natgillin/translations-raw huggingface dataset:
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, nevedno v poglavju 6.1.
• Hypersensitivity to the active substance or to any of the excipients listed in section 2 or section
Pri sočasni uporabi klopidogrela z atenololom, nifedipinom, ali z obema - atenololom in nifedipinom - niso opazili nobenih klinično pomembnih farmakodinamičnih interakcij.
No clinically significant pharmacodynamic interactions were observed when clopidogrel was co administered with atenolol, nifedipine, or both atenolol and nifedipine.
in inhibitorji glikoproteinov IIb/IIIa (zmanjšanje RT =18,2 %; IZ: 6,5 %, 28,3 %).
The use of clopidogrel in CURE was associated with a decrease in the need of thrombolytic therapy (RRR=43.3%; CI: 24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR=18.2%; CI: 6.5%, 28.3%).
Zdravilo Klopidogrel Teva Pharma B.V. vsebuje laktozo
Clopidogrel Teva Pharma B.V. contains lactose
Plodnost Šudije na živalih niso pokazale, da bi klopidogrel vplival na plodnost.
Fertility Clopidogrel was not shown to alter fertility in animal studies.
HDPE steklenička po 30 tablet:
30 tablets HDPE bottle:
Za dodatne informacije glejte navodilo za uporabo.
See leaflet for further information
Aktivni presnovek klopidogrela selektivno zavira vezavo adenozin-difosfata (ADP) na njegov trombocitni receptor P2Y12
The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation.
Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v
Each film-coated tablet contains 75 mg of clopidogrel (as hydrobromide).
se statistično ni razlikoval od acetilsalicilne kisline (zmanjšanje RT=4,0 %; IZ: -22,5 do 11,7 [p=0,639]).
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]).
Zdravilo Klopidogrel Teva Pharma B.V. je na voljo v perforiranih pretisnih omotih iz aluminija, ki se odlepijo, in sicer po 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 tablet; ter perforiranih pretisnih omotih iz aluminija, in sicer po 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1
Clopidogrel Teva Pharma B.V. is supplied in peelable perforated blisters of aluminium/ aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablet; perforated blisters of aluminium/ aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablet or HDPE bottles with polypropylene closures or child resistant polypropylene closures and silica gel desiccant containing 30 or 100 tablets.
Klopidogrel Teva Pharma B.V. 75 mg filmsko obložene tablete klopidogrel
Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets clopidogrel
Klopidogrel
Breast-feeding
Z ZDRAVILOM Teva Pharma B.V.
Teva Pharma B.V.,
Zdravilo Klopidogrel Teva Pharma B.V. vsebuje laktozo.
Clopidogrel Teva Pharma B.V. contains lactose.
IME IMETNIKA DOVOLJENJA
MARKETING AUTHORISATION HOLDER
Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland
Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tél/Tel: +49 731 402 02
Zdravilo Klopidogrel Teva Pharma B.V. vam je bilo predpisano v naslednjih primerih:
You have been prescribed Clopidogrel Teva Pharma B.V. because:
Navodila za odstranjevanje tablet
Push the tablet out
gre večina alelov z zmanjšanim delovanjem pri Kavkazijcih(85%) in pri Azijcih (99 %), ki so slabi metabolizatorji.
The CYP2C19*2 and CYP2C19*3 alleles account for the majority of reduced function alleles in Caucasian (85%) and Asian (99%) poor metabolisers.
HDPE stekleničke po 30 tablet:
30 tablets HDPE bottles:
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):
Uncommon side effects (may affect up to 1 in 100 people):
so preprečili z zmanjšanjem relativnega tveganja: 22 % v 0. - 1. mesecu (IZ: 8,6, 33,4), 32 % v 1.
New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
s placebom + acetilsalicilno kislino (6,7 % v primerjavi s 4,3 %).
In ACTIVE-A, the rate of major bleeding was greater in the clopidogrel + ASA group than in the placebo + ASA group (6.7% versus 4.3%).
