País: Canadà
Idioma: anglès
Font: Health Canada
TOPIRAMATE
APOTEX INC
N03AX11
TOPIRAMATE
100MG
TABLET
TOPIRAMATE 100MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0132938002; AHFS:
APPROVED
2006-04-19
_ _ _APO-TOPIRAMATE (topiramate tablets) _ _ _ _Page 1 of 88 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-TOPIRAMATE Topiramate Tablets Tablets, 25 mg, 50 mg, 100 mg and 200 mg, oral Apotex Standard Antiepileptic / Migraine Prophylaxis APOTEX INC. Date of Initial Authorization: 150 Signet Drive APR 19, 2006 Toronto, Ontario M9L 1T9 Date of Revision: NOV 17, 2023 Submission Control Number: 277804 _ _ _APO-TOPIRAMATE (topiramate tablets) _ _ _ _Page 2 of 88 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Metabolic Acidosis 04/2022 7 WARNINGS AND PRECAUTIONS, Ophthalmologic 03/2023 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 ................................................................................... 5 4.1 Dosing Considerations .................................................................................... Llegiu el document complet