PH 12 STERILE DILUENT FOR FLOLAN LIQUID

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

GLYCINE; SODIUM CHLORIDE; WATER

Beschikbaar vanaf:

GLAXOSMITHKLINE INC

ATC-code:

V07AB

INN (Algemene Internationale Benaming):

SOLVENTS AND DILUTING AGENTS, INCL IRRIGAT SOLUT

Dosering:

94MG; 73.3MG; 50ML

farmaceutische vorm:

LIQUID

Samenstelling:

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

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

50ML

Prescription-type:

Ethical

Therapeutisch gebied:

DILUENTS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2015-07-16

Productkenmerken

_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
...............