qanastek/EMEA-V3 huggingface dataset:
Then, the usual dose is one 75-mg tablet of Clopidogrel BMS per day to be taken orally with or without food, and at the same time each day.
Wara, id- doża normali hija ta ’ pillola waħda ta ’ 75 mg Clopidogrel BMS kuljum li għandha tittieħed mill- ħalq ma ’ l - ikel jew fuq stonku vojt u fl- istess ħin kull ġurnata.
You should take clopidogrel for as long as your doctor continues to prescribe it.
Għandek tieħu clopidogrel sakemm it- tabib jibqa ’ jagħmillek ir- riċetta.
If you take more Clopidogrel BMS than you should:
Jekk tieħu Clopidogrel BMS aktar milli suppost:
Contact your doctor or the nearest emergency department because of the increased risk of bleeding.
Għarraf lit- tabib jew mur fl- eqreb dipartiment ta ’ l- emerġenza minħabba r- riskju ogħla ta ’ fsada.
If you forget to take Clopidogrel BMS:
Jek tinsa tieħu Clopidogrel BMS:
If you forget to take a dose of clopidogrel, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Jekk tinsa tieħu xi doża ta ’ clopidogrel, iżda tiftakar fit- 12- il siegħa ta ’ wara, ħu l- pillola mill- ewwel, imbagħad ħu l- pillola li jkun imiss fil- ħin tas- soltu.
If you forget for more than 12 hours, simply take the next single dose at the usual time.
Jekk tinsa tieħu Clopidogrel BMS għal aktar minn 12- il siegħa, sempliċiment ħu d- doża waħda li jkun imiss fil- ħin tas- soltu.
Do not take a double dose to make up for the forgotten individual doses.
Tiħux doża doppja biex tagħmel tajjeb għad- doża li tkun insejt tieħu.
For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of clopidogrel by referring to the calendar printed on the blister.
Għall- pakketti ta ’ 7, 14, 28 u 84 pilloli, tista ’ tiċċekkja l- ġurnata li fiha ħadt l- aħħar il- pillola ta ’ clopidogrel billi tirreferi għall- kalendarju stampat fuq il- folja.
If you stop taking Clopidogrel BMS:
Meta tieqaf tieħu Clopidogrel BMS:
Do not stop the treatment.
Twaqqafx il- kura.
Contact your doctor or pharmacist before stopping.
Informa lit- tabib jew l- ispizjar tiegħek qabel twaqqaf il- kura.
Like all medicines, Clopidogrel BMS can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Clopidogrel BMS jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Contact your doctor immediately if you experience:
Għarraf lit- tabib tiegħek minnufih jekk:
- fever, signs of infection or extreme tiredness.
- jitlagħlek id- deni, ikollok sinjali ta ’ infezzjoni jew ħafna għeja.
These may be due to rare decrease of some
Dawn jista ’ jkunu minħabba
blood cells.
tnaqqis rari ta ’ xi ċelluli tad- demm.
- signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or
- sinjali ta ’ mard tal- fwied bħal sfurija tal- ġilda u/ jew ta ’ l- għajnejn (suffejra), kemm jekk dan
not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see ‘Take special care with Clopidogrel BMS’).
huwa assoċjat jew le ma ’ emoraġija li tidher taħt il- ġilda bħala tikek ħomor irqaq u/ jew konfużjoni (ara 'Oqgħod attent ħafna b' Clopidogrel BMS ').
- swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.
- nefħa fil- ħalq jew disturbi fil- ġilda bħal raxxijiet u ħakk, infafet fil- ġilda.
These
Dawn jistgħu jkunu
may be the signs of an allergic reaction.
sinjali ta 'reazzjoni allerġika.
The most common side effect (affects 1 to 10 patients in 100) reported with clopidogrel is bleeding.
L- iżjed effett sekondarju komuni (jaffettwa minn 1 sa 10 pazjenti minn kull 100) irrappurtat b ’ clopidogrel hija l- fsada.
Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine.
Din tista 'sseħħ bħala fsada fl- istonku jew fl- imsaren, tbenġil, ematoma (fsada jew tbenġil mhux tas- soltu taħt il- ġilda), tinfaraġ, demm fl- awrina.
