qanastek/EMEA-V3 huggingface dataset:
Circadin 2 mg prolonged-release tablets melatonin
Circadin 2 mg pilloli li jerħu l- mediċina bil- mod Melatonin
17 PACKAGE LEAFLET:
17 FULJETT TA ’ TAGĦRIF:
Circadin 2 mg prolonged-release tablets Melatonin
Circadin 2 mg pilloli li jerħu l- mediċina bil- mod Melatonin
What Circadin is and what it is used for 2.
X’ inhu Circadin u għalxiex jintuża 2.
Before you take Circadin 3.
Qabel ma tieħu Circadin 3.
How to take Circadin 4.
Kif għandek tieħu Circadin 4.
How to store Circadin 6.
Kif taħżen Circadin 6.
WHAT CIRCADIN IS AND WHAT IT IS USED FOR
X’ INHU CIRCADIN U GĦALXIEX JINTUŻA
The active substance of Circadin, melatonin, belongs to a natural group of hormones produced by the body.
Is- sustanza attiva ta ’ Circadin, melatonin, jagħmel parti minn grupp naturali ta ’ ormoni magħmula mill- ġisem.
Circadin is used as monotherapy for the short-term treatment of primary insomnia (difficulty in getting to sleep or staying asleep, or poor quality of sleep for at least one month), characterised by poor quality of sleep in patients aged 55 years and older.
Circadin jintuża bħala monoterapija għall- kura ta ’ żmien qasir ta ’ insomnija primarja (diffikultà biex torqod jew biex tibqa rieqed, jew irqad ta ’ kwalità baxxa għal mill- anqas xahar), ikkaratterizzata minn irqad ta ’ kwalità baxxa f’ pazjenti b’ età ta ’ 55 sena jew aktar.
BEFORE YOU TAKE CIRCADIN
QABEL MA TIEĦU CIRCADIN
Do not take Circadin
Tieħux Circadin
- if you are allergic (hypersensitive) to melatonin or any of the other ingredients of Circadin.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal melatonin jew sustanzi oħra ta ’
- if drowsiness is likely to cause a risk to your safety;
- jekk sturdament għandu mnejn jikkawża riskju għas- sigurta ’ tiegħek;
- if you suffer from any liver problems;
- jekk tbati minn xi problemi tal- fwied;
- if you suffer from kidney problems;
- jekk tbati minn problemi tal- kliewi;
- if you suffer from any autoimmune disease (where the body is ‘ attacked’ by its own
- jekk tbati minn xi mard awtoimmuni (fejn il- ġisem huwa ‘ attakkat ’ mis- sistema immuni tiegħu
immune system).
stess).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription BEFORE you start the treatment as they may affect the action of Circadin.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta QABEL ma tibda l- kura għax dawn jista ’ jkollhom effett fuq l- azzjoni ta ’ Circadin.
These medicines include hypnotics and tranquilisers (e. g. benzodiazepines), fluvoxamine, thioridazine and imipramine (used to treat depression or psychiatric problems), oestrogen (contraceptives or hormone replacement therapy), cimetidine and psoralens (used to treat skin problems e. g. psoriasis).
Dawn il- mediċini jinkludu ipnotiċi u kalmanti (e. ż. benzodiazepines), fluvoxamine, thioridazine u imipramine (użat għall- kura ta ’ depressjoni jew problemi psikjatriċi), oestrogen (kontraċettivi jew terapija ta ’ sostituzzjoni ta ’ l- ormon), cimetidine u psoralens (użat għall - kura ta ’ problemi tal- ġilda e. ż. psorajiżi).
18 Taking Circadin with food and drink Take Circadin after you have eaten.
Meta tieħu Circadin ma ’ l- ikel u max- xorb Ħu Circadin wara li tiekol.
Do not drink alcohol before, during or after taking Circadin.
Tixrobx alkoħol qabel, waqt, jew wara li tieħu Circadin.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
18 Tqala u Treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
It is not recommended to take Circadin if you are pregnant or suspect that you may be pregnant.
Mhux rakkomandat li tieħu Circadin jekk int tqila jew taħseb li tista ’ tkun tqila.
It is not recommended to take Circadin if you are breast feeding.
Mhux rakkomandat li tieħu Circadin jekk qed tredda ’.
Driving and using machines Circadin may cause drowsiness.
Sewqan u tħaddim ta ’ magni Circadin jista ’ jikkawża sturdament.
If you are affected, you should not drive or operate machinery.
Jekk tiġi affetwat lilek m’ għandekx issuq jew tħaddem magni.
If you suffer from continued drowsiness, then you should consult your doctor.
Jekk issofri minn sturdament kontinwu għandek tkellem lit- tabib tigħek.
Important information about some of the ingredients of Circadin Each prolonged-release tablet contains 80 mg of lactose-monohydrate.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Circadin Kull pillola li terħi l- mediċina bil- mod fiha 80 mg ta ’ lactose- monohydrate.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi zokkrijiet, kellem lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
HOW TO TAKE CIRCADIN
KIF GĦANDEK TIEĦU CIRCADIN
Always take Circadin exactly as your doctor has told you.
