TARO-ZOLEDRONIC ACID CONCENTRATE SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

MAH:

TARO PHARMACEUTICALS INC

ATC_code:

M05BA08

INN:

ZOLEDRONIC ACID

dosage:

4MG

pharmaceutical_form:

SOLUTION

composition:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

administration_route:

INTRAVENOUS

units_in_package:

6* 5ML(VIAL)

prescription_type:

Prescription

therapeutic_area:

BONE RESORPTION INHIBITORS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2014-02-26

SPC

PRODUCT MONOGRAPH
PR
TARO-ZOLEDRONIC ACID CONCENTRATE
(ZOLEDRONIC ACID FOR INJECTION)
4 MG ZOLEDRONIC ACID/5 ML INCORPORATED AS THE MONOHYDRATE
Sterile concentrate for injection
MUST BE DILUTED BEFORE USE
Bone Metabolism Regulator
TARO PHARMACEUTICALS INC.
130 East Drive,
Brampton, Ontario, Canada
L6T 1C1
CONTROL NUMBER:
222810
DATE OF PREPARATION:
January 2, 2019
_TARO-ZOLENDRONIC ACID CONCENTRATE _
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Page 2 of 55
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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
.......................................................................................................................
23
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
.......