natgillin/translations-raw huggingface dataset:
Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor, and the subsequent ADP-mediated activation of the GPIIb/IIIa complex, thereby inhibiting platelet aggregation.
Klopidogrel selektivno zavira vezavo adenozin difosfata (ADP) na njegov trombocitni receptor in tako preko z ADP posredovane aktivacije kompleksa glikoproteina IIb/ IIIa zavira agregacijo trombocitov.
18 amplification of platelet activation by released ADP.
Klopidogrel prav tako zavira agregacijo trombocitov, sproženo z drugimi agonisti, z blokado ojačitve aktivacije 18 trombocitov s sproščenim ADP.
At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
V stanju dinamičnega ravnovesja je bila povprečno opažena raven zaviranja z odmerkom 75 mg na dan med 40% in 60%.
Patients were randomised to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years.
Bolniki so bili naključno razdeljeni v skupine, ki so prejemale klopidogrel 75 mg/ dan ali ASA 325 mg/ dan, spremljali so jih od 1 do 3 let.
8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to 18.7 [p=0.258]).
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)).
In patients who were enrolled in the trial on the sole basis of a recent myocardial 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)).
Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) or placebo (N=6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies.
Bolniki so bili naključno razporejeni v skupino, ki je prejemala klopidogrel (začetni odmerek 300 mg, nato 75 mg/ dan, n=6. 259) ali skupino, ki je prejemala placebo (n=6. 303), oboje prejeto v kombinaciji z ASA (75- 325 mg enkrat na dan) in drugimi standardnimi terapijami.
In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
V študiji CURE je 823 (6, 6%) bolnikov sočasno prejemalo terapijo z antagonisti receptorjev glikoproteinov IIb/ IIIa.
Heparins were administered in more than 90% of the patients and the relative rate of bleeding between clopidogrel and placebo was not significantly affected by the concomitant heparin therapy.
Heparine so 19 uporabljali pri več kot 90% bolnikov, sočasna uporaba heparinske terapije ni pomembno vplivala na relativni delež krvavitev med klopidogrelom in placebom.
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)).
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).
24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR = 18.2%; CI:
24, 3%, 57, 5%) in inhibitorji glikoproteinov IIb/ IIIa (zmanjšanje RT =18, 2%; IZ:
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.
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)).
Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Bolniki so dobivali klopidogrel (300 mg udarni odmerek, nato pa 75 mg na dan, n=1. 752) ali placebo (n=1. 739), oboje v kombinaciji z ASA (150 mg do 325 mg kot udarni odmerek, nato 75 mg do 162 mg na dan), fibrinolitičnim sredstvom in po potrebi heparinom.
68.7%, non-fibrin specific:
20 68, 7%, nefebrinsko specifične:
Patients received clopidogrel (75 mg/day, n=22,961) or placebo (n=22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge.
Bolniki so 28 dni oziroma do odpusta dobivali klopidogrel (75 mg na dan, n=22. 961) ali placebo (n=22. 891) v kombinaciji z ASA (162 mg na dan).
However, plasma concentrations of the parent compound are very low and below the quantification limit (0.00025 mg/l) beyond 2 hours.
5. 2 Farmakokinetične lastnosti
3mg/l after repeated 75 mg oral doses) occurred approximately 1 hour after dosing.
3 mg/ l po večkratnih 75 mg peroralnih odmerkih) se je pojavila približno 1 uro po odmerjanju.
The elimination half-life of the main circulating metabolite was 8 hours after single and repeated administration.
Razpolovni čas izločanja glavnega krožečega metabolita je bil 8 ur po enkratnem in večkratnem dajanju.
After repeated doses of 75 mg clopidogrel per day, plasma levels of the main circulating metabolite were lower in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min) compared to subjects with moderate renal disease (creatinine clearance from 30 to 60 ml/min) and to levels observed in other studies with healthy subjects.
Po večkratnih odmerkih 75 mg klopidogrela na dan, je bila plazemska raven glavnega krožečega metabolita nižja pri osebah s hudo ledvično boleznijo (očistek kreatinina 5 do 15 ml/ min) v primerjavi z osebami z zmerno ledvično boleznijo (očistek kreatinina 30 do 60 ml/ min) in v primerjavi z ravnmi, opaženimi v drugih študijah z zdravimi osebami.
Although inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, the prolongation of bleeding was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Čeprav je bila inhibicija z ADP sprožene agregacije trombocitov manjša (25%) od tiste, opažene pri zdravih osebah, je bilo podaljšanje krvavitve podobno
Daily dosing for 10 days with clopidogrel 75 mg/day was safe and well tolerated.
Dnevno odmerjanje 75 mg/ dan, 10 dni, je bilo varno in so ga bolniki dobro prenašali.
However, plasma levels of the main circulating metabolite together with the effect of clopidogrel on ADP-induced platelet aggregation and bleeding time were comparable between these groups.
