natgillin/translations-raw huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Winthrop to Sanofi Pharma Bristol-Myers Squibb SNC on 16 July 2008.
Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel Winthrop, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pharma Bristol- Myers Squibb SNC dne 16. julija 2008.
The full EPAR for Clopidogrel Winthrop is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel Winthrop je na voljo tukaj.
EU/ 1/ 08/ 465/ 001 EU/ 1/ 08/ 465/ 002 EU/ 1/ 08/ 465/ 003 EU/ 1/ 08/ 465/ 004 EU/ 1/ 08/ 465/ 005 EU/ 1/ 08/ 465/ 006 EU/ 1/ 08/ 465/ 007 EU/ 1/ 08/ 465/ 008 EU/ 1/ 08/ 465/ 009 EU/ 1/ 08/ 465/ 010 EU/ 1/ 08/ 465/ 011 EU/ 1/ 08/ 465/ 012 EU/ 1/ 08/ 465/ 013 EU/ 1/ 08/ 465/ 014 EU/ 1/ 08/ 465/ 015 EU/ 1/ 08/ 465/ 016 EU/ 1/ 08/ 465/ 017 EU/ 1/ 08/ 465/ 018 EU/ 1/ 08/ 465/ 019
EU/ 1/ 08/ 465/ 001 EU/ 1/ 08/ 465/ 002 EU/ 1/ 08/ 465/ 003 EU/ 1/ 08/ 465/ 004 EU/ 1/ 08/ 465/ 005 EU/ 1/ 08/ 465/ 006 EU/ 1/ 08/ 465/ 007 EU/ 1/ 08/ 465/ 008 EU/ 1/ 08/ 465/ 009 EU/ 1/ 08/ 465/ 010 EU/ 1/ 08/ 465/ 011 EU/ 1/ 08/ 465/ 012 EU/ 1/ 08/ 465/ 013 EU/ 1/ 08/ 465/ 014 EU/ 1/ 08/ 465/ 015 EU/ 1/ 08/ 465/ 016 EU/ 1/ 08/ 465/ 017 EU/ 1/ 08/ 465/ 018
Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop
Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop Clopidogrel Winthrop
Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu)
Pretisni omot (PVC/ PVDC/ alu) Pretisni omot (alu/ alu) Pretisni omot (PVC/ PVDC/ alu) Pretisni omot (alu/ alu) Pretisni omot (PVC/ PVDC/ alu) Pretisni omot (alu/ alu) Pretisni omot (PVC/ PVDC/ alu) Pretisni omot (alu/ alu) Pretisni omot (PVC/ PVDC/ alu) Pretisni omot (alu/ alu) Pretisni omot (PVC/ PVDC/ alu) Pretisni omot (alu/ alu) Pretisni omot (PVC/ PVDC/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (PVC/ PVDC/ alu)
14 14 28 28 30 30 50 x 1 50 x 1 84 84 90 90 100 100 4x1 30 x 1 100 x 1 7 7
14 14 28 28 30 30 50x1 50x1 84 84 90 90 100 100 4x1 30x1 100x1 7
Clopidogrel Winthrop 75 mg film-coated tablets
Clopidogrel Winthrop 75 mg filmsko obložene tablete
ST segment elevation acute myocardial infarction: clopidogrel should be given as a single daily dose of 75 mg initiated with a 300-mg loading dose in combination with ASA and with or without thrombolytics.
starejši od 75 let, je treba zdravljenje s klopidogrelom začeti brez udarnega odmerka.
3 Therapeutic experience with clopidogrel is limited in patients with renal impairment.
Terapevtske izkušnje s klopidogrelom so omejene pri bolnikih z ledvično okvaro.
Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses.
3 Izkušnje so omejene pri bolnikih z zmerno jetrno boleznijo, ki imajo lahko hemoragično diatezo.
Clopidogrel Winthrop contains lactose.
Zdravilo Clopidogrel Winthrop vsebuje laktozo.
4 The pharmacokinetics of digoxin or theophylline were not modified by the co-administration of clopidogrel.
Farmakokinetika digoksina ali teofilina nista bili spremenjeni ob sočasni uporabi klopidogrela.
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Winthrop.
Iz varnostnih razlogov naj se z dojenjem med zdravljenjem z zdravilom Clopidogrel Winthrop ne nadaljuje.
