素果８０公絲膜衣錠

Country: Taiwan

Language: Chinese

Source: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Active ingredient:

SIMVASTATIN

Available from:

美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)

ATC code:

C10AA01

Pharmaceutical form:

膜衣錠

Composition:

SIMVASTATIN (2406002900) 80MG

Units in package:

鋁箔盒裝

Class:

製　劑

Prescription type:

須由醫師處方使用

Manufactured by:

MERCK SHARP & DOHME LTD. SHOTTON LANE, CRAMLINGTON, NORTHUMBERLAND, NE23 3JU, UNITED KINDOMHERTFORD ROAD HODDESDON HERFFORDSHIRE EN11 9BU UNITED KINGDOM GB

Therapeutic area:

simvastatin

Therapeutic indications:

高膽固醇血症、高三酸甘油酯血症，降低冠心病高危險群或冠心病患者的心血管事件發生率及冠心病致死率、患有異核質家族性高膽固醇血症的兒童病患。

Product summary:

註銷日期: 2013/10/09; 註銷理由: 自請註銷; 有效日期: 2016/03/20; 英文品名: ZOCOR 80MG F.C. TABLETS

Authorization status:

已註銷

Authorization date:

2001-03-20

Patient Information leaflet

PROFILE: ASG-LRF-200x280 CONSTRUCTION: Continuous Printed Sheet.
Electronically Counted as Wound onto Core. GRAIN DIRECTION: Machine (Long Grain) ROLL OUTSIDE DIAMETER: 300mm = Minimum;
550mm = Maximum COMMENTS: No Smudges or Show-through Permissible on
Reg. Mark Corridor. UNWIND DIRECTION:
EDGE CODE:
MATERIAL GROUP:
PRINTER:
Black
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PR
PROPRIETARY
P1
P2
N/A
03-JUL-13-v02
119703A02
123 (Sample)
N/A
RF1 (See Register: REG499)
N/A
P185
素果
®
20公絲膜衣錠，40公絲膜衣錠，
80公絲膜衣錠
ZOCOR
®
20 MG F.C. TABLET, 40 MG F.C. TABLET,
80 MG F.C. TABLET
(SIMVASTATIN, MSD)
PC-MK0733-T-102012
20公絲 衛署藥輸字第020037號
0733-TWN-2013-007275
40公絲 衛署藥輸字第023506號
80公絲 衛署藥輸字第 023144號
本藥須由醫師處方使用
ZOCOR
®
(simvastatin, MSD)為降膽固醇劑，由土麴菌
(Aspergillus
terreus)
之發酵產物合成而得。
ZOCOR為無活性之內酯，口服後水解為其β-氫氧酸型式；此為其主
代謝物，且為3-hydroxy-3-methylglutaryl-coenzyme
A,
HMG-CoA還
原酵素之抑制劑；此酵素負責催化膽固醇生合成之早期步驟，其亦為
速率決定步驟。依臨床研究顯示ZOCOR對異型接合子(heterozygous)
家族性及非家族性高膽固醇血症，混合型高血脂症病患其膽固醇
過高且單獨以飲食控制效果不佳者，可有效降低其總血漿膽固醇
(total plasma cholesterol;
total-C)、低密度脂蛋白膽固醇(low-density
lipoprotein cholesterol; LDL-C)、三酸甘油酯(triglycerides;
TG)及極低
密度脂蛋白膽固醇(very-low-density lipoprotein cholesterol;
VLDL-C)
並升高高密度脂蛋白膽固醇(HDL-C)濃度。以ZOCOR治療，二週內
即可得到顯著療效，四至六週後即達最佳