APX-CLOPIDOGREL/ASPIRIN 75/100 clopidogrel (as hydrogen sulfate)/aspirin 75 mg/100 mg tablet blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

aspirin, Quantity: 100 mg; clopidogrel hydrogen sulfate, Quantity: 97.875 mg (Equivalent: clopidogrel, Qty 75 mg)

זמין מ:

Sanofi-Aventis Australia Pty Ltd

טופס פרצבטיות:

Tablet, film coated

הרכב:

Excipient Ingredients: hyprolose; mannitol; Carnauba Wax; colloidal anhydrous silica; maize starch; microcrystalline cellulose; hydrogenated castor oil; stearic acid; macrogol 6000; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

30 tablets

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

APX-Clopidogrel is a fixed-dose combination product 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). APX-Clopidogrel 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, APX-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.

leaflet_short:

Visual Identification: Light Pink, oval, slightly biconvex, film-coated, engraved with "C75" on one side and "A100" on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

מצב אישור:

Registered

תאריך אישור:

2020-08-18

עלון מידע

APX-CLOPIDOGREL/ASPIRIN 75/100
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING APX-CLOPIDOGREL/ASPIRIN 75/100?
APX-Clopidogrel/Aspirin 75/100 contains the active ingredient
clopidogrel and aspirin. APX-Clopidogrel/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. For more information, see Section 1.
Why am I using APX-Clopidogrel/Aspirin 75/100? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE APX-CLOPIDOGREL/ASPIRIN 75/100?
Do not use if you have ever had an allergic reaction to
APX-Clopidogrel/Aspirin 75/100 or any of the ingredients listed at the
end of
the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS,
TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see
Section 2. What should I know before I use APX-Clopidogrel/
Aspirin 75/100? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with APX-Clopidogrel/Aspirin 75/100 and
affect how it works. A list of these medicines is in Section 3.
What if I am taking other medicines? in the full CMI.
4.
HOW DO I USE APX-CLOPIDOGREL/ASPIRIN 75/100?
Take APX-Clopidogrel/Aspirin 75/100 only as prescribed by your doctor
and follow his or her directions carefully. More instructions
can be found in Section 4. How do I use APX-Clopidogrel/Aspirin
75/100? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING APX-CLOPIDOGREL/ASPIRIN 75/100?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
APX-Clopidogrel/Aspirin 75/100
•
Tell your doctor immediately if you are injured while taking
APX-Clopidogrel/Aspirin 75/100
•
Tell your doctor that you are taking APX-Clopidogrel/Aspirin 75/100 if
you are

מאפייני מוצר

_ _
apx-clop-asp-ccdsv21-piv2-18may22
1
AUSTRALIAN PRODUCT INFORMATION – APX-
CLOPIDOGREL/ASPIRIN 75/100 (CLOPIDOGREL (AS HYDROGEN
SULFATE)/ ASPIRIN) FILM COATED TABLET
1
NAME OF THE MEDICINE
Clopidogrel (as hydrogen sulfate) and aspirin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each APX-Clopidogrel/Aspirin 75/100 tablet contains clopidogrel 75 mg
(as clopidogrel
hydrogen sulfate) and aspirin 100 mg.
Excipient with known effect: lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APX-Clopidogrel/Aspirin 75/100 tablets are light pink, oval, slightly
biconvex, film-coated,
engraved with “C75” on one side and “A100” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
APX-Clopidogrel/Aspirin 75/100 is a fixed-dose combination product.
APX-Clopidogrel/Aspirin 75/100 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). APX-Clopidogrel/Aspirin 75/100 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, APX-Clopidogrel/Aspirin
75/100 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.
_ _
apx-clop-asp-ccdsv21-piv2-18may22
2
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
APX-Clopidogrel/Aspirin 75/100 is given as a single tablet once a day
taken with adequate
water.
ACUTE CORONARY SYNDROME
APX-Clopidogrel/Aspirin 75/100 is used following an initial loading
dose of 300 mg
clopidogrel in combination with a