ACT ZOLEDRONIC ACID SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Available from:

ACTAVIS PHARMA COMPANY

ATC code:

M05BA08

INN (International Name):

ZOLEDRONIC ACID

Dosage:

5MG

Pharmaceutical form:

SOLUTION

Composition:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG

Administration route:

INTRAVENOUS

Units in package:

100ML

Prescription type:

Prescription

Therapeutic area:

BONE RESORPTION INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0141761003; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2020-04-08

Summary of Product characteristics

_ _
_ACT ZOLEDRONIC ACID Product Monograph _
_Page 1 of 64_
PRODUCT MONOGRAPH
PR
ACT_ _ZOLEDRONIC ACID
(Zoledronic Acid Injection)
Sterile Solution for Intravenous Infusion
5 mg /100 mL zoledronic acid (as zoledronic acid monohydrate)
Bone Metabolism Regulator
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Revision:
June 1, 2017
Control No.: 205792
_ _
_ACT ZOLEDRONIC ACID Product Monograph _
_Page 2 of 64_
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
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
25
DOSAGE AND ADMINISTRATION
.............................................................................
27
OVERDOSAGE
...............................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 29
STORAGE AND STABILITY
.........................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
......................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 33
PART II: SCIENTIFIC INFORMATION
..............................................................................
34
PHARMACEUTICAL INFORMATION
....................