ZOLEDRONIC ACID FOR INJECTION SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Verfügbar ab:

TEVA CANADA LIMITED

ATC-Code:

M05BA08

INN (Internationale Bezeichnung):

ZOLEDRONIC ACID

Dosierung:

4MG

Darreichungsform:

SOLUTION

Zusammensetzung:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

5ML

Verschreibungstyp:

Prescription

Therapiebereich:

BONE RESORPTION INHIBITORS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2014-02-26

Fachinformation

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
................................................................