Riik: Kanada
keel: inglise
Allikas: Health Canada
FOLLITROPIN ALFA
EMD SERONO, A DIVISION OF EMD INC., CANADA
G03GA05
FOLLITROPIN ALFA
5.5MCG
POWDER FOR SOLUTION
FOLLITROPIN ALFA 5.5MCG
INTRAMUSCULAR
1ML
Prescription
GONADOTROPINS AND ANTIGONADOTROPINS
Active ingredient group (AIG) number: 0145621003; AHFS:
APPROVED
2003-09-19
_ _ 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 Lugege kogu dokumenti