИ 
ACID REDUCING AGENTS
↑ Статини 
Relapsea
С базови NS5A RAV 97% (73/75) 
Overall SVR12 83% (75/90) Genotype 1
Омепразол (20 mg веднъж дневно)/ софосбувир/велпатасвир (400/100 mg единична доза на гладно)в 
Proton pump inhibitors Omeprazole (20 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose fasted)c
Таблица 14: ТВО12 в проучване ASTRAL-4 по HCV генотип Epclusa за 12 седмици (n = 90) 
Table 14: SVR12 in study ASTRAL-4 by HCV genotype
Посъветвайте се с лекар или фармацевт, ако вземате лекарства, използвани за лечение на стомашна язва, киселини в стомаха или киселинен рефлукс, тъй като могат да увеличат количеството велпатасвир в кръвта Ви. 
heartburn or acid reflux as they can decrease the amount of velpatasvir in your blood.
88% са били от бяла раса, 7% са били чернокожи; 33% при изходното ниво са били с индекс на телесна маса от най-малко 30 kg/m2; 62% са имали не-CC IL28B алели (CT или TT); 80% на изходното ниво са имали 
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.
За пациенти с компенсирана цироза, инфектирани с генотип 3, може да се обмисли добавяне на рибавирин. 
Addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis (see section 5.1.)
Прием 1 час след диализа 
hr After Dialysis
Възможност други лекарствени продукти да повлияят действието на Epclusa Софосбувир и велпатасвир са субстрати на лекарствените транспортери P-gp и BCRP. Велпатасвир е също субстрат и на лекарствения транспортер OATP1B. In vitro e наблюдаван бавен метаболзъм на велпатасвир чрез CYP2B6, CYP2C8 и CYP3A4. 
Potential for other medicinal products to affect Epclusa Sofosbuvir and velpatasvir are substrates of drug transporters P-gp and BCRP.
(n = 11) 
GT-2 (n = 11)
(n = 12) 
GT-3 (n = 12)
(n = 118) 
GT-1b (n = 118)
В по СРТ 
(eGFR ≥50
Таблица 17: ТВО12 в проучване ASTRAL-5 по HCV генотип Epclusa за 12 седмици (n = 106) 
Table 17: SVR12 in study ASTRAL-5 by HCV genotype
Правастатин 
↑ Statins
< 30 ml/ 
(eGFR ≥30
Циклоспорин ↔ ↔ Не се налага корекция на дозата на Epclusa или циклоспорин при започване на едновременно приложение. 
No dose adjustment of Epclusa or ciclosporin is required at initiation of co-administration.
(n = 41) 
GT-6 (n = 41)
Може да се обмисли Epclusa + рибавирин за 24 седмици (вж. точка 4.4). 
Patients who have previously failed therapy with an NS5A-containing regimen Epclusa + ribavirin for 24 weeks may be considered (see section 4.4).
Таблица 10: ТВО12 в проучване ASTRAL-1 по HCV генотип Epclusa за 12 седмици (n = 624) 
Table 10: SVR12 in study ASTRAL-1 by HCV genotype
Toto opatření pomáhá chránit životní prostředí. 
These measures will help to protect the environment.
3 roky 
3 years
Mohou to být příznaky alergické reakce. 
These may be the signs of an allergic reaction.
Pacienti byli léčeni po dobu až 1 roku. 
Patients were treated for up to one year.
Optimální délka léčby nebyla formálně stanovena. 
The optimal duration of treatment has not been formally established.
Mohl by jí ublížit, a to i tehdy, má-li stejné příznaky jako Vy. 
It may harm them, even if their symptoms are the same as yours.
Neutropenie včetně závažné neutropenie 
Neutropenia, including severe neutropenia
Halucinace, zmatenost 
Hallucinations, confusion
- Tento přípravek byl předepsán Vám. 
- This medicine has been prescribed for you.
Velmi vzácné 
Very rare
Běloši (n=1356) Černoši (n=966) Číňané (n=573) 
White (n=1356) Black (n=966) Chinese (n=573)
Nedávejte jej žádné další osobě. 
Do not pass it on to others.
