PLAVICOR 75, clopidogrel (as hydrogen sulfate) 75 mg, film coated tablets, blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

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

Предлага се от:

Pharmacor Pty Ltd

INN (Международно Name):

clopidogrel hydrogen sulfate

Лекарствена форма:

Tablet, film coated

Композиция:

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

Начин на приложение:

Oral

Броя в опаковка:

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

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

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.

Каталог на резюме:

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: 36 Months; Container Temperature: Store below 25 degrees Celsius

Статус Оторизация:

Registered

Дата Оторизация:

2012-05-17

Листовка

PLAVICOR 75 (V 02)
1
PLAVICOR 75
_clopidogrel_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Plavicor tablets.
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
Plavicor, your doctor has weighed
the risks of you taking Plavicor
against the expected benefits it will
have for you.
Always follow the instructions that
your doctor and pharmacist give you
about Plavicor tablets
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING PLAVICOR.
YOU MAY WISH TO KEEP IT TO READ
AGAIN.
WHAT PLAVICOR IS
USED FOR
PLAVICOR CONTAINS THE MEDICINE
CLOPIDOGREL. PLAVICOR BELONGS 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).
Plavicor is 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
Plavicor 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 ALSO BE PRESCRIBED
ASPIRIN.
Your doctor may have prescribed
this medicine for another use. If you
want more information, ask your
doctor.
Plavicor is only available on a
doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
YOU SHOULD NOT TAKE PLAVICOR

Данни за продукта

Plavicor 75 (V 02) Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
PLAVICOR 75
(CLOPIDOGREL HYDROGEN SULFATE) FILM COATED TABLET
1
NAME OF THE MEDICINE
Clopidogrel hydrogen sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains clopidogrel hydrogen sulfate equivalent to
clopidogrel 75 mg.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Plavicor 75 - 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
Plavicor Tablets are 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). Plavicor Tablets are 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, Plavicor Tablets have 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.
Plavicor 75 (V 02) Page 2 of 28
In patients with acute coronary syndrome:
•
unstable angina or non-ST-elevation myocardial infarction -
clopidogrel treatment should be
initiated with a 300 mg loading dose and then continued long-term at
75 mg onc