GONAL-F POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FOLLITROPIN ALFA

Disponibil de la:

EMD SERONO, A DIVISION OF EMD INC., CANADA

Codul ATC:

G03GA05

INN (nume internaţional):

FOLLITROPIN ALFA

Dozare:

5.5MCG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

FOLLITROPIN ALFA 5.5MCG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

1ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

GONADOTROPINS AND ANTIGONADOTROPINS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2003-09-19

Caracteristicilor produsului

_ _
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