Amlodipine

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

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下载 产品特点 (SPC)
07-02-2012

有效成分:

Amlodipine besilate 13.88mg equivalent to 10 mg Amlodipine;  

可用日期:

Ipca Pharma (NZ) Pty Limited

INN(国际名称):

Amlodipine besilate 13.88 mg (equivalent to 10 mg Amlodipine)

剂量:

10 mg

药物剂型:

Tablet

组成:

Active: Amlodipine besilate 13.88mg equivalent to 10 mg Amlodipine   Excipient: Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Magnesium stearate Microcrystalline cellulose Sodium starch glycolate

每包单位数:

Blister pack, PVC/PVDC, 28 tablets

类:

Prescription

处方类型:

Prescription

厂商:

Glochem Industries Limited

疗效迹象:

Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme inhibitor.

產品總結:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC - 56 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC - 84 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 250 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 500 tablets - 24 months from date of manufacture stored at or below 25°C

授权日期:

2006-06-01

产品特点

                                1
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Vasorex
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amlodipine besilate 2.5 mg, 5 mg and 10 mg tablets
3 PHARMACEUTICAL FORM
Vasorex 2.5 mg tablets are white to off white, round with “C”
debossed on one side and
“126” on the other side. Alternatively, they are debossed on one
side with “3235” and
“WPI” on the other side. Each tablet contains amlodipine besilate
equivalent to 2.5 mg of
amlodipine.
Vasorex 5 mg tablets are white to off white, round with “C”
debossed on one side and
“127” on the other side. Alternatively, they are debossed on one
side with “3236” and
“WPI” on the other side. Each tablet contains amlodipine besilate
equivalent to 5 mg
amlodipine.
Vasorex 10 mg tablets are white to off white, round with “C”
debossed on one side and
“128” on the other side. Alternatively, they are debossed on one
side with “3237” and
“WPI” on the other side. Each tablet contains amlodipine besilate
equivalent to 10 mg
amlodipine.
Do not halve the tablet as dose equivalence when the tablet is divided
has not been
established.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Vasorex is indicated for the first line treatment of hypertension and
can be used as the
sole agent to control blood pressure in the majority of patients.
Patients not adequately
controlled on a single antihypertensive agent may benefit from the
addition of amlodipine,
which has been used in combination with a thiazide diuretic, beta
adrenoceptor blocking
agent, or an angiotensin-converting enzyme inhibitor.
Vasorex is indicated for the first line treatment of myocardial
ischaemia, whether due to
fixed obstruction (stable angina) and/or vasospasm/vasoconstriction
(Prinzmetal's or
variant angina) of coronary vasculature.
Vasorex
may
be
used
where
the
clinical
presentation
suggests
a
possible
vasospastic/vasoconstrictive component but where
vasospasm/vasoconstriction has not
been confirmed. Vasorex may be used alone as monotherapy, or in
combination with other
anti
                                
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