Possia

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
01-02-2013
Summary of Product characteristics Summary of Product characteristics (SPC)
01-02-2013
Public Assessment Report Public Assessment Report (PAR)
07-01-2011

Active ingredient:

Ticagrelor

Available from:

AstraZeneca AB

ATC code:

B01AC24

INN (International Name):

ticagrelor

Therapeutic group:

Aġenti antitrombotiċi

Therapeutic area:

Peripheral Vascular Diseases; Acute Coronary Syndrome

Therapeutic indications:

Possia, ko amministrati bl-aċidu Aċetilsaliċiliku (ASA), huwa indikat għall-prevenzjoni ta ' l-avvenimenti ta ' atherothrombotic fil-pazjenti adulti ma sindromi coronary akuta (anġina instabbli, mhux-ST-elevazzjoni myocardial infarzjoni [NSTEMI]-tnaqqis jew il-ST-elevazzjoni myocardial infarzjoni [STEMI]); inklużi pazjenti amministrati medikament, u dawk li huma amministrati bl-intervent coronary perkutanja (PCI) jew coronary artery by-pass tilqim (CABG).

Product summary:

Revision: 2

Authorization status:

Irtirat

Authorization date:

2010-12-03

Patient Information leaflet

                                29
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
30
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
POSSIA 90 MG PILLOLI MIKSIJA B’ RITA
ticagrelor
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK..
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar
tiegħek.
-
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara, anki jekk ikollhom l-istess sinjali ta’ mard
bħal tiegħek..
-
Jekk ikollok xi effett sekondarju kellem lit-tabib jew lill-ispiżjar
tiegħek. Dan jinkludi xi effett
sekondarju possibbli li m’huwiex elenkat f’dan il-fuljett.
F’DAN IL-FULJETT:
1.
X’inhu Possia u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Possia
3.
Kif għandek tieħu Possia
4.
Effetti sekondarji li jista’ jkollu
5.
Kif taħżen Possia
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU POSSIA U GĦALXIEX JINTUŻA
X’INHU POSSIA
Possia fiħ is-sustanza attiva tissejjaħ ticagrelor. Din tippartjeni
għall-
grupp ta’ mediċini jissejħu
antiplejtlits.
KIF JAĦDEM POSSIA
Possia jaffetwa ċelloli jissejħu ‘plejtlits’ (jissejħu wkoll
tromboċiti). Dawn huma ċelloli żgħar ħafna
fid-demm tiegħek li jgħinu sabiex tieqaf il-fsada billi jingħaqdu
flimkien sabiex jagħlqu toqob irqaq
fil-kanali tad-demm li jkunu maqtugħa jew danneġġati.
Madankollu plejtlits jistgħu jifformaw demm magħqud ġewwa kanali
tad-demm morda fil-qalb u l-
moħħ. Dan jista’ jkun ta’ periklu kbir għax:
•
Id-demm magħqud jista’ jaqta kompletament il-provista tad-demm- dan
jista’ jkkawża attakk
tal-qalb (infart mijokardjali) jew puplesija, jew
•
Id-demm magħqud jista jimblokka parzjalment il-kanali tad-demm lejn
il-qalb- dan inaqqas iċ-
ċirkulazzjoni tad-demm lejn il-qalb u jista jikkawża uġigħ
fis-sider li jmur u jiġi (tissejjaħ
anġina mhux stabbli)
Pos
                                
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Summary of Product characteristics

                                1
_ _
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Possia 90 mg pilloli miksija b’rita
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
_ _
Kull pillola miksija b’rita fiha 90 mg ticagrelor
_ _
Għal-lista kompluta ta’ sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita (pillola).
Pilloli tondi, konvessi miż-żewġ naħat, sofor immarkati
b’‘90’ fuq ‘T’ minn naħa waħda u lixxi fuq
in-naħa l-oħra.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Possia, mogħti ma’ acetylsalicylic acid (ASA), huwa indikat
għall-prevenzjoni ta’ każijiet
aterotrombotiċi f’pazjenti adulti b’Sindromi Akuti Koronarji
(anġina mhux stabbli, Infart
Mijokardijaku b’elevazzjoni mhux tal-ST [NSTEMI] jew Infart
Mijokardijaku b’elevazzjoni tal-ST
[STEMI]); inklużi pazjenti li jkunu maniġġati b’mod mediku, u
dawk li huma maniġġati b’intervent
koronarju perkutaneju (PCI) jew by-pass b’trapjant tal-arterja
koronarja (CABG).
Għal aktar tagħrif, ara sezzjoni 5.1
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
Il-kura bi Possia għandha tinbeda b’doża waħda ta’ tagħbija
ta’ 180 mg (żewġ pilloli ta’ 90 mg) u
imbagħad titkompla b’90 mg darbtejn kuljum.
Pazjenti li qed jieħdu Possia għandhom jieħdu wkoll ASA kuljum,
sakemm mhux speċifikament
kontraindikata. Wara doża tal-bidu ta’ ASA, Possia għandu
jittieħed ma’ doża ta’ manteniment ta’
ASA ta’ 75 mg sa 150 mg (ara sezzjoni 5.1).
Il-kura hija rakkomandata għal mill-anqas 12-il xahar sakemm ma jkunx
indikat b’mod kliniku li
Possia għandu jitwaqqaf (ara sezzjoni 5.1). Esperjenza ta’ aktar
minn 12-il xahar hija limitata.
F’pazjenti b’Sindromi Koronarji Akuti (ACS), it-twaqqif prematur
ta’ kwalunkwe terapija kontra l-
plejtlets, inkluż Possia, jista’ jwassal f’żieda ta’ riskju
ta’ mewt kardjovaskulari, jew infart
mijokardijaku minħabba l-marda tal-pazjent . It-twaqqi
                                
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Active ingredient Ticagrelor

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