ZOLEDRONIC ACID FOR INJECTION CONCENTRATE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Available from:

OMEGA LABORATORIES LIMITED

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:

1VIAL*5ML

Prescription type:

Prescription

Therapeutic area:

BONE RESORPTION INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2014-02-26

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
Z
OLEDRONIC
A
CID
F
OR
I
NJECTION
C
ONCENTRATE
4 mg/5 mL zoledronic acid (as zoledronic acid monohydrate)
Bone Metabolism Regulator
Omega Laboratories Limited
Date of Preparation: February 18, 2014
11 177 Hamon
Montreal, Quebec
H3M 3E4
Control No. 158614, 171670
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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
.................................................................................................
22
DOSAGE AND ADMINISTRATION
.............................................................................
22
OVERDOSAGE
................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 27
STORAGE AND STABILITY
.........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.........................................................................................................
35
DETAILED PHARMACOLOGY
..................................................