CLOPIDOGREL SANDOZ PHARMA clopidogrel (as hydrogen sulfate) 75 mg, film coated tablets, blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

clopidogrel hydrogen sulfate, Quantity: 97.875 mg (Equivalent: clopidogrel, Qty 75 mg)

متاح من:

Sandoz Pty Ltd

INN (الاسم الدولي):

clopidogrel hydrogen sulfate

الشكل الصيدلاني:

Tablet, film coated

تركيب:

Excipient Ingredients: hydrogenated castor oil; colloidal anhydrous silica; hyprolose; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide red

طريقة التعاطي:

Oral

الوحدات في الحزمة:

14 Tablets in blister pack, 28 Tablets in blister pack, 112 Tablets in blister pack, 7 Tablets in blister pack, 280 Tablets in blister pack, 30 Tablets in blister pack, 84 Tablets in blister pack, 50 Tablets in blister pack, 4 Tablets in blister pack, 56 Tablets in blister pack

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

For prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. ,Acute Coronary Syndrome: Clopidogrel Tablets is indicated in combination with aspirin for patients with: ,- Unstable angina or non-ST-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). Clopidogrel Tablets is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularization (surgical or PCI, with or without stent); ,- ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, Clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

ملخص المنتج:

Visual Identification: Pink coloured, round, biconvex, film coated tablets, debossed with 'Cl' on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

الوضع إذن:

Registered

تاريخ الترخيص:

2012-05-17

نشرة المعلومات

CLOPIDOGREL SANDOZ PHARMA
®
1
CLOPIDOGREL
SANDOZ PHARMA
®
_clopidogrel hydrogen sulfate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Clopidogrel Sandoz
Pharma.
It does not contain all the available
information. Some of the information
it contains may not apply to you.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. In deciding to give you
Clopidogrel Sandoz Pharma tablets,
your doctor has weighed the risks of
you taking Clopidogrel Sandoz
Pharma tablets against the expected
benefits it will have for you.
Always follow the instructions that
your doctor and pharmacist give you
about Clopidogrel Sandoz Pharma.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING CLOPIDOGREL
SANDOZ PHARMA.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CLOPIDOGREL
SANDOZ PHARMA IS
USED FOR
CLOPIDOGREL SANDOZ PHARMA
TABLETS CONTAIN THE MEDICINE
CLOPIDOGREL. CLOPIDOGREL SANDOZ
PHARMA TABLETS BELONG TO A GROUP
OF MEDICINES CALLED ANTIPLATELET
MEDICINES.
Platelets are very small blood cells
which clump together during blood
clotting. By preventing this
clumping, anti-platelet medicines
reduce the chances of blood clots
forming (a process called
thrombosis).
Clopidogrel Sandoz Pharma tablets
are used to prevent blood clots
forming in hardened blood vessels (a
process known as atherothrombosis)
which can lead to events such as
stroke, heart attack or death.
You may have been prescribed
Clopidogrel Sandoz Pharma tablets
to help prevent blood clots forming
and to reduce the risk of stroke, heart
attack and death because:
•
YOU HAVE PREVIOUSLY SUFFERED A
HEART ATTACK, STROKE OR HAVE A
CONDITION KNOWN AS PERIPHERAL
ARTERIAL DISEASE (LEG PAIN ON
WALKING OR AT REST).
•
YOU HAVE SUFFERED ACUTE
CORONARY SYNDROME (EITHER A
SEVERE TYPE OF CHEST PAIN CALLED
UNSTABLE ANGINA, OR A HEART
ATTACK). IN THIS CASE YOU MAY

خصائص المنتج

200916-clopidogrel sandoz pharma-pi
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION
CLOPIDOGREL SANDOZ PHARMA
® (CLOPIDOGREL HYDROGEN SULFATE)
FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Clopidogrel hydrogen sulfate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg clopidogrel hydrogen sulfate.
_List of excipients with known effect:_
Lactose anhydrous.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Clopidogrel 75 mg film coated tablets - Pink coloured, round,
biconvex, film coated tablets,
debossed with 'Cl' on one side and plain on other side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Prevention
of
vascular
ischaemia
associated
with
atherothrombotic
events
(myocardial
infarction, stroke and vascular death) in patients with a history of
symptomatic atherosclerotic
disease.
ACUTE CORONARY SYNDROME
Clopidogrel Sandoz Pharma is indicated in combination with aspirin for
patients with:
•
Unstable angina or non-ST-elevation myocardial infarction in order to
prevent early
and long-term atherothrombotic events (myocardial infarction, stroke,
vascular death
or refractory ischaemia). Clopidogrel Sandoz Pharma is indicated for
the treatment of
acute coronary syndrome whether or not patients undergo cardiac
revascularisation
(surgical or PCI, with or without stent).
•
ST-segment elevation acute myocardial infarction in order to prevent
atherothrombotic
events. In this population, clopidogrel has been shown to reduce the
rate of death from
any cause and the rate of a combined endpoint of death, re-infarction
or stroke in
medically treated patients eligible for thrombolytic therapy.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
Clopidogrel should be taken once a day with or without food.
ADULTS
Generally, clopidogrel should be given as a single daily dose of 75
mg.
In patients with acute coronary syndrome:
•
unstable angina or non-ST-elevation myocardial infarction –
clopidogrel treatment
should be initiated with 300 mg loading dose and then continue