qanastek/EMEA-V3 huggingface dataset:
2,172 of these had a stent inserted during the study.
2, 172 minn dawn kellhom stent infilzata waqt l- istudju.
In ST-elevation myocardial infarction, Plavix was compared with a placebo in two studies, CLARITY (over 3,000 patients, where the patients received Plavix for up to eight days) and COMMIT (almost 46,000 patients, where the patients received Plavix with or without metoprolol for up to four weeks).
Fl- attakki tal- qalb akkumpanjati minn elevazzjoni ta ’ l- ST, Plavix tqabbel ma ’ plaċebo f’ żewġ studji, CLARITY (bis- sehem ta ’ iktar minn 3, 000 pazjent, fejn il- pazjenti ngħataw Plavix għal mhux iktar minn tmint ijiem) u COMMIT (bis - sehem ta ’ kważi 46, 000 pazjent, fejn il- pazjenti ngħataw Plavix ma ’ jew mingħajr metoprolol għal mhux iktar minn 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 misduda, attakk tal- qalb ieħor jew mewt, waqt l- istudju.
What benefit has Plavix shown during the studies?
X’ inhuma l- benefiċċji ta ’ Plavix li ntwerew waqt dawn l- istudji?
Plavix was more effective than aspirin at preventing new ischaemic events.
Plavix kien iktar effettiv mill- aspirina fil- prevenzjoni ta ’ episodji iskemiċi ġodda.
There were 939 events in the Plavix group, and 1,020 in the aspirin group.
Kien hemm 939 episodju fil- grupp ta ’ Plavix, u 1, 020 fil- grupp ta ’ l- aspirina.
This corresponds to a relative reduction in risk of 8.7% compared to aspirin.
Dan jikkorrispondi għal tnaqqis relattiv fir- riskju ta ’ 8. 7% meta mqabbel ma ’ l- aspirina.
Risk reduction means that fewer patients will have new ischaemic events when they receive Plavix, 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 Plavix instead of aspirin).
Tnaqqis fir- riskju jfisser li inqas pazjenti jkollhom episodji iskemiċi ġodda meta jingħataw Plavix milli meta jingħataw l- aspirina (fi kliem ieħor, madwar 10 pazjenti minn kull 1, 000 jevitaw li jkollhom episodju iskemiku ġdid fi żmien sentejn mill- bidu tat - trattament bi Plavix minflok l- 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 tat- taqsima ST, it- tnaqqis relattiv globali fir- riskju ta ’ episodju meta mqabbel mal- plaċebo kien 20%.
In ST-elevation myocardial infarction, fewer patients on Plavix had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Fl- attakki tal- qalb b’ elevazzjoni tat- taqsima ST, inqas pazjenti li kienu qed jieħdu Plavix kellhom episodji milli pazjenti li kienu qed jieħdu l- plaċebo (262 u 377 rispettivament fl - istudju CLARITY, u 2, 121 u 2, 310 rispettivament fl- istudju COMMIT).
This showed that Plavix reduces the risk of an event.
Dan wera li Plavix inaqqas ir - riskju ta ’ episodju.
What is the risk associated with Plavix?
X’ inhu r- riskju assoċjat ma ’ Plavix?
The main risk of Plavix is bleeding.
Ir- riskju ewlieni ta ’ Plavix huwa l- ħruġ tad- demm.
Diarrhoea, abdominal pain and dyspepsia (indigestion or heartburn) are common (seen in between 1 and 10 patients in 100).
Id- dijarea, l- uġigħ ta ’ żaqq u l- uġigħ jew ħruq fl - istonku (indiġestjoni) huma komuni (dehru f’ bejn pazjent wieħed u għaxar pazjenti minn kull mija).
For the full list of all side effects reported with Plavix, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rrappurtati ma ’ Plavix, ara l- Fuljett ta ’ Tagħrif.
Plavix 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.
Plavix m’ għandux jintuża minn persuni li jistgħu jkunu allerġiċi għal clopidogrel jew għal kwalunkwe mill- ingredjenti l- oħra, minn persuni bi problemi severi fil- fwied, jew li jkollhom mard li jista ’ jikkawża l- ħruġ tad- demm.
For the full list of restrictions, please see the Package Leaflet.
Għal- lista sħiħa tar- restrizzjonijiet, jekk jogħġbok ara l- Fuljett ta ’ Tagħrif.
Why has Plavix been approved?
Għaliex ġie approvat Plavix?
The Committee for Medicinal products for Human Use (CHMP) decided that Plavix’ s benefits are greater than its risks for patients at risk of atherothrombotic events.
Il- Kumitat għall- prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Plavix huma ikbar mir- riskji tiegħu fil- prevenzjoni ta ’ episodji aterotrombotiċi.
The Committee recommended that Plavix be given marketing authorisation.
Il- Kumitat irrakkomanda li Plavix jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Plavix:
Tagħrif ieħor dwar Plavix:
The European Commission granted a marketing authorisation valid throughout the European Union for Plavix 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 full EPAR for Plavix is available here.
L- EPAR sħiħ għal Plavix huwa disponibbli minn hawnhekk.
