Country: Canada
Language: English
Source: Health Canada
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)
MARCAN PHARMACEUTICALS INC
J01MA02
CIPROFLOXACIN
500MG
TABLET
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 500MG
ORAL
10/50/1000
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0123207001; AHFS:
APPROVED
2012-02-22
_MAR-CIPROFLOXACIN Page _ _1_ _ of _ _64_ _ _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr MAR-CIPROFLOXACIN Ciprofloxacin Tablets Tablets, 250 mg, 500 mg and 750mg ciprofloxacin (as ciprofloxacin hydrochloride), Oral British Pharmacopoeia (BP) Antibacterial Agent Marcan Pharmaceuticals Inc., 2 Gurdwara Road, Suite #112, Ottawa, ON, K2E 1A2 Submission Control Number: 265922 Date of Initial Authorization: FEB 22, 2021 Date of Revision: JUL 22, 2022 _MAR-CIPROFLOXACIN Page _ _2_ _ of _ _64_ _ _ _ _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 07/2022 4 DOSAGE AND ADMINISTRATION, 4.5 MISSED DOSE 07/2022 7 WARNINGS AND PRECAUTIONS 10/2020 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............................................................. Read the complete document