TARO-TESTOSTERONE CAPSULE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TESTOSTERONE UNDECANOATE

זמין מ:

TARO PHARMACEUTICALS INC

קוד ATC:

G03BA03

INN (שם בינלאומי):

TESTOSTERONE

כמות:

40MG

טופס פרצבטיות:

CAPSULE

הרכב:

TESTOSTERONE UNDECANOATE 40MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

10

סוג מרשם:

Schedule G (CDSA IV)

איזור תרפויטי:

ANDROGENS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2014-02-20

מאפייני מוצר

_TARO-TESTOSTERONE (TESTOSTERONE UNDECANOATE CAPSULES)_ _40 MG_
_ _
_ _
_ _
_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_
_ _
_ _
_ _
_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...............................................