ACTONEL TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Доступна с:

WARNER CHILCOTT CANADA CO

код АТС:

M05BA07

ИНН (Международная Имя):

RISEDRONIC ACID

дозировка:

75MG

Фармацевтическая форма:

TABLET

состав:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 75MG

Администрация маршрут:

ORAL

Штук в упаковке:

2

Тип рецепта:

Prescription

Терапевтические области:

BONE RESORPTION INHIBITORS

Обзор продуктов:

Active ingredient group (AIG) number: 0135301004; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2016-08-05

Характеристики продукта

PRODUCT MONOGRAPH
Pr
ACTONEL
®
Risedronate Sodium (as the hemi-pentahydrate) Tablets, USP
5 mg, 30 mg, 35 mg, 75 mg and 150 mg
Pr
ACTONEL DR
®
Risedronate Sodium (as the hemi-pentahydrate) Delayed-Release Tablets
35 mg
Bisphosphonates
Warner Chilcott Canada Co.
Mississauga, Ontario
L5N 6J5
Date of Revision:
February 29, 2016
Submission Control No: 188707
2
TABLE OF CONTENTS
PAGE
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.............................................................................3
INDICATIONS AND CLINICAL USE
...................................................................................3
CONTRAINDICATIONS
........................................................................................................4
WARNINGS AND PRECAUTIONS
......................................................................................4
ADVERSE REACTIONS
........................................................................................................7
DRUG INTERACTIONS
......................................................................................................14
DOSAGE AND
ADMINISTRATION...................................................................................16
OVERDOSAGE
.....................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
.................................................................19
STORAGE AND STABILITY
..............................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................26
PART II: SCIENTIFIC INFORMATION
................................................................................27
PHARMACEUTICAL INFORMATION
..............................................................................27
CLINICAL TRIALS
..................................................................