Arrow - Clopid

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Clopidogrel bisulfate 97.875mg equivalent to clopidogrel 75 mg

Dostupné z:

Teva Pharma (New Zealand) Limited

INN (Medzinárodný Name):

Clopidogrel bisulfate 97.875 mg (equivalent to clopidogrel 75 mg)

Dávkovanie:

75 mg

Forma lieku:

Film coated tablet

Zloženie:

Active: Clopidogrel bisulfate 97.875mg equivalent to clopidogrel 75 mg Excipient: Colloidal silicon dioxide Dimeticone Hydrogenated castor oil Hyprolose Instacoat universal pink A05G30176 Lactose monohydrate

Počet v balení:

Blister pack, Al/Al cold formable, 28 tablets

Trieda:

Prescription

Typ predpisu:

Prescription

Výrobca:

Macleods Pharmaceuticals Limited

Terapeutické indikácie:

Prevention of vascular ischaemia associated with atherothrombotic events (MI, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease.

Prehľad produktov:

Package - Contents - Shelf Life: Blister pack, Al/Al cold formable - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Al/Al cold formable - 84 tablets - 36 months from date of manufacture stored at or below 25°C

Dátum Autorizácia:

2012-11-06

Súhrn charakteristických

Version 1.2
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Arrow – Clopid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains c
lopidogrel hydrogen sulfate equivalent to clopidogrel 75 mg.
Excipient with known effect:
lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pink, circular, biconvex, film-coated tablet debossed “L 11” on
one side of the tablet and plain on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of vascular ischaemia associated with atherothrombotic
events (MI, stroke and vascular
death) in patients with a history of symptomatic atherosclerotic
disease.
ACUTE CORONARY SYNDROME
Arrow-Clopid is indicated in combination with aspirin for patients
with:
•
Unstable angina or non-ST elevation MI. Arrow-Clopid is indicated for
early and long-term
reduction of atherothrombotic events (myocardial infarction, stroke,
vascular death and refractory
ischaemia) whether or not patients undergo cardiac revascularisation
(surgical or PCI, with or
without stent).
•
ST-segment elevation acute myocardial infarction. 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
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 at 75 mg once a day
(with aspirin 75 mg-325 mg daily).
•
ST elevation acute myocardial infarction – clopidogrel treatment
should be given as a single daily
dose of 75 mg initiated with or without a 300 mg loading dose in
combination with aspirin and
with or without thrombolytics.
SPECIAL POPULATIONS
_Renal impairment _
Therapeutic experience is limited in patients with renal impairment.
(see section 4.4 Special
warnings and precautions