In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
F’ numru żgħir ta ’ każijiet oħra ġew irrappurtati fsada fl- għajn, fir- ras, fil- pulmun jew fil- ġogi.
If you experience prolonged bleeding when taking Clopidogrel BMS If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Jekk tbati minn fsada għal perijodu twil waqt li qed tieħu Clopidogrel BMS Jekk taqta 'x' imkien jew tweġġa', id- demm jista 'jdum aktar mis- soltu biex jieqaf.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see ‘Take special care with Clopidogrel BMS’).
Madanakollu, jekk id- demm li ħiereġ jinkwetak, għandek tkellem lit- tabib tiegħek minnufih (ara 'Oqgħod attent ħafna b' Clopidogrel BMS ').
Other side effects reported with clopidogrel are:
Effetti sekondarji oħra li ġew irrappurtati b’ clopidogrel huma:
Common side effects (affects 1 to 10 patients in 100):
Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 pazjenti minn kull 100):
Diarrhoea, abdominal pain, indigestion or heartburn.
Dijarea, uġigħ addominali, indiġestjoni jew ħruq fl- istonku.
Uncommon side effects (affects 1 to 10 patients in 1,000):
Effetti sekondarji mhux komuni (jaffettwaw minn 1 sa 10 pazjenti minn kull 1, 000):
Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, abnormal touch sensation.
Uġigħ ta ’ ras, ulċera fl- istonku, rimettar, tqalligħ, stitikezza, gass żejjed fl- istonku jew fl- imsaren, raxxijiet, ħakk, sturdament, sensazzjoni tal- ħass mhux normali.
Rare side effect (affects 1 to 10 patients in 10,000):
Effetti sekondarji rari (jaffettwaw minn 1 sa 10 pazjenti minn kull 10, 000):
Vertigo.
Vertigo.
Very rare side effects (affects less than 1 patient in 10,000): jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; taste disorders.
Effetti sekondarji rari ħafna (jaffettwaw anqas minn pazjent 1 minn kull 10, 000): suffejra; uġigħ addominali qawwi flimkien ma 'jew mingħajr uġigħ fid- dahar; deni, diffikultajiet fin- nifs kultant assoċjati mas- sogħla; reazzjonijiet allerġiċi ġeneralizzati; nefħa fil- ħalq; infafet fil- ġilda; reazzjoni allerġika fil- ġilda; infjammazzjoni tal- ħalq (stomatite); tnaqqis fil- pressjoni tad- demm; konfużjoni; alluċinazzjonijiet; uġigħ fil- ġogi; uġigħ muskolari; tibdiliet fit- togħma.
In addition, your doctor may identify changes in your blood or urine test results.
Barra minn hekk, it- tabib tiegħek jista ’ jinduna b’ xi tibdil fir- riżultati tat- testijiet tad- demm jew ta ’ l - awrina tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE CLOPIDOGREL BMS
KIF TAĦŻEN CLOPIDOGREL BMS
Do not use clopidogrel after the expiry date which is stated on the carton and on the blister.
Tużax clopidogrel wara d- data ta ’ skadenza li tidher fuq il - kaxxa few fuq il- folja.
Refer to the storage conditions on the carton.
Irreferi fuq il- kaxxa għall- kundizzjonijiet ta ’ kif jinħażen.
If Clopidogrel BMS is supplied in PVC/PVDC/aluminium blisters, store below 30°C.
Jekk Clopidogrel BMS huwa fornut ġo folji tal- PVC/ PVDC/ Aluminju, aħżen f’ temperatura taħt 30°C.
If Clopidogrel BMS is supplied in all aluminium blisters, it does not require any special storage conditions.
42 Jekk Clopidogrel BMS huwa fornut ġo folji kollha kemm huma ta ’ l- aluminju, din Din il- mediċina m’ għandhiex bżonn ħażna speċjali.
Do not use Clopidogrel BMS if you notice any visible sign of deterioration.
Tużax Clopidogrel BMS jekk tinnota xi sinjali visibli ta ’ deterjorament.
40 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Clopidogrel BMS contains The active substance is clopidogrel.
