ANDROGEL

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

TESTOSTERONE

Dostupné s:

BGP PHARMA ULC

ATC kód:

G03BA03

INN (Mezinárodní Name):

TESTOSTERONE

Dávkování:

12.5MG

Léková forma:

GEL

Složení:

TESTOSTERONE 12.5MG

Podání:

TRANSDERMAL

Jednotky v balení:

60 DOSES

Druh předpisu:

Schedule G (CDSA IV)

Terapeutické oblasti:

ANDROGENS

Přehled produktů:

Active ingredient group (AIG) number: 0106405003; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2010-12-01

Charakteristika produktu

_ _
_ANDROGEL_
_®_
_ Product Monograph _
_Page 1 of 42 _
_Date of Revision: August 27, 2015 ; Control No. 184619_
PRODUCT MONOGRAPH
ANDROGEL
®
TESTOSTERONE GEL
1%
ANDROGENS
BGP Pharma ULC
8401 Trans-Canada Highway
Saint-Laurent, Quebec
H4S 1Z1
Date of Revision: August 27, 2015
Submission Control No: 184619
®
Registered Trademark Abbott Laboratories (USA) , Licensed use by BGP
Pharma ULC, Saint-Laurent, Quebec, H4S 1Z1
_ _
_ANDROGEL_
_®_
_ Product Monograph _
_Page 2 of 42 _
_Date of Revision: August 27, 2015 ; Control No. 184619_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION........... Error! Bookmark not
defined.
SUMMARY PRODUCT INFORMATION ...................... ERROR! BOOKMARK NOT
DEFINED.
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND
PRECAUTIONS..................................................................................
4
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
..................................................................................................
18
DOSAGE AND ADMINISTRATION
..............................................................................
19
OVERDOSAGE
................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 22
STORAGE AND
STABILITY..........................................................................................
25
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 25
PART II: SCIENTIFIC INFORMATION
...............................................................................