TARO-TESTOSTERONE GEL

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

TESTOSTERONE

Boleh didapati daripada:

TARO PHARMACEUTICALS INC

Kod ATC:

G03BA03

INN (Nama Antarabangsa):

TESTOSTERONE

Dos:

1%

Borang farmaseutikal:

GEL

Komposisi:

TESTOSTERONE 1%

Laluan pentadbiran:

TRANSDERMAL

Unit dalam pakej:

2.5GX30

Jenis preskripsi:

Schedule G (CDSA IV)

Kawasan terapeutik:

ANDROGENS

Ringkasan produk:

Active ingredient group (AIG) number: 0106405004; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2017-05-05

Ciri produk

Page 1 of 39
PRODUCT MONOGRAPH
TARO-TESTOSTERONE GEL
TESTOSTERONE GEL
1% W/W
ANDROGENS
FOR TOPICAL USE ONLY
Taro Pharmaceuticals Inc.
130 East Brampton,
Ontario L6T 1C1
Submission Control No: 243359 Date of Preparation: October 19, 2020
Page 2 of 39
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS
.....................................................................................................
4
WARNINGS AND PRECAUTIONS
....................................................................................
4
ADVERSE
REACTIONS....................................................................................................
11
DRUG INTERACTIONS
....................................................................................................
18
DOSAGE AND ADMINISTRATION
................................................................................
19
OVERDOSAGE
..................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 21
STORAGE AND STABILITY
............................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 24
PART II: SCIENTIFIC INFORMATION
..................................................................................
26
PHARMACEUTICAL INFORMATION
............................................................................
26
CLINICAL TRIALS
........................................................................................