PAMIDRONATE DISODIUM OMEGA 9 MG/ML SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PAMIDRONATE DISODIUM

Sẵn có từ:

OMEGA LABORATORIES LIMITED

Mã ATC:

M05BA03

INN (Tên quốc tế):

PAMIDRONIC ACID

Liều dùng:

9MG

Dạng dược phẩm:

SOLUTION

Thành phần:

PAMIDRONATE DISODIUM 9MG

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: 0123608006; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2004-03-09

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
PAMIDRONATE DISODIUM OMEGA
(PAMIDRONATE DISODIUM FOR INJECTION)
3 MG / ML, 6 MG / ML AND 9 MG / ML
Sterile Solution for Injection
For intravenous infusion only
THERAPEUTIC CLASSIFICATION
Bone Metabolism Regulator
Omega Laboratories Limited
Date of Revision:
11 177 Hamon Street
February 17, 2022
Montreal, Quebec
H3M 3E4
Submission
Control No: 254663
_Product Monograph - _
_Pr_
_Pamidronate Disodium Omega Page 2 of 44 _
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
..............................................................................................
16
DOSAGE AND ADMINISTRATION
...........................................................................
16
OVERDOSAGE
...........................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 21
STORAGE AND STABILITY
......................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 25
PART II: SCIENTIFIC INFORMATION
.............................................................................26
PHARMACEUTICAL INFORMATION
.......................................................................
26
CLINICAL TRIALS
.............................................................................