Clopidogrel Teva Pharma B.V.

Nchi: Umoja wa Ulaya

Lugha: Kiingereza

Chanzo: EMA (European Medicines Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
03-02-2015
Tabia za bidhaa Tabia za bidhaa (SPC)
03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma (PAR)
03-02-2015

Viambatanisho vya kazi:

clopidogrel (as hydrobromide)

Inapatikana kutoka:

Teva Pharma B.V. 

ATC kanuni:

B01AC04

INN (Jina la Kimataifa):

clopidogrel

Kundi la matibabu:

Antithrombotic agents

Eneo la matibabu:

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

Matibabu dalili:

Prevention of atherothrombotic eventsClopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease;adult 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);ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.Prevention of atherothrombotic and thromboembolic events in atrial fibrillationIn adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Bidhaa muhtasari:

Revision: 4

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2011-06-16

Taarifa za kipeperushi

                                B. PACKAGE LEAFLET
32
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL TEVA PHARMA B.V. 75 MG FILM-COATED TABLETS
clopidogrel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you have any side effects, including any side effects not listed in
this leaflet, talk your doctor
or pharmacist. See section 4
WHAT IS IN THIS LEAFLET
1.
What Clopidogrel Teva Pharma B.V. is and what it is used for
2.
What you need to know before you take Clopidogrel Teva Pharma B.V.
3.
How to take Clopidogrel Teva Pharma B.V.
4.
Possible side effects
5.
How to store Clopidogrel Teva Pharma B.V.
6.
Contents of the pack and other information
1. WHAT CLOPIDOGREL TEVA PHARMA B.V. IS AND WHAT IT IS USED FOR
Clopidogrel Teva Pharma B.V contains clopidogrel and belongs to a
group of medicines called
“platelet aggregation inhibitors.” It works by stopping certain
particles in your blood (“platelets”)
from sticking together to form blood clots which can block blood flow
to important parts of your body
including your heart and your brain.
If you suffer from hardening of the arteries (“atherosclerosis”)
there is an increased risk of a blood clot
forming in your blood vessels. In adults Clopidogrel Teva Pharma B.V.
reduces the risk of blood clots
forming which in turn reduces the risk of serious conditions such as
heart attack and stroke from
occurring.
You have been prescribed Clopidogrel Teva Pharma B.V. because:
•
You have hardening of the arteries and have recently suffered from a
heart attack, a stroke or
have a condition known as “peripheral arterial disease” (diseases
of the blood vessels except
those in the brain and heart).
•
You have 
                                
                                Soma hati kamili

Tabia za bidhaa

                                ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as
hydrobromide).
Excipients with known effect:
Each tablet contains 62.16 mg lactose monohydrate and 10 mg
hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light pink to pink, capsule-shaped film-coated tablets debossed with
“C75” on one side and plain on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Prevention of atherothrombotic events _
Clopidogrel is indicated in:
•
Adult patients suffering from myocardial infarction (from a few days
until less than 35 days),
ischaemic stroke (from 7 days until less than 6 months) or established
peripheral arterial disease.
•
Adult 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)
-
ST segment elevation acute myocardial infarction, in combination with
ASA in medically
treated patients eligible for thrombolytic therapy.
_Prevention of atherothrombotic and thromboembolic events in atrial
fibrillation _
In adult patients with atrial fibrillation who have at least one risk
factor for vascular events, are not
suitable for treatment with Vitamin K antagonists (VKA) and who have a
low bleeding risk,
clopidogrel is indicated in combination with ASA for the prevention of
atherothrombotic and
thromboembolic events, including stroke.
For further information please refer to section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
•
Adults and older people
Clopidogrel should be given as a single daily dose of 75 mg.
2
Medicinal product no longer authorised
In patients suff
                                
                                Soma hati kamili

Bidhaa zinazofanana

Viambatanisho vya kazi clopidogrel (as hydrobromide)

clopidogrel (as hydrobromide)

ATC kanuni B01AC04

B01AC04

Mzalishaji au wazalishaji wadogowadogo Teva Pharma B.V. 

Teva Pharma B.V. 

INN (Jina la Kimataifa) clopidogrel

clopidogrel

Nyaraka katika lugha zingine

Taarifa za kipeperushi Taarifa za kipeperushi Kibulgaria 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kibulgaria 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kibulgaria 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kihispania 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kihispania 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kihispania 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kicheki 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kicheki 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kicheki 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kidenmaki 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kidenmaki 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kidenmaki 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kijerumani 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kijerumani 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kijerumani 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kiestonia 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kiestonia 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiestonia 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kigiriki 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kigiriki 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kigiriki 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kifaransa 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kifaransa 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kifaransa 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kiitaliano 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kiitaliano 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiitaliano 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kilatvia 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kilatvia 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kilatvia 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kilithuania 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kilithuania 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kilithuania 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kihungari 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kihungari 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kihungari 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kimalta 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kimalta 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kimalta 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kiholanzi 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kiholanzi 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiholanzi 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kipolandi 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kipolandi 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kipolandi 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kireno 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kireno 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kireno 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kiromania 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kiromania 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiromania 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kislovakia 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kislovakia 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kislovakia 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kislovenia 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kislovenia 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kislovenia 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kifinlandi 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kifinlandi 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kifinlandi 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kiswidi 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kiswidi 03-02-2015
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiswidi 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kinorwe 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kinorwe 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kiaisilandi 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kiaisilandi 03-02-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kroeshia 03-02-2015
Tabia za bidhaa Tabia za bidhaa Kroeshia 03-02-2015

Tafuta arifu zinazohusiana na bidhaa hii

Taadhari Clopidogrel Teva Pharma B.V.

Clopidogrel Teva Pharma B.V.

Tazama historia ya hati

Historia ya nyaraka Historia ya nyaraka

Clopidogrel Teva Pharma B.V.