Dejjem għandek tieħu Circadin skond il- parir tat- tabib.
The dose is one Circadin tablet taken daily by mouth, after food, 1-2 hours before bedtime, for 3 weeks.
Id- doża li ssoltu tingħata hija ta ’ pillola waħda Circadin meħuda kuljum mil- ħalq, wara l- ikel, siegħa sa sagħtejn qabel ħin l- irqad, għal 3 ġimgħat.
You should swallow the tablet whole.
Għandek tibla l- pillola sħiħa.
Circadin tablets should not be crushed or cut in half.
Il- pilloli Circadin m’ għandhomx jiġu mfarrka jew maqsuma fi tnejn.
If you take more Circadin than you should If you have accidentally taken too much of your medicine, contact your doctor or pharmacist as soon as possible.
Jekk tieħu Circadin aktar milli suppost Jekk bi żball ħadt iż- żejjed mill- mediċina tiegħek, għarraf lit- tabib jew lill- ispiżjar tiegħek malajr kemm jista ’ jkun.
Taking more than the recommended daily dose may make you feel drowsy.
It- teħid ta ’ aktar mid- doża rakkomandata ta ’ kuljum jista ’ jġiegħlek tħossok sturdut.
If you forget to take Circadin If you forget to take your tablet, take another as soon as you remember, before going to sleep, or wait until it is time to take your next dose, then go on as before.
Jekk tinsa tieħu Circadin Jekk tinsa tieħu l- pillola tiegħek, ħu oħra hekk kif tiftakar, qabel ma tmur torqod, jew stenna sal- ħin li fiħ għandek tieħu d- doża li jmissek, u wara kompli bħal qabel.
If you stop taking Circadin There are no known harmful effects if treatment is interrupted or ended early.
Jekk tieqaf tieħu Circadin M’ hemm l- ebda effetti avversi magħrufa jekk il- kura tiġi interrotta jew imwaqqfa kmieni.
The use of Circadin is not known to cause any withdrawal effects after treatment completion.
L- użu ta ’ Circadin m’ hux magħruf li jikkawża effetti ta ’ rtirar wara li tintemm l- kura.
Like all medicines, Circadin can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Circadin jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following events are considered to be uncommon (i. e. likely to occur in fewer than 1 in 100 patients):
L - avvenimenti li ġejjin huma kkunsidrati bħala mhux komuni (i. e., x’ aktarx li jseħħu f’ anqas minn 1 minn kull 100 pazjent):
Irritability, nervousness, restlessness, insomnia, abnormal dreams, migraine, psychomotor hyperactivity (restlessness associated with increased activity), dizziness, somnolence (tiredness), abdominal pain, constipation, dry mouth, hyperbilirubinaemia (changes in the composition of your blood which could cause yellowing of the skin or eyes (jaundice), hyperhidrosis (excessive sweating), asthenia (feeling of weakness) and weight increase.
Irritabilità, nervi, aġitazzjoni, nuqqas ta ’ rqad, ħolm mhux normali, emigranja, iperattività psikomotorja (aġitazzjoni assoċjata ma ’ żieda fl- attività), sturdament, ngħas (għeja), uġigħ addominali, stitikezza, ħalq xott, iperbilirubinimja (bidliet fil- kompożizzjoni tad- demm tiegħek li jistgħu jikkawżaw li l- ġilda jew l- għajnejn jisfaru (suffejra) iperidrożi (għaraq eċċessiv), astenja (tħossok debboli) u żieda fil- piż.
The following events are considered to be rare (i. e., likely to occur in fewer than 1 in 1,000 patients):
L- avvenimenti li ġejjin huma kkunsidrati bħala rari (i. e., x’ aktarx li jseħħu f’ anqas minn 1 minn kull 1, 000 pazjent):
19 Herpes Zoster (shingles), leukopenia, thrombocytopenia, hypertriglyceridaemia, altered mood, aggression, agitation, crying, early morning awakening, increased libido (increased sex drive), memory impairment, disturbance in attention, poor quality sleep, reduced visual acuity (visual impairment), blurred vision, increased lacrimation (watery eyes), positional vertigo (dizziness when standing), hot flushes, gastrointestinal upset, vomiting, abnormal bowel sounds, flatulence (wind), salivary hypersecretion (excess saliva production), halitosis (bad breath), abnormal liver function test (increased liver enzymes), eczema, erythema (skin rash), pruritic rash (itchy rash), pruritus (itching), dry skin, nail disorder, night sweats, muscle cramp, neck pain, priapism (increased duration of erection) and fatigue (tiredness).
