TESTOSTERONE ENANTHATE INJECTION, USP SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-03-2023
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Active ingredient:
TESTOSTERONE ENANTHATE
Available from:
HIKMA CANADA LIMITED
ATC code:
G03BA03
INN (International Name):
TESTOSTERONE
Dosage:
200MG
Pharmaceutical form:
SOLUTION
Composition:
TESTOSTERONE ENANTHATE 200MG
Administration route:
INTRAMUSCULAR
Units in package:
15G/50G
Prescription type:
Schedule G (CDSA IV)
Product summary:
Active ingredient group (AIG) number: 0106403001; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-03-17
Summary of Product characteristics
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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
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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
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