Clopidogrel 1A Pharma

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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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:

klopidogrel

Available from:

Acino Pharma GmbH 

ATC code:

B01AC04

INN (International Name):

clopidogrel

Therapeutic group:

Antitrombotična sredstva

Therapeutic area:

Periferne žilne bolezni

Therapeutic indications:

Clopidogrel je navedeno pri odraslih za preprečevanje atherothrombotic dogodkov v:Bolnike, ki trpijo za miokardni infarkt (od nekaj dni do manj kot 35 dni), ischaemic kap (od 7 dni do manj kot 6 mesecev) ali sedež periferne arterijske bolezni. Bolnike, ki trpijo za akutni koronarni sindrom:- Ne ST segmentu višinskih akutni koronarni sindrom (nestabilna angina pektoris ali non Q val miokardni infarkt), vključno z bolniki, ki opravljajo stent umestitev po perkutani koronarni intervenciji, v kombinaciji z acetilsalicilne kisline (ASA). - ST segmentu višinskih akutni miokardni infarkt, v kombinaciji s ASA v medicinsko zdravljenih bolnikih, ki izpolnjujejo pogoje za thrombolytic terapija. Za nadaljnje informacije, prosimo, preberite razdelek 5.

Product summary:

Revision: 1

Authorization status:

Umaknjeno

Authorization date:

2009-07-28

Patient Information leaflet

                                22
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte v originalnem pretisnem omotu za zagotovitev zaščite pred
vlago.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Acino Pharma GmbH
Am Windfeld 35
84714 Miesbach
Nemčija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/09/542/001
EU/1/09/542/002
EU/1/09/542/003
EU/1/09/542/004
EU/1/09/542/005
EU/1/09/542/006
EU/1/09/542/007
13.
ŠTEVILKA SERIJE
Serija
14.
NAČIN IZDAJANJA ZDRAVILA
Izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Klopidogrel 1A Pharma 75 mg
Zdravilo nima veā dovoljenja za promet
23
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PRETISNI OMOT
s po 14, 28, 30, 50, 84, 90 ali 100 filmsko obloženimi tabletami
1.
IME ZDRAVILA
Klopidogrel 1A Pharma 75 mg filmsko obložene tablete
klopidogrel
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Acino Pharma GmbH
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Serija
5.
DRUGI PODATKI
Zdravilo nima veā dovoljenja za promet
24
B. NAVODILO ZA UPORABO
Zdravilo nima veā dovoljenja za promet
25
NAVODILO ZA UPORABO
KLOPIDOGREL 1A PHARMA 75 MG FILMSKO OBLOŽENE TABLETE
klopidogrel
PRED ZAČETKOM JEMANJA NATANČNO PREBERITE NAVODILO!
-
Navodilo shranite. Morda ga boste želeli ponovno prebrati.
-
Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s
farmacevtom.
-
Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Njim bi lahko celo
škodovalo, čeprav imajo znake bolezni, podobne vašim.
-
Če katerikoli neželeni učinek postane resen ali če opazite
katerikoli neželeni učinek, ki ni
omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
NAVODILO VSEBUJE:
1.
Kaj je zdravilo Klopidogrel 1A Pharma in za kaj ga uporabljamo
2.
Kaj morate vedeti, preden boste vzeli zdravilo Klopidogrel 1A Pharma
3.
Kako jemati zdravilo Klopidogrel 1A Pharma
4.
Mož
                                
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Summary of Product characteristics

                                1
DODATEK I
POVZETEK GLAVNIH ZNAČI
LNOSTI Z
DRAVILA
Zdravilo nima veā dovoljenja za promet
2
1.
IME ZDRAVILA
Klopidogrel 1A Pharma 75 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena filmsko obložena tableta vsebuje 75 mg klopidogrela v obliki
klopidogrelijevega besilata.
Pomožne snovi: ena tableta vsebuje 3,80 mg hidrogeniranega
ricinusovega olja.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Filmsko obložena tableta.
Bele do belkaste, marmorirane, okrogle, bikonveksne filmsko obložene
tablete.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Klopidogrel je indiciran pri odraslih za preprečevanje
aterotrombotičnih dogodkov pri:

bolnikih z miokardnim infarktom (od nekaj dni do manj kot 35 dni),
ishemično kapjo (od
7 dni do manj kot 6 mesecev) ali dokazano periferno arterijsko
boleznijo.

bolnikih z akutnim koronarnim sindromom:
-
akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina
ali miokardni
infarkt brez Q zobca), vključno z bolniki, katerim je bil vstavljen
stent po perkutani
koronarni intervenciji, v kombinaciji z acetilsalicilno kislino (ASA
– acetylsalicylic acid).
-
akutni miokardni infarkt z elevacijo ST spojnice v kombinaciji z ASA
pri bolnikih, ki se
zdravijo z zdravili in so primerni za trombolitično zdravljenje.
Za dodatne informacije glejte poglavje 5.1.
4.2
ODMERJANJE IN NAČIN UPORABE

Odrasli in starostniki
Klopidogrel se mora dajati kot enkratni dnevni odmerek 75 mg, s hrano
z ali brez nje.hrane.
Pri bolnikih z akutnim koronarnim sindromom:
–
Akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina
ali miokardni infarkt
brez Q zobca): zdravljenje moramo začeti z enkratnim udarnim odmerkom
300 mg klopidogrela
in nadaljevati s 75 mg enkrat na dan (s 75 mg do 325 mg
acetilsalicilne kisline (ASA) dnevno).
Ker so bili visoki odmerki ASA povezani s povišanim tveganjem za
krvavitve, se priporoča, da
odmerek ASA ni večji od 100 mg. Optimalno trajanje zdravljenja še ni
bilo formalno potrjeno
                                
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Similar products

Active ingredient klopidogrel

klopidogrel

ATC code B01AC04

B01AC04

Marketed by Acino Pharma GmbH 

Acino Pharma GmbH 

INN (International Name) clopidogrel

clopidogrel

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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
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