qanastek/EMEA-V3 huggingface dataset:
Irbesartan Winthrop prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Irbesartan Winthrop jipprevjeni li angiotensin- II tingħaqad ma ’ dawn ir- riċetturi, u jwassal il- vini tad- demm biex jirrilassaw u b’ hekk il - pressjoni tinżel.
Irbesartan Winthrop slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Winthrop inaqqas ir- rata tat- tnaqqis tal- funzjoni tal- kliewi f’ pazjenti bi pressjoni għolja u b’ dijabete ta 'tip 2.
Irbesartan Winthrop is used to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
Irbesartan Winthrop jintuża biex jikkura pressjoni għolja tad- demm (pressjoni għolja) biex jipproteġi lill- kliewi f’ pazjenti bi pressjoni għolja ħafna, b’ dijabete ta ’ tip 2 u b’ evidenza mit- testijiet tal- laboratorju ta ’ indeboliment fil- funzjoni tal- kliewi.
BEFORE YOU TAKE IRBESARTAN WINTHROP
QABEL MA TIEĦU IRBESARTAN WINTHROP
Do not take Irbesartan Winthrop if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan Winthrop during the last 6 months of pregnancy, see section Pregnancy and breastfeeding if you are breast-feeding
Tiħux Irbesartan Winthrop jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal irbesartan jew sustanzi oħra ta 'Irbesartan Winthrop matul l- aħħar sitt xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ jekk qegħda tredda ’
Irbesartan Winthrop should not be given to children and adolescents (under 18 years).
Irbesartan Winthrop m’ għandux jingħata lit- tfal u adoloxxenti (taħt it- 18- il sena).
Take special care with Irbesartan Winthrop Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Irbesartan Winthrop for diabetic kidney disease.
Oqgħod attent ħafna b' Irbesartan Winthrop Għid lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik: jekk ikollok rimettar jew dijarea eċċessiva jekk tbati minn problemi fil- kliewi jekk tbati minn problemi tal- qalb jekk tirċievi Irbesartan Winthrop għal mard tal- kliewi dijabetiku.
Irbesartan Winthrop is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section Pregnancy and breastfeeding.
Irbesartan Winthrop mhuwiex rakkomandat kmieni matul it- tqala u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek wara l- ewwel 3 xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ.
Irbesartan Winthrop does not usually interact with other medicines.
Ġeneralment, Irbesartan Winthrop ma għandux effetti ma ’ mediċini oħra.
Taking Irbesartan Winthrop with food and drink Irbesartan Winthrop can be taken with or without food.
Meta tieħu Irbesartan Winthrop ma 'l- ikel u max- xorb Irbesartan Winthrop jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
Usually, your doctor will advise you to take another medicine instead of Irbesartan Winthrop, as Irbesartan Winthrop is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Normalment, it- tabib tiegħek jagħtik parir li tieħu mediċina oħra minflok Irbesartan Winthrop, minħabba li Irbesartan Winthropmhuwiex rakkomandat kmieni matul it- tqala, u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek jekk jintuża wara l- ewwel 3 xhur tat- tqala.
Appropriate antihypertensive drug must usually replace Irbesartan Winthrop before starting a pregnancy.
Mediċina xierqa kontra l- pressjoni għolja għandha normalment tissostitwixxi Irbesartan Winthropqabel il- bidu ta ’ tqala.
Your doctor will normally advise you to stop taking Irbesartan Winthrop as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu Irbesartan Winthrop malli ssir taf li inti ħriġt tqila.
If you become pregnant during therapy with Irbesartan Winthrop, please inform and see your doctor without delay.
Jekk toħroġ tqila matul terapija b ’ Irbesartan Winthrop, jekk jogħġbok avża u ara lit- tabib tiegħek minnufih.
Irbesartan Winthrop is unlikely to affect your ability to drive or use machines.
Sewqan u tħaddim ta 'magni Mhux mistenni li Irbesartan Winthrop itellfek milli issuq jew tħaddem magni.
Important information about some of the ingredients of Irbesartan Winthrop Irbesartan Winthrop contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'Irbesartan Winthrop Irbesartan Winthrop fih lactose.
HOW TO TAKE IRBESARTAN WINTHROP
KIF GĦANDEK TIEĦU IRBESARTAN WINTHROP
Always take Irbesartan Winthrop exactly as your doctor has told you.
Dejjem għandek tieħu Irbesartan Winthrop skond il- parir tat- tabib.
Method of administration Irbesartan Winthrop is for oral use.
Metodu ta ’ għoti Irbesartan Winthrop huwa għal użu mill- ħalq.
You can take Irbesartan Winthrop with or without food.
