ZOLEDRONIC ACID FOR INJECTION CONCENTRATE SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Предлага се от:

DR REDDY'S LABORATORIES LTD

АТС код:

M05BA08

INN (Международно Name):

ZOLEDRONIC ACID

дозиране:

4MG

Лекарствена форма:

SOLUTION

Композиция:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

5ML(1 VIAL)

Вид предписание :

Prescription

Терапевтична област:

BONE RESORPTION INHIBITORS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2014-03-21

Данни за продукта

1
PRODUCT MONOGRAPH
Pr
ZOLEDRONIC ACID FOR INJECTION CONCENTRATE
4 mg/5 mL zoledronic acid (as zoledronic acid monohydrate)
Bone Metabolism Regulator
DIN Owner:
DR. REDDY’S LABORATORIES LIMITED
Bachupally 500 090 - INDIA
Imported By:
DATE OF REVISION:
DR. REDDY’S LABORATORIES CANADA INC.
Mississauga ON L4W 4Y1 Canada
July 19, 2019
Submission Control No: 228529
2
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
..............................................................................................................
21
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
...........................................................