EU Number EU/ 1/ 98/ 069/ 001a EU/ 1/ 98/ 069/ 001b EU/ 1/ 98/ 069/ 002a EU/ 1/ 98/ 069/ 002b EU/ 1/ 98/ 069/ 003a EU/ 1/ 98/ 069/ 003b EU/ 1/ 98/ 069/ 004a EU/ 1/ 98/ 069/ 004b EU/ 1/ 98/ 069/ 005a EU/ 1/ 98/ 069/ 005b EU/ 1/ 98/ 069/ 006a EU/ 1/ 98/ 069/ 006b EU/ 1/ 98/ 069/ 007a EU/ 1/ 98/ 069/ 007b EU/ 1/ 98/ 069/ 008 EU/ 1/ 98/ 069/ 009 EU/ 1/ 98/ 069/ 010 EU/ 1/ 98/ 069/ 011a EU/ 1/ 98/ 069/ 011b
Numru ta ’ l- EU EU/ 1/ 98/ 069/ 001a EU/ 1/ 98/ 069/ 001b EU/ 1/ 98/ 069/ 002a EU/ 1/ 98/ 069/ 002b EU/ 1/ 98/ 069/ 003a EU/ 1/ 98/ 069/ 003b EU/ 1/ 98/ 069/ 004a EU/ 1/ 98/ 069/ 004b EU/ 1/ 98/ 069/ 005a EU/ 1/ 98/ 069/ 005b EU/ 1/ 98/ 069/ 006a EU/ 1/ 98/ 069/ 006b EU/ 1/ 98/ 069/ 007a EU/ 1/ 98/ 069/ 007b EU/ 1/ 98/ 069/ 008 EU/ 1/ 98/ 069/ 009 EU/ 1/ 98/ 069/ 010 EU/ 1/ 98/ 069/ 011a EU/ 1/ 98/ 069/ 011b
Invented name Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix
Isem inventat Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix Plavix
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 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 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 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) folji (alu/ 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 7
Plavix 75 mg film-coated tablets
Plavix 75 mg pilloli miksija b’ rita
Combined therapy should be started as early
Pazjenti li għandhom iżjed minn 75 sena fl- età għandhom jinbdew fuq clopidogrel mingħajr id- doża qawwija tal- bidu.
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.
3 Plavix contains lactose.
Plavix fih lactose.
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.
4 Apart from the specific medicinal product interaction information described above, interaction studies with clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed.
Apparti mill- informazzjoni dwar l- interazzjoni ta ’ prodotti mediċinali speċifiċi kif spjegat qabel, ma sarux studji dwar l- interazzjoni ta ’ clopidogrel ma ’ xi prodotti mediċinali li s- soltu jingħataw lill - pazjenti li jkollhom mard tat- trombożi ta ’ l- arterji.
As a precautionary measure, breast-feeding should not be continued during treatment with Plavix.
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’ Plavix.
5 In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups (0.6% versus 0.5% in the clopidogrel + ASA and the placebo + ASA groups, respectively).
F’ COMMIT, ir- rata totali ta ’ fsada maġġuri mhux ċerebrali jew ta ’ fsada ċerebrali kienet baxxa u simili fiż- zewġ gruppi (0. 6% kontra 0. 5% fil- gruppi clopidogrel + ASA u l- plaċebo + ASA, rispettivament).
Immune system disorders
Disturbi fis- sistema immuni Disturbi psikjatriċi
Serum sickness, anaphylactoid reactions
Mard minn seru barrani, reazzjonijiet anafilattiċi Alluċinazzjonijiet, konfużjoni Tibdiliet fit- togħma
Hallucinations, confusion
Fsada
Nervous system disorders
nervuża
reported with fatal outcome), headache, paraesthesia, dizziness Eye disorders
Disturbi fl- għajnejn
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).
Hypromellose (E464) Lactose Triacetin (E1518) Titanium dioxide (E171) Red iron oxide (E172) Carnauba wax
Hypromellose (E464) Lactose Triacetin (E1518) Titanium dioxide (E171) iron oxide aħmar (E172) Carnauba wax
EU/ 1/ 98/ 069/ 001a - Cartons of 28 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 001b - Cartons of 28 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 002a - Cartons of 50x1 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 002b - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 003a - Cartons of 84 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 003b - Cartons of 84 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 004a - Cartons of 100 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 004b - Cartons of 100 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 005a - Cartons of 30 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 005b - Cartons of 30 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 006a - Cartons of 90 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 006b - Cartons of 90 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 007a - Cartons of 14 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 007b - Cartons of 14 film-coated tablets in all aluminium blisters EU/ 1/ 98/ 069/ 011a - Cartons of 7 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 98/ 069/ 011b - Cartons of 7 film-coated tablets in all aluminium blisters
EU/ 1/ 98/ 069/ 001a – Kaxex ta ’ 28 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 069/ 001b - Kaxex ta ’ 28 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 069/ 002a - Kaxex ta ’ 50x1 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 069/ 002b - Kaxex ta ’ 50x1 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 069/ 003a - Kaxex ta ’ 84 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 069/ 003b - Kaxex ta ’ 84 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 069/ 004a - Kaxex ta ’ 100 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 069/ 004b - Kaxex ta ’ 100 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 069/ 005a - Kaxex ta ’ 30 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 069/ 005b - Kaxex ta ’ 30 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 069/ 006a - Kaxex ta ’ 90 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 069/ 006b - Kaxex ta ’ 90 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 069/ 007a - Kaxex ta ’ 14- il pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 069/ 007b - Kaxex ta ’ 14- il pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 98/ 069/ 011a - Kaxex ta ’ 7 pilloli miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 98/ 069/ 011b - Kaxex ta ’ 7 pilloli miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum
Plavix 300 mg film-coated tablets
Plavix 300 mg pilloli miksija b’ rita
The benefit of the
It - terapija ikkombinata għandha tinbeda mill- aktar fis possibbli wara li s- sintomi jitfaċċaw u
13
14 titkompla għal mhux anqas minn erba ’ ġimgħat.
