ACT ZOLEDRONIC ACID CONCENTRATE 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:

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:

CANCELLED PRE MARKET

Autorisatie datum:

2017-09-01

Productkenmerken

_ACT ZOLEDRONIC ACID Concentrate Product Monograph _
_Page 1 of 51_
PRODUCT MONOGRAPH
PR
ACT_ _ZOLEDRONIC ACID CONCENTRATE
(Zoledronic acid for Injection)
Sterile Liquid Concentrate: 4 mg/5 mL zoledronic acid (as zoledronic
acid monohydrate) for
intravenous infusion
Bone Metabolism Regulator
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, ON
Canada, L5N 6J5
Date of Revision:
August 18, 2014
Submission Control No: 176793_ _
_ACT ZOLEDRONIC ACID Concentrate Product Monograph _
_Page 2 of 51_
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
..................................................................................................
12
DRUG INTERACTIONS
..................................................................................................
20
DOSAGE AND ADMINISTRATION
..............................................................................
21
OVERDOSAGE
................................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 26
STORAGE AND STABILITY
..........................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
...................................................