ZOLEDRONIC ACID FOR INJECTION SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

MAH:

FRESENIUS KABI CANADA LTD

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:

2014-11-13

SPC

_ _
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID FOR INJECTION
4 mg/5 mL zoledronic acid (as zoledronic acid monohydrate)
CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION
Bone Metabolism Regulator
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Revision:
May 26, 2017
Submission Control No: 205586
_ _
_Zoledronic Acid for Injection-PM-ENG-v6.0 _
_ _
_Page 2 of 56_
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
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
22
DOSAGE AND ADMINISTRATION
.............................................................................
23
OVERDOSAGE
...............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 32
PART II: SCIENTIFIC INFORMATION
................................................................................34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.............................................................................................