5 In CURE, the major bleeding event rate for clopidogrel+ASA was dose-dependent on ASA (< 100mg:
V CURE je bil delež dogodkov z velikimi krvavitvami za klopidogrel in ASA odvisen od odmerka ASA (< 100 mg:
In CLARITY, there was an overall increase in bleeding in the clopidogrel + ASA group (17.4%) vs. the placebo + ASA group (12.9%). The incidence of major bleeding was similar between groups (1.3% versus 1.1% for the clopidogrel + ASA and the placebo + ASA groups, respectively).
Incidenca večjih krvavitev je bila v
Taste disturbances
Intrakranialna
reported with fatal outcome), headache, paraesthesia, dizziness
krvavitev (opisani so primeri s smrtnim izidom), glavobol, parestezije, omotica Očesne bolezni
Gastrointestinal disorders
Želodčna razjeda Retroperitonealna Krvavitev v prebavila in Bolezni prebavil
Gastrointestinal haemorrhage, diarrhoea, abdominal
Krvavitev v prebavila, driska, bolečine v trebuhu, dispepsija
Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea,
in razjeda na dvanajstniku, gastritis, bruhanje, navzea, zaprtje, flatulenca
Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis,
retroperitonealna krvavitev s smrtnim izidom, pankreatitis, kolitis (vključno z ulceroznim ali limfocitnim kolitisom), stomatitis
pain, dyspepsia constipation, flatulence
6
colitis (including ulcerative or lymphocytic colitis), stomatitis
Organski sistem Bolezni jeter, žolčnika in žolčevodov
Hepato-biliary disorders
Občasni
Acute liver failure, hepatitis, abnormal liver function test
Redki
Skin and subcutaneous tissue disorders
Zelo redki Akutna odpoved jeter, hepatitis, nenormalni testi jetrne funkcije
Bruising Rash, pruritus, skin bleeding (purpura)
Bolezni kože in podkožja Bolezni mišično - skeletnega sistema in vezivnega tkiva
Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, rash erythematous, urticaria, eczema, lichen planus
Modrice
Musculoskeletal, connective tissue and bone disorders
Izpuščaj, srbenje, kožne krvavitve (purpura)
Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Bulozen dermatitis (toksična epidermalna nekroliza, Stevens - Johnsonov sindrom, multiformni eritem), angioedem, eritematozen izpuščaj, urtikarija, ekcem, lihen planus Mišično- skeletne krvavitve (hemartroza), artritis, artralgija, mialgija
General disorders
Splošne težave in spremembe na mestu aplikacije Preiskave
Bleeding at
Krvavitve na mestu vboda
and administration puncture site site conditions Investigations
Podaljšan čas krvavitve, zmanjšano število nevtrofilcev, zmanjšano število trombocitov
Bleeding time prolonged, neutrophil count decreased, platelet count decreased
Zvišana telesna temperatura
Biotransformation of clopidogrel is necessary to produce inhibition of platelet aggregation.
Biotransformacija klopidogrela je nujna za dosego inhibicije agregacije trombocitov.
Clopidogrel also inhibits platelet aggregation induced by other agonists by blocking the amplification of platelet activation by released ADP.
Klopidogrel prav tako zavira agregacijo trombocitov, sproženo z drugimi agonisti, z blokado ojačitve aktivacije trombocitov s sproščenim ADP.
8 infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR = -4.0%; CI: -22.5 to 11.7 [p=0.639]).
Pri bolnikih, ki so bili vključeni v preskušanje samo na podlagi nedavnega miokardnega infarkta, je bil klopidogrel numerično inferioren, vendar se statistično ni razlikoval od ASA (zmanjšanje RT= - 4, 0%; IZ: - 22, 5 do 11, 7 [p=0, 639]).
The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Delež bolnikov s primarnim opazovanim dogodkom [srčno- žilna (SŽ) smrt, miokardni infarkt (MI) ali kap] je bil 582 (9, 3%) v skupini, zdravljeni s klopidogrelom, in 719 (11, 4%) v skupini, ki je prejemala placebo, to je 20% zmanjšanje relativnega tveganja (95% IZ od 10% - 28%; p=0, 00009) v skupini, zdravljeni s klopidogrelom (17% zmanjšanje relativnega tveganja, če so bili bolniki 8 zdravljeni konzervativno, 29% kadar je bila izvedena perkutana transluminalna koronarna angioplastika (PTCA) z ali brez stenta in 10%, če je bila izvedena premostitvena operacija koronarnih arterij (CABG).
The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/ LMWH, GPIIb/ IIIa antagonists, lipid lowering medicinal products, beta
Koristi, ki so jih opazili s klopidogrelom, so bile neodvisne od drugih akutnih in dolgotrajnih srčnožilnih terapij (kot je heparin / nizkomolekularni heparin, antagonisti glikoproteina, IIb/ IIIa, učinkovinami za zniževanje lipidov, zaviralci adrenergičnih receptorjev beta in zaviralci angiotenzinske konvertaze (ACEI)).
After repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Po večkratnih peroralnih odmerkih 75 mg na dan se klopidogrel hitro absorbira.
However, plasma concentrations of the parent compound are very low and below the quantification limit (0.00025 mg/ l) beyond 2 hours.
Vendar pa so plazemske koncentracije izhodne spojine zelo majhne in pod mejo določljivosti (0, 00025 mg/ l) po 2 urah.
10 The kinetics of the main circulating metabolite were linear (plasma concentrations increased in proportion to dose) in the dose range of 50 to 150 mg of clopidogrel.
Kinetika glavnega krožečega metabolita je bila linearna (plazemske koncentracije so se povišale sorazmerno z odmerkom) v razponu odmerkov 50 do 150 mg klopidogrela.
In all aluminium blisters, this medicinal product does not require any special storage conditions.
11 Za shranjevanje zdravila v aluminijastih pretisnih omotih niso potrebna posebna navodila.
6.5 Nature and content of container
6. 5 Vrsta ovojnine in vsebina
Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France F-75013 Paris – France
Sanofi Pharma Bristol- Myers Squibb SNC 174 avenue de France F - 75013 Paris - Francija
EU/ 1/ 08/ 465/ 001 - Cartons of 14 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 002 - Cartons of 14 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 003 - Cartons of 28 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 004 - Cartons of 28 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 005 - Cartons of 30 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 006 - Cartons of 30 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 007 - Cartons of 50x1 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 008 - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 009 - Cartons of 84 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 010 - Cartons of 84 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 011 - Cartons of 90 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 012 - Cartons of 90 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 013 - Cartons of 100 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 014 - Cartons of 100 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 018 - Cartons of 7 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 019 - Cartons of 7 film-coated tablets in all aluminium blisters
EU/ 1/ 08/ 465/ 001 - škatle s 14 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 465/ 002 - škatle s 14 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 08/ 465/ 003 - škatle z 28 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 465/ 004 - škatle z 28 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 08/ 465/ 005 - škatle s 30 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 465/ 006 - škatle s 30 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 08/ 465/ 007 - škatle s 50x1 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 465/ 008 - škatle s 50x1 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 08/ 465/ 009 - škatle z 84 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 465/ 010 - škatle z 84 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 08/ 465/ 011 - škatle z 90 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 465/ 012 - škatle z 90 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 08/ 465/ 013 - škatle s 100 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 465/ 014 - škatle s 100 filmsko obloženimi tabletam v aluminijastih pretisnih omotih EU/ 1/ 08/ 465/ 018 - škatle s 7 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 465/ 019 - škatle s 7 filmsko obloženimi tabletam v aluminijastih pretisnih omotih
Clopidogrel Winthrop 300 mg film-coated tablets
Clopidogrel Winthrop 300 mg filmsko obložene tablete
Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks.
S kombiniranim zdravljenjem je potrebno začeti čim prej po nastopu simptomov in z njim
maintenance dose, clopidogrel should be given as a single daily dose of 75 mg with or
Za vzdrževalno zdravljenje je treba klopidogrel uporabljati v enkratnem odmerku 75 mg na dan, s hrano ali brez nje.
15 In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
Zaradi pomanjkanja podatkov klopidogrela ne moremo priporočiti prvih 7 dni po akutni ishemični kapi.
Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses.
14 Izkušnje so omejene pri bolnikih z zmerno jetrno boleznijo, ki imajo lahko hemoragično diatezo.
16 Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the co- administration of phenobarbital, cimetidine, or oestrogen.
Poleg tega na farmakodinamično aktivnost klopidogrela ni pomembno vplivala sočasna uporaba fenobarbitala, cimetidina ali estrogena.
17 In CURE, the major bleeding event rate for clopidogrel+ASA was dose-dependent on ASA (< 100mg:
V CURE je bil delež dogodkov z velikimi krvavitvami za klopidogrel in ASA odvisen od odmerka ASA (< 100 mg:
In CLARITY, there was an overall increase in bleeding in the clopidogrel + ASA group (17.4%) vs. the placebo + ASA group (12.9%).The incidence of major bleeding was similar between groups (1.3% versus 1.1% for the clopidogrel + ASA and the placebo + ASA groups, respectively).
Incidenca večjih krvavitev je bila v obeh skupinah podobna (1, 3% v skupini s klopidogrelom in ASA ter 1, 1% v skupini s placebom in ASA).
