SANDOZ ADAPALENE / BENZOYL PEROXIDE GEL

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ADAPALENE; BENZOYL PEROXIDE

Доступно од:

SANDOZ CANADA INCORPORATED

АТЦ код:

D10AD53

INN (Међународно име):

ADAPALENE, COMBINATIONS

Дозирање:

0.1%; 2.5%

Фармацеутски облик:

GEL

Састав:

ADAPALENE 0.1%; BENZOYL PEROXIDE 2.5%

Пут администрације:

TOPICAL

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Терапеутска област:

KERATOLYTIC AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0252888001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2019-09-09

Карактеристике производа

_SANDOZ ADAPALENE/BENZOYL PEROXIDE Product Monograph _
_Page 1 of 41_
PRODUCT MONOGRAPH
Pr
SANDOZ ADAPALENE/BENZOYL PEROXIDE
adapalene and benzoyl peroxide topical gel, 0.1%/2.5% w/w
Acne Therapy
SANDOZ CANADA INC.
110 rue de Lauzon
Boucherville, Québec J4B1E6
Date of Preparation:
September 5, 2019
Submission Control No: 230590
_SANDOZ ADAPALENE/BENZOYL PEROXIDE Product Monograph _
_Page 2 of 41_
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
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................17
SPECIAL HANDLING INSTRUCTIONS
.......................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
................................................................................18
PHARMACEUTICAL INFORMATION
.........................................................................