qanastek/EMEA-V3 huggingface dataset:
Each film-coated tablet contains 300 mg of clopidogrel (as hydrogen sulphate).
Kull pillola miksija b’ rita fiha 300 mg ta ’ clopidogrel (bħala hydrogen sulphate).
Excipients: each tablet contains 12 mg lactose and 13.2 mg hydrogenated castor oil.
Sustanzi mhux attivi: kull pillola fiha 12 mg lactose u 13. 2 mg castor oil idroġenat.
Pink, oblong, engraved with « 300 » on one side and « 1332 » on the other side.
Roża, oblunga, b ’ “ 300 ” imnaqqax fuq naħa waħda u “ 1332 ” imnaqqax fuq in- naħa l- oħra.
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).
Bis- segment mhux ST elevat (anġina instabbli jew infart mijokardijaku mhux- mewġa - Q), li jinkludu pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutaneju, flimkien ma ’ acetylsalicylic acid (ASA).
This 300 mg tablet of clopidogrel is intended for use as a loading dose in patients suffering from acute coronary syndrome: − 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) 75 mg-325 mg daily).
il- kura bi clopidogrel għandha tinbeda b’ doża waħda qawwija tal- bidu ta ’ 300 mg u titkompla b’ 75 mg darba kuljum (b’ acetylsalicylic acid (ASA) 75 mg- 325 mg kuljum).
Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg.
Billi dożi ogħla ta ’ ASA kienu assoċjati ma ’ riskju ikbar ta ’ dmija huwa rakkomandat li d - doża ta ’ ASA ma tkunx ikbar minn 100 mg.
The optimal duration of treatment has not been formally established.
Ma ġiex stabbilit formalment l- aħjar tul tal - kura.
Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5.1).
Tagħrif minn studji kliniċi jindika li l- kura tista ’ tibqa ’ sejra sa 12- il xahar, u l- aħjar benefiċċju ġie osservat fi żmien 3 xhur (ara sezzjoni 5. 1).
−
- Infart mijokardijaku akut bis- segment ST elevat: clopidogrel għandu jingħata bħala doża
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.
waħda kuljum ta ’ 75 mg li tinbeda wara doża qawwija tal- bidu ta ’ 300 mg flimkien ma ’ ASA u bis- sustanzi trombolitiċi jew mingħajrhom.
For patients over 75 years of age clopidogrel, should be initiated without a loading dose.
Pazjenti li għandhom iżjed minn 75 sena fl- età għandhom jinbdew fuq clopidogrel mingħajr id- doża ta ’ ikkargar.
Combined therapy should be started as early
It- terapija ikkombinata għandha tinbeda mill- aktar fis possibbli wara li s- sintomi jitfaċċaw u
as possible after symptoms start and continued for at least four weeks.
14 titkompla għal mhux anqas minn erba ’ ġimgħat.
For the maintenance dose, clopidogrel should be given as a single daily dose of 75 mg with or without food.
Bħala doża ta ’ manteniment, clopidogrel għandu jingħata bħala doża waħda ta ’ 75 mg kuljum ma ’ l- ikel jew fuq stonku vojt.
For this dose, tablets containing 75 mg are available.
Għal din id- doża issib pilloli li fihom 75 mg.
Due to the risk of bleeding and haematological undesirable effects, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8).
Minħabba r- riskju tad- dmija u effetti ematoloġiċi mhux mixtieqa, kull meta jkun hemm sintomi kliniċi waqt il- kura li jindikaw dmija għandhom jiġu stabbiliti mal- ewwel l- għadd taċ- ċelluli tad- demm u/ jew ittestjar ieħor xieraq (ara sezzjoni 4. 8).
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 including Cox-2 inhibitors.
Bħal fil- każ ta ’ sustanzi oħra kontra l- plejtlets, clopidogrel għandu jintuża b’ kawtela ma ’ pazjenti li jista ’ jkollhom riskju ta ’ iktar dmija minn trawma, operazzjoni jew kundizzjonijiet patoloġiċi oħra u pazjenti li jkunu qed jirċievu l- kura b’ ASA, heparin, inibituri ta ’ glycoprotein IIb/ IIIa, jew mediċini kontra l- infjammazzjoni li m’ humiex sterojdi li jinkludu l- inibituri ta ’ Cox- 2.
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.
Il- pazjenti għandhom jiġu osservati b’ attenzjoni għal kull sinjal ta ’ dmija inkluż dmija moħbija, speċjalment waqt l- ewwel ġimgħat tal- kura u/ jew wara proċeduri kardijaċi invażivi jew operazzjoni.
Clopidogrel prolongs bleeding time and should be used with caution in patients who have lesions with a propensity to bleed (particularly gastrointestinal and intraocular).
Clopidogrel itawwal iż- żmien tad- dmija u għand jintuża b’ kawtela f’ pazjenti li għandhom feriti b’ tendenza li jnixxu d- demm (speċjalment dawk gastro - intestinali u fl- għajnejn).
Therapeutic experience with clopidogrel is limited in patients with renal impairment.
15 L- esperjenza terapewtika bi clopidogrel f’ pazjenti b’ indeboliment fil- kliewi hija limitata.
Therefore clopidogrel should be used with caution in these patients (see section 4.2).
Għalhekk clopidogrel għandu jintuża b’ kawtela f’ dawn il- pazjenti (ara sezzjoni 4. 2).
14 Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses.
L- esperjenza f’ pazjenti b’ mard moderat fil- fwied li jista ’ jkollhom dijatesi qed inixxu d- demm hija limitata.
This product contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Dan il- prodott fih castor oil idroġenat li jista ’ jikkawża taqlib ta ’ l- istonku u dijarrea.
Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions that receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Inibituri ta ’ Glycoprotein IIb/ IIIa: clopidogrel għandu jintuża b’ kawtela f’ pazjenti li jista ’ jkollhom riskju ta ’ tkattir fid- dmija minħabba trawma, operazzjonijiet jew kundizzjonijiet patoloġiċi oħra li jirċievu l- inibituri ta ’ glycoprotein IIb/ IIIa flimkien mal- prodott mediċinali (ara sezzjoni 4. 4).
Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel.
L- it- teħid flimkien ma ’ heparin ma kellu l- ebda effett fuq l- inibizzjoni ta ’ l- aggregazzjoni tal- plejtlets indott minn clopidogrel.
Thrombolytics: the safety of the concomitant administration of clopidogrel, fibrin or non-fibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction.
Trombolitiċi: is- sigurta` ta ’ - t- teħid flimkien ta ’ clopidogrel, sustanzi trombolitiċi speċifiċi għall - fibrina jew li m’ humiex u heparin ġiet eżaminata f’ pazjenti li kellhom infart mijokardijaku akut.
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)
L - inċidenza tad- dmija klinikament sinifikanti kienet simili għal dik osservata meta sustanzi trombolitiċi u heparin jingħataw flimkien ma ’ ASA (ara sezzjoni 4. 8).
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): in a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
Mediċina anti- infjammatorja mhux sterojdika (NSAIDs): fi studju klinku li sar b’ voluntiera f’ saħħithom l- għoti ta ’ clopidogrel u naproxen flimkien żiedet id- dmija moħbija gastro- intestinali.
However, due to the lack of interaction studies with other NSAIDs it is presently unclear whether there is an increased risk of gastrointestinal bleeding with all NSAIDs.
Madankollu, minħabba li ma sarux studji dwar l- interazzjoni ma ’ NSAIDs oħra bħalissa mhux ċar jekk hemmx riskju ta ’ żieda fid- dmija gastrointestinali ma ’ NSAIDs kollha.
Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the co- administration of phenobarbital, cimetidine, or oestrogen.
Ma ġewx osservati interazzjonijiet farmakodinamiċi li kienu klinikament sinifikanti meta colpidogrel ingħata flimkien ma ’ atenolol, nifedipine, jew kemm atenolol u nifedipine. Barra minn hekk, l- attivita` farmakodinamika ta ’ clopidogrel ma ġietx influwenzata b’ mod sinifikanti mit- teħid flimkien ma ’ phenobarbital, cimetidine, jew oestrogen.
The pharmacokinetics of digoxin or theophylline were not modified by the co-administration of clopidogrel.
16 Il- karatteristiċi farmakokinetiċi ta ’ digoxin jew theophylline ma ġewx modifikati bl- amministrazjoni flimkien ma ’ clopidogrel.
Data from studies with human liver microsomes indicated that the carboxylic acid metabolite of clopidogrel could inhibit the activity of Cytochrome P450 2C9.
Tagħrif minn studji b’ mikrosomi tal- fwied uman indikaw li l- metabolit ta ’ carboxylic acid ta ’ clopidogrel jista ’ jinibixxi l- attivita` ta ’ Cytochrome P450 2C9.
This could potentially lead to increased plasma levels of medicinal products such as phenytoin and tolbutamide and the NSAIDs, which are
Potenzjalment dan jista ’ jwassal għal livelli ogħla fil- plażma ta ’ prodotti mediċinali bħal phenytoin u tolbutamide u NSAIDs, li huma metabolizzati minn Cytochrome P450 2C9.
However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
Madankollu, pazjenti li daħlu fi studji kliniċi bi clopidogrel ngħataw varjeta` ta ’ prodotti mediċinali fl- istess ħin u dawn kienu jinkludu dijuretiċi, beta blockers ACEI, antagonisti tal- kalċju, sustanzi li jbaxxu l- kolesterol, vasodilataturi koronarji, sustanzi kontra d- dijabete (inkluża l- insulina), sustanzi antiepilettiċi, u antagonisti GPIIb/ IIIa mingħajr ma kien hemm evidenza ta ’ interazzjonijiet avversi klinikament sinifikanti.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp ta 'l - embriju/ fetu, ħlas jew żvilupp wara t- twelid (ara sezzjoni 5. 3).
It is unknown whether clopidogrel is excreted in human breast milk.
Mhux magħruf jekk clopidogrel joħroġx fil- ħalib tas- sider uman.
Animal studies have shown excretion of clopidogrel in breast milk.
Studji fuq il- bhejjem urew li clopidogrel joħroġ fil- ħalib tas- sider.
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel BMS.
Bħala miżura ta ’ prekawzjoni, id- treddigħ m’ għandux jitkompla waqt il- kura b ’ Clopidogrel BMS.
Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
In ġenerali, clopidogrel 75 mg/ jum kien jikkompara ma 'ASA 325 mg/ jum f' CAPRIE irrispettivament mill- età, sess u razza.
In CURE, the major bleeding event rate for clopidogrel+ASA was dose-dependent on ASA (< 100mg:
17 F' CURE, ir- rata ta ’ avvenimenti ta 'fsada maġġuri għal clopidogrel+ASA kienet tiddependi fuq id - doża ta ’ ASA (< 100 mg:
16 consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Dan kien konsistenti fil- firxa ta ’ sottogruppi ta ’ pazjenti migbura skond linja bażi ta ’ karatteristiċi u t- tip ta ’ terapija fibrinolitika jew bil- heparin.
Their frequency is defined using the following conventions: common (≥1/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); rare (≥1/10,000 to < 1/1,000); very rare (< 1/10,000).
Il- frekwenza tagħhom hija definita skond dawn il - konvenzjonijiet: komuni (≥1/ 100 sa < 1/ 10); mhux komuni (≥/ 1, 000 sa < 1/ 100); rari (≥1/ 10, 000 sa < 1/ 1, 000); rari ħafna (< 1/ 10, 000).
