APO-TRAMADOL/ACET TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Commercializzato da:

APOTEX 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:

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:

2009-11-06

Scheda tecnica

_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
.......................