ZOLEDRONIC ACID FOR INJECTION SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponible depuis:

JUNO PHARMACEUTICALS CORP.

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:

2016-01-04

Résumé des caractéristiques du produit

_Zoledronic Acid for Injection Product Monograph _
_Page 1 of 50_
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID FOR INJECTION
4 mg / 5 mL zoledronic acid (as zoledronic acid monohydrate)
Sterile Concentrate Solution for Intravenous Infusion
Bone Metabolism Regulator
JUNO PHARMACEUTICALS CORP.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
DATE OF REVISION:
September 22, 2020
SUBMISSION CONTROL NO.: 243250
_Zoledronic Acid for Injection Product Monograph _
_Page 2 of 50_
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
..........................................................................21
OVERDOSAGE
............................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
.........................................................25
STORAGE AND STABILITY
......................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................29
PART II: SCIENTIFIC INFORMATION
.........................................................................30
PHARMACEUTICAL INFORMATION
.....................................................................30
CLINICAL TRIALS
...........................................................................