RISEDRONATE TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)

可用日期:

SANIS HEALTH INC

ATC代码:

M05BA07

INN（国际名称）:

RISEDRONIC ACID

剂量:

30MG

药物剂型:

TABLET

组成:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 30MG

给药途径:

ORAL

每包单位数:

30

处方类型:

Prescription

治疗领域:

BONE RESORPTION INHIBITORS

產品總結:

Active ingredient group (AIG) number: 0135301001; AHFS:

授权状态:

CANCELLED PRE MARKET

授权日期:

2019-01-24

产品特点

PRODUCT MONOGRAPH
PR
RISEDRONATE
Risedronate sodium (as the monohydrate)
5 mg, 30 mg, 35 mg Tablets
Manufacturer’s Standard
Bone Metabolism Regulator
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
March 16, 2017
Submission Control No.: 203183
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_RISEDRONATE Tablets _
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_Page 2 of 50_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
12
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
.................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL INFORMATION
.................................................................................
23
DETAILED PHARMACOLOGY
.................................................