19 Herpes Zoster (ħruq ta ’ Sant ’ Antnin), lewkopenja, tromboċitopenja, ipertrigliċeridimja, bidla fil - burdata, aggressjoni, aġitazzjoni, biki, qawmien kmieni filgħodu, żieda fil- libido (żieda fl- aptit għas - sess), indeboliment tal- memorja, disturbi fl- attenzjoni, rqad ta ’ kwalità ħażina, akutezza tal- vista mnaqqsa (indeboliment fil- vista), vista mċajpra, żieda fid- dmugħ (għajnejn idemmgħu), vertigo pożizzjonali (sturdament waqt il- waqfien), fwawar, taqlib gastro- intestinali, rimettar, ħsejjes tal - musrana mhux nornali, flattulenza (gass), żieda fit- tnixxija tal- bżieq (produzzjoni eċċessiva tal- bżieq), alitosi (riħa ħażina fil- ħalq), testijiet tal- funzjoni tal- fwied mhux normali (żieda fl- enżimi tal- fwied), ekżema, eritima (raxx tal- ġilda), raxx pruritika (raxx bil- ħakk), pruritus (ħakk), ġilda xotta, disturbi fid- dwiefer, għaraq matul il- lejl, bugħawwieġ fil- muskoli, uġigħ fl- għonq, priapismu (żieda fid - dewmien tal- erezzjoni) u għeja (tħossok bla saħħa).
HOW TO STORE CIRCADIN
KIF TAĦŻEN CIRCADIN
Do not use Circadin after the expiry date which is stated on the carton.
Tużax Circadin wara d- data ta ’ skadenza li tidher fuq il- kartuna.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għall - aħħar ġurnata ta ’ dak ix- xahar.
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- drenaġġ jew ma ’ l- iskart domestiku.
What Circadin contains
X’ fih Circadin
- The active substance is melatonin.
- Is- sustanza attiva hi melatonin.
- The other ingredients are ammonio methacrylate copolymer type B, calcium hydrogen
- Is- sustanzi l- oħra huma ammonio methacrylate copolymer type B, calcium hydrogen phosphate
phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talc and magnesium stearate.
dihydrate, lactose monohydrate, silica (colloidal anhydrous), talkum and magnesium stearate.
What Circadin looks like and contents of the pack Circadin 2 mg prolonged-release tablets are available as white to off-white round bi-convex shaped tablets.
Id- Dehra ta ’ Circadin u l- kontenuti tal- pakkett Circadin 2 mg pilloli li jerħu l- mediċina bil- mod huma disponibbli bħala pilloli bojod għal offwajt, tondu u bbuzzati fuq iż- żewġ naħat.
Each carton of tablets contains one blister strip of 20 or 21 tablets.
Kull kartuna ta ’ pilloli fiha strixxa tal- folja waħda b’ 20 jew 21 pillola.
20 Manufacturer:
20 Il- Manifattur:
Sites responsible for Batch Release in the EEA: -
Is- siti responsabbli għall- Ħruġ tal- Lott fl- EEA: -
Penn Pharmaceutical Services Ltd Units 23-24 Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA UK
Penn Pharmaceutical Services Ltd Units 23- 24 Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA UK
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (huwa parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Clopidogrel BMS?
X’ inhu Clopidogrel BMS?
Clopidogrel BMS is a medicine that contains the active substance clopidogrel.
Clopidogrel BMS huwa mediċina li fiha s- sustanza attiva clopidogrel.
It is available as pink tablets (round:
Jiġi bħala pilloli roża (tondi:
75 mg; oblong:
75 mg; oblongi:
This medicine is the same as Iscover, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal Iscover, li hija diġà awtorizzata fl- Unjoni Ewropea (UE).
The company that makes Iscover has agreed that its scientific data can be used for Clopidogrel BMS.
Il - kumpanija li tagħmel Iscover qablet li l- informazzjoni xjentifika tagħha tista ’ tintuża għal Clopidogrel BMS.
What is Clopidogrel BMS used for?
Għal xiex jintuża Clopidogrel BMS?
Clopidogrel BMS is used in adult patients to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Clopidogrel BMS jintuża f’ pazjenti adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t- twebbis ta ’ l- arterji).
Clopidogrel BMS can be given to the following groups of patients: • patients who have recently had a myocardial infarction (heart attack).
Clopidogrel BMS jista ’ jingħata lill- gruppi ta ’ pazjenti li ġejjin: • pazjenti li jkun għadu kemm tahom infart mijokardiku (attakk tal- qalb).
Clopidogrel BMS can be started between a few days and 35 days after the attack; • patients who have had a recent ischaemic stroke (non-bleeding stroke).
Clopidogrel BMS jista ’ jinbeda fl- ewwel ftit jiem wara l- attakk u sa 35 ġurnata wara; • pazjenti li riċentement tkun tathom puplesija iskemika (puplesija li ma tkunx seħħet minħabba ħruġ ta ’ demm).
Clopidogrel BMS can be started between seven days and six months after the attack; • patients with peripheral arterial disease (problems with blood flow in the arteries); • patients who have a condition known as ‘ acute coronary syndrome ’, when it should be given in combination with aspirin (another anticoagulant), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Clopidogrel BMS jista ’ jinbeda bejn sebat ijiem u sitt xhur wara li jkun seħħ l - attakk; • pazjenti b’ mard fl- arterji periferali (problemi bil- fluss tad- demm fl- arterji); • pazjenti b’ kundizzjoni magħrufa bħala ‘ sindromu koronarju akut ’, meta jingħata ma ’ l- aspirina (antikoagulant ieħor), fosthom f’ pazjenti li tkun iddaħħlitilhom stent (tubu qasir imqiegħed f’ arterja biex ma jħallihiex tingħalaq).
