Riik: Kanada
keel: inglise
Allikas: Health Canada
TOPIRAMATE
MINT PHARMACEUTICALS INC
N03AX11
TOPIRAMATE
100MG
TABLET
TOPIRAMATE 100MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0132938002; AHFS:
APPROVED
2008-08-19
_MINT-TOPIRAMATE (topiramate) _ _Page 1 of 78_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MINT-TOPIRAMATE topiramate tablets, USP tablets, 25 mg, 100 mg and 200 mg, oral Antiepileptic/Migraine Prophylaxis Mint Pharmaceuticals Inc. 6575 Davand Drive Mississauga, Ontario L5T 2M3 Date of Initial Authorization: August 19, 2008 Date of Revision: November 28, 2023 Submission Control Number: 278199 _MINT-TOPIRAMATE (topiramate) _ _Page 2 of 78_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Ophthalmologic 09/2022 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential, Teratogenic Risk 11/2023 7 WARNINGS AND PRECAUTIONS, Information for Patients, Fetal Toxicity 11/2023 7.1.1 Pregnant Women 11/2023 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 ................................................................................................................. 4 1.2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ................................................................................................... 4 4 DOSAGE AND ADMINISTRATION .................................................................................. 4 4.1 Dosing Considerations ............................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment ................................... Lugege kogu dokumenti