natgillin/translations-raw huggingface dataset:
− Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Ako je prošlo manje od 12 sati nakon uobičajenog termina uzimanja lijeka: bolesnik treba odmah uzeti dozu, a sljedeću dozu treba uzeti prema uobičajenom rasporedu.
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.
U randomiziranoj, dvostrukoslijepoj studiji s paralelnim skupinama (CLARINET), 906 pedijatrijskih bolesnika (novorođenčad i dojenčad) s cijanotičnom kongenitalnom bolešću srca ublaženom sistemsko-plućnim arterijskim šantom, bilo je randomizirano da primaju klopidogrel u dozi od 0,2
Push the tablet out.
Istisnuti tabletu.
Switching from a more potent P2Y12 receptor inhibitor to clopidogrel in association with aspirin after acute phase in ACS has been evaluated in two randomized investigator-sponsored studies (ISS)TOPIC and TROPICAL-ACS - with clinical outcome data.
Prelazak s potentnijeg inhibitora P2Y12 receptora na klopidogrel u kombinaciji s acetilsalicilatnom kiselinom nakon akutne faze akutnog koronarnog sindroma ispitan je u dva randomizirana ispitivanja sponzorirana od strane ispitivača (engl. investigator-sponsored studies, ISS) TOPIC i
Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)*
Poremećaji imunološkog sustava serumska bolest, anafilaktoidne reakcije, križno reaktivna preosjetljivost na lijekove iz skupine tienopiridinima (kao što su tiklopidin, prasugrel) (vidjeti dio 4.4)*, autoimuni inzulinski sindrom koji može dovesti do teške hipoglikemije, osobito u bolesnika s podtipom HLA
The concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.5).
Ne preporučuje se istodobna primjena klopidogrela i drugih oralnih antikoagulansa jer to može pojačati intenzitet krvarenja (vidjeti dio 4.5.).
Patients should be told that it might take longer than usual to stop bleeding when they take clopidogrel (alone or in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician.
Bolesnicima koji uzimaju klopidogrel (kao monoterapiju ili u kombinaciji s ASK) potrebno je objasniti da će krvarenje možda trajati dulje nego obično i da moraju obavijestiti liječnika o svakom neočekivanom krvarenju (s obzirom na mjesto i trajanje krvarenja).
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).
trombozu šanta ili kardiološku intervenciju prije 120-og dana starosti nakon događaja za koji se smatra da je trombološke prirode (89 [19,1%] za klopidogrel skupinu i 90 [20,5%] za placebo skupinu)
How to store Clopidogrel Teva
Kako čuvati Klopidogrel Teva
Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
(toksična epidermalna nekroliza, Stevens Johnsonov sindrom, erythema multiforme, akutna generalizirana egzantematozna pustuloza (AGEP)), angioedem, sindrom preosjetljivosti izazvane lijekom, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (engl.
Calendar pack of aluminium-aluminium perforated blisters containing 28x1film coated tablets
Aluminijski perforirani blisteri u kalendarskom pakovanju koje sadrži 28x1 filmom obloženu tabletu
14x1 film-coated tablets 28x1 film-coated tablets 30x1 film-coated tablets 50x1 film-coated tablets 84x1 film-coated tablets 90x1 film-coated tablets 100x1 film-coated tablets
14x1 filmom obloženih tableta 28x1 filmom obloženih tableta 30x1 filmom obloženih tableta 50x1 filmom obloženih tableta 84x1 filmom obloženih tableta 90x1 filmom obloženih tableta 100x1 filmom obloženih tableta
Clopidogrel Teva is unlikely to affect your ability to drive or to use machines.
Teva ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
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.
Ako mislite da se bilo što od navedenog odnosi na Vas, ili niste sigurni, obratite se svom liječniku prije uzimanja lijeka Klopidogrel Teva.
o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections, - anti-retroviral medicines (medicines to treat HIV infections), - carbamazepine, a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer.
o selektivne inhibitore ponovne pohrane serotonina (uključujući, ali ne ograničeno na fluoksetin i fluvoksamin), lijekove koji se obično koriste za liječenje depresije, - omeprazol ili esomeprazol, lijekove za smanjenje želučanih tegoba, - flukonazol ili vorikonazol, lijekove koji se primjenjuju za liječenje gljivičnih infekcija, - efavirenz, lijek koji se primjenjuje za liječenje HIV (virus humane imunodeficijencije) infekcija, - antiretrovirusne lijekove (lijekovi za liječenje infekcije HIV-om),
This statistically significant difference was mainly driven by fewer bleeding events, with no difference reported in ischaemic endpoints (p=0.36), while BARC ≥2 bleeding occurred less frequently in the de-escalated DAPT group (4.0%) versus 14.9% in the unchanged DAPT group (p<0.01).