Clopidogrel BMS can be used in patients who are having a heart attack with an ‘ ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Clopidogrel BMS jista ’ jintuża f’ pazjenti li jkollhom attakk tal- qalb flimkien ma ’ ‘ elevazzjoni fit- taqsima ST ’ (riżultat mhux normali ta ’ l - elettrokardjogramma jew ECG) meta t- tabib ikun ikkunsidra li jkunu se jibbenefikaw mit - trattament.
It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘ non-Q-wave’ myocardial infarction.
Jista ’ jintuża wkoll f’ pazjenti li ma jkollhomx din l- abnormalità fl- ECGm jekk ikollhom anġina instabbli (uġigħ sever fis- sider) jew li jkollhom infart mijokardiku ‘ mhux tal - mewġa Q ’ (‘ non- Q- wave ’).
How is Clopidogrel BMS used?
Kif jintuża Clopidogrel BMS?
The standard dose of Clopidogrel BMS is one 75 mg tablet once a day, taken with or without food.
Id- doża standard ta ’ Clopidogrel BMS hija ta ’ pillola waħda ta ’ 75 mg darba kuljum, ma ’ l- ikel jew fuq stonku vojt.
In acute coronary syndrome, Clopidogrel BMS is used together with aspirin (another anticoagulant) and treatment generally starts with a loading dose of one 300 mg tablet or four 75 mg tablets.
Fis- sindromu koronarju akut, Clopidogrel BMS jintuża ma ’ l- aspirina (anticoagulant ieħor) u t - trattament ġeneralment jibda b’ doża waħdanija ta ’ pillola ta ’ 300 mg jew erba ’ pilloli ta ’ 75 mg.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Dan 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. hu segwit minn doża standard ta ’ 75 mg darba kuljum għal ta ’ l- inqas erba ’ ġimgħat (f’ infart mijokardiku ta ’ elevazzjoni tat- taqsima ST) jew għal mhux iktar minn 12- il xahar (fis- sindromu mingħajr elevazzjoni tat- taqsima ST).
How does Clopidogrel BMS work?
Kif jaħdem Clopidogrel BMS?
The active substance in Clopidogrel BMS, clopidogrel, is an inhibitor of platelet aggregation.
Is- sustanza attiva f’ Clopidogrel BMS, clopidogrel, hu inibitur ta ’ l- aggregazzjoni tal- pjastrini (platelets).
This means that it helps to prevent blood clots from forming.
Dan ifisser li jgħin biex jimpedixxi d- demm milli jagħqad.
When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating).
Meta d- demm jagħqad, dan jiġri minħabba ċelloli speċjali fid- demm, il- pjastrini, li jeħlu ma ’ xulxin (jaggregaw).
Clopidogrel stops the platelets aggregating by blocking a substance called ADP from binding to a special receptor on their surface.
Clopidogrel iwaqqaf il- pjastrini milli jaggregaw billi jimblokka sustanza msejħa ADP milli tingħaqad ma ’ riċettur speċjali fuq is- superfiċje tagħhom.
This stops the platelets becoming ‘ sticky’, reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Dan iwaqqaf il- pjastrini milli jibdew ‘ iweħħlu ’, fejn b’ hekk jitnaqqas ir - riskju li jiffurmaw l- għaqid tad- demm u jgħin fil- prevenzjoni ta ’ attakk tal- qalb ieħor jew ta ’ attakk ta ’ puplesija.
How has Clopidogrel BMS been studied?
Kif ġie studjat Clopidogrel BMS?
The effectiveness of Clopidogrel BMS as an anticoagulant was compared with that of aspirin in a study called CAPRIE including around 19,000 patients with atherothrombosis.
L- effikaċja ta ’ Clopidogrel BMS bħala anticoagulant tqabblet ma ’ dik ta ’ l- aspirina fi studju msejjaħ CAPRIE li fih ħadu sehem madwar 19, 000 pazjent b’ aterotrombożi.
Neither the patient nor the doctor knew which medicine the patient was receiving.
La l- pazjent u lanqas it- tabib ma kien jaf liema mediċina kien qed jingħata l- pazjent.
The main measure of effectiveness was how many patients experienced a new ‘ ischaemic event’ (heart attack, ischaemic stroke or death) over one to three years.
Il- kejl ewlieni ta ’ l- effikaċja kien l- għadd ta ’ pazjenti li esperjenzaw ‘ każ iskemiku ’ (attack tal- qalb, puplesija iskemika jew mewt) f’ tul ta ’ bejn sena sa tliet snin.
In non-ST segment elevation acute coronary syndrome, Clopidogrel BMS was compared with placebo (a dummy treatment) in over 12,000 patients for up to a year (CURE study):
Fis- sindromu koronarju akut mhux mingħajr elevazzjoni fit- taqsima ST, Clopidogrel BMS tqabbel ma ’ plaċebo (trattament finta) f’ iktar minn 12, 000 pazjent għal mhux iktar minn sena (l- istudju CURE):
2,172 of the patients had a stent inserted during the study.
