TARO-TESTOSTERONE CYPIONATE INJECTION SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

TESTOSTERONE CYPIONATE

Dostępny od:

TARO PHARMACEUTICALS INC

Kod ATC:

G03BA03

INN (International Nazwa):

TESTOSTERONE

Dawkowanie:

100MG

Forma farmaceutyczna:

SOLUTION

Skład:

TESTOSTERONE CYPIONATE 100MG

Droga podania:

INTRAMUSCULAR

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Schedule G (CDSA IV)

Dziedzina terapeutyczna:

ANDROGENS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2020-01-29

Charakterystyka produktu

PRODUCT MONOGRAPH TARO-TESTOSTERONE CYPIONATE INJECTION
Testosterone Cypionate Injection
100 mg / mL sterile solution
Taro Standard
Androgens
Taro Pharmaceutical Inc.
130 East Drive
Brampton, ON
L6T 1C1 Canada
Date of Revision:
May 26, 2022
Submission Control No: 263625
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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 INFORMATION
.....................................................................
15
CLINICAL TRIALS
.............................................................