Hallucinations, confusion
Intrakranialna
Nervous system disorders
Motnje okusa
reported with fatal outcome), headache, paraesthesia, dizziness
Ušesne bolezni, vključno z motnjami labirinta
System Organ Class
Vrtoglavica
Uncommon
Žilne bolezni
Very rare
Hematom
Eye bleeding (conjunctival, ocular, retinal)
Resne krvavitve, krvavitev operacijske rane, vaskulitis, hipotenzija
Ear and labyrinth disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora
Vertigo
Epistaksa
Vascular disorders
Krvavitve v dihalih (hemoptiza, pljučna krvavitev), bronhospazem, intersticijski pnevmonitis
Haematoma
Želodčna razjeda Retroperitonealna Krvavitev v prebavila in Bolezni prebavil
Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension
Krvavitev v prebavila, driska, bolečine v trebuhu,
Respiratory, thoracic and mediastinal disorders
in razjeda na dvanajstniku, gastritis, bruhanje, navzea, zaprtje, flatulenca
Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis
retroperitonealna krvavitev s smrtnim izidom, pankreatitis, kolitis (vključno z ulceroznim ali
Gastrointestinal haemorrhage, diarrhoea, abdominal
Organski sistem
Retroperitoneal haemorrhage
Pogosti dispepsija
Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis,
Občasni
pain, dyspepsia constipation, flatulence
Redki
colitis (including ulcerative or lymphocytic colitis), stomatitis
Zelo redki limfocitnim kolitisom), stomatitis
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja Bolezni mišično - skeletnega sistema in vezivnega tkiva
Bruising Rash, pruritus, skin bleeding (purpura)
Modrice
8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to
8, 9 do 36, 2), in šibkejšo (ni bila pomembno različna od ASA) pri bolnikih s kapjo (zmanjšanje RT=7, 3%; IZ: - 5, 7 do 18, 7 (p=0, 258)).
The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
19 Delež bolnikov s primarnim opazovanim dogodkom [srčno- žilna (SŽ) smrt, miokardni infarkt (MI) ali kap] je bil 582 (9, 3%) v skupini, zdravljeni s klopidogrelom, in 719 (11, 4%) v skupini, ki je prejemala placebo, to je 20% zmanjšanje relativnega tveganja (95% IZ od 10% - 28%; p=0, 00009) v skupini, zdravljeni s klopidogrelom (17% zmanjšanje relativnega tveganja, če so bili bolniki zdravljeni konzervativno, 29% kadar je bila izvedena perkutana transluminalna koronarna angioplastika (PTCA) z ali brez stenta in 10%, če je bila izvedena premostitvena operacija koronarnih arterij (CABG).
21 The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/LMWH, GPIIb/IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
Koristi, ki so jih opazili s klopidogrelom, so bile neodvisne od drugih akutnih in dolgotrajnih srčnožilnih terapij (kot je heparin / nizkomolekularni heparin, antagonisti glikoproteina, IIb/ IIIa, učinkovinami za zniževanje lipidov, zaviralci adrenergičnih receptorjev beta in zaviralci angiotenzinske konvertaze (ACEI)).
24, 47%; p < 0.001), mainly related to a reduction in occluded infarct-related arteries.
20 Primarni opazovani dogodek je bil opažen pri 15, 0% bolnikov v skupini s klopidogrelom in 21¸7% bolnikov v skupini s placebom, kar predstavlja absolutno zmanjšanje za 6, 7% in 36% zmanjšanje verjetnosti v prid klopidogrela (95% IZ od 24% do 47%; p < 0, 001) v glavnem zaradi zmanjšanja zaradi infarkta zamašenih arterij.
However, plasma concentrations of the parent compound are very low and below the quantification limit (0.00025 mg/l) beyond 2 hours.
Vendar pa so plazemske koncentracije izhodne spojine zelo majhne in pod mejo določljivosti (0, 00025 mg/ l) po 2 urah.
22 The kinetics of the main circulating metabolite were linear (plasma concentrations increased in proportion to dose) in the dose range of 50 to 150 mg of clopidogrel.
Kinetika glavnega krožečega metabolita je bila linearna (plazemske koncentracije so se povišale sorazmerno z odmerkom) v razponu odmerkov 50 do 150 mg klopidogrela.
The pharmacokinetics and pharmacodynamics of clopidogrel were assessed in a single and multiple dose study in both healthy subjects and those with cirrhosis (Child-Pugh class A or B).
21 Farmakokinetika in farmakodinamika klopidogrela sta bili ocenjeni v študiji enkratnega in večkratnega odmerka tako pri zdravih osebah kot pri tistih s cirozo (Child- Pugh klasifikacija A ali B).
