VIVAGLOBIN SOLUTION

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

IMMUNOGLOBULIN G (HUMAN)

Доступна с:

CSL BEHRING CANADA INC

код АТС:

J06BA01

ИНН (Международная Имя):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASC. ADM

дозировка:

160MG

Фармацевтическая форма:

SOLUTION

состав:

IMMUNOGLOBULIN G (HUMAN) 160MG

Администрация маршрут:

SUBCUTANEOUS

Штук в упаковке:

3ML/10ML/20ML

Тип рецепта:

Schedule D

Терапевтические области:

SERUMS

Обзор продуктов:

Active ingredient group (AIG) number: 0151002002; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2015-04-02

Характеристики продукта

_ _
_Product Monograph - Schedule D _
_Page 1 of 32_
PRODUCT MONOGRAPH
VIVAGLOBIN
®
Immune Globulin Subcutaneous (Human)
16% Protein Solution (160 mg/mL)
Passive Immunizing Agent
CSL Behring Canada, Inc.
55 Metcalfe Street, Suite 1460
Ottawa, Ontario
KIP 6L5
Date of Revision: November 22, 2010
CONTROL #: 143341
DATE OF APPROVAL: January 20, 2011
_Product Monograph - Schedule D _
_Page 2 of 32_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND
PRECAUTIONS.................................................................................
4
ADVERSE
REACTIONS...................................................................................................
6
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND
ADMINISTRATION.............................................................................
12
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 14
STORAGE AND
STABILITY.........................................................................................
17
SPECIAL HANDLING INSTRUCTIONS
......................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 17
PART II: SCIENTIFIC INFORMATION
................................................................