natgillin/translations-raw huggingface dataset:
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu/
Bottles contain 30 or 100 film-coated tablets.
Bočice sadržavaju 30 ili 100 filmom obloženih tableta.
Clopidogrel has been evaluated for safety in more than 44,000 patients who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Sigurnost primjene klopidogrela ispitana je na više od 44 000 bolesnika koji su sudjelovali u kliničkim ispitivanjima, uključujući više od 12 000 bolesnika koji su lijek primali godinu dana ili više.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
Do not use this medicine after the expiry date which is stated on the outer carton, bottle or blister, after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, bočici ili blisteru iza oznake „EXP“.
Clopidogrel Teva 75 mg
Klopidogrel Teva 75 mg
Your doctor should have prescribed Clopidogrel Teva and acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Liječnik Vam treba propisati Klopidogrel Teva i acetilsalicilatnu kiselinu ako ne možete uzimati oralne antikoagulanse te nemate rizik od velikog krvarenja.
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, Velika Britanija
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu
While you are taking Clopidogrel Teva:
Dok uzimate Klopidogrel Teva:
After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Nakon jednokratne i ponovljene oralne doze od 75 mg na dan, klopidogrel se brzo apsorbira.
What Clopidogrel Teva is and what it is used for
Što je Klopidogrel teva i za što ste koristi
Light pink to pink, capsule-shaped film-coated tablets debossed with “93” on one side and “7314” on the other side.
Svijetlo ružičaste do ružičaste filmom obložene tablete u obliku kapsula s utisnutom oznakom „93“ na jednoj i „7314“ na drugoj strani.
This is linked to the way your medicine works as it prevents the ability of blood clots to form.
To je povezano s načinom na koji lijek djeluje jer sprječava mogućnost stvaranja krvnih ugrušaka.
For the 28x1 tablets pack size, you can check the day on which you last took a tablet of Clopidogrel Teva by referring to the calendar printed on the blister
Za pakiranje od 28x1 tableta, možete provjeriti dan kada ste zadnji put uzeli tabletu Klopidogrel
Based on enrollment criteria, physicians enrolled patients in ACTIVE-W if they were candidates for vitamin K antagonist (VKA) therapy (such as warfarin).
Na osnovi uključujućih kriterija liječnici su bolesnike uključivali u studiju ACTIVE-W ako su bili kandidati za terapiju antagonistima vitamina K (kao što je varfarin).
What Clopidogrel Teva is and what it is used for What you need to know before you take Clopidogrel Teva How to take Clopidogrel Teva Possible side effects
Što je Klopidogrel Teva i za što se koristi Što morate znati prije nego što počnete uzimati Klopidogrel Teva Kako uzimati Klopidogrel Teva
• The active substance is clopidogrel.
• Djelatna tvar je klopidogrel.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING BOTTLE LABEL (30 or 100 film-coated tablets)
PODACI KOJE NAJMANJE MORA SADRŽAVATI UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI (30 ili 100 filmom obloženih tableta)
You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Teva and acetylsalicylic acid for this condition.
Trebalo Vam je biti rečeno da su za ovo stanje 'oralni antikoagulansi' učinkovitiji od acetilsalicilatne kiseline ili kombinirane primjene Klopidogrel
Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Klopidogrel i glavni cirkulirajući (neaktivni) metabolit reverzibilno se in vitro vežu za proteine u ljudskoj plazmi (98%, odnosno 94%).
Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC Code: B01AC04.
Farmakoterapijska skupina:Antitrombotici, inhibitori agregacije trombocita izuzev heparina, ATK oznaka: B01AC04.
The primary outcome, a composite of cardiovascular death, stroke, urgent revascularization, and
Primarni ishod, koji se sastojao od kardiovaskularne smrti, moždanog udara, hitne revaskularizacije i
Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
Teva Pharma Belgium N.V./S.A. Tel/Tél: +32 3 820 73 73
If you forget to take a dose of Clopidogrel Teva, but remember within 12 hours of usual time,take your tablet straightaway and then take your next tablet at the usual time.
Ako zaboravite uzeti jednu dozu Klopidogrela Teva, ali se toga sjetite u roku od 12 sati, odmah uzmite tabletu, a sljedeću tabletu uzmite u uobičajeno vrijeme.