Ko jemljete zdravilo Klopidogrel Teva Pharma B.V.:
While you are taking Clopidogrel Teva Pharma B.V.:
Bolezni kože in podkožja bulozni dermatitis (toksična epidermalna nekroliza, StevensJohnsonov sindrom, multiformni eritem), angioedem, z zdravili povzročen
Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Klopidogrel se najprej presnovi v 2-oksoklopidogrel, ki je vmesen presnovek.
Clopidogrel is first metabolised to a 2-oxo-clopidogrel intermediate metabolite.
- Akutni miokardni infarkt z elevacijo ST spojnice: klopidogrel je potrebno dajati v enkratnem dnevnem odmerku 75 mg, zdravljenje pa je potrebno začeti
- 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.
HDPE stekleničke po 100 tablet:
100 tablets HDPE bottles:
Q zobca), vključno z bolniki, katerim je bil vstavljen stent po perkutani koronarni intervenciji, v kombinaciji z acetilsalicilno kislino (ASA - acetylsalicylic acid).
- Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA) - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
spomnite po več kot 12 urah, izpustite pozabljeni odmerek in naslednji odmerek vzemite ob običajnem času.
If you forget to take a dose of Clopidogrel Teva Pharma B.V., but don't remember within 12 hours of the missed dose, skip the missed dose and take the next tablet at the usual time.
s klopidogrelom
Film-coating
IME ZDRAVILA IN POT(I) UPORABE Klopidogrel Teva Pharma B.V. 75 mg filmsko obložene tablete klopidogrel peroralna uporaba
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets clopidogrel oral use
in približno 46 % z blatom v 120 urnem intervalu po odmerjanju. Po enem peroralnem odmerku 75 mg je razpolovni čas klopidogrela približno 6 ur. Razpolovni čas izločanja glavnega (neaktivnega) krožečega metabolita je bil 8 ur po enkratnem in večkratnem dajanju.
The elimination half-life of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Po uporabi klopidogrela je bila opisana pridobljena hemofilija.
Acquired haemophilia has been reported following use of clopidogrel.
Pridobljena hemofilija
Acquired haemophilia
tiklopidin, druga antiagregacijska zdravila,
• Ticlopidine, other antiplatelet agent.
Kako jemati zdravilo Klopidogrel Teva Pharma B.V.
How to take Clopidogrel Teva Pharma B.V.
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
Rare side effects (may affect up to 1 in 1000 people):
cimetidina, ki je CYP2C19 inhibitor) ali antacidi, ovirajo antitrombocitno delovanje klopidogrela.
There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers (except cimetidine which is a CYP2C19 inhibitor) or antacids interfere with antiplatelet activity of clopidogrel.
ZUNANJA
Excipients
Dojenje
Haematoma
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
Very rare side effects (may affect up to 1 in 10,000 people):
Če med zdravljenjem z zdravilom Klopidogrel Teva Pharma B.V. zanosite, se takoj posvetujte
If you become pregnant while taking Clopidogrel Teva Pharma B.V., consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
IME ZDRAVILA Klopidogrel Teva Pharma B.V. 75 mg filmsko obložene tablete
NAME OF THE MEDICINAL PRODUCT Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets
ETIKETA STEKLENIČKE (30 in 100 filmsko obloženih tablet)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING BOTTLE LABEL (30 or 100 film-coated tablets)
spomnite do 12 ur od vašega običajnega časa jemanja, takoj vzemite tableto.
If you forget to take a dose of Clopidogrel Teva Pharma B.V., but remember within 12 hours of the missed dose, take your tablet straight away and then take your next tablet at the usual time.
Študija je ocenila farmakokinetiko in antiagregacijski odziv po uporabi odmerka 300 mg in potem 75 mg/dan ter 600 mg in potem 150 mg/dan, vsako od obeh shem skupaj 5 dni (stanje dinamičnega ravnovesja).
