PMS-TESTOSTERONE CAPSULE
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
22-01-2018
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Aktiva substanser:
TESTOSTERONE UNDECANOATE
Tillgänglig från:
PHARMASCIENCE INC
ATC-kod:
G03BA03
INN (International namn):
TESTOSTERONE
Dos:
40MG
Läkemedelsform:
CAPSULE
Sammansättning:
TESTOSTERONE UNDECANOATE 40MG
Administreringssätt:
ORAL
Enheter i paketet:
30/60/100/120
Receptbelagda typ:
Schedule G (CDSA IV)
Terapiområde:
ANDROGENS
Produktsammanfattning:
Active ingredient group (AIG) number: 0120414001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2009-05-08
Produktens egenskaper
PRODUCT MONOGRAPH
C
PMS-TESTOSTERONE
(Testosterone Undecanoate)
40 mg Capsules
ANDROGEN
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
January 22, 2018
SUBMISSION CONTROL NO.: 212640
_pms-TESTOSTERONE Product Monograph Page 2 of 29_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
..................................................................................................
10
DOSAGE AND ADMINISTRATION
..............................................................................
11
OVERDOSAGE
................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 12
STORAGE AND STABILITY
.........................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 15
PART II: SCIENTIFIC INFORMATION
................................................................................
16
PHARMACEUTICAL INFORMATION
.........................................................................
16
CLINICAL TRIALS
...................................................................
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