DIVALPROEX TABLET (DELAYED-RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

VALPROIC ACID (DIVALPROEX SODIUM)

Boleh didapati daripada:

APOTEX INC

Kod ATC:

N03AG01

INN (Nama Antarabangsa):

VALPROIC ACID

Dos:

250MG

Borang farmaseutikal:

TABLET (DELAYED-RELEASE)

Komposisi:

VALPROIC ACID (DIVALPROEX SODIUM) 250MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MISCELLANEOUS ANTICONVULSANTS

Ringkasan produk:

Active ingredient group (AIG) number: 0112996001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2021-05-27

Ciri produk

_DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) _
_Page 1 of 77_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DIVALPROEX
Divalproex Sodium Delayed-Release Tablets
Delayed-Release Tablets, 125 mg, 250 mg and 500 mg valproic acid (as
divalproex sodium),
Oral
Apotex Standard
Antiepileptic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
May 27, 2021
Date of Revision:
November 9, 2022
Submission Control Number: 264752
_DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) _
_Page 2 of 77_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
11/2022
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic: Serious or
Fatal Hepatotoxicity
11/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric: Behavioural Disorders
11/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
11/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women, Pregnancy
Exposure Risk related to Valproate
11/2022
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
............................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
....................................................... 6
4