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).
Plavix contains lactose.
Plavix fih lactose.
As a precautionary measure, breast-feeding should not be continued during treatment with Plavix.
Bħala miżura ta ’ prekawzjoni, id- treddigħ m’ għandux jitkompla waqt il- kura b’ Plavix.
EU/1/98/069/008 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/009 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/010 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters
EU/ 1/ 98/ 069/ 008 – Pakketti ta ’ 4x1 pilloli miksijin b’ rita ġo folji mtaqqbin ta ’ doża waħda kollha kemm huma ta ’ l- aluminju EU/ 1/ 98/ 069/ 009 – Pakketti ta ’ 30x1 pilloli miksijin b’ rita ġo folji mtaqqbin ta ’ doża waħda kollha kemm huma ta ’ l- aluminju EU/ 1/ 98/ 069/ 010 – Pakketti ta ’ 100x1 pilloli miksijin b’ rita ġo folji mtaqqbin ta ’ doża waħda kollha kemm huma ta ’ l- aluminju
- Plavix 75 mg film-coated tablets
- Plavix 75 mg pilloli miksija b' rita
- Plavix 300 mg film-coated tablets
- Plavix 300 mg pilloli miksija b' rita
Plavix 75 mg film-coated tablets clopidogrel
Plavix 75 mg pillola miksija b’ rita clopidogrel
EU/1/98/069/001a 28 tablets EU/1/98/069/001b 28 tablets EU/1/98/069/002a 50x1 tablets EU/1/98/069/002b 50x1 tablets EU/1/98/069/003a 84 tablets EU/1/98/069/003b 84 tablets EU/1/98/069/004a 100 tablets EU/1/98/069/004b 100 tablets EU/1/98/069/005a 30 tablets EU/1/98/069/005b 30 tablets EU/1/98/069/006a 90 tablets EU/1/98/069/006b 90 tablets EU/1/98/069/007a 14 tablets EU/1/98/069/007b 14 tablets EU/1/98/069/011a 7 tablets EU/1/98/069/011b 7 tablets
EU/ 1/ 98/ 069/ 001a 28 pillola EU/ 1/ 98/ 069/ 001b 28 pillola EU/ 1/ 98/ 069/ 002a 50x1 pilloli EU/ 1/ 98/ 069/ 002b 50x1 pilloli EU/ 1/ 98/ 069/ 003a 84 pillola EU/ 1/ 98/ 069/ 003b 84 pillola EU/ 1/ 98/ 069/ 004a 100 pillola EU/ 1/ 98/ 069/ 004b 100 pillola EU/ 1/ 98/ 069/ 005a 30 pillola EU/ 1/ 98/ 069/ 005b 30 pillola EU/ 1/ 98/ 069/ 006a 90 pillola EU/ 1/ 98/ 069/ 006b 90 pillola EU/ 1/ 98/ 069/ 007a 14– il pillola EU/ 1/ 98/ 069/ 007b 14– il pillola EU/ 1/ 98/ 069/ 011a 7 pilloli EU/ 1/ 98/ 069/ 011b 7 pilloli
29 PARTICULARS TO APPEAR ON BLISTERS (boxes of 7, 14, 28 or 84 tablets)
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI (kaxxi ta ’ 7, 14, 28 jew 84 pillola)
Plavix 75 mg film-coated tablets clopidogrel
Plavix 75 mg pilloli miksija b’ rita clopidogrel
30 PARTICULARS TO APPEAR ON BLISTERS (boxes of 30, 50x1, 90 or 100 tablets)
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- FOLJI (kaxxi ta’ 30, 50x1, 90 jew 100 pillola)
Plavix 75 mg film-coated tablets clopidogrel
Plavix 75 mg pilloli miksijin b’ rita clopidogrel
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Plavix 300 mg film-coated tablets clopidogrel
Plavix 300 mg pilloli miksija b’ rita clopidogrel
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
EU/1/98/069/008 4x1 film-coated tablets EU/1/98/069/009 30x1 film-coated tablets EU/1/98/069/010 100x1 film-coated tablets
4x1 pilloli miksija b’ rita 30x1 pilloli miksija b’ rita 100x1 pilloli miksija b’ rita
BLISTER /Box of 4x1, 30x1 or 100x1 tablets
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI FOLJA/ kaxxa ta ’ 4x1, 30x1 jew 100x1 pilloli
Plavix 300 mg film-coated tablets clopidogrel
Plavix 300 mg pilloli miksijin b’ rita clopidogrel
35 PACKAGE LEAFLET:
35 B.
What Plavix is and what it is used for 2.
X’ inhu Plavix u għalxiex jintuża 2.
Before you take Plavix 3.
Qabel ma tieħu Plavix 3.
How to take Plavix 4.
