TRAMAPHEN-ODAN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
03-07-2012
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Aktiv bestanddel:
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Tilgængelig fra:
ODAN LABORATORIES LTD
ATC-kode:
N02AJ13
INN (International Name):
TRAMADOL AND PARACETAMOL
Dosering:
325MG; 37.5MG
Lægemiddelform:
TABLET
Sammensætning:
ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100/500
Recept type:
Narcotic (CDSA I)
Terapeutisk område:
OPIATE AGONISTS
Produkt oversigt:
Active ingredient group (AIG) number: 0250601001; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2014-10-31
Produktets egenskaber
1 | P a g e
PRODUCT MONOGRAPH
PR
TRAMAPHEN-ODAN
Acetaminophen and Tramadol hydrochloride tablets, House Std
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Centrally Acting Analgesic
ODAN LABORATORIES LTD.
DATE OF PREPARATION:
325 STILLVIEW AVENUE
JULY 3, 2012
POINTE-CLAIRE, QC
CANADA H9R 2Y6
Control# 156402
2 | P a g e
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..............................................................................
3
SUMMARY PRODUCT INFORMATION
..........................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................................
3
CONTRAINDICATIONS
..................................................................................................................
4
WARNINGS AND PRECAUTIONS
...................................................................................................
4
ADVERSE REACTIONS
...................................................................................................................
9
DRUG ABUSE, ADDICTION AND DEPENDENCE
...........................................................................
12
DRUG INTERACTIONS
.................................................................................................................
13
DOSAGE AND ADMINISTRATION
...............................................................................................
14
OVERDOSAGE
.............................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
17
STORAGE AND STABILITY
...........................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 21
PART II: SCIENTIFIC INFORMATION
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