PMS-PAMIDRONATE POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PAMIDRONATE DISODIUM

Sẵn có từ:

PHARMASCIENCE INC

Mã ATC:

M05BA03

INN (Tên quốc tế):

PAMIDRONIC ACID

Liều dùng:

30MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

PAMIDRONATE DISODIUM 30MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

10 ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

BONE RESORPTION INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0123608004; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2002-09-10

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
PMS-PAMIDRONATE
(Pamidronate disodium for injection, House standard)
15mg/vial, 30 mg/vial, 60 mg/vial and 90 mg/vial
For intravenous infusion only
BONE METABOLISM REGULATOR
PHARMASCIENCE INC
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
March 30, 2017
Montreal, Quebec
H4P 2T4
www.pharmascience.com
CONTROL NO. 200445
_pms-PAMIDRONATE Product Monograph _
_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
.......................................................................................................
14
DOSAGE AND ADMINISTRATION
...................................................................................
15
OVERDOSAGE
.....................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 20
STORAGE AND
STABILITY...............................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 25
PART II: SCIENTIFIC INFORMATION
................................................................................
26
PHARMACEUTICAL
INFORMATION...............................................................................
26
CLINICAL TRIALS
....................