Kif għandek tieħu Plavix 4.
Possible side effects 5 How to store Plavix 6.
Effetti sekondarju li jista jkollu 5.
Further information
Kif taħżen Plavix 6.
WHAT PLAVIX IS AND WHAT IT IS USED FOR
X’ INHU PLAVIX U GĦALXIEX JINTUŻA
Plavix belongs to a group of medicines called antiplatelet medicinal products.
Plavix jifforma parti minn grupp ta ’ mediċini msejħa prodotti mediċinali ta ’ kontra l- plejtlets.
Plavix 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).
Plavix jittieħed biex inaqqas ir- riskju li ċapep tad- demm (trombi) jifformaw fl- arterji mwebbsin (arterji), proċess imsejjaħ aterotrombosi, li jista ’ jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal- qalb, jew mewt).
You have been prescribed Plavix to help prevent blood clots and reduce the risk of these severe events because:
Ingħatajt Plavix biex inaqqas ir- riskju ta ’ ċapep tad- demm u l- konsegwenzi severi tagħhom għaliex:
BEFORE YOU TAKE PLAVIX
QABEL MA TIEĦU PLAVIX
Do not take Plavix: • If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Plavix; • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain; • If you suffer from severe liver disease.
• Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- clopidogrel jew sustanzi oħra ta ’ Plavix; • Jekk tbati minn kundizzjoni medika li fil- preżent qiegħda tikkawża fsada, bħal ulċera fl- istonku jew fsada ġewwa l- moħħ; • Jekk tbati minn mard sever tal- fwied.
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Plavix.
Jekk taħseb li xi waħda minn dawn tgħodd għalik, jew jekk għandek xi dubju, ħu parir tat- tabib tiegħek qabel tibda tieħu Plavix.
36 Take special care with Plavix:
37 Oqgħod attent ħafna b’ Plavix:
If any of the situations mentioned below apply to you, you should tell your doctor before taking Plavix: • if you have a risk of bleeding such as
Jekk xi sitwazzjoni msemmija hawn taħt tgħodd għalik, ħu parir tat- tabib tiegħek qabel tibda tieħu Plavix: • jekk tinsab f’ riskju ta ’ fsada bħal:
While you are taking Plavix: • 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 Plavix: • 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.
Plavix is not intended for use in children or adolescents.
Plavix m’ għandux jingħata lit- tfal jew lill- adolexxenti.
Some other medicines may influence the use of Plavix or vice versa.
Xi mediċini oħra jistgħu jeffettwaw l- użu ta ’ Plavix u viċe- versa.
The use of oral anticoagulants (medicines used to reduce blood clotting) with Plavix is not recommended.
L- użu ta ’ sustanzi kontra l- koagulazzjoni tad- demm li jittieħdu mill- ħalq (mediċini li jraqqu d- demm) flimkien ma ’ Plavix mhux irrakkomandat.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Plavix in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Jekk ħassejt uġigħ qawwi f’ sidrek (anġina mhux stabbli jew attakk tal- qalb), jista ’ jingħatalek Plavix flimkien ma ’ acetylsalicylic acid, sustanza inkorporata f’ ħafna mediċini użati biex itaffu l- uġigħ u jnaqqsu d- deni.
Taking Plavix with food and drink Food/meals have no influence.
Meta tiehu Plavix ma ’ l- ikel jew ix- xorb Ikel/ ikliet m’ għandhomx effett.
Plavix may be taken with or without food.
Plavix jista ’ jittieħed ma ’ l- ikel jew mingħajru.
37 Pregnancy and breast-feeding It is preferable not to use this product during pregnancy and breast-feeding.
Huwa preferibbli li ma tużax dan il- prodott waqt it- tqala u t- treddigħ.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Plavix.
38 Qabel ma tibda tieħu Plavix, tinforma lit- tabib jew lill- ispiżjar/ a tiegħek jekk inti tqila jew taħseb li inti tqila.
If you become pregnant while taking Plavix, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Jekk toħroġ tqila waqt li qiegħda tieħu Plavix, għarraf minnufih lit- tabib tiegħek billi huwa rrakkomandat li ma tieħux clopidrogrel waqt it- tqala.
Ask your doctor or pharmacist for advice before taking any medicine.
Waqt li qiegħed tieħu Plavix, għandek tikkonsulta mat- tabib tiegħek dwar it- treddigħ tat- tarbija. Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
Plavix is unlikely to affect your ability to drive or to use machines.
Sewqan u tħaddim ta ’ magni Plavix m’ għandux jaffettwa is- sewqan jew it- tħaddim ta ’ magni.
Plavix contains lactose and hydrogenated castor oil.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Plavix Plavix fih lactose u castor oil idroġenat.
HOW TO TAKE PLAVIX
KIF GĦANDEK TIEĦU PLAVIX
Always take Plavix exactly as your doctor has told you.
Dejjem għandek tieħu Plavix skond il- parir tat- tabib.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Plavix (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment.
Jekk kellek uġigħ sever f’ sidrek (anġina instabbli jew attakk tal- qalb), it- tabib jista ’ jagħtik 300 mg ta ’ Plavix (pillola 1 ta '300 mg jew 4 pilloli ta ’ 75 mg) darba fil- bidu tal- kura.
