ZOLEDRONIC ACID - A SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Available from:

SANDOZ CANADA INCORPORATED

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:

2019-08-01

Summary of Product characteristics

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_Zoledronic Acid – A _
_ Page 1 of 62 _
PRODUCT MONOGRAPH
PR ZOLEDRONIC ACID - A
(zoledronic acid injection)
5 mg/100 mL solution for intravenous infusion
Bone Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, Quebec
J4B 7K8
Date of Revision:
July 4, 2017
Control No.: 205813
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_Zoledronic Acid – A Page 2 of 62 _
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
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................25
OVERDOSAGE
................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................30
SPECIAL HANDLING INSTRUCTIONS
.......................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................31
PART II: SCIENTIFIC INFORMATION
...............................................................................32
PHARMACEUTICAL INFORMATION
..........................................................................32
CLINICAL TRIALS
..........................................................................................................33
DETAILED PHARMACOLOGY
..........................