Država: Kanada
Jezik: engleski
Izvor: Health Canada
METRONIDAZOLE; NYSTATIN
SANOFI-AVENTIS CANADA INC
G01AA51
NYSTATIN, COMBINATIONS
500MG; 100000UNIT
OVULE
METRONIDAZOLE 500MG; NYSTATIN 100000UNIT
VAGINAL
10
Prescription
ANTIBIOTICS
Active ingredient group (AIG) number: 0202573001; AHFS:
APPROVED
2000-10-12
_FLAGYSTATIN (metronidazole and nystatin) _ _Page 1 of 29 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr FLAGYSTATIN® (500 mg metronidazole and 100,000 IU nystatin) Vaginal Ovules Trichomonacide – Moniliacide Sanofi-aventis Canada Inc. 2905 Place Louis R.-Renaud Laval, Quebec H7V 0A3 Date of Initial Authorization: December 31, 1979 Date of Revision: May 9, 2022 Submission Control Number: 259350 _ _ _FLAGYSTATIN (metronidazole and nystatin) _ _Page 2 of 29 _ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, Psychiatric 09/2021 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 .......................................................................................................... 4 1.2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION................................................................................. 4 4.1 Dosing Considerations ....................................................................................... 4 4.2 Recommended Dose and Dosage Adjustment..................................................... 5 4.5 Missed Dose ............................................................................. Pročitajte cijeli dokument