A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metaboliser groups (ultrarapid, extensive, intermediate and poor), evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg/day and 600 mg followed by 150 mg/day, each for a total of 5 days (steady state).
trombocitov podobno kot pri zdravih preiskovancih. Tudi povprečno podaljšanje časa krvavitve je bilo v obeh skupinah podobno.
The mean bleeding time prolongation was also similar in the two groups.
zmanjšanje števila belih krvnih celic, zaradi česar je tveganje za okužbo večje (nevtropenija),
Reduced levels of certain white blood cells which increases the risk of infection (neutropenia) Vertigo (dizziness accompanied by a whirling sensation) Bleeding inside the abdomen
ter z/brez uporabe trombolitikov. Pri bolnikih, ki so starejši od 75 let, je treba zdravljenje
For patients over 75 years of age clopidogrel should be initiated without a loading dose.
ŠKATLICA za stekleničke (30 ali 100 filmsko obloženih tablet)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON of bottles (30 or 100 film-coated tablets)
sistemske hipertenzije; predhodno možgansko kap, tranzitorno ishemično atako (TIA) ali sistemski embolus (ne v osrednjem živčevju); disfunkcijo levega prekata z iztisnim deležem levega prekata (LVEF) < 45 %; ali dokumentirano bolezen perifernih žil. Povprečna ocena CHADS2 je bila 2,0 (razpon: od 0 do 6).
Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age ≥75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
Če dojite ali nameravate dojiti, se pred jemanjem
If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine.
Zlasti post-hoc analiza podatkov 2172 bolnikov (17 % celotne populacije CURE), ki so jim namestili žilno opornico (Stent-CURE), je ob klopidogrelu v primerjavi
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).
s kombinacijo klopidrogela in ASA, ki bi bilo daljše od štirih tednov, v tem okviru
The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section 5.1).
V študiji CURE je 823 (6,6 %) bolnikov sočasno prejemalo
In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
- Perforirani pretisni omoti vsebujejo 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta.
- Perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
- If you have any side effects, including any side effects not listed in this leaflet, talk your doctor or pharmacist.
Otroci in mladostniki Ne dajajte
Posology: • Adults and older people
s klopidogrelom (17 % zmanjšanje relativnega tveganja, če so bili bolniki zdravljeni konzervativno, 29 % kadar je bila izvedena perkutana transluminalna koronarna angioplastika (PTKA) z ali brez stenta in 10 %, če je bila izvedena premostitvena operacija koronarnih arterij (POKA)).
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)).
otekanje ust ali bolezni kože, kot so izpuščaj, srbenje in mehurji na koži. To so lahko znaki alergijske reakcije.
• Swelling in the mouth or skin disorders such as rashes, itching and blistering of the skin.
in ireverzibilno veže na trombocitne receptorje in tako zavre agregacijo trombocitov.
The active thiol metabolite which has been isolated in vitro, binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation.
Podatki se nanašajo na klopidogrel
These results indicate that clopidogrel can be administered with pantoprazole.
in acetilsalicilno kislino sočasno uporabljali do enega leta (glejte poglavje 5.1).
However, clopidogrel and ASA have been administered together for up to one year (see section
ASA (75-100 mg na dan) je treba uvesti in nadaljevati v kombinaciji
In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75-100 mg daily) should be initiated and continued in combination with clopidogrel (see section 5.1).
Teva Pharma B.V. Computerweg 10 3542 DR Utrecht Nizozemska
3542 DR Utrecht The Netherlands
Podrobne informacije o zdravilu
EFFECTIVE USE OF THE MEDICINAL PRODUCT
- Perforirani pretisni omoti, ki se odlepijo, vsebujejo 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta.
- Peelable perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet.
srčna kap), vam lahko zdravnik na začetku zdravljenja da enkrat 300 mg zdravila Klopidogrel Teva Pharma B.V. Nato je običajni odmerek ena 75-mg tableta zdravila Klopidogrel Teva Pharma B.V. na dan.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Pharma B.V. once at the start of treatment.
