TRAMADOL-ACET TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Предлага се от:

PRO DOC LIMITEE

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:

CANCELLED POST MARKET

Дата Оторизация:

2019-09-11

Данни за продукта

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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRAMADOL-ACET
tramadol hydrochloride and acetaminophen tablets, USP
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Centrally Acting Analgesic
PRO DOC LTÉE
Date of Revision:
2925, boul. Industriel
December 12, 2018
Laval, Quebec
H7L 3W9
SUBMISSION CONTROL NUMBER: 221949
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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
.................................................................................
17
DRUG INTERACTIONS
.................................................................................
21
DOSAGE AND ADMINISTRATION
................................................................ 25
OVERDOSAGE
.............................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................ 29
STORAGE AND STABILITY
..........................................................................
36
SPECIAL HANDLING INSTRUCTIONS
....................................................... 37
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................... 37
PART II: SCIENTIFIC INFORMATION
................................................................. 38
PHARMACEUTICAL INFORMATION
............................................................ 38
CLINICAL TRIALS
........................................................................................
39
DETAILED PHARMACOLOGY
......................................................................
43
TOXICOLOGY...............................