ZOLEDRONIC ACID FOR INJECTION SOLUTION
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
15-02-2022
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Werkstoffen:
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
Beschikbaar vanaf:
TEVA CANADA LIMITED
ATC-code:
M05BA08
INN (Algemene Internationale Benaming):
ZOLEDRONIC ACID
Dosering:
4MG
farmaceutische vorm:
SOLUTION
Samenstelling:
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG
Toedieningsweg:
INTRAVENOUS
Eenheden in pakket:
5ML
Prescription-type:
Prescription
Therapeutisch gebied:
BONE RESORPTION INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0141761002; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2014-02-26
Productkenmerken
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
................................................................
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