Ova statistički značajna razlika uglavnom je posljedica manjeg broja događaja krvarenja, bez prijavljene razlike u ishemijskim mjerama ishoda (p=0,36), dok se BARC stupanj krvarenja ≥ 2 javljao rjeđe u skupini s de-eskaliranim
• If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
• ako imate poremećaj koji izaziva krvarenje, kao što je, primjerice, želučani čir ili krvarenje u mozgu • ako patite od teške bolesti jetre.
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Teva:
Ako se na Vas odnosi bilo koje od dolje navedenih stanja morate obavijestiti liječnika, prije nego što uzmete Klopidogrel Teva: • ako postoji opasnost od krvarenja poput
Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP.
Klopidogrel, također, inhibira agregaciju trombocita induciranu drugim agonistima, pored ADP-a, i to blokiranjem pojačavanja aktivacije trombocita oslobođenim ADP-om.
When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
izloženost aktivnom metabolitu bila je veća nego kod režima doziranja od 300 mg/75 mg.
− 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).
• odraslih bolesnika koji boluju od akutnog koronarnog sindroma: - Akutni koronarni sindrom bez elevacije ST-segmenta (nestabilna angina ili non-Q infarkt miokarda), uključujući bolesnike koji se podvrgavaju ugradnji stenta nakon perkutane koronarne intervencije, u kombinaciji s acetilsalicilatnom kiselinom (ASK).
Kounis syndrome (vasospastic allergic angina / allergic myocardial infarction) in the context of a
Kounisov sindrom (alergijska vazospastična angina
EU/1/09/540/010 14x1 film-coated tablets EU/1/09/540/011 28x1 film-coated tablets EU/1/09/540/012 30x1 film-coated tablets EU/1/09/540/013 50x1 film-coated tablets EU/1/09/540/014 84x1 film-coated tablets EU/1/09/540/015 90x1 film-coated tablets EU/1/09/540/016
EU/1/09/540/010 14x1 filmom obloženih tableta EU/1/09/540/011 28x1 filmom obloženih tableta EU/1/09/540/012 30x1 filmom obloženih tableta EU/1/09/540/013 50x1 filmom obloženih tableta EU/1/09/540/014 84x1 filmom obloženih tableta EU/1/09/540/015 90x1 filmom obloženih tableta EU/1/09/540/016 100x1 filmom obloženih tableta EU/1/09/540/017 28x1 filmom obloženih tableta
Rare side effect (may affect up to 1 in 1000 people):
Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba):
EU/1/09/540/001 14x1 film-coated tablets EU/1/09/540/002 28x1 film-coated tablets EU/1/09/540/003 30x1 film-coated tablets EU/1/09/540/004 50x1 film-coated tablets EU/1/09/540/005 84x1 film-coated tablets EU/1/09/540/006 90x1 film-coated tablets EU/1/09/540/007 100x1 film-coated tablets
EU/1/09/540/001 14x1 filmom obloženih tableta EU/1/09/540/002 28x1 filmom obloženih tableta EU/1/09/540/003 30x1 filmom obloženih tableta EU/1/09/540/004 50x1 filmom obloženih tableta EU/1/09/540/005 84x1 filmom obloženih tableta EU/1/09/540/006 90x1 filmom obloženih tableta EU/1/09/540/007 100x1 filmom obloženih tableta
Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters.
Upute o vađenju tableta iz blistera nalaze se na kutiji u kojoj su blisteri s odvojivom folijom.
The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Sigurnost primjene i djelotvornost klopidogrela procijenjena je u 5 dvostrukoslijepih studija koje su uključivale više od 88 000 bolesnika: studija CAPRIE, u kojoj se uspoređivao klopidogrel i ASK te
(<1/10,000); not known (cannot be estimated from the available data).
Nuspojave s nepoznatom učestalošću (učestalost se ne može procijeniti iz dostupnih podataka):
− Calendar pack of perforated blisters of aluminium/aluminium containing 28x1 tablets
− Aluminijskim perforiranim blisterima u kalendarskom pakovanju koje sadrži 28x1 tabletu.
TEVA Pharmaceutical Works Private Limited Company Pallagi út 13
Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet TEVA Pharmaceutical Works Private Limited Company Pallagi út 13
Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
2% za bijelce, 4% za crnce i 14% za Kineze.
