ZOLEDRONIC ACID CONCENTRATE SOLUTION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Доступно од:

APOTEX INC

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:

2015-07-20

Карактеристике производа

Page 1 of 51
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID CONCENTRATE
ZOLEDRONIC ACID FOR INJECTION
4 mg / 5 mL zoledronic acid (as zoledronic acid monohydrate)
Sterile concentrate solution for intravenous infusion
BONE METABOLISM REGULATOR
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION:
March 12, 2021
SUBMISSION CONTROL NUMBER: 246127
Page 2 of 51
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
..................................................................................
20
OVERDOSAGE
...............................................................................................................
24
ACTION AND CLINICAL
PHARMACOLOGY....................................................................
24
STORAGE AND STABILITY
............................................................................................
28
DOSAGE FORMS, COMPOSITION AND
PACKAGING.................................................... 29
PART II: SCIENTIFIC INFORMATION
.................................................................................
30
PHARMACEUTICAL INFORMATION
...............................................................................
30
CLINICAL TRIALS
...............................................................