TARO-TESTOSTERONE GEL
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
19-10-2020
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Aktiv bestanddel:
TESTOSTERONE
Tilgængelig fra:
TARO PHARMACEUTICALS INC
ATC-kode:
G03BA03
INN (International Name):
TESTOSTERONE
Dosering:
1%
Lægemiddelform:
GEL
Sammensætning:
TESTOSTERONE 1%
Indgivelsesvej:
TRANSDERMAL
Enheder i pakken:
2.5GX30
Recept type:
Schedule G (CDSA IV)
Terapeutisk område:
ANDROGENS
Produkt oversigt:
Active ingredient group (AIG) number: 0106405004; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2017-05-05
Produktets egenskaber
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
........................................................................................
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