ABLAVAR SOLUTION

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

GADOFOSVESET TRISODIUM

Доступна с:

LANTHEUS MI CANADA INC

код АТС:

V08CA11

ИНН (Международная Имя):

GADOFOSVESET

дозировка:

244MG

Фармацевтическая форма:

SOLUTION

состав:

GADOFOSVESET TRISODIUM 244MG

Администрация маршрут:

INTRAVENOUS

Штук в упаковке:

100

Тип рецепта:

Ethical

Терапевтические области:

OTHER DIAGNOSTIC AGENTS

Обзор продуктов:

Active ingredient group (AIG) number: 0151671001; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2016-03-07

Характеристики продукта

_ _
_ _
Page 1 of 46
PRODUCT MONOGRAPH
ABLAVAR
TM
(gadofosveset trisodium injection)
244 mg/mL (0.25mmol/mL)
INTRAVENOUS CONTRAST ENHANCEMENT AGENT FOR MAGNETIC RESONANCE IMAGING
(MRI)
FOR INTRAVENOUS USE
Lantheus MI Canada, Inc.
1111 Dr. Frederik-Philips Boulevard
Montreal, QC Canada
Control No.: 176017
Date of Revision:
October 1, 2014
_ _
_ _
Page 2 of 46
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
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
................................................................................24
PHARMACEUTICAL INFORMATION
..........................................................................24
CLINICAL TRIALS
..........................................................................................................25
DETAILED PHARMA