Tista ’ tieħu Irbesartan Winthrop ma ’ l- ikel kif ukoll mingħajr ikel.
It is important that you continue to take Irbesartan Winthrop until your doctor tells you otherwise.
Huwa importanti li tkompli tieħu Irbesartan Winthrop sakemm it- tabib tiegħek ma jgħidlekx mod ieħor.
If you take more Irbesartan Winthrop than you should If you accidentally take too many tablets, contact your doctor immediately.
Jekk tieħu Irbesartan Winthrop aktar milli suppost Jekk aċċidentalment tieħu ħafna pilloli, ikkuntattja mill- ewwel lit- tabib tiegħek.
If a child swallows some tablets, contact your doctor immediately.
It- tfal ma għandhomx jieħdu Irbesartan Winthrop Irbesartan Winthrop ma għandux jingħata lil tfal ta ’ taħt it- 18- il sena. jekk tifel/ tifla jibla/ tibla xi pilloli, ikkuntattja mill- ewwel lit- tabib tiegħek.
If you forget to take Irbesartan Winthrop If you accidentally miss a daily dose, just take the next dose as normal.
Jekk tinsa tieħu Irbesartan Winthrop Jekk aċċidentalment taqbeż id- doża tal- ġurnata, ħu id- doża li jmiss bħas- soltu.
Like all medicines, Irbesartan Winthrop can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Irbesartan Winthrop jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you get any of these symptoms or get short of breath, stop taking Irbesartan Winthrop and contact your doctor immediately.
Jekk ikollok kwalunkwe sintomu minn dawn li ġejjin jew inkella ssofri minn qtugħ ta ’ nifs, tiħux aktar Irbesartan Winthrop u kkuntattja lit- tabib tiegħek minnufih.
Side effects reported in clinical studies for patients treated with Irbesartan Winthrop were:
L- effetti sekondarji rrappurtati fl- istudji kliniċi għall- pazjenti kkurati b’ Irbesartan Winthrop kienu:
Some undesirable effects have been reported since marketing of Irbesartan Winthrop but the frequency for them to occur is not known.
93 Xi effetti sekondarji ġew irrappurtati minn mindu Irbesartan Winthrop tqiegħed fis- suq iżda l - frekwenza li jseħħu biha mhix magħrufa.
These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Dawn l- effetti mhux mixtieqa huma: uġigħ ta 'ras, disturbi fit- togħma, żarżir fil- widnejn, bugħawwieġ, uġigħ fil- ġogi u fil- muskoli, funzjoni tal- fwied anormali, livelli għoljin ta ’ potassium fid- demm, funzjoni tal- kliewi indebolita, u infjammazzjoni tal- vini ż - żgħar li taffettwa l- ġilda (kundizzjoni magħrufa bħala leukocytoclastic vasculitis).
HOW TO STORE IRBESARTAN WINTHROP
KIF TAĦŻEN IRBESARTAN WINTHROP
Do not use Irbesartan Winthrop after the expiry date which is stated on the carton and on the blister after EXP.
Tużax Irbesartan Winthrop wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il- folja wara JIS.
The expiry date refers to the last day of that month.
Id - data ta 'skadenza tirreferi għall- aħħar ġurnata ta' dak ix- xahar.
What Irbesartan Winthrop contains The active substance is irbesartan.
X' fih Irbesartan Winthrop Is- sustanza attiva hi irbesartan.
Each tablet of Irbesartan Winthrop 75 mg contains 75 mg irbesartan.
Kull pillola ta ’ Irbesartan Winthrop 75 mg fiha 75 mg ta ’ irbesartan.
What Irbesartan Winthrop looks like and contents of the pack Irbesartan Winthrop 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Id- dehra ta ’ Irbesartan Winthrop u l- kontenuti tal- pakkett Il- pilloli Irbesartan Winthrop 75 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2771 imnaqqax fuq in- naħa l- oħra.
Irbesartan Winthrop 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan Winthrop 75 mg jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
INFORMATION FOR THE USER Irbesartan Winthrop 150 mg tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Winthrop 150 mg pilloli irbesartan
Some undesirable effects have been reported since marketing of Irbesartan Winthrop but the frequency for them to occur is not known.
100 Xi effetti sekondarji ġew irrappurtati minn mindu Irbesartan Winthrop tqiegħed fis- suq iżda l - frekwenza li jseħħu biha mhix magħrufa.
Each tablet of Irbesartan Winthrop 150 mg contains 150 mg irbesartan.
Kull pillola ta ’ Irbesartan Winthrop 150 mg fiha 150 mg ta ’ irbesartan.
What Irbesartan Winthrop looks like and contents of the pack Irbesartan Winthrop 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Id- dehra ta ’ Irbesartan Winthrop u l- kontenuti tal- pakkett Il- pilloli Irbesartan Winthrop 150 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2772 imnaqqax fuq in- naħa l- oħra.
