APO-VALPROIC ACID ORAL SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

VALPROIC ACID (SODIUM VALPROATE)

Beschikbaar vanaf:

APOTEX INC

ATC-code:

N03AG01

INN (Algemene Internationale Benaming):

VALPROIC ACID

Dosering:

250MG

farmaceutische vorm:

SOLUTION

Samenstelling:

VALPROIC ACID (SODIUM VALPROATE) 250MG

Toedieningsweg:

ORAL

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Therapeutisch gebied:

MISCELLANEOUS ANTICONVULSANTS

Product samenvatting:

Active ingredient group (AIG) number: 0112996002; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

1998-07-03

Productkenmerken

_APO-VALPROIC ACID (Valproic Acid Capsules) _
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_Page 1 of 78 _
_APO-VALPROIC ACID ORAL SOLUTION (Valproic Acid Oral Solution)_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-VALPROIC ACID
Valproic Acid Capsules
Capsules, 250 mg, Oral
USP
Pr
APO-VALPROIC ACID ORAL SOLUTION
Valproic Acid Oral Solution
Oral solution, 250 mg / 5 mL valproic acid (as sodium valproate), Oral
USP
Antiepileptic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Submission Control Number: 278761
Date of Initial Authorization:
AUG
13, 2021
Date of Revision:
OCT 05, 2023
_APO-VALPROIC ACID (Valproic Acid Capsules) _
_ _
_Page 2 of 78 _
_APO-VALPROIC ACID ORAL SOLUTION (Valproic Acid Oral Solution)_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Hepatotoxicity
10/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
04/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism:
Hyperammonemia
10/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism: Patients at
Risk of Hypocarnitinemia
10/2023
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic: Serious or
Fatal Hepatotoxicity
10/2023
7 WARNINGS AND PRECAUTIONS, Psychiatric: Behavioural Disorders
04/2023
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
04/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women, Pregnancy
Exposure Risk related to Valproate
10/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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5
1
INDICATIONS
................................................................................................................
5
1.1
Pediatric