V študijo COMMIT z 2x2 faktorsko raziskovalno zasnovo je bilo vključenih 45.852 bolnikov v 24 urah po nastopu
The 2x2 factorial design COMMIT trial included 45,852 patients presenting within 24 hours of the onset of the symptoms of suspected MI with supporting ECG abnormalities (i.e. ST elevation, ST depression or left bundle-branch block).
Teva Pharma Belgium N.V./S.A. Tel/Tél: +32 3 820 73 73
Tel/Tél: +32 3 820 73 73
Bolezni prebavil krvavitev v retroperitonealna krvavitev krvavitev v prebavila in retroperitonealna krvavitev s smrtnim izidom, pankreatitis, kolitis (vključno z ulceroznim ali limfocitnim
Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Hujše krvavitve so bile v obeh skupinah večinoma ekstrakranialne (5,3 % v skupini
Major bleeding was mostly of extracranial origin in both groups (5.3% in the clopidogrel + ASA group; 3.5% in the placebo +ASA group), mainly from the gastrointestinal tract (3.5% vs. 1.8%).
spoja ali srčno intervencijo pred starostjo 120 dni po dogodku, za katerega je bilo ocenjeno, da je trombotične narave: v skupini
There was no significant difference between groups in the primary composite endpoint of death, shunt thrombosis or cardiac-related intervention prior to 120 days of age following an event considered of thrombotic nature (89 [19.1%] for the clopidogrel group and 90 [20.5%] for the placebo group) (see section 4.2).
s skupino
Common
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
The number of patients who reached the primary endpoint (time to first occurrence of stroke, MI, non-CNS systemic embolism or vascular death) was 832 (22.1%) in the group treated with clopidogrel + ASA and 924 (24.4%) in the placebo + ASA group (relative risk reduction of 11.1%; 95% CI of 2.4% to 19.1%; p=0.013), primarily due to a large reduction in the incidence of strokes.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki bromida).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg clopidogrel (as hydrobromide)
s placebom + acetilsalicilno kislino (0,8 %). Med skupinama ni bilo
+ ASA treatment group compared to the placebo + ASA group (1.4% versus 0.8%, respectively).
• zdravila, ki razgrajujejo krvne strdke (npr.
• Medicines used to break down blood clots (e.g. alteplase and streptokinase).
Organski sistem Pogosti
Nervous system disorders
in acetilsalicilno kislino je možna in lahko poveča tveganje za pojav krvavitev.
A pharmacodynamic interaction between clopidogrel and acetylsalicylic acid is possible, leading to increased risk of bleeding.
21 % (vzdrževalni odmerek).
The decrease was associated with a 39% (loading dose) and 21% (maintenance dose) reduction of inhibition of platelet aggregation.
V študiji CURE število velikih krvavitev s klopidogrelom
There was an excess of intracranial bleeding in the clopidogrel
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
Common side effects (may affect up to 1 in 10 people):
ZUNANJA OVOJNINA - pretisni omoti, ki se odlepijo (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON of peelable blisters (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet)
izpuščaj, srbenje, nenormalen občutek za dotik,
Neutropenia, including severe neutropenia
Če menite, da se karkoli od navedenega nanaša na vas ali če ste kakorkoli v dvomih, se posvetujte
• If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Teva Pharma B.V.
in eden njegovih presnovkov zavira agregacijo trombocitov.
Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation.
Zdravilo Klopidogrel Teva Pharma B.V. vsebuje tudi hidrogenirano ricinusovo olje Ta lahko povzroči želodčne težave in drisko.
Clopidogrel Teva Pharma B.V. contains hydrogenated castor oil.
Po večkratnem odmerjanju 75 mg klopidogrela na dan 10 dni pri bolnikih
After a single oral dose of 75 mg, clopidogrel has a half-life of approximately 6 hours.
glavobol in omotica,
Headache and dizziness
so večji delež dogodkov ugotovili samo pri slabih metabolizatorjih v primerjavi z dobrimi.