EU/1/08/465/015 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/465/016 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/465/017 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters
EU/ 1/ 08/ 465/ 017 - Škatle s 100 x 1 filmsko obloženih tablet v perforiranih pretisnih omotih za enkratni odmerek, ki so v celoti iz aluminija.
25 ANNEX II
23 DODATEK II
- Clopidogrel Winthrop 75 mg film-coated tablets
− Clopidogrel Winthrop 75 mg filmsko obložene tablete
Sanofi Winthrop Industrie 1, route de la Vierge, Ambarès & Lagrave F-33565 Carbon Blanc Cedex France
Sanofi Winthrop Industrie 1, rue de la vierge Ambarès & Lagrave F- 33565 Carbon Blanc Cedex Francija
Sanofi-Synthelabo Limited Edgefield avenue, Fawdon, Newcastle-Upon-Tyne, Tyne & Wear NE3 3TT United Kingdom
Sanofi Synthelabo Limited Edgefield avenue, Fawdon Newcastle- Upon- Tyne, Tyne & Wear NE3 3TT Velika Britanija
Sanofi Winthrop Industrie 6, boulevard de l'Europe F -21800 Quétigny France
Sanofi Winthrop Industrie 6, boulevard de l’ Europe F- 21800 Quétigny Francija
- Clopidogrel Winthrop 300 mg film-coated tablets
− Clopidogrel Winthrop 300 mg filmsko obložene tablete
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 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.
Sistem farmakovigilance 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.
27 ANNEX III
25 DODATEK III
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 7, 14, 28, 30, 50x1, 84, 90 or 100 tablets
27 PODATKI NA ZUNANJI OVOJNINI Škatla s 7, 14, 28, 30, 50x1, 84, 90 ali 100 tabletami
Clopidogrel Winthrop 75 mg film-coated tablets clopidogrel
Clopidogrel Winthrop 75 mg filmsko obložene tablete klopidogrel
Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France – F-75013 Paris - France
Sanofi Pharma Bristol- Myers Squibb SNC 174 avenue de France- F - 75013 Paris – Francija
EU/1/08/465/001 14 tablets EU/1/08/465/002 14 tablets EU/1/08/465/003 28 tablets EU/1/08/465/004 28 tablets EU/1/08/465/005 30 tablets EU/1/08/465/006 30 tablets EU/1/08/465/007 50x1 tablets EU/1/08/465/008 50x1 tablets EU/1/08/465/009 84 tablets EU/1/08/465/010 84 tablets EU/1/08/465/011 90 tablets EU/1/08/465/012 90 tablets EU/1/08/465/013 100 tablets EU/1/08/465/014 100 tablets EU/1/08/465/018 7 tablets EU/1/08/465/019 7 tablets
EU/ 1/ 08/ 465/ 001 14 tablet EU/ 1/ 08/ 465/ 002 14 tablet EU/ 1/ 08/ 465/ 003 28 tablet EU/ 1/ 08/ 465/ 004 28 tablet EU/ 1/ 08/ 465/ 005 30 tablet EU/ 1/ 08/ 465/ 006 30 tablet EU/ 1/ 08/ 465/ 007 50x1 tablet EU/ 1/ 08/ 465/ 008 50x1 tablet EU/ 1/ 08/ 465/ 009 84 tablet EU/ 1/ 08/ 465/ 010 84 tablet EU/ 1/ 08/ 465/ 011 90 tablet EU/ 1/ 08/ 465/ 012 90 tablet EU/ 1/ 08/ 465/ 013 100 tablet EU/ 1/ 08/ 465/ 014 100 tablet EU/ 1/ 08/ 465/ 018 7 tablet EU/ 1/ 08/ 465/ 019 7 tablet
31 PARTICULARS TO APPEAR ON BLISTERS (boxes of 7, 14, 28 or 84 tablets)
29 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU (Škatle po 7, 14, 28 ali 84 tablet)
32 PARTICULARS TO APPEAR ON BLISTERS (boxes of 30, 50x1, 90 or 100 tablets)
30 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU (Škatle po 30, 50x1, 90 ali 100 tablet)
OUTER CARTON/Box of 4x1, 30x1 or 100x1 tablets
31 PODATKI NA ZUNANJI OVOJNINI Škatla s 4x1, 30x1, ali 100x1 tabletami
Clopidogrel Winthrop 300 mg film-coated tablets clopidogrel
Clopidogrel Winthrop 300 mg filmsko obložene tablete klopidogrel