TESTOSTERONE ENANTHATE INJECTION, USP SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

TESTOSTERONE ENANTHATE

可用日期:

HIKMA CANADA LIMITED

ATC代码:

G03BA03

INN（国际名称）:

TESTOSTERONE

剂量:

200MG

药物剂型:

SOLUTION

组成:

TESTOSTERONE ENANTHATE 200MG

给药途径:

INTRAMUSCULAR

每包单位数:

15G/50G

处方类型:

Schedule G (CDSA IV)

產品總結:

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

授权状态:

APPROVED

授权日期:

2023-03-17

产品特点

_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