GONAL-F POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

FOLLITROPIN ALFA

Tilgjengelig fra:

EMD SERONO, A DIVISION OF EMD INC., CANADA

ATC-kode:

G03GA05

INN (International Name):

FOLLITROPIN ALFA

Dosering :

33MCG

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

FOLLITROPIN ALFA 33MCG

Administreringsrute:

INTRAMUSCULAR

Enheter i pakken:

1ML

Resept typen:

Prescription

Terapeutisk område:

GONADOTROPINS AND ANTIGONADOTROPINS

Produkt oppsummering:

Active ingredient group (AIG) number: 0145621005; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2020-02-28

Preparatomtale

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