Taste disturbances
Fsada
Ear and labyrinth disorders
Tibdiliet fit- togħma
Vertigo
nervuża
Vascular disorders
intrakranjali (ġew irrapportati xi każijiet b’ eżitu fatali), uġigħ ta ’ ras, parestiżja, sturdament
Haematoma
Disturbi fl- għajnejn
Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension
Fsada fl- għajn (tal- konġuntiva, okulari, tar - retina)
Respiratory, thoracic and mediastinal disorders
Disturbi fil- widnejn u fis- sistema labirintika
Epistaxis
Vertigo
Gastrointestinal Gastrointestinal
Disturbi vaskulari
Gastric ulcer and
Ematoma
Retroperitoneal Gastrointestinal and
Emorraġija serja, emorraġija ta ’ ferita minn operazzjoni, vaskulite, pressjoni baxxa
disorders
Epistassi
haemorrhage, diarrhoea, abdominal pain, dyspepsia
Fsada fil- passaġġ respiratorju (emoptisi, emorraġija fil- pulmun), bronkospażmu, pulmonite interstizjali
duodenal ulcer, haemorrhage gastritis, vomiting, nausea, constipation, flatulence
Disturbi gastro - intestinali Disturbi fil- fwied u fil - marrara
retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Emorraġija Ulċera gastrika u Emorraġija gastro - ulċera dwodenali, tar - intestinali, gastrite, rimettar, retroperitonew dijarea, tqalligħ, uġigħ stitikezza, gas fl - addominali, istonku dispepsja
Acute liver failure, hepatitis, abnormal liver function test
Emorraġija gastro - intestinali u tar - retroperitonew b’ eżitu fatali, pankreatite, kolite (inklużi kolite ulċerattiva jew limfoċitika), stomatite Insuffiċjenza akuta tal - fwied, epatite, test tal - funzjoni tal- fwied anormali
Rash, pruritus, skin bleeding (purpura)
Tbenġil Raxx, ħakk, fsada fil- ġilda (purpura)
Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications.
Doża eċċessiva wara teħid ta ’ clopidrogel tista ’ twassal għall żieda fil- ħin ta ’ dmija u komplikazzjonijiet ta ’ dmija sussegwenti.
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.
Cloipidogrel jinibixxi b’ mod selettiv l- irbit ta ’ adenosine diphosphate (ADP) mar- riċettur tal- plejtlets, u l- attivazzjoni wara tal- kumpless GPIIb/ IIIa permezz ta ’ ADP, u għalhekk l- aggregazzjoni tal- plejtlet tiġi inibita.
Clopidogrel also inhibits platelet aggregation induced by other agonists by blocking the
Clopidogrel jinibixxi wkoll l- aggregazzjoni tal- plejtlets li tkun indotta minn agonisti oħra billi jibblukka l - amplifikazzjoni ta ’ l- attivazzjoni tal- plejtlets li sseħħ permezz ta’ l- ADP meħlus.
Patients were randomised to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years.
Il- pazjenti kienu randomised għal clopidogrel 75 mg/ jum jew ASA 325 mg/ jum, u ġew osservati għal bejn sena u 3 snin.
In the myocardial infarction subgroup, most of the patients received ASA for the first few days following the acute myocardial infarction.
Fis- sottogrupp ta ’ l- infart mijokardijaku, il- biċċa l- kbiratal- pazjenti ngħataw ASA għall- ewwel jiem wara infart mijokardijaku akut.
0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Fl- analiżi ta ’ l - intenzjoni tal- kura, ġew osservati 939 avveniment fil- grupp ta ’ clopidogrel u 1 020 avveniment b’ ASA (tnaqqis tar- riskju relattiv (RRR) ta ’ 8. 7%, [95% CI: minn 0. 2 għal 16. 4]; p = 0. 045), li jikkorrispondi, għal kull 1 000 pazjent ttrattati għal sentejn, ma ’ 10 [CI: minn 0 sa 20] pazjenti oħra li evitaw avveniment iskemiku ġdid.
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]).
F’ analiżi tas- sottogrupp permezz ta ’ kundizzjoni qwalifikanti (infart mijokardijaku, puplesija iskemika, u PAD) il- benefiċċju jidher li kien l- ikbar (b’ relevanza statistika ta ’ p = 0. 003) f’ pazjenti li ddaħħlu minħabba PAD (speċjalment dawk li kellhom ukoll storja medika ta ’ infart mijokardijaku) (RRR = 23. 7%; CI: minn 8. 9 sa 36. 2) u inqas (mhux differenti b’ mod sinifikanti minn ASA) f’ pazjenti b’ puplesija (RRR = 7. 3%; CI: minn - 5. 7 sa 18. 7 [p=0. 258]).
In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
F’ pazjenti li ddaħħlu fil- prova minħabba infart mijokardijaku reċenti biss, clopidogrel kien numerikament inqas, imma mhux statistikament differenti minn ASA (RRR = - 4. 0%; CI: minn - 22. 5 sa 11. 7 [p=0. 639]). Barra minn hekk, l- analiżi tas - sottogrupp skond l- eta` ssuġġeriet li l- benefiċċju ta ’ clopidogrel għal pazjenti li kellhom iktar minn 75 sena kien inqas minn dak osservat f’ pazjenti ≤75 sena.
Acute coronary syndrome
20 Sindromu koronarju akut
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.
Il - pazjenti kienu randomised għal clopidogrel (doża qawwija tal- bidu ta ’ 300 mg u wara 75 mg/ jum, N = 6, 259) jew il- plaċebo (N = 6, 303), u t- tnejn ingħataw flimkien ma ’ ASA (75- 325 mg darba kuljum) u terapiji oħrastandard.