X’ fih Clopidogrel BMS Is- sustanza attiva hi clopidogrel.
Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Kull pillola fiha 75 mg ta ’ clopidogrel (bħala hydrogen sulphate).
The other ingredients are mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose in the tablet core, and lactose (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172), titanium dioxide (E171), and carnauba wax in the tablet coating.
Is- sustanzi l- oħra huma mannitol (E421), castor oil idroġenat, microcrystalline cellulose, macrogol 6000 u hydroxypropylcellulose b’ sostituzzjoni baxxa fil- qalba tal- pillola, u lactose (iz- zokkor li jinsab fil- ħalib), hypromellose (E464), triacetin (E1518), iron oxide aħmar (E172), titanium dioxide (E171), u carnauba wax fir- rita tal- pillola.
What Clopidogrel BMS looks like and contents of the pack
Id- dehra ta ’ Clopidogrel BMS u l- kontenuti tal- pakkett
Clopidogrel BMS 75-mg tablets are round, biconvex, pink, film-coated tablets engraved on one side with the number ‘75’ and on the other side with the number ‘1171’.
Il- pilloli ta ’ Clopidogrel BMS 75- mg huma tondi, konvessi miż- żewġ naħat, ta ’ kulur roża, pilloli miksija b’ rita bin- numru ‘ 75 ’ imnaqqax fuq naħa waħda u n- numru ‘ 1171 ’ imnaqqax fuq in- naħa l - oħra.
They are supplied in cardboard cartons containing 7, 14, 28, 30, 84, 90 and 100 tablets in PVC/PVDC/Aluminium blisters or in all aluminium blisters, or 50x1 tablets in PVC/PVDC/Aluminium blisters or in all aluminium perforated unit-dose blisters.
Huma fornuti f’ kaxex tal- kartun li fihom 7, 14, 28, 30, 84, 90 u 100 pilloli ġo folji tal - PVC/ PVDC/ Aluminju jew ġo folji magħmulin kollha mill- aluminju, jew 50x1 pilloli f' folji tal - PVC/ PVDC/ Aluminju jew f' folji mtaqqbin b’ doża waħda kollha kemm huma ta ’ l- aluminju.
Not all pack sizes may be marketed.
Mhux id - daqsijiet kollha tal- pakketti jistgħu jkunu għal skop kummerċjali.
Marketing Authorisation Holder and Manufacturer:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur:
Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq:
Sanofi Winthrop Industrie 1, rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France and/or Sanofi-Synthelabo Limited, Edgefield Avenue, Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT - UK, United Kingdom and/or Sanofi Winthrop Industrie 6, boulevard de l'Europe, F-21800 Quétigny, France
Sanofi Winthrop Industrie 1, rue de la Vierge, Ambarès & Lagrave, F- 33565 Carbon Blanc cedex, Franza u/ jew Sanofi- Synthelabo Limited, Edgefield Avenue, Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT - UK, Renju Unit u/ jew Sanofi Winthrop Industrie 6, boulevard de l’ Europe, F- 21800 Quétigny, Franza
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
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42 This leaflet was last approved in MM/YYYY
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - mediċini (EMEA): http: // www. emea. europa. eu /
43 PACKAGE LEAFLET:
45 FULJETT TA ’ TAGĦRIF:
Clopidogrel BMS 300 -mg film-coated tablets clopidogrel
Clopidogrel BMS 300 mg pilloli miksija b’ rita clopidogrel
- This medicine has been prescribed for you.
- Din il- mediċina giet mogħtija lilek.
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, proċess imsejjaħ aterotrombosi, li jista ’ jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal- qalb, jew mewt).
- 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 (attakk
infarction’ (heart attack).
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..
Do not take Clopidogrel BMS:
Tiħux Clopidogrel BMS:
44 If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking clopidogrel.
46 Jekk taħseb li xi waħda minn dawn tgħodd għalik, jew jekk għandek xi dubju, ħu parir tat- tabib tiegħek qabel tibda tieħu clopidogrel.
Take special care with Clopidogrel BMS:
Oqgħod attent ħafna b ’ Clopidogrel:
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 BMS: • 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.
