RALIVIA TABLET (EXTENDED-RELEASE)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

TRAMADOL HYDROCHLORIDE

Saatavilla:

BAUSCH HEALTH, CANADA INC.

ATC-koodi:

N02AX02

INN (Kansainvälinen yleisnimi):

TRAMADOL

Annos:

300MG

Lääkemuoto:

TABLET (EXTENDED-RELEASE)

Koostumus:

TRAMADOL HYDROCHLORIDE 300MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Narcotic (CDSA I)

Terapeuttinen alue:

OPIATE AGONISTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0151694001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2011-02-10

Valmisteyhteenveto

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
RALIVIA
®
Tramadol Hydrochloride
Extended-release tablets, 100 mg, 200 mg, and 300 mg, for oral use
Opioid Analgesic
Bausch Health, Canada Inc.
Date of Initial Authorization:
2150 St-Elzear Blvd. West
August 31, 2007
Laval, Quebec
H7L 4A8
Date of Revision:
March 23, 2022
Control #: 256175
_ _
_N_
_RALIVIA_
_®_
_ Product Monograph Page 2 of 51_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing
Considerations
03/2022
7 WARNINGS AND PRECAUTIONS, Drug Abuse, Addiction,
Dependence and Misuse
03/2022
7 WARNINGS AND PRECAUTIONS, Neurologic
06/2021
7 WARNINGS AND PRECAUTIONS, Respiratory
06/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
4
1
INDICATIONS.............................................................................................................
4
1.1 Pediatrics
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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 Dose and Dosage Adjustment
.......................................................