GONAL-F POWDER FOR SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

FOLLITROPIN ALFA

Fáanlegur frá:

EMD SERONO, A DIVISION OF EMD INC., CANADA

ATC númer:

G03GA05

INN (Alþjóðlegt nafn):

FOLLITROPIN ALFA

Skammtar:

5.5MCG

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

FOLLITROPIN ALFA 5.5MCG

Stjórnsýsluleið:

INTRAMUSCULAR

Einingar í pakka:

1ML

Gerð lyfseðils:

Prescription

Lækningarsvæði:

GONADOTROPINS AND ANTIGONADOTROPINS

Vörulýsing:

Active ingredient group (AIG) number: 0145621003; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2003-09-19

Vara einkenni

_ _
GONAL-f Product Monograph
Page 1 of 41
PRODUCT MONOGRAPH
Pr GONAL-F
®
Follitropin alfa for Injection
75 IU (5.5 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:
October 1, 2020
Submission Control No: 239613
®
Registered trademark of Merck KGaA, Darmstadt, Germany
_ _
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
............................................................................
8
Respiratory and Cardiovascular
..............................................................................
8
Dependence/Tolerance
............................................................................................
8
Sexual
Function/Reproduction................................................................................
8
Special Populations
.................................................................................................
9
Monitoring and Laborato