ZOLEDRONIC ACID FOR INJECTION SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

可用日期:

PFIZER CANADA ULC

ATC代码:

M05BA08

INN（国际名称）:

ZOLEDRONIC ACID

剂量:

4MG

药物剂型:

SOLUTION

组成:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

给药途径:

INTRAVENOUS

每包单位数:

5ML

处方类型:

Prescription

治疗领域:

BONE RESORPTION INHIBITORS

產品總結:

Active ingredient group (AIG) number: 0141761002; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2021-04-08

产品特点

PRODUCT MONOGRAPH
Pr
ZOLEDRONIC ACID FOR INJECTION
4 MG/5 ML (0.8 MG/ML)
ZOLEDRONIC ACID (AS ZOLEDRONIC ACID MONOHYDRATE)
STERILE SOLUTION
BONE METABOLISM REGULATOR
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision: April
30, 2018
Control No.: 210700
_Product Monograph - _
_Pr_
_Zoledronic Acid for Injection _
_Page 2 of 54 _
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
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................22
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................31
PART II: SCIENTIFIC INFORMATION
...............................................................................33
PHARMACEUTICAL INFORMATION
..........................................................................33
CLINICAL TRIALS
..........................................................................................................34
DETAILED PHA