SANDOZ ADAPALENE / BENZOYL PEROXIDE GEL

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ADAPALENE; BENZOYL PEROXIDE

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

D10AD53

INN (Kansainvälinen yleisnimi):

ADAPALENE, COMBINATIONS

Annos:

0.1%; 2.5%

Lääkemuoto:

GEL

Koostumus:

ADAPALENE 0.1%; BENZOYL PEROXIDE 2.5%

Antoreitti:

TOPICAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

KERATOLYTIC AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2019-09-09

Valmisteyhteenveto

_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
.........................................................................