TESTOSTERONE ENANTHATE INJECTION, USP SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

TESTOSTERONE ENANTHATE

Mevcut itibaren:

HIKMA CANADA LIMITED

ATC kodu:

G03BA03

INN (International Adı):

TESTOSTERONE

Doz:

200MG

Farmasötik formu:

SOLUTION

Kompozisyon:

TESTOSTERONE ENANTHATE 200MG

Uygulama yolu:

INTRAMUSCULAR

Paketteki üniteler:

15G/50G

Reçete türü:

Schedule G (CDSA IV)

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2023-03-17

Ürün özellikleri

_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