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.
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 may be taken with or without food.
Clopidogrel jista ’ jittieħed ma ’ l- ikel jew mingħajru.
45 Pregnancy and breast-feeding It is preferable not to use this product during pregnancy and breast-feeding.
47 Tqala u treddigħ 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, għandek tinforma lit- tabib jew lill- ispiżjar/ a tiegħek jekk inti tqila jew taħseb li inti tqila.
If you become pregnant while taking clopidogrel, 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 tiħux clopidogrel fit- tqala.
Clopidogrel BMS contains lactose and hydrogenated castor oil.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Clopidogrel BMS Clopidogrel BMS fih lactose u castor oil idroġenat.
Then, the usual dose is one 75 mg tablet of Clopidogrel BMS per day to be taken orally with or without food, and at the same time each day.
Wara, id- doża normali hija ta ’ pillola waħda ta ’ 75 mg Clopidogrel BMS kuljum li għandha tittieħed mill- ħalq ma ’ l - ikel jew fuq stonku vojt u fl- istess ħin kull ġurnata.
not associated with bleeding which appears under the skin as red pinpoint dots, and/or confusion (see ‘Take special care with Clopidogrel BMS’).
huwa assoċjat jew le ma ’ emoraġija li tidher taħt il- ġilda bħala tikek ħomor irqaq u/ jew konfużjoni (ara 'Oqgħod attent ħafna b' Clopidogrel BMS ').
The most common side effect (affects 1 to 10 patients in 100) reported with clopidogrel is bleeding.
L- iżjed effett komuni (jaffettwa minn 1 sa 10 pazjenti minn kull 100) irrappurtat b ’ Clopidogrel BMS hija l- fsada.
Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual
Din tista 'sseħħ bħala fsada fl- istonku jew fl- imsaren, tbenġil, ematoma (fsada jew
46 bleeding or bruising under the skin), nose bleed, blood in the urine.
48 tbenġil mhux tas- soltu taħt il- ġilda), tinfaraġ, demm fl- awrina.
If you experience prolonged bleeding when taking Clopidogrel BMS If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Jekk tbati minn fsada għal perjodu twil waqt li qed tieħu clopidogrel Jekk taqta 'x' imkien jew tweġġa', id- demm jista 'jdum aktar mis- soltu biex jieqaf.
Other side effects reported with clopidogrel are:
Effetti oħra li ġew irrappurtati b ’ clopidogrel huma:
Do not use clopidogrel after the expiry date which is stated on the carton and on the blister.
Tużax clopidogrel wara d- data ta ’ skadenza li tidher fuq il - kaxxa jew fuq il- folja.
Do not use clopidogrel if you notice any visible sign of deterioration.
Tużax clopidogrel jekk tinnota xi sinjali visibli ta ’ deterjorament.
Each tablet contains 300 mg of clopidogrel (as hydrogen sulphate).
Kull pillola fiha 300 mg ta ’ clopidogrel (bħala hydrogen sulphate).
The other ingredients are mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose in the tablet core, and lactose (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172), titanium dioxide (E171), and carnauba wax in the tablet coating.
Is- sustanzi l- oħra huma mannitol (E421), castor oil idroġenat, microcrystalline cellulose, macrogol 6000 u hydroxypropylcellulose b’ sostituzzjoni baxxa, fil- qalba tal- pillola u lactose (iz- zokkor li jinsab fil- ħalib), hypromellose (E464), triacetin (E1518), iron oxide aħmar (E172), titanium dioxide (E171), u carnauba wax fir- rita tal- pillola.
47 What Clopidogrel BMS looks like and contents of the pack
49 Id- dehra ta ’ Clopidogrel BMS u l- kontenuti tal- pakkett
Clopidogrel BMS 300-mg tablets are oblong, pink, film-coated tablets engraved on one side with the number ‘300’ and on the other side with the number ‘1332’.
Il- pilloli ta ’ Clopidogrel BMS 300 mg huma oblungi, ta ’ kulur roża, pilloli miksija b’ rita bin- numru ‘ 300 ’ imnaqqax fuq naħa waħda u n- numru ‘ 1332 ’ imnaqqax fuq in- naħa l- oħra.
