Riik: Kanada
keel: inglise
Allikas: Health Canada
VALPROIC ACID (DIVALPROEX SODIUM)
MYLAN PHARMACEUTICALS ULC
N03AG01
VALPROIC ACID
500MG
TABLET (DELAYED-RELEASE)
VALPROIC ACID (DIVALPROEX SODIUM) 500MG
ORAL
100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0112996003; AHFS:
APPROVED
2016-11-16
_ _ _ _ _MYLAN-DIVALPROEX (divalproex sodium)_ _ _ _Page 1 of 70_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr MYLAN-DIVALPROEX divalproex sodium Delayed-Release Tablets, 125 mg, 250 mg, 500 mg valproic acid (as divalproex sodium), Oral Manufacturer’s Standard Antiepileptic Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, Ontario M8Z 2S6 Date of Initial Authorization: NOV 16, 2016 Date of Revision: MAR 14, 2024 Submission Control Number: 280863 _ _ _ _ _ _ _MYLAN-DIVALPROEX (divalproex sodium)_ _ _ _Page 2 of 70_ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 02/2023 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Hepatotoxicity 02/2023 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 06/2022 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism: Hyperammonemia 02/2023 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism: Patients at Risk of Hypocarnitinemia 02/2023 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic: Serious or Fatal Hepatotoxicity 02/2023 7 WARNINGS AND PRECAUTIONS, Psychiatric: Behavioural Disorders 10/2021 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 04/2021 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women, Pregnancy Exposure Risk related to Valproate 02/2023 _ _ 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 ....................................................................... 5 1 INDICATIONS ................................................................................................................ 5 1.1 Pediatrics ................................................................................................................. 5 1.2 Geriatrics ................... Lugege kogu dokumenti