APO-OXCARBAZEPINE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

OXCARBAZEPINE

Tilgængelig fra:

APOTEX INC

ATC-kode:

N03AF02

INN (International Name):

OXCARBAZEPINE

Dosering:

150MG

Lægemiddelform:

TABLET

Sammensætning:

OXCARBAZEPINE 150MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS ANTICONVULSANTS

Produkt oversigt:

Active ingredient group (AIG) number: 0140461001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2015-05-01

Produktets egenskaber

_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
.................................................