ACT ZOLEDRONIC ACID SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Beschikbaar vanaf:

ACTAVIS PHARMA COMPANY

ATC-code:

M05BA08

INN (Algemene Internationale Benaming):

ZOLEDRONIC ACID

Dosering:

5MG

farmaceutische vorm:

SOLUTION

Samenstelling:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

100ML

Prescription-type:

Prescription

Therapeutisch gebied:

BONE RESORPTION INHIBITORS

Product samenvatting:

Active ingredient group (AIG) number: 0141761003; AHFS:

Autorisatie-status:

CANCELLED PRE MARKET

Autorisatie datum:

2020-04-08

Productkenmerken

_ _
_ACT ZOLEDRONIC ACID Product Monograph _
_Page 1 of 64_
PRODUCT MONOGRAPH
PR
ACT_ _ZOLEDRONIC ACID
(Zoledronic Acid Injection)
Sterile Solution for Intravenous Infusion
5 mg /100 mL zoledronic acid (as zoledronic acid monohydrate)
Bone Metabolism Regulator
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Revision:
June 1, 2017
Control No.: 205792
_ _
_ACT ZOLEDRONIC ACID Product Monograph _
_Page 2 of 64_
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
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
25
DOSAGE AND ADMINISTRATION
.............................................................................
27
OVERDOSAGE
...............................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 29
STORAGE AND STABILITY
.........................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
......................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 33
PART II: SCIENTIFIC INFORMATION
..............................................................................
34
PHARMACEUTICAL INFORMATION
....................