Ország: Kanada
Nyelv: angol
Forrás: Health Canada
NIFEDIPINE
AA PHARMA INC
C08CA05
NIFEDIPINE
5MG
CAPSULE
NIFEDIPINE 5MG
ORAL
100
Prescription
DIHYDROPYRIDINES
Active ingredient group (AIG) number: 0115253003; AHFS:
APPROVED
2010-06-14
_NIFEDIPINE (Nifedipine Capsules) _ _Page 1 of 36_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR NIFEDIPINE Nifedipine Capsules Capsules, 5 mg and 10 mg, Oral USP Anti-Anginal Agent AA PHARMA INC. 1165 Creditstone Road Unit # 1 Vaughan, Ontario L4K 4N7 www.aapharma.ca/en/ Date of Initial Authorization: JUN 16, 2010 Date of Revision: DEC 01, 2023 Submission Control Number: 271662 _NIFEDIPINE (Nifedipine Capsules) _ _Page 2 of 36_ RECENT MAJOR LABEL CHANGES None N/A 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 4 DOSAGE AND ADMINISTRATION ...................................................................................... 5 4.1 Dosing Considerations ............................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment ........................................................ 5 4.4 Administration ......................................................................................................... 5 4.5 Missed Dose ............................................................................... Olvassa el a teljes dokumentumot