ZYTRAM XL TABLET (EXTENDED-RELEASE)

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

TRAMADOL HYDROCHLORIDE

Disponible des:

PURDUE PHARMA

Codi ATC:

N02AX02

Designació comuna internacional (DCI):

TRAMADOL

Dosis:

75MG

formulario farmacéutico:

TABLET (EXTENDED-RELEASE)

Composición:

TRAMADOL HYDROCHLORIDE 75MG

Vía de administración:

ORAL

Unidades en paquete:

50/60

tipo de receta:

Narcotic (CDSA I)

Área terapéutica:

OPIATE AGONISTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2010-12-02

Fitxa tècnica

_ _
_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
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4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
............................................................................................
6
4.2
Recommended