APO-VALPROIC ACID ORAL SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

VALPROIC ACID (SODIUM VALPROATE)

Dostopno od:

APOTEX INC

Koda artikla:

N03AG01

INN (mednarodno ime):

VALPROIC ACID

Odmerek:

250MG

Farmacevtska oblika:

SOLUTION

Sestava:

VALPROIC ACID (SODIUM VALPROATE) 250MG

Pot uporabe:

ORAL

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS ANTICONVULSANTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

1998-07-03

Lastnosti izdelka

_APO-VALPROIC ACID (Valproic Acid Capsules) _
_ _
_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
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
5
1
INDICATIONS
................................................................................................................
5
1.1
Pediatric