Irbesartan Winthrop 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan Winthrop 150 mg jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
INFORMATION FOR THE USER Irbesartan Winthrop 300 mg tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Winthrop 300 mg pilloli irbesartan
Some undesirable effects have been reported since marketing of Irbesartan Winthrop but the frequency for them to occur is not known.
107 Xi effetti sekondarji ġew irrappurtati minn mindu Irbesartan Winthrop tqiegħed fis- suq iżda l - frekwenza li jseħħu biha mhix magħrufa.
Each tablet of Irbesartan Winthrop 300 mg contains 300 mg irbesartan.
Kull pillola ta ’ Irbesartan Winthrop 300 mg fiha 300 mg ta ’ irbesartan.
What Irbesartan Winthrop looks like and contents of the pack Irbesartan Winthrop 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Id- dehra ta ’ Irbesartan Winthrop u l- kontenuti tal- pakkett Il- pilloli Irbesartan Winthrop 300 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2773 imnaqqax fuq in- naħa l- oħra.
Irbesartan Winthrop 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan Winthrop 300 mg jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
INFORMATION FOR THE USER Irbesartan Winthrop 75 mg film-coated tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Winthrop 75 mg pilloli miksijin b’ rita irbesartan
Irbesartan Winthrop is unlikely to affect your ability to drive or use machines.
Sewqan u tħaddim ta ’ magni Mhux mistenni li Irbesartan Winthrop itellfek milli issuq jew tħaddem magni.
If you accidentally take too many tablets, contact your doctor immediately.
Jekk tieħu Irbesartan Winthrop aktar milli suppost Jekk aċċidentalment tieħu ħafna pilloli, ikkuntattja mill- ewwel lit- tabib tiegħek.
If you accidentally miss a daily dose, just take the next dose as normal.
Jekk tinsa tieħu Irbesartan Winthrop Jekk aċċidentalment taqbeż id- doża tal- ġurnata, ħu id- doża li jmiss bħas- soltu.
Some undesirable effects have been reported since marketing of Irbesartan Winthrop but the frequency for them to occur is not known.
114 Xi effetti sekondarji ġew irrappurtati minn mindu Irbesartan Winthrop tqiegħed fis- suq iżda l - frekwenza li jseħħu biha mhix magħrufa.
What Irbesartan Winthrop looks like and contents of the pack Irbesartan Winthrop 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Id- dehra ta ’ Irbesartan Winthrop u l- kontenuti tal- pakkett Il- pilloli Irbesartan Winthrop 75 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2871 imnaqqax fuq in- naħa l- oħra.
Irbesartan Winthrop 75 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Irbesartan Winthrop 75 mg miksijin b’ rita jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56, 84 jew 98 pillola miksija b’ rita.
INFORMATION FOR THE USER Irbesartan Winthrop 150 mg film-coated tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Winthrop 150 mg pilloli miksijin b’ rita irbesartan
Some undesirable effects have been reported since marketing of Irbesartan Winthrop but the frequency for them to occur is not known.
121 Xi effetti sekondarji ġew irrappurtati minn mindu Irbesartan Winthrop tqiegħed fis- suq iżda l - frekwenza li jseħħu biha mhix magħrufa.
What Irbesartan Winthrop looks like and contents of the pack Irbesartan Winthrop 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Id- dehra ta ’ Irbesartan Winthrop u l- kontenuti tal- pakkett Il- pilloli Irbesartan Winthrop 150 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2872 imnaqqax fuq in- naħa l- oħra.
Irbesartan Winthrop 150 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Irbesartan Winthrop 150 mg miksijin b’ rita jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56, 84 jew 98 pillola miksija b’ rita.
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 - France
122 SANOFI WINTHROP INDUSTRIE 30- 36 Avenue Gustave Eiffel, BP 7166 F- 37071 Tours Cedex 2 - Franza
INFORMATION FOR THE USER Irbesartan Winthrop 300 mg film-coated tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Winthrop 300 mg pilloli miksijin b’ rita irbesartan
Some undesirable effects have been reported since marketing of Irbesartan Winthrop but the frequency for them to occur is not known.
128 Xi effetti sekondarji ġew irrappurtati minn mindu Irbesartan Winthrop tqiegħed fis- suq iżda l - frekwenza li jseħħu biha mhix magħrufa.
What Irbesartan Winthrop looks like and contents of the pack Irbesartan Winthrop 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Id- dehra ta ’ Irbesartan Winthrop u l- kontenuti tal- pakkett Il- pilloli Irbesartan Winthrop 300 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2873 imnaqqax fuq in- naħa l- oħra.
