Clopidogrel 1A Pharma

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
28-02-2011
Summary of Product characteristics Summary of Product characteristics (SPC)
28-02-2011
Public Assessment Report Public Assessment Report (PAR)
28-02-2011

Active ingredient:

clopidogrel

Available from:

Acino Pharma GmbH 

ATC code:

B01AC04

INN (International Name):

clopidogrel

Therapeutic group:

Aġenti antitrombotiċi

Therapeutic area:

Mard vaskulari periferali

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. - Pazjenti li jbatu mis-sindromu koronarju akut: Mhux elevazzjoni tas-segment ST sindromu koronarju akut (anġina instabbli jew mhux tal-mewġa Q 'infart mijokardijaku), li jinkludu pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutanju, flimkien ma' acetylsalicylic acid (ASA). L - 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: 1

Authorization status:

Irtirat

Authorization date:

2009-07-28

Patient Information leaflet

                                ANNESS I
SOMMARJU TAL-KARATTERISTIĊI T
AL-PRODOTT
1
Prodott mediċinali li m’għadux awtorizzat
1.
ISEM TAL-PRODOTT MEDIĊINALI
Clopidogrel 1A Pharma 75 mg pilloli miksija b’rita
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull pillola miksija b'rita fiha 75 mg ta’ Clopidogrel (bħala
besilate).
Sustanzi mhux attivi: kull pillola fiha 3.80 mg ta’ castor oil
idroġenat.
Għal-lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita
Pilloli miksija b’rita, bojod sa bojod jagħtu fil-griż, qishom
tal-irħam, tondi u bikonvessi.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta’
avvenimenti 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 ta’
l-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
bilmediċini 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 anzj
ani
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 
                                
                                Read the complete document

Summary of Product characteristics

                                ANNESS I
SOMMARJU TAL-KARATTERISTIĊI T
AL-PRODOTT
1
Prodott mediċinali li m’għadux awtorizzat
1.
ISEM TAL-PRODOTT MEDIĊINALI
Clopidogrel 1A Pharma 75 mg pilloli miksija b’rita
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull pillola miksija b'rita fiha 75 mg ta’ Clopidogrel (bħala
besilate).
Sustanzi mhux attivi: kull pillola fiha 3.80 mg ta’ castor oil
idroġenat.
Għal-lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita
Pilloli miksija b’rita, bojod sa bojod jagħtu fil-griż, qishom
tal-irħam, tondi u bikonvessi.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta’
avvenimenti 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 ta’
l-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
bilmediċini 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 anzj
ani
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 
                                
                                Read the complete document

Similar products

Active ingredient clopidogrel

clopidogrel

ATC code B01AC04

B01AC04

Marketed by Acino Pharma GmbH 

Acino Pharma GmbH 

INN (International Name) clopidogrel

clopidogrel

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 28-02-2011
Summary of Product characteristics Summary of Product characteristics Bulgarian 28-02-2011
Public Assessment Report Public Assessment Report Bulgarian 28-02-2011
Patient Information leaflet Patient Information leaflet Spanish 28-02-2011
Summary of Product characteristics Summary of Product characteristics Spanish 28-02-2011
Public Assessment Report Public Assessment Report Spanish 28-02-2011
Patient Information leaflet Patient Information leaflet Czech 28-02-2011
Summary of Product characteristics Summary of Product characteristics Czech 28-02-2011
Public Assessment Report Public Assessment Report Czech 28-02-2011
Patient Information leaflet Patient Information leaflet Danish 28-02-2011
Summary of Product characteristics Summary of Product characteristics Danish 28-02-2011
Public Assessment Report Public Assessment Report Danish 28-02-2011
Patient Information leaflet Patient Information leaflet German 28-02-2011
Summary of Product characteristics Summary of Product characteristics German 28-02-2011
Public Assessment Report Public Assessment Report German 28-02-2011
Patient Information leaflet Patient Information leaflet Estonian 28-02-2011
Summary of Product characteristics Summary of Product characteristics Estonian 28-02-2011
Public Assessment Report Public Assessment Report Estonian 28-02-2011
Patient Information leaflet Patient Information leaflet Greek 28-02-2011
Summary of Product characteristics Summary of Product characteristics Greek 28-02-2011
Public Assessment Report Public Assessment Report Greek 28-02-2011
Patient Information leaflet Patient Information leaflet English 28-02-2011
Summary of Product characteristics Summary of Product characteristics English 28-02-2011
Public Assessment Report Public Assessment Report English 28-02-2011
Patient Information leaflet Patient Information leaflet French 28-02-2011
Summary of Product characteristics Summary of Product characteristics French 28-02-2011
Public Assessment Report Public Assessment Report French 28-02-2011
Patient Information leaflet Patient Information leaflet Italian 28-02-2011
Summary of Product characteristics Summary of Product characteristics Italian 28-02-2011
Public Assessment Report Public Assessment Report Italian 28-02-2011
Patient Information leaflet Patient Information leaflet Latvian 28-02-2011
Summary of Product characteristics Summary of Product characteristics Latvian 28-02-2011
Public Assessment Report Public Assessment Report Latvian 28-02-2011
Patient Information leaflet Patient Information leaflet Lithuanian 28-02-2011
Summary of Product characteristics Summary of Product characteristics Lithuanian 28-02-2011
Public Assessment Report Public Assessment Report Lithuanian 28-02-2011
Patient Information leaflet Patient Information leaflet Hungarian 28-02-2011
Summary of Product characteristics Summary of Product characteristics Hungarian 28-02-2011
Public Assessment Report Public Assessment Report Hungarian 28-02-2011
Patient Information leaflet Patient Information leaflet Dutch 28-02-2011
Summary of Product characteristics Summary of Product characteristics Dutch 28-02-2011
Public Assessment Report Public Assessment Report Dutch 28-02-2011
Patient Information leaflet Patient Information leaflet Polish 28-02-2011
Summary of Product characteristics Summary of Product characteristics Polish 28-02-2011
Public Assessment Report Public Assessment Report Polish 28-02-2011
Patient Information leaflet Patient Information leaflet Portuguese 28-02-2011
Summary of Product characteristics Summary of Product characteristics Portuguese 28-02-2011
Public Assessment Report Public Assessment Report Portuguese 28-02-2011
Patient Information leaflet Patient Information leaflet Romanian 28-02-2011
Summary of Product characteristics Summary of Product characteristics Romanian 28-02-2011
Public Assessment Report Public Assessment Report Romanian 28-02-2011
Patient Information leaflet Patient Information leaflet Slovak 28-02-2011
Summary of Product characteristics Summary of Product characteristics Slovak 28-02-2011
Public Assessment Report Public Assessment Report Slovak 28-02-2011
Patient Information leaflet Patient Information leaflet Slovenian 28-02-2011
Summary of Product characteristics Summary of Product characteristics Slovenian 28-02-2011
Public Assessment Report Public Assessment Report Slovenian 28-02-2011
Patient Information leaflet Patient Information leaflet Finnish 28-02-2011
Summary of Product characteristics Summary of Product characteristics Finnish 28-02-2011
Public Assessment Report Public Assessment Report Finnish 28-02-2011
Patient Information leaflet Patient Information leaflet Swedish 28-02-2011
Summary of Product characteristics Summary of Product characteristics Swedish 28-02-2011
Public Assessment Report Public Assessment Report Swedish 28-02-2011

Search alerts related to this product

Alerts Clopidogrel Pharma

Clopidogrel Pharma

View documents history

Documents history Documents history

Clopidogrel 1A Pharma