They are supplied in cardboard cartons containing 4x1, 30x1 and 100x1 tablets in all aluminium perforated unit-dose blisters.
Issibhom f’ kaxex tal - kartun li fihom 4x1, 30x1 u 100x1 pilloli ġo folji mtaqqbin ta ’ doża waħda magħmulin kollha kemm huma mill- aluminju.
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakketti jistgħu jkunu għal skop kummerċjali.
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
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq.
Belgique/België/Belgien BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.
Belgique/ België/ Belgien Bristol- Myers Squibb Belgium S. A. / N. V.
Magyarország BRI STOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
Magyarország Bristol- Myers Squibb Gyógyszerkereskedelmi Kft.
Eesti BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT Tel: +372 640 1 301
Eesti Österreich Bristol- Myers Squibb Gyógyszerkereskedelmi Kft Tel: +372 640 1301
48 España BRISTOL-MYERS SQUIBB, S.A.
50 España Bristol- Myers Squibb, S. A.
Ireland BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD Tel: + 353 (1 800) 749 749
Ireland Bristol- Myers Squibb Pharmaceuticals Ltd Tel: + 353 (1 800) 749 749
Ísland VISTOR HF Sími: + 354 535 7000
Ísland Vistor hf Sími: + 354 535 7000
Latvija BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
Latvija Bristol- Myers Squibb Gyógyszerkereskedelmi Kft.
This leaflet was last approved in MM/YYYY
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /
What is Clopidogrel Winthrop?
X’ inhu Clopidogrel Winthrop?
Clopidogrel Winthrop is a medicine that contains the active substance clopidogrel.
Clopidogrel Winthrop huwa mediċina li fiha s- sustanza attiva clopidogrel.
This medicine is the same as Plavix, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal Plavix, li hija diġà awtorizzata fl- Unjoni Ewropea (UE).
The company that makes Plavix has agreed that its scientific data can be used for Clopidogrel Winthrop.
Il- kumpanija li tagħmel Plavix qablet li l- informazzjoni xjentifika tagħha tista ’ tintuża għal Clopidogrel Winthrop.
What is Clopidogrel Winthrop used for?
Għal xiex jintuża Clopidogrel Winthrop?
Clopidogrel Winthrop is used in adult patients to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Clopidogrel Winthrop jintuża f’ pazjenti adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t- twebbis ta ’ l- arterji).
Clopidogrel Winthrop can be given to the following groups of patients: • patients who have recently had a myocardial infarction (heart attack).
Clopidogrel Winthrop jista ’ jingħata lill - gruppi ta ’ pazjenti li ġejjin: • pazjenti li jkun għadu kemm tahom infart mijokardiku (attakk tal- qalb).
Clopidogrel Winthrop 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 Winthrop 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 Winthrop 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 Winthrop 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 Winthrop 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 Winthrop 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.
How is Clopidogrel Winthrop used?
Kif jintuża Clopidogrel Winthrop?
The standard dose of Clopidogrel Winthrop is one 75 mg tablet once a day, taken with or without food.
Id- doża standard ta ’ Clopidogrel Winthrop hija ta ’ pillola waħda ta ’ 75 mg darba kuljum, ma ’ l- ikel jew fuq stonku vojt.
In acute coronary syndrome, Clopidogrel Winthrop 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 Winthrop 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 hu segwit minn doża standard ta ’ 75 mg darba kuljum għal ta ’ l- inqas erba ’ ġimgħat (f’ infart 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. mijokardiku ta ’ elevazzjoni tat- taqsima ST) jew għal mhux iktar minn 12- il xahar (fis- sindromu mingħajr elevazzjoni tat- taqsima ST).
How does Clopidogrel Winthrop work?
Kif jaħdem Clopidogrel Winthrop?
The active substance in Clopidogrel Winthrop, clopidogrel, is an inhibitor of platelet aggregation.
Is- sustanza attiva f’ Clopidogrel Winthrop, clopidogrel, hu inibitur ta ’ l- aggregazzjoni tal- pjastrini (platelets).
How has Clopidogrel Winthrop been studied?
