BONEFOS SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CLODRONATE DISODIUM (CLODRONATE DISODIUM TETRAHYDRATE)

Sẵn có từ:

BAYER INC

Mã ATC:

M05BA02

INN (Tên quốc tế):

CLODRONIC ACID

Liều dùng:

60MG

Dạng dược phẩm:

SOLUTION

Thành phần:

CLODRONATE DISODIUM (CLODRONATE DISODIUM TETRAHYDRATE) 60MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

5ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

BONE RESORPTION INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0122982003; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2018-12-27

Đặc tính sản phẩm

_ _
_BONEFOS Product Monograph _
_Page 1 of 29_
PRODUCT MONOGRAPH
PR BONEFOS
®
Clodronate disodium for injection
60 mg/mL
for slow intravenous infusion only
and
Clodronate disodium capsules
400 mg/capsule
Bone metabolism regulator
(Antihypercalcemic agent)
Bayer Inc.
2920 Matheson Boulevard East,
Mississauga, Ontario
L4W 5R6
www.bayer.ca
Submission Control No. 200438
Date of Revision:
March 30, 2017
© 2017, Bayer Inc.
® TM see www.bayer.ca/tm-mc.
_ _
_BONEFOS Product Monograph _
_Page 2 of 29_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
................................................................................16
PHARMACEUTICAL INFORMATION
..........................................................................1