ZOLEDRONIC ACID - Z SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

MAH:

SANDOZ CANADA INCORPORATED

ATC_code:

M05BA08

INN:

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

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2013-02-15

SPC

_Zoledronic Acid – Z _
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_Page 1 of 51 _
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID - Z
(Zoledronic acid for Injection)
4 mg zoledronic acid/5 mL incorporated as the monohydrate for
intravenous infusion
Bone Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Date of Revision:
July 21, 2017
Control No. : 206684
_Zoledronic Acid – Z _
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_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
........................................................................
25
STORAGE AND STABILITY
.....................................................................................................
29
DOSAGE FORMS, COMPOSITION AND
PACKAGING......................................................... 29
PART II: SCIENTIFIC INFORMATION
...............................................................................
30
PHARMACEUTICAL INFORMATION
..................................................