2, 172 minn dawn kellhom stent infilzata waqt l- istudju.
In ST segment elevation myocardial infarction, Clopidogrel BMS was compared with placebo in two studies:
Fl- infarti mijokardiċi akkumpanjati minn elevazzjoni ta ’ l- ST, Clopidogrel BMS tqabbel ma ’ plaċebo f’ żewġ studji:
CLARITY (over 3,000 patients, where the patients received Clopidogrel BMS for up to eight days) and COMMIT (almost 46,000 patients, where the patients received Clopidogrel BMS with or without metoprolol for up to four weeks).
CLARITY (bis- sehem ta ’ iktar minn 3, 000 pazjent, fejn il- pazjenti ngħataw Clopidogrel BMS għal mhux iktar minn tmint ijiem) u COMMIT (bis- sehem ta ’ kważi 46, 000 pazjent, fejn il- pazjenti ngħataw Clopidogrel BMS ma ’ jew mingħajr metoprolol għal mhux iktar minn erba ’ ġimgħat).
The main measure of effectiveness was how many patients experienced an ‘ event’ such as a blocked artery, another heart attack or death, during the study.
Il- kejl ewlieni ta ’ l- effikaċja kien l- għadd ta ’ pazjenti li kellhom ‘ każ ’ bħal arterja misduda, attakk tal- qalb ieħor jew mewt, waqt l - istudju.
What benefit has Clopidogrel BMS shown during the studies?
Liema benefiċċju wera Clopidogrel BMS waqt l- istudji li twettqu?
Clopidogrel BMS was more effective than aspirin at preventing new ischaemic events.
Clopidogrel BMS kien iktar effikaċi mill- aspirina fil- prevenzjoni ta ’ każijiet iskemiċi.
There were 939 events in the Clopidogrel BMS group, and 1,020 in the aspirin group.
Kien hemm 939 każ fil- grupp ta ’ Clopidogrel BMS, u 1, 020 fil- grupp ta ’ l- aspirina.
This corresponds to a relative reduction in risk of 9% compared with aspirin.
Dan jikkorrispondi għat- tnaqqis relattiv fir- riskju ta ’ 9% meta mqabbel ma ’ l- aspirina.
Risk reduction means that fewer patients will have new ischaemic events when they receive Clopidogrel BMS, than if they receive aspirin.
Tnaqqis tar- riskju jfisser li inqas pazjenti jkollhom każijiet iskemiċi ġodda meta jirċievu trattament b’ Clopidogrel BMS, milli kieku jingħataw l - aspirina.
In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Clopidogrel BMS instead of aspirin.
Fi kliem ieħor, madwar 10 pazjenti minn 1, 000 jevitaw każ iskemiku sentejn wara li jibdew jieħdu Clopidogrel BMS minflok l- aspirina.
In non-ST segment elevation acute coronary syndrome, the overall relative reduction in the risk of an event compared with placebo was 20%.
Fis- sindromu koronarju akut mingħajr elevazzjoni tat- taqsima ST, it- tnaqqis relattiv ġenerali fir- riskju ta ’ każ meta mqabbel ma ’ plaċebo kien ta ’ 20%.
There was also a reduction in the patients who had a stent inserted.
Kien hemm ukoll tnaqqis fil- pazjenti li ddaħħlitilhom stent.
In ST segment elevation myocardial infarction, fewer patients on Clopidogrel BMS had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
F’ infart mijokardiku b’ elevazzjoni tat- taqsima ST, inqas pazjenti li ngħataw Clopidogrel BMS kellhom każijiet milli fil- pazjenti li ngħataw plaċebo (262 u 377 rispettivament fl- istudju CLARITY, u 2, 121 u 2, 310 rispettivament fl- istudju COMMIT).
This showed that Clopidogrel BMS reduces the risk of an event.
Dan wera li Clopidogrel BMS inaqqas ir- riskju ta ’ każ.
What is the risk associated with Clopidogrel BMS?
X’ inhu r- riskju assoċjat ma ’ Clopidogrel BMS?
The most common side effects with Clopidogrel BMS (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal (tummy) pain, dyspepsia (indigestion), bruising and bleeding where the skin is punctured.
L- effetti sekondarji l- iktar komuni ma ’ Clopidogrel BMS (li dehru f’ bejn 1 u 10 pazjent minn kull 100) huma ematoma (ġabra ta ’ demm taħt il- ġilda), epistassi (fġir ta ’ l- imnieħer), emorraġija gastrointestinali (ħruġ ta ’ demm fiż- żaqq jew fil- musrana), dijarrea, uġigħ addominali (taż- żaqq), dispepsija (indiġestjoni), tbenġil u ħruġ ta ’ demm fejn il- ġilda tittaqqab.
For the full list of all side effects reported with Clopidogrel BMS, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Clopidogrel BMS, ara l- Fuljett ta 'Tagħrif.
Clopidogrel BMS should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients, or in patients who have severe liver disease, or have a disease which may cause bleeding.
