GONAL-F POWDER FOR SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

FOLLITROPIN ALFA

Boleh didapati daripada:

EMD SERONO, A DIVISION OF EMD INC., CANADA

Kod ATC:

G03GA05

INN (Nama Antarabangsa):

FOLLITROPIN ALFA

Dos:

150UNIT

Borang farmaseutikal:

POWDER FOR SOLUTION

Komposisi:

FOLLITROPIN ALFA 150UNIT

Laluan pentadbiran:

INTRAMUSCULAR

Unit dalam pakej:

1ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

GONADOTROPINS AND ANTIGONADOTROPINS

Ringkasan produk:

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

Status kebenaran:

MARKETED

Tarikh kebenaran:

1997-07-25

Ciri produk

_ _
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
................................................