PH 12 STERILE DILUENT FOR FLOLAN LIQUID

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

GLYCINE; SODIUM CHLORIDE; WATER

Доступна з:

GLAXOSMITHKLINE INC

Код атс:

V07AB

ІПН (Міжнародна Ім'я):

SOLVENTS AND DILUTING AGENTS, INCL IRRIGAT SOLUT

Дозування:

94MG; 73.3MG; 50ML

Фармацевтична форма:

LIQUID

Склад:

GLYCINE 94MG; SODIUM CHLORIDE 73.3MG; WATER 50ML

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

50ML

Тип рецепту:

Ethical

Терапевтична области:

DILUENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0357090001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2015-07-16

Характеристики продукта

_FLOLAN, epoprostenol powder for injection _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
FLOLAN
Epoprostenol Powder for Injection
0.5 or 1.5 mg epoprostenol (as epoprostenol sodium) per vial,
Intravenous
Vasodilator
GlaxoSmithKline Inc.
100 Milverton Drive
Suite 800
Mississauga, ON
L5R 4H1
Canada
Date of Initial Authorization:
March 6, 1997
Date of Revision:
MAR 26, 2024
Submission Control Number: 278168
_©_
_2024 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies _
_FLOLAN, epoprostenol powder for injection _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
03/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
4
DOSAGE AND ADMINISTRATION
..................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.3
Reconstitution
...............