Land: Canada
Sprog: engelsk
Kilde: Health Canada
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)
MINT PHARMACEUTICALS INC
J01MA02
CIPROFLOXACIN
500MG
TABLET
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 500MG
ORAL
100
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0123207001; AHFS:
APPROVED
2014-05-15
_ MINT-CIPROFLOX _ _Page _ _1_ _ of _ _62_ _ _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr MINT-CIPROFLOX Ciprofloxacin Tablets Tablets, 500 mg and ciprofloxacin (as ciprofloxacin hydrochloride), Oral British Pharmacopoeia (BP) Antibacterial Agent Mint Pharmaceuticals Inc. 6575 Davand Drive Mississauga, ON, L5T 2M3 Date of Initial Authorization: MAY 15, 2014 Date of Revision: AUG 22, 2022 Submission Control Number: 262485 _ MINT-CIPROFLOX _ _Page _ _2_ _ of _ _62_ _ _ _ _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 08/2022 4 DOSAGE AND ADMINISTRATION, 4.5 MISSED DOSE 08/2022 7 WARNINGS AND PRECAUTIONS 09/2020 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 ............................................................................................................................... 7 1.2 Geriatrics ............................................................................................................................... 7 2. CONTRAINDICATIONS ......................................................................................................... 7 3. SERIOUS WARNINGS AND PRECAUTIONS BOX ..................................................................... 8 4. DOSAGE AND ADMINISTRATION ......................................................................................... 8 4.1 Dosing Considerations..................................................................................... Læs hele dokumentet