Zeptejte se svého lékárníka, jak máte likvidovat přípravky, které již nepotřebujete. 
Ask your pharmacist how to dispose of medicines no longer required.
DALŠÍ ZVLÁŠTNÍ UPOZORNĚNÍ, POKUD JE POTŘEBNÉ 
OTHER SPECIAL WARNING(S), IF NECESSARY
4.7 Účinky na schopnost řídit a obsluhovat stroje 
4.7 Effects on ability to drive and use machines
Léčivé přípravky se nesmí vyhazovat do odpadních vod nebo domácího odpadu. 
Medicines should not be disposed of via wastewater or household waste.
Z O.O. 
S R.O.
Střední hodnota prodloužení doby krvácivosti byla v obou skupinách rovněž obdobná. 
The mean bleeding time prolongation was also similar in the two groups.
ZVLÁŠTNÍ OPATŘENÍ PRO LIKVIDACI NEPOUŽITÝCH LÉČIVÝCH PŘÍPRAVKŮ NEBO ODPADU Z TAKOVÝCH LÉČIVÝCH PŘÍPRAVKŮ, POKUD JE TO VHODNÉ 
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Tento léčivý přípravek nevyžaduje žádné zvláštní podmínky uchovávání. 
This medicinal product does not require any special storage conditions.
TTP je potenciálně fatální stav vyžadující neodkladnou léčbu včetně plasmaferézy. 
TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Proto je třeba vyvarovat se současného podávání inhibitorů protonové pumpy, pokud není absolutně nezbytné. 
Therefore, concomitant use of Proton Pump Inhibitors should be avoided unless absolutely necessary.
Uchovávejte mimo dosah a dohled dětí. 
Keep out of the reach and sight of children.
Kontaktujte ihned svého lékaře, pokud se u Vás objeví: horečka, známky infekce nebo extrémní únava. 
Contact your doctor immediately if you experience: - fever, signs of infection or extreme tiredness.
s jinými léčivými přípravky a jiné formy interakce 
4.5 Interaction with other medicinal products and other forms of interaction
Kombinovaná terapie by měla být zahájena co nejdříve po nástupu příznaků a měla by pokračovat po dobu nejméně 4 týdnů. 
Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks.
Bezpečnostní profil klopidogrelu v této podskupině pacientů navíc neukázal žádné zvláštní riziko. 
Moreover, the safety profile of clopidogrel in this subgroup of patients did not raise any particular concern.
Studie na zvířatech nenaznačují přímé nebo nepřímé škodlivé vlivy vzhledem k těhotenství, vývoji embrya/plodu, porodu nebo postnatálnímu vývoji (viz bod 5.3). 
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Nežádoucí účinky, které se vyskytly buď během klinických hodnocení nebo byly spontánně hlášeny, jsou uvedeny v tabulce níže. 
Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in the table below.
Vzhledem k nedostatku údajů nelze klopidogrel doporučit během prvních 7 dnů po akutní ischemické cévní mozkové příhodě. 
In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
Systém farmakovigilance 
Pharmacovigilance system
V páté kohortové studii (n=2 208; Simon) byla zvýšená četnost příhod pozorována pouze u pomalých metabolizátorů. 
In the fifth cohort study (n=2,208; Simon), the increased event rate was observed only in poor metabolisers.
DATUM PRVNÍ REGISTRACE/PRODLOUŽENÍ REGISTRACE Datum první registrace: 16. 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 July 2008
Trombotická trombocytopenická purpura (TTP) byla po užití klopidogrelu hlášena velmi zřídka, někdy po krátké expozici. 
Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure.
Nepoužívejte klopidogrel po datu ukončení použitelnosti, které je uvedeno na krabičce a blistru. 
Do not use Clopidogrel BMS after the expiry date which is stated on the carton and on the blister.
Pokud má pacient podstoupit plánovanou operaci a antiagregační účinek není dočasně žádoucí, je třeba klopidogrel vysadit 7 dní před výkonem. 
If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, clopidogrel should be discontinued 7 days prior to surgery.