If you become pregnant while taking Clopidogrel Teva, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Ako zatrudnite za vrijeme uzimanja lijeka Klopidogrel Teva, odmah se posavjetujte s liječnikom jer nije preporučeno uzimati klopidogrel za vrijeme trudnoće.
• if you have kidney or liver disease.
• ako imate bolest bubrega ili jetre
• Signs of liver problems such as yellowing of the skin and /or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions').
• znakove oštećenja funkcije jetre kao što su žuta boja kože ili očiju (žutica), bez obzira jesu li povezani s krvarenjem koje se pojavljuje kao crvene točkice ispod kože i/ili zbunjenošću (vidjeti dio 2. "Upozorenja i mjere opreza");
• Clopidogrel Teva is supplied in:
Klopidogrel Teva dostupan je u:
Other medicines and Clopidogrel Teva
Drugi lijekovi Klopidogrel Teva
Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Ostali aleli povezani sa izostankom ili smanjenim metabolizmom uključuju CYP2C19*4, *5, *6, *7 i *8, ali oni su manje zastupljeni.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment.
Ako ste imali jake bolove u prsištu (nestabilna angina ili srčani udar), liječnik Vam u početku liječenja može jednokratno dati 300 mg Klopidogrela Teva (1 tableta od 300 mg ili 4 tablete od po 75 mg).
The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Klinički značajne nuspojave opažene u studijama CAPRIE, CURE, CLARITY, COMMIT i ACTIVE-A opisane su u daljnjem tekstu.
In a relative bioavailability study in adults, the constituted solution of clopidogrel showed a similar extent and slightly higher rate of absorption of the main circulating (inactive) metabolite compared to the authorised tablet.
U relativnoj studiji bioraspoloživosti lijeka u odraslih, konstituirana otopina klopidogrela pokazala je sličan raspon i neznatno veću brzinu apsorpcije glavnog cirkulirajućeg (neaktivnog) metabolita, u usporedbi s tabletom.
Each film-coated tablet contains 59.05 mg of lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 59,05 mg laktoze ( u obliku monohidrata)
Seventy-three percent (73%) of patients enrolled into the ACTIVE-A study were unable to take VKA due to physician assessment, inability to comply with INR (international normalised ratio) monitoring, predisposition to falling or head trauma, or specific risk of bleeding; for 26% of the patients, the physician's decision was based on the patient's unwillingness to take VKA.
73% bolesnika uključenih u studiju ACTIVE-A nisu bili sposobni za uzimanje terapije VKA prema procjeni liječnika, zbog nemogućnosti praćenja INR (International Normalised Ratio), sklonosti padanju ili traumatskim ozljedama glave ili zbog specifičnog rizika od krvarenja; za 26% bolesnika odluka liječnika bila je temeljena na nevoljnosti bolesnika za uzimanje terapije VKA.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDER BLISTER
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP KALENDARSKI BLISTER
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects').
Ako ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika (vidjeti dio 4. „Moguće nuspojave“).
If you forget to take Clopidogrel Teva
Ako ste zaboravili uzeti Klopidogrel Teva
30 film-coated tablets 100 film-coated tablets
30 filmom obloženih tableta 100 filmom obloženih tableta
The prevalence of CYP2C19 alleles that result in intermediate and poor CYP2C19 metabolism differs according to race/ethnicity (see Pharmacogenetics).
Prevalencija CYP2C19 alela koji rezultiraju umjerenim i slabim CYP2C19 metabolizmom razlikuje se prema rasi/etničkoj skupini (vidjeti dio „Farmakogenetika“).
What you need to know before you take Clopidogrel Teva Do not take Clopidogrel Teva
Što morate znati prije nego počnete uzimati Klopidogrel Teva
• You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) 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 section 4 ‘Possible side effects').
• Također, odmah obavijestite svog liječnika ako se pojavi medicinsko stanje (koje se naziva trombotična trombocitopenična purpura ili „TTP“) sa simptomima koji uključuju vrućicu i potkožne modrice koji se mogu pojaviti kao crvene točkice, sa ili bez neobjašnjivog teškog umora, zbunjenosti i žute boje kože ili očiju (žutica) (vidjeti dio 4. "Moguće nuspojave").
