BIACNA TOPICAL GEL

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CLINDAMYCIN PHOSPHATE; TRETINOIN

זמין מ:

BAUSCH HEALTH, CANADA INC.

קוד ATC:

D10AF51

INN (שם בינלאומי):

CLINDAMYCIN, COMBINATIONS

כמות:

1.2%; 0.025%

טופס פרצבטיות:

GEL

הרכב:

CLINDAMYCIN PHOSPHATE 1.2%; TRETINOIN 0.025%

מסלול נתינה (של תרופות):

TOPICAL

יחידות באריזה:

2/30/60G

סוג מרשם:

Prescription

איזור תרפויטי:

KERATOLYTIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0252829001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2010-12-07

מאפייני מוצר

PRODUCT MONOGRAPH
PR
BIACNA
®
Clindamycin Phosphate and Tretinoin Gel
1.2% w/w and 0.025% w/w
ACNE THERAPY
BAUSCH HEALTH, CANADA INC.
2150 St-Elzear Blvd West
Laval, Quebec H7L 4A8
Canada
DATE OF REVISION:
October 2, 2020
Submission Control No: 238498
_BIACNA_
_®_
_ - Product Monograph _
_Page 2 of 30 _
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
...................................................................................................
7
DRUG INTERACIONS
......................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
10
OVERDOSAGE
...............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 11
STORAGE AND STABILITY
.........................................................................................
11
SPECIAL HANDLING INSTRUCTIONS
......................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 12
PART II: SCIENTIFIC INFORMATION
...............................................................................
13
PHARMACEUTICAL INFORMATION
.........................................................................
13
CLINICAL TRIALS
........................................................................