Bleeding time prolonged, neutrophil count decreased, platelet count decreased
Pretrage produljeno vrijeme krvarenja, smanjen broj neutrofila, smanjen broj trombocita
hypersensitivity reaction due to clopidogrel*
/ alergijski infarkt miokarda) u kontekstu reakcije preosjetljivosti na klopidogrel*
TEVA GmbH Tel: (49) 731 402 08
Tel: (49) 731 402 08
Each film-coated tablet contains 75 mg clopidogrel (as hydrogen sulfate).
Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrelhidrogensulfata).
Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5.1).
Rezultati kliničkih ispitivanja podupiru trajanje liječenja do 12 mjeseci, a najveći učinak zabilježen je u trećem mjesecu liječenja
The cumulative incidence of all bleeding events (BARC class 1 to 5) was 9% (114 events) in the guided de-escalation group versus 11% (137 events) in the control group (p=0.14).
5) bila je 9% (114 događaja) u skupini s vođenom de-eskalacijom u odnosu na 11% (137 događaja) u kontrolnoj skupini (p=0,14).
Tel: +(39) 028917981
Teva Italia S.r.l. Tel: +(39) 0289179805
Vertigo, enlarged breasts in males.
Vrtoglavica, povećanje grudi u muškaraca.
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).
104 tjedna u dozama do 77 mg/kg dnevno (što predstavlja barem 25 puta veću izloženost nego u ljudi koji primaju kliničku dozu od 75 mg/dan).
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
PRILOG II A. PROIZVOĐAČ ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
In a dose escalation study of 86 neonates or infants up to 24 months of age at risk for thrombosis (PICOLO), clopidogrel was evaluated at consecutive doses of 0.01, 0.1 and 0.2 mg/kg in neonates and infants and 0.15 mg/kg only in neonates.
mjeseca te s rizikom od tromboze (PICOLO), procijenjen je učinak klopidogrela u konsekutivnim dozama od 0,01, 0,1 i 0,2 mg/kg u novorođenčadi i dojenčadi te u dozi od 0,15 mg/kg samo u novorođenčadi.
• Swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.
• oticanje u ustima ili kožni poremećaji kao što su osip i svrbež te mjehurići na koži; ovi simptomi mogu biti znakovi alergijske reakcije.
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).
U tzv. post-hoc analizi 2.172 bolesnika (17% ukupne CURE populacije) koji su se podvrgli ugradnji stenta (Stent-CURE), podaci su pokazali da je klopidogrel u usporedbi s placebom pokazao značajno smanjenje relativnog rizika od 26,2% za koprimarni ishod
No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultrarapid, extensive and intermediate metabolisers.
Nisu opažene značajne razlike u izloženosti aktivnom metabolitu i prosječnoj vrijednosti inhibicije agregacije trombocita
Fri
Ut
Iron oxide red (E172) Iron oxide yellow (E172) Indigo carmine aluminium lake (E132)
Film-ovojnica: laktoza hidrat hipromeloza (E464) titanijev dioksid (E171) makrogol 4000 željezov oksid, crveni (E172) željezo oksid, žuti (E172) Indigo carmine aluminium lake (E132)
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u. nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
− Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (type A), hydrogenated vegetable oil and sodium laurilsulfate.
• Pomoćne tvari su (vidjeti dio 2 „Klopidogrel Teva sadrži laktozu“): Jezgra tablete: laktoza hidrat, mikrokristalična celuloza, hidroksipropilceluloza (E463), krospovidon (tip A), hidrogenizirano biljno ulje i natrijev laurilsulfat.
As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).
Zbog opreza se ne preporučuje istodobna primjena klopidogrela i lijekova koji su jaki ili umjereni inhibitori CYP2C19 (vidjeti dio 4.4. i 5.2.).
In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p=0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR=23.7%; CI: 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]).
U analizi podskupina sačinjenih prema stanju (infarkt miokarda, ishemijski moždani udar, BPA) najveću su korist od liječenja (postignuta statistička značajnost pri p = 0,003) imali bolesnici s bolešću perifernih arterija (BPA), posebno oni koji su u anamnezi imali infarkt miokarda (RRR = 23,7%; CI:
Uncommon side effects (may affect up to 1 in 100 people):
Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba):
TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) This randomized, open-label trial included ACS patients requiring PCI.
Ovo randomizirano, otvoreno ispitivanje uključivalo je bolesnike s akutnim koronarnim sindromom u kojih je bila potrebna perkutana koronarna intervencija (PCI).
Clopidogrel Teva 75 mg film-coated tablets clopidogrel
Klopidogrel Teva 75 mg filmom obložene tablete klopidogrel
The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking clopidogrel 75 mg/day.
