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:

FRESENIUS KABI CANADA LTD

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:

APPROVED

授权日期:

2014-11-13

产品特点

_ _
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID FOR INJECTION
4 mg/5 mL zoledronic acid (as zoledronic acid monohydrate)
CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION
Bone Metabolism Regulator
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Revision:
May 26, 2017
Submission Control No: 205586
_ _
_Zoledronic Acid for Injection-PM-ENG-v6.0 _
_ _
_Page 2 of 56_
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
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
22
DOSAGE AND ADMINISTRATION
.............................................................................
23
OVERDOSAGE
...............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 32
PART II: SCIENTIFIC INFORMATION
................................................................................34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.............................................................................................