PMS-METHYLPHENIDATE ER TABLET (EXTENDED-RELEASE)

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

METHYLPHENIDATE HYDROCHLORIDE

Доступна с:

PHARMASCIENCE INC

код АТС:

N06BA04

ИНН (Международная Имя):

METHYLPHENIDATE

дозировка:

18MG

Фармацевтическая форма:

TABLET (EXTENDED-RELEASE)

состав:

METHYLPHENIDATE HYDROCHLORIDE 18MG

Администрация маршрут:

ORAL

Штук в упаковке:

100

Тип рецепта:

Schedule G (CDSA III)

Терапевтические области:

Respiratory and CNS Stimulants

Обзор продуктов:

Active ingredient group (AIG) number: 0107548004; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2019-11-29

Характеристики продукта

PRODUCT MONOGRAPH
PMS-METHYLPHENIDATE ER
Methylphenidate Hydrochloride Extended-Release Tablets, House Standard
18 mg, 27 mg, 36 mg, and 54 mg
CNS STIMULANT
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
June 20, 2019
Montréal, Canada
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO: 228697
_pms-METHYLPHENIDATE ER Product Monograph _
_Page 2 of 50 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
20
DOSAGE AND ADMINISTRATION
.....................................................................................
22
OVERDOSAGE
.......................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 25
STORAGE AND STABILITY
.................................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 29
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
.................................................................................
31
CLINICAL TRIALS
............