Vendar pa je bila plazemska raven glavnega krožečega metabolita skupaj z učinkom klopidogrela na z ADP sproženo agregacijo trombocitov in čas krvavitve primerljiva med obema skupinama.
21 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti
These occurred at doses representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day and were a consequence of an effect on hepatic metabolising enzymes.
Pojavile so se pri odmerkih, ki predstavljajo najmanj 25- kratno izpostavljenost kot pri človeku ob prejemanju kliničnega odmerka 75 mg/ dan in so bile posledica učinka na jetrne presnovne encime.
At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/or vomiting) of clopidogrel was also reported in rat and baboon.
Pri zelo visokih odmerkih so pri podganah in pavijanih poročali tudi o slabem želodčnem prenašanju (gastritis, želodčne erozije in/ ali bruhanje).
There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
Ni bilo dokazov o kancerogenem učinku pri dajanju klopidogrela mišim 78 tednov in podganam 104 tedne v odmerkih do 77 mg/ kg na dan (kar predstavlja najmanj 25- krat višjo izpostavljenost kot pri človeku ob prejemanju kliničnega odmerka 75 mg/ dan).
Hypromellose (E464) Lactose Triacetin (E1518) Titanium dioxide (E171) Red iron oxide (E172) Carnauba wax
Obloga: hipromeloza (E464) laktoza triacetin (E1518) titanov dioksid (E171) rdeči železov oksid (E172) karnauba vosek
6. 3 Shelf-life
22 6. 3 Rok uporabnosti
22 6.5 Nature and content of container
6. 5 Vrsta ovojnine in vsebina
EU/1/08/464/015 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/464/016 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/464/017 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters
EU/ 1/ 08/ 464/ 017 - Škatle s 100 x 1 filmsko obloženih tablet v perforiranih pretisnih omotih za enkratni odmerek, ki so v celoti iz aluminija.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http://www.emea.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea.. europa. eu /
Sanofi Winthrop Industrie 1, route de la vierge, Ambarès & Lagrave F-33565 Carbon Blanc Cedex France
Sanofi Winthrop Industrie 1, route 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
Sanofi Winthrop Industrie 1, rue 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
CONDITIONS OF THE MARKETING AUTH ORISATION
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
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 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
Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Ena tableta vsebuje 75 mg klopidogrela (v obliki hidrogensulfata).
14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50x1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets 7 film-coated tablets
7 filmsko obloženih tablet.
EXP {MM/YYYY}
{MM/ LLLL}
Store below 30°C (for PVC/PVDC/aluminium blisters) Or No special storage conditions (for all aluminium blisters)
Za shranjevanje zdravila niso potrebna posebna navodila (za aluminijaste pretisne omote).
EU/1/08/464/001 14 tablets EU/1/08/464/002 14 tablets EU/1/08/464/003 28 tablets EU/1/08/464/004 28 tablets EU/1/08/464/005 30 tablets EU/1/08/464/006 30 tablets EU/1/08/464/007 50x1 tablets EU/1/08/464/008 50x1 tablets EU/1/08/464/009 84 tablets EU/1/08/464/010 84 tablets EU/1/08/464/011 90 tablets EU/1/08/464/012 90 tablets EU/1/08/464/013 100 tablets EU/1/08/464/014 100 tablets EU/1/08/464/018 7 tablets EU/1/08/464/019 7 tablets
EU/ 1/ 08/ 464/ 001 14 tablet EU/ 1/ 08/ 464/ 002 14 tablet EU/ 1/ 08/ 464/ 003 28 tablet EU/ 1/ 08/ 464/ 004 28 tablet EU/ 1/ 08/ 464/ 005 30 tablet EU/ 1/ 08/ 464/ 006 30 tablet EU/ 1/ 08/ 464/ 007 50x1 tablet EU/ 1/ 08/ 464/ 008 50x1 tablet EU/ 1/ 08/ 464/ 009 84 tablet EU/ 1/ 08/ 464/ 010 84 tablet EU/ 1/ 08/ 464/ 011 90 tablet EU/ 1/ 08/ 464/ 012 90 tablet EU/ 1/ 08/ 464/ 013100 tablet EU/ 1/ 08/ 464/ 014100 tablet EU/ 1/ 08/ 464/ 018 7 tablet EU/ 1/ 08/ 464/ 019 7 tablet
Batch number:
Serija:
INSTRUCTIONS ON USE
NAČIN IZDAJANJA ZDRAVILA
30 PARTICULARS TO APPEAR ON BLISTERS (boxes of 7, 14, 28 or 84 tablets)
30 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU (Škatle po 7, 14, 28 ali 84 tablet)
Batch number
Serija:
Calendar days Mon Tue Wed Thu Fri Sat Sun
Pon Tor Sre Čet Pet Sob Ned
Week 1 Week 2 (for boxes of 14, 28 and 84 tablets) Week 3 (for boxes of 28 and 84 tablets) Week 4 (for boxes of 28 and 84 tablets)
Teden 1 Teden 2 (samo za škatle z 14, 28 in 84 tabletami) Teden 3 (samo za škatle z 28 in 84 tabletami) Teden 4 (samo za škatle z 28 in 84 tabletami)
31 PARTICULARS TO APPEAR ON BLISTERS (boxes of 30, 50x1, 90 or 100 tablets)
31 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
32 PODATKI NA ZUNANJI OVOJNINI Škatla s 4x1, 30x1, ali 100x1 tabletami
Each tablet contains 300 mg of clopidogrel (as hydrogen sulphate)
Ena tableta vsebuje 300 mg klopidogrela (v obliki hidrogensulfata).
