龍壽黴素膜衣錠１５０毫克

国家: 台湾

语言: 中文

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

有效成分:

ROXITHROMYCIN

可用日期:

賽諾菲股份有限公司 台北市信義區松仁路3號7樓 (97168356)

ATC代码:

J01FA06

药物剂型:

膜衣錠

组成:

ROXITHROMYCIN (0812500600) 150.000MG

每包单位数:

鋁箔盒裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

SANOFI-AVENTIS FRANCE 1-13, BOULEVARD ROMAIN ROLLAND 75014 PARIS-FRANCE FR

治疗领域:

roxithromycin

疗效迹象:

對ＲＵＬＩＤ具感受性菌所引起之各種中度感染症

產品總結:

註銷日期: 2018/07/03; 註銷理由: 自請註銷; 有效日期: 2019/09/30; 英文品名: RULID 150MG FILM COATED TABLET

授权状态:

已註銷

授权日期:

2014-08-20

资料单张

3
Tissue distribution is good, especially in lung tissue, tonsils and
prostate
tissue, 6 and 12 hours after repeated doses of roxithromycin.
•
Roxithromycin is 96% bound to plasma proteins. The drug mainly binds
to alpha-1-acid glycoprotein. This binding is saturable and decreases
when roxithromycin concentrations exceed 4mg/l.
•
Very limited amounts of roxithromycin, i.e. less than 0.05
％
of the
administered dose, are excreted in breast milk.
_METABOLISM_:
Roxithromycin is relatively poorly metabolized; more than half of the
drug is
excreted unchanged. Three metabolites have been identified in the
urine and
feces: descladinose roxithromycin is the main metabolite, and N-mono
and
N-didemethyl
roxithromycin
are
minor
metabolites.
The
proportions
of
roxthromycin and its three metabolites are similar in the urine and
feces.
_EXERETION_:
Roxithromycin is mainly excreted by the fecal route. Seventy-two hours
after oral administration of
14
C-radiolabeled roxithromycin, urinary excretion
of radioactivity accounts for only 12% of the total amount eliminated
in the
urine and the feces.
PHARMACEUTICAL PARTICULARS–
LIST OF EXCIPIENTS
Hydroxypropylcellulose,
polyoxyethylene-polyoxypropylene
glycol
(Pluronic
®
F68),
povidone,
anhydrous
colloidal
silica
(Aerosil
®
200),
magnesium stearate, talc, maize starch.
SHELF LIFE:
3 years.
STORAGE CONDITIONS:
Store at a temperature not exceeding 25
°
C
.
NATURE AND CONTENTS OF OUTER PACKAGING:
10 coated tablets in (PVC/aluminum) blister packs.
MANUFACTURE:
AVENTIS INTERCONTINENTAL
56, Route de Choisy au Bac,
F-60200 Compiegne, France
ref. France SmPC_18-02-10