RALIVIA TABLET (EXTENDED-RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

TRAMADOL HYDROCHLORIDE

Dostopno od:

BAUSCH HEALTH, CANADA INC.

Koda artikla:

N02AX02

INN (mednarodno ime):

TRAMADOL

Odmerek:

300MG

Farmacevtska oblika:

TABLET (EXTENDED-RELEASE)

Sestava:

TRAMADOL HYDROCHLORIDE 300MG

Pot uporabe:

ORAL

Enote v paketu:

15G/50G

Tip zastaranja:

Narcotic (CDSA I)

Terapevtsko območje:

OPIATE AGONISTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2011-02-10

Lastnosti izdelka

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
....................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
4
1
INDICATIONS.............................................................................................................
4
1.1 Pediatrics
..............................................................................................................
4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS
..............................................................................................
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
.......................................................