Clopidogrel BMS ma għandux jintuża f’ nies li jistgħu jkunu ipersensittivi (allerġiċi) għal clopidogrel jew xi ingredjenti ieħor, jew f’ pazjenti li jkollhom mard sever fil- fwied, jew li jkollhom xi marda li tista ’ tikkawża l- ħruġ tad- demm.
Why has Clopidogrel BMS been approved?
Għaliex ġie approvat Clopidogrel BMS?
The Committee for Medicinal Products for Human Use (CHMP) decided that Clopidogrel BMS’ s benefits are greater than its risks in adults for the prevention of atherothrombotic events.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Clopidogrel BMS jisbqu r- riskji tiegħu f’ adulti għall- prevenzjoni ta ’ każijiet aterotrombotiċi.
The Committee recommended that Clopidogrel BMS be given marketing authorisation.
Il - Kumitat irrakkomanda li Clopidogrel BMS jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Clopidogrel BMS:
2/ 3 Informazzjoni oħra dwar Clopidogrel BMS:
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel BMS to Bristol Myers Squibb Pharma EEIG on 16 July 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- UE, għal Clopidogrel BMS lil Bristol Myers Squibb Pharma EEIG fl- 16 ta ’ Lulju 2008.
The full EPAR for Clopidogrel BMS is available here.
L- EPAR sħiħ għal Clopidogrel BMS jista ’ jiġi kkonsultat hawn.
2/ 3 This summary was last updated in 05-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
EU/ 1/ 08/ 464/ 001 EU/ 1/ 08/ 464/ 002 EU/ 1/ 08/ 464/ 003 EU/ 1/ 08/ 464/ 004 EU/ 1/ 08/ 464/ 005 EU/ 1/ 08/ 464/ 006 EU/ 1/ 08/ 464/ 007 EU/ 1/ 08/ 464/ 008 EU/ 1/ 08/ 464/ 009 EU/ 1/ 08/ 464/ 010 EU/ 1/ 08/ 464/ 011 EU/ 1/ 08/ 464/ 012 EU/ 1/ 08/ 464/ 013 EU/ 1/ 08/ 464/ 014 EU/ 1/ 08/ 464/ 015 EU/ 1/ 08/ 464/ 016 EU/ 1/ 08/ 464/ 017 EU/ 1/ 08/ 464/ 018 EU/ 1/ 08/ 464/ 019
Numru ta ’ l- EU EU/ 1/ 08/ 464/ 001 EU/ 1/ 08/ 464/ 002 EU/ 1/ 08/ 464/ 003 EU/ 1/ 08/ 464/ 004 EU/ 1/ 08/ 464/ 005 EU/ 1/ 08/ 464/ 006 EU/ 1/ 08/ 464/ 007 EU/ 1/ 08/ 464/ 008 EU/ 1/ 08/ 464/ 009 EU/ 1/ 08/ 464/ 010 EU/ 1/ 08/ 464/ 011 EU/ 1/ 08/ 464/ 012 EU/ 1/ 08/ 464/ 013 EU/ 1/ 08/ 464/ 014 EU/ 1/ 08/ 464/ 015 EU/ 1/ 08/ 464/ 016 EU/ 1/ 08/ 464/ 017 EU/ 1/ 08/ 464/ 013 EU/ 1/ 08/ 464/ 014
Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS
Isem inventat Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS
75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 300 mg 300 mg 300 mg 75 mg 75 mg
Qawwa 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 300 mg 300 mg 300 mg 75 mg 75 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Għamla farmaċewtika Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Mnejn jingħata Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu)
Il- pakkett Folja (PVC/ PVDC/ alu) Folja (alu/ alu) Folja (PVC/ PVDC/ alu) Folja (alu/ alu) Folja (PVC/ PVDC/ alu) Folja (alu/ alu) Folja (PVC/ PVDC/ alu Folja (alu/ alu) Folja (PVC/ PVDC/ alu) Folja (alu/ alu) Folja (PVC/ PVDC/ alu) Folja (alu/ alu) Folja (PVC/ PVDC/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (PVC/ PVDC/ alu) Folja (alu/ alu)
14 14 28 28 30 30 50 x 1 50 x 1 84 84 90 90 100 100 4x1 30 x 1 100 x 1 7 7
Daqs tal- pakkett 14 14 28 28 30 30 50x1 50x1 84 84 90 90 100 100 4x1 30x1 100x1 7 7
Clopidogrel BMS 75 mg film-coated tablets
Clopidogrel BMS 75 mg pilloli miksija b’ rita
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Kull pillola miksija b' rita fiha 75 mg clopidogrel (bħala hydrogen sulphate).
Excipients: each tablet contains 3 mg lactose and 3.3 mg hydrogenated castor oil.
Sustanzi mhux attivi: kull pillola fiha 3 mg lactose u 3. 3 mg castor oil idroġenat
Film-coated tablet.
Pillola miksija b’ rita
Pink, round, biconvex, engraved with « 75 » on one side and « 1171 » on the other side.
Roża, tonda, konvessa miż- żewġ naħat, b ’ “ 75 ” imnaqqax fuq naħa waħda u “ 1171 ” imnaqqax fuq in - naħa l- oħra.
