দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
FOLLITROPIN ALFA
EMD SERONO, A DIVISION OF EMD INC., CANADA
G03GA05
FOLLITROPIN ALFA
300UNIT
SOLUTION
FOLLITROPIN ALFA 300UNIT
SUBCUTANEOUS
0.5ML
Prescription
GONADOTROPINS AND ANTIGONADOTROPINS
Active ingredient group (AIG) number: 0145621009; AHFS:
APPROVED
2005-08-19
_ _ GONAL-f Pen ® Product Monograph_ _ _Page 1 of 43_ PRODUCT MONOGRAPH PR GONAL-F PEN Follitropin alfa Injection 300 IU/0.5 mL (22 µg/0.5 mL), 450 IU/0.75 mL (33 µg/0.75 mL) and 900 IU/1.5 mL (66 µg/1.5 mL) in prefilled pens filled by mass Pharmaceutical Standard: Professed Therapeutic Classification: Gonadotropin EMD Serono, A Division of EMD Inc., Canada 2695 North Sheridan Way, Suite 200 Mississauga ON L5K 2N6 A Business of Merck KGaA, Darmstadt, Germany Date of Initial Approval: August 19, 2005 Date of Revision: May 3, 2019 Merck KGaA, Darmstadt, Germany Submission Control No.: 224799 _ _ GONAL-f Pen ® Product Monograph_ _ _Page 2 of 43_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION .................................................................... 3 DESCRIPTION ................................................................................................................. 3 INDICATIONS AND CLINICAL USE .......................................................................... 3 CONTRAINDICATIONS ................................................................................................ 4 WARNINGS AND PRECAUTIONS .............................................................................. 4 ADVERSE REACTIONS ................................................................................................. 9 DRUG INTERACTIONS ............................................................................................... 12 DOSAGE AND ADMINISTRATION .......................................................................... 12 OVERDOSAGE .............................................................................................................. 14 ACTION AND CLINICAL PHARMACOLOGY ....................................................... 14 STORAGE AND STABILITY....................................................................................... 16 SPECIAL HANDLING INSTRUCTIONS ..... সম্পূর্ণ নথি পড়ুন