SANDOZ ADAPALENE / BENZOYL PEROXIDE FORTE GEL

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

ADAPALENE; BENZOYL PEROXIDE

Доступна з:

SANDOZ CANADA INCORPORATED

Код атс:

D10AD53

ІПН (Міжнародна Ім'я):

ADAPALENE, COMBINATIONS

Дозування:

0.3%; 2.5%

Фармацевтична форма:

GEL

Склад:

ADAPALENE 0.3%; BENZOYL PEROXIDE 2.5%

Адміністрація маршрут:

TOPICAL

Одиниць в упаковці:

15G/50G

Тип рецепту:

Prescription

Терапевтична области:

KERATOLYTIC AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0252888002; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2021-06-21

Характеристики продукта

PRODUCT MONOGRAPH
PR
SANDOZ
 ADAPALENE / BENZOYL PEROXIDE
adapalene and benzoyl peroxide topical gel
0.1%/2.5% w/w
PR
SANDOZ
 ADAPALENE / BENZOYL PEROXIDE FORTE
adapalene and benzoyl peroxide topical gel
0.3%/2.5% w/w
Acne Therapy
SANDOZ CANADA INC.
110 De Lauzon Street
Boucherville, Québec
J4B1E6
Submission Control No.: 253183
Date of Revision:
June 1
7
, 2021
_Sandoz Adapalene/ Benzoyl Peroxide & _
_Sandoz Adapalene/ Benzoyl Peroxide Forte Product Monograph _
_Page 2 of 45_
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
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................18
SPECIAL HANDLING INSTRUCTIONS
.......................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
................................................................................20
PHARMACEUTICA