EU/1/08/464/015 4x1 film-coated tablets EU/1/08/464/016 30x1 film-coated tablets EU/1/08/464/017 100x1 film-coated tablets
EU/ 1/ 08/ 464/ 015 4x1 filmsko obloženih tablet EU/ 1/ 08/ 464/ 016 30x1 filmsko obloženih tablet EU/ 1/ 08/ 464/ 017 100x1 filmsko obloženih tablet
BLISTER /Box of 4x1, 30x1 or 100x1 tablets
34 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU (Škatle po 4x1, 30x1 ali 100x1 tablet)
36 PACKAGE LEAFLET:
36 NAVODILO ZA UPORABO
What Clopidogrel BMS is and what it is used for 2.
Kaj je zdravilo Clopidogrel BMS in za kaj ga uporabljamo 2.
Before you take Clopidogrel BMS 3.
Kaj morate vedeti, preden boste vzeli zdravilo Clopidogrel BMS 3.
How to take Clopidogrel BMS 4.
Kako jemati zdravilo Clopidogrel BMS 4.
Possible side effects 5 How to store Clopidogrel BMS 6.
Shranjevanje zdravila Clopidogrel BMS 6.
- You have a condition of hardening of arteries (also known as atherosclerosis), and
- imate stanje otrdelih arterij (znano tudi kot ateroskleroza), in
- You have previously experienced a heart attack, stroke or have a condition known as peripheral
- ste predhodno doživeli srčni napad, kap ali imeli stanje, ki je znano kot periferna arterijska
arterial disease, or
bolezen, ali
- You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial
- ste doživeli hudo obliko bolečine v prsih, znano kot “ nestabilna angina ” ali “ miokardni infarkt ”
infarction’ (heart attack).
(srčni napad).
BEFORE YOU TAKE CLOPIDOGREL BMS
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO CLOPIDOGREL BMS
Do not take Clopidogrel BMS:
Ne jemljite zdravila Clopidogrel BMS:
• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel BMS; • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain; • If you suffer from severe liver disease.
- če imate zdravstveno stanje, ki trenutno povzroča krvavitev, kot je rana na želodcu ali krvavitev
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking clopidogrel.
Če menite, da se karkoli od navedenega nanaša na vas, ali če ste kakorkoli v dvomih, se posvetujte s
37 Take special care with Clopidogrel BMS:
37 svojim zdravnikom, preden boste vzeli klopidogrel.
If any of the situations mentioned below apply to you, you should tell your doctor before taking clopidogrel: • if you have a risk of bleeding such as
Če katerokoli od spodaj navedenih stanj velja za vas, morate o tem obvestiti svojega zdravnika, preden boste vzeli zdravilo klopidogrel: • če imate tveganje za krvavitev, kot je:
- a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer)
- zdravstveno stanje s tveganjem za notranjo krvavitev (kot je rana na želodcu)
a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
- krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitev v tkivih, organih ali
- - -
sklepih vašega telesa).
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)
you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the
- načrtovan kirurški poseg (vključno na zobeh) v naslednjih 7 dneh
last seven days • if you are taking another type of medicine (see ‘Taking other medicines’). • if you have kidney or liver disease
• če ste imeli strdek v možganski arteriji (ishemična kap), ki se je pojavil v zadnjih sedmih dneh • če jemljete druge vrste zdravil (glejte “ Jemanje drugih zdravil ”) • če imate ledvične ali jetrne bolezni
While you are taking clopidogrel: • You should tell your doctor if a surgery (including dental) is planned. • You should also tell your doctor immediately if you develop a medical condition that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see ‘POSSIBLE SIDE EFFECTS’). • If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Ko jemljete klopidogrel: • morate povedati zdravniku, če imate predvideno kakšno operacijo (vključno z zobozdravstvenim posegom). • morate takoj povedati zdravniku, če razvijete bolezensko stanje z vročino in modricami pod kožo, ki se lahko pojavijo kot drobne rdeče pike, z ali brez nerazložljive hude utrujenosti, zmedenosti, porumenele kože ali oči (zlatenica) (glejte MOŽNI NEŽELENI UČINKI). • se lahko krvavitev ustavi počasneje kot ponavadi, če se urežete ali poškodujete.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see ‘POSSIBLE SIDE EFFECTS’). • Your doctor may order blood tests. • You should tell your doctor or pharmacist if you notice any side effect not listed in the ‘POSSIBLE SIDE EFFECTS’ section of this leaflet or if you notice that a side effect gets serious.
