TARO-FUSIDIC ACID CREAM

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

FUSIDIC ACID (FUSIDIC ACID HEMIHYDRATE)

Dostupné s:

TARO PHARMACEUTICALS INC

ATC kód:

D06AX01

INN (Mezinárodní Name):

FUSIDIC ACID

Dávkování:

2%

Léková forma:

CREAM

Složení:

FUSIDIC ACID (FUSIDIC ACID HEMIHYDRATE) 2%

Podání:

TOPICAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Přehled produktů:

Active ingredient group (AIG) number: 0114230003; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2022-06-17

Charakteristika produktu

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-FUSIDIC ACID
Fusidic acid cream
Cream, 2% w/w Fusidic acid
(as hemihydrate), Topical
Taro Standard
Antibiotic
Taro Pharmaceuticals Inc.
Date of Initial Authorization:
130 East Drive, Brampton
June 10, 2022
Ontario, L6T 1C1
Submission Control No.: 225901
_Page 2 of 24 _
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_TARO-FUSIDIC ACID Product Monograph _
TABLE OF
CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 3
1
INDICAT ION S ...............................
................................ ................................
......................... 3
2
CONTRAINDICAT IONS
............................... ................................
................................ ......... 3
3
DOSAGE AND ADMINISTRATION
............................... ................................
....................... 3
3.1
Administration
...........................................................................................................
3
4
OVERDOSAGE
..................................................................................................................... 4
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .
............................ 4
6
WARNINGS AND PRECAUTIONS
............................... . ............................... .
....................... 4
6.1
Special Populations
......... . . .. . . . .. . . . .. . . .. . . . .. . . . .. . . .. . .
. .. . . .. . . . .. . . .. . . . .. . . . .. . . .. . . . .. . . .. .
. . .. . . . .. . . .. . .
5
6.1.1
Pregnant Women
....... . .. . . . .. . . .. . . . .. . . .. . . . .. . . . .. . . .
.. . . .. . . . .. . . .. . . . .. . . . .. . . .. . . . .. . . .. . .
. .. . . .. . . . .. . . . ..
5
6.1.2
Breast-feeding
.......... . . .. . . . .. . . .. . . . .. . . . .. . . .. . . . .. .
. .. . . . .. . . . .. . . .. . . . .. . . . .. . . .. . . . .. . . ..
. . . .. . . . .. . . .. . . . .. .
5