Држава: Канада
Језик: Енглески
Извор: Health Canada
FLUCONAZOLE
APOTEX INC
J02AC01
FLUCONAZOLE
50MG
TABLET
FLUCONAZOLE 50MG
ORAL
100
Prescription
AZOLES
Active ingredient group (AIG) number: 0122529001; AHFS:
APPROVED
1998-10-09
_APO-FLUCONAZOLE (Fluconazole Tablets) _ _ _ _Page 1 of 56 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr APO-FLUCONAZOLE Fluconazole Tablets Tablets, 50 mg, 100 mg and 200 mg, oral Apotex Standard Antifungal Agent APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: OCT 09, 1998 Date of Revision: AUG 22, 2023 Submission Control Number: 274760 _APO-FLUCONAZOLE (Fluconazole Tablets) _ _ _ _Page 2 of 56 _ RECENT MAJOR LABEL CHANGES 7. WARNINGS AND PRECAUTIONS 11/2022 9. DRUG INTERACTIONS 08/2023 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 4.5 Missed Dose .................................................................................................................... 8 5 Прочитајте комплетан документ