TRAMACET TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Commercializzato da:

JANSSEN INC

Codice ATC:

N02AJ13

INN (Nome Internazionale):

TRAMADOL AND PARACETAMOL

Dosaggio:

325MG; 37.5MG

Forma farmaceutica:

TABLET

Composizione:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Via di somministrazione:

ORAL

Confezione:

10/60

Tipo di ricetta:

Narcotic (CDSA I)

Area terapeutica:

OPIATE AGONISTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2020-09-25

Scheda tecnica

_EDMS-RIM-595345 v6.0 _
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_Page 1 of 62 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
TRAMACET
®
tramadol hydrochloride and acetaminophen tablets, USP
37.5 mg tramadol hydrochloride/325
mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Preparation:
July 14, 2005
Date of Revision:
June 7, 2022
SUBMISSION CONTROL NO: 260176
All trademarks used under license.
© 2022 Janssen Inc.
_EDMS-RIM-595345 v6.0 _
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_Page 2 of 62 _
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
...............................................................................................17
DRUG INTERACTIONS
................................................................................................21
DOSAGE AND ADMINISTRATION
.............................................................................26
OVERDOSAGE
.............................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
........................................................................................37
SPECIAL HANDLING
INSTRUCTIONS.......................................................................37
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................37
PART II: SCIENTIFIC INFORMATION
..................................................