ZOLEDRONIC ACID FOR INJECTION SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Saatavilla:

JUNO PHARMACEUTICALS CORP.

ATC-koodi:

M05BA08

INN (Kansainvälinen yleisnimi):

ZOLEDRONIC ACID

Annos:

4MG

Lääkemuoto:

SOLUTION

Koostumus:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

5ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

BONE RESORPTION INHIBITORS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2016-01-04

Valmisteyhteenveto

_Zoledronic Acid for Injection Product Monograph _
_Page 1 of 50_
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID FOR INJECTION
4 mg / 5 mL zoledronic acid (as zoledronic acid monohydrate)
Sterile Concentrate Solution for Intravenous Infusion
Bone Metabolism Regulator
JUNO PHARMACEUTICALS CORP.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
DATE OF REVISION:
September 22, 2020
SUBMISSION CONTROL NO.: 243250
_Zoledronic Acid for Injection Product Monograph _
_Page 2 of 50_
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
............................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
.........................................................25
STORAGE AND STABILITY
......................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................29
PART II: SCIENTIFIC INFORMATION
.........................................................................30
PHARMACEUTICAL INFORMATION
.....................................................................30
CLINICAL TRIALS
...........................................................................