APO-OXCARBAZEPINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

OXCARBAZEPINE

Tersedia dari:

APOTEX INC

Kode ATC:

N03AF02

INN (Nama Internasional):

OXCARBAZEPINE

Dosis:

300MG

Bentuk farmasi:

TABLET

Komposisi:

OXCARBAZEPINE 300MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS ANTICONVULSANTS

Ringkasan produk:

Active ingredient group (AIG) number: 0140461002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-05-01

Karakteristik produk

_APO-OXCARBAZEPINE (Oxcarbazepine tablets) _
_ _
_Page 1 of 70_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-OXCARBAZEPINE
Oxcarbazepine Tablets
Tablets, 150 mg, 300 mg and 600 mg, oral
Apotex Standard
Antiepileptic
ATC code: N03AF02
APOTEX INC
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
July 31, 2006
Date of Revision:
May 1, 2023
Submission Control Number: 270099
_APO-OXCARBAZEPINE (Oxcarbazepine tablets) _
_ _
_Page 2 of 70_
RECENT MAJOR LABEL CHANGES
None at the time of authorization
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
...................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................................. 4
4
DOSAGE AND ADMINISTRATION
...................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
.................................................