APO-DIVALPROEX TABLET (DELAYED-RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

VALPROIC ACID (DIVALPROEX SODIUM)

Disponibil de la:

APOTEX INC

Codul ATC:

N03AG01

INN (nume internaţional):

VALPROIC ACID

Dozare:

125MG

Forma farmaceutică:

TABLET (DELAYED-RELEASE)

Compoziție:

VALPROIC ACID (DIVALPROEX SODIUM) 125MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

MISCELLANEOUS ANTICONVULSANTS

Rezumat produs:

Active ingredient group (AIG) number: 0112996004; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2021-12-21

Caracteristicilor produsului

_APO-DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) _
_ Page 1 of 79 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-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
Submission
Control Number:
280469
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAR 23, 1999
Date of Revision:
NOV
17, 2023
_APO-DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) _
_ Page 2 of 79 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
11/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Hepatotoxicity
11/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
02/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism:
Hyperammonemia
11/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism: Patients
at Risk of Hypocarnitinemia
11/2023
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic: Serious
or Fatal Hepatotoxicity
11/2023
7 WARNINGS AND PRECAUTIONS, Psychiatric: Behavioural Disorders
02/2023
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
02/2023
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
.............................................................. 4
1
INDICATIONS
...........................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
..................................