TARO-TESTOSTERONE CAPSULE

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

TESTOSTERONE UNDECANOATE

Tilgængelig fra:

TARO PHARMACEUTICALS INC

ATC-kode:

G03BA03

INN (International Name):

TESTOSTERONE

Dosering:

40MG

Lægemiddelform:

CAPSULE

Sammensætning:

TESTOSTERONE UNDECANOATE 40MG

Indgivelsesvej:

ORAL

Enheder i pakken:

10

Recept type:

Schedule G (CDSA IV)

Terapeutisk område:

ANDROGENS

Produkt oversigt:

Active ingredient group (AIG) number: 0120414001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2014-02-20

Produktets egenskaber

_TARO-TESTOSTERONE (TESTOSTERONE UNDECANOATE CAPSULES)_ _40 MG_
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_Page 1 of 28_
PRODUCT MONOGRAPH
TARO-TESTOSTERONE
TESTOSTERONE UNDECANOATE CAPSULES
40 MG
ANDROGEN
TARO PHARMACEUTICALS INC.
DATE OF PREPARATION
:
130 East Drive, Brampton
October 25, 2018
Ontario L6T 1C1
CONTROL NO: 220849
_TARO-TESTOSTERONE (TESTOSTERONE UNDECANOATE CAPSULES)_ _40 MG_
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_Page 2 of 28_
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.................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND
ADMINISTRATION............................................................................
11
OVERDOSAGE..........................................................................
.................................
12
ACTION AND CLINICAL
PHARMACOLOGY............................................................
12
STORAGE AND
STABILITY..........................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
......................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................
14
PART II: SCIENTIFIC INFORMATION
...................................................................
15
PHARMACEUTICAL
INFORMATION.........................................................................
15
CLINICAL
TRIALS...............................................