Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
FUSIDATE SODIUM
LEO PHARMA INC
D06AX01
FUSIDIC ACID
2%
OINTMENT
FUSIDATE SODIUM 2%
TOPICAL
5G/30G
Prescription
ANTIBIOTICS
Active ingredient group (AIG) number: 0114229001; AHFS:
MARKETED
1984-12-31
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR FUCIDIN ® Fusidic acid 2% Cream Sodium fusidate 2% Ointment Antibiotic LEO Pharma Inc. Thornhill, Ontario L3T 7W8 www.leo-pharma.com/canada Date of initial approval: Aug 9, 1985 Date of Revision: July 10, 2017 Submission Control No.: 202631 ®Registered trademark of LEO Pharma A/S used under license by LEO Pharma Inc., Thornhill, ON LEO® _ _ _FUCIDIN® (fusidic acid/sodium fusidate) Product Monograph, version 1.04_ _ _ _Page 2 of 24_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ................................................................. 3 1 INDICATIONS ........................................................................................................................ 3 2 CONTRAINDICATIONS ........................................................................................................ 3 3 DOSAGE AND ADMINISTRATION ...................................................................................... 3 3.1 Administration ............................................................................................................. 3 4 OVERDOSAGE ..................................................................................................................... 4 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................. 4 6 WARNINGS AND PRECAUTIONS ....................................................................................... 5 6.1 Special Populations .................................................................................................... 5 6.1.1 Pregnant Women .................................................................................................... 5 6.1.2 Breast-feeding ......................................................................................................... 6 7 ADVERSE REACTIONS ....................................................................................................... 6 7.1 Adverse Reaction Overview .................................... Đọc toàn bộ tài liệu