In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
F’ CURE, 823 pazjent ingħataw terapija ta ’ antagonista għar- riċettur GPIIb/ IIIa fl- istess ħin.
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.
Ngħataw heparins lil iktar minn 90% tal- pazjenti u r - rata relattiva ta ’ dmija bejn clopidogrel u l- plaċebo ma ġietx affettwata b’ mod sinifikanti bit- terapija ta ’ heparin li ngħatat fl- istess ħin.
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)).
In- numru ta ’ pazjenti li għaddew mill- punt primarju ta ’ tmiem [mewt kardjovaskulari (CV), infart mijokardijaku (MI) jew puplesija] kien 582 (9. 3%) fil- grupp ikkurat bi clopidogrel u 719 (11. 4%) fil - grupp ikkurat bil- plaċebo, li jissarraf fi tnaqqis fir- riskju relattiv ta ’ 20% (95% CI ta ’ 10% - 28%; p=0. 00009) għall- grupp ikkurat bi clopidogrel (tnaqqis fir- riskju relattiv ta ’ 17% f’ pazjenti li kienu kkurati b’ mod konservattiv, 29% meta kellhom anġoplastija koronarja transluminali perkutanja (PTCA) bi stent jew mingħajru u 10% meta kellhom trapjant ta 'bajpass f' arterja koronarja (CABG)).
24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR = 18.2%; CI:
24. 3%, 57. 5%) u inibituri ta ’ GPIIb/ IIIa (RRR = 18. 2%; CI:
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.
In- numri ta ’ pazjenti li kellhom punt ko- primarju ta ’ tmiem (mewt b’ CV, MI, puplesija jew iskemija li mhux qed tirrisondi għall- kura) kien 1 035 (16. 5%) fil- grupp ikkurat bi clopidogrel u 1 187 (18. 7%) fil- grupp ikkurat bil- plaċebo, tnaqqis ta ’ 14% fir- riskju relattiv) (95% CI ta ’ 6% - 21%, p= 0. 0005) għall- grupp ikkurat bi clopidogrel.
The results obtained in populations with different characteristics (e.g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis.
Ir- riżultati f’ popolazzjonijiet b’ karatteristiċi differenti (eż. anġina instabbli jew MI ta ’ mewġa mhux Q, minn livelli baxxa sa għolja ta ’ riskju, dijabete, il- bżonn ta ’ revaskularizzazzjoni, eta`, sess eċċ.) kienu konsistenti mar- riżultati ta ’ l- analiżi primarja.
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).
Il- benefiċċji osservati bi clopidogrel kienu indipendenti minn terapiji kardjovaskulari oħra akuti u fit - tul (bħall - heparin/ LMWH, antagonisti ta ’ GPIIb/ IIIa, prodotti mediċinali li jbaxxu l- lipidi, imblokkaturi tar- riċetturi beta u inibituri ta ’ ACE).
The CLARITY trial included 3,491 patients presenting within 12 hours of the onset of a ST elevation MI and planned for thrombolytic therapy.
Il- pazjenti rċevew
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.
21 clopidogrel (300 mg bħala d- doża qawwija inizjali segwita minn 75 mg / kuljum, n=1752) jew il - plaċebo (n=1739), it- tnejn ma ’ ASA (150 sa 325 mg bħala doża qawwija inizjali segwita minn 75 sa 162 mg/ kuljum), sustanza fibrinolitika u, fejn kien xieraq, heparin.
A total of 99.7% of patients received fibrinolytics (fibrin specific:
It - total ta ’ 99. 7% tal- pazjenti rċevew is- sustanzi fibrinolitiċi (speċifiċi għall- fibrin:
31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
31. 1%), 89. 5% heparin, 78. 7% imblokkaturi tar- riċetturi beta, 54. 7% inibituri ACE u 63% statins.
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:
Ħmistax fil- mija (15. 0%) tal- pazjenti fil- grupp tal- clopidogrel u 21. 7% tal- grupp bil- plaċebo laħqu l - punt primarju u aħħari, li jirrappreżentaw tnaqqis assolut ta ’ 6. 7% u 36% ta ’ tnaqqis probabbli favur clopidogrel (95% CI:
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.
Il- pazjenti ngħataw clopidogrel (75 mg/ kuljum, n=22, 961) jew il- plaċebo (n=22, 891), flimkien ma ’ ASA (162 mg/ kuljum), għal 28 jum jew sakemm ġew illiċenzjati mill- isptar.
However, plasma concentrations of the parent compound are very low and below the quantification limit (0.00025 mg/l) beyond 2 hours.
Madankollu, il - konċentrazzjonijiet fil- plażma tas- sustanza oriġinali huma baxxi ħafna u taħt il- limitu kwalifikanti (0. 00025 mg/ l) wara sagħtejn.
Peak plasma levels of this metabolite (approx.
Clopidogrel huwa metabolizzat b’ mod estensiv fil- fwied u l- metabolit prinċipali, li mhux attiv, huwa d- derivattiv ta ’ carboxylic acid, li jirrappreżenta madwar 85% tal- kompost li qed jiċċirkola fil- plażma.
3mg/l after repeated 75 mg oral doses) occurred approximately 1 hour after dosing.
Il- livelli massimi fil- plażma ta ’ dan il- metabolit (Bejn wieħed u ieħor 3 mg/ l wara dożi ripetuti ta ’ 75 mg mill- ħalq) seħħew bejn wieħed u ieħor siegħa wara d- dożaġġ.
Clopidogrel and the main circulating metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
22 Clopidogrel u l- metabolit prinċipali ċirkolanti jintrabtu b’ mod reversibbli in vitro mal- proteini umani tal- plażma (98% u 94% rispettivament).
Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Wara doża orali ta ’ clopidogrel 14C- tikkettatfil- bniedem, bejn wieħed u ieħor 50% kien mneħħi fl - urina u bejn wieħed u ieħor 46% ħareġ fl- ippurgar fl- intervall ta ’ 120 siegħa wara d- dożaġġ.
The elimination half-life of the main circulating metabolite was 8 hours after single and repeated administration.
Il- half - life tat- tneħħija tal- metabolit prinċipali ċirkolanti kien 8 sigħat wara amministrazzjoni waħda u ripetuta.
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.
Wara dożi ripetuti ta ’ 75 mg ta ’ clopidogrel kuljum, il- livelli fil- plażma tal- metabolit prinċipali ċirkolanti kienu iktar baxxi f’ persuni b’ mard sever tal- kliewi (tneħħija tal- kreatinina minn 5 sa 15 ml/ min) meta mqabbla ma ’ persuni b’ mard moderat tal- kliewi (tneħħija tal- kreatitina minn 30 sa 60 ml/ min) u mal- livelli osservati fi studji oħra b’ persuni f’ saħħithom.
In addition, clinical tolerance was good in all patients.
Għalkemm l- inibizzjoni ta ’ l - agreggrazzjoni tal- plejtlets indotti minn ADP kien iktar baxx (25%) minn dak osservat f’ persuni f’ saħħithom, it- titwil tad- dmija kien simili għal dak osservat f’ persuni f’ saħħithom li kienu qed jingħataw 75 mg ta ’ clopidogrel kuljum. Barra minn hekk, it- tolleranza klinika kienet tajba fil- pazjenti kollha.
Daily dosing for 10 days with clopidogrel 75 mg/day was safe and well tolerated.
Kienet aċċertata s- sigurta` tad- dożaġġ ta ’ kuljum għal 10 ijiem bi clopidogrel 75 mg/ jum, u kienet ittollerata sew.
21 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
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.
Dawn seħħew f’ dożi li jirrappreżentaw mill- inqas 25 darba l- espożizzjoni li ġiet osservata fil- bnedmin li ngħataw doża klinika ta ’ 75 mg/ jum u kienu bħala konsegwenza ta ’ effett fuq l- enzimi metabolizzanti fil- fwied.
At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/or vomiting) of clopidogrel was also reported in rat and baboon.
F’ dożi għolja ħafna, ġiet irrapurtata tollerabilita` baxxa fiż- żaqq (gastrite, erożjonijiet gastriċi u/ jew rimettar) ta ’ clopidogrel fil- firien u l- babwini.
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).
Ma kienx hemm evidenza ta ’ riskju ta ’ kanċer meta clopidogrel ingħata għal 78 ġimgħa lill- ġrieden u 104 ġimgħa lill- firien meta dawn ingħataw dożi sa 77 mg/ kg kuljum (li jirrappreżenta espożizzjoni mill- inqas 25 darba dik osservata fil- bnedmin li kienu qed jingħataw doża klinika ta ’ 75 mg/ jum).
Hypromellose (E464) Lactose Triacetin (E1518) Titanium dioxide (E171) Red iron oxide (E172) Carnauba wax
Hypromellose (E464) Lactose Triacetin (E1518) Titanium dioxide (E171) Iron oxide aħmar (E172) Carnauba wax
6. 3 Shelf-life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
3 years
3 snin6. 4
6.4 Special precautions for storage
Prekawzjonijiet speċjali għall- ħażna
This medicinal product does not require any special storage conditions.
m’ għandhiex bżonn ħażna speċjali.
22 6.5 Nature and content of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Aluminium perforated unit-dose blisters in cardboard cartons containing 4x1, 30x1 and 100x1 film-coated tablets.
Folji mtaqqbin ta 'l- aluminju ta ’ doża waħda f' kaxxi tal- kartun li fihom 4x1, 30x1 u 100x1 pilloli miksijin b' rita.
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/ 015 - Pakketti ta ’ 4x1 pilloli miksijin b’ rita ġo folji mtaqqbin ta ’ doża waħda kollha kemm huma ta ’ l- aluminju EU/ 1/ 08/ 464/ 016 - Pakketti ta ’ 30x1 pilloli miksijin b’ rita ġo folji mtaqqbin ta ’ doża waħda kollha kemm huma ta ’ l- aluminju EU/ 1/ 08/ 464/ 017 - Pakketti ta ’ 100x1 pilloli miksijin b’ rita ġo folji mtaqqbin ta ’ doża waħda kollha kemm huma ta ’ l- aluminju
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http://www.emea.europa.eu/
Informazzjoni dettaljata dwar dan il- prodott tinstab fuq il- website ta ’ l- Agenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /
23 ANNEX II
25 ANNESS II
- Clopidogrel BMS 75 mg film-coated tablets
- Clopidogrel BMS 75 mg pilloli miksija b' rita
Sanofi Winthrop Industrie 1, route 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 Franza
Sanofi-Synthelabo Limited Edgefield avenue, Fawdon, Newcastle-Upon-Tyne, Tyne & Wear NE3 3TT United Kingdom
Sanofi Synthelabo Limited Edgefield Avenue Fawdon Newcastle upon Tyne NE3 3TT – UK Renju Unit
Sanofi Winthrop Industrie 6, boulevard de l'Europe F-21800 Quétigny France
Sanofi Winthrop Industrie 6, Boulevard de l’ Europe F- 21800 Quétigny Franza
- Clopidogrel BMS 300 mg film-coated tablets
- Clopidogrel BMS 300 mg pilloli miksija b' rita
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 Franza
CONDITIONS OF THE MARKETING AUTH ORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Not applicable
Ma jgħoddx f’ dan il- każ
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.
