DEPO-TESTOSTERONE INJ 100MG/ML SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

TESTOSTERONE CYPIONATE

Disponibil de la:

PFIZER CANADA ULC

Codul ATC:

G03BA03

INN (nume internaţional):

TESTOSTERONE

Dozare:

100MG

Forma farmaceutică:

SOLUTION

Compoziție:

TESTOSTERONE CYPIONATE 100MG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

10ML

Tip de prescriptie medicala:

Schedule G (CDSA IV)

Zonă Terapeutică:

ANDROGENS

Rezumat produs:

Active ingredient group (AIG) number: 0106401001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2001-06-04

Caracteristicilor produsului

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_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
_ _
_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