ACT ZOLEDRONIC ACID CONCENTRATE SOLUTION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Доступно од:

ACTAVIS PHARMA COMPANY

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 PRE MARKET

Датум одобрења:

2017-09-01

Карактеристике производа

_ACT ZOLEDRONIC ACID Concentrate Product Monograph _
_Page 1 of 51_
PRODUCT MONOGRAPH
PR
ACT_ _ZOLEDRONIC ACID CONCENTRATE
(Zoledronic acid for Injection)
Sterile Liquid Concentrate: 4 mg/5 mL zoledronic acid (as zoledronic
acid monohydrate) for
intravenous infusion
Bone Metabolism Regulator
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, ON
Canada, L5N 6J5
Date of Revision:
August 18, 2014
Submission Control No: 176793_ _
_ACT ZOLEDRONIC ACID Concentrate Product Monograph _
_Page 2 of 51_
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
..................................................................................................
12
DRUG INTERACTIONS
..................................................................................................
20
DOSAGE AND ADMINISTRATION
..............................................................................
21
OVERDOSAGE
................................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 26
STORAGE AND STABILITY
..........................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
...................................................