ALPROSTADIL INJECTION USP SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-08-2016
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
ALPROSTADIL
Available from:
ADVANCED DOSAGE FORMS INC.
ATC code:
C01EA01
INN (International Name):
ALPROSTADIL
Dosage:
500MCG
Pharmaceutical form:
SOLUTION
Composition:
ALPROSTADIL 500MCG
Administration route:
INTRAVASCULAR
Units in package:
1ML
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS VASODILATATING AGENTS
Product summary:
Active ingredient group (AIG) number: 0115288012; AHFS:
Authorization status:
APPROVED
Authorization date:
2008-06-04
Summary of Product characteristics
_ _
_Alprostadil Injection USP _
_Page 1 of 16_
_Product Monograph _
PRODUCT MONOGRAPH
Pr ALPROSTADIL INJECTION USP
Alprostadil
500 mcg/mL Injection
USP
Prostaglandin
Advanced Dosage Forms Inc.
Date of Preparation:
502 Lakeshore Road
August 24, 2016
Beaconsfield, Quebec
H4W 4J7
Imported & Distributed by:
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario
L6H 6R4
Control # 197071
_ _
_Alprostadil Injection USP _
_Page 2 of 16_
_Product Monograph _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................................
3
SUMMARY
PRODUCT
INFORMATION
..............................................................................................................
3
INDICATIONS
AND
CLINICAL
USE
....................................................................................................................
3
CONTRAINDICATIONS
.........................................................................................................................................
3
WARNINGS
AND
PRECAUTIONS
........................................................................................................................
3
ADVERSE
REACTIONS
.........................................................................................................................................
5
DRUG
INTERACTIONS
..........................................................................................................................................
6
DOSAGE
AND
ADMINISTRATION
......................................................................................................................
6
OVERDOSAGE
........................................................................................................................................................
7
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................................................
8
STORAGE
AND
STABILITY
...............................................................
Read the complete document
