DEPO-TESTOSTERONE INJ 100MG/ML SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-07-2018
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Active ingredient:
TESTOSTERONE CYPIONATE
Available from:
PFIZER CANADA ULC
ATC code:
G03BA03
INN (International Name):
TESTOSTERONE
Dosage:
100MG
Pharmaceutical form:
SOLUTION
Composition:
TESTOSTERONE CYPIONATE 100MG
Administration route:
INTRAMUSCULAR
Units in package:
10ML
Prescription type:
Schedule G (CDSA IV)
Therapeutic area:
ANDROGENS
Product summary:
Active ingredient group (AIG) number: 0106401001; AHFS:
Authorization status:
APPROVED
Authorization date:
2001-06-04
Summary of Product characteristics
_ _
_DEPO-TESTOSTERONE Product Monograph _
_ _
_Page 1 of 20_
PRODUCT MONOGRAPH
DEPO-TESTOSTERONE
testosterone cypionate injection
100 mg/mL sterile solution
USP
Androgens
Pfizer Canada Inc.
17, 300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Revision:
July 12, 2018
Submission Control No: 217239
©
Pfizer Canada Inc., 2018
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_DEPO-TESTOSTERONE Product Monograph _
_Page 2 of 20 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFO
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