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:

77MCG

Borang farmaseutikal:

POWDER FOR SOLUTION

Komposisi:

FOLLITROPIN ALFA 77MCG

Laluan pentadbiran:

INTRAMUSCULAR

Unit dalam pakej:

2ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

GONADOTROPINS AND ANTIGONADOTROPINS

Ringkasan produk:

Active ingredient group (AIG) number: 0145621006; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2019-04-30

Ciri produk

_ _
Gonal-f Product Monograph
Page 1 of 43
PRODUCT MONOGRAPH
Pr
GONAL-F
®
Follitropin alfa for Injection
75 IU (5.5 µg), 450 IU (33 µg) and 1050 IU (77 µg)
Lyophilized powder for reconstitution
Pharmaceutical Standard: Professed
Therapeutic Classification: Gonadotropin
EMD Serono, A Division of EMD Inc., Canada
2695 North Sheridan Way, Suite 200
Mississauga ON
L5K 2N6
Date of Initial Approval:
September 19, 2003
Date of Revision:
May 3, 2019
Submission Control No: 224799
®
Registered trademark of Merck KGaA, Darmstadt, Germany
_ _
Gonal-f Product Monograph
Page 2 of 43
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
..............................................................................
8
Dependence/Tolerance
............................................................................................
8
Sexual
Function/Reproduction................................................................................
8
Special Populations
.........................................................................................