ZOLEDRONIC ACID CONCENTRATE FOR INJECTION SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Tilgjengelig fra:

GENERIC MEDICAL PARTNERS INC

ATC-kode:

M05BA08

INN (International Name):

ZOLEDRONIC ACID

Dosering :

4MG

Legemiddelform:

SOLUTION

Sammensetning:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

BONE RESORPTION INHIBITORS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2014-05-08

Preparatomtale

_Page 1 of 54_
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID CONCENTRATE FOR INJECTION
(Zoledronic Acid for Injection)
4 mg zoledronic acid/5 mL incorporated as the monohydrate for
intravenous infusion
Concentrate – must be diluted before use
Bone Metabolism Regulator
Generic Medical Partners Inc.
251 Consumers Road, Suite 1200,
Toronto, Ontario, Canada
M2J 4R3
DATE OF REVISION:
August 14, 2017
Control No.: 207383
_Page 2 of 54_
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
................................................................................................................
25
ACTION AND CLINICAL
PHARMACOLOGY............................................................
25
STORAGE AND STABILITY
.........................................................................................
29
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 30
PART II: SCIENTIFIC INFORMATION
..............................................................................
31
PHARMACEUTICAL INFORMATION
.........................................................................
31
CLINICAL TRIALS
..............................................................