Irbesartan Winthrop 300 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Irbesartan Winthrop 300 mg miksijin b’ rita jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56, 84 jew 98 pillola miksija b’ rita.
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 - France
129 SANOFI WINTHROP INDUSTRIE 30- 36 Avenue Gustave Eiffel, BP 7166 F- 37071 Tours Cedex 2 - Franza
What is Iscover?
X’ inhu Iscover?
Iscover are pink tablets.
Iscover huma pilloli roża.
Iscover contains the active ingredient clopidogrel (75 mg).
Iscover fih is- sustanza attiva clopidogrel (75 mg).
What is Iscover used for?
Għal x’ hiex jintuża Iscover?
Iscover is used in adult patients to prevent atherothrombotic events (problems caused by blood clots and hardening of arteries).
Iscover jintuża f’ pazjenti adulti biex jipprevjeni episodji aterotrombotiċi (problemi ikkaġunati minn ċapep tad- demm u ebusija ta ’ l- arterji).
Iscover can be given to: • patients who have recently had a myocardial infarction (heart attack); Iscover can be started in the few days after the attack and up to 35 days later, • patients who have had a recent ischaemic stroke (non-bleeding stroke); Iscover can be started in the 7 days after the attack and up to 6 months later, • patients with peripheral arterial disease (problem with blood flow in the arteries), • patients who have a condition known as acute coronary syndrome, when it should be given with aspirin (another anticoagulant), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Iscover jista ’ jingħata lil: • pazjenti li riċentement kellhom infart majokardjali (attakk tal- qalb); Iscover jista ’ jinbeda fil - ftit ġranet ta ’ wara l- attakk u sa 35 jum aktar tard, • pazjenti li kellhom puplesija iskemika riċenti (puplesija mingħajr fsada); Iscover jista ’ jinbeda 7 ijiem wara l- attakk u sa 6 xhur wara, • pazjenti b’ mard arterjali periferali (problema bil- passaġġ tad- demm fl- arterji), • pazjenti li għandhom kondizzjoni magħrufa bħala sindromu koronarju akut, meta għandu jingħata ma ’ l- aspirina (antikoagulant ieħor), inklużi pazjenti li kellhom stent imdaħħal (tubu qasir impoġġi ġo arterja biex jimpedixxiha milli tingħalaq).
Iscover 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.
Iscover jista ’ jintuża f’ pazjenti b’ attakk tal- qalb b ’ “ elevazzjoni tas- segment ST ” (b’ reġistrazzjoni annormali fuq l - elektrokardjogramma jew EKG) meta t- tabib jaħseb li huma jistgħu jibbenifikaw 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 m’ għandhomx din ir- reġistrazzjoni anormali fuq l - ECG, jekk ikollhom anġina instabbli (tip ta ’ uġigħ qawwi fis- sider) jew li kellhom infart majokardjali mingħajr mewġa Q (non- Q- wave).
How is Iscover used?
Kif jintuża Iscover?
Iscover should be given as a single daily dose of 75 mg (one tablet) with or without food.
Iscover għandu jingħata bħala doża waħda ta ’ 75 mg (pillola waħda) ta ’ kuljum ma ’ l- ikel jew fuq stonku vojt.
In acute coronary syndrome, Iscover is used together with aspirin and the treatment generally starts with a 300 mg loading dose, which is followed by a daily dose of 75 mg for at least 4 weeks in ST elevation myocardial infarction or for up to 12 months in non-ST elevation syndrome.
Fis- sindromu koronarju akut, Iscover jintuża flimkien ma ’ l- aspirina u t- trattament ġeneralment jibda b’ doża ta ’ tagħbija ta ’ 300 mg, li hija imbagħad segwita minn doża ta ’ kuljum ta ’ 75 mg għal ta ’ l- anqas 4 ġimgħat f’ infart majokardjali b’ elevazzjoni ST jew sa 12- il xahar fis - sindromu mingħajr elevazzjoni ST.
How does Iscover work?
Kif jaħdem Iscover?
Iscover is an inhibitor of platelet aggregation.
Iscover huwa impeditur ta ’ l- aggregazzjoni tal- platelets.
This means that it helps to prevent blood clots from forming.
Dan ifisser li jgħin biex jipprevjeni milli jiffurmaw ċapep tad- demm.
When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating).
Meta d- demm jagħqad, dan iseħħ minħabba li ċelloli speċjali fid- demm, il- platelets, jeħlu flimkien (jaggregaw).
This stops the platelets becoming ‘ sticky’.