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
Clopidogrel huwa indikat fl- adulti għall- prevenzjoni ta ’ avvenimenti aterotrombotiċi f ’:
• Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
• Pazjenti li għandhom infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard stabbilit ta ’ l- arterji periferali.
• Patients suffering from acute coronary syndrome:
• Pazjenti li għandhom is- sindromu koronarju akut:
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).
ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Infart mijokardijaku akut b’ segment ST elevat, flimkien ma ’ ASA f’ pazjenti ittrattati bil - mediċini u eliġibbli għat- terapija trombolitika
For further information please refer to section 5.1.
Għal aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5. 1.
• Adults and elderly
• Adulti u anzjani
Clopidogrel should be given as a single daily dose of 75 mg with or without food.
Clopidogrel għandu jingħata darba kuljum bħala doża ta ’ 75 mg ma ’ l- ikel jew mingħajru.
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).
Bis- segment mhux ST elevat (anġina instabbli jew infart mijokardijaku mhux- mewġa - Q): 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).
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.
Infart mijokardijaku akut bis- segment ST elevat: clopidogrel għandu jingħata bħala doża 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
Pazjenti li għandhom iżjed minn 75 sena fl- età għandhom jinbdew fuq clopidogrel mingħajr id- doża qawwija tal- bidu.
2
It -
Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks.
2 terapija ikkombinata għandha tinbeda mill- aktar fis possibbli wara li s- sintomi jitfaċċaw u titkompla għal mhux anqas minn erba ’ ġimgħat.
The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section 5.1).
Il- benefiċċju ta clopidogrel ma ’ ASA għal aktar minn erba ’ ġimgħat ma kienx studjat f’ din is- sitwazzjoni (ara sezzjoni 5. 1).
• Paediatric patients The safety and efficacy of clopidogrel in children and adolescents have not yet been established.
• Pazjenti pedjatriċi Is- sigurtà u l- effikaċja ta 'clopidogrel fit- tfal u fl- adolexxenti għadhom ma ġewx stabbiliti.
• Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4).
• Indeboliment renali L- esperjenza terapewtika hija limitata f’ pazjenti b’ indeboliment renali (ara sezzjoni 4. 4).
• Hepatic impairment Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4).
• Indeboliment epatiku L- esperjenza terapewtika hija limitata f’ pazjenti b’ mard epatiku moderat li jista ’ jkollhom dijateżi emorraġika (ara sezzjoni 4. 4).
• Hypersensitivity to the active substance or to any of the excipients. • Severe liver impairment. • Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
• Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi. • Indeboliment sever tal- fwied. • Dmija qawwija patoloġika bħal f’ ulċera peptika jew emorraġija fil- kranju.
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 efetti 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 f ’ 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.
The concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.5).
(ara sezzjoni 4. 5).
If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, clopidogrel should be discontinued 7 days prior to surgery.
Jekk pazjent jagħżel li jkollu operazzjoni u l- effett kontra l- plejtlits huwa temporanjament mhux mixtieq, clopidogrel m’ għandux jibqa ’ jingħata 7 ijiem qabel l- operazzjoni.
Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken.
Il- pazjenti għandhom jinformaw lit- tobba u d- dentisti li qegħdin jieħdu clopidogrel qabel ma tiġi ppjanata xi operazzjoni u qabel ma jittieħed xi prodott mediċinali ġdid.
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 għandu jintuża b’ kawtela f’ pazjenti li għandhom feriti b’ tendenza li jnixxu d- demm (speċjalment dawk gastro - intestinali u fl- għajnejn).
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.
Il- pazjenti għandhom ikunu jafu li meta jieħdu clopidogrel (waħdu jew flimkien ma ’ ASA) id- dmija tista ’ ddum iktar mis- soltu biex tieqaf, u li għandhom jirrapurataw dmija li mhix normali (kemm fis- sit kif ukoll fit- tul ta ’ żmien) lit- tabib tagħhom.
Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure.
Ġiet irrapurtata Purpura Trombotika Tromboċitopenika (TTP) b’ mod rari ħafna wara l- użu ta ’ clopidrogel, xi kultant wara espożizzjoni qasira.
It is characterised by thrombocytopenia and microangiopathic haemolytic anaemia associated with either neurological findings, renal dysfunction or fever.
Din hi karatterizzata bi tromboċitopenja u anemija emolitika mikroanġjopatika marbuta ma ’ sitwazzjonijiet newroloġiċi jew kliewi li ma jaħdmux b’ mod normali jew deni.
TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
TTP hija kundizzjoni li tista ’ tkun fatali u li għandha bżonn kura mal- ewwel, inkluz il- plażmafereżi.
In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
Minħabba n- nuqqas ta ’ tagħrif, clopidogrel ma jistgħax jiġi rakkomandat waqt l- ewwel 7 ijiem wara puplesija iskemika akuta.
Therapeutic experience with clopidogrel is limited in patients with renal impairment.
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).
3 Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses.
