TRAMAPHEN-ODAN TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
03-07-2012
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Aktívna zložka:
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Dostupné z:
ODAN LABORATORIES LTD
ATC kód:
N02AJ13
INN (Medzinárodný Name):
TRAMADOL AND PARACETAMOL
Dávkovanie:
325MG; 37.5MG
Forma lieku:
TABLET
Zloženie:
ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG
Spôsob podávania:
ORAL
Počet v balení:
100/500
Typ predpisu:
Narcotic (CDSA I)
Terapeutické oblasti:
OPIATE AGONISTS
Prehľad produktov:
Active ingredient group (AIG) number: 0250601001; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2014-10-31
Súhrn charakteristických
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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