ZOLEDRONIC ACID CONCENTRATE SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-03-2021
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Active ingredient:
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
Available from:
APOTEX 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:
5ML
Prescription type:
Prescription
Therapeutic area:
BONE RESORPTION INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0141761002; AHFS:
Authorization status:
APPROVED
Authorization date:
2015-07-20
Summary of Product characteristics
Page 1 of 51
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID CONCENTRATE
ZOLEDRONIC ACID FOR INJECTION
4 mg / 5 mL zoledronic acid (as zoledronic acid monohydrate)
Sterile concentrate solution for intravenous infusion
BONE METABOLISM REGULATOR
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION:
March 12, 2021
SUBMISSION CONTROL NUMBER: 246127
Page 2 of 51
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
..................................................................................
20
OVERDOSAGE
...............................................................................................................
24
ACTION AND CLINICAL
PHARMACOLOGY....................................................................
24
STORAGE AND STABILITY
............................................................................................
28
DOSAGE FORMS, COMPOSITION AND
PACKAGING.................................................... 29
PART II: SCIENTIFIC INFORMATION
.................................................................................
30
PHARMACEUTICAL INFORMATION
...............................................................................
30
CLINICAL TRIALS
...............................................................
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