ARSENIC TRIOXIDE SOLUTION FOR INJECTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

ARSENIC TRIOXIDE

Доступна з:

PHEBRA PTY LTD

Код атс:

L01XX27

ІПН (Міжнародна Ім'я):

ARSENIC TRIOXIDE

Дозування:

10MG

Фармацевтична форма:

SOLUTION

Склад:

ARSENIC TRIOXIDE 10MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

15G/50G

Тип рецепту:

Prescription

Терапевтична области:

ANTINEOPLASTIC AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0108756003; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2019-04-15

Характеристики продукта

_ARSENIC TRIOXIDE SOLUTION FOR INJECTION Product Monograph _
_Page 1 of 49 _
PRODUCT MONOGRAPH
PR
ARSENIC TRIOXIDE SOLUTION FOR INJECTION
(ARSENIC TRIOXIDE)
For Injection
10 mg/10 mL (1 mg/mL) vial
Antineoplastic
Phebra Pty Ltd
19 Orion Road
Lane Cove West
Australia, 2066
Canadian Importer:
ICON Plc
4 Innovation Drive
Dundas, Ontario
L9H 7P3
Date of Revision:
November 7, 2019
Submission Control No: 232909
_ARSENIC TRIOXIDE SOLUTION FOR INJECTION Product Monograph _
_Page 2 of 49 _
TABLE OF CONTENT
PART I: HEALTH PROFESSIONAL INFORMATION
..............................................3
SUMMARY PRODUCT INFORMATION
............................................................3
INDICATIONS AND CLINICAL USE
..................................................................3
CONTRAINDICATIONS
.......................................................................................4
WARNINGS AND PRECAUTIONS
......................................................................4
ADVERSE REACTIONS
........................................................................................9
DRUG INTERACTIONS
......................................................................................19
DOSAGE AND ADMINISTRATION
..................................................................21
OVERDOSAGE
....................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
................................................24
STORAGE AND STABILITY
..............................................................................27
SPECIAL HANDLING INSTRUCTIONS
...........................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................27
PART II: SCIENTIFIC INFORMATION
....................................................................28
PHARMACEUTICAL INFORMATION
..............................................................28
CLINICAL TRIALS
............................................................................