In CHARISMA and one cohort study (Simon), an increased event rate was observed only in poor metabolisers when compared to extensive metabolisers.
s smrtnim izidom), glavobol, parestezije, omotica motnje okušanja
Intracranial bleeding (some cases were reported with fatal outcome), headache, paraesthesia, dizziness
Bolnike so randomizirali na prejemanje klopidogrela 0,2 mg/kg (n = 467) ali placeba (n = 439) obenem s sočasnim osnovnim zdravljenjem do tedaj, ko je bila opravljena operacija druge stopnje.
In a randomised, double-blind, parallel-group study (CLARINET), 906 paediatric patients (neonates and infants) with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt were randomised to receive clopidogrel 0.2 mg/kg (n=467) or placebo (n=439) along with concomitant background therapy up to the time of second stage surgery.
Uporaba 75 mg klopidogrela na dan ni spremenila farmakokinetike S-varfarina ali
Although the administration of clopidogrel 75 mg/day did not modify the pharmacokinetics of S-warfarin or International Normalised Ratio (INR) in patients receiving long-term warfarin therapy, coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent effects on hemostasis.
Shranjavenja zdravila Klopidogrel Teva Pharma B.V.
How to store Clopidogrel Teva Pharma B.V.
s premeno trombocitov.
Vascular disorders
Terapevtske izkušnje
CLINICAL PARTICULARS
30 filmsko obloženih tablet 100 filmsko obloženih tablet peroralna uporaba Pred uporabo preberite priloženo navodilo.
Discard 30 days after first opening 100 tablets HDPE bottle: Discard 100 days after first opening
Zdravilo Klopidogrel Teva Pharma B.V. klopidogrel in spada v skupino zdravil imenovano »zaviralci agregacije trombocitov«.
Clopidogrel Teva Pharma B.V contains clopidogrel and belongs to a group of medicines called “platelet aggregation inhibitors.” It works by stopping certain particles in your blood (“platelets”) from sticking together to form blood clots which can block blood flow to important parts of your body including your heart and your brain.
V natisnjenem navodilu za uporabo zdravila mora biti navedeno
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Zdravilo Klopidogrel Teva Pharma B.V. lahko jemljete
Clopidogrel Teva Pharma B.V. with food and drink You can take Clopidogrel Teva Pharma B.V. with or without food.
Q zobca) do 24 ur po zadnji epizodi bolečine v prsih ali simptomih, skladnih z ishemijo.
The CURE study included 12,562 patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischaemia.
trombocite ohrani vso njihovo preostalo življenjsko dobo (približno 7-10 dni)
Due to the irreversible binding, platelets exposed are affected for the remainder of their lifespan (approximately 7-10 days) and recovery of normal platelet function occurs at a rate consistent with platelet turnover.
s placebom, to je 14 % zmanjšanje relativnega tveganja (95 % IZ od 6 % -21 %, p=0,0005) za skupino, zdravljeno
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.
sindrom preobčutljivosti (sindrom DIHS, DrugInduced
Eye bleeding (conjunctival, ocular, retinal)
ŠKATLICA za pretisne omote (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta)
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets)
Допълнителна информация за RoActemra можете да намерите на уебсайта на Агенцията: ema.europa.eu/medicines/human/EPAR/RoActemra.
Further information on RoActemra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/RoActemra.
Какви мерки се предприемат, за да се гарантира безопасната и ефективна употреба на RoActemra?
What measures are being taken to ensure the safe and effective use of RoActemra?
Пакетът ще включва също сигнална карта за пациента с важна информация за пациентите относно безопасността.
The pack will also include a patient alert card with key safety information for patients.
Всички пациенти са лекувани и с кортикостероид, приемът на който се прекратява след постепенно намаляване на дозата в продължение на 6 или 12 месеца.
All patients were also treated with a corticosteroid, which was stopped after reducing the dose gradually over 6 or 12 months.