TRENTAL TABLET (EXTENDED-RELEASE)
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
12-04-2011
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Aktiv bestanddel:
PENTOXIFYLLINE
Tilgængelig fra:
SANOFI-AVENTIS CANADA INC
ATC-kode:
C04AD03
INN (International Name):
PENTOXIFYLLINE
Dosering:
400MG
Lægemiddelform:
TABLET (EXTENDED-RELEASE)
Sammensætning:
PENTOXIFYLLINE 400MG
Indgivelsesvej:
ORAL
Enheder i pakken:
60
Recept type:
Prescription
Terapeutisk område:
HEMORRHEOLOGIC AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0115837001; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2013-03-01
Produktets egenskaber
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_Page 1 of 21_
PRODUCT MONOGRAPH
P
r
TRENTAL
®
(pentoxifylline sustained release tablets, 400 mg Mfr. Std.)
Vasoactive agent
ATC Code : C04AD03
sanofi-aventis Canada Inc.
DATE OF REVISION:
2150 St. Elzear Blvd. West
MARCH 30, 2011
Laval, Quebec H7L 4A8
SUBMISSION CONTROL NO.: 142355
s-a Version dated
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_Page 2 of 21_
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
...................................................................................
7
DOSAGE
AND
ADMINISTRATION
............................................................... 8
OVERDOSAGE
.................................................................................................
8
ACTION
AND
CLINICAL
PHARMACOLOGY.............................................. 9
STORAGE
AND
STABILITY
...........................................................................
9
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ............................. 10
PART II: SCIENTIFIC INFORMATION
....................................................... 11
PHARMACEUTICAL
INFORMATION.........................................................
11
DETAILED
PHARMACOLOGY
....................................................................
12
TOXICOLOGY
................................................................................................
14
REFERENCES
.................................................................................................
18
PART III: CONSUMER
INFORMATION...................................................... 20
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