ZOLEDRONIC ACID FOR INJECTION SOLUTION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Доступно од:

JUNO PHARMACEUTICALS CORP.

АТЦ код:

M05BA08

INN (Међународно име):

ZOLEDRONIC ACID

Дозирање:

4MG

Фармацеутски облик:

SOLUTION

Састав:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Пут администрације:

INTRAVENOUS

Јединице у пакету:

5ML

Тип рецептора:

Prescription

Терапеутска област:

BONE RESORPTION INHIBITORS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2016-01-04

Карактеристике производа

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