Clopidogrel Teva Generics B.V.

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
12-05-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
12-05-2014
Public Assessment Report Public Assessment Report (PAR)
12-05-2014

Active ingredient:

clopidogrel (as hydrochloride)

Available from:

Teva Pharma B.V.

ATC code:

B01AC04

INN (International Name):

clopidogrel

Therapeutic group:

Aġenti antitrombotiċi

Therapeutic area:

Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke

Therapeutic indications:

Clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta 'avvenimenti aterotrombotiċi f': Pazjenti li jbatu minn infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard arterjali periferali. Patients suffering from acute coronary syndrome:Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). Elevazzjoni tas-segment ST infart mijokardijaku akut, flimkien ma ' ASA f'medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika. Għall-aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.

Product summary:

Revision: 3

Authorization status:

Irtirat

Authorization date:

2010-10-28

Patient Information leaflet

                                23
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
24
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU
MINNU
CLOPIDOGREL TEVA GENERICS B.V. 75 MG PILLOLI MIKSIJA B’RITA
Clopidogrel
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar
tiegħek.
-
Din il-mediċina giet mogħtija lilek M’għandekx tgħaddiha lil
persuni oħra. Tista’ tagħmlilhom
il-ħsara, anki jekk ikollhom l-istess sintomi bħal tiegħek.
-
Jekk xi wieħed mill-effetti sekondarji jiggrava jew jekk tinnota xi
effetti sekondarji li m’humiex
imsemmijin f’dan il-fuljett, jekk jogħġbok, għid lit-tabib jew
lill-ispiżjar tiegħek.
F’DAN IL-FULJETT:
1.
X’inhu Clopidogrel Teva Generics B.V. u għalxiex jintuża
2.
Qabel ma tieħu Clopidogrel Teva Generics B.V.
3.
Kif għandek tieħu Clopidogrel Teva Generics B.V.
4.
Effetti sekondarju li jista jkollu
5.
Kif taħżen Clopidogrel Teva Generics B.V.
6.
Aktar tagħrif
1.
X’INHU CLOPIDOGREL TEVA GENERICS B.V. U GĦALXIEX JINTUŻA
Clopidogrel Teva Generics B.V. jappartjeni għal grupp ta’ mediċini
msejħa prodotti mediċinali ta’
kontra l-plejtlets. Plejtlets huma partijiet żgħar ħafna fid-demm,
li jinġemġħu flimkien waqt li jkun qed
jagħqad id-demm. Il-prodotti mediċinali ta’ kontra l-plejtlets
jilqgħu għal dan u jnaqqsu
l-possibbiltajiet li jiffurmaw emboli tad-demm (proċess imsejjaħ
trombożi).
Clopidogrel Teva Generics B.V. jittieħed biex inaqqas ir-riskju li
emboli tad-demm (trombi) jifformaw
fl-arterji mwebbsin (arterji), proċess imsejjaħ aterotrombosi, li
jista’ jwassal għal konsegwenzi
aterotrombotiċi (bħal puplesija, attakk tal-qalb, jew mewt).
Ingħatajt Clopidogrel Teva Generics B.V. biex inaqqas ir-riskju ta’
emboli tad-demm u l-konsegwenzi
severi tagħhom għaliex:
-
Għandek kun
dizzjoni fejn l
-arterji tiegħek qegħdin jibbiesu (magħrufa wkoll bħala
aterosk
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-P
RODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Clopidogrel Teva Generics B.V. 75 mg pilloli miksija b’rita
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
_ _
Kull pillola miksija b'rita fiha 75 mg clopidogrel (bħala
hydrochloride).
Sustanzi mhux attivi:
Kull pillola fiha 13 mg żejt ir-riġnu idroġenat
Għal-lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita
Pilloli roża, tondi u daqsxejn mżaqqha miż-żewġ naħat miksijin
b’rita.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta’ każijiet
aterotrombotiċi f’:
•
Pazjenti li għandhom infart mijokardijaku (minn ftit jiem sa inqas
minn 35 jum), puplesija
iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard stabbilit
tal-arterji periferali.
•
Pazjenti li għandhom is-sindromu koronarju akut:
-
Bis-segment mhux ST elevat (anġina instabbli jew infart mijokardijaku
mhux-mewġa-Q),
li jinkludu pazjenti fi proċess li titpoġġa
_stent_
wara intervent koronarju perkutaneju,
flimkien ma’ acetylsalicylic acid
(ASA).
-
Infart mijokardijaku akut b’segment ST elevat, flimkien ma’ ASA
f’pazjenti ittrattati
bil-mediċini u eliġibbli għat-terapija trombolitika
Għal aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.1.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
•
Adulti u anzjani
Clopidogrel għandu jingħata darba kuljum bħala doża ta’ 75 mg
ma’ l-ikel jew mingħajru.
F’pazjenti bis-sindromu koronarju akut:
-
Bis-segment mhux ST elevat (anġina instabbli jew infart mijokardijaku
mhux-mewġa-
Q): il-kura bi clopidogrel għandha tinbeda b’doża waħda qawwija
tal-bidu ta’ 300 mg u
titkompla b’75 mg darba kuljum (b’acetylsalicylic acid (ASA) 75
mg-325 mg kuljum).
Billi dożi ogħla ta’ ASA kienu assoċjati ma’ riskju ikbar ta’
dmija huwa rakkomandat li
d-doża ta’ ASA ma tkunx ikbar minn 100 mg. Ma ġiex stab
                                
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Similar products

Active ingredient clopidogrel (as hydrochloride)

clopidogrel (as hydrochloride)

ATC code B01AC04

B01AC04

Marketed by Teva Pharma B.V.

Teva Pharma B.V.

INN (International Name) clopidogrel

clopidogrel

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