Then, the usual dose is one 75-mg tablet of Plavix 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 Plavix kuljum li għandha tittieħed mill- ħalq ma ’ l- ikel jew fuq stonku vojt u fl- istess ħin kull ġurnata.
You should take Plavix for as long as your doctor continues to prescribe it.
Għandek tieħu Plavix sakemm it- tabib jibqa ’ jagħmillek ir- riċetta.
If you take more Plavix than you should:
Jekk tieħu Plavix aktar milli suppost:
If you forget to take Plavix:
Jek tinsa tieħu Plavix:
If you forget to take a dose of Plavix, 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 ’ Plavix, 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 Plavix għal aktar minn 12- il siegħa, sempliċiment ħu d- doża waħda li jkun imiss fil - ħin tas- soltu.
For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Plavix 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 ’ Plavix billi tirreferi għall- kalendarju stampat fuq il- folja.
If you stop taking Plavix:
Meta tieqaf tieħu Plavix:
38 4.
39 4.
Like all medicines, Plavix can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Plavix jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see ‘Take special care with Plavix’).
huwa assoċjat jew le ma ’ emoraġija li tidher taħt il- ġilda bħala tikek ħomor irqaq u/ jew konfużjoni (ara 'Oqgħod attent ħafna b' Plavix').
The most common side effect (affects 1 to 10 patients in 100) reported with Plavix is bleeding.
L- iżjed effett komuni (jaffettwa minn 1 sa 10 pazjenti minn kull 100) irrappurtat b’ Plavix hija l - fsada.
If you experience prolonged bleeding when taking Plavix 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 Plavix 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 Plavix’).
Madanakollu, jekk id- demm li ħiereġ jinkwetak, għandek tkellem lit- tabib tiegħek minnufih (ara 'Oqgħod attent ħafna b' Plavix').
Other side effects reported with Plavix are:
Effetti oħra li ġew irrappurtati b’ Plavix huma:
HOW TO STORE PLAVIX
KIF TAĦŻEN PLAVIX
Do not use Plavix after the expiry date which is stated on the carton and on the blister.
Tużax Plavix wara d- data ta ’ skadenza li tidher fuq il - kaxxa few fuq il- folja.
If Plavix is supplied in PVC/PVDC/aluminium blisters, store below 30°C.
Jekk Plavix huwa fornut ġo folji tal- PVC/ PVDC/ Aluminju, aħżen f’ temperatura taħt 30°C.
If Plavix is supplied in all aluminium blisters, it does not require any special storage conditions.
Jekk Plavix huwa fornut ġo folji kollha kemm huma ta ’ l- aluminju, din m’ għandhiex bżonn ħażna speċjali.
Do not use Plavix if you notice any visible sign of deterioration.
40 Tużax Plavix jekk tinnota xi sinjali visibli ta ’ deterjorament.
What Plavix contains The active substance is clopidogrel.
X’ fih Plavix Is- sustanza attiva hi clopidogrel.
What Plavix looks like and contents of the pack
Id- dehra ta ’ Plavix u l- kontenuti tal- pakkett
Plavix 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 ’ Plavix 75- mg huma tondi, konvessi miż- żewġ naħat, ta ’ kulur roża, bin- numru ‘ 75 ’ imnaqqax fuq naħa waħda u n- numru ‘ 1171 ’ imnaqqax fuq in- naħa l- oħra.
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.
Danmark sanofi-aventis Denmark A/S Tlf: +45 45 16 70 00
41 Nederland Danmark sanofi- aventis Netherlands B. V. sanofi- aventis Denmark A/ S Tel: +31 (0) 182 557 755 Tlf: +45 45 16 70 00
41 This leaflet was last approved in MM/YYYY
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
42 PACKAGE LEAFLET:
42 FULJETT TA ’ TAGĦRIF:
Plavix 300 -mg film-coated tablets clopidogrel
Plavix 300 mg pilloli miksija b’ rita clopidogrel
Plavix 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).
Plavix 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).
Do not take Plavix:
Tiħux Plavix:
• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Plavix; • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain; • If you suffer from severe liver disease.
• Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- clopidogrel jew sustanzi oħra ta ’ Plavix; • Jekk tbati minn kundizzjoni medika li fil- preżent qiegħda tikkawża fsada, bħal ulċera fl- istonku jew fsada ġewwa l- moħħ; • Jekk tbati minn mard sever tal- fwied.
If any of the situations mentioned below apply to you, you should tell your doctor before taking Plavix: • if you have a risk of bleeding such as
43 Jekk taħseb li xi waħda minn dawn tgħodd għalik, jew jekk għandek xi dubju, ħu parir tat- tabib tiegħek qabel tibda tieħu Plavix.
- a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer)
Jekk xi sitwazzjoni msemmija hawn taħt tgħodd għalik, ħu parir tat- tabib tiegħek qabel tibda tieħu Plavix: • jekk tinsab f’ riskju ta ’ fsada bħal:
44 Pregnancy and breast-feeding It is preferable not to use this product during pregnancy and breast-feeding.
44 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 Plavix.
Qabel ma tibda tieħu Plavix, għandek tinforma lit- tabib jew lill- ispiżjar/ a tiegħek jekk inti tqila jew taħseb li inti tqila.
If you become pregnant while taking Plavix, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Jekk toħroġ tqila waqt li qiegħda tieħu Plavix, għarraf minnufih lit- tabib tiegħek billi huwa rrakkomandat li ma tiħux clopidogrel fit- tqala.