3 L- esperjenza f’ pazjenti b’ mard moderat fil- fwied li jista ’ jkollhom dijatesi qed inixxu d- demm hija limitata.
Clopidogrel should therefore be used with caution in this population (see section 4.2).
Għalhekk clopidogrel għandu jintuża b’ kawtela ma ’ din il- popolazzjoni (ara sezzjoni 4. 2).
Clopidogrel BMS contains lactose.
Clopidogrel BMS fih lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għall - galactose, nuqqas ta ’ Lapp lactase jew malassorbiment ta ’ glucose- galactose m’ għandhomx jieħdu dan il- prodott mediċinali.
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
Oral anticoagulants: the concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.4).
Sustanzi kontra l- koagulazzjoni tad- demm li jittieħdu mill- ħalq: mhix rakkomandata l - amministrazzjoni ta ’ clopidogrel flimkien ma ’ sustanzi kontra l- koagulazzjoni tad- demm li jittieħdu mill- ħalq billi dan jista ’ jkattar l- intensita` tad- dmija (ara sezzjoni 4. 4).
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).
Acetylsalicylic acid (ASA):
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.
ASA ma biddilx l- inibizzjoni medjata permezz ta ’ clopidogrel ta ’ l - aggregazzjoni ta ’ plejtlets indotta minn ADP, imma clopidogrel saħħaħ l- effett ta ’ ASA fuq l - aggregazzjoni ta ’ plejtlets indotta mil- collagen.
However, concomitant administration of 500 mg of ASA twice a day for one day did not significantly increase the prolongation of bleeding time induced by clopidogrel intake.
Madankollu, it- teħid flimkien ta ’ 500 mg ta ’ ASA darbtejn kuljum għal jum wieħed ma kabbarx b’ mod sinifikanti t- titwil tal- ħin tad- dmija li seħħ minħabba clopidogrel.
A pharmacodynamic interaction between clopidogrel and acetylsalicylic acid is possible, leading to increased risk of bleeding.
Huwa possibbli li jkun hemm interazzjoni farmakodinamika bejn clopidogrel u acetylsalicylic acid, li jista ’ jwassal għal riskju ikbar ta ’ dmija.
Therefore, concomitant use should be undertaken with caution (see section 4.4).
Għalhekk, l- użu flimkien għandu jsir b’ kawtela (ara sezzjoni 4. 4).
However, clopidogrel and ASA have been administered together for up to one year (see section 5.1).
Madankollu, clopidogrel u ASA ngħataw flimkien sa sena (ara sezzjoni 5. 1).
Heparin: in a clinical study conducted in healthy subjects, clopidogrel did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation.
Heparin: fi studju kliniku li sar f’ persuni f’ saħħithom, ma kienx hemm bżonn bidla fid- doża minħabba clopidogrel, l- anqas ma ’ dan biddel l- effett ta ’ heparin fuq il- koagulazzjoni.
Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel.
It- teħid flimkien ma ’ heparin ma kellu l- ebda effett fuq l- inibizzjoni ta ’ l- aggregazzjoni tal- plejtlets indott minn clopidogrel.
A pharmacodynamic interaction between clopidogrel and heparin is possible, leading to increased risk of bleeding.
Huwa possibbli li jkun hemm interazzjoni farmakodinamika bejn clopidogrel u heparin, li jista ’ jwassal għal riskju ikbar ta ’ dmija.
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` tat- 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- ghoti 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 gastrointesinali ma ’ NSAIDs kollha.
Consequently, NSAIDs including Cox-2 inhibitors and clopidogrel should be co-administered with caution (see section 4.4).
Għalhekk għandu jkun hemm kawtela meta NSAIDs u clopidogrel jingħataw flimkien (ara sezzjoni 4. 4).
Other concomitant therapy: a number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Terapija oħra meħuda fl- istess ħin: saru numru ta ’ studji kliniċi oħra bi clopidogrel u prodotti mediċinali oħra li ngħataw flimkien biex tiġi investigata l- possibilita` ta ’ interazzjonijiet farmakodinamiċi u farmakokinetiċi.
No clinically significant pharmacodynamic interactions were observed when clopidogrel was co-administered with atenolol, nifedipine, or both atenolol and nifedipine.
Ma ġewx osservati interazzjonijiet farmakodinamiċi li kienu klinikament sinifikanti meta colpidogrel ingħata flimkien ma ’ atenolol, nifedipine, jew kemm atenolol u nifedipine.
Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the co- administration of phenobarbital, cimetidine, or oestrogen.
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.
Il- karatteristiċi farmakokinetiċi ta ’ digoxin jew theophylline ma ġewx modifikati bl- amministrazjoni flimkien ma ’ clopidogrel.
Antacids did not modify the extent of clopidogrel absorption.
Antaċidi ma mmodifikawx kemm gie assorbit clopidogrel.
4 metabolised by Cytochrome P450 2C9.
4 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.
Data from the CAPRIE study indicate that phenytoin and tolbutamide can be safely co-administered with clopidogrel.
Tagħrif mill- istudju CAPRIE jindika li phenytoin u tolbutamide jistgħu jiġu amministrat b’ sigurta` flimkien ma ’ clopidogrel.