Kif ġie studjat Clopidogrel Winthrop?
The effectiveness of Clopidogrel Winthrop 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 Winthrop 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.
In non-ST segment elevation acute coronary syndrome, Clopidogrel Winthrop 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 Winthrop tqabbel ma ’ plaċebo (trattament finta) f’ iktar minn 12, 000 pazjent għal mhux iktar minn sena (l- istudju CURE):
In ST segment elevation myocardial infarction, Clopidogrel Winthrop was compared with placebo in two studies:
Fl- infarti mijokardiċi akkumpanjati minn elevazzjoni ta ’ l- ST, Clopidogrel Winthrop tqabbel ma ’ plaċebo f’ żewġ studji:
CLARITY (over 3,000 patients, where the patients received Clopidogrel Winthrop for up to eight days) and COMMIT (almost 46,000 patients, where the patients received Clopidogrel Winthrop with or without metoprolol for up to four weeks).
CLARITY (bis - sehem ta ’ iktar minn 3, 000 pazjent, fejn il- pazjenti ngħataw Clopidogrel Winthrop għal mhux iktar minn tmint ijiem) u COMMIT (bis- sehem ta ’ kważi 46, 000 pazjent, fejn il- pazjenti ngħataw Clopidogrel Winthrop 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 Winthrop shown during the studies?
Liema benefiċċju wera Clopidogrel Winthrop waqt l- istudji li twettqu?
Clopidogrel Winthrop was more effective than aspirin at preventing new ischaemic events.
Clopidogrel Winthrop kien iktar effikaċi mill- aspirina fil- prevenzjoni ta ’ każijiet iskemiċi.
There were 939 events in the Clopidogrel Winthrop group, and 1,020 in the aspirin group.
Kien hemm 939 każ fil- grupp ta ’ Clopidogrel Winthrop, 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 Winthrop, than if they receive aspirin.
Tnaqqis tar- riskju jfisser li inqas pazjenti jkollhom każijiet iskemiċi ġodda meta jirċievu trattament b’ Clopidogrel Winthrop, 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 Winthrop instead of aspirin.
Fi kliem ieħor, madwar 10 pazjenti minn 1, 000 jevitaw każ iskemiku sentejn wara li jibdew jieħdu Clopidogrel Winthrop minflok l- aspirina.
In ST segment elevation myocardial infarction, fewer patients on Clopidogrel Winthrop 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 Winthrop 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 Winthrop reduces the risk of an event.
Dan wera li Clopidogrel Winthrop inaqqas ir- riskju ta ’ każ.
What is the risk associated with Clopidogrel Winthrop?
X’ inhu r- riskju assoċjat ma ’ Clopidogrel Winthrop?
The most common side effects with Clopidogrel Winthrop (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 Winthrop (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 Winthrop, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Clopidogrel Winthrop, ara l- Fuljett ta 'Tagħrif.
Clopidogrel Winthrop 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 Winthrop 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 Winthrop been approved?
Għaliex ġie approvat Clopidogrel Winthrop?
The Committee for Medicinal Products for Human Use (CHMP) decided that Clopidogrel Winthrop’ 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 Winthrop jisbqu r- riskji tiegħu f’ adulti għall- prevenzjoni ta ’ każijiet aterotrombotiċi.
The Committee recommended that Clopidogrel Winthrop be given marketing authorisation.
Il - Kumitat irrakkomanda li Clopidogrel Winthrop jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Clopidogrel Winthrop:
2/ 3 Informazzjoni oħra dwar Clopidogrel Winthrop:
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Winthrop to Sanofi Pharma Bristol-Myers Squibb SNC on 16 July 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- UE, għal Clopidogrel Winthrop lil Sanofi Pharma Bristol- Myers Squibb SNC fl- 16 ta ’ Lulju 2008.
The full EPAR for Clopidogrel Winthrop is available here.
L- EPAR sħiħ għal Clopidogrel Winthrop jista ’ jiġi kkonsultat hawn.
