RATIO-PENTOXIFYLLINE TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
18-09-2009
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Active ingredient:
PENTOXIFYLLINE
Available from:
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
ATC code:
C04AD03
INN (International Name):
PENTOXIFYLLINE
Dosage:
400MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
PENTOXIFYLLINE 400MG
Administration route:
ORAL
Units in package:
60/100/500TABS
Prescription type:
Prescription
Therapeutic area:
HEMORRHEOLOGIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0115837001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2010-08-02
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
ratio-PENTOXIFYLLINE
(pentoxifylline)
400 mg Sustained-Release Tablets
Vasoactive agent
ratiopharm inc.
17800, rue Lapointe
Mirabel (Québec)
Canada, J7J 1P3
Date of Revision:
September 18, 2009
Submission Control No: 131604
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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...................................................................................
5
DRUG
INTERACTIONS
...................................................................................
6
DOSAGE
AND
ADMINISTRATION
............................................................... 8
OVERDOSAGE
.................................................................................................
8
ACTION
AND
CLINICAL
PHARMACOLOGY.............................................. 8
STORAGE
AND
STABILITY
...........................................................................
9
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ............................... 9
PART II: SCIENTIFIC INFORMATION
....................................................... 10
PHARMACEUTICAL
INFORMATION.........................................................
10
DETAILED
PHARMACOLOGY
....................................................................
11
TOXICOLOGY
................................................................................................
13
REFERENCES
.................................................................................................
17
PART III: CONSUMER
INFORMATION...................................................... 19
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_Page 3 of 20_
P
ratio-PENTOXIFYLLINE
(pentoxifylli
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