ZOLEDRONIC ACID FOR INJECTION SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

M05BA08

DCI (Dénomination commune internationale):

ZOLEDRONIC ACID

Dosage:

4MG

forme pharmaceutique:

SOLUTION

Composition:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

5ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

BONE RESORPTION INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2014-02-26

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID FOR INJECTION
CONCENTRATE
4 mg /5 mL zoledronic acid (as zoledronic acid monohydrate)
Sterile solution, for Intravenous Infusion
Bone Metabolism Regulator
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
M1B 2K9
Date of Revision:
Feb. 15, 2022
Control No. : 254854
_Page 2 of 52 _
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
.........................................................................................................
21
DOSAGE AND ADMINISTRATION
.....................................................................................
22
OVERDOSAGE
.......................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 26
STORAGE AND STABILITY
.................................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 31
PART II: SCIENTIFIC INFORMATION
...............................................................................
32
PHARMACEUTICAL INFORMATION
.................................................................................
32
CLINICAL TRIALS
................................................................