EU/ 1/ 08/ 465/ 001 EU/ 1/ 08/ 465/ 002 EU/ 1/ 08/ 465/ 003 EU/ 1/ 08/ 465/ 004 EU/ 1/ 08/ 465/ 005 EU/ 1/ 08/ 465/ 006 EU/ 1/ 08/ 465/ 007 EU/ 1/ 08/ 465/ 008 EU/ 1/ 08/ 465/ 009 EU/ 1/ 08/ 465/ 010 EU/ 1/ 08/ 465/ 011 EU/ 1/ 08/ 465/ 012 EU/ 1/ 08/ 465/ 013 EU/ 1/ 08/ 465/ 014 EU/ 1/ 08/ 465/ 015 EU/ 1/ 08/ 465/ 016 EU/ 1/ 08/ 465/ 017 EU/ 1/ 08/ 465/ 018 EU/ 1/ 08/ 465/ 019
Numru ta ’ l- EU EU/ 1/ 08/ 465/ 001 EU/ 1/ 08/ 465/ 002 EU/ 1/ 08/ 465/ 003 EU/ 1/ 08/ 465/ 004 EU/ 1/ 08/ 465/ 005 EU/ 1/ 08/ 465/ 006 EU/ 1/ 08/ 465/ 007 EU/ 1/ 08/ 465/ 008 EU/ 1/ 08/ 465/ 009 EU/ 1/ 08/ 465/ 010 EU/ 1/ 08/ 465/ 011 EU/ 1/ 08/ 465/ 012 EU/ 1/ 08/ 465/ 013 EU/ 1/ 08/ 465/ 014 EU/ 1/ 08/ 465/ 015 EU/ 1/ 08/ 465/ 016 EU/ 1/ 08/ 465/ 017 EU/ 1/ 08/ 465/ 018 EU/ 1/ 08/ 465/ 019
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Clopidogrel Winthrop 75 mg film-coated tablets
Clopidogrel Winthrop 75 mg pilloli miksija b’ rita
4.2 Posology and method of administration
Pożoloġija u metodu ta ’ kif għandu jingħata 4. 2
For patients over 75 years of age clopidogrel should be initiated without a loading dose.
It -
3 Therapeutic experience with clopidogrel is limited in patients with renal impairment.
L- esperjenza terapewtika bi clopidogrel f’ pazjenti b’ indeboliment fil- kliewi hija limitata.
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 Winthrop contains lactose.
Clopidogrel Winthrop fih lactose.
4 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.
Data from studies with human liver microsomes indicated that the carboxylic acid metabolite of clopidogrel could inhibit the activity of 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.
This could potentially lead to increased plasma levels of medicinal products such as phenytoin and tolbutamide and the NSAIDs, which are metabolised by Cytochrome P450 2C9.
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.
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Winthrop.
Studji fuq il- bhejjem urew li clopidogrel joħroġ fil- ħalib tas- sider.. Bħala miżura ta ’ prekawzjoni, id- treddigħ m’ għandux jitkompla waqt il- kura b ’ Clopidogrel Winthrop.
5 In CURE, the major bleeding event rate for clopidogrel+ASA was dose-dependent on ASA (< 100mg:
F' CURE, ir- rata ta ’ avvenimenti ta 'fsada maġġuri għal clopidogrel+ASA kienet tiddependi fuq id - doża ta ’ ASA (< 100 mg:
In CLARITY, there was an overall increase in bleeding in the clopidogrel + ASA group (17.4%) vs. the placebo + ASA group (12.9%). The incidence of major bleeding was similar between groups (1.3% versus 1.1% for the clopidogrel + ASA and the placebo + ASA groups, respectively).
L- inċidenza ta ’ fsada maġġuri kienet simili bejn il- gruppi (1. 3% kontra 1. 1% għal gruppi clopidogrel + ASA u l- plaċebo + ASA, rispettivament).
This was 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.
