Država: Kanada
Jezik: angleščina
Source: Health Canada
TESTOSTERONE
TARO PHARMACEUTICALS INC
G03BA03
TESTOSTERONE
1%
GEL
TESTOSTERONE 1%
TRANSDERMAL
2.5GX30
Schedule G (CDSA IV)
ANDROGENS
Active ingredient group (AIG) number: 0106405004; AHFS:
APPROVED
2017-05-05
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 ........................................................................................ Preberite celoten dokument