GONAL-F POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

FOLLITROPIN ALFA

Verfügbar ab:

EMD SERONO, A DIVISION OF EMD INC., CANADA

ATC-Code:

G03GA05

INN (Internationale Bezeichnung):

FOLLITROPIN ALFA

Dosierung:

150UNIT

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

FOLLITROPIN ALFA 150UNIT

Verabreichungsweg:

INTRAMUSCULAR

Einheiten im Paket:

1ML

Verschreibungstyp:

Prescription

Therapiebereich:

GONADOTROPINS AND ANTIGONADOTROPINS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0145621011; AHFS:

Berechtigungsstatus:

MARKETED

Berechtigungsdatum:

1997-07-25

Fachinformation

_ _
Gonal-f Product Monograph
Page 1 of 41
PRODUCT MONOGRAPH
Pr
GONAL-F
®
Follitropin alpha for Injection
37.5 IU (2.8 µg), 75 IU (5.5 µg), 150 IU (11 µg), 450 IU (33 µg)
and 1050 IU (77 µg)
Lyophilized powder for reconstitution
Pharmaceutical Standard: Professed
Therapeutic Classification: Gonadotropin
Serono Canada Inc.
2695 North Sheridan Way, Suite 200
Mississauga ON
L5K 2N6
Date of Approval:
February 22, 2007
Submission Control No: 109665
_ _
Gonal-f Product Monograph
Page 2 of 41
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 4
SUMMARY PRODUCT INFORMATION
.......................................................................
4
DESCRIPTION...................................................................................................................
4
INDICATIONS AND CLINICAL
USE.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND
PRECAUTIONS.................................................................................
5
General....................................................................................................................
5
Overstimulation of the Ovary During FSH Therapy
.............................................. 6
Carcinogenesis and Mutagenesis
............................................................................
7
Respiratory and
Cardiovascular..............................................................................
7
Dependence/Tolerance............................................................................................
8
Sexual
Function/Reproduction................................................................................
8
Special
Populations.................................................................................................
8
Monitoring and Laboratory Tests
................................................