Clopidogrel, is- sustanza attiva f’ Iscover, twaqqaf il- platelets milli jaggregaw billi timblokka sustanza, ADP, milli torbot ma ’ riċettur speċjali fuq il- wiċċ tagħhom.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Iscover been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Dan iwaqqaf lill- platelets milli jsiru ‘ jwaħħlu ’.
The effectiveness of Iscover as an anticoagulant was examined in a study (CAPRIE) of around 19,000 patients with atherothrombosis, where Iscover was compared with aspirin.
L- effettività ta ’ Iscover bħala antikoagulant ġiet eżaminata fi studju (CAPRIE) ta ’ madwar 19, 000 pazjent b’ aterotrombożi, fejn Iscover tqabbel ma ’ aspirina.
Neither the patient nor the doctor knew what medicine the patient was receiving.
La l- pazjent u lanqas it- tabib ma kienu jafu x’ mediċina kien qed jirċievi l- pazjent.
The study lasted from one to three years, and examined the rate of new ischaemic events (heart attacks, ischaemic strokes, and death).
L- istudju dam minn sena sa tlett snin, u eżamina r- rata ta ’ episodji iskemiċi ġodda (attakki tal- qalb, puplesiji iskemiċi, jew mewt).
In non-ST elevation acute coronary syndrome, Iscover was compared to a placebo (a dummy treatment) in over 12,000 patients for up to one year (CURE study):
Fis- sindromu koronarju akut mingħajr elevazzjoni ST, Iscover tqabbel ma ’ plaċebo (trattament finta) f’ aktar minn 12, 000 pazjent sa sena (studju CURE):
2,172 of these had a stent inserted during the study.
2, 172 kellhom stent imdaħħal waqt l- istudju.
In ST-elevation myocardial infarction, Iscover was compared with a placebo in two studies, CLARITY (over 3,000 patients, where the patients received Iscover for up to eight days) and COMMIT (almost 46,000 patients, where the patients received Iscover with or without metoprolol for up to four weeks).
Fl- attakki tal- qalb akkumpanjati minn elevazzjoni ta ’ l- ST, Iscover tqabbel ma ’ plaċebo f’ żewġ studji, CLARITY (aktar minn 3, 000 pazjent, fejn il- pazjenti rċevew Iscover sa tmin tijiem) u COMMIT (kważi 46, 000 pazjent, fejn il - pazjenti rċevew Iscover ma ’ jew mingħajr metoprolol sa erba ’ ġimgħat).
The studies looked at how many patients experienced an ‘ event’ such as a blocked artery, another heart attack or death, during the study.
L- istudji analizzaw kemm kien hemm pazjenti li kellhom episodji bħal arterja imblokkata, attakk tal- qalb ieħor jew mewt, waqt l - istudju.
What benefit has Iscover shown during the studies?
X’ benefiċċju wera Iscover waqt l- istudji?
Iscover was more effective than aspirin at preventing new ischaemic events.
Iscover kien aktar effettiv mill- aspirina biex jimpedixxi episodji iskemiċi ġodda.
There were 939 events in the Iscover group, and 1020 in the aspirin group.
Kien hemm 939 episodju fil- grupp Iscover, u 1020 fil- grupp aspirina.
This corresponds to a relative reduction in risk of 8.7% compared to aspirin.
Dan jikkorrispondi ma ’ tnaqqis fir- riskju relattiv ta ’ 8. 7% meta mqabbel ma ’ l- aspirina.
Risk reduction means that fewer patients will have new ischaemic events when they receive Iscover, than if they receive aspirin (in other words, about 10 patients in 1,000 will avoid having a new ischaemic event within two years of starting Iscover instead of aspirin).
Tnaqqis fir- riskju jfisser li anqas pazjenti jkollhom episodji iskemiċi ġodda meta jirċievu Iscover, milli kieku jirċievu aspirina (fi kliem ieħor 10 pazjenti f’ 1000 jevitaw li jkollhom episodju iskemiku ġdid fi żmien sentejn li jibdew Iscover minflok aspirina).
In non-ST elevation acute coronary syndrome, the overall relative reduction in the risk of an event compared to placebo was 20%.
Fis- sindromu koronarju akut mingħajr elevazzjoni ST, it- tnaqqis relattiv totali fir- riskju ta ’ episodju 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 kellhom stent imdaħħal.
In ST-elevation myocardial infarction, fewer patients on Iscover 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 majokardjali b’ elevazzjoni ST, pazjenti fuq Iscover kellhom inqas episodji milli pazjenti fuq plaċebo (262 kontra 377 fl- istudju CLARITY, u 2, 121 kontra 2, 310 fl- istudju COMMIT).
This showed that Iscover reduces the risk of an event.
Dan juri li Iscover inaqqas ir- riskju ta ’ episodju.
What is the risk associated with Iscover?
