TESTOSTERONE ENANTHATE INJECTION, USP SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TESTOSTERONE ENANTHATE

Tersedia dari:

HIKMA CANADA LIMITED

Kode ATC:

G03BA03

INN (Nama Internasional):

TESTOSTERONE

Dosis:

200MG

Bentuk farmasi:

SOLUTION

Komposisi:

TESTOSTERONE ENANTHATE 200MG

Rute administrasi :

INTRAMUSCULAR

Unit dalam paket:

15G/50G

Jenis Resep:

Schedule G (CDSA IV)

Ringkasan produk:

Active ingredient group (AIG) number: 0106403001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2023-03-17

Karakteristik produk

_Testosterone Enanthate Injection, USP _
_Page 1 of 17 _
PRESCRIBING INFORMATION
TESTOSTERONE ENANTHATE INJECTION, USP
Solution for Injection,
200 mg / mL
Androgens
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, ON
L5R 3P9, Canada
Date of Preparation:
March 17, 2023
Submission Control No: 264978
C
_Testosterone Enanthate Injection, USP _
_Page 2 of 17 _
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
DOSAGE AND ADMINISTRATION
...................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
11
STORAGE AND STABILITY
...............................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 13
PART II: SCIENTIFIC INFORMATION
..................................................................................
14
PHARMACEUTICAL
INFORMATION
................................................................................
14
CLINICAL TRIALS
.............................................................................................................
14
PART III: CONSUMER
INFORMATION................................................................................
16
_Testosterone Enanthate Injection, USP _
_Page 3