APO-TRAMADOL/ACET TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Tilgjengelig fra:

APOTEX INC

ATC-kode:

N02AJ13

INN (International Name):

TRAMADOL AND PARACETAMOL

Dosering :

325MG; 37.5MG

Legemiddelform:

TABLET

Sammensetning:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Narcotic (CDSA I)

Terapeutisk område:

OPIATE AGONISTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2009-11-06

Preparatomtale

_Page 1 of 70 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
APO-TRAMADOL/ACET
Tramadol Hydrochloride/Acetaminophen Tablets, USP
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Revision:
September 14, 2022
SUBMISSION CONTROL NUMBER: 266547
_Page 2 of 70 _
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
..............................................................................................
18
DRUG INTERACTIONS
.............................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
28
OVERDOSAGE..........................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 32
STORAGE AND STABILITY
.......................................................................................
40
SPECIAL HANDLING INSTRUCTIONS
....................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 40
PART II: SCIENTIFIC INFORMATION
........................................................................
41
PHARMACEUTICAL INFORMATION
.........................................................................
41
CLINICAL TRIALS
.......................