RIVA-TRAMADOL/ACET TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Предлага се от:

LABORATOIRE RIVA INC.

АТС код:

N02AJ13

INN (Международно Name):

TRAMADOL AND PARACETAMOL

дозиране:

325MG; 37.5MG

Лекарствена форма:

TABLET

Композиция:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Начин на приложение:

ORAL

Броя в опаковка:

30/500

Вид предписание :

Narcotic (CDSA I)

Терапевтична област:

OPIATE AGONISTS

Каталог на резюме:

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

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2015-07-22

Данни за продукта

_RIVA-TRAMADOL/ACET_
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PRODUCT MONOGRAPH
Pr
RIVA-TRAMADOL/ACET
Tramadol Hydrochloride and Acetaminophen Tablets
(37.5 mg tramadol hydrochloride/325 mg acetaminophen)
Centrally Acting Analgesic
LABORATOIRE RIVA INC.
660 Industriel blvd.
Blainville, Quebec, Canada.
J7C 3V4
www.labriva.com
Control No. 182318
Date of Revision:
March 17, 2015
_RIVA-TRAMADOL/ACET_
Page 2 of 40
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
.................................................................................................
10
DRUG ABUSE, ADDICTION AND DEPENDENCE
.................................................... 13
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 17
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
........