ZOLEDRONIC ACID FOR INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponibil de la:

JUNO PHARMACEUTICALS CORP.

Codul ATC:

M05BA08

INN (nume internaţional):

ZOLEDRONIC ACID

Dozare:

4MG

Forma farmaceutică:

SOLUTION

Compoziție:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

5ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

BONE RESORPTION INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2016-01-04

Caracteristicilor produsului

_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
...........................................................................