X’ inhu r- riskju assoċjat ma ’ Iscover?
The main risk of Iscover is bleeding.
Ir- riskju ewlieni ta ’ Iscover huwa fsada.
Diarrhoea, abdominal pain and dyspepsia (indigestion or heartburn) are common (seen in between 1 and 10 patients in 100).
Dijarea, uġigħ addominali u dispepsja (indiġestjoni jew ħruq ta ’ stonku) huma komuni (dehru f ’ bejn 1 u 10 pazjenti minn kull100).
Other side effects are uncommon or rare.
Effetti sekondarji oħra m’ humiex komuni jew huma rari.
For the full list of all side effects reported with Iscover, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ Iscover, ara l - Fuljett ta ’ Tagħrif.
Iscover should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients, who have severe liver disease, or have a disease which may cause bleeding.
Iscover m’ għandux jintuża f’ nies li jistgħu jkunu allerġiċi għal clopidrogrel jew għal xi sustanza oħra tiegħu, li għandhom mard serju tal- fwied, jew li għandhom marda li tista ’ tikkaġuna fsada.
For the full list of restrictions, please see the Package Leaflet.
Għal- lista sħiħa ta ’ restrizzjonijiet, jekk jogħġbok ara l- Fuljett ta ’ Tagħrif.
Why has Iscover been approved?
Għal x’ hiex ġie approvat Iscover?
The Committee for Medicinal products for Human Use (CHMP) decided that Iscover’ s benefits are greater than its risks for patients at risk of atherothrombotic events.
Il- Kumitat għal Prodotti Mediċinali għall- Użu tal- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Iscover huma akbar mir- riskji tiegħu għal pazjenti b’ riskju ta ’ episodji aterotrombotiċi.
The Committee recommended that Iscover be given marketing authorisation.
Il- Kumitat irrikkmanda li Iscover jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Iscover:
Tagħrif ieħor dwar Iscover:
The European Commission granted a marketing authorisation valid throughout the European Union for Iscover to Sanofi Pharma Bristol-Myers Squibb SNC on 15 July 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- UE kollha għal Plavix lil Sanofi Pharma Bristol- Myers Squibb SNC fil- 15 ta ’ Lulju 1998.
The Marketing Authorisation was renewed on 15 July 2003.
L- Awtorizzazzjoni għat - Tqegħid fis- Suq ġiet imġedda fil- 15 ta ’ Lulju 2003.
The full EPAR for Iscover is available here.
L- EPAR sħiħ għal Iscover huwa disponibbli minn hawnhekk.
EU Number EU/ 1/ 98/ 070/ 001a EU/ 1/ 98/ 070/ 001b EU/ 1/ 98/ 070/ 002a EU/ 1/ 98/ 070/ 002b EU/ 1/ 98/ 070/ 003a EU/ 1/ 98/ 070/ 003b EU/ 1/ 98/ 070/ 004a EU/ 1/ 98/ 070/ 004b EU/ 1/ 98/ 070/ 005a EU/ 1/ 98/ 070/ 005b EU/ 1/ 98/ 070/ 006a EU/ 1/ 98/ 070/ 006b EU/ 1/ 98/ 070/ 007a EU/ 1/ 98/ 070/ 007b EU/ 1/ 98/ 070/ 008 EU/ 1/ 98/ 070/ 009 EU/ 1/ 98/ 070/ 010 EU/ 1/ 98/ 070/ 011a EU/ 1/ 98/ 070/ 011b
Numru ta ’ l- EU EU/ 1/ 98/ 070/ 001a EU/ 1/ 98/ 070/ 001b EU/ 1/ 98/ 070/ 002a EU/ 1/ 98/ 070/ 002b EU/ 1/ 98/ 070/ 003a EU/ 1/ 98/ 070/ 003b EU/ 1/ 98/ 070/ 004a EU/ 1/ 98/ 070/ 004b EU/ 1/ 98/ 070/ 005a EU/ 1/ 98/ 070/ 005b EU/ 1/ 98/ 070/ 006a EU/ 1/ 98/ 070/ 006b EU/ 1/ 98/ 070/ 007a EU/ 1/ 98/ 070/ 007b EU/ 1/ 98/ 070/ 008 EU/ 1/ 98/ 070/ 009 EU/ 1/ 98/ 070/ 010 EU/ 1/ 98/ 070/ 011a
Invented name Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover
Isem inventat Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover Iscover
Strength 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
Pharmaceutical Form 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
Route of Administration 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
Packaging 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 folji (PVC/ PVDC/ alu) folji (alu/ alu) folji (PVC/ PVDC/ alu) folji (alu/ alu) folji (PVC/ PVDC/ alu) folji (alu/ alu) folji (PVC/ PVDC/ alu) folji (alu/ alu) folji (PVC/ PVDC/ alu) folji (alu/ alu) folji (PVC/ PVDC/ alu) folji (alu/ alu) folji (PVC/ PVDC/ alu) folji (alu/ alu) folji (alu/ alu) folji (alu/ alu) folji (alu/ alu) folji (PVC/ PVDC/ alu)
Package size 28 28 50 50 84 84 100 100 30 30 90 90 14 14 4x1 30 x 1 100 x 1 7 7
Daqs tal- pakkett 28 28 50 50 84 84 100 100 30 30 90 90 14 14 4x1 30 x 1 100 x 1 7
Iscover 75 mg film-coated tablets
Iscover 75 mg pilloli miksija b’ rita
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.
TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
TTP hija kondizzjoni li tista ’ tkun fatali u li għandha bżonn kura mal- ewwel, inkluz il- plażmafereżi.
Iscover contains lactose.
Iscover 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.
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 heparins ġiet eżaminata f’ pazjenti li kellhom infart mijokardijaku akut.
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.
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.
As a precautionary measure, breast-feeding should not be continued during treatment with Iscover.
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’ Iscover.
Bleeding is the most common reaction reported both in clinical studies as well as in post-marketing experience where it was mostly reported during the first month of treatment.
Il- fsada hija r- reazzjoni l- aktar kommuni li ġiet irraportata kemm fl- istudji kliniċi kif ukoll wara li l - prodott tpoġġa fis- suq fejn l- aktar li ġiet irraportata kienet fl- ewwel xahar tal- kura.
Blood and the lymphatic system disorders
Disturbi tad- demm u
Thrombocytopenia, leucopenia, eosinophilia
Tromboċitopenja,
Neutropenia, including severe neutropenia
Newtropenja,
Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia
tromboċitopenika
Immune system disorders
tas- sistema limfatika
Serum sickness, anaphylactoid reactions
trombotika (TTP) (ara
Psychiatric disorders
newtropenja severa
Hallucinations, confusion
Disturbi fis- sistema immuni Disturbi psikjatriċi
Intracranial bleeding (some cases were
Fsada
Eye bleeding (conjunctival, ocular, retinal)
Disturbi fl- għajnejn
Gastrointestinal Gastrointestinal
Emorraġija gastro - Ulċera gastrika u Emorraġija Disturbi gastro -
Gastric ulcer and
ulċera dwodenali, tar -
Retroperitoneal Gastrointestinal and
intestinali u tar -
disorders
intestinali
haemorrhage, diarrhoea, abdominal pain, dyspepsia
gastro - intestinali, dijarea, uġigħ addominali, dispepsja
duodenal ulcer, haemorrhage gastritis, vomiting, nausea, constipation, flatulence
gastrite, rimettar, retroperitonew tqalligħ, stitikezza, gas fl - istonku
retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
retroperitonew b’ eżitu fatali, pankreatite, kolite (inklużi kolite ulċerattiva jew limfoċitika), stomatite
Hepato-biliary disorders
Disturbi fil- fwied u fil - marrara
Acute liver failure, hepatitis, abnormal liver function test
Insuffiċjenza akuta tal - fwied, epatite, test tal - funzjoni tal- fwied anormali
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit - tessuti ta ’ taħt il- ġilda Disturbi muskolu - skeltrali, tat- tessut konnettiv u fl- għadam
General disorders and administration site conditions
Glomerulonefrite, żieda tal- kreatinina fid- demm Deni
Bleeding at puncture site
Investigazzjonijiet
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 ’ kondizzjoni 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 patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR = -4.0%; CI: -22.5 to 11.7 [p=0.639]).
F’ pazjenti li ddaħħlu fil- prova minħabba infart mijokardijaku reċenti biss, clopidogrel kien numerikament inqas, imma mhux statistikament differenti minn ASA.
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.
(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.
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- riċetturi GPIIb/ IIIa fl- istess ħin.
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.
In particular, in a post-hoc analysis in 2,172 patients (17% of the total CURE population) who underwent stent placement (Stent-CURE), the data showed that clopidogrel compared to placebo, demonstrated a significant RRR of 26.2% favouring clopidogrel for the co-primary endpoint (CV death, MI, stroke) and also a significant RRR of 23.9% for the second co-primary endpoint (CV death, MI, stroke or refractory ischaemia).
Partikularment, f’ analiżi post- hoc f ’ 2172 pazjenti (17% tal- popolazzjoni kollha CURE) li kellhom stent impoġġija (Stent- CURE), id- data wriet li clopidogrel, imqabbel ma plaċebo, wera RRR sinifikanti ta ’ 26. 2% favur clopidogrel għal punt ko- primarju ta ’ tmiem (mewt b ’ CV, MI, puplesija) u wkoll RRR sinifikanti ta ’ 23. 9% għatt- tieni punt ko- primarju ta ’ tmiem (mewt b ’ CV, MI, puplesija jew iskemija li mhux qed tirrispondi ghall- kura).
