AURO-TRAMADOL/ACETAMINOPHEN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Предлага се от:

AURO PHARMA 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:

100

Вид предписание :

Narcotic (CDSA I)

Терапевтична област:

OPIATE AGONISTS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2015-03-27

Данни за продукта

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_AURO-TRAMADOL/ACETAMINOPHEN Product Monograph_ Page 1 of 63
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
AURO-TRAMADOL/ACETAMINOPHEN
Tramadol hydrochloride and Acetaminophen Tablets, USP
37.5 mg tramadol hydrochloride / 325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
AURO PHARMA INC.
3700 Steeles Avenue
West, Suite # 402
Woodbridge, Ontario
L4L 8K8, CANADA
Date of Revision:
July 26, 2022
Submission Control No: 265352
_ _
_AURO-TRAMADOL/ACETAMINOPHEN Product Monograph_ Page 2 of 63
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
..............................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
4
WARNINGS AND PRECAUTIONS
........................................................................................
5
ADVERSE REACTIONS
........................................................................................................
18
DRUG INTERACTIONS
........................................................................................................
22
DOSAGE AND ADMINISTRATION
....................................................................................
27
OVERDOSAGE
......................................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 31
STORAGE AND STABILITY
................................................................................................
37
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 37
PA