Very rare
Purpura
Blood and the lymphatic system disorders
Tromboċitopenja, Newtropenja, Disturbi tad- demm u tromboċitopenika inkluża tas- sistema limfatika
Thrombocytopenia, leucopenia, eosinophilia
lewkopenja, eosinofilja
Neutropenia, including severe neutropenia
newtropenja severa
Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia
trombotika (TTP) (ara sezzjoni 4. 4), anemija aplastika, panċitopenja, agranuloċitosi, tromboċitopenja severa, granuloċitopenja, anemija
Serum sickness, anaphylactoid reactions
Disturbi psikjatriċi
Psychiatric disorders
Disturbi fis- sistema
Hallucinations, confusion
Disturbi fl- għajnejn
Nervous system disorders
Disturbi fil- widnejn u fis- sistema labirintika
Intracranial bleeding (some cases were
Disturbi respiratorji, toraċiċi u medjastinali
Taste disturbances
Epistassi
reported with fatal outcome), headache, paraesthesia, dizziness
Fsada fil- passaġġ respiratorju (emoptisi, emorraġija fil- pulmun), bronkospażmu, pulmonite interstizjali
Eye disorders
Rari Ħafna
Eye bleeding (conjunctival, ocular, retinal)
Emorraġija gastro - Ulċera gastrika u Emorraġija Disturbi gastro -
Ear and labyrinth disorders
Emorraġija
Vertigo
ulċera dwodenali, tar -
Vascular disorders
intestinali u tar -
Haematoma
intestinali
Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension
gastro - intestinali, dijarea, uġigħ addominali, dispepsja
Respiratory, thoracic and mediastinal disorders
gastrite, rimettar, retroperitonew tqalligħ, stitikezza, gas fl - istonku
Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis
retroperitonew b’ eżitu fatali, pankreatite, kolite (inklużi kolite ulċerattiva jew limfoċitika), stomatite
Gastrointestinal disorders
Disturbi fil- fwied u fil - marrara
Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea,
Insuffiċjenza akuta tal - fwied, epatite, test tal - funzjoni tal- fwied anormali
Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis,
Disturbi fil- ġilda u fit - tessuti ta ’ taħt il- ġilda Disturbi muskolu - skeltrali, tat- tessut konnettiv u fl- għadam
Hepato-biliary disorders
Tbenġil
Bruising Rash, pruritus, skin bleeding (purpura)
Raxx, ħakk, fsada fil- ġilda (purpura)
Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, rash erythematous, urticaria, eczema, lichen planus
Dermatite bulloża (nekroliżi tossika ta ’ l - epidermide, Sindromu ta ’ Stevens Johnson, eritema multiforme), anġjoedima, raxx eritematika, urtikarja, ekżema, lichen planus Fsada muskolu- skeltrali (emartrożi), artrite, artralġja, majalġja
Musculoskeletal, connective tissue and bone disorders
Disturbi fil- kliewi u fis- sistema urinarja Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata
Renal and urinary disorders
Fsada fis- sit tat- titqib
Glomerulonephritis, blood creatinine increased
Glomerulonefrite, żieda tal- kreatinina fid- demm Deni
General disorders
Investigazzjonijiet
Clopidogrel also inhibits platelet aggregation induced by other agonists by blocking the amplification of platelet activation by released ADP.
7 amplifikazzjoni ta ’ l- attivazzjoni tal- plejtlets li sseħħ permezz ta ’ l- ADP meħlus.
In patients who were enrolled in the trial on the sole basis of a recent myocardial
F’ pazjenti li ddaħħlu fil- prova minħabba infart mijokardijaku reċenti biss, clopidogrel kien numerikament inqas, imma mhux statistikament differenti minn ASA.
8 infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR = -4.0%; CI: -22.5 to 11.7 [p=0.639]).
(RRR = - 4. 0%; CI: minn - 22. 5 sa 11. 7 [p=0. 639]).
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)).
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
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).
10 The kinetics of the main circulating metabolite were linear (plasma concentrations increased in proportion to dose) in the dose range of 50 to 150 mg of clopidogrel.
Il- karatteristiċi kinetiċi tal- metabolit ċirkolanti prinċipali kienu lineari (il- konċentrazzjonijiet fil - plażma żdiedu b’ mod proporzjonali mad- doża) fil- medda tad- doża ta ’ bejn 50 u 150 mg ta ’ clopidogrel.
6.5 Nature and content of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France F-75013 Paris – France
Sanofi Pharma Bristol- Myers Squibb SNC 174 Avenue de France F- 75013 Paris - Franza