PAMIDRONATE DISODIUM FOR INJECTION SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

PAMIDRONATE DISODIUM

Доступно од:

FRESENIUS KABI CANADA LTD

АТЦ код:

M05BA03

INN (Међународно име):

PAMIDRONIC ACID

Дозирање:

9MG

Фармацеутски облик:

SOLUTION

Састав:

PAMIDRONATE DISODIUM 9MG

Пут администрације:

INTRAVENOUS

Јединице у пакету:

10ML

Тип рецептора:

Prescription

Терапеутска област:

BONE RESORPTION INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0123608006; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2015-02-04

Карактеристике производа

PRODUCT MONOGRAPH
PR
PAMIDRONATE DISODIUM FOR INJECTION
(pamidronate disodium)
3 mg / mL, 6 mg / mL and 9 mg / mL
Solution for Injection
For Intravenous Infusion Only
Bone Metabolism Regulator
FRESENIUS KABI CANADA LTD.
Date of Revision:
165 Galaxy Blvd, Suite 100
March 12, 2019
Toronto, ON M9W 0C8
Submission Control No: 224510
Pamidronate Disodium for Injection_-_Product Monograph
Page 2 of 41
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
.........................................................................................................
10
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
.....................................................................................
15
OVERDOSAGE
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 19
STORAGE AND STABILITY
.................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
.................................................................................
24
CLINICAL