MYLAN-TRAMADOL/ACET TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN

Доступна з:

MYLAN PHARMACEUTICALS ULC

Код атс:

N02AJ13

ІПН (Міжнародна Ім'я):

TRAMADOL AND PARACETAMOL

Дозування:

37.5MG; 325MG

Фармацевтична форма:

TABLET

Склад:

TRAMADOL HYDROCHLORIDE 37.5MG; ACETAMINOPHEN 325MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

30/100/500

Тип рецепту:

Narcotic (CDSA I)

Терапевтична области:

OPIATE AGONISTS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2017-05-08

Характеристики продукта

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_Page 1 of 46_
PRODUCT MONOGRAPH
Pr
MYLAN-
TRAMADOL/ACET
acetaminophen and tramadol hydrochloride tablets
37.5 mg tramadol hydrochloride/325 mg acetaminophen
MYLAN STD.
Centrally Acting Analgesic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
July 18, 2016
Submission Control No: 196618
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_Page 2 of 46_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
17
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
PART II: SCIENTIFIC INFORMATION
..............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
26
DETAILED PHARMACOLOGY
....................................................................................
30
TOXICOLOGY
...........................................................................................................