ZOLEDRONIC ACID FOR INJECTION SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

MAH:

PFIZER CANADA ULC

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:

CANCELLED POST MARKET

authorization_date:

2021-04-08

SPC

PRODUCT MONOGRAPH
Pr
ZOLEDRONIC ACID FOR INJECTION
4 MG/5 ML (0.8 MG/ML)
ZOLEDRONIC ACID (AS ZOLEDRONIC ACID MONOHYDRATE)
STERILE SOLUTION
BONE METABOLISM REGULATOR
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision: April
30, 2018
Control No.: 210700
_Product Monograph - _
_Pr_
_Zoledronic Acid for Injection _
_Page 2 of 54 _
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
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................22
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................31
PART II: SCIENTIFIC INFORMATION
...............................................................................33
PHARMACEUTICAL INFORMATION
..........................................................................33
CLINICAL TRIALS
..........................................................................................................34
DETAILED PHA