TARO-TRAMADOL/ACET TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Beschikbaar vanaf:

SUN PHARMA CANADA 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:

100

Prescription-type:

Narcotic (CDSA I)

Therapeutisch gebied:

OPIATE AGONISTS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2012-09-04

Productkenmerken

N
TARO-TRAMADOL/ACET – Product Monograph
Page 1 of 68
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
TARO-TRAMADOL/ACET
Acetaminophen and Tramadol hydrochloride tablets, House Std.
37.5 mg tramadol hydrochloride / 325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
Sun Pharma Canada Inc.
Date of Revision:
126 East Drive
October 25, 2023
Brampton, Ontario
L6T 1C1
Control No.: 272054
N
TARO-TRAMADOL/ACET – Product Monograph
Page 2 of 68
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
.....................................................................................
27
OVERDOSAGE
........................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
31
STORAGE AND STABILITY
.................................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 38
PART II: SCIENTIFIC INFORMATION
...............................................................................
39
PHARMACEUTICAL INFORMATION
.............