Če pa vas glede krvavitve skrbi, se nemudoma posvetujte z zdravnikom (glejte MOŽNI NEŽELENI UČINKI). • lahko vaš zdravnik naroči preiskave krvi. • obvestite svojega zdravnika ali farmacevta, če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v poglavju MOŽNI NEŽELENI UČINKI tega navodila za uporabo.
Clopidogrel is not intended for use in children or adolescents.
Klopidogrel ni namenjen za uporabo pri otrocih ali mladostnikih.
Some other medicines may influence the use of clopidogrel or vice versa.
Nekatera druga zdravila lahko vplivajo na uporabo klopidogrela in obratno.
The use of oral anticoagulants (medicines used to reduce blood clotting) with clopidogrel is not recommended.
Uporaba peroralnih antikoagulantov (zdravil, ki se uporabljajo za zmanjševanje strjevanja krvi) z klopidogrelom ni priporočljiva.
You should specifically tell your doctor if you take a non-steroidal anti-inflammatory drug, usually used to treat painful and/or inflammatory conditions of muscle or joints, or if you take heparin or any other medicine used to reduce blood clotting.
Še posebej pomembno je, da obvestite svojega zdravnika, če jemljete nesteroidna protivnetna zdravila, ki se običajno uporabljajo za lajšanje bolečine in/ ali vnetja mišic ali sklepov, ali če jemljete heparin, ali katerokoli drugo zdravilo, ki se uporablja za zmanjševanje strjevanja krvi.
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.
Priložnostna uporaba acetilsalicilne kisline (ne več kot 1. 000 mg v kateremkoli 24 urnem obdobju) na splošno ne bi smela povzročati težav, vendar pa se morate o daljši uporabi v drugih okoliščinah posvetovati s svojim zdravnikom.
Taking Clopidogrel BMS with food and drink Food/meals have no influence.
Jemanje zdravila Clopidogrel BMS skupaj s hrano in pijačo Hrana/ obroki nimajo vpliva.
Clopidogrel may be taken with or without food.
Klopidogrel lahko jemljete s hrano ali brez nje.
38 Pregnancy and breast-feeding It is preferable not to use this product during pregnancy and breast-feeding.
38 Če ste noseči ali mislite, da ste noseči, morate o tem obvestiti svojega zdravnika ali farmacevta, preden vzamete klopidogrel.
Clopidogrel is unlikely to affect your ability to drive or to use machines.
Ni verjetno, da bi klopidogrel vplival na vašo sposobnost za vožnjo ali upravljanje strojev.
Clopidogrel BMS contains lactose and hydrogenated castor oil.
Pomembne informacije o nekaterih sestavinah zdravila Clopidogrel BMS Zdravilo Clopidogrel BMS vsebuje laktozo in hidrogenirano ricinusovo olje.
Hydrogenated castor oil may cause stomach upset or diarrhoea.
Hidrogenirano ricinusovo olje lahko povzroči želodčne motnje ali drisko.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel BMS (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment.
Če ste imeli hudo bolečino v prsih (nestabilna angina pektoris ali srčna kap), vam lahko zdravnik na začetku zdravljenja da enkrat 300 mg zdravila Clopidogrel BMS (eno 300- mg tableto ali štiri 75- mg tablete).
Then, the usual dose is one 75-mg tablet of Clopidogrel BMS per day to be taken orally with or without food, and at the same time each day.
Nato je običajni odmerek ena 75- mg tableta zdravila Clopidogrel BMS na dan, ki jo lahko vzamete s hrano ali brez nje; odmerek morate jemati vsak dan ob istem času.
You should take clopidogrel for as long as your doctor continues to prescribe it.
Klopidogrel morate jemati, vse dokler vam ga vaš zdravnik predpisuje.
Contact your doctor or the nearest emergency department because of the increased risk of bleeding.
Zaradi povečanega tveganja krvavitve se posvetujte s svojim zdravnikom ali oddelkom najbližje nujne zdravniške pomoči.
If you forget to take a dose of clopidogrel, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Če pozabite vzeti odmerek zdravila Clopidogrel BMS in se nanj spomnite do 12 ur po ustaljenem času, takoj vzemite tableto in nato vzemite naslednjo tableto spet ob ustaljenem času jemanja.