PAT-TRAMADOL/ACET TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Beschikbaar vanaf:

PATRIOT A DIVISION OF JANSSEN INC

ATC-code:

N02AJ13

INN (Algemene Internationale Benaming):

TRAMADOL AND PARACETAMOL

Dosering:

325MG; 37.5MG

farmaceutische vorm:

TABLET

Samenstelling:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Toedieningsweg:

ORAL

Eenheden in pakket:

60

Prescription-type:

Narcotic (CDSA I)

Therapeutisch gebied:

OPIATE AGONISTS

Product samenvatting:

Active ingredient group (AIG) number: 0250601001; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2014-11-11

Productkenmerken

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_Page 1 of 40 _
PRODUCT MONOGRAPH
PR
PAT-TRAMADOL/ACET
tramadol hydrochloride and acetaminophen tablets, USP
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Centrally Acting Analgesic
Patriot, a division of Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.patriot-canada.ca
Date of Preparation:
July 9, 2012
Date of Revision:
September 5, 2014
SUBMISSION CONTROL NO: 177222
© 2014 Patriot, a Division of Janssen Inc.
_ _
_Page 2 of 40 _
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
.........................................................................................................
10
DRUG ABUSE, ADDICTION AND DEPENDENCE
............................................................ 12
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 17
STORAGE AND STABILITY
.................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
.........................................