Vzhledem k tomu, že studie CAPRIE nebyla cílena na hodnocení účinnosti individuálních podskupin, není jasné, zda rozdíly v hodnotách relativního snížení rizika, které se objevily u jednotlivých kvalifikujících onemocnění, skutečně existují nebo zda jsou výsledkem náhody. 
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
Příležitostné užití acetylsalicylové kyseliny (ne více než 1000 mg kdykoli během 24 hodin) by většinou nemělo způsobit potíže, ale dlouhodobé užívání za jiných podmínek byste měl(a) konzultovat 
An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Nelze proto vyloučit jejich účinek, přímý (slabá toxicita) nebo nepřímý (nízká palatabilita). 
Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be
Newcastle upon Tyne, Tyne & Wear NE3 3TT, Velká Británie a/nebo 
Newcastle Upon Tyne, Tyne & Wear NE3 3TT - UK, United Kingdom and/or
Dále se při analýze podskupin podle věku ukázalo, že přínos klopidogrelu u pacientů starších 75 let byl menší než u pacientů ve věku ≤ 75 let. 
In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
U asijské populace jsou dostupné omezené údaje pro hodnocení klinických důsledků genotypizace tohoto CYP na klinické příhody. 
From literature, limited data in Asian populations are available to assess the clinical implication of genotyping of this CYP on clinical outcome events.
Byla provedena řada klinických studií současného podávání klopidogrelu a jiných léčivých přípravků za účelem zjištění potenciálních farmakodynamických a farmakokinetických interakcí. 
A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
V příbalové informaci k léčivému přípravku musí být uveden název a adresa výrobce odpovědného za propouštění dané šarže. 
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Poruchy krve a lymfatického systému 
Blood and the lymphatic system disorders
- Máte-li jakékoli další otázky, zeptejte se svého lékaře nebo lékárníka. 
- If you have any further questions, ask your doctor or your pharmacist.
Tyto stavy mohou být následkem vzácně se vyskytujícího snížení počtu některých krvinek. 
These may be due to rare decrease of some blood cells.
Není známo, zda je klopidogrel vylučován do lidského mléka. 
It is unknown whether clopidogrel is excreted in human breast milk.
Pro další informace čtěte příbalovou informaci. 
See leaflet for further information.
Nepoužívejte klopidogrel, pokud si všimnete jakýchkoli viditelných známek poškození. 
Do not use Clopidogrel BMS if you notice any visible sign of deterioration.
Pro další informace viz bod 5.1. 
For further information please refer to section 5.1.
Máte-li jakékoli další otázky, týkající se užívání tohoto přípravku, zeptejte se svého lékaře nebo lékárníka. 
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Podobně jako všechny léky, může mít i Clopidogrel BMS nežádoucí účinky, které se ale nemusí vyskytnout u každého. 
Like all medicines, Clopidogrel BMS can cause side effects, although not everybody gets them.
Kromě toho Vám může lékař zjistit změny ve výsledcích vyšetření krve nebo moči. 
In addition, your doctor may identify changes in your blood or urine test results.
Přečtěte si pozorně celou příbalovou informaci dříve, než začnete tento přípravek užívat. 
Read all of this leaflet carefully before you start taking this medicine.
Krvácení je nejběžnějším účinkem hlášeným z klinických hodnocení i po uvedení přípravku na trh, kdy bylo hlášeno nejčastěji během prvního měsíce léčby. 
Bleeding is the most common reaction reported both in clinical studies as well as in post-marketing experience where it was mostly reported during the first month of treatment.
Clopidogrel BMS Vám byl předepsán, aby napomohl prevenci vzniku krevních sraženin a snížil riziko 
You have been prescribed Clopidogrel BMS to help prevent blood clots and reduce the risk of these
Nebyl pozorován účinek na počet rehospitalizací pro nestabilní anginu pectoris. 
There was no observed effect on the rate of rehospitalisation for unstable angina.
Pacienti se vzácnou vrozenou intolerancí galaktózy, vrozeným deficitem laktázy nebo glukózo-galaktózovou malabsorbcí by neměli tento léčivý přípravek užívat. 
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
NÁVOD K POUŽITÍ 
INSTRUCTIONS ON USE