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq irid jassigura li s- sistema ta' farmakoviġilanza, kif deskritta f' verżjoni 2. 0 ippreżentat f' Modulu 1. 8. 1. ta 'l- Applikazzjoni għall- Awtorizzazzjoni għat - Tqegħid fis- Suq, tkun fis- seħħ u implimentata qabel u waqt li l- prodott ikun tqiegħed fis- suq.
25 ANNEX III
27 ANNESS III
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 7, 14, 28, 30, 50x1, 84, 90 or 100 tablets
Kaxxa ta ’ 7, 14, 28, 30, 50x1, 84, 90 jew 100 pillola
Clopidogrel BMS 75 mg film-coated tablets clopidogrel
Clopidogrel BMS 75 mg pillola miksija b’ rita clopidogrel
Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Kull pillola fiha75 mg ta ’ clopidogrel (bħala hydrogen sulphate).
It also contains: hydrogenated castor oil and lactose.
Fiha ukoll: castor oil idroġenat u lactose u.
See leaflet for further information.
Ara l- fuljett għal aktar informazzjoni.
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
14 – il pillola miksija b’ rita 28 pillola miksija b’ rita 30 pillola miksija b’ rita 50x1 pilloli miksijin b’ rita 84 pillola miksija b’ rita 90 pillola miksija b’ rita 100 pillola miksija b’ rita 7 pilloli miksija b’ rita
Oral use Read the package leaflet before use.
Użu orali Aqra l- fuljett ta ’ tagħrif qabel l- użu
Keep out of the reach and sight of children.
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal
EXP {MM/YYYY}
JIS [XX/ SSSS]
Store below 30°C (for PVC/PVDC/aluminium blisters) Or No special storage conditions (for all aluminium blisters)
Aħżen f’ temperatura taħt 30°C (għall- folji tal- PVC/ PVDC/ Aluminju) Jew M’ hemmx bżonn kundizzjonijiet speċjali ta ’ kif jinħażen (għall- folji kollha kemm huma ta ’ l - aluminju)
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– il pillola EU/ 1/ 08/ 464/ 002 14– il pillola EU/ 1/ 08/ 464/ 003 28 pillola EU/ 1/ 08/ 464/ 004 28 pillola EU/ 1/ 08/ 464/ 005 30 pillola EU/ 1/ 08/ 464/ 006 30 pillola EU/ 1/ 08/ 464/ 007 50x1 pilloli EU/ 1/ 08/ 464/ 008 50x1 pilloli EU/ 1/ 08/ 464/ 009 84 pillola EU/ 1/ 08/ 464/ 010 84 pillola EU/ 1/ 08/ 464/ 011 90 pillola EU/ 1/ 08/ 464/ 012 90 pillola EU/ 1/ 08/ 464/ 013 100 pillola EU/ 1/ 08/ 464/ 014 100 pillola EU/ 1/ 08/ 464/ 018 7 pilloli EU/ 1/ 08/ 464/ 019 7 pilloli
Batch number:
Lott
30 PARTICULARS TO APPEAR ON BLISTERS (boxes of 7, 14, 28 or 84 tablets)
32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI (kaxxi ta ’ 7, 14, 28 jew 84 pillola)
Clopidogrel BMS 75 mg film-coated tablets clopidogrel
Clopidogrel BMS 75 mg pilloli miksija b’ rita clopidogrel
EXP {MM/YYYY}
JIS {XX/ SSSS}
Batch number
Lott
Calendar days Mon Tue Wed Thu Fri Sat Sun
Ġranet tal- ġimgħa
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)
Ġimgħa 1 Ġimgħa 2 (għall- kaxxa ta ’ 14, 28 u 84 pilloli) Ġimgħa 3 (għall- kaxxa ta ’ 28 u 84 pilloli) Ġimgħa 4 (għall- kaxxa ta ’ 28 u 84 pilloli)
31 PARTICULARS TO APPEAR ON BLISTERS (boxes of 30, 50x1, 90 or 100 tablets)
33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- FOLJI (kaxxi ta’ 30, 50x1, 90 jew 100 pillola)
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
34 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON/Box of 4x1, 30x1 or 100x1 tablets
KARTUNA TA ’ BARRA/ Kaxxa ta ’ 4x1, 30x1 jew 100x1 pilloli
Clopidogrel BMS 300 mg film-coated tablets clopidogrel
Clopidogrel BMS 300 mg pilloli miksija b’ rita clopidogrel
Each tablet contains 300 mg of clopidogrel (as hydrogen sulphate)
Kull pillola fiha 300 mg ta ’ clopidogrel (bħala hydrogen sulphate).
It also contains: hydrogenated castor oil and lactose.
Fiha wkoll: lactose u castor oil idroġenat.
4x1 film-coated tablets 30x1 film-coated tablets 100x1 film-coated tablets
4x1 pilloli miksija b’ rita 30x1 pilloli miksija b’ rita 100x1 pilloli miksija b’ rita
Read the package leaflet before use.
Użu orali Aqra l- fuljett ta ’ tagħrif qabel l- użu
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 pilloli miksija b’ rita EU/ 1/ 08/ 464/ 016 30x1 pilloli miksija b’ rita EU/ 1/ 08/ 464/ 017 100x1 pilloli miksija b’ rita
BLISTER /Box of 4x1, 30x1 or 100x1 tablets
36 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI FOLJA/ kaxxa ta ’ 4x1, 30x1 jew 100x1 pilloli
36 PACKAGE LEAFLET:
38 FULJETT TA ’ TAGĦRIF:
- This medicine has been prescribed for you.
- Din il- mediċina giet mogħtija lilek M’ għandekx tgħaddiha lil persuni oħra.
What Clopidogrel BMS is and what it is used for 2.
