TESTOSTERONE ENANTHATE INJECTION, USP SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

TESTOSTERONE ENANTHATE

Disponível em:

HIKMA CANADA LIMITED

Código ATC:

G03BA03

DCI (Denominação Comum Internacional):

TESTOSTERONE

Dosagem:

200MG

Forma farmacêutica:

SOLUTION

Composição:

TESTOSTERONE ENANTHATE 200MG

Via de administração:

INTRAMUSCULAR

Unidades em pacote:

15G/50G

Tipo de prescrição:

Schedule G (CDSA IV)

Resumo do produto:

Active ingredient group (AIG) number: 0106403001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2023-03-17

Características técnicas

_Testosterone Enanthate Injection, USP _
_Page 1 of 17 _
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
_Testosterone Enanthate Injection, USP _
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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
_Testosterone Enanthate Injection, USP _
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