TESTOSTERONE CYPIONATE INJECTION, USP LIQUID

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

TESTOSTERONE CYPIONATE

Disponible desde:

STERIMAX INC

Código ATC:

G03BA03

Designación común internacional (DCI):

TESTOSTERONE

Dosis:

100MG

formulario farmacéutico:

LIQUID

Composición:

TESTOSTERONE CYPIONATE 100MG

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

5 X 2ML

tipo de receta:

Schedule G (CDSA IV)

Área terapéutica:

ANDROGENS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2016-04-20

Ficha técnica

PRESCRIBING INFORMATION
TESTOSTERONE CYPIONATE INJECTION, USP
Testosterone Cypionate Injection USP
100 mg/mL Sterile Solution
Androgens
Cytex Pharmaceuticals Inc.
5545 Macara Street
Halifax, Nova Scotia
B3K 1W1
SUBMISSION CONTROL NUMBER:
110815
DATE OF REVISION: DECEMBER 21, 2007
_Cytex Testosterone Cypionate Injection, USP Prescribing Information
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
DRUG
INTERACTIONS.................................................................................................
9
DOSAGE AND ADMINISTRATION
...........................................................................
9
OVERDOSAGE.............................................................................................................
10
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
10
STORAGE AND
STABILITY.......................................................................................
12
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................ 12
PART II: SCIENTIFIC
INFORMATION......................................................................
13
PHARMACEUTICAL INFORMATION
......................................................................
13
CLINICAL TRIALS
......................................................................................................
13
TOXICOLOGY................................................................