As no clinical data on exposure to clopidogrel during pregnancy are available, it is preferable not to use clopidogrel during pregnancy as a precautionary measure.
S obzirom na to da nema podataka o primjeni klopidogrela u trudnica, preporučuje se, kao mjera opreza, ne koristiti klopidogrel za vrijeme trudnoće.
Omeprazole 80 mg once daily administered either at the same time as clopidogrel or with 12 hours between the administrations of the two drugs decreased the exposure of the active metabolite by 45% (loading dose) and 40% (maintenance dose).
Omeprazol primijenjen u dozi od 80 mg na dan, istodobno s klopidogrelom ili s razmakom od 12 sati od primjene dvaju lijekova, smanjio je koncentraciju aktivnog metabolita klopidogrela za 45% (udarna doza) i 40% (doza održavanja).
The guided de-escalation did not result in an increased combined risk of ischemic events (2.5% in the deescalation group vs 3.2% in the control group; p non-inferiority=0.0115), nor in the key secondary endpoint of BARC bleeding ≥2 ((5%) in the de-escalation group versus 6% in the control group (p=0.23)).
Vođena de-eskalacija nije rezultirala povećanjem u kombiniranom riziku od ishemijskih događaja (2,5% u skupini sa vođenom de-eskalacijom u odnosu na 3,2% u kontrolnoj skupini; p neinferiornosti=0,0115) niti u ključnoj sekundarnoj mjeri ishoda BARC stupnja krvarenja ≥ 2 ((5%) u skupini s vođenom de-eskalacijom nasuprot 6% u kontrolnoj skupini (p=0,23)).
− For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.
- Ako je prošlo više od 12 sati: bolesnik treba sljedeću dozu uzeti prema uobičajenom rasporedu i ne smije uzeti dvostruku dozu.
For minor cuts and injuries, e.g., cutting yourself shaving, this is usually of no concern.
Za male posjekotine ili ozljede, kao što su, primjerice, porezotine nastale tijekom brijanja, ne treba se zabrinjavati.
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Teva.
Kao mjera opreza, treba prestati s dojenjem za vrijeme liječenja lijekom
The ACTIVE-A study (N=7,554) was a multicenter, randomized, double-blind, placebo-controlled study which compared clopidogrel 75 mg/day + ASA (N=3,772) to placebo + ASA (N=3,782).
Studija ACTIVE-A (n=7554) bila je multicentrična, randomizirana, dvostrukoslijepa, placebom kontrolirana studija u kojoj se uspoređivao učinak klopidogrela u dozi od 75 mg/dnevno uz ASK (n=3772) u odnosu na placebo uz ASK (n=3782).
The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and
Populacija bolesnika uključivala je 27,8% žena, 58,4% bolesnika ≥60 godina (26% ≥70 godina) i 54,5% bolesnika koji su primali fibrinolitike.
The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.
CYP2C19 uz sudjelovanje nekoliko drugih CYP enzima, uključujući CYP1A2, CYP2B6 i CYP3A4.
(≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
<1/100); rijetke (≥1/10 000, <1/1000); vrlo rijetke (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
A pharmacodynamic interaction between clopidogrel and acetylsalicylic acid is possible, leading to increased risk of bleeding.
Farmakodinamička interakcija između klopidogrela i acetilsalicilatne kiseline moguća je i može povećati rizik od krvarenja.
Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery.
uključujući okultno krvarenje, poglavito tijekom prvih tjedana liječenja i/ili nakon invazivnih kardioloških postupaka ili kirurških zahvata.
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%).
U studiji ACTIVE-A, stopa velikih krvarenja bila je veća u skupini klopidogrel + ASK nego u skupini placebo + ASK (6,7% naspram 4,3%).
A pharmacodynamic interaction between clopidogrel and heparin is possible, leading to increased risk of bleeding.
Farmakodinamička interakcija između klopidogrela i heparina moguća je i može povećati rizik od krvarenja.
Then, the recommended dose is one 75-mg tablet of Clopidogrel Teva per day as described above.
