PH 12 STERILE DILUENT FOR FLOLAN LIQUID

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

GLYCINE; SODIUM CHLORIDE; WATER

Disponibil de la:

GLAXOSMITHKLINE INC

Codul ATC:

V07AB

INN (nume internaţional):

SOLVENTS AND DILUTING AGENTS, INCL IRRIGAT SOLUT

Dozare:

94MG; 73.3MG; 50ML

Forma farmaceutică:

LIQUID

Compoziție:

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

Calea de administrare:

INTRAVENOUS

Unități în pachet:

50ML

Tip de prescriptie medicala:

Ethical

Zonă Terapeutică:

DILUENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2015-07-16

Caracteristicilor produsului

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