PAMIDRONATE DISODIUM FOR INJECTION SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PAMIDRONATE DISODIUM

Sẵn có từ:

FRESENIUS KABI CANADA LTD

Mã ATC:

M05BA03

INN (Tên quốc tế):

PAMIDRONIC ACID

Liều dùng:

3MG

Dạng dược phẩm:

SOLUTION

Thành phần:

PAMIDRONATE DISODIUM 3MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

10ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

BONE RESORPTION INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0123608001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2015-02-04

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
PAMIDRONATE DISODIUM FOR INJECTION
(pamidronate disodium)
3 mg / mL, 6 mg / mL and 9 mg / mL
Solution for Injection
For Intravenous Infusion Only
Bone Metabolism Regulator
FRESENIUS KABI CANADA LTD.
Date of Revision:
165 Galaxy Blvd, Suite 100
March 12, 2019
Toronto, ON M9W 0C8
Submission Control No: 224510
Pamidronate Disodium for Injection_-_Product Monograph
Page 2 of 41
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
.........................................................................................................
10
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
.....................................................................................
15
OVERDOSAGE
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 19
STORAGE AND STABILITY
.................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
.................................................................................
24
CLINICAL