PIAX PLUS ASPIRIN 75/100 clopidogrel (as hydrogen sulfate) and aspirin 75 mg/100 mg uncoated tablet blister pack

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

aspirin, Quantity: 100 mg; clopidogrel hydrogen sulfate, Quantity: 97.87 mg (Equivalent: clopidogrel, Qty 75 mg)

Доступна з:

Medis Pharma Pty Ltd

ІПН (Міжнародна Ім'я):

Aspirin,clopidogrel hydrogen sulfate

Фармацевтична форма:

Tablet

Склад:

Excipient Ingredients: lactose; crospovidone; glycerol dibehenate; hydrogenated castor oil; microcrystalline cellulose; Colour

Адміністрація маршрут:

Oral

Одиниць в упаковці:

28, 112, 14, 84, 2, 100, 30, 280, 50, 98, 4, 7

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

Clopidogrel/Aspirin is a fixed-dose combination product.,Clopidogrel/Aspirin is intended as continuation of therapy in patients with acute coronary syndrome already initiated with separate clopidogrel and aspirin products: 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/Aspirin 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/Aspirin 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.

Огляд продуктів:

Visual Identification: Mottled purple, oval, biconvex tablets debossed 'CL7' on one face and 'S1' on the other; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизація:

Licence status A

Дата Авторизація:

2014-10-27

інформаційний буклет

PIAX PLUS® ASPIRIN 75/100
1
PIAX PLUS® ASPIRIN
75/100
_UNCOATED TABLETS _
_contains the active ingredients clopidogrel hydrogen sulfate and
aspirin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PIAX PLUS
ASPIRIN 75/100 tablets.
It does not contain all of 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 PIAX
PLUS ASPIRIN 75/100, your doctor
has weighed the risks of you taking
PIAX PLUS ASPIRIN 75/100
against the expected benefits it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Please read this leaflet carefully
before you start taking PIAX PLUS
ASPIRIN 75/100.
You may need to read it again.
WHAT PIAX PLUS
ASPIRIN 75/100 IS
USED FOR
PIAX PLUS ASPIRIN 75/100
CONTAINS THE MEDICINES CLOPIDOGREL
AND ASPIRIN. PIAX PLUS ASPIRIN
75/100 BELONGS TO A GROUP OF
MEDICINES CALLED ANTI-PLATELET
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).
PIAX PLUS ASPIRIN 75/100 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 PIAX
PLUS ASPIRIN 75/100 to help
prevent blood clots forming and to
reduce the risk of heart attack, stroke
or death, because you have suffered a
severe type of chest pain called
unstable angina, or had a heart attack.
Your doctor may have prescribed this
medicine for another use. If you want
more information, ask your doctor.
PIAX PLUS ASPIRIN 75/100 is
only available on a doctor's
prescription.
BEFORE YOU TAKE PIAX
PLUS ASPIRIN 75/100
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PIAX PLUS ASPIRIN
75/100 IF:
•
YOU ARE ALLERGIC TO

Характеристики продукта

AUSTRALIAN PRODUCT INFORMATION
PIAX
®
PLUS ASPIRIN 75/100
_Clopidogrel and aspirin tablets _
1
NAME OF THE MEDICINE
Aspirin/Clopidogrel hydrogen sulfate
_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg of clopidogrel (as clopidogrel hydrogen
sulfate) and 100 mg of aspirin as the active
ingredients.
Excipients with known effect: Contains sugars (as lactose)
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PIAX PLUS ASPIRIN 75/100 tablets are mottled purple, oval, biconvex,
debossed with ‘CL7’ on one side
and ’S1’ on the other side.
_ _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clopidogrel/Aspirin is a fixed-dose combination product.
Clopidogrel/Aspirin is intended as continuation of therapy in patients
with acute coronary syndrome already
initiated with separate clopidogrel and aspirin products:
•
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/Aspirin 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/Aspirin 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
ADULTS
Clopidogrel/Aspirin is given as a single tablet (75mg/75mg or
75mg/100mg) once a day taken with adequate
water.
ACUTE CORONARY SYNDROME
Clopidogrel/Aspirin is used following an initial loading dose of 300
mg clopidogrel in combination with
aspirin in patients with acute coronary syndrome:
•
Unstable angina or non-ST-elevation myocardial infarction:
-
Treatment should be initiated with a single 300 m