ZOLEDRONIC ACID CONCENTRATE FOR INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Available from:

GENERIC MEDICAL PARTNERS INC

ATC code:

M05BA08

INN (International Name):

ZOLEDRONIC ACID

Dosage:

4MG

Pharmaceutical form:

SOLUTION

Composition:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

BONE RESORPTION INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2014-05-08

Summary of Product characteristics

_Page 1 of 54_
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID CONCENTRATE FOR INJECTION
(Zoledronic Acid for Injection)
4 mg zoledronic acid/5 mL incorporated as the monohydrate for
intravenous infusion
Concentrate – must be diluted before use
Bone Metabolism Regulator
Generic Medical Partners Inc.
251 Consumers Road, Suite 1200,
Toronto, Ontario, Canada
M2J 4R3
DATE OF REVISION:
August 14, 2017
Control No.: 207383
_Page 2 of 54_
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
..................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
20
DOSAGE AND ADMINISTRATION
.............................................................................
21
OVERDOSAGE
................................................................................................................
25
ACTION AND CLINICAL
PHARMACOLOGY............................................................
25
STORAGE AND STABILITY
.........................................................................................
29
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 30
PART II: SCIENTIFIC INFORMATION
..............................................................................
31
PHARMACEUTICAL INFORMATION
.........................................................................
31
CLINICAL TRIALS
..............................................................