ETIDROCAL TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ETIDRONATE DISODIUM; CALCIUM (CALCIUM CARBONATE)

Sẵn có từ:

COBALT PHARMACEUTICALS COMPANY

Mã ATC:

M05BB01

INN (Tên quốc tế):

ETIDRONIC ACID AND CALCIUM, SEQUENTIAL

Liều dùng:

400MG; 500MG

Dạng dược phẩm:

TABLET

Thành phần:

ETIDRONATE DISODIUM 400MG; CALCIUM (CALCIUM CARBONATE) 500MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

14 WHITE-76 BLUE TABS

Loại thuốc theo toa:

Prescription

Khu trị liệu:

BONE RESORPTION INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0241781001; AHFS:

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2017-09-01

Đặc tính sản phẩm

Page 1 of 31
_ _
_ _
_ _
PRODUCT MONOGRAPH
PR
ETIDROCAL
Etidronate Disodium Tablets USP
400 mg
and
Calcium Carbonate Tablets USP
1,250 mg calcium carbonate per tablet
(equivalent to 500 mg elemental calcium)
BONE METABOLISM REGULATOR
Cobalt Pharmaceuticals Company
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
CONTROL NO.: 167412
DATE OF REVISION:
SEPTEMBER 30, 2013
Page 2 of 31
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
...................................................................................................
8
DOSAGE AND ADMINISTRATION
...............................................................................
9
OVERDOSAGE
...............................................................................................................
11
ACTIONS AND CLINICAL PHARMACOLOGY
......................................................... 11
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFIC INFORMATION
...............................................................................
15
CLINICAL TRIALS
.........................................................................................................
16
DETAILED PHARMACOLOGY
...........................................................................