Teva je jedna tableta od 75 mg dnevno, kao što je opisano iznad.
What Clopidogrel Teva looks like and contents of the pack
Teva izgleda i sadržaj pakiranja
After the 300 mg/75 mg dose regimen, antiplatelet responses were decreased in the poor metabolisers with mean IPA (5 μM ADP) of 24% (24 hours) and 37% (Day 5) as compared to IPA of 39% (24 hours) and 58% (Day 5) in the extensive metabolisers and 37% (24 hours) and 60% (Day 5) in the intermediate metabolisers.
Nakon režima doziranja od 300 mg/75 mg, antitrombocitni odgovor bio je smanjen u slabih metabolizatora sa srednjom vrijednosti IAT (5 μM ADP) od 24% (nakon 24 sata) te 37% (na dan 5), u usporedbi s vrijednostima IAT-e od 39% (24 sata) i 58% (dan 5) za brze metabolizatore te 37% (24 sata) i 60% (dan 5) za umjerene metabolizatore.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Teva.
Ako ste trudni ili sumnjate na trudnoću, obavijestite svog liječnika ili ljekarnika prije nego što uzmete
During non clinical studies in rat and baboon, the most frequently observed effects were liver changes.
5.3 Neklinički podaci o sigurnosti primjene Tijekom nekliničkih ispitivanja na štakorima i babunima, najčešće zabilježeni učinci bile su promjene na jetri.
− ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
- Akutni infarkt miokarda s elevacijom ST-segmenta, u kombinaciji s ASK u medikamentozno liječenih bolesnika pogodnih za liječenje trombolitičkom terapijom.
How to take Clopidogrel Teva
Kako uzimati Klopidogrel Teva
In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
U manjem broju slučajeva, također su zabilježena krvarenja u oku, glavi, trbušnoj šupljini , plućima ili zglobovima.
EU/1/09/540/008 30 film-coated tablets EU/1/09/540/009 100 film-coated tablets
EU/1/09/540/008 30 filmom obloženih tableta EU/1/09/540/009 100 filmom obloženih tableta
Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel.
Istodobna primjena heparina nije imala učinka na inhibiciju agregacije trombocita induciranu klopidogrelom.
Acetylsalicylic acid (ASA): ASA did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet aggregation.
Acetilsalicilatna kiselina (ASK): ASK nije utjecala na promjenu klopidogrelom posredovane inhibicije agregacije trombocita inducirane ADP-om, ali je klopidogrel potencirao učinak ASK na agregaciju trombocita posredovanu kolagenom.
Contents of the pack and other information What Clopidogrel Teva contains
Sadržaj pakiranja i druge informacije Što Klopidogrel
Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed or blood in the urine.
Krvarenje se može pojaviti u obliku krvarenja u želucu ili crijevima, modrica, hematoma (neuobičajeno krvarenje ili modrice ispod kože),
Consistent with the above results, in a meta-analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to extensive metabolisers.
U skladu s gore navedenim rezultatima, metaanaliza koja je uključivala 6 studija sa 335 osoba liječenih klopidogrelom u stanju dinamičke ravnoteže, pokazala je da je izloženost aktivnom metabolitu smanjena za 28% za umjerene metabolizatore te 72% za slabe metabolizatore, dok je inhibicija agregacije trombocita (5 μM ADP) smanjena s razlikama za vrijednosti IAT-a od 5,9%, odnosno 21,4%, u usporedbi s brzim metabolizatorima.
In addition, IPA was 32% (24 hours) and 61% (Day 5), which were greater than in the poor metabolisers receiving the 300 mg/75 mg regimen, and were similar to the other CYP2C19 metaboliser groups receiving the 300 mg/75 mg regimen.
vrijednost IAT iznosila je 32% (24 sata) i 61% (dan 5), što je više nego u slabih metabolizatora koji su primali doze od 300 mg/75 mg i slično je ostalim skupinama CYP2C19 metabolizatora koje su primale doze od 300 mg/75 mg.
− HDPE bottles with polypropylene closures or child resistant polypropylene closures and silica gel desiccant containing 30 or 100 tablets.
