TARO-TESTOSTERONE GEL

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

TESTOSTERONE

Pieejams no:

TARO PHARMACEUTICALS INC

ATĶ kods:

G03BA03

SNN (starptautisko nepatentēto nosaukumu):

TESTOSTERONE

Deva:

1%

Zāļu forma:

GEL

Kompozīcija:

TESTOSTERONE 1%

Ievadīšanas:

TRANSDERMAL

Vienības iepakojumā:

5GX30

Receptes veids:

Schedule G (CDSA IV)

Ārstniecības joma:

ANDROGENS

Produktu pārskats:

Active ingredient group (AIG) number: 0106405004; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2017-05-05

Produkta apraksts

Page 1 of 39
PRODUCT MONOGRAPH
TARO-TESTOSTERONE GEL
TESTOSTERONE GEL
1% W/W
ANDROGENS
FOR TOPICAL USE ONLY
Taro Pharmaceuticals Inc.
130 East Brampton,
Ontario L6T 1C1
Submission Control No: 243359 Date of Preparation: October 19, 2020
Page 2 of 39
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....................................................................................................
11
DRUG INTERACTIONS
....................................................................................................
18
DOSAGE AND ADMINISTRATION
................................................................................
19
OVERDOSAGE
..................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 21
STORAGE AND STABILITY
............................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 24
PART II: SCIENTIFIC INFORMATION
..................................................................................
26
PHARMACEUTICAL INFORMATION
............................................................................
26
CLINICAL TRIALS
........................................................................................