SimStatin

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Simvastatin 5mg

Tillgänglig från:

AFT Pharmaceuticals Ltd

INN (International namn):

Simvastatin 5 mg

Dos:

5 mg

Läkemedelsform:

Film coated tablet

Sammansättning:

Active: Simvastatin 5mg Excipient: Butylated hydroxyanisole Hyprolose Hypromellose Iron oxide yellow Lactose Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Purified talc   Purified water Titanium dioxide

Enheter i paketet:

Blister pack, PVC/PE/PVDC/Al (30 tablets), 30 tablets

Klass:

Prescription

Receptbelagda typ:

Prescription

Tillverkad av:

Zhejiang Hisun Pharmaceutical Co. Ltd

Produktsammanfattning:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/Al (30 tablets) - 30 tablets - 24 months from date of manufacture stored at or below 25°C

Tillstånd datum:

2001-07-16

Produktens egenskaper

NEW ZEALAND DATA SHEET
Page 1 of 18
1 SIMSTATIN TABLETS
SimStatin 5mg tablets
SimStatin 10mg tablets
SimStatin 20mg tablets
SimStatin 40mg tablets
SimStatin 80mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5mg tablet contains simvastatin 5mg
Each 10mg tablet contains simvastatin 10mg
Each 20mg tablet contains simvastatin 20mg
Each 40mg tablet contains simvastatin 40mg
Each 80mg tablet contains simvastatin 80mg
Excipients with known effect
Butylated hydroxyanisole
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
SimStatin 5mg tablets are a yellow, oblong, biconvex, filmcoated
tablet, scored and debossed
with “5” on one side and debossed “SVT” on the other.
SimStatin 10mg tablets are a white oblong, biconvex, filmcoated
tablet, scored and debossed
with “10” on one side and debossed “SVT” on the other.
SimStatin 20mg tablets are a white oblong, biconvex, filmcoated
tablet, scored and debossed
with “20” on one side and debossed “SVT” on the other.
SimStatin 40mg tablets are a white oblong, biconvex, filmcoated
tablet, scored and debossed
with “40” on one side and debossed “SVT” on the other.
SimStatin 80mg tablets are a white oblong, biconvex, filmcoated
tablet, debossed with “80”
and “SVT” on the other.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Patients at High Risk of Coronary Heart Disease (CHD) or With Existing
CHD
In patients at high risk of CHD (with or without hyperlipidemia but
with a total cholesterol of >
3.5 mmol/L), ie., patients with diabetes, history of stroke or other
cerebrovascular disease,
peripheral vessel disease, or with existing CHD, SimStatin is
indicated to:
NEW ZEALAND DATA SHEET
Page 2 of 18
•
Reduce the risk of total mortality by reducing CHD deaths;
•
Reduce
the
risk
of
major
vascular
events
(a
composite
of
non-fatal
myocardial
infarction, CHD death, stroke, or revascularization procedures;
•
Reduce the risk of major coronary events (a composite of non-fatal
myocardial
infarction or CHD deaths);
•
R