S dozom od 0,2 mg/kg postignut je prosječni postotak inhibicije od 49,3% (5 µM
Clopidogrel Teva 75 mg film-coated tablets
Klopidogrel Teva 75 mg filmom obložene tablete
- a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
- medicinskih stanja kod kojih postoji opasnost od unutrašnjeg krvarenja (kao što je želučani čir), - poremećaja krvi zbog čega ste skloni unutrašnjim krvarenjima (krvarenje u tkivima, organima ili zglobovima), - nedavne teške ozljede,
Clopidogrel Teva contains lactose
Teva sadrži laktozu
Fertility Clopidogrel was not shown to alter fertility in animal studies.
U ispitivanjima na životinjama, klopidogrel nije pokazao utjecaj na plodnost.
The incidence of clinically significant bleeding was similar to that observed when thrombolytic agents and heparin are co-administered with ASA (see section 4.8).
Incidencija klinički značajnog krvarenja bila je slična onoj zamijećenoj pri istodobnoj primjeni trombolitika i heparina s
Secondary prevention of atherothrombotic events Clopidogrel is indicated in:
Klopidogrel je indiciran u:
In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group.
U studiji CLARITY uočeno je ukupno povećanje krvarenja u grupi klopidogrel uz ASK u odnosu na skupinu koja je uzimala placebo uz ASK.
- You have a condition of hardening of arteries (also known as atherosclerosis), and - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
- ste imali teški oblik boli u prsištu, poznat pod nazivom “nestabilna angina” ili “infarkt miokarda” (srčani udar).
• The film-coated tablets are light pink to pink, film coated, capsule shaped tablets.
• Filmom obložene tablete su svjetlo ružičaste do ružičaste filmom obložene tablete u obliku kapsula, s utisnutom oznakom „93“ na jednoj i „7314“ na drugoj strani.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Teva in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Klopidogrel Teva u kombinaciji s acetilsalicilatnom kiselinom, tvari prisutnom u mnogim lijekovima za ublažavanje boli i snižavanje temperature.
− Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA)
Akutni koronarni sindrom bez elevacije ST-segmenta (nestabilna angina ili non-Q infarkt miokarda): liječenje klopidogrelom treba započeti s jednokratnom udarnom dozom od 300
Clopidogrel Teva contains sodium
Teva sadrži natrij
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.
(najprije udarnu dozu od 300 mg, a nakon toga dozu od 75 mg na dan, n=1752) ili placebo (n=1739), oboje u kombinaciji s ASK (150 do 325 mg kao udarna doza nakon čega je slijedila doza od 75 do 162
• Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg.
Klopidogrel se daje u jednokratnoj dnevnoj dozi od 75 mg.
The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Teva per day to be taken orally with or without food, and at the same time each day.
Preporučena doza, uključujući za bolesnike sa stanjem zvanim "fibrilacija atrija" (nepravilni otkucaji srca), je jedna tableta Klopidogrela
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).
umjereni i slabi), procijenjen je farmakokinetički i antitrombocitni odgovor primjenom doze od 300 mg, nakon čega je slijedila doza od 75 mg/dan te primjenom doze od 600 mg, nakon čega je slijedila doza od 150 mg/dan, u trajanju od ukupno 5 dana (stanje dinamičke ravnoteže).
Gynaecomastia
Klopidogrel
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).
Primjenu ASK (75-100 mg na dan) treba započeti i nastaviti davati u kombinaciji s klopidogrelom (vidjeti dio
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions').
Ukoliko ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika (vidjeti dio
Perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets.
Perforirani blisteri sadržavaju 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ili 100x1 filmom obloženih tableta.
Separate one individual blister cell from the rest of the strip by gently tearing along the perforations around it.
Laganim potezom uzduž perforacije odvojiti jediničnu dozu od ostatka blistera.
In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p=0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
[95% CI: 0,2 do 16,4]; p=0,045) što, odgovara broju od dodatnih 10 bolesnika kojima je spriječen novi ishemijski događaj, na svakih 1000 bolesnika liječenih 2 godine [CI: 0 do 20]. Analiza ukupne smrtnosti, sekundarnog ishoda studije, nije pokazala značajnu razliku između klopidogrela (5,8%) i
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets)
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 filmom obloženih tableta)
Thur
Čet
INSTRUCTIONS ON USE.
NAVOĐENJE DJELATNE/IH
There was no statistically significant difference in the rates of fatal bleeding (1.1% in the clopidogrel + ASA group and 0.7% in the placebo +ASA group) and haemorrhagic stroke (0.8% and 0.6%, respectively) between groups.
+ ASK i 0,7% u skupini placebo + ASK) i hemoragijskog moždanog udara (0,8% naspram 0,6%).
− Peelable perforated blisters of aluminium/aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablets
Aluminijskim perforiranim blisterima s jediničnim dozama koji sadržavaju 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ili 100x1 tableta