While taking Plavix, consult your doctor about the breast-feeding of a baby.
Waqt li qiegħed tieħu Plavix, għandek tikkonsulta mat- tabib tiegħek dwar it- treddigħ tat- tarbija.
HOW TO TAKE PLAVIX
KIF GĦANDEK TIEĦU PLAVIX 3.
Then, the usual dose is one 75 mg tablet of Plavix 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 Plavix 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 Plavix’).
huwa assoċjat jew le ma ’ emoraġija li tidher taħt il- ġilda bħala tikek ħomor irqaq u/ jew konfużjoni (ara 'Oqgħod attent ħafna b' Plavix').
In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
45 Jekk tbati minn fsada għal perjodu twil waqt li qed tieħu Plavix Jekk taqta 'x' imkien jew tweġġa', id- demm jista 'jdum aktar mis- soltu biex jieqaf.
Do not use Plavix after the expiry date which is stated on the carton and on the blister.
Tużax Plavix wara d- data ta ’ skadenza li tidher fuq il - kaxxa jew fuq il- folja.
Do not use Plavix if you notice any visible sign of deterioration.
Tużax Plavix jekk tinnota xi sinjali visibli ta ’ deterjorament.
46 What Plavix looks like and contents of the pack
46 Id- dehra ta ’ Plavix u l- kontenuti tal- pakkett
Plavix 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 ’ Plavix 300 mg huma oblungi, ta ’ kulur roża, miksijin b’ rita u 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.
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.
Ireland sanofi-aventis Ireland Ltd.
47 Slovenija Ireland sanofi- aventis d. o. o. sanofi- aventis Ireland Ltd.
Posaconazole SP 40 mg/ ml oral suspension
Posaconazole SP 40 mg/ ml suspensjoni orali
Posaconazole SP is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):
Posaconazole SP jintuża għall- kura ta ’ infezzjonijiet tal- fungu f’ adulti (ara sezzjoni 5. 1):
Posaconazole SP is also indicated for prophylaxis of invasive fungal infections in the following patients:
Posaconazole SP huwa indikat ukoll għal profilassi ta ’ infezzjonijiet tal- fungu invasiva fil- pazjenti li ġejjin:
In patients who cannot tolerate a Infections (IFI)/ Intolerant meal or a nutritional supplement, Posaconazole SP should be patients with IFI
F’ pazjenti li ma jifilħux ikla Fungu (IFI) / Pazjenti li ma jifilħux b’ IFI
administered at a dose of 200 mg (5 ml) four times a day.
jew xi suppliment nutrizzjonali, Posaconazole SP għandu jingħata bħala doża ta ’ 200 mg (5 ml) erba ’ darbiet kuljum.
Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression, and clinical response.
It - terapija għandha ddum skon is- severità ta ’ l- infezzjoni li jkun hemm, irkupru minn sopressjoni tas- sistema immuni u r - rispons kliniku.
Each dose of Posaconazole SP should be administered with a meal, or with a nutritional supplement in patients who cannot tolerate food to enhance the oral absorption and to ensure adequate exposure.
Kull doża ta ’ Posaconazole SP għandha tingħata ma ’ ikla, jew ma ’ suppliment nutrizzjonali f’ pazjenti li ma jistgħux iżommu ikel sabiex jgħin għall- assorbiment orali u jiżgura esponiment xieraq.
The duration of therapy is based on recovery from neutropenia or immunosuppression.
It - terapija għadha ddum skond l- irkupru min- newtropenja jew l - immunosoppressjoni.
For patients with acute myelogenous leukemia or myelodysplastic syndromes, prophylaxis with Posaconazole SP should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3.
Għal pazjenti b’ sindromi ta ’ lewkimja majeloġenuża jew majelodisplastika, profilassi b’ Posaconazole SP għandha tibda ħafna ġranet qabel ma tkun mistennija li tfeġġ in- newtropenja u titkompla għal 7 ijiem wara li l- għadd tan- newtrofili jitla ’ fuq il- 500 ċellula kull mm3.
Co-administration with the HMG-CoA reductase inhibitors simvastatin, lovastatin and atorvastatin (see section 4.5).
3 L- għotja flimkien ma ’ impedituri ta ’ HMG- CoA reductase simvastatin, lovastatin u atorvastatin (ara sezzjoni 4. 5).
Caution should be used when prescribing Posaconazole SP to patients with hypersensitivity to other azoles.
Għandha ssir attenzjoni meta jiġi ordnat Posaconazole SP għal pazjenti li jkollhom sensittività eċċessiva għal azoles oħrajn.
Patients who develop abnormal liver function tests during Posaconazole SP therapy must be routinely monitored for the development of more severe hepatic injury.
Pazjenti li jiżviluppaw anormalitajiet fit- testijiet tal- funzjoni tal - fwied waqt terapija b’ Posaconazole SP għandhom ikunu eżaminati regolarment għall- iżvilupp ta ’ ħsara epatika aktar serja.
Discontinuation of Posaconazole SP should be considered if clinical signs and symptoms are consistent with development of liver disease.
It- twaqqif ta ’ Posaconazole SP għandu jitqies jekk is- sinjali u s- sintomi kliniċi juru żvilupp ta ’ mard epatiku.
