ZYTRAM XL TABLET (EXTENDED-RELEASE)

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

TRAMADOL HYDROCHLORIDE

Disponibbli minn:

PURDUE PHARMA

Kodiċi ATC:

N02AX02

INN (Isem Internazzjonali):

TRAMADOL

Dożaġġ:

75MG

Għamla farmaċewtika:

TABLET (EXTENDED-RELEASE)

Kompożizzjoni:

TRAMADOL HYDROCHLORIDE 75MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

50/60

Tip ta 'preskrizzjoni:

Narcotic (CDSA I)

Żona terapewtika:

OPIATE AGONISTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0151694007; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2010-12-02

Karatteristiċi tal-prodott

_ _
_ZYTRAM XL_
_®_
_ (tramadol HCl controlled release tablets) _
_Page 1 of 46_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
ZYTRAM XL®
Tramadol Hydrochloride
Controlled Release Tablets, 75, 100, 150, 200, 300 and 400 mg, Oral
Purdue Pharma Standard
Opioid Analgesic
ATC code: N02AX02
Purdue Pharma
3381 Steeles Avenue East, Suite 310
Toronto, Ontario
M2H 3S7
Date of Initial Approval:
Sept 28, 2006
Date of Revision:
December 01, 2023
Submission Control Number: 274793
_ _
_ZYTRAM XL_
_®_
_ (tramadol HCl controlled release tablets) _
_Page 2 of 46_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
12/2023
7 WARNING AND PRECAUTIONS
12/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
............................................................................................
6
4.2
Recommended