TARO-TESTOSTERONE GEL
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
19-10-2020
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
TESTOSTERONE
Inapatikana kutoka:
TARO PHARMACEUTICALS INC
ATC kanuni:
G03BA03
INN (Jina la Kimataifa):
TESTOSTERONE
Kipimo:
1%
Dawa fomu:
GEL
Tungo:
TESTOSTERONE 1%
Njia ya uendeshaji:
TRANSDERMAL
Vitengo katika mfuko:
5GX30
Dawa ya aina:
Schedule G (CDSA IV)
Eneo la matibabu:
ANDROGENS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0106405004; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2017-05-05
Tabia za bidhaa
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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