PIAX clopidogrel (as hydrogen sulfate) 75mg film-coated tablet blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

clopidogrel hydrogen sulfate, Quantity: 97.9 mg (Equivalent: clopidogrel, Qty 75 mg)

Предлага се от:

Alphapharm Pty Ltd

INN (Международно Name):

clopidogrel hydrogen sulfate

Лекарствена форма:

Tablet, film coated

Композиция:

Excipient Ingredients: colloidal anhydrous silica; lactose; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate; titanium dioxide; hypromellose; macrogol 8000; polydextrose; macrogol 400

Начин на приложение:

Oral

Броя в опаковка:

7, 4, 56, 28, 14, 84, 280, 50, 112

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

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: Piax 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). Piax 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, Piax 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: A white film-coated, round, biconvex, beveled edge tablet debossed with "M" on one side of the tablet and "C27" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Оторизация:

Licence status A

Дата Оторизация:

2010-05-21

Листовка

PIAX
_clopidogrel (as hydrogen sulfate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Piax.
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. Your doctor has weighed the
risks of you taking Piax against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT PIAX IS USED FOR
PIAX contains the medicine
clopidogrel. Clopidogrel belongs to a
group of medicines known as
antiplatelet medicines.
Platelets are very small blood cells
which clump together during blood
clotting. By preventing this
clumping, antiplatelet medicines
reduce the chances of blood clots
forming (a process called
thrombosis).
Piax is used to prevent blood clots
forming in hardened blood vessels as
they can lead to events such as
stroke, heart attack or death.
You have been prescribed Piax 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.
Piax is only available on a doctor's
prescription.
BEFORE YOU TAKE PIAX
_WHEN YOU MUST NOT TAKE IT_
Do not take Piax if:
•
you are allergic to any medicine
containing clopidogrel
•
you are allergic to any of the
ingredients listed at the end of
this leaflet
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing,

Данни за продукта

AUSTRALIAN PRODUCT INFORMATION
PIAX
_Clopidogrel (as hydrogen sulfate) film coated tablets _
1 NAME OF THE MEDICINE
Clopidogrel hydrogen sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 75 mg of clopidogrel (as hydrogen
sulfate) as the active ingredient.
Excipients with known effect: Sugars (as lactose) and trace quantities
of galactose and sulfites.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
PIAX 75 mg film coated tablet: white, film coated, round, biconvex,
beveled edge tablet, debossed with “M”
on one side of the tablet and “C27” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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
PIAX 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). PIAX
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, PIAX 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
DOSE 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 a single 300 mg loading dose and then continued long-term