68.7%, non-fibrin specific:
68. 7%, mhux speċifiċi għall- fibrina:
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% l- inibituri ACE u 63% statins.
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) seħħew bejn wieħed u ieħor siegħa wara d- dożaġġ.
The pharmacokinetics and pharmacodynamics of clopidogrel were assessed in a single and multiple dose study in both healthy subjects and those with cirrhosis (Child-Pugh class A or B).
Il- karatteristiċi farmakokinetiċi u farmakodinamiċi ta ’ clopidogrel tqiesu fi studju dwar dożi singoli u multipli kemm f’ persuni f’ saħħithom u f’ dak li kellhom ċirrożi (Child- Pugh klassi A jewB).
Bristol Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
Bristol Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Renju Unit
EU/ 1/ 98/ 070/ 001a - Cartons of 28 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 070/ 001b - Cartons of 28 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 070/ 002a - Cartons of 50x1 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 070/ 002b - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 070/ 003a - Cartons of 84 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 070/ 003b - Cartons of 84 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 070/ 004a - Cartons of 100 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 070/ 004b - Cartons of 100 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 070/ 005a - Cartons of 30 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 070/ 005b - Cartons of 30 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 070/ 006a - Cartons of 90 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 070/ 006b - Cartons of 90 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 070/ 007a - Cartons of 14 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 070/ 007b - Cartons of 14 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 070/ 011a - Cartons of 7 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 070/ 011b - Cartons of 7 film-coated tablets in all aluminium blisters
EU/ 1/ 98/ 070/ 001a – Kaxex ta ’ 28 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 070/ 001b - Kaxex ta ’ 28 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 070/ 002a - Kaxex ta ’ 50x1 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 070/ 002b - Kaxex ta ’ 50x1 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 070/ 003a - Kaxex ta ’ 84 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 070/ 003b - Kaxex ta ’ 84 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 070/ 004a - Kaxex ta ’ 100 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 070/ 004b - Kaxex ta ’ 100 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 070/ 005a - Kaxex ta ’ 30 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 070/ 005b - Kaxex ta ’ 30 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 070/ 006a - Kaxex ta ’ 90 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 070/ 006b - Kaxex ta ’ 90 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 070/ 007a - Kaxex ta ’ 14- il pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 070/ 007b - Kaxex ta ’ 14- il pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 070/ 011a - Kaxex ta ’ 7 pilloli miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 070/ 011b - Kaxex ta ’ 7 pilloli miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum
15 July 1998 Date of latest renewal:
15 ta ’ Lulju 1998 Data ta ’ l- aħħar tiġdid:
15 July 2008
15 ta ’ Lulju 2008
Iscover 300 mg film-coated tablets
Iscover 300 mg pilloli miksija b’ rita
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 qawwija tal- bidu.
Combined therapy should be started as early
It - terapija ikkombinata għandha tinbeda mill- aktar fis possibbli wara li s- sintomi jitfaċċaw u
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.
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 ħemolitika mikroanġjopatika marbuta ma ’ sitwazzjonijiet newroloġiċi jew kliewi li ma jaħdmux b’ mod normali jew deni.
14 Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses.
15 L- esperjenza f’ pazjenti b’ mard moderat fil- fwied li jista ’ jkollhom dijatesi qed inixxu d- demm hija limitata.
Data from studies with human liver microsomes indicated that the carboxylic acid metabolite of clopidogrel could inhibit the activity of Cytochrome P450 2C9.
16 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.
As a precautionary measure, breast-feeding should not be continued during treatment with Iscover.
Bħala miżura ta ’ prekawzjoni, id- treddigħ m’ għandux jitkompla waqt il- kura b’ Iscover.
Psychiatric disorders
eosinofilja
Hallucinations, confusion
newtropenja severa
Nervous system disorders
Disturbi fis- sistema immuni Disturbi psikjatriċi
Intracranial bleeding (some cases were
Disturbi fis- sistema
System Organ Class
18 Sistema tal- klassifika ta ’ l- organi
18 amplification of platelet activation by released ADP.
19 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 infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR = -4.0%; CI: -22.5 to 11.7 [p=0.639]).
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]).
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.
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.
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.
20 rata relattiva ta ’ dmija bejn clopidogrel u l- plaċebo ma ġietx affettwata b’ mod sinifikanti bit- terapija ta ’ heparin li ngħatat fl- istess ħin.