Posaconazole SP must not be administered with medicinal products that are substrates for CYP3A4 and are known to prolong the QTc interval (see sections 4.3 and 4.5).
Posaconazole SP m’ għandux jingħata ma ’ prodotti mediċinali li huma sottostrati għal CYP3A4 u magħrufin li jtawlu l- intervall QTc (ara sezzjonijiet 4. 3 u 4. 5).
Posaconazole SP should be administered with caution to patients with pro-arrhythmic conditions such as: • Congenital or acquired QTc prolongation • Cardiomyopathy, especially in the presence of cardiac failure • Sinus bradycardia • Existing symptomatic arrhythmias • Concomitant use with medicinal products known to prolong the QTc interval (other than those mentioned in section 4.3).
Posaconazole SP għandu jingħata b’ attenzjoni lill- pazjenti b’ kundizzjonijiet pro- arritmiċi bħal: • Meta l- QTc jiġi prolongat minħabba raġunijiet konġeniti jew b’ mod akkwiżit • Kardjomajopatija, l- aktar meta jkun hemm insuffiċjenza kardijaka • Sinus bradikardja • Preżenza ta ’ arritmiji sintomatiċi • L- użu fl- istess ħin ta ’ prodotti mediċinali magħrufin li jtawwlu l- interval QTc (minbarra dawk imsemmijin f’ sezzjoni 4. 3).
Therefore, inhibitors (e. g. verapamil, ciclosporin, quinidine, clarithromycin, erythromycin, etc.) or inducers (e. g. rifampicin, rifabutin, certain anticonvulsants, etc.) of these clearance pathways may increase or decrease posaconazole plasma concentrations, respectively.
Għalhekk, impedituri (eż. verapamil, ciclosporin, quinidine, clarithromycin, erythromycin, eċċ.) jew indutturi (eż. rifampicin, rifabutin, xi
4 Rifabutin (300 mg once a day) decreased the Cmax (maximum plasma concentration) and AUC (area under the plasma concentration time curve) of posaconazole to 57% and 51%, respectively.
Rifabutin (300 mg darbtejn kuljum) inaqqas is- Cmax (l- ogħla konċentrazzjoni fil- plażma) u l- AUC (erja taħt il- kurva tal- konċentrazzjoni fil- plażma mal- ħin) ta ’ posaconzole għal 57% u 51% rispettivament.
HMG-CoA reductase inhibitors metabolised through CYP3A4 (e. g. simvastatin, lovastatin, and atorvastatin):
5 Impedituri ta ’ HMG- CoA reductase metabolizzati permezz ta ’ CYP3A4 (eż. simvastatin, lovastatin u atorvastatin):
Treatment with these HMG-CoA reductase inhibitors
Posaconazole jista ’ jżid b’ mod sostanzjali l- livelli fil- plażma ta ’ impedituri ta ’ HMG - CoA reductase li huma metabolizzati minn CYP3A4.
5 should be discontinued during treatment with posaconazole as increased levels have been associated with rhabdomyolysis (see section 4.3).
Kura b’ dawn l- impedituri ta ’ HMG- CoA reductase għandha titwaqqaf waqt il- kura b’ posaconazole għax żiediet fil- livelli kienu assoċjati ma ’ rabdomajelożi (ara sezzjoni 4. 3).
Following co-administration of oral posaconazole (400 mg twice daily) with atazanavir (300 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 2.6-fold and 3.7-fold (range 1.2 to 26- fold), respectively.
Wara l - għotja fl- istess ħin ta ’ posaconazole mill- ħalq (400 mg darbtejn kuljum) ma ’ atazanavir (300 mg darba kuljum) għal 7 ijiem f’ individwi b’ saħħithom is- Cmax u l- AUC ta ’ atazanavir żdied b’ medja ta ’
Following co-administration of oral posaconazole (400 mg twice daily) with atazanavir and ritonavir (300/ 100 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 1.5-fold and 2.5-fold (range 0.9 to 4.1-fold), respectively.
Wara l- għotja fl- istess ħin ta ’ posaconazole mill- ħalq (400 mg darbtejn kuljum) ma ’ azatanavir u ritonavir (300/ 100 mg darba kuljum) għal 7 ijiem f’ individwi b’ saħħithom is- Cmax u l- AUC ta ’ atazanavir żdiedu b’ medja ta ’ 1. 5- il darba u 2. 5- il darba (medda 0. 9 sa 4. 1- il darba), rispettivament.
The safety of posaconazole has been assessed in > 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience.
7 Is- sigurtà ta ’ posaconazole ġiet stmata f ’ > 2, 400 pazjent u voluntiera b’ saħħithom li ddaħħlu fi provi kliniċi u minn esperjenza ta ’ wara t- tqegħid fis- suq.
