PENDO-RISEDRONATE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Sẵn có từ:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Mã ATC:

M05BA07

INN (Tên quốc tế):

RISEDRONIC ACID

Liều dùng:

35MG

Dạng dược phẩm:

TABLET

Thành phần:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30

Loại thuốc theo toa:

Prescription

Khu trị liệu:

BONE RESORPTION INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0135301003; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2014-08-01

Đặc tính sản phẩm

PRODUCT MONOGRAPH
Pr
PENDO-RISEDRONATE
Risedronate Sodium Tablets, USP
(as the hemi-pentahydrate)
35 mg
BONE METABOLISM REGULATOR
PENDOPHARM, a Division of Pharmascience Inc.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
www.pendopharm.com
Date of Preparation:
July 30, 2014
Control number: 175814
_pendo-RISEDRONATE Product Monograph _
_Page 2 of 34_
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
...................................................................................................
6
DRUG INTERACTIONS
....................................................................................................
9
DOSAGE AND
ADMINISTRATION..............................................................................
11
OVERDOSAGE
................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 12
STORAGE AND STABILITY
.........................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 16
PART II: SCIENTIFIC INFORMATION
...............................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
.........................................................................................................
18
DETAILE