X’ inhu Clopidogrel BMS u għalxiex jintuża 2.
Before you take Clopidogrel BMS 3.
Qabel ma tieħu Clopidogrel BMS 3.
How to take Clopidogrel BMS 4.
Kif għandek tieħu Clopidogrel BMS 4.
Possible side effects 5 How to store Clopidogrel BMS 6.
Kif taħżen Clopidogrel BMS 6.
WHAT CLOPIDOGREL BMS IS AND WHAT IT IS USED FOR
X’ INHU CLOPIDOGREL BMS U GĦALXIEX JINTUŻA
Clopidogrel BMS belongs to a group of medicines called antiplatelet medicinal products.
Clopidogrel BMS jifforma parti minn grupp ta ’ mediċini msejħa prodotti mediċinali ta ’ kontra l - plejtlets.
Platelets are very small structures in the blood, smaller than red or white blood cells, which clump together during blood clotting.
Plejtlets huma partijiet żgħar ħafna fid- demm, iżgħar miċ- ċelluli ħomor jew bojod tad- demm, li jinġemġħu flimkien waqt li jkun qed jagħqad id- demm.
By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).
Il- prodotti mediċinali ta ’ kontra l- plejtlets jilqgħu għal dan u jnaqqsu l- possibbiltajiet li jiffurmaw ċapep tad- demm (proċess imsejjaħ trombożi).
Clopidogrel BMS is taken 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).
Clopidogrel BMS jittieħed biex inaqqas ir- riskju li ċapep tad- demm (trombi) jifformaw fl- arterji mwebbsin (arterji), proċess imsejjaħ aterotrombożi, li jista ’ jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal- qalb, jew mewt).
You have been prescribed Clopidogrel BMS to help prevent blood clots and reduce the risk of these severe events because:
Ingħatajt Clopidogrel BMS biex inaqqas ir- riskju ta ’ ċapep tad- demm u l- konsegwenzi severi tagħhom għaliex:
- You have a condition of hardening of arteries (also known as atherosclerosis), and
- Għandek kundizzjoni fejn l- arterji tiegħek qegħdin jibbiesu (magħrufa wkoll bħala
- You have previously experienced a heart attack, stroke or have a condition known as peripheral
aterosklerożi), u
arterial disease, or
- Kellek attakk tal- qalb, puplesija jew kundizzjoni magħrufa bħala mard periferali arterjali, jew
- You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial
- Kellek uġigħ sever f’ sidrek magħruf bħala ‘ anġina mhux stabbli ’ jew ‘ infart mijokardijaku
infarction’ (heart attack).
(attakk ta ’ qalb).
For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow.
Għatt- trattament ta ’ din il- kundizzjoni t- tabib tiegħek seta ’ poġġa stent fl - arterja li nstaddet jew li djieqet biex iċ- ċirkolazzjoni effettiva tad- demm tiġi restawrata..
You should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
Inti trid tingħata wkoll mit- tabib tiegħek acetylsalicylic acid (sustanza li tinsab f’ ħafna mediċini u li tintuża biex ittaffi l- uġigħ u tniżżel id- deni kif ukoll biex tippreveni li jifformaw ċapep ta ’ demm).
BEFORE YOU TAKE CLOPIDOGREL BMS
QABEL MA TIEĦU CLOPIDOGREL BMS
Do not take Clopidogrel BMS:
Tieħux 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.
• Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- clopidogrel jew sustanzi oħra ta ’ Clopidogrel BMS; • Jekk tbati minn kundizzjoni medika li fil- preżent qiegħda tikkawża fsada, bħal ulċera fl- istonku jew fsada ġewwa l- moħħ; • Jekk tbati minn mard sever tal- fwied.
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking clopidogrel.
39 Jekk taħseb li xi waħda minn dawn tgħodd għalik, jew jekk għandek xi dubju, ħu parir tat- tabib tiegħek qabel tibda tieħu clopidogrel.
37 Take special care with Clopidogrel BMS:
Oqgħod attent ħafna b ’ Clopidogrel BMS:
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
Jekk xi sitwazzjoni msemmija hawn taħt tgħodd għalik, ħu parir tat- tabib tiegħek qabel tibda tieħu clopidogrel: • jekk tinsab f’ riskju ta ’ fsada bħal:
a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
kundizzjoni medika li tpoġġik f’ riskju ta ’ fsada interna (bħal ulċera fl- istonku) mard fid- demm li jwassal għal fsada interna (dmija f’ xi tessuti, organi jew ġogi ta ’ ġismek);
a recent serious injury a recent surgery (including dental) a planned surgery (including dental) in the next seven days
ferita serja riċenti; operazzjoni riċenti (anki tas- snien); operazzjoni li ser issirlek (anki tas- snien) fis- sebat ijiem li ġejjin.
last seven days • if you are taking another type of medicine (see ‘Taking other medicines’). • if you have kidney or liver disease
• jekk fl- aħħar sebat ijiem kellek ċappa ta 'demm f' arterja f' moħħok (puplesija iskemika) • jekk qiegħed/ qiegħda tieħu xi tip ta ’ mediċina oħra (ara ‘ Meta tieħu mediċini oħra ’). • jekk tbati minn mard tal- kliewi jew tal- fwied.
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.
Waqt li qiegħed/ qiegħda tieħu clopidogrel: • Għandek tgħid lit- tabib tiegħek jekk għandek xi operazzjoni ppjanata (anki tas- snien). • Għandek ukoll tgħid lit- tabib tiegħek minnufih jekk tiżviluppa kundizzjoni medika li tinkludi deni u tbenġil taħt il- ġilda li jidher bħal tikek ħomor irqaq, flimkien ma 'jew mingħajr għeja kbira mhux spjegata, konfużjoni, sfurija tal- ġilda jew ta' l- għajnejn (suffejra) (ara 'EFFETTI SEKONDARJI LI JISTA' JKOLLU '). • Jekk taqta' x' imkien jew tweġġa ', id- demm jista' jdum aktar mis- soltu biex jieqaf.
