ZOLEDRONIC ACID FOR INJECTION SOLUTION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Доступно од:

PFIZER CANADA ULC

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:

CANCELLED POST MARKET

Датум одобрења:

2021-04-08

Карактеристике производа

PRODUCT MONOGRAPH
Pr
ZOLEDRONIC ACID FOR INJECTION
4 MG/5 ML (0.8 MG/ML)
ZOLEDRONIC ACID (AS ZOLEDRONIC ACID MONOHYDRATE)
STERILE SOLUTION
BONE METABOLISM REGULATOR
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision: April
30, 2018
Control No.: 210700
_Product Monograph - _
_Pr_
_Zoledronic Acid for Injection _
_Page 2 of 54 _
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
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................22
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................31
PART II: SCIENTIFIC INFORMATION
...............................................................................33
PHARMACEUTICAL INFORMATION
..........................................................................33
CLINICAL TRIALS
..........................................................................................................34
DETAILED PHA