TEVA-TRAMADOL/ACETAMINOPHEN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Commercializzato da:

TEVA CANADA LIMITED

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:

60/100

Tipo di ricetta:

Narcotic (CDSA I)

Area terapeutica:

OPIATE AGONISTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2012-09-04

Scheda tecnica

Page 1 of 65
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
TEVA-TRAMADOL/ACETAMINOPHEN
Tramadol Hydrochloride and Acetaminophen Tablets
Teva Standard
37.5 mg tramadol hydrochloride
/ 325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission
Control Number: 265723
Date of Preparation:
September 04, 2012
Date of Revision:
November 25, 2022
Page 2 of 65
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION............................................. 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL
USE...........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
5
ADVERSE REACTIONS
.............................................................................................
18
DRUG
INTERACTIONS..............................................................................................
22
DOSAGE AND
ADMINISTRATION...........................................................................
27
OVERDOSAGE
...........................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 31
STORAGE AND
STABILITY......................................................................................
38
SPECIAL HANDLING INSTRUCTIONS
....................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 38
PART II: SCIENTIFIC INFORMATION
................................................................. 39
PHARMACEUTICAL
INFORMATION...............................................................