This is linked to the way your medicine works as it prevents the ability of blood clots to form.
Dan minħabba l- mod ta 'kif taħdem il- mediċina tiegħek billi ma tħallix li jiffurmaw iċ- ċapep tad- demm.
For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern.
Għal qtugħ u feriti żgħar eż. meta taqta 'x' imkien, meta tqaxxar, normalment m' hemmx għalfejn tinkwieta.
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.
Madanakollu, jekk id- demm li ħiereġ jinkwetak, għandek tkellem lit- tabib tiegħek minnufih (ara 'EFFETTI SEKONDARJI LI JISTA' JKOLLU '). • It- tabib tiegħek jista' jordnalek testijiet tad- demm. • Għandek tgħid lit- tabib jew lill- ispiżjar tiegħek jekk tinnota xi effett mhux mixtieq li mhux imniżżel fis- sezzjoni 'EFFETTI SEKONDARJI LI JISTA' JKOLLU 'ta' dan il- fuljett jew jekk tinnota effett mhux mixtieq li qiegħed jiggrava.
Clopidogrel is not intended for use in children or adolescents.
Clopidogrel m’ għandux jingħata lit- tfal jew lill- adolexxenti.
Some other medicines may influence the use of clopidogrel or vice versa.
Xi mediċini oħra jistgħu jeffettwaw l- użu ta ’ clopidogrel u viċe- versa.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
The use of oral anticoagulants (medicines used to reduce blood clotting) with clopidogrel is not recommended.
L- użu ta ’ sustanzi kontra l- koagulazzjoni tad- demm li jittieħdu mill- ħalq (mediċini li jraqqu d- demm) flimkien ma ’ clopidogrel mhux irrakkomandat.
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.
Għandek speċifikament tgħid lit- tabib tiegħek jekk qiegħed tieħu xi prodott mediċinali li huwa anti - infjammatorju li mhux sterojde, normalment użat biex jiġi ittrattat l- uġigħ u/ jew kundizzjonijiet infjammatorji tal - muskoli jew tal- ġogi, jew jekk qed tieħu l- eparina jew xi mediċina oħra użata biex traqqaq id- demm.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel BMS in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Jekk ħassejt uġigħ qawwi f’ sidrek (anġina mhux stabbli jew attakk tal- qalb), jista ’ jingħatalek Clopidogrel BMS flimkien ma ’ acetylsalicylic acid, sustanza inkorporata f’ ħafna mediċini użati biex itaffu l- uġigħ u jnaqqsu d- deni.
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.
L- użu ta ’ kultant ta ’ acetylsalicylic acid (ta ’ mhux aktar minn 1000 mg f’ perijodu ta ’ 24 siegħa) ġeneralment m’ għandux joħloq problema, iżda l- użu fit- tul f’ cirkostanzi oħrajn għandu jiġi diskuss mat- tabib tiegħek.
Taking Clopidogrel BMS with food and drink Food/meals have no influence.
Meta tiehu Clopidogrel BMS ma ’ l- ikel jew ix- xorb Ikel/ ikliet m’ għandhomx effett. clopidogrel jista ’ jittieħed ma ’ l- ikel jew mingħajru.
Clopidogrel may be taken with or without food.
40 Tqala u treddigħ
38 Pregnancy and breast-feeding It is preferable not to use this product during pregnancy and breast-feeding.
Huwa preferibbli li ma tużax dan il- prodott waqt it- tqala u t- treddigħ.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking clopidogrel.
Qabel ma tibda tieħu clopidogrel, tinforma lit- tabib jew lill- ispiżjar/ a tiegħek jekk inti tqila jew taħseb li inti tqila.
If you become pregnant while taking Clopidogrel BMS, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Jekk toħroġ tqila waqt li qiegħda tieħu Clopidogrel BMS, għarraf minnufih lit- tabib tiegħek billi huwa rrakkomandat li ma tieħux clopidrogrel waqt it- tqala.
While taking Clopidogrel BMS, consult your doctor about the breast-feeding of a baby.
Waqt li qiegħed tieħu Clopidogrel BMS, għandek tikkonsulta mat- tabib tiegħek dwar it- treddigħ tat - tarbija.
Clopidogrel is unlikely to affect your ability to drive or to use machines.
Sewqan u tħaddim ta ’ magni Clopidogrel m’ għandux jaffettwa is- sewqan jew it- tħaddim ta ’ magni.
Clopidogrel BMS contains lactose and hydrogenated castor oil.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Clopodogrel BMS Clopidogrel BMS fih lactose u castor oil idroġenat.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib qallek li għandek intolleranza għal ċerti tipi ta ’ zokkor, ikkuntatja lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
Hydrogenated castor oil may cause stomach upset or diarrhoea.
Castor oil idroġenat jista ’ jikkawża taqlib ta ’ l- istonku jew dijarrea
HOW TO TAKE CLOPIDOGREL BMS
KIF GĦANDEK TIEĦU CLOPIDOGREL BMS
Always take Clopidogrel BMS exactly as your doctor has told you.
Dejjem għandek tieħu Clopidogrel BMS skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat - tabib jew ma ’ l- ispżjar tiegħek jekk ikollok xi dubju.
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.
Jekk kellek uġigħ sever f’ sidrek (anġina instabbli jew attakk tal- qalb), it- tabib jista ’ jagħtik 300 mg ta ’ Clopidogrel BMS (pillola 1 ta '300 mg jew 4 pilloli ta ’ 75 mg) darba fil- bidu tal- kura.