Bočicama od polietilena visoke gustoće (HDPE) s polipropilenskim čepom ili polipropilenskim sigurnosnim zatvaračem za djecu i silika gelom kao sredstvom za sušenje koje sadržavaju 30 ili 100 tableta.
You should take Clopidogrel Teva for as long as your doctor continues to prescribe it.
Lijek Klopidogrel Teva trebate uzimati onoliko dugo koliko Vam je rekao Vaš liječnik.
Fifteen percent (15.0%) of patients in the clopidogrel group and 21.7% in the placebo group reached the primary endpoint, representing an absolute reduction of 6.7% and a 36% odds reduction in favor of clopidogrel (95% CI: 24, 47%; p<0.001), mainly related to a reduction in occluded infarct-related arteries.
Petnaest posto (15,0%) bolesnika u skupini s klopidogrelom i 21,7% u skupini s placebom dostigli su primarni ishod, što predstavlja apsolutno smanjenje od 6,7% i smanjenje izgleda (engl. „odds reduction“) od 36% u korist klopidogrela (95% CI: 24, 47%; p<0,001), većinom povezano sa smanjenjem okluzije arterija povezanih s infarktom.
If you stop taking Clopidogrel Teva Do not stop the treatment unless your doctor tells you so.
Ne prekidajte liječenje osim ako Vam to ne savjetuje liječnik.
Clopidogrel Teva is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Teva uzimaju odrasli za sprječavanje stvaranja krvnih ugrušaka (tromba) u otvrdnutim krvnim žilama (arterijama), a taj poremećaj zove se aterotromboza i može dovesti do aterotrombotičkih događaja (kao što su moždani udar, srčani udar ili smrt).
Lactose monohydrate Cellulose, microcrystalline Hydroxypropylcellulose (E463) Crospovidone (type A) Hydrogenated vegetable oil Sodium laurilsulfate
Jezgra tablete laktoza hidrat celuloza mikrokristalična hidroksipropilceluloza (E463) krospovidon (tip A) hidrogenizirano biljno ulje natrijev laurilsulfat
− Tablet coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172) and indigo carmine aluminium lake (E132).
Ovojnica tablete: laktoza hidrat, hipromeloza (E464), titanijev dioksid (E171), makrogol 4000, crveni željezov oksid (E172), žuti željezov oksid (E172) i indigo carmine aluminium lake (E132).
As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs), or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Kao i u slučaju drugih antitrombocitnih lijekova, klopidogrel s oprezom treba davati bolesnicima koji su izloženi povećanom riziku od krvarenja zbog povrede, kirurških zahvata ili drugih patoloških stanja te bolesnicima koji se liječe ASK, heparinom, inhibitorima glikoproteina IIb/IIIa ili nesteroidnim protuupalnim lijekovima (NSAIL), uključujući Cox-2 inhibitore ili selektivne inhibitore ponovne pohrane serotonina (SSRI) ili druge lijekove povezane s rizikom od krvarenja kao što je pentoksifilin (vidjeti dio 4.5).
Patients should be evaluated for history of hypersensitivity to thienopyridines (such as clopidogrel, ticlopidine, prasugrel) since cross-reactivity among thienopyridines has been reported (see section 4.8).
Kod bolesnika treba procijeniti prethodnu preosjetljivost na tienopiridin u povijesti bolesti (kao što su klopidogrel, tiklopidin, prasugrel) budući da je zabilježena ukrižena reaktivnost među tienopiridinima (vidjeti dio 4.8).
Aluminium-aluminium peelable perforated unit-dose blisters, aluminium-aluminium perforated unit dose blisters and HDPE bottles with polypropylene closures or child resistant polypropylene closures and silica gel desiccant.
Aluminijski perforirani blisteri s odvojivom folijom i s jediničnim dozama, aluminijski perofrirani blisteri s jediničnim dozama i bočice od polietilena visoke gustoće (HDPE) s polipropilenskim čepom ili polipropilenskim sigurnosnim zatvaračem za djecu i silika gelom kao sredstvom za sušenje.
Do not use this medicine if you notice any visible sign of deterioration Do not throw away any medicines of via wastewater or household waste.
Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.