Ear and labyrinth disorder
Disturbi fil- widnejn u fis- sistema labirintika
blurred vision diplopia, scotoma
disturb psikotiku, dipressjoni parasteżija, sturdament, ngħas, uġigħ ta ’ ras aċċessjonijiet, newropatija, ipoesteżija, tregħid inċident ċerebrovaskulari, enċefalopatija, newropatija periferali, sinkope vista mċajpra diplopja, skotoma
torsade de pointes, sudden death, ventricular tachycardia, cardio-respiratory arrest, cardiac failure, myocardial infarction
tnaqqis tas- smigħ sindrome ta ’ titwil tal- QT§, elettrokardjogramma anormali§, palpitazzjonijiet torsade de pointes, mewt f’ daqqa, takikardija ventrikulari, arrest kardjo- respiratorju, insuffiċjenza kardijaka, infart majokardijaku
Respiratory, thoracic and mediastinal disorders Rare: pulmonary hypertension, interstitial pneumonia, pneumonitis Gastrointestinal disorders Common:
Disturbi respiratorji, toraċiċi u medjastinali Rari: ipertensjoni pulmonari, pulmonite fl- interstizzju, infezzjoni fil- pulmun
Common:
disturbi menstruwali Mhux komuni: uġigħ fis- sider Rari:
medicine level changed
tibdil fil- livelli ta ’ mediċini
* During post-marketing surveillance severe hepatic injury with fatal outcome has been reported (see section 4.4).
* Waqt is- sorveljanza ta ’ wara t- tqegħid fis- suq kienet irrappurtata ħsara severa fil- fwied li wasslet għall- mewt (ara sezzjoni 4. 4).
Pharmacotherapeutic group:
9 Kategorija farmakoterapewtika:
Aspergillus species (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), Candida species (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi, and species of Fusarium, Rhizomucor, Mucor, and Rhizopus.
Mikrobijoloġija Intwera li posaconazole huwa effettiv in vitro kontra l- mikro- organiżmi li ġejjin: Speċi ta ’ Aspergillus (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), speċi ta ’ Candida (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi, u speċi ta ’ Fusarium, Rhizomucor, Mucor, u Rhizopus.
Overall efficacy of posaconazole at the end of treatment for invasive aspergillosis in comparison to an external control group Overall Response Success by Species All mycologically confirmed
Rispons globali Suċċess skond l- ispeċi Kollha konfermati b’ mod
group
10 mikoloġiku
Clinical success rate at Day 14 Clinical success rate 4 weeks after end of treatment Clinical success rate was defined as the number of cases assessed as having a by the total number of cases eligible for analysis.
Rata ta ’ suċċess kliniku ma ’ Jum 14 Rata ta ’ suċċess kliniku 4 ġimgħat wara li ntemmet il- kura Rata ta ’ suċċess kliniku kienet definita bħala n- numru ta ’ każijiet meqjusa li diviż man- numru totali ta ’ każijiet eliġibbli għall- analiżi.
91.7% (155/ 169) 68.5% (98/ 143) clinical response (cure
91. 7% (155/ 169) 68. 5% (98/ 143) għandhom rispons kliniku
92.5% (148/ 160) 61.8% (84/ 136) or improvement) divided
92. 5% (148/ 160) 61. 8% (84/ 136) (fejqan jew titjib)
Prophylaxis of Invasive Fungal Infections (IFIs) (Studies 316 and 1899)
Profilassi ta ’ Infezzjonijiet Invażivi tal- Fungu (IFIs) (Studji 316 u 1899)
Two randomised, controlled prophylaxis studies were conducted among patients at high risk for developing invasive fungal infections.
Żewġ studji ta ’ profilassi randomised bil- kontroll saru b’ pazjenti li għandhom jiżviluppaw infezzjonijiet invażivi tal- fungu.
Study 1899 was a randomised, evaluator-blinded study of posaconazole oral suspension (200 mg three times a day) versus fluconazole suspension (400 mg once daily) or itraconazole oral solution (200 mg twice a day) in neutropenic patients who were receiving cytotoxic chemotherapy for acute myelogenous leukemia or myelodysplastic syndromes.
11 Studju 1899 kien wieħed randomised, blinded għall- evalwatur ta ’ suspensjoni orali ta ’ posaconazole (200 mg tliet darbiet kuljum) kontra suspensjoni ta ’ fluconazole (400 mg darba kuljum) jew soluzzjoni orali ta ’ itraconazole (200 mg darbtejn kuljum) f’ pazjenti newtropeniċi li kienu qed jirċievu kimoterapija ċitotossika għall- lewkimja majeloġenuża jew sindromi majelodisplastiċi.
A key secondary endpoint was the incidence of proven/ probable IFIs at 100 days post-randomization.
Endpoint sekondarju essenzjali kien l- inċidenza ta ’ IFI’ s li probabbli/ ġew pruvati wara 100 jum minn meta saret ir- randomisation.
New diagnosis of acute myelogenous leukemia was the most common underlying condition (435/ 602, [72%]).
Lewkimja majeloġenuża li tkun għada kif ġiet dijanjostikata hija l- aktar kundizzjoni komuni (435/ 602, [72%]).
Proportion (%) of patients with proven/ probable IFIs On-treatment periodb 1899d 316e
Proporzjon (%) ta ’ pazjenti b’ IFIs pruvati/ probabbli Perjodu fuq il- kurab 1899d 316e
12 Table 6.
12 Tabella 6.
Use in paediatric patients Sixteen patients 8-17 years of age were treated with 800 mg/ day in a study for invasive fungal infections.
L- użu f’ pazjenti pedjatriċi Sittax il- pazjent f’ etajiet ta ’ bejn 8- 17- il sena kienu kkurati b’ 800 mg/ jum fi studju dwar infezzjonijiet invażivi tal- fungu.