natgillin/translations-raw huggingface dataset:
Plavix can be given to: • patients who have recently had a myocardial infarction (heart attack); Plavix can be started in the few days after the attack and up to 35 days later, • patients who have had a recent ischaemic stroke (non-bleeding stroke); Plavix can be started in the 7 days after the attack and up to 6 months later, • patients with peripheral arterial disease (problem with blood flow in the arteries), • patients who have a condition known as acute coronary syndrome, when it should be given with aspirin (another anticoagulant), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Zdravilo Plavix se lahko daje: • bolnikom, ki so nedavno imeli miokardni infarkt (srčni napad); z jemanjem zdravila Plavix je mogoče začeti nekaj dni po napadu in do 35 dni po njem; • bolnikom, ki so nedavno imeli ishemično kap (kap zaradi žilne zapore); z jemanjem zdravila Plavix je mogoče začeti v 7 dnevih po napadu in do 6 mesecev po njem; • bolnikom s periferno arterijsko boleznijo (težavami s pretokom krvi v arterijah); • bolnikom z akutnim koronarnim sindromom, pri katerih se mora zdravilo dajati skupaj z aspirinom (drugim antikoagulantom), vključno z bolniki, katerim je bil vstavljen stent (kratka cevka, nameščena v arteriji, da prepreči njeno zapiranje).
Plavix can be used in patients who are having a heart attack with an ‘ ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Zdravilo Plavix se lahko uporablja pri bolnikih, ki imajo srčni napad z „ elevacijo spojnice ST “ (nenormalni zapis na elektrokardiogramu ali EKG), če zdravnik meni, da bi zdravilo lahko bolniku pomagalo.
It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘ non-Q-wave’ myocardial infarction.
Lahko se uporablja tudi pri bolnikih, ki nimajo tega nenormalnega zapisa na EKG, če imajo nestabilno angino (resno obliko bolečine v prsih) ali so imeli miokardni infarkt brez Q zobca.
Plavix should be given as a single daily dose of 75 mg (one tablet) with or without food.
Zdravilo Plavix se daje kot enkratni dnevni odmerek 75 mg (ena tableta), z ali brez hrane.
In acute coronary syndrome, Plavix is used together with aspirin and the treatment generally starts with a 300 mg loading dose, which is followed by a daily dose of 75 mg for at least 4 weeks in ST elevation myocardial infarction or for up to 12 months in non-ST elevation syndrome.
Pri akutnem koronarnem sindromu se Plavix uporablja skupaj z aspirinom, zdravljenje pa se na splošno začne s 300 mg udarnim odmerkom, ki mu sledi jemanje 75 mg dnevnega odmerka v trajanju najmanj 4 tedne pri miokardnem infarktu z elevacijo spojnice ST ali največ 12 mesecev pri sindromu brez elevacije spojnice ST.
Plavix is an inhibitor of platelet aggregation.
Zdravilo Plavix je zaviralec agregacije trombocitov.
When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating).
Strjevanje krvi omogočajo posebne celice v krvi, krvne ploščice, ki se medsebojno zlepljajo (agregirajo).
This stops the platelets
Klopidogrel, učinkovina v zdravilu Plavix, zavira zlepljanje trombocitov tako, da onemogoča vezavo snovi ADP na posebni receptor na njihovi površini.
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The effectiveness of Plavix as an anticoagulant was examined in a study (CAPRIE) of around 19,000 patients with atherothrombosis, where Plavix was compared with aspirin.
Učinkovitost zdravila Plavix kot antikoagulanta so preučevali v okviru študije (CAPRIE), ki je vključevala približno 19. 000 bolnikov z aterotrombozo, pri čemer so zdravilo Plavix primerjali z aspirinom.
The study lasted from one to three years, and examined the rate of new ischaemic events (heart attacks, ischaemic strokes and death).
Spremljanje posameznega bolnika je trajalo od enega do treh let, pri čemer je študija preučevala število novih ishemičnih dogodkov (srčnih napadov, ishemičnih kapi in smrti).
2,172 of these had a stent inserted during the study.
Pri zdravljenju akutnega koronarnega sindroma brez elevacije spojnice ST so zdravilo Plavix primerjali s placebom (zdravilom brez zdravilne učinkovine) pri več kot 12. 000 bolnikih, zdravljenih do enega leta (študija CURE), pri čemer je 2172 bolnikov med študijo imelo vstavljen stent.
In ST-elevation myocardial infarction, Plavix was compared with a placebo in two studies, CLARITY (over 3,000 patients, where the patients received Plavix for up to eight days) and COMMIT (almost 46,000 patients, where the patients received Plavix with or without metoprolol for up to four weeks).
Pri zdravljenju miokardnega infarkta z elevacijo spojnice ST so zdravilo Plavix primerjali s placebom v dveh študijah, CLARITY (ki je vključevala več kot 3000 bolnikov, ki so do osem dni prejemali zdravilo Plavix) in COMMIT (ki je vključevala skoraj 46. 000 bolnikov, ki so do štiri tedne prejemali zdravilo Plavix z ali brez metoprolola).
What benefit has Plavix shown during the studies?
Kakšne koristi je zdravilo Plavix izkazalo med raziskavami?
There were 939 events in the Plavix group, and 1,020 in the aspirin group.
V skupini, ki je prejemala Plavix, je bilo naštetih 939 dogodkov, v skupini, zdravljeni z aspirinom, pa 1020.
Risk reduction means that fewer patients will have new ischaemic events when they receive Plavix, than if they receive aspirin (in other words, about 10 patients in 1,000 will avoid having a new ischaemic event within two years of starting Plavix instead of aspirin).
Zmanjšanje tveganja pomeni, da bo manj bolnikov doživelo nov ishemični napad, če bodo prejemali zdravilo Plavix kot pa če bodo prejemali aspirin (z drugimi besedami, približno 10 bolnikov od 1000 se bo izognilo novemu ishemičnemu napadu v dveh letih po pričetku prejemanja zdravila Plavix namesto aspirina).
In ST-elevation myocardial infarction, fewer patients on Plavix had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Pri miokardnem infarktu z elevacijo spojnice ST je bilo število bolnikov, pri katerih so se pojavili dogodki, manjše med bolniki, ki so jemali zdravilo Plavix, kot med bolniki, ki so prejemali placebo (262 v primerjavi s 377 v študiji CLARITY ter 2121 v primerjavi z 2310 v študiji COMMIT).
The main risk of Plavix is bleeding.
Glavno tveganje, povezano z zdravilom Plavix, so krvavitve.
For the full list of all side effects reported with Plavix, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Plavix, glejte Navodilo za uporabo.
Plavix should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients, who have severe liver disease, or have a disease which may cause bleeding.
Zdravila Plavix se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) klopidogrel ali katero koli drugo sestavino zdravila, imajo hudo obolenje jeter ali bolezen, ki lahko povzroči krvavenje.
The Committee for Medicinal products for Human Use (CHMP) decided that Plavix’ s benefits are greater than its risks for patients at risk of atherothrombotic events.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Plavix za bolnike, pri katerih obstaja nevarnost aterotrombotičnih dogodkov, večje od z njim povezanih tveganj.
The Committee recommended that Plavix be given marketing authorisation.
Zato je priporočil odobritev dovoljenja za promet z zdravilom Plavix.
Other information about Plavix:
Druge informacije o zdravilu Plavix:
The European Commission granted a marketing authorisation valid throughout the European Union for Plavix to Sanofi Pharma Bristol-Myers Squibb SNC on 15 July 1998.
Evropska komisija je dovoljenje za promet z zdravilom Plavix, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pharma Bristol- Myers Squibb SNC dne 15. julija 1998.
The Marketing Authorisation was renewed on 15 July 2003.
Dovoljenje za promet z zdravilom je bilo podaljšano 15. julija 2003.
The full EPAR for Plavix is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Plavix je na voljo tukaj.
EU Number EU/ 1/ 98/ 069/ 001a EU/ 1/ 98/ 069/ 001b EU/ 1/ 98/ 069/ 002a EU/ 1/ 98/ 069/ 002b EU/ 1/ 98/ 069/ 003a EU/ 1/ 98/ 069/ 003b EU/ 1/ 98/ 069/ 004a EU/ 1/ 98/ 069/ 004b EU/ 1/ 98/ 069/ 005a EU/ 1/ 98/ 069/ 005b EU/ 1/ 98/ 069/ 006a EU/ 1/ 98/ 069/ 006b EU/ 1/ 98/ 069/ 007a EU/ 1/ 98/ 069/ 007b EU/ 1/ 98/ 069/ 008 EU/ 1/ 98/ 069/ 009 EU/ 1/ 98/ 069/ 010 EU/ 1/ 98/ 069/ 011a EU/ 1/ 98/ 069/ 011b
Številka EU EU/ 1/ 98/ 069/ 001a EU/ 1/ 98/ 069/ 001b EU/ 1/ 98/ 069/ 002a EU/ 1/ 98/ 069/ 002b EU/ 1/ 98/ 069/ 003a EU/ 1/ 98/ 069/ 003b EU/ 1/ 98/ 069/ 004a EU/ 1/ 98/ 069/ 004b EU/ 1/ 98/ 069/ 005a EU/ 1/ 98/ 069/ 005b EU/ 1/ 98/ 069/ 006a EU/ 1/ 98/ 069/ 006b EU/ 1/ 98/ 069/ 007a EU/ 1/ 98/ 069/ 007b EU/ 1/ 98/ 069/ 008 EU/ 1/ 98/ 069/ 009 EU/ 1/ 98/ 069/ 010 EU/ 1/ 98/ 069/ 011a EU/ 1/ 98/ 069/ 011b
Invented name Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix
Izmišljeno ime Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix
Combined therapy should be started as early
S
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.
3 Plavix contains lactose.
3 Zdravilo Plavix vsebuje laktozo.
4 Apart from the specific medicinal product interaction information described above, interaction studies with clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed.
4 Razen zgoraj navedenih podatkov o specifičnih interakcijah z zdravili, študij o interakcijah klopidogrela z nekaterimi drugimi zdravili, ki jih bolniki z aterotrombotično boleznijo pogosto uporabljajo, niso izvedli.
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).
5 In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups (0.6% versus 0.5% in the clopidogrel + ASA and the placebo + ASA groups, respectively).
5 V študiji COMMIT je bil skupni delež večjih necerebralnih krvavitev ali cerebralne krvavitve nizek in podoben v obeh skupinah (0, 6% v skupini s klopidogrelom in ASA ter 0, 5% v skupini s placebom in ASA).
System Organ Class
Organski sistem Bolezni kože in podkožja Bolezni mišično - skeletnega sistema in vezivnega tkiva
Common
Pogosti Modrice
Retroperitoneal Gastrointestinal and
Občasni Izpuščaj, srbenje, kožne krvavitve (purpura)
disorders
Redki
retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Zelo redki Bulozen dermatitis (toksična epidermalna nekroliza, Stevens - Johnsonov sindrom, multiformni eritem), angioedem, eritematozen izpuščaj, urtikarija, ekcem, lihen planus Mišično- skeletne krvavitve (hemartroza), artritis, artralgija, mialgija
Hepato-biliary disorders
Bolezni sečil
Bruising
Hematurija
Musculoskeletal, connective tissue and bone disorders
Glomerulonefritis, zvišanje kreatinina v krvi
Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Splošne težave in spremembe na mestu aplikacije Preiskave
Renal and urinary disorders
Krvavitve na mestu vboda
General disorders and administration site conditions
Podaljšan čas krvavitve, zmanjšano število nevtrofilcev, zmanjšano število trombocitov
Bleeding at puncture site
Zvišana telesna temperatura
Investigations
4. 9 Preveliko odmerjanje
The safety and efficacy of clopidogrel have been evaluated in 4 double-blind studies involving over 80,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY and COMMIT studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
7 Varnost in učinkovitost klopidogrela so vrednotili v 4 dvojno slepih študijah, v katere je bilo vključenih več kot 80. 000 bolnikov: študija CAPRIE je obsegala primerjavo klopidogrela in ASA, v študijah CURE, CLARITY in COMMIT pa so primerjali klopidogrel s placebom; oboje pa so bolniki dobivali v kombinaciji z ASA in drugo standardno terapijo.
8 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 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 number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo- treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Število bolnikov s primarnim opazovanim dogodkom (srčno- žilna smrt, MI, kap ali neodzivna ishemijo) je bilo 1. 035 (16, 5%) v skupini zdravljeni s klopidogrelom in 1. 187 (18, 8%) v skupini s placebom, to je 14% zmanjšanje relativnega tveganja (95% IZ od 6% - 21%, p=0, 0005) za skupino, zdravljeno s klopidogrelom.
In particular, in a post-hoc analysis in 2,172 patients (17% of the total CURE population) who underwent stent placement (Stent-CURE), the data showed that clopidogrel compared to placebo, demonstrated a significant RRR of 26.2% favouring clopidogrel for the co-primary endpoint (CV death, MI, stroke) and also a significant RRR of 23.9% for the second co- primary endpoint (CV death, MI, stroke or refractory ischaemia).
Zlasti post hoc analiza podatkov 2172 bolnikov (17% celotne populacije CURE), ki so jim namestili žilno opornico (Stent- CURE), je ob klopidogrelu v primerjavi s placebom pokazala značilno, 26, 2% zmanjšanje RT za sestavljen primarni opazovani dogodek (srčno - žilna smrt, miokardni infarkt, možganska kap) in tudi značilno, 23, 9% zmanjšanje RT za drug sestavljen primarni opazovani dogodek (srčno- žilna smrt, miokardni infarkt, možganska kap ali neodzivna ishemija).
ST elevation, ST depression or left bundle-branch block).
9 V študijo COMMIT z 2x2 faktorsko raziskovalno zasnovo je bilo vključenih 45. 852 bolnikov v 24 urah po nastopu simptomov, ki bi lahko kazali na miokardni infarkt, z neustreznimi vrednostmi EKG, ki so to potrjevale (elevacija ST spojnice, depresija ST spojnice ali levokračni blok).
10 5.3 Preclinical safety data
10 5. 3 Predklinični podatki o varnosti
11 6.5 Nature and content of container
11 6. 5 Vrsta ovojnine in vsebina
EU/ 1/ 98/ 069/ 001a - Cartons of 28 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 001b - Cartons of 28 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 002a - Cartons of 50x1 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 002b - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 003a - Cartons of 84 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 003b - Cartons of 84 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 004a - Cartons of 100 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 004b - Cartons of 100 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 005a - Cartons of 30 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 005b - Cartons of 30 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 006a - Cartons of 90 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 006b - Cartons of 90 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 007a - Cartons of 14 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 007b - Cartons of 14 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 011a - Cartons of 7 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 011b - Cartons of 7 film-coated tablets in all aluminium blisters
EU/ 1/ 98/ 069/ 001a - škatle z 28 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 98/ 069/ 001b - škatle z 28 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 98/ 069/ 002a - škatle s 50x1 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 98/ 069/ 002b - škatle s 50x1 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 98/ 069/ 003a - škatle z 84 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 98/ 069/ 003b - škatle z 84 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 98/ 069/ 004a - škatle s 100 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 98/ 069/ 004b - škatle s 100 filmsko obloženimi tabletam v aluminijastih pretisnih omotih EU/ 1/ 98/ 069/ 005a - škatle s 30 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 98/ 069/ 005b - škatle s 30 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 98/ 069/ 006a - škatle z 90 filmsko obloženimi tabletami v PVC/ PVDV/ alu pretisnih omotih EU/ 1/ 98/ 069/ 006b - škatle z 90 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 98/ 069/ 007a - škatle s 14 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 98/ 069/ 007b - škatle s 14 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 98/ 069/ 011a - škatle s 7 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 98/ 069/ 011b - škatle s 7 filmsko obloženimi tabletami v aluminijastih pretisnih omotih
The benefit of the
S kombiniranim zdravljenjem je potrebno začeti čim prej po nastopu simptomov in z njim
combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section 5.1).
Koristnosti zdravljenja s kombinacijo klopidrogela in ASA, ki bi bilo daljše od štirih tednov, v tem okviru niso preučevali (glejte poglavje 5. 1).
19 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).
The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Število bolnikov s primarnim opazovanim dogodkom (SŽ smrt, MI, kap ali neodzivna ishemijo) je bilo 1. 035 (16, 5%) v skupini zdravljeni s klopidogrelom in 1. 187 (18, 8%) v skupini s placebom, to je 14% zmanjšanje relativnega tveganja (95% IZ od 6% - 21%, p=0, 0005) za skupino, zdravljeno s klopidogrelom.
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)).
EU/1/98/069/008 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/009 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/010 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters
EU/ 1/ 98/ 069/ 010 - Škatle s 100 x 1 filmsko obloženih tablet v perforiranih pretisnih omotih za enkratni odmerek, ki so v celoti iz aluminija.
- Plavix 300 mg film-coated tablets
- Plavix 300 mg filmsko obložene tablete
EU/1/98/069/001a 28 tablets EU/1/98/069/001b 28 tablets EU/1/98/069/002a 50x1 tablets EU/1/98/069/002b 50x1 tablets EU/1/98/069/003a 84 tablets EU/1/98/069/003b 84 tablets EU/1/98/069/004a 100 tablets EU/1/98/069/004b 100 tablets EU/1/98/069/005a 30 tablets EU/1/98/069/005b 30 tablets EU/1/98/069/006a 90 tablets EU/1/98/069/006b 90 tablets EU/1/98/069/007a 14 tablets EU/1/98/069/007b 14 tablets EU/1/98/069/011a 7 tablets EU/1/98/069/011b 7 tablets
EU/ 1/ 98/ 069/ 001a 28 tablet EU/ 1/ 98/ 069/ 001b 28 tablet EU/ 1/ 98/ 069/ 002a 50x1 tablet EU/ 1/ 98/ 069/ 002b 50x1 tablet EU/ 1/ 98/ 069/ 003a 84 tablet EU/ 1/ 98/ 069/ 003b 84 tablet EU/ 1/ 98/ 069/ 004a 100 tablet EU/ 1/ 98/ 069/ 004b 100 tablet EU/ 1/ 98/ 069/ 005a 30 tablet EU/ 1/ 98/ 069/ 005b 30 tablet EU/ 1/ 98/ 069/ 006a 90 tablet EU/ 1/ 98/ 069/ 006b 90 tablet EU/ 1/ 98/ 069/ 007a 14 tablet EU/ 1/ 98/ 069/ 007b 14 tablet EU/ 1/ 98/ 069/ 011a 7 tablet EU/ 1/ 98/ 069/ 011b 7 tablet
29 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)
30 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)
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