ZOMETA CONCENTRATE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Available from:

NOVARTIS PHARMACEUTICALS CANADA 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:

2003-12-05

Summary of Product characteristics

_ZOMETA_
_®_
_ Product Monograph _
_Page 1 of 50 _
_ _
PRODUCT MONOGRAPH
PR
ZOMETA
® CONCENTRATE
(Zoledronic acid for Injection)
4 mg zoledronic acid/5 mL incorporated as the monohydrate for
intravenous infusion
Bone Metabolism Regulator
Novartis Pharmaceuticals Canada Inc.
Dorval, Quebec
H9S 1A9
Date of Revision:
April 13, 2017
Control No. 200447
ZOMETA is a registered trademark
_ZOMETA_
_®_
_ Product Monograph _
_Page 2 of 50 _
_ _
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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................28
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTICAL INFORMATION
..........................................................................30
CLINICAL TRIALS
...............................................