البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
FLUCONAZOLE
TEVA CANADA LIMITED
J02AC01
FLUCONAZOLE
100MG
TABLET
FLUCONAZOLE 100MG
ORAL
50/100/500/1000
Prescription
AZOLES
Active ingredient group (AIG) number: 0122529002; AHFS:
APPROVED
2002-06-06
TEVA-FLUCONAZOLE ( Fluconazole Tablets ) Page 1 of 53 _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TEVA-FLUCONAZOLE Fluconazole Tablets Tablets, 50 mg and 100 mg, Oral Teva Standard Antifungal Agent Teva Canada Limited 30 Novopharm Court, Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Submission Control Number: 274570 Date of Initial Authorization: August 24, 2016 Date of Revision: June 20, 2023 TEVA-FLUCONAZOLE ( Fluconazole Tablets ) Page 2 of 53 _ _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS 11/2022 9 DRUG INTERACTIONS 06/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................. 4 1 INDICATIONS ................................................................................................................... 4 1.1 Pediatrics(<18 years of age) ............................................................................................ 4 1.2 Geriatrics .......................................................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................................... 5 4 DOSAGE AND ADMINISTRATION ..................................................................................... 5 4.1 Dosing Considerations ..................................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ................................................................ 5 4.4 Missed Dose ............................................................................................................ اقرأ الوثيقة كاملة