TARO-FUSIDIC ACID CREAM

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

FUSIDIC ACID (FUSIDIC ACID HEMIHYDRATE)

Tersedia dari:

TARO PHARMACEUTICALS INC

Kode ATC:

D06AX01

INN (Nama Internasional):

FUSIDIC ACID

Dosis:

2%

Bentuk farmasi:

CREAM

Komposisi:

FUSIDIC ACID (FUSIDIC ACID HEMIHYDRATE) 